Utilization of Pressure Measurement for Detecting Reuse of Patient Lines

Abstract

A fluid injector system configured to execute injection commands in connection with diagnostic imaging includes a memory for storing a predetermined pressure profile representative of the pressure a priming fluid is expected to generate in a typical administration line, and a controller operably coupled to the drive element to pressurize and inject at least one fluid through a target administration line. The controller includes a processor configured to perform operations including: actuating the drive element to prime the target administration line; determining a discrete pressure profile representative of a measurement of the current pressure experienced during priming of the target administration line; comparing the discrete pressure profile to the predetermined pressure profile; and determining, based on the results of the comparison, whether the target administration line contained at least one of a liquid or a gas as a residual fluid prior to priming.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 723,718, filed on August 28, 2018, the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The present disclosure broadly relates to the detection of reuse of components of a single - use disposable fluid path set in a fluid injector system. More specifically, the present disclosure relates to a fluid injector system, a computer program product, and a method for detecting reuse of components of a single - use disposable fluid path set in such a fluid injector system using pressure measurement.

[0003] In many medical diagnostic and treatment procedures, a medical practitioner, such as a physician, injects one or more medical fluids into a patient. In recent years, several medical fluid delivery systems for injecting fluids, such as contrast agent solutions (often simply referred to as "contrast agents"), cleaning agents or diluents such as saline, and other medical fluids, under pressure have been developed for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other molecular imaging procedures. Generally, these medical fluid delivery systems are designed to deliver a pre - set amount of fluid at a pre - set flow rate.

[0004] In some injection procedures, a healthcare provider places a catheter or needle into a patient's vein or artery. The catheter or needle is connected to either a manual or an automatic fluid injector system by tubing and a connector that interfaces with the fluid injector system. An automatic fluid injector system typically includes at least one syringe connected to at least one fluid injector having, for example, a powered linear piston. The at least one syringe includes, for example, a source of contrast agent and / or a source of flush solution. The healthcare provider inputs settings into the electronic control system of the fluid injector for a specified amount of contrast agent and / or saline and for each specified injection rate. A single-use disposable set of connectors and associated tubing is connected to the fluid injector system to deliver one or more fluids to the patient.

[0005] To prevent contamination between patients and medical devices, the connectors and associated tubing of each single-use disposable set are preferably exchanged between patients. However, a user may attempt to reuse the connectors of a single-use disposable set to save time and cost, which is an unhygienic and potentially dangerous practice.

[0006] A variety of manual and automatic fluid delivery systems are known in the medical field, but there continues to be a need for an improved multi-fluid delivery system configured for use in medical diagnostic and treatment procedures and for delivering one or more fluids to a patient in such procedures. In particular, there is a need for fluid delivery systems and single-use disposable set connectors that facilitate and enforce the performance of safe and hygienic operations.

PRIOR ART DOCUMENTS

PATENT DOCUMENTS

[0007]

PATENT DOCUMENT 1

PATENT DOCUMENT 2

[0008] The present disclosure generally relates to a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method. The fluid injector system can include a memory for storing a predetermined pressure profile, and the predetermined pressure profile is executed for a typical administration line and can represent the pressure expected to be generated by the priming fluid in the typical administration line during the process of a priming operation that completely eliminates residual fluid from the typical administration line with the priming fluid. Further, the fluid injector system can include a control device operably combined with at least one drive component configured to pressurize and inject at least one fluid through a target administration line to a patient. The control device includes at least one processor programmed or configured to perform operations including: operating at least one drive component to prime the target administration line with at least one fluid as the priming fluid; determining an individual pressure profile representing a measured value of the current pressure generated during priming of the target administration line with at least one fluid during the process of the priming operation performed with at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; and determining based on the result of the comparison whether the target administration line contained at least one of a liquid as residual fluid and a gas as residual fluid prior to priming.

[0009] According to another example, a typical dosing line is either (i) an unused dosing line, such that the residual fluid is a gas, and thus the predetermined pressure profile represents the pressure that the priming fluid is expected to generate when, during the priming operation, the gas in the unused dosing line is completely displaced by the priming fluid when priming the unused dosing line, or (ii) a previously used dosing line, such that the residual fluid is at least partially liquid, and thus the predetermined pressure profile represents the pressure that the priming fluid is expected to generate when, during the priming operation, the liquid in the previously used dosing line is completely displaced by the priming fluid when priming the previously used dosing line. When the typical dosing line is an unused dosing line, at least one processor is configured to determine that the target dosing line contained gas as the residual fluid when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison.

[0010] According to another example, the operation can further include generating a warning indicating that the target dosing line has not been used before it is primed with at least one fluid in the priming operation when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison. The operation can further include permitting the execution of an injection command when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison.

[0011] According to another example, the target administration line can include at least one check valve that, like a typical administration line, impedes the flow of fluid in the proximal direction. The result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range is that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through at least one check valve of a typical administration line corresponding to this at least one pressure inflection point, the individual pressure profile is normalized with respect to the steady-state value of this individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of this predetermined pressure profile, it is determined that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and the individual pressure profile is normalized with respect to the steady-state value of this individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of this predetermined pressure profile, and each point along the individual pressure profile is determined to correlate within the specified tolerance range with the corresponding point on the predetermined pressure profile, and can include at least one of these.

[0012] According to another example, the typical administration line can be an administration line that has been used previously, and when the result of the comparison is that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range, at least one processor can be configured to determine that the target administration line contained liquid as residual fluid. The operation can further include generating a warning indicating that the target administration line has been used before it is primed by at least one fluid in the priming operation when the result of the comparison is that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range.

[0013] According to another example, the target administration line can include at least one check valve that prevents the flow of fluid in the proximal direction, similar to a typical administration line. The result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range means that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through at least one check valve of the typical administration line corresponding to this at least one pressure inflection point, the individual pressure profile is normalized with respect to the steady-state value of this individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of this predetermined pressure profile, it is determined that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and the individual pressure profile is normalized with respect to the steady-state value of this individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of this predetermined pressure profile, and it is determined that each point along the individual pressure profile correlates within the specified tolerance range with the corresponding point on the predetermined pressure profile, and can include at least one of them.

[0014] According to another example, at least one fluid used for priming the target administration line can include at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of a contrast medium and a diluent. The step of determining the individual pressure profile can include the step of measuring the motor current of at least one drive component.

[0015] According to another example, the target administration line, like a typical administration line, can include a first check valve that prevents the flow of fluid in the proximal direction and a second check valve that prevents the flow in the proximal direction. The second check valve may be located distally of the first check valve. During priming of the target administration line, the operation further includes identifying a first pressure inflection point of an individual pressure profile caused by at least one fluid passing through the first check valve of the target administration line, and identifying at least one of a second pressure inflection point of an individual pressure profile caused by at least one fluid passing through the second check valve of the target administration line and a steady-state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant. When comparing the individual pressure profile with a predetermined pressure profile, the operation can further include determining, based on the result of the comparison, that the administration line is fully primed.

[0016] According to another example, the target administration line, like a typical administration line, can include a single check valve located at the distal end of the target administration line. This single check valve can prevent the flow of fluid in the proximal direction. During priming of the target administration line, the operation further includes identifying at least one of a pressure inflection point of an individual pressure profile caused by at least one fluid passing through the single check valve of the target administration line and a steady-state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant. When comparing the individual pressure profile with a predetermined pressure profile, the operation can further include determining, based on the result of the comparison, that a component of the fluid path set is connected to the distal end of the administration line.

[0017] According to another example, a computer program product for detecting multiple uses of a dosing line using a fluid injector system can be configured to execute an injection command in relation to a diagnostic imaging method. The computer program product can include a non-transitory computer-readable medium having memory for storing a predetermined pressure profile. The predetermined pressure profile can represent the pressure expected to be generated by the priming fluid in a typical dosing line during the priming operation that completely removes residual fluid from the typical dosing line with the priming fluid. The non-transitory computer-readable medium, when executed by at least one processor, causes the at least one processor to perform steps including operating at least one drive component of the fluid injector system to prime the target dosing line with the priming fluid, determining an individual pressure profile representing a measured value of the current pressure generated during the priming of the target dosing line with the at least one fluid during the priming operation performed with the at least one fluid, comparing the individual pressure profile with the predetermined pressure profile, and determining based on the result of the comparison whether the target dosing line contained at least one of liquid as residual fluid and gas as residual fluid before priming. The non-transitory computer-readable medium can further include one or more instructions that cause the at least one processor to execute an operation including these steps.

[0018] According to another example, a typical dosing line is either (i) an unused dosing line, such that the residual fluid is a gas, and thus the predetermined pressure profile represents the pressure that would be expected to be generated by the priming fluid when, during the priming operation, the gas in the unused dosing line is completely displaced by the priming fluid when priming the unused dosing line, or (ii) a previously used dosing line, such that the residual fluid is at least partially liquid, and thus the predetermined pressure profile represents the pressure that would be expected to be generated by the priming fluid when, during the priming operation, the liquid in the previously used dosing line is completely displaced by the priming fluid when priming the previously used dosing line. When the typical dosing line is an unused dosing line, when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison, one or more instructions, when executed by at least one processor, can cause the at least one processor to determine that the target dosing line contained a gas as the residual fluid.

[0019] According to another example, one or more instructions, when executed by at least one processor, can cause the at least one processor to perform a further operation including generating a warning indicating that the target dosing line had not been used before being primed by at least one fluid when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison. One or more instructions, when executed by at least one processor, can cause the at least one processor to perform a further operation including permitting the execution of an injection command when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison.

[0020] According to another example, the target dosing line can include at least one check valve that prevents the flow of fluid in the proximal direction, similar to a typical dosing line. The result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range is that at least one processor determines that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target dosing line correlates with at least one pressure inflection point in the predetermined pressure profile caused by a priming fluid passing through at least one check valve of a typical dosing line corresponding to this at least one pressure inflection point, at least one processor normalizes the individual pressure profile with respect to the steady-state value of this individual pressure profile, at least one processor normalizes the predetermined pressure profile with respect to the steady-state value of this predetermined pressure profile, at least one processor determines that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and normalizes the individual pressure profile with respect to the steady-state value of this individual pressure profile, normalizes the predetermined pressure profile with respect to the steady-state value of this predetermined pressure profile, and determines that each point along the individual pressure profile correlates within the specified tolerance range with the corresponding point on the predetermined pressure profile, and can include at least one of the above.

[0021] According to another example, a typical dosing line can be a previously used dosing line, and when the correlation between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified tolerance range, one or more instructions, when executed by at least one processor, can cause the at least one processor to determine that the target dosing line contained liquid as residual fluid. The one or more instructions, when executed by at least one processor, when the correlation between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified tolerance range, can cause the at least one processor to perform a further operation including generating a warning indicating that the target dosing line had been used before being primed with at least one fluid in a priming operation.

[0022] According to another example, the target administration line can include at least one check valve that, like a typical administration line, impedes the flow of fluid in the proximal direction. The result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range is that at least one processor determines that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by priming fluid passing through at least one check valve of a typical administration line corresponding to this at least one pressure inflection point, at least one processor normalizes the individual pressure profile with respect to the steady-state value of this individual pressure profile, at least one processor normalizes the predetermined pressure profile with respect to the steady-state value of this predetermined pressure profile, at least one processor determines that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and at least one processor normalizes the individual pressure profile with respect to the steady-state value of this individual pressure profile, at least one processor normalizes the predetermined pressure profile with respect to the steady-state value of this predetermined pressure profile, and at least one processor determines that each point along the individual pressure profile correlates within the specified tolerance range with the corresponding point on the predetermined pressure profile, and can include at least one of these.

[0023] According to another example, at least one fluid used for priming the target administration line can include at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of a contrast medium and a diluent. The step of determining the individual pressure profile can include, by at least one processor, measuring the motor current of at least one drive component.

[0024] According to another example, the target administration line can include, similar to a typical administration line, a first check valve that prevents the flow of fluid in the proximal direction and a second check valve that prevents the flow in the proximal direction. The second check valve may be located distal to the first check valve. During priming of the target administration line, the operation further includes identifying a first pressure inflection point of an individual pressure profile caused by at least one fluid passing through the first check valve of the target administration line, and identifying at least one of a second pressure inflection point of an individual pressure profile caused by at least one fluid passing through the second check valve of the target administration line and a steady state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant. When comparing the individual pressure profile with a predetermined pressure profile, the operation can further include determining, based on the result of the comparison, that the administration line is fully primed.

