Preload the contrast injection protocol into the drug delivery line

Abstract

The fluid injector system includes a control device operably associated with at least one drive component, the at least one drive component being used to actuate a plurality of fluid containers in fluid communication with a patient through a drug delivery line. The control device includes at least one processor programmed or configured to allow programming of a diagnostic injection protocol including one or more stages, at least one of the first fluid container and the second fluid container being selectively actuatable by the at least one drive component according to the diagnostic injection protocol to allow injection of at least one of the first fluid and the second fluid into the patient. The control device is also programmed or configured to allow selection and execution of at least partially preloading at least one of the first fluid and the second fluid into the drug delivery line according to one or more stages of the diagnostic injection protocol.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 655,368, filed on April 10, 2018, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to a fluid injector system having a control device to allow at least one of a first fluid and a second fluid to be at least partially preloaded into a drug administration line according to one or more stages of a diagnostic injection protocol. The present disclosure also relates to a computer program product and a computer-implemented method that allows the first fluid and / or the second fluid to be at least partially preloaded into a drug administration line according to one or more stages of a diagnostic injection protocol of the type that can be performed by such a fluid injector system. Background Art

[0004] In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, infuses a patient with one or more medical fluids. In recent years, several medical fluid delivery systems have been developed for pressurized infusion of fluids, such as contrast solutions (often referred to simply as "contrast"), flushing agents such as saline, and other medical fluids, for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other molecular imaging procedures. In general, these medical fluid delivery systems are designed to deliver a preset amount of fluid at a preset flow rate.

[0005] Medical fluid delivery systems are usually connected to patients via dosing lines. However, the dosing lines must be filled with fluid to remove or flush air from the dosing lines before being attached to the patient, to remove air from the dosing lines. Once the air is removed, the fluid remains in the dosing lines and is ready to be injected into the patient during the initial stage of the injection process. Medical fluid delivery systems are usually calibrated to take into account the fluid volume of the dosing lines, and thus ensure that an appropriate amount of medical fluid is injected into the patient, regardless of the initial volume of the fluid used to perfuse the lines. However, the relatively large diameter and length of some dosing lines may cause a significant amount of additional fluid to be injected into the patient. In particular, if the patient is a child, the volume of fluid used to perfuse the dosing lines may represent a clinically significant amount of fluid relative to the patient's body size and blood volume. Some adult patients may also be particularly sensitive to injecting additional fluids for various clinical reasons. In addition, the volume of fluid used to perfuse the dosing lines may represent a significant amount of the total fluid delivered. In particular, during MRI procedures, where the total volume of contrast solution may be as low as 2 to 5 milliliters (ml), a typical administration line volume of 8 ml may result in injecting more than twice the amount of flushing / priming fluid as contrast solution. Summary of the invention

[0006] In view of the foregoing, a need exists for a method of operating a medical fluid delivery system without delivering unnecessary fluid to a patient.

[0007] The present disclosure is generally directed to systems, methods, and computer program products to allow administration lines of a fluid injector system to be at least partially preloaded according to one or more phases of a diagnostic infusion protocol.

[0008] According to some aspects and examples of the present disclosure, a fluid injector system may include a control device operably associated with at least one drive component for actuating a plurality of fluid containers. The plurality of fluid containers can be placed in fluid communication with a patient via a dosing line, a first fluid container of the fluid containers can be filled with a first fluid containing a contrast solution, and a second fluid container of the fluid containers can be filled with a second fluid containing an irrigant. The control device may include at least one processor, the at least one processor being programmed or configured to allow programming of a diagnostic injection scheme comprising one or more stages, according to which at least one fluid container of the first fluid container and the second fluid container can be selectively actuated by at least one drive component to allow at least one of the first fluid container and the second fluid container to be injected into the patient via the dosing line, thereby achieving enhancement of at least one region of interest thereof during the scan duration of a diagnostic imaging procedure. The control device may also be programmed or configured to allow selection and execution of at least one of the first fluid and the second fluid to be at least partially preloaded into the dosing line according to one or more stages of the diagnostic injection scheme upon completion of programming the diagnostic injection scheme and priming the dosing line with the second fluid.

[0009] According to some aspects and examples of the present disclosure, the fluid injector system may further include a user interface operably associated with at least one processor. The user interface may be configured to accept multiple user inputs associated with the control of multiple operations of the fluid injector system. A collection of multiple user inputs may be associated with the control of a corresponding collection of multiple operations, and the multiple operations are related to the selection and execution of allowing at least one of the first fluid and the second fluid to be at least partially preloaded into the administration line according to one or more stages of the diagnostic injection scheme.

[0010] According to some aspects and examples of the present disclosure, a set of multiple user inputs may include: selecting a preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection scheme into the drug administration line; executing the preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates multiple fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the drug administration line according to one or more stages of the diagnostic injection scheme; and disabling the preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0011] According to some aspects and examples of the present disclosure, the control device may also be programmed or configured to calculate the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme. Thus, when executing the preload command to enter the user interface, once it is determined according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is equal to the capacity of the administration line, the control device actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. The control device, once it is determined according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is less than the capacity of the administration line, actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme and the subsequent supplementary volume of the second fluid into the administration line according to one or more stages of the diagnostic injection scheme, the supplementary volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. Upon determining that the total volume of at least one of the first fluid and the second fluid to be injected is greater than the capacity of the administration line according to the diagnostic injection protocol, the control device actuates one or more of the multiple fluid containers and thereby preloads as much of at least one of the first fluid and the second fluid into the administration line as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol and retains the remainder of the diagnostic injection protocol within programming until the diagnostic injection protocol is performed on the patient, and thereby expel from the administration line the volume of the second fluid used to perfuse the administration line with the second fluid.

[0012] According to some aspects and examples of the present disclosure, a user interface may be configured to display information associated with a status of at least partially preloading at least one of the first and second fluids into a dosing line according to one or more phases of a diagnostic infusion protocol.

[0013] According to some aspects and examples of the present disclosure, a user interface can be configured to display at least one of the following: a total volume of at least one of the first fluid and the second fluid to be injected according to a diagnostic injection protocol, and for each of one or more stages of the diagnostic injection protocol, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be injected into the patient during administration of the patient.

[0014] According to some aspects and examples of the present disclosure, a first one of the fluid containers may include a syringe, and a second one of the fluid containers may include a syringe.

[0015] According to some aspects and examples of the present disclosure, a computer program product is disclosed to allow at least one of a first fluid and a second fluid to be at least partially preloaded into a drug delivery line according to one or more stages of a diagnostic injection scheme. The computer program product may include at least one non-transitory computer-readable medium, which includes one or more instructions, which, when executed by at least one processor, enable at least one processor to allow the diagnostic injection scheme to be programmed into a control device of a fluid injector system. The control device may be operably associated with at least one drive component for selectively actuating a plurality of fluid containers. The plurality of fluid containers may be capable of being placed in fluid communication with a patient through a drug delivery line, a first fluid container in the fluid container being capable of being filled with a first fluid containing a contrast solution, and a second fluid container in the fluid container being capable of being filled with a second fluid containing a flushing agent. When executed by at least one processor, the one or more instructions may also enable the at least one processor, upon completion of programming the diagnostic injection scheme and priming the drug delivery line with the second fluid, to allow the selection and execution of at least one of the first fluid and the second fluid being at least partially preloaded into the drug delivery line according to one or more stages of the diagnostic injection scheme.

[0016] According to some aspects and examples of the present disclosure, when executed by at least one processor, the one or more instructions may further cause the at least one processor to receive at least one of a plurality of user inputs associated with control of a plurality of operations of the fluid injector system from a user interface operably associated with the at least one processor. The set of the plurality of user inputs may be associated with control of a corresponding set of the plurality of operations, the plurality of operations being associated with selection and execution of allowing at least one of the first fluid and the second fluid to be at least partially preloaded into the administration line according to one or more stages of the diagnostic injection protocol.

[0017] According to some aspects and examples of the present disclosure, a set of multiple user inputs includes: selecting a preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection scheme into the drug administration line; executing the preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates multiple fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the drug administration line according to one or more stages of the diagnostic injection scheme; and disabling the preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0018] According to some aspects and examples of the present disclosure, when executed by at least one processor, one or more instructions may further cause the at least one processor to calculate the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme. Thus, when executing the preload command input into the user interface, the at least one processor, upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is equal to the capacity of the administration line, actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. The at least one processor, upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is less than the capacity of the administration line, actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme and the subsequent supplementary volume of the second fluid into the administration line according to one or more stages of the diagnostic injection scheme, the supplementary volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. At least one processor, upon determining that the total volume of at least one of the first fluid and the second fluid to be injected is greater than the capacity of the administration line according to the diagnostic injection protocol, actuates one or more fluid containers of a plurality of fluid containers, and thereby preloads as much of at least one of the first fluid and the second fluid into the administration line as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and retains the remainder of the diagnostic injection protocol within programming until the diagnostic injection protocol is performed on the patient, and thereby expel from the administration line the volume of the second fluid used to prime the administration line with the second fluid.

[0019] According to some aspects and examples of the present disclosure, when executed by at least one processor, one or more instructions may also cause the at least one processor to display, via a user interface, information associated with a status of at least partially preloading at least one of a first fluid and a second fluid into a dosing line according to one or more stages of a diagnostic injection protocol.

[0020] According to some aspects and examples of the present disclosure, when executed by at least one processor, one or more instructions may also cause the at least one processor to display, via a user interface, at least one of the following: a total volume of at least one of the first fluid and the second fluid to be injected according to a diagnostic injection protocol, and for each of one or more stages of the diagnostic injection protocol, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be injected into the patient during administration of the patient.

[0021] According to some aspects and examples of the present disclosure, a first one of the fluid containers may include a syringe, and a second one of the fluid containers may include a syringe.

[0022] According to some aspects and examples of the present disclosure, a computer-implemented method is disclosed to allow at least one of a first fluid and a second fluid to be at least partially preloaded into a dosing line according to one or more stages of a diagnostic injection protocol. The method includes programming the diagnostic injection protocol into a control device of a fluid injector system via at least one processor, and the control device is operably associated with at least one drive component for selectively actuating multiple fluid containers. Multiple fluid containers can be placed in fluid communication with a patient through a dosing line, a first fluid container in the fluid containers can be filled with a first fluid containing a contrast solution, and a second fluid container in the fluid containers can be filled with a second fluid containing a flushing agent. The method also includes, once the programming of the diagnostic injection protocol and the priming of the dosing line with the second fluid are completed, allowing, via at least one processor, the selection and execution of at least one of the first fluid and the second fluid to be at least partially preloaded into the dosing line according to one or more stages of the diagnostic injection protocol.

