System and method for contrast-enhanced imaging with low contrast agent doses

Abstract

A system for providing a medical procedure plan comprises a fluid injector and at least one processor configured to select a specific dose of contrast agent from a plurality of doses of contrast agent to be administered by the fluid infusion system during an infusion procedure to a patient, to automatically execute an infusion protocol for the infusion procedure based on the selection of a specific dose of contrast agent from a plurality of doses of contrast agent, the infusion protocol includes a specific dose, to generate images of a region of the patient's body based on the automatic execution of the infusion protocol, to generate image analysis results of the images of the region of the patient's body, and to determine whether the image analysis results meet an image quality threshold. Methods, fluid injectors, and their components are also disclosed.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 512,899, filed Jul. 10, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to devices, systems, and methods for delivering contrast agents to patients and for use in medical imaging procedures, and more particularly to devices, systems, and methods for delivering accurate and / or small amounts of contrast agent and / or standard amounts of contrast agent to enhance images during medical imaging procedures.

Background Art

[0003] Infusion systems, such as fluid infusion systems (e.g., medical fluid delivery systems), can be used by medical personnel in medical diagnostic procedures and / or medical treatment procedures, or in medical procedures including both. For example, a medical professional can use a fluid infusion system to inject one or more medical fluids into a patient. Fluid infusion systems can be used for the pressure infusion of medical fluids, such as radiographic contrast materials (e.g., contrast agents), and / or flushing agents, such as saline (e.g., normal saline, 0.9% normal saline), in medical imaging procedures, such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), single photon emission computed tomography (SPECT), and hybrid imaging techniques such as SPECT / CT, PET / CT, and PET / MRI. Fluid infusion systems can also be used to deliver medical fluids or liquid medications to a patient during other procedures and / or treatments, including nuclear medicine imaging, molecular imaging, radiopharmaceutical injection, cardiovascular local treatment, and image-guided radiation therapy, such as MRI-guided linear accelerator (MR / LINAC). In some cases, a fluid infusion system is designed to deliver a fixed amount of medical fluid to a patient at one or more flow rates.

[0004] In medical treatment or procedures, the amount of medical fluid delivered to a patient may be measured in volume. In some cases, precise dose measurement may be performed on the patient for proper imaging, appropriate treatment, and / or to avoid adverse reactions, including complications to the patient's health. Furthermore, to avoid such adverse reactions, a partial dose (e.g., a micro-partial dose) of the medical fluid may be administered to the patient during the procedure.

[0005] However, research protocols, including medical fluid administration protocols and / or imaging protocols, are complex and therefore difficult for users to track and implement during medical fluid infusion and imaging procedures, including enhanced imaging procedures. Furthermore, fluid infusion systems may include larger injectors with larger volume syringes that do not provide adequate volume control or precise measurement of accurate doses of medical fluid for delivery to the patient during enhanced imaging procedures. Specifically, fluid infusion systems may enable partial dose (e.g., micro-partial dose) administration, but may be limited to such partial doses and do not provide the ability to deliver standard doses of medical fluid that may be required during enhanced imaging procedures. [Overview of the project] [Problems that the invention aims to solve]

[0006] In light of the above, there is a need for devices, systems, and methods for delivering precise (e.g., partial and / or standard) volumes of medical fluids, such as contrast agents, and for enhancing images during medical imaging procedures based on the delivery of precise volumes of medical fluids. [Means for solving the problem]

[0007] Accordingly, aspects of the present disclosure relate to non-limiting embodiments of devices, systems, and methods for delivering precise and / or small amounts of contrast agent and / or standard amounts of contrast agent during medical imaging procedures to enhance images during medical imaging procedures.

[0008] Further non-limiting embodiments or aspects are described in the following numbered clauses.

[0009] Section 1: A method for performing an injection procedure, comprising: using at least one processor to select a specific dose of contrast fluid from a plurality of doses of contrast fluid to be administered to a patient during the injection procedure; using at least one processor to automatically execute an injection protocol for the injection procedure based on the selection of a specific dose of contrast fluid from a plurality of doses of contrast fluid, wherein the injection protocol includes the specific dose; using at least one processor to generate an image of a region of the patient's body based on the automatic execution of the injection protocol; using at least one processor to generate an image analysis result of the image of the region of the patient's body; and using at least one processor to determine whether the image analysis result meets an image quality threshold.

[0010] The method according to paragraph 1, further comprising the steps of: automatically executing an additional injection protocol for an injection procedure based on the determination that the image analysis results do not meet an image quality threshold; generating additional image analysis results for images of a region of the patient's body; and determining whether the additional image analysis results meet an image quality threshold.

[0011] Paragraph 3: The method according to Paragraph 1 or 2, wherein the step of selecting a specific dose of contrast fluid from a plurality of doses of contrast fluid to be administered to a patient during an infusion procedure includes the step of determining whether to administer a standard dose of contrast fluid or a partial dose of contrast fluid to the patient during the infusion procedure.

[0012] Section 4: The method according to any one of Sections 1 to 3, comprising the step of automatically executing an infusion protocol for an infusion procedure, based on a decision to administer a partial dose of contrast fluid to a patient during an infusion procedure, wherein the infusion protocol includes a partial dose.

[0013] Section 5: The method according to any one of sections 1 to 4, wherein the step of automatically performing an infusion protocol for an infusion procedure includes the step of controlling a partial-dose fluid infusion component to administer a partial dose of contrast fluid to a patient during the infusion procedure.

[0014] Paragraph 6: The method according to any one of paragraphs 1 to 5, wherein the step of selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure includes the step of automatically selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure based on the results of inference by a machine learning model.

[0015] Paragraph 7: The method according to any one of paragraphs 1 to 6, comprising the steps of: automatically selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, providing input to a machine learning model based on a request for inference of the machine learning model, the input comprising a plurality of features, the plurality of features comprising at least one of the patient's weight, patient's height, patient's age, patient's sex, patient's body type, patient's medical history, patient's physiological status, patient's physiological measurements, or any combination thereof; and generating an output of the machine learning model based on the input, the output comprising a prediction of the dose of contrast fluid to be administered to the patient during an infusion procedure.

[0016] Section 8: A system for providing a medical procedure plan, comprising: a fluid injector; and at least one processor coupled to the fluid injector, configured to select a specific dose of contrast fluid from a plurality of doses of contrast fluid to be administered by the fluid infusion system during an infusion procedure to a patient, to automatically execute an infusion protocol for an infusion procedure based on the selection of a specific dose of contrast fluid from a plurality of doses of contrast fluid, the infusion protocol includes a specific dose, to generate images of a region of the patient's body based on the automatic execution of the infusion protocol, to generate image analysis results of the images of the region of the patient's body, and to determine whether the image analysis results meet an image quality threshold.

[0017] Clause 9: The system as described in Clause 8, wherein at least one processor is further programmed or configured to automatically execute an additional injection protocol for an injection procedure based on a determination that the image analysis results do not meet the image quality threshold, generate additional image analysis results for images of a region of the patient's body, and determine whether the additional image analysis results meet the image quality threshold.

[0018] Paragraph 10: The system according to either Paragraph 8 or 9, wherein, when selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor is further programmed or configured to determine whether to administer a standard dose of contrast fluid or a partial dose of contrast fluid during the infusion procedure to the patient.

[0019] Paragraph 11: The system according to any one of paragraphs 8 to 10, wherein, when an infusion protocol for an infusion procedure is automatically executed, at least one processor is further programmed or configured to automatically execute the infusion protocol for an infusion procedure based on a decision to administer a partial dose of contrast fluid to a patient during the infusion procedure, and the infusion protocol includes a partial dose.

[0020] Paragraph 12: The system according to any one of paragraphs 8 to 11, wherein, when automatically executing an infusion protocol for an infusion procedure, at least one processor is further programmed or configured to control a partial-dose fluid infusion component to administer a partial dose of contrast fluid to a patient during the infusion procedure.

[0021] Paragraph 13: The system according to any one of paragraphs 8 to 12, wherein, when selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor is further programmed or configured to automatically select a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, based on the results of inference by a machine learning model.

[0022] Paragraph 14: The system according to any one of paragraphs 8 to 13, wherein, when automatically selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor provides input to a machine learning model based on a request for inference of the machine learning model, the input comprising multiple features, the multiple features comprising at least one of the following: patient weight, patient height, patient age, patient sex, patient body type, patient medical history, patient physiological status, patient physiological measurements, or any combination thereof, and generates an output of the machine learning model based on the input, the output being further programmed or configured to include a prediction of the dose of contrast fluid to be administered to the patient during the infusion procedure.

[0023] Section 15: A fluid infusion system for providing a medical procedure plan, comprising: a fluid injector comprising a partial-dose fluid infusion component and a standard-dose fluid infusion component; and at least one processor coupled to the fluid injector, configured to determine during an infusion procedure to a patient whether to administer a standard dose of contrast fluid by the standard-dose fluid infusion component or a partial dose of contrast fluid by the partial-dose fluid infusion component; to automatically execute an infusion protocol for an infusion procedure based on the determination of one of administering a partial dose of contrast fluid by the partial-dose fluid infusion component and administering a standard dose of contrast fluid by the standard-dose fluid infusion component during an infusion procedure to a patient; to generate images of a region of the patient's body based on the automatic execution of the infusion protocol; to generate image analysis results of the images of the region of the patient's body; and to determine whether the image analysis results meet an image quality threshold.

[0024] Section 16: The fluid injection system according to Section 15, wherein the partial-dose fluid injection component comprises a partial-dose fluid injection pump, and at least one processor is configured to operate the partial-dose fluid injection pump when automatically executing an injection protocol for an injection procedure.

[0025] Clause 17: The fluid injection system according to Clause 15 or 16, wherein, when operating a partial-dose fluid injection pump, at least one processor is configured to receive fluid flow data from a sensor, determine the fluid flow rate in a fluid path based on the fluid flow data received from the sensor, and output a control signal to the partial-dose fluid injection pump.

[0026] Item 18: When operating the partial-dose fluid injection pump, at least one processor receives fluid data including an indication from the sensor as to whether air is present in the fluid path, determines whether a threshold amount of air is present in the fluid path based on the fluid data received from the sensor, and is configured to output a control signal to the partial-dose fluid injection pump based on determining that air is present in the fluid path, the fluid injection system according to any one of Items 15 to 17.

[0027] Item 19: When operating the partial-dose fluid injection pump, at least one processor receives contrast fluid concentration data from the sensor, determines the concentration of the contrast fluid in the fluid path based on the contrast fluid concentration data received from the sensor, and is configured to output a control signal to the partial-dose fluid injection pump, the fluid injection system according to any one of Items 15 to 18.

[0028] Item 20: The fluid injector includes at least one fluid injection pump, at least one fluid source, and a first tube set having at least one valve assembly, the at least one valve assembly being configured to selectively provide a fluid connection between at least one fluid source and the first tube set, between the first tube set and at least one fluid injection pump, or between at least one fluid source, the first tube set, and at least one fluid injection pump, the fluid injection system according to any one of Items 15 to 19.

[0029] Item 21: The first tube set includes a connector member configured to connect to a second tube set, the second tube set being connected to a catheter configured to be fluid-connected to a patient, and the at least one valve assembly being configured to selectively provide a fluid connection between the first tube set and the second tube set, the fluid injection system according to any one of Items 15 to 20.

[0030] Section 22: A fluid injector comprising two or more fluid infusion pumps and two or more fluid sources, each of the two or more fluid infusion pumps comprising a reservoir, a plunger and a drive member, wherein at least one processor is configured to receive infusion protocol data relating to an infusion protocol for an infusion procedure, determine control parameters for the drive member based on the infusion protocol data, and output a control signal to the drive member to actuate the drive member and deliver a selected dose of contrast fluid to the patient, the control signal being based on the control parameters, as described in any one of sections 15 to 21.

[0031] Paragraph 23: A fluid injector comprising two or more fluid infusion pumps and two or more fluid sources, each of the two or more fluid infusion pumps comprising a tube, a rotating member and a drive member, wherein at least one processor is configured to receive infusion protocol data relating to an infusion protocol for an infusion procedure, determine control parameters for the drive member based on the infusion protocol data, and output a control signal to the drive member to actuate the drive member to deliver a selected dose of contrast fluid to the patient, the control signal being based on the control parameters, as described in any one of paragraphs 15 to 22.

[0032] Paragraph 24: The fluid infusion system according to any one of paragraphs 15 to 23, wherein at least one processor is further programmed or configured to automatically execute an additional infusion protocol for an infusion procedure based on a determination that the image analysis results do not meet an image quality threshold, generate additional image analysis results for a region of the patient's body, and determine whether the additional image analysis results meet an image quality threshold.

[0033] Paragraph 25: A fluid infusion system according to any one of paragraphs 15 to 24, wherein, when selecting a specific dose of contrast fluid from a plurality of doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor is further programmed or configured to determine whether to administer a standard dose of contrast fluid or a partial dose of contrast fluid during the infusion procedure to the patient.