[0025] According to another example, the target administration line can include, similar to a typical administration line, a single check valve located at the distal end of the target administration line. This single check valve can prevent the flow of fluid in the proximal direction. During priming of the target administration line, the operation further includes identifying at least one of a pressure inflection point of an individual pressure profile caused by at least one fluid passing through the single check valve of the target administration line and a steady state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant. When comparing the individual pressure profile with a predetermined pressure profile, the operation can further include determining, based on the result of the comparison, that a component of the fluid path set is connected to the distal end of the target administration line.

[0026] According to another example, a method for detecting multiple uses of a dosing line using a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method includes the steps of providing a memory for storing a predetermined pressure profile, where the predetermined pressure profile is executed for a typical dosing line and represents the pressure expected to be generated by the priming fluid in the typical dosing line during the process of a priming operation that completely eliminates residual fluid from the typical dosing line with the priming fluid; operating at least one drive component of the fluid injector system to prime the target dosing line with the priming fluid; determining an individual pressure profile representing a measured value of the current pressure generated during the priming of the target dosing line with at least one fluid during the process of the priming operation executed with at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; and determining, based on the result of the comparison, whether the target dosing line contained at least one of liquid as residual fluid and gas as residual fluid before priming.

[0027] According to another example, the disclosure of the present application can be characterized by one or more of the following clauses.

[0028] Clause 1: A fluid injector system configured to execute an injection command in relation to a diagnostic imaging method, the fluid injector system comprising a memory for storing a predetermined pressure profile, the predetermined pressure profile being representative of the pressure expected to be generated by the priming fluid in a typical administration line during the process of a priming operation that completely eliminates residual fluid from the typical administration line with the priming fluid, a control device operably combined with at least one drive component configured to pressurize and inject at least one fluid through a target administration line into a patient, the control device comprising at least one processor programmed or configured to perform operations including: operating at least one drive component to prime the target administration line with at least one fluid as the priming fluid; determining an individual pressure profile representative of a measured value of the current pressure generated during priming of the target administration line with at least one fluid during the process of a priming operation performed with at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; and determining based on the result of the comparison whether the target administration line contained at least one of a liquid as residual fluid and a gas as residual fluid prior to priming. A fluid injector system comprising the control device.

[0029] Clause 2: A typical dosing line is either (i) an unused dosing line, such that the residual fluid is a gas, and thus a predetermined pressure profile represents the pressure expected to be produced by the priming fluid when, during the priming operation, the gas in the unused dosing line is completely displaced by the priming fluid when priming the unused dosing line, or (ii) a previously used dosing line, such that the residual fluid is at least partially liquid, and thus a predetermined pressure profile represents the pressure expected to be produced by the priming fluid when, during the priming operation, the liquid in the previously used dosing line is completely displaced by the priming fluid when priming the previously used dosing line, of the fluid injector system according to Clause 1.

[0030] Clause 3: A typical dosing line is an unused dosing line, and when the correlation between the individual pressure profile and the predetermined pressure profile is within a specified tolerance as a result of the comparison, at least one processor is configured to determine that the target dosing line contained gas as the residual fluid, of the fluid injector system according to Clause 1 or 2.

[0031] Clause 4: The operation further includes generating a warning indicating that the target dosing line has not been used before it is primed with at least one fluid when the correlation between the individual pressure profile and the predetermined pressure profile is within a specified tolerance as a result of the comparison, of the fluid injector system according to any one of Clauses 1 to 3.

[0032] Clause 5: The operation further includes permitting the execution of an injection command when the correlation between the individual pressure profile and the predetermined pressure profile is within a specified tolerance as a result of the comparison, of the fluid injector system according to any one of Clauses 1 to 4.

[0033] Clause 6: The target administration line, like a typical administration line, includes at least one check valve that impedes the flow of fluid in the proximal direction, and the result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range means that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line is identified as correlating with at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through at least one check valve of the typical administration line corresponding to the at least one pressure inflection point; the individual pressure profile is normalized with respect to the steady-state value of the individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of the predetermined pressure profile, and it is determined that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile; and the individual pressure profile is normalized with respect to the steady-state value of the individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of the predetermined pressure profile, and it is determined that each point along the individual pressure profile correlates within the specified tolerance range with the corresponding point on the predetermined pressure profile. The fluid injector system according to any one of Clauses 1 to 5 includes at least one of the above.

[0034] Clause 7: The typical administration line is an administration line used previously, and when the result of the comparison shows that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range, at least one processor is configured to determine that the target administration line contained liquid as residual fluid. The fluid injector system according to any one of Clauses 1 to 6.

[0035] Clause 8: The operation further includes, when the correlation between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified allowable range, generating a warning indicating that the target administration line has been used before being primed with at least one fluid in the priming operation, for the fluid injector system according to any one of Clauses 1 to 7.

[0036] Clause 9: The target administration line includes at least one check valve that prevents the flow of fluid in the proximal direction, similar to a typical administration line. The result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified allowable range means that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through at least one check valve of a typical administration line corresponding to the at least one pressure inflection point, normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and it is determined that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and it is determined that each point along the individual pressure profile correlates within the specified allowable range with the corresponding point on the predetermined pressure profile, for the fluid injector system according to any one of Clauses 1 to 8.

[0037] Clause 10: At least one fluid used for priming the target administration line includes at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of a contrast medium and a diluent, for the fluid injector system according to any one of Clauses 1 to 9.

[0038] Clause 11: The fluid injector system according to any one of Clauses 1 to 10, wherein the step of determining the individual pressure profile includes the step of measuring the motor current of at least one drive component.

[0039] Clause 12: The target administration line, similar to a typical administration line, includes a first check valve that prevents the flow of fluid in the proximal direction and a second check valve that prevents the flow in the proximal direction. The second check valve is located on the distal side of the first check valve. During the priming of the target administration line, the operation further includes identifying a first pressure inflection point of the individual pressure profile caused by at least one fluid passing through the first check valve of the target administration line, and identifying at least one of a second pressure inflection point of the individual pressure profile caused by at least one fluid passing through the second check valve of the target administration line and a steady-state portion of the individual pressure profile where the pressure caused in the target administration line remains substantially constant, thereby determining that the target administration line is fully primed. The fluid injector system according to any one of Clauses 1 to 11.

[0040] Clause 13: The target administration line, similar to a typical administration line, includes a single check valve located at the distal end of the target administration line. The single check valve prevents the flow of fluid in the proximal direction. During the priming of the target administration line, the operation further includes identifying at least one of a pressure inflection point of the individual pressure profile caused by at least one fluid passing through the single check valve of the target administration line and a steady-state portion of the individual pressure profile where the pressure caused in the target administration line remains substantially constant, thereby determining that a component of the fluid path set is connected to the distal end of the target administration line. The fluid injector system according to any one of Clauses 1 to 12.

[0041] Article 14: A computer program product for detecting multiple uses of a dosing line using a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method, the computer program product being a non-transitory computer-readable medium comprising a memory for storing a predetermined pressure profile, the predetermined pressure profile being representative of the pressure expected to be generated by the priming fluid in a typical dosing line during a priming operation that completely removes residual fluid from the typical dosing line with the priming fluid, the non-transitory computer-readable medium further comprising one or more instructions that, when executed by at least one processor, cause the at least one processor to perform the steps of: operating at least one drive component of the fluid injector system to prime a target dosing line with a priming fluid; determining an individual pressure profile representative of a measured value of the current pressure generated during priming of the target dosing line with at least one fluid during a priming operation performed with at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; and based on the result of the comparison, determining whether the target dosing line contained at least one of liquid as residual fluid and gas as residual fluid prior to priming.

[0042] Clause 15: A typical dosing line is either (i) an unused dosing line, such that the residual fluid is a gas, and thus the predetermined pressure profile represents the pressure expected to be generated by the priming fluid when, during the priming operation, the gas in the unused dosing line is completely displaced by the priming fluid upon priming of the unused dosing line, or (ii) a previously used dosing line, such that the residual fluid is at least partially liquid, and thus the predetermined pressure profile represents the pressure expected to be generated by the priming fluid when, during the priming operation, the liquid in the previously used dosing line is completely displaced by the priming fluid upon priming of the previously used dosing line, which is one of the computer program products described in Clause 14.

[0043] Clause 16: A typical dosing line is an unused dosing line, and when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison, one or more instructions, when executed by at least one processor, cause the at least one processor to determine that the target dosing line contained gas as the residual fluid, which is the computer program product described in Clause 14 or 15.

[0044] Clause 17: One or more instructions, when executed by at least one processor, cause the at least one processor to perform further operations including generating a warning indicating that the target dosing line has not been used before it is primed by at least one fluid in the priming operation when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance as a result of the comparison, which is the computer program product described in any of Clauses 14 to 16.

[0045] Clause 18: One or more instructions, when executed by at least one processor, cause the at least one processor to perform further operations including permitting the execution of an injection instruction when the correlation between an individual pressure profile and a predetermined pressure profile is within a specified tolerance as a result of a comparison, the computer program product according to any one of Clauses 14 to 17.

[0046] Clause 19: The target administration line, like a typical administration line, includes at least one check valve that impedes the flow of fluid in the proximal direction, and the result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified tolerance is, in at least one processor, that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by priming fluid passing through at least one check valve of a typical administration line corresponding to the at least one pressure inflection point, in at least one processor, normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, in at least one processor, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, in at least one processor, determining that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and determining that each point along the individual pressure profile correlates within the specified tolerance with the corresponding point on the predetermined pressure profile, the computer program product according to any one of Clauses 14 to 18.

[0047] Clause 20: When, as a result of the comparison, the correlation between the individual pressure profile and the predetermined pressure profile is within the specified allowable range, one or more instructions, when executed by at least one processor, cause the at least one processor to determine that the target administration line contained liquid as residual fluid, a computer program product according to any one of Clauses 14 to 19.

[0048] Clause 21: One or more instructions, when executed by at least one processor, when the correlation between the individual pressure profile and the predetermined pressure profile is within the specified allowable range as a result of the comparison, cause the at least one processor to perform a further operation including generating a warning indicating that the target administration line has been used before being primed with at least one fluid in a priming operation, a computer program product according to any one of Clauses 14 to 20.

[0049] Clause 22: The target administration line, like a typical administration line, includes at least one check valve that prevents the flow of fluid in the proximal direction, and the result of the comparison that the correlation between the individual pressure profile and the predetermined pressure profile is within the specified allowable range is that at least one processor determines that at least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through at least one check valve of the target administration line correlates with at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through at least one check valve of the typical administration line corresponding to the at least one pressure inflection point, at least one processor normalizes the individual pressure profile with respect to the steady-state value of the individual pressure profile, at least one processor normalizes the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, at least one processor determines that the area under the curve of the normalized individual pressure profile correlates with the area under the curve of the predetermined pressure profile, and at least one processor normalizes the individual pressure profile with respect to the steady-state value of the individual pressure profile, at least one processor normalizes the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and at least one processor determines that each point along the individual pressure profile correlates within the specified allowable range with the corresponding point on the predetermined pressure profile, including at least one of the above, a computer program product according to any of Clauses 14 to 21.

[0050] Clause 23: The at least one fluid used for priming the target administration line includes at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of a contrast medium and a diluent, a computer program product according to any of Clauses 14 to 22.

[0051] Clause 24: The step of determining the individual pressure profile is a computer program product according to any one of Clauses 14 to 23, including, in at least one processor, the step of measuring the motor current of at least one drive component.

[0052] Clause 25: The target administration line, similar to a typical administration line, comprises a first check valve that prevents the flow of fluid in the proximal direction and a second check valve that prevents the flow in the proximal direction, the second check valve being located distally of the first check valve. During the priming of the target administration line, the operation further includes identifying a first pressure inflection point of the individual pressure profile caused by at least one fluid passing through the first check valve of the target administration line, and identifying at least one of a second pressure inflection point of the individual pressure profile caused by at least one fluid passing through the second check valve of the target administration line and a steady-state portion of the individual pressure profile where the pressure caused in the target administration line remains substantially constant, whereby it is determined that the target administration line is fully primed. It is a computer program product according to any one of Clauses 14 to 24.

[0053] Clause 26: The target administration line, similar to a typical administration line, comprises a single check valve located at the distal end of the target administration line, the single check valve preventing the flow of fluid in the proximal direction. During the priming of the target administration line, the operation further includes identifying at least one of a pressure inflection point of the individual pressure profile caused by at least one fluid passing through the single check valve of the target administration line and a steady-state portion of the individual pressure profile where the pressure caused in the target administration line remains substantially constant, whereby it is determined that a component of the fluid path set is connected to the distal end of the target administration line. It is a computer program product according to any one of Clauses 14 to 25.

