Systems, methods, and computer programs for detecting blockages and improving pressure limiting behavior in fluid injector devices.

Abstract

Systems, methods, and computer program products for blockage detection and / or pressure limiting in fluid injector systems are disclosed. The fluid injector system may include at least one fluid injector device, one or more drive components, and a control device. The control device may include at least one processor programmed or configured to: provide instructions to the fluid injector system to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; determine a first fluid pressure measurement within at least one fluid injector device at a first time; determine a second fluid pressure measurement within at least one fluid injector device at a second time; determine a pressure difference between the first and second fluid pressure measurements; calculate a change in the compliance volume of at least one fluid injector device based on the determined pressure difference; compare the calculated change in compliance volume with the predetermined fluid flow rate; repeat these steps throughout the fluid injection process; and determine whether a blockage or partial blockage has occurred downstream of at least one fluid injector device.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 938,407, filed November 21, 2019, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to systems, apparatus, products, devices, and methods for improved blockage detection and improved pressure limiting behavior of fluid injector devices. Background Technology

[0004] In many medical diagnostic and treatment procedures, medical practitioners (internists or radiologists) use powered fluid injector systems to administer one or more fluids to patients. Numerous powered fluid injector systems have been developed for pressurized fluid injection in procedures such as angiography, computed tomography (CT), molecular imaging (e.g., PET imaging), and magnetic resonance imaging (MRI).

[0005] Sometimes, blockages (i.e., substantial blockages in fluid flow) can occur at tandem locations between the fluid injector system and the injection site (e.g., patient catheter). Conventional fluid injector systems rely solely on pressure monitoring to account for such blockages. That is, the fluid flow rate is progressively reduced as a predetermined pressure limit is reached during the injection process (e.g., ultimately due to a blockage), thereby lowering the system pressure. However, because the predetermined pressure limit is chosen for the actual fluid injector system, not for the injection site and / or intermediate components (e.g., tubing, etc.), the blockage location may experience significantly higher pressures than expected before reaching the fluid injector system's pressure limit.

[0006] Furthermore, conventional fluid injector systems are typically programmed to monitor pressure changes until a predetermined pressure limit is reached, at which point the fluid flow rate can be reduced by a corresponding percentage. However, the required flow rate reduction is often overestimated, leading to frequent motor speed variations (which can reduce motor life) and potentially affecting the iodine delivery rate (IDR) to the point that the imaging process cannot be successfully completed.

[0007] Therefore, there is a need in the art to improve the blockage detection and pressure limiting behavior of fluid injector devices. Summary of the Invention

[0008] Therefore, systems, devices, products, apparatuses and / or methods for fluid injector systems are provided that provide improved blockage detection and / or pressure limiting behavior.

[0009] In some non-limiting embodiments or aspects, a fluid injector system is disclosed, configured to administer at least one fluid during fluid injection. The fluid injector system may include: at least one fluid injector device; one or more drive components; and a control device, which may include at least one processor programmed or configured to: provide instructions to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate; determine a first fluid pressure measurement within the at least one fluid injector device at a first time; determine a second fluid pressure measurement within the at least one fluid injector device at a second time; determine a pressure difference between the first and second fluid pressure measurements; calculate a change in the compliance volume of the at least one fluid injector device based on the pressure difference; compare the calculated change in compliance volume with the predetermined fluid flow rate; repeat the above steps throughout the fluid injection process; determine whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device; and if a blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0010] In some non-limiting embodiments or aspects, the operating data may include one or more operating parameters that are related to at least one of the following: one or more drive components of a fluid injector system, one or more of at least one fluid injector device, and one or more disposable components configured for use with a fluid injector device.

[0011] In some non-limiting embodiments or aspects, at least one fluid injector device may include: at least one fluid reservoir; and at least one plunger associated with at least one fluid reservoir, wherein the at least one plunger is releasably engaged with a piston of the fluid injector system.

[0012] In some non-limiting embodiments or aspects, if the calculated change in compliance volume is equal to a predetermined threshold of the volume component of a predetermined fluid flow rate, it can be determined that a blockage has occurred downstream of at least one fluid injector device. For example, if the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of a predetermined fluid flow rate, the control device can determine that a blockage has occurred.

[0013] In some non-limiting embodiments or aspects, the controller may compare the calculated change with a predetermined fluid flow rate to determine the true flow rate measurement. In various embodiments, if the calculated true flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate, it is determined that a blockage has occurred downstream of at least one fluid injector device.

[0014] In some non-limiting embodiments or aspects, if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of the predetermined fluid flow rate, it is determined that at least one fluid injector device may have experienced or has experienced at least partial blockage downstream.

[0015] In some non-limiting embodiments or aspects, at least one processor is programmable or configured to reduce the delivery rate of at least one piston of at least one fluid injector device if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of the predetermined fluid flow rate.

[0016] In some non-limiting embodiments or aspects, at least one processor may be programmed or configured to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0017] In some non-limiting embodiments or aspects, at least one processor may be programmed or configured to subtract a calculated change in compliance volume from the volume component of the delivery rate of at least one piston of at least one fluid injector device to determine the true fluid flow rate flowing out of at least one fluid injector device.

[0018] In some non-limiting embodiments or aspects, at least one processor may be programmed or configured to adjust the delivery rate of at least one piston of at least one fluid injector device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0019] In some non-limiting embodiments or aspects, a computer-implemented method for at least partial obstruction detection and pressure limiting of a fluid injector system configured to administer at least one fluid during fluid injection is disclosed. The method may include: providing instructions to the fluid injector system using a control device including at least one processor to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; determining a first fluid pressure measurement within the at least one fluid injector device at a first time; determining a second fluid pressure measurement within the at least one fluid injector device at a second time; determining a pressure difference between the first and second fluid pressure measurements using the control device; calculating a change in compliance volume of the at least one fluid injector device based on the pressure difference using the control device; comparing the calculated change in compliance volume with the predetermined fluid flow rate using the control device; repeating the method steps throughout the fluid injection process; and determining whether obstruction or partial obstruction has occurred downstream of the at least one fluid injector device, and if obstruction or partial obstruction is determined to have occurred, programming or configuring at least one processor to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0020] In some non-limiting embodiments or aspects, the method may further include: determining, using a control device, that a blockage has occurred if the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0021] In some non-limiting embodiments or aspects, the method may further include comparing a calculated change in compliance volume with a predetermined fluid flow rate to determine a true flow rate measurement. In a particular embodiment, the method may further include determining, using a control device, that a blockage has occurred if the calculated true flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate.

[0022] In some non-limiting embodiments or aspects, the method may further include determining, using a control device, that a blockage has occurred if the calculated true flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate.

[0023] In some non-limiting embodiments or aspects, the method may further include using a control device to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0024] In some non-limiting embodiments or aspects, the first time to determine the first fluid pressure measurement may be the time before a pre-programmed pressure limit is reached, and the second time to determine the second fluid pressure measurement is the time when or after the pre-programmed pressure limit is reached.

[0025] In some non-limiting embodiments or aspects, the method may further include subtracting a calculated change in compliance volume from a volume component of the delivery rate of at least one piston of at least one fluid injector device using a control device to determine the true fluid flow rate flowing out of at least one fluid injector device.

[0026] In some non-limiting embodiments or aspects, the method may further include adjusting the delivery rate of at least one piston of at least one fluid injector device with a control device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0027] In some non-limiting embodiments or aspects, a computer program product for at least partial obstruction detection and pressure limiting of a fluid injector system configured to administer at least one fluid during fluid injection is disclosed. The computer program product may include at least one non-transitory computer-readable medium, which may include one or more instructions, which, when executed by at least one processor, cause at least one processor to: provide instructions to the fluid injector system to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; determine a first fluid pressure measurement within the at least one fluid injector device at a first time; determine a second fluid pressure measurement within the at least one fluid injector device at a second time; determine a pressure difference between the first and second fluid pressure measurements; calculate a change in compliance volume of the at least one fluid injector device based on the determined pressure difference; compare the calculated change in compliance volume with the predetermined fluid flow rate; repeat the above steps during fluid injection; and determine whether obstruction or partial obstruction has occurred downstream of the at least one fluid injector device, and if obstruction or partial obstruction is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0028] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, cause at least one processor to determine that a blockage has occurred if the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0029] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, may cause at least one processor to: calculate a predetermined fluid flow rate and compare it with a change in compliant volume to determine a true flow rate measurement. In a particular embodiment, one or more instructions, when executed by at least one processor, determine that a blockage has occurred downstream of at least one fluid injector device if the calculated true flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate.

[0030] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, may cause at least one processor to reduce the delivery rate of at least one piston of at least one fluid injector device if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of the predetermined fluid flow rate.

