This disclosure relates generally to systems, devices, products, apparatus, and methods that are used for configurable/customizable pressure limiting behavior for fluid injection devices. Configuration and/or customization of the pressure limiting behavior may be performed by a user or by the system based on a series of inputted parameters.
In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician or radiologist, injects a patient with one or more fluids using a powered fluid injector system. In recent years, a number of powered fluid injector systems for pressurized injection of fluids have been developed for use in procedures such as angiography, computed tomography (CT), molecular imaging (such as PET imaging), and magnetic resonance imaging (MRI).
Patient catheters used in any powered injection procedure include pressure ratings which are selected to prevent intravenous (IV) site failure during the injection procedure. Depending on factors such as, e.g., the type of procedure, the age of the patient, etc., fluid injector systems have pre-programmed pressure limits to ensure that the fluid pressure does not exceed the rating of the patient catheter used at the injection site. For some catheters commonly used at sensitive injection sites such as, e.g., Central Venous Catheters, Peripherally Inserted Central Catheter (PICC), etc., there is a desire to ensure that the fluid pressure does not exceed the pressure limit. However, even with the pre-programmed pressure limits, the maximum recorded pressure may still be in excess of these pre-programmed pressure limits in some cases.
Alternatively, in other procedures where slight overpressure may not be as undesirable, it may be more advantageous to maintain the fluid flow rate as close as possible to the commanded injection flow rate in order to ensure that the injection procedure is successfully completed. However, in current fluid injector systems, when the pre-programmed pressure limit is breached, the fluid flow is significantly reduced so as to quickly lower the pressure in the system. Unfortunately, this abrupt reduction in fluid flow may negatively affect the injection procedure and may necessitate that the injection be aborted and/or repeated.
Despite these potential issues, the pressure limits are typically determined by the manufacturer and hard-coded into the system, and the medical practitioner is unable to configure or customize the pressure limiting behavior to suit a particular injection procedure. Accordingly, there is a need in the art to improve the setting of pressure limiting behavior for fluid injection devices.
Accordingly, provided are systems, devices, products, apparatus, and/or methods for a fluid injector system that provides for improved pressure limiting behaviors.
In some non-limiting embodiments or aspects, a fluid injector system may be configured for administering at least one fluid. The fluid injector system may include: at least one fluid injector device; at least one user interface; and a control device in communication with the at least one user interface, the control device utilize at least one of internal inputs and external inputs to instruct the at least one fluid injector device to perform a fluid injection procedure according to a profile that determines prioritization of maintaining flow rate or limiting a fluid delivery pressure. The at least one of internal inputs and external inputs may be selected from the group consisting of receiving a maximum pressure limit for a fluid injection procedure; receiving a programmed fluid flow rate for the fluid injection procedure; receiving a maximum fluid flow rate reduction input for the fluid injection procedure, wherein the maximum fluid flow rate reduction input is selected by a user via the at least one user interface or by the system based off of at least one of patient information and system injection parameters; receiving a pressure limit sensitivity input for the fluid injection procedure, wherein the pressure limit sensitivity input is selected by the user via the at least one user interface; and or any combination thereof, and wherein the control device is further configured to instruct the at least one fluid injector device to perform the injection procedure based on one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
In some non-limiting embodiments or aspects, the at least one user interface may include at least one graphical user interface and wherein the at least one graphical user interface displays a flow rate profile of the fluid injection procedure, wherein the displayed flow rate profile further indicates one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
In some non-limiting embodiments or aspects, the at least one processor may be further programmed or configured to reduce the fluid flow rate of the at least one fluid injector device to provide a reduction in flow rate below the programmed fluid flow rate when a predetermined threshold pressure relative to the maximum pressure limit is reached.
In some non-limiting embodiments and aspects, the reduction in fluid flow rate may have one of a linear or non-linear flow reduction profile.
In some non-limiting embodiments and aspects, the reduction of fluid flow rate is based on at least one input provided by a user of the fluid injector device. For example, in certain embodiments the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures. In various embodiments, the at least one user input provided by the user is selected by the user from a series of inputs saved in a protocol library or inputted manually by the user prior to initiation of the fluid injection procedure.