[0054] Article 27: A method for detecting multiple uses of an administration line using a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method, the method comprising the steps of: providing a memory for storing a predetermined pressure profile, the predetermined pressure profile being representative of the pressure expected to be generated by the priming fluid within a typical administration line during the process of a priming operation that completely eliminates residual fluid from the typical administration line with the priming fluid; operating at least one drive component of the fluid injector system to prime the target administration line with the priming fluid; determining an individual pressure profile representative of a measured value of the current pressure generated during the priming of the target administration line with at least one fluid during the process of a priming operation executed with at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; and determining, based on the result of the comparison, whether the target administration line contained at least one of liquid as residual fluid and gas as residual fluid prior to priming.

[0055] These features and characteristics of the fluid injector system, computer program product, and method of operation, as well as other features and characteristics, and the functions of the associated elements and combinations of parts of the structure, and the economics of manufacture, will become further apparent by consideration of the following description and the appended claims, which form a part of this specification, with reference to the accompanying drawings, which are also to be regarded as part of this specification. However, it should be clearly understood that the drawings are for illustrative and explanatory purposes only.

Brief Description of the Drawings

[0056]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

[0057] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the present disclosure as oriented in the figures of the drawings. When used in relation to a syringe, a connector of a single - use disposable set, and / or a component of a fluid path set, the term "proximal" refers to the portion of the syringe, connector of the single - use disposable set, and / or component of the fluid path set that is closest to the injector when the syringe, connector of the single - use disposable set, and / or component of the fluid path set is oriented such that it is connected to the injector. The term "distal" refers to the portion of the syringe, connector of the single - use disposable set, and / or component of the fluid path set that is farthest from the injector when the syringe, connector of the single - use disposable set, and / or component of the fluid path set is oriented such that it is connected to the injector.

[0058] As used herein, the term "correlation" and its derivatives refer to an observed and / or calculated relationship between data. Correlation can include, for example, the relative difference between two or more data points, the statistical relationship between two or more data points, and combinations thereof. As used herein, the term "specified tolerance" refers to a predetermined percentage difference, a predetermined standard deviation, a predetermined statistical correlation coefficient, and the like. For example, if a first value is within a predetermined percentage difference (e.g., within 10%) of a second value, the first value may exhibit a correlation within the specified tolerance of the second value. Similarly, if a data point is within a range of a predetermined standard deviation (e.g., within one standard deviation) of a data set, that data point may exhibit a correlation within the specified tolerance of the data set. Similarly, if a particular feature (e.g., an inflection point) of a first curve is within a predetermined range (e.g., within a range of 10 sampling time intervals) of a similar feature of a second curve, the first curve may exhibit a correlation within the specified tolerance of the second curve. Similarly, if the area under a first curve is within a range of a predetermined percentage difference (e.g., within 10%) of the area under a second curve, the first curve may exhibit a correlation within the specified tolerance of the second curve.

[0059] As used herein, the term "normalization" and its derivatives refer to adjusting the individual values of a data set to a common scale. For example, normalization can refer to dividing all values of a data set by a value corresponding to a steady-state condition such that each value of the normalized data set is referenced to the steady-state condition.

[0060] As used herein, the term "and / or" refers to both or either of the two possibilities stated. For example, when used in reference to "the first and / or second predetermined pressure profile", this expression refers to a combination of both the first and second predetermined pressure profiles, or either the first predetermined pressure profile or the second predetermined pressure profile.

[0061] All numbers used in this specification and the claims should be understood to be modified in all instances by the term "about." The terms "about," "approximately," and "substantially" mean within plus or minus 10 percent of the stated value.

[0062] As used herein, the term "at least one of" is synonymous with "one or more of." For example, the expression "at least one of A, B, and C" means any one of A, B, and C, or any combination of two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more of only A, one or more of only B, one or more of only C, one or more of A and one or more of B, one or more of A and one or more of C, one or more of B and one or more of C, or one or more of all of A, B, and C. Similarly, as used herein, the term "at least two of" is synonymous with "two or more of." For example, the expression "at least two of D, E, and F" means any combination of two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more of D and one or more of E, one or more of D and one or more of F, one or more of E and one or more of F, or one or more of all of D, E, and F.

[0063] 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 the present disclosure. Accordingly, the specific dimensions and other physical characteristics related to the examples disclosed herein should not be regarded as limitations.

[0064] Although the present disclosure is described primarily in the context of the MEDRAD® Centargo CT Injection System, it will be apparent to those skilled in the art that the present disclosure is applicable to a variety of injection systems and their associated consumables (e.g., syringes, tubing, etc.). Examples of such injection systems include the MEDRAD® Stellant CT Injection System, MEDRAD® Stellant FLEX CT Injection System, MEDRAD® MRXperion MR Injection System, and MEDRAD® Mark 7 Arterion Injection System provided by Bayer HealthCare LLC.

[0065] Referring now to the drawings, like reference numerals refer to like parts throughout several views of the drawings, and the present disclosure relates, in some of its aspects and examples, generally to a multi-fluid medical injector / injection system 100 (hereinafter, "fluid injector system 100") configured to deliver fluid to a patient using a connector of a single-use disposable set (SUDS) 190 in a multi-patient disposable set (MUDS) 130. The fluid injector system 100 includes a number of components as described individually herein. Generally, the fluid injector system 100 includes a powered injector or other delivery device and a fluid delivery set intended to be combined with the injector for delivering one or more fluids under pressure from one or more containers containing multiple aliquots of the one or more fluids to a patient, as described herein. Various devices, components, and features of the fluid injector system 100 and the fluid delivery set combined with the fluid injector system are also described in detail herein.

[0066] Referring to FIG. 1, the fluid injector system 100 includes an injector housing 102 having opposite sides 104, a distal or upper end 106, and a proximal or lower end 108. In some examples, the housing 102 can be supported on a base 110 having one or more wheels 112 for rotatably and movably supporting the housing 102 on a floor surface. The one or more wheels 112 can be lockable to prevent the housing 102 from unintentionally moving after being positioned at a desired location. At least one handle 114 can be provided to facilitate movement and positioning of the fluid injector system 100. In other examples, the housing 102 can be removably or non-removably fixed to a stationary surface such as a floor, ceiling, wall, or other structure. The housing 102 houses various mechanical drive components, electrical and power components necessary to drive the mechanical drive components, and control components such as electronic memory and electronic control devices (hereinafter, one or more electronic control devices) used to control the operation of a reciprocable piston element 103 (shown in FIG. 2) incorporated in the fluid injector system 100 described herein. Such a piston element 103 can be reciprocated by electromechanical drive components such as a ball screw shaft driven by a motor, a voice coil actuator, a rack and pinion gear drive, a linear motor, and the like. In some examples, at least some of the mechanical drive components, electrical and power components, and control components can be provided on the base 110.

[0067] Continuing to refer to FIG. 1, the fluid injector system 100 has at least one door 116 that encloses at least some of the MUDS, mechanical drive components, electrical and power components, and control components. The door 116 is desirably movable between an open position and a closed position (shown in FIG. 1). In some examples, the door 116 can be lockable.

[0068] The fluid injector system 100 further includes at least one bulk fluid connector 118 for connection to at least one bulk fluid source 120. In some examples, a plurality of bulk fluid connectors 118 can be provided. For example, as shown in FIG. 1, three bulk fluid connectors 118 can be provided side by side or in other arrangements. In some examples, at least one bulk fluid connector 118 can be a spike configured to removably connect to at least one bulk fluid source 120 such as a vial, bottle, or bag. At least one bulk fluid connector 118 can have a reusable or non-reusable interface with each new bulk fluid source 120. As described herein, at least one bulk fluid connector 118 can be formed on a multi-patient disposable set. At least one bulk fluid source 120 can be configured to receive a medical fluid for delivering to the fluid injector system 100 such as saline, contrast agent solution, or other medical fluids. The housing 102 can have at least one support member 122 for supporting at least one bulk fluid source 120 when connected to the fluid injector system 100.

[0069] Referring further to FIG. 1, the fluid injector system 100 includes one or more user interfaces 124, such as a graphical user interface (GUI) display window. The user interface 124 can display information related to a fluid injection procedure involving the fluid injector system 100, such as the current flow rate, fluid pressure, and remaining volume of at least one bulk fluid source 120 connected to the fluid injector system 100, and can be a touch screen GUI that enables operator input of commands and / or data related to the operation of the fluid injector system 100. Although the user interface 124 is shown on the injector housing 102, such a user interface 124 may be in the form of a remote display that is wired or wirelessly linked to the housing 102 of the fluid injector system 100 as well as to the control and mechanical elements. In some examples, the user interface 124 may be a tablet computer that is removably connected to the housing 102 and is wired or wirelessly linked to and communicates with the housing 102 of the fluid injector system 100 as well as to the control and mechanical elements. Further, the fluid injector system 100 and / or the user interface 124 can include at least one control button 126 for tactile operation by an operator of the fluid injector system 100. In certain examples, the at least one control button 126 can be part of a keyboard for operator input of commands and / or data. The at least one control button 126 is wired to one or more electronic control devices incorporated into the fluid injector system 100 and can provide direct input to the one or more electronic control devices. The at least one control button 126 can also be a graphic part of the user interface 124, such as a touch screen.In any configuration, at least one control button 126 preferably, but not limited thereto, provides to the operator of the fluid injector system 100 with: (1) confirmation of attachment or removal of a multi-patient disposable set, (2) locking / unlocking of the multi-patient disposable set, (3) filling / purging of the fluid injector system 100, (4) input of information and / or data regarding the patient and / or the infusion procedure, (5) preloading of the fluid injector system 100, and (6) starting / stopping of the infusion procedure. The user interface 124 and / or any electronic processing unit incorporated in the fluid injector system 100 may be connected, either wired or wirelessly, to an operating and / or data storage system such as a hospital network system.

[0070] Referring to FIG. 2, the fluid injector system 100 includes a MUDS 130 removably connected to the fluid injector system 100 for delivering one or more fluids from one or more bulk fluid sources 120 to a patient. Examples and features of the MUDS are further described in Patent Document 1, the disclosure of which is hereby incorporated by reference in its entirety. The MUDS 130 can include one or more syringes or pumps 132. In some examples, the number of syringes 132 may correspond to the number of bulk fluid sources 120. For example, referring to FIG. 2, the MUDS 130 has three syringes 132 in a side-by-side arrangement such that each syringe 132 can communicate with one or more of the bulk fluid sources 120. In some examples, one or two bulk fluid sources 120 can be connected to one or more syringes 132 of the MUDS 130. Each syringe 132 can be communicated with one of the bulk fluid sources 120 by a corresponding bulk fluid connector 118 and an associated MUDS fluid path 134. The MUDS fluid path 134 can have a spike element connected to the bulk fluid connector 118. In some examples, the bulk fluid connector 118 can be provided directly on the MUDS 130.

[0071] Referring further to FIG. 2, the MUDS 130 is removably connectable to the housing 102 of the fluid injector system 100. As would be understood by one of ordinary skill in the art, it may be desirable to fabricate at least a portion of the MUDS 130 from a transparent medical grade plastic to facilitate visual verification of the establishment of communication with the fluid injector system 100. Visual verification is also desirable to confirm the absence of air bubbles within various fluid connections. Alternatively, at least a portion of the MUDS 130 and / or the door 116 can include a window (not shown) for visualizing connections between various components. It is also possible to provide various optical sensors (not shown) for detecting and verifying the connections. Further, various lighting elements (not shown), such as light emitting diodes (LEDs), may be provided to activate one or more optical sensors and indicate that proper connections have been established between various components.