[0031] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, can enable at least one processor to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0032] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, can cause at least one processor to subtract a calculated change in compliance volume from the volume component of the delivery rate of at least one piston of at least one fluid injector device to determine the true fluid flow rate flowing out of at least one fluid injector device.

[0033] In some non-limiting embodiments or aspects, one or more instructions, when executed by at least one processor, can cause at least one processor to adjust the delivery rate of at least one piston of at least one fluid injector device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0034] In some non-limiting embodiments or aspects, a fluid injector system is disclosed, configured to administer at least one fluid during fluid injection. The fluid injector system may include: at least one fluid injector device; one or more drive components; and a control device including at least one processor, the at least one processor being programmed or configured to: provide instructions to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate; determine the fluid flow rate within the at least one fluid injector device at a first time; monitor the fluid flow rate within the at least one fluid injector device until a second time; calculate the actual fluid flow rate delivered from the at least one fluid injector device based on the flow rate over the time interval between the first and second times; compare the calculated actual fluid flow rate with the predetermined fluid flow rate; and repeat the above steps throughout the fluid injection process.

[0035] In some non-limiting embodiments or aspects, the operating data may include one or more operating parameters associated with at least one of the following: one or more drive components of a fluid injector system, one or more of at least one fluid injector device, and one or more disposable components configured for use with a fluid injector device.

[0036] In some non-limiting embodiments or aspects, at least one fluid injector device may include: at least one fluid reservoir; and at least one plunger associated with at least one fluid reservoir, wherein the at least one plunger is releasably engaged with a piston of the fluid injector system.

[0037] In some non-limiting embodiments or aspects, if the calculated actual fluid flow rate delivered from at least one fluid injector device is not equal to a predetermined threshold of a predetermined fluid flow rate, it can be determined that a blockage has occurred downstream of at least one fluid injector device.

[0038] In some non-limiting embodiments or aspects, at least one processor may be programmed or configured to reduce or stop the delivery rate of at least one piston of at least one fluid injector device if a blockage is detected.

[0039] In some non-limiting embodiments or aspects, if the actual fluid flow rate is within and / or close to a predetermined threshold of the predetermined fluid flow rate, it can be determined that at least a partial blockage may have occurred downstream of at least one fluid injector device.

[0040] In some non-limiting embodiments or aspects, at least one processor may be programmed or configured to reduce the delivery rate of at least one piston of at least one fluid injector device if the actual fluid flow rate is within and / or close to a predetermined threshold of the predetermined fluid flow rate.

[0041] Further non-limiting embodiments are described in the following numbered clauses:

[0042] Clause 1. A fluid injector system configured to administer at least one fluid during fluid injection, the fluid injector system comprising: at least one fluid injector device; one or more drive components; and a control device including at least one processor, the at least one processor being programmed or configured to: provide instructions to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate; determine a first fluid pressure measurement within the at least one fluid injector device at a first time; determine a second fluid pressure measurement within the at least one fluid injector device at a second time; determine a pressure difference between the first fluid pressure measurement and the second fluid pressure measurement; calculate a change in compliance volume of the at least one fluid injector device based on the pressure difference; compare the calculated change in compliance volume with the predetermined fluid flow rate; repeat the above steps throughout the fluid injection process; and determine whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if a blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0043] Clause 2. The fluid injector system according to Clause 1, wherein the control device determines that a blockage has occurred if the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0044] Clause 3. A fluid injector system according to Clause 1 or 2, wherein a calculated change in compliance volume is compared with a predetermined fluid flow rate to determine a true flow rate measurement.

[0045] Clause 4. A fluid injector system pursuant to Clause 3, wherein if the calculated actual flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate, it is determined that a blockage has occurred downstream of at least one fluid injector device.

[0046] Clause 5. The fluid injector system according to Clause 1, wherein if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of the predetermined fluid flow rate, it is determined that at least one fluid injector device may have experienced or has experienced at least partial blockage downstream.

[0047] Clause 6. A fluid injector system according to Clause 5, wherein at least one processor is programmed or configured to reduce the delivery rate of at least one piston of at least one fluid injector device if a calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0048] Clause 7. A fluid injector system according to any one of Clauses 1 to 6, wherein at least one processor is programmed or configured to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0049] Clause 8. A fluid injector system according to any one of Clauses 1 to 7, wherein at least one processor is programmed or configured to subtract a calculated change in compliance volume from a volume component of the delivery rate of at least one piston of at least one fluid injector device to determine the true fluid flow rate exiting at least one fluid injector device.

[0050] Clause 9. The fluid injector system according to Clause 8, wherein the at least one processor is programmed or configured to adjust the delivery rate of at least one piston of the at least one fluid injector device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0051] Clause 10. A computer-implemented method for at least partial blockage detection and pressure limiting in a fluid injector system configured to administer at least one fluid during fluid injection, the method comprising: providing instructions to the fluid injector system using a control device including at least one processor to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; determining a first fluid pressure measurement within the at least one fluid injector device at a first time; determining a second fluid pressure measurement within the at least one fluid injector device at a second time; determining a pressure difference between the first and second fluid pressure measurements using the control device; calculating a change in compliance volume of the at least one fluid injector device based on the pressure difference using the control device; comparing the calculated change in compliance volume with the predetermined fluid flow rate using the control device; repeating the method steps throughout the fluid injection process; and determining whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if a blockage or partial blockage is determined to have occurred, programming or configuring at least one processor to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0052] Clause 11. The computer-implemented method according to Clause 10 further includes: determining, using a control device, that a blockage has occurred if the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0053] Clause 12. The computer-implemented method according to Clause 10 or 11 further includes comparing the calculated change in compliance volume with a predetermined fluid flow rate to determine the true flow rate measurement.

[0054] Clause 13. The computer-implemented method according to Clause 12 further includes: determining, using a control device, that a blockage has occurred if the calculated actual flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate.

[0055] Clause 14. The computer-implemented method according to Clause 10 further includes: if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of the predetermined fluid flow rate, then using a control device to reduce the delivery rate of at least one piston of at least one fluid injector device.

[0056] Clause 15. The computer-implemented method according to any one of Clauses 10 to 14 further includes using a control device to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0057] Clause 16. The computer-implemented method according to Clause 15, wherein the first time for determining the first fluid pressure measurement is the time before reaching a pre-programmed pressure limit, and wherein the second time for determining the second fluid pressure measurement is the time at which or after reaching the pre-programmed pressure limit.

[0058] Clause 17. The computer-implemented method according to any one of Clauses 10 to 16 further includes subtracting a calculated change in compliance volume from a volume component of the delivery rate of at least one piston of at least one fluid injector device using a control device to determine the true fluid flow rate exiting at least one fluid injector device.

[0059] Clause 18. The computer-implemented method according to Clause 17 further includes adjusting the delivery rate of at least one piston of at least one fluid injector device using a control device, such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0060] Clause 19. A computer program product for at least partial blockage detection and pressure limiting of a fluid injector system configured to administer at least one fluid during fluid injection, the computer program product comprising at least one non-transitory computer-readable medium comprising one or more instructions, which, when executed by at least one processor, cause at least one processor to: provide instructions to the fluid injector system to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; determine a first fluid pressure measurement within at least one fluid injector device at a first time; determine a second fluid pressure measurement within at least one fluid injector device at a second time; determine a pressure difference between the first and second fluid pressure measurements; calculate a change in compliance volume of at least one fluid injector device based on the determined pressure difference; compare the calculated change in compliance volume with the predetermined fluid flow rate; repeat the above steps during fluid injection; and determine whether a blockage or partial blockage has occurred downstream of at least one fluid injector device, and if a blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of at least one piston of at least one fluid injector device.

[0061] Clause 20. A computer program product pursuant to Clause 19, wherein one or more instructions, when executed by at least one processor, cause at least one processor to: if the calculated change in compliance volume is equal to a predetermined threshold of a volume component of a predetermined fluid flow rate, within a predetermined threshold of a volume component of a predetermined fluid flow rate, or greater than a predetermined threshold of a volume component of a predetermined fluid flow rate.

[0062] Clause 21. A computer program product pursuant to Clause 19 or 20, wherein one or more instructions, when executed by at least one processor, cause at least one processor to: compare a calculated predetermined fluid flow rate with a change in compliant volume to determine a true flow rate measurement.

[0063] Clause 22. A computer program product pursuant to Clause 21, wherein one or more instructions, when executed by at least one processor, determine that a blockage has occurred downstream of at least one fluid injector device if the calculated actual flow rate is less than or equal to a predetermined percentage of a predetermined fluid flow rate.