In some non-limiting embodiments and aspects, the reduction in fluid flow rate is based on at least one internally sourced or externally sourced input. For example, in certain embodiments the at least one internally sourced or externally sourced input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and combinations of any thereof. The one or more barcodes is located on a patient record, the fluid injector, a medical fluid container, a sterile disposable, and combinations thereof.
In some non-limiting embodiments or aspects, the maximum fluid flow rate reduction input may be user- or system-selectable within a range of 0% to 100% of the programmed fluid flow rate. In some non-limiting embodiments or aspects, the at least one processor may be programmed or configured to abort the injection procedure if the maximum fluid flow rate reduction input of a critical number (e.g., 0%) is selected and a pressure of the at least one fluid is detected to equal or exceed the maximum pressure limit. In other embodiments, the fluid injection may be aborted when a predetermined threshold is reached or exceeded, where the threshold may be a percentage of the programmed pressure limit.
In some non-limiting embodiments or aspects, the pressure limit sensitivity input may be user- or system-selectable within a configurable range from low sensitivity to high sensitivity.
In some non-limiting embodiments or aspects, the at least one processor may be programmed or configured to abort the injection procedure if specific configuration criteria are met and the pressure is detected to equal or exceed the predetermined pressure threshold.
In some non-limiting embodiments or aspects, a method of user- or system-configurable pressure limiting behavior for a fluid injector system may be configured for administering at least one fluid. The method may comprise providing at least one of internal inputs and external inputs to a fluid injector system; prioritizing maintaining flow rate or limiting a fluid delivery pressure based on the at least one of the internal inputs and the external inputs; developing an injection profile based on the prioritizing; and instructing an at least one fluid injector device to perform a fluid injection procedure according to the injection profile. According to certain non-limiting embodiments or aspects, wherein providing the at least one of internal inputs and external inputs comprises an operation selected from the group consisting of inputting or selecting a maximum pressure limit for an injection procedure into at least one user interface in communication with a control device of the fluid injector system, wherein the control device comprises at least one processor; inputting or selecting a programmed fluid flow rate for injecting at least one fluid from the at least one fluid injector device; inputting or selecting a maximum fluid flow rate reduction input for the injection procedure based off of at least one of patient information and system injection parameters; inputting or selecting a pressure limit sensitivity input for the injection procedure; and combinations of any thereof. According to certain non-limiting embodiments or aspects, the method may further comprise generating, by the control device, instructions to the fluid injector system to perform the injection procedure based on the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
In some non-limiting embodiments or aspects, the at least on user interface may include at least one graphical user interface and wherein the at least one graphical user interface displays a flow rate profile of the fluid injection procedure, wherein the displayed flow rate profile further indicates one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
In some non-limiting embodiments or aspects, the method may further include reducing, by the control device, the fluid flow rate of the at least one fluid injector device to provide a reduction in flow rate below the programmed fluid flow rate when a predetermined threshold pressure relative to the maximum pressure limit is reached.
In some non-limiting embodiments or aspects, reducing the fluid flow rate is based on at least one input provided by a user of the fluid injector device. For example, in certain embodiments, the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures. In certain embodiments, the at least one user input provided by the user is selected by the user from a series of inputs saved in a protocol library or inputted manually by the user prior to initiation of the fluid injection procedure.
In some non-limiting embodiments or aspects, reducing the fluid flow rate is based on at least one internally sourced or externally sourced input. For example, in certain embodiments, the at least one internally sourced or externally sourced input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and combinations of any thereof. The one or more barcodes is located on a patient record, the fluid injector, a medical fluid container, a sterile disposable, and combinations thereof.
In some non-limiting embodiments or aspects, inputting or selecting the maximum fluid flow rate reduction input may include inputting or selecting a user- or system-selectable input within a range of 0% to 100% of the programmed fluid flow rate.
In some non-limiting embodiments or aspects, the method may further comprise aborting the injection procedure if a maximum fluid flow rate reduction input of a critical number (e.g., 0%) is selected and a pressure of the at least one fluid is detected to exceed the maximum pressure limit. In other embodiments, the fluid injection may be aborted when a predetermined threshold is reached or exceeded, where the threshold may be a percentage of the programmed pressure limit.
In some non-limiting embodiments or aspects, inputting or selecting the pressure limit sensitivity input may include inputting or selecting a user- or system-selectable input within a configurable range from low sensitivity to high sensitivity.