[0072] Referring specifically to FIG. 2, a schematic diagram of various fluid paths of the fluid injector system 100 is shown. The MUDS 130 can include one or more valves 136, such as stopcock valves, to control which medical fluid or combination of medical fluids is withdrawn from the bulk fluid source 120 for multiple doses and further delivered to the patient through each syringe 132. In some examples, one or more valves 136 can be provided at the distal end of the plurality of syringes 132 or on the manifold 148. The manifold 148 can communicate with the first end of the MUDS fluid path 134 that connects each syringe 132 to the corresponding bulk fluid source 120, via the valve 136 and / or syringe 132. The second end of the MUDS fluid path 134 on the opposite side can be connected to each bulk fluid connector 118 configured to communicate with the bulk fluid source 120. Depending on the position of the one or more valves 136, fluid can be drawn into one or more syringes 132 or delivered from one or more syringes 132. In a first position, such as during filling of the syringe 132, the one or more valves 136 are oriented such that fluid flows from the bulk fluid source 120 through a fluid inlet line 150, such as the MUDS fluid path, to the desired syringe 132. During the filling procedure, the one or more valves 136 are arranged to block the flow of fluid through one or more fluid outlet lines 152 or the manifold 148. For example, in a second position, such as during a fluid delivery procedure, fluid from one or more syringes 132 is delivered to the manifold 148 via one or more fluid outlet lines 152 or syringe valve outlet ports. During the delivery procedure, the one or more valves 136 are arranged to block the flow of fluid through one or more fluid inlet lines 150. The one or more valves 136, fluid inlet line 150, and / or fluid outlet line 152 can be integrated with the manifold 148. The one or more valves 136 can be selectively positioned in the first or second position manually or by automatic operation. For example, an operator can position the one or more valves 136 in the desired position for filling or fluid delivery.In other examples, at least a portion of the fluid injector system 100 is operable to automatically position one or more valves 136 at a desired location for filling or fluid delivery based on an operator input as described herein.

[0073] Referring further to FIG. 2, in some examples, the fluid outlet line 152 can also be connected to a waste reservoir 156 of the fluid injector system 100. The waste reservoir 156 is desirably separated from the syringe 132 to prevent contamination. In some examples, the waste reservoir 156 is configured to receive waste fluid discharged from the syringe 132, for example, during a flushing, priming, or preloading operation. The waste reservoir 156 may be removable from the housing 102 to dispose of the contents of the waste reservoir 156. In other examples, the waste reservoir 156 can have a drain port (not shown) for emptying the contents of the waste reservoir 156 without removing the waste reservoir 156 from the housing 102. In some examples, the waste reservoir 156 is provided as a separate component from the MUDS 130.

[0074] Having generally described the components of the fluid injector system 100 and the MUDS 130, the structure and use of a single-use disposable set (SUDS) 190 and its interaction with the MUDS 130 will now be described. Hereinafter, the SUDS 190 may also be referred to as an administration line.

[0075] Referring to FIGS. 3A and 3B, the fluid injector system 100 has a connection port 192 configured to form a releasable communication with at least a portion of the SUDS 190. In some examples, the connection port 192 can be formed on the MUDS 130. The connection port 192 can be shielded by at least a portion of the housing 102 of the fluid injector system 100. For example, by retracting the connection port 192 inside the housing 102, it is possible to prevent or limit a user or patient from touching the portion of the connection port 192 that comes into contact with the fluid injected into the patient, thereby causing contamination, and maintaining the sterility of the connection port 192. In some examples, the connection port 192 is retracted into an opening 194 formed on the housing 102 of the fluid injector system 100, or the connection port 192 can have a shielding structure (not shown) surrounding at least a portion of the connection port 192. In other examples, the connection port 192 can be formed directly on the housing 102 and connected to the MUDS 130 by a fluid path (not shown). As described herein, it is possible to connect the SUDS 190 to the connection port 192 formed on at least a portion of the MUDS 130 and / or the housing 102. Desirably, the connection between the SUDS 190 and the connection port 192 is a releasable connection such that it is possible to selectively disconnect the SUDS 190 from the connection port 192 (FIG. 3A) and connect it to the connection port 192 (FIG. 3B). In some examples, the SUDS 190 can be disconnected from the connection port 192 and discarded after each fluid delivery procedure, and a new SUDS 190 can be connected to the connection port 192 for a subsequent fluid delivery procedure.

[0076] Continuing to refer to FIGS. 3A and 3B, the waste inlet port 196 can be provided separately from the connection port 192. The waste inlet port 196 communicates with the waste reservoir 156. In some examples, the waste reservoir 156 is provided separately from the SUDS 190 such that it can receive fluid from the waste inlet port 196 into the waste reservoir 156. At least a portion of the SUDS 190 can be removably connected or combined with the waste inlet port 196, for example, to direct waste fluid into the waste reservoir 156 during a priming operation that expels air from the SUDS 190. The waste reservoir 156 can have an observation window 198 with indicia 200, such as a graduated marking indicating the fill level of the waste reservoir 156.

[0077] Referring to FIG. 4A, the SUDS 190 has a fluid inlet port 202 configured to be removably connected to a connection port 192 (shown in FIG. 3A). The fluid inlet port 202 receives fluid provided from the fluid injector system 100. The fluid inlet port 202 is desirably a hollow tubular structure as shown in FIG. 4B. The SUDS 190 further has a waste outlet port 204 configured to be removably connected to or combined with a waste inlet port 196 (shown in FIG. 3A). The waste outlet port 204 receives waste fluid, for example, during priming or flushing operations of the SUDS 190, and sends such waste fluid to the waste reservoir 156. The waste outlet port 204 is desirably a hollow tubular structure as shown in FIG. 4B. The waste outlet port 204 can be connected, inserted, or disposed in the waste inlet port 196 such that waste fluid can flow through the waste inlet port 196 to the waste reservoir 156. The fluid inlet port 202 and the waste outlet port 204 can be separated from each other by a spacer 206. In some examples, the spacer 206 is dimensioned to position the fluid inlet port 202 and the waste outlet port 204 in alignment with the connection port 192 and the waste inlet port 196, respectively. It should be noted that the SUDS 190 is shown in FIG. 4A in a state after being removed from a package (not shown). Prior to use, the SUDS 190 is desirably packaged in a pre-sterilized sealed package that protects the SUDS 190 from contamination by contaminants in the air or on a surface. Alternatively, the sealed package and the SUDS 190 may be sterilized after packaging.

[0078] The SUDS 190 desirably has an asymmetric structure, and thus, a user can attach the SUDS 190 to the MUDS 130 in only one orientation. In this way, the user is prevented from attaching the fluid inlet port 202 to the waste inlet port 196. In some examples, fins 207 can be provided on at least a portion of the SUDS 190 to prevent incorrect insertion of the SUDS 190 into the connection port 192. In a particular example, the fins 207 can be formed on the spacer 206 in proximity to the waste outlet port 204. In this way, the fins 207 can prevent incorrect insertion of the SUDS 190 into the connection port 192. It is also possible to use structures and shapes other than the fins 207 to prevent incorrect insertion of the SUDS 190 into the connection port 192.

[0079] In some examples, the tubing 208 can be connected to the fluid inlet port 202 at the proximal end 210 of the tubing 208. The tubing 208 is configured to deliver the fluid received from the fluid inlet port 202. The distal end 212 of the tubing 208 can have a connector 214 that includes a one-way check valve configured to connect to the waste outlet port 204 or a fluid path (not shown) connected to a patient. The tubing 208 can be made from a flexible material such as a medical-grade plastic material that allows the tubing 208 to be coiled. The connector 214 can be configured as a luer lock connector (either a male luer lock connector or a female luer lock connector, depending on the desired application) or other medical connector. In some examples, the connector 214 can include a one-way check valve 280 to prevent backflow of fluid from a catheter or other component attached to the connector 214 into the tubing 208, as shown in FIGS. 4B and 4C.

[0080] Continuing to refer to FIG. 4A, the SUDS 190 can have a locking tab 216, which is configured to selectively lock the SUDS 190 to the fluid injector system 100 in response to engagement between the locking tab 216 and at least a portion of the fluid injector system 100. In some examples, the locking tab 216 can be a flexible tab that is deflectable between an engaged position and a disengaged position by deflecting at least a portion of the locking tab 216. The locking tab 216 can have a push surface 218 that, when pushed, deflects the locking tab 216 from the engaged position to the disengaged position, allowing insertion of the SUDS 190 into the fluid injector system 100 and removal from the fluid injector system 100. In some examples, the locking tab 216 can be configured to releasably engage and lock into a receiving slot 217 (shown in FIG. 4C) on the MUDS 130.

[0081] Referring to FIG. 4B, the SUDS 190 can have a first annular skirt 224 that extends circumferentially around the proximal end 226 of the fluid inlet port 202 and a second annular skirt 220 that extends circumferentially around the distal end 222 of the fluid inlet port 202. The first annular skirt 224 and the second annular skirt 220 surround the fluid inlet port 202 to prevent inadvertent contact and contamination. The first annular skirt 224 can have one or more recesses 228 (shown in FIG. 4A) that extend through its sidewall. The one or more recesses 228 can provide a locking interface with corresponding locking elements (not shown) on the fluid injector system 100. The second annular skirt 220 can have at least one indentation 230 (shown in FIG. 4A) to facilitate gripping and handling of the SUDS 190. In some examples, the second annular skirt 220 can have a non-planar surface with one or more ribs to facilitate gripping and handling of the SUDS 190.

[0082] Continuing to refer to FIG. 4B, at least one annular seal 234 can be provided around the proximal end 226 of the fluid inlet port 202. The at least one annular seal 234 can seal the fluid inlet port 202 so that fluid does not leak through the SUDS 190. The at least one annular seal 234 can provide a fluid seal between the SUDS 190 and the MUDS 130 so that when the SUDS 190 and the MUDS 130 are in communication with each other, fluid can flow from the MUDS 130 to the SUDS 190 without leakage. A one-way check valve 236 can be provided within the lumen of the fluid inlet port 202 to prevent fluid from flowing in the reverse direction from the SUDS 190 to the MUDS 130.

[0083] Referring to FIG. 4C, the SUDS 190 shown in FIG. 4A is shown connected to the fluid injector system 100. FIG. 4C shows a connection port 192 formed on the MUDS 130, although in other examples, the connection port 192 may be formed as a part of the housing 102 (shown in FIG. 1). The fluid inlet port 202 of the SUDS 190 is connected to the connection port 192 to establish a flow path in the direction of arrow F shown in FIG. 4C. The fluid passing through the fluid inlet port 202 flows through the one-way valve 236 into the pipe 208. Fluid that may drip from the interface between the fluid inlet port 202 and the connection port 192 is collected in the waste reservoir 156. The waste reservoir 156 can be shaped to collect fluid that may drip from the SUDS 190 when the SUDS 190 is removed from the MUDS 130. Further, when the SUDS 190 is connected to the connection port 192, the outlet of the waste outlet port 204 is disposed within the waste inlet port 196 so that waste fluid from the pipe 208 can be discharged into the waste reservoir 156. A spacer 206 can define an insertion stop surface for defining the depth of insertion of the SUDS 190 into the connection port 192.

[0084] Referring to FIG. 5, the fluid injector system 100 can have a sensor system 238 configured to identify the communication between the SUDS 190 and the MUDS 130. The sensor system 238 can include at least one sensing element such as a sensor fin 240 on the SUDS 190 and a corresponding sensor 242 on the fluid injector system 100 or the MUDS 130. The sensor 242 can be configured to detect the presence and absence of at least one sensor fin 240 or other sensing element. In some examples, a sensing element such as at least one sensor fin 240 is formed on the lock tab 216 of the SUDS 190, as shown, for example, in FIG. 4A. In other examples, a sensing element such as at least one sensor fin 240 can be formed on any part of the SUDS 190. The sensor 242 can be an optical sensor mounted and fixed in a respective mount formed on the housing 102 of the fluid injector system 100. As would be understood by those skilled in the art in the field of powered medical fluid injectors, the sensor 242 can be electronically connected to an electronic control device used to individually control the operation of the fluid injector system, such as the operation of one or more piston elements, based at least in part on the input from the sensor 242. A sensing element such as the sensor fin 240 can have one or more reflective surfaces that reflect visible or infrared light detected by the sensor 242. In other examples, a mechanical interaction between the sensing element and the sensor 242 can be used.

[0085] In some examples, the SUDS 190 can further include anti-reuse mechanisms. For example, the SUDS 190 can include one or more frangible sensor elements, tabs, or structures that bend or break when the SUDS 190 is removed from the MUDS 130. The absence of these mechanisms can prevent the reinsertion and reuse of the SUDS 190 after removal. In this way, it can be ensured that the SUDS 190 is used only for one fluid delivery procedure.

[0086] Other examples and features of SUDS190 are described in Patent Document 2, the disclosure of which is hereby incorporated by reference in its entirety.

