Convenient single-dose MR contrast agent package and accurate delivery system

Abstract

A fluid infusion system configured to perform an infusion procedure in connection with a diagnostic imaging procedure includes an administration line having a cartridge that defines an internal chamber. The cartridge includes an inlet port that communicates with the internal chamber, an outlet port that communicates with the internal chamber, a medical fluid contained within the internal chamber, and a plunger that is movable within the internal chamber. The administration line further includes an inlet tube that communicates with the inlet port and is configured to connect to a fluid infusion device, and an outlet tube that communicates with the outlet port. The fluid infusion system may also include a controller configured to operate the fluid infusion device.

Description

Technical Field

[0001] Background Art[[ID=…]] Field of the Disclosure This disclosure relates to fluid injector systems, and more particularly to single-dose administration lines for fluid injector systems.

Background Art

[0002] In many medical diagnostic and therapeutic procedures, a practitioner such as a physician injects one or more medical fluids into a patient. In recent years, many medical fluid delivery systems for the pressurized injection of fluids such as contrast solutions (often simply referred to as "contrast agents"), flushing agents (such as saline), and other medical fluids have been developed for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other molecular imaging procedures.

[0003] A problem often associated with existing systems for performing fluid injection is the accuracy of fluid delivery. Due to the high pressures required to inject contrast agents, mechanical slack and volumes within the components of the system can result in clinically significant over-delivery and / or under-delivery of fluid. Furthermore, with the advancement of treatments, the amount of contrast agent required to perform a particular procedure has been decreasing. While seemingly positive from a treatment perspective, existing devices may lack the accuracy required to reliably deliver low volumes of contrast agent. For example, existing systems often have syringe volumes of 100 mL or more, while some procedures require the injection of as little as 5 mL of contrast agent.

[0004] Furthermore, contrast agents are conventionally supplied to medical facilities in bulk containers that do not necessarily correlate with the dosage requirements of individual patients. The storage of contrast agents can present challenges that can lead to significant waste of unused dosages and associated costs. Therefore, medical facilities must carefully manage the amount and type of contrast agent kept on hand, which of course limits the options for immediately available contrast agents.

[0005] Finally, maintaining hygienic practices is always a concern in all infusion procedures, and this is often overlooked by physicians who attempt off-label use of components or reuse of components intended for single use. [Overview of the project] [Problems that the invention aims to solve]

[0006] Considering the above, there is a need for patient lines and fluid delivery systems that ensure adherence to recommended replacement schedules for patient lines. Furthermore, there is a need for systems containing contrast agents in individually packaged doses that can be easily stored for extended periods before use. Against this backdrop, aspects or examples of the present disclosure relate to fluid injector systems configured to perform injection procedures in connection with diagnostic imaging procedures. [Means for solving the problem]

[0007] In some embodiments, a dosing line for use with a fluid injector system is presented. The fluid injector system includes a drive mechanism for pressurizing a diluent contained in a fluid container, and a controller operably associated with the drive mechanism. The controller includes a programming system for enabling the programming of an infusion protocol having at least one step, according to at least one step, which controls the flow of the diluent to the dosing line by the drive mechanism. The dosing line comprises a cartridge. The cartridge comprises an inlet port defining an internal chamber and communicating fluidly with the internal chamber, an outlet port communicating fluidly with the internal chamber, a medical fluid contained within the internal chamber, and a plunger movable within the internal chamber. The dosing line also comprises an inlet tube configured to communicate fluidly with the inlet port of the cartridge and connect to a fluid container, an outlet tube communicating fluidly with the outlet port of the cartridge, and a bypass tube connecting the inlet tube and the outlet tube in parallel with the cartridge. The bypass tube includes a crack pressure valve, which is configured to prevent diluent from flowing from a fluid container through the inlet tube to a second section of the bypass tube when a first pressure proximal to the crack pressure valve is below a predetermined threshold pressure. When the drive mechanism is in operation, diluent flows from the fluid container through the inlet tube and the inlet port to construct a first pressure proximal to the plunger in the cartridge and proximal to the crack pressure valve, so that (i) as long as the first pressure is below a predetermined threshold pressure, the crack pressure valve prevents the diluent from flowing through the crack pressure valve, thereby preventing the diluent from entering the outlet tube of the administration line, and (ii) as long as the first pressure is above a second pressure distal to the plunger in the cartridge, the medical fluid flows from the outlet port of the cartridge into the outlet tube of the administration line.

[0008] In some embodiments, the fluid container includes a syringe.

[0009] In some embodiments, the administration line further includes a valve having a first position in which the bypass tube is in fluid communication with the outlet tube, and a second position in which the bypass tube is isolated from the outlet tube.

[0010] In some embodiments, the medical fluid includes a contrast agent.

[0011] In some embodiments, the administration line further includes a stopper to restrict the movement of the plunger within the internal chamber of the cartridge.

[0012] In some embodiments, the stopper includes a rod that extends into an internal chamber and engages with the plunger to restrict the movement of the plunger.

[0013] In some embodiments, the depth of the rod within the internal chamber is adjustable.

[0014] The fluid infusion system includes a dosing line comprising a cartridge, the cartridge comprising an inlet port communicating with the internal chamber and fluid, an outlet port communicating with the internal chamber and fluid, a medical fluid contained within the internal chamber, and a plunger movable within the internal chamber. The dosing line further includes an inlet tube communicating with the inlet port and configured to connect to a fluid infusion device, and an outlet tube communicating with the outlet port and fluid. The fluid infusion system further includes a controller configured to operate the fluid infusion device.

[0015] In some embodiments, the administration line further includes a bypass tube that connects the inlet tube and outlet tube in parallel with the cartridge.

[0016] In some embodiments, the administration line further includes a valve having a first position in which the bypass tube is in fluid communication with the outlet tube, and a second position in which the bypass tube is isolated from the outlet tube.

[0017] In some embodiments, at least one of the inlet port and the outlet port is irremovably connected to the cartridge.

[0018] In some embodiments, the fluid injector system further includes a housing having a syringe interface for receiving a syringe barrel.

[0019] In some embodiments, the fluid injector system further includes a housing having a cartridge clamp for holding a cartridge.

[0020] In some embodiments, the controller is configured to communicate with the cartridge clamp to determine the volume of the cartridge.

