Systems and methods for testing vascular access using an electrokinetic fluid injector system

Abstract

The fluid injector system has a controller for operatively controlling injection of contrast / saline into a patient. The controller allows a user to program a diagnostic injection procedure having phases according to which the contrast / saline is injected into the patient to result in enhancement of an area of ​​the patient during an imaging procedure. The controller also allows a user to program a test injection procedure to be performed before the diagnostic injection procedure. The test injection procedure can be performed as (a) a variable single-phase test injection, in which the flow rate at which the saline is delivered is selectable prior to performance of the test injection and can be changed during performance of the variable single-phase test injection, and / or (b) a multi-phase test injection, in which the flow rate at which the saline is delivered is selectable for each phase of the multi-phase test injection prior to performance of the multi-phase test injection.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 655,365, filed Apr. 10, 2018, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] Background of the Disclosure The present disclosure relates to systems, methods, and computer program products for testing blood vessel access using a powered fluid injector, and more particularly, to systems and methods for testing the acceptability of blood vessel access using a powered fluid injector configured to enable adjustment of the fluid delivery rate during a test injection procedure. The present disclosure further relates to systems and methods for testing the acceptability of blood vessel access using a powered fluid injector configured to have multiple injection phases during a test injection procedure.

Background Art

[0003] In many medical diagnostic and treatment procedures, a practicing physician, such as a doctor, injects one or more medical fluids into a patient. In recent years, several medical fluid delivery systems for pressure injecting fluids such as contrast solutions (often simply referred to as "contrast" or "contrast medium"), 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 imaging procedures. Generally, these medical fluid delivery systems, such as electromechanical fluid injectors, are designed to deliver such fluids by one or more injection protocols, each including one or more phases, to enhance regions of interest within a patient's body during an imaging diagnostic procedure. Examples of electromechanical fluid injectors capable of delivering fluids by user-programmable single-phase or multi-phase diagnostic injection procedures include the MEDRAD® Stellant CT Injection System and the MEDRAD® MRXperion MR Injection System, both of which are provided by Bayer HealthCare LLC.

[0004] In some infusion procedures, fluid is delivered to a patient via a fluid path set or tubing having a proximal end connected to an electromechanical fluid injector and a distal end connected to a vascular access device that is inserted into a blood vessel, such as a patient's vein. To ensure proper placement of a needle, cannula, catheter, central line, or other vascular access device, special efforts are often made to ensure that in the patient's blood vessel, the end of the blood vessel is clear (i.e., not clotted or otherwise blocked) and is fully inserted into the blood vessel without puncturing the blood vessel wall. In some cases, extravasation can occur when fluid, such as contrast and / or saline, is injected into the surrounding tissue rather than the patient's blood vessel. An integrity check may be performed to avoid extravasation of contrast and / or saline into the patient's tissue and to ensure that the end of the vascular access device is not blocked and allows fluid flow with the blood vessel.

[0005] Patency checking can confirm that the fluid path set and associated vascular access device are fluidly connected to the patient's blood vessels. A test injection can be performed with an electro - motive fluid injector using a fixed delivery rate of a quantity of fluid such as a saline solution. Prior art electro - motive fluid injectors such as the MEDRAD® Stellant Injection System and the MEDRAD® MRXperion MR Injection System currently cannot perform a test injection where the quantity or flow rate can be varied, or where the test injection can have two or more phases, and the delivery volume and delivery rate of the fluid are fixed. Such a test injection allows the clinician to check the suitability of the vascular access point and receive fluid at the same flow rate as that used for diagnostic injection. The clinician can visually observe and / or palpate the area near the injection site to ensure that the vascular access device is properly inserted into the blood vessel and to check for any leaks in the tubing used with the vascular access device. In some examples or aspects, the clinician can observe a pressure graph on the electro - motive injector system to determine whether the expected pressure was generated during the test injection. After the patency check is completed, the diagnostic injection procedure can be performed by programming or otherwise selecting the desired diagnostic injection protocol. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] Conventional patency checking devices and methods are known in the medical field, but improved patency checking devices and methods are still in demand. Therefore, it would be desirable to provide an improved system and method for testing vascular access using an electro - motive fluid injector. MEANS FOR SOLVING THE PROBLEMS

[0007] The present disclosure relates to a system, computer program product, and method for testing the receptivity of vascular access using an electro - motive fluid injector system configured to enable adjustment of the rate at which fluid can be delivered during a test injection. The present disclosure further relates to a system, computer program product, and method for testing the receptivity of vascular access using an electro - motive fluid injector system configured to perform a test injection including a plurality of phases. Various examples or aspects of the present disclosure may be characterized by one or more of the following numbered clauses.

[0008] Clause 1. A fluid injector system comprising a controller operably associated with at least one drive member to enable at least one fluid contained within at least one fluid container to be injected into a patient, the controller including a programming system to enable programming of at least one diagnostic injection procedure including at least one diagnostic injection phase, wherein, according to the at least one diagnostic injection phase, at least one fluid is to be injected into the patient to effect highlighting of at least one region of interest of the patient over a scan time of an imaging diagnostic procedure, and the programming system is further for enabling programming of a test injection procedure to be performed prior to the diagnostic injection procedure, the test injection procedure being executable as at least one of: (a) a variable single - phase test injection, wherein a flow rate at which at least one fluid is to be delivered is selectable prior to execution of the variable single - phase test injection and is variable during execution of the variable single - phase test injection; and (b) a multi - phase test injection, wherein a flow rate at which at least one fluid is to be delivered is selectable for each phase of the multi - phase test injection prior to execution of the multi - phase test injection.

[0009] Clause 2. The fluid injector system according to Clause 1, wherein the test injection procedure can be further carried out as a fixed single-phase test injection in which the flow rate at which at least one fluid is to be delivered and the amount of at least one fluid to be delivered are fixed.

[0010] Clause 3. The fluid injector system according to Clause 1 or 2, wherein at least one fluid to be delivered during the variable single-phase test injection is physiological saline.

[0011] Clause 4. The fluid injector system according to any one of Clauses 1 to 3, wherein at least one fluid to be delivered during at least one phase of the multi-phase test injection is physiological saline.

[0012] Clause 5. The fluid injector system according to any one of Clauses 1 to 4, wherein in the case of a variable single-phase test injection, the amount of at least one fluid to be delivered is selectable before the execution of the variable single-phase test injection.

[0013] Clause 6. The fluid injector system according to any one of Clauses 1 to 5, wherein in the case of a multi-phase test injection, the amount of at least one fluid to be delivered is selectable before the execution of the multi-phase test injection.

[0014] Clause 7. The fluid injector system according to any one of Clauses 1 to 6, wherein in the case of a multi-phase test injection, the amount of at least one fluid to be delivered is different for each phase of the multi-phase test injection.

[0015] Clause 8. The fluid injector system according to any one of Clauses 1 to 7, wherein in the case of a multi-phase test injection, the flow rate at which at least one fluid is to be delivered is different for each phase of the multi-phase test injection.

[0016] Clause 9. The fluid injector system according to any one of Clauses 1 - 8, wherein the flow rate at which at least one fluid is to be delivered during the execution of a variable single - phase test injection is varied by varying the speed of at least one drive member.

[0017] Clause 10. The fluid injector system according to any one of Clauses 1 - 9, wherein the speed of at least one drive member is varied by a manual input using a control element.

[0018] Clause 11. The fluid injector system according to any one of Clauses 1 - 10, wherein the control element is one or more buttons or dials.

[0019] Clause 12. The fluid injector system according to any one of Clauses 1 - 11, wherein the programming system is further configured to enable adjustment of the flow rate at which at least one fluid is to be delivered during at least one diagnostic injection phase based on a desired flow rate determined during the execution of a variable single - phase test injection.

[0020] Clause 13. The fluid injector system according to any one of Clauses 1 - 12, wherein the multi - phase test injection includes at least a first phase having a first flow rate and a second phase following the first phase, and the second phase has a second flow rate.

[0021] Clause 14. The fluid injector system according to any one of Clauses 1 - 13, wherein the second flow rate is different from the first flow rate.

