Systems and methods for configurable pressure limiting behavior for fluid infusion devices

Abstract

Systems and methods are disclosed for user- or system-configurable and adaptable pressure limiting behavior in fluid injection systems / devices. The fluid injector system may include at least one fluid injector device, at least one user interface, and a control device with at least one processor. The at least one processor may be programmed or configured to receive a maximum pressure limit for an injection procedure, receive a programmed fluid flow rate for the injection procedure, receive a maximum fluid flow rate reduction input for the injection procedure, the maximum fluid flow rate reduction input being selected by a user via the at least one user interface, receive a pressure limit sensitivity input for the injection procedure, and the pressure limit sensitivity input being selected by a user via the at least one user interface. The at least one processor may also be configured to control the at least one fluid injector device to perform the injection procedure based on the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 938,436, filed November 21, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to systems, devices, products, apparatus, and methods used for configurable / customizable pressure limiting behavior for fluid injection devices. The configuration and / or customization of the pressure limiting behavior may be performed by a user or a system based on a set of input parameters. [Background technology]

[0003] In many medical diagnostic and therapeutic procedures, medical personnel, such as physicians or radiologists, use powered fluid injector systems to inject one or more fluids into a patient. In recent years, several powered fluid injector systems have been developed for pressurized injection of fluids for use in procedures such as angiography, computed tomography (CT), molecular imaging (such as PET imaging), and magnetic resonance imaging (MRI).

[0004] Patient catheters used in any powered infusion procedure include pressure ratings selected to prevent intravenous (IV) site failure during the infusion procedure. Depending on factors such as the type of procedure and the patient's age, fluid injector systems have preprogrammed pressure limits to ensure that fluid pressure does not exceed the rating of the patient catheter used at the infusion site. For example, for some catheters commonly used in sensitive infusion sites, such as central venous catheters and peripherally inserted central catheters (PICCs), it is desirable to ensure that fluid pressure does not exceed the pressure limit. However, even with preprogrammed pressure limits, the maximum recorded pressure may still exceed these preprogrammed pressure limits in some cases.

[0005] Alternatively, in other procedures where slight overpressure is not necessarily undesirable, it may be more advantageous to maintain the fluid flow rate as close as possible to the commanded injection rate to ensure successful completion of the injection procedure. However, in current fluid injector systems, if a preprogrammed pressure limit is violated, the fluid flow rate is significantly reduced to quickly reduce the pressure within the system. Unfortunately, this sudden reduction in fluid flow rate can have a detrimental effect on the injection procedure, potentially requiring the injection to be interrupted and / or repeated. Summary of the Invention [Problem to be solved by the invention]

[0006] Despite these potential problems, pressure limits are typically determined by the manufacturer and hard-coded into the system, leaving medical personnel unable to configure or customize the pressure limit behavior to suit a particular injection procedure. Thus, there is a need in the art for improved pressure limit behavior settings for fluid injection devices. [Means for solving the problem]

[0007] Thus, there is provided a system, device, product, apparatus, and / or method for a fluid injector system that provides improved pressure limiting behavior.

[0008] In some non-limiting embodiments or aspects, a fluid infuser system may be configured to administer at least one fluid. The fluid infuser system may include at least one fluid infuser device, at least one user interface, and a control device in communication with the at least one user interface, wherein the control device directs the at least one fluid infuser device to perform a fluid injection procedure according to a profile that utilizes at least one of an internal input and an external input to determine the prioritization of maintaining a flow rate or limiting a fluid delivery pressure. At least one of the internal input and the external input may be selected from the group consisting of: receiving a maximum pressure limit for the fluid injection procedure; receiving a programmed fluid flow rate for the fluid injection procedure; receiving a maximum fluid flow rate reduction input for the fluid injection procedure, wherein the maximum fluid flow rate reduction input is selected or received by a user via at least one user interface or by the system based on at least one of patient information and system injection parameters; receiving a pressure limit sensitivity input for the fluid injection procedure, wherein the pressure limit sensitivity input is selected or received by a user via at least one user interface, and / or any combination thereof; and the control device is further configured to instruct the at least one fluid injector device to perform the injection procedure based on one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

[0009] In some non-limiting embodiments or aspects, the at least one user interface may include at least one graphical user interface, wherein the at least one graphical user interface displays a flow profile of the fluid injection procedure, the displayed flow profile further indicating one or more of a maximum pressure limit, a programmed fluid flow rate, a maximum fluid flow rate reduction input, and a pressure limit sensitivity input.

[0010] In certain non-limiting embodiments or aspects, the at least one processor may be further programmed or configured to reduce the fluid flow rate of the at least one fluid injector device to achieve a flow rate reduction below a programmed fluid flow rate when a predetermined threshold pressure relative to a maximum pressure limit is reached.

[0011] In some non-limiting embodiments and aspects, the fluid flow rate reduction may have one of a linear or a non-linear flow rate reduction profile.

[0012] In some non-limiting embodiments and aspects, the reduction in fluid flow rate is based on at least one input provided by a user of the fluid injector device. For example, in certain embodiments, the at least one user-provided input is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures. In various embodiments, the at least one user-provided input is selected by the user from a set of inputs stored in a protocol library or manually entered by the user prior to the start of the fluid injection procedure.

[0013] In some non-limiting embodiments and aspects, the reduction in fluid flow rate is based on at least one internally or externally supplied input. For example, in certain embodiments, the at least one internally or externally supplied input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof. The one or more barcodes are located on patient records, fluid injectors, medical fluid containers, sterile disposables, and combinations thereof.

[0014] In some non-limiting embodiments or aspects, the maximum fluid flow rate reduction input may be user or system selectable within a range of 0% to 100% of the programmed fluid flow rate. In some non-limiting embodiments or aspects, the at least one processor may be programmed or configured to interrupt the infusion procedure if a critical number (e.g., 0%) of the maximum fluid flow rate reduction input is selected and the pressure of at least one fluid is detected to be equal to or greater than the maximum pressure limit. In other embodiments, the fluid infusion may be interrupted when a predetermined threshold is reached or exceeded, which may be a percentage of the programmed pressure limit.

[0015] In some non-limiting embodiments or aspects, the pressure limit sensitivity input may be user or system selectable within a configurable range from low sensitivity to high sensitivity.

[0016] In certain non-limiting embodiments or aspects, the at least one processor may be programmed or configured to interrupt the injection procedure when specific configuration criteria are met and the pressure is detected to be equal to or greater than a predetermined pressure threshold.

[0017] In certain non-limiting embodiments or aspects, a user- or system-configurable pressure limiting behavior method for a fluid injector system may be configured to administer at least one fluid, the method including providing at least one of an internal input and an external input to the fluid injector system, prioritizing maintaining a flow rate or limiting a fluid delivery pressure based on the at least one of the internal input and the external input, developing an injection profile based on the prioritization, and instructing at least one fluid injector device to perform a fluid injection procedure according to the injection profile. According to certain non-limiting embodiments or aspects, providing at least one of the internal input and the external input includes an operation selected from the group consisting of: inputting or selecting a maximum pressure limit for the injection procedure into at least one user interface in communication with a control device of the fluid injector system, the control device comprising at least one processor; inputting or selecting a programmed fluid flow rate for injecting at least one fluid from the at least one fluid injector device; inputting or selecting a maximum fluid flow rate reduction input for the injection procedure based on at least one of patient information and system injection parameters; inputting or selecting a pressure limit sensitivity input for the injection procedure; and any combination thereof. According to certain non-limiting embodiments or aspects, the method may further include generating, by the control device, instructions to the fluid injector system to perform the injection procedure based on the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

[0018] In some non-limiting embodiments or aspects, the at least one user interface may include at least one graphical user interface, wherein the at least one graphical user interface displays a flow profile of the fluid injection procedure, the displayed flow profile further indicating one or more of a maximum pressure limit, a programmed fluid flow rate, a maximum fluid flow rate reduction input, and a pressure limit sensitivity input.

[0019] In some non-limiting embodiments or aspects, the method may further include reducing the fluid flow rate of at least one fluid injector device by the control device to achieve a flow rate reduction below a programmed fluid flow rate when a predetermined threshold pressure relative to a maximum pressure limit is reached.

[0020] In some non-limiting embodiments or aspects, the step of reducing the fluid flow rate is based on at least one input provided by a user of the fluid injector device. For example, in certain embodiments, the at least one user-provided input is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures. In certain embodiments, the at least one user input provided by the user is selected by the user from a set of inputs stored in a protocol library or manually entered by the user prior to the start of the fluid injection procedure.

[0021] In some non-limiting embodiments or aspects, the step of reducing the fluid flow rate is based on at least one internally or externally supplied input. For example, in certain embodiments, the at least one internally or externally supplied input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof. The one or more barcodes are located on patient records, fluid injectors, medical fluid containers, sterile disposables, and combinations thereof.

[0022] In some non-limiting embodiments or aspects, entering or selecting a maximum fluid flow reduction input may include entering or selecting a user or system selectable input within a range of 0% to 100% of the programmed fluid flow rate.

[0023] In some non-limiting embodiments or aspects, the method may further include suspending the infusion procedure if a critical number (e.g., 0%) of maximum fluid flow rate reduction input is selected and the pressure of at least one fluid is detected to exceed the maximum pressure limit. In other embodiments, the fluid infusion may be suspended when a predetermined threshold is reached or exceeded, which may be a percentage of the programmed pressure limit.

