Convenient single dose mr contrast agent package and accurate delivery system

Abstract

A fluid injector system configured to perform an injection procedure in connection with a diagnostic imaging procedure includes an administration line having a cartridge defining an internal chamber. The cartridge 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 in fluid communication with the inlet port and configured for connection to a fluid injector and an outlet tube in fluid communication with the outlet port. The fluid injector system may also include a controller configured to actuate the fluid injector.

Description

CONVENIENT SINGLE DOSE MR CONTRAST AGENT PACKAGE AND ACCURATE DELIVERY SYSTEMBACKGROUNDField of Disclosure

[0001] The present disclosure relates to fluid injector systems, and more particularly to a single dose administration line for a fluid injector system.Description of Related Art

[0002] In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, injects a patient with one or more medical fluids. In recent years, a number of medical fluid delivery systems for pressurized injection of fluids, such as a contrast solution (often referred to simply as “contrast”), a flushing agent (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 injections is accuracy of fluid delivery. Due to the high pressure necessary to inject contrast, mechanical slack and capacitance within components of the systems can result in clinically significant over-delivery and / or under-delivery of fluid. Moreover, advancements in treatment have reduced the volume of contrast needed to perform certain procedures. While ostensibly positive from a treatment perspective, existing devices may lack the precision necessary to reliably deliver low contrast volumes. For example, existing systems often have syringe capacities of 100 mL or more, while some procedures require injection of as low as 5 mL of contrast.

[0004] Additionally, contrast is conventionally supplied to healthcare facilitates in containers of nominal quantity not necessarily correlated with individual patient dosage requirements. Storage of contrast can present challenges that may lead to significant waste of unused dosages and the associated expense. As such, healthcare facilities must be judicious in the quantity and types of contrast kept on hand, which naturally leads to a limited selection of readily available contrast.

[0005] Finally, maintaining hygienic practices is always of concern with any injection procedure, which is often overlooked by practitioners attempting off label use of components or re-use of components intended only for a single use.SUMMARY OF THE DISCLOSURE

[0006] In view of the foregoing, there exists a need for patient lines and fluid delivery systems that enforce the recommended replacement schedule of the patient lines. Additionally, there exists a need for systems including individualized dosages of contrast that can be stored easily and for extended periods of time prior to use. Against this background, aspects or examples of the present disclosure are directed to a fluid injector system configured to perform an injection procedure in connection with a diagnostic imaging procedure.

[0007] In some embodiments, an administration line is presented for use with a fluid injector system. The fluid injection system has a drive mechanism for use in pressurizing a diluent contained within a fluid container and a controller operably associated with the drive mechanism. The controller includes a programming system to allow programming of an injection protocol having at least one phase according to which the drive mechanism controls the flow of the diluent into the administration line. The administration line comprises a cartridge. The cartridge defines an internal chamber and comprises 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 also comprises: an inlet tube in fluid communication with the inlet port of the cartridge and configured for connection to the fluid container; an outlet tube in fluid communication 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 configured to prevent the diluent from the fluid container via the inlet tube from flowing from a first section of the bypass tube to a second section of the bypass tube when a first pressure at a proximal side of the crack pressure valve is below a predetermined threshold pressure. Upon operation of the drive mechanism, the diluent flows from the fluid container through the inlet tube and the inlet port to build the first pressure against a proximal side of the plunger within the cartridge and against the proximal side of the crack pressure valve such that as long as the first pressure (i) is below the predetermined threshold pressure the crack pressure valve prevents the diluent from flowing therethrough thereby preventing the diluent from entering the outlet tube of the administration line; and (ii) exceeds a second pressure against a distal side of the plunger within the cartridge the medical fluid will flow from the outlet port thereof 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 comprises contrast.

[0011] In some embodiments, the administration line further includes a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

[0012] In some embodiments, the stop comprises a rod extending into the internal chamber and configured to engage the plunger to limit the travel thereof.

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

[0014] The fluid injector system includes an administration line including a cartridge defining an internal chamber and including 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 in fluid communication with the inlet port and configured for connection to a fluid injector, and an outlet tube in fluid communication with the outlet port. The fluid inj ector system further includes a controller configured to actuate the fluid injector.

[0015] In some embodiments, the administration line further includes a bypass tube connecting the inlet tube and the 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 are non- releasably connected to the cartridge.

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

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

[0020] In some embodiments, the controller is in communication with the cartridge clamp and is configured to determine a volume of the cartridge.

[0021] In some embodiments, the fluid injector system further includes a pressure sensor in communication with the controller. The controller is configured to determine a 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 the valve of the administration line.

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

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

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

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

[0027] In some embodiments, the fluid injector system further includes a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

[0028] In some embodiments, the stop includes a rod extending into the internal chamber and configured to engage the plunger to limit the travel of the plunger.

