Systems and methods for detecting fluid type in tubing for a fluid injector device - Patents.com

Abstract

The fluid injector system includes at least one injector for pressurizing and delivering at least one fluid from the at least one fluid reservoir, at least one fluid path section providing fluid communication between a bulk fluid reservoir and a syringe connected to the at least one injector, and at least one sensor disposed along the at least one fluid path section. The at least one sensor includes an emitter configured to emit light through the at least one fluid path section, and a detector configured to receive the light emitted through the at least one fluid path section and generate an electrical signal based on at least one characteristic of the received light. The fluid injector system may further include at least one processor programmed or configured to determine at least one of an identity of the at least one fluid present in the fluid path section, a concentration of the at least one fluid in the fluid path section, and at least one characteristic of the fluid path section based on the electrical signal generated by the detector.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 212,055, filed June 17, 2021, the disclosure of which is incorporated by reference in its entirety herein.

[0002] The present disclosure relates to the field of fluid injectors and devices for injecting contrast media for contrast medical imaging procedures. In particular, embodiments of a system and method for detecting air and fluid type (contrast and saline) and fluid concentration within a fluid tubing set of a fluid injector device are described. [Background technology]

[0003] In many medical diagnostic and therapeutic procedures, physicians inject one or more medical fluids into a patient. In recent years, numerous injector-actuated syringes and powered fluid injectors for pressurized injection of medical fluids, such as imaging contrast media solutions (often simply referred to as "contrast media"), flushing agents such as saline or lactated Ringer's, and other medical fluids, have been developed for use in imaging procedures such as cardiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging procedures. Generally, these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure, duration, and / or flow rate.

[0004] Typically, the fluid injector has at least one drive member, such as, for example, a plunger or a piston, that connects to the syringe via a connection with an engagement feature on the proximal end wall of the syringe. Alternatively, the fluid injector may include one or more peristaltic pumps for injecting the medical fluid from a fluid reservoir. The syringe may include a rigid barrel having a syringe plunger slidably disposed within the barrel. The drive member drives the plunger proximally and / or distally relative to a longitudinal axis of the barrel to draw or deliver fluid, respectively, into or from the syringe barrel. In certain applications, the medical fluid is injected into the vasculature at fluid pressures of up to 300 psi for CT imaging procedures, or up to 1200 psi for CV imaging procedures, for example.

[0005] During a particular injection in which both contrast and flushing fluids are injected into a patient, it is important that the system and user know which syringes contain contrast and which contain flushing fluids, ensure that the correct amounts of contrast and flushing fluids are injected at the correct time in the injection procedure to minimize or eliminate overinjection of contrast, and utilize the correct contrast agent to ensure that the correct contrast agent concentration is used. Because certain injection fluids are expensive and can cause harm to a patient if administered incorrectly, new methods and devices are needed to verify the type and concentration of fluid loaded into the corresponding syringes and to enable the injection system to clearly indicate which syringe contains which injection fluid. Summary of the Invention [Means for solving the problem]

[0006] In consideration of the above needs, the present disclosure provides systems, devices, and methods for detecting contents in a fluid line during a medical fluid injection procedure. Certain embodiments of the present disclosure are directed to a fluid injector system. The system includes at least one injector for pressurizing and delivering at least one fluid from at least one fluid reservoir, at least one fluid path section providing fluid communication between a bulk fluid reservoir and a syringe connected to the at least one injector, and at least one sensor disposed along the at least one fluid path section. The at least one sensor includes an emitter configured to emit light through the at least one fluid path section, and a detector configured to receive the light emitted through the at least one fluid path section and generate an electrical signal based on at least one characteristic of the received light. The system further includes at least one processor programmed or configured to determine at least one of an identity of at least one fluid present in the fluid path section, a concentration of at least one fluid in the fluid path section, and at least one characteristic of the fluid path section based on the electrical signal generated by the detector.

[0007] In some embodiments, the emitter is disposed on a first side of the fluid path section and the detector is disposed on a second side of the fluid path section, the second side of the fluid path section being approximately 180° opposite the first side of the fluid path section.

[0008] In some embodiments, the fluid infuser system further includes a first fluid reservoir and a second fluid reservoir for delivering the first fluid and the second fluid, respectively. The system further includes a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor. The first fluid path section is associated with the first sensor and the second fluid path section is associated with the second sensor.

[0009] In some embodiments, the fluid infuser system further includes a first bulk fluid container in fluid communication with the first fluid reservoir and a second bulk fluid container in fluid communication with the second fluid reservoir, the first sensor is positioned to detect fluid entering the first fluid reservoir from the first bulk fluid container during a fill operation of the first fluid reservoir, and the second sensor is positioned to detect fluid entering the second fluid reservoir from the second bulk fluid container during a fill operation of the second fluid reservoir.

[0010] In some embodiments, the at least one processor is programmed or configured to determine, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir and that the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.

[0011] In some embodiments, the at least one processor is programmed or configured to perform an action selected from: stopping the fill operation in response to determining that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and adjusting the injection protocol to ensure that injection parameters are updated to switch the identities of the first and second fluid reservoirs such that the first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.

[0012] In some embodiments, the at least one processor is programmed or configured to modify the injection protocol by configuring the first fluid reservoir to inject a fluid that was originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject a fluid that was originally intended to be injected by the first fluid reservoir.

[0013] In some embodiments, the at least one processor is programmed or configured to adjust the display of a graphical user interface or illuminate a light source associated with the fluid reservoir to indicate that the first fluid reservoir contains a fluid that was originally intended to be injected by the second fluid reservoir, and that the second fluid reservoir contains a fluid that was originally intended to be injected by the first fluid reservoir.

[0014] In some embodiments, the fluid infuser system further includes a manifold including at least one fluid pathway section, an inlet port connected to a syringe tip of at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.