[0024] In some non-limiting embodiments or aspects, entering or selecting a pressure-limited sensitivity input may include entering or selecting a user- or system-selectable input within a configurable range from low sensitivity to high sensitivity.

[0025] In some non-limiting embodiments or aspects, the method may further include interrupting the injection procedure when specific configuration criteria are met and the pressure is detected to exceed a predetermined pressure threshold.

[0026] Further non-limiting embodiments are described in the following numbered clauses:

[0027] Clause 1. A fluid injector system configured to administer at least one fluid, the fluid injector system comprising: at least one fluid injector device; at least one user interface; and a control device in communication with the at least one user interface, the control device comprising at least one processor programmed or configured to instruct the at least one fluid injector device to perform a fluid injection procedure according to a profile utilizing at least one of an internal input and an external input to determine the prioritization of maintaining a flow rate or limiting a fluid delivery pressure.

[0028] Clause 2. The fluid injector system of clause 1, wherein at least one of the internal input and the external input receives a maximum pressure limit for the fluid injection procedure, receives a programmed fluid flow rate for the fluid injection procedure, receives a maximum fluid flow rate reduction input for the fluid injection procedure, wherein the maximum fluid flow rate reduction input is selected by a user via at least one user interface or by the system based on at least one of patient information and system injection parameters, receives a pressure limit sensitivity input for the fluid injection procedure, wherein the pressure limit sensitivity input is selected from the group consisting of: selected by a user via at least one user interface, received, and any combination thereof, and the control device is further configured to instruct at least one fluid injector device to perform the injection procedure based on one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

[0029] Clause 3. A fluid injector system as described in clause 1 or 2, wherein at least one user interface includes at least one graphical user interface, wherein the at least one graphical user interface displays a flow profile of the fluid injection procedure, and wherein the displayed flow profile further indicates one or more of a maximum pressure limit, a programmed fluid flow rate, a maximum fluid flow rate reduction input, and a pressure limit sensitivity input.

[0030] Clause 4. A fluid injector system as described in any one of clauses 1 to 3, wherein at least one processor is programmed or configured to limit the fluid delivery pressure by reducing the fluid flow rate, diluting a more viscous fluid with a less viscous fluid, or a combination thereof.

[0031] Clause 5. A fluid injector system as described in any one of clauses 1 to 3, wherein at least one processor is further programmed or configured to reduce the fluid flow rate of at least one fluid injector device to achieve a flow rate reduction below a programmed fluid flow rate when a predetermined threshold pressure relative to a maximum pressure limit is reached.

[0032] Clause 6. The fluid infuser system of clause 5, wherein the fluid flow rate reduction has one of a linear or a non-linear flow rate reduction profile.

[0033] Clause 7. The fluid infuser system of clause 5, wherein the reduction in fluid flow rate is based on at least one input provided by a user of the fluid infuser device.

[0034] Clause 8. The fluid injector system of clause 7, wherein at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures.

[0035] Clause 9. A fluid injector system as described in Clause 8, wherein at least one user input provided by the user is selected by the user from a set of inputs stored in a protocol library or is manually entered by the user prior to the start of the fluid injection procedure.

[0036] Clause 10. The fluid infuser system of clause 5, wherein the reduction in fluid flow rate is based on at least one internally supplied or externally supplied input.

[0037] Clause 11. The fluid injector system of clause 10, wherein at least one internally or externally supplied input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof, and wherein the one or more barcodes are placed on the patient record, the fluid injector, the medical fluid container, the sterile disposable, and combinations thereof.

[0038] Clause 12. A fluid infuser system as described in any one of clauses 2 to 11, wherein the maximum fluid flow rate reduction input is user or system selectable within the range of 0% to 100% of the programmed fluid flow rate.

[0039] Clause 13. A fluid injector system as described in any one of clauses 2 to 12, wherein at least one processor is programmed or configured to interrupt the injection procedure when a 0% maximum fluid flow reduction input is selected and the pressure of at least one fluid is detected to be equal to or greater than the maximum pressure limit.

[0040] Clause 14. A fluid injector system according to any one of clauses 2 to 13, wherein the pressure limit sensitivity input is user or system selectable within a configurable range from low sensitivity to high sensitivity.

[0041] Clause 15. A fluid injector system as described in any one of clauses 5 to 14, wherein at least one processor is programmed or configured to interrupt the injection procedure when specific configuration criteria are met and pressure is detected to be equal to or greater than a predetermined pressure threshold.

[0042] Clause 16. A method of user or system configurable pressure limiting behavior for a fluid injector system configured to administer at least one fluid, the method comprising the steps of providing at least one of an internal input and an external input to the fluid injector system, prioritizing maintenance of flow rate or limiting fluid delivery pressure based on the at least one of the internal input and the external input, developing an injection profile based on the prioritization, and instructing at least one fluid injector device to perform a fluid injection procedure in accordance with the injection profile.

[0043] Clause 17. The method of clause 16, wherein the step of providing at least one of the internal input and the external input includes an operation selected from the group consisting of: inputting or selecting a maximum pressure limit for the injection procedure into at least one user interface in communication with a control device of the fluid injector system, the control device having at least one processor; inputting or selecting a programmed fluid flow rate for injecting at least one fluid from the at least one fluid injector device; inputting or selecting a maximum fluid flow rate reduction input for the injection procedure based on at least one of patient information and system injection parameters; inputting or selecting a pressure limit sensitivity input for the injection procedure; and any combination thereof.

[0044] Clause 18. The method of clause 17, further comprising the step of generating, by the control device, instructions to the fluid injector system to perform an injection procedure based on the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

[0045] Clause 19. The method of any one of clauses 16 to 18, wherein the at least one user interface includes at least one graphical user interface, the at least one graphical user interface displays a flow profile of the fluid injection procedure, and the displayed flow profile further indicates one or more of a maximum pressure limit, a programmed fluid flow rate, a maximum fluid flow rate reduction input, and a pressure limit sensitivity input.

[0046] Clause 20. The method of any one of clauses 16 to 19, further comprising limiting the fluid delivery pressure by reducing the fluid flow rate, diluting a more viscous fluid with a less viscous fluid, or a combination thereof.

[0047] Clause 21. The method of any one of clauses 16 to 20, further comprising the step of reducing the fluid flow rate of at least one fluid infuser device by the control device to achieve a reduction in flow rate below a programmed fluid flow rate when a predetermined threshold pressure relative to a maximum pressure limit is reached.

[0048] Clause 22. The method of clause 21, wherein the step of decreasing the fluid flow rate is based on at least one input provided by a user of the fluid infuser device.

[0049] Clause 23. The method of clause 22, wherein the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures.

[0050] Clause 24. The method of clause 23, wherein at least one user input provided by the user is selected by the user from a set of inputs stored in a protocol library or is manually entered by the user prior to the start of the fluid injection procedure.

[0051] Clause 25. The method of clause 21, wherein the step of reducing the fluid flow rate is based on at least one internally supplied or externally supplied input.

[0052] Clause 26. The method of clause 25, wherein the at least one internally or externally supplied input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof, and wherein the one or more barcodes are placed on a patient record, a fluid injector, a medical fluid container, a sterile disposable, and combinations thereof.

[0053] Clause 27. The method of any one of clauses 17 to 26, wherein the step of entering or selecting a maximum fluid flow rate reduction input comprises entering or selecting a user or system selectable input within a range of 0% to 100% of the programmed fluid flow rate.

[0054] Clause 28. The method of any one of clauses 17 to 27, further comprising the step of interrupting the infusion procedure if a 0% maximum fluid flow reduction input is selected and the pressure of at least one fluid is detected to exceed the maximum pressure limit.

[0055] Clause 29. The method of any one of clauses 17 to 28, wherein the step of entering or selecting a pressure limiting sensitivity input comprises entering or selecting a user or system selectable input within a configurable range from low sensitivity to high sensitivity.

[0056] Clause 30. The method of any one of clauses 21 to 28, further comprising the step of interrupting the injection procedure when a specific configuration criterion is met and the pressure is detected to exceed a predetermined pressure threshold.

[0057] These and other features and characteristics of the present disclosure, as well as the method of operation and function of the associated elements of structure, and the combination of parts and economies of manufacture, will become more apparent from a consideration of the following description and appended claims, taken in conjunction with the accompanying drawings, all of which form a part hereof, and in which like reference numerals designate corresponding parts in the various views. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the present disclosure. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0058] Further advantages and details of the present disclosure are explained in more detail below with reference to exemplary embodiments or aspects illustrated in the accompanying schematic drawings. [Brief explanation of the drawings]