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

[0030] Other embodiments of the present disclosure are directed to an administration line for use with a fluid injector system. The administration line includes a cartridge defining an internal chamber and including 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 in fluid communication with the inlet port and configured for connection 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 connecting 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 are non- releasably connected to the cartridge.

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

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

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

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

[0038] In some embodiments, a fluid pressure necessary to displace the plunger of the cartridge is less than the predetermined threshold pressure.

[0039] In some embodiments, the administration line further includes a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

[0040] In some embodiments, the stop includes a rod extending into the internal chamber and configured to engage the plunger to limit the travel of the plunger.

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

[0042] Other embodiments of the present disclosure are directed to an administration line for use with a fluid injector system. The administration line includes an inlet tube having a proximal end configured for connection to a fluid injector and a distal end configured for connection to a prefilled cartridge containing a medical fluid, an outlet tube having a proximal end configured for connection to the prefilled cartridge, a bypass tube 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 are configured for non-releasable connection to the prefilled cartridge.

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

[0045] These and other features and characteristics of administration lines, fluid injector systems, and methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only.BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG. 1 is a schematic view of a fluid injector system in accordance with an aspect or example of the present disclosure;

[0047] FIG. 2 is a perspective view of a cartridge of the fluid injector system of FIG. 1;

[0048] FIG. 3 is a side view of the cartridge of FIG. 2;

[0049] FIG. 4 is a top view of an administration line of the fluid injector system of FIG. 1 in accordance with an aspect or example of the present disclosure;

[0050] FIG. 5 is a top view of an administration line of the fluid injector system of FIG. 1 in accordance with an aspect or example of the present disclosure;

[0051] FIG. 6 is a schematic view of the administration line of FIG. 4 or 5, with a control valve in a first position;

[0052] FIG. 7 is a schematic view of the administration line of FIG. 4 or 5, with a control valve in a second position;

[0053] FIG. 8 is a perspective view of the cartridge and housing of the fluid injector system of FIG. 1;

[0054] FIG. 9 is a perspective view of a fluid injector system in accordance with an aspect or example of the present disclosure;

[0055] FIG. 10 is an exploded perspective view of the fluid injector system of FIG. 9;

[0056] FIG. 11 is an exploded perspective view of a check valve of the fluid injector system of FIG. 9;

[0057] FIG. 12 is a front view of the check valve of FIG. 11;

[0058] FIG. 13 is a cross-sectional view of the check valve taken along line A-A of FIG.12;

[0059] FIG. 14 is a front view of a cartridge of the fluid injector system of FIG. 9;

[0060] FIG. 15 is a cross-sectional view of the cartridge taken along line B-B of FIG. 14;

[0061] FIG. 16 is a perspective view of a fluid injector system in accordance with an aspect or example of the present disclosure;

[0062] FIG. 17 is an exploded perspective view of the fluid injector system of FIG. 16;

[0063] FIG. 18 is an exploded perspective view of the cartridge of the fluid injector system of FIG. 16;

[0064] FIG. 19 is a front view of the cartridge of FIG. 18;

[0065] FIG. 20 is a cross-sectional view of the cartridge taken along line C-C of FIG. 19; and

[0066] FIG. 21 is a communication schematic of the fluid injector system in accordance with an aspect or example of the present disclosure.

[0067] FIG. 22 is a schematic view of the administration line of FIG. 1 connected to a single-head fluid injection system.

[0068] FIG. 23 is a perspective view of the administration line of FIG. 9 connected to a single-head fluid injection system.

[0069] FIG. 24 is a perspective view of the administration line of FIG. 16 connected to a single-head fluid injection system.DETAILED DESCRIPTION

[0070] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures.

[0071] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the disclosure can assume various alternative orientations.

[0072] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value.

[0073] As used herein, the term “at least one of’ is synonymous with “one or more of’. For example, the phrase “at least one of A, B, and C” means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term “at least two of’ is synonymous with “two or more of’. For example, the phrase “at least two of D, E, and F” means any combination of any two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.

[0074] It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary examples of the disclosure. Hence, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.

[0075] When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “distal” refers to a portion of said component nearest to a patient When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “proximal” refers to a portion of said component nearest to the inj ector of the fluid inj ector system (i . e. the portion of said component farthest from the patient) When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “upstream” refers to a direction away from the patient and towards the injector of the fluid injector system. For example, if a first component is referred to as being “upstream” of a second component, the first component is located nearer to the injector than the second component is to the injector. When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “downstream” refers to a direction towards the patient and away from the injector of the fluid injector system. For example, if a first component is referred to as being “downstream” of a second component, the first component is located nearer to the patient than the second component is to the patient.

[0076] Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, the present disclosure is generally directed to fluid injector systems, administration lines, and methods of operation thereof.