[0022] Clause 15. The fluid injector system according to any one of Clauses 1 - 14, wherein the second flow rate is higher than the first flow rate.

[0023] Clause 16. The fluid injector system according to any one of Clauses 1 - 15, wherein the test injection procedure and at least one diagnostic injection procedure define an overall injection protocol.

[0024] A computer program product for enabling programming of test injection procedures to be performed using a fluid injector system prior to a diagnostic injection procedure, the computer program product comprising at least one non-transitory computer-readable medium including one or more instructions which, when executed by at least one processor, enable the at least one processor to cause a user to select, via the fluid injector system, a test injection procedure to be performed from among a variable single-phase test injection and a multi-phase test injection, such that: (a) when the variable single-phase test injection is selected, a flow rate at which at least one fluid is to be delivered during the variable single-phase test injection is selectable prior to execution of the variable single-phase test injection and is changeable during execution of the variable single-phase test injection; and (b) when the multi-phase test injection is selected, a flow rate at which at least one fluid is to be delivered during the multi-phase test injection is selectable for each phase of the multi-phase test injection prior to execution of the multi-phase test injection.

[0025] Clause 18. The one or more instructions, when executed by at least one processor, further enable the at least one processor to cause a user to select, via the fluid injector system, a fixed single-phase test injection, such that when the fixed single-phase test injection is selected, a flow rate at which at least one fluid is to be delivered during the fixed single-phase test injection and an amount of at least one fluid to be delivered during the fixed single-phase test injection are fixed, the computer program product according to clause 17.

[0026] Clause 19. The computer program product according to clause 17 or 18, wherein at least one fluid to be delivered during the variable single-phase test injection is saline.

[0027] Article 20. A computer program product according to any one of Articles 17 to 19, wherein at least one fluid to be delivered during at least one phase of the multi-phase test injection is physiological saline.

[0028] Article 21. A computer program product according to any one of Articles 17 to 20, wherein in the case of a variable single-phase test injection, the amount of at least one fluid to be delivered is selectable before the execution of the variable single-phase test injection.

[0029] Article 22. A computer program product according to any one of Articles 17 to 21, wherein in the case of a multi-phase test injection, the amount of at least one fluid to be delivered is selectable before the execution of the multi-phase test injection.

[0030] Article 23. A computer program product according to any one of Articles 17 to 22, wherein in the case of a multi-phase test injection, the amount of at least one fluid to be delivered is different for each phase of the multi-phase test injection.

[0031] Article 24. A computer program product according to any one of Articles 17 to 23, wherein in the case of a multi-phase test injection, the flow rate at which at least one fluid is to be delivered is different for each phase of the multi-phase test injection.

[0032] Article 25. A computer program product according to any one of Articles 17 to 24, wherein in the execution of a variable single-phase test injection, the flow rate at which at least one fluid is to be delivered is changed by changing the speed of at least one drive member.

[0033] Article 26. A computer program product according to any one of Articles 17 to 25, wherein the speed of at least one drive member is changed by manual input using a control element.

[0034] Article 27. A computer program product according to any one of Articles 17 to 26, wherein the control element is one or more buttons or dials.

[0035] Article 28. Further configured such that when one or more instructions are executed by at least one processor, it enables adjusting the flow rate at which at least one fluid is to be delivered during at least one diagnostic injection phase based on a desired flow rate determined during the execution of a variable single-phase test injection. A computer program product according to any one of Articles 17 to 27.

[0036] Article 29. A computer program product according to any one of Articles 17 to 28, wherein the multi-phase test injection includes at least a first phase having a first flow rate and a second phase following the first phase, and the second phase has a second flow rate.

[0037] Article 30. A computer program product according to any one of Articles 17 to 29, wherein the second flow rate is different from the first flow rate.

[0038] Article 31. A computer program product according to any one of Articles 17 to 30, wherein the second flow rate is higher than the first flow rate.

[0039] Article 32. A computer program product according to any one of Articles 17 to 31, wherein the test injection procedure and at least one diagnostic injection procedure define an overall injection protocol.

[0040] A computer-executed method for performing a test injection procedure using a fluid injector system having at least one drive member for injecting at least one fluid contained within at least one fluid container into a patient, the method comprising using at least one processor to drive the at least one drive member at a first drive speed to deliver the at least one fluid at a first flow rate; and changing the first drive speed to a second drive speed different from the first drive speed to change the flow rate at which the at least one fluid is delivered from the first flow rate to a second flow rate different from the first flow rate, wherein changing the first drive speed to the second drive speed includes one of (a) receiving user input via a control element operably connected to the at least one processor during a variable single-phase test injection, and (b) using the at least one processor to proceed to the next test injection phase of a multi-phase test injection, the next test injection phase including the second drive speed.

[0041] The computer-executed method of clause 33, wherein the second drive speed is higher than the first drive speed.

[0042] The computer-executed method of clause 33, wherein the second drive speed is lower than the first drive speed.

[0043] The computer-executed method according to any one of clauses 33 to 34, further comprising using at least one processor to select an amount of at least one fluid to be delivered before driving the at least one drive member.

[0044] The computer-executed method according to any one of clauses 33 to 36, further comprising using at least one processor to select the first drive speed before driving the at least one drive member.

[0045] Clause 38. The method further includes a step of performing a diagnostic injection procedure following the test injection procedure, the diagnostic injection procedure including at least one diagnostic injection phase, and according to the at least one diagnostic injection phase, at least one fluid is to be injected into the patient so as to bring about an enhancement of at least one region of interest of the patient over the scan time of the imaging diagnostic procedure. The computer-executed method according to any one of Clauses 33 to 37.

[0046] Clause 39. The computer-executed method according to any one of Clauses 33 to 38, wherein the flow rate at which at least one fluid is to be injected during at least one diagnostic injection phase is based on a desired flow rate determined during the execution of the test injection procedure.

[0047] These and other features and characteristics of the system, computer program product, and method for testing the receptivity of vascular access using an electro-fluidic injector, as well as the manner of operation and function of the associated elements of the structure and the combination of the parts and economy of manufacture, will become more apparent upon consideration of the following description and the appended claims, with reference to the accompanying drawings forming a part hereof. It should be clearly understood, however, that the drawings are for the purpose of illustration and description only.

Brief Description of the Drawings

[0048]

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[0049] In FIGS. 1 - 10, unless otherwise noted, like reference numerals refer to like elements.

[0050] The above figures generally show preferred non-limiting examples or aspects of the systems and methods of the present disclosure. In this description, various examples or aspects of the apparatus are presented, but this description should in no way be construed as limiting the present disclosure. Further, modifications, concepts, and applications of the examples or aspects of the present disclosure should be construed by those skilled in the art as being included by, but not limited to, the figures and description herein.

[0051] The following description is provided to enable a person of ordinary skill in the art to make and use the described examples or embodiments contemplated for carrying out the present disclosure. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to a person of ordinary skill in the art. It is intended that all such modifications, variations, equivalents, and alternatives fall within the spirit and scope of the present disclosure.

[0052] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof are to be related to the present disclosure as oriented in the drawings. When used with respect to a fluid path set, the term "proximal" refers to a portion of the fluid path set on the line closest to the motorized fluid injector. When used with respect to a fluid path set, the term "distal" refers to a portion of the fluid path set closest to the injection site on the patient. When used with respect to a fluid path set or a syringe of a motorized fluid injector, the term "radial" refers to a direction in a cross-sectional plane perpendicular to the longitudinal axis of the syringe or administration line. When used with respect to a fluid path set or a syringe of a motorized fluid injector, the term "circumferential" refers to a direction around the inner or outer surface of the sidewall of the syringe or administration line. When used with respect to a fluid path set or a syringe of a motorized fluid injector, the term "axial" refers to a direction along the longitudinal axis of the syringe or fluid path set extending between the proximal end and the distal end.

[0053] When used herein in the context of an infusion procedure, the term "protocol" refers to a group of parameters such as flow rate, amount to be infused, duration, etc., that define the amount of one or more fluids to be delivered to a patient during the infusion procedure. Such parameters may vary during the course of the infusion procedure. When used herein, the term "phase" generally refers to a group of parameters that define the amount of one or more fluids to be delivered to a patient during a period (or phase duration) that can be less than the total duration of the infusion procedure. Thus, the parameters of a phase provide a description of the infusion over a time instance corresponding to the phase duration. The infusion protocol for a particular infusion procedure can be, for example, single-phase, or two or more phases (multi-phase).