[0059] [Figure 1] 1 is a perspective view of a fluid injector system according to an example of the present disclosure. [Figure 2] 2 is a perspective view of a multiple disposable set for use with the fluid infuser system of FIG. 1. [Figure 3] FIG. 10 is a perspective view of a fluid injector system according to another example of the present disclosure. [Figure 4] FIG. 1 is a schematic diagram of an electronic control system for a fluid injector system according to an example of the present disclosure. [Figure 5] FIG. 1 is a diagram of a graphical user interface of a fluid injector system according to an example of the present disclosure. [Figure 6] FIG. 10 is a diagram of a graphical user interface of a fluid injector system according to another example of the present disclosure. [Figure 7] FIG. 10 is a diagram of a graphical user interface of a fluid injector system according to another example of the present disclosure. [Figure 8] FIG. 10 is a diagram of a graphical user interface of a fluid injector system according to another example of the present disclosure. [Figure 9] FIG. 10 is a diagram of a graphical user interface of a fluid injector system according to another example of the present disclosure. [Figure 10] 10 is a graphical representation of the configurable space under user-defined or system-defined maximum flow reduction settings according to an example of the present disclosure. [Figure 11] 10 is a graphical representation of the configurable space under user-defined or system-defined maximum flow reduction settings according to another example of the present disclosure. [Figure 12A] 10 is a pressure graph under a first user-defined or system-defined pressure limit sensitivity setting according to an example of the present disclosure. [Figure 12B] 10 is a pressure graph under a second user-defined or system-defined pressure limiting sensitivity setting according to another example of the present disclosure. [Figure 12C] 10 is a pressure graph under a third user-defined or system-defined pressure limiting sensitivity setting according to another example of the present disclosure. [Figure 12D]10 is a pressure graph under a fourth user-defined or system-defined pressure limiting sensitivity setting according to another example of the present disclosure. [Figure 13] FIG. 10 is a flowchart diagram of a fluid injection procedure according to an example of the present disclosure. [Figure 14] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to an example of the present disclosure. [Figure 15] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 16] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 17] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 18] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 19] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 20] 10 is a graphical representation of corresponding pressure versus time and flow rate versus time under user or system configuration settings for a fluid injection procedure according to another example of the present disclosure. [Figure 21] FIG. 10 illustrates a depiction on a graphical user interface of a slide selector for adjusting the prioritization between pressure limit and flow maintenance user configuration settings for a fluid injection procedure according to an example of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0060] For purposes of the following description, the terms "top," "bottom," "right," "left," "vertical," "horizontal," "upper," "lower," "transverse," "longitudinal," and their derivatives shall refer to the present disclosure as shown in the drawings. When used in reference to a syringe in a multi-patient disposable set, the term "proximal" refers to the portion of the syringe closest to the piston for delivering fluid from the syringe.

[0061] Spatial or directional terms such as "left," "right," "inside," "outside," "upper," and "lower" should not be considered limiting as the present invention can assume various alternative orientations.

[0062] All numbers used in this specification and claims should be understood to be modified in all instances by the term "about." The terms "approximately," "about," and "substantially" refer to a range of plus or minus ten percent of the stated value.

[0063] As used herein, the term "at least one of" is synonymous with "one or more of." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more As alone, or one or more Bs alone, or one or more Cs alone, or one or more As and one or more Bs, or one or more As and one or more Cs, or one or more Bs and one or more Cs. Similarly, as used herein, the term "at least two of" is synonymous with "two or more of." For example, the phrase "at least two of D, E, and F" means any combination of any two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more of D and one or more of E, or one or more of D and one or more of F, or one or more of E and one or more of F, or one or more of all of D, E, and F.

[0064] It should also be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary of the present disclosure, and thus specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.

[0065] When used in reference to a fluid reservoir, such as a syringe, rolling diaphragm, or multiple syringe disposable set, the term "distal" refers to the portion of the fluid reservoir closest to the patient. When used in reference to a fluid reservoir, such as a syringe, rolling diaphragm, or multiple syringe disposable set, the term "proximal" refers to the portion of the fluid reservoir closest to the injector system.

[0066] As used herein, the terms “communication” and “communicating” may refer to receiving, receiving, transmitting, transferring, providing, etc., information (e.g., data, signals, messages, instructions, commands, etc.). One unit (e.g., a device, a system, a component of a device or system, a combination thereof, etc.) communicating with another unit means that one unit can directly or indirectly receive information from the other unit and / or transmit information to the other unit. This may refer to a direct or indirect connection that is wired and / or wireless in nature. Furthermore, two units may communicate with each other even if the transmitted information is modified, processed, relayed, and / or routed between the first and second units. For example, a first unit may communicate with a second unit even if the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may communicate with a second unit if at least one intermediate unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet, etc.) containing data. It will be appreciated that numerous other configurations are possible.

[0067] The term "server," as used herein, may refer to one or more computing devices, such as a processor, a storage device, and / or similar computer components, that communicate with client devices and / or other computing devices over a network, such as the Internet or a private network, and, in some examples, facilitate communication between other servers and / or client devices. It will be appreciated that various other configurations are possible. The term "system," as used herein, may refer to one or more computing devices or combinations of computing devices, such as, but not limited to, a processor, a server, a client device, a software application, and / or other similar components. Additionally, references to a "server" or a "processor" as used herein may refer to a previously listed server and / or processor, a different server and / or processor, and / or a combination of servers and / or processors listed as performing the previous step or function. For example, as used herein and in the claims, a first server and / or a first processor listed as performing a first step or function may refer to the same or a different server and / or processor listed as performing a second step or function.

[0068] Non-limiting embodiments or aspects of the present disclosure relate to systems, devices, products, apparatus, and / or methods for fluid injector systems that achieve improved pressure limiting behavior. In particular, the fluid injector systems provided herein may include computer algorithms and methods that enable a user or system to direct at least one fluid injector device of the fluid injector system to perform a fluid injection procedure according to a profile that determines the prioritization between maintaining fluid flow rate and limiting fluid delivery pressure, utilizing at least one of internal inputs, e.g., input by the system, or external inputs, e.g., input by a user or hospital information network or other storage data device. In accordance with the present disclosure, the terms "flow rate" and "fluid flow rate" may be considered analogous to the injection rate of a drug or contrast agent, which can be altered by increasing or decreasing the overall flow rate of a solution containing the drug or contrast agent. In other embodiments, the flow rate or fluid flow rate may be altered by changing the concentration of the drug or contrast agent in the solution, for example, by dilution with saline or addition of a more concentrated solution of the drug or contrast agent, which can have the effect of changing the amount of drug / contrast agent delivered per delivered volume, or by exponentially reducing the viscosity, which in turn can reduce the pressure of the fluid in the system. It will be appreciated that the flow rate or fluid flow rate may be altered by various combinations that change the overall flow of the solution or by changing the concentration and / or viscosity of the solution.

[0069] For example, depending on one or more of the inputs, the fluid delivery system may prioritize maintaining flow rate or limiting fluid delivery pressure, select or adapt a fluid injection protocol or injection profile that sets a predetermined pressure threshold, and interrupt the injection procedure if pressure is detected, predicted, or trended at or above the predetermined pressure threshold, the predetermined pressure threshold being at least partially determined by at least one of internal or external input information.

[0070] According to various embodiments, at least one of the internal or external inputs may include a maximum pressure limit for the injection procedure, a programmed fluid flow rate for infusing at least one fluid from the at least one fluid injection device, a maximum fluid flow rate reduction input for the injection procedure based on at least one of patient information and system injection parameters, a pressure limit sensitivity input for the injection procedure, and any various combinations thereof. For example, depending on the patient's age and / or overall health, including, for example, the health of the patient's vasculature, a user or system may prioritize maintaining flow rate or limiting fluid delivery pressure. For example, in older patients or patients with poorer vascular health (e.g., weaker vessel walls), a user or system may prioritize limiting fluid delivery pressure to avoid complications during the fluid delivery procedure. In another embodiment, if a patient is the same age but has better vascular health, the prioritization may place more emphasis on maintaining flow rate and less emphasis on limiting fluid delivery pressure. In another embodiment, if a patient is healthy with a strong vasculature, a user or system may prioritize maintaining flow rate. As a result of prioritization based on user or system input, imaging techniques can provide an optimal fluid flow profile for the patient while minimizing potential hazards during the injection procedure.

[0071] User input may result from information based on, but not limited to, patient exams, patient history data, user experience with patients of similar health or condition, prescribed injection procedure or protocol type, injection time, contrast agent type, and various combinations thereof. System input may result from, but is not limited to, information based on past injector data, past patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof. One or more barcodes may be placed on patient records, fluid injectors, medical fluid containers, sterile disposables, and combinations thereof, and may contain unique information about the item on which the barcode is placed. In various embodiments, the entered information may be a combination of user-entered information and system-entered information. Taking the entered information into account, the at least one control device can then generate a fluid flow that accommodates an injection profile specific to the patient and the particular fluid injector.

[0072] According to certain embodiments, the pressure limit sensitivity may range between low and high sensitivity. In certain embodiments, the pressure limit sensitivity may have one or more intermediate sensitivities between low and high sensitivity, such as medium or "moderate sensitivity," depending on the desired fluid flow profile. According to other embodiments, the pressure limit sensitivity may be on a sliding scale between low and high sensitivity. According to various embodiments, the prioritization between pressure limit sensitivity and maintaining fluid flow may be on opposite ends of a scale, as shown in FIG. 21 . That is, when pressure limit sensitivity is a high priority (i.e., high pressure limit sensitivity), maintaining fluid flow may be a low priority, and when pressure limit sensitivity is a low priority (i.e., low pressure limit sensitivity), maintaining fluid flow may be a high priority.

[0073] According to various embodiments, inputting at least one of internal or external inputs and / or changing the prioritization between pressure limit sensitivity and maintaining fluid flow rate may occur before starting an infusion procedure or may occur while the infusion procedure is in progress. The infusion protocol may be updated based on either pre-infusion data and / or real-time infusion data being collected during the infusion procedure. According to certain embodiments, the determination of an acceptable infusion profile may be weighted to prioritize pre-infusion information over real-time infusion information, or vice versa. Furthermore, the infusion information may include, for example, pressure, fluid flow rate, scanner data or image feedback, patient physiological feedback (e.g., ECG signal, blood pressure, heart rate, temperature), or a combination thereof.