In some non-limiting embodiments or aspects, the method may further comprise aborting the injection procedure if specific configuration criteria are met and the pressure is detected to exceed the predetermined pressure threshold.
Further non-limiting embodiments are set forth in the following numbered clauses:
Clause 1. A fluid injector system configured for administering at least one fluid, the fluid injector system comprising: at least one fluid injector device; at least one user interface; and a control device in communication with the at least one user interface, the control device comprising at least one processor programmed or configured to utilize at least one of internal inputs and external inputs to instruct the at least one fluid injector device to perform a fluid injection procedure according to a profile that determines prioritization of maintaining flow rate or limiting a fluid delivery pressure.
Clause 2 The fluid injector system of clause 1, wherein the at least one of internal inputs and external inputs are selected from the group consisting of: receiving a maximum pressure limit for a fluid injection procedure; receiving a programmed fluid flow rate for the fluid injection procedure; receiving a maximum fluid flow rate reduction input for the fluid injection procedure, wherein the maximum fluid flow rate reduction input is selected by a user via the at least one user interface or by the system based off of at least one of patient information and system injection parameters; receiving a pressure limit sensitivity input for the fluid injection procedure, wherein the pressure limit sensitivity input is selected by the user via the at least one user interface; and any combination thereof, wherein the control device is further configured to instruct the at least one fluid injector device to perform the injection procedure based on one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
Clause 3. The fluid injector system of clause 1 or 2, wherein the at least one user interface comprises at least one graphical user interface and wherein the at least one graphical user interface displays a flow rate profile of the fluid injection procedure, wherein the displayed flow rate profile further indicates one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
Clause 4. The fluid injector system of any one of clauses 1 to 3, wherein the at least one processor is programmed or configured to limiting a fluid delivery pressure by reducing a flow rate of the fluid, diluting a more viscous fluid with a less viscous fluid, or combinations thereof.
Clause 5. The fluid injector system of any one of clauses 1 to 3, wherein the at least one processor is further programmed or configured to reduce the fluid flow rate of the at least one fluid injector device to provide a reduction in flow rate below the programmed fluid flow rate when a predetermined threshold pressure relative to the maximum pressure limit is reached.
Clause 6. The fluid injector system of clause 5, wherein the reduction in fluid flow rate has one of a linear or non-linear flow reduction profile.
Clause 7. The fluid injector system of clause 5, wherein the reduction of fluid flow rate is based on at least one input provided by a user of the fluid injector device.
Clause 8. The fluid injector system of clause 7, wherein the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures.
Clause 9. The fluid injector system of clause 8, wherein the at least one user input provided by the user is selected by the user from a series of inputs saved in a protocol library or inputted manually by the user prior to initiation of the fluid injection procedure.
Clause 10. The fluid injector system of clause 5, wherein the reduction in fluid flow rate is based on at least one internally sourced or externally sourced input.
Clause 11. The fluid injector system of clause 10, wherein the at least one internally sourced or externally sourced input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and combinations of any thereof, wherein the one or more barcodes is located on a patient record, the fluid injector, a medical fluid container, a sterile disposable, and combinations thereof.
Clause 12. The fluid injector system of any one of clauses 2 to 11, wherein the maximum fluid flow rate reduction input is user- or system-selectable within a range of 0% to 100% of the programmed fluid flow rate.
Clause 13. The fluid injector system of any one of clauses 2 to 12, wherein the at least one processor is programmed or configured to abort the injection procedure if the maximum fluid flow rate reduction input of 0% is selected and a pressure of the at least one fluid is detected to equal or exceed the maximum pressure limit.
Clause 14. The fluid injector system of any one of clauses 2 to 13, wherein the pressure limit sensitivity input is user- or system-selectable within a configurable range from low sensitivity to high sensitivity.
Clause 15. The fluid injector system of any one of clauses 5 to 14, wherein the at least one processor is programmed or configured to abort the injection procedure if specific configuration criteria are met and the pressure is detected to equal or exceed the predetermined pressure threshold.
Clause 16. A method of user- or system-configurable pressure limiting behavior for a fluid injector system configured for administering at least one fluid comprising: providing at least one of internal inputs and external inputs to a fluid injector system; prioritizing maintaining flow rate or limiting a fluid delivery pressure based on the at least one of the internal inputs and the external inputs; developing an injection profile based on the prioritizing; and instructing an at least one fluid injector device to perform a fluid injection procedure according to the injection profile.