[0015] In some embodiments, the at least one processor is programmed or configured to determine an optimal fill rate for the at least one fluid reservoir based on at least one identity of the fluid and a concentration of the fluid in the at least one fluid pathway section.

[0016] In some embodiments, the optimal fill rate comprises a maximum rate at which to fill the at least one fluid reservoir that minimizes the introduction of air bubbles into the fluid as it enters the at least one fluid reservoir.

[0017] In some embodiments, the detector is configured to output a first voltage signal when the at least one fluid path section contains a contrast medium, the detector is configured to output a second voltage signal when the fluid path section contains saline, and the at least one processor is configured to determine an identity of an infusion fluid in the at least one fluid path section based on a difference between the first and second voltage signals.

[0018] In some embodiments, the detector is configured to output a third voltage signal when the at least one fluid path section contains air, and the at least one processor is programmed or configured to determine that air is present in the at least one fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.

[0019] In some embodiments, when the detector determines that the fluid path section contains air, the detector is configured to provide an alert to a user that the bulk fluid reservoir is empty.

[0020] In some embodiments, the at least one processor is programmed or configured to determine a concentration of the contrast medium in the at least one fluid path section based on the electrical signal generated by the at least one sensor, and to increase a rate of saline injected during the injection procedure to dilute the concentration of the contrast medium delivered to the patient.

[0021] In some embodiments, the at least one processor is programmed or configured to determine a concentration of the contrast medium in the fluid path section based on the electrical signal generated by the at least one sensor, and to reduce the injection rate of saline during the injection procedure to increase the concentration of the contrast medium delivered to the patient.

[0022] In some embodiments, the emitter is positioned to emit light perpendicular to a fluid flow direction through the at least one fluid path section.

[0023] In some embodiments, the at least one processor is programmed or configured to determine, based on the electrical signal, that at least one fluid path section exists between the emitter and the detector.

[0024] In some embodiments, the emitter is configured to emit light in the ultraviolet spectrum. The emitted light may have a wavelength of about 300 nm to about 400 nm.

[0025] In some embodiments, the emitter is configured to emit light in the infrared spectrum. The emitted light can have a wavelength of about 700 nm to about 2000 nm.

[0026] In some embodiments, the emitter is configured to emit light in the visible spectrum. The emitted light may have a wavelength of about 400 nm to about 700 nm.

[0027] In some embodiments, the at least one processor is programmed or configured to drive the emitter with a first emitter current, the first emitter current configured to saturate the detector when the first fluid is present in the fluid path section.

[0028] In some embodiments, the at least one processor is programmed or configured to drive the emitter with a second emitter current greater than the first emitter current, the second emitter current configured to saturate the detector when a second fluid is present in the fluid path section.

[0029] Another embodiment of the present disclosure is directed to a method for determining one or more fluid characteristics of a fluid flowing in at least one fluid path section of a fluid injector system, the method including emitting light from an emitter of at least one sensor through the at least one fluid path section, detecting the light that has passed through the at least one fluid path section with a detector of a first proximal sensor, and determining at least one of an identity of an infusion fluid present in a fluid path set, a concentration of the infusion fluid in the fluid path set, and at least one characteristic of the fluid path section based on an electrical signal generated by the detector.

[0030] In some embodiments, the emitter is disposed on a first side of the fluid path section and the detector is disposed on a second side of the fluid path section, the second side of the fluid path section being approximately 180° opposite the first side of the fluid path section.

[0031] In some embodiments, the fluid infuser system includes a first fluid reservoir and a second fluid reservoir for delivering a first fluid and a second fluid, respectively, a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor, the first fluid path section being associated with the first sensor and the second fluid path section being associated with the second sensor.

[0032] In some embodiments, the fluid infuser system further includes a first bulk fluid container in fluid communication with the first fluid reservoir and a second bulk fluid container in fluid communication with the second fluid reservoir, the first sensor is positioned to detect fluid entering the first fluid reservoir during a fill operation of the first fluid reservoir, and the second sensor is positioned to detect fluid entering the second fluid reservoir during a fill operation of the second fluid reservoir.

[0033] In some embodiments, the method further includes determining, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir and that the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.

[0034] In some embodiments, the method further includes stopping the filling operation in response to determining that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir.

[0035] In some embodiments, the method further includes adjusting the injection protocol to ensure that injection parameters are updated to switch the identities of the first and second fluid reservoirs such that the first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.

[0036] In some embodiments, the method further includes modifying the injection protocol by configuring the first fluid reservoir to inject a fluid that was originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject a fluid that was originally intended to be injected by the first fluid reservoir.

[0037] In some embodiments, the method further includes adjusting a display of a graphical user interface or illuminating a light source associated with the fluid reservoir to indicate that the first fluid reservoir contains a fluid that was originally intended to be injected by the second fluid reservoir, and that the second fluid reservoir contains a fluid that was originally intended to be injected by the first fluid reservoir.

[0038] In some embodiments, the fluid infuser system further includes a manifold including at least one fluid pathway section, an inlet port connected to a syringe tip of at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.

[0039] In some embodiments, the method further comprises determining an optimal fill rate for the at least one fluid reservoir based on at least one identity of the fluid and a concentration of the fluid in the at least one fluid pathway section.

[0040] In some embodiments, the optimal fill rate comprises a maximum rate at which to fill the at least one fluid reservoir that minimizes the introduction of air bubbles into the fluid as it enters the at least one fluid reservoir.

[0041] In some embodiments, the detector is configured to output a first voltage signal when the at least one fluid path section contains a contrast medium. The detector is configured to output a second voltage signal when the fluid path section contains saline. The method further includes determining an identity of an infusion fluid in the at least one fluid path section based on a difference between the first and second voltage signals.