[0021] In some embodiments, the fluid injector system further includes a pressure sensor that communicates with a controller. The controller is configured to determine the fluid pressure in the bypass tube via the pressure sensor.

[0022] In some embodiments, the fluid injector system further includes a housing having a valve interface for receiving a valve for the administration line.

[0023] In some embodiments, the controller is configured to move the valve between a first position and a second position via a valve interface.

[0024] In some embodiments, the medical fluid contains a contrast agent, and the controller is configured to inject saline solution from a fluid injector.

[0025] In some embodiments, the bypass tube includes a crack pressure valve, which is configured to prevent fluid flow from a first section of the bypass tube to a second section of the bypass tube when the fluid pressure proximal to the crack pressure valve falls below a predetermined threshold pressure.

[0026] In some embodiments, the fluid pressure required to displace the plunger of the cartridge is less than a predetermined threshold pressure.

[0027] In some embodiments, the fluid injector system further includes a stopper for restricting movement of the plunger within the internal chamber of the cartridge.

[0028] In some embodiments, the stopper includes a rod that extends into the internal chamber and is configured to engage the plunger to restrict movement of the plunger.

[0029] In some embodiments, the depth of the rod within the internal chamber is adjustable.

[0030] Other embodiments of the present disclosure relate to an administration line for use with a fluid injector system. The administration line includes a cartridge that defines an internal chamber and includes an inlet port in fluid communication with the internal chamber, an outlet port in fluid communication with the internal chamber, a medical fluid contained within the internal chamber, and a plunger movable within the internal chamber. The administration line further includes an inlet tube configured to be in fluid communication with the inlet port and to connect to a fluid injector, and an outlet tube in fluid communication with the outlet port.

[0031] In some embodiments, the administration line further includes a bypass tube that connects the inlet tube and the outlet tube in parallel with the cartridge.

[0032] In some embodiments, the administration line further includes a valve having a first position in which the bypass tube is in fluid communication with the outlet tube and a second position in which the bypass tube is isolated from the outlet tube.

[0033] In some embodiments, at least one of the inlet port and the outlet port is non-removably connected to the cartridge.

[0034] In some embodiments, the plunger is located in a proximal position within the internal chamber.

[0035] In some embodiments, the plunger is configured to move distally within the inner chamber in response to the pressure difference between the inlet port and the inner chamber.

[0036] In some embodiments, the medical fluid includes a contrast agent.

[0037] In some embodiments, the bypass tube includes a crack pressure valve, which is configured to prevent fluid flow from a first section of the bypass tube to a second section of the bypass tube when the fluid pressure proximal to the crack pressure valve falls below a predetermined threshold pressure.

[0038] In some embodiments, the fluid pressure required to displace the cartridge plunger is below a predetermined threshold pressure.

[0039] In some embodiments, the administration line further includes a stopper to restrict the movement of the plunger within the internal chamber of the cartridge.

[0040] In some embodiments, the stopper includes a rod that extends into an internal chamber and is configured to engage with the plunger to restrict the movement of the plunger.

[0041] In some embodiments, the depth of the rod within the internal chamber is adjustable.

[0042] Other embodiments of the present disclosure relate to a dosing line for use with a fluid injector system. The dosing line includes an inlet tube having a proximal end configured to connect to a fluid injector and a distal end configured to connect to a pre-filled cartridge containing a medical fluid; an outlet tube having a proximal end configured to connect to a pre-filled cartridge; a bypass tube that is in fluid communication with the inlet tube and the outlet tube; and a valve having a first position in which the bypass tube is in fluid communication with the outlet tube and a second position in which the bypass tube is isolated from the outlet tube.

[0043] In some embodiments, at least one of the inlet port and the outlet port is configured to be irremovably connected to the pre-filled cartridge.

[0044] In some embodiments, the bypass tube includes a crack pressure valve, which is configured to prevent fluid flow from a first section of the bypass tube to a second section of the bypass tube when the fluid pressure proximal to the crack pressure valve falls below a predetermined threshold pressure.

[0045] The operating methods and functions of the dosing lines, fluid injector systems, and combinations of related structural elements and components, as well as their other features and characteristics and manufacturing economics, will become more apparent with reference to the accompanying drawings and in consideration of the following description and the accompanying claims, all of which form part of this specification. However, it should be clearly understood that the drawings are for illustrative and illustrative purposes only. [Brief explanation of the drawing]

[0046] [Figure 1] This is a schematic diagram of a fluid injector system relating to one aspect or example of the present disclosure. [Figure 2] Figure 1 is a perspective view of the cartridge of the fluid injector system. [Figure 3] Figure 2 is a side view of the cartridge. [Figure 4]Figure 1 is a top view of the administration line of a fluid injector system relating to one aspect or example of this disclosure. [Figure 5] Figure 1 is a top view of the administration line of a fluid injector system relating to one aspect or example of this disclosure. [Figure 6] This is a schematic diagram of the administration line shown in Figure 4 or Figure 5, with the control valve in the first position. [Figure 7] This is a schematic diagram of the administration line shown in Figure 4 or Figure 5, with the control valve in the second position. [Figure 8] Figure 1 is a perspective view of the cartridge and housing of the fluid injector system. [Figure 9] This is a perspective view of a fluid injector system relating to one aspect or example of the present disclosure. [Figure 10] Figure 9 is an exploded perspective view of the fluid injector system. [Figure 11] Figure 9 is an exploded perspective view of the check valve of the fluid injector system. [Figure 12] Figure 11 is a front view of the check valve. [Figure 13] This is a cross-sectional view of the check valve along line AA in Figure 12. [Figure 14] Figure 9 is a front view of the cartridge of the fluid injector system. [Figure 15] Figure 14 shows a cross-sectional view of the cartridge along the BB line. [Figure 16] This is a perspective view of a fluid injector system relating to one aspect or example of the present disclosure. [Figure 17] Figure 16 is an exploded perspective view of the fluid injector system. [Figure 18] Figure 16 is an exploded perspective view of the cartridge of the fluid injector system. [Figure 19] Figure 18 is a front view of the cartridge. [Figure 20] This is a cross-sectional view of the cartridge along the CC line in Figure 19. [Figure 21] This is a schematic communication diagram of a fluid injector system relating to one aspect or example of the present disclosure. [Figure 22]This is a schematic diagram of the administration line shown in Figure 1, connected to a single-head fluid injection system. [Figure 23] Figure 9 is a perspective view of the administration line connected to a single-head fluid injection system. [Figure 24] Figure 16 is a perspective view of the administration line connected to a single-head fluid infusion system. [Modes for carrying out the invention]

[0047] For the purposes of the following explanation, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “upper end,” “lower end,” “horizontal,” and “vertical,” and their derivatives, shall be used in relation to their disclosure when they are oriented in a drawing.