Clause 17. The method of clause 16, wherein providing the at least one of internal inputs and external inputs comprises an operation selected from the group consisting of: inputting or selecting a maximum pressure limit for an injection procedure into at least one user interface in communication with a control device of the fluid injector system, wherein the control device comprises at least one processor; inputting or selecting a programmed fluid flow rate for injecting at least one fluid from the at least one fluid injector device; inputting or selecting a maximum fluid flow rate reduction input for the injection procedure based off of at least one of patient information and system injection parameters; inputting or selecting a pressure limit sensitivity input for the injection procedure; and combinations of any thereof.
Clause 18. The method of clause 17 further comprising generating, by the control device, instructions to the fluid injector system to perform the injection procedure based on the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
Clause 19. The method of any one of clauses 16 to 18, wherein the at least on user interface comprises at least one graphical user interface and wherein the at least one graphical user interface displays a flow rate profile of the fluid injection procedure, wherein the displayed flow rate profile further indicates one or more of the maximum pressure limit, the programmed fluid flow rate, the maximum fluid flow rate reduction input, and the pressure limit sensitivity input.
Clause 20. The method of any one of clauses 16 to 19, further comprising limiting a fluid delivery pressure by reducing a flow rate of the fluid, diluting a more viscous fluid with a less viscous fluid, or combinations thereof.
Clause 21. The method of any one of claims 16 to 20, further comprising reducing, by the control device, the fluid flow rate of the at least one fluid injector device to provide a reduction in flow rate below the programmed fluid flow rate when a predetermined threshold pressure relative to the maximum pressure limit is reached.
Clause 22. The method of clause 21, wherein reducing the fluid flow rate is based on at least one input provided by a user of the fluid injector device.
Clause 23. The method of clause 22, wherein the at least one input provided by the user is provided for all fluid injection procedures performed by the fluid injector system, provided for each fluid injection procedure, or provided for a limited set of fluid injection procedures.
Clause 24. The method of clause 23, wherein the at least one user input provided by the user is selected by the user from a series of inputs saved in a protocol library or inputted manually by the user prior to initiation of the fluid injection procedure.
Clause 25. The method of clause 21, wherein reducing the fluid flow rate is based on at least one internally sourced or externally sourced input.
Clause 26. The method of clause 25, wherein the at least one internally sourced or externally sourced input is selected from the group consisting of historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and combinations of any thereof, wherein the one or more barcodes is located on a patient record, the fluid injector, a medical fluid container, a sterile disposable, and combinations thereof.
Clause 27. The method of any one of clauses 17 to 26, wherein inputting or selecting the maximum fluid flow rate reduction input comprises inputting or selecting a user- or system-selectable input within a range of 0% to 100% of the programmed fluid flow rate.
Clause 28. The method of any one of clauses 17 to 27, further comprising aborting the injection procedure if a maximum fluid flow rate reduction input of 0% is selected and a pressure of the at least one fluid is detected to exceed the maximum pressure limit.
Clause 29. The method of any of clauses 17 to 28, wherein inputting or selecting the pressure limit sensitivity input comprises inputting or selecting a user- or system-selectable input within a configurable range from low sensitivity to high sensitivity.
Clause 30. The method of any one of clauses 21 to 28, further comprising aborting the injection procedure if specific configuration criteria are met and the pressure is detected to exceed the predetermined pressure threshold.
These and other features and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the disclosure. As used in the specification and the claims, the singular form of “a,” “an,” and “the” include plural referents unless context clearly dictates otherwise.
Additional advantages and details of the disclosure are explained in greater detail below with reference to the exemplary embodiments or aspects that are illustrated in the accompanying schematic figures, in which:
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. When used in relation to a syringe of a multi-patient disposable set, the term “proximal” refers to a portion of a syringe nearest a piston for delivering fluid from a syringe.
Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.
All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value.
As used herein, the term “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term “at least two of” is synonymous with “two or more of”. For example, the phrase “at least two of D, E, and F” means any combination of any two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.
It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary examples of the disclosure. Hence, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.