[0087] Since the components of the fluid injector system 100, the MUDS 130, and the SUDS 190 have been described generally, next, a method of operation using the SUDS 190 will be described in detail. In use, a healthcare provider or user removes the disposable SUDS 190 from its package (not shown) and inserts the fluid inlet port 202 into the connection port 192 of the MUDS 130. As described above, the SUDS 190 must be inserted in the correct orientation such that the fluid inlet port 202 aligns with the connection port 192 and the waste outlet port 204 aligns with the waste inlet port 196. The SUDS 190 can be secured to the MUDS 130 by inserting the lock tab 216 into the receiving slot 217 on the MUDS 130. When the SUDS 190 is securely connected to the MUDS 130 as sensed, for example, by the sensor 242, the fluid injector system 100 (shown in FIG. 1) draws fluid into one or more of the plurality of syringes 132 of the MUDS 130 and performs an automatic priming or flushing operation to remove air from the MUDS 130 and the SUDS 190. During such priming or flushing operation, fluid from the MUDS 130 is injected through the connection port 192 into the tubing 208 of the SUDS 190. The fluid flows through the tubing 208, the connector 214, and the waste outlet port 204 and into the waste reservoir 156. After the automatic priming or flushing operation is complete, an optional preloading of the tubing 208 can be performed in response to an injection command by injecting one or more fluids from the MUDS 130 through the connection port 192. Further details of the preloading operation will be described in more detail below. After completion of the automatic priming or flushing operation and the optional preloading operation, the healthcare provider disconnects the connector 214 from the waste outlet port 204. The connector 214 can then be connected to the patient through a catheter, a vascular access device, a needle, or a further fluid path configured to facilitate delivery of fluid to the patient. When fluid delivery is complete, the SUDS 190 is disconnected from the patient and the MUDS 130 by removing the lock tab 216 of the SUDS 190 from the receiving slot 217 of the MUDS 130.Next, the healthcare provider can discard the SUDS190. In certain instances, removing the SUDS190 from the MUDS130 activates a reuse prevention mechanism (not shown), preventing reinsertion and reuse of the SUDS190.

[0088] Referring to FIG. 6, an electronic control device 900 can be combined with a fluid injector system 100 to control the filling and delivery operations. In some examples, the electronic control device 900 can control the operation of various valves, piston members, and other elements to perform a desired filling or delivery procedure. For example, the electronic control device 900 can include various individual computer-readable media components. For example, this computer-readable media can include any media accessible by the electronic control device 900, such as volatile media, non-volatile media, removable media, non-removable media, temporary media, non-temporary media, etc. As a further example, this computer-readable media can be a media implemented by any method or technology for storing information such as computer-readable instructions, data structures, program modules, or other data, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, or other memory technologies, CD-ROM, digital versatile disk (DVD), or other optical disk storage, magnetic cassette, magnetic tape, magnetic disk storage, or other magnetic storage devices, or any other media that can be used to store desired information and is accessible by the electronic control device 900, etc., including computer storage media. Further, this computer-readable media can include a communication media, such as computer-readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave or other carrier mechanism, and can include any information distribution media, wired media (such as a wired network or a direct wiring connection), and wireless media (such as an acoustic signal, a radio frequency signal, an optical signal, an infrared signal, a biological signal, a barcode signal, etc.). Of course, any combination of the above should be included within the scope of the computer-readable media.

[0089] The electronic control device 900 further includes a system memory 908 having a computer storage medium in the form of volatile and non-volatile memories such as ROM and RAM. A basic input / output system (BIOS) with appropriate computer-based routines assists in the transfer of information between components within the electronic control device 900 and is typically stored in the ROM. The RAM portion of the system memory 908 is typically immediately accessible to the processor 904 and contains, for example, an operating system, an application programming interface, application programs, program modules, program data, and other instruction-based computer-readable code, or accommodates data and program modules that are currently being operated on by the processor 904.

[0090] Continuing to refer to FIG. 6, the electronic control device 900 can also include other removable or non-removable, volatile or non-volatile, temporary or non-temporary computer storage media products. For example, the electronic control device 900 communicates with and controls a hard disk drive 912, which is a non-removable non-volatile magnetic medium, through a non-removable memory interface 910, and a magnetic disk drive unit 916 (which reads and writes to a removable non-volatile magnetic disk 918), an optical disk drive unit 920 (which reads and writes to a removable non-volatile optical disk 922 such as a CD-ROM), a universal serial bus (USB) port 921 used in connection with a removable memory card, etc., and can include a removable non-volatile memory interface 914 that communicates with and controls these. However, other removable or non-removable, volatile or non-volatile computer storage media such as magnetic tape cassettes, DVDs, digital video tapes, solid state RAM, solid state ROM, etc., although not limited to these, can be considered for use in a typical computing system environment 902. These various removable or non-removable, volatile or non-volatile magnetic media communicate with the processor 904 and other components of the electronic control device 900 via the system bus 906. The drives and their associated computer storage media shown in FIG. 6 above provide storage for the operating system, computer-readable instructions, application programs, data structures, program modules, program data, and other instruction-based computer-readable code for the electronic control device 900 (regardless of whether this is a copy of the information and data in the system memory 908).

[0091] The user can input commands, information, and data into the electronic control device 900 via the user input interface 928 using a specific attachable or operable input device such as the user interface 124 shown in FIG. 1. For example, various such input devices can be utilized that include any configuration facilitating the input of data and information from external sources to the electronic control device 900, such as microphones, trackballs, joysticks, touch pads, touch screens, scanners, etc. As described, these input devices and other input devices are often connected to the processor 904 via the user input interface 928 coupled to the system bus 906, but may also be connected by other interfaces and bus structures such as parallel ports, game ports, or USB. Even further, the data and information can be presented or provided to the user in an easily understandable form or format via specific output devices such as a monitor 930 (visually displaying this information and data in electronic form), a printer 932 (physically displaying this information and data in printed form), a speaker 934 (audibly presenting this information and data in an audible form that can be heard), etc. All of these devices communicate with the electronic control device 900 via an output interface 936 coupled to the system bus 906. Any such peripheral output device is considered to be used to provide information and data to the user.

[0092] The electronic control device 900 can operate within the network environment 938 by using a communication device 940 that is integral with the electronic control device 900 or located at a location remote from the electronic control device 900. This communication device 940 can, via the communication interface 942, operate by other components of the electronic control device 900 and communicate with other components of the electronic control device 900. Using such a configuration, the electronic control device 900 can connect to one or more remote computers, such as the remote computer 944, which may be a personal computer, server, router, network personal computer, peer device, or other common network node, or communicate in other ways, typically including many or all of the components described above in relation to the electronic control device 900. For example, using a suitable communication device 940, such as a modem, network interface or adapter, the computer 944 can operate within local area networks (LANs) and wide area networks (WANs) and communicate via them, but can also include other networks such as virtual private networks (VPNs), office networks, enterprise networks, intranets, the Internet, etc.

[0093] As used herein, the electronic control device 900 can include, or be operative to execute, custom designed software or off-the-shelf software to form a dedicated and particular computing system by executing and implementing the process steps of the methods and systems of the present disclosure. Accordingly, the methods and systems can include one or more electronic control devices 900 or similar computing devices having a computer-readable storage medium that can store computer-readable program code or instructions that cause a processor 904 to execute, configure, or otherwise implement the methods, processes, and data manipulations of the transformations described below in connection with the present disclosure. Still further, the electronic control device 900 can be in the form of a personal computer, a personal digital assistant, a portable computer, a laptop, a palmtop, a mobile device, a cellular phone, a server, or any other type of computing device having the necessary processing hardware to appropriately process data to effectively implement the fluid injector system, computer program product, and methods implemented by a computer of the present disclosure.

[0094] It will be apparent to those skilled in the art that the system can utilize a database physically located on one or more computers, which may or may not be the same as each server. For example, the programming software on the electronic control device 900 can control a database physically stored on a separate processor of the network.

[0095] In some examples, the electronic control device 900 can be programmed such that automatic replenishment is performed based on a pre-programmed trigger minimum amount in each syringe 132. For example, when the amount of fluid remaining in at least one of the syringes 132 is less than the pre-programmed amount, the syringe replenishment procedure is automatically initiated by the electronic control device 900. The electronic control device 900 combined with the fluid injector system 100 can determine that the pre-programmed trigger minimum amount has been reached by tracking the amount of fluid delivered from each syringe 132 during operation of the fluid injector system 100. Alternatively, fluid level sensors can be incorporated into the fluid injector system 100 and inputs from these fluid level sensors can be provided to the electronic control device 900 so that the electronic control device 900 can determine that the pre-programmed trigger minimum amount has been reached in at least one of the syringes 132. The filling amount and replenishment rate can be pre-programmed into the electronic control device 900. The automatic replenishment procedure can be automatically stopped by the electronic control device 900 or interrupted manually. Further, at the completion of the fluid injection procedure, the automatic replenishment procedure can be initiated if there is not sufficient fluid in at least one of the syringes 132 to perform the next programmed fluid injection procedure.

[0096] During the replenishment procedure, one or more of the bulk fluid sources 120 combined with each syringe 132 may run out (e.g., there may not be sufficient fluid initially present to complete a full replenishment of one or more syringes 132). Thus, a replacement bulk fluid source 120 is needed and replacement of such a bulk fluid source 120 is preferably done quickly. The fluid injector system 100 can have an indicator, such as an auditory and / or visual indicator, to inform the operator that a change of the bulk fluid source 120 is required before using the fluid injector system 100.

[0097] As described above, when the SUDS 190 is firmly connected to the MUDS 130, as sensed by, e.g., the sensor 242, the MUDS 130 and the SUDS 190 can be primed automatically or manually. In such a priming operation, saline or another suitable diluent is injected from the MUDS 130 through the connection port 192 into the tubing 208 of the SUDS 190 and into the waste reservoir 156. The flow of the priming fluid towards the waste reservoir 156 purges the residual fluid from the fluid injector system 100 by pushing the residual fluid within the manifold 148 of the SUDS 190 and / or the MUDS 130 out of the distal end 212 of the tubing 208. In this way, the priming fluid replaces the residual fluid within the SUDS 190 with the priming fluid. During the priming operation, various components of the fluid injector system 100 can communicate with the electronic control device 900 to continuously or intermittently monitor the pressure generated during the delivery of the priming fluid from the MUDS 130 through the SUDS 190. By monitoring this pressure, the electronic control device 900 can determine various characteristics of the SUDS 190 and related components. In various aspects or examples of the present disclosure, the electronic control device 900 is utilized to determine whether the SUDS 190 has been previously used, whether the SUDS 190 has been fully primed, whether components of an additional fluid path set are connected to the connector 214 of the SUDS 190, the length of the SUDS 190, and / or the age of the SUDS 190. These and other aspects and examples of the present disclosure are discussed in detail herein.

[0098] In some embodiments or examples, the electronic control device 900 can be utilized to determine whether the SUDS 190 has been previously used based on the residual fluid extruded from the SUDS 190 during priming. If unused, the SUDS 190 may initially be filled with a gas such as air or other gas injected into the SUDS 190 during manufacturing and / or packaging, while a used SUDS 190 may be filled with a liquid such as residual medical liquid from a previously executed injection command. The electronic control device 900 can determine whether the residual fluid extruded from the SUDS 190 during priming was a gas indicating that the SUDS 190 is unused, or a liquid indicating that the SUDS 190 has been previously used. The determination of whether the extruded residual fluid is a gas or a liquid can be based on the pressure profile generated during the priming of the SUDS 190. The pressure profile can be obtained by measuring, at predetermined time intervals, the pressure resulting from the extrusion of the residual fluid from the SUDS 190 when the priming fluid is injected through the SUDS 190 during the priming operation of the SUDS 190. Hereinafter, this pressure profile representing the actual measured pressure over time of the priming operation will be referred to as the "individual pressure profile".

[0099] To determine whether the residual fluid extruded from the SUDS 190 during priming was a gas or a liquid, the electronic control device 900 can compare the individual pressure profile with a predetermined pressure profile. The predetermined pressure profile represents the pressure expected to be generated within this typical SUDS by the priming fluid during the priming operation performed on a typical SUDS. In particular, the predetermined pressure profile can represent the pressure expected to occur in an unused SUDS during the same priming operation as the priming operation performed on the actual SUDS 190 of interest. The predetermined pressure profile can be obtained through pressure measurements of a typical SUDS known to be unused.

