Systems, methods, and computer program products for controlling a fluid injection system based on hydraulic resistance
By determining fluid characteristics and adjusting motor controller gains based on viscosity, the method optimizes fluid injection systems for precise and consistent delivery, addressing the challenges of viscosity variations in medical fluid delivery.
Patent Information
- Application Number
- JP2022574255
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-06-02
- Filing Date
- 2021-06-01
- Publication Date
- 2025-11-05
- Estimated Expiration
- 2041-06-01
AI Technical Summary
Existing fluid injection systems struggle to accurately control the operation of powered fluid injectors, particularly in managing viscosity variations of medical fluids, leading to inconsistent delivery rates and pressures.
A method and system for controlling fluid injection systems by determining fluid characteristics, estimating viscosity, calculating hydraulic resistance scores, and adjusting motor controller gains based on these factors to optimize fluid delivery.
Enhances the precision and consistency of fluid injection by accounting for viscosity and other fluid properties, improving the accuracy and reliability of medical fluid delivery.
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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 704,893, filed June 2, 2020, the entire disclosure of which is incorporated herein by reference in its entirety.
[0002] The present disclosure relates generally to systems, devices, products, apparatus, and methods for controlling a fluid injection system, and in various embodiments, to systems, products, and methods for controlling a fluid injection system based on a motor controller gain of a motor of a powered fluid injector within the fluid injection system. [Background technology]
[0003] Fluid injection devices (e.g., medical fluid delivery devices), such as powered injector devices, may be used by medical personnel, such as physicians, in medical diagnostic and / or therapeutic procedures. For example, medical personnel may use a fluid injection device to inject one or more medical fluids into a patient. Fluid injection devices may be used for pressurized injection of medical fluids, such as radiographic contrast fluids (e.g., contrast agents, radiocontrast media, etc.), and / or flushing agents, such as saline, in medical imaging procedures, such as cardiovascular angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET). In some cases, fluid injection devices are designed to deliver a preset amount of medical fluid at a preset flow rate. Summary of the Invention [Means for solving the problem]
[0004] Thus, provided are systems, devices, articles of manufacture, apparatus, and / or methods for controlling a fluid injection system that improve operation of a motor of a powered fluid injector within the fluid injection system. Further non-limiting embodiments are described in the following numbered clauses:
[0005] Clause 1: A method for controlling a fluid injection system, comprising the steps of: determining, using at least one processor, at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol being associated with a medical fluid involved in the power injection protocol; determining, using at least one processor, an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculating, using at least one processor, a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; and determining, using at least one processor, one or more motor controller gains of a motor of a powered fluid injector in the power injection protocol based on the hydraulic resistance score.
[0006] Clause 2: The method of clause 1, wherein the step of determining at least one characteristic of the power injection protocol includes the steps of determining a steady-state characteristic of saline flowing through an orifice in a fluid path of the powered fluid injector, determining a steady-state characteristic of a contrast agent flowing through the orifice, and calculating a characteristic ratio, the characteristic ratio being a ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent; the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the contrast agent based on the characteristic ratio; and the step of calculating a hydraulic resistance score includes calculating a hydraulic resistance score based on the estimate of the viscosity of the contrast agent.
[0007] Clause 3: The method of clause 1 or 2, further comprising implementing one or more motor controller gains in a motor of the powered fluid injector.
[0008] Clause 4: A method according to any one of clauses 1 to 3, wherein the motor is a motor of a pump of a powered fluid injector, the pump of the powered fluid injector comprising a piston or peristaltic pump configured to drive a plunger of a syringe.
[0009] Clause 5: The method of any one of clauses 1 to 4, wherein the method further includes a step of determining whether the characteristic ratio satisfies a threshold value, and wherein the step of calculating the hydraulic resistance score includes a step of calculating the hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold value.
[0010] Clause 6: The method of any one of clauses 1 to 5, wherein determining whether the characteristic ratio satisfies a threshold comprises determining whether the characteristic ratio satisfies a threshold equal to 1.
[0011] Clause 7: The method of any one of clauses 1 to 6, wherein the steady-state characteristics of the saline flowing through the orifice include a steady-state flow rate of the saline flowing through the orifice based on a constant pressure of the saline, the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent, the characteristic ratio includes a flow rate ratio, the flow rate ratio being a ratio of the steady-state flow rate of the saline to the steady-state flow rate of the contrast agent, and the step of calculating the characteristic ratio includes a step of calculating the flow rate ratio based on the steady-state flow rate of the saline and the steady-state flow rate of the contrast agent.
[0012] Clause 8: The method of any one of clauses 1 to 7, wherein the steady-state characteristics of the saline flowing through the orifice include a steady-state pressure of the saline flowing through the orifice based on a constant flow rate of the saline, the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent, the characteristic ratio includes a pressure ratio, the pressure ratio being the ratio of the steady-state pressure of the saline to the steady-state pressure of the contrast agent, and the step of calculating the characteristic ratio includes the step of calculating the pressure ratio based on the steady-state pressure of the saline and the steady-state pressure of the contrast agent.
[0013] Clause 9: A method according to any one of clauses 1 to 8, wherein the method further comprises determining a value of hydraulic capacitance of the medical fluid involved in the power injection protocol, and wherein determining the motor controller gain comprises determining the motor controller gain based on the value of hydraulic capacitance of the medical fluid involved in the power injection protocol.
[0014] Clause 10: The method of any one of clauses 1 to 9, wherein the step of determining at least one characteristic of the power injection protocol includes the steps of determining a first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state, wherein when the power injection protocol is in the vacuum fill state, the power injection protocol is blocked from receiving medical fluid in the fluid reservoir; and determining a second pressure of the power injection protocol when the power injection protocol is in a normal fill state, wherein when the power injection protocol is in the normal fill state, the power injection protocol is open to receiving medical fluid in the fluid reservoir; and calculating a pressure difference of the power injection protocol between the vacuum fill state and the normal fill state based on the first pressure of the power injection protocol and the second pressure of the power injection protocol, and wherein the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the medical fluid based on the pressure difference of the power injection protocol between the vacuum fill state and the normal fill state.
[0015] Clause 11: A method according to any one of clauses 1 to 10, wherein the step of determining the first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state includes the steps of determining a steady state force exerted on a force component of the pump when the power injection protocol is in a vacuum fill state, and determining a rate of movement of the force component of the pump when the power injection protocol is in a vacuum fill state.
[0016] Clause 12: A method according to any one of clauses 1 to 11, wherein the step of determining the second pressure of the power injection protocol when the power injection protocol is in a normal filling state includes the steps of determining a steady-state force exerted on a force component of the pump when the power injection protocol is in a normal filling state, and determining a rate of movement of the force component of the pump when the power injection protocol is in a normal filling state.
[0017] Clause 13: A method according to any one of clauses 1 to 12, wherein the step of determining at least one characteristic of the power injection protocol includes the steps of determining a force exerted on a force component of a pump during each of a plurality of filling operations of a fluid reservoir, wherein each filling operation of a fluid reservoir includes an operation performed to fill the fluid reservoir with a medical fluid, and determining a fill flow rate of the medical fluid through an orifice during each of the plurality of filling operations of a fluid reservoir, and wherein the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the medical fluid based on the force exerted on a force component of the pump during each of the plurality of filling operations of a fluid reservoir and the fill flow rate through the orifice during each of the plurality of filling operations of a fluid reservoir.
[0018] Clause 14: A method according to any one of clauses 1 to 13, wherein the step of determining the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir includes the step of determining the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir based on at least one of the amount of friction between the force component of the pump and a wall of the fluid reservoir, the area of the force component of the pump, the length of the tubing component through which the medical fluid flows into the fluid reservoir, and the diameter of the tubing component through which the medical fluid flows into the fluid reservoir.
[0019] Clause 15: A method according to any one of clauses 1 to 14, wherein the method further comprises performing a linear regression calculation based on the force exerted on the force component of the pump during each filling operation of the fluid reservoir among the plurality of filling operations of the fluid reservoir and the filling flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir, and wherein determining an estimate of the viscosity of the medical fluid comprises determining an estimate of the viscosity of the medical fluid based on the linear regression calculation.
[0020] Clause 16: A method according to any one of clauses 1 to 15, wherein the step of determining at least one characteristic of the power injection protocol includes the steps of controlling a force component of a pump of the powered fluid injector to perform an operation to fill the fluid path; and determining a fill time of the fluid path, the fill time of the fluid path comprising an amount of time a volume of the fluid path is filled with medical fluid; and wherein the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the medical fluid based on the fill time of the fluid path.
[0021] Clause 17: A method according to any one of clauses 1 to 16, wherein the step of controlling the force component of a pump of a powered fluid injector to fill the fluid path includes controlling the force component of a pump of a powered fluid injector to generate a constant pressure during the operation of filling the fluid path, and the step of calculating the hydraulic resistance score includes calculating the hydraulic resistance score based on at least one value of the constant pressure, the area of the force component of the pump, the distance traveled by the force component of the pump during the operation of filling the fluid path, and the fill time of the fluid path.
[0022] Clause 18: A method according to any one of clauses 1 to 17, wherein the step of determining at least one characteristic of the powered injection protocol includes the steps of controlling a power component of a pump of a powered fluid injector to provide a fluid flow of the medical fluid within a lumen of a tubing component of the fluid injection system; controlling the power component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component; and detecting a characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, and wherein the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the medical fluid based on the characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0023] Clause 19: A method according to any one of clauses 1 to 18, wherein the step of controlling the force component of the pump of the powered fluid injector to provide a fluid flow of the fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to provide a laminar flow of the fluid within the lumen of the tubing component, and the step of controlling the force component of the pump of the powered fluid injector to change at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to transition from a laminar flow of the fluid within the lumen of the tubing component to a turbulent flow of the fluid within the lumen of the tubing component.
[0024] Clause 20: A method according to any one of clauses 1 to 19, wherein the step of controlling a force component of a pump of a powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component comprises the step of controlling a force component of the pump of the powered fluid injector to induce cavitation in the medical fluid.
[0025] Clause 21: A method according to any one of clauses 1 to 20, wherein the step of controlling a force component of a pump of a powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tube component includes the step of controlling a force component of a pump of the powered fluid injector to shear one or more air bubbles present in the medical fluid.
[0026] Clause 22: A method according to any one of clauses 1 to 21, wherein the step of controlling a force component of a pump of a powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tube component includes the step of controlling a force component of a pump of the powered fluid injector to generate turbulence in the medical fluid.
[0027] Clause 23: The method of any one of clauses 1 to 22, wherein the step of determining at least one characteristic of the power injection protocol includes determining a time interval during which fluid flows from a high pressure side of the actuating fluid control component to a low pressure side of the actuating fluid control component, and the step of determining an estimate of the viscosity of the medical fluid includes determining an estimate of the viscosity of the medical fluid based on the time interval.
[0028] Clause 24: A system for controlling a fluid injection system comprising at least one processor, the at least one processor being programmed or configured to: determine at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol being associated with a medical fluid involved in the power injection protocol; determine an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculate a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; and determine one or more motor controller gains of a motor of a powered fluid injector in the power injection protocol based on the hydraulic resistance score.
[0029] Clause 25: The system described in Clause 24, wherein when determining at least one characteristic of the power injection protocol, the at least one processor is programmed or configured to determine a steady-state characteristic of saline flowing through an orifice in a fluid path of the powered fluid injector, determine a steady-state characteristic of contrast agent flowing through the orifice, and calculate a characteristic ratio, the characteristic ratio being a ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent; when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the contrast agent based on the characteristic ratio; and when calculating the hydraulic resistance score, the at least one processor is programmed or configured to calculate the hydraulic resistance score based on the estimate of the viscosity of the contrast agent.
[0030] Clause 26: The system of clause 24 or 25, wherein the at least one processor is further programmed or configured to implement one or more motor controller gains for a motor of the powered fluid injector.
[0031] Clause 27: A system described in any one of clauses 24 to 26, wherein the motor is a motor of a pump of a powered fluid injector, and the pump of the powered fluid injector comprises a piston or peristaltic pump configured to drive a plunger of a syringe.
[0032] Clause 28: The system of any one of clauses 24 to 27, wherein the at least one processor is further programmed or configured to determine whether the characteristic ratio satisfies a threshold value, and when calculating the hydraulic resistance score, the at least one processor is programmed or configured to calculate the hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold value.
[0033] Clause 29: A system described in any one of clauses 24 to 28, wherein when determining whether the characteristic ratio satisfies a threshold, at least one processor is programmed or configured to determine whether the characteristic ratio satisfies a threshold equal to 1.
[0034] Clause 30: A system described in any one of clauses 24 to 29, wherein the steady state characteristics of the saline flowing through the orifice include a steady state flow rate of the saline flowing through the orifice based on a constant pressure of the saline, and the steady state characteristics of the contrast agent flowing through the orifice include a steady state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent, and the characteristic ratio includes a flow rate ratio, the flow rate ratio being the ratio of the steady state flow rate of the saline to the steady state flow rate of the contrast agent, and when calculating the characteristic ratio, at least one processor is programmed or configured to calculate the flow rate ratio based on the steady state flow rate of the saline and the steady state flow rate of the contrast agent.
[0035] Clause 31: A system described in any one of clauses 24 to 30, wherein the steady-state characteristics of the saline flowing through the orifice include a steady-state pressure of the saline flowing through the orifice based on a constant flow rate of the saline, and the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent, and the characteristic ratio includes a pressure ratio, the pressure ratio being the ratio of the steady-state pressure of the saline to the steady-state pressure of the contrast agent, and when calculating the characteristic ratio, at least one processor is programmed or configured to calculate the pressure ratio based on the steady-state pressure of the saline and the steady-state pressure of the contrast agent.
[0036] Clause 32: A system described in any one of clauses 24 to 31, wherein the at least one processor is further programmed or configured to determine a value of hydraulic capacitance of the medical fluid involved in the power injection protocol, and when determining the motor controller gain, the at least one processor is programmed or configured to determine the motor controller gain based on the value of hydraulic capacitance of the medical fluid involved in the power injection protocol.