When used in relation to a fluid reservoir, such as a syringe, a rolling diaphragm, or multiple syringe disposable set, the term “distal” refers to a portion of the fluid reservoir nearest to a patient. When used in relation to a fluid reservoir, such as a syringe, a rolling diaphragm, or multiple syringe disposable set, the term “proximal” refers to a portion of the fluid reservoir nearest to the injector system.
As used herein, the terms “communication” and “communicate” may refer to the reception, receipt, transmission, transfer, provision, and/or the like of information (e.g., data, signals, messages, instructions, commands, and/or the like). For one unit (e.g., a device, a system, a component of a device or system, combinations thereof, and/or the like) to be in communication with another unit means that the one unit is able to directly or indirectly receive information from and/or transmit information to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature. Additionally, two units may be in communication with each other even though the information transmitted may be modified, processed, relayed, and/or routed between the first and second unit. For example, a first unit may be in communication with a second unit even though the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediary unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet and/or the like) that includes data. It will be appreciated that numerous other arrangements are possible.
As used herein, the term “server” may refer to one or more computing devices, such as processors, storage devices, and/or similar computer components that communicate with client devices and/or other computing devices over a network, such as the Internet or private networks, and, in some examples, facilitate communication among other servers and/or client devices. It will be appreciated that various other arrangements are possible. As used herein, the term “system” may refer to one or more computing devices or combinations of computing devices such as, but not limited to, processors, servers, client devices, software applications, and/or other like components. In addition, reference to “a server” or “a processor,” as used herein, may refer to a previously-recited server and/or processor that is recited as performing a previous step or function, a different server and/or processor, and/or a combination of servers and/or processors. For example, as used in the specification and the claims, a first server and/or a first processor that is recited as performing a first step or function may refer to the same or different server and/or a processor recited as performing a second step or function.
Non-limiting embodiments or aspects of the present disclosure are directed to systems, devices, products, apparatus, and/or methods for a fluid injector system that provides for improved pressure limiting behaviors. In particular, fluid injector systems provided herein may include computer algorithms and follow methods that allow a user or the system to utilize at least one of an internal input, for example an input by the system, or an external input, for example an input by a user or a hospital information network or other storage data device, to instruct at least one fluid injector device of the fluid injector system to perform a fluid injection procedure according to a profile that determines prioritization between maintaining a fluid flow rate and limiting a fluid delivery pressure. According to the present disclosure, the terms “flow rate” and “fluid flow rate” may be considered analogous to drug or contrast infusion rate, which can be altered by increasing or decreasing the overall flow of the drug or contrast containing solution. In other embodiments, flow rate or fluid flow rate may be altered by changing the concentration of the drug or contrast within the solution, for example by dilution with saline or addition of more concentrated solution of the drug or contrast agent, which can have the effect of changing the amount of drug/contrast delivered per volume delivered or can reduce the viscosity exponentially and drop the pressure of the fluid in the system due to reduced viscosity. It will be understood that the flow rate or fluid flow rate may be altered by various combinations of changing the overall flow of the solution or by altering the concentration and/or viscosity of the solution.
For example a depending on one or more of the inputs, the fluid delivery system may select or adapt a fluid injection protocol or injection profile that prioritizes maintaining flow rate or limiting a fluid delivery pressure and sets a predetermined pressure threshold and to abort the injection procedure if the pressure is detected, predicted, or trending to a equal or exceed a predetermined pressure threshold, where the predetermined pressure threshold is at least partially determined by the at least one of the internal input or an external input information.
According to various embodiments, the at least one of the internal input or an external input may include a maximum pressure limit for an injection procedure, a programmed fluid flow rate for injecting at least one fluid from the at least one fluid injector device, a maximum fluid flow rate reduction input for the injection procedure based off of at least one of patient information and system injection parameters, a pressure limit sensitivity input for the injection procedure, and various combinations of any thereof. For example, depending on the age of the patient and/or the overall health of the patient, including for example, the health of the vascular system of the patient, the user or system may prioritize maintaining flow rate or limiting a fluid delivery pressure. For example, in an older patient or a patient having poor vascular health (e.g., weak vascular walls), the user or system may prioritize limiting the fluid delivery pressure to avoid complications during the fluid delivery procedure. In another embodiment, where the patient may be the same age but have better vascular health, the prioritization may place more weight on maintaining flow rate and less on limiting fluid delivery pressure. In another embodiment, where the patient is healthy with a strong vascular system, the user or system may prioritize maintaining flow rate. As a result of the prioritization based on user or system input, the imaging procedure may provide an optimal fluid flow profile for the patient while minimizing potential hazards during the injection procedure.