[0074] Various injection parameters that may be input by the user and / or the fluid injector system to at least partially prioritize between pressure limiting and flow rate maintenance include, but are not limited to, historical data from the system or user, data supplied to the system by the user, external systems (such as a picture archiving and communication system (PACS), radiology information system (RIS), hospital information system (HIS), external medical records, etc.), data from barcodes, RFID tags, and other near-field communication tags such as tags on injector disposables, contrast and medical fluid containers, catheters, patient wristbands, etc., one or more look-up tables of various parameters for a particular injection protocol stored in memory of a control device, a network server, or in a hard-copy version available to the user, among others. According to various embodiments, the parameters may be pre-configured as part of an individual protocol, the parameters may be received from the scanner as part of patient treatment information or other data packets, or the parameters may be configured to change or update automatically based on a combination of injection protocol and disposables (e.g., syringe size, catheter size, fluid type, etc.), or various combinations of parameters received from these sources.

[0075] Referring to the drawings, in which like reference numerals refer to like parts throughout the several views of the drawings, one aspect or example of the present disclosure generally relates to a multi-fluid medical injector / injector system 100 (hereinafter "fluid injector system 100") that, in certain embodiments, may include a multi-use disposable set (MUDS) 130 configured to deliver fluids to a patient using a single-use disposable set (SUDS) connector (not shown), or, in other embodiments, may include two or more disposable fluid reservoirs or syringes that can be disposed of after a single injection procedure or a certain number of injection procedures. The fluid injector system 100 may include multiple components, which are individually described herein. Generally, the fluid injector system 100 depicted in FIGS. 1-2 includes a powered injector or other administration device, as well as a fluid delivery set intended to be associated with the injector for delivering one or more fluids under pressure from one or more multi-dose containers to a patient, as described herein. The various devices, components, and features of the fluid injector system 100 and its associated fluid delivery set are similarly described in detail herein. Although various example methods and processes are illustrated with reference to injector systems having multiple use disposable set ("MUDS") and single use disposable set ("SUDS") configurations in FIGS. 1-2, the present disclosure is not limited to such injector systems and may be utilized with other syringe-based injector systems, such as, but not limited to, those described in U.S. Patent Nos. 7,553,294, 7,563,249, 8,945,051, 9,173,995, 10,124,110, 10,507,319, and 10,583,256, and U.S. Application No. 15 / 568,505, the disclosures of each of which are incorporated herein by this reference in their entirety.

[0076] 1, an example fluid injector system 100 includes an injector housing 102 that encloses various mechanical drive components, electrical and power components necessary to drive the mechanical drive components, and control components such as electronic memory and electronic control devices used to control the operation of a reciprocable piston (not shown) associated with the fluid injector system 100 described herein. Such piston may be reciprocatable via an electromechanical drive component such as a ball screw shaft driven by a motor, a voice coil actuator, a rack and pinion gear drive, a linear motor, or the like.

[0077] The fluid infuser system 100 may include at least one bulk fluid connector 118 for connecting with at least one bulk fluid source 120. In some examples, multiple bulk fluid connectors 118 may be provided. For example, as shown in the fluid infuser embodiment illustrated in FIG. 1, three bulk fluid connectors 118 may be provided side-by-side or in other arrangements. In some examples, the at least one bulk fluid connector 118 may include a spike configured to removably connect to at least one bulk fluid source 120, such as a vial, bottle, or bag. The at least one bulk fluid connector 118 may be formed on a multiple-use disposable set ("MUDS") described herein. The at least one bulk fluid source 120 may be configured to receive a medical fluid, such as saline, lactated Ringer's solution, imaging contrast medium solution, or other medical fluid, for delivery to a patient by the fluid infuser system 100.

[0078] 2, MUDS 130 is configured to be removably connected to fluid injector system 100 for delivering one or more fluids from one or more bulk fluid sources 120 to a patient. Example embodiments and features of MUDS are further described in PCT International Publication No. WO 2016 / 112163, filed January 7, 2016, the disclosure of which is incorporated herein by reference in its entirety. MUDS 130 may include one or more fluid reservoirs, such as one or more syringes 132. As used herein, the term "fluid reservoir" refers to any container capable of receiving and delivering a fluid, for example, during a fluid infusion procedure, including, for example, a syringe, a rolling diaphragm, a pump, a compressible bag, etc. A fluid reservoir may include an interior volume of at least a portion of a fluid pathway, such as one or more lengths of tubing in fluid communication with the interior of the fluid reservoir, including a portion of the fluid pathway that remains in fluid communication with the fluid reservoir after the system is closed or fluidly isolated from the remainder of the fluid pathway. In some examples, the number of fluid reservoirs may correspond to the number of bulk fluid sources 120 (shown in FIG. 1). For example, with reference to FIG. 2, MUDS 130 has three syringes 132 arranged side-by-side such that each syringe 132 is fluidly connectable to one or more of the three corresponding bulk fluid sources 120. In some examples, one or more bulk fluid sources 120 may be connected to one or more syringes 132 of MUDS 130. Each syringe 132 may be fluidly connectable to one of the bulk fluid sources 120 by a corresponding bulk fluid connector 118 and associated MUDS fluid pathway 134. The MUDS fluid path 134 may have a spike element that connects to the bulk fluid connector 118 and the fluid line 150. In some examples, the bulk fluid connector 118 may be provided directly on the MUDS 130.

[0079] 1 and 2 , the MUDS 130 may include one or more valves 136, such as stopcock valves, for controlling which medical fluids or combinations of medical fluids are drawn from the multi-dose bulk fluid source 120 (see FIG. 1 ) into the fluid reservoirs 132 and / or delivered to the patient from each fluid reservoir 132. In some examples, the one or more valves 136 may be provided at the distal ends of the multiple syringes 132 or in a manifold 148. The manifold 148 may be selectively fluidly connected to the interior volumes of the syringes 132 via the valves 136. The interior volumes of the syringes 132 may be selectively fluidly connected to first ends of MUDS fluid pathways 134 connecting each syringe 132 to a corresponding bulk fluid source 120 via the valves 136. Opposing second ends of the MUDS fluid pathways 134 may be connected to respective bulk fluid connectors 118 configured to fluidly connect with the bulk fluid sources 120. Depending on the position of the one or more valves 136, fluid may be drawn into or delivered from the internal volume of the one or more syringes 132. In a first position, such as during filling of a syringe 132, the one or more valves 136 are directed to allow fluid to flow from the bulk fluid source 120 through a fluid inlet line 150, such as a MUDS fluid path, to the desired syringe 132. During a filling procedure, the one or more valves 136 are positioned to block or close fluid flow through one or more fluid outlet lines 152 or the manifold 148. In a second position, such as during a fluid delivery procedure, fluid from the one or more syringes 132 is delivered through one or more fluid outlet lines 152 or syringe valve outlet ports to the manifold 148. During a delivery procedure, the one or more valves 136 are positioned to block or close fluid flow through one or more fluid inlet lines 150. In the third position, the one or more valves 136 are oriented such that fluid flow through the one or more fluid inlet lines 150 and the one or more fluid outlet lines 152 or manifold 148 is blocked or closed.Thus, in the third position, each of the one or more valves 136 isolates the corresponding syringe 132 and prevents fluid flow into or out of the interior volume of the corresponding syringe 132. As such, each of the one or more syringes 132 and the corresponding valve 136 defines a closed system.

[0080] One or more valves 136, fluid inlet line 150, and / or fluid outlet line 152 may be integrated into or fluidly communicate with manifold 148. One or more valves 136 may be selectively placed in a first or second position by a manual or automatic process. For example, an operator may place one or more valves 136 in a desired position for filling, fluid delivery, or a closed position. In other examples, at least a portion of fluid infuser system 100 is operable to automatically place one or more valves 136 in a desired position for filling, fluid delivery, or a closed position based on input by an operator or by a protocol executed by an electronic control unit.

[0081] 1 and 2 , according to described embodiments, the fluid injector system 100 may have a connection port 192 configured to form a releasable fluid connection with at least a portion of the SUDS. In some examples, the connection port 192 may be formed in the MUDS 130. As described herein, the SUDS may be connected to the connection port 192 formed in at least a portion of the MUDS 130 and / or the housing 102. Desirably, the connection between the SUDS and the connection port 192 is a releasable connection to allow the SUDS to be selectively connected and disconnected from the connection port 192. In some examples, the SUDS may be disconnected from the connection port 192 and placed after each fluid delivery procedure, and a new SUDS may be connected to the connection port 192 for a subsequent fluid delivery procedure. The SUDS may be used to deliver one or more medical fluids to a patient via a SUDS fluid line having a distal end that can be selectively disconnected from the body of the SUDS and connected to a patient catheter. Other examples and features of SUDS are described in U.S. Patent Application No. 2016 / 0331951, filed July 7, 2016, the disclosure of which is incorporated herein by reference in its entirety.

[0082] 1 , fluid injector system 100 may include one or more user interfaces 124, such as a graphical user interface (GUI) display window. User interface 124 may display information related to a fluid injection procedure involving fluid injector system 100, such as the status or progress of the injection, the current flow rate, the fluid pressure, and the volume remaining in at least one bulk fluid source 120 connected to fluid injector system 100, and may be a touchscreen GUI that allows an operator to input commands and / or data for operation of fluid injector system 100. Additionally, fluid injector system 100 and / or user interface 124 may include at least one control button 126 for tactile actuation by a personnel operator of fluid injector system 100. At least one control button 126 may be a graphical portion of user interface 124, such as a touchscreen.