[0037] Clause 33: The system described in any one of clauses 24 to 32, wherein when determining at least one characteristic of the power injection protocol, the at least one processor is programmed or configured to: determine a first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state, and when the power injection protocol is in the vacuum fill state, the power injection protocol is closed to receiving medical fluid in the fluid reservoir; determine a second pressure of the power injection protocol when the power injection protocol is in a normal fill state, and when the power injection protocol is in the normal fill state, the power injection protocol is open to receiving medical fluid in the fluid reservoir; and calculate a pressure difference of the power injection protocol between the vacuum fill state and the normal fill state based on the first pressure of the power injection protocol and the second pressure of the power injection protocol; and when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the medical fluid based on the pressure difference of the power injection protocol between the vacuum fill state and the normal fill state.
[0038] Clause 34: A system described in any one of clauses 24 to 33, wherein when determining the first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state, at least one processor is programmed or configured to determine a steady state force exerted on a force component of the pump when the power injection protocol is in a vacuum fill state and to determine a rate of movement of the force component of the pump when the power injection protocol is in a vacuum fill state.
[0039] Clause 35: A system described in any one of clauses 24 to 34, wherein when determining the second pressure of the power injection protocol when the power injection protocol is in a normal filling state, at least one processor is programmed or configured to determine a steady-state force exerted on a force component of the pump when the power injection protocol is in a normal filling state and to determine a rate of movement of the force component of the pump when the power injection protocol is in a normal filling state.
[0040] Clause 36: A system described in any one of clauses 24 to 35, wherein when determining at least one characteristic of the power injection protocol, the at least one processor is programmed or configured to determine a force exerted on a force component of the pump during each filling operation of the fluid reservoir among a plurality of filling operations of the fluid reservoir, each filling operation of the fluid reservoir including an operation performed to fill the fluid reservoir with medical fluid, and to determine a filling flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir, and when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the medical fluid based on the force exerted on the force component of the pump during each filling operation of the plurality of filling operations of the fluid reservoir and the filling flow rate through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir.
[0041] Clause 37: A system described in any one of clauses 24 to 36, wherein when determining the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir, at least one processor is programmed or configured to determine the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir based on at least one of the amount of friction between the force component of the pump and the wall of the fluid reservoir, the area of the force component of the pump, the length of the tubing component through which the medical fluid flows to the fluid reservoir, and the diameter of the tubing component through which the medical fluid flows to the fluid reservoir.
[0042] Clause 38: The system of any one of clauses 24 to 37, wherein the at least one processor is further programmed or configured to perform a linear regression calculation based on the force exerted on the force component of the pump during each filling operation of the fluid reservoir among the plurality of filling operations of the fluid reservoir and the filling flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir, and when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the medical fluid based on the linear regression calculation.
[0043] Clause 39: A system described in any one of clauses 24 to 38, wherein when determining at least one characteristic of the powered injection protocol, the at least one processor is programmed or configured to control a force component of a pump of the powered fluid injector to perform an operation to fill the fluid path and to determine a fill time of the fluid path, the fill time of the fluid path comprising an amount of time over which the volume of the fluid path is filled with medical fluid, and when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the medical fluid based on the fill time of the fluid path.
[0044] Clause 40: A system described in any one of clauses 24 to 39, wherein, when controlling a force component of a pump of a powered fluid injector to fill a fluid path, at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to generate a constant pressure during the operation of filling the fluid path, and when calculating the hydraulic resistance score, the at least one processor is programmed or configured to calculate the hydraulic resistance score based on at least one value of the constant pressure, the area of the force component of the pump, the distance traveled by the force component of the pump during the operation of filling the fluid path, and the fill time of the fluid path.
[0045] Clause 41: A system described in any one of clauses 24 to 40, wherein when determining at least one characteristic of the powered injection protocol, the at least one processor is programmed or configured to control a force component of a pump of the powered fluid injector to provide a fluid flow of the medical fluid within a lumen of a tubing component of the fluid injection system, control the force component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, and detect a characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component; and when determining an estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the medical fluid based on the characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0046] Clause 42: A system described in any one of clauses 24 to 41, wherein when controlling the force component of the pump of the powered fluid injector to provide a fluid flow of the fluid within the lumen of the tubing component, the at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to provide a laminar flow of the fluid within the lumen of the tubing component, and when controlling the force component of the pump of the powered fluid injector to change at least one state of the fluid flow of the medical fluid within the lumen of the tubing component, the at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to transition from a laminar flow of the fluid within the lumen of the tubing component to a turbulent flow of the fluid within the lumen of the tubing component.
[0047] Clause 43: A system described in any one of clauses 24 to 42, wherein at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to induce cavitation in the medical fluid when controlling the force component of the pump of the powered fluid injector to change at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0048] Clause 44: A system described in any one of clauses 24 to 43, wherein when controlling the force component of the pump of the powered fluid injector to change at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to shear one or more air bubbles present in the medical fluid.
[0049] Clause 45: A system described in any one of clauses 24 to 44, wherein at least one processor is programmed or configured to control the force component of the pump of the powered fluid injector to generate turbulence in the medical fluid when controlling the force component of the pump of the powered fluid injector to change at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0050] Clause 46: A system described in any one of clauses 24 to 45, wherein when determining at least one characteristic of the power injection protocol, the at least one processor is programmed or configured to determine a time interval during which fluid flows from a high pressure side of the actuating fluid control component to a low pressure side of the actuating fluid control component, and when determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimate of the viscosity of the medical fluid based on the time interval.
[0051] Clause 47: A computer program product for controlling a fluid injection system, the computer program product comprising at least one non-transitory computer-readable medium containing one or more instructions, the one or more instructions, when executed by at least one processor, causing the at least one processor to determine at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol being associated with a medical fluid involved in the power injection protocol, the one or more instructions causing the at least one processor to determine an estimate of viscosity of the medical fluid based on the at least one characteristic of the power injection protocol, calculate a hydraulic resistance score based on the estimate of viscosity of the medical fluid, and determine one or more motor controller gains of a motor of a powered fluid injector in the power injection protocol based on the hydraulic resistance score.
[0052] Clause 48: The computer program product of Clause 47, wherein the one or more instructions for causing at least one processor to determine at least one characteristic of the powered injection protocol cause the at least one processor to determine a steady-state characteristic of saline flowing through an orifice in a fluid path of the powered fluid injector, determine a steady-state characteristic of a contrast agent flowing through the orifice, and calculate a characteristic ratio, the characteristic ratio being a ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent; the one or more instructions for causing the at least one processor to determine an estimate of the viscosity of the medical fluid cause the at least one processor to determine an estimate of the viscosity of the contrast agent based on the characteristic ratio; and the one or more instructions for causing the at least one processor to calculate a hydraulic resistance score cause the at least one processor to calculate the hydraulic resistance score based on the estimate of the viscosity of the contrast agent.
[0053] Clause 49: The computer program product of clause 47 or 48, wherein the one or more instructions further cause at least one processor to implement one or more motor controller gains for a motor of the powered fluid injector.
[0054] Clause 50: A computer program product described in any one of clauses 47 to 49, wherein the motor is a motor of a pump of a powered fluid injector, the pump of the powered fluid injector comprising a piston or peristaltic pump configured to drive a plunger of a syringe.
[0055] Clause 51: A computer program product described in any one of clauses 47 to 50, wherein the one or more instructions further cause at least one processor to determine whether the characteristic ratio satisfies a threshold and cause the at least one processor to calculate a hydraulic resistance score, wherein the one or more instructions cause the at least one processor to calculate a hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold.
[0056] Clause 52: A computer program product as described in any one of clauses 47 to 51, wherein the one or more instructions for causing at least one processor to determine whether the characteristic ratio satisfies a threshold cause the at least one processor to determine whether the characteristic ratio satisfies a threshold equal to 1.
[0057] Clause 53: A computer program product as described in any one of clauses 47 to 52, wherein the steady state characteristics of the saline flowing through the orifice include a steady state flow rate of the saline flowing through the orifice based on a constant pressure of the saline, and the steady state characteristics of the contrast agent flowing through the orifice include a steady state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent, the characteristic ratio includes a flow rate ratio, the flow rate ratio being the ratio of the steady state flow rate of the saline to the steady state flow rate of the contrast agent, and the one or more instructions causing at least one processor to calculate the characteristic ratio cause the at least one processor to calculate the flow rate ratio based on the steady state flow rate of the saline and the steady state flow rate of the contrast agent.
[0058] Clause 54: A computer program product as described in any one of clauses 47 to 53, wherein the steady state characteristics of the saline flowing through the orifice include a steady state pressure of the saline flowing through the orifice based on a constant flow rate of the saline, the steady state characteristics of the contrast agent flowing through the orifice include a steady state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent, the characteristic ratio includes a pressure ratio, the pressure ratio being the ratio of the steady state pressure of the saline to the steady state pressure of the contrast agent, and the one or more instructions causing at least one processor to calculate the characteristic ratio cause the at least one processor to calculate the pressure ratio based on the steady state pressure of the saline and the steady state pressure of the contrast agent.
[0059] Clause 55: A computer program product as described in any one of clauses 47 to 54, wherein the one or more instructions further cause at least one processor to determine a hydraulic capacitance value of the medical fluid involved in the power injection protocol and cause at least one processor to determine a motor controller gain, the one or more instructions causing at least one processor to determine a motor controller gain based on the hydraulic capacitance value of the medical fluid involved in the power injection protocol.
[0060] Clause 56: The one or more instructions for causing at least one processor to determine at least one characteristic of the power injection protocol include causing the at least one processor to determine a first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state, wherein the power injection protocol is blocked from receiving medical fluid in the fluid reservoir when the power injection protocol is in a vacuum fill state, and the one or more instructions for causing the at least one processor to determine a second pressure of the power injection protocol when the power injection protocol is in a normal fill state, and wherein the power injection protocol is blocked from receiving medical fluid in the fluid reservoir when the power injection protocol is in a normal fill state. 56. The computer program product of any one of clauses 47 to 55, wherein the reservoir is open to receiving medical fluid, and the one or more instructions cause at least one processor to calculate a power injection protocol pressure difference between a vacuum fill state and a normal fill state based on a power injection protocol first pressure and a power injection protocol second pressure, and cause the at least one processor to determine an estimate of the viscosity of the medical fluid.
[0061] Clause 57: A computer program product described in any one of clauses 47 to 56, wherein the one or more instructions that cause at least one processor to determine a first pressure of the power injection protocol when the power injection protocol is in a vacuum fill state cause the at least one processor to determine a steady state force exerted on a force component of the pump when the power injection protocol is in a vacuum fill state and determine a rate of movement of the force component of the pump when the power injection protocol is in a vacuum fill state.
[0062] Clause 58: A computer program product as described in any one of clauses 47 to 57, wherein the one or more instructions that cause at least one processor to determine a second pressure of the power injection protocol when the power injection protocol is in a normal filling state cause the at least one processor to determine a steady state force exerted on a force component of the pump when the power injection protocol is in a normal filling state and determine a rate of movement of the force component of the pump when the power injection protocol is in a normal filling state.
[0063] Clause 59: A computer program product as described in any one of clauses 47 to 58, wherein the one or more instructions for causing at least one processor to determine at least one characteristic of the power injection protocol cause the at least one processor to determine a force exerted on a force component of the pump during each filling operation of the fluid reservoir among a plurality of filling operations of the fluid reservoir, each filling operation of the fluid reservoir including an operation performed to fill the fluid reservoir with medical fluid, the one or more instructions for causing the at least one processor to determine a filling flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir, and the one or more instructions for causing the at least one processor to determine an estimate of the viscosity of the medical fluid cause the at least one processor to determine an estimate of the viscosity of the medical fluid based on the force exerted on the force component of the pump during each filling operation of the plurality of filling operations of the fluid reservoir and the filling flow rate through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir.
[0064] Clause 60: A computer program product as described in any one of clauses 47 to 59, wherein the one or more instructions for causing at least one processor to determine the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir cause the at least one processor to determine the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir based on at least one of the amount of friction between the force component of the pump and the wall of the fluid reservoir, the area of the force component of the pump, the length of the tubing component through which the medical fluid flows to the fluid reservoir, and the diameter of the tubing component through which the medical fluid flows to the fluid reservoir.
[0065] Clause 61: A computer program product described in any one of clauses 47 to 60, wherein the one or more instructions further cause at least one processor to perform a linear regression calculation based on the force exerted on the force component of the pump during each filling operation of the fluid reservoir among the plurality of filling operations of the fluid reservoir and the filling flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir, and cause the at least one processor to determine an estimate of the viscosity of the medical fluid, the one or more instructions causing the at least one processor to determine an estimate of the viscosity of the medical fluid based on the linear regression calculation.
[0066] Clause 62: A computer program product as described in any one of clauses 47 to 61, wherein the one or more instructions causing at least one processor to determine at least one characteristic of the powered injection protocol cause the at least one processor to control a force component of a pump of the powered fluid injector to perform an operation to fill the fluid path, determine a fill time of the fluid path, the fill time of the fluid path comprising an amount of time a volume of the fluid path is filled with medical fluid, and the one or more instructions causing the at least one processor to determine an estimate of the viscosity of the medical fluid cause the at least one processor to determine an estimate of the viscosity of the medical fluid based on the fill time of the fluid path.
[0067] Clause 63: A computer program product described in any one of clauses 47 to 62, wherein the one or more instructions that cause at least one processor to control a force component of a pump of a powered fluid injector to fill a fluid path cause the at least one processor to control the force component of the pump of the powered fluid injector to generate a constant pressure during the operation of filling the fluid path, and the one or more instructions that cause the at least one processor to calculate a hydraulic resistance score cause the at least one processor to calculate the hydraulic resistance score based on at least one value of the constant pressure, the area of the force component of the pump, the distance traveled by the force component of the pump during the operation of filling the fluid path, and the fill time of the fluid path.