[0054] As used herein, the term "at least one of" is synonymous with "one or more of". For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more of only A, or one or more of only B, or one or more of only C, 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 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.

[0055] Also, it should be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present disclosure. Accordingly, the specific dimensions and other physical characteristics related to the examples disclosed herein should not be regarded as limiting.

[0056] Although the present invention will be described herein mainly in connection with the MEDRAD® Centargo CT Injection System, it will be apparent to those skilled in the art that the present invention can be applied to a wide variety of injection systems. Examples of this type of injection system include the MEDRAD® Stellant CT Injection System, the MEDRAD® Stellant FLEX CT Injection System, and the MEDRAD® MRXperion MR Injection System (all provided by Bayer HealthCare LLC), the ulrichINJECT CT motion™ CT Contrast Media Injector provided by ulrich medical, and the CT Expres® 3D Contrast Media Delivery System provided by Bracco Diagnostics Inc.

[0057] Referring to the drawings in which like reference characters refer to like parts throughout several views of the drawings, the present disclosure generally relates to an electromechanical fluid injector system 100 (hereinafter, “fluid injector system 100”) configured to test the receptivity of vascular access by adjusting a fluid delivery rate during a test injection phase and / or multiple test injection phases, as described herein. Generally, the fluid injector system 100, as described herein, has an electromechanical injector administrator or device and a fluid delivery set intended to be associated with the injector to deliver one or more fluids from one or more multi-dose containers under pressure into a patient. The various devices, components, and features of the fluid injector system 100 and the fluid delivery set associated with the fluid injector system 100 are also detailed herein.

[0058] Referring to FIG. 1, the fluid injector system 100 has at least one reservoir 132 that is fluidly connected to a fluid path set 160. The at least one reservoir 132 is configured to be filled with at least one fluid F, such as a contrast agent, a saline aqueous solution, or any desired medical fluid. At least one fluid F from the at least one reservoir 132 can be delivered to a patient using the fluid path set 160. The at least one reservoir 132 may be pre-filled or may have the ability to be filled with at least one fluid. The at least one reservoir 132 can be at least one syringe, at least one rolling diaphragm syringe, at least one bottle, or at least one collapsible bag.

[0059] The system 100 further includes a fluid injector 101, such as an automatic or electric fluid injector, configured to deliver fluid F from at least one reservoir 132 to a patient using the fluid path set 160. For example, the injector 101 can be configured to drive a plunger 144 of at least one reservoir 132 with a drive member 103, such as a piston, to deliver fluid F from the at least one fluid reservoir 132 through the fluid path set 160. The at least one drive member 103 can be reciprocally operable to selectively fill at least one reservoir 132 or to deliver fluid from at least one reservoir 132. In some examples or embodiments, the injector 101 can be configured to removably receive at least one reservoir 132. The injector 101 can be a multi-syringe injector, and a plurality of syringes may be oriented in parallel or in another spatial relationship and are operated separately by respective pistons associated with the injector 101.

[0060] Continuing to refer to FIG. 1, the flow of fluid from at least one reservoir 132 can be adjusted by a fluid control module or controller 123 configured to operate various valves, stopcocks, and flow rate adjustment structures to adjust the delivery of at least one fluid F to the patient based on injection parameters selected by the user, such as injection flow rate, duration, total injection volume, etc. The controller 123 is generally configured to perform various functions, and the functions of the controller 123, as described herein, have the ability to assist in testing the receptivity of the vascular access by adjusting the fluid delivery rate during the test injection procedure and / or a plurality of test injection phases during the test injection procedure.

[0061] Referring to FIG. 2A, a fluid injector system 100 according to some examples or aspects of the present disclosure is shown. The fluid injector system 100 includes a fluid injector 101 having an injector housing 102 with opposing sides 104, a distal or upper end 106, and a proximal or lower end 108. The housing 102 may be supported on a base 110 having one or more wheels 112 for rotatably and movably supporting the housing 102 on a floor surface. The one or more wheels 112 may be lockable to prevent inadvertent movement when the housing 102 is positioned in a desired location. At least one handle 114 may be provided to facilitate movement and positioning of the fluid injector system 100. In other examples or aspects, the housing 102 may be removably or non-removably fixed to a fixed surface such as a floor, ceiling, wall, or other structure. The housing 102 encloses various mechanical drive components, the electrical and power components necessary to drive the mechanical drive components, and control components such as an electronic memory and an electronic control device (hereinafter, one or more electronic control devices) used to control the operation of a reciprocating drive member such as the drive member 103 (shown in FIG. 3) associated with the fluid injector system 100 described herein. Such a drive member 103 may be reciprocally operable by an electromechanical drive component such as a ball screw shaft driven by a motor, a voice coil actuator, a rack and pinion gear drive, a linear motor, or the like. In some examples or aspects, at least some of the mechanical drive components, electrical and power components, and control components may be provided on the base 110.

[0062] Referring to FIG. 2B and continuing to refer to FIG. 2A, the fluid injector system 100 has at least one door 116 that encloses at least some of the mechanical drive components, electrical and power components, and control components. The door 116 is preferably movable in the direction of arrow A between an open position (shown in FIG. 2B) and a closed position (shown in FIG. 2A). In some examples or aspects, the door 116 may be lockable.

[0063] The fluid injector system 100 further includes at least one bulk fluid connector 118 for connecting to at least one bulk fluid source 120. In some examples or aspects, a plurality of bulk fluid connectors 118 may be provided. For example, as shown in FIGS. 2A and 2B, three bulk fluid connectors 118 may be provided in a parallel arrangement or other arrangement. In some examples or aspects, at least one bulk fluid connector 118 can be a spike configured to removably connect to at least one bulk fluid source 120 such as a vial, bottle, bag, etc. At least one bulk fluid connector 118 can have a reusable or non-reusable interface with each new bulk fluid source 120. At least one bulk fluid connector 118 can be formed on or attached to tubing having a multi-patient disposable set as described herein. At least one bulk fluid source 120 can be configured to receive a medical fluid such as saline, contrast agent, or other medical fluid delivered to the fluid injector system 100. The housing 102 can have at least one support member 122 for supporting the at least one bulk fluid source 120 when the at least one bulk fluid source 120 is connected to the fluid injector system 100.

[0064] The fluid injector system 100 can be operably associated with a controller 123. The controller 123 can be adapted to control the operation of the fluid injector system 100 by enabling a user to manually select injection parameters or select a predefined injection protocol. In some embodiments, the controller 123 can have one or more buttons, knobs, touch pads, displays, switches, dials, or other input and / or output devices to enable a user to manually select injection parameters or select a predefined injection protocol among users. Alternatively, this functionality may be present with an external control unit or with the fluid injector system 100. In any case, the controller 123 controls, for example, but not limited to, injection pressure, the amounts and flow rates of various fluids to be delivered to a patient, and / or the ratios of various fluids to be delivered to the patient.

[0065] Referring to FIG. 2A, the fluid injector system 100 includes one or more user interfaces 124, such as a graphical user interface (GUI) display window, for controlling one or more aspects of the fluid injector system 100 via a controller 123. The user interface 124 can display information related to a fluid injection procedure for the fluid injector system 100, such as the current flow rate, fluid pressure, and the amount remaining in at least one bulk fluid source 120 connected to the fluid injector system 100. The user interface 124 can be a touch screen GUI that enables an operator to input commands and / or data for the operation of the fluid injector system 100. For example, one or more buttons, knobs, touch pads, displays, switches, dials, or other input and / or output controls can be presented as user-selectable regions of the touch screen GUI to enable the user to manually select injection parameters or select a predefined injection protocol. The user interface 124 is shown on the injector housing 102 together with the controller 123, but in some examples or aspects, the user interface 124 can be a tablet that is removably connected to the housing 102 and communicates with the housing 102 via a wired or wireless link.