[0042] In some embodiments, the detector is configured to output a third voltage signal when the at least one fluid path section contains air. The method further includes determining that there is air in the fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.

[0043] In some embodiments, the method further includes providing an alert to a user that the bulk fluid reservoir is empty when the detector determines that the fluid path section contains air.

[0044] In some embodiments, the method further includes determining a concentration of the contrast medium in the at least one fluid path section based on the electrical signal generated by the at least one sensor, and increasing a rate of saline injected during the injection procedure to dilute the concentration of the contrast medium delivered to the patient.

[0045] In some embodiments, the method further includes determining a concentration of the contrast medium in the at least one fluid path section based on the electrical signal generated by the at least one sensor, and reducing an injection rate of saline during the injection procedure to increase a concentration of the contrast medium delivered to the patient.

[0046] In some embodiments, the emitter is positioned to emit light perpendicular to a fluid flow direction through the at least one fluid path section.

[0047] In some embodiments, the method further includes determining, based on the electrical signal, that at least one fluid path section exists between the emitter and the detector.

[0048] In some embodiments, the emitter is configured to emit light in the ultraviolet spectrum. The emitted light may have a wavelength of about 300 nm to about 400 nm.

[0049] In some embodiments, the emitter is configured to emit light in the infrared spectrum. The emitted light can have a wavelength of about 700 nm to about 2000 nm.

[0050] In some embodiments, the emitter is configured to emit light in the visible spectrum. The emitted light may have a wavelength of about 400 nm to about 700 nm.

[0051] In some embodiments, the method further includes driving the emitter with a first emitter current, the first emitter current configured to saturate the detector when the first fluid is present in the fluid path section.

[0052] In some embodiments, the method further includes driving the emitter with a second emitter current greater than the first emitter current, the second emitter current configured to saturate the detector when a second fluid is present in the fluid path section.

[0053] Further aspects or examples of the present disclosure are described in the following numbered clauses:

[0054] Clause 1. A fluid injector system comprising: at least one injector for pressurizing and delivering at least one fluid from at least one fluid reservoir; at least one fluid path section providing fluid communication between a bulk fluid reservoir and a syringe connected to the at least one injector; at least one sensor disposed along the at least one fluid path section, the at least one sensor comprising an emitter configured to emit light through the at least one fluid path section and a detector configured to receive the light emitted through the at least one fluid path section and generate an electrical signal based on at least one characteristic of the received light; and at least one processor programmed or configured to determine at least one of an identity of at least one fluid present in the fluid path section, a concentration of the at least one fluid in the fluid path section, and at least one characteristic of the fluid path section based on the electrical signal generated by the detector.

[0055] Clause 2. A fluid injector system as described in clause 1, wherein the emitter is disposed on a first side of the fluid path section and the detector is disposed on a second side of the fluid path section, the second side of the fluid path section being approximately 180° opposite the first side of the fluid path section.

[0056] Clause 3. The fluid injector system of clause 1 or 2, further comprising a first fluid reservoir and a second fluid reservoir for delivering a first fluid and a second fluid, respectively, a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor, wherein the first fluid path section is associated with the first sensor and the second fluid path section is associated with the second sensor.

[0057] Clause 4. A fluid injector system as described in any one of clauses 1 to 3, further comprising a first bulk fluid container in fluid communication with the first fluid reservoir and a second bulk fluid container in fluid communication with the second fluid reservoir, wherein a first sensor is positioned to detect fluid entering the first fluid reservoir from the first bulk fluid container during a filling operation of the first fluid reservoir, and a second sensor is positioned to detect fluid entering the second fluid reservoir from the second bulk fluid container during a filling operation of the second fluid reservoir.

[0058] Clause 5. A fluid infuser system as described in any one of clauses 1 to 4, wherein at least one processor is programmed or configured to determine, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and that the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.

[0059] Clause 6. The fluid injector system of any one of clauses 1 to 5, wherein at least one processor is programmed or configured to perform an action selected from: stopping the filling operation in response to a determination that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and adjusting the injection protocol to ensure that injection parameters are updated to switch the identities of the first and second fluid reservoirs so that the first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.

[0060] Clause 7. A fluid injector system as described in any one of clauses 1 to 6, wherein at least one processor is programmed or configured to modify an injection protocol by configuring a first fluid reservoir to inject a fluid that was originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject a fluid that was originally intended to be injected by the first fluid reservoir.

[0061] Clause 8. A fluid injector system as described in any one of clauses 1 to 7, wherein at least one processor is programmed or configured to adjust the display of a graphical user interface or illuminate a light source associated with the fluid reservoir to indicate that the first fluid reservoir contains a fluid that was originally intended to be injected by the second fluid reservoir, and that the second fluid reservoir contains a fluid that was originally intended to be injected by the first fluid reservoir.

[0062] Clause 9. A fluid injector system as described in any one of clauses 1 to 8, further comprising a manifold having at least one fluid path section, an inlet port connected to a syringe tip of at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.

[0063] Clause 10. A fluid infuser system as described in any one of clauses 1 to 9, wherein at least one processor is programmed or configured to determine an optimal filling rate of at least one fluid reservoir based on at least one identification information of the fluid and a concentration of the fluid in at least one fluid pathway section.

[0064] Clause 11. A fluid infuser system as described in any one of clauses 1 to 10, wherein the optimal fill rate comprises a maximum rate at which to fill the at least one fluid reservoir that minimizes the introduction of air bubbles into the fluid as it enters the at least one fluid reservoir.

[0065] Clause 12. A fluid injector system as described in any one of clauses 1 to 11, wherein the detector is configured to output a first voltage signal when at least one fluid path section contains a contrast medium, and the detector is configured to output a second voltage signal when the fluid path section contains saline, and the at least one processor is programmed or configured to determine an identity of the injection fluid in the at least one fluid path section based on a difference between the first voltage signal and the second voltage signal.