[0034] Paragraph 26: A fluid infusion system according to any one of paragraphs 15 to 25, wherein at least one processor is further programmed or configured to automatically execute an infusion protocol for an infusion procedure based on a decision to administer a partial dose of contrast fluid to a patient during the infusion procedure, and the infusion protocol includes a partial dose.

[0035] Paragraph 27: The fluid infusion system according to any one of paragraphs 15 to 26, wherein, when automatically executing an infusion protocol for an infusion procedure, at least one processor is further programmed or configured to control a partial-dose fluid infusion component to administer a partial dose of contrast fluid to a patient during the infusion procedure.

[0036] Paragraph 28: The fluid infusion system according to any one of paragraphs 15 to 27, wherein, when selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor is further programmed or configured to automatically select a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, based on the results of inference by a machine learning model.

[0037] Paragraph 29: A fluid infusion system according to any one of paragraphs 15 to 28, wherein, when automatically selecting a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, at least one processor provides input to a machine learning model based on a request for inference of the machine learning model, the input comprising multiple features, the multiple features comprising at least one of the following: patient weight, patient height, patient age, patient sex, patient body type, patient medical history, patient physiological status, patient physiological measurements, or any combination thereof, and generates an output of the machine learning model based on the input, the output being further programmed or configured to include a prediction of the dose of contrast fluid to be administered to the patient during the infusion procedure.

[0038] Paragraph 30: A fluid infusion system for providing fluid infusion as part of a medical treatment plan, comprising: a fluid injector comprising a first dose fluid infusion component and a second dose fluid infusion component; and at least one processor coupled to the fluid injector, configured to simultaneously deliver a first fluid from the first dose fluid infusion component and a second fluid from the second dose fluid infusion component during fluid infusion, wherein the delivery rate of the first fluid and the delivery rate of the second fluid are independently specified over the duration of the fluid infusion, or the total delivery volume of the first fluid and the total delivery volume of the second fluid are independently specified over the duration of the infusion.

[0039] Section 31: The fluid injector comprises two or more fluid infusion pumps and two or more fluid sources, each of the two or more fluid infusion pumps comprising a reservoir, a plunger and a drive member, and at least one processor is configured to receive infusion protocol data relating to an infusion protocol for an infusion procedure, determine control parameters for the drive member based on the infusion protocol data, and output a control signal to the drive member to actuate the drive member and deliver a selected dose of contrast fluid to the patient, the control signal being based on the control parameters, as described in Section 30.

[0040] Paragraph 32: The fluid injection system described in paragraph 30 or 31, wherein the accuracy of the delivery flow rate of the first dose fluid injection component and the accuracy of the delivery flow rate of the second dose fluid injection component are designed, specified, verified, tested, and / or validated separately, and / or the accuracy of the total delivery volume of the first dose fluid injection component and the accuracy of the total delivery volume of the second dose fluid injection component are designed, specified, verified, tested, and / or validated separately.

[0041] Further details and advantages of the various examples described in detail herein will become apparent when you examine the following detailed descriptions of the various examples in conjunction with the accompanying drawings.

[0042] Further advantages and details are described in more detail below with reference to the exemplary embodiments shown in the attached figures. [Brief explanation of the drawing]

[0043] [Figure 1] This figure shows non-limiting embodiments of environments in which the devices, systems, methods, and / or products described herein may be implemented, according to aspects of this disclosure. [Figure 2] This is a diagram of a non-limiting embodiment of a system for providing medical treatment plans according to aspects of the present disclosure. [Figure 3] Figures 1 and 2 show non-limiting embodiments of components of one or more systems or one or more devices according to aspects of the present disclosure. [Figure 4] This is a flowchart of a non-limiting embodiment of the process for performing an administration procedure according to an aspect of the present disclosure. [Figure 5] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 6] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 7] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 8] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 9] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 10] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 11]This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 12] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 13] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 14] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 15] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 16] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 17] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Figure 18] This is a schematic diagram of a non-limiting embodiment of a fluid injector for use with a fluid injection system and various components thereof, according to aspects of the present disclosure. [Modes for carrying out the invention]

[0044] Corresponding reference numerals indicate corresponding parts through some of the figures. The examples and embodiments described herein illustrate exemplary embodiments of the disclosure, and such embodiments should not be construed as limiting the scope of the disclosure.

[0045] For the purposes of the following description, the terms “end,” “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper,” “base,” “lateral,” “longitudinal,” and their derivatives shall be used in relation to this disclosure as shown in the drawings. However, it should be understood that this disclosure may assume various alternative displacement forms and step sequences unless expressly otherwise specified. It should also be understood that certain devices and processes shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of this disclosure. Accordingly, specific dimensions and other physical features relating to embodiments or aspects of the embodiments disclosed herein should not be considered limiting unless otherwise indicated.

[0046] The aspects, components, elements, structures, actions, steps, functions, instructions, etc., used herein should not be construed as important or essential unless expressly stated otherwise. Furthermore, where 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.” Additionally, where 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) and may be used interchangeably with “one or more” or “at least one.” When only one item is intended, the term “one” or a similar term is used. Furthermore, where used herein, terms such as “has,” “have,” and “having” are intended to be open-ended terms. Additionally, the phrase “based on” is intended to mean “at least partially based on” unless otherwise specified. The phrase "based on" can also mean "in response to" and, as appropriately referenced herein, can indicate conditions for automatically triggering a specified action of an electronic device (e.g., a processor, computing device, etc.).

[0047] As used herein, the terms “communicate” and “communicate” may refer to the reception, acceptance, transmission, transfer, provision, etc., of information (e.g., data, signals, messages, instructions, commands, etc.). Communication between one unit (e.g., a device, a system, a component of a device or system, a combination thereof) and another unit means that one unit can directly or indirectly receive information from and / or transmit information to the other unit. This may refer to direct or indirect connections that are essentially wired and / or wireless. Furthermore, two units can communicate with each other even if the transmitted information is modified, processed, relayed, and / or routed between the first and second units. For example, the first unit can communicate with the second unit without the first unit passively receiving information and actively transmitting information to the second unit. As another example, 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, then the first unit can communicate with the second unit. In a non-limiting embodiment, a message can refer to a network packet containing data (e.g., a data packet). It will be understood that many other configurations are possible.

[0048] As used herein, the term “system” can refer to one or more computing devices or combinations of computing devices, including, but not limited to, processors, servers, client devices, software applications, and / or other similar components. In addition, as used herein, references to “servers” or “processors” can refer to the previously listed servers and / or processors listed as performing the preceding step or function, different servers and / or processors, and / or combinations of servers and / or processors. For example, as used herein and in the claims, a first server and / or first processor listed as performing the first step or function can refer to the same or different servers and / or processors listed as performing the second step or function.

[0049] As used herein, the term “image quality” can refer to the level of precision with which an imaging system captures, processes, stores, compresses, transmits, and / or displays the signals that form an image, and may include individual visual features, factors, and / or attributes, as well as combinations of visual features, factors, and / or attributes, that contribute to image quality. Some features that contribute to the level of precision may include sufficient image contrast, sufficient signal-to-noise ratio (S / N), sufficient image resolution, a limited level of image blur, and a limited amount of image artifacts. Similarly, “image enhancement” or “sufficient image enhancement” can refer to the level of improvement in the precision with which an imaging system captures, processes, stores, compresses, transmits, and / or displays the signals that form an image, and may include improvements in individual visual features, factors, and / or attributes, as well as combinations of visual features, factors, and / or attributes, that contribute to image quality.

[0050] When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “distal” refers to the part of the component closest to the patient. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “proximal” refers to the part of the component closest to the injector of the fluid infusion system (i.e., the part of the component furthest from the patient). When used in reference to a syringe in a multi-patient disposable set, the term “proximal” refers to the part of the syringe closest to the piston for delivering fluid from the syringe. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “upstream” refers to the direction away from the patient toward the injector of the fluid infusion system. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “downstream” refers to the direction away from the patient toward the injector of the fluid infusion system.

[0051] Non-limiting embodiments or aspects of this disclosure generally relate to devices, systems, and methods for use in delivering medical fluids to a patient for medical imaging procedures, and more particularly to devices, systems, and methods for delivering precise and / or small amounts of contrast agent and / or standard amounts of contrast agent to enhance images during medical imaging procedures. In non-limiting embodiments or aspects, an administration protocol management system (hereinafter referred to as the “protocol management system”) can select a specific dose of contrast agent from a plurality of doses of contrast agent to be administered to a patient during an administration (e.g., infusion) procedure; automatically execute an administration protocol for the administration procedure, including the specific dose, based on the selection of a specific dose of contrast agent from a plurality of doses of contrast agent; generate images of areas of the patient’s body based on the automatic execution of the administration protocol; generate image analysis results of the images of areas of the patient’s body; and determine whether the image analysis results meet an image quality threshold. In non-limiting embodiments, the contrast agent may be a contrast fluid, the administration procedure may include an infusion procedure, and the administration protocol may include an infusion protocol.

[0052] In a non-limiting embodiment, the protocol management system may automatically execute an additional injection protocol for an injection procedure based on the determination that the image analysis results do not meet the image quality threshold, generate additional image analysis results for images of areas of the patient's body, and determine whether the additional image analysis results meet the image quality threshold.

[0053] In a non-limiting embodiment, when selecting a specific dose of contrast agent from multiple doses of contrast agent to be administered during an infusion procedure to a patient, the protocol management system can determine whether to administer a standard dose or a partial dose of the contrast agent during the infusion procedure to the patient.

[0054] In a non-limiting embodiment, when an infusion protocol for an infusion procedure is automatically executed, the protocol management system may automatically execute the infusion protocol for the infusion procedure based on a decision to administer a partial dose of contrast agent to the patient during the infusion procedure, and the infusion protocol may include a partial dose.

[0055] In a non-limiting embodiment, when an infusion protocol for an infusion procedure is automatically executed, the protocol management system can control the partial-dose fluid infusion components to administer a partial dose of contrast agent to the patient during the infusion procedure.

[0056] In a non-limiting embodiment, when selecting a specific dose of contrast agent from multiple doses of contrast agent to be administered to a patient during an infusion procedure, the protocol management system can automatically select a specific dose of contrast agent from multiple doses of contrast agent to be administered to a patient during an infusion procedure, based on the results of inference by a machine learning model.

[0057] In a non-limiting embodiment, when automatically selecting a specific dose of contrast agent from multiple doses of contrast agent to be administered to a patient during an infusion procedure, the protocol management system can provide input to a machine learning model based on a request for inference to the machine learning model, and generate an output from the machine learning model based on the input, the output including a prediction of the dose of contrast agent to be administered to the patient during the infusion procedure. The input may include multiple features, which may include at least one of the following: patient weight, patient height, patient age, patient sex, patient body type, patient medical history, patient physiological status, patient physiological measurements, or any combination thereof.

[0058] Furthermore, non-limiting embodiments provide fluid injection systems and imaging systems, including an image acquisition or imaging device, a fluid injector, and associated components. In non-limiting embodiments, the fluid injector may include a partial-dose fluid injector component and / or a standard-dose fluid injection component. In non-limiting embodiments, the partial-dose fluid injector component and / or a standard-dose fluid injection component may include at least one fluid injection pump, at least one fluid source, at least one tube set, and at least one valve assembly for selectively providing a fluid connection between at least one fluid source and a first tube set, between the first tube set and at least one fluid injection pump, or between at least one fluid source, the first tube set, and at least one fluid injection pump.

[0059] In this way, embodiments of the present disclosure enable the precise and efficient delivery of accurate and / or small amounts of contrast agent and / or standard amounts of contrast agent to enhance images during medical imaging procedures.

[0060] In some non-limiting embodiments, the protocol management system may include artificial intelligence, database systems, and / or other computer programs as a way of implementing the functionality of the protocol management system. The protocol management system may utilize natural language and / or voice control that can be integrated into radiological diagnostic settings. Furthermore, the collected information may be translated into natural language (e.g., a given language) so that protocols can be immediately monitored and controlled by the appropriate individuals. Furthermore, the collected information may be in the native language of the speaker or the location where the procedure is being performed, and may be made available to local authorities in such language, and / or may be automatically translated into a common language for central analysis and memory. System improvements can be achieved through data analysis and time for both technicians and medical device manufacturers. Using natural language processing in the form of recording and / or translating voice data (e.g., conversations) can generate more accurate and timely protocol information. In non-limiting embodiments, the protocol management system may automate the communication of information related to protocols, procedures, and events, enabling faster internal transmission of data and replacing existing manual processes that consume time and network resources.

[0061] Referring here to Figure 1, Figure 1 is a diagram of a non-limiting embodiment of an environment in which a system, method, and / or product described herein may be implemented according to aspects of the present disclosure. As shown in Figure 1, the environment 100 may include a protocol management system 102, data sources 104-1 to 104-N (hereinafter referred to individually as data source 104, or collectively as data source 104, as appropriate), a user device 106, a fluid injection system 108, a medical imaging system 110, hospital information 112, and a communication network 114. In some non-limiting embodiments, the protocol management system 102, data sources 104, user device 106, fluid injection system 108, medical imaging system 110, and / or hospital information system 112, as well as any subsystems thereof (e.g., a radiology information management system, a scheduling system, a billing system, or any other electronic recording system), may be interconnected via wired connections, wireless connections, or a combination of wired and wireless connections (e.g., establishing connections for communication). Any device or system within environment 100 can communicate with other devices or systems within the same or a different communication network 114.