[0083] 1-2 illustrate one example of a fluid injector system 100 and associated components and structures, it should be understood that the present disclosure is not limited to any particular type or variety of fluid injector system 100. Referring now to FIG. 3, another non-limiting example of a fluid injector system 100 according to the present disclosure includes at least one fluid reservoir, such as a syringe 12, at least one piston (not shown) connectable to at least one plunger 14, and a fluid control module (not shown). The at least one syringe 12 is generally adapted to interface with at least one component of the system, such as a syringe port 13. The fluid injector system 100 is generally configured to deliver at least one fluid F to a patient during an injection procedure. The fluid injector system 100 is configured to releasably receive at least one syringe 12 filled with at least one fluid F, such as contrast medium, saline, lactated Ringer's solution, or any desired medical fluid. The system may be a multi-syringe injector, with several syringes oriented side-by-side or in another spatial relationship and separately actuated by respective pistons associated with the injectors. At least one syringe 12 may be oriented in any manner, such as straight up, straight down, or positioned at any angle. In another embodiment, the fluid injector 100 may interface with one or more rolling diaphragm syringes (not shown). Non-limiting examples of rolling diaphragm syringe-based injectors are described in U.S. Patent Application Nos. 15 / 305,285 and 15 / 568,505 and PCT International Application No. PCT / US2017 / 056747, the disclosures of which are incorporated herein.

[0084] 3 , the injector system 100 may be used during a medical procedure to inject at least one medical fluid F into a patient's vascular system by driving the plunger 14 of the at least one syringe 12 with a driving member, such as at least one piston 103 (see FIG. 4 ). The at least one piston may be reciprocally movable relative to at least a portion of the at least one syringe, such as the plunger 14. Upon engagement, the at least one piston may move the plunger 14 toward the distal end 19 of the at least one syringe, as well as retract the plunger 14 toward the proximal end 11 of the at least one syringe 12.

[0085] The tubing set 17 (e.g., first and second fluid conduits 17a and 17b, as well as a common fluid conduit 20) may be in fluid communication with the outlet ports of each syringe 12 to fluidly connect each syringe to a catheter (not shown) inserted into a patient at a vascular access site for delivery of fluid F from each syringe 12 to the catheter. The first and second fluid conduits 17a and 17b may be connected to the common fluid conduit 20 by any suitable mechanism known in the art (e.g., a Y-connector or a T-connector). The fluid infuser system 100 shown in FIG. 3 is an open system due to the lack of valves capable of isolating the syringes 12 from each other and from at least a portion of the tubing set 17. However, it should be understood that a valve similar or identical to the valve 136 described with reference to the fluid infuser system 100 of FIGS. 1 and 2 may be added distal to the syringes 12 to convert the fluid infuser system 100 of FIG. 3 into a closed system.

[0086] 4 , a fluid infuser system 100 according to the present disclosure may be associated with and controlled by an electronic control device 400 configured to execute one or more infuser protocols, including, for example, filling, priming, and delivery operations. In some examples, the electronic control device 400 may control the operation of various valves, stopcocks, piston members, and other elements to affect desired gas / air removal, filling, and / or delivery procedures. The electronic control device 400 may include at least one processor 404, memory 408, input components 410, and output components 412. The electronic control device may further include a bus that enables communication between the components of the electronic control device 400. The at least one processor 404 may be implemented in hardware, firmware, or a combination of hardware and software. For example, processor 404 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc.). Memory 408 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid-state disk, etc.) and / or another type of computer-readable medium. Input components 410 may include components that enable electronic control device 400 to receive information, such as via user input (e.g., user interface 124). Output components 412 may include components that provide output information from electronic control device 400 (e.g., user interface 124).

[0087] Electronic control device 400 may be programmed or configured to perform one or more processes and / or methods based on at least one processor 404 executing software instructions stored by a computer-readable medium, such as memory 408. When executed, the software instructions stored in memory 408 may cause at least one processor 404 to perform one or more processes and / or methods described herein.

[0088] 4, electronic control device 400, and more particularly at least one processor 404, can be in operative communication with one or more components of fluid injector system 100 to control the operation of fluid injector system 100. Electronic control device 400 can be in operative communication with one or more drive components 510a, 510b, 510n associated with one or more fluid reservoirs 500a, 500b, 500n, respectively, of fluid injector system 100 to control the filling and delivery of fluid from fluid reservoirs 500a, 500b, 500n. More specifically, one or more drive components 510a, 510b, 510n may each be associated with one of the fluid reservoirs 500a, 500b, 500n such that fluid contained in each of the fluid reservoirs 500a, 500b, 500n may be selectively delivered by actuation of the associated drive component 510a, 510b, 510n. The fluid reservoirs 500a, 500b, 500n may be or correspond to the syringe 132 of the fluid injector system 100 of FIGS. 1-2 and / or the syringe 12 of the fluid injector system 100 of FIG. 3, or other syringe-type structures such as the rolling diaphragm syringes described herein. The one or more drive components 510a, 510b, 510n may be or correspond to the piston (not shown) of the fluid injector system 100 of FIGS. 1-3. One or more fluid reservoirs 500a, 500b, 500n may be in fluid communication with a fluid conduit 530 for delivering fluid to a catheter or other component connected to a patient. Fluid conduit 530 may be or correspond to SUDS of fluid infuser system 100 of Figures 1-2 and / or tubing set 17 of fluid infuser system 100 of Figure 3.

[0089] In embodiments and examples of closed fluid infuser systems 100 (e.g., the fluid infuser systems 100 of FIGS. 1 and 2), electronic control device 400 may further be in operative communication with one or more valves 520a, 520b, 520n to rotate or otherwise actuate valves 520a, 520b, 520n to direct flow into or out of one or more of fluid reservoirs 500a, 500b, 500n and / or isolate flow from one or more of fluid reservoirs 500a, 500b, 500n to fluid conduit 530. Valves 520a, 520b, 520n may be or correspond to valves 136 described herein in connection with FIG.

[0090] As discussed above, conventional fluid injector systems utilize pressure limit settings that are determined by the manufacturer and hard-coded into the system. However, to support diverse patient populations, various injection protocols, and multiple IV sites / types, a user- or system-configurable and / or customizable method of setting pressure limit behavior is needed. Therefore, according to one aspect of the present disclosure, a fluid injection system and method for providing user- or system-configurable injector performance settings is disclosed.

[0091] 5-9, a graphical user interface (GUI) 200 is shown in accordance with various embodiments of the present disclosure. While only one GUI 200 is shown, it should be understood that multiple GUIs 200 may be present. The GUI 200 may be, for example, a touchscreen interface located on the user interface 124 of the fluid injector system 100, as shown in FIG. 1. However, it should be understood that the GUI 200 is not so limited and may be located remotely from the fluid injector system 100. The GUI 200 includes at least two user- or system-configurable inputs: a maximum flow rate reduction input 202 and a pressure limit sensitivity input 204. Based on the settings selected by the medical professional for each of these inputs, customizable injector behavior is achievable, with the selection being made depending on whether maintaining flow rate (i.e., contrast / iodine delivery rate, or IDR) or ensuring that pressure limits are never violated is more important given the variables of the injection procedure.

[0092] In addition to at least two user- or system-configurable inputs, GUI 200 may also include a programmed pressure limit indicator 206 and an adaptive flow graph 208. The pressure limit identified on the programmed pressure limit indicator 206 is typically pre-programmed based on the type of injection procedure. For example, for an injection procedure associated with CT imaging, the programmed pressure limit may be 300 psi, while for an angiography procedure, the programmed pressure limit may be 1200 psi. In some embodiments, the programmed pressure limit may be input via GUI 200. As described in further detail below, adaptive flow graph 208 provides the medical practitioner with a visual indication of the user- or system-customized injector settings relative to one another. However, it should be understood that adaptive flow graph 208 may be omitted from GUI 200, and only the user- or system-configurable inputs are shown.

[0093] 5, a GUI 200 is shown with a first setup configuration. As shown in this exemplary configuration, the maximum flow reduction input 202 is set to 50% and the pressure limit sensitivity 204 is set to "medium." Additionally, the programmed pressure limit indicator 206 indicates a pressure limit of 300 psi for the target infusion procedure.

[0094] With respect to the maximum flow rate reduction input 202, a healthcare professional can select a flow rate reduction within a configurable range of 0% to 50% of the initially programmed (i.e., commanded) flow rate. For example, according to a non-limiting embodiment, if the maximum flow rate reduction input 202 is set to 50% (as shown in FIG. 5 ) and the programmed flow rate is 5 mL / s, the flow rate will not be reduced below 2.5 mL / s because the injector system is operating at or near the programmed pressure limit. Similarly, if the maximum flow rate reduction input 202 is set to 40% and the programmed flow rate is 5 mL / s, the flow rate will not be reduced below 3 mL / s at or near the programmed pressure limit. Thus, configuring a lower maximum flow rate reduction input 202 ensures that the infusion system prioritizes maintaining fluid flow even when the programmed pressure limit is approached and / or reached. In this manner, infusion procedures where pressure sensitivity is less important than sufficient fluid flow rate may be accommodated by a user- or system-configurable setting that prioritizes a lower flow rate reduction rate over pressure limit sensitivity.

[0095] If the pressure indicates that the minimum flow rate cannot be achieved, the system can be configured to abort the infusion procedure entirely. Similarly, if the user configures the maximum flow rate reduction input 202 to be 0% (i.e., no allowable change in flow rate), the infusion can be aborted if the pressure is detected to exceed the programmed pressure limit.