[0068] Clause 64: A computer program product as described in any one of clauses 47 to 63, wherein the one or more instructions for causing at least one processor to determine at least one characteristic of a powered injection protocol cause the at least one processor to control a force component of a pump of a powered fluid injector to provide a fluid flow of the medical fluid within a lumen of a tubing component of the fluid injection system, control the force component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, detect a characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, and the one or more instructions for causing the at least one processor to determine an estimate of the viscosity of the medical fluid cause the at least one processor to determine an estimate of the viscosity of the medical fluid based on the characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0069] Clause 65: A computer program product as described in any one of clauses 47 to 64, wherein the one or more instructions for causing at least one processor to control a force component of a pump of the powered fluid injector to provide a fluid flow of the fluid within the lumen of the tubing component cause the at least one processor to control the force component of the pump of the powered fluid injector to provide a laminar flow of the fluid within the lumen of the tubing component, and the one or more instructions for causing at least one processor to control the force component of the pump of the powered fluid injector to change at least one state of the fluid flow of the medical fluid within the lumen of the tubing component cause the at least one processor to control the force component of the pump of the powered fluid injector to transition from a laminar flow of the fluid within the lumen of the tubing component to a turbulent flow of the fluid within the lumen of the tubing component.
[0070] Clause 66: A computer program product described in any one of clauses 47 to 65, wherein one or more instructions that cause at least one processor to control a force component of a pump of a powered fluid injector to change at least one condition of a fluid flow of the medical fluid within a lumen of a tubing component cause at least one processor to control a force component of a pump of the powered fluid injector to induce cavitation in the medical fluid.
[0071] Clause 67: A computer program product described in any one of clauses 47 to 66, wherein the one or more instructions that cause at least one processor to control a force component of a pump of a powered fluid injector to change at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component cause the at least one processor to control a force component of the pump of the powered fluid injector to shear one or more air bubbles present in the medical fluid.
[0072] Clause 68: A computer program product as described in any one of clauses 47 to 67, wherein the one or more instructions that cause at least one processor to control a force component of a pump of a powered fluid injector to change at least one condition of a fluid flow of the medical fluid within the lumen of the tubing component cause the at least one processor to control a force component of the pump of the powered fluid injector to generate turbulence in the medical fluid.
[0073] Clause 69: A computer program product as described in any one of clauses 47 to 68, wherein the one or more instructions that cause at least one processor to determine at least one characteristic of the power injection protocol cause the at least one processor to determine a time interval during which fluid flows from a high pressure side of the actuating fluid control component to a low pressure side of the actuating fluid control component, and the one or more instructions that cause the at least one processor to determine an estimate of the viscosity of the medical fluid cause the at least one processor to determine an estimate of the viscosity of the medical fluid based on the time interval.
[0074] These and other features and characteristics of the present disclosure, as well as the method of operation, function of associated elements of construction, combination of parts, and economies of manufacture, will become apparent from a consideration of the following description and appended claims with reference to the accompanying drawings, which form a part hereof, in which like reference characters indicate corresponding parts in the various views. It is to be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended as a definition of the limits of the present disclosure. As used in the specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.
[0075] Further advantages and details of the present disclosure are explained in more detail below with reference to exemplary embodiments shown in the accompanying schematic drawings. [Brief explanation of the drawings]
[0076] [Figure 1]FIG. 1 is a diagram of a non-limiting embodiment of an environment in which the systems, devices, products, apparatus, and / or methods described herein may be implemented in accordance with the principles of the present disclosure. [Figure 2] FIG. 2 is a diagram of a non-limiting embodiment of components of one or more systems or one or more devices of FIG. 1. [Figure 3] 1 is a flow chart of a non-limiting embodiment of a process for controlling a fluid injection system. [Figure 4] FIG. 1 illustrates a non-limiting embodiment of a powered fluid injector. [Figure 5] 1 is a schematic diagram of a powered fluid injector with components for delivering medical fluid to a patient. [Figure 6] FIG. 1 is a diagram of a process for optimizing fluid delivery in a fluid injection system. [Figure 7] FIG. 6 is a diagram of the components of the powered fluid injector of FIG. 5. [Figure 8A] 1 is a graph of flow rate of a medical fluid versus time at constant pressure. [Figure 8B] 1 is a graph of pressure versus time at a constant flow rate of medical fluid. [Figure 9] FIG. 10 is a plot of multiple lines representing plunger force versus fill flow rate for values of contrast agent viscosity. DETAILED DESCRIPTION OF THE INVENTION
[0077] For purposes of the following description, the terms "end," "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, shall refer to the present disclosure as shown in the drawings. However, it should be understood that the present disclosure may contemplate alternative variations and sequences of steps, unless expressly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described below are merely exemplary embodiments of the present disclosure. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting, unless otherwise indicated.
[0078] As used herein, aspects, components, elements, structures, operations, steps, functions, instructions, and the like should not be construed as critical or essential unless expressly stated as such. Also, as used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more" and "at least one." Furthermore, as used herein, the term "set" is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." Where only one item is intended, the term "one" or similar language is used. Also, as used herein, terms such as "has," "have," and "having" are intended to be open-ended terms. Furthermore, the phrase "based on" is intended to mean "based at least in part on," unless otherwise specified. In appropriate context, the phrase "based on" may be synonymous with the phrase "in response to," which may indicate a condition (e.g., a trigger condition) when a step, action, function, etc. is performed.
[0079] In some non-limiting embodiments, all numbers used in the specification and claims can be understood to be modified in all instances by the term "about." The terms "approximately," "about," and "substantially" can mean a range of plus or minus 10% of the stated value.
[0080] 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 only, or one or more Bs only, or one or more Cs only, 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, or all one or more of A, B, and C. Similarly, as used herein, the term "at least two of" is synonymous with "two or more of." For example, the phrase "at least two of D, E, and F" means any combination of two or more of D, E, and F.
[0081] When used in reference to a fluid reservoir, such as a syringe, the term "distal" can refer to the portion of the fluid reservoir closest to the patient. When used in reference to a fluid reservoir, such as a syringe, the term "proximal" can refer to the portion of the fluid reservoir closest to the injector system.
[0082] As used herein, the terms “communication” and “communicating” can refer to receiving, accepting, transmitting, forwarding, providing, etc., information (e.g., data, signals, messages, instructions, commands, etc.). This can 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 can communicate with a second unit if at least one intermediate unit (e.g., a third unit located between the first and second units) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments, a message can refer to a network packet (e.g., a data packet, etc.) containing data.
[0083] As used herein, the term "system" can 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, as well as one or more mechanical features or devices operated at least in part by a computing device. Additionally, references to a "server" or a "processor" as used herein can 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 a 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 can refer to the same or a different server and / or processor listed as performing a second step or function.
[0084] Some non-limiting embodiments are described herein in relation to thresholds. As used herein, meeting a threshold can refer to a value that is greater than, or equal to, or less than, or equal to, the threshold.
[0085] As used herein, the term contrast includes solutions of contrast media and mixtures of contrast media with diluents such as saline. During a dual-flow injection procedure, a selected ratio of contrast media and saline is delivered to a patient by, for example, simultaneous operation of a contrast pump and a saline pump at a selected fluid delivery rate with appropriate mixing. During a medical imaging procedure, a fluid injection procedure may be performed in which a powered fluid injector is used to inject a contrast media into a patient's body. The contrast media can increase the contrast of structures, organs, and / or fluids within the body so that an image of the body can be generated. In some cases, the contrast media may be injected through a catheter (e.g., an intravenous catheter or an intra-arterial catheter) inserted into the patient's body. During a fluid injection procedure, as the contrast media is injected into the patient's body, the fluid injection system may encounter hydraulic resistance, which may be the resistance of the contrast media, flushing fluid, or other medical fluid flowing through a fluid pathway from a reservoir in the powered fluid injector, through the catheter, and into the patient's vascular system. The hydraulic resistance created by a catheter depends primarily on factors such as the length and inner diameter (ID) of the catheter, along with the viscosity, density, and / or flow rate of the medical fluid traveling through the catheter. In some cases, the hydraulic resistance may be increased by increasing one or more of the length of the catheter and / or the density, flow rate, and / or viscosity of the medical fluid traveling through the catheter, and the hydraulic resistance may be decreased by one or more of increasing the ID of the catheter, decreasing the length of the catheter, and / or decreasing the density, flow rate, and / or viscosity of the medical fluid.
[0086] Because the system may use proportional, integral, and derivative (PID) control, hydraulic resistance experienced by the fluid injection system may affect control. The motor controller gains associated with PID control may include values that provide reasonable motor performance across a wide variety of equipment and programmed protocol combinations, while also performing well against extremes in hydraulic resistance experienced during some injection procedures. In certain embodiments, conditions in which accurate motor control may be difficult include, but are not limited to, small-diameter catheters and / or highly viscous fluids, which may require relatively large pressures to move medical fluid through the catheter at a given flow rate. Inaccuracies in motor control may result in the motor overshooting or undershooting the target pressure, which may pose a safety hazard or compromise achievable medical fluid pressure and flow rate.
[0087] Non-limiting embodiments of the present disclosure relate to systems, devices, products, apparatus, and / or methods for controlling a fluid injection system. In some non-limiting embodiments, the infusion management system may include at least one processor programmed or configured to: determine at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol associated with a medical fluid involved in the power injection protocol; determine an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculate a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; and determine one or more motor controller gains of a motor of a powered fluid injector in the power injection protocol based on the hydraulic resistance score, the motor configured to reciprocate a piston of the fluid injector, for example, to reciprocate a plunger of a syringe, to draw in or deliver the medical fluid to a patient via a fluid pathway, such as a fluid line and catheter. In some non-limiting embodiments, when determining at least one characteristic of the powered injection protocol, the at least one processor may be programmed or configured to: determine a steady-state characteristic of saline flowing through an orifice in a fluid path of a powered fluid injector, such as a lumen of a catheter, a lumen of a tube, a distal nozzle of a syringe, or a tubing connector of a peristaltic pump; determine a steady-state characteristic of a contrast agent flowing through the orifice; and calculate a characteristic ratio that is a ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent. Further, when determining an estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine an estimate of the viscosity of the medical fluid based on the characteristic ratio; and when calculating the hydraulic resistance score, the at least one processor may be programmed or configured to calculate the hydraulic resistance score based on the estimate of the viscosity of the medical fluid. While many of the non-limiting embodiments are described using a contrast medium as the medical fluid, it should be understood that other medical fluids may also be used as the injected fluid medium, and that the various embodiments disclosed herein are not limited to imaging contrast agents.
[0088] In some non-limiting embodiments, the at least one processor may be further programmed or configured to implement one or more motor controller gains on a motor of the powered fluid injector. In some non-limiting embodiments, the motor is a motor of a pump of the powered fluid injector, and the pump of the powered fluid injector may include a piston configured to drive a plunger of a syringe or rotate a rotatable component of a peristaltic pump. In some non-limiting embodiments, the at least one processor may be further programmed or configured to determine whether the characteristic ratio satisfies a threshold value, and when calculating the hydraulic resistance score, the at least one processor may be programmed or configured to calculate the hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold value. In some non-limiting embodiments, when determining whether the characteristic ratio satisfies the threshold value, the at least one processor is programmed or configured to determine whether the characteristic ratio satisfies a threshold value equal to 1.
[0089] In some non-limiting embodiments, the steady-state characteristic of saline flowing through an orifice, such as a lumen of a catheter, a lumen of a tube, a distal nozzle of a syringe, or a tubing connector of a peristaltic pump, comprises a steady-state flow rate of saline flowing through the orifice based on a constant pressure of saline, the steady-state characteristic of contrast agent flowing through the orifice comprises a steady-state flow rate of contrast agent flowing through the orifice based on a constant pressure of contrast agent, and the characteristic ratio comprises a flow rate ratio, the flow rate ratio being the ratio of the steady-state flow rate of saline to the steady-state flow rate of contrast agent. When calculating the characteristic ratio, the at least one processor is programmed or configured to calculate the flow rate ratio based on the steady-state flow rate of saline and the steady-state flow rate of contrast agent. In some non-limiting embodiments, the steady-state characteristic of saline flowing through the orifice comprises a steady-state pressure of saline flowing through the orifice based on a constant flow rate of saline, and the steady-state characteristic of contrast agent flowing through the orifice comprises a steady-state pressure of contrast agent flowing through the orifice based on a constant flow rate of contrast agent. The characteristic ratio includes a pressure ratio, the pressure ratio being a ratio of a steady-state pressure of the saline to a steady-state pressure of the contrast agent, and when calculating the characteristic ratio, the at least one processor is programmed or configured to calculate the pressure ratio based on the steady-state pressure of the saline and the steady-state pressure of the contrast agent. In some non-limiting embodiments, the at least one processor may be further programmed or configured to determine a value of a hydraulic capacitance of a medical fluid involved in the power injection protocol, and when determining the motor controller gain, the at least one processor may be programmed or configured to determine the motor controller gain based on the value of the hydraulic capacitance of the medical fluid involved in the power injection protocol.
[0090] In some non-limiting embodiments, when determining at least one characteristic of the power injection protocol, the at least one processor may be programmed or configured to: determine a first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, i.e., closed to receiving medical fluid in the fluid reservoir; determine a second pressure of the power injection protocol when the power injection protocol is in a normal-fill state, i.e., open to receiving medical fluid in the fluid reservoir; and calculate a pressure difference of the power injection protocol between the vacuum-fill state and the normal-fill state based on the first pressure of the power injection protocol and the second pressure of the power injection protocol. When determining an estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine an estimate of the viscosity of the medical fluid based on a pressure difference of the power injection protocol between the vacuum-fill state and the normal-fill state.