[0062] In some non-limiting embodiments, the protocol management system 102 may include one or more devices that can communicate with a data source 104, a user device 106, a fluid injection system 108, a medical imaging system 110, and / or a hospital information system 112 via a communication network 114. For example, the protocol management system 102 may include one or more computing devices such as one or more computers, one or more servers (e.g., a cloud server, a group of servers, etc.), one or more desktop computers, or one or more mobile devices (e.g., one or more tablets, one or more smartphones, etc.). In some non-limiting embodiments, the protocol management system 102 may include one or more (e.g., multiple) applications (e.g., software applications) that perform a set of functions on an external API, enabling the protocol management system 102 to send data to an external system associated with the external application programming interface (API) and to receive data from an external system associated with the external API. In some non-limiting embodiments, the application may be supported by an application associated with the fluid injection system 108, which enables the protocol management system 102, which can function as a control room display, to be the sole device controlling other systems and / or devices, in which case the protocol management system 102 may provide authentication functionality. In some non-limiting embodiments, the protocol management system 102 may be a component of the user device 106, the fluid injection system 108, the medical imaging system 110, and / or the hospital information system 112.

[0063] In some non-limiting embodiments, the data source 104 may include one or more devices that can communicate with the protocol management system 102, user device 106, fluid injection system 108, medical imaging system 110, and / or hospital information system 112 via the communication network 114. For example, the data source 104 may include a server, a computing device such as a desktop computer, a mobile device (e.g., a tablet, smartphone, wearable such as a wearable health sensor), and so on. In some non-limiting embodiments, the data source 104 may include an electronic recording system such as an electronic medical record (EMR) system and / or an electronic health record (EHR) system, a patient treatment tracking system, a hospital information system (HIS) 112, a medical imaging information system, a radiological analysis system, and / or an image archiving and communication system such as a picture archiving and communication system (PACS). Additionally or alternatively, data source 104 may include devices related to equipment such as medical imaging systems (e.g., imaging scanners), fluid injection systems (e.g., fluid injectors), communication equipment related to medical devices (e.g., wearable medical devices such as handheld medical devices and portable health sensors), and / or devices related to patients (e.g., user devices such as computing devices operated by patients).

[0064] In some non-limiting embodiments, the user device 106 may include one or more devices capable of communicating with the protocol management system 102, the data source 104, the fluid injection system 108, the medical imaging system 110, and / or the hospital information system 112 via the communication network 114. For example, the user device 106 may include one or more computing devices such as computers, including desktop computers, workstation devices, laptops, tablets, etc. In some non-limiting embodiments, at least part of the processes performed on the user device 106 may be performed on a remote server (e.g., a cloud computing server). In some non-limiting embodiments, the user device 106 may provide a user interface for controlling the operation of the fluid injection system 108, including generating commands for the fluid injection system 108 and / or providing commands to the fluid injection system 108. Additionally or alternatively, the user device 106 may display the operating parameters of the fluid injection system 108 while the fluid injection system 108 is operating (e.g., during real-time operation). In some non-limiting embodiments, the user device 106 can provide interconnectivity between the fluid injection system 108 and other devices or systems, such as a scanner device (not shown). In some non-limiting embodiments, the user device 106 may include a Certegra® workstation provided by Bayer. In some non-limiting embodiments, the user device 106 may include a display unit (e.g., a display device, display screen, etc.) such as a computer monitor, touchscreen, or heads-up display, which can be used to display a user interface (e.g., a graphical user interface (GUI) for a software application), through which the user can interact with the user device 106 to view parameters and / or control the operation of the fluid injection system 108.For example, a user of user device 106 can provide input to user device 106 using one or more hardware or software components of user device 106, such as a touchscreen, mouse, trackpad, keyboard, stylus, gesture-detecting camera (as disclosed in International Publication No. 2021 / 108286), microphone for receiving voice commands, etc.

[0065] In some non-limiting embodiments, the fluid infusion system 108 may include one or more devices that can communicate with a protocol management system 102, a data source 104, a user device 106, a medical imaging system 110, and / or a hospital information system 112 via a communication network 114. For example, the fluid infusion system 108 may include one or more computing devices such as one or more computers, one or more servers (e.g., a cloud server, a group of servers, etc.), one or more desktop computers, or one or more mobile devices (e.g., one or more tablets, one or more smartphones, etc.). In some non-limiting embodiments, the fluid infusion system 108 may include one or more infusion devices (e.g., one or more fluid infusion devices, one or more fluid injectors). In some non-limiting embodiments, the fluid infusion system 108 may be configured to administer (e.g., inject, deliver, etc.) a contrast fluid containing a contrast agent to a patient, and / or to administer an aqueous fluid such as saline to a patient before, during, and / or after administration of the contrast fluid. For example, the fluid infusion system 108 may directly inject one or more prescribed doses of contrast fluid into the patient's bloodstream. In some non-limiting embodiments, the fluid infusion system 108 may be configured to administer aqueous fluid via a subcutaneous injection needle and syringe. In some non-limiting embodiments, the fluid infusion system 108 may be configured to administer aqueous fluid to a patient through a peripheral venous line (PIV) and catheter, where one or more prescribed doses of contrast fluid are introduced into the PIV and administered to the patient via the catheter. In some non-limiting embodiments, the fluid infusion system 108 may be configured to administer aqueous fluid into an artery via a catheter. In some non-limiting embodiments, the fluid infusion system 108 may be configured to administer aqueous fluid to organs, tissues, spaces, or tubes other than blood vessels.For example, in some non-limiting embodiments, the contrast agent may be administered intraarterially for angiographic procedures performed in a cardiac catheterization laboratory or vascular surgery laboratory using an intraarterial catheter. In some non-limiting embodiments, the fluid infusion system 108 is configured to inject a certain dose of contrast fluid, followed by the administration of a specific volume of aqueous fluid. In some non-limiting embodiments, the fluid infusion system 108 is patented as follows: U.S. Patent Application No. 09 / 715,330, filed November 17, 2000, granted as U.S. Patent No. 6,643,537; U.S. Patent Application No. 09 / 982,518, filed October 18, 2001, granted as U.S. Patent No. 7,094,216; U.S. Patent Application No. 10 / 825,866, filed April 16, 2004, granted as U.S. Patent No. 7,556,619; U.S. Patent Application No. 10 / 825,866, filed May 7, 2009, This may include one or more exemplary fluid injection devices disclosed in U.S. Patent Application No. 12 / 437,011, granted as Patent No. 8,337,456; U.S. Patent Application No. 12 / 476,513, filed on 2 June 2009 and granted as U.S. Patent No. 8,147,464; and U.S. Patent Application No. 11 / 004,670, filed on 3 December 2004 and granted as U.S. Patent No. 8,540,698, each of which disclosures are incorporated herein by reference in their entirety. In some non-limiting embodiments, the fluid infusion system 108 may include the MEDRAD® Stellant CT infusion system, the MEDRAD® Stellant FLEX CT infusion system, the MEDRAD® MRXperion MR infusion system, the MEDRAD® Mark 7 Arterion infusion system, the MEDRAD® Intego PET infusion system, or the MEDRAD® Centargo CT infusion system, all of which are supplied by Bayer Healthcare LLC.

[0066] In some non-limiting embodiments, the medical imaging system 110 may include one or more devices that can communicate with a protocol management system 102, a data source 104, a user device 106, a fluid injection system 108, and / or a hospital information system 112 via a communication network 114. In some non-limiting embodiments, the medical imaging system 210 may include one or more scanners, such as computed tomography (CT) scanners and / or magnetic resonance imaging (MRI) scanners, that can communicate via a communication network and perform medical imaging procedures, including the use of medical fluids such as radiographic contrast materials.

[0067] In some non-limiting embodiments, the hospital information system 112 may include one or more devices that can communicate with the protocol management system 102, the data source 104, the user device 106, the fluid injection system 108, and / or the medical imaging system 110 via the communication network 114. For example, the hospital information system 112 may include one or more computing devices, such as one or more desktop computers, one or more mobile devices, and one or more servers. In some non-limiting embodiments, the hospital information system 112 may include one or more subsystems, such as a patient procedure tracking system (e.g., a system for operating modality worklists, a system for providing patient demographic information for fluid injection procedures and / or medical imaging procedures), a fluid injector management system, an image archiving and communication system (e.g., a picture archiving and communication system (PACS)), a radiology information system (RIS), and / or a radiology analysis system (e.g., Radimetrics® Enterprise Application, sold by Bayer HealthCare LLC), and / or other similar systems or devices.

[0068] In some non-limiting embodiments, the communication network 114 may include one or more wired and / or wireless networks. For example, the communication network 114 may include cellular networks (e.g., Long-Term Evolution (LTE®) networks, 3G networks, 4G networks, 5G networks, 6G networks, Code Division Multiple Access (CDMA) networks, etc.), public land mobile networks (PLMN), local area networks (LANs), wide area networks (WANs), metropolitan area networks (MANs), telephone networks (e.g., public switched telephone networks (PSTNs)), private networks, ad hoc networks, intranets, the Internet, fiber optic-based networks, cloud computing networks, short-range wireless communication networks (e.g., Bluetooth® networks, near-field communication (NFC) networks, etc.), and / or combinations of these or other types of networks.

[0069] The number and arrangement of systems and / or devices shown in Figure 1 are provided as an example. Additional systems and / or devices, fewer systems and / or devices, different systems and / or devices, or systems and / or devices in different arrangements than those shown in Figure 1 may exist. Furthermore, two or more systems and / or devices shown in Figure 1 may be implemented within a single system or single device, or a single system or single device shown in Figure 1 may be implemented as multiple distributed systems or devices. Additionally or alternatively, a set of systems or devices in environment 100 (e.g., one or more systems, one or more devices) may perform one or more functions that are described as being performed by another set of systems or devices in environment 100.

[0070] Referring here to Figure 2, Figure 2 is a diagram of a non-limiting embodiment of the system 200 for providing medical treatment plans. In some non-limiting embodiments, one or more of the functions described herein with respect to the system 200 may be performed (e.g., entirely, partially, and / or similarly) by the protocol management system 102. In some non-limiting embodiments, one or more of the functions described herein with respect to the system 200 may be performed (e.g., entirely, partially, and / or similarly) by another device or group of devices separate from and / or including the protocol management system 102, such as a workstation device 206 (e.g., including a display unit 206A), a fluid injection system 208 (e.g., including a fluid injector 208A), a medical imaging system 210, a hospital information system 212, an electronic health record system 216 and / or an electronic medical record system 218.

[0071] As shown in Figure 2, the system 200 includes a protocol management system 102, a workstation device 206 including a display unit 206A, a fluid injection system 208 including a fluid injector 208A, a medical imaging system 210, a hospital information system 212, an electronic health record system 216, and an electronic medical record system 218. In some non-limiting embodiments, the protocol management system 102 can interconnect the fluid injection system 108, the workstation device 206, the medical imaging system 210, the hospital information system 212, the electronic health record system 216, and / or the electronic medical record system 218 via wired connections, wireless connections, or a combination of wired and wireless connections (e.g., establishing connections for communication, and / or similar). In some non-limiting embodiments, the workstation device 206 may be the same as or similar to the user device 106. In some non-limiting embodiments, the fluid injection system 208 may be the same as or similar to the fluid injection system 108. In some non-limiting embodiments, the medical imaging system 210 may be the same as, or used in the same way as, the medical imaging system 110. In some non-limiting embodiments, the hospital information system 212 may be the same as, or used in the same way as, the hospital information system 112 and / or data source 104 (for example, subsystems of the hospital information system 212 may be the same as or similar to those of data source 104). In some non-limiting embodiments, the electronic health record system (EHR) 216 and / or electronic medical record system (EMR) 218 ​​may be the same as, or used in the same way as, data source 104.

[0072] As further shown in Figure 2, the hospital information system 212 may include multiple subsystems. These subsystems may include a patient treatment tracking system 212A, an image archiving and communication system 212B, a radiology information system 212C, and a radiology analysis system 212D. In some non-limiting embodiments, the protocol management system 102 may receive healthcare data from the hospital information system 212 via a communication network (e.g., communication network 114) according to a communication protocol for communicating data related to information science. For example, the protocol management system 102 can receive data related to patient procedures from the hospital information system 212 (e.g., the patient procedure tracking system 212A) via a communication network in accordance with the Medical Digital Image Communication (DICOM®) communication protocol, data related to the operation of the fluid injection system 208 from the hospital information system 212 via a communication network based on API calls (e.g., API calls from the protocol management system 102), data related to radiographic images from the hospital information system 212 (e.g., the image archiving and communication system 212B) via a communication network in accordance with the DICOM® communication protocol, data related to patient examination procedures from the hospital information system 212 (e.g., the radiological information system 212C) via a communication network in accordance with the Health Level Seven (HL7) standard communication protocol, and / or data related to radiation dose during medical imaging procedures from the hospital information system 212 (e.g., the radiological analysis system 212D) via a communication network based on API calls (e.g., API calls from the protocol management system 102 to the radiological analysis system 212D).