[0048] Spatial or directional terms such as “left,” “right,” “inner,” “outer,” “above,” and “below” should not be considered limiting, as this disclosure can take on various alternative orientations.

[0049] All figures used in the specification and claims should be understood to be modified in all cases by the term “approximately.” The terms “approximately,” “about,” and “substantially” mean a range of ±10% of the stated value.

[0050] Where 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 of A, B, and C. Similarly, where 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.

[0051] It should be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely illustrative examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0052] 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 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 toward the injector of the fluid infusion system. For example, if a first component is referred to as “upstream” of a second component, the first component is located closer to the injector than the second component. 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 toward the patient. For example, if a first component is referred to as “downstream” of a second component, the first component is located closer to the patient than the second component.

[0053] As similar reference numerals point to similar parts in several drawings, this disclosure generally relates to fluid injector systems, dosing lines, and methods of operation thereof.

[0054] Referring first to Figures 1 to 3, an example of a fluid injector system 1000 according to the present disclosure includes a housing 100 and a fluid injector such as a syringe 120. The syringe 120 may be pre-filled with a medical fluid such as saline or another diluent. The housing 100 may include a syringe interface 102 for receiving and holding the barrel 122 of the syringe 120. The housing 100 may further include an actuator 104 for pushing down the rod and / or plunger of the rod-plunger assembly 124 of the syringe 120 to inject fluid from the syringe 120. The actuator 104 may be any number of devices such as a piston, lead screw, ball screw, etc., and may be embodied, for example, as part of an MR-compatible syringe pump. The actuator 104 may also be embodied in the head of a single-head fluid injection system, such as the MEDRAD® Envision CT Injection System, or even in one of the heads of a dual-head fluid injection system, such as the MEDRAD® MRXperion MR Injection System, MEDRAD® Stellant FLEX CT Injection System, or MEDRAD® Stellant CT Injection System, provided by Bayer HealthCare LLC. The actuator 104 may be actuated by the controller 900 of the housing 100, along with various other components of the fluid injector system 1000 described herein, to inject fluid from the syringe 120 at a predetermined rate. The controller 900, which may also be embodied in the aforementioned syringe pump or the aforementioned single-head or dual-head fluid injection system, may include at least one processor configured to execute instructions stored in a computer-readable medium. The controller 900 may be configured to perform one or more injection procedures on the fluid injector system 1000 according to one or more injection protocols stored in the controller 900's memory or accessible by the controller 900.

[0055] The fluid injector system 1000 may further include an administration line 200 that provides a fluid pathway between the syringe 120 and the patient. The administration line 200 may include a cartridge 300 that contains a predetermined amount of medical fluid F, such as a contrast agent, or may be configured to receive a cartridge 300. As shown in Figures 2 and 3, the cartridge 300 includes a barrel 302 that defines an internal chamber 304. An inlet port 306 is in fluid communication with the internal chamber 304 at the proximal end of the cartridge 300, and an outlet port 308 is in fluid communication with the internal chamber 304 at the distal end of the cartridge 300. A plunger 310 is longitudinally slidable within the internal chamber 304 between the inlet port 306 and the outlet port 308. The cartridge 300 may be pre-filled with the plunger 310 in its most proximal position toward the inlet port 306, such that the medical fluid F is located between the outlet port 308 and the plunger 310. When the fluid pressure at the inlet port 306 exceeds the fluid pressure at the outlet port 308, the plunger 310 moves distally toward the outlet port 308, pushing the medical fluid F out of the cartridge 300. Continuing to refer to Figure 3, the cartridge 300 may include a removable cap (not shown) that seals the inlet port 306 and the outlet port 308 for storage.

[0056] The internal chamber 304 of the cartridge 300 may have a predetermined volume corresponding to the amount of medical fluid F required for a particular infusion procedure. Therefore, as described in detail herein, the appropriate amount of medical fluid F is delivered to the patient, provided the cartridge 300 is emptied and the administration line 200 is flushed to inject any remaining fluid. Thus, the cartridge 300 enhances the accuracy of the infusion procedure by eliminating the risk of over-delivery of medical fluid F to the patient. Furthermore, the accuracy of the infusion procedure is not compromised by volume or mechanical slack within the fluid infusion system 1000, as the entire amount of medical fluid F in the cartridge 300 is easily delivered to the patient simply by flushing the administration line after the cartridge 300 is emptied. Examples of the volume of the internal chamber 304 include, but are not limited to, 5 mL, 10 mL, 15 mL, 20 mL, and 30 mL. The cartridge 300 may be sealed or protected from environmental contamination and degradation in the medical facility where the infusion procedure is performed, so that the cartridge 300 has a considerable shelf life, such as three years.

[0057] Referring here to Figure 4, in the use of the fluid injector system 1000, the caps (not shown) covering ports 306 and 308 of the cartridge 300 are removed, and the inlet port 306 and outlet port 308 of the cartridge 300 are connected to the administration line 200. The administration line 200 may include an inlet tube 202 having a proximal connector 204 configured to connect to the outlet port 126 of the syringe 120. The distal connector 206 of the inlet tube 202 is configured to connect to the inlet port 306 of the cartridge 300. The administration line 200 may further include an outlet tube 210 having a proximal connector 212 configured to connect to the outlet port 308 of the cartridge 300. The distal end (not shown) of the outlet tube 210 is configured to include or connect to a catheter inserted into the patient.