[0077] Referring first to FIGS. 1 to 3, an example of a fluid injector system 1000 in accordance with the present disclosure includes a housing 100 and a fluid injector, such as a syringe 120. The syringe 120 may be prefilled with a medical fluid, such as saline or another diluent. The housing 100 may include a syringe interface 102 for receiving and holding a barrel 122 of the syringe 120. The housing 100 may further include an actuator 104 for depressing a rod and / or plunger of a rod and 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, for example, be embodied as part of an MR compatible syringe pump. Actuator 104 may also be embodied within the head of a single-head fluid injection system such as the MEDRAD® Envision CT Injection System or even one of the heads of a dual -head fluid injection system such as the MEDRAD® MRXperion MR Injection System, the MEDRAD® Stellant FLEX CT Injection System, or the MEDRAD® Stellant CT Injection System offered by Bayer Healthcare LLC. The actuator 104, along with various other components of the fluid injection system 1000 described herein, may be actuated by a controller 900 of the housing 100 to inject fluid from the syringe 120 at a predetermined rate. The controller 900, which may also be embodied within the aforementioned syringe pump or theaforementioned single-head or dual-head fluid injection systems, may include at least one processor configured to execute instructions stored on a computer readable media. The controller 900 may be configured to perform one or more injection procedures of the fluid injector system 1000 according to one or more injection protocols stored in a memory of or accessible by the controller 900.

[0078] The fluid injector system 1000 may further include an administration line 200 providing a fluid path between the syringe 120 and a patient. The administration line 200 may include, or may be configured to receive, a cartridge 300 containing a predetermined volume of medical fluid F, such as contrast. As shown in FIGS. 2-3, the cartridge 300 includes a barrel 302 defining an internal chamber 304. An inlet port 306 is in fluid communication with the internal chamber 304 at a 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 slidable within the internal chamber 304 in a longitudinal direction between the inlet port 306 and the outlet port 308. The cartridge 300 may be prefilled with the plunger 310 in a proximal-most position toward the inlet port 306, such that the medical fluid F is between the outlet port 308 and the plunger 310. If fluid pressure at the inlet port 306 exceeds fluid pressure at the outlet port 308, the plunger 310 moves distally toward the outlet port 308 forcing the medical fluid F out of the cartridge 300. With continued reference to FIG. 3 the cartridge 300 may include removable caps (not shown) sealing the inlet port 306 and the outlet port 308 for storage.

[0079] The internal chamber 304 of the cartridge 300 may have a predetermined volume corresponding to a volume of the medical fluid F required for a particular injection procedure. As such, the appropriate volume of the medical fluid F is delivered to the patient so long as the cartridge 300 is emptied and the administration line 200 is flushed to inject any residual fluid, as discussed in detail herein. The cartridge 300 thus increases the accuracy of the injection procedure by eliminating the risk of over-delivery of the medical fluid F to the patient. Furthermore, accuracy of the injection procedure is not compromised by capacitance or mechanical slack within the fluid injector system 1000, because the entirety of the medical fluid F within the cartridge 300 is readily delivered to the patient simply by ensuring that the cartridge 300 has been emptied and the administration line subsequently flushed. Example volumes for the internal chamber 304 include but are not limited to 5 mL, 10 mL, 15 mL, 20 mL, 30 mL, etc. The cartridge 300 may be sealed or otherwise protected from environmental contamination and degradation such that the cartridge 300 has a significant shelf life, for example three years, in a healthcare facility where the injection procedure is performed.

[0080] Referring now to FIG. 4, in use of the fluid injector system 1000, the caps (not shown) that cover ports 306 and 308 of the cartridge 300 are removed and the inlet port 306 and the 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 for connection to an outlet port 126 of the syringe 120. A distal connector 206 of the inlet tube 202 is configured for connection 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 for connection to the outlet port 308 of the cartridge 300. A distal end (not shown) of the outlet tube 210 includes or is configured to connect to a catheter inserted into a patient.

[0081] The inlet port 306 and the outlet port 308 of the cartridge 300 may form a non- releasable, tamper-proof connection with the inlet tube 202 and the outlet tube 210, respectively, of the administration line 200. That is, once the inlet port 306 of the cartridge 300 is connected to the distal connector 206 of the inlet tube 202, the cartridge 300 cannot be disconnected from the inlet tube 202 without destroying the inlet port 306 and / or the distal connector 206. Similarly, once the outlet port 308 of the cartridge 300 is connected to the proximal connector 212 of the outlet tube 210, the cartridge 300 cannot be disconnected from the outlet tube 210 without destroying the outlet port 308 and / or the proximal connector 212. The feature of non-releasability of the inlet port 306 and the outlet port 308 of the cartridge 300 prevents reuse of the administration line 200 and / or the cartridge 300, thus ensuring users follow protocols for replacing the administration line 200 after each use.