[0023] According to some aspects and examples of the present disclosure, the method may also include receiving, from a user interface operably associated with at least one processor, at least one of a plurality of user inputs associated with control of a plurality of operations of the fluid injector system. The plurality of user inputs may be associated with control of a corresponding set of a plurality of operations, the plurality of operations being associated with selection and execution of enabling at least one of the first fluid and the second fluid to be at least partially preloaded into the administration line according to one or more phases of the diagnostic injection protocol.

[0024] According to some aspects and examples of the present disclosure, a set of multiple user inputs may include: selecting a preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection scheme into the drug administration line; executing the preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates multiple fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the drug administration line according to one or more stages of the diagnostic injection scheme; and disabling the preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0025] According to some aspects and examples of the present disclosure, the method may further include calculating, with at least one processor, the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme. Thus, when executing the preload command input into the user interface, when the at least one processor determines that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme is equal to the capacity of the administration line, the control device actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. When the at least one processor determines that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme is less than the capacity of the administration line, the control device actuates one or more fluid containers of the plurality of fluid containers, and thereby preloads the total volume of the diagnostic injection scheme and the subsequent supplementary volume of the second fluid into the administration line according to one or more stages of the diagnostic injection scheme, the supplementary volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line. Upon determining with at least one processor that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is greater than the capacity of the administration line, the control device actuates one or more of the plurality of fluid containers and thereby preloads as much of at least one of the first fluid and the second fluid into the administration line as the capacity of the administration line will allow according to one or more phases of the diagnostic injection protocol and retains the remainder of the diagnostic injection protocol within programming until the diagnostic injection protocol is performed on the patient, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid

[0026] According to some aspects and examples of the present disclosure, the method may further include displaying, via a user interface, information associated with a status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol.

[0027] According to some aspects and examples of the present disclosure, the method may also include displaying at least one of the following through a user interface: a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol; and for each of one or more stages of the diagnostic injection protocol, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be injected into the patient during the patient's administration.

[0028] According to some aspects and examples of the present disclosure, a first one of the fluid containers may include a syringe, and a second one of the fluid containers may include a syringe.

[0029] Other examples of the present disclosure are described in the following non-limiting terms:

[0030] Item 1. A fluid injector system comprising: a control device operably associated with at least one drive component for actuating a plurality of fluid containers, the plurality of fluid containers being capable of being placed in fluid communication with a patient via a drug delivery line, a first fluid container of the fluid containers being capable of being filled with a first fluid comprising a contrast solution, and a second fluid container of the fluid containers being capable of being filled with a second fluid comprising an irrigation agent; and the control device comprising at least one processor, the at least one processor being programmed or configured to allow programming of a diagnostic injection scheme comprising one or more stages, according to which at least one of the first fluid container and the second fluid container is selectively actuable by the at least one drive component to allow at least one of the first fluid and the second fluid to be injected into the patient via the drug delivery line, thereby achieving enhancement of at least one region of interest thereof during the scan duration of a diagnostic imaging procedure; wherein the control device is further programmed or configured to allow selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the drug delivery line according to one or more stages of the diagnostic injection scheme, upon completion of programming of the diagnostic injection scheme and priming of the drug delivery line with the second fluid.

[0031] Item 2. The fluid injector system of Item 1, further comprising a user interface operably associated with the at least one processor, the user interface configured to accept a plurality of user inputs associated with control of a plurality of operations of the fluid injector system, wherein a set of the plurality of user inputs is associated with control of a corresponding set of a plurality of operations, the plurality of operations being related to allowing selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection scheme.

[0032] Clause 3. The fluid injector system of clause 1 or 2, wherein the set of multiple user inputs comprises:

[0033] a select preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system for at least partially preloading the diagnostic injection scheme into the administration line; an execute preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates the multiple fluid containers and thereby executes at least partially preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection scheme; and a disable preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0034] Clause 4. A fluid injector system as described in any of Clauses 1 to 3, wherein the control device is further programmed or configured to calculate the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme, so that when the execute preload command is input into the user interface, the control device: upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is equal to the capacity of the administration line, actuates one or more of the multiple fluid containers, and thereby preloads the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme, and thereby discharges the volume of the second fluid used to fill the administration line with the second fluid from the administration line; upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is less than the capacity of the administration line, actuates one or more of the multiple fluid containers, and thereby preloads the total volume of the diagnostic injection scheme into the administration line according to the diagnostic injection scheme. One or more stages of the protocol preload the administration line with a total volume of the diagnostic injection protocol and a subsequent supplemental volume of the second fluid, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to fill the administration line with the second fluid; and upon determining according to the diagnostic injection protocol that the total volume of at least one of the first and second fluids to be injected is greater than the capacity of the administration line, actuating one or more of the multiple fluid containers, and thereby preloading the administration line with as much of at least one of the first and second fluids as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and retaining the remainder of the diagnostic injection protocol within the programming until the diagnostic injection protocol is performed on the patient, and thereby expelling from the administration line the volume of the second fluid used to fill the administration line with the second fluid.

[0035] Clause 5. A fluid injector system as described in any of Clauses 1 to 4, wherein the user interface is configured to display information associated with a status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol.

[0036] Clause 6. A fluid injector system as described in any of Clauses 1 to 5, wherein the user interface is configured to display at least one of: the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol; and for each of one or more stages of the diagnostic injection protocol, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be injected into the patient during administration to the patient.

[0037] Clause 7. The fluid injector system of any of Clauses 1 to 6, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

[0038] Item 8. A computer program product for allowing at least one of a first fluid and a second fluid to be at least partially preloaded into a drug delivery line according to one or more stages of a diagnostic injection protocol, the computer program product comprising at least one non-transitory computer-readable medium, the at least one non-transitory computer-readable medium comprising one or more instructions that, when executed by at least one processor, cause the at least one processor to: allow the diagnostic injection protocol to be programmed into a control device of a fluid injector system, the control device being operably associated with at least one drive component for selectively actuating a plurality of fluid containers, the plurality of fluid containers being capable of being placed in fluid communication with a patient through the drug delivery line, a first fluid container of the fluid containers being capable of being filled with the first fluid comprising a contrast solution, and a second fluid container of the fluid containers being capable of being filled with the second fluid comprising an irrigation agent; and upon completion of programming of the diagnostic injection protocol and priming of the drug delivery line with the second fluid, allow selection and execution of at least one of the first fluid and the second fluid being at least partially preloaded into the drug delivery line according to one or more stages of the diagnostic injection protocol.

[0039] Clause 9. A computer program product as described in Clause 8, wherein when the one or more instructions are executed by at least one processor, the at least one processor is further caused to: receive at least one of a plurality of user inputs associated with the control of a plurality of operations of the fluid injector system from a user interface operably associated with the at least one processor, wherein a set of the plurality of user inputs is associated with the control of a corresponding set of a plurality of operations, the plurality of operations being related to allowing selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection scheme.

[0040] Clause 10. A computer program product as described in clause 8 or 9, wherein the set of multiple user inputs includes: a select preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system for at least partially preloading the diagnostic injection scheme into the drug administration line; an execute preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates the multiple fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the drug administration line according to one or more stages of the diagnostic injection scheme; and a disable preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0041] Clause 11. A computer program product as described in any of clauses 8 to 10, wherein when the one or more instructions are executed by at least one processor, the at least one processor is further caused to: calculate the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme, so that when the execution preload command is input into the user interface, the at least one processor: upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is equal to the capacity of the drug administration line, actuate one or more of the multiple fluid containers, and thereby preload the total volume of the diagnostic injection scheme into the drug administration line according to one or more stages of the diagnostic injection scheme, and thereby discharge the volume of the second fluid used to fill the drug administration line with the second fluid from the drug administration line; upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is less than the capacity of the drug administration line, actuate one or more of the multiple fluid containers actuating one or more of the plurality of fluid containers and thereby preloading the administration line with as much of the first fluid and the second fluid as the capacity of the administration line will allow according to one or more stages of the diagnostic infusion protocol and a subsequent supplemental volume of the second fluid, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic infusion protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; and upon determining according to the diagnostic infusion protocol that the total volume of at least one of the first fluid and the second fluid to be infused is greater than the capacity of the administration line, actuating one or more of the plurality of fluid containers and thereby preloading the administration line with as much of the first fluid and the second fluid as the capacity of the administration line will allow according to one or more stages of the diagnostic infusion protocol and retaining the remainder of the diagnostic infusion protocol within the programming until the diagnostic infusion protocol is performed on the patient, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid.

[0042] Clause 12. A computer program product as described in any of clauses 8 to 11, wherein when the one or more instructions are executed by at least one processor, the at least one processor is also caused to: display, via the user interface, information associated with the status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection scheme.

[0043] Clause 13. A computer program product as described in any of clauses 8 to 12, wherein when the one or more instructions are executed by at least one processor, the at least one processor is further caused to: display via the user interface at least one of: the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme; and for each of one or more stages of the diagnostic injection scheme, a specific volume of at least one of the first fluid and the second fluid, and the flow rate at which the specific volume is to be injected into the patient during the patient's administration.

[0044] Clause 14. The computer program product of any of Clauses 8 to 13, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

[0045] Clause 15. A computer-implemented method for allowing at least one of a first fluid and a second fluid to be at least partially preloaded into a drug administration line according to one or more phases of a diagnostic infusion protocol, the method comprising:

[0046] The diagnostic injection protocol is programmed into a control device of a fluid injector system via at least one processor, the control device being operably associated with at least one drive component for selectively actuating a plurality of fluid containers, the plurality of fluid containers being capable of being placed in fluid communication with a patient via a dosing line, a first fluid container of the fluid containers being capable of being filled with the first fluid comprising a contrast solution, and a second fluid container of the fluid containers being capable of being filled with the second fluid comprising an irrigation agent; and upon completion of programming of the diagnostic injection protocol and priming of the dosing line with the second fluid, allowing selection and execution via the at least one processor of at least partially preloading at least one of the first fluid and the second fluid into the dosing line according to one or more stages of the diagnostic injection protocol.

[0047] Clause 16. The computer-implemented method as described in Clause 15 further includes: receiving, from a user interface operably associated with the at least one processor, at least one of a plurality of user inputs associated with control of a plurality of operations of the fluid injector system, wherein a set of the plurality of user inputs is associated with control of a corresponding set of a plurality of operations related to allowing selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol.

[0048] Clause 17. A computer-implemented method as described in clause 15 or 16, wherein the set of multiple user inputs includes: a select preload command, when the select preload command is input into the user interface, the control device prepares the fluid injector system for at least partially preloading the diagnostic injection protocol into the administration line; an execute preload command, when the execute preload command is input into the user interface after the select preload command, the control device actuates the multiple fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol; and a disable preload command, when the disable preload command is input into the user interface after the select preload command, the control device disables the effect of the select preload command.