[0058] The inlet port 306 and outlet port 308 of cartridge 300 can form non-removable tamper-proof connections with the inlet tube 202 and outlet tube 210 of the administration line 200, respectively. That is, when the inlet port 306 of cartridge 300 is connected to the distal connector 206 of the inlet tube 202, cartridge 300 cannot be removed from the inlet tube 202 without damaging the inlet port 306 and / or the distal connector 206. Similarly, when the outlet port 308 of cartridge 300 is connected to the proximal connector 212 of the outlet tube 210, cartridge 300 cannot be removed from the outlet tube 210 without damaging the outlet port 308 and / or the proximal connector 212. The non-removable feature of the inlet port 306 and outlet port 308 of cartridge 300 prevents the reuse of the administration line 200 and / or cartridge 300, and therefore ensures that the user follows a protocol for replacing the administration line 200 after each use.

[0059] Continuing to refer to Figure 4, the administration line 200 may include a bypass tube 220 in parallel with the cartridge 300. In particular, the inlet tube 202 may branch at a multi-directional fitting 208 (e.g., a T-shaped or Y-shaped fitting) upstream of the distal connector 206. The first outlet of the multi-directional fitting 208 may be in fluid communication with the distal connector 206 of the inlet tube 202, and the second outlet of the multi-directional fitting 208 may be in fluid communication with the bypass tube 220. Similarly, the outlet tube 210 may include a directional control valve 214, such as a stopcock, downstream of the proximal connector 212. The first inlet of the control valve 214 may be in fluid communication with the proximal connector 212 of the outlet tube 210, and the second inlet of the control valve 214 may be in fluid communication with the bypass tube 220. Figure 5 shows an alternative embodiment of the administration line in which the distal connector 206 of the inlet tube 202 is integrated with a multi-directional fitting 208, and the proximal connector 212 of the outlet tube 210 is integrated with a control valve 214.

[0060] Referring here to Figures 4-7, the control valve 214 may be movable between at least two positions to control the flow of fluid to the outlet tube 210. In the first position shown in Figure 6, the fluid path 216 of the control valve 214 is directed to provide fluid communication between the bypass tube 220 and the outlet tube 210, while isolating the cartridge 300 from the outlet tube 210. Thus, the fluid injected from the syringe 120 into the inlet tube 202 flows into the bypass tube 220 and then into the outlet tube 210. Because the control valve 214 prevents fluid from flowing out of the outlet port 308, the medical fluid F in the cartridge 300 is isolated from the rest of the administration line 200. Therefore, the fluid pressure acting on the upstream or proximal surface of the plunger 310 cannot displace the plunger 310 to inject the medical fluid F.

[0061] In the second position shown in Figure 7, the fluid path 216 of the control valve 214 is directed to provide fluid communication between the cartridge 300 and the outlet tube 210, while isolating the bypass tube 220 from the outlet tube 210. Therefore, the fluid injected from the syringe 120 into the inlet tube 202 cannot flow into the outlet tube 210 through the bypass tube 220. Instead, the fluid injected from the syringe 120 pressurizes the inlet tube 202 until the fluid pressure at the inlet port 306 of the cartridge 300 exceeds the fluid pressure in the internal chamber 304 of the cartridge 300. The pressure difference between the inlet port 306 and the internal chamber 304 causes the plunger 310 to move distally within the internal chamber 304, injecting the medical fluid F from the cartridge 300 into the outlet tube 210.

[0062] To move the control valve 214 from a first position and a second position, the control valve 214 may be operated manually by the user or electronically by a controller 900 of the fluid injector system 1000. The housing 100 may include a valve interface 150 that receives and acts on the control valve 214, as best shown in Figure 1. During the infusion procedure, the control valve 214 may initially be set to a first position to allow fluid to flow from the syringe 120 to the outlet tube 210 via the bypass tube 220. With the control valve 214 in the first position, the syringe 120 may be operated to inject saline solution and purge and / or prime the administration line 200. By purging and / or priming the administration line 200, air is removed from the administration line 200 before connecting the administration line to the patient.

[0063] After the administration line 200 has been purged and / or primed, the administration line 200 can be connected to the patient, the control valve 214 can be moved to a second position, and the syringe 120 can be further actuated to pressurize the inlet tube 202. The fluid pressure in the inlet tube 202 moves the plunger 310 of the cartridge 300 distally within the internal chamber 304, pushing the medical fluid F out of the cartridge 300 into the outlet tube 210. As shown in Figure 7, the bolus of medical fluid F advances distally within the outlet tube 210 until the plunger 310 reaches the distal end of the internal chamber 304 of the cartridge 300. Due to the volume of the outlet tube 210, at least a portion of the bolus of medical fluid F remains in the outlet tube 210 after the medical fluid F has been discharged from the cartridge 300. To complete the infusion of medical fluid F into the patient, the control valve 214 can be returned to the first position, the syringe 120 can be further activated to inject additional saline solution, and the medical fluid F can be flushed out of the outlet tube 210.

[0064] Referring again to Figure 4, the administration line 200 may further include a pressure sensor 222 provided on the bypass tube 220 to detect the fluid pressure in the bypass tube 220. The pressure sensor 222 may be operable to communicate with the controller 900 and may be used to detect blockages, such as twisting of the administration line 200 or blockages caused by the patient bending their arm while the administration line 200 is being inserted. The controller 900 may display the fluid pressure detected by the pressure sensor 222 on the user interface 160 of the housing 100 (see Figure 1) or on a remote user interface (e.g., a control room unit) that communicates with the fluid injector system 1000. In some embodiments or examples, the controller 900 may display the fluid pressure numerically on the user interface 160. Alternatively, the controller 900 may display the fluid pressure as an approximation such as "LOW", "MEDIUM", or "HIGH". If the controller 900 detects an obstruction, or if the controller 900 determines that the fluid pressure is outside a predetermined range, the controller 900 may stop the injection procedure.

[0065] Referring again to Figure 1, and further to Figure 8, the housing 100 may further include a cartridge clamp 170 for receiving a cartridge 300. The cartridge clamp 170 may communicate with a controller 900 so that the controller 900 can determine the size of the cartridge 300. In particular, the controller 900 may determine the size of the cartridge 300 based on the position of the cartridge clamp 170 engaging with the cartridge 300. For example, the cartridge clamp 170 may consist of one or more clips that can be opened and closed to engage with the cartridge 300. The controller 900 may determine the relative position of the clips when engaged with the cartridge 300 and, based on that position, determine the diameter D of the cartridge 300. In addition to, or instead of, the clips, the cartridge clamp 170 may include one or more V-blocks, band clamps, or other mechanical devices for securing the cartridge 300 to the housing 100. In some embodiments or examples, cartridges 300 of all volumes may have a common length such that the volume of the cartridge 300 can be determined from the diameter D of the cartridge 300, since the length is known.