[0082] With continued reference to FIG. 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-way fitting 208 (e.g. a tee or wye fitting) upstream of the distal connector 206. A first outlet of the multi-way fitting 208 may be in fluid communication with the distal connector 206 of the inlet tube 202, and a second outlet of the multi-way 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. A first inlet of the control valve 214 may be in fluid communication with the proximal connector 212 of the outlet tube 210, and a second inlet of the control valve 214 may be in fluid communication with the bypass tube 220. FIG. 5 shows an alternate embodiment of the administration line in which the distal connector 206 of the inlet tube 202 is integral with the multi-way fitting 208, and the proximal connector 212 of the outlet tube 210 is integral with the control valve 214.

[0083] Referring now to FIGS. 4 to 7, the control valve 214 may be movable between at least two positions to control fluid flow into the outlet tube 210. In a first position, shown in FIG. 6, a fluid path 216 of the control valve 214 is oriented to provide fluid communication between the bypass tube 220 and the outlet tube 210, while isolating the cartridge 300 from the outlet tube 210. As such, fluid injected from the syringe 120 into the inlet tube 202 flows into the bypass tube 220 and then to the outlet tube 210. The medical fluid F within the cartridge 300 is isolated from the remainder of the administration line 200 because the control valve 214 prevents fluid flow out of the outlet port 308. As such, fluid pressure on the upstream, or proximal, face of the plunger 310 cannot displace the plunger 310 to inject the medical fluid F.

[0084] In a second position, shown in FIG. 7, the fluid path 216 of the control valve 214 is oriented to provide fluid communication between the cartridge 300 and the outlet tube 210, while isolating the bypass tube 220 from the outlet tube 210. As such, fluid injected from the syringe 120 into the inlet tube 202 cannot flow through the bypass 220 and into the outlet tube 210. Instead, fluid injected from the syringe 120 pressurizes the inlet tube 202 until a fluid pressure at the inlet port 306 of the cartridge 300 exceeds a fluid pressure in the internal chamber 304 of the cartridge 300. The pressure differential between the inlet port 306 and the internal chamber 304 causes the plunger 310 to move distally within the internal chamber 304 to inject the medical fluid F within the cartridge 300 into the outlet tube 210.

[0085] To move the control valve 214 from the first position and the second position the control valve 214 may be manually operated by a user, or may be electronically operated by the controller 900 of the fluid injector system 1000. The housing 100 may include a valve interface 150, as best shown in FIG. 1, that receives and actuates the control valve 214. During an injection procedure, the control valve 214 may be initially set to the first position to allow fluid 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 actuated to inject saline to purge and / or prime the administration line 200. Purging and / or priming the administration line 200 removes air from the administration line 200 prior to connecting the administration line to the patient.

[0086] After the administration line 200 has been purged and / or primed, the administration line 200 may be connected to the patient, the control valve 214 may be moved to the second position, and the syringe 120 may be further actuated to pressurize the inlet tube 202. The fluid pressure in the inlet tube 202 forces the plunger 310 of the cartridge 300 to move distally within the internal chamber 304, forcing the medical fluid F out of the cartridge 300 and into the outlet tube 210. A bolus of the medical fluid F advances distally in the outlet tube 210 until the plunger 310 reaches the distal end of the internal chamber 304 of cartridge 300, as shown inFIG. 7. Due to the volume of the outlet tube 210, at least of portion of the bolus of the medical fluid F remains in the outlet tube 210 after the medical fluid F has been evacuated from the cartridge 300. To complete the injection of the medical fluid F into the patient, the control valve 214 may be returned to the first position, and the syringe 120 may be further actuated to inject additional saline to flush the medical fluid F from the outlet tube 210.

[0087] Referring again to FIG. 4, the administration line 200 may further include a pressure sensor 222 provided on the bypass tube 220 to detect fluid pressure within the bypass tube 220. The pressure sensor 222 may be in operative communication with the controller 900, and may be used to detect occlusions, such as a kink in the administration line 200 or an occlusion due to the patient bending his / her arm while the administration line 200 is inserted. The controller 900 may display the fluid pressure detected by the pressure sensor 222 on a user interface 160 of the housing 100 (see FIG. 1), or on a remote user interface (e.g. a control room unit) in communication with the fluid injector system 1000. In some aspects or examples, the controller 900 may display the fluid pressure on the user interface 160 numerically. Alternatively, the controller 900 may display the fluid pressure as an approximation such as “LOW”, “MEDIUM”, “HIGH”, etc. If the controller 900 detects an occlusion or if the controller 900 determines that the fluid pressure is outside a predetermined range, the controller 900 may halt the injection procedure.