[0049] Clause 18. A computer-implemented method as described in any of Clauses 15-17, further comprising: calculating the total volume of at least one of the first fluid and the second fluid to be injected using the at least one processor according to the diagnostic injection scheme, so that when the execute preload command is input into the user interface, the control device: upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is equal to the capacity of the administration line, actuating one or more of the multiple fluid containers, and thereby preloading the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme, and thereby expelling the volume of the second fluid used to fill the administration line with the second fluid from the administration line; upon determining according to the diagnostic injection scheme that the total volume of at least one of the first fluid and the second fluid to be injected is less than the capacity of the administration line, actuating one or more of the multiple fluid containers, and thereby preloading the total volume of the diagnostic injection scheme into the administration line according to one or more stages of the diagnostic injection scheme One or more stages of the injection protocol preload the administration line with a total volume of the diagnostic injection protocol and a subsequent supplemental volume of the second fluid, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to fill the administration line with the second fluid; and upon determining according to the diagnostic injection protocol that the total volume of at least one of the first and second fluids to be injected is greater than the capacity of the administration line, actuating one or more of the multiple fluid containers, and thereby preloading the administration line with as much of at least one of the first and second fluids as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and retaining the remainder of the diagnostic injection protocol within the programming until the diagnostic injection protocol is performed on the patient, and thereby expelling from the administration line the volume of the second fluid used to fill the administration line with the second fluid.

[0050] Clause 19. A computer-implemented method as described in any of Clauses 15-18, further comprising: displaying, using the user interface, information associated with a status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol.

[0051] Clause 20. A computer-implemented method as described in any of Clauses 15-19, further comprising: displaying with the user interface at least one of: the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection scheme; and for each of one or more stages of the diagnostic injection scheme, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be injected into the patient during administration to the patient.

[0052] Clause 21. The computer-implemented method of any of Clauses 15-20, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

[0053] These and other features and characteristics of the fluid injector system, as well as the combination of computer program products and methods of operation and the functionality of related elements of the structure and economy of parts and manufacturing will become more apparent after consideration of the following description and illustrations. Reference is made to the appended claims with reference to the accompanying drawings, all of which constitute a part of this specification. It should be expressly understood, however, that the drawings are for illustration and description purposes only. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 is a perspective view of a multi-fluid delivery system according to an example;

[0055] Figure 2 yes Figure 1 Schematic diagram of various fluid paths within a multi-fluid delivery system;

[0056] Figure 3A is a perspective view of a connection interface prior to connecting a single use disposable set (SUDS) connector to a multi-fluid delivery system;

[0057] Figure 3B is a diagram showing a SUDS connector connected to a multi-fluid delivery system Figure 3A A stereogram of a connection interface;

[0058] Figure 4A yes Figure 3A and Figure 3B An enlarged perspective view of the SUDS connector shown in;

[0059] Figure 4B yes Figure 4A A longitudinal cross-sectional view of the SUDS connector shown in;

[0060] Figure 4C is connected to the port of the multi-fluid delivery system Figure 4A-4B A partial cross-sectional view of the SUDS connector shown in;

[0061] Figure 5 yes Figure 4C A perspective view of the SUDS connector shown in , with portions of the multi-fluid delivery system and a multi-patient disposable set (MUDS) connected thereto broken away;

[0062] Figure 6 is a schematic diagram of an electronic control system of a multi-fluid delivery system according to another example;

[0063] Fig. 7A is a schematic diagram of a partially preloaded single-use disposable kit connector according to one example;

[0064] Figure 7B is based on Fig. 7A A schematic diagram of an example fully preloaded single use disposable kit connector;

[0065] Figure 8 is a schematic diagram of a fully preloaded single-use disposable kit connector according to another example; and

[0066] Fig. 9 is a flowchart illustrating a method of preloading operation according to one example. DETAILED DESCRIPTION

[0067] For purposes of the description below, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives shall relate to the present disclosure as presented in the accompanying drawings. When used in connection with a syringe of a multi-patient disposable kit, the term "proximal" refers to the portion of the syringe closest to the piston element for delivering fluid from the syringe. When used in connection with a single-use disposable kit connector, the term "distal" refers to the portion of the syringe that is closest to the user or patient when the single-use disposable kit connector is oriented for connection to a multi-fluid injector system. When used in connection with a syringe of a fluid injector system, the term "distal" refers to the portion of the syringe that is closest to the delivery nozzle. When used in connection with a single-use disposable connector, the term "proximal" refers to the portion of the single-use disposable connector that is closest to the multi-fluid injector system when the single-use disposable connector is oriented for connection to the multi-fluid injector system.

[0068] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary examples of the present disclosure. Therefore, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered limiting.

[0069] Although mainly in The present disclosure is described in the context of the Centargo CT infusion system, and it will be apparent to one of ordinary skill in the art that the present invention can be applied to a variety of infusion systems, including their associated disposables (e.g., syringes, tubing, etc.). Examples of such infusion systems include the Centargo CT infusion system provided by Bayer Healthcare GmbH. Stellant CT injection system, Stellant FLEX CT injection system, MRXperion MR Infusion System and Mark 7 Arterion Infusion System.

[0070] Referring to the accompanying drawings, wherein like reference numerals refer to like parts throughout several of the drawings, the present disclosure generally relates to a multi-fluid medical injector / injection system 100 (hereinafter "fluid injector system 100") having a multi-patient disposable set (MUDS) 130 configured to deliver fluids to a patient using a single-use disposable set (SUDS) 190 connector. The fluid injector system 100 includes a plurality of components described separately herein. In general, the fluid injector system 100 has a powered injector or other drug delivery device and a fluid delivery kit intended to be associated with the injector to deliver one or more fluids under pressure to a patient from one or more multi-dose containers, as described herein. Various devices, components, and features of the fluid injector system 100 and the fluid delivery kit associated therewith are also described in detail herein.

[0071] refer to Figure 1 , the fluid injector system 100 includes an injector housing 102 having opposing lateral sides 104, a distal or upper end 106, and a proximal or lower end 108. In some examples, the housing 102 can be supported on a base 110 having one or more wheels 112 to rotatably and movably support the housing 102 on the ground. One or more wheels 112 can be lockable to prevent the housing 102 from unintentionally moving when positioned in a desired position. At least one handle 114 can be provided to facilitate moving and positioning the fluid injector system 100. In other examples, the housing 102 can be removably or non-removably fastened to a fixed surface, such as a floor, ceiling, wall or other structure. The housing 102 encloses various mechanical drive components, electrical power and power components required to drive the mechanical drive components, and control components, such as electronic memory and electronic control devices (hereinafter (multiple) electronic control devices) for controlling the reciprocatingly movable piston element 103 ( Figure 2Such a piston element 103 may be reciprocally operable via an electromechanical drive component (such as a ball screw driven by a motor, a voice coil actuator, a rack and pinion transmission, a linear motor, etc.). In some examples, at least some of the mechanical drive components, the power and power components, and the control components may be provided on the base 110.

[0072] Continue to refer Figure 1 , the fluid injector system 100 has at least one door 116 that encloses at least some of the MUDS, mechanical drive components, electrical and power components, and control components. The door 116 is desirably in an open position and a closed position ( Figure 1 In some examples, door 116 may be lockable.

[0073] The fluid injector system 100 also includes at least one bulk fluid connector 118 to connect to at least one bulk fluid source 120. In some examples, a plurality of bulk fluid connectors 118 may be provided. Figure 1 As shown, three body fluid connectors 118 can be provided in a side-by-side or other arrangement. In some examples, at least one body fluid connector 118 can be a spike configured to be removably connected to at least one body fluid source 120, such as a vial, bottle, or bag. At least one body fluid connector 118 can have a reusable or non-reusable interface with each new body fluid source 120. At least one body fluid connector 118 can be formed on a multi-patient disposable kit as described herein. At least one body fluid source 120 can be configured to receive a medical fluid, such as saline, contrast solution, or other medical fluid, for delivery to the fluid injector system 100. The housing 102 can have at least one support member 122 to support at least one body fluid source 120 when the at least one body fluid source 120 is connected to the fluid injector system 100.

[0074] Continue to refer Figure 1, the fluid injector system 100 includes one or more user interfaces 124, such as a graphical user interface (GUI) display window. The user interface 124 can display information related to the fluid injection process involving the fluid injector system 100, such as the current flow rate, fluid pressure, and the volume remaining in at least one bulk fluid source 120 connected to the fluid injector system 100, and can be a touch screen GUI that allows an operator to enter commands and / or data for the operation of the fluid injector system 100. Although the user interface 124 is shown as being on the injector housing 102, such a user interface 124 can also be in the form of a remote display that is wired or wirelessly linked to the housing 102 and the control and mechanical elements of the fluid injector system 100. In some examples, the user interface 124 can be a tablet computer that is removably connected to the housing 102 and is wired or wirelessly linked to communicate with the housing 102 and the control and mechanical elements of the fluid injector system 100. In addition, the fluid injector system 100 and / or the user interface 124 can include at least one control button 126 for tactile operation by an on-duty operator of the fluid injector system 100. In some examples, the at least one control button 126 can be part of a keyboard for inputting commands and / or data by the operator. The at least one control button 126 can be hardwired to (multiple) electronic control devices associated with the fluid injector system 100 to provide direct input to (multiple) electronic control devices. The at least one control button 126 can also be a graphical portion of the user interface 124, such as a touch screen. In any arrangement, at least one control button 126 desirably provides certain individual control features to an on-duty operator of the fluid injector system 100, such as, but not limited to: (1) confirming that a multi-patient disposable set has been loaded or unloaded; (2) locking / unlocking of a multi-patient disposable set; (3) filling / purging of the fluid injector system 100; (4) entering information and / or data related to a patient and / or an infusion procedure; (5) preloading the fluid injector system 100; and (6) starting / stopping an infusion procedure. The user interface 124 and / or any electronic processing unit associated with the fluid injector system 100 may be connected to an operating and / or data storage system, such as a hospital network system, by wire or wirelessly.

[0075] refer to Figure 2, the fluid injector system 100 includes a MUDS 130 that is removably connected to the fluid injector system 100 to deliver one or more fluids from one or more body fluid sources 120 to a patient. Examples and features of a MUDS are further described in International Patent Application Publication No. WO 2016 / 112163, filed on January 7, 2016, entitled “Multiple Fluid Delivery System with Multi-UseDisposable Set and Features Thereof,” the disclosure of which is incorporated herein by reference in its entirety. The MUDS 130 can include one or more syringes or pumps 132. In some examples, the number of syringes 132 can correspond to the number of body fluid sources 120. For example, referring to Figure 2 , the MUDS 130 has three syringes 132 arranged side by side so that each syringe 132 is fluidly connectable to one or more of the body fluid sources 120. In some examples, one or two body fluid sources 120 can be connected to one or more syringes 132 of the MUDS 130. Each syringe 132 can be fluidly connectable to one of the body fluid sources 120 through a corresponding body fluid connector 118 and an associated MUDS fluid path 134. The MUDS fluid path 134 can have a spike element that connects to the body fluid connector 118. In some examples, the body fluid connector 118 can be provided directly on the MUDS 130.