[0073] In some non-limiting embodiments, the electronic health record system 216 may include one or more devices that can communicate with the protocol management system 102, the workstation device 206, the fluid injection system 208, the medical imaging system 210, the hospital information system 212, and / or the electronic medical record system 218 via a communication network (e.g., communication network 114). In some non-limiting embodiments, the electronic health record system 216 may include one or more devices that receive, manage, store, and / or transmit electronic medical records (e.g., electronic health records) containing medical record data related to a patient's medical record, such as demographics, medical history, drug therapy and allergies, immune status, laboratory results, radiographic images, vital signs, personal statistics (e.g., age, weight, height, etc.), and billing information, relevant to a particular case of medical care. Additionally or alternatively, the electronic health record system 216 may include one or more devices that receive, manage, store, and / or transmit electronic medical records containing medical record data related to various providers and / or locations of medical care (e.g., offices, clinics, hospitals, etc.). Additionally or alternatively, the electronic health record system 216 may include a patient portal (e.g., a web-based interface) that allows patients to interact with their respective electronic medical records. In some non-limiting embodiments, the electronic health record system 216 may be a data source for the protocol management system 102, the workstation device 206, the fluid injection system 208, the medical imaging system 210, the hospital information system 212, and / or the electronic medical record system 218.

[0074] In some non-limiting embodiments, the electronic medical record system 218 may include one or more devices that can communicate with the protocol management system 102, the workstation device 206, the fluid injection system 208, the medical imaging system 210, the hospital information system 212, and / or the electronic health record system 216 via a communication network (e.g., communication network 114). In some non-limiting embodiments, the electronic medical record system 218 may include one or more devices that receive, manage, store, and / or transmit electronic medical records (e.g., electronic health records) containing medical record data related to a patient's medical record, such as demographics, medical history, drug therapy and allergies, immune status, laboratory results, radiographic images, vital signs, personal statistics (e.g., age, weight, height, etc.), and billing information, relevant to a particular case of medical care. Additionally or alternatively, the electronic medical record system 218 may include one or more devices that receive, manage, store, and / or transmit electronic medical records containing medical record data related to various providers and / or locations of medical care (e.g., offices, clinics, hospitals, etc.). Additionally or alternatively, the electronic medical record system 218 may include a patient portal (e.g., a web-based interface) that allows patients to interact with their respective electronic medical records. In some non-limiting embodiments, the electronic medical record system 218 may be a data source for the protocol management system 102, the workstation device 206, the fluid injection system 208, the medical imaging system 210, the hospital information system 212, and / or the electronic health record system 216.

[0075] In some non-limiting embodiments, the protocol management system 102 may include multiple applications, each of which may be associated with an API (e.g., a first API associated with a first application, a second API associated with a second application, a third API associated with a third application, etc.) that enables other systems and / or devices to interface with the protocol management system 102 (e.g., to communicate, establish a communication interface, etc.) and / or enable the protocol management system 102 to interface with other systems and / or devices (e.g., individual subsystems of the hospital information system 212, such as the patient treatment tracking system 212A, the image archiving and communication system 212B, the radiology information system 212C, and / or the radiology analysis system 212D). In some non-limiting embodiments, the protocol management system 102 may provide a user interface (e.g., via an application that includes a user interface, such as a web-based user interface) that enables users to access information such as medical findings (e.g., patient medical findings).

[0076] As further shown in Figure 2, the workstation device 206 may include a display unit 206A. In some non-limiting embodiments, the display unit 206A may display a user interface provided by the protocol management system 102 (e.g., a web-based user interface). In some non-limiting embodiments, the display unit 206A may include a computing device such as a smart display unit, a portable computer such as a tablet, a laptop, etc. In some non-limiting embodiments, the display unit 206A may include a touchscreen for receiving user input. In some non-limiting embodiments, the display unit 206A may include a display device (e.g., a monitor, screen, and / or similar for displaying visual information).

[0077] As further shown in Figure 2, the fluid injection system 208 may include a fluid injector 208A. In some non-limiting embodiments, the protocol management system 102 can transmit data related to images received from the medical imaging system 210 to the fluid injection system 208 via a communication network. For example, the protocol management system 102 can transmit data related to images received from the medical imaging system 210 to the fluid injection system 208 via a communication network based on API calls from the fluid injection system 208. In some non-limiting embodiments, the protocol management system 102 can transmit data related to fluid injection procedures received from the fluid injection system 208 to the medical imaging system 210 via a communication network (e.g., data related to the volume, flow rate, and / or time for injecting a radiocontrast agent into a patient). For example, the protocol management system 102 can transmit data related to fluid injection procedures received from the fluid injection system 108 to the medical imaging system 210 via a communication network based on API calls from the medical imaging system 210 (e.g., API calls for the imaging system interface (ISI), API calls for the ISI2 interface, API calls for the Connect.CT interface, etc.). In some non-limiting embodiments, the medical imaging system 210 can perform medical imaging procedures on a patient based on data including an infusion protocol related to a fluid infusion procedure. In some non-limiting embodiments, the protocol management system 102 can receive data related to the operation of the medical imaging system 210 from the medical imaging system 210 via a communication network based on an API call (e.g., an API call from the protocol management system 102 to the medical imaging system 210).

[0078] In some non-limiting embodiments, the protocol management system 102 can provide a communication interface between the hospital information system 212 and the fluid injection system 208, thereby enabling the fluid injection system 208 to receive data based on API calls from the fluid injection system 208 to the protocol management system 102. In some non-limiting embodiments, the protocol management system 102 can transmit data related to information received from the hospital information system 212 to the fluid injection system 208 via a communication network (e.g., communication network 114). For example, the protocol management system 102 can transmit data related to information received from the hospital information system 212 to the fluid injection system 208 via a communication network based on API calls from the fluid injection system 208.

[0079] Referring now to Figure 3, which is a diagram of exemplary components of device 300. Device 300 may correspond to one or more of the following devices: protocol management system 102, data source 104, user device 106, workstation device 206, fluid injection system 108 and / or fluid injection system 208 (e.g., one or more devices of fluid injection system 108 and / or fluid injection system 208), medical imaging system 110 and / or medical imaging system 210 (e.g., one or more devices of medical imaging system 110 and / or medical imaging system 210), hospital information system 112 and / or hospital information system 212 (e.g., one or more devices of hospital information system 112 and / or hospital information system 212), electronic health record system 216 (e.g., one or more devices of electronic health record system 216), and / or electronic medical record system 218 (e.g., one or more devices of electronic medical record system 218). In some non-limiting embodiments, the protocol management system 102, data source 104, user device 106, workstation device 206, fluid injection system 108 and / or fluid injection system 208, medical imaging system 110 and / or medical imaging system 210, hospital information system 112 and / or hospital information system 212, electronic health record system 216 and / or electronic medical record system 218 may include at least one device 300 and / or at least one component of device 300.

[0080] As shown in Figure 3, device 300 may include a bus 302, a processor 304, memory 306, storage components 308, input components 310, output components 312, and a communication interface 314. Bus 302 may include components that enable communication between components of device 300. In some non-limiting embodiments, the processor 304 may be implemented in hardware, firmware, or a combination of hardware and software. For example, the processor 304 may include a processor (e.g., a central processing unit (CPU), graphics processing unit (GPU), accelerator processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.). Memory 306 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 the processor 304.

[0081] The storage component 308 can store information and / or software related to the operation and use of device 300. For example, the storage component 308, along with a corresponding drive, may include a hard disk (e.g., magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), a compact disc (CD), a digital multipurpose disc (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable media.

[0082] The input component 310 may include components that enable the device 300 to receive information via user input or the like (e.g., a touchscreen display, keyboard, keypad, mouse, buttons, switches, microphone, etc.). Additionally or alternatively, the input component 310 may include sensors for sensing information (e.g., a Global Positioning System (GPS) component, accelerometer, gyroscope, actuator, etc.). The output component 312 may include components that provide output information from the device 300 (e.g., a display, speaker, one or more light-emitting diodes (LEDs), etc.).

[0083] The communication interface 314 may include transceiver-like components (e.g., transceivers, separate receivers and transmitters) that enable device 300 to communicate with other devices via wired connections, wireless connections, or a combination of wired and wireless connections. The communication interface 314 may also enable device 300 to receive information from and / or provide information to other devices. For example, the communication interface 314 may include Ethernet interfaces, optical interfaces, coaxial interfaces, infrared interfaces, radio frequency (RF) interfaces, Universal Serial Bus (USB) interfaces, Wi-Fi® interfaces, cellular network interfaces, and the like.

[0084] Device 300 can perform one or more processes described herein. Device 300 can perform these processes based on a processor 304 that executes software instructions stored in a computer-readable medium, such as memory 306 and / or storage component 308. A computer-readable medium (e.g., non-temporary computer-readable medium) is defined herein as a non-temporary memory device. A memory device may include a memory space located within a single physical storage device, or a memory space extending across multiple physical storage devices.

[0085] Software instructions may be read into memory 306 and / or storage component 308 from another computer-readable medium or from another device via the communication interface 314. When executed, the software instructions stored in memory 306 and / or storage component 308 can cause the processor 304 to execute one or more processes described herein. Additionally or alternatively, hardwired circuits may be used instead of or in combination with software instructions to execute one or more processes described herein. Therefore, the embodiments described herein are not limited to any particular combination of hardware circuits and software.

[0086] The number and arrangement of components shown in Figure 3 are provided as an example. In some non-limiting embodiments, device 300 may include additional components, fewer components, different components, or components in different arrangements than those shown in Figure 3. Additionally or alternatively, a set of components of device 300 (e.g., one or more components) may perform one or more functions that are described as being performed by another set of components of device 300.

[0087] Referring now to Figure 4, Figure 4 is a flowchart of a non-limiting embodiment of process 400 for performing an injection procedure according to an aspect of the present disclosure. In some non-limiting embodiments, one or more of the steps of process 400 are performed by the protocol management system 102 (e.g., entirely, partially, etc.). In some non-limiting embodiments, one or more of the steps of process 400 are performed by another device or group of devices separate from or including the protocol management system 102, such as a data source (e.g., data source 104), a user device (e.g., user device 106, workstation device 206), a fluid injection system (e.g., fluid injection system 108, such as one or more devices of fluid injection system 108), a medical imaging system (e.g., medical imaging system 110, such as one or more devices of medical imaging system 110), and / or a hospital information system (e.g., hospital information system 112, such as one or more devices of hospital information system 112, hospital information system 212, such as one or more subsystems of hospital information system 212, etc.).

[0088] As shown in Figure 4, in step 402, process 400 may include determining the dose of medical fluid to be administered during the infusion procedure. The protocol management system 102 may determine whether to administer a standard dose or a partial dose of contrast fluid to the patient during the infusion procedure. In some non-limiting embodiments, the protocol management system 102 may determine the dose of medical fluid to be administered during the infusion procedure based at least in part on patient-related healthcare data. The protocol management system 102 may receive healthcare data from multiple data sources 104. In some non-limiting embodiments, the data source 104 may include at least one of the following: an electronic health record (EHR) system, an electronic medical record (EMR) system, a patient treatment tracking system, a hospital information system (HIS), a medical imaging information system, a radiographic image analysis system, and / or an image archiving and communication system (such as a picture archiving and communication system (PACS)). Additionally or alternatively, data source 104 may include devices related to equipment such as medical imaging systems (e.g., imaging scanners), fluid injection systems (e.g., fluid injectors), communication equipment related to medical devices (e.g., wearable medical devices such as handheld medical devices and portable health sensors), and / or devices related to patients (e.g., user devices such as computing devices operated by patients). In some non-limiting embodiments, data source 104 may include one or more sensors, one or more diagnostic devices (e.g., bedside diagnostic devices), and / or one or more monitoring devices (e.g., bedside patient monitoring devices), such as the systems disclosed in U.S. Patent Application No. 17 / 921,245, filed April 30, 2021, and granted as U.S. Patent No. 11,896,352, the disclosures of which are incorporated herein by reference in their entirety.