[0088] Referring again to FIG. 1 and with additional reference to FIG. 8, the housing 100 may further include a cartridge clamp 170 for receiving the cartridge 300. The cartridge clamp 170 may be in communication with the controller 900 to allow the controller 900 to 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 in engagement with the cartridge 300. For example, the cartridge clamp 170 may consist of one or more clips that may be opened and closed to engage the cartridge 300. The controller 900 may determine the relative position of the clip when engaged with the cartridge 300 and, based on that position, determine the diameter D of the cartridge 300. In addition to or as an alternative to 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 aspects 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, as the length is known.

[0089] In some aspects 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 size cartridge 300 is attached for the desired injection procedure. If the controller 900 determinesthat a cartridge 300 of the incorrect size is attached, the controller 900 may prohibit performance of the injection procedure. In some aspects or examples, the controller 900 may generate parameters for an injection based on the volume of the cartridge 300. In particular, the controller 900 may determine the volume of fluid needed to be injected from the syringe 120 in order to empty the cartridge 300.

[0090] Referring now to FIGS. 9 to 15, an aspect or example of the fluid injector system 1000 is illustrated. The fluid injector system 1000 of this aspect or example is similar to that of FIGS. 1 to 8, and components not specifically described herein with respect to FIGS. 9 to 15 may be the same or similar to components of the aspect or example of FIGS. 1 to 8 having like reference numerals. The fluid injector system 1000 includes a syringe 120 or other suitable fluid injector fluidly connected to an inlet of the proximal multi-way fitting 208. One outlet of the multi-way fitting 208 is fluidly connected to a first section 220a of the bypass tube 220, for example via an adapter 224. A second outlet of the multi-way fitting 208 is fluidly connected to the inlet port 306 of the cartridge 300. In similar manner, a distal multi-way fitting 230 (e.g. a tee or wye fitting) is fluidly connected to the outlet port 308 of the cartridge 300, a second section 220b of the bypass tube 220 (for example via an adapter 226), and the outlet tube 210 (for example via an adapter 232). As with the aspect or example of FIGS. 1-8, this arrangement creates parallel fluid paths through the bypass tube 220 and the cartridge 300. As with the aspect or example of FIGS. 1-8, the bypass tube 220; the outlet tube 210; the fittings 208, 230; the adapters 224, 226, 232; and (in some examples) the cartridge 300 may be supplied as a tamper-proof sub-assembly, referred to herein as the administration line 200, to prevent reuse of the components.

[0091] The first and second sections 220a, 220b of the bypass tube 220 are in selective fluid communication via a crack pressure valve 400. The path of fluid flow out of the syringe 120 is dictated by the crack pressure valve 400, which is configured to be normally closed below a predetermined threshold pressure. That is, fluid cannot flow through the crack pressure valve 400 when fluid pressure at the proximal side of the crack pressure valve 400 is below the predetermined threshold pressure. With the plunger 310 of the cartridge 300 in the proximal- most position (as shown in FIG. 3), injection of fluid from the syringe 120 increases the fluid pressure on the proximal side of the plunger 310 and causes the plunger 310 to move distally. The plunger 310 and the crack pressure valve 400 are selected such that the fluid pressure necessary to distally displace the plunger 310 is less than the predetermined threshold pressure. When the plunger 310 reaches the distal end of the internal chamber 304 of the cartridge 300 and cannot travel any farther, fluid pressure on the proximal side of the plunger 310 and in thefirst section 220a of the bypass tube 220 increases until the fluid pressure exceeds the predetermined threshold pressure of the crack pressure valve 400. At this point, the crack pressure valve 400 opens and 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. Continued injection of fluid from the syringe 120 thus bypasses the cartridge 300 and can be performed to flush the medical fluid F from the distal multi-way fitting 230 and the outlet tube 210.

[0092] Referring now to FIGS. 11 to 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. An annular lip 414 of the valve body 410 seals against the socket 404, and may be secured to the socket 404 via an adhesive, ultrasonic welding, interference fit, or the like. A deformable shuttle 420 rests in the cradle 412, and is longitudinally constrained by an end stop 416. The shuttle 420 engages and seals an inlet orifice 430 of the valve body 410, selectively preventing fluid flow past the shuttle 420. The predetermined pressure threshold of the crack pressure valve 400 is a function of the compressibility of the shuttle 420. In particular, the predetermined pressure threshold is the fluid pressure at the inlet orifice 430 necessary to the compress the shuttle 420 distally and thereby allow fluid from the inlet orifice 430 to flow into the cradle 412. The cradle 412 may include one or more channels 418 that allows fluid to flow around the compressed shuttle 420, past the end stop 416, and out of the housing 402.

[0093] Referring now to FIGS. 14 and 15, the barrel 302 of the cartridge 300 may define an open proximal end into which the plunger 310 is inserted during assembly. An end cap 324 including the inlet port 306 may be secured 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. An internal sidewall 326 of the end cap 324 may have the same internal diameter as the barrel 302 so that the plunger 310 slides smoothly over the transition between the end cap 324 and the barrel 302. In other aspects or examples, the end cap 324 may fit over the barrel 302 - i.e. the barrel 302 is received within the end cap 324. The end cap 324 and the barrel 302 may be joined by an adhesive, welding, interference fit, or the like.