[0064] Clause 23. A computer program product pursuant to Clause 19, wherein one or more instructions, when executed by at least one processor, cause at least one processor to reduce the delivery rate of at least one piston of at least one fluid injector device if the calculated change in compliance volume is within and / or close to a predetermined threshold of the volume component of a predetermined fluid flow rate.

[0065] Clause 24. A computer program product pursuant to any one of Clauses 19 to 23, wherein one or more instructions, when executed by at least one processor, cause at least one processor to determine when a pre-programmed pressure limit of at least one fluid injector device has been reached.

[0066] Clause 25. A computer program product pursuant to any one of Clauses 21 to 24, wherein one or more instructions, when executed by at least one processor, cause at least one processor to subtract a calculated change in compliance volume from a volume component of the delivery rate of at least one piston of at least one fluid injector device to determine the true fluid flow rate exiting at least one fluid injector device.

[0067] Clause 26. A computer program product pursuant to Clause 25, wherein one or more instructions, when executed by at least one processor, cause at least one processor to adjust the delivery rate of at least one piston of at least one fluid injector device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

[0068] Clause 27. A fluid injector system configured to administer at least one fluid during fluid injection, the fluid injector system comprising: at least one fluid injector device; one or more drive components; and a control device including at least one processor, the at least one processor being programmed or configured to: provide instructions to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate; determine a fluid flow rate within the at least one fluid injector device at a first time; monitor the fluid flow rate within the at least one fluid injector device up to a second time; calculate an actual fluid flow rate delivered from the at least one fluid injector device based on the flow rate over the time interval between the first and second times; compare the calculated actual fluid flow rate with a predetermined fluid flow rate; repeat the above steps throughout the fluid injection process; and determine whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if a blockage or partial blockage is determined to have occurred, the at least one processor being programmed or configured to reduce or stop the delivery rate of at least one piston of the at least one fluid injector device.

[0069] Clause 28. A fluid injector system pursuant to Clause 27, wherein if the calculated actual fluid flow rate delivered from at least one fluid injector device is not equal to a predetermined threshold of a predetermined fluid flow rate, it is determined that a blockage has occurred downstream of at least one fluid injector device.

[0070] Clause 29. A fluid injector system pursuant to Clause 27 or 28, wherein if the actual fluid flow rate is within and / or close to a predetermined threshold of a predetermined fluid flow rate, it is determined that at least one fluid injector device may have experienced or has experienced at least partial blockage downstream.

[0071] Clause 30. A fluid injector system pursuant to Clause 29, wherein at least one processor is programmed or configured to reduce the delivery rate of at least one piston of at least one fluid injector device if the actual fluid flow rate is within and / or close to a predetermined threshold of a predetermined fluid flow rate.

[0072] These and other features and characteristics of this disclosure, as well as the operational methods, functions, and manufacturing economies of related structural elements and combinations of parts, will become more apparent upon consideration of the following description and appended claims (all of which form part of this specification), wherein like reference numerals denote corresponding parts in the figures. However, it should be clearly understood that these figures are for illustrative and explanatory purposes only and are not intended to be limiting of this disclosure. As used in the specification and claims, the singular forms “a,” “an,” and “the” include plural indicators unless the context clearly requires otherwise. Attached Figure Description

[0073] Other advantages and details of this disclosure will be explained in more detail below with reference to exemplary embodiments or aspects shown in the accompanying drawings, wherein:

[0074] Figure 1 A perspective view of a fluid injector system according to an example of this disclosure;

[0075] Figure 2 Is with Figure 1 A three-dimensional diagram of a reusable, disposable kit used in conjunction with a fluid injector system;

[0076] Figure 3 This is a perspective view of a fluid injector system according to another example of this disclosure;

[0077] Figure 4 This is a schematic diagram of the electronic control system of a fluid injector system according to an example of this disclosure;

[0078] Figure 5 It is a graphical representation of the compliant volume of a fluid injector system according to an example of this disclosure under varying fluid flow rate and pressure changes;

[0079] Figure 6 This is a flowchart illustrating a method according to one aspect of this disclosure;

[0080] Figure 7 This is a flowchart illustrating a method according to another aspect of this disclosure;

[0081] Figure 8 This is a flowchart illustrating a method according to another aspect of this disclosure;

[0082] Figure 9 It is a graphical representation of various programming or measurement aspects of a fluid injector system during an injection process according to an example of this disclosure;

[0083] Figure 10 It is a graphical representation of various programming or measurement aspects of a fluid injector system during the injection process according to another example of this disclosure;

[0084] Figure 11 It is a graphical representation of various programming or measurement aspects of a fluid injector system during the injection process according to another example of this disclosure; and

[0085] Figure 12 It is a graphical representation of various programming or measurement aspects of a fluid injector system during an injection process according to an example of this disclosure. Detailed Implementation

[0086] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives shall be used in relation to the meaning of this disclosure in the accompanying drawings. When used with respect to a syringe in a multi-patient disposable kit, the term “near” refers to the portion of the syringe closest to the piston used to deliver fluid from the syringe.

[0087] Spatial or directional terms such as “left,” “right,” “inner,” “outer,” “up,” and “down” should not be considered as limitations, as the invention can take various alternative orientations.

[0088] In all cases, all figures used in the specification and claims should be understood to be modified by the term "about". The terms "approximately", "about", and "substantially" refer to a range of plus or minus ten percent of the stated value.

[0089] As used herein, the term "at least one" is synonymous with "one or more". 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 individual A's; or one or more individual B's; or one or more individual C's; or one or more A's and one or more B's; or one or more A's and one or more C's; or one or more B's and one or more C's; or one or more A's, B's, and C's. Similarly, as used herein, the term "at least two" is synonymous with "two or more". 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 D's and one or more E's; or one or more D's and one or more F's; or one or more E's and one or more F's; or one or more D's, E's, and F's.

[0090] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0091] When used relative to a fluid reservoir (such as an injector, rolling diaphragm, or multi-injector disposable kit), the term "far" refers to the portion of the fluid reservoir closest to the patient. When used relative to a fluid reservoir (such as an injector, rolling diaphragm, or multi-injector disposable kit), the term "near" refers to the portion of the fluid reservoir closest to the injector system.

[0092] As used herein, the terms "communication" and "transmission" can refer to the receipt, acceptance, transmission, delivery, provision, etc., of information (e.g., data, signals, messages, instructions, commands, etc.). For one unit (e.g., a device, system, component of a device or system, or a combination thereof) to communicate with another unit means that the first unit is able to receive information directly or indirectly from and / or transmit information to the other unit. This can refer to a direct or indirect connection that is inherently wired and / or wireless. Furthermore, the two units can communicate with each other even if the transmitted information may be modified, processed, relayed, and / or routed between them. For example, the first unit can communicate with the second unit even if it passively receives information and does not actively transmit information to it. As another example, the first unit can communicate with the second unit if at least one intermediate unit (e.g., a third unit located between the first and second units) processes information received from the first unit and transmits the processed information to the second unit. In some non-limiting embodiments or aspects, a message can refer to a network packet containing data (e.g., a data packet, etc.). It should be understood that many other arrangements are possible.

[0093] As used herein, the term "server" can 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 via a network (such as the Internet or a private network) and, in some examples, facilitate communication between other servers and / or client devices. It should be understood that various other arrangements are possible. As used herein, the term "system" can refer to one or more computing devices or combinations of computing devices (e.g., but not limited to processors, servers, client devices, software applications, and / or other similar components). Furthermore, as used herein, references to "server" or "processor" can refer to the server and / or processor previously stated to perform the preceding steps or functions, different servers and / or processors, and / or combinations of servers and / or processors. For example, as used in the specification and claims, a first server and / or first processor stated to perform a first step or function can refer to the same or different server and / or processor stated to perform a second step or function.

[0094] Referring to the accompanying drawings, wherein like reference numerals refer to the same parts throughout several views, one aspect or example of this disclosure generally relates to a multi-fluid medical injector / injector system 100 (hereinafter “fluid injector system 100”), which in some embodiments may include a multiple-use disposable kit (MUDS) 130 configured for delivering fluid to a patient using a single-use disposable kit (SUDS) connector (not shown), and in other embodiments may include two or more disposable fluid reservoirs or syringes that can be discarded after a single injection procedure or a specific number of injection procedures. The fluid injector system 100 may include multiple components, as described individually herein. Figure 1-2 The fluid infuser system 100 shown has a powered infuser or other drug delivery device and a fluid delivery kit, the fluid delivery kit being intended to be associated with the infuser to deliver one or more fluids from one or more multi-dose containers under pressure to a patient, as described herein. Various devices, components, and features of the fluid infuser system 100 and the associated fluid delivery kit are also described in detail herein. While references have Figure 1-2 The injector systems configured with multiple-use disposable kits (“MUDS”) and single-use disposable kits (“SUDS”) illustrate various examples of methods and processes, but this disclosure is not limited to such injector systems and can be used with other syringe-based injector systems, such as, but not limited to, those disclosed in U.S. Patent Nos. 7,553,294, 7,563,249, 8,945,051, 9,173,995, 10,124,110, 10,507,319, and 10,583,256 and U.S. Application Serial No. 15 / 568,505; the disclosure of each of these is incorporated herein by reference in its entirety.