[0089] In some non-limiting embodiments, patient-related healthcare data may include medical record data related to the patient's medical records, protected health information related to the patient, demographic information related to the patient, identification data related to the patient's identifier, data related to patient examination procedures (e.g., fluid infusion procedures and / or medical imaging procedures performed on the patient), such as data related to contrast fluids provided during fluid infusion procedures, the gauge of the catheter used during fluid infusion procedures, and fluid infusion protocols for fluid infusion procedures. In some non-limiting embodiments, the protocol management system 102 may store patient-related healthcare data in a data structure (e.g., a database). For example, the protocol management system 102 may store patient-related healthcare data in a data structure along with the patient's unique identifier. In some non-limiting embodiments, patient-related healthcare data may include the patient's imaging history. For example, if the patient has undergone an imaging procedure within the preceding 24 hours, the use of a partial dose of contrast agent may be instructed to avoid inducing iodine overload in the patient. Furthermore, if the patient has previously undergone imaging procedures and a partial dose of contrast agent was initially used, and the initial dose percentage of contrast agent was insufficient for the imaging procedure (e.g., a diagnostic scan), a larger dose percentage can be indicated or selected for the current imaging procedure. In some non-limiting embodiments, the results of the imaging procedure (e.g., image analysis results of images generated according to the imaging procedure using a partial dose of contrast agent (e.g., a low-dose scan)) may be captured by the protocol management system 102 and included in the healthcare data (e.g., as part of the procedure data record). For example, the results of the imaging procedure may include details about the previous procedure, such as "partial dose (e.g., low dose) successful, initial partial dose unsuccessful, further partial dose required," or "initial partial dose unsuccessful, standard dose required." This information can be used for future patient imaging procedures and / or as part of a training record dataset for any machine learning algorithm for partial dose calculation.

[0090] In some non-limiting embodiments, the protocol management system 102 can retrieve patient-related healthcare data from at least one of a plurality of data sources based on a patient-related identifier. For example, the protocol management system 102 can transmit a patient-related identifier (e.g., a unique patient identifier, such as a unique patient identifier for patient medical records) to a data source 104, such as a hospital information system, and the protocol management system 102 can receive patient-related healthcare data from the data source 104. In some non-limiting embodiments, the data source 104 can receive a patient-related identifier, retrieve patient-related healthcare data based on the identifier, and transmit the patient-related healthcare data to the protocol management system 102. In some non-limiting embodiments, the identifier may be related to the patient's patient record (e.g., the patient's patient record stored in the patient treatment tracking system 212A of the hospital information system 212).

[0091] In some non-limiting embodiments, the protocol management system 102 can generate patient profiles. For example, the protocol management system 102 can generate patient profiles based on healthcare data related to the patient. In some non-limiting embodiments, the protocol management system 102 can generate patient profiles based on demographic information and / or protected health information related to the patient.

[0092] In some non-limiting embodiments, the protocol management system 102 can select a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to the patient during an infusion procedure. In some non-limiting embodiments, the protocol management system 102 can automatically select a dose of medical fluid to be administered to the patient during an infusion procedure based on the results of inference by a machine learning model. In some non-limiting embodiments, the protocol management system 102 can provide input to a machine learning model based on a request for inference to the machine learning model, and the input may include multiple features. For example, the multiple features may include at least one of the following: patient weight, patient height, patient age, patient body type and / or proxy of patient body type (e.g., physical characteristics, body type, build, body surface area, weight, height, body mass index (BMI), lean body mass, etc.), patient medical history, patient physiological status, patient physiological measurements (e.g., heart rate, cardiac output, ejection fraction, respiratory rate, etc.), or any combination thereof. In some non-limiting embodiments, the multiple features may further include the patient's body surface area, body mass index (BMI), disease status and condition. For example, in patients with renal disease and poor renal function (e.g., as measured by a low glomerular filtration rate (GFR) and / or high creatinine levels), it is often preferable to minimize the iodine dose during CT or angiography medical imaging procedures. In some non-limiting embodiments, the features may further include results from previous imaging, previous study results, previous test results, laboratory values ​​from blood, urine, etc., and any other data. In some non-limiting embodiments, one or more of the features may be automatically extracted from images acquired by the protocol management system 102 or previously acquired images (e.g., native scan, scout scan, etc.), and may be quantitative or qualitative features, radiomic features, etc. In some non-limiting embodiments, the protocol management system 102 may determine inputs based on healthcare data received from multiple data sources 104.In some non-limiting embodiments, the protocol management system 102 can generate outputs from a machine learning model based on inputs, and these outputs may include predictions of the dose of contrast fluid to be administered to the patient during the infusion procedure. In some non-limiting embodiments, when selecting a specific dose of contrast fluid to be administered during the infusion procedure, the protocol management system 102 can determine whether to administer a standard dose or a partial dose of the contrast fluid to the patient during the infusion procedure.

[0093] As shown in Figure 4, in step 404, process 400 may include executing an infusion protocol for the infusion procedure. For example, the protocol management system 102 may automatically execute an infusion protocol for the infusion procedure based on determining the dose of medical fluid to be administered during the infusion procedure and selecting a specific dose of contrast fluid from multiple doses of contrast fluid, and the infusion protocol may include a specific dose. In some non-limiting embodiments, the protocol management system 102 may automatically execute an infusion protocol for the infusion procedure based on determining that a partial dose of contrast fluid will be administered during the infusion procedure and selecting a specific partial dose of contrast fluid from multiple doses of contrast fluid, and the infusion protocol may include a specific partial dose. In some non-limiting embodiments, the protocol management system 102 may automatically execute an infusion protocol for the infusion procedure based on determining that a standard dose of contrast fluid will be administered during the infusion procedure and selecting a specific standard dose of contrast fluid from multiple doses of contrast fluid, and the infusion protocol may include a specific standard dose.

[0094] In some non-limiting embodiments, the protocol management system 102 is associated with a fluid infusion system (e.g., fluid infusion system 108, fluid infusion system 208) including a fluid injector (e.g., fluid injector 208A), and the fluid injector includes a partial-dose fluid infusion component and a standard-dose fluid infusion component. In such embodiments, the protocol management system 102 can automatically execute an infusion protocol for an infusion procedure based on determining whether a partial dose of the contrast fluid is administered by the partial-dose fluid infusion component during the infusion procedure to the patient, or whether a standard dose of the contrast fluid is administered by the standard-dose fluid infusion component during the infusion procedure to the patient. In some non-limiting embodiments, the protocol management system 102 can automatically execute an infusion protocol for an infusion procedure by controlling the partial-dose fluid infusion component to administer a partial dose of the contrast fluid during the infusion procedure to the patient.

[0095] In some non-limiting embodiments, the partial-dose fluid injection component includes a partial-dose fluid injection pump, and the protocol management system 102 automatically executes an injection protocol for an injection procedure by operating the partial-dose fluid injection pump. In some non-limiting embodiments, the protocol management system 102 can operate the partial-dose fluid injection pump by receiving fluid flow data from a sensor, determining the fluid flow rate in the fluid path based on the fluid flow data received from the sensor, and outputting a control signal to the partial-dose fluid injection pump. In some non-limiting embodiments, the protocol management system 102 can operate the partial-dose fluid injection pump by receiving fluid data from a sensor, including an indication of whether air is present in the fluid path, determining whether a threshold amount of air is present in the fluid path based on the fluid data received from the sensor, and outputting a control signal to the partial-dose fluid injection pump based on the determination that air is present in the fluid path. In some non-limiting embodiments, the protocol management system 102 can operate the partial-dose fluid injection pump by receiving contrast fluid concentration data from a sensor, determining the concentration of the contrast fluid in the fluid path based on the contrast fluid concentration data received from the sensor, and outputting a control signal to the partial-dose fluid injection pump. For example, the fluid protocol management system 102 can operate a partial-dose fluid injection pump disclosed in U.S. Patent Application No. 09 / 267,238, filed on March 12, 1999, and granted as U.S. Patent No. 6,317,623, the disclosure of which is incorporated herein by reference in its entirety.

[0096] In some non-limiting embodiments, the fluid injector may include one or more fluid injection pumps and one or more fluid sources. In some non-limiting embodiments, the fluid injector may include one or more fluid injection pumps and two or more fluid sources. In some non-limiting embodiments, the fluid injector may include two or more fluid injection pumps and two or more fluid sources. In some non-limiting embodiments, the fluid injection pump (e.g., a syringe-based pump) may include a reservoir, a plunger, and a drive member. In some non-limiting embodiments, the fluid injection pump (e.g., a peristaltic pump or a gear pump) may include a tube, a rotating member, and a drive member. In some non-limiting embodiments, the protocol management system 102 can automatically execute an injection protocol for an injection procedure by receiving an injection protocol for the injection procedure and associated injection protocol data. The protocol management system 102 can receive injection protocol data from multiple data sources 104. In some non-limiting embodiments, the injection protocol data may include one or more instructions relating to the injection procedure. In some non-limiting embodiments, the protocol management system 102 can determine control parameters for a drive member based on injection protocol data and can output a control signal to the drive member to actuate the drive member and deliver a selected dose of contrast fluid to the patient, the control signal may be based on the control parameter. For example, the control parameter may include a specific length or increment of time, a specific linear distance, or a specific number of rotations at which the protocol management system actsuate the drive member, and the control parameter may correspond to the delivery of a specific dose, such as a selected dose of contrast fluid for the injection procedure.

[0097] As shown in Figure 4, in step 406, process 400 may include generating images of the patient's body. For example, the protocol management system 102 may generate images of areas of the patient's body based on automatically executing an injection protocol. In some non-limiting embodiments, the protocol management system 102 may communicate with medical imaging systems (e.g., medical imaging system 110, medical imaging system 210, e.g., their components) to generate images of the patient's body. In some non-limiting embodiments, the medical imaging system (e.g., medical imaging scanner) may include devices and components specific to a particular imaging procedure and the type of image to be generated, including angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), single-photon emission tomography (SPECT), hybrid imaging techniques such as SPECT / CT, PET / CT, PET / MRI, and / or other imaging procedures.

[0098] In some non-limiting embodiments, the protocol management system 102 can receive imaging data related to the imaging protocol from multiple data sources 104. In some non-limiting embodiments, the protocol management system 102 can provide the imaging data to a medical imaging system to generate images of areas of the patient's body. In some non-limiting embodiments, the imaging data may include features such as the type of image acquired by the imaging system, the location on the patient's body where the image is acquired, the size of the image acquired, the duration of the imaging exposure where the image is acquired (e.g., the time elapsed since the patient was exposed to light, radiation, or other energy source), the duration of the body's exposure to a contrast fluid where the image is acquired (e.g., the time elapsed since the contrast fluid was administered), and / or any combination thereof. In some non-limiting embodiments, the imaging data may include source characteristics relating to the associated imaging procedure. For example, in the case of CT imaging, the source characteristics may include energy level (kVp) and radiation dose (mAs), and in the case of MRI imaging, the source characteristics may include static magnetic field strength, pulse sequence, and acquisition model used. In some non-limiting embodiments, the protocol management system 102 may generate commands for generating images of body regions and / or provide commands to the imaging system 210. In some non-limiting embodiments, the commands may be based on data received from multiple data sources 104, the data may include injection protocol data, healthcare data, imaging data, and / or any combination thereof.

[0099] As shown in Figure 4, in step 408, process 400 may include generating image analysis results for the image. For example, the protocol management system 102 may generate image analysis results for images of the patient's body based on images of areas of the patient's body generated by the protocol management system 102. In some non-limiting embodiments, the image analysis results may be based on the results of inference by a machine learning model. In some non-limiting embodiments, when generating image analysis results for an image, the protocol management system may provide input to the machine learning model based on a request for inference to the machine learning model and generate output from the machine learning model based on the input. In some non-limiting embodiments, the input may include image-related data such as the image model, image features, the image itself, and / or a combination thereof. In some non-limiting embodiments, the protocol management system 102 may receive image-related data from multiple data sources 104, the multiple data sources may include one or more scanners and / or one or more sensors associated with the medical imaging system 210. In some non-limiting embodiments, the output of the machine learning model may include quantitative data related to the image, such as resolution, clarity, sharpness, brightness, image contrast, signal-to-noise ratio (S / N), level of image blur, and amount of image artifacts. In some non-limiting embodiments, the output may be qualitative.

[0100] As shown in Figure 4, in step 410, process 400 may include determining whether the image analysis result satisfies a threshold image quality. For example, the protocol management system 102 may determine whether the image analysis result satisfies a threshold image quality. In some non-limiting embodiments, the image analysis result may be based on quantitative data related to the image analysis result. In some non-limiting embodiments, determining whether the image analysis result satisfies a threshold image quality may be based on inference of a machine learning model. For example, the protocol management system 102 may provide quantitative data related to the image analysis result of an image as input to a machine learning model and generate an output regarding whether the image analysis result satisfies a threshold image quality. The protocol management system 102 may also provide the threshold itself as input. In some non-limiting embodiments, when determining whether an image analysis result meets a threshold image quality, the output may be binary (e.g., yes, threshold image quality is met, or no, threshold image quality is not met), tertiary (e.g., yes, threshold image quality is met, no, threshold image quality is not met, or the image analysis result is inconclusive regarding whether the threshold image quality is met), or may include multiple determinations, such as specific data points of the image analysis result that meet and / or do not meet the image quality threshold. In some non-limiting embodiments, determining whether an image analysis result meets a threshold image quality may be based on a qualitative output. For example, in some non-limiting embodiments, determining whether an image analysis result meets a threshold image quality may be based on a visual review qualitative output (e.g., manual review of the image by a technician or user).