[0094] Referring now to FIGS. 16 to 20, an aspect or examples of the fluid injector system 1000 including an adjustable stop 500 in the cartridge 300 is illustrated. The fluid injector system 1000 of this aspect or example is otherwise similar to that of FIGS. 9 to 15. Components not specifically described herein with respect to FIGS. 16 to 20 may be the sameor similar to components of the aspect or example of FIGS. 9 to 15 having like reference numerals. The adjustable stop 500 limits the distal travel of the plunger 310 to control the amount of medical fluid F that is delivered to the patient. The adjustable stop 500 may be used, for example, when the injection procedure calls for a dosage of the medical fluid F less than the total amount medical fluid F in the cartridge. The adjustable stop 500 may include a rod 502 that extends into the internal chamber 304 of the cartridge 300 through a rod port 330 in the distal end of the barrel 302. As shown in FIG. 20, the plunger 310 engages the rod 502 prior to contacting the distal end of the internal chamber 304. As such, the medical fluid F on the distal side of the plunger 310 is not delivered to the patient. Once the plunger 310 engages the rod 502, continued actuation of the syringe 120 increases fluid pressure on the proximal side of the plunger 310 until the crack pressure valve 400 opens.

[0095] As shown in FIGS. 18 and 20, an O-ring 508 or similar sealing component may be disposed in the rod port 330 around the rod 502 to prevent leakage of the medical fluid F out of the rod port 330. A lock nut 506 secures the O-ring 508 in place. The rod 502 may be threaded, with a complementary thread in the rod port 330, to allow adjustment of the depth of the rod 502 within the internal chamber 304. A distal end of the rod 502 may include a knob 504 to facilitate adjustment of the rod 502. The knob 504 may also serve as a stop that limits the maximum insertion depth of the rod 502 into the internal chamber 304 due to engagement of the knob 504 with the rod port 330. In some aspects or examples, the rod 502 may be configured for manual adjustment. In some aspects or examples, the knob 504 may be automatically adjusted by an actuator 550 associated with the controller 900 (see FIG. 21). For example, the controller 900 may be configured to set the depth of the rod 502 within the internal chamber 304 so as to deliver a predetermined dosage of the medical fluid F from the cartridge 300

[0096] The aspects or examples illustrated in FIGS. 9 to 20 may include a housing 100 for holding the components of the fluid injector system 1000, in a similar manner as shown in FIGS. 1 and 8. The fluid injector system 1000 of FIGS. 9 to 20 may also include an automatic actuator 104 for depressing a rod and / or plunger of a rod and plunger assembly 124 of the syringe 120, again in similar manner as shown in FIG. 1.

[0097] In contrast to the aspects or examples described in connection with FIGS. 1 to 8, the aspects or examples of FIGS. 9 to 20 do not rely on an actively controlled valve (i.e. the directional control valve 214 shown in FIGS. 4 to 7) to the control whether fluid injected from the syringe 120 flows into the cartridge 300 or through the bypass tube 220. Instead, the crack pressure valve 400 of the aspects or examples of FIGS. 9 to 20 passively controls the path offluid flow, as described above, by remaining closed until the fluid pressure proximal to the plunger 310 exceeds the predetermined pressure threshold of the crack pressure valve 400. However, in some aspects or examples, the fluid injector system 1000 may include both the directional control valve 214 and the crack pressure valve 400 to allow additional control of the fluid flow.

[0098] Referring now to FIG. 21, a communication schematic of the fluid injector system 1000 is shown. Housing 100 may be provided in a room with the patient, with the controller 900 in communication with a user interface device 800, e.g. a computer, laptop, smartphone, etc., in a remote location. The controller 900 may include at least one processor and may communicate with and receive commands from the user input device 800 over a wired or wireless network such as Ethernet, WiFi, Bluetooth, etc. As such, the user (e.g. a physician) does not need to be in the room with the patient during performance of an injection procedure.

[0099] Like the controller 900, the user input device 800 may include at least one processor configured to execute instructions stored on a computer readable media. The input device 800 may be configured to transmit instructions to the controller 900 to initiate, pause, stop, or otherwise regulate an injection procedure. The input device 800 may further be configured to receive notification and / or alerts from the controller 900, such as a pressure reading from the pressure sensor 222.