[0091] In some non-limiting embodiments, when determining a first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, the at least one processor may be programmed or configured to determine a steady-state force exerted on at least one force component of the pump (e.g., piston or rotor) when the power injection protocol is in a vacuum-fill state and to determine a rate of movement of the force component of the pump when the power injection protocol is in a vacuum-fill state. In some non-limiting embodiments, when determining a second pressure of the power injection protocol when the power injection protocol is in a normal-fill state, the at least one processor may be programmed or configured to determine a steady-state force exerted on at least one force component of the pump when the power injection protocol is in a normal-fill state and to determine a rate of movement of the at least one force component of the pump when the power injection protocol is in a normal-fill state. In some non-limiting embodiments, when determining the at least one characteristic of the power injection protocol, the at least one processor may be programmed or configured to determine a force exerted on at least one force component of the pump during each fluid reservoir fill operation of a plurality of fluid reservoir fill operations, each fluid reservoir fill operation including operations performed to fill the fluid reservoir with medical fluid and to determine a fill flow rate of the medical fluid through the orifice during each of the plurality of fluid reservoir fill operations. When determining the estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine an estimate of the viscosity of the medical fluid based on the force exerted on the at least one force component of the pump during each of the plurality of fluid reservoir fill operations and the fill flow rate through the orifice during each of the plurality of fluid reservoir fill operations.
[0092] In some non-limiting embodiments, when determining the force exerted on at least one force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir, the at least one processor may be programmed or configured to determine the force exerted on the force component of the pump during each filling operation of the multiple filling operations of the fluid reservoir based on at least one of an amount of friction between the force component of the pump and a wall of the fluid reservoir, an area of the force component of the pump, a length of a tubing component through which the medical fluid flows into the fluid reservoir, and a diameter of a tubing component through which the medical fluid flows into the fluid reservoir. In some non-limiting embodiments, the at least one processor may be further programmed or configured to perform a linear regression calculation based on the force exerted on the at least one force component of the pump during each filling operation of the fluid reservoir among the multiple filling operations of the fluid reservoir and a fill flow rate of the medical fluid through the orifice during each filling operation of the multiple filling operations of the fluid reservoir, and when determining an estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine an estimate of the viscosity of the medical fluid based on the linear regression calculation. In some non-limiting embodiments, when determining the at least one characteristic of the power injection protocol, the at least one processor may be programmed or configured to control at least one force component of a pump of the powered fluid injector to perform an operation to fill the fluid path, causing a fill time of the fluid path to be determined, the fill time of the fluid path comprising an amount of time a volume of the fluid path is filled with medical fluid; and when determining the estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine the estimate of the viscosity of the medical fluid based on the fill time of the fluid path.
[0093] In certain non-limiting embodiments, when controlling at least one force component of a pump of the powered fluid injector to fill the fluid path, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to generate a constant pressure during the operation of filling the fluid path, and when calculating the hydraulic resistance score, the at least one processor may be programmed or configured to calculate the hydraulic resistance score based on values of at least one of the constant pressure, the area of the force component of the pump, the distance traveled by the force component of the pump during the operation of filling the fluid path, and the fill time of the fluid path. In some non-limiting embodiments, when determining the at least one characteristic of the powered injection protocol, the at least one processor may be programmed or configured to: control at least one force component of a pump of the powered fluid injector to provide a fluid flow of the medical fluid within a lumen of a tubing component of the fluid injection system; control the force component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component; and detect a characteristic associated with altering the at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component; and when determining an estimate of the viscosity of the medical fluid, the at least one processor may be programmed or configured to determine an estimate of the viscosity of the medical fluid based on the characteristic associated with altering the at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
[0094] In some non-limiting embodiments, when controlling the force component of the pump of the powered fluid injector to provide a fluid flow within the lumen of the tubing component, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to provide a laminar flow of the fluid within the lumen of the tubing component, and when controlling the force component of the pump of the powered fluid injector to alter at least one condition of the flow of the medical fluid within the lumen of the tubing component, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to transition from a laminar flow of the fluid within the lumen of the tubing component to a turbulent flow of the fluid within the lumen. In some non-limiting embodiments, when controlling the force component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to induce cavitation in the medical fluid. In certain non-limiting embodiments, when controlling the force component of the pump to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to shear one or more air bubbles present in the medical fluid. In certain non-limiting embodiments, when controlling the force component of the pump of the powered fluid injector to alter at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component, the at least one processor may be programmed or configured to control the force component of the pump of the powered fluid injector to generate turbulence in the medical fluid.In some non-limiting embodiments, when determining at least one characteristic of the power injection protocol, the at least one processor may be programmed or configured to determine a time interval during which fluid flows from a high pressure side of the actuating fluid control component to a low pressure side of the actuating fluid control component, and when determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimate of the viscosity of the medical fluid based on the time interval.
[0095] In this manner, non-limiting embodiments of the present disclosure provide improved motor control accuracy based on the use of gain scheduling. Gain scheduling may be used to adjust gains to best accommodate hydraulic resistances generated by components of the fluid injection system or components connected to the fluid injection system (e.g., connected to a powered fluid injector). In this manner, control of the motor of the powered fluid injector may be improved, thereby improving the bolus quality and volume accuracy of the delivered medical fluid, radiological image quality, and the quality of the resulting diagnosis or treatment. Knowing both the hydraulic resistance and the setpoint (e.g., target) flow rate allows for prediction of the time to steady state for both pressure and flow rate, as well as the value of the steady-state values of pressure and flow rate. If the steady-state pressure is defined at or near the beginning of the fluid injection procedure, the velocity of the force component (e.g., piston or rotor) may be more precisely controlled to avoid maximum or minimum pressure events, more accurately deliver fluid, and / or react to other events that may occur during the fluid injection procedure. Furthermore, the fluid injection system may be able to predict whether a programmed protocol is achievable based on the hydraulic resistances associated with the characteristics of various components of the fluid injector settings. For example, a user feedback system may be implemented to alert the user if the programmed protocol is calculated to exceed a programmed pressure limit before starting the injection. Such a system and feature would spare the patient unnecessary contrast and / or radiation exposure by alerting the user that the fluid injection protocol is unachievable, rather than simply starting the injection.
[0096] 1 shows a diagrammatic embodiment of an exemplary environment 100 in which the devices, systems, and / or methods described herein may be implemented. The environment 100 includes an infusion management system 102, a fluid infusion system 104, a remote assistance system 108, and a communication network 110. In some non-limiting embodiments, the infusion management system 102, the fluid infusion system 104, and / or the remote assistance system 108 may be interconnected (e.g., establish a connection to communicate) via a wired connection, a wireless connection, or a combination of wired and wireless connections.
[0097] In some non-limiting embodiments, the infusion management system 102 may include one or more devices capable of communicating with one or more of the fluid infusion systems 104 and / or the remote assistance system 108 via the communications network 110. For example, the infusion management system 102 may include a computing device such as a computer, a server, a group of servers, and / or other similar devices. In some non-limiting embodiments, the infusion management system 102 may be configured to receive data associated with an infusion system (e.g., the fluid infusion system 104), generate a uniform resource locator (URL), and / or generate a QR code based on the URL. In some non-limiting embodiments, the infusion management system 102 may be a component of the fluid infusion system 104.
[0098] In some non-limiting embodiments, the fluid injection system 104 may include one or more devices capable of communicating with the injection management system 102 and / or the remote assistance system 108 via the communications network 110. For example, the fluid injection system 104 may include computing devices, such as one or more computers, servers, groups of servers, and / or other similar devices. In some non-limiting embodiments, the fluid injection system 104 includes one or more injection devices (e.g., one or more fluid injection devices). In some non-limiting embodiments, the fluid injection system 104 is configured to administer a contrast agent to the patient and to administer an aqueous fluid, such as saline, to the patient before, during, and / or after administration of the contrast agent. For example, the fluid injection system 104 may inject one or more prescribed doses of contrast fluid directly into the patient's bloodstream via a syringe and catheter. In some non-limiting embodiments, the fluid injection system 104 may be configured to continuously administer an aqueous fluid to the patient through a peripherally inserted central catheter (PICC) and catheter, or one or more prescribed doses of contrast fluid may be introduced into the PICC and administered to the patient via the catheter. In some non-limiting embodiments, the fluid injection system 104 may be configured to inject a dose of contrast fluid followed by a specific volume of aqueous fluid, or may be configured to administer a "dual flow" mixture of a selected ratio of contrast agent and saline mixture.
[0099] In some non-limiting embodiments, the fluid injection system 104 may include one or more exemplary injection systems or injectors disclosed in U.S. Pat. Nos. 6,643,537; 7,094,216; 7,556,619; 8,337,456; 8,147,464; and 8,540,698, the disclosures of each of which are incorporated herein by reference in their entirety. In some non-limiting embodiments, suitable fluid injection systems include, but are not limited to, a CT fluid injection system, a CV angiography fluid injection system, an MRI fluid injection system, and a PET fluid injection system, such as the MEDRAD® Stellant CT injection system, the MEDRAD® Stellant FLEX CT injection system, the MEDRAD® MRXperion MR injection system, the MEDRAD® Mark 7 Arterion injection system, the MEDRAD® Intego PET injection system, or the MEDRAD® Centargo CT injection system, available from Bayer HealthCare LLC, Indianola, PA.
[0100] In some non-limiting embodiments, the fluid injection system 104 may include a workstation device, which may include one or more devices capable of communicating with one or more of the infusion management system 102, the fluid injection system 104, and / or the remote assistance system 108 via the communications network 110. In some non-limiting embodiments, the workstation device may include a computing device, such as one or more computers, including a desktop computer, laptop, tablet, smartphone, etc. In some non-limiting embodiments, the workstation device may provide a control interface for controlling the operation of the fluid injection system 104, including providing input to the fluid injection system 104. Additionally or alternatively, the workstation device may display operating parameters of the fluid injection system 104 during operation (e.g., during real-time operation). In some non-limiting embodiments, the workstation device may provide interconnectivity between the fluid injection system 104 and other devices or systems, such as a scanner device (not shown). In some non-limiting embodiments, the workstation device may include a Certegra® Workstation offered by Bayer HealthCare LLC.
[0101] In some non-limiting embodiments, the remote assistance system 108 may include one or more devices capable of communicating with the infusion management system 102 and / or the fluid infusion system 104 via the communications network 110. For example, the remote assistance system 108 may include a computing device such as a computer, a server (e.g., a web server), a group of servers, and / or other similar devices. In some non-limiting embodiments, the remote assistance system 108 may include a back-end system associated with the infusion management system 102 and / or the fluid infusion system 104. In some non-limiting embodiments, the remote assistance system 108 may include a cloud computing system that stores data in an associated database. In some non-limiting embodiments, the remote assistance system 108 may interact with the fluid infusion system 104 to provide functionality such as remote device services for the fluid infusion system 104 (e.g., VirtualCARE® Remote Device Support Services for Infusion Systems offered by Bayer HealthCare LLC). In some non-limiting embodiments, the remote assistance system 108 may be operated by or on behalf of the original equipment manufacturer (OEM) of the fluid injection system 104 (e.g., the OEM of one or more components or devices of the fluid injection system 104), the provider of the fluid injection system 104, the imaging site or hospital where the fluid injection system 104 operates, a maintenance technician assigned to the fluid injection system 104, etc.
[0102] In some non-limiting embodiments, communication network 110 may include one or more wired and / or wireless networks. For example, communication network 110 may include a cellular network, a local area network (LAN), a private network, an ad-hoc network, an intranet, the Internet, an optical fiber-based network, a cloud computing network, a short-range wireless communication network (e.g., a Bluetooth network, a near field communication (NFC) network, etc.), etc., and / or a combination of these or other types of networks.
[0103] The number and arrangement of systems, devices, and networks shown in Figure 1 are provided as an example. Additional, fewer, different, and / or differently arranged systems and / or devices may be present. Furthermore, two or more systems or devices shown in Figure 1 may be implemented within a single system or device, or a single system or device may be implemented as multiple distributed systems or devices. Additionally or alternatively, a set of systems or devices (e.g., one or more systems, one or more devices, etc.) of environment 100 may perform one or more functions described as being performed by another set of systems or another set of devices of environment 100.
[0104] 2 shows a diagram of example components of device 200. Device 200 may correspond to one or more devices of infusion management system 102, fluid infusion system 104, and / or remote assistance system 108. In some non-limiting embodiments, infusion management system 102, fluid infusion system 104, and / or remote assistance system 108 may include at least one device 200 and / or at least one component of device 200. Device 200 may include one or more of a bus 202, a processor 204, a memory 206, a storage component 208, an input component 210, an output component 212, and a communication interface 214.
[0105] Bus 202 may include components that enable communication between components of device 200. In some non-limiting embodiments, processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, processor 204 may include a processor, microprocessor, digital signal processor (DSP), and / or any processing component that can be programmed to perform a function. Memory 206 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions for use by processor 204.
[0106] Storage component 208 may store information and / or software related to the operation and use of device 200. For example, storage component 208 may include a hard disk (e.g., a magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium along with a corresponding drive.
[0107] Input components 210 may include components that enable device 200 to receive information via user input (e.g., a touchscreen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, etc.), etc. Additionally or alternatively, input components 210 may include one or more sensors for sensing information (e.g., an air sensor, a temperature sensor, a pressure sensor, an encoder, an accelerometer, a gyroscope, an actuator, etc.). Output components 212 may include components that provide output information from device 200 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).
[0108] Communications interface 214 may include components such as a transceiver that allow device 200 to communicate with other devices via a wired connection, a wireless connection, or a combination of wired and wireless connections, etc. Communications interface 214 may allow device 200 to receive or transmit information to another device. For example, communications interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a cellular network interface, etc.
[0109] The device 200 may perform one or more processes described herein based on the processor 204 executing software instructions stored by a computer-readable medium, such as the memory 206 and / or the storage component 208.