[0101] In some non-limiting embodiments, if the protocol management system 102 determines that the image analysis results do not meet the image quality threshold, the protocol management system 102 may repeat process 400 or the steps of process 400 to improve the image analysis results. For example, the protocol management system 102 may automatically execute an additional injection protocol, generate additional image analysis results of images of the patient's body, and determine whether the additional image analysis results meet the threshold image quality.

[0102] In some non-limiting embodiments, if the protocol management system 102 determines that the image analysis results do not meet the image quality threshold, the protocol management system 102 can automatically execute an additional injection protocol for the additional injection procedure based on determining the dose of medical fluid to be administered during the additional injection procedure and selecting a specific dose of contrast fluid from multiple doses of contrast fluid, and the injection protocol may include a specific dose. In some non-limiting embodiments, the protocol management system 102 can automatically execute an additional injection protocol for the additional injection procedure based on determining that a partial dose of contrast fluid is to be administered during the additional injection procedure and selecting a specific partial dose of contrast fluid from multiple doses of contrast fluid, and the additional injection protocol may include a specific partial dose. In some non-limiting embodiments, the protocol management system 102 can automatically execute an injection protocol for the additional injection procedure based on determining that a standard dose of contrast fluid is to be administered during the additional injection procedure and selecting a specific standard dose of contrast fluid from multiple doses of contrast fluid, and the additional injection protocol may include a specific standard dose. In some non-limiting embodiments, the protocol management system 102 may determine that a partial dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results, and may select a specific partial dose from a plurality of partial doses to improve the image analysis results. In some non-limiting embodiments, the protocol management system 102 may determine that a standard dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results, and may select a specific standard dose of contrast fluid from a plurality of partial doses to improve the image analysis results.

[0103] For example, after image analysis results generated according to the execution of an injection protocol for an injection procedure in which a standard dose of contrast fluid is administered, the protocol management system 102 may determine that another standard dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results, or that a partial dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results. The protocol management system 102 may further determine a specific dose of contrast fluid to be administered during the additional injection procedure. In some non-limiting embodiments, after image analysis results generated according to the execution of an injection protocol for an injection procedure in which a partial dose of contrast fluid is administered, the protocol management system 102 may determine that another partial dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results, or that a standard dose of contrast fluid is administered during an additional injection procedure to improve the image analysis results, and the protocol management system 102 may further determine a specific dose of contrast fluid to be administered during the additional injection procedure.

[0104] In some non-limiting embodiments, the protocol management system 102 may then generate additional image analysis results of images of areas of the patient's body. In some non-limiting embodiments, generating additional image analysis may include generating additional images of areas of the patient's body according to step 406 of process 400, as described herein.

[0105] In some non-limiting embodiments, the protocol management system 102 can generate additional image analysis results for images of patient body regions without acquiring additional images. For example, the protocol management system 102 can generate an initial image, generate an initial image analysis result for the image, determine if the image analysis result does not meet the threshold image quality, execute an additional injection protocol for the injection procedure, generate a enhanced image of the patient body region (e.g., enhanced initial image), generate an image analysis result, and determine whether the image analysis result meets the threshold image quality before acquiring the image.

[0106] In some non-limiting embodiments, the protocol management system 102 may then generate additional image analysis results of the image according to step 408 of process 400, as described herein. In some non-limiting embodiments, the protocol management system may then determine whether the additional image analysis results meet the threshold image quality. In some non-limiting embodiments, if the protocol management system 102 determines that the image analysis results do not meet the image quality threshold, the protocol management system 102 may repeat process 400 or the steps of process 400 to improve the image analysis results.

[0107] Referring here to Figures 5 to 18, Figures 5 to 18 are schematic diagrams of non-limiting embodiments of a fluid injector 500 for use with a fluid infusion system (e.g., fluid infusion system 108, fluid infusion system 208) and various components thereof, according to aspects of the present disclosure. In some non-limiting embodiments, a fluid infusion system for providing a medical treatment plan may include a fluid injector 500, as shown in Figures 5 to 8.

[0108] Continuing with reference to Figures 5 to 8, Figures 5 to 8 show exemplary embodiments of a fluid injector 500 for use with a fluid injection system. In some non-limiting embodiments, the fluid injector 500 may include at least one fluid injection pump 522, at least one fluid source 524, and a first tube set 526 having at least one valve assembly 528. In some non-limiting embodiments, at least one valve assembly 528 may be configured to selectively provide a fluid connection between at least one fluid source 524 and the first tube set 526, between the first tube set 526 and at least one fluid injection pump 522, or between at least one fluid source 524, the first tube set 526, and at least one fluid injection pump 522.

[0109] As shown in Figures 5 to 8, the fluid injector 500 may include one or more fluid injection pumps 522 (which may be individually referred to as fluid injection pumps 522a, 522b, 522c, 522d, etc.) (e.g., syringe-based pumps, peristaltic pumps, gear pumps) and one or more fluid sources 524 (which may be individually referred to as fluid sources 524a, 524b, 524c, 524d, etc.) (e.g., at least one vial, bottle, bag, container). Figure 5 shows a total of five fluid injection pumps 522 and five fluid sources 524. However, it should be understood that any number of fluid injection pumps 522 and any number of fluid sources 524 may be used and controlled by an injection system (e.g., fluid injection system 108) and / or a protocol management system (e.g., protocol management system 102).

[0110] Continuing to refer to Figures 5 to 8, the first tube set 526 may include a connector member 530 (e.g., a fluid path element) configured to connect to the second tube set 532, and the second tube set 532 may connect to a catheter 534 configured to be fluidly connected to patient P. In some non-limiting embodiments, at least one valve assembly 528 may be configured to selectively provide a fluid connection between the first tube set 526 and the second tube set 532.

[0111] In some non-limiting embodiments, each fluid injection pump 522 (e.g., a syringe-based pump) may include a reservoir 536 (e.g., reservoirs 536a, 536b, 536c, 536d, 536e), a plunger 538 (e.g., plungers 538a, 538b, 538c, 538d, 538e), and a drive member 540 (e.g., pistons such as drive members 540a, 540b, 540c, 540d, 540e). In some non-limiting embodiments, a fluid injection pump 522a (e.g., a peristaltic pump, a gear pump) may include a tube, a rotating member, and a drive member. In some non-limiting embodiments, the fluid injector 500 may further include one or more actuators 544 configured to actuate (e.g., give movement to) the drive member 540 of the fluid injection pump 522. In some non-limiting embodiments, one or more of the fluid injection pumps 522 may include partial-dose fluid injection components and standard-dose fluid injection components. For example, in some non-limiting embodiments, any of the fluid injection pumps 522 may include a partial-dose fluid injection component that can include a partial-dose fluid injection pump. For example, in some non-limiting embodiments, any of the fluid injection pumps 522 may include one or more exemplary partial-dose fluid injection components described herein with respect to Figures 9 to 18, as well as any of those disclosed in International Patent Application PCT / US2024 / 022782, filed on April 3, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0112] In some non-limiting embodiments, the fluid injector 500 may further include one or more sensors 542 (which may be individually referred to as fluid injection pumps 542a, 542b, 542c, 542d, etc.). For example, one or more sensors 542 may include flow sensors, air sensors, concentration sensors, or other useful sensors. One or more sensors may be placed at various locations and positions on the first tube set 526 to provide data as input to the protocol management system 102.

[0113] In some non-limiting embodiments, the first tube set 526 may be a reusable set such that the first tube set 526 maintains sterility and is suitable for multiple infusion procedures to multiple patients without contaminating its reusable components. In some non-limiting embodiments, the reusable aspect of the system can be prepared for use by assembling a fluid pathway that includes the first tube set 526, a second tube set 532, and a fluid source 524, and by exhausting the air from the fluid pathway elements. The MEDRAD® Centargo CT infusion system offered by Bayer HealthCare LLC is a similar system. As shown in Figure 5, the valve assembly 528 of the first tube set 526 may include one or more valves 528a, 528b, 528c, 528d, etc., at various locations and positions on the first tube set 526 to provide fluid connections between various components of the fluid pathway. As further shown in Figure 5, a catheter 534 (e.g., patient IV) is connected to a fluid infusion unit 500 using a connecting member 530. In some non-limiting embodiments, the fluid injector 500 may also include a waste container W for containing the flushing agent and / or contrast fluid and / or unused flushing agent and / or contrast fluid discharged during priming.

[0114] Based on the intended study, information or data (e.g., patient details such as weight, height, condition, medication, allergies, and details of the infusion protocol) can be received by the protocol management system 102 as described herein, and the protocol management system 102 can provide a medical treatment plan and / or perform the infusion treatment. In some non-limiting embodiments, the protocol management system 102 and / or other systems described herein (e.g., fluid infusion system 108, medical imaging system 110) may be programmed by the operator, the operator may be offered programs for their confirmation, or the programs may be set and the operator may be allowed to confirm and modify the programs as needed.

[0115] In the exemplary system shown in Figure 5, the fluid infusion pumps 522a, 522b, and 522c may be syringes of similar size having, for example, a maximum deliverable volume of about 194 ml, and therefore may have similar performance characteristics. The fluid source 524a may include a flushing solution, such as saline, used to prime the fluid pathway elements, flush other drugs from the fluid pathway elements into the patient, move the drugs through the patient's peripheral circulation to its central circulation, and at that point the drugs are carried forward by the central circulation.

[0116] In some non-limiting embodiments, fluid sources 524a and 524b may contain contrast fluids. This exemplary configuration can provide the ability to inject a total volume greater than the total volume that one fluid infusion pump 522 (e.g., syringe) can hold, or the ability to deliver the entire dose even if one fluid source 524 is empty and has not yet been replaced, so that one of the fluid infusion pumps 522 has less fluid than is needed to administer the entire dose. In some non-limiting embodiments, the fluid sources 524 may contain different contrast fluids.

[0117] In some non-limiting embodiments, the fluid injector 500 may include only two fluid infusion pumps 522a, 522b, similar to the MEDRAD® MRXperion MR infusion system provided by Bayer HealthCare LLC, which uses only two fluid infusion pumps 522. In some examples, fluid infusion pump 522a may be used for flushing and may have a nominal volume of 110 ml. In some non-limiting embodiments, fluid infusion pump 522b may be used to administer contrast fluid and may have a nominal volume of about 65 ml. In some non-limiting embodiments, if the fluid injector 500 includes only one fluid infusion pump 522b for administering contrast agent, and the contrast fluid runs out from the fluid source 524b before the fluid infusion pump 522b is filled, the user may intervene to change the fluid source in order to continue the procedure. Additional fluid infusion pumps 522 may be used to infuse additional drugs (e.g., cardiac stressors for cardiac imaging).

[0118] In some non-limiting embodiments, the fluid injector 500 may utilize two fluid injection pumps 522 having syringes that deliver the same fluid but have significantly different cross-sectional areas, for example, five or ten times or more.

[0119] In some non-limiting embodiments, the fluid injection pump 522b may have a syringe with a nominal volume of 65 ml, as in the MRXperion, and the fluid injection pump 522c may have a reservoir 536c with a volume of 5 ml or 3 ml. In such exemplary embodiments, the fluid injection pump 522b can be used to deliver a volume greater than the capacity of the reservoir 536b of the fluid injection pump 522c, and the fluid injection pump 522c can be used to deliver a volume within its capacity.

[0120] The fluid infusion pump 522a is used to deliver the flushing fluid and may therefore use a larger syringe, such as a nominal 110 ml syringe. The required volume and flow rate of the flushing fluid generally do not change even if the volume of contrast agent or drug being delivered varies over a wide range, because a sufficient flow is needed to move the drug through the tube and the patient's vein within a reasonable timeframe, and a sufficient flush volume is needed to completely flush the line to the patient after the drug flow has stopped.

[0121] Referring now to Figure 6, which shows a non-limiting embodiment of the simplified fluid injector 500 functioning as described above, with a fluid injection pump 522b that can accommodate a larger syringe and a fluid injection pump 522c that can accommodate a smaller syringe, both connected to the same fluid source 524b containing the contrast fluid. This exemplary configuration accommodates the required range of fluid delivery.

[0122] Referring here to Figure 7, which shows a non-limiting embodiment of the fluid injector 500, the fluid injection pump 522d may include a partial-dose fluid injection component, which may be provided pre-filled with the same contrast fluid contained in the fluid source 524b. When a partial dose of the contrast fluid is anticipated to be needed, or when it is determined that a partial dose of the contrast fluid is required for a particular study, a small, pre-filled syringe may be included in the fluid injection pump 522d and connected to a fluid pathway line for delivery, depending on the requirements of the determined injection protocol.

[0123] In some non-limiting embodiments, the reservoir 536d of the fluid infusion pump 522d may be filled through valves 528c, 528d, 528h, and 528g with contrast agent from the fluid infusion pump 522b that had been previously drawn from the fluid source 524b. In this operation, valve 528W may be closed to prevent the fluid from flowing to the waste container W or patient P. After filling the fluid infusion pump 522a, the fluid infusion pump 522a may purge the line between the fluid infusion pumps 522b and 522d to the waste container W, thereby preventing the contrast fluid from being delivered to patient P until it is delivered by the fluid infusion pump 522b or 522d.