[0066] Clause 13. A fluid injector system as described in any one of clauses 1 to 12, wherein the detector is configured to output a third voltage signal when at least one fluid path section contains air, and the at least one processor is programmed or configured to determine that air is present in the at least one fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.

[0067] Clause 14. A fluid injector system as described in any one of clauses 1 to 13, wherein the detector is configured to provide an alert to a user that the bulk fluid reservoir is empty when the detector determines that the fluid path section contains air.

[0068] Clause 15. A fluid injector system as described in any one of clauses 1 to 14, wherein at least one processor is programmed or configured to determine a concentration of contrast medium in at least one fluid pathway section based on an electrical signal generated by at least one sensor, and to increase a rate of saline injected during the injection procedure to dilute the concentration of the contrast medium delivered to the patient.

[0069] Clause 16. A fluid injector system as described in any one of clauses 1 to 15, wherein at least one processor is programmed or configured to determine a concentration of contrast medium in the fluid pathway section based on an electrical signal generated by the at least one sensor, and to reduce an injection rate of saline during the injection procedure to increase the concentration of contrast medium delivered to the patient.

[0070] Clause 17. A fluid injector system as described in any one of clauses 1 to 16, wherein the emitter is positioned to emit light perpendicular to a fluid flow direction through at least one fluid path section.

[0071] Clause 18. A fluid injector system as described in any one of clauses 1 to 17, wherein at least one processor is programmed or configured to determine, based on the electrical signal, that at least one fluid path section exists between the emitter and the detector.

[0072] Clause 19. A fluid injector system according to any one of clauses 1 to 18, wherein the emitter is configured to emit light in the ultraviolet spectrum.

[0073] Clause 20. A fluid injector system according to any one of clauses 1 to 19, wherein the emitted light has a wavelength of about 300 nm to about 400 nm.

[0074] Clause 21. A fluid injector system according to any one of clauses 1 to 20, wherein the emitter is configured to emit light in the infrared spectrum.

[0075] Clause 22. A fluid injector system according to any one of clauses 1 to 21, wherein the emitted light has a wavelength of from about 700 nm to about 2000 nm.

[0076] Clause 23. A fluid injector system according to any one of clauses 1 to 22, wherein the emitter is configured to emit light in the visible spectrum.

[0077] Clause 24. A fluid injector system according to any one of clauses 1 to 23, wherein the emitted light has a wavelength of about 400 nm to about 700 nm.

[0078] Clause 25. A fluid injector system as described in any one of clauses 1 to 24, wherein at least one processor is programmed or configured to drive the emitter with a first emitter current, the first emitter current configured to saturate the detector when a first fluid is present within the fluid path section.

[0079] Clause 26. A fluid injector system as described in any one of clauses 1 to 25, wherein at least one processor is programmed or configured to drive the emitter with a second emitter current greater than the first emitter current, the second emitter current configured to saturate the detector when a second fluid is present within the fluid path section.

[0080] Clause 27. A method for determining one or more fluid characteristics of a fluid flowing within at least one fluid path section of a fluid injector system, the method comprising the steps of: emitting light from an emitter of at least one sensor through the at least one fluid path section; detecting the light that has passed through the at least one fluid path section with a detector of a first proximal sensor; and determining at least one of an identity of an infusion fluid present in a fluid path set, a concentration of the infusion fluid in the fluid path set, and at least one characteristic of the fluid path section based on an electrical signal generated by the detector.

[0081] Clause 28. The method of clause 27, wherein the emitter is disposed on a first side of the fluid path section and the detector is disposed on a second side of the fluid path section, the second side of the fluid path section being approximately 180° opposite the first side of the fluid path section.

[0082] Clause 29. The method of clause 27 or 28, wherein the fluid injector system comprises a first fluid reservoir and a second fluid reservoir for delivering a first fluid and a second fluid, respectively, a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor, wherein the first fluid path section is associated with the first sensor and the second fluid path section is associated with the second sensor.

[0083] Clause 30. The method of any one of clauses 27 to 29, wherein the fluid injector system further comprises a first bulk fluid container in fluid communication with the first fluid reservoir and a second bulk fluid container in fluid communication with the second fluid reservoir, the first sensor being positioned to detect fluid entering the first fluid reservoir during a filling operation of the first fluid reservoir, and the second sensor being positioned to detect fluid entering the second fluid reservoir during a filling operation of the second fluid reservoir.

[0084] Clause 31. The method of any one of clauses 27 to 30, further comprising determining, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and that the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.

[0085] Clause 32. The method of any one of clauses 27 to 31, further comprising stopping the filling operation in response to determining that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir.

[0086] Clause 33. The method of any one of clauses 27 to 32, further comprising the step of adjusting the injection protocol to ensure that injection parameters are updated to switch the identities of the first and second fluid reservoirs so that the first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.

[0087] Clause 34. The method of any one of clauses 27 to 33, further comprising the step of modifying the injection protocol by configuring the first fluid reservoir to inject a fluid that was originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject a fluid that was originally intended to be injected by the first fluid reservoir.

[0088] Clause 35. The method of any one of clauses 27 to 34, further comprising adjusting the display of a graphical user interface or illuminating a light source associated with the fluid reservoir to indicate that the first fluid reservoir contains a fluid that was originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains a fluid that was originally intended to be injected by the first fluid reservoir.

[0089] Clause 36. The method of any one of clauses 27 to 35, wherein the fluid injector system further comprises a manifold, the manifold comprising at least one fluid path section, an inlet port connected to a syringe tip of at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.