[0096] While the example shown herein provides a configurable flow rate reduction range of 0% to 50%, it should be understood that the configurable range for the maximum flow rate reduction input 202 can be less than or greater than 0% to 50% and does not necessarily need to be a percentage-based range. The range can be narrowed depending on the imaging modality, with the acceptable reduction in flow rate determined based on the flow rate at which the acquired images are still considered diagnostically sufficient. For example, in CT imaging, the configurable flow rate reduction range may be 0% to 50%. For other imaging modalities where flow rate is less critical to a successful imaging procedure, the configurable flow rate range may be, for example, from 0% to 100%, with 100% meaning that the infusion is completely interrupted.

[0097] Referring to the pressure limit sensitivity input 204 in FIG. 5 , a “medium” setting may be selected from a range of incrementally configurable settings, extending, for example, from “low,” “medium / high,” to “high.” In this configuration, selecting “high” sensitivity instructs the infusion system to ensure that the pressure does not exceed the programmed pressure limit or threshold. Such a pressure limit sensitivity selection may be particularly applicable to infusion procedures performed on sensitive infusion sites or sensitive patients, where it is paramount that the pressure remain below the pressure rating of all system components. Conversely, selecting “low” sensitivity provides the system with greater flexibility to maintain the programmed flow rate while still limiting the pressure from significantly exceeding the programmed pressure limit or threshold. As shown in FIG. 5 , the “medium” setting provides a compromise between the “high” and “low” sensitivity selections. Additional incremental sensitivity settings (e.g., “low / medium,” “medium / high,” etc.) that may be selected by the user provide more nuanced sensitivity between “low” and “medium” or between “medium” and “high.” Furthermore, it should be understood that the pressure limit sensitivity input 204 is not limited to these selections, and that a numeric sensitivity range (e.g., 0-10) or other type of incremental range may be implemented. At a "high" (or maximum) sensitivity setting, the maximum allowable flow reduction is achieved before or when the initial pressure limit or threshold is reached. Conversely, at a "low" (or minimum) sensitivity setting, flow reduction may first begin when the initial pressure limit or threshold is reached.

[0098] According to specific embodiments, when considering a range of responsiveness to pressure increases (i.e., "low" to "medium" to "high"), the range may be set such that "low" is 15% to 35% of maximum responsiveness; for example, in one embodiment, "low" may be 25% of maximum responsiveness; "medium" may be 40% to 60% of maximum responsiveness; for example, in one embodiment, "medium" may be 50% of maximum responsiveness; "high" may be 65% to 85% of maximum responsiveness; for example, in one embodiment, "high" may be 75% of maximum responsiveness. "Low / medium" and "medium / high" may be similar ranges between "low" and "medium" and between "medium" and "high," respectively. According to other embodiments, the responsiveness range may be determined by inputs such as maximum flow reduction, or may be hard-coded values ​​depending on the system configuration, the modality in which the device is being used, the clinical setting, the patient setting, etc. All of these numbers may be changed as needed. For example, in one embodiment, "low" may be 90% of maximum reactivity, "medium" may be 95%, and "high" may be 100%. One skilled in the art can envision other ranges of settings for "low," "medium," and "high" according to other embodiments.

[0099] The adaptive flow graph 208 provides a visual interpretation of injector behavior based on user- or system-selected settings of the maximum flow rate reduction input 202 and the pressure limit sensitivity input 204. In the example shown in FIG. 5 , it should be understood that the commanded flow rate is maintained until the measured pressure reaches 285 psi, or 95% of the programmed pressure limit. According to various embodiments, the threshold may vary depending on the system configuration, modality, infusion rate, syringe and / or tubing size, catheter size or configuration, patient information, and any combination thereof. Once this threshold is reached, the flow rate is reduced by as much as 50% of the commanded flow rate, even if the pressure increases above the programmed pressure limit of 300 psi (i.e., to 315 psi, or 105% of the programmed pressure limit). The flow rate reduction may be based on a predetermined flow rate reduction profile, which may be linear or nonlinear (e.g., polynomial, exponential, logarithmic, etc.). This predetermined flow rate reduction and tolerance for slight overpressure is enabled by the user- or system-configured “medium” pressure limit sensitivity input 204. Additionally, a user or system configured "50%" maximum flow reduction input 202 allows for a wide predetermined range of flow reduction from 0% to 50% of the commanded flow rate.

[0100] 6-9, further examples of the GUI 200 are shown under various user-defined or system-defined configurations. In FIG. 6, the maximum flow rate reduction input 202 is set to 25% and the pressure limit sensitivity input 204 is set to "low." Thus, as explained above, the injection procedure shown in FIG. 6 prioritizes maintaining fluid flow rate over not exceeding the programmed pressure limit. This is readily discernible by the adaptive flow graph 208 in FIG. 6, which shows that under "low" pressure limit sensitivity, the commanded flow rate is actually maintained up to the point where the programmed pressure limit is reached (i.e., a pressure of 300 psi). Then, after the programmed pressure limit is reached, the flow rate is reduced based on a predetermined linear or nonlinear flow rate reduction profile, but only to an amount that is 25% of the commanded flow rate. In this way, the fluid flow rate is substantially maintained even after the programmed pressure limit is reached.

[0101] Conversely, FIG. 7 illustrates an infusion procedure in which sensitivity to pressure limits takes priority over maintaining flow rate. As shown, the maximum flow rate reduction input 202 is set to 50% and the pressure limit sensitivity input 204 is set to “high.” Referring to the adaptive flow graph 208 in FIG. 7 , under “high” pressure limit sensitivity, all flow rate reductions occur before the point at which the programmed pressure limit (i.e., 300 psi) is reached in an attempt to ensure that the programmed pressure limit is not exceeded. Then, after the programmed pressure limit is reached, flow rate reductions are maintained at the maximum level (i.e., 50%) in an attempt to reduce the pressure below the predetermined pressure limit. In some embodiments, when “high” pressure limit sensitivity is selected, the infusion system may be configured to abort fluid infusion if and when the pressure is detected to be equal to or greater than the programmed pressure limit. In other embodiments, the infusion system may be configured to abort fluid infusion if and when the pressure is detected to be equal to or greater than a predetermined secondary pressure threshold different from the programmed pressure limit.

[0102] FIG. 8 illustrates an infusion procedure in which sensitivity to pressure limits takes a slight priority over maintaining flow rate. As shown, the maximum flow rate reduction input 202 is set to 50% and the pressure limit sensitivity input 204 is set to “medium / high.” Referring to the adaptive flow graph 208 in FIG. 8 , under “medium / high” pressure limit sensitivity, all flow rate reductions occur before the point at which the programmed pressure limit (i.e., 300 psi) is reached in an attempt to ensure that the programmed pressure limit is not exceeded. Then, after the programmed pressure limit (300 psi at approximately a 38% flow rate reduction) is reached, flow rate reductions are maintained at an intermediate level in an attempt to reduce the pressure below the predetermined pressure limit. In some embodiments, when “medium / high” pressure limit sensitivity is selected, the infusion system may be configured to abort fluid infusion if and when the pressure is detected to be equal to or greater than the programmed pressure limit. In other embodiments, the infusion system may be configured to abort fluid infusion if and when the pressure is detected to be equal to or greater than a predetermined secondary pressure threshold different from the programmed pressure limit.

[0103] FIG. 9 illustrates an infusion procedure in which maintaining flow rate takes a slight priority over sensitivity to pressure limits. As shown, the maximum flow rate reduction input 202 is set to 50% and the pressure limit sensitivity input 204 is set to “Low / Medium.” Referring to the adaptive flow graph 208 in FIG. 9 , under “Low / Medium” pressure limit sensitivity, after reaching a programmed pressure limit (i.e., 300 psi), the flow rate is reduced by 50% of the commanded flow rate based on a predetermined linear or nonlinear flow reduction profile. In this way, the fluid flow rate is substantially maintained even after reaching the programmed pressure limit, and the flow rate reduction is maintained at a low level. In some embodiments, when “Low / Medium” pressure limit sensitivity is selected, the infusion system may be configured to interrupt fluid infusion if and when the pressure is detected to be at or above the programmed pressure limit.

[0104] 5-9 provide an example of a GUI 200 in which one of the maximum flow reduction input 202 and the pressure limit sensitivity input 204 is set to a relatively "extreme" setting (i.e., "high" pressure limit sensitivity, 50% maximum flow reduction, etc.), it should be understood that under any given injection protocol, such extreme settings may not be necessary and more moderate settings for both inputs may be optimal. Indeed, in some embodiments, the injector system may include default logic, set by the manufacturer, in which the injection protocol is set to a moderate flow reduction and a moderate pressure limit sensitivity.

[0105] Additionally, while one of the maximum flow reduction input 202 and the pressure limit sensitivity input 204 is illustrated and described herein as being input via a touchscreen GUI 200, it should be understood that other forms of user interface may be utilized to provide such input. For example, the user interface may include a keyboard, a mouse, one or more buttons, one or more knobs, etc. Furthermore, as described above, the user interface may be integrated into the fluid infuser system 100 or may be located remotely from the fluid infuser system 100. If located remotely from the fluid infuser system 100, the user interface may be capable of wired or wireless communication with the electronic control device 400. Referring to FIG. 21 , an embodiment for a GUI 200 having a user-adjustable sliding scale between prioritizing pressure limit 2110 and maintaining fluid flow 2130, including an intermediate protocol 2120, is shown. The GUI 200 may be a touchscreen that allows a user to adjust the prioritization by sliding their finger along the scale to the desired prioritization. Alternatively, the sliding scale may be adjusted by a keyboard, a mouse, one or more buttons, or one or more knobs associated with the GUI and controller.