[0095] refer to Figure 1 According to one example, a fluid injector system 100 includes an injector housing 102 that encloses various mechanical drive components, electrical and power components required to drive the mechanical drive components, and control components, such as electronic memory and electronic control devices, for controlling the operation of a reciprocating piston (not shown) associated with the fluid injector system 100 described herein. Such a piston can be reciprocated via electromechanical drive components, such as ball screws driven by electric motors, voice coil actuators, rack and pinion systems, linear motors, etc.

[0096] The fluid injector system 100 may include at least one bulk fluid connector 118 for connection to at least one bulk fluid source 120. In some examples, multiple bulk fluid connectors 118 may be provided. For example, such as... Figure 1 As illustrated in the fluid injector embodiment, three high-capacity fluid connectors 118 may be provided in a side-by-side or other arrangement. In some examples, at least one high-capacity fluid connector 118 may include spikes configured for removable connection to at least one high-capacity fluid source 120, such as a vial, bottle, or bag. At least one high-capacity fluid connector 118 may be formed on a multiple-use disposable kit (“MUDS”), as described herein. At least one high-capacity fluid source 120 may be configured to receive medical fluids (such as saline, Ringer's lactate, imaging contrast media solution, or other medical fluids) for delivery to a patient by the fluid injector system 100.

[0097] refer to Figure 2 The MUDS 130 is configured for removable connection to a fluid infuser system 100 to deliver one or more fluids from one or more mass fluid sources 120 to a patient. Examples and features of embodiments of the MUDS are further described in PCT International Publication No. WO2016 / 112163, filed January 7, 2016, the disclosure of which is incorporated herein by reference in its entirety. The MUDS 130 may include one or more fluid reservoirs, such as one or more syringes 132. As used herein, the term “fluid reservoir” refers to any container capable of drawing and delivering fluid, for example, during a fluid infusion procedure, including, for example, syringes, rolling diaphragms, pumps, compressible bags, etc. A fluid reservoir may include at least a portion of the internal volume (such as one or more tubing lengths) of a fluid passage in fluid communication with the interior of the fluid reservoir, including a portion of the fluid passage that remains in fluid communication with the fluid reservoir after the system is shut down or fluidly isolated from the remainder of the fluid passage. In some examples, the number of fluid reservoirs may correspond to the mass fluid source 120 ( Figure 1 The number shown. For example, refer to Figure 2 The MUDS 130 has three syringes 132 arranged side-by-side, such that each syringe 132 is fluidly connectable to one or more of three corresponding high-capacity fluid sources 120. In some examples, one or more high-capacity fluid sources 120 may be connected to one or more syringes 132 of the MUDS 130. Each syringe 132 may be fluidly connected to one of the high-capacity fluid sources 120 by a corresponding high-capacity fluid connector 118 and an associated MUDS fluid path 134. The MUDS fluid path 134 may have spike elements that connect to the high-capacity fluid connector 118 and the fluid line 150. In some examples, the high-capacity fluid connector 118 may be provided directly on the MUDS 130.

[0098] Continue to refer to Figure 1 and Figure 2MUDS 130 may include one or more valves 136 (such as stopcocks) to control which medical fluid or combination of medical fluids is drawn from a multi-dose, high-volume fluid source 120 (see [link]). Figure 1 Fluid can be drawn into or / or delivered from each fluid reservoir 132 to a patient. In some examples, one or more valves 136 may be provided on the distal ends of the plurality of syringes 132 or on a manifold 148. The manifold 148 may be in selective fluid communication with the internal volume of the syringes 132 via valves 136. The internal volume of the syringes 132 may be in selective fluid communication with a first end of a MUDS fluid path 134 via valves 136, the first end of which connects each syringe 132 to a corresponding mass fluid source 120. A corresponding second end of the MUDS fluid path 134 may be connected to a corresponding mass fluid connector 118, which is configured for fluid connection with the mass fluid source 120. Depending on the location of one or more valves 136, fluid may be aspirated into or delivered from the internal volume of one or more syringes 132. In a first position, such as during filling syringe 132, one or more valves 136 are oriented to allow fluid to flow from a bulk fluid source 120 through a fluid inlet line 150 (such as a MUDS fluid path) into the desired syringe 132. During the filling process, one or more valves 136 are positioned to block or shut off fluid flow through one or more fluid outlet lines 152 or manifolds 148. In a second position, such as during fluid delivery, fluid from one or more syringes 132 is delivered to manifold 148 through one or more fluid outlet lines 152 or syringe valve outlet ports. During the delivery process, one or more valves 136 are positioned to block or shut off fluid flow through one or more fluid inlet lines 150. In a third position, one or more valves 136 are oriented to block or shut off fluid flow through one or more fluid inlet lines 150 and one or more fluid outlet lines 152 or manifolds 148. Thus, in the third position, each of the one or more valves 136 isolates the corresponding syringe 132 and prevents fluid flow into or out of the internal volume of the corresponding syringe 132. Therefore, each of one or more syringes 132 and its corresponding valve 136 defines a closed system.

[0099] One or more valves 136, fluid inlet lines 150, and / or fluid outlet lines 152 may be integrated into or fluidly communicated via manifold 148. One or more valves 136 may be selectively positioned to a first or second position by manual or automatic operation. For example, an operator may position one or more valves 136 to a desired position for filling, fluid delivery, or to a closed position. In other examples, at least a portion of the fluid injector system 100 is operable to automatically position one or more valves 136 to a desired position for filling, fluid delivery, or to an automatic closed position based on input from an operator or a scheme executed by an electronic control unit.

[0100] Continue to refer to Figure 1 and Figure 2 According to the described embodiments, the fluid injector system 100 may have a connection port 192 configured to form a releasable fluid connection with at least a portion of the SUDS. In some examples, the connection port 192 may be formed on the MUDS 130. As described herein, the SUDS may be connected to the connection port 192, which is formed on at least a portion of the MUDS 130 and / or the housing 102. Desiredly, the connection between the SUDS and the connection port 192 is a releasable connection to allow the SUDS to be selectively connected to and disconnected from the connection port 192. In some examples, the SUDS may be disconnected from and discarded from the connection port 192 after each fluid delivery process, and a new SUDS may be connected to the connection port 192 for subsequent fluid delivery processes. The SUDS may be used to deliver one or more medical fluids to a patient via an SUDS fluid line 208 having a distal end that can be selectively disconnected from the body of the SUDS and connected to a patient catheter. Other examples and features of SUDS are described in U.S. Patent Publication No. 2016 / 0331951, filed July 7, 2016, the disclosure of which is incorporated herein by reference in its entirety.

[0101] Refer again Figure 1The fluid injector system 100 may include one or more user interfaces 124, such as a graphical user interface (GUI) display window. The user interface 124 may display information related to the fluid injection process involving the fluid injector system 100 (such as injection status or progress, current flow rate, fluid pressure, and remaining volume in at least one high-capacity fluid source 120 connected to the fluid injector system 100), and may be a touchscreen GUI that allows an operator to input commands and / or data to operate the fluid injector system 100. Furthermore, the fluid injector system 100 and / or the user interface 124 may include at least one control button 126 for tactile operation by a caregiver of the fluid injector system 100. The at least one control button 126 may be a graphical portion of the user interface 124, such as a touchscreen.

[0102] Although Figure 1-2 An example of a fluid injector system 100 and associated components and structures is shown. It should be understood that this disclosure is not limited to any particular type or kind of fluid injector system 100. Reference is now made to... Figure 3 Another non-limiting example of the fluid injector system 100 according to this disclosure includes at least one fluid reservoir (such as syringe 12), at least one piston 103 (not shown) connectable to at least one plunger 14, and a fluid control module (not shown). At least one syringe 12 is generally adapted to engage with at least one component of the system (such as syringe port 13). The fluid injector system 100 is generally configured to deliver at least one fluid F to a patient during an infusion process. The fluid injector system 100 is configured to releasably receive at least one syringe 12, which is to be filled with at least one fluid F (such as contrast media, saline solution, Ringer's lactate, or any desired medical fluid). The system may be a multi-syringe injector, wherein several syringes may be oriented side-by-side or in another spatial relationship and are separately actuated by corresponding pistons associated with the injector. At least one syringe 12 may be oriented in any manner, such as upright, inverted, or positioned at any angle. In another embodiment, the fluid injector 100 may engage with one or more rolling diaphragm injectors (not shown). Non-limiting examples of injectors based on rolling diaphragm syringes are described in U.S. Application Serial Nos. 15 / 305,285 and 15 / 568,505 and PCT International Application No. PCT / US2017 / 056747, the disclosure of which is incorporated herein by reference.