[0090] Clause 37. The method of any one of clauses 27 to 36, further comprising determining an optimal fill rate for at least one fluid reservoir based on at least one identity of the fluid and a concentration of the fluid in at least one fluid pathway section.

[0091] Clause 38. The method of any one of clauses 27 to 37, wherein the optimal filling rate comprises a maximum rate at which to fill the at least one fluid reservoir that minimizes the introduction of air bubbles into the fluid as it enters the at least one fluid reservoir.

[0092] Clause 39. A method according to any one of clauses 27 to 38, wherein the detector is configured to output a first voltage signal when at least one fluid path section contains a contrast medium and the detector is configured to output a second voltage signal when the fluid path section contains saline, the method further comprising determining an identity of an injection fluid in the at least one fluid path section based on a difference between the first voltage signal and the second voltage signal.

[0093] Clause 40. A method according to any one of clauses 27 to 39, wherein the detector is configured to output a third voltage signal when at least one fluid path section contains air, and the method further comprises determining that there is air in the fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.

[0094] Clause 41. The method of any one of clauses 27 to 40, further comprising the step of providing an alert to a user that the bulk fluid reservoir is empty when the detector determines that the fluid path section contains air.

[0095] Clause 42. The method of any one of clauses 27 to 41, further comprising the steps of determining a concentration of contrast medium in at least one fluid path section based on an electrical signal generated by at least one sensor, and increasing a rate of saline injected during the injection procedure to dilute the concentration of the contrast medium delivered to the patient.

[0096] Clause 43. The method of any one of clauses 27 to 42, further comprising the steps of determining a concentration of the contrast medium in at least one fluid path section based on an electrical signal generated by the at least one sensor, and reducing the injection rate of saline during the injection procedure to increase the concentration of the contrast medium delivered to the patient.

[0097] Clause 44. A method according to any one of clauses 27 to 43, wherein the emitter is arranged to emit light perpendicular to a fluid flow direction through at least one fluid path section.

[0098] Clause 45. The method of any one of clauses 27 to 44, further comprising determining based on the electrical signal that at least one fluid path section exists between the emitter and the detector.

[0099] Clause 46. The method of any one of clauses 27 to 45, wherein the emitter is configured to emit light in the ultraviolet spectrum.

[0100] Clause 47. The method of any one of clauses 27 to 46, wherein the emitted light has a wavelength of about 300 nm to about 400 nm.

[0101] Clause 48. The method of any one of clauses 27 to 47, wherein the emitter is configured to emit light in the infrared spectrum.

[0102] Clause 49. The method of any one of clauses 27 to 48, wherein the emitted light has a wavelength of about 700 nm to about 2000 nm.

[0103] Clause 50. The method of any one of clauses 27 to 49, wherein the emitter is configured to emit light in the visible spectrum.

[0104] Clause 51. The method of any one of clauses 27 to 50, wherein the emitted light has a wavelength of about 400 nm to about 700 nm.

[0105] Clause 52. The method of any one of clauses 27 to 51, further comprising driving the emitter with a first emitter current, the first emitter current configured to saturate the detector when the first fluid is present in the fluid path section.

[0106] Clause 53. The method of any one of clauses 27 to 52, further comprising driving the emitter with a second emitter current greater than the first emitter current, the second emitter current configured to saturate the detector when a second fluid is present in the fluid path section.

[0107] Further details and advantages of the various examples described in detail herein will become apparent upon consideration of the following detailed description of the various examples in conjunction with the accompanying drawings. [Brief description of the drawings]

[0108] [Figure 1] FIG. 1 is a perspective view of a fluid injector system according to one embodiment of the present disclosure. [Diagram 2] 1 is a schematic diagram of a fluid injector system according to one embodiment of the present disclosure. [Diagram 3] FIG. 2 is a front cross-sectional view of a sensor module according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional front view of the sensor module of FIG. 3 associated with a liquid-filled fluid path section. [Diagram 5] FIG. 4 is a front cross-sectional view of the sensor module of FIG. [Figure 6] FIG. 2 is a front view of a manifold and manifold housing module according to one embodiment of the present disclosure. [Figure 7] FIG. 13 is a side cross-sectional view of a syringe tip, fluid path section, and sensor module according to one embodiment of the present disclosure. [Figure 8A] 11 is a histogram of sensor output voltage for various fluids in a fluid path section using infrared light according to one embodiment of the present disclosure. [Figure 8B]8B is a plot of the standard deviation of the sensor output voltage from FIG. 8A for various types of contrast media in a fluid path section using infrared light. [Figure 9] 11 is a graph of average sensor output voltage for various concentrations of contrast medium in a fluid pathway section using infrared light according to one embodiment of the present disclosure. [Figure 10] 11 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using ultraviolet light according to an embodiment of the present disclosure. [Figure 11] 11 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using ultraviolet light according to an embodiment of the present disclosure. [Figure 12] 1 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure. [Figure 13] 1 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure. [Figure 14] 1 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure. [Figure 15] 1 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure. [Figure 16] FIG. 13 is a front cross-sectional view of an eccentric fluid path section. [Figure 17] FIG. 13 is a side cross-sectional view of a fluid path section having a draft. [Figure 18] FIG. 13 is a side cross-sectional view of a fluid path section having a surface finish. [Figure 19] FIG. 13 is a front cross-sectional view of a non-circular fluid path section. [Figure 20] FIG. 13 is a front cross-sectional view of a fluid path section having burrs. [Figure 21A] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21B]1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21C] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21D] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21E] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21F] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 21G] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Fig. 21H] 1 is a graph illustrating detector output voltage as a function of emitter current according to one embodiment of the disclosure. [Figure 22] 11 is a graph of sensor output voltage versus time for various conditions and configurations of syringe caps. [Figure 23] FIG. 2 is a circuit diagram of a sensor according to one embodiment of the disclosure. [Figure 24] FIG. 2 is a perspective view of a syringe tip, manifold, and sensor module according to one embodiment of the disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0109] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Spatial or directional terms, such as "left," "right," "inside," "outside," "up," "down," and the like, refer to the invention as depicted in the drawings and should not be considered limiting as the invention may assume various alternative orientations.