User input may result from, but is not limited to, information based from patient examination, patient history data, user experience with patients of similar health or condition, type of prescribed injection procedure or protocol, time of injection, type of contrast, and various combinations thereof. System input may result from, but is not limited to, information based on historical injector data, historical patient data, information from one or more barcodes, one or more lookup tables, and combinations of any thereof. The one or more barcodes may be located on a patient record, the fluid injector, a medical fluid container, a sterile disposable, and combinations thereof, and may contain specific information on the article where the barcode is located. In various embodiments the inputted information may be a combination of user inputted information and system inputted information. Taking into account the inputted information, at least one control device may then develop an adaptive fluid flow for the injection profile that is specific for the patient and the particular fluid injector.
According to certain embodiments, the pressure limit sensitivity may range between a low sensitivity and a high sensitivity. In certain embodiments, the sensitivity of the pressure limit may have one or more intermediate sensitivities between low sensitivity and high sensitivity, such as an intermediate or “medium sensitivity”, depending on the desired fluid flow profile. According to other embodiments, the pressure limit sensitivity may be on a sliding scale between low sensitivity and high sensitivity. According to various embodiments, prioritization between pressure limit sensitivity and maintaining fluid flow rate may be at opposite ends of the scale as illustrated in
According to various embodiments inputting the at least one of the internal input or an external input and/or changing the prioritization between pressure limit sensitivity and maintaining fluid flow rate may be done prior to starting the injection procedure or can be done during the execution of the injection procedure. The injection protocol may be updated based on any of the before-injection data and/or based on real-time injection data being collected during the injection procedure. According to certain embodiments, the determination of the allowable injection profile may be weighted to provide priority to pre-injection information over real-time injection information or vice versa. Further, the injection information may include, for example, pressure, fluid flow rate, scanner data or image feedback, patient physiological feedback (e.g., ECG signal, blood pressure, heart rate, body temperature) or combinations thereof.
Various injection parameters that may be inputted, by the user and/or the fluid injector system, to at least partially prioritize between pressure limitation and maintaining flow rate include but are not limited to: historical data from the system or the user; data fed into the system from the user, an external system (picture archiving and communications systems (PACS), radiology information systems (RIS), hospital information systems (HIS), external medical records, etc.), data from barcodes, RFID tags, and other near-field communication tags, such as tags on injector disposables, contrast media and medical fluid containers, catheters, patient wristband etc.; one or more lookup table on various parameters for specific injection protocols, e.g., stored within the memory of the control device, a network server, or hard copy versions available to user, among others. According to various embodiments, the parameters may be configured previously as part of each individual protocol, the parameters may be received from the scanner as part of the patient procedure information or other data packet, the parameters may be otherwise configured to automatically change or update based on the combination of injection protocol and disposable (e.g., syringe size, catheter size, fluid type. etc.), or various combinations of parameters received from these sources.
Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, one aspect or example of the present disclosure is generally directed to a multi-fluid medical injector/injector system 100 (hereinafter “fluid injector system 100”) which in certain embodiments may include a multi-use disposable set (MUDS) 130 configured for delivering fluid to a patient using a single-use disposable set (SUDS) connector (not shown) and in other embodiments may include two or more disposable fluid reservoirs or syringes, which may be disposed after one injection procedure or a specific number of injection procedures. The fluid injector system 100 may include multiple components as individually described herein. Generally, the fluid injector system 100 depicted in
With reference to
The fluid injector system 100 may include at least one bulk fluid connector 118 for connection with at least one bulk fluid source 120. In some examples, a plurality of bulk fluid connectors 118 may be provided. For example, as shown in the fluid injector embodiment illustrated in
With reference to
With continued reference to
The one or more valves 136, fluid inlet lines 150, and/or fluid outlet lines 152 may be integrated into or in fluid communication via the manifold 148. The one or more valves 136 may be selectively positioned to the first or second position by manual or automatic handling. For example, the operator may position the one or more valves 136 into the desired position for filling, fluid delivery, or the closed position. In other examples, at least a portion of the fluid injector system 100 is operable for automatically positioning the one or more valves 136 into a desired position for filling, fluid delivery, or the closed position based on input by the operator or by a protocol executed by the electronic control unit.