[0110] Software instructions may be loaded into memory 206 and / or storage component 208 from another computer-readable medium or from another device via communications interface 214. Execution of the software instructions stored in memory 206 and / or storage component 208 may cause processor 204 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, the embodiments described herein are not limited to any specific combination of hardware circuitry and software.
[0111] The number and arrangement of components shown in Figure 2 are provided as an example. In some non-limiting embodiments, device 200 may include additional components, fewer components, different components, or components arranged differently than those shown in Figure 2.
[0112] This disclosure provides details regarding estimating hydraulic resistance experienced by one or more components of a fluid injection system (e.g., fluid injection system 104) based on the physical characteristics of various components of the fluid injection system, such as the internal shape and length of components, such as a catheter, through which fluid flows during the fluid injection procedure, and / or the viscosity of the medical fluid used in the fluid injection procedure. In some non-limiting embodiments, pressure differentials generated by a powered fluid injector and flow restrictions including passive and / or active components may be used to measure fluid properties such as fluid density, fluid viscosity, and / or air content (e.g., the volume of air bubbles in the fluid).
[0113] In some non-limiting embodiments, when the pressure and flow rate are known, physical properties of the fluid injection system may also be measured, such as catheter geometry (e.g., length, inner diameter, etc.), tubing geometry (e.g., length, diameter, volume, viscoelastic properties, etc.), and fluid reservoir properties (e.g., plunger friction against the syringe wall). While the present disclosure utilizes a syringe-based fluid injection system for exemplary embodiments, other methods of generating pressure via peristaltic pumps, deformation of an elastic container, etc. are also within the scope of the present disclosure.
[0114] In some non-limiting embodiments, the pressure-flow relationship in a fluid injection system may be given by Equation 1:
number
number
[0115] In some non-limiting embodiments, the fluid injection system may generate distinct pressure differential waveforms over time. For example, the fluid injection system may generate a constant pressure waveform, a waveform having a linear ramp in pressure, a waveform having a step change in pressure, a polynomial varying pressure waveform, an exponentially varying pressure waveform, a sinusoidally varying pressure waveform, a pressure impulse waveform, etc. As used herein, a positive pressure may be a pressure greater than atmospheric pressure and may include a pressure that induces fluid flow from the fluid injector toward the patient. As used herein, a negative pressure differential may include a pressure less than atmospheric pressure and may include a pressure that induces fluid flow toward the fluid injection system 104.
[0116] According to various non-limiting embodiments, a fluid injection system may generate a pressure differential across a flow restriction, such as a reduction in the inner diameter of a fluid flow path. Given the known hydraulic resistance of the flow restriction, the flow rate may be measured and used to determine one or more fluid characteristics (e.g., characteristics of a power injection protocol) and / or physical characteristics of the fluid injection system. In some non-limiting embodiments, the flow restriction may be based on a passive component (e.g., a fill spike, disposable tubing, a J-tube, a prime tube, a catheter, etc.) or an active component (e.g., a multi-position stopcock, a pinch valve, etc.). In some non-limiting embodiments, an active component may be used to control the hydraulic resistance. For example, the hydraulic resistance may be controllable by changing the inner diameter or area of an orifice in an active component through which the fluid flows. In some non-limiting embodiments, the hydraulic resistance of the flow restriction may be unknown, and the hydraulic resistance may be determined using known flow rates and pressures. Resistance to fluid flow R TOTAL,i is partly related to viscous effects and partly related to inertial or density effects, as shown by Equation 2. R TOTAL,i =R viscous +R inertial (Formula 2)
[0117] In some non-limiting embodiments, hydraulic resistance can be attributed to the capillary effect of laminar flow, and viscous flow in a circular cross section is expressed as R in Equation 3 viscous is expressed as the Hagen-Poiseuille equation for fluid flow through a pipe.
number
number
[0118] Density and inertial effects on hydraulic resistance can be associated with local flow restrictions or sudden changes in fluid path cross-section, such as the inlet of a tubing component from the end of a fluid reservoir, the transition from a first tubing component having a first inner diameter (ID) to a second tubing component having a second ID, or the distal opening of a catheter that opens into a patient's blood vessel. The components of hydraulic resistance are expressed as R in Equation 4: inertial It is expressed as:
number
number
number
[0119] 3 shows a flowchart of a non-limiting embodiment of a process 300 for controlling a fluid infusion system. In some non-limiting embodiments, one or more of the steps of process 300 are performed at least in part by infusion management system 102. In some non-limiting embodiments, one or more of the steps of process 300 may be performed at least in part by another device or group of devices separate from or including infusion management system 102, such as fluid infusion system 104 and / or remote assistance system 108.
[0120] As shown in FIG. 3 , at step 302, process 300 includes determining, by, for example, the infusion management system 102, at least one characteristic of a power injection protocol. In some non-limiting embodiments, the at least one characteristic may include a steady-state characteristic of a medical fluid flowing through a fluid path of the fluid injection system 104. For example, the at least one characteristic may include a steady-state characteristic of a medical fluid flowing through an orifice of a fluid path of the fluid injection system 104. In some non-limiting embodiments, the medical fluid may include a flushing agent, a contrast agent, and / or a combination thereof. In some non-limiting embodiments, the infusion management system 102 may determine the at least one characteristic of the power injection protocol based on data received from one or more sensors, e.g., one or more sensors located on a component of the fluid injection system 104, located within a component of the fluid injection system 104, located on a fluid path of the fluid injection system 104, located near an environment of the fluid injection system 104, etc. In some non-limiting embodiments, the data received from the one or more sensors may include operating parameters of a fluid injection operation performed by the fluid injection system 104. In some non-limiting embodiments, the operating parameters of the fluid injection operations performed by the fluid injection system 104 may include one or more exemplary data types disclosed in U.S. Pat. Nos. 7,457,804; 7,996,381; and 8,521,716, the disclosures of each of which are incorporated by reference in their entirety.
[0121] In some non-limiting embodiments, the infusion management system 102 may operate (e.g., advance, retract, rotate, etc.) a force component (e.g., a plunger, piston, peristaltic pump, etc.) to maintain a constant pressure in a fluid pathway of the fluid injection system 104. In some non-limiting embodiments, the infusion management system 102 may operate the force component at a constant speed to generate a constant flow rate in a fluid pathway of the fluid injection system 104. In some non-limiting embodiments, when operating the force component at a constant pressure, the infusion management system 102 may measure the flow rate through the fluid pathway. In some non-limiting embodiments, when operating the force component to generate a constant flow rate in the fluid pathway, the infusion management system 102 may measure the pressure of the medical fluid in the fluid pathway.
[0122] In some non-limiting embodiments, the injection management system 102 may determine at least one steady-state characteristic of the contrast agent flowing through an orifice of a fluid path of the fluid injection system 104. In some non-limiting embodiments where an orifice is referenced, the orifice may be replaced with a capillary tube, and the calculation may be performed in the same or similar manner. Additionally or alternatively, the injection management system 102 may determine a steady-state characteristic of saline flowing through an orifice of a fluid path of the fluid injection system 104. In some non-limiting embodiments, the injection management system 102 may calculate a characteristic ratio that is the ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent.
[0123] In some non-limiting embodiments, the infusion management system 102 may determine the diameter of an orifice of a fluid pathway of the fluid injection system 104. For example, the infusion management system 102 may determine the diameter of an orifice of a fluid pathway of the fluid injection system 104 when the medical fluid flowing through the orifice reaches a steady-state flow rate (e.g., a flow rate that remains the same as the diameter of the orifice is increased). In some non-limiting embodiments, the infusion management system 102 may store the value of the diameter of the orifice of the fluid pathway of the fluid injection system 104 in a memory of the infusion management system 102. According to other embodiments, the diameter of the orifice may be entered into the fluid injection system by, for example, a user or by scanning a barcode or other information containing symbols or numbers associated with the fluid pathway.
[0124] In some non-limiting embodiments, the steady-state characteristic of the saline flowing through the orifice may include a steady-state flow rate of the saline flowing through the orifice based on a constant pressure of the saline. Further, the steady-state characteristic of the contrast agent flowing through the orifice may include a steady-state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent. The characteristic ratio may include a flow rate ratio, which is the ratio of the steady-state flow rate of the saline to the steady-state flow rate of the contrast agent. In some non-limiting embodiments, when calculating the characteristic ratio, the infusion management system 102 may calculate the flow rate ratio based on the steady-state flow rate of the saline and the steady-state flow rate of the contrast agent.
[0125] In some non-limiting embodiments, the steady-state characteristic of the saline flowing through the orifice may include a steady-state pressure of the saline flowing through the orifice based on a constant flow rate of the saline. Further, the steady-state characteristic of the contrast agent flowing through the orifice may include a steady-state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent. The characteristic ratio may include a pressure ratio, which is the ratio of the steady-state pressure of the saline to the steady-state pressure of the contrast agent. In some non-limiting embodiments, when calculating the characteristic ratio, the infusion management system 102 may calculate the pressure ratio based on the steady-state pressure of the saline and the steady-state pressure of the contrast agent.
[0126] In some non-limiting embodiments, the infusion management system 102 may determine the hydraulic capacitance values of the medical fluids involved in the power injection protocol. For example, the infusion management system 102 may determine the hydraulic capacitance values of the flushing agent (e.g., saline) and / or the contrast agent involved in the power injection protocol.
[0127] In certain non-limiting embodiments, the infusion management system 102 may determine a first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, e.g., when the power injection protocol is closed to receiving fluid in the reservoir of the fluid injection system 104. In certain non-limiting embodiments, the infusion management system 102 may determine a second pressure of the power injection protocol when the power injection protocol is in a normal-fill state, e.g., when the power injection protocol is open to receiving fluid in the reservoir of the fluid injection system 104. In certain non-limiting embodiments, when determining the first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, the infusion management system 102 may determine a steady-state force exerted on a force component of a pump of the powered fluid injector when the power injection protocol is in a vacuum-fill state and determine a rate of movement of the force component. In some non-limiting embodiments, when determining the second pressure of the power injection protocol when the power injection protocol is in the normal fill state, the infusion management system 102 may determine a steady-state force exerted on a force component of the pump when the power injection protocol is in the normal fill state and determine a movement rate of the force component. In some non-limiting embodiments, the infusion management system 102 may calculate a pressure difference of the power injection protocol between a vacuum fill state and a normal fill state based on the first pressure and the second pressure. In some non-limiting embodiments, the pump of the powered fluid injector may include a piston and / or peristaltic pump configured to drive a plunger of a syringe.
[0128] In some non-limiting embodiments, the infusion management system 102 may determine a force exerted on a force component of a pump (e.g., a piston, a plunger, a rotor, etc.) during each reservoir fill operation of the fluid infusion system 104 among a plurality of reservoir fill operations. Each reservoir fill operation includes an operation performed to fill the reservoir with fluid, and the infusion management system 102 may determine a fill flow rate of the fluid through an orifice during each of the plurality of fill operations. In some non-limiting embodiments, when determining the force exerted on the pump force component during each of the plurality of reservoir fill operations, the infusion management system 102 may determine the force exerted on the pump force component during each of the plurality of fill operations based on the amount of friction between the pump force component and a wall of the reservoir (e.g., between the plunger and a wall of the syringe), the amount of friction between the medical fluid and a wall of the reservoir or a wall of the tubing, the area of the pump force component, the length of the tubing through which the fluid flows to the reservoir, and / or the inner diameter of the tubing through which the fluid flows to the reservoir. In some non-limiting embodiments, the infusion management system 102 may perform a linear regression calculation based on the force exerted on the force component of the pump during each reservoir filling operation of the multiple reservoir filling operations and the fill flow rate of the fluid through the orifice during each reservoir filling operation of the multiple reservoir filling operations.
[0129] In some non-limiting embodiments, the infusion management system 102 may control a force component of a pump of a powered fluid injector of the fluid injection system 104 to perform an operation to fill the fluid pathway and may determine a fill time for the fluid pathway. In some non-limiting embodiments, the fill time for the fluid pathway may include the amount of time the volume of the fluid pathway is filled with medical fluid (e.g., saline, contrast, etc.). In some non-limiting embodiments, when controlling the force component of the pump of the powered fluid injector to fill the fluid pathway, the infusion management system 102 may control the force component of the pump of the powered fluid injector to generate a constant pressure.
[0130] In some non-limiting embodiments, the infusion management system 102 may control a force component of a pump of a powered fluid injector of the fluid injection system 104 to provide fluid flow within a lumen of a tubing component (e.g., tubing, catheter, needle, etc.) of the fluid injection system, control the force component of the pump of the powered fluid injector of the fluid injection system 104 to change at least one condition of the fluid flow of the fluid within the lumen of the tubing component, and detect a characteristic associated with the change in at least one condition of the fluid flow of the fluid within the lumen of the tubing component. In some non-limiting embodiments, the infusion management system 102 may control the force component of the pump of the powered fluid injector to provide a laminar flow of the fluid within the lumen of the tubing component. In some non-limiting embodiments, the infusion management system 102 may control the force component of the pump of the powered fluid injector to transition from a laminar flow of the fluid within the lumen of the tubing component to a turbulent flow of the fluid within the lumen. In some non-limiting embodiments, the infusion management system 102 may control the force component of the pump of the powered fluid injector to induce cavitation in the medical fluid. In some non-limiting embodiments, the infusion management system 102 may control a force component of a pump of a powered fluid injector to shear one or more air bubbles present in the medical fluid. In some non-limiting embodiments, the infusion management system 102 may control a force component of a pump of a powered fluid injector to create turbulence in the medical fluid.
[0131] In some non-limiting embodiments, the infusion management system 102 may determine the time interval during which fluid flows from a high-pressure side of an actuating fluid control component, such as a flow restriction or orifice, to a low-pressure side of the actuating fluid control component.
[0132] 3, at step 304, the process 300 includes determining an estimate of the viscosity of the medical fluid used in the power injection protocol. For example, the infusion management system 102 may determine the estimate of the viscosity of the medical fluid used in the power injection protocol based on at least one characteristic of the power injection protocol. In some non-limiting embodiments, the infusion management system 102 may determine the estimate of the viscosity of the medical fluid based on a characteristic ratio (e.g., the ratio of the steady-state characteristic of saline to the steady-state characteristic of the contrast agent).