[0076] Also refer to Figure 2 , the MUDS 130 is removably connectable to the housing 102 of the fluid injector system 100. As will be appreciated by one of ordinary skill in the art, it may be desirable to construct at least a portion of the MUDS 130 from a transparent medical grade plastic to facilitate visual verification that a fluid connection has been established with the fluid injector system 100. Visual verification is also desired to determine that there are no bubbles within the various fluid connections. Alternatively, at least a portion of the MUDS 130 and / or the door 116 may include windows (not shown) to visualize the connections between the various components. Various optical sensors (not shown) may also be provided to detect and verify the connections. In addition, various light emitting elements (not shown), such as light emitting diodes (LEDs), may be provided to actuate one or more optical sensors and indicate that a proper connection has been established between the various components.

[0077] Specific reference Figure 2, provides a schematic diagram of various fluid paths of the fluid injector system 100. The MUDS 130 may include one or more valves 136, such as stopcocks, to control which medical fluid or combination of medical fluids is drawn from the multi-dose body fluid source 120 and / or delivered to the patient through each syringe 132. In some examples, the one or more valves 136 may be provided on the distal ends of the multiple syringes 132 or on a manifold 148. The manifold 148 may be in fluid communication with a first end of a MUDS fluid path 134 that connects each syringe 132 to a corresponding body fluid source 120 via the valves 136 and / or the syringes 132. An opposite second end of the MUDS fluid path 134 may be connected to a corresponding body fluid connector 118 that is configured to be fluidly connected to the body fluid source 120. Depending on the position of the one or more valves 136, fluid may be drawn into the one or more syringes 132 or may be delivered from the one or more syringes 132. In a first position, such as during the filling of the syringe 132, the one or more valves 136 are oriented so that fluid flows from the body fluid source 120 through the fluid inlet line 150 (such as the MUDS fluid path) to the desired syringe 132. During the filling process, the one or more valves 136 are positioned so that the fluid flow through the one or more fluid outlet lines 152 or the manifold 148 is blocked. In a second position, such as during the fluid delivery process, the fluid from the one or more syringes 132 is delivered to the manifold 148 through the one or more fluid outlet lines 152 or the syringe valve outlet ports. During the delivery process, the one or more valves 136 are positioned so that the fluid flow through the one or more fluid inlet lines 150 is blocked. The one or more valves 136, the fluid inlet line 150 and / or the fluid outlet line 152 can be integrated into the manifold 148. The one or more valves 136 can be selectively positioned to the first position or the second position by manual or automatic manipulation. For example, the operator can position the one or more valves 136 to the desired position for filling or fluid delivery. In other examples, at least portions of fluid injector system 100 may be operable to automatically position one or more valves 136 to a desired position for filling or fluid delivery based on operator input, as described herein.

[0078] Continue to refer Figure 2In some examples, the fluid outlet line 152 can also be connected to a waste reservoir 156 of the fluid injector system 100. The waste reservoir 156 is desirably separate from the syringe 132 to prevent contamination. In some examples, the waste reservoir 156 is configured to receive waste fluid discharged from the syringe 132 during, for example, a flushing, priming, or preloading operation. The waste reservoir 156 can be removable from the housing 102 so that the contents of the waste reservoir 156 are discarded. In other examples, the waste reservoir 156 can have a drain port (not shown) to empty the contents of the waste reservoir 156 without removing the waste reservoir 156 from the housing 102. In some examples, the waste reservoir 156 is provided as a separate component from the MUDS 130.

[0079] Having generally described the components of the fluid injector system 100 and the MUDS 130 , the structure and method of use of a single use disposable set of tools (SUDS) 190 and its interaction with the MUDS 130 will now be described.

[0080] refer to Figure 3A and Figure 3B , the fluid injector system 100 has a connection port 192 that is configured to form a releasable fluid connection with at least a portion of the SUDS 190. In some examples, the connection port 192 can be formed on the MUDS 130. The connection port 192 can be shielded by at least a portion of the housing 102 of the fluid injector system 100. For example, recessing the connection port 192 within the interior of the housing 102 can keep the connection port 192 sterile by preventing or limiting a user or patient from touching and contaminating the portion of the connection port 192 that contacts the fluid to be injected into the patient. In some examples, the connection port 192 is recessed within an opening 194 formed on the housing 102 of the fluid injector system 100, or the connection port 192 can have a shielding structure (not shown) surrounding at least a portion of the connection port 192. In other examples, the connection port 192 can be formed directly on the housing 102 and connected to the MUDS 130 by a fluid path (not shown). As described herein, the SUDS 190 may be connected to a connection port 192 formed on at least a portion of the MUDS 130 and / or the housing 102. Desirably, the connection between the SUDS 190 and the connection port 192 is a releasable connection to allow the SUDS 190 to be selectively disconnected from the connection port 192 ( Figure 3A ) and connect to port 192 ( Figure 3B ). In some examples, the SUDS 190 may be disconnected from the connection port 192 and discarded after each fluid delivery procedure, and a new SUDS 190 may be connected to the connection port 192 for a subsequent fluid delivery procedure.

[0081] Continue to refer Figure 3A and Figure 3B , a waste inlet port 196 may be provided separately from the connection port 192. The waste inlet port 196 is in fluid communication with the waste reservoir 156. In some examples, the waste reservoir 156 is provided separately from the SUDS 190 such that fluid from the waste inlet port 196 may be delivered to the waste reservoir 156. At least a portion of the SUDS 190 may be releasably connected to or associated with the waste inlet port 196 to introduce waste fluid into the waste reservoir 156 during, for example, a priming operation to vent air from the SUDS 190. The waste reservoir 156 may have a viewing window 198 with markings 200, such as graduated markings, indicating the fill level of the waste reservoir 156.

[0082] refer to Figure 4A SUDS 190 has a fluid inlet port 202 configured to connect to the connection port 192 ( Figure 3A The fluid inlet port 202 receives fluid delivered from the fluid injector system 100. The fluid inlet port 202 is desirably a hollow, tubular structure, such as Figure 4B SUDS 190 also has a waste outlet port 204 configured to communicate with waste inlet port 196 ( Figure 3A The waste outlet port 204 receives waste fluid and delivers such waste fluid to the waste reservoir 156 during, for example, a priming or flushing operation of the SUDS 190. The waste outlet port 204 is desirably a hollow, tubular structure, such as Figure 4B As shown. The waste outlet port 204 can be connected to, inserted into, or located in the waste inlet port 202 so that waste fluid can flow through the waste inlet port 202 and continue to the waste liquid reservoir 156. The fluid inlet port 202 and the waste outlet port 204 can be separated from each other by a spacer 206. In some examples, the spacer 206 is sized to position the fluid inlet port 202 and the waste outlet port 204 to align with the connection port 192 and the waste inlet port 196, respectively. Note that the SUDS 190 is Figure 4A 1 is shown after being removed from packaging (not shown). Prior to use, the SUDS 190 is desirably packaged in a pre-sterilized, sealed package that protects the SUDS 190 from contamination by airborne or surface-borne contaminants. Alternatively, the sealed package and SUDS 190 may be sterilized after packaging.

[0083] The SUDS 190 desirably has an asymmetric structure so that a user can only attach the SUDS 190 to the MUDS 130 in one orientation. In this way, the user is prevented from attaching the fluid inlet port 202 to the waste inlet port 196. In some examples, a fin 207 may be provided on at least a portion of the SUDS 190 to prevent the SUDS 190 from being incorrectly inserted into the connection port 192. In certain examples, the fin 207 may be formed on the spacer 206 proximate the waste outlet port 204. In this way, the fin 207 may interfere with incorrect insertion of the SUDS 190 into the connection port 192. Structures and shapes other than the fin 207 may be used to prevent the SUDS 190 from being incorrectly inserted into the connection port 192.

[0084] In some examples, tubing 208 (also referred to as a dosing line) can be connected to the fluid inlet port 202 at its proximal end 210. The tubing 208 is configured to deliver fluid received from the fluid inlet port 202. The distal end 212 of the tubing 208 can have a connector 214, which can include a one-way check valve that is configured to connect to the waste outlet port 204 or a fluid path connected to a patient (not shown). The tubing 208 can be formed of a flexible material, such as a medical grade plastic material, which allows the tubing 208 to be coiled. The connector 214 can be a Luer lock connector (male Luer lock connector or female Luer lock connector, depending on the desired application) or other medical connector configurations. In some examples, the connector 214 can include at least one one-way check valve 280 therein, such as Figure 4C Alternatively, the one-way check valve may be located elsewhere in the SUDS 190 between the fluid inlet port 202 and the connector 214 .

[0085] Continue to refer Figure 4A , the SUDS 190 may have a locking tab 216 configured to selectively lock the SUDS 190 with the fluid injector system 100, depending on engagement of the locking tab 216 with at least a portion of the fluid injector system 100. In some examples, the locking tab 216 may be a flexible tab that is deflectable between an engaged position and a disengaged position by deflecting at least a portion of the locking tab 216. The locking tab 216 may have a pressing surface 218 that, when pressed, deflects the locking tab 216 from the engaged position to the disengaged position to insert and remove the SUDS 190 from the fluid injector system 100. In some examples, the locking tab 216 may be configured to engage with a receiving slot 217 ( Figure 4C ) are releasably locked into engagement.

[0086] refer to Figure 4BSUDS 190 may have a first annular skirt 224 extending circumferentially around a proximal end 226 of the fluid inlet port 202 and a second annular skirt 220 extending circumferentially around a distal end 222 of the fluid inlet port 202. The first and second annular skirts 224, 220 surround the fluid inlet port 202 to prevent inadvertent contact and contamination. The first annular skirt 224 may have one or more recesses 228 ( Figure 4A The one or more recesses 228 may provide a locking interface with a corresponding locking element (not shown) on the fluid injector system 100. The second annular skirt 220 may have at least one indentation 230 (in Figure 4A ), to facilitate gripping and manipulating the SUDS 190. In some examples, the second annular skirt 220 may have a textured surface having one or more ribs to facilitate gripping and manipulating the SUDS 190.

[0087] Continue to refer Figure 4B , at least one annular seal 234 may be provided around the proximal end 226 of the fluid inlet port 202. The at least one annular seal 234 may seal the fluid inlet port 202 to prevent fluid from leaking through the SUDS 190. The at least one annular seal 234 may provide a fluid seal between the SUDS 190 and the MUDS 130 when the SUDS 190 and the MUDS 130 are fluidly connected to each other to allow fluid to flow from the MUDS 130 to the SUDS 190 without leakage. A one-way check valve 236 may be provided within the lumen of the fluid inlet port 202 to prevent fluid from flowing from the SUDS 190 to the MUDS 130 in the reverse direction.