With continued reference to
Referring again to
While
With continued reference to
A tubing set 17 (e.g., first and second fluid conduits 17a and 17b, and common fluid conduit 20) may be in fluid communication with an outlet port of each syringe 12 to place each syringe in fluid communication with a catheter for delivering the fluid F from each syringes 12 to the catheter (not shown) inserted into a patient at a vascular access site. The first and second fluid conduits 17a and 17b may be connected to the common fluid conduit 20 by any suitable mechanism known in the art (e.g., a Y-connector or a T-connector). The fluid injector system 100 shown in
Referring now to
The electronic control device 400 may be programmed or configured to perform one or more processes and/or methods based on the at least one processor 404 executing software instructions stored by a computer-readable medium, such as memory 408. When executed, software instructions stored in memory 408 may cause the at least one processor 404 to perform one or more processes and/or methods described herein.
With continued reference to
In aspects and examples of a closed fluid injector system 100 (e.g., the fluid injector system 100 of
As noted above, conventional fluid injector systems utilize pressure limit settings that are determined by the manufacturer and hard-coded into the system. However, in order to support a diverse patient population, a variety of injection protocols, and multiple IV sites/types, there is a need for user- or system-configurable and/or customizable methods of setting pressure limiting behavior. As such, and in accordance with an aspect of the disclosure, a fluid injection system and method for providing user- or system-configurable injector performance settings is disclosed.
Referring to
In addition to the at least two user- or system-configurable inputs, the GUI 200 may also include a programmed pressure limit indicator 206 and an adaptive flow graph 208. The pressure limit identified on the programmed pressure limit indicator 206 is typically pre-programmed based on the type of injection procedure. For example, for an injection procedure related to CT imaging, the programmed pressure limit may be 300 psi, while for an angiography procedure, the programmed pressure limit may be 1200 psi. In some embodiments, the programmed pressure limit may be input via the GUI 200. As will be described in further detail below, the adaptive flow graph 208 provides the practitioner with a visual indication of the user- or system-customized injector settings relative to one another. However, it is to be understood that the adaptive flow graph 208 may be omitted from the GUI 200, with only the user- or system-configurable inputs being shown.
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Regarding the maximum flow reduction input 202, the practitioner is able to select the flow rate reduction within a configurable range of 0% to 50% of an originally programmed (i.e., commanded) flow rate. For example, according to a non-limiting embodiment, if the maximum flow reduction input 202 is set to 50% (as shown in
In the event that the pressure dictates that the minimum flow rate cannot be achieved, the system can be configured to abort the injection procedure entirely. Similarly, if the user configures the maximum flow rate reduction input 202 to be 0% (i.e., no permissible change in flow rate), the injection can be aborted if the pressure is ever detected to exceed the programmed pressure limit.
While a configurable flow reduction range of 0% to 50% is provided in the examples illustrated herein, it is to be understood that the configurable range of maximum flow reduction input 202 may be lesser or greater than 0% to 50% and need not necessarily be a percentage-based range. The range can be narrowed dependent upon the imaging modality, with the acceptable reduction in flow rate being determined based upon a flow rate at which an acquired image would still be considered sufficient for diagnostics. For example, in CT imaging, the configurable flow reduction range may be 0% to 50%. In other imaging modalities where flow rate is less crucial to a successful imaging procedure, the configurable flow range may be, e.g., from 0-100%, where 100% means the injection is aborted completely.
Referring to the pressure limit sensitivity input 204 in
According to specific embodiments when considering the range of responsiveness to increasing pressure (i.e., “Low” to “Medium” to “High”) the range may be set such that: “Low” may range from 15% to 35% of the maximum responsiveness, for example in one embodiment, “Low” may be 25%; “Medium” may range from 40% to 60% of the maximum responsiveness, for example in one embodiment, “Medium” may be 50%; and “High” may range from 65% to 85% of the maximum responsiveness, for example in one embodiment, “High” may be 75%. “Low/Medium” and “Medium/High” may be then be a similar range between “Low” and “Medium” and between “Medium” and “High”, respectively. According to other embodiments, the range of responsiveness may be determined by inputs such as maximum flow rate reduction; or may be hard-coded values depending on the system configuration, modality within which the device is being used, clinical settings, patient settings, etc. These numbers can all change as desired. For example, in one embodiment, “Low” may be 90%, “Medium” may be 95%, and “High” may be 100% of the maximum responsiveness. One of skill in the art can envision other set ranges for “Low”, “Medium”, and “High” according to other embodiments.