[0133] In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on the pressure difference between when the power injection protocol is in a vacuum fill state and when the power injection protocol is in a normal fill state. In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on the force exerted on a force component of a pump of the power injection device during each of multiple fill operations of a fluid reservoir of the fluid injection system 104 and the fill flow rate through an orifice of the fluid injection system 104 during each of multiple fill operations of the fluid reservoir. In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on a linear regression calculation. In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on the fill time of a fluid path of the fluid injection system 104. In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on a characteristic associated with altering at least one condition of the fluid flow of the medical fluid within the lumen of a tubing component of the fluid infusion system 104. In some non-limiting embodiments, the infusion management system 102 may determine an estimate of the viscosity of the medical fluid based on a time interval over which the fluid flows from a high pressure side of the active fluid control component to a low pressure side of the active fluid control component.
[0134] In some non-limiting embodiments, the injection management system 102 may determine an estimate of the viscosity of the medical fluid used in the power injection protocol based on the hydraulic capacitance of the medical fluid, for example, the hydraulic capacitance values of the contrast agent and / or saline involved in the power injection protocol.
[0135] 3, at step 306, the process 300 includes calculating a hydraulic resistance score. For example, the infusion management system 102 may calculate the hydraulic resistance score based on an estimate of the viscosity of the medical fluid, such as an estimate of the viscosity of the medical fluid and an estimate of the diameter of an orifice of a fluid path of the fluid infusion system 104 (e.g., a value of the diameter of an orifice of a fluid path of the fluid infusion system 104 when the medical fluid flowing through the orifice reaches a steady-state flow rate).
[0136] In some non-limiting embodiments, the infusion management system 102 may determine whether the characteristic ratio satisfies a threshold, and the infusion management system 102 may calculate a hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold. In some non-limiting embodiments, the infusion management system 102 may cancel the calculation of the hydraulic resistance score based on a determination that the characteristic ratio (e.g., the ratio of the steady-state characteristic of the saline to the steady-state characteristic of the contrast agent) does not satisfy a threshold. In some non-limiting embodiments, when determining whether the characteristic ratio satisfies a threshold, the infusion management system 102 may determine whether the characteristic ratio satisfies (e.g., is greater than or equal to) a threshold, for example, a threshold equal to 1.
[0137] In some non-limiting embodiments, the infusion management system 102 may calculate the hydraulic resistance score based on an estimate of the viscosity of the contrast agent. In some non-limiting embodiments, the infusion management system 102 may calculate the hydraulic resistance score based on at least one of the following values: a constant pressure (e.g., a constant pressure generated during the operation of filling the fluid path), an area of a force component of a pump of a powered fluid injector, a distance traveled by the force component of the pump during the operation of filling the fluid path, and / or a fill time of the fluid path.
[0138] 3, at step 308, the process 300 includes determining one or more motor controller gains for the motor of the powered fluid injector, for example, based on the hydraulic resistance score. Additionally or alternatively, the infusion management system 102 may determine one or more motor controller gains based on the hydraulic capacitance of the medical fluid involved in the power injection protocol.
[0139] In some non-limiting embodiments, the infusion management system 102 may implement one or more motor controller gains for a pump motor of a powered fluid injector. For example, the infusion management system 102 may schedule one or more motor controller gains and instruct the pump motor to operate according to one or more of the one or more motor controller gains.
[0140] FIG. 4 shows a diagram of a non-limiting embodiment of a powered fluid injector 400, such as the MEDRAD® Stellant FLEX CT injection system. In some non-limiting embodiments, the powered fluid injector 400 may be the same as or similar to the fluid injection system 104. The injector head unit 401 may include a housing 402 and at least one fluid reservoir 404, such as a syringe. In some non-limiting embodiments, the powered fluid injector 400 may include a drive component (e.g., a force component) for controlling fluid flow into and out of the fluid reservoirs 404, such as a piston associated with each of the syringes 404 that drives a plunger 406 within the barrel of the syringe 404, as shown in FIG. 4. In some non-limiting embodiments, each of the fluid reservoirs 404 is adapted to releasably interface with the housing 402 at a port 408. Each fluid reservoir 404 of the powered fluid injector 400 is configured to be filled with at least one medical fluid, such as an imaging contrast medium, saline, or the like. Each fluid reservoir 404 may be filled with a different medical fluid F. In some non-limiting embodiments, the powered fluid injector 400 may be a multi-syringe injector as shown, and several fluid reservoirs 404 may be oriented side-by-side or in another spatial relationship and are separately actuated by respective pistons associated with the powered fluid injector 400.
[0141] In some non-limiting embodiments, the powered fluid injector 400 may be used during a medical procedure to inject at least one medical fluid F into a patient's vascular system by driving a plunger 406 associated with a fluid reservoir 404 having a drive component. The drive component may move the plunger 406 to expel the fluid F from the fluid reservoir 404 into and through the fluid pathway set 412 during priming, purging, and / or fluid delivery steps. In some non-limiting embodiments, the fluid pathway set 412 may include at least one tube or tubing set configured to fluidly communicate with each fluid reservoir 404, placing each fluid reservoir 404 in fluid communication with a flexible administration tubing and associated catheter to deliver the fluid F from each fluid reservoir 404 to a vascular access site.
[0142] 5 shows a schematic diagram of a non-limiting embodiment of a powered fluid injector 500. Powered fluid injector 500 may include a housing 511 and one or more fluid reservoirs, such as syringes 512. Powered fluid injector 500 may include drive components for controlling fluid flow into and out of the fluid reservoirs, such as pistons 513 associated with each of syringes 512 that drive plungers 514 within the barrels of syringes 512. Each piston 513 may be independently driven by an associated fluid actuator 516, such as a linear actuator, a ball screw, a lead screw, a rack and pinion, a pump roller, or the like.
[0143] The description of the powered fluid injector 500 herein generally relates to an embodiment in which the fluid reservoir is a syringe 512 and the drive component for controlling fluid flow includes a piston 513 and a plunger 514 operably associated with the syringe 512. However, it should be understood that the present disclosure is not limited to such embodiments. In some non-limiting embodiments, the fluid injection system may include a fluid pump as the fluid reservoir and a pump roller as the drive component. In some non-limiting embodiments, a fluid injection system contemplated and encompassed by the present disclosure may include a bag as the fluid reservoir and a compression actuator configured to compress the bag as the drive component. Accordingly, references to a "syringe" herein should be understood to encompass any type of fluid reservoir, including syringes, fluid pumps, bags, etc. References herein to a "piston," "plunger," and "piston actuator" are similarly understood to encompass any device operably associated with a fluid reservoir and configured to control fluid flow into or out of the fluid reservoir. In particular, the term "fluid actuator" may be used herein to encompass one or more devices operatively associated with a fluid reservoir and configured to control fluid flow into or out of the fluid reservoir. Specific examples of "fluid actuator" as used herein include a piston actuator 516 configured to actuate a piston 513 within a syringe 512 by extending or retracting the piston 513, a pump rotor configured to actuate a fluid pump (e.g., a peristaltic pump) by compressing tubing associated with the fluid pump, and a compression actuator configured to compress and / or squeeze a bag.
[0144] In some non-limiting embodiments, the powered fluid injector 500 can be configured to deliver at least one medical fluid F, such as imaging contrast medium, saline, or any desired medical fluid, to a patient during an injection procedure. In some non-limiting embodiments, the syringes 512 of the powered fluid injector 500 can be configured to be filled with at least one medical fluid F. Each syringe 512 may be filled with a different medical fluid F. The powered fluid injector 500 may be a multi-syringe injector, as shown, where several syringes 512 may be oriented side-by-side or in another spatial relationship and are separately actuated by respective pistons associated with the powered fluid injector 500.
[0145] In some non-limiting embodiments, powered fluid injector 500 may be used during a medical procedure to inject at least one medical fluid F into a patient's vascular system by driving plungers 514 associated with syringes 512, each having a piston 513, as generally described for powered fluid injector 400 described herein. Powered fluid injector 500 may include a fluid pathway set 570 having at least one tube or tubing set configured in fluid communication with each syringe 512 to place the syringes 512 in fluid communication with an administration line 576. A distal end of administration line 576 may be configured in fluid communication with a catheter 578 configured for insertion into a vascular access site. Thus, fluid communication may be established between syringes 512 and a patient so that medical fluid F can be infused from syringe 512 into the patient. Fluid pathway set 570 may include at least one sensor 580, for example, located along the fluid path defined by fluid pathway set 570. At least one sensor 580 may be positioned in various other locations, such as in other fluid pathways of fluid pathway set 570, administration line 576, or regions of the length of catheter 578. Sensor 580 may be configured to detect one or more operating parameters of the fluid injection operation. In some non-limiting embodiments, sensor 580 may include an air sensor for detecting whether air is present in the fluid pathway.
[0146] 5, powered fluid injector 500 may include a controller 590 for controlling the actuation of piston 513 via piston actuator 516 and for controlling other components of powered fluid injector 500. In some non-limiting embodiments, controller 590 may be the same as or similar to infusion management system 102. In some embodiments, controller 590 may be housed within housing 511. In some embodiments, controller 590 may be mounted remotely from housing 511, such as in a separate room from housing 511, to avoid operator exposure to radiation during diagnostic procedures. In some embodiments, controller 590 may include multiple components (described herein), some of which are housed within housing 511 and some of which are mounted remotely from housing 511.
[0147] In some non-limiting embodiments, powered fluid injector 500 can be configured to perform one or more injection procedures according to one or more injection protocols stored in memory accessible by or programmed into controller 590. Prior to performing an injection procedure, air can be evacuated or purged from syringes 512 before connecting fluid pathway sets 576 to catheters 578. During a purge operation, pistons 513 can be extended to a distal-most position within corresponding syringes 512 so that air is forced out of syringes 512. Syringes 512 and other portions of fluid pathways 570 can then be filled. During a fill operation, pistons 513 can be retracted proximally to draw medical fluid F from bulk fluid source 520 into syringes 512, for example, via valves 502, 504. During a priming operation, powered fluid injector 500 may be oriented with the head (e.g., housing 511) of powered fluid injector 500 facing upward with syringe 512 positioned vertically, allowing air to accumulate at the distal end of syringe 512. Piston 513 may extend distally to push plunger 514 to remove air from syringe 512. Fluid pathway set 570 and administration line 576 may also be primed to remove air, for example, within prime tubing or bulk fluid source 520. Once the purging, filling, and priming operations are complete, administration line 576 may be connected to catheter 578 inserted into the patient, and the fluid infusion protocol may be initiated.
[0148] 5, powered fluid injector 500 may include user input devices 540 configured to enable manual control of pistons 513 and associated actuators 516. User input devices 540 may include electromechanical elements such as rotary knobs, rotary dials, levers, sliders, etc. In some embodiments, each user input device 540 may include a touchscreen or microphone configured to receive voice commands. In some embodiments, each user input device 540 may be associated with one of syringes 512. Each user input device 540 may be in electrical communication with controller 590 such that, upon receiving at least one signal from user input device 540, controller 590 actuates the associated piston 513 via the associated actuator 516.
[0149] In some non-limiting embodiments, user input devices 540 may be mounted or embedded anywhere on housing 511, such as on the back, side, or top of housing 511. In some embodiments, each user input device 540 may be mounted remotely from housing 511, such as in a separate room from housing 511, so that an operator can control piston 513 from a separate room that is not exposed to radiation during the performance of a diagnostic procedure. In some embodiments, each user input device 540 may be mounted or embedded in a scanner (e.g., a CT, CV, PET, or MRI imaging device) configured to perform a diagnostic imaging procedure on a patient.
[0150] 5, powered fluid injector 500 may include at least one user interface 524, such as a graphical user interface (GUI). User interface 524 may display information about the fluid injection procedure, such as the injection status or progress, the current flow rate, fluid pressure, and amount remaining in syringe 512 and bulk fluid source 520 connected to powered fluid injector 500, as well as whether the programmed injection protocol is determined to exceed the parameters of powered fluid injector 500 according to the processes described herein. User interface 524 may be in electronic communication with controller 590 to allow a user to input parameters and control the process of the fluid injection procedure.
[0151] Powered fluid injector 500 may further include valves 502, 504, 506 disposed at various positions along fluid pathway set 570. Each of valves 502, 504, 506 may be in the form of an isolation valve, stopcock, and / or flow control valve for regulating the flow of medical fluid F to the patient. Valves 502 and 504 may be provided in fluid pathway set 570 between syringe 512 and bulk fluid source 520. Valve 506 may be provided in fluid pathway set 570 downstream of valves 502 and 504. Each of valves 502, 504, 506 may be controllable by controller 590 or a user to regulate the flow of fluid F through fluid pathway set 570. For example, any or all of valves 502, 504, 506 may be closed by controller 590 in response to detection of air in fluid pathway set 570. During a fill operation, valves 502 and 504 may be actuated by controller 590 to provide fluid communication between syringe 512 and bulk fluid source 520 so that syringe 512 can draw medical fluid F from bulk fluid source 520. Valves 502 and 504 may isolate syringe 512 and bulk fluid source 520 from administration line 576 during the fill phase to prevent syringe 512 from drawing fluid and / or air from the atmosphere. Valves 502 and 504 may also be selectively closed by controller 590 to prevent backflow of pressurized medical fluid F from fluid pathway set 570 to syringe 512 due to differences in pressure and / or fluid viscosity between syringe 512 and fluid pathway set 570.
[0152] Further details and examples of suitable non-limiting power injector systems, including syringes, controllers, air detectors, and / or fluid path sets, are described in U.S. Pat. Nos. 5,383,858; 7,553,294; 7,666,169; 8,945,051; 10,022,493; and 10,507,319, the disclosures of which are incorporated herein by reference in their entireties.