[0066] In some embodiments or examples, once the controller 900 determines the volume of the cartridge 300 using the cartridge clamp 170, the controller 900 verifies that the correct-sized cartridge 300 is fitted for the desired injection procedure. If the controller 900 determines that the wrong-sized cartridge 300 is fitted, the controller 900 may prohibit the execution of the injection procedure. In some embodiments or examples, the controller 900 may generate parameters for injection based on the volume of the cartridge 300. In particular, the controller 900 may determine the amount of fluid that needs to be injected from the syringe 120 to empty the cartridge 300.

[0067] Referring here to Figures 9 to 15, one aspect or example of the fluid injector system 1000 is shown. This aspect or example of the fluid injector system 1000 is similar to that of Figures 1 to 8, and components not specifically described herein with respect to Figures 9 to 15 may be the same as or similar to the components of the aspect or example of Figures 1 to 8 having similar reference numerals. The fluid injector system 1000 includes a syringe 120 or other suitable fluid injector fluid-connected to the inlet of a proximal multidirectional fitting 208. One outlet of the multidirectional fitting 208 is fluid-connected to a first section 220a of a bypass tube 220, for example, via an adapter 224. The second outlet of the multidirectional fitting 208 is fluid-connected to the inlet port 306 of a cartridge 300. Similarly, distal multidirectional fittings 230 (e.g., T-shaped or Y-shaped fittings) are fluid-connected to the outlet port 308 of the cartridge 300, the second section 220b of the bypass tube 220 (e.g., via adapter 226), and the outlet tube 210 (e.g., via adapter 232). As in the embodiments or examples shown in Figures 1 to 8, this configuration forms parallel fluid paths through the bypass tube 220 and the cartridge 300. As in the embodiments or examples shown in Figures 1 to 8, the bypass tube 220, the outlet tube 210, fittings 208, 230, adapters 224, 226, 232, and (in some examples) the cartridge 300 may be supplied as tamper-proof subassemblies, referred to herein as dosing lines 200, to prevent reuse of the components.

[0068] The first section 220a and the second section 220b of the bypass tube 220 are selectively fluid-connected via a crack pressure valve 400. The fluid flow path from the syringe 120 is determined by the crack pressure valve 400, which is configured to always close below a predetermined threshold pressure. That is, if the fluid pressure on the proximal side of the crack pressure valve 400 falls below the predetermined threshold pressure, the fluid cannot flow through the crack pressure valve 400. With the plunger 310 of the cartridge 300 in its most proximal position (as shown in Figure 3), the injection of fluid from the syringe 120 increases the fluid pressure on the proximal side of the plunger 310, moving the plunger 310 distally. The plunger 310 and the crack pressure valve 400 are selected such that the fluid pressure required to displace the plunger 310 distally is below the predetermined threshold pressure. When the plunger 310 reaches the distal end of the internal chamber 304 of the cartridge 300 and can no longer move, the fluid pressure in the proximal side of the plunger 310 and in the first section 220a of the bypass tube 220 increases until the fluid pressure exceeds a predetermined threshold pressure of the crack pressure valve 400. At this point, the crack pressure valve 400 opens, and the fluid subsequently injected from the syringe 120 flows through the first section 220a of the bypass tube 220, the crack pressure valve 400, and the second section 220b of the bypass tube. Thus, continuous injection of fluid from the syringe 120 can be performed to bypass the cartridge 300 and flush the medical fluid F from the distal multi-directional fitting 230 and the outlet tube 210.

[0069] Referring here to Figures 11-13, the crack pressure valve 400 includes a housing 402 and a valve body 410. The housing 402 may include a socket 404 configured to receive a cradle 412 of the valve body 410. The annular lip 414 of the valve body 410 seals against the socket 404 and can be fixed to the socket 404 via adhesive, ultrasonic welding, a press fit, or the like. A deformable shuttle 420 is placed within the cradle 412 and is longitudinally constrained by an end stopper 416. The shuttle 420 engages with the inlet orifice 430 of the valve body 410 to seal the inlet orifice 430 and selectively prevents fluid flow through the shuttle 420. A predetermined pressure threshold of the crack pressure valve 400 is a function of the compressibility of the shuttle 420. In particular, a predetermined pressure threshold is the fluid pressure at the inlet orifice 430, which is the pressure required to compress the shuttle 420 distally, thereby allowing the fluid from the inlet orifice 430 to flow into the cradle 412. The cradle 412 may include one or more channels 418 that allow the fluid to flow around the compressed shuttle 420, pass through the end stopper 416, and exit the housing 402.

[0070] Referring here to Figures 14 and 15, the barrel 302 of the cartridge 300 may form an open proximal end into which the plunger 310 is inserted during assembly. An end cap 324, including an inlet port 306, may be fixed to the open proximal end of the barrel 302 to seal the internal chamber 304 after the plunger 310 has been installed. The barrel 302 may have a flared proximal end 322 configured to receive the end cap 324. The inner side wall 326 of the end cap 324 may have the same inner diameter as the barrel 302 so that the plunger 310 slides smoothly across the transition between the end cap 324 and the barrel 302. In other embodiments or examples, the end cap 324 may be fitted onto the barrel 302, i.e., the barrel 302 may be received within the end cap 324. The end cap 324 and the barrel 302 may be joined by adhesive, welding, interference fit, etc.

[0071] Referring here to Figures 16-20, one embodiment or example of a fluid injector system 1000 including an adjustable stopper 500 within a cartridge 300 is shown. The fluid injector system 1000 of this embodiment or example is otherwise similar to that of Figures 9-15. Components not specifically described herein with respect to Figures 16-20 may be the same as or similar to the components of the embodiment or example of Figures 9-15 having similar reference numerals. The adjustable stopper 500 controls the amount of medical fluid F delivered to the patient by restricting the distal movement of the plunger 310. The adjustable stopper 500 may be used, for example, when the infusion procedure requires a dose of medical fluid F less than the total amount of medical fluid F in the cartridge. The adjustable stopper 500 may include a rod 502 extending into the internal chamber 304 of the cartridge 300 through a rod port 330 at the distal end of the barrel 302. As shown in Figure 20, the plunger 310 engages with the rod 502 before contacting the distal end of the internal chamber 304. In this way, the medical fluid F on the distal side of the plunger 310 is not delivered to the patient. Once the plunger 310 engages with the rod 502, the continued operation of the syringe 120 increases the fluid pressure on the proximal side of the plunger 310 until the crack pressure valve 400 opens.