[0103] Continue to refer to Figure 3 The injector system 100 can be used during a medical procedure by using a drive component (such as at least one piston 103) (see...). Figure 4The plunger 14 of at least one syringe 12 is driven to inject at least one medical fluid F into the patient's vascular system. At least one piston is reciprocally operable on at least a portion of at least one syringe (such as plunger 14). Once engaged, at least one piston can move plunger 14 toward the distal end 19 of at least one syringe and retract plunger 14 toward the proximal end 11 of at least one syringe 12.

[0104] The tubing kit 17 (e.g., a first fluid conduit 17a and a second fluid conduit 17b, and a common fluid conduit 20) can be in fluid communication with the outlet port of each syringe 12 to place each syringe in fluid communication with a catheter to deliver fluid F from each syringe 12 to a catheter (not shown) inserted into the patient at a vascular access location. The first fluid conduit 17a and the second fluid conduit 17b can be connected to the common fluid conduit 20 via any suitable means known in the art (e.g., a Y-connector or a T-connector). Figure 3 The fluid injector system 100 shown is an open system because there are no valves capable of isolating the injectors 12 from each other and at least partially from the tubing assembly 17. However, it should be understood that valves can be added further away from the injectors 12 (as per the reference). Figure 1 and Figure 2 The valve 136 described in the fluid injector system 100 is similar to or the same as that described in the fluid injector system 100, for use in... Figure 3 The fluid injector system 100 is transformed into a closed system.

[0105] For reference Figure 4The fluid injector system 100 according to this disclosure can be associated with and controlled by an electronic control device 400, which is configured to perform one or more injector programs, including, for example, filling, pre-filling, and delivery operations. In some examples, the electronic control device 400 can control the operation of various valves, stopcocks, piston components, and other elements to influence desired gas / air removal, filling, and / or delivery processes. The electronic control device 400 may include at least one processor 404, a memory 408, an input component 410, and an output component 412. The electronic control device may also include a bus that allows communication between components of the electronic control device 400. At least one processor 404 can be implemented as hardware, firmware, or a combination of hardware and software. For example, the processor 404 may include a processor (e.g., a central processing unit (CPU), graphics processing unit (GPU), accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform functions (e.g., a field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc.). Memory 408 may include a hard disk (e.g., a magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.) and / or another type of computer-readable medium. Input component 410 may include components that allow electronic control device 400 to receive information, such as via user input (e.g., user interface 124). Output component 412 may include components that provide output information from electronic control device 400 (e.g., user interface 124).

[0106] The electronic control device 400 can be programmed or configured to perform one or more processes and / or methods based on software instructions stored in a computer-readable medium such as memory 408, executed by at least one processor 404. When executed, the software instructions stored in memory 408 can cause at least one processor 404 to perform one or more processes and / or methods described herein.

[0107] Continue to refer to Figure 4An electronic control device 400 (more particularly, at least one processor 404) is operatively communicatively connected to one or more components of the fluid injector system 100 to control the operation of the fluid injector system 100. The electronic control device 400 is operatively communicatively connected to one or more drive components 510a, 510b, 510n to control the filling of fluid and the delivery of fluid from fluid reservoirs 500a, 500b, 500n, each of which is associated with one or more fluid reservoirs 500a, 500b, 500n of the fluid injector system 100. More particularly, each of the one or more drive components 510a, 510b, 510n may be associated with one of the fluid reservoirs 500a, 500b, 500n such that fluid contained in each of the fluid reservoirs 500a, 500b, 500n can be selectively delivered via actuation of the associated drive component 510a, 510b, 510n. Fluid storage devices 500a, 500b, and 500n can be Figure 1-2 The syringe 132 and / or of the fluid injector system 100 Figure 3 The fluid injector system 100 may use a syringe 12 or other syringe-type structure (such as a rolling diaphragm syringe), or a corresponding one, as described herein. One or more drive components 510a, 510b, 510n may be Figure 1-3 The piston (not shown) of the fluid injector system 100, or a corresponding piston, may be present. One or more fluid reservoirs 500a, 500b, 500n may be in fluid communication with the fluid conduit 530 to deliver fluid to a catheter or other component connected to the patient. The fluid conduit 530 may be... Figure 1-2 SUDS and / or fluid injector system 100 Figure 3 The piping kit 17 of the fluid injector system 100, or a corresponding one thereof.

[0108] In a closed fluid injector system 100 (e.g., Figure 1 and Figure 2 In aspects and examples of the fluid injector system 100, the electronic control device 400 may also be operatively communicatively connected to one or more valves 520a, 520b, 520n to rotate or otherwise actuate the valves 520a, 520b, 520n to direct inflows and outflows and / or isolate flows from one or more of the fluid reservoirs 500a, 500b, 500n to the fluid conduit 530. Valves 520a, 520b, 520n may be combined herein with... Figure 2 The valve 136 described may correspond to it.

[0109] During the fluid injection process of the fluid injector system 100, a load is applied to the system by, for example, one or more drive components 510a, 510b, 510n, and the resulting changes in fluid pressure within each fluid reservoir (i.e., fluid reservoirs 500a, 500b, 500n) cause the system to store some elastic energy in the form of an increased internal volume (i.e., expansion) of the fluid reservoirs 500a, 500b, 500n, or, for example, an elastic mechanical deflection of the plungers coupled to each drive component. This pressure-related increase in volume is referred to as a change in the compliance volume of the system. Based on the known characteristics of each fluid reservoir 500a, 500b, 500n and the fluid injector system 100 as a whole, the measured changes in fluid pressure within the system allow for the calculation of the corresponding change in compliance volume. In one embodiment, the change in compliance volume can be determined by a global equation executed by, for example, at least one processor 404 using information about changes in fluid pressure, fluid flow rate, etc. In another embodiment, the compliance volume can be determined by using one or more sensors capable of measuring, for example, the expansion, deflection, etc., of various components of the system. The various components of the system. In yet another embodiment, the change in compliant volume of a particular component (e.g., a fluid reservoir of a certain size / model) can be predetermined, and the component may include a scannable barcode or other indicator that provides the compliant volume characteristics of the component under various pressure and flow rate conditions. It should be understood that other methods for determining compliant volume are also possible.

[0110] Due to system compliance based on changes in internal pressure during the fluid injection process, and losses due to increased internal volume and / or elastic mechanical deflection, the actual outflow rate from the system may be lower than the guided / commanded flow rate controlled, for example, by each associated drive component 510a, 510b, 510n. However, according to aspects of this disclosure, the seemingly undesirable compliance characteristics of the system can actually be used to quickly detect blockages at cascade locations between the power fluid injector system and the injection location, as will be further detailed below.

[0111] As is known in the art, obstruction is a disturbance in the fluid flow path that causes a pressure increase by reducing the outflow rate from the system. Obstructions can occur at any location between the fluid injector system and the injection site for various reasons, such as tubing kinks, catheters pointing towards the vein wall, or anatomical valves with the catheter tip pressed into the vessel. When obstruction occurs, the fluid pressure at the obstruction site increases significantly, which is particularly undesirable if the obstruction site is located at or near the injection site (i.e., the patient's catheter). Therefore, rapid identification and response to detected obstructions are necessary. While current fluid injector systems do implement pressure limiting to attempt to avoid undesirable pressure overshoot, these pressure limits apply to the fluid injector system itself, which may experience much higher pressures during normal (i.e., unobstructed) operation than at the injection site. However, when complete obstruction occurs, the pressure experienced at the obstruction site is essentially equal to the pressure experienced by the fluid injector system. Therefore, when the fluid injector system reaches its predetermined pressure limit and implements fluid flow rate reduction or other safety measures, the obstruction site may suffer an undesirable pressure increase.

[0112] The blocking detection method according to embodiments of this disclosure will be described below based on an example scenario, but it should be understood that this disclosure is not limited to the settings and values ​​described for that example.

[0113] In the example scenario, a controllable drive component (such as a piston) is driven forward to generate a fluid flow rate of 2 mL / s. As the drive component moves forward through the fluid reservoir, the fluid injector system 100 is configured to continuously monitor pressure changes within the system at given time intervals. For example, when the drive component is at a position of 150 mL in the fluid reservoir, a pressure of 50 psi is measured at a first time (T = 0 s). The system is then configured to determine the pressure at a second time (T = 1 s) to identify any pressure changes. In the example scenario, the pressure measured at the second time (T = 1 s) is 110 psi, indicating a pressure increase of 60 psi within a one-second interval.