[0088] refer to Figure 4C , Figure 4A The SUDS 190 shown in FIG. 1 is shown connected to the fluid injector system 100. Although Figure 4C The connection port 192 is shown formed on the MUDS 130. In other examples, the connection port 192 may be formed on the housing 102 ( Figure 1 The fluid inlet port 202 of the SUDS 190 is connected to the connection port 192 to Figure 4C192. The spacer 206 may define an insertion stop surface to limit the depth of insertion of the SUDS 190 into the connection port 192.

[0089] refer to Figure 5 , the fluid injector system 100 may have a sensor system 238 adapted to identify when the SUDS 190 is in fluid communication with the MUDS 130. The sensor system 238 may include at least one sensing element, such as a sensor fin 240, on the SUDS 190 and a corresponding sensor 242 on the fluid injector system 100 or the MUDS 130. The sensor 242 may be configured to detect the presence or absence of the at least one sensor fin 240 or other sensing element. In some examples, the sensing element, such as the at least one sensor fin 240, is formed on the locking tab 216 of the SUDS 190, such as Figure 4A . In other examples, a sensing element such as at least one sensor fin 240 may be formed on any portion of the SUDS 190. The sensor 242 may be an optical sensor that is seated and secured to a corresponding mounting formed on the housing 102 of the fluid injector system 100. As will be appreciated by those familiar with the art of powered medical fluid injectors, the sensor 242 may be electronically coupled to an electronic control device that is used to separately control the operation of the fluid injector system, such as the operation of one or more piston elements, based at least in part on input from the sensor 242. The sensing element such as the sensor fin 240 may have one or more reflective surfaces that reflect visible or infrared light to be detected by the sensor 242. In other examples, a mechanical interaction between the sensing element and the sensor 242 may be used.

[0090] In some examples, the SUDS 190 may also include anti-reuse features. For example, the SUDS 190 may include one or more breakable sensor elements, sheets, or structures that fold or break when the SUDS 190 is removed from the MUDS 130. The absence of these features may prevent the SUDS 190 from being reinserted and reused after removal. In this way, it may be ensured that the SUDS 190 is used for only one fluid delivery procedure.

[0091] Other examples and features of the SUDS 190 are described in U.S. Patent Application Publication No. 2016 / 0331951, filed on July 7, 2016, and entitled “Single-Use Disposable Set Connector,” the disclosure of which is incorporated herein by reference in its entirety.

[0092] Having generally described the components of the fluid injector system 100, MUDS 130, and SUDS 190, the method of operation of using the SUDS 190 will now be described in detail. In use, a medical technician or user removes the disposable SUDS 190 from its packaging (not shown) and inserts the fluid inlet port 202 into the connection port 192 on the MUDS 130. As described above, the SUDS 190 must be inserted in the correct orientation so that the fluid inlet port 202 is aligned to connect with the connection port 192 and the waste outlet port 204 is aligned to connect with the waste inlet port 196. The SUDS 190 can be secured to the MUDS 130 by inserting the locking tab 216 into the receiving slot 217 on the MUDS 130. Once the SUDS 190 is securely connected to the MUDS 130 (e.g., as sensed by the sensor 242), the fluid injector system 100 ( Figure 1190 ) draws fluid into one or more of the plurality of syringes 132 of the MUDS 130 and performs an automated priming or flushing operation to remove air from the MUDS 130 and SUDS 190. During such a priming or flushing operation, fluid from the MUDS 130 is injected through the connection port 192 and into the tubing 208 of the SUDS 190. The fluid flows through the tubing 208, the connector 214 and through the waste outlet port 204 and into the waste reservoir 156. Once the automated priming or flushing operation is completed, the tubing 208 may be optionally preloaded by injecting fluid from the MUDS 130 through the connection port 192. Additional details of the preloading operation will be described in more detail later. After the automated priming or flushing operation and the optional preloading operation are completed, the medical technician disconnects the connector 214 from the waste outlet port 204. The connector 214 may then be connected to the patient via a catheter, a vascular access device, a needle, or an additional fluid path kit to facilitate fluid delivery to the patient. Once the fluid delivery is complete, the SUDS 190 is disconnected from the patient and the MUDS 130 by disengaging the locking tabs 216 of the SUDS 190 from the receiving slots 217 on the MUDS 130. The medical technician may then discard the SUDS 190. In some examples, removal of the SUDS 190 from the MUDS 130 activates an anti-reuse feature (not shown), thereby preventing reinsertion and reuse of the SUDS 190.

[0093] refer to Figure 6, the electronic control device 900 can be associated with the fluid injector system 100 to control filling and delivery operations. In some examples, the electronic control device 900 can control the operation of various valves, piston components and other elements to achieve the desired filling or delivery process. For example, the electronic control device 900 can include a variety of discrete computer-readable media components. For example, the computer-readable medium can include any media that can be accessed by the electronic control device 900, such as volatile media, non-volatile media, removable media, non-removable media, temporary media, non-temporary media, and the like. As other examples, the computer-readable medium may include computer storage media, such as media implemented in any method or technology for storing information, such as computer-readable instructions, data structures, program modules, or other data; random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, or other memory technology; CD-ROM, digital versatile disk (DVD), or other optical disk storage; magnetic cassettes, tapes, magnetic disk storage, or other magnetic storage devices; or any other medium that can be used to store desired information and can be accessed by the electronic control device 900. In addition, the computer-readable medium may include communication media, such as computer-readable instructions, data structures, program modules, or other data in modulated data signals, such as carrier waves or other transmission mechanisms, and include any information delivery media, wired media (such as wired networks and wired direct connections), and wireless media (such as acoustic signals, radio frequency signals, optical signals, infrared signals, biometric signals, two-dimensional code signals, etc.). Of course, any combination of the above should also be included in the scope of computer-readable media.

[0094] The electronic control device 900 also includes a system memory 908, which has computer storage media in the form of volatile and non-volatile memory, such as ROM and RAM. A basic input / output system (BIOS) with appropriate computer-based routines assists in transferring information between components within the electronic control device 900 and is usually stored in ROM. The system memory 908 typically contains data and program modules that are immediately accessible to the processor 904 or currently running on the processor 904, such as operating systems, application programming interfaces, application programs, program modules, program data, and other instruction-based computer readable code.

[0095] Continue to refer Figure 6, the electronic control device 900 may also include other removable or non-removable, volatile or non-volatile, transient or non-transitory computer storage media products. For example, the electronic control device 900 may include a non-removable memory interface 910 that communicates with and controls a hard disk drive 912 (e.g., a non-removable, non-volatile magnetic medium); and a removable, non-volatile memory interface 914 that communicates with and controls: a disk drive unit 916 (which reads and writes a removable, non-volatile disk 918), an optical drive unit 920 (which reads and writes a removable, non-volatile optical disk 922, such as a CD ROM), a universal serial bus (USB) port 921 used in conjunction with a removable memory card, and the like. However, it is contemplated that other removable or non-removable, volatile or non-volatile computer storage media may be used in the exemplary computing system environment 902, including but not limited to magnetic cassettes, DVDs, digital video tapes, solid-state RAM, solid-state ROM, and the like. These various removable or non-removable, volatile or non-volatile magnetic media communicate with the processor 904 and other components of the electronic control device 900 via the system bus 906. Figure 6 The drives and their associated computer storage media illustrated in the figure provide storage of the operating system, computer readable instructions, applications, data structures, program modules, program data, and other instruction-based, computer readable code for the electronic control device 900 (whether or not such information and data is duplicated in the system memory 908).

[0096] The user can input commands, information and data through some attachable or operable input device (such as Figure 1 124) is input into the electronic control device 900 via a user input interface 928. A variety of such input devices may be employed, such as microphones, trackballs, joysticks, touch pads, touch screens, scanners, etc., including any arrangement that facilitates input of data and information from external sources to the electronic control device 900. As described, these and other input devices are typically connected to the processor 904 via a user input interface 928 coupled to the system bus 906, but may be connected by other interfaces and bus structures, such as a parallel port, a game port, or a USB. In addition, the data and information may be presented or provided to the user in an understandable form or format through certain output devices, such as a monitor 930 (to visually display the information and data in electronic form), a printer 932 (to physically display the information and data in printed form), a speaker 934 (to audibly present the information and data in audible form), and the like. All of these devices communicate with the electronic control device 900 via an output interface 936 coupled to the system bus 906. It is contemplated that any such peripheral output device may be used to provide information and data to the user.

[0097] The electronic control device 900 can operate in the network environment 938 by using a communication device 940, which is integrated into the electronic control device 900 or remote therefrom. The communication device 940 is operable and communicates with other components of the electronic control device 900 through a communication interface 942. Using such an arrangement, the electronic control device 900 can be connected or otherwise communicated with one or more remote computers such as remote computers 944, which can be personal computers, servers, routers, network personal computers, peer devices, or other common network nodes, and typically include many or all of the components described above in conjunction with the electronic control device 900. Using appropriate communication devices 940 (e.g., modems, network interfaces or adapters, etc.), the computer 944 can operate within and communicate through local area networks (LANs) and wide area networks (WANs), but can also include other networks, such as virtual private networks (VPNs), office networks, enterprise networks, intranets, the Internet, and the like.

[0098] As used herein, the electronic control device 900 includes or is operable to execute appropriate custom designed or conventional software to perform and implement the processing steps and systems of the methods of the present disclosure, thereby forming a specialized and specific computing system. Accordingly, the methods and systems may include one or more electronic control devices 900 or similar computing devices, which have a computer-readable storage medium capable of storing computer-readable program code or instructions, which cause the processor 904 to execute, configure or otherwise implement the methods, processes and conversion data operations discussed hereinafter in conjunction with the present disclosure. In addition, the electronic control device 900 can be in the form of a personal computer, a personal digital assistant, a portable computer, a laptop computer, a handheld computer, a mobile device, a mobile phone, a server, or any other type of computing device that has the necessary processing hardware to properly process data to effectively implement the fluid injector system, computer program product and computer-implemented method of the present disclosure.

[0099] Those skilled in the relevant art will appreciate that the system can utilize a database physically located on one or more computers that may or may not be the same as its corresponding server. For example, the programming software on the electronic control device 900 can control a database physically stored on a separate processor of a network or other.

[0100] In some examples, the electronic control device 900 can be programmed so that automatic refilling occurs based on a preprogrammed trigger minimum volume in the corresponding syringe 132. For example, when the volume of fluid remaining in at least one of the syringes 132 is less than the programmed volume, the syringe refill process is automatically initiated by the electronic control device 900. The electronic control device 900 associated with the fluid injector system 100 can determine that the preprogrammed trigger minimum volume has been reached by tracking the volume of fluid dispensed from the corresponding syringe 132 during operation of the fluid injector system 100. Alternatively, fluid level sensors can be integrated into the fluid injector system 100, and inputs from these fluid level sensors can be provided to the electronic control device 900 so that the electronic control device 900 can determine when the preprogrammed trigger minimum volume has been reached in at least one of the syringes 132. The fill volume and rate of refilling can be preprogrammed in the electronic control device 900. The automatic refill process can be automatically stopped by the electronic control device 900 or can be manually interrupted. Additionally, an automatic refill process may be initiated when, upon completion of a fluid injection process, there is insufficient fluid in at least one of the syringes 132 to proceed with the next programmed fluid injection process.