[0072] As shown in Figures 18 and 20, an O-ring 508 or similar sealing component may be placed inside the rod port 330 around the rod 502 to prevent leakage of medical fluid F from the rod port 330. A lock nut 506 secures the O-ring 508 in place. The rod 502 may be screwed into complementary threads in the rod port 330 to allow adjustment of the depth of the rod 502 within the internal chamber 304. The distal end of the rod 502 may include a knob 504 to facilitate adjustment of the rod 502. The knob 504 may also function as a stopper that limits the maximum insertion depth of the rod 502 into the internal chamber 304 through engagement between the knob 504 and the rod port 330. In some embodiments or examples, the rod 502 may be configured for manual adjustment. In some embodiments or examples, the knob 504 may be automatically adjusted by an actuator 550 associated with a controller 900 (see Figure 21). For example, the controller 900 may be configured to set the depth of the rod 502 in the internal chamber 304 so as to deliver a predetermined dose of medical fluid F from the cartridge 300.

[0073] The embodiments or examples shown in Figures 9 to 20 may include a housing 100 for holding components of the fluid injector system 1000 in a manner similar to that shown in Figures 1 and 8. The fluid injector system 1000 of Figures 9 to 20 may also include an automatic actuator 104 for pushing down the rod and / or plunger of the rod-plunger assembly 124 of the syringe 120, in a manner similar to that shown in Figure 1.

[0074] In contrast to the embodiments or examples described in relation to Figures 1 to 8, the embodiments or examples in Figures 9 to 20 do not rely on an actively controlled valve (i.e., the directional control valve 214 shown in Figures 4 to 7) to control whether the fluid injected from the syringe 120 flows into the cartridge 300 or through the bypass tube 220. Instead, the crack pressure valve 400 in the embodiments or examples of Figures 9 to 20 passively controls the fluid flow path as described above by remaining closed until the fluid pressure proximal to the plunger 310 exceeds a predetermined pressure threshold of the crack pressure valve 400. However, in some embodiments or examples, the fluid injector system 1000 may include both the directional control valve 214 and the crack pressure valve 400 to allow for additional control of the fluid flow.

[0075] Referring here to Figure 21, a schematic diagram of the communication of the fluid injector system 1000 is shown. The housing 100 may be located in the patient's room, and the controller 900 communicates with a user interface device 800, such as a remote computer, laptop, or smartphone. The controller 900 may include at least one processor and may communicate with the user input device 800 via a wired or wireless network such as Ethernet®, WiFi®, or Bluetooth®, and receive commands from the user input device. Therefore, the user (e.g., a physician) does not need to be in the patient's room while the infusion procedure is being performed.

[0076] Similar to the controller 900, the user input device 800 may include at least one processor configured to execute instructions stored in a computer-readable medium. The input device 800 may be configured to send instructions to the controller 900 to start, pause, stop, or otherwise adjust the injection procedure. The input device 800 may be further configured to receive notifications and / or warnings from the controller 900, such as pressure readings from the pressure sensor 222.

[0077] It is evident that each of the administration lines disclosed herein may be implemented, at least in part, as a disposable, manually operated fluid injector system. For example, in an unrestricted embodiment of the fluid injector system 1000 shown in Figures 1 to 8, the actuator 104 of the saline syringe 120 may take the form of a flange. Once a suitable cartridge 300 (i.e., a cartridge of a predetermined volume) is selected and placed in the housing 100, and the syringe 120 is pre-filled or primed with medical fluid F (e.g., saline), such a flange can be manually pressed to advance the rod and plunger at the end of the rod-plunger assembly 124 distally into the barrel 122, thereby discharging the medical fluid F (saline) from the syringe 120. Driven by saline solution received from syringe 120, the fluid injector system 1000 shown in Figures 1-8 delivers either contrast agent from cartridge 300 or saline solution from bypass tube 220 to outlet tube 210, provided that the position selected for control valve 214 and the fluid pressure on the proximal surface of plunger 310 allow it as described above. Similarly, in non-limiting embodiments of the fluid injector system 1000 shown in Figures 9-15, the actuator 104 of saline syringe 120 can also take the form of a flange. Once a suitable cartridge 300 is selected and placed in the administration line 200 between fixtures 208 and 230, and the syringe 120 is pre-filled or primed with medical fluid F, such a flange can be manually pushed to advance the rod and its plunger of assembly 124 distally into the barrel of syringe 120, thereby discharging the medical fluid F (saline solution) from syringe 120. Driven by saline solution received from syringe 120, the fluid injector system 1000 shown in Figures 9-15 delivers either contrast agent from cartridge 300 or saline solution from bypass tube 220 into outlet tube 210, in accordance with the pressure generated throughout the crack pressure valve 400 in bypass tube 220, as disclosed above.The fluid injector system 1000 shown in Figures 16 to 20, which is substantially identical to the fluid injector system 1000 shown in Figures 9 to 15 except for the adjustable stopper 500, may also be implemented as a disposable manual operation system.

[0078] It should also be apparent that each of the dosing lines disclosed herein may be implemented as a separate, disposable unit for use with an automated fluid injector system. In one non-limiting embodiment, the dosing line 1000 of Figure 1 can be used as a disposable unit for and in connection with the single-head fluid injector system shown in Figure 22. In another non-limiting embodiment, the dosing line 1000 of Figure 9 can be used as a disposable unit for and in connection with the single-head fluid injector system shown in Figure 23. Similarly, in yet another non-limiting embodiment, the dosing line 1000 of Figure 16 can be used as a disposable unit for and in connection with the single-head fluid injector system shown in Figure 24.