[0066] Continuing to refer to FIG. 2A, the fluid injector system 100 and / or the user interface 124 can include at least one control button 126 for tactile operation by an attendant operator of the fluid injector system 100. In certain examples or embodiments, the at least one control button 126 can be part of a keyboard for an operator to input commands and / or data. The at least one control button 126 can be wired-connected to one or more electronic control devices associated with the fluid injector system 100 to enable direct input to the one or more electronic control devices. The at least one control button 126 can also be a graphic portion of the user interface 124, such as a touch screen. In any arrangement, the at least one control button 126 is desirably provided with specific individual control functions for an attendant operator of the fluid injector system 100, including, but not limited to, (1) inputting information and / or data related to a patient, a test injection procedure, and / or a diagnostic injection procedure, (2) initiating and / or verifying filling / purging of the fluid injector system 100, (3) starting / stopping a test injection procedure or a diagnostic injection procedure, etc. As used herein, a “test injection procedure” refers to a fluid delivery procedure in which the fluid injector system 100 is used for the purpose of testing the patency of an injection site, while a “diagnostic injection procedure” refers to a fluid delivery procedure in which the fluid injector system 100 is used for diagnostic evaluation other than testing the patency of an injection site, such as when delivering contrast during an imaging procedure.

[0067] Referring to FIG. 2B, the fluid injector system 100 can have a multi-patient disposable set (MUDS) 130 removably connected to the fluid injector system 100 for delivering one or more fluids from one or more bulk fluid sources 120 to a patient. The MUDS 130 can be configured to deliver fluid using a fluid path set as described herein. Examples of suitable MUDS 130 and fluid path set configurations for embodiments of the fluid injector system 100 of the present disclosure are described in International Patent Application Publication No. WO 2016 / 112163 pamphlet and International Patent Application Publication No. WO 2015 / 106107 pamphlet, and the respective disclosures of both pamphlets are hereby incorporated by reference in their entirety into this specification.

[0068] The fluid injector system 100 includes at least one slot or connection port 128 (shown in FIG. 2A) for releasably connecting a single-use disposable set to the MUDS 130 as described herein. The MUDS 130 can include one or more fluid reservoirs or syringes 132. In some examples or aspects, the number of syringes 132 can correspond to the number of bulk fluid sources 120. For example, referring to FIG. 2B, in a particular example or aspect, the MUDS 130 has three syringes 132 arranged in parallel such that each syringe 132 can be fluid-connected to one of the bulk fluid sources 120. One or more bulk fluid sources 120 can be connected to one or more syringes 132 of the MUDS 130. Each syringe 132 can be fluid-connectable to one of the bulk fluid sources 120 by a corresponding bulk fluid connector 118 and associated MUDS fluid path 134. The MUDS fluid path 134 can have a spike element that connects to the bulk fluid connector 118. In some examples or aspects, the bulk fluid connector 118 may be provided directly on the MUDS 130.

[0069] Referring to FIG. 3, each syringe 132 has an elongated substantially cylindrical syringe body 138 having a front or distal end 140 and a rear or proximal end 142. A syringe plunger 144 is disposed within the syringe body 138 and is reciprocally movable within the syringe body 138 by the movement of a drive member 103 associated with the fluid injector system 100. The distal end 140 of the syringe body 138 is, as described herein, substantially conical in shape, tapering towards a vertex or conical point, which vertex or conical point is adapted to interact with a corresponding vertex curve formed in a recess defined within the fluid injector system 100. The vertex or conical point of the syringe is disposed along the central longitudinal axis L of the syringe body 138. Each syringe 132 has an outlet or conduit 146 at the end of the vertex or conical point. The outlet 146 of each syringe 132 is in fluid communication with a valve 136, which valve 136 provides fluid communication with the manifold 148 and the bulk fluid connector 118. The manifold 148 can also support the syringe 132 such that the syringe 132 can be handled as a single integral structure. The syringes 132 can be arranged in a parallel orientation or in other orientations that maintain the relative arrangement of the syringes 132.

[0070] Continuing to refer to FIG. 3, one or more valves 136, such as stopcock valves, can be configured to control which medical fluid or combination of medical fluids is aspirated from the multi-dose bulk fluid source 120 and / or delivered to the patient through each syringe 132. In some examples or embodiments, one or more valves 136 may be provided on the distal ends 140 of the plurality of syringes 132 or on the manifold 148. The manifold 148 can be in fluid communication with a first end of a MUDS fluid path 134 that connects each syringe 132 to a corresponding bulk fluid source 120 via the valve 136 and / or the syringe 132. The opposite second end of the MUDS fluid path 134 can be connected to the bulk fluid connector 118 configured to be in fluid connection with the bulk fluid source 120.

[0071] Depending on the position of one or more valves 136, fluid may be drawn into one or more syringes 132, or fluid may be delivered from one or more syringes 132. In a first position, such as during filling of the syringe 132, one or more valves 136 are oriented so that fluid flows from the bulk fluid source 120 through a fluid inlet line 150, such as the MUDS fluid path 134, into the desired syringe 132. During the filling procedure, one or more valves 136 are arranged so that the flow of fluid through one or more fluid outlet lines 152 or the manifold 148 is blocked. In a second position, such as during a fluid delivery procedure, fluid from one or more syringes 132 is delivered to the manifold 148 through one or more fluid outlet lines 152 or syringe valve outlet ports.

[0072] During the fluid delivery procedure, one or more valves 136 may be arranged so that the flow of fluid through one or more fluid inlet lines 150 is blocked. In a third position, all fluid flow into and out of one or more syringes 132 can be blocked, for example, by orienting one or more valves 136 to a position where there is no fluid flow between the interior of the syringe 132 and either the fluid inlet line 150 or one or more fluid outlet lines 152 / manifold 148. One or more valves 136, fluid inlet lines 150, and / or fluid outlet lines 152 may be incorporated into the manifold 148. One or more valves 136 can be selectively arranged in the first position, the second position, or the third position by manual or automatic handling. For example, an operator can position one or more valves 136 in a desired position for filling or fluid delivery. In other examples, at least a portion of the fluid injector system 100 is operable to automatically position one or more valves 136 in a desired position for filling or fluid delivery based on an input by an operator, as described herein. For example, the operator input may be entered via the user interface 124.

[0073] Continuing to refer to FIG. 3, in some examples or aspects, the fluid outlet line 152 may also be connected to a waste reservoir 156 on the fluid injector system 100. The waste reservoir 156 is desirably separated from the syringe 132 to prevent contamination. In some examples or aspects, the waste reservoir 156 is configured to receive waste fluid discharged from the syringe 132, for example, during a priming operation. The waste reservoir 156 may be removable from the housing 102 to dispose of the contents of the waste reservoir 156. In other examples, the waste reservoir 156 can have a drain port (not shown) for emptying the contents of the waste reservoir 156 without removing the waste reservoir 156 from the housing 102. In some examples or aspects, the waste reservoir 156 is provided as a separate component from the MUDS 130.

[0074] Referring to FIG. 4, a fluid path set 160 according to an example or aspect of the present disclosure is shown. The fluid path set 160 is configured to connect to a connection port 128 (shown in FIG. 2A) on at least a portion of the housing 102 of the MUDS 130 and / or the fluid injector system 100. The connection port 128 may be in fluid communication with the fluid outlet line 152 on the MUDS 130. Desirably, the connection between the fluid path set 160 and the connection port 128 is a releasable connection that allows the fluid path set 160 to be selectively disconnected from and connected to the connection port 128. In some examples or aspects, the fluid path set 160 may be disconnected from the connection port 128 and discarded after each fluid delivery procedure, and a new fluid path set 160 may be connected to the connection port 128 for subsequent fluid delivery procedures.

[0075] Continuing to refer to FIG. 4, the fluid path set 160 has a fluid inlet port 164 configured for releasable connection with the connection port 128, and the fluid inlet port 164 receives fluid delivered from the fluid injector system 100 from the connection port 128. The fluid path set 160 further has a fluid outlet port 166 configured for connection to the vascular access device 168. In some examples or embodiments, the fluid outlet port 166 can be a luer-type fitting or other connection mechanism configured for connection to the vascular access device 168. The fluid inlet port 164 and the fluid outlet port 166 are fluidly connected by a first tubing 170 having a first lumen 171.