[0114] As mentioned above, an increase in fluid pressure within a system leads to an increase in the internal volume of various components and / or elastomechanical deflection, which can be characterized as compliance volume. In the example above, where a pressure increase of 60 psi is achieved at the 150 mL position of the fluid reservoir over a one-second time interval, the increased compliance volume of the system is calculated to be 2 mL. That is, there is a 2 mL "loss" in the system due to the increase in internal volume and / or elastomechanical deformation under pressure. As previously stated, the details of the equations or other methods for determining compliance volume can vary depending on the system characteristics.

[0115] With a compliant volume of 2 mL at a pressure peak of 60 psi at time T = 1 s, the actual flow rate out of the fluid reservoir decreases accordingly. However, since the fluid flow rate in the example above is 2 mL / s, a compliant volume of 2 mL determined at time T = 1 s implies that the actual fluid flow rate out of the system at time T = 1 s is zero (null). With a fluid flow rate of 0 out of the system, yet a measured fluid pressure of 110 psi, a complete blockage must have occurred downstream. Thus, according to aspects of this disclosure, the compliant volume of the system can be continuously calculated at various time intervals during the injection process to detect potential blockages in real time, thereby helping to avoid undesirable pressure increases at the blockage location.

[0116] refer to Figure 5 The diagram illustrates an example of its use in conjunction with the aforementioned blockage detection method. Using the calculated compliance volume, the system can be configured to simply monitor pressure changes over a given time interval, and based on the equation(s) used to determine the compliance volume, a threshold for acceptable pressure changes over that given time interval can be determined. For example, Figure 5 The graphs in the diagram illustrate the compliance volume equations for systems with specified fluid flow rates of 2 mL / s, 4 mL / s, and 6 mL / s, respectively. Referring to the 2 mL / s line on the graph, the true flow rate is shown as 2 mL / s at time T = 0 s. However, when an increase in fluid pressure is measured during a one-second time interval, the true flow rate out of the system decreases accordingly due to the increase in the system's compliance volume, eventually reaching a true flow rate of 0 mL / s if and when a pressure increase of 60 psi is achieved within the one-second time interval. As illustrated in the example above, only complete blockage would result in this "zero flow rate" condition. Similarly, when the specified fluid flow rate is 4 mL / s, a threshold is reached (i.e., true flow rate = 0 mL / s) when a pressure increase of 150 psi is achieved within the one-second time interval, while for a fluid flow rate of 6 mL / s, the threshold is reached when a pressure increase of 300 psi is achieved within the one-second time interval. It should be understood that these flow rate and pressure values ​​are for the purposes of this example only, and different flow rates, pressure values, and thresholds may exist depending on the system configuration.

[0117] Although the example above uses a one-second time interval for the purpose of simplification, it should be understood that the actual implementation of this method can determine the pressure difference calculated over much shorter intervals (e.g., 100-200ms), thereby ensuring rapid detection (and response) to any potential blockage.

[0118] Therefore, when using the compliant volume equation, the system only needs to monitor pressure changes over a given time interval to detect blockages. In one embodiment, if a blockage is detected, the system can trigger a reduction in the fluid flow rate to sufficiently reduce the pressure at the blockage location. In another embodiment, when a blockage is detected, the system can trigger an alarm or other safety protocol.

[0119] Additionally and / or alternatively, while the aforementioned threshold relates to the point where the actual flow rate out of the system equals 0 mL / s (i.e., complete blockage), in other embodiments, the threshold for actual flow rate reduction may be a number greater than zero when implementing fluid flow rate reduction and / or other safety protocols. For example, if the actual flow rate out of the system drops to less than 30% of the specified flow rate during a given time interval, the system may trigger a fluid flow rate reduction because such a reduction may indicate at least partial blockage or other obstruction in the system, which could lead to an undesirable pressure increase at or near the injection site. By reducing the fluid flow rate before reaching zero actual flow rate, the injection process can continue at a reduced flow rate until the blockage or partial blockage of the flow is remedied.

[0120] Next, according to another aspect of this disclosure, the same logic used above for blockage detection can also be used to optimize the pressure limits of a fluid injector system.

[0121] As mentioned above, fluid injector systems may be subject to predetermined pressure limits. These limits can be based on various factors, such as procedure type and patient age. Typically, when a fluid injector system reaches its predetermined pressure limit, the fluid flow rate abruptly decreases to reduce the pressure below the limit. The flow rate can then be increased again to return the flow to the desired rate, with the flow rate repeatedly decreasing upon reaching the pressure limit again. However, these continuous variations in fluid flow rate cause speed variations in many motors within the system, affecting overall motor life and potentially leading to poor volumetric accuracy. Furthermore, the required reduction in fluid flow rate is often overestimated, resulting in an excessively low flow rate, which can adversely affect the injection process.

[0122] Using the above logic, the calculated change in the system's compliance volume when a predetermined pressure limit is reached can be used to optimize system performance. Specifically, according to one aspect of this disclosure, an electronic control device (e.g., electronic control device 400) can be configured to monitor the moment when the predetermined pressure limit is reached. At this time, the processor of the electronic control device (e.g., processor 404) can be configured to query the fluid pressure change in the last time period immediately preceding the reaching of the predetermined pressure limit. In one example, this time period could be the last second interval before reaching the predetermined pressure limit. However, in practical implementations, this time period may be much shorter than one second (e.g., 250 milliseconds).

[0123] Using the pressure difference determined during that final time interval, the change in the system's compliance volume can be calculated using any of the methods described above. Determining the compliance volume based on the pressure difference immediately preceding the predetermined pressure limit is optimal because the system components will not experience higher fluid pressures than at that moment, thus the change in compliance volume will be maximized for the specified injection process.

[0124] Next, using the determined change in compliance volume, the processor can be configured to subtract the change in compliance volume from the guided fluid flow rate to determine the true outflow rate from the system. In one example, refer again... Figure 5 If the commanded fluid flow rate is 4 mL / s, and the pressure difference measured in the last second interval before reaching the predetermined pressure limit is 60 psi, then the compliance volume of the system is calculated to be approximately 2 mL. Therefore, to determine the true flow rate out of the system at this point, the compliance volume is subtracted from the volume component of the commanded fluid flow rate (i.e., 4 mL minus 2 mL equals the true fluid flow rate of 2 mL / s at the predetermined pressure limit). It should be understood that the time interval for measuring the pressure difference can be any predetermined time interval. The chosen time interval can be based on the system's processing capacity and can be less than one second (i.e., milliseconds). The use of a one-second interval in the example scenario here is merely for simplicity, and it should be understood that the time interval described herein should not be considered limiting.

[0125] Using the actual fluid flow rate calculated at this point, the processor can then be configured to update the fluid flow rate of commands to drive components (such as pistons) to match the actual fluid flow rate. By reducing the fluid flow rate in this way, the pressure should stabilize near a predetermined pressure limit. If the initial reduction in the fluid flow rate does not prevent the pressure from rising (i.e., reaching the predetermined pressure limit again), the system can be configured to continue reducing the fluid flow rate by measuring the pressure rise over a given time interval and determining recursive updates to the fluid flow rate using the same method described above for the initial reduction.

[0126] By using the calculated change in compliant volume to reduce the flow rate as described above, the system's pressure limiting performance should be significantly improved because the number of motor speed changes will be greatly reduced compared to conventional pressure limiting methods. This reduction in motor speed changes improves pressure accuracy under predetermined pressure limits because the current fluctuations from motor speed changes are reduced, resulting in better volumetric accuracy performance and increased motor life.

[0127] Next, refer to Figure 6The illustration depicts a method 200 according to one aspect of this disclosure. First, at 202, fluid is delivered from at least one fluid injector device at a predetermined (i.e., commanded) fluid flow rate. The at least one fluid injector device may be one or more of, for example, an injector, a compressible bag, a peristaltic pump, a piping kit, etc. At 204, a first fluid pressure measurement is determined within the at least one fluid injector device at a first time. Then, at 206, a second fluid pressure measurement is determined within the at least one fluid injector device at a second time.

[0128] Next, at 208, the pressure difference between the determined first fluid pressure measurement and the second fluid pressure measurement is determined. At 210, using the determined pressure difference, the change in compliance volume of at least one fluid injector device is calculated. Then, at 212, the calculated change in compliance volume is compared with a predetermined flow rate.