[0106] 10-11, there are shown graphical visualizations of the configurable space under various user- or system-selected flow behavior settings. In FIG. 10, the shaded area 300 represents the possible configurable space when a 50% maximum flow reduction input is selected. With such a wide range of flow reduction, the shaded area 300 illustrates various possible user- or system-selectable configurations, ranging from a "high" pressure limit sensitivity, where all flow reduction occurs before the programmed pressure limit is reached, to a "low" pressure limit sensitivity, where all flow reduction occurs after the programmed pressure limit is reached.

[0107] Figure 11 is similar to Figure 10, except that the shaded area 350 represents the possible settable space when a 10% maximum flow reduction input is selected. As can be easily discerned from Figure 11, reducing the maximum flow reduction input provides a much smaller settable space at or near the programmed pressure limit, which may be advantageous when maintaining flow rate is to be prioritized. While not shown, it should be understood that a similar graphical visualization can be generated for any maximum flow reduction input (i.e., any input between 0% and 50%).

[0108] Next, Figures 12A-12D show the expected differences in pressure graphs for a particular injection (eg, a 5 mL / s contrast injection) under various user or system selected configurations for pressure-limited sensitivity.

[0109] First, Figure 12A shows a "high" pressure limit sensitivity setting. As can be seen, under this "high" sensitivity setting, the system pressure is allowed to gradually approach the programmed pressure limit (e.g., 300 psi), but the flow rate is reduced by a sufficient amount so that there is a substantial margin between the observed system pressure and the pressure limit; i.e., the 300 psi pressure limit is never reached.

[0110] 12B shows a "default" pressure limit sensitivity setting. Unlike the "high" setting described above with respect to FIG. 12A, the "default" setting may allow the system pressure to more closely approach (and possibly reach) the programmed pressure limit. As described above, under such a "default" setting, the system may allow a moderate amount of flow reduction, as well as moderate pressure sensitivity.

[0111] Referring to Figure 12C, a "medium" pressure limit sensitivity is shown, allowing the system pressure to actually exceed the programmed pressure limit slightly. As also described with respect to Figure 5 above, such a setting can allow for slight overpressure in exchange for improved fluid flow rate.

[0112] And finally, Figure 12D shows a "Low" pressure limit sensitivity setting. Under the "Low" setting, the system pressure is allowed to exceed the programmed pressure limit by a significant amount (e.g., about 15-20 psi), thereby causing fluid flow to override the programmed pressure limit, similar to the example described above with respect to Figure 6.

[0113] Referring now to FIG. 13, an exemplary logical workflow 600 is shown in accordance with one embodiment of the present disclosure.

[0114] Initially, user inputs regarding maximum flow reduction and pressure limit sensitivity are received at 602. As described above, these user inputs may be received, for example, via a GUI or other user interface. At 604, the injection procedure is initiated and appropriate pressure limiting behavior is initialized based on the user inputs.

[0115] At 606, the fluid pressure during the injection procedure is monitored by any suitable method. A determination is then made at 608 as to whether the determined pressure reaches a Threshold 1 pressure. In some embodiments, Threshold 1 is a predetermined pressure level below a programmed pressure limit. For example, Threshold 1 may be a pressure level that is, for example, 1% to 20% below the programmed pressure limit.

[0116] If not (i.e., threshold 1 has not been reached), the workflow returns to 606 and pressure continues to be monitored. If it is, however, a determination is made at 610 as to whether the user- or system-entered pressure limit sensitivity is greater than 0. In this particular example, a pressure limit sensitivity of 0 is considered the highest (or "high") pressure sensitivity setting, and it is most important that the pressure limit not be exceeded during a particular injection procedure. If not (i.e., pressure limit sensitivity is set to 0), the injection is aborted at 612. Alternatively, if it is (i.e., pressure limit sensitivity is set greater than 0), a determination is made at 614 as to whether the maximum flow rate reduction is greater than 0. In this example, a maximum flow rate reduction of 0 is considered a user setting where no flow rate reduction is allowed for a particular injection procedure. If not (i.e., maximum flow rate reduction is set to 0), the injection is aborted at 616. If it is, however (i.e., maximum flow rate reduction is set greater than 0), the flow rate may be reduced at 618. Such a reduction in fluid flow rate means a corresponding reduction in pressure during injection so as not to reach a programmed pressure limit (or exceed a given threshold amount). As noted above, the reduction in flow rate may be based on a predetermined flow rate reduction profile, which may be linear or non-linear (e.g., polynomial, exponential, logarithmic, etc.).

[0117] Next, at 620, a determination is made as to whether Threshold 2 pressure has been reached. In some examples, Threshold 2 pressure may be a pressure level that is, for example, 1% to 20% above the programmed pressure limit. However, it should be understood that Threshold 2 pressure may also be less than 1% above, equal to, or below the programmed pressure limit, depending on pressure limit sensitivity and user settings. If so (i.e., Threshold 2 pressure has been reached), then at 622 the system may stop flow rate reduction and / or abort the infusion procedure. However, if not (i.e., Threshold 2 pressure has not been reached), then the workflow returns to 618, where the fluid flow rate may be further reduced. The flow rate may continue to be reduced until Threshold 2 pressure is reached, a maximum flow rate reduction is reached, or the identified pressure falls below Threshold 1.

[0118] 14-20, exemplary fluid injection scenarios according to embodiments described herein are shown.

[0119] Referring first to FIG. 14 , a 10% maximum flow reduction and a “high” pressure limit sensitivity setting are entered by the user as described above, and a programmed pressure limit of 300 PSI is also set. As shown in the corresponding pressure vs. time and flow vs. time graphs, during an injection procedure, as the flow rate rises to meet the programmed flow rate setting, the pressure also rises, potentially eventually reaching a Threshold 1 pressure below the programmed pressure limit. Once Threshold 1 pressure is reached, the system is configured to reduce the flow rate to avoid reaching the programmed pressure limit. Although a 10% maximum flow reduction (i.e., 90% of the programmed flow rate) is set, in the injection procedure shown in FIG. 14 , the pressure stabilizes below the programmed pressure limit, and a full 10% reduction in flow rate is not required. Because the pressure never reaches the programmed pressure limit, the maximum fluid flow reduction is never reached. Thus, the system is able to maintain a flow rate closer to the programmed flow rate while keeping the pressure below the programmed pressure limit.

[0120] Referring to FIG. 15, an injection scenario similar to that described above with respect to FIG. 14 is shown, in which a 10% maximum flow rate reduction and a "high" pressure limit sensitivity setting have been entered by the user, and a programmed pressure limit of 300 PSI has also been set. However, unlike the injection scenario shown in FIG. 14, in FIG. 15, once the pressure reaches Threshold 1, the flow rate is reduced but still reaches the programmed pressure limit. Because the pressure limit sensitivity is set to "high," all of the allowable flow rate reduction (10%) is achieved in the time interval between when Pressure Threshold 1 is reached and when the pressure reaches the programmed pressure limit. At that point, the flow rate is maintained at 90% of the programmed flow rate. However, as shown in the pressure versus time graph, the pressure stabilizes at 90% flow rate and the pressure does not reach Threshold 2 pressure. Because Threshold 2 pressure has not been reached, the injection procedure does not need to be interrupted and can continue at the reduced flow rate. In this scenario, the programmed pressure limit is reached, but because the pressure limit sensitivity is set to "high," all of the allowable fluid flow reduction is achieved in the time interval between when the pressure reaches Threshold 1 and when the pressure reaches the programmed pressure limit.

[0121] Referring now to FIG. 16, a graphical illustration of an infusion scenario is shown with a "high" pressure limit sensitivity and a relatively high maximum flow rate reduction of 50%. Similar to the scenario illustrated in FIG. 14 above, as the flow rate increases to meet the programmed flow rate setting, the pressure also increases, eventually reaching a threshold pressure of 1, which is below the programmed pressure limit. Once threshold pressure 1 is reached, the system is configured to reduce the flow rate to avoid reaching the programmed pressure limit. However, rather than abruptly reducing the flow rate to the maximum amount (50%), the system is configured to reduce the flow rate more gradually (linearly or nonlinearly), thereby allowing the pressure to stabilize below the programmed pressure limit, much less than the required maximum reduction of 50% of flow rate. In this infusion scenario, the pressure never reaches the programmed pressure limit, and therefore the maximum fluid flow rate reduction is never reached. Thus, the system is able to maintain a flow rate closer to the programmed flow rate while keeping the pressure below the programmed pressure limit.

[0122] FIG. 17 illustrates an infusion scenario similar to that described above with respect to FIG. 16, but with a relatively high maximum flow rate reduction of 50% set with a "high" pressure limit sensitivity. However, unlike the infusion scenario illustrated in FIG. 16, in FIG. 17, when the pressure reaches Threshold 1, the flow rate is reduced, but still reaches (and actually exceeds) the programmed pressure limit. Because the pressure limit sensitivity is set to "high," the full allowable flow rate reduction of 50% is achieved in the time interval between when pressure Threshold 1 is reached and when the pressure reaches the programmed pressure limit. At that point, the flow rate is maintained at 50% of the programmed flow rate. However, as shown in the pressure versus time graph, the pressure stabilizes at 50% flow rate and does not reach Threshold 2 pressure. Because Threshold 2 pressure has not been reached, the infusion procedure does not need to be interrupted and can continue at a reduced flow rate. According to this infusion scenario, the programmed pressure limit is reached, but because the pressure limit sensitivity is set to "high," the full allowable fluid flow rate reduction is achieved in the time interval between when the pressure reaches Threshold 1 and when the pressure reaches the programmed pressure limit.