[0076] Continuing to refer to FIG. 4, in some examples or embodiments, the vascular access device 168 can be a peripheral line configured for placement within the microvasculature of a patient's arm or leg. In other examples or embodiments, the vascular access device 168 can be a central line configured for placement within a larger blood vessel of the patient. Examples of various vascular access devices 168 include, but are not limited to, a peripheral intravenous catheter (PIV), a midline catheter, a peripherally inserted central catheter (PICC), a central venous catheter (CVC), and an implanted port. In some examples or embodiments, the vascular access device 168 can have a connector 172 configured for connection to the fluid outlet port 166. The vascular access device 168 further comprises a second tubing 174 having a second lumen 175. The distal end 176 of the vascular access device 168 is placed within the blood vessel and is configured to enable fluid delivery to the blood vessel.

[0077] Since the structure of the fluid injector system 100 has been described, the exemplary injection procedure will now be described with reference to FIG. 5. The injection procedure executed by the fluid injector system 100 can be enabled by a computer program. The computer program product can include at least one non-transitory computer-readable medium having one or more instructions executable by at least one processor to cause the at least one processor to execute all or part of the injection procedure. In some examples or aspects, the at least one non-transitory computer-readable medium and the at least one processor can each include, or can correspond to, the memory 206 and the processor 204, as described in more detail later with reference to FIG. 10. In some examples or aspects, the injection procedure can be configured as an injection procedure protocol having a group of preselected parameters, such as, for example, the flow rate, amount, and type of fluid to be injected. The injection procedure protocol can have one or more sub-protocols, such as a test injection protocol or a diagnostic injection protocol. Depending on the imaging procedure, the clinician can design an injection procedure protocol having the desired test injection sub-protocol and the desired diagnostic injection sub-protocol. Selection and input of the protocol, injection parameters, saving and editing of injection phase information and delays, etc. may be performed via the user interface 124 of the fluid injector system 101.

[0078] The injection procedure protocol may be set up such that the test injection procedure sub-protocol is executed first, whereby the clinician can verify the patency of the injection site. After the test injection procedure sub-protocol is completed, the diagnostic injection procedure sub-protocol may be executed, during which at least one diagnostic injection phase is executed, and according to this diagnostic injection phase, at least one fluid will be injected into the patient so as to result in the enhancement of at least one region of interest. In some examples or aspects, the test injection procedure may be performed independently of and not as part of the injection procedure protocol. As described herein, the test injection procedure may, in some cases, assist the clinician in ensuring proper placement of a needle, cannula, catheter, central line, or other vascular access device within the patient's vascular structure, ensuring that the end of the vascular structure is clear (i.e., not coagulated or otherwise blocked) and is fully inserted into the blood vessel without piercing the wall.

[0079] Continuing to refer to FIG. 5, in step 200, an injection procedure protocol is selected. In some examples or embodiments, the injection procedure protocol may be stored in the controller 123 of the fluid injector system 100 as part of a protocol library. The desired injection procedure protocol may be invoked via the user interface 124. In some examples or embodiments, when a desired injection procedure protocol is selected, a test injection protocol for that injection procedure is automatically selected. In other examples or embodiments, the user may independently select a desired test injection protocol to be executed as part of the overall injection procedure protocol. For example, the test injection procedure may be selected in step 202 by pressing or selecting a button 126 on the housing 102 or the user interface 124. In some examples or embodiments, the button 126 may have a label such as "Test Injection" to indicate that pressing or selecting the button 126 enables a test injection procedure for performing an integrity check. Pressing or selecting the button 126 may display a menu of commands available on the user interface 124 for controlling or editing the test injection protocol.

[0080] Continuing to refer to FIG. 5, in steps 202a, 202b, 202c, one of a plurality of test injection protocols may be selected. In some examples or aspects, the selection of the test injection protocol may be automatically performed by the selection of the overall injection protocol in step 200. In other examples or aspects, the user may independently select the desired test injection protocol. For example, the user interface 124 may present a menu having a plurality of available test injection protocols. The user may select the desired test injection protocol based on the desired fluid, the flow rate of the fluid during the test injection procedure, and / or the amount of fluid delivered during the test injection procedure. In some examples or aspects, the user may select, in step 202, one of the following test injection protocols, namely (a) a fixed single-phase test injection (202a), (b) a variable single-phase test injection (202b), or (c) a multi-phase test injection (202c).

[0081] In a fixed single-phase test injection (202a), the controller 123 controls the fluid injector 101 to deliver a fixed amount of fluid at a target flow rate. Continuing to refer to FIG. 5, prior to initiating the test injection, at step 204a, the user can select at least one of the amount and flow rate of the fluid to be delivered to the patient during the test injection procedure. In some examples or embodiments, the user interface 124 can display proposed amount and / or flow rate values that simulate the test injection conditions for the diagnostic injection procedure to be followed. This amount and flow rate may be pre-set, and the user may be permitted to change the pre-selected values prior to initiating the test injection procedure. The amount of the fixed single-phase test injection (202a) can be based on a pre-set default or a historical amount used in a previous test injection procedure. In some examples or embodiments, this amount can be changed prior to initiating the test injection procedure. For example, an interface for adjusting the amount of fluid delivered during the fixed single-phase test injection (202a) can be displayed on the user interface 124, so that the user can increase or decrease the desired amount of fluid from the pre-set default by making appropriate selections on the user interface 124. Similarly, the flow rate of the fixed single-phase test injection (202a) can be based on a pre-set default or a historical flow rate used in a previous test injection procedure. In some examples or embodiments, the flow rate can be changed prior to initiating the test injection procedure. For example, an interface for adjusting the flow rate of the fluid delivered during the fixed single-phase test injection (202a) can be displayed on the user interface 124, so that the user can increase or decrease the desired flow rate from the pre-set default by making appropriate selections on the user interface 124.

[0082] Continuing to refer to FIG. 5, after selecting the desired amount and flow rate of the fixed single-phase test injection (202a) in step 204a, the selected fixed single-phase test injection (202a) is executed in step 206a. In this step, fluid F from at least one reservoir 132 is delivered to the patient via fluid path set 160 by driving fluid F from at least one reservoir 132 using fluid injector 101. For example, the fixed single-phase test injection (202a) can include the injection of one fluid, such as saline, at the preselected amount and flow rate selected in step 204a. The fixed single-phase test injection (202a) can be initiated, for example, by selecting a labeled button 126 labeled "Start" on user interface 124. A graph showing the flow rate of the fixed single-phase test injection (202a) as a function of time is shown in FIG. 6. At time T1 indicating the start of the test injection, fluid injector 101 rapidly increases the flow rate to target flow rate F1. This target flow rate is maintained throughout the test injection until a predetermined amount of fluid is delivered, at which point the test injection ends at time T2.

[0083] During the test injection, the user evaluates the test injection by visually observing and / or palpating the injection site. The user can further observe the quality of the image achieved at a preselected volume and flow rate. At the end of a fixed single-phase test injection (202a), such as when a predetermined volume of fluid has been delivered, the fluid injector 101 can automatically end the test injection procedure at step 208a. In some examples or aspects, the user can have the option to end the test injection procedure at any time during the test injection, for example, by selecting or pressing a button labeled "End" to stop the delivery of fluid to the fluid injector 101. In some examples or aspects, after the test injection procedure has ended, a diagnostic injection protocol can be initiated at step 210a. In some examples or aspects, the diagnostic injection protocol at step 210a can include at least one diagnostic injection phase, and according to this diagnostic injection phase, at least one fluid is to be injected into the patient to bring about an enhancement of at least one region of interest of the patient over the scan time of the imaging diagnostic procedure. The flow rate at which at least one fluid is to be injected during at least one diagnostic injection phase can be automatically adjusted based on the desired flow rate determined during the execution of the test injection procedure at steps 206a - 208a.