[0124] Referring here to Figure 8, Figure 8 shows a non-limiting embodiment that avoids the need to flush the line to the waste container W. The valve 528b associated with the fluid injection pump 522a containing the flushing solution may be connected to a connector member 530' and a fluid path element connecting the connector member 530 to the valve 528h of the fluid injection pump 522d. The connector member 530 can then be connected to the catheter 534 and the patient P. Thus, the contrast agent can be delivered from the fluid injection pump 522d by flushing from the fluid injection pump 522a without affecting the line between the valve 528d and the waste valve 528W.

[0125] Referring here to Figures 9 to 18, Figures 9 to 18 show exemplary embodiments of the partial-dose fluid injection component 900 (hereinafter, "partial component 900"). The partial component 900 can be implemented in place of, or in addition to, one or more fluid injectors such as the fluid injector 500 and / or the fluid injection pump 522 in a fluid injection system such as the fluid injection system 108, in order to perform an injection protocol for an injection procedure as described herein. In some non-limiting embodiments, the partial component 900 may include a partial-dose fluid injection pump. In some non-limiting embodiments, the partial component 900 may be a partial-dose fluid injection pump (e.g., a syringe-based pump, a peristaltic pump, a gear pump). In some non-limiting embodiments, the partial component 900 may be a syringe such as a microsyringe.

[0126] Referring here to Figure 9, Figure 9 shows a non-limiting embodiment of a sub-component 900 in which the fluid injection pump 522b can deliver smaller, more precise volumes of contrast fluid to a sub-pump 922, which can be a microsyringe, a small-bore pump, a small-bore cylinder, etc. The movement of the plunger 938 in the sub-pump 922 may be monitored by a camera or other sensor to ensure that it is filled to the precise volume. The contrast fluid may also be delivered by delivering saline, which is a flushing fluid, from the fluid injection pump 522a, which first delivers the contrast agent from the sub-pump 922 and then flows to the patient P. The contrast fluid may also be delivered by saline flushing until the plunger 938 hits the bottom and a pressure spike occurs. The contrast fluid may be pre-filled into the sub-pump 922 by either a manual hand syringe (not shown) or any other fluid injector pump described herein (e.g., fluid injection pump 522).

[0127] Referring here to Figures 10-12, Figures 10-12 show non-limiting embodiments of a sub-component 900 in which a sub-pump 922 (e.g., a smaller diameter fluid injection pump) is effectively housed within a fluid injection pump 522 (e.g., a larger diameter fluid injection pump). The fluid injection pump 522 and the sub-pump 922 may be driven by two independent actuators 544, 594, with the effect that moving a smaller piston or plunger rod results in more precise fluid delivery, and moving a larger plunger delivers a larger volume and / or flow rate.

[0128] Referring here to Figure 13, Figure 13 shows a non-limiting embodiment of a sub-component 900 in which a peristaltic-like mechanism for compressing the tube is used as one of the fluid injector pumps, for example, as a fluid injection pump 522. The tube may be filled with contrast agent from a fluid source 524 using reciprocating fingers 930 in a linear peristaltic motion. When filled with only the outlet pinch valve 934 closed, the fluid in the tube 926 can be isolated from the fluid source by closing the inlet pinch valve 932. To deliver the fluid, the outlet pinch valve 934 is opened and one or more of the fingers 930 of various sizes can be compressed in a controllable manner by varying amounts to deliver a range of required volumes.

[0129] Referring now to Figure 14, Figure 14 shows a non-limiting embodiment of a sub-component 900 in which the fluid injection pump 522 has a small syringe 922 and refills and dispenses the small syringe 922 multiple times during injection.

[0130] Referring now to Figure 15, Figure 15 shows a non-limiting embodiment of a component 900 in which a small syringe 922 accurately delivers a contrast agent into a patient line filled with saline. Once in the line, the injector can deliver the contrast agent and subsequent saline to the patient by dispensing fluid from the fluid infusion pump 522.

[0131] Referring here to Figures 16A to 16C, Figures 16A to 16C show non-limiting embodiments of a sub-component 900 in which a syringe for the manual delivery of a small amount of contrast agent utilizes a finger-shaped stopper 960 to prevent over-delivery by the person performing the injection.

[0132] Referring now to Figure 17, Figure 17 shows a non-limiting embodiment of the sub-component 900 in which saline wash is controlledly directed to flush the contrast agent from a series of small, precise volumes to deliver a desired dose to the patient.

[0133] Referring now to Figure 18, Figure 18 shows a non-limiting embodiment of a sub-component 900 in which the delivery accuracy from the syringe is controlled by a central rod or plunger whose diameter is slightly smaller than the syringe inner diameter (ID), and which can be manufactured using a more precise mechanism than the syringe barrel, such as centerless grinding.

[0134] In some non-limiting embodiments, an in-bore injector, such as the one disclosed in U.S. Patent Application No. 10 / 921,083, filed on 18 August 2004 and granted as U.S. Patent No. 7,632,245, whose entire disclosure is incorporated herein by reference, can be implemented as a component 900 for use with the fluid injector 500. Delivery accuracy can be sufficient by selecting, filling, and positioning a syringe appropriate to the volume to be used for the patient under study. Optionally, the syringe may be pre-filled precisely to the volume to be delivered, and thus its entire volume delivered, after which a saline flush may be performed.

[0135] In additional embodiments, when two or more fluids, such as contrast agents and saline, are delivered simultaneously and their total volumes and flow rates differ significantly from one another, it is beneficial to recognize that current practices for determining, describing, programming, or specifying, testing, verifying, and validating fluid delivery as a percentage of the total flow rate of contrast agent are difficult for users to understand, calculate, consider, and program, as well as difficult for engineers and designers to design, specify, verify, test, and validate. For example, in the case of a small patient with artificial intelligence (AI) applied to a study for image enhancement (e.g., fast image reconstruction using sparse sampling), the total dose of contrast agent may be, for example, 0.4 ml and may need to be delivered over 15 seconds to provide a sufficient enhancement duration for successful image acquisition, resulting in a contrast agent flow rate of 0.0267 ml / s. In some non-limiting embodiments, as disclosed in U.S. Patent Application No. 17 / 177,954, filed on 17 February 2021 and granted as U.S. Patent No. 11,717,605, whose disclosure is incorporated herein by reference in whole, it may be desirable to have a total volumetric flow to the patient at least 1 ml / s for adults so that the fluid moves through the arm to the central circulation at a sufficiently consistent rate. This injection may be followed by, for example, a 30 ml saline flush at 1 ml / s. Thus, in this example, the contrast agent percentage is 2.67%. This small ratio between the contrast agent volume and the injection volume and flow rate also affects how the flow rate and volumetric accuracy can be most usefully designed, specified, verified, tested, and / or validated. Injectors generally specify accuracy as a fixed value plus a programmed percentage of the total volume or flow rate. However, if only 2.67% contrast agent is injected, and it is desirable that the flow rate and volume of the contrast agent be accurate with a 10% precision, then when the contrast agent is programmed as a percentage of the total fluid, the precision of the total fluid, which is mainly controlled by the precision of the flash fluid, needs to be accurate with a precision of approximately 0.267% ((10% * 0.0267 ml / S) / 1 ml / S).

[0136] In some non-limiting embodiments, the flow rates or volumes of two or more fluids injected together over a given duration may be programmed or specified individually, separately, or independently, in identical or compatible units. In this example, the injection may be programmed to inject a 0.4 ml contrast agent volume for 15 seconds and simultaneously flush with 15 ml of saline for the same duration, or to inject a 4 ml contrast agent volume at a flow rate of 0.0267 ml / S and flush with 15 ml at 0.9733 ml / S, or the contrast agent may be programmed to flush with 0.9733 ml / S for 15 seconds at a flow rate of 0.0267 ml / S for a duration of 15 seconds, where, for a constant flow, the flow rate is equal to the volume divided by the duration.

[0137] In some non-limiting embodiments, in the injector specification, design, verification, testing, validation, and / or approval processes for devices, systems, associated components, and methods for delivering precise and / or small amounts of contrast agent and / or standard amounts of contrast agent and / or saline, the precision of each fluid and / or flow rate may be specified as precision relating to the individual flow rate or volume, rather than the total or net flow rate or volume of the combined flow. In some non-limiting examples, as discussed herein, the contrast agent volume may be specified as a volume of 0.4 ml + / - 10% and a flow rate of 0.0267 ml / s + / - 10%, and the saline flush may be specified as a volume of 15 ml + / - 10% and a flow rate of 1 ml / s + / - 10%. The contrast agent may be injected into the flushing fluid flow, in which case, for example, if the flushing fluid mistakenly flows to a higher level, the total fluid will be more diluted than if the flash had been delivered accurately at the programmed flash flow rate. However, the amount of contrast agent entering the patient's body over time may only be affected by the error in the contrast agent flow rate. This is because a higher flushing fluid volume results in a greater total fluid movement per unit time, but a lower concentration of contrast agent. Consequently, under a first-order approximation, the amount of contrast agent entering the patient per unit time may not be affected by the error in the flash flow rate. In some non-limiting examples, the contrast agent flow rate may be + / - 5%, while the flash flow rate may be + / - 20%. In practice, the consistency of the flash flow rate may be more important than the precision of the flash flow rate. The precise specification and specified percentage of precision depend on several factors, such as what is possible, what is required by regulatory bodies, and factors affecting image quality. In some non-limiting embodiments, it may also be useful to specify the precision (or variability) and absolute precision of the injection.

[0138] In the above example, the contrast agent and injection duration are described as the same, with a dual-flow phase followed by a saline-only flush phase. However, in some non-limiting embodiments, the injection can be described or programmed as a single, longer saline phase with a shorter contrast agent phase that may start after some delay and end before the end of the saline phase. This type of injection is shown in Figure 5A of U.S. Patent Application No. 17 / 606,532, filed 2 June 2020 and published as U.S. Patent Application Publication No. 2022 / 0133982A1, whose disclosure is incorporated herein by reference in its entirety. If the flow rate of the contrast agent is significantly smaller than the flow rate of saline, for example less than 10%, the flow rate of saline may optionally remain constant, with only the contrast agent flow being added.

[0139] Several examples of devices, systems, associated components, and methods for delivering precise and / or small amounts of contrast agent and / or standard amounts of contrast agent to enhance images during medical imaging procedures are shown in the accompanying figures and described in detail above, but other embodiments will be obvious to those skilled in the art and can be easily created without departing from the scope and spirit of the disclosure. Therefore, the foregoing description is intended to be illustrative rather than restrictive. The various embodiments of the disclosure described above are defined by the accompanying claims, and all modifications to the disclosed concepts that fall within the same meaning and scope as the claims should be included within those scopes.

[0140] The systems, methods, and various embodiments and aspects thereof described above are described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments; however, such details are for that purpose only, and it should be understood that this disclosure is not limited to the embodiments or aspects described, but rather intended to cover modifications and equivalent configurations within the spirit and scope of the system. For example, this disclosure is intended to allow, wherever possible, one or more features of any embodiment or aspect to be combined with one or more features of any other embodiment or aspect. In fact, any of these features can be combined in ways not specifically disclosed herein. [Explanation of Symbols]

[0141] 100 Environment, 102 Protocol Management System, 102 Fluid Protocol Management System, 104 Data Source, 106 User Device, 108 Fluid Injection System, 110 Medical Imaging System, 112 Hospital Information, 112 Hospital Information System, 114 Communication Network, 200 System, 206 Workstation Device, 206A Display Unit, 208 Fluid Injector, 208 Fluid Injection System, 208A Fluid Injector, 210 Imaging System, 210 Medical Imaging System, 212 Hospital Information System, 212A Patient Treatment Tracking System, 212B Image Archive and Communication System, 212C Radiology Information System, 212D Radiology Analysis System, 216 Electronic Health Record System, 218 Electronic Medical Record System, 300 Device, 302 Bus, 304 Processor, 306 Memory, 308 Storage Components, 310 Input Components, 312 Output Components, 314 Communication interface, 400 process, 402 step, 404 step, 406 step, 408 step, 410 step, 500 fluid injector, 500 fluid injection system, 522 fluid injector pump, 522 fluid injection pump, 522a fluid injection pump, 522b fluid injection pump, 522c fluid injection pump, 522d fluid injection pump, 524 fluid source, 524a fluid source, 524b fluid source, 524c fluid source, 524d fluid source, 526 tube set, 528 valve assembly, 528W valve, 528W waste valve, 528a valve, 528b valve, 528c valve, 528d valve, 528g valve, 528h valve, 530 connector component, 530 connecting component, 530' connector component, 532 tube set, 534 Catheter, 536 Reservoir, 536a Reservoir, 536b Reservoir, 536c Reservoir, 536d Reservoir, 536e Reservoir, 538 Plunger, 538a Plunger, 538b Plunger, 538c Plunger, 538d Plunger, 538e Plunger, 540 Drive Member, 540a Drive Member, 540b Drive Member, 540c Drive Member, 540d Drive Member, 540e Drive Member, 542 Sensor, 542a Fluid Injection Pump, 542b Fluid Injection Pump, 542c Fluid Injection Pump, 542dFluid injection pump, 544 actuator, 594 actuator, 900 partial-dose fluid injection component, 900 partial component, 922 mini syringe, 922 partial pump, 926 tubing, 930 finger, 930 reciprocating finger, 932 inlet pinch valve, 934 outlet pinch valve, 938 plunger, 960 finger-shaped stopper

Claims

1. A method for performing an injection procedure, The steps include using at least one processor to select a specific dose of contrast fluid from multiple doses of contrast fluid to be administered to a patient during an infusion procedure, A step of automatically executing an injection protocol for the injection procedure, based on selecting a specific dose of the contrast fluid from a plurality of doses of the contrast fluid using at least one processor, wherein the injection protocol includes the specific dose; A step of generating an image of a region of the patient's body based on automatically executing the injection protocol using at least one processor, A step of generating image analysis results of the image of the region of the patient's body using at least one processor, A step of determining whether the image analysis result satisfies an image quality threshold using at least one processor, A method for performing an injection procedure, including the following.