[0123] Conversely, referring to FIG. 18, an infusion scenario with similar user settings (i.e., maximum flow rate reduction = 50%, pressure limit sensitivity = high) is shown, but the pressure continues to increase even though the full 50% allowable flow rate reduction is achieved in the time interval between when the pressure reaches Threshold 1 and when the pressure reaches the programmed pressure limit. While the maximum 50% reduced flow rate is maintained, the pressure eventually increases until it reaches a pressure of Threshold 2, at which point the system is configured to abort the infusion procedure and completely shut off fluid flow before the infusion procedure is completed. According to this infusion scenario, the programmed pressure limit is reached, but because the pressure limit sensitivity is set to "high," the full allowable fluid flow rate reduction is achieved in the time interval between when the pressure reaches Threshold 1 and when the pressure reaches the programmed pressure limit, and therefore the infusion is aborted when Pressure Threshold 2 is reached.

[0124] Referring now to FIG. 19, an injection scenario according to another embodiment of the present disclosure is illustrated. Unlike the injection scenarios described above with respect to FIGS. 14-18, the injection scenario of FIG. 19 pertains to an injection procedure in which the pressure limit sensitivity is set to "low" and the maximum flow rate reduction is 50% of the programmed flow rate. As shown, as the flow rate increases over time to reach the programmed flow rate, the pressure also increases toward the programmed pressure limit, eventually crossing the Threshold 1 pressure. However, because the pressure limit sensitivity is "low," the system is configured to maintain the programmed flow rate even after the Threshold 1 pressure is reached. As shown, the fluid pressure stabilizes before finally reaching the programmed pressure limit. Thus, the "low" pressure limit sensitivity allows the injection procedure to be completed without initiating a flow rate reduction. According to this injection scenario, the programmed pressure limit is never reached, and therefore, no fluid flow rate reduction is initiated because the pressure limit sensitivity is set to "low."

[0125] Finally, referring to FIG. 20, an infusion scenario with user-defined or system-defined settings similar to those described in FIG. 19 is shown, with the pressure limit sensitivity set to "low" and the maximum flow rate reduction set to 50% of the programmed flow rate. However, in FIG. 20, the pressure eventually rises to the point where the programmed pressure limit is reached. Because the pressure limit sensitivity is set to "low," flow rate reduction is not initiated until the programmed pressure limit is reached. As shown, the pressure eventually stabilizes before reaching the pressure threshold 2, and the maximum 50% flow rate reduction is not required to achieve such stabilization. Thus, because the pressure sensitivity is "low," the infusion procedure does not need to be interrupted and can continue beyond the lowest possible flow rate and beyond the programmed pressure limit. According to this infusion scenario, the programmed pressure limit is reached, and because the pressure limit sensitivity is set to "low," fluid flow rate reduction is initiated when the pressure exceeds the programmed pressure limit. However, because pressure threshold 2 is never reached, maximum fluid flow rate reduction is not achieved.

[0126] While FIGS. 14-20 describe infusion scenarios that rely on two threshold pressures (Threshold 1 and Threshold 2), it should be understood that there may be more than two threshold pressures relative to the programmed pressure limit. For example, a third threshold pressure (Threshold 3) may be utilized such that the infusion procedure may be interrupted whenever Threshold 3 is reached. Depending on user-defined or system-defined settings, Threshold 3 may be different from Threshold 1, Threshold 2, and the programmed pressure limit, or may be equal to any of Threshold 1, Threshold 2, or the programmed pressure limit. According to certain embodiments, the third pressure threshold (Threshold 3) may be at a pressure value between the programmed pressure limit and Threshold 2, may be at a pressure between the programmed pressure limit and Threshold 1, or may be greater than Threshold 2.

[0127] While the present disclosure has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. [Explanation of symbols]

[0128] 11 Proximal end 12 syringes 13 Syringe port 14 Plunger 17 tube sets 17a first fluid conduit 17b second fluid conduit 19 Distal end 20 Common fluid conduit 100 Fluid Injector System 102 Injector housing 103 Piston 118 Bulk Fluid Connector 120 Bulk Fluid Source 124 User Interface 126 control buttons 130 Multi-Use Disposable Sets (MUDS) 132 Syringe, fluid reservoir 134 MUDS fluid pathways 136 Valve 148 Manifold 150 Fluid Inlet Line 152 fluid outlet line 192 connection port 200 Graphical User Interface (GUI) 202 Maximum flow rate reduction input 204 Pressure limit sensitivity input 206 Pressure Limit Indicator 208 Adaptive Flow Graph 300 Shaded area 350 Shaded area 400 Electronic Control Devices 404 processor 408 memory 410 Input Component 412 Output Components 500a fluid reservoir 500b fluid reservoir 500n fluid reservoir 510a Drive components 510b Drive components 510n drive components 520a valve 520b valve 520n valve 530 Fluid conduit 600 Logical Workflows 2110 Pressure Limit 2120 Intermediate Protocol 2130 Maintaining fluid flow

Claims

1. 1. A fluid infuser system configured to administer at least one fluid, the fluid infuser system comprising: at least one fluid injector device; at least one user interface; a control device in communication with at least one of the user interfaces, the control device comprising at least one processor programmed or configured to direct at least one of the fluid injector devices to perform a fluid injection procedure according to a profile that utilizes at least one of an internal input and an external input to determine the prioritization of maintaining a flow rate or limiting a fluid delivery pressure; Equipped with the control device is further configured to instruct at least one of the fluid injector devices to perform a fluid injection procedure based on one or more of a maximum pressure limit, a programmed fluid flow rate, a maximum fluid flow rate reduction input, and a pressure limit sensitivity input; 1. A fluid injector system, wherein the pressure limit sensitivity input is user or system selectable within a configurable range from low sensitivity to high sensitivity; and wherein the at least one processor is further programmed or configured to decrease the fluid flow rate of at least one of the fluid injector devices to decrease the flow rate below the programmed fluid flow rate when a predetermined threshold pressure relative to the maximum pressure limit is reached according to a patient characteristic; the predetermined threshold pressure is less than the maximum pressure limit when the pressure limit sensitivity input is high, and the predetermined threshold pressure is equal to the maximum pressure limit when the pressure limit sensitivity input is low; A fluid injector system, wherein the internal input is input by the fluid injector system and the external input is input by a user, a hospital information network, or other storage data device.

2. the at least one internal input and the at least one external input is selected from the group consisting of receiving the maximum pressure limit for a fluid injection procedure, receiving the programmed fluid flow rate for the fluid injection procedure, receiving the maximum fluid flow rate reduction input for the fluid injection procedure, and receiving the pressure limit sensitivity input for the fluid injection procedure, and any combination thereof, wherein the maximum fluid flow rate reduction input is selected by a user via at least one of the user interfaces or by the fluid injector system based on at least one of patient information and system injection parameters, and the pressure limit sensitivity input is selected by the user via at least one of the user interfaces. The fluid infuser system of claim 1 .

3. the at least one user interface includes at least one graphical user interface, the at least one graphical user interface displaying a flow profile of the fluid injection procedure; the displayed flow profile further indicates one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.

3. The fluid injector system of claim 1 or 2.

4. 4. The fluid injector system of claim 1, wherein at least one of the processors is programmed or configured to limit fluid delivery pressure by reducing the flow rate of the fluid, by diluting a relatively high viscosity fluid with a relatively low viscosity fluid, or a combination thereof.

5. The fluid infuser system of any one of claims 1 to 3, wherein the fluid flow rate reduction has a linear or non-linear flow rate reduction profile.

6. The fluid injector system of any one of claims 1 to 3, wherein the reduction in fluid flow rate is based on at least one input provided by a user of the fluid injector device.

7. 7. The fluid injector system of claim 6, wherein the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, for each fluid injection procedure, or for a limited set of fluid injection procedures.

8. 8. The fluid injector system of claim 7, wherein the at least one user input provided by the user is selected by the user from a set of inputs stored in a protocol library or is manually entered by the user prior to the start of the fluid injection procedure.

9. the reduction in fluid flow is based on at least one internally supplied or externally supplied input; 4. The fluid injector system of claim 1, wherein at least one of the internally or externally sourced inputs is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, real-time inject data being collected during an injection procedure, and any combination thereof.

10. the at least one internally or externally provided input is selected from the group consisting of: historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and any combination thereof; wherein the one or more bar codes are placed on a patient record, a fluid infuser, a medical fluid container, a sterile disposable, and combinations thereof; 10. The fluid infuser system of claim 9.

11. 11. The fluid infuser system of any one of claims 2 to 10, wherein the maximum fluid flow rate reduction input is user or system selectable within the range of 0% to 100% of the programmed fluid flow rate.

12. 12. The fluid injector system of claim 2, wherein at least one of the processors is programmed or configured to abort the fluid injection procedure when the maximum fluid flow reduction input of 0% is selected and the pressure of at least one of the fluids is detected to be equal to or greater than the maximum pressure limit.

13. 13. The fluid injector system of claim 5, wherein at least one of the processors is programmed or configured to interrupt the fluid injection procedure when specific configuration criteria are met and pressure is detected to be equal to or greater than a predetermined pressure threshold.

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