[0110] All numbers used in the specification and claims should be understood as modified in all instances by the term "about." The term "about" means to include plus or minus 25 percent of the stated value, such as plus or minus 10 percent of the stated value. However, this should not be construed as limiting any analysis of values ​​under the doctrine of equivalents. Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values ​​and any and all subranges or subratios subsumed therein. For example, a range or ratio described as "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10, i.e., all subranges or subratios starting from a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent average values ​​over the specified ranges and / or ratios. Terms such as "first," "second," and the like are not intended to refer to a particular order or chronology, but to different conditions, properties, or elements.

[0111] All documents mentioned herein are "incorporated by reference" in their entirety.

[0112] The term "at least" is synonymous with "more than or equal to." The term "not more than" is synonymous with "less than or equal to." As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes A only, B only, C only, or A and B, A and C, or B and C, or all of A, B, and C. The term "includes" is synonymous with "comprises."

[0113] When used in relation to a syringe, the term "proximal" refers to the portion of the syringe closest to the piston element for engaging the end wall of the syringe and delivering fluid from the syringe. When used in relation to a fluid pathway, the term "proximal" refers to the portion of the fluid pathway closest to the injector system when the fluid pathway is connected to the injector system. When used in relation to a syringe, the term "distal" refers to the portion of the syringe closest to the delivery nozzle. When used in relation to a fluid pathway, the term "distal" refers to the portion of the fluid pathway closest to the patient when the fluid pathway is connected to the injector system. The term "radial" refers to the direction in a cross section perpendicular to the longitudinal axis of the syringe, extending between the proximal and distal ends. The term "circumferential" refers to the direction around the inner or outer surface of the sidewall of the syringe. The term "axial" refers to the direction along the longitudinal axis of the syringe, extending between the proximal and distal ends.

[0114] It should be understood that the present disclosure may contemplate alternative variations and step sequences unless expressly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present disclosure. Hence, specific dimensions and other physical characteristics relating to the examples disclosed herein are not to be considered as limiting.

[0115] Referring to the drawings, in which like reference numbers refer to like parts throughout the several views of the drawings, the present disclosure provides systems, components, devices, and methods for detecting and analyzing fluid contents of a fluid path section during a fluid filling operation. Referring initially to FIGS. 1 and 2, an embodiment of a dual syringe fluid injector system 2000 is shown. The fluid injector system 2000 is configured to inject two medical fluids from respective fluid reservoirs 10A, 10B, shown as syringes in the accompanying drawings. In some embodiments, the first fluid reservoir 10A contains an imaging contrast medium for angiography (CV), MRI, PET, or computed tomography (CT) injection procedures, and the second fluid reservoir 10B contains a flushing fluid, such as saline or lactated Ringer's. As will be appreciated by those skilled in the art, the contrast fluid is typically an aqueous solution of a contrast compound at a defined concentration. A variety of contrast compounds at different concentrations are known in the art. Fluid is injected from the fluid reservoirs 10A, 10B through a series of fluid path elements connecting the fluid reservoirs 10A, 10B to a catheter 110 inserted into the patient's vascular system. The fluid injector system 2000 may further include bulk fluid containers 19A and 19B for filling and refilling each syringe 10A, 10B with imaging contrast medium and flushing fluid, respectively. The system 2000 includes a fluid path set including a first syringe line 208A in fluid communication with the tip or nozzle 16A of the first syringe 10A, a first fill line 216A in fluid communication with the first bulk fluid container 19A, and a first patient line 210A in fluid communication with the catheter 110. In some embodiments, the first syringe line 208A, the first fill line 216A, and / or the first patient line 210A are fluidly connected with a manifold or a T-joint (see, e.g., FIGS. 6 and 24). The fluid pathway set further includes a syringe line 208B in fluid communication with the tip or nozzle 16B of the second syringe 10B, a fill line 216B in fluid communication with the second bulk fluid container 19B, and a patient line 210B in fluid communication with the catheter 110.In some embodiments, the syringe line 208B, the fill line 216B, and / or the patient line 210B are fluidly connected with a manifold or T-joint (see, e.g., FIGS. 6 and 24). The arrangement of the fluid path set allows fluid to be drawn from the first bulk fluid container 19A into the first syringe 10A via the first fill line 216A and the first syringe line 208A. Fluid can be infused into the patient from the first syringe 10A via the first syringe line 208A, the patient line 210A, and the catheter 110. Similarly, fluid may be drawn from the second bulk fluid container 19B into the second syringe 10B via the second fill line 216B and the second syringe line 208B. Fluid can be injected from the second syringe 10B through the second syringe line 208B, the second patient line 210B, and the catheter 110 into the patient. The syringe lines 208A, 208B, the fill lines 216A, 216B, and the outlet lines 210A, 210B may be made of flexible tubing, although various portions thereof, such as the luer connector, the sensor area, and the mixing chamber, may be rigid. Although the fluid injector 12 shown in Figures 1 and 2 is shown with a first contrast syringe and a second flushing fluid syringe, in certain injection procedures, only the contrast agent may be used without an associated flushing fluid. According to these embodiments, the fluid injector 12 may only engage with the first syringe 10A and the associated first bulk fluid container 19A, as well as the fluid path components for injecting the contrast agent into the patient. The flushing side of the fluid injector 12 may remain empty during such single fluid injection procedures. Alternatively, a fluid injector (not shown) configured to engage with only a single syringe may utilize various embodiments of the sensor modules and methods described herein.