[0129] At 214, it is determined whether the calculated change in compliance volume is equal to or within a predetermined threshold of the volume component of the predetermined fluid flow rate. If not, the method returns to 202 and continues to deliver fluid at the predetermined fluid flow rate. However, if yes, at 216, the fluid delivery rate of at least one fluid injector device is reduced. The method then returns to 202 and delivers fluid at the predetermined (now reduced) fluid flow rate.

[0130] While the methods described above utilize pressure measurements and calculated changes in compliant volume to detect blockages (and / or potential blockages), it should be understood that this disclosure is not limited thereto. For example, in other embodiments described in further detail below, the system may rely on calculated actual flow rates exiting at least one fluid injector device to determine whether a blockage has occurred or is likely to occur.

[0131] refer to Figure 7 The diagram illustrates a method 600 according to another aspect of this disclosure. First, at 602, the injection process is set with a predetermined threshold and a pressure limit. The predetermined threshold may be, for example, a blockage threshold based on the expected pressure and / or flow rate from the system during the injection process.

[0132] At 604, the injection process begins, and at 606, the timer starts. At the moment the timer starts (time t = 0), the pressure or actual fluid flow rate is measured at 608. At 610, the system waits for the timer to elapse. It should be understood that the timer can be set to any predetermined time. Then, at 612, at the moment the timer has elapsed (time t = (timer ends)), the pressure or actual fluid flow rate is measured.

[0133] Next, at 614, using pressure or flow rate measured at two separate times, at least one processor of the system is configured to calculate or measure the actual flow rate exiting the system. Then, at 616, this actual flow rate is compared to a blockage threshold. The blockage threshold could be, for example, the expected flow rate range of the system under normal operating conditions. If the actual flow rate is equal to or below the blockage threshold, it may be an indication that blockage has occurred or may occur.

[0134] At 618, it is determined whether a blockage threshold has been exceeded. If not, the method can return to 606, and a new timer can be set to continue monitoring / measuring the system's pressure or flow rate during the injection process. However, if yes (i.e., the blockage threshold has been exceeded), then at 620, at least one processor can be configured to instruct the fluid injection system to stop the injection.

[0135] In addition to blockage detection, according to another embodiment, the system can utilize actual flow rate measurements / calculations to provide enhanced pressure limiting. An example flowchart of a method for providing such enhanced pressure limiting is shown in [the flowchart]. Figure 8 This is explained in the text.

[0136] refer to Figure 8 The diagram illustrates a method 700 according to another aspect of this disclosure. First, at 702, the injection process is set with a predetermined threshold and a pressure limit. The predetermined threshold may be, for example, a pressure threshold based on the expected pressure level in the system during the injection process.

[0137] At 704, the injection process begins, and at 706, the timer starts. At the moment the timer starts (time t = 0), the pressure or actual fluid flow rate is measured at 708. At 710, the system waits for the timer to elapse. It should be understood that the timer can be set to any predetermined time. Then, at 712, at the moment the timer has elapsed (time t = (timer ends)), the pressure or actual fluid flow rate is measured.

[0138] Next, at 714, using the pressure or flow rate measured at two separate times, at least one processor of the system can be configured to calculate or measure the actual flow rate exiting the system. At 716, the calculated or measured actual (or true) flow rate exiting the system is then stored, for example, in the system's memory.

[0139] At 718, it is determined whether a predetermined pressure threshold has been reached. If not, the method can return to 706, and a new timer can be set to continue monitoring / measuring the system's pressure or flow rate during the injection process. However, if yes (i.e., the predetermined pressure threshold has been reached), then at 720, at least one processor can be configured to instruct the fluid injection system to set the fluid delivery rate of the system's command to the actual (or true) flow rate value last stored before the pressure threshold was reached. In this way, the system's pressure limiting performance can be significantly improved.

[0140] For reference Figure 9-12 The graphs show various comparisons of the injection process under different operating conditions.

[0141] First refer to Figure 9 The figure shows a graphical representation of pressure versus time during the injection process, commanded / programmed flow rate versus time, change in compliance volume versus time, and measured outflow rate versus time under normal (i.e., unobstructed) operating conditions. As shown, when comparing the pressure versus time and flow rate versus time graphs, the pressure within the system increases as the flow rate rises to the programmed flow rate. However, the pressure stabilizes before reaching the programmed pressure limit, indicating that the fluid flowing out of the system is relatively unobstructed (i.e., under normal operating conditions). Furthermore, the change in compliance volume follows a curve substantially similar to the expected pressure curve under normal operating conditions, and the measured actual outflow rate is substantially similar to the programmed flow rate, with slight variations due to changes in the system's compliance volume.

[0142] Conversely, refer to Figure 10 The graph shows a graphical representation of the injection process in which blockage occurs (or is detected). Comparing the pressure versus time and flow rate versus time graphs again, the pressure increases as the flow rate increases to the programmed flow rate. However, unlike the normal (i.e., unobstructed) situation described above, in… Figure 10 In this process, the pressure gradually increases while the programmed flow rate remains constant, eventually reaching and exceeding the programmed pressure limit. The change in the compliance volume curve follows the pressure curve, as the increased pressure leads to a corresponding change in the compliance volume. Under these conditions, it can be inferred that a blockage has occurred. Therefore, as described above, when a blockage (or potential blockage) is detected, the system can be configured to abort the injection process. This can be seen in the measured flow rate versus time graph, which illustrates that when a blockage occurs, the measured (i.e., actual) flow rate out of the system drops to zero, at which point the injection can be stopped to prevent further pressure increases at the blockage location.

[0143] For reference Figure 11 According to another embodiment of this disclosure, a graphical representation of the injection process in which blockage occurs (or is detected) is shown. Similar to the description of... Figure 10As shown and described, as the flow rate increases to the programmed flow rate, the pressure in the system rises. However, due to blockage, the pressure increases gradually while the programmed flow rate remains constant, eventually reaching and exceeding the programmed pressure limit. However, compared to... Figure 10 Unlike the scenario described, when a blockage (or potential blockage) is detected, the system can be configured to abort the injection process before the measured (i.e., actual) flow rate out of the system reaches zero. More specifically, a predetermined blockage threshold (e.g., 30% of the programmed flow rate) may exist at which the system is configured to abort the injection process. It may be desirable to abort the injection before the actual flow rate out of the system reaches zero to avoid potentially undesirable pressure spikes at the blockage location.

[0144] Next, refer to Figure 12 The diagram illustrates a graphical representation of an injection process according to another embodiment of the present disclosure. Specifically, the graphical representation shows an injection process utilizing the optimized pressure limiting method described above. Comparing the pressure versus time graph with a programmed / command flow rate versus time graph, it can be seen that the system pressure increases when the flow rate reaches the programmed flow rate. However, referring to the measured (i.e., actual) flow rate versus time graph, it is clear that the actual flow rate out of the system is lower than the programmed flow rate. As described above, this difference may be at least partly due to a change in the compliant volume of the system under pressure. Thus, according to one aspect of the present disclosure, to mitigate any additional pressure increase, the system can be configured to reduce the programmed flow rate to substantially equal to the measured flow rate, which can act as a pressure stabilizer during the injection process.

[0145] Although this disclosure has been described in detail for illustrative purposes based on embodiments or aspects currently considered most practical and preferred, it should be understood that such detailed description is for that purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect.

Claims

1. A fluid injector system configured to administer at least one fluid during fluid injection, the fluid injector system comprising: At least one fluid injector device; One or more drive components; and The control device includes at least one processor, said at least one processor being programmed or configured to: Instructions are given to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate. The first fluid pressure measurement within the at least one fluid injector device is determined at the first moment. A second fluid pressure measurement is determined within the at least one fluid injector device at a second time. Determine the pressure difference between the first fluid pressure measurement and the second fluid pressure measurement. The change in the compliant volume of the at least one fluid injector device is continuously calculated based on the pressure difference, wherein the compliant volume is due to the increase in volume of the at least one fluid injector device under fluid pressure and elastic mechanical deflection of the one or more drive components. The calculated change in compliance volume is compared with the predetermined fluid flow rate. Repeat the above steps throughout the fluid injection process, and The processor determines whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if the blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of one or more drive components of the at least one fluid injector device.

2. The fluid injector system according to claim 1, wherein, If the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of the predetermined fluid flow rate, the control device determines that the blockage has occurred.

3. The fluid injector system according to claim 1 or 2, wherein, The calculated change in compliance volume is compared with the predetermined fluid flow rate to determine the calculated true flow rate measurement.

4. The fluid injector system according to claim 3, wherein, If the calculated actual flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate, then it is determined that a blockage has occurred downstream of the at least one fluid injector device.

5. The fluid injector system according to claim 1, wherein, If the change in the calculated compliance volume is within or close to a predetermined threshold of the volume component of the predetermined fluid flow rate, it is determined that at least partial blockage may have occurred downstream of the at least one fluid injector device.