[0153] A further example of a non-limiting embodiment of the present disclosure is described with respect to powered fluid injector 500 shown in FIG. 5. In the description herein, syringe 512 can refer to either syringe 512a or syringe 512b unless otherwise specified. FIG. 6 shows a diagram of a non-limiting embodiment of process flow 600, providing details regarding the first and second examples described below. Additionally, FIG. 7 shows a diagram of a non-limiting embodiment of a portion of FIG. 5, providing details regarding the first and second examples described below.
[0154] In the first example, a variable diameter valve as shown in FIG.
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[0155] The controller 590 can then gradually open the valve 506 to allow fluid flow while infusing a first fluid, such as saline. While the valve 506 is open, the controller 590 can measure the flow rate, for example, by recording changes in the count of an encoder or other flow measurement device associated with the motor over a time interval. When the flow rate remains the same as the diameter of the valve 506 gradually increases, this indicates that the valve 506 has exceeded the diameter of the catheter 578. The controller 590 can record the diameter of the valve 506 at which a steady-state flow rate of saline is detected.
[0156] Referring to a first example, the controller 590 may close the valve 506 and release pressure on the saline syringe 512a of the powered fluid injector 500. The controller 590 may move the plunger 514 of the second syringe 512b containing the contrast agent to generate a constant pressure (e.g., approximately 1-5 psi). The controller 590 may then open the valve 506 in small increments to allow the flow of the contrast agent. While the valve 506 is open, the controller 590 may measure the flow rate by recording the change in counts of an encoder associated with the motor over a time interval. As shown in the graph of FIG. 8A, the diameter of the valve 506
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[0157] Referring to the first example, the controller 590 can close the valve 506. The controller 590 can calculate the flow rate ratio of the steady-state flow rate of saline to the contrast agent and use the flow rate ratio to provide an estimate of the viscosity of the contrast agent. In some non-limiting embodiments, the controller 590 can determine the estimate of the viscosity of the contrast agent using a look-up table and / or an internal database that uses the flow rate ratio. If the flow rate ratio is equal to 1, the controller 590 can determine that the first syringe 512a and the second syringe 512b are loaded with the same medical fluid. If the flow rate ratio is less than 1, the controller 590 can determine that the first syringe 512a and the second syringe 512b are filled with the incorrect medical fluid (e.g., the contrast agent is contained in the first syringe 512a and the saline is contained in the second syringe 512b). In certain embodiments, the controller 590 may compare the estimate of the viscosity of the contrast agent to known contrast agent viscosities and known concentrations to determine the identity of the contrast agent being used in the injection protocol. In dual-flow protocols (i.e., where a programmed ratio of saline and contrast agent is mixed in the fluid lines and injected), the controller 590 may compare the estimate of the viscosity of the contrast agent to the known viscosity of the saline / contrast agent solution to determine whether the correct ratio is being injected.
[0158] Referring to a first example, in certain embodiments, controller 590 may calculate a hydraulic resistance score based on an estimate of the viscosity of the contrast agent and the diameter of valve 506 at which a steady-state flow rate of the contrast agent is detected. Controller 590 may then determine one or more motor controller gains for the motor of powered fluid injector 500. In some non-limiting embodiments, the one or more motor controller gains may be adjusted to preset values that are optimized based on the range of the hydraulic resistance score to achieve administration of a precise volume of contrast agent and saline during the injection protocol.
[0159] In some non-limiting embodiments, controlling the plunger 514 of the syringe 512 under constant pressure may also enable measurement of various viscoelastic properties of the fluid injection system, such as hydraulic capacitance (e.g., creep, stress relaxation, etc.). Hydraulic capacitance may refer to the tendency of elastic components, such as syringe walls, tubing walls, etc., to deform under constant applied stress. Additionally, hydraulic capacitance may be included as a component of hydraulic impedance, where elastic components tend to expand when a fluid path is pressurized under pressures ranging from 100 psi to 1200 psi. Due to the expanding elastic component, the volume of the fluid path containing the elastic component increases, which may require a change (e.g., an increase in amplitude) in the control signal sent to the motor of the powered fluid injector 500 to maintain constant pressure and achieve accurate fluid delivery. Thus, the operational suitability of the powered fluid injector 500 for a power injection protocol and the associated loss of accuracy may be restored based on the change in the control signal over a short period of time.
[0160] In a second example, the operation described with respect to the first example may be substantially the same, except that the controller 590 may move the plunger 514 of the syringe 512 to generate a constant flow rate. As shown in the graph of FIG. 8B, the diameter of the valve 506
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[0161] In a third example, a negative pressure differential may be used during a fill operation of syringe 512 to determine the fluid viscosity of the fill fluid. Referring to the third example, syringe 512 may be partially filled from bulk fluid source 520, and air may be purged from fluid path set 570. The fluid path of powered fluid injector 500 may be isolated from the system via valves 502, 504. Controller 590 may then retract plunger 514 via piston 513 so that a negative pressure differential is drawn on the fluid path of powered fluid injector 500. The force generated by piston 513 may be monitored, and controller 590 may stop movement of piston 513 when a steady-state force is reached. Controller 590 may record the velocity and steady-state force of piston 513. Controller 590 may relieve the negative pressure differential by returning piston 513 to its original starting position when the fluid path of powered fluid injector 500 is isolated. The controller 590 may open the fluid path to the bulk fluid source 520 via valve 502 or valve 504 and retract the plunger 514 to fill the remaining contents of the syringe 512. The controller 590 may record the velocity and steady-state fill force of the piston 513. The controller 590 may then calculate the pressure difference between the vacuum-fill steady state and the normal-fill steady state to determine the viscosity of the contrast agent. During the vacuum sequence, the fluid pressure may be known, which may be -14.7 psi at sea level; therefore, the vacuum force, which is the fluid pressure multiplied by the cross-sectional area of the plunger 514, plus any load generated by the piston 513 must equal the amount of force retracting the plunger 514 through the piston 513 at that velocity. The amount of force may be based on the friction plus resistance of the piston 513, as shown by Equation 6: F R (v p )=F vacuum +F friction +F resistance =(14.7*A p )+F friction +F resistance (Formula 6) where F R is the known velocity v p is the force that retracts the plunger 514, and Ap is the cross-sectional area of plunger 514, and F friction is the force associated with friction between the plunger 514 and the wall of the syringe 512, and F resistance is the resistance to filling due to the geometry of the tubing components, fluid viscosity, and the velocity of the piston 513. Equation 6 can be applied to both vacuum and fill sequences, and since no fluid is flowing into the syringe 512, F resistance is equal to 0 during the vacuum sequence, and F friction In addition to the benefit of estimating hydraulic resistance, if the measured friction is significantly less than expected, this may indicate an undesirable situation, e.g., a manufacturing problem, and / or the user is attempting to reuse the syringe beyond recommended limits. During subsequent filling sequences, the known F friction Using F resistance Equation 6 can be used to calculate F resistance Comparing the calculated value of with this pressure drop calibration at a viscosity of 1 cP allows an estimate of the viscosity of the contrast agent to be determined. The accuracy of the delivered volume of fluid during a fluid injection protocol can then be corrected and optimized, as described herein. The measured pressure drop difference between saline and a 20 cP contrast agent is approximately 5 psi.
[0162] In a fourth example, determining the viscosity estimate may be performed during the fill operation of syringe 512. In this manner, the need to flow contrast agent through the patient while determining an estimate of the viscosity of the contrast agent may be alleviated. The measured force on plunger 514 during the fill sequence of syringe 512 is the friction force between plunger 514 and the wall of syringe 512 and the pressure difference across plunger 514, as shown in Equation 7. F Fill =F plunger friction +F FillΔP (Formula 7) Surface kinetic friction is not a function of velocity to first order, but can be considered a constant at multiple flow rates during the filling operation of syringe 512. Assuming the atmospheric pressure is the same inside syringe 512 and behind plunger 514, the pressure difference across plunger 514 can be modeled by the Hagen-Poiseuille equation, and the applied force is the product of this pressure difference and the plunger projected area A, as shown in Equation 8: plunger is equivalent to multiplying
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[0163] Known lengths L, fill tube inner diameter D, and plunger projected area A of the tubing components involved in the filling sequence plunger With constant viscosity and plunger friction, Equation 8 yields a linear relationship between fill plunger force and fill flow rate. The y-intercept of this line can be the plunger friction force, and the slope of this line has all known constants except viscosity. By filling syringe 512 at multiple flow rates and measuring the fill force, multiple plots of lines representing plunger force versus fill flow rate can be generated. All of these calculations are performed by controller 590, and the results can be displayed or used in further algorithmic calculations. FIG. 9 shows a diagram of a non-limiting embodiment of multiple plots of lines representing plunger force versus fill flow rate for values of contrast agent viscosity μ. A linear regression of the plunger force and flow rate plot shown in FIG. 9 can provide a slope that can be used to determine an estimate of the contrast agent's viscosity. While the example reflects laminar flow, the example may be extended to nonlinear and / or transient and / or non-laminar (e.g., turbulent) flows.
[0164] In a fifth example, one or more sensors (e.g., air sensors) to detect total air may be used to determine an estimate of the viscosity of the contrast agent. In one example, two sensors may be used with powered fluid injector 500. A first air sensor may be located near the distal end of syringe 512, and a second air sensor may be located distal to the fluid path (e.g., at or near valve 506). The flow rate j from the syringe at time i is
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[0165] Referring to a fifth example, an empty syringe 512 may be placed in the powered fluid injector 500, and then a second syringe 512b may be filled with contrast media. The controller 590 may close the valve 506 and open the valves 502 and 504. The controller 590 may actuate the plunger 514 of the second syringe 512b to cause fluid to flow toward the first syringe 512a. The controller 590 may determine an amount of time to fill a volume of the fluid path between the second syringe 512b and the first syringe 512a at a known flow rate. The controller 590 may determine an estimate of the viscosity of the contrast media based on the amount of time to fill the volume of the fluid path. For example, a priming operation of the powered fluid injector 500 may be performed to remove contrast media and air from the saline fluid path.
[0166] In a sixth example, a nonlinear pressure waveform may be used to generate an effect on a fluid. The effect may include transitioning the fluid flow from laminar to turbulent flow. In this way, the flow rate at the turbulent transition is related to the fluid viscosity. Turbulence may be detected using a sensor such as an accelerometer to measure vibrations. A sudden change in the fluid velocity vector is acceleration and may be used to identify the inflection point between turbulent and laminar flow on the pressure-flow curve. Equation 4 identifies inertial hydraulic drag due to changes in cross section, which may accelerate the fluid so that the accelerometer can measure acceleration. The effect may further include inducing fluid cavitation to generate detectable bubbles. The pressure or flow rate at which cavitation occurs depends on the viscosity of the fluid. The effect may further include shearing existing bubbles and using the flow rate and air detection signal to determine an estimate of viscosity. The flow rate at which bubbles shear within the fluid depends on the viscosity of the fluid. The effect may further include causing the onset and persistence of turbulence with increasing flow rate.
[0167] In a seventh example, an active fluid control component may be used to determine an estimate of the viscosity of a contrast agent. Active fluid control components may be desirable because they allow for a variety of combinations of plunger and fluid control movements. For example, a stopcock may be opened and closed under various pressure waveforms, including linear, polynomial, exponential, and step relationships between position and time. The time it takes for fluid to exit the active fluid control component to release pressure can then be measured and related to the viscosity of the fluid.
[0168] While the present disclosure has been described in detail for purposes of explanation based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for that purpose only and that the disclosure is not limited to the disclosed embodiments, 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]
[0169] 100 Environment 102 Infusion Management System 104 Fluid Injection System 108 Remote Support System 110 Communication Network 200 devices 202 Bus 204 processors 206 memory 208 Memory Components 210 Input Components 212 Output Components 214 Communication Interface 300 processes 400 Powered Fluid Injector 401 Injector Head Unit 402 Housing 404 Fluid reservoir, syringe 406 Plunger 408 port 412 Fluid Path Set 500 Powered Fluid Injector 502 Valve 504 Valve 506 Valve 511 Housing 512 Syringe 512a First syringe 512b Second Syringe 513 Piston 514 Plunger 516 Actuator 520 Bulk Fluid Source 524 User Interface 540 User Input Devices 570 Fluid Path Set 576 Administration Line 578 Catheter 580 Sensors 590 Controller 600 Process Flow
Claims
1. 1. A method for controlling a fluid injection system, comprising: determining, with at least one processor, at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol associated with a medical fluid involved in the power injection protocol, the determining the at least one characteristic of the power injection protocol comprising: determining steady-state characteristics of saline flowing through an orifice in a fluid path of the powered fluid injector; determining steady state characteristics of the contrast agent flowing through the orifice; calculating a characteristic ratio, said characteristic ratio being a ratio of the steady state characteristic of saline to the steady state characteristic of the contrast agent; Including, The method comprises: determining, with the at least one processor, an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculating, with the at least one processor, a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; determining, with the at least one processor, one or more motor controller gains for a motor of the powered fluid injector in the power injection protocol based on the hydraulic resistance score; A method comprising:
2. The step of determining the estimated viscosity of the medical fluid, comprising: determining an estimate of the viscosity of the contrast agent based on the characteristic ratio; Including, The step of calculating the hydraulic resistance score comprises: calculating the hydraulic resistance score based on the estimate of the viscosity of the contrast agent; Including, The method of claim 1.
3. 3. The method of claim 1 or 2, further comprising implementing the one or more motor controller gains in the motor of the powered fluid injector.
4. 4. The method of claim 1, wherein the motor is a motor of a pump of the powered fluid injector, the pump of the powered fluid injector comprising a piston or peristaltic pump configured to drive a plunger of a syringe.
5. further comprising determining whether the characteristic ratio satisfies a threshold; calculating the hydraulic resistance score includes calculating the hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold value.
5. The method according to any one of claims 1 to 4.
6. The method of claim 5 , wherein determining whether the characteristic ratio satisfies the threshold comprises determining whether the characteristic ratio satisfies a threshold equal to one.