[0084] Continuing to refer to FIG. 5, in a variable single-phase test injection (202b), the controller 123 controls the fluid injector 101 to deliver fluid at a first flow rate and enables a change from the first flow rate to a second flow rate during the test injection procedure. In some examples or aspects, the first flow rate can be higher or lower than the second flow rate. The second flow rate can correspond to the rate at which fluid is to be injected during the diagnostic test procedure. The user can manually increase or decrease the flow rate from the first flow rate to the second flow rate as the test injection progresses. In some examples or aspects, the user can observe a pressure graph on the fluid injector system 100 during the variable single-phase test injection and increase or decrease the flow rate based on the output of the pressure graph.

[0085] Before starting the test injection, at step 204b, the user can select at least one of the amount of fluid and the first flow rate that should be delivered to the patient at the start of the test injection procedure. This amount and the first flow rate may be pre-set, and the user may be permitted to change the pre-selected values before starting the test injection procedure. The amount of the variable single-phase test injection (202b) can be based on a pre-set default or a historical amount used in a previous test injection procedure. In some examples or aspects, this amount can be changed before starting the test injection procedure. For example, an interface for adjusting the amount of fluid delivered during the variable single-phase test injection (202b) can be displayed on the user interface 124, so that the user can increase or decrease the desired amount of fluid from the pre-set default by making appropriate selections on the user interface 124. Similarly, the first flow rate of the variable single-phase test injection (202b) can be based on a pre-set default or a historical flow rate used in a previous test injection procedure. In some examples or aspects, the first flow rate can be changed before starting the test injection procedure. For example, an interface for adjusting the first flow rate of the fluid delivered during the variable single-phase test injection (202b) can be displayed on the user interface 124, so that the user can increase or decrease the desired first flow rate from the pre-set default by making appropriate selections on the user interface 124.

[0086] After selecting the desired amount and the first flow rate of the variable single-phase test injection (202b), the selected variable single-phase test injection (202b) is performed in step 206b. In this step, fluid F from at least one reservoir 132 is delivered to the patient via the fluid path set 160 by driving fluid F from at least one reservoir 132 using the fluid injector 101. For example, the variable single-phase test injection (202b) can include the injection of one fluid, such as saline, at the preselected amount and the first flow rate selected in step 204b. The variable single-phase test injection (202b) can be initiated, for example, by selecting a button 126 labeled "Start" on the user interface 124.

[0087] During the test injection, the user evaluates the test injection by visually observing and / or palpating the injection site. At step 207b, the user can choose to adjust or change the flow rate of the fluid from a first flow rate to a second flow rate or a target flow rate when the fluid is being delivered. For example, the user can increase or decrease the flow rate from the first flow rate to the second flow rate. In some examples or embodiments, such as those shown in FIG. 9A, an interface for adjusting the flow rate during the test injection can be displayed on the user interface 124, so that the user can increase or decrease the desired flow rate from the first flow rate by making appropriate selections on the user interface 124. For example, as shown in FIG. 9A, the user interface 124 can have a control element 127 for increasing or decreasing the flow rate during the test injection. Although FIG. 9A shows the control element 127 as a button displayed on the user interface 124, the control element 127 can be a physical element. The user can further observe a pressure graph 129 of the first flow rate on the user interface 124. Increasing or decreasing the flow rate through the user interface 124 during the test injection affects the corresponding pressure graph 129, thereby enabling the user to determine the optimal flow rate to be used during the diagnostic injection procedure. In other words, live adjustment of the flow rate can be performed based on the observed feedback from the injection site, the pressure graph 129, and the patient's reaction.

[0088] Referring to FIG. 9A, region 131 of user interface 124 identifies the flow rate of the variable single-phase protocol, and region 133 identifies the amount of fluid to be delivered. Region 135 identifies the type of fluid to be delivered. Since the severity of saline infiltration into the patient's tissue when the injection site is not open is not as severe as when contrast is used, saline is typically used for the test injection. Before starting the test injection procedure, the user can change these parameters and thereby switch to the protocol editing mode or user interface by pressing any of these regions. In this mode / user interface, the user can change and save the flow rate, amount, and type of fluid to the desired flow rate, amount, and type. User interface 124 can further include a control unit 143 for temporarily stopping the injection and a control unit 145 for stopping the injection.

[0089] In other examples or aspects, the fluid injector 101 can have one or more physical buttons 126 or dials for adjusting the flow rate during a test injection. In some examples, the user can make multiple adjustments to the flow rate from a first flow rate. For example, the user can first increase (or decrease) the flow rate from the first flow rate to a second flow rate and then continue with one or more flow rate adjustments from the second flow rate. In some examples or aspects, the user can continue to increase (or decrease) the flow rate until the pressure graph 129 shows a desired pressure value. At the end of the variable single-phase test injection (202b), the fluid injector 101 can automatically end the test injection procedure at step 208b. In some examples or aspects, the user can have the option to end the test injection procedure at any time during the test injection, for example, by selecting or pressing a button labeled "End" to stop the delivery of fluid to the fluid injector 101. In some examples or aspects, after ending the test injection procedure, the diagnostic injection protocol can start at step 210b. In some examples or aspects, the diagnostic injection protocol at step 210b can include at least one diagnostic injection phase, and according to this diagnostic injection phase, at least one fluid will be injected into the patient to bring about enhancement of at least one region of interest of the patient over the scan time of the imaging diagnostic procedure. The flow rate at which at least one fluid should be injected during at least one diagnostic injection phase can be automatically adjusted based on the desired flow rate determined during the execution of the test injection procedure in steps 206b - 208b.

[0090] Depending on the results of the test injection procedure, the user can adjust the injection parameters of the diagnostic injection procedure. For example, the user can adjust the pre-programmed flow rate of the diagnostic injection procedure, such as by increasing or decreasing the flow rate based on observations made during the test injection procedure, such as the output of the pressure graph.

[0091] An exemplary graph showing the flow rate of the variable single-phase test injection (202b) as a function of time is shown in FIG. 7. At time T1 indicating the start of the test injection, the fluid injector 101 rapidly increases the flow rate to a first flow rate F1. During the test injection process, the user can increase the flow rate from the first flow rate F1 to a second flow rate or a target flow rate F2 at time T2. FIG. 7 shows that the second flow rate or the target flow rate F2 is higher than the first flow rate F1, but the second flow rate or the target flow rate F2 may be lower than the first flow rate F1. Further, each flow rate is shown as having the same duration, but the durations of each flow rate may be different. Further, FIG. 7 shows the change from the first flow rate F1 to the second flow rate or the target flow rate F2 as a step function, but this change can be gradually achieved as a ramp function. The test injection ends at time T3.

[0092] Referring to FIG. 5, in the multi-phase test injection (202c), the controller 123 controls the fluid injector 101 to deliver one or more fluids in a plurality of phases. The plurality of phases can be stored in the controller 123 as a test injection protocol. Before starting the test injection, the user can select one from a plurality of stored multi-phase test injection protocols. Each multi-phase test injection protocol has at least two phases, and each phase defines a flow rate and a duration (i.e., the amount to be injected). Each phase can have a preset amount and flow rate. In some examples or aspects, each phase can have a programmed flow rate that gradually increases.

[0093] In some examples or embodiments, at step 204c, the user may be permitted to change the preselected values for each phase before initiating the test injection procedure. In some examples or embodiments, the user can define a new test injection protocol by selecting the desired fluid, flow rate, and amount to be delivered in each phase of the multi-phase test injection. The multi-phase test injection (202c) can use one or more fluids. For example, the multi-phase test injection (202c) can use a contrast agent and saline, and a saline flush can follow the injection of the contrast agent, or a bolus of the contrast agent can be surrounded by a slug of saline. In further examples, the multi-phase test injection (202c) can be performed using only the contrast agent or only saline.

[0094] Referring to FIG. 9B, the user interface 124 can have an area 137 that identifies the flow rate for each phase of the multi-phase test injection protocol, and area 139 identifies the amount of fluid to be delivered during each phase. Area 141 identifies the type of fluid to be delivered to each phase. Before initiating the multi-phase test injection procedure, the user can change these parameters by pressing on any of these areas, thereby switching to a protocol editing mode or user interface. In this mode / user interface, the user can change and save the flow rate, amount, and type of fluid to the desired flow rate, amount, and type of fluid for each phase of the multi-phase test injection protocol. The user interface 124 can further have a control 147 for initiating the injection, a control 143 for pausing the injection temporarily, and a control 145 for stopping the injection.