[0100] It should be apparent that each of the administration lines disclosed herein may be implemented, at least in part, as a disposable, manually operated fluid injector system. In a non-limiting embodiment of fluid injector system 1000 of FIGS. 1-8, for example, the actuator 104 of saline syringe 120 can take the form of a flange. Once an appropriate cartridge 300 (i.e., a cartridge of a predetermined volume) is selected and installed in housing 100 and syringe 120 is prefilled or primed with medical fluid F (e g., saline), such a flange can be manually pushed to advance the rod of rod and plunger assembly 124 and the plunger at the end thereof distally into barrel 122 and thereby expel the medical fluid F (saline) from syringe 120. Powered by the saline received from syringe 120, the fluid injector system 1000 of FIGS. 1-8 will deliver into outlet tube 210 either contrast from cartridge 300 or saline from bypass tube 220 should the position selected for control valve 214 and the fluid pressure against the proximal face of plunger 310 permit it as disclosed above. Similarly, in a non-limiting embodiment of fluid injector system 1000 of FIGS. 9-15, the actuator 104 of saline syringe 120 can also take the form of a flange. Once an appropriate cartridge 300 is selected and installed in administration line 200 between fittings 208 and 230 and syringe 120 is prefilled or primed with medical fluid F, such a flange can be manually pushed to advance the rod of assembly 124 and the plungerthereof distally into the barrel of syringe 120 and thereby expel the medical fluid F (saline) from syringe 120. Powered by the saline received from syringe 120, the fluid injector system 1000 of FIGS. 9-15 will deliver into outlet tube 210 either contrast from cartridge 300 or saline from bypass tube 220 depending on the pressure developed across crack pressure valve 400 in bypass tube 220 as disclosed above. The fluid injector system 1000 of FIGS. 16-20, being nearly identical to fluid injector system 1000 of FIGS. 9-15 with the exception of adjustable stop 500, may also be implemented as a disposable, manually operated system.

[0101] It also should be apparent that each of the administration lines disclosed herein may be implemented as a separate disposable for use with an automated fluid injector system. In one non-limiting embodiment, the administration line 1000 of FIG. 1 can be used as a disposable for and in connection with the single-head fluid injector system shown in FIG. 22. In another non-limiting embodiment, the administration line 1000 of FIG. 9 can be used as a disposable for and in connection with the single-head fluid injector system shown in FIG. 23. Similarly, in yet another non-limiting embodiment, the administration line 1000 of FIG. 16 can be used as a disposable for and in connection with the single-head fluid injector system shown in FIG. 24.

[0102] In particular, in the non-limiting embodiment shown in FIG. 23, the administration line 1000 is illustrated in connection with a single-head fluid injector system. An example of such a single-head fluid injector system could be the MEDRAD® Envision CT Injection System, though it may also be implemented with one of the heads of a dual-head fluid injection system such as the MEDRAD® MRXperion MR Injection System, the MEDRAD® Stellant FLEX CT Injection System, or the MEDRAD® Stellant CT Injection System , all offered by Bayer Healthcare LLC. The fluid injection system has a drive mechanism 130 for use in pressurizing a diluent contained within 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 to allow programming of an injection protocol having at least one phase according to which the drive mechanism 130 controls the flow of the diluent into the administration line 1000. Essentially identical to that shown in FIGS. 9-15, the administration line 1000 comprises a cartridge 300. The cartridge 300 defines an internal chamber 304 and comprises an inlet port 306 in fluid communication with the internal chamber 304, an outlet port 308 in fluid communication with the internal chamber 304, a medical fluid F (e.g., contrast) contained within the internal chamber 304; and a plunger 310 movable within the internal chamber 304. The administration line 1000 also comprises: an inlet tube in fluid communication with the inlet port 306 of the cartridge 300 and configured for connection to the fluid container 120; anoutlet tube 210 in fluid communication with the outlet port 308 of the cartridge 300; and a bypass tube 220 connecting the inlet tube and the outlet tube 210 in parallel with the cartridge 300. The bypass tube 220 includes a crack pressure valve 400 configured to prevent the diluent from the fluid container 120 via the inlet tube from flowing from a first section 220a of the bypass tube 220 to a second section 220b of the bypass tube 220 when a first pressure at a proximal side of the crack pressure valve 400 is below a predetermined threshold pressure. Upon operation of the drive mechanism 130, the diluent flows from the fluid container 120 through the inlet tube and the inlet port 306 to build the first pressure against a proximal side of the plunger 310 within the cartridge 300 and against the proximal side of the crack pressure valve 400 such that as long as the first pressure (i) is below the predetermined threshold pressure the crack pressure valve 400 prevents the diluent from flowing therethrough thereby preventing the diluent from entering the outlet tube 210 of the administration line 1000; and (ii) exceeds a second pressure against a distal side of the plunger 310 within the cartridge 300 the medical fluid will flow from the outlet port 308 thereof into the outlet tube 210 of the administration line 1000.