7. the steady-state characteristic of saline flowing through the orifice comprises a steady-state flow rate of saline flowing through the orifice based on a constant pressure of saline; the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent; the characteristic ratio includes a flow rate ratio, the flow rate ratio being a ratio of the steady-state flow rate of saline to the steady-state flow rate of the contrast agent; calculating the characteristic ratio includes calculating the flow ratio based on the steady-state flow rate of saline and the steady-state flow rate of the contrast agent; 7. The method according to any one of claims 1 to 6.
8. the steady-state characteristics of saline flowing through the orifice include a steady-state pressure of saline flowing through the orifice based on a constant flow rate of saline; the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent; the characteristic ratio includes a pressure ratio, the pressure ratio being a ratio of the steady-state pressure of saline to the steady-state pressure of the contrast agent; calculating the characteristic ratio includes calculating the pressure ratio based on the steady-state pressure of saline and the steady-state pressure of the contrast agent; 8. The method according to any one of claims 1 to 7.
9. determining a value of hydraulic capacitance of the medical fluid involved in the power injection protocol; determining the motor controller gain includes determining the motor controller gain based on the value of hydraulic capacitance of the medical fluid involved in the power injection protocol.
9. The method according to any one of claims 1 to 8.
10. determining the at least one characteristic of the power injection protocol; determining a first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, the power injection protocol being blocked from receiving the medical fluid in a fluid reservoir when the power injection protocol is in the vacuum-fill state; determining a second pressure of the power injection protocol when the power injection protocol is in a normal fill state, the power injection protocol being open to receiving medical fluid in the fluid reservoir when the power injection protocol is in the normal fill state; calculating a pressure difference of the power injection protocol between the vacuum fill state and the normal fill state based on the first pressure of the power injection protocol and the second pressure of the power injection protocol; Including, determining the estimated viscosity of the medical fluid includes determining the estimated viscosity of the medical fluid based on the pressure differential of the power injection protocol between the vacuum fill condition and the normal fill condition; The method of claim 1.
11. determining the first pressure of the power injection protocol when the power injection protocol is in the vacuum fill state; determining a steady state force exerted on a force component of a pump when the power injection protocol is in the vacuum fill state; determining a rate of movement of the force component of the pump when the power injection protocol is in the vacuum fill state; 11. The method of claim 10, comprising:
12. determining the second pressure of the power injection protocol when the power injection protocol is in the normal fill state; determining a steady state force exerted on a force component of the pump when the power injection protocol is in the normal fill state; determining a rate of movement of the force component of the pump when the power injection protocol is in the normal fill state; 12. The method of claim 11, comprising:
13. determining the at least one characteristic of the power injection protocol; determining a force exerted on a force component of a pump during each of a plurality of filling operations of a fluid reservoir, the each filling operation of the fluid reservoir including an operation performed to fill the fluid reservoir with a medical fluid; determining a fill flow rate of the medical fluid through an orifice during each of the plurality of fill operations of the fluid reservoir; Including, determining the estimated viscosity of the medical fluid includes determining the estimated viscosity of the medical fluid based on the force exerted on the force component of the pump during each of the plurality of filling operations of the fluid reservoir and the fill flow rate through the orifice during each of the plurality of filling operations of the fluid reservoir; The method of claim 1.
14. determining the force exerted on the force component of the pump during each of a plurality of filling operations of a fluid reservoir, determining the force exerted on the force component of the pump during each of the plurality of filling operations of the fluid reservoir based on at least one of an amount of friction between the force component of the pump and a wall of the fluid reservoir, an area of the force component of the pump, a length of a tubing component through which the medical fluid flows to the fluid reservoir, and a diameter of the tubing component through which the medical fluid flows to the fluid reservoir.
14. The method of claim 13, comprising:
15. performing a linear regression calculation based on the force exerted on the force component of the pump during each filling operation of the fluid reservoir among the plurality of filling operations of the fluid reservoir and the fill flow rate of the medical fluid through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir; determining the estimate of the viscosity of the medical fluid includes determining the estimate of the viscosity of the medical fluid based on the linear regression calculation; 15. The method of claim 13 or 14.
16. determining the at least one characteristic of the power injection protocol; controlling a force component of a pump of the powered fluid injector to perform an operation to fill a fluid path; determining a fill time of the fluid pathway, the fill time of the fluid pathway comprising an amount of time a volume of the fluid pathway is filled with the medical fluid; Including, determining the estimate of the viscosity of the medical fluid includes determining the estimate of the viscosity of the medical fluid based on the fill time of the fluid path; The method of claim 1.
17. controlling the force component of the pump of the powered fluid injector to fill the fluid path comprises controlling the force component of the pump of the powered fluid injector to generate a constant pressure during the operation of filling the fluid path; calculating the hydraulic resistance score includes calculating the hydraulic resistance score based on at least one value of the constant pressure, an area of the force component of the pump, a distance traveled by the force component of the pump during the operation of filling the fluid path, and a fill time of the fluid path.
17. The method of claim 16.
18. determining the at least one characteristic of the power injection protocol; controlling a force component of a pump of the powered fluid injector to provide a fluid flow of the medical fluid into a lumen of a tubing component of the fluid injection system; controlling the force component of the pump of the powered fluid injector to modify at least one condition of fluid flow of the medical fluid within the lumen of the tubing component; detecting a characteristic associated with altering the at least one condition of fluid flow of the medical fluid within the lumen of the tubing component; Including, determining the estimate of viscosity of the medical fluid includes determining the estimate of viscosity of the medical fluid based on the characteristic associated with altering the at least one condition of fluid flow of the medical fluid within the lumen of the tubing component; The method of claim 1.
19. controlling the force component of the pump of the powered fluid injector to provide a fluid flow of fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to provide a laminar flow of fluid within the lumen of the tubing component; controlling the force component of the pump of the powered fluid injector to change the at least one condition of fluid flow of the medical fluid within the lumen of the tubing component includes controlling the force component of the pump of the powered fluid injector to transition from laminar fluid flow within the lumen of the tubing component to turbulent fluid flow within the lumen of the tubing component.
19. The method of claim 18.
20. 20. The method of claim 18 or 19, wherein controlling the force component of the pump of the powered fluid injector to alter the at least one condition of fluid flow of the medical fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to induce cavitation in the medical fluid.
21. 21. The method of claim 18, wherein controlling the force component of the pump of the powered fluid injector to change the at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to shear one or more air bubbles present in the medical fluid.
22. 22. The method of any one of claims 18 to 21, wherein controlling the force component of the pump of the powered fluid injector to alter the at least one condition of fluid flow of the medical fluid within the lumen of the tubing component comprises controlling the force component of the pump of the powered fluid injector to generate turbulence in the medical fluid.
23. determining the at least one characteristic of the power injection protocol includes determining a time interval during which fluid flows from a high pressure side of an actuation fluid control component to a low pressure side of the actuation fluid control component; determining the estimate of viscosity of the medical fluid includes determining the estimate of viscosity of the medical fluid based on the time interval; The method of claim 1.
24. 1. A system for controlling a fluid injection system comprising at least one processor, the at least one processor comprising: a power injection protocol control unit configured to determine at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol being associated with a medical fluid involved in the power injection protocol; When determining the at least one characteristic of the power injection protocol, the at least one processor: determining steady-state characteristics of saline flowing through an orifice in a fluid path of the powered fluid injector; determining steady-state characteristics of the contrast agent flowing through the orifice; and calculating a characteristic ratio, the characteristic ratio being a ratio of the steady-state characteristic of saline to the steady-state characteristic of the contrast agent; The at least one processor: determining an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculating a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; determining one or more motor controller gains for a motor of the powered fluid injector in the power injection protocol based on the hydraulic resistance score; A system that is programmed or configured to:
25. The method of claim 25, wherein when determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine an estimate of the viscosity of the contrast agent based on the characteristic ratio; When calculating the hydraulic resistance score, the at least one processor is programmed or configured to calculate the hydraulic resistance score based on the estimated viscosity of the contrast agent.
25. The system of claim 24.
26. 26. The system of claim 24 or 25, wherein the at least one processor is further programmed or configured to implement the one or more motor controller gains in the motor of the powered fluid injector.
27. the at least one processor is further programmed or configured to determine whether the characteristic ratio satisfies a threshold; When calculating the hydraulic resistance score, the at least one processor is programmed or configured to calculate the hydraulic resistance score based on a determination that the characteristic ratio satisfies the threshold value.
27. A system according to any one of claims 24 to 26.
28. the steady-state characteristic of saline flowing through the orifice comprises a steady-state flow rate of saline flowing through the orifice based on a constant pressure of saline; the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state flow rate of the contrast agent flowing through the orifice based on a constant pressure of the contrast agent; the characteristic ratio includes a flow rate ratio, the flow rate ratio being a ratio of the steady-state flow rate of saline to the steady-state flow rate of the contrast agent; When calculating the characteristic ratio, the at least one processor is programmed or configured to calculate the flow ratio based on the steady-state flow rate of saline and the steady-state flow rate of the contrast agent.
28. A system according to any one of claims 24 to 27.
29. the steady-state characteristics of saline flowing through the orifice include a steady-state pressure of saline flowing through the orifice based on a constant flow rate of saline; the steady-state characteristics of the contrast agent flowing through the orifice include a steady-state pressure of the contrast agent flowing through the orifice based on a constant flow rate of the contrast agent; the characteristic ratio includes a pressure ratio, the pressure ratio being a ratio of the steady-state pressure of saline to the steady-state pressure of the contrast agent; When calculating the characteristic ratio, the at least one processor is programmed or configured to calculate the pressure ratio based on the steady-state pressure of saline and the steady-state pressure of the contrast agent.
29. A system according to any one of claims 24 to 28.
30. the at least one processor is further programmed or configured to determine a hydraulic capacitance value of the medical fluid involved in the power injection protocol; When determining the motor controller gain, the at least one processor is programmed or configured to determine the motor controller gain based on the value of hydraulic capacitance of the medical fluid involved in the power injection protocol.
30. A system according to any one of claims 24 to 29.
31. When determining the at least one characteristic of the power injection protocol, the at least one processor: determining a first pressure of the power injection protocol when the power injection protocol is in a vacuum-fill state, and blocking the power injection protocol from receiving the medical fluid in a fluid reservoir when the power injection protocol is in the vacuum-fill state; determining a second pressure of the power injection protocol when the power injection protocol is in a normal fill state, the power injection protocol being open to receiving medical fluid in the fluid reservoir when the power injection protocol is in the normal fill state; calculating a pressure difference of the power injection protocol between the vacuum fill state and the normal fill state based on the first pressure of the power injection protocol and the second pressure of the power injection protocol; programmed or configured to When determining the estimated value of viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimated value of viscosity of the medical fluid based on the pressure difference of the power injection protocol between the vacuum fill state and the normal fill state.
25. The system of claim 24.
32. When determining the at least one characteristic of the power injection protocol, the at least one processor: determining a force exerted on a force component of the pump during each of a plurality of filling operations of the fluid reservoir, the each filling operation of the fluid reservoir including an operation performed to fill the fluid reservoir with medical fluid; determining a fill flow rate of the medical fluid through an orifice during each of the plurality of fill operations of the fluid reservoir; programmed or configured to When determining the estimated value of viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimated value of viscosity of the medical fluid based on the force exerted on the force component of the pump during each filling operation of the plurality of filling operations of the fluid reservoir and the fill flow rate through the orifice during each filling operation of the plurality of filling operations of the fluid reservoir.
25. The system of claim 24.
33. When determining the at least one characteristic of the power injection protocol, the at least one processor: controlling a force component of a pump of the powered fluid injector to perform an operation to fill a fluid path; and determining a fill time of the fluid pathway, the fill time of the fluid pathway comprising an amount of time a volume of the fluid pathway is filled with the medical fluid; When determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimate of the viscosity of the medical fluid based on the fill time of the fluid path.
25. The system of claim 24.
34. upon determining the at least one characteristic of the power injection protocol, the at least one processor controls a force component of a pump of the powered fluid injector to provide a fluid flow of the medical fluid within a lumen of a tubing component of the fluid injection system; controlling the force component of the pump of the powered fluid injector to modify at least one condition of fluid flow of the medical fluid within the lumen of the tubing component; detecting a characteristic associated with altering the at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component; programmed or configured to When determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimate of the viscosity of the medical fluid based on the characteristic associated with altering the at least one condition of the fluid flow of the medical fluid within the lumen of the tubing component.
25. The system of claim 24.
35. when determining the at least one characteristic of the power injection protocol, the at least one processor is programmed or configured to determine a time interval during which fluid flows from a high pressure side of an actuating fluid control component to a low pressure side of the actuating fluid control component; When determining the estimate of the viscosity of the medical fluid, the at least one processor is programmed or configured to determine the estimate of the viscosity of the medical fluid based on the time interval.
25. The system of claim 24.
36. 1. A computer program product for controlling a fluid injection system, the computer program product comprising at least one non-transitory computer-readable medium comprising one or more instructions that, when executed by at least one processor, cause the at least one processor to: The one or more instructions for causing the at least one processor to determine at least one characteristic of a power injection protocol, the at least one characteristic of the power injection protocol being associated with a medical fluid involved in the power injection protocol, may include causing the at least one processor to: determining steady-state characteristics of saline flowing through an orifice in a fluid path of the powered fluid injector; determining steady-state characteristics of the contrast agent flowing through the orifice; calculating a characteristic ratio, said characteristic ratio being a ratio of said steady state characteristic of saline to said steady state characteristic of said contrast agent; the one or more instructions causing the at least one processor to determine an estimate of the viscosity of the medical fluid based on the at least one characteristic of the power injection protocol; calculating a hydraulic resistance score based on the estimate of the viscosity of the medical fluid; determining one or more motor controller gains for a motor of the powered fluid injector in the power injection protocol based on the hydraulic resistance score; Computer program products.
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