[0095] After selecting the desired multi-phase test injection (202c), the selected multi-phase test injection (202c) is executed in step 206c. In this step, fluid F from at least one reservoir 132 is delivered to the patient via the fluid path set 160 by driving the fluid F from at least one reservoir 132 using the fluid injector 101. The multi-phase test injection (202c) can be initiated, for example, by selecting a button 126 labeled "Start" on the user interface 124.

[0096] During the test injection, the user evaluates the test injection by visually observing and / or palpating the injection site. The user can further observe the quality of the images achieved at various phases of the selected multi-phase protocol. At the end of the multi-phase test injection (202c), the fluid injector 101 can automatically end the test injection procedure in step 208c. In some examples or embodiments, the user can have the option to end the test injection procedure at any time during the test injection, for example, by selecting or pressing a button labeled "End" to stop the delivery of fluid to the fluid injector 101.

[0097] An exemplary graph showing the flow rate of the multi-phase test injection (202c) as a function of time is shown in FIG. 8. A 3-phase protocol using a single fluid is shown, although other test injection protocols can have fewer or more phases using one or more fluids. At time T1 indicating the start of the first phase of the test injection, the fluid injector 101 rapidly increases the flow rate of the first fluid to the first flow rate F1. At the end of the first phase at time T2, the first flow rate F1 can be automatically increased to the second flow rate F2 during the second phase. FIG. 8 shows that the second flow rate F2 is higher than the first flow rate F1, although the second flow rate F2 can be lower than the first flow rate F1. At the end of the second phase at time T3, the second flow rate F2 can be automatically increased to the third flow rate F3 during the third phase. The third flow rate F3 can be the target flow rate. FIG. 8 shows that the third flow rate F3 is higher than the second flow rate F2, although the third flow rate F3 can be lower than the second flow rate F2. Further, each flow rate is shown as having the same duration, although the durations of each flow rate can be different. Further, FIG. 8 shows the change from the first flow rate F1 to the second flow rate F2 and the change from the second flow rate F2 to the third flow rate F3 as step functions, although these changes can be implemented gradually as ramp functions. The third phase of the test injection ends at time T4.

[0098] Variable single-phase test injection (202b) and multi-phase test injection (202c) provide several advantages during the test injection procedure. Starting the test injection procedure at a low flow rate and subsequently increasing the flow rate improves patient comfort during the procedure. Since the patient is accustomed to how a liquid injection feels at a low flow rate, the patient is less likely to become anxious due to an increase in the flow rate during the same test injection. In variable single-phase test injection, if the patient is not satisfied with the high flow rate, the user can reduce the flow rate. Multi-phase test injection provides the ability to enable complex test injections as part of an overall injection protocol that can be integrated into a diagnostic protocol, thereby improving the speed and efficiency of the entire procedure.

[0099] Referring now to FIG. 10, FIG. 10 is a diagram of an example of components of the fluid injector system 100 shown in FIGS. 1, 2A-2B, and 3. These components include a bus 202, a processor 204, a memory 206, a storage component 208, an input component 210, an output component 212, and a communication interface 214.

[0100] The bus 202 can include one or more components that enable communication between the other components shown in FIG. 10. In some non-limiting embodiments or aspects, the processor 204 can be implemented in hardware, firmware, or a combination of hardware and software. For example, the processor 204 can include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform functions (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc.). The memory 206 can include a random access memory (RAM), a read only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions for use by the processor 204.

[0101] The storage component 208 can store information and / or software related to the operation and use of the fluid injector system 100. For example, the storage component 208 can include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium, along with a corresponding drive device.

[0102] The input component 210 can include one or more components that enable the fluid injector system 100 to receive information via one or more user interfaces 124, keyboards, keypads, mice, buttons, switches, microphones, etc. Additionally, or alternatively, the input component 210 can include sensors for sensing information (e.g., a global positioning system (GPS) component, accelerometer, gyroscope, actuator, etc.). The output component 212 can include one or more components (e.g., one or more user interfaces 124, speakers, one or more light-emitting diodes (LEDs), etc.) that provide output information from the fluid injector system 100.

[0103] The communication interface 214 can include a component such as a transceiver (e.g., a transceiver, separate receiver, and transmitter, etc.) that enables the fluid injector system 100 to communicate with other devices via a wired connection, wireless connection, or a combination of wired and wireless connections, etc. The communication interface 214 can enable the fluid injector system 100 to receive information from and / or provide information to other devices. For example, the communication interface 214 can include an Ethernet interface, optical interface, coaxial interface, infrared interface, radio frequency (RF) interface, universal serial bus (USB) interface, Wi-Fi® interface, cellular network interface, and / or the like.

[0104] The fluid injector system 100 can execute one or more of the processes described herein. The fluid injector system 100 can execute these processes based on a processor 204 that executes software instructions stored by a computer-readable medium such as a memory 206 and / or a storage component 208. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. The memory device includes a memory space disposed within a single physical storage device or a memory space spanning multiple physical storage devices.

[0105] The software instructions may be read into the memory 206 and / or the storage component 208 from another computer-readable medium or from another device via a communication interface 214. When executed, the software instructions stored in the memory 206 and / or the storage component 208 can cause the processor 204 to execute one or more of the processes described herein. Additionally, or alternatively, instead of software instructions or in combination with software instructions, a wired circuit may be used to execute one or more of the processes described herein. Accordingly, the embodiments or aspects described herein are not limited to a particular combination of hardware circuitry and software.

[0106] The number and arrangement of the components shown in FIG. 10 are provided by way of example. In some non-limiting embodiments or aspects, the fluid injector system 100 can include additional components, fewer components, different components, or differently arranged components than those shown in FIG. 10. Additionally, or alternatively, one set of components of the fluid injector system 100 (e.g., one or more components) can execute one or more functions described as being performed by another set of components of the fluid injector system 100.

[0107] Some examples or aspects of systems and methods for testing the receptivity of vascular access using an electro - dynamic fluid injector are shown in the accompanying drawings and described in detail above. However, other examples or aspects will be apparent to those skilled in the art and can be readily made by those skilled in the art without departing from the scope and spirit of the present disclosure. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any example or aspect can be combined with one or more features of other examples or aspects. Accordingly, the foregoing description is illustrative rather than limiting.

Description of the reference numerals

[0108] 100 Electro - dynamic fluid injector system 100" Fluid injector system 101 Injector, fluid injector 102 Injector housing 103 Driving member 104 Opposite side 106 Distal end, upper end 108 Proximal end, lower end 110 Base 112 Wheel 114 Handle 116 Door 118 Bulk fluid connector 120 Bulk fluid source 122 Support member 123 Fluid control module, controller 124 User interface 126 Control button 127 Control element 128 Slot, connection port 129 Pressure graph 130 Multi - patient disposable set (MUDS) 131 Region 132 Reservoir, syringe 133 Region 134 MUDS fluid path 135 Region 136 Valve 137 area 138 syringe body 139 area 140 front end, distal end 141 area 142 rear end, proximal end 143 control unit for temporarily stopping injection 144 plunger, syringe plunger 145 control unit for stopping injection 146 discharge port or conduit 147 control unit for starting injection 148 manifold 150 fluid inlet line 152 fluid outlet line 156 waste reservoir 160 fluid path set 164 fluid inlet port 166 fluid outlet port 168 vascular access device 170 first tubing 171 first lumen 172 connector 174 second tubing 175 second lumen 176 distal end 204 processor 206 memory 208 storage component 210 input component 212 output component 214 communication interface

Claims

Claim 1 A fluid injector system comprising at least one drive member operably associated with a controller to enable injection of at least one fluid contained within at least one fluid container into a patient, wherein the controller includes a programming system to enable programming of at least one diagnostic injection procedure including at least one diagnostic injection phase, and according to the at least one diagnostic injection phase, the at least one fluid is to be injected into the patient so as to effect enhancement of at least one region of interest of the patient over a scan time of an imaging diagnostic procedure, wherein the programming system is further for enabling programming of a test injection procedure to be performed prior to the diagnostic injection procedure, the test injection procedure being a variable single-phase test injection, wherein a flow rate at which the at least one fluid is to be delivered is selectable prior to execution of the variable single-phase test injection and is variable between a first flow rate and a second flow rate different from the first flow rate during execution of the variable single-phase test injection, and is executable as, a fluid injector system. Claim 2 The fluid injector system of claim 1, wherein the test injection procedure is a multi-phase test injection, wherein the flow rate at which the at least one fluid is to be delivered is selectable for each phase of the multi-phase test injection prior to execution of the multi-phase test injection, and is further executable as at least one of the multi-phase test injection and a fixed single-phase test injection in which the flow rate at which the at least one fluid is to be delivered and the amount of the at least one fluid to be delivered are fixed. Claim 3 The fluid injector system of claim 1, wherein the at least one fluid to be delivered during the variable single-phase test injection is saline. Claim 4 The fluid injector system of claim 2, wherein the at least one fluid to be delivered during at least one phase of the multi-phase test injection is saline. Claim 5 The fluid injector system according to claim 1, wherein, in the case of the variable single-phase test injection, the amount of the at least one fluid to be delivered is selectable before the execution of the variable single-phase test injection.