[0100] The correlation between an individual pressure profile and a predetermined pressure profile indicates whether the SUDS 190 contained gas as the residual fluid or liquid as the residual fluid before the priming operation. Predetermined pressure profiles of various typical SUDS can be presented graphically to facilitate the interpretation and comparison of the predetermined pressure profile and the individual pressure profile. FIG. 7 shows a graph 700 including a graphical representation of a first predetermined pressure profile 710 and a graphical representation of a second predetermined pressure profile 720, where the x-axis is time and the y-axis is pressure. In the example shown in FIG. 7, the time is represented in units of 200 milliseconds (ms), and the pressure is represented in units of kilopascals (kPa). For the first predetermined pressure profile 710, the graphed pressure corresponds to the expected pressure of a typical SUDS known to be unused, while for the second predetermined pressure profile 720, the graphed pressure corresponds to the expected pressure of a typical SUDS known to be used. FIG. 7 further includes a graphical representation of an individual pressure profile 730 generated during priming of the SUDS 190. The time in the graph starts from 0 milliseconds corresponding to the start of the priming operation and continues until the completion of the priming operation.

[0101] Various events during the priming operation can be understood from graph 700 of FIG. 7 by identifying specific pressure values and / or the time variation of the pressure values. The first inflection point 712 of the first predetermined pressure profile 710 may correspond to the point in time when the priming fluid passes through the one-way check valve 236 of the fluid inlet port 202 of a typical SUDS. In particular, the pressure change at the first inflection point 712 indicates that the one-way check valve 236 opens in response to the accumulation of fluid pressure in the MUDS 130 leading to a typical SUDS. Similarly, the second inflection point 714 of the predetermined pressure profile 710 may correspond to the point in time when the priming fluid passes through the one-way check valve 280 in the connector 214 at the distal end of a typical SUDS. The pressure change at the second inflection point 714 indicates that the one-way check valve 280 opens in response to the accumulation of fluid pressure in a typical SUDS. Following the second inflection point 714, the pressure fluctuations of the predetermined pressure profile 710 settle into a steady state portion 716 corresponding to the time interval during which the priming fluid freely flows through both one-way check valves 236, 280 of a typical SUDS.

[0102] Continuing to refer to FIG. 7, the graphical representation of the second predetermined pressure profile 720 can include a first inflection point 722, a second inflection point 724, and a steady state portion 726. The first inflection point 722 can correspond to the point in time when the priming fluid passes through the one-way check valve 236 of the fluid inlet port 202 of a typical SUDS, the second inflection point 724 can correspond to the point in time when the priming fluid passes through the one-way check valve 280 in the connector 214 of a typical SUDS, and the steady state portion 726 can correspond to the time interval during which the priming fluid freely flows through both one-way check valves 236, 280 of a typical SUDS.

[0103] Continuing to refer to FIG. 7, the graphical representation of the individual pressure profile 730 can include a first inflection point 732, a second inflection point 734, and a steady state portion 736. The first inflection point 732 can correspond to the time when the priming fluid passes through the one-way check valve 236 of the fluid inlet port 202 of the SUDS 190, and the second inflection point 734 can correspond to the time when the priming fluid passes through the one-way check valve 280 within the connector 214 of the SUDS 190. The steady state portion 736 can correspond to the time interval during which the priming fluid freely flows through both one-way check valves 236, 280 of the SUDS 190.

[0104] In FIG. 7, a typical SUDS represented by the first predetermined pressure profile 710 is unused, that is, the residual fluid contained in this typical SUDS before priming is gas. In contrast, a typical SUDS represented by the second predetermined pressure profile 720 has been previously used, that is, at least a part of the residual fluid contained in this typical SUDS before priming is liquid. The individual pressure profile 730 illustrates an unused SUDS 190.

[0105] Having generally described the characteristics of the overall pressure profile, a method 800 according to some aspects and examples of the present disclosure for detecting the reuse of the SUDS 190 will be described with reference to FIG. 8. In step 802, the method 800 can include the step of providing a memory for storing the predetermined pressure profile 710. The memory can be, for example, integrated with the electronic control device 900 or a hard disk drive 912 or other memory device that communicates with the electronic control device 900. Sometimes, the memory can store, as a database, the individual pressure measurements and corresponding time indices of the first pressure profile 710 and the second predetermined pressure profile 720.

[0106] Continuing to refer to FIG. 8, at step 804, method 800 may further include operating at least one drive component of fluid injector system 100, such as one or more of piston elements 103, to prime SUDS 190. The priming operation of step 804 can be performed substantially as described above, such as by injecting physiological saline or other suitable diluent from MUDS 130 through connection port 192 into piping 208 of SUDS 190 and waste reservoir 156.

[0107] Continuing to refer to FIG. 8, at step 806, method 800 may further include determining individual pressure profile 730 as described above, by measuring the pressure that occurs during the priming of SUDS 190 in the priming operation of step 804. In some aspects or examples, the pressure that occurs during the priming of SUDS 190 represented by individual pressure profile 730 can be obtained and / or derived by measuring the current drawn by the electromechanical drive component of piston element 103 that injects the priming fluid, i.e., the motor current. In other aspects or examples, the pressure that occurs during the priming of SUDS 190 represented by individual pressure profile 730 can be obtained and / or derived by one or more pressure transducers (not shown) attached to MUDS 130 and / or SUDS 190 in communication with the priming fluid. Other methods of pressure measurement will be understood by those skilled in the art. In some aspects or examples, each pressure measurement value of individual pressure profile 730 can be stored in a hard disk drive 912 or other memory device that is integral with, or communicates with, electronic control device 900, together with a corresponding time index indicating the relative time at which each pressure measurement value occurred.

[0108] Continuing to refer to FIG. 8, at step 808, method 800 may further include comparing the individual pressure profile 730 to at least one of a first predetermined pressure profile 710 and a second predetermined pressure profile 720. Various methods can be utilized to compare the individual pressure profile 730 to at least one of the first predetermined pressure profile 710 and the second predetermined pressure profile 720. In some aspects or examples, the electronic control device 900 can compare the pressure measurements and / or time indices associated with the first inflection point 712, the second inflection point 714, and the steady state portion 716 of the first predetermined pressure profile 710 to the pressure measurements and / or time indices associated with the first inflection point 732, the second inflection point 734, and the steady state portion 736 of the individual pressure profile 730. Alternatively, or in addition, the electronic control device 900 can compare the pressure measurements and / or time indices associated with the first inflection point 722, the second inflection point 724, and the steady state portion 726 of the second predetermined pressure profile 720 to the pressure measurements and / or time indices associated with the first inflection point 732, the second inflection point 734, and the steady state portion 736 of the individual pressure profile 730. In some aspects or examples, the electronic control device 900 can compare specific pressure measurements at similar or identical time indices of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730.

[0109] In some embodiments or examples, step 808 may include normalizing one or both of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730 by the electronic control device 900 to facilitate comparison of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730. In particular, the individual pressure profile 730 can be normalized such that for the steady state portion 736, the pressure value in the steady state portion 736 is normalized to a value of 1. Normalization can be performed by dividing the individual pressure measurements of the individual pressure profile 730 by the steady state pressure value (e.g., the average of the values in the steady state portion 736). The first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 can be normalized in the same way for their respective steady state portions 716. FIG. 9 shows a normalized graph 700' of FIG. 7 including the normalized first predetermined pressure profile 710' and second predetermined pressure profile 720' and the normalized individual pressure profile 730' which is the normalization of the first predetermined pressure profile 710 and the second predetermined pressure profile 720 and the individual pressure profile 730 of FIG. 7. By normalizing the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730, the steady state portions 716', 726', 736' are normalized to a value of 1, so that comparison is facilitated regardless of the individual machine and / or calibration differences of the fluid injector system 100. With the normalized first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730, the electronic control device 900 can, in some embodiments or examples, compare the area under the curve of the normalized first predetermined pressure profile 710' and / or the second predetermined pressure profile 720' with the area under the curve of the normalized individual pressure profile 730'.

[0110] In some embodiments or examples, step 808 may include comparing the linear trend lines of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730 over a predetermined period. A best-fit straight line can be applied to the portion between two predetermined time indices of the two of the predetermined pressure profiles 710, 720. Similarly, a best-fit straight line can be applied to the portion between the same two time indices of the individual pressure profiles 730. Next, the best-fit straight lines of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730 can be compared to determine the characteristics of the SUDS 190 during the priming operation.

[0111] In other embodiments or examples, step 808 may include the multiple comparison methods described above. Each comparison method can be weighted as part of an overall comparison score that can lead to conclusions regarding the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730.

[0112] Continuing to refer to FIG. 8, in step 810, method 800 may further include determining, based on at least one result of the comparison in step 808, whether the SUDS 190 contained at least one of a liquid as a residual fluid and a gas as a residual fluid prior to priming in step 804. Various methods can be used to make the determination in step 810. Generally, the electronic control device 900 can determine the correlation between one or more features and / or values of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730 compared in step 808. If the correlation is within a specified tolerance range, the electronic control device 900 can determine that the SUDS 190 contained a residual fluid that was at least partially of the same phase (e.g., liquid or gas) as the residual fluid typically contained in a SUDS prior to priming.

[0113] In some embodiments or examples, the electronic control device 900 can determine that the SUDS 190 contained a liquid or gas as a residual fluid based on the correlation of the first predetermined pressure profile 710 and / or the second predetermined pressure profile 720 and the individual pressure profile 730 being within a specified tolerance range, including the first inflection points 712, 722, 732, the second inflection points 714, 724, 734, and / or the steady state portions 716, 726, 736. In the example shown in FIG. 7, the first inflection point 712 of the first predetermined pressure profile 710 occurs at approximately 275 kPa and 700 ms, while the first inflection point 722 of the second predetermined pressure profile 720 occurs at approximately 350 kPa and 750 ms. FIG. 7 shows that the first inflection point 732 of the individual pressure profile 730 occurs at approximately 240 kPa and 650 ms. If the correlation (e.g., the difference in pressure and / or the difference in time index) is within the specified tolerance range (e.g., a 10% difference), the electronic control unit 900 can determine that the SUDS 190 contained a residual fluid of the same phase (e.g., liquid or gas) as a typical SUDS prior to the priming operation. In contrast, if the correlation is outside the specified tolerance range, the electronic control unit 900 can determine that the SUDS 190 contained a residual fluid of a different phase than a typical SUDS prior to the priming operation. In this example, since the correlation of the pressure and time index of the first predetermined pressure profile 710 and the individual pressure profile 730, and / or the correlation of the pressure and time index of the second predetermined pressure profile 720 and the individual pressure profile 730 is outside the specified tolerance range, the electronic control unit 900 can determine that the SUDS 190 contained a residual fluid of a different phase than a typical SUDS prior to the priming operation. Since a typical SUDS contained air prior to the priming operation, the electronic control unit 900 can thus determine that the SUDS 190 contained a liquid prior to priming, i.e., was used in a previously executed injection command.

[0114] In some embodiments or examples, step 810 may include determining that the SUDS 190 contained a liquid or a gas as a residual fluid based on the correlation of the normalized first pressure profile 710' and / or the second predetermined pressure profile 720' and the normalized individual pressure profile 730'. In particular, the electronic control device 900 can determine whether the correlation between the area under the curve of the normalized individual pressure profile 730' and the area under the curve of the first pressure profile 710' and / or the second predetermined pressure profile 720' is within a specified tolerance range. If the electronic control device 900 makes an affirmative determination, the residual fluid contained in the SUDS 190 before priming was in the same phase as the residual fluid of a typical SUDS. If the electronic control device 900 makes a negative determination, the residual fluid contained in the SUDS 190 before priming was in a different phase from the residual fluid of a typical SUDS. Based on this determination, the electronic control unit 900 can determine whether the SUDS 190 was used in a previously executed injection command.

[0115] In some embodiments or examples, step 810 may include determining that the SUDS 190 contained a liquid or a gas as a residual fluid based on the correlation of the best-fit lines of the first pressure profile 710, the second predetermined pressure profile 720, and the individual pressure profile 730. Similar to the above-described embodiment, the electronic control unit 900 can determine that the SUDS 190 contained a residual fluid of the same phase as a typical SUDS before the priming operation if the correlation is within the specified tolerance range. Conversely, if the correlation is outside the specified tolerance range, the electronic control unit 900 can determine that the SUDS 190 contained a residual fluid of a different phase from a typical SUDS before the priming operation. Based on this determination, the electronic control unit 900 can determine whether the SUDS 190 was used in a previously executed injection command.

[0116] In other aspects or examples, step 810 may include the above-described methods for determining whether the residual fluid contained in the SUDS 190 before priming was a liquid or a gas. Each of these determinations can be weighted as part of an overall score that can lead to conclusions regarding previous use of the SUDS 190.