[0101] During the refilling process, one or more of the body fluid sources 120 associated with the corresponding syringes 132 may become empty (e.g., initially lack sufficient fluid to complete a complete refill of one or more syringes 132). Therefore, replacement of the body fluid source 120 is necessary, and such replacement of the body fluid source 120 is desirably performed quickly. The fluid injector system 100 can have an indicator, such as an audible and / or visual indicator, to indicate to the operator that replacement of the body fluid source 120 is necessary before the fluid injector system 100 can be used.

[0102] As described above, once the SUDS 190 is fixedly connected to the MUDS 130 (e.g., as sensed by the sensor 242), the fluid injector system 100 can automatically prime the MUDS 130 and the SUDS 190. During such a priming operation, saline or another suitable flushing agent from the MUDS 130 is injected into the tubing 208 of the SUDS 190 through the connection port 192, and into the waste reservoir 156. The flow of saline toward the waste reservoir 156 purges air from the fluid injector system by forcing any air in the MUDS 130 and SUDS 190 to exit the distal end 212 of the tubing 208. The saline thereby displaces any air in the tubing 208, causing the tubing 208 to become filled with saline.

[0103] After priming the tubing 208 with saline, the tubing 208 may be preloaded with one or more medical fluids associated with a clinical or therapeutic fluid delivery procedure to be performed on a patient according to an infusion protocol. The one or more medical fluids may be preloaded as described above with reference to Figure 2 During the described filling process, saline is drawn into the first of the plurality of syringes 132, and then the saline may be delivered to the SUDS 190 and used to prime the circuit 208, as described above with reference to Figure 3A-3B Described. Delivery of one or more medical fluids to the SUDS 190 during the preloading operation will then partially or completely displace the saline from the tubing 208 by pushing the saline through the waste outlet port 204 and into the waste reservoir 156. At this point, the tubing 208 can be connected to the patient and the infusion protocol can be initiated. Because the tubing 208 is partially or completely filled with one or more medical fluids other than saline at this stage, unnecessary injection of saline into the patient as part of the fluid delivery process can be avoided. In some examples, a catheter, vascular access device, needle, or additional fluid path kit that facilitates fluid delivery to the patient can be connected to the tubing 208 prior to preloading of the tubing 208, so that one or more medical fluids are also preloaded into the vascular access device, needle, or additional fluid path kit.

[0104] Now refer to Figure 7A-7B An exemplary method of preloading the SUDS 190 for an infusion protocol is described. In the exemplary case currently described, the tubing 208 of the SUDS 190 has an internal volume of 8 milliliters. The infusion protocol, in this exemplary case an MR infusion, calls for delivery of 5 milliliters of contrast solution followed by delivery of 20 milliliters of flushing agent. Prior to preloading, contrast solution may be drawn from a first one of the body phase fluid sources 120 into a first one of the plurality of syringes 132, and flushing agent may be drawn from a second one of the body phase fluid sources 120 into a second one of the plurality of syringes 132. The valve 136 of the SUDS 130 may then be closed such that subsequent actuation of the syringes 132 directs the fluid contained therein to the SUDS 190 as described above. During preloading, a first one of the syringes 132 is actuated to advance a first bolus 710 of 5 milliliters of contrast solution into the proximal end of the tubing 208, as shown in FIG. Fig. 7A If a priming operation is performed prior to preloading, advancement of the first bolus 710 in tubing 208 displaces an equal volume of residual fluid from the priming operation and expels the residual fluid from the distal end of tubing 208. A second syringe in syringe 132 is then actuated to advance a second bolus 720 of flushing agent into the proximal end of tubing 208, as indicated by Figure 7B208 and expel other residual fluid (if any) from the priming operation from the tubing 208. In this example, because the total volume of the contrast solution (5 ml) and the flushing agent (20 ml) of the infusion protocol exceeds the capacity of the tubing 208 (8 ml), the initial volume of the second bolus 720 is substantially equal to the capacity of the tubing 208 (8 ml) minus the volume of the first bolus 710 (5 ml). Therefore, the initial volume of the second bolus 720 is 3 ml. Once the second bolus 720 is advanced into the tubing 208, preloading is complete and actuation of the second syringe in the syringe 132 is paused.

[0105] At this stage, the first bolus 710 occupies the tubing 208 immediately adjacent to the distal end of the tubing 208, and the second bolus 720 occupies the tubing 208 adjacent to the first bolus 710 and the proximal end of the tubing 208, as indicated by Figure 7B As can be understood. No or negligible amount of residual fluid from the flushing / irrigation operation is present in the pipeline 208. The distal end of the pipeline 208 can be connected to the patient then, and an injection scheme can be initiated. The second syringe in the syringe 132 is actuated again to advance the remaining volume of the flushing agent required in the injection scheme into the pipeline 208. That is, additional 17 milliliters of flushing agent are injected into the patient, equaling the total volume (20 milliliters) required in the injection scheme minus the initial volume (3 milliliters) of the second bolus 720. Along with the flushing agent of the remaining volume required in the injection scheme being advanced into the pipeline 208, the first bolus 710 and the second bolus 720 are subsequently replaced and injected into the patient from the pipeline 208. The injection scheme is then completed. In this exemplary case, the patient receives a total injection volume of 25 milliliters of fluid, equaling 8 milliliters of preloaded volume (that is, 5 milliliters of the first bolus 710 plus 3 milliliters of the second bolus 720), plus 17 milliliters of the remaining volume of flushing agent injected after the pipeline 208 is connected to the patient. Once the total volume (25 mL) is injected, 8 mL of flush will remain in line 208 after the injection protocol is completed.

[0106] As from Figure 7A-7B As is apparent from the above description of the exemplary scenario shown in , preloading the tubing 208 allows an infusion protocol to be performed without unnecessarily infusing residual fluid from an infusion procedure into the patient. Furthermore, the contrast solution is infused into the patient with minimal delay because the first bolus 710 is proximate to the distal end of the tubing 208 and no flushing / priming fluid must be expelled from the tubing 208 before the first bolus 710 reaches the patient. Furthermore, as distinct from simply priming the tubing 208 with contrast solution, preloading the tubing 208 allows the first bolus 710 to contain a volume that is less than the total capacity of the tubing 208. Thus, the patient is not infused with additional contrast solution beyond that required in the infusion protocol.

[0107] Of course, the above reference Figure 7A-7B The exemplary scenarios described are not limited to the various injection schemes that can be accomplished by preloading the SUDS 190. Figure 8 , generally showing that any number of boluses 800a-800n can be used with Figure 7A-7B The first bolus 710 and the second bolus 720 are preloaded into the tubing 208 in a similar manner as described above. The number of boluses 800a-800n is limited only by the capacity of the tubing 208. Some of the boluses 800a-800n may contain the same fluid. For example, if the injection protocol requires alternating injections of contrast solution and irrigant, the first bolus 800a and the third bolus 800c may contain contrast solution, while the second bolus 800b and the fourth bolus 800d may contain irrigant. This may be achieved by alternately actuating and de-actuating the syringes 132 containing the contrast solution and the irrigant, respectively. In some examples, individual boluses of the boluses 800a-800n may contain multiple types of fluids in any proportion required by the injection protocol. This may be achieved by actuating multiple syringes of the syringes 132 simultaneously. In some examples, the boluses 800a-800n may have different volumes from each other, or the same volume as each other. In some examples, only a single bolus 800a may be preloaded, resulting in substantially the same effect as priming the tubing 208 with the fluid contained in the single bolus 800a would produce.

[0108] Continue to refer Figure 8 Also refer to Figure 1 , the operator can design and / or initiate a preloading process, including the number, volume, and fluid content of the boluses 800a-800n, using at least one control button 126 and / or the user interface 124 of the fluid injector system 100. In addition, the operator can cancel the preloading process using at least one control button 126 and / or the user interface 124 of the fluid injector system 100. The user interface 124 can include a sensory indicator of the preloading status so that the operator is alerted when the preloading is complete and the tubing 208 can be connected to the patient. The sensory indicator can include, for example, a light, an icon, a status bar, an audible sound, or a combination thereof. The sensory indicator can also indicate that because the tubing 208 is preloaded, there is a minimized delay in the contrast solution (or other medical fluid required for the injection protocol) being delivered to the patient. The operator can thereby use the sensory indicator to adjust other parts of the treatment process (such as the timing of the MR or CT scan) to match the timing of the contrast solution delivery to the patient.

[0109] Now refer to it again Figures 6 to 8, an operator may input a command containing an injection protocol via the user input interface 928 of the electronic control device 900. The processor 904 of the electronic control device 900 may be programmed or configured to preload the SUDS 190 based on information contained in the injection protocol, such as the number of boluses, the medical fluid per bolus, and the volume of each bolus. The processor 904 of the electronic control device 900 may be programmed or configured to actuate the injector 132 in a manner necessary to implement the preloaded injection protocol. For example, referring to Figure 7A-7B , the processor 904 may be programmed or configured to actuate the first syringe of the syringes 132 to advance 5 ml of contrast solution into the tubing 208 to form the first bolus 710. The processor 904 may also be programmed or configured to actuate the second syringe of the syringes 132 to advance 3 ml of flushing agent into the tubing 208 to form the second bolus 720. In some examples, the processor 904 may be configured to calculate the available capacity of the tubing 208 after advancing the first bolus 710 to determine the volume of the second bolus 720. Figure 7A-7B In the example of FIG. 1 , the processor 904 may calculate that after advancing the 5 milliliters of contrast solution required for the infusion protocol, the circuit 208 has 3 milliliters of remaining capacity. The processor 904 may then determine that, after the 20 milliliters of flush required in the infusion protocol, only 3 milliliters can be advanced to the circuit 208 without expelling the first bolus 710. The processor 904 therefore advances only 3 milliliters of flush from the second syringe in the syringe 132. The processor 904 then advances the remaining 17 milliliters of flush required for the infusion protocol, plus an additional 8 milliliters of flush to account for the capacity of the circuit 208 after the SUDS 190 has been connected to the patient, in order to inject the full 20 milliliters of flush required in the infusion protocol. More generally, the processor 904 may be programmed or configured to calculate the available capacity of the circuit 208, i.e., the total capacity of the circuit 208 less the volume of any bolus 710, 720, 800a-800n already advanced, and size subsequent boluses 710, 720, 800a-800n to have a volume no greater than the available capacity.