6. The fluid injector system according to claim 2, wherein, in the case of the multi-phase test injection, the amount of the at least one fluid to be delivered is selectable before the execution of the multi-phase test injection.

7. The fluid injector system according to claim 2, wherein, in the case of the multi-phase test injection, the amount of the at least one fluid to be delivered is different for each phase of the multi-phase test injection.

8. The fluid injector system according to claim 2, wherein, in the case of the multi-phase test injection, the flow rate at which the at least one fluid is to be delivered is different for each phase of the multi-phase test injection.

9. The fluid injector system according to claim 1, wherein the flow rate at which the at least one fluid is to be delivered during the execution of the variable single-phase test injection is changed by changing the speed of the at least one drive member.

10. The fluid injector system according to claim 1, wherein the speed of the at least one drive member is changed by manual input using a control element.

11. The fluid injector system according to claim 10, wherein the control element is one or more buttons or dials.

12. The fluid injector system according to claim 1, wherein the programming system is further configured to enable adjustment of the flow rate at which the at least one fluid is to be delivered during the at least one diagnostic injection phase based on a desired flow rate determined during the execution of the variable single-phase test injection.

13. The fluid injector system according to claim 2, wherein the multi-phase test injection includes at least a first phase having a first phase flow rate and a second phase following the first phase, and the second phase has a second phase flow rate.

14. The fluid injector system according to claim 13, wherein the second phase flow rate is different from the first phase flow rate.

15. The fluid injector system according to claim 13, wherein the second phase flow rate is higher than the first phase flow rate.

16. The fluid injector system of claim 1, wherein the test injection procedure and the at least one diagnostic injection procedure define an overall injection protocol.

17. A non-transitory computer-readable medium for enabling programming of a test injection procedure to be performed using a fluid injector system prior to a diagnostic injection procedure, the non-transitory computer-readable medium including one or more instructions that, when executed by at least one processor, cause the at least one processor to enable a user to select, via the fluid injector system, the test injection procedure to be performed as a variable single-phase test injection, such that upon selection of the variable single-phase test injection, a flow rate at which at least one fluid is to be delivered during the variable single-phase test injection is selectable prior to execution of the variable single-phase test injection and is variable between a first flow rate and a second flow rate different from the first flow rate during execution of the variable single-phase test injection.

18. The one or more instructions, when executed by at least one processor, further cause the at least one processor to enable the user to select, via the fluid injector system, a multi-phase test injection, wherein upon selection of the multi-phase test injection, a flow rate at which at least one fluid is to be delivered during the multi-phase test injection is selectable for each phase of the multi-phase test injection prior to execution of the multi-phase test injection, and a fixed single-phase test injection, wherein upon selection of the fixed single-phase test injection, a flow rate at which at least one fluid is to be delivered during the fixed single-phase test injection and an amount of the at least one fluid to be delivered during the fixed single-phase test injection are fixed. The non-transitory computer-readable medium of claim 17.

19. The non-transitory computer-readable medium of claim 17, wherein the at least one fluid to be delivered during the variable single-phase test injection is saline.

20. The non-transitory computer-readable medium according to claim 18, wherein the at least one fluid to be delivered during at least one phase of the multi-phase test injection is physiological saline.

21. The non-transitory computer-readable medium according to claim 17, wherein in the case of the variable single-phase test injection, the amount of the at least one fluid to be delivered is selectable before the variable single-phase test injection is performed.

22. The non-transitory computer-readable medium according to claim 18, wherein in the case of the multi-phase test injection, the amount of the at least one fluid to be delivered is selectable before the multi-phase test injection is performed.

23. The non-transitory computer-readable medium according to claim 18, wherein in the case of the multi-phase test injection, the amount of the at least one fluid to be delivered is different for each phase of the multi-phase test injection.

24. The non-transitory computer-readable medium according to claim 18, wherein in the case of the multi-phase test injection, the flow rate at which the at least one fluid is to be delivered is different for each phase of the multi-phase test injection.

25. The fluid injector system further includes at least one drive member, and the flow rate at which the at least one fluid is to be delivered during the variable single-phase test injection is changed by changing the speed of the at least one drive member. The non-transitory computer-readable medium according to claim 17.

26. The fluid injector system further includes at least one drive member, and the speed of the at least one drive member is changed by manual input using a control element. The non-transitory computer-readable medium according to claim 17.

27. The non-transitory computer-readable medium according to claim 26, wherein the control element is one or more buttons or dials.

28. When the one or more instructions are executed by at least one processor, the flow rate at which the at least one fluid is to be delivered during at least one phase of the diagnostic injection procedure is based on the desired flow rate determined during the variable single-phase test injection. The non-transitory computer-readable medium according to claim 17, further configured to enable adjustment.

29. The non-transitory computer-readable medium according to claim 18, wherein the multi-phase test injection includes at least a first phase having a first-phase flow rate and a second phase following the first phase, and the second phase has a second-phase flow rate.

30. The non-transitory computer-readable medium according to claim 29, wherein the second-phase flow rate is different from the first-phase flow rate.

31. The non-transitory computer-readable medium according to claim 29, wherein the second-phase flow rate is higher than the first-phase flow rate.

32. The non-transitory computer-readable medium according to claim 17, wherein the test injection procedure and the diagnostic injection procedure define an overall injection protocol.

33. A method executed by a computer for performing a test injection procedure using a fluid injector system having at least one drive member configured to inject at least one fluid contained within at least one fluid container into a patient, the method comprising: using at least one processor to drive the at least one drive member at a first drive speed to deliver the at least one fluid at a first flow rate; changing the first drive speed to a second drive speed different from the first drive speed to change the flow rate at which the at least one fluid is delivered from the first flow rate to a second flow rate different from the first flow rate; comprising: the step of changing the first drive speed to the second drive speed includes: receiving user input during a variable single-phase test injection via a control element operably connected to the at least one processor. A method executed by a computer.

34. The method according to claim 33, wherein the step of changing the first drive speed to the second drive speed is a step of advancing to the next test injection phase of a multi-phase test injection using the at least one processor, the next test injection phase including the second drive speed.

35. The method according to claim 33, wherein the second drive speed is higher or lower than the first drive speed.

36. The method according to claim 33, further comprising using the at least one processor to select an amount of the at least one fluid to be delivered before driving the at least one drive member.

37. The method according to claim 33, further comprising the step of selecting the first driving speed using the at least one processor before driving the at least one driving member.

38. The method according to claim 33, further comprising the step of performing a diagnostic injection procedure following the test injection procedure, the diagnostic injection procedure including at least one diagnostic injection phase, and according to the at least one diagnostic injection phase, the at least one fluid being injected into the patient so as to bring about an enhancement of at least one region of interest of the patient over the scan time of an imaging diagnostic procedure.

39. The method according to claim 38, wherein the flow rate at which the at least one fluid is to be injected during the at least one diagnostic injection phase is based on a desired flow rate determined during the execution of the test injection procedure.

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