[0079] In particular, in the non-limiting embodiment shown in Figure 23, the administration line 1000 is shown in relation to a single-head fluid injector system. An example of such a single-head fluid injector system may be the MEDRAD® Envision CT infusion system, but it may also be implemented with one of the heads of a dual-head fluid infusion system, such as the MEDRAD® MRXperion MR infusion system, the MEDRAD® Stellant FLEX CT infusion system, or the MEDRAD® Stellant CT infusion system, all provided by Bayer HealthCare LLC. The fluid injector system has a drive mechanism 130 for use in pressurizing a diluent contained in a fluid container (e.g., syringe 120), and a controller 900 operably associated with the drive mechanism 130. The controller 900 includes a programming system for enabling the programming of an infusion protocol having at least one step, according to at least one step, in which the drive mechanism 130 controls the flow of the diluent to the administration line 1000. Essentially identical to those shown in Figures 9 to 15, the administration line 1000 comprises a cartridge 300. The cartridge 300 comprises an inlet port 306 that defines an internal chamber 304 and is in fluid communication with the internal chamber 304, an outlet port 308 that is in fluid communication with the internal chamber 304, a medical fluid F (e.g., contrast agent) contained within the internal chamber 304, and a plunger 310 that is movable within the internal chamber 304. The administration line 1000 also comprises an inlet tube configured to be in fluid communication with the inlet port 306 of the cartridge 300 and connected to a fluid container 120, an outlet tube 210 that is in fluid communication with the outlet port 308 of the cartridge 300, and a bypass tube 220 that connects the inlet tube and the outlet tube 210 in parallel with the cartridge 300.The bypass tube 220 includes a crack pressure valve 400, which is configured to prevent the diluent from flowing from the fluid container 120 through the inlet tube to the second section 220b of the bypass tube when the first pressure at the base end of the crack pressure valve 400 falls below a predetermined threshold pressure. When the drive mechanism 130 is in operation, the diluent flows from the fluid container 120 through the inlet tube and inlet port 306 to construct a first pressure relative to the proximal side of the plunger 310 in the cartridge 300 and the proximal side of the crack pressure valve 400, so that (i) as long as the first pressure is below a predetermined threshold pressure, the crack pressure valve 400 prevents the diluent from flowing through the crack pressure valve 400, thereby preventing the diluent from entering the outlet tube 210 of the administration line 1000, and (ii) as long as the first pressure is above a second pressure relative to the distal side of the plunger 310 in the cartridge 300, the medical fluid flows from the outlet port 308 of the cartridge into the outlet tube 210 of the administration line 1000.

[0080] In another non-limiting embodiment shown in Figure 24, the dosing line 1000 is also shown in relation to a single-head fluid injector system. The dosing line 1000 in this embodiment or example is similar to that shown in Figures 9-15 and 23, and components not specifically described herein with respect to Figure 24 and related Figures 16-20 may be the same as or similar to the components of the embodiments or examples in Figures 9-15 and 23. Figure 24 also shows an adjustable stopper 500 and related components, similar to those in Figures 16-20, all of which have been described in detail above and apply similarly to those in Figure 24.

[0081] Examples of fluid injector systems, dosing lines, and methods of operation thereof have been provided in the foregoing description, and those skilled in the art can modify and change these examples without departing from the scope and spirit of the present disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The foregoing disclosure is defined by the attached claims, and all changes to the disclosures that fall within the meaning and scope equivalent to the claims should be encompassed within those scopes. [Explanation of symbols]

[0082] 100 Housing 102 Syringe Interface 104 Actuator 120 syringes, fluid containers 122 barrels 124 Plunger Assembly 126 Exit Port 130 Drive mechanism 150 Valve Interface 160 User Interfaces 170 Cartridge Clamp 200 administration lines 202 Inlet tube 204 Proximal Connector 206 Distal Connector 208 Multi-directional mounting fixture 210 Outlet tube 212 Proximal Connector 214 Control valve 216 Fluid paths 220 Bypass Tube Section 220a Section 220b 222 Pressure Sensor 224 adapter 226 Adapter 230 Distal multi-directional mounting device 232 Adapter 300 cartridges 302 barrels 304 Internal Chamber 306 Entrance Port 308 Exit Port 310 Plunger 322 Proximal end 324 End Cap 326 Internal side wall 330 Rod Port 400 Crack Pressure Valve 402 Housing 404 socket 410 Valve body 412 Cradle 414 Ring Lip 416 End Stopper 418 channels 420 Shuttle 430 Entrance Orifice 500 Stopper 502 Rod 504 Knob 506 Lock Nut 508 O-ring 550 Actuators 800 Input devices, user interface devices 900 Controller 1000 Fluid Injector System, Dosage Line

Claims

1. In a dosing line for use with a fluid injector system, the fluid injector system comprises a drive mechanism for pressurizing a diluent contained in a fluid container, and a controller operably associated with the drive mechanism, the controller including a programming system for enabling the programming of an injection protocol having at least one step, the drive mechanism controlling the inflow of the diluent into the dosing line according to the at least one step, and the dosing line To define the internal chamber, The inlet port that communicates with the internal chamber, The outlet port is in fluid communication with the internal chamber, The medical fluid contained within the internal chamber, A plunger that is movable within the internal chamber, A cartridge equipped with, An inlet tube configured to communicate with the inlet port of the cartridge and to connect to the fluid container, An outlet tube that communicates fluid with the outlet port of the cartridge, A bypass tube connecting the inlet tube and the outlet tube in parallel with the cartridge, comprising a crack pressure valve, wherein the crack pressure valve is configured to prevent the diluent from flowing from the fluid container through the inlet tube to the second section of the bypass tube when the first pressure on the proximal side of the crack pressure valve is below a predetermined threshold pressure, Equipped with, An administration line in which the diluent flows from the fluid container through the inlet tube and the inlet port to construct a first pressure relative to the proximal side of the plunger in the cartridge and the proximal side of the crack pressure valve, so that (i) the crack pressure valve prevents the diluent from flowing through the crack pressure valve as long as the first pressure is below the predetermined threshold pressure, thereby preventing the diluent from entering the outlet tube of the administration line, and (ii) the medical fluid flows from the outlet port of the cartridge into the outlet tube of the administration line as long as the first pressure is above a second pressure relative to the distal side of the plunger in the cartridge.

2. The administration line according to claim 1, wherein the fluid container includes a syringe.

3. The administration line according to claim 1, further comprising a valve having a first position in which the bypass tube is in fluid communication with the outlet tube, and a second position in which the bypass tube is isolated from the outlet tube.