[0110] Reference Fig. 9 , an example of a method 950 involving at least partial preloading of a drug delivery line will now be described with respect to method steps 952-963. In some examples, a method may be used Fig. 9 The method shown in Figure 7A-8The method 950 as performed by the fluid injector system 100 may be implemented by a computer program product. The computer program product may 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 perform all or part of the diagnostic injection process. In some examples or aspects, the at least one non-transitory computer-readable medium and the at least one processor may include or correspond to the memory 908 and the processor 904, respectively, as described above with reference to Figure 6 described.

[0111] Throughout the execution of steps 952-963 of method 950, at least one processor 904 can be in operative communication with the user interface 124 to facilitate input of one or more user inputs associated with control of multiple operations of the fluid injector system 100. For example, a set of one or more user inputs can be associated with a corresponding set of controls for multiple operations related to allowing selection and execution of at least partially preloading a dosing line with a first and / or second fluid according to one or more stages of a diagnostic injection protocol. The user inputs can include, for example, a "select preload" command, a "execute preload" command, and a "disable preload" command. Each of these user input commands will be discussed in more detail below in conjunction with the method steps associated with each of the user inputs. The user inputs can be entered into the user interface 124 via the user input interface 928, as described above with reference to FIG. Figure 6 Various input devices of the user input interface 928 may be employed to receive user input, for example, a microphone, a trackball, a joystick, a touch pad, a touch screen, a scanner, a keyboard, a mouse, and combinations thereof.

[0112] Continue to refer Fig. 9 In step 952, at least one processor 904 of the fluid injector system 100 can be programmed with a diagnostic injection scheme. The diagnostic injection scheme can include one or more stages, according to which at least one of the first fluid container and the second container can be selectively actuatable by at least one drive component. In some examples, each of the first fluid container and the second fluid container can be one or more syringes in the syringe 132, the first fluid container is configured to be filled with a first fluid (e.g., a contrast solution), and the second fluid container is configured to be filled with a second fluid (e.g., an irrigant). The at least one drive component can be, for example, one or more of the piston elements 103. When executed by the at least one processor 904, the diagnostic injection scheme can cause the at least one drive component to actuate one or more of the fluid containers via the piston element 103, and thereby inject at least one of the first fluid and the second fluid into the patient via a drug delivery line. As mentioned above, the drug delivery line can be, for example, tubing 208.

[0113] Continue to refer Fig. 9 At step 954, at least one processor 904 of the fluid injector system 100 may actuate the second fluid container to prime the administration line, as described above. That is, the irrigant from the MUDS 130 is injected into the tubing 208 of the SUDS 190 through the connection port 192, and ultimately flows to the connector 214 at the distal end of the SUDS 190. Any excess irrigant may then drip from the connector 214 into the waste reservoir 156, to which the connector 214 is typically connected during the priming operation. This clears air from the fluid injector system 100 by forcing air in the MUDS 130 and SUDS 190 to exit the distal end 212 of the tubing 208. Thus, the irrigant displaces any air in the tubing 208, causing the tubing 208 to become filled with irrigant.

[0114] Continue to refer Fig. 9 In step 955, at least one processor 904 of the fluid injector system 100 can be programmed or configured to allow selection of at least partially preloading into the administration line. At least partially preloading can include at least one of the first fluid and the second fluid according to one or more stages of the diagnostic injection protocol. At least partially preloading can be determined or selected by the at least one processor 904 based on the diagnostic injection protocol. In particular, the volume of the first fluid and / or the volume of the second fluid to be preloaded into the administration line can be determined by the at least one processor 904 based on the volume of the first fluid and / or the volume of the second fluid specified in one or more stages of the diagnostic injection protocol. Step 955 can be initiated by the user entering a "select preload" command into the user interface 124 as user input. Once the diagnostic injection protocol has been programmed and the administration line is primed, entering the "select preload" command will cause the at least one processor 904 to prepare the fluid injector system 100 to at least partially preload the diagnostic injection protocol into the administration line. For example, input of a “select preload” command will cause the at least one processor 904 to prepare the fluid injector system 100 to accept user input of a “execute preload” command at step 956 of method 950 .

[0115] Continue to refer Fig. 9, at step 956, at least one processor 904 determines whether to perform preloading according to the diagnostic injection scheme. In some examples, at least one processor 904 may wait for an "execute preloading" command input from the user into the user interface 124. If the "execute preloading" command is received after the "select preloading" command, at least one processor 904 determines to perform preloading and advances the method to step 957. If the "execute preloading" command is not received after the "select preloading" command, or if the user instead inputs a "disable preloading" command, the at least one processor returns to step 955 and waits for the user to re-enter the "select preloading" command.

[0116] Continue to refer Fig. 9 At step 957, after determining to perform the preload operation, at least one processor 904 compares the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection scheme with the volume capacity (B) of the administration line.

[0117] At step 958, at least one processor determines whether the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity (B) of the administration line. If at least one processor 904 determines that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity (B) of the administration line, then at least one processor 904, at step 959, actuates one or more of the fluid containers, and thereby preloads the total volume of the diagnostic injection protocol into the administration line according to one or more stages of the diagnostic injection protocol. For example, if the administration line has a capacity of 8 milliliters, and the total volume of the first fluid and the second fluid specified by the diagnostic injection protocol is 8 milliliters, at least one processor 904 preloads 8 milliliters of fluid specified by the fluid injection protocol into the administration line. In some examples, actuating one or more of the fluid containers includes actuating a piston element 103 associated with the syringe 132 to advance at least a portion of the fluid contained in the syringe 132 into the tubing 208. Due to the preloading, the volume of the second fluid used in priming the administration line is expelled therefrom. In step 959, because the total volume of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity of the administration line, all fluids required for the diagnostic injection protocol are advanced into the administration line during the preload period.

[0118] At step 958, if at least one processor 904 determines that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is not equal to the capacity (B) of the administration line, then at least one processor 904 determines at step 960 whether the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is less than the capacity (B) of the administration line. If at least one processor 904 determines that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is less than the capacity (B) of the administration line, then at least one processor 904 actuates one or more of the fluid containers at step 961, and thereby preloads the total volume of the diagnostic injection protocol into the administration line according to one or more stages of the diagnostic injection protocol. In some examples, at least one processor 904 then actuates the second fluid container to preload the administration line with a supplemental volume of the second fluid, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol. For example, if the dosing line has a capacity of 8 milliliters, and the total volume of the first fluid and the second fluid specified by the diagnostic injection scheme is 5 milliliters, then at least one processor 904 preloads 5 milliliters of fluid specified by the fluid injection scheme into the dosing line, followed by 3 milliliters of supplementary volume to make the total preload volume reach 8 milliliters, or equal to the capacity of the dosing line. This prepares the diagnostic injection scheme to be immediately injected into the patient. In some examples, one or more of the actuating fluid containers include actuating piston elements 103 associated with syringe 132, pushing at least part of the fluid contained in syringe 132 into pipeline 208. Due to the preload, the volume of the second fluid used in the perfusion dosing line is discharged therefrom. In step 961, because the total volume of the first fluid and the second fluid to be injected according to the diagnostic injection scheme is less than the capacity of the dosing line, all the fluids required for the diagnostic injection scheme are pushed into the dosing line during the preload. The supplementary volume of the second fluid is preloaded so that the total volume of the diagnostic injection scheme is pushed to the far end of the dosing line, and the fluid used in the perfusion dosing line is thereby discharged.

[0119] At step 960, if at least one processor 904 determines that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection scheme is not less than the capacity (B) of the administration line, then at least one processor 904 determines that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection scheme is greater than the capacity (B) of the administration line. Then at step 963, at least one processor 904 actuates one or more of the fluid containers, and thereby preloads the first fluid and the second fluid into the administration line as much as the capacity of the administration line will allow according to one or more stages of the diagnostic injection scheme. For example, if the administration line has a capacity of 8 milliliters, and the total volume of the first fluid and the second fluid specified by the diagnostic injection scheme is 25 milliliters, at least one processor 904 first preloads 8 milliliters of fluid specified by the fluid injection scheme into the administration line. Due to the preloading, the volume of the second fluid used in the perfusion administration line is discharged therefrom. In some examples, actuating one or more of the fluid containers includes actuating the piston element 103 associated with the syringe 132 to advance at least part of the fluid contained in the syringe 132 into the pipeline 208. After preloading up to the capacity of the dosing line, at least one processor 904 retains the remainder of the diagnostic injection protocol within the programming. For example, if 8 milliliters of fluid are preloaded into the dosing line out of a total of 25 milliliters specified by the diagnostic injection protocol, the programming retains a log of the remaining 17 milliliters that are not preloaded into the dosing line. Then when the diagnostic injection protocol is performed on the patient, at least one processor 904 injects the remainder of the diagnostic injection protocol. That is, when the diagnostic injection protocol is performed on the patient, the 8 milliliters of fluid preloaded into the dosing line will first be injected into the patient, and then the 17 milliliters that have been retained within the programming will be injected before the diagnostic injection process is performed.

[0120] For each diagnostic injection protocol programmed into the fluid injector system 100, the method 950 will only include one of steps 959, 961, and 963. During subsequent diagnostic injections, based on the determinations made by at least one processor 904 at steps 958, 960, and 962, the same steps may be performed or another of steps 959, 961, and 963 may be performed as part of the method 950. It should also be understood that the order of steps 958, 960, and 962 may be changed without departing from the scope of the present disclosure. For example, at least one processor 904 may first perform step 962, and if it is determined that the total volume (A) of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is not greater than the capacity (B) of the administration line, then at least one processor 904 may then perform steps 958 and / or 960.

[0121] Continue to refer Fig. 9After preloading the administration line according to steps 959, 961, or 963, at least one processor 904 of the fluid injector system 100 can be programmed or configured to perform a diagnostic infusion protocol on the patient. In particular, at least one processor 904 actuates one or more of the fluid containers to inject the total volume of the first fluid and the second fluid specified by the protocol into the patient. If the total volume of the first fluid and the second fluid specified by the protocol is completely preloaded into the administration line as in step 959, then only when the diagnostic infusion process is being performed on the patient, at least one processor 904 will actuate the second fluid container to push the flushing agent into the administration line behind the preloaded fluid. If the total volume of the first fluid and the second fluid specified by the protocol is preloaded into the administration line along with a supplemental volume of saline as in step 961, then at least one processor 904 will similarly actuate the second fluid container to push the flushing agent into the line, thereby pushing the total volume of the diagnostic infusion protocol into the patient. When the remainder of the diagnostic infusion protocol is retained by programming as in step 963, the remainder will be infused into the patient immediately after the portion of the protocol that is actually preloaded into the administration line. This is accomplished by actuating the second fluid container via at least one processor 904 to push additional flushing agent into the administration line in a volume equal to the capacity of the administration line, and thereby push the entire diagnostic infusion protocol into the patient.