The adaptive flow graph 208 provides for a visual illustration of the injector behavior based on the user- or system-selected settings of the maximum flow rate reduction input 202 and the pressure limit sensitivity input 204. In the example shown in
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Additionally, while the of the maximum flow rate reduction input 202 and the pressure limit sensitivity input 204 are shown and described herein as being input via the touchscreen GUI 200, it is to be understood that other forms of user interfaces may be utilized to provide such inputs. For example, the user interface may include a keyboard, a mouse, one or more buttons, one or more knobs, etc. Furthermore, as noted above, the user interface may be integrated into the fluid injector system 100 or it may be located remotely from fluid injector system 100. If located remotely from fluid injector system 100, the user interface may be capable of wired or wireless communication with the electronic control device 400. Referring to
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As discussed above, under such a “Default” setting, the system may allow for a moderate amount of flow reduction, as well as a moderate pressure sensitivity.
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First, at 602, user inputs are received regarding the maximum flow reduction and pressure limit sensitivity. As described above, these user inputs may be received via, e.g., a GUI or other user interface. At 604, an injection procedure is initiated, with the appropriate pressure limiting behavior being initialized based on the user inputs.
At 606, fluid pressure during the injection procedure is monitored via any appropriate method. Then, at 608, a determination is made as to whether or not the determined pressure has reached a Threshold 1 pressure. In some embodiments, Threshold 1 is a predetermined pressure level below the programmed pressure limit. For example, Threshold 1 may be a pressure level that is, e.g., 1%-20% below the programmed pressure limit.
If no (i.e., Threshold 1 has not been reached), the workflow returns to 606 and the pressure continues to be monitored. However, if yes, a determination is made, at 610, whether or not the user- or system-input pressure limit sensitivity is greater than 0. In this particular example, a pressure limit sensitivity of 0 is considered to be the highest (or “High”) pressure sensitivity setting, wherein it is of the utmost importance during a particular injection procedure that the pressure limit may not be exceeded. If no (i.e., the pressure limit sensitivity is set to 0), the injection is aborted at 612. Alternatively, if yes (i.e., the pressure limit sensitivity is set to greater than 0), a determination is made, at 614, whether or not the maximum flow reduction is greater than 0. In this example, a maximum flow reduction of 0 is considered to be a user setting of no flow reduction allowed for the particular injection procedure. If no, (i.e., the maximum flow reduction is set to 0), the injection is aborted at 616. However, if yes (i.e., the maximum flow reduction is set to greater than 0), then the flow rate may be reduced at 618. Such a reduction in fluid flow rate is meant to correspondingly reduce the pressure during the injection such that the programmed pressure limit is not reached (or exceeded over a given threshold amount). As described above, the reduction in flow rate may be based on a predetermined flow reduction profile, which may be linear or non-linear (e.g., polynomial, exponential, logarithmic, etc.).
Next, at 620, a determination is made as to whether or not a Threshold 2 pressure has been reached. In some examples, the Threshold 2 pressure may be a pressure level that is, e.g., 1%-20% above the programmed pressure limit. However, it is to be understood that the Threshold 2 pressure may also be less than 1% above the programmed pressure limit, equal to the programmed pressure limit, or even below the programmed pressure limit, depending upon pressure limit sensitivity and the user settings. If yes (i.e., the Threshold 2 pressure has been reached), then, at 622, the system may stop the flow reduction and/or abort the injection procedure. However, if no (i.e., the Threshold 2 pressure has not been reached), then the workflow may return to 618, further reducing the fluid flow rate. The flow rate may continue to be reduced until either pressure Threshold 2 is reached, the maximum flow rate reduction is reached, or the determined pressure is below Threshold 1.
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Although the disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect.
This application claims the benefit of U.S. Provisional Patent Application No. 62/938,436 filed on 21 Nov. 2019, the disclosure of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/060956 | 11/18/2020 | WO |
Number | Date | Country | |
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62938436 | Nov 2019 | US |