[0116] Further details and examples of suitable non-limiting powered injector systems, including syringes, tubing and fluid path components, shut-off valves, pinch valves, controllers, and air detectors, can be found in U.S. Pat. Nos. 5,383,858, 7,553,294, 7,666,169, 8,945,051, 10,022,493, and 10,507,319, as well as International Application Nos. PCT / US2013 / 061275, PCT / US2013 / 061276, and PCT / US2013 / 061277. No. 018 / 034613, International Application No. PCT / US2020 / 049885, International Application No. PCT / US2021 / 035273, International Application No. PCT / US2021 / 029963, International Application No. PCT / US2021 / 018523, International Application No. PCT / US2021 / 037623, International Application No. PCT / US2021 / 037574, and International Application No. PCT / US2021 / 045298, the disclosures of which are incorporated herein by reference in their entireties.

[0117] 1 and 2, the injector system 2000 includes a first piston 13A and a second piston 13B associated with each of the syringes 10A, 10B, respectively. Each of the pistons 13A, 13B is configured to drive a respective plunger 14A, 14B in the barrel of the respective syringe 10A, 10B. The fluid injector system 2000 includes a controller 900 in electronic communication with various components of the system 2000 to perform an injection procedure. In particular, the controller 900 can include at least one processor programmed or configured to operate the pistons 13A, 13B and various other components of the injector system 2000 to deliver medical fluids according to a programmed protocol for the injection procedure, including, for example, monitoring at least one fluid characteristic of one or more fluids being drawn into the syringes 10A, 10B, and determining at least one of a fluid identification and a fluid concentration. The controller 900 can then adjust at least one parameter of the injection protocol based on at least one of the fluid identification information and the fluid concentration, such as switching the syringe identification information of the injection protocol so that the correct fluid is identified with the correct syringe 10 and the correct injection parameters are utilized, changing the display so that the syringe image on the display represents the correct fluid in the syringe, displaying the correct light color associated with the correct fluid type (e.g., blue for saline, green for contrast, red for air) and indicating the concentration of the contrast agent on the display, adjusting the injection protocol to inject the correct ratio of contrast agent and saline when an incorrect contrast agent concentration was loaded into the contrast agent syringe, switching the color of one or more light emitting elements (such as LED lights) associated with the syringe to provide an alert to the user that one or more errors have occurred during the fluid fill operation, such as the incorrect fluid has been filled into the syringe, the bulk fluid container is empty because only air has been drawn into the syringe, changing the incorrect contrast agent concentration injection protocol, etc.The controller 900 may include a computer readable medium, such as a memory, in which one or more injection protocols may be stored for execution by at least one processor. The controller 900 is configured to actuate the pistons 13A, 13B to reciprocate the plungers 14A, 14B within the syringes 10A, 10B, thereby performing and stopping the injection procedure. The fluid injector system 2000 may further include at least one graphical user interface (GUI) 11 through which an operator may interact with the controller 900 to view and control the status of the injection procedure. Similarly, if the fluid injector system 2000 includes one or more pumps, such as a peristaltic pump, the associated controller 900 may operate various components of the fluid injector, such as an air sensor module described herein, to ensure that the correct fluid type is flowing through the correct fluid path elements based on the associated bulk fluid container, and if the fluid type is not correct, the controller 900 may make necessary adjustments and notifications to the injection protocol based on the actual fluid identified in the particular fluid pump.

[0118] The controller 900 may be programmed or configured to execute a fill operation in which the piston 13A, 13B associated with each syringe 10A, 10B is retracted toward the proximal end of the syringe 10A, 10B to draw an injection fluid F (e.g., imaging contrast medium or flushing fluid) from the bulk fluid container 19A, 19B into the syringe 10A, 10B, respectively. During such a fill operation, the controller 900 may be programmed or configured to selectively actuate various valves, stopcocks, or clamps (such as pinch clamps) to establish fluid communication between the respective syringes 10A, 10B and the bulk fluid containers 19A, 19B via the fill lines 216A, 216B to control the filling of the syringes 10A, 10B with the appropriate injection fluid F. As described herein, during a fill operation, the fluid flowing through the fill lines 216A, 216B is monitored by the fluid sensors described herein to identify one or more characteristics of the fluid in the fill lines 216A or 216B, and, if necessary, the controller 900 can make necessary adjustments to the system, injection protocol, etc., or alert the user, based on one or more characteristics of the fluid in the fill lines 216A or 216B.

[0119] After the fill and priming operations (wherein excess air is removed from the syringes and various fluid path elements by flowing fluid from the syringes through the fluid path elements), the controller 900 may be programmed or configured to execute a fluid delivery operation during which pistons 13A, 13B associated with one or both of the syringes 10A, 10B move toward the distal ends of the syringes to inject an injection fluid F into the first patient line 210A and the second patient line 210B, respectively, at a specified flow rate and time to deliver a desired amount of fluid F. The controller 900 may be programmed or configured to selectively actuate various valves, stopcocks, and / or pinch clamps to establish fluid communication between the syringes 10A, 10B and the patient via the patient lines 210A, 210B. The patient lines 210A, 210B finally merge before connecting to the catheter 110 in a turbulent mixing chamber, such as that described in International Application No. US2021 / 019507, the disclosure of which is incorporated herein in its entirety.