2. Based on the determination that the image analysis results do not meet the image quality threshold, the step of automatically executing an additional injection protocol for the injection procedure, The steps include generating additional image analysis results for the images of the region of the patient's body, The steps include determining whether the additional image analysis results satisfy the image quality threshold, The method according to claim 1, further comprising:

3. The step of selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure is: The step of determining whether to administer a standard dose or a partial dose of the contrast fluid to the patient during the injection procedure. The method according to claim 1, including the method described in claim 1.

4. The step of automatically executing the injection protocol for the injection procedure is: A step of automatically executing the infusion protocol for the infusion procedure based on a decision to administer the partial dose of the contrast fluid during the infusion procedure to the patient, wherein the infusion protocol includes the partial dose. The method according to claim 3, including the method described in claim 3.

5. The step of automatically executing the injection protocol for the injection procedure is: The step of controlling a partial-dose fluid infusion component to administer the partial dose of the contrast fluid during the infusion procedure to the patient. The method according to claim 3, including the method described in claim 3.

6. The step of selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure is: A step of automatically selecting a specific dose of the contrast fluid from a plurality of doses of the contrast fluid to be administered to the patient during an infusion procedure, based on the results of inference by a machine learning model. The method according to claim 1, including the method described in claim 1.

7. The step of automatically selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure is: A step of providing input to the machine learning model based on the request for inference of the machine learning model, wherein the input includes a plurality of features, and the plurality of features are Patient's weight, Patient's height, Patient's age, Patient's gender, Patient's body type, Patient's medical history, The patient's physiological state, Physiological measurements of the patient, or Any combination A step including at least one of the following, A step of generating an output of the machine learning model based on the input, wherein the output includes a prediction of the dose of the contrast fluid to be administered to the patient during the infusion procedure, The method according to claim 6, including the method described in claim 6.

8. A system for providing medical treatment plans, Fluid injector, At least one processor coupled to the fluid injector, During the infusion procedure to the patient, a specific dose of contrast fluid is selected from multiple doses of contrast fluid administered by the fluid infusion system. Based on selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid, an injection protocol for the injection procedure is automatically executed, and the injection protocol includes the specific dose. Based on the automatic execution of the injection protocol, images of the patient's body region are generated. The image analysis results of the image of the area of ​​the patient's body are generated. The image analysis results determine whether the image quality threshold is met. A system comprising at least one processor configured as follows: A system for providing medical treatment plans, equipped with the necessary features.

9. The aforementioned at least one processor is Based on the determination that the image analysis results do not meet the image quality threshold, an additional injection protocol for the injection procedure is automatically executed. The system generates additional image analysis results for the images of the area of ​​the patient's body. The results of the additional image analysis determine whether the image quality threshold is met. The system according to claim 8, further configured as follows.

10. When selecting a particular dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor, During the injection procedure for the patient, it is determined whether to administer a standard dose of the contrast fluid or a partial dose of the contrast fluid. The system according to claim 8, further programmed or configured as follows.

11. When the injection protocol for the injection procedure is automatically executed, the at least one processor, Based on the decision to administer the partial dose of the contrast fluid during the infusion procedure to the patient, the infusion protocol for the infusion procedure is automatically executed. The system according to claim 10, further programmed or configured such that the injection protocol includes the partial dose.

12. When the injection protocol for the injection procedure is automatically executed, the at least one processor, Control the partial-dose fluid infusion component to administer the partial dose of the contrast fluid during the infusion procedure to the patient. The system according to claim 10, further programmed or configured as follows.

13. When selecting a particular dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor, Based on the inference results of the machine learning model, the system automatically selects the specific dose of the contrast fluid from the multiple doses of the contrast fluid administered to the patient during the infusion procedure. The system according to claim 8, further programmed or configured as follows.

14. When automatically selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor: An input is provided to the machine learning model based on the inference request of the machine learning model, the input includes a plurality of features, and the plurality of features are Patient's weight, Patient's height, Patient's age, Patient's gender, Patient's body type, Patient's medical history, The patient's physiological state, Physiological measurements of the patient, or Any combination of them Includes at least one of the following: Based on the input, the machine learning model generates an output, the output including a prediction of the dose of the contrast fluid to be administered to the patient during the infusion procedure. The system according to claim 13, further programmed or configured as follows.

15. A fluid injection system for providing medical treatment plans, A fluid injector, Partial-dose fluid injection components, and Standard dose fluid injection components A fluid injector equipped with, At least one processor coupled to the fluid injector, During the infusion procedure to the patient, it is determined whether to administer a standard dose of the contrast fluid using the standard dose fluid infusion component, or a partial dose of the contrast fluid using the partial dose fluid infusion component. During the injection procedure for the patient, the partial dose of the contrast fluid is administered by the partial-dose fluid injection component, and During the injection procedure for the patient, the standard dose of the contrast fluid is administered by the standard dose fluid injection component. Based on determining one of the above, the injection protocol for the injection procedure is automatically executed. Based on the automatic execution of the injection protocol, images of the patient's body region are generated. The image analysis results of the image of the area of ​​the patient's body are generated. The image analysis results determine whether the image quality threshold is met. A system comprising at least one processor configured as follows: A fluid injection system equipped with the following features.

16. The partial-dose fluid injection component comprises a partial-dose fluid injection pump, and when the injection protocol for the injection procedure is automatically executed, the at least one processor, The partial-dose fluid injection pump is operated. The fluid injection system according to claim 15, configured as described above.

17. When operating the partial-dose fluid injection pump, the at least one processor, The sensor receives fluid flow data, Based on the fluid flow data received from the sensor, the fluid flow rate in the fluid path is determined. A control signal is output to the aforementioned partial-dose fluid injection pump. The fluid injection system according to claim 16, configured as described above.

18. When operating the partial-dose fluid injection pump, the at least one processor, The sensor receives fluid data, including an indication of whether air is present in the fluid path. Based on the fluid data received from the sensor, it is determined whether a threshold amount of air exists in the fluid path. Based on the determination that air is present in the fluid path, a control signal is output to the partial-dose fluid injection pump. The fluid injection system according to claim 16, configured as described above.

19. When operating the partial-dose fluid injection pump, the at least one processor, The sensor receives contrast fluid concentration data. Based on the contrast fluid concentration data received from the sensor, the concentration of the contrast fluid in the fluid path is determined. A control signal is output to the aforementioned partial-dose fluid injection pump. The fluid injection system according to claim 16, configured as described above.

20. The aforementioned fluid injector is At least one fluid injection pump, At least one fluid source, A first tube set having at least one valve assembly, Equipped with, The at least one valve assembly is configured to selectively provide a fluid connection between the at least one fluid source and the first tube set, between the first tube set and the at least one fluid injection pump, or between the at least one fluid source, the first tube set, and the at least one fluid injection pump. The fluid injection system according to claim 15.

21. The first tube set includes a connector member configured to connect to the second tube set, The second tube set is connected to a catheter configured to be fluidly connected to the patient, The at least one valve assembly is configured to selectively provide a fluid connection between the first tube set and the second tube set. The fluid injection system according to claim 20.

22. The aforementioned fluid injector is Two or more fluid injection pumps, Two or more fluid sources, Equipped with, Each of the two or more fluid injection pumps is Reservoir and, Plunger and, Driving member and Equipped with, The aforementioned at least one processor is Receive the injection protocol and associated injection protocol data for the injection procedure. Based on the injection protocol data, the control parameters of the drive member are determined. The drive member is activated to output a control signal to the drive member for delivering the selected dose of the contrast fluid to the patient. The fluid injection system according to claim 15, configured such that the control signal is based on the control parameter.

23. The aforementioned fluid injector is Two or more fluid injection pumps, Two or more fluid sources, Equipped with, Each of the two or more fluid injection pumps is Tube and, Rotating member and Driving member and Equipped with, The aforementioned at least one processor is Receive the injection protocol and associated injection protocol data for the injection procedure. Based on the injection protocol data, the control parameters of the drive member are determined. The drive member is activated to output a control signal to the drive member for delivering the selected dose of the contrast fluid to the patient. The fluid injection system according to claim 15, configured such that the control signal is based on the control parameter.

24. The aforementioned at least one processor is Based on the determination that the image analysis results do not meet the image quality threshold, an additional injection protocol for the injection procedure is automatically executed. The system generates additional image analysis results for the images of the area of ​​the patient's body. The results of the additional image analysis determine whether the image quality threshold is met. The fluid injection system according to claim 15, further configured as follows.

25. When selecting a specific dose of the contrast fluid from a plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor, During the injection procedure for the patient, it is determined whether to administer a standard dose of the contrast fluid or a partial dose of the contrast fluid. The fluid injection system according to claim 15, further programmed or configured as follows.

26. When the injection protocol for the injection procedure is automatically executed, the at least one processor, Based on the decision to administer the partial dose of the contrast fluid during the infusion procedure to the patient, the infusion protocol for the infusion procedure is automatically executed. The fluid injection system according to claim 25, further programmed or configured such that the injection protocol includes the partial dose.

27. When the injection protocol for the injection procedure is automatically executed, the at least one processor, Control the partial-dose fluid infusion component to administer the partial dose of the contrast fluid during the infusion procedure to the patient. The fluid injection system according to claim 25, further programmed or configured as follows.

28. When selecting a particular dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor, Based on the inference results of the machine learning model, the system automatically selects the specific dose of the contrast fluid from the multiple doses of the contrast fluid administered to the patient during the infusion procedure. The fluid injection system according to claim 25, further programmed or configured as follows.

29. When automatically selecting a specific dose of the contrast fluid from the plurality of doses of the contrast fluid administered to the patient during the infusion procedure, the at least one processor: An input is provided to the machine learning model based on the inference request of the machine learning model, the input includes a plurality of features, and the plurality of features are Patient's weight, Patient's height, Patient's age, Patient's gender, Patient's body type, Patient's medical history, The patient's physiological state, Physiological measurements of the patient, or Any combination of them Includes at least one of the following: Based on the input, the machine learning model generates an output, the output including a prediction of the dose of the contrast fluid to be administered to the patient during the infusion procedure. The fluid injection system according to claim 28, further programmed or configured as follows.

30. A fluid infusion system for providing fluid infusion as part of a medical treatment plan, A fluid injector, A first dose fluid injection component, A second dose fluid injection component, A fluid injector equipped with, At least one processor coupled to the fluid injector, During the fluid injection, the first fluid from the first dose fluid injection component and the second fluid from the second dose fluid injection component are delivered simultaneously. It is configured in such a way, The delivery flow rates of the first fluid and the delivery flow rates of the second fluid are specified independently over the duration of the fluid injection, or The total delivery volume of the first fluid and the total delivery volume of the second fluid are specified independently over the duration of the injection. At least one processor, A fluid injection system equipped with the following features.

31. The aforementioned fluid injector is Two or more fluid injection pumps, Two or more fluid sources, Equipped with, Each of the two or more fluid injection pumps is Reservoir and, Plunger and, Driving member and Equipped with, The aforementioned at least one processor is Receive the injection protocol and associated injection protocol data for the injection procedure. Based on the injection protocol data, the control parameters of the drive member are determined. The drive member is activated to output a control signal to the drive member for delivering the selected dose of the contrast fluid to the patient. The fluid injection system according to claim 30, configured such that the control signal is based on the control parameters.

32. The accuracy of the delivery flow rate of the first dose fluid injection component and the accuracy of the delivery flow rate of the second dose fluid injection component are designed, specified, verified, tested, and / or validated separately, and / or The accuracy of the total delivery volume of the first dose fluid injection component and the accuracy of the total delivery volume of the second dose fluid injection component are designed, specified, verified, tested, and / or validated separately. The fluid injection system according to claim 30.

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