[0122] Throughout the execution of steps 952-963 of method 950, at least one processor 904 can be in operable communication with user interface 124 to cause user interface 124 to display information associated with the state of at least one of the first fluid and the second fluid being at least partially preloaded into the administration line according to one or more stages of the diagnostic injection scheme. The information associated with the state can include, for example, the total volume of the first and / or second fluid to be injected according to the diagnostic injection scheme, the volume of the first and / or second fluid that has been injected at any time during the execution of the diagnostic injection scheme, the volume of the first and / or second fluid remaining to be injected at any time during the execution of the diagnostic injection scheme, and / or the flow rate of the first and / or second fluid being injected at any time during the execution of the diagnostic injection scheme. At least one processor 904 can also cause user interface 124 to display information about each of the one or more stages of the diagnostic injection scheme, such as a specific volume and / or flow rate of the first and / or second fluid to be injected during each stage, and a specific volume and / or flow rate of the first and / or second fluid being injected during the current stage.

[0123] Although several examples of fluid delivery systems, computer program products, and methods for preloading single-use disposable kit connectors are shown in detail in the drawings and described herein above, other examples will be apparent and readily available to those skilled in the art without departing from the scope and spirit of the present disclosure. For example, it should also be understood that the present disclosure contemplates that, to the extent possible, one or more features of any example may be combined with one or more features of any other example. Accordingly, the foregoing description is intended to be illustrative rather than limiting.

Claims

1. A fluid injector system comprising: a control device operably associated with at least one drive member for actuating a plurality of fluid containers, the plurality of fluid containers being placeable in fluid communication with a patient via a dosing line, a first fluid container of the plurality of fluid containers being fillable with a first fluid comprising a contrast solution, and a second fluid container of the plurality of fluid containers being fillable with a second fluid comprising an irrigant; and the control device comprising at least one processor programmed or configured to allow programming of a diagnostic injection protocol including one or more phases, according to which at least one of the first fluid container and the second fluid container is selectively actuatable by the at least one drive member to allow injection of at least one of the first fluid and the second fluid into the patient via the administration line to achieve enhancement of at least one region of interest thereof during a scan duration of a diagnostic imaging procedure; The control device is also programmed or configured to allow selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol before initiating the diagnostic injection protocol and upon completion of programming of the diagnostic injection protocol and priming of the administration line with the second fluid.

2. The fluid injector system of claim 1, further comprising a user interface operably associated with the at least one processor, the user interface configured to accept a plurality of user inputs associated with control of a plurality of operations of the fluid injector system, wherein a set of the plurality of user inputs is associated with control of a corresponding set of the plurality of operations, the plurality of operations being related to allowing selection and execution of at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol.

3. The fluid injector system of claim 2, wherein the set of multiple user inputs comprises: selecting a preload command, wherein when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection protocol into the administration line; an execute preload command, wherein when the execute preload command is input into the user interface after the select preload command, the control device actuates the plurality of fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol; as well as A disable preload command is input into the user interface after the select preload command is input, and the control device disables the effect of the select preload command.

4. The fluid injector system of claim 3, wherein the control device is further programmed or configured to calculate a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol, such that when the execute preload command is input into the user interface, the control device: actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol according to one or more phases of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first and second fluids to be injected according to the diagnostic injection protocol is less than the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol and a subsequent supplemental volume of the second fluid according to one or more phases of the diagnostic injection protocol, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; and When it is determined according to the diagnostic injection protocol that the total volume of at least one of the first fluid and the second fluid to be injected is greater than the capacity of the administration line, one or more of the multiple fluid containers are actuated, and thereby at least one of the first fluid and the second fluid is preloaded into the administration line as much as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and the remainder of the diagnostic injection protocol is retained within the programming until the diagnostic injection protocol is performed on the patient, and the volume of the second fluid used to fill the administration line with the second fluid is discharged from the administration line.

5. A fluid injector system as described in claim 2, wherein the user interface is configured to display information associated with the status of at least partially pre-loading at least one of the first fluid and the second fluid into the administration line according to one or more stages of the diagnostic injection protocol.

6. The fluid injector system of claim 2, wherein the user interface is configured to display at least one of: a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol; and For each of the one or more phases of the diagnostic infusion protocol, a specific volume of at least one of the first fluid and the second fluid, and a flow rate at which the specific volume is to be infused into the patient during administration to the patient.

7. The fluid injector system of claim 1, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

8. A computer program product for enabling at least one of a first fluid and a second fluid to be at least partially preloaded into an administration line according to one or more phases of a diagnostic injection protocol, the computer program product comprising at least one non-transitory computer readable medium, the at least one non-transitory computer readable medium comprising one or more instructions that, when executed by at least one processor, cause the at least one processor to: allowing the diagnostic injection protocol to be programmed into a control device of a fluid injector system, the control device being operably associated with at least one drive component for selectively actuating a plurality of fluid containers, the plurality of fluid containers being placeable in fluid communication with a patient via the administration line, a first fluid container of the fluid containers being fillable with the first fluid comprising a contrast solution, and a second fluid container of the fluid containers being fillable with the second fluid comprising an irrigant; and Prior to initiating the diagnostic injection protocol, and upon completion of programming of the diagnostic injection protocol and priming of the administration line with the second fluid, selection and execution of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol are allowed.

9. The computer program product of claim 8, wherein when the one or more instructions are executed by at least one processor, further causes the at least one processor to: receiving, from a user interface operably associated with the at least one processor, at least one of a plurality of user inputs associated with control of a plurality of operations of the fluid injector system, wherein the set of multiple user inputs is associated with control of a corresponding set of multiple operations related to allowing selection and execution of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol.

10. The computer program product of claim 9, wherein the set of multiple user inputs comprises: selecting a preload command, wherein when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection protocol into the administration line; an execute preload command, wherein when the execute preload command is input into the user interface after the select preload command, the control device actuates the plurality of fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol; as well as A disable preload command is input into the user interface after the select preload command is input, and the control device disables the effect of the select preload command.

11. The computer program product of claim 9, wherein when the one or more instructions are executed by at least one processor, further causes the at least one processor to: The total volume of at least one of the first fluid and the second fluid to be injected is calculated according to the diagnostic injection scheme, so that when the execute preload command is input into the user interface, the at least one processor: actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol according to one or more phases of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first and second fluids to be injected according to the diagnostic injection protocol is less than the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol and a subsequent supplemental volume of the second fluid according to one or more phases of the diagnostic injection protocol, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; and When it is determined according to the diagnostic injection protocol that the total volume of at least one of the first fluid and the second fluid to be injected is greater than the capacity of the administration line, one or more of the multiple fluid containers are actuated, and thereby at least one of the first fluid and the second fluid is preloaded into the administration line as much as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and the remainder of the diagnostic injection protocol is retained within the programming until the diagnostic injection protocol is performed on the patient, and the volume of the second fluid used to fill the administration line with the second fluid is discharged from the administration line.

12. The computer program product of claim 9, wherein when the one or more instructions are executed by at least one processor, further causes the at least one processor to: Information associated with a status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic infusion protocol is displayed via the user interface.

13. The computer program product of claim 9, wherein when the one or more instructions are executed by at least one processor, further causes the at least one processor to: At least one of the following is displayed via the user interface: a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol; and For each of the one or more phases of the diagnostic infusion protocol, a specific volume of at least one of the first fluid and the second fluid and a flow rate at which the specific volume is to be infused into the patient during administration to the patient.

14. The computer program product of claim 8, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

15. A computer-implemented method for allowing at least one of a first fluid and a second fluid to be at least partially preloaded into a drug administration line according to one or more phases of a diagnostic infusion protocol, the method comprising: programming the diagnostic injection protocol into a control device of a fluid injector system via at least one processor, the control device being operably associated with at least one drive component for selectively actuating a plurality of fluid containers, the plurality of fluid containers being placeable in fluid communication with a patient via a dosing line, a first fluid container of the fluid containers being fillable with the first fluid comprising a contrast solution, and a second fluid container of the fluid containers being fillable with the second fluid comprising an irrigant; as well as Prior to initiating the diagnostic infusion protocol and upon completion of programming of the diagnostic infusion protocol and priming of the administration line with the second fluid, enabling selection and execution via the at least one processor of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic infusion protocol.

16. The computer-implemented method of claim 15, further comprising: receiving at least one of a plurality of user inputs associated with control of a plurality of operations of the fluid injector system from a user interface operably associated with the at least one processor, wherein the set of multiple user inputs is associated with control of a corresponding set of multiple operations related to allowing selection and execution of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol.

17. The computer-implemented method of claim 16, wherein the set of multiple user inputs comprises: selecting a preload command, wherein when the select preload command is input into the user interface, the control device prepares the fluid injector system to at least partially preload the diagnostic injection protocol into the administration line; an execute preload command, wherein when the execute preload command is input into the user interface after the select preload command, the control device actuates the plurality of fluid containers and thereby performs at least partial preloading of at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic injection protocol; as well as A disable preload command is input into the user interface after the select preload command is input, and the control device disables the effect of the select preload command.

18. The computer-implemented method of claim 16, further comprising: calculating, with the at least one processor, a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol, such that when the execute preload command is input into the user interface, the control device: actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol is equal to the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol according to one or more phases of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; actuating one or more of the plurality of fluid containers upon determining that the total volume of at least one of the first and second fluids to be injected according to the diagnostic injection protocol is less than the capacity of the administration line, thereby preloading the administration line with the total volume of the diagnostic injection protocol and a subsequent supplemental volume of the second fluid according to one or more phases of the diagnostic injection protocol, the supplemental volume being equal to the capacity of the administration line minus the total volume of the diagnostic injection protocol, and thereby expelling from the administration line the volume of the second fluid used to prime the administration line with the second fluid; and When it is determined according to the diagnostic injection protocol that the total volume of at least one of the first fluid and the second fluid to be injected is greater than the capacity of the administration line, one or more of the multiple fluid containers are actuated, and thereby at least one of the first fluid and the second fluid is preloaded into the administration line as much as the capacity of the administration line will allow according to one or more stages of the diagnostic injection protocol, and the remainder of the diagnostic injection protocol is retained within the programming until the diagnostic injection protocol is performed on the patient, and the volume of the second fluid used to fill the administration line with the second fluid is discharged from the administration line.

19. The computer-implemented method of claim 16, further comprising: Information associated with a status of at least partially preloading at least one of the first fluid and the second fluid into the administration line according to one or more phases of the diagnostic infusion protocol is displayed with the user interface.

20. The computer-implemented method of claim 16, further comprising: Displaying, with the user interface, at least one of the following: a total volume of at least one of the first fluid and the second fluid to be injected according to the diagnostic injection protocol; as well as For each of the one or more phases of the diagnostic infusion protocol, a specific volume of at least one of the first fluid and the second fluid and a flow rate at which the specific volume is to be infused into the patient during administration of the drug to the patient.

21. The computer-implemented method of claim 15, wherein a first one of the fluid containers comprises a syringe and a second one of the fluid containers comprises a syringe.

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