6. The fluid injector system according to claim 5, wherein, The at least one processor is programmed or configured to reduce the delivery rate of one or more drive components of the at least one fluid injector device if the calculated compliance volume change is within or close to a predetermined threshold of the volume component of the predetermined fluid flow rate.

7. The fluid injector system according to claim 1 or 2, wherein, The at least one processor is programmed or configured to determine when a pre-programmed pressure limit of the at least one fluid injector device has been reached.

8. The fluid injector system according to claim 1 or 2, wherein, The at least one processor is programmed or configured to subtract the calculated change in compliance volume from the volume component of the delivery rate of one or more drive components of the at least one fluid injector device to determine the calculated true fluid flow rate flowing out of the at least one fluid injector device.

9. The fluid injector system according to claim 8, wherein, The at least one processor is programmed or configured to adjust the delivery rate of one or more drive components of the at least one fluid injector device such that the calculated actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

10. A computer-implemented method for at least partial blockage detection and pressure limiting in a fluid injector system, said fluid injector system configured to administer at least one fluid during fluid injection, the method comprising: The fluid injector system is given instructions by a control device including at least one processor to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; The first fluid pressure measurement within the at least one fluid injector device is determined at the first moment; A second fluid pressure measurement is determined within the at least one fluid injector device at a second time. The control device is used to determine the pressure difference between the first fluid pressure measurement and the second fluid pressure measurement; The control device continuously calculates the change in the compliant volume of the at least one fluid injector device based on the pressure difference, wherein the compliant volume is due to the increase in volume of the at least one fluid injector device under pressure and elastic mechanical deflection of one or more drive components; The control device is used to compare the calculated change in compliance volume with the predetermined fluid flow rate; Repeat the method steps throughout the fluid injection process; and Determine whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if it is determined that the blockage or partial blockage has occurred, then the at least one processor is programmed or configured to reduce or stop the delivery rate of one or more drive components of the at least one fluid injector device; and The computer-implemented method described herein is for non-therapeutic purposes.

11. The computer-implemented method according to claim 10, further comprising: If the calculated change in compliance volume is equal to or greater than a predetermined threshold of the volume component of the predetermined fluid flow rate, then the control device determines that a blockage has occurred.

12. The computer-implemented method of claim 10 or 11, further comprising comparing the calculated change in compliance volume with the predetermined fluid flow rate to determine a calculated true flow rate measurement.

13. The computer-implemented method according to claim 12, further comprising: If the calculated actual flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate, then the control device determines that a blockage has occurred.

14. The computer-implemented method of claim 11, further comprising determining whether the at least partial blockage has occurred, and if the calculated change in compliance volume is within or close to a predetermined threshold of the volume component of the predetermined fluid flow rate, reducing the delivery rate of one or more drive components of the at least one fluid injector device with the control device.

15. The computer-implemented method of claim 10 or 11, further comprising using the control device to determine when a pre-programmed pressure limit of the at least one fluid injector device has been reached.

16. The computer-implemented method of claim 15, wherein the first time of determining the first fluid pressure measurement is a time before the pre-programmed pressure limit is reached, and wherein the second time of determining the second fluid pressure measurement is a time when or after the pre-programmed pressure limit is reached.

17. The computer-implemented method of claim 10 or 11, further comprising subtracting the calculated change in compliance volume from the volume component of the delivery rate of one or more drive components of the at least one fluid injector device using the control device to determine the calculated true fluid flow rate out of the at least one fluid injector device.

18. The computer-implemented method of claim 17, further comprising adjusting the delivery rate of one or more drive components of the at least one fluid injector device using the control device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

19. A computer program product for at least partial blockage detection and pressure limiting of a fluid injector system configured to administer at least one fluid during fluid injection, the computer program product comprising at least one non-transitory computer-readable medium comprising one or more instructions, said one or more instructions, when executed by at least one processor, causing said at least one processor to: Instructions are given to the fluid injector system to deliver fluid from at least one fluid injector device at a predetermined fluid flow rate; The first fluid pressure measurement within the at least one fluid injector device is determined at the first moment; A second fluid pressure measurement is determined within the at least one fluid injector device at a second time. Determine the pressure difference between the first fluid pressure measurement and the second fluid pressure measurement; The change in the compliant volume of the at least one fluid injector device is continuously calculated based on a determined pressure difference, wherein the compliant volume is due to the increase in volume of the at least one fluid injector device under pressure and elastic mechanical deflection of one or more drive components. The calculated change in compliance volume is compared with the predetermined fluid flow rate; The above steps are repeated during the fluid injection process; and The processor determines whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if the blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of one or more drive components of the at least one fluid injector device.

20. The computer program product according to claim 19, wherein, When one or more instructions are executed by the at least one processor, the at least one processor determines that the blockage has occurred if the change in the calculated compliance volume is equal to or greater than a predetermined threshold of the volume component of the predetermined fluid flow rate.

21. The computer program product according to claim 19 or 20, wherein, When one or more instructions are executed by the at least one processor, the at least one processor: compares the calculated change in compliance volume with a predetermined fluid flow rate to determine the calculated true flow rate measurement.

22. The computer program product according to claim 21, wherein, When one or more instructions are executed by the at least one processor, if the calculated actual flow rate is less than or equal to a predetermined percentage of the predetermined fluid flow rate, then it is determined that a blockage has occurred downstream of the at least one fluid injector device.

23. The computer program product according to claim 20, wherein, When one or more instructions are executed by the at least one processor, the at least one processor causes the at least one processor to reduce the delivery rate of one or more drive components of the at least one fluid injector device if the change in the calculated compliance volume is within or close to a predetermined threshold of the volume component of the predetermined fluid flow rate.

24. The computer program product according to claim 19 or 20, wherein, The one or more instructions, when executed by the at least one processor, enable the at least one processor to determine when the pre-programmed pressure limit of the at least one fluid injector device has been reached.

25. The computer program product according to claim 19 or 20, wherein, When executed by the at least one processor, the one or more instructions cause the at least one processor to subtract the calculated change in compliance volume from the volume component of the delivery rate of one or more drive components of the at least one fluid injector device to determine the calculated true fluid flow rate flowing out of the at least one fluid injector device.

26. The computer program product of claim 25, wherein the one or more instructions, when executed by the at least one processor, cause the at least one processor to adjust the delivery rate of one or more drive components of the at least one fluid injector device such that the determined actual fluid flow rate is substantially the same as the predetermined fluid flow rate.

27. A fluid injector system configured to administer at least one fluid during fluid injection, the fluid injector system comprising: At least one fluid injector device; One or more drive components; and The control device includes at least one processor, said at least one processor being programmed or configured to: Instructions are given to the fluid injector system to deliver fluid from the at least one fluid injector device at a predetermined fluid flow rate. The first fluid pressure measurement within the at least one fluid injector device is determined at the first moment. A second fluid pressure measurement is determined within the at least one fluid injector device at a second time. Determine the pressure difference between the first fluid pressure measurement and the second fluid pressure measurement. The change in the compliant volume of the at least one fluid injector device is continuously calculated based on the determined pressure difference. The fluid flow rate within the at least one fluid injector device is determined at the first time. The fluid flow rate within the at least one fluid injector device is monitored until the second time. Based on the flow rate during the time interval between the first time and the second time, the actual fluid flow rate delivered from the at least one fluid injector device is continuously calculated. The compliant volume is due to the increase in volume of the at least one fluid injector device under pressure and elastic mechanical deflection of one or more drive components. The calculated actual fluid flow rate is compared with the predetermined fluid flow rate. Repeat the above steps throughout the fluid injection process, and The processor determines whether a blockage or partial blockage has occurred downstream of the at least one fluid injector device, and if the blockage or partial blockage is determined to have occurred, the at least one processor is programmed or configured to reduce or stop the delivery rate of one or more drive components of the at least one fluid injector device.

28. The fluid injector system of claim 27, wherein, If the calculated actual fluid flow rate delivered from the at least one fluid injector device is not equal to a predetermined threshold of the predetermined fluid flow rate, then it is determined that a blockage has occurred downstream of the at least one fluid injector device.

29. The fluid injector system according to claim 27 or 28, wherein, If the actual fluid flow rate is within or close to a predetermined threshold of the predetermined fluid flow rate, it is determined that at least a partial blockage may have occurred downstream of the at least one fluid injector device.

30. The fluid injector system of claim 29, wherein, The at least one processor is programmed or configured to reduce the delivery rate of one or more drive components of the at least one fluid injector device if the actual fluid flow rate is within or close to a predetermined threshold of the predetermined fluid flow rate.

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