4. The administration line according to claim 1, wherein the medical fluid contains a contrast agent.

5. The administration line according to claim 1, further comprising a stopper for restricting the movement of the plunger within the internal chamber of the cartridge.

6. The fluid injector system according to claim 5, wherein the stopper comprises a rod that extends into the internal chamber and engages with the plunger to restrict the movement of the plunger.

7. The administration line according to claim 6, wherein the depth of the rod in the internal chamber is adjustable.

8. In a fluid injector system configured to perform an injection procedure in connection with a diagnostic imaging procedure, The administration line, To define the internal chamber, The inlet port that communicates with the internal chamber, The outlet port is in fluid communication with the internal chamber, The medical fluid contained within the internal chamber, A plunger that is movable within the internal chamber, A cartridge equipped with, An inlet tube is configured to communicate with the inlet port and to be connected to a fluid injector, An outlet tube that communicates with the aforementioned outlet port, An administration line equipped with, A controller configured to operate the fluid injector, A fluid injector system equipped with the following features.

9. The fluid injector system according to claim 8, wherein the administration line further comprises a bypass tube connecting the inlet tube and the outlet tube in parallel with the cartridge.

10. The fluid injector system according to claim 9, wherein the administration line further comprises a valve having a first position in which the bypass tube is in fluid communication with the outlet tube and a second position in which the bypass tube is isolated from the outlet tube.

11. The fluid injector system according to claim 8, wherein at least one of the inlet port and the outlet port is irremovably connected to the cartridge.

12. The fluid injector system according to claim 8, further comprising a housing having a syringe interface for receiving a syringe barrel.

13. The fluid injector system according to claim 8, further comprising a housing having a cartridge clamp for holding the cartridge.

14. The fluid injector system according to claim 13, wherein the controller is configured to communicate with the cartridge clamp and to determine the volume of the cartridge.

15. The fluid injector system according to claim 9, further comprising a pressure sensor that communicates with the controller, wherein the controller is configured to determine the fluid pressure in the bypass tube via the pressure sensor.

16. The fluid injector system according to claim 10, further comprising a housing having a valve interface for receiving the valve of the administration line.

17. The fluid injector system according to claim 9, wherein the controller is configured to move the valve between a first position and a second position via the valve interface.

18. The medical fluid includes a contrast agent, The fluid injector system according to claim 8, wherein the controller is configured to inject physiological saline solution from the fluid injector.

19. The fluid injector system according to claim 9, wherein the bypass tube is equipped with a crack pressure valve, and the crack pressure valve is configured to prevent the flow of fluid from a first section of the bypass tube to a second section of the bypass tube when the fluid pressure on the proximal side of the crack pressure valve falls below a predetermined threshold pressure.

20. The fluid injector system according to claim 9, wherein the fluid pressure required to displace the plunger of the cartridge is less than the predetermined threshold pressure.

21. The fluid injector system according to claim 8, further comprising a stopper for restricting the movement of the plunger within the internal chamber of the cartridge.

22. The fluid injector system according to claim 21, wherein the stopper comprises a rod that extends into the internal chamber and is configured to engage with the plunger to restrict the movement of the plunger.

23. The fluid injector system according to claim 22, wherein the depth of the rod in the internal chamber is adjustable.

24. A dosing line for use with a fluid injector system, To define the internal chamber, The inlet port that communicates with the internal chamber, The outlet port is in fluid communication with the internal chamber, The medical fluid contained within the internal chamber, A plunger that is movable within the internal chamber, A cartridge equipped with, An inlet tube configured to communicate with the inlet port and connect to a syringe, wherein the syringe is able to deliver the diluent contained within the syringe to the inlet port of the cartridge when pressurized; An outlet tube that communicates with the aforementioned outlet port, An administration line equipped with this.

25. The administration line according to claim 24, further comprising a bypass tube connecting the inlet tube and the outlet tube in parallel with the cartridge.

26. The administration line according to claim 24, further comprising a valve having a first position in which the bypass tube is in fluid communication with the outlet tube, and a second position in which the bypass tube is isolated from the outlet tube.

27. The administration line according to claim 24, wherein at least one of the inlet port and the outlet port is irremovably connected to the cartridge.

28. The administration line according to claim 24, wherein the plunger is provided at a proximal position within the internal chamber.

29. The administration line according to claim 24, wherein the plunger is configured to move distally within the internal chamber in response to a pressure difference between the inlet port and the internal chamber.

30. The administration line according to claim 24, wherein the medical fluid contains a contrast agent.

31. The administration line according to claim 25, wherein the bypass tube is equipped with a crack pressure valve, and the crack pressure valve is configured to prevent the flow of fluid from a first section of the bypass tube to a second section of the bypass tube when the fluid pressure on the proximal side of the crack pressure valve falls below a predetermined threshold pressure.

32. The administration line according to claim 31, wherein the fluid pressure required to displace the plunger of the cartridge is less than the predetermined threshold pressure.

33. The administration line according to claim 24, further comprising a stopper for restricting the movement of the plunger within the internal chamber of the cartridge.

34. The administration line according to claim 33, wherein the stopper comprises a rod that extends into the internal chamber and is configured to engage with the plunger to restrict the movement of the plunger.

35. The administration line according to claim 34, wherein the depth of the rod in the internal chamber is adjustable.

36. A dosing line for use with a fluid injector system, An inlet tube having a proximal end configured to connect to a fluid injector and a distal end configured to connect to a pre-filled cartridge containing medical fluid, An outlet tube having a proximal end configured to connect to the pre-filled cartridge, A bypass tube that is in fluid communication with the inlet tube and the outlet tube, A valve having a first position in which the bypass tube is in fluid communication with the outlet tube, and a second position in which the bypass tube is isolated from the outlet tube, An administration line equipped with this.

37. The administration line according to claim 36, wherein at least one of the inlet port and the outlet port is configured to be irremovably connected to the pre-filled cartridge.

38. The administration line according to claim 36, wherein the bypass tube is equipped with a crack pressure valve, and the crack pressure valve is configured to prevent the flow of fluid from the first section of the bypass tube to the second section of the bypass tube when the fluid pressure on the proximal side of the crack pressure valve falls below a predetermined threshold pressure.

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