[0103] In another non-limiting embodiment illustrated in FIG. 24, the administration line 1000 is also shown in connection with a single-head fluid injector system. The administration line 1000 of this aspect or example is similar to that depicted in FIGS. 9-15 and 23, and components not specifically described herein with respect to FIG. 24, and related FIGS. 16- 20, may be the same or similar to components of the aspects or examples of FIGS. 9-15 and 23. FIG. 24, like FIGS. 16-20, also depicts adjustable stop 500 and related components, all of which described in detail above and which apply with equal relevance to FIG. 24.

[0104] While examples of fluid injector systems, administration lines, and methods of operation thereof were provided in the foregoing description, those skilled in the art may make modifications and alterations to these examples without departing from the scope and spirit of the disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The disclosure described hereinabove is defined by the appended claims, and all changes to the disclosure that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS1. An administration line for use with a fluid injector system, the fluid injection system having a drive mechanism for use in pressurizing a diluent contained within a fluid container and a controller operably associated with the drive mechanism, the controller including a programming system to allow programming of an injection protocol having at least one phase according to which the drive mechanism controls the flow of the diluent into the administration line, the administration line comprising: a cartridge defining an internal chamber and comprising: 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; an inlet tube in fluid communication with the inlet port of the cartridge and configured for connection to the fluid container; an outlet tube in fluid communication 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 including a crack pressure valve configured to prevent the diluent from the fluid container via the inlet tube from flowing from a first section of the bypass tube to a second section of the bypass tube when a first pressure at a proximal side of the crack pressure valve is below a predetermined threshold pressure; wherein, upon operation of the drive mechanism, the diluent flows from the fluid container through the inlet tube and the inlet port to build the first pressure against a proximal side of the plunger within the cartridge and against the proximal side of the crack pressure valve such that as long as the first pressure (i) is below the predetermined threshold pressure the crack pressure valve prevents the diluent from flowing therethrough thereby preventing the diluent from entering the outlet tube of the administration line; and (ii) exceeds a second pressure against a distal side of the plunger within the cartridge the medical fluid will flow from the outlet port thereof into the outlet tube of the administration line.

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

3. The administration line of claim 1, further including 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 of claim 1 wherein the medical fluid comprises contrast.

5. The administration line of claim 1 , further including a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

6. The fluid injector system of claim 5, wherein the stop comprises a rod extending into the internal chamber and configured to engage the plunger to limit the travel thereof.

7. The administration line of claim 6, wherein a depth of the rod within the internal chamber is adjustable.

8. A fluid injector system configured to perform an injection procedure in connection with a diagnostic imaging procedure, the fluid injector system comprising: an administration line comprising: a cartridge defining an internal chamber and comprising: 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; an inlet tube in fluid communication with the inlet port and configured for connection to a fluid injector; an outlet tube in fluid communication with the outlet port; and a controller configured to actuate the fluid injector.

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

11. The fluid injector system of claim 8, wherein at least one of the inlet port and the outlet port are non-releasably connected to the cartridge.

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

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

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

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

16. The fluid injector system of claim 10, further comprising a housing having a valve interface for receiving the valve of the administration line.17 The fluid injector system of claim 9, wherein the controller is configured to move the valve between the first position and the second position via the valve interface.

18. The fluid injector system of claim 8, wherein the medical fluid comprises contrast, and wherein the controller is configured to inject saline from the fluid injector.

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

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

21. The fluid injector system of claim 8, further comprising a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

22. The fluid injector system of claim 21, wherein the stop comprises a rod extending into the internal chamber and configured to engage the plunger to limit the travel of the plunger.

23. The fluid injector system of claim 22, wherein a depth of the rod within the internal chamber is adjustable.

24. An administration line for use with a fluid injector system, the administration line comprising: a cartridge defining an internal chamber and comprising: 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; an inlet tube in fluid communication with the inlet port and configured for connection to a syringe, the syringe for enabling a diluent contained therein to be delivered upon pressurization thereof to the inlet port of the cartridge; and an outlet tube in fluid communication with the outlet port.

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

26. The administration line of 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 of claim 24, wherein at least one of the inlet port and the outlet port are non-releasably connected to the cartridge.

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

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

30. The administration line of claim 24, wherein the medical fluid comprises contrast.

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

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

33. The administration line of claim 24, further comprising a stop for limiting the travel of the plunger in the internal chamber of the cartridge.

34. The administration line of claim 33, wherein the stop comprises a rod extending into the internal chamber and configured to engage the plunger to limit the travel of the plunger.

35. The administration line of claim 34, wherein a depth of the rod within the internal chamber is adjustable.

36. An administration line for use with a fluid injector system, the administration line comprising: an inlet tube having a proximal end configured for connection to a fluid injector and a distal end configured for connection to a prefilled cartridge containing a medical fluid;an outlet tube having a proximal end configured for connection to the prefilled cartridge; a bypass tube 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.

37. The administration line of claim 36, wherein at least one of the inlet port and the outlet port are configured for non-releasable connection to the prefilled cartridge.

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

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