[0117] In some aspects or examples, the determination made at step 810 can be used to generate a warning indicating whether the SUDS 190 has been used previously. In particular, the electronic control unit 900 can generate a warning if it is determined that the SUDS 190 contains at least partially fluid as a residual fluid before priming, i.e., has been used in a previously executed injection command. The warning can be generated by the electronic control unit 900 in the form of visual, audible, tactile, or other sensory outputs configured to prompt the attention of a physician or other care provider. In some aspects or examples, the warning can be a graphic displayed on one or more user interfaces 124 of the fluid injector system 100, a noise emitted from a speaker 934 of the fluid injector system 100, or a combination thereof.

[0118] In some aspects or examples, the determination made at step 810 can be input into a compliance report generated by the electronic control unit 900. The compliance report can be displayed on one or more user interfaces 124 of the fluid injector system 100 to provide visual feedback regarding compliance with hygiene practices, such as, for example, the routine replacement of the SUDS 190. The compliance report can also be stored in a compliance database for future analysis of hygiene practices. Further details regarding the generation, display, and analysis of compliance reports using the fluid injector system 100 are presented in Patent Document 3, the disclosure of which is hereby incorporated by reference in its entirety.

[0119] In some embodiments or examples, the determination made at step 810 can prevent the start of an injection command if the electronic control unit 900 determines that the SUDS 190 has been previously used. In particular, the electronic control unit 900 can prohibit the start of a permitted injection command if the SUDS 190 is determined to contain at least partially fluid as residual fluid before priming, i.e., has been used in a previously executed injection command. Conversely, the electronic control unit 900 can permit the start of a permitted injection command if the SUDS 190 is determined to contain gas as residual fluid before priming, i.e., is unused.

[0120] As described above, monitoring the pressure generated during the priming operation can also be used to determine characteristics of the SUDS 190 other than the residual fluid contained in the SUDS 190. In some embodiments or examples, the electronic control unit 900 can determine whether the SUDS 190 has been fully primed based on the individual pressure profile 730. FIG. 10 shows a method 850 that can be used to determine whether the SUDS 190 has been fully primed. At step 852, the method 850 can include identifying a first inflection point 732 of the individual pressure profile 730 caused by at least one fluid passing through the one-way check valve 236 of the SUDS 190. The electronic control unit 900 can identify the first inflection point 732 by identifying a sharp increase in pressure followed by a horizontal region of pressure due to the opening of the check valve 236. In some examples or embodiments, the electronic control unit 900 compares the individual pressure profile 730 with the first pressure profile 710 and / or a second predetermined pressure profile 720 and determines whether the first inflection point 732 of the individual pressure profile 730 correlates within a specified tolerance with the first inflection point 712 of the first predetermined pressure profile 710 and / or the first inflection point 722 of the second predetermined pressure profile 720.

[0121] Continuing to refer to FIG. 10, method 850 may further include, at step 854, identifying a second inflection point 734 of the individual pressure profile 730 caused by at least one fluid passing through the one-way check valve 280 of the SUDS 190. The electronic control unit 900 compares the individual pressure profile 730 with the first and / or second predetermined pressure profiles 710, 720, and determines that the second inflection point 734 of the individual pressure profile 730 correlates within a specified tolerance with the second inflection points 714, 724 of the first pressure profile 710' and / or the second predetermined pressure profile 720, thereby identifying the second inflection point 734. If the electronic control unit 900 cannot identify the second inflection point 734 of the individual pressure profile 730 that correlates within the specified tolerance, the electronic control unit 900 can determine that the priming fluid has not reached the one-way check valve 280 and, thus, the SUDS 190 is not fully primed.

[0122] Continuing to refer to FIG. 10, method 850 may further include, at step 856, identifying a steady state portion 736 of an individual pressure profile 730 caused by freely flowing priming fluid after passing through both one-way check valves 236, 280 of SUDS 190. The electronic control unit 900 can identify the steady state portion 736 by determining that the pressure is constant after a predetermined time during the priming operation. The electronic control unit 900 compares the individual pressure profile 730 with the first pressure profile 710 and / or a second predetermined pressure profile 720, and determines that the steady state portion 736 of the individual pressure profile 730 correlates within a specified tolerance with the steady state portions 716, 726 of the first pressure profile 710 and / or the second predetermined pressure profile 720, thereby identifying the steady state portion 736. If the electronic control unit 900 cannot identify that the steady state portion 736 of the individual pressure profile 730 correlates within the specified tolerance, the electronic control unit 900 can determine that the priming fluid has not reached a steady state and thus SUDS 190 is not fully primed. If the electronic control unit 900 identifies either the second inflection point 734 at step 854 or the steady state portion 736 at step 856, the electronic control unit 900 can determine that the SUDS is fully primed.

[0123] In some aspects or examples of method 850, only one of steps 854 and 856 can be performed. Also, note that the method 850 described above assumes that SUDS 190 includes both one-way check valves 236 and 280. However, in some aspects or examples, the one-way check valve 236 may be omitted, and in the absence of the one-way check valve 236, the first inflection point 732 is not expected to appear, so method 850 may be performed without including step 852.

[0124] In some embodiments or examples, the electronic control unit 900 can determine the length of the SUDS 190 based on the individual pressure profile 730. The electronic control unit 900 can determine the elapsed time between a first inflection point 732 and a second inflection point 734 of the individual pressure profile 730 that represents the time during which the one-way check valves 236, 280 are open. Further, the electronic control unit 900 can determine the amount of fluid injected into the SUDS 190, for example, based on the displacement of the piston element 103 during this elapsed time, to determine the internal volume of the SUDS 190. The internal volume of the SUDS 190 can be converted to length by dividing this internal volume by the known cross-sectional area of the pipe 208.

[0125] In some embodiments or examples, the electronic control unit 900 can determine the presence or absence of components of an additional fluid path set connected to the connector 214 of the SUDS 190 based on the individual pressure profile 730. The presence of components of an additional fluid path set, such as an extension line, can introduce additional characteristics into the individual pressure profile 730, such as a third inflection point or a higher steady-state pressure. In particular, components of an additional fluid path set can introduce additional restrictions into the fluid path, such as an additional one-way check valve or a narrower lumen, which can cause a pressure inflection or a higher steady-state pressure when the priming fluid passes through. FIG. 11 shows a graph of a modified individual pressure profile 730'' representing the first predetermined pressure profile 710 and the SUDS 190 with components of an additional fluid path set attached. The electronic control unit 900 can identify that the pressure in the steady-state portion 736'' of the modified individual pressure profile 730'' is higher than the pressure in the steady-state portion 716 of the first predetermined pressure profile and determine that components of an additional fluid path set are connected to the SUDS 190.

[0126] In some embodiments or examples, the electronic control unit 900 can take into account differences in pressure profiles according to the age of the SUDS 190. FIG. 12 shows a first predetermined pressure profile 710 representing a relatively new or early (i.e., not aged) typical SUDS, compared to an aged second predetermined pressure profile 738 representing an unused but aged typical SUDS. Further, a third predetermined pressure profile 740 represents a relatively new and previously used typical SUDS, and a fourth predetermined pressure profile 742 represents an aged and previously used typical SUDS. Various characteristics of the pressure profiles 710, 738, 740, 742, such as inflection points and steady-state portions, can be identified, compared, and analyzed by the electronic control unit 900 as generally described herein in steps 808 and 810 of method 800 to determine the age of the SUDS represented by the pressure profiles 710, 738, 740, 742.

[0127] In some embodiments or examples, the electronic control unit 900 can consider differences in pressure profiles corresponding to the fluid present in the manifold 148 at the start of the priming operation. FIG. 13 shows a first predetermined pressure profile 710 representative of an unused typical SUDS when saline is present as the fluid in the manifold 148. Also shown are predetermined pressure profiles 744, 746, and 748 representative of (i) an unused typical SUDS when contrast agent is present as the fluid in the manifold 148, (ii) a previously used typical SUDS when saline is present as the fluid in the manifold 148, and (iii) a previously used typical SUDS when contrast agent is present as the fluid in the manifold 148, respectively. Various characteristics of the predetermined pressure profiles 710, 744, 746, 748, such as inflection points and steady state portions, can be identified, compared, and analyzed by the electronic control unit 900 as generally described herein in steps 808 and 810 of method 800. In this way, the type of fluid (e.g., saline or contrast agent) present in the manifold 148 at the start of the priming operation can be considered in the comparison between the individual pressure profile and the predetermined pressure profile.

[0128] In some embodiments or examples of the present disclosure, methods 800, 850, and other methods and processes described herein can be implemented in the fluid injector system 100 by a computer program product. The computer program product can include at least one non-transitory computer-readable medium having one or more instructions executable by at least one processor to cause the at least one processor to execute all or a portion of method 800. In some examples or embodiments, as described above with reference to FIG. 6, the at least one non-transitory computer-readable medium and the at least one processor can include, or can correspond to, memory 908 and processor 904, respectively.

[0129] Examples of fluid injector systems, computer program products, and related methods are shown in the accompanying drawings and described in detail herein, but other examples will be apparent and readily formable by those skilled in the art without departing from the scope and spirit of the present disclosure. For example, it should be understood that the present disclosure is intended to be able to combine one or more features of any example with one or more features of any other example, to the extent possible. Accordingly, the foregoing description is not intended to be limiting, but rather is intended to be illustrative.

Explanation of Signs

[0130] 100 Fluid injector system 102 Injector housing 103 Piston element 104 Side 106 Distal end or upper end 108 Proximal end or lower end 110 Base 112 Wheel 114 Handle 116 Door 118 Bulk fluid connector 120 Bulk fluid source 122 Support member 124 User interface 126 Control button 130 Multiple-use disposable set (MUDS) 132 Syringe 134 MUDS fluid path 136 Valve 148 Manifold 150 Fluid inlet line 152 Fluid outlet line 156 Waste reservoir 190 Single-use disposable set (SUDS) 192 Connection port 194 Opening 196 Waste inlet port 198 Observation window 200 Mark 202 Fluid inlet port 204 Waste outlet port 206 Spacer 207 Fin 208 Pipe 210 Proximal end of the pipe 212 Distal end of the pipe 214 Connector 216 Lock tab 217 Receiving slot 218 Pushing surface 220 Second annular skirt 222 Distal end of the fluid inlet port 224 First annular skirt 226 Proximal end of the fluid inlet port 228 Recess of the first annular skirt 230 Depression of the second annular skirt 234 Annular seal 236 Check valve 238 Sensor system 240 Sensor fin 242 Sensor 280 Check valve 700 Graph 700’ Graph 710 First predetermined pressure profile 710’ First predetermined pressure profile 712 First inflection point 714 Second inflection point 716 Steady state portion 716’ Steady state portion 720 Second predetermined pressure profile 720’ Second predetermined pressure profile 722 First inflection point 724 Second inflection point 726 Steady state portion 726’ Steady state portion 730 Individual pressure profile 730’ Individual pressure profile 732 First inflection point 734 Second inflection point 736 Steady state portion 736' Steady State Portion 736'' Steady State Portion 738 Second Predetermined Pressure Profile 740 Third Predetermined Pressure Profile 742 Fourth Predetermined Pressure Profile 744 Predetermined Pressure Profile 746 Predetermined Pressure Profile 748 Predetermined Pressure Profile 900 Electronic Control Device / Electronic Control Unit 902 Computer System Environment 904 Processor 906 System Bus 908 System Memory 910 Non-Removable Memory Interface 912 Hard Disk Drive 914 Removable Non-Volatile Memory Interface 916 Magnetic Disk Drive Unit 918 Magnetic Disk 920 Optical Disk Drive Unit 921 USB Port 922 Optical Disk 923 Memory Card 924 Keyboard 926 Mouse 928 User Input Interface 930 Monitor 932 Printer 934 Speaker 936 Output Interface 938 Network Environment 940 Communication Device 942 Communication Interface 944 Computer

Claims

1. A fluid injector system configured to execute an injection command related to a diagnostic imaging method, the fluid injector system comprising: a memory for storing a predetermined pressure profile, the predetermined pressure profile representing the pressure expected to be generated inside the typical administration line by the priming fluid during a priming operation performed in the typical administration line when the priming fluid completely expels fluid from the typical administration line; the memory; a control device operably combined with at least one drive component configured to pressurize at least one fluid and inject the at least one fluid into a patient through a target administration line, the target administration line being one of the typical administration lines, the control device: actuating the at least one drive component to prime the target administration line with the at least one fluid as the priming fluid; determining an individual pressure profile indicative of a measured value of the current pressure generated when priming the target administration line with the at least one fluid during the priming operation performed with the at least one fluid; comparing the individual pressure profile with the predetermined pressure profile; based on the result of the comparison, determining whether the target administration line contained liquid as residual fluid before priming the target administration line; the control device including at least one processor programmed or configured to perform an operation comprising: A fluid injector system comprising:

2. The typical administration line is: (i) an unused administration line, such that the fluid is a gas, whereby the predetermined pressure profile represents the pressure expected to be generated by the priming fluid during priming of the unused administration line when the gas inside the unused administration line is completely expelled by the priming fluid during the priming operation; the unused administration line; or (ii) A previously used administration line, as a result of which the fluid is at least partially liquid, and thus the predetermined pressure profile is the pressure that the priming fluid is expected to generate when, during the priming of the previously used administration line, the liquid in the previously used administration line is completely displaced by the priming fluid over the course of the priming operation. The previously used administration line, The fluid injector system according to claim 1, which is as described above. **Claim 3** The typical administration line is an unused administration line. When the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within a specified tolerance range as a result of the comparison, the at least one processor is configured to determine that the target administration line contained the gas as the residual fluid. The fluid injector system according to claim 2. **Claim 4** The operation is When the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range as a result of the comparison, the fluid injector system according to claim 3 further includes generating a notification indicating that the target administration line has not been used before being primed by the at least one fluid in the priming operation. **Claim 5** The operation is When the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range as a result of the comparison, the fluid injector system according to claim 3 further includes permitting the execution of the injection command. **Claim 6** The target administration line, like the typical administration line, includes at least one check valve that prevents the flow of fluid in the proximal direction. The result of the comparison that the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified tolerance range is At least one pressure inflection point in the individual pressure profile caused by at least one fluid passing through the at least one check valve of the target dosing line is within a predetermined range of the difference from at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through the at least one check valve of the typical dosing line corresponding to the at least one pressure inflection point, Normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and determining that the difference between the area under the curve of the normalized individual pressure profile and the area under the curve of the predetermined pressure profile is within a predetermined range, and Normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and determining that the difference between each point along the individual pressure profile and the corresponding point on the predetermined pressure profile is within a predetermined range, including at least one of The fluid injector system according to claim 3.

7. The typical dosing line is the previously used dosing line, and when the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified tolerance range, the at least one processor is configured to determine that the target dosing line contained the liquid as the residual fluid. The fluid injector system according to claim 2.

8. The operation is When the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified tolerance range, further including generating a notification indicating that the target dosing line has been used before being primed by the at least one fluid in the priming operation. The fluid injector system according to claim 7.

9. The target dosing line, like the typical dosing line, includes at least one check valve that prevents the flow of fluid in the proximal direction. The result of the comparison that the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified allowable range is at least one pressure inflection point in the individual pressure profile caused by the at least one fluid passing through the at least one check valve of the target administration line is identified as being within a predetermined range of the difference from at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through the at least one check valve of the typical administration line corresponding to the at least one pressure inflection point the individual pressure profile is normalized with respect to the steady-state value of the individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of the predetermined pressure profile, and it is determined that the difference between the area under the curve of the normalized individual pressure profile and the area under the curve of the predetermined pressure profile is within a predetermined range, and at least one of: the individual pressure profile is normalized with respect to the steady-state value of the individual pressure profile, the predetermined pressure profile is normalized with respect to the steady-state value of the predetermined pressure profile, and it is determined that the difference between each point along the individual pressure profile and the corresponding point on the predetermined pressure profile is within a predetermined range The fluid injector system according to claim 3.

10. The fluid injector system according to claim 1, wherein the at least one fluid used for priming the target administration line includes at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of the contrast medium and the diluent.

11. The fluid injector system according to claim 1, wherein determining the individual pressure profile includes measuring the motor current of the at least one drive component.

12. The target administration line includes, similar to the typical administration line, a first check valve that prevents the flow of fluid in the proximal direction, and a second check valve that prevents the flow in the proximal direction, wherein the second check valve is located on the distal side of the first check valve. During priming of the target administration line, the operation is identifying a first pressure inflection point of the individual pressure profile caused by the at least one fluid passing through the first check valve of the target administration line; identifying at least one of a second pressure inflection point of the individual pressure profile caused by the at least one fluid passing through the second check valve of the target administration line and a steady state portion of the individual pressure profile in which the pressure caused in the target administration line remains substantially constant; further comprising The fluid injector system according to claim 3, whereby it is determined that the target administration line is fully primed. [

13. ] The target administration line, like the typical administration line, comprises a single check valve located at the distal end of the target administration line, the single check valve preventing the flow of fluid in the proximal direction. During priming of the target administration line, the operation identifying at least one of a pressure inflection point of the individual pressure profile caused by the at least one fluid passing through the single check valve of the target administration line and a steady state portion of the individual pressure profile in which the pressure caused in the target administration line remains substantially constant further comprising identifying; The fluid injector system according to claim 1, whereby it is determined that a component of the fluid path set is connected to the distal end of the target administration line. [

14. ] A non-transitory computer-readable medium for detecting multiple uses of an administration line using a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method, The non-transitory computer-readable medium comprises a memory for storing a predetermined pressure profile, the predetermined pressure profile being executed for a typical administration line and representing the pressure expected to be generated by the priming fluid within the typical administration line during a priming operation that completely expels the fluid from the typical administration line with the priming fluid; The non-transitory computer-readable medium, when executed by at least one processor, causes the at least one processor to A step of operating at least one drive component of the fluid injector system to prime a target administration line with the priming fluid, wherein the target administration line is one of the typical administration lines. A step of determining an individual pressure profile representing a measured value of the current pressure generated during priming of the target administration line with the at least one fluid over the course of the priming operation performed with the at least one fluid. A step of comparing the individual pressure profile with the predetermined pressure profile. Further including one or more instructions for causing an operation to be performed that includes a step of determining, based on the result of the comparison, whether the target administration line contained a liquid as residual fluid prior to the priming. A non-transitory computer-readable medium.

15. The typical administration line is (i) an unused administration line, as a result of which the fluid is a gas, and thus the predetermined pressure profile represents the pressure expected to be generated by the priming fluid when the gas in the unused administration line is completely displaced by the priming fluid during the priming operation over the course of the priming operation, or (ii) a previously used administration line, as a result of which the fluid is at least partially a liquid, and thus the predetermined pressure profile represents the pressure expected to be generated by the priming fluid when the liquid in the previously used administration line is completely displaced by the priming fluid during the priming operation over the course of the priming operation, being one of the two. The non-transitory computer-readable medium according to claim 14.

16. The typical administration line is the unused administration line, and when the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within a specified tolerance as a result of the comparison, the one or more instructions, when executed by the at least one processor, cause the at least one processor to determine that the target administration line contained the gas as the residual fluid. The non-transitory computer-readable medium according to claim 15.

17. When the one or more instructions are executed by the at least one processor, when, as a result of the comparison, the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified allowable range, causing the at least one processor to perform a further operation of generating a notification indicating that the target administration line has not been used before being primed by the at least one fluid in the priming operation. The non-transitory computer-readable medium according to claim 16.

18. When the one or more instructions are executed by the at least one processor, when, as a result of the comparison, the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified allowable range, causing the at least one processor to perform a further operation of permitting the execution of the injection command. The non-transitory computer-readable medium according to claim 16.

19. The target administration line, like the typical administration line, includes at least one check valve that prevents the flow of fluid in the proximal direction. The result of the comparison that the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified allowable range is identified by the at least one processor as the difference between at least one pressure inflection point in the individual pressure profile caused by the at least one fluid passing through the at least one check valve of the target administration line and at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through the at least one check valve of the typical administration line corresponding to the at least one pressure inflection point being within a predetermined range. With the at least one processor, normalize the individual pressure profile with respect to the steady-state value of the individual pressure profile, with the at least one processor, normalize the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, with the at least one processor, determine that the difference between the area under the curve of the normalized individual pressure profile and the area under the curve of the predetermined pressure profile is within a predetermined range, and normalize the individual pressure profile with respect to the steady-state value of the individual pressure profile, normalize the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and determine that the difference between each point along the individual pressure profile and the corresponding point on the predetermined pressure profile is within a predetermined range The non-transitory computer-readable medium according to claim 16, comprising at least one of the above.

20. The typical dosing line is the previously used dosing line, and when the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within a specified tolerance range, the one or more instructions, when executed by the at least one processor, cause the at least one processor to determine that the target dosing line contained the liquid as the residual fluid. The non-transitory computer-readable medium according to claim 15.

21. The one or more instructions, when executed by the at least one processor, When the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile as a result of the comparison is within the specified tolerance range, cause the at least one processor to perform a further operation including generating a notification indicating that the target dosing line was used before being primed by the at least one fluid in the priming operation. The non-transitory computer-readable medium according to claim 20.

22. The target dosing line, like the typical dosing line, includes at least one check valve that prevents the flow of fluid in the proximal direction. The result of the comparison that the relative difference between two or more data points between the individual pressure profile and the predetermined pressure profile is within the specified allowable range is by the at least one processor, at least one pressure inflection point in the individual pressure profile caused by the at least one fluid passing through the at least one check valve of the target administration line is the at least one check valve of the typical administration line corresponding to the at least one pressure inflection point Identifying that the difference from at least one pressure inflection point in the predetermined pressure profile caused by the priming fluid passing through is within a predetermined range, by the at least one processor, normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, by the at least one processor, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and by the at least one processor, the area under the curve of the normalized individual pressure profile is within a predetermined range of the difference from the area under the curve of the predetermined pressure profile. Determining, and The non-transitory computer-readable medium according to claim 16, including at least one of the following: by the at least one processor, normalizing the individual pressure profile with respect to the steady-state value of the individual pressure profile, and by the at least one processor, normalizing the predetermined pressure profile with respect to the steady-state value of the predetermined pressure profile, and by the at least one processor, determining that the difference between each point along the individual pressure profile and the corresponding point on the predetermined pressure profile is within a predetermined range. **Claim 23** The non-transitory computer-readable medium according to claim 14, wherein the at least one fluid used for priming the target administration line includes at least one of (i) a diluent, (ii) a contrast medium, and (iii) a mixture of the contrast medium and the diluent. **Claim 24** The non-transitory computer-readable medium according to claim 14, wherein determining the individual pressure profile includes measuring, by the at least one processor, a motor current of the at least one drive component. **Claim 25** The target administration line includes, similar to the typical administration line, a first check valve that impedes the flow of fluid in the proximal direction and a second check valve that impedes the proximal flow, where the second check valve is located distally of the first check valve. During priming of the target administration line, the operation includes identifying a first pressure inflection point of the individual pressure profile caused by at least one fluid passing through the first check valve of the target administration line, and identifying at least one of a second pressure inflection point of the individual pressure profile caused by at least one fluid passing through the second check valve of the target administration line and a steady state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant, and further includes thereby determining that the target administration line is fully primed, the non - transient computer - readable medium of claim 16. **Claim 26** The target administration line includes, similar to the typical administration line, a single check valve located at the distal end of the target administration line, where the single check valve impedes the flow of fluid in the proximal direction. During priming of the target administration line, the operation includes identifying a pressure inflection point of the individual pressure profile caused by at least one fluid passing through the single check valve of the target administration line and identifying at least one of a steady state portion of the individual pressure profile in which the pressure induced in the target administration line remains substantially constant, thereby determining that a component of the fluid path set is connected to the distal end of the target administration line, the non - transient computer - readable medium of claim 14. **Claim 27** A method for detecting multiple uses of an administration line using a fluid injector system configured to execute an injection command in relation to a diagnostic imaging method, the method comprising A step of preparing a memory for storing a predetermined pressure profile, wherein the predetermined pressure profile is executed for a typical dosing line and represents the pressure expected to be generated by the priming fluid in the typical dosing line during a priming operation to completely remove fluid from the typical dosing line with the priming fluid. A step of actuating at least one drive component of the fluid injector system to prime a target dosing line with the priming fluid, wherein the target dosing line is one of the typical dosing lines. A step of determining an individual pressure profile representing a measured value of the current pressure occurring during priming of the target dosing line with the at least one fluid during the priming operation performed with the at least one fluid. A step of comparing the individual pressure profile with the predetermined pressure profile. A step of determining, based on the result of the comparison, whether the target dosing line contained liquid as residual fluid before the priming. A method comprising.

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