[0120] According to various embodiments, the system 2000 includes one or more sensors and / or sensor modules configured to detect air and / or fluid in a fluid path element, such as the fill line 216A, 216B, associated with each syringe 10A, 10B. As shown in Figures 1 and 2, a first sensor module 300A is disposed in operative communication with the first syringe tip 16A, and a second sensor module 300B is disposed in operative communication with the second syringe tip 16B. Alternatively or additionally, the first and second sensor modules 300A, 300B may be associated with the fill lines 216A, 216B. The sensor modules 300A, 300B are in electronic communication with the controller 900 such that the controller 900 can determine at least one characteristic of the fluid contents of the fluid path section 570 (associated with the fluid lines 208A, 208B, 216A, and / or 216B) based on the signals transmitted by the sensor modules 300A, 300B. For example, based on the signals transmitted by the sensor modules 300A, 300B, the controller 900 may be configured to determine the identity of the fluid in the fluid path section 570, the concentration of the medical fluid in the fluid path section 570, the presence of air in the fluid path section 570, the priming state of the fluid path section 570, the characteristics of the fluid path section (e.g., absorption, refractive index, tubing size, and / or manufacturing defects), and any combination thereof. Figures 1 and 2 show the sensor modules 300A, 300B associated with the syringe tips 16A, 16B. However, in alternative embodiments, the sensor modules 300A, 300B may be associated with essentially any component of the fluid pathway set, including the syringe lines 208A, 208B, the fill lines 216A, 216B, or the patient lines 210A, 210B. In some embodiments, the system 2000 may further include a third sensor module 300C downstream of the junction of the patient lines 210A, 210B, functionally similar to the first and second sensor modules 300A, 300B.

[0121] 3-5, in some embodiments, each sensor module 300A, 300B, 300C may include one or more sensors 310 each including an emitter 312 and a collector or detector 314, as shown in FIG. 3. The emitter 312 and the detector 314 are spaced apart from one another to define a gap G within which an operatively associated fluid path section 570 is positioned. The emitter 312 is configured to emit electromagnetic radiation ER (e.g., light) at a predetermined wavelength toward the detector 314. The electromagnetic radiation ER must pass through the fluid path section 570 to reach the detector 314. The fluid within the fluid path section 570, and in some embodiments, the structure of the fluid path section 570 itself, absorbs and / or refracts some amount of the electromagnetic radiation ER generated by the emitter 312, thus preventing that amount of electromagnetic radiation ER from reaching the detector 314. In addition, the contents of the fluid path section 570, and in some embodiments, the structure of the fluid path section 570 itself, diverge or converge the electromagnetic radiation ER before it reaches the detector 314 due to the refractive index of the fluid and the fluid path section 570. The measured absorption and / or refraction difference can be used to distinguish between an empty sensor 310 in which the fluid path section 570 is operably inserted into the field of the sensor 310, as compared to one in which the fluid path section 570 contains only air. In certain embodiments, the signal from the sensor 310 can further indicate whether the fluid path section 570 is properly inserted into the sensor 310. Once the fluid path section 570 is properly installed in the sensor module 300A, 300B, 300C, the sensor module 300A, 300B, 300C can then use the measured refraction difference to determine whether the fluid path section 570 contains a liquid fluid (contrast agent or aqueous flushing fluid) or air.

[0122] In some embodiments, the emitter 312 may be one or more light emitting diodes (LEDs) or liquid crystals configured to emit electromagnetic radiation ER at a predetermined wavelength (or range of wavelengths), although other emitter sources are within the scope of the present disclosure. In certain embodiments, the emitter 312 may be capable of emitting electromagnetic radiation ER at two or more wavelengths depending on the fluid being measured. For example, the emitter 312 may be configured to emit light at a first wavelength and emit light at a second or another wavelength depending on the requirements of the fluid infusion procedure. The detector 314 may be any detector capable of converting the amount of light received into an electrical signal, such as a phototransistor, photoresistor, or photodiode. In various embodiments, the detector 314 may be configured to measure the amount of electromagnetic radiation ER received at different specific wavelengths depending on the wavelength emitted by the emitter 312. The controller 900 may be configured to control the wavelength of light emitted by the emitter 312 and detected by the detector 314. In some embodiments, the emitter 312 is configured to emit electromagnetic radiation in the infrared (IR) spectrum, for example, between about 700 nanometers (nm) and about 2000 nm. In some embodiments, the emitter 312 is configured to emit electromagnetic radiation in the ultraviolet (UV) spectrum, for example, between about 10 nm and about 400 nm. In specific embodiments, the electromagnetic radiation emitted by the emitter 312 can have a wavelength of about 700 nm to about 2000 nm, in some embodiments, about 1440 nm to about 1460 nm, and in certain embodiments, about 1450 nm. In another embodiment, the electromagnetic radiation emitted by the emitter 312 can have a wavelength in the IR spectrum of about 750 nm to about 950 nm, or in other embodiments, about 800 nm to about 900 nm, in some embodiments, about 880 nm to about 900 nm, and in certain embodiments, about 890 nm.In another embodiment, the electromagnetic radiation emitted by the emitter 312 can have a wavelength in the UV spectrum of about 300 nm to about 400 nm, or in another embodiment, about 350 nm to about 400 nm, in some embodiments, about 390 nm to about 400 nm, and in certain embodiments, about 395 nm. In some embodiments, the emitter 312 can be configured to emit acoustic energy, such as ultrasonic energy, and the detector 314 can be configured to detect the acoustic energy. Electromagnetic radiation at the aforementioned wavelengths (e.g., IR or UV wavelengths) can have advantages over other imaging protocols, such as ultrasound, in that the electromagnetic radiation does not require acoustic coupling (e.g., compressive contact) between the fluid path section 570 and the sensor 310.

[0123] The particular wavelength of electromagnetic radiation may be selected based on the fluid F used in the injection procedure and the structural characteristics of the fluid path section 570. In particular, the wavelength(s) of electromagnetic radiation may be selected that provides the greatest difference in the output signal of the detector 314 for the various fluids of interest. For example, the emitter 312 may be selected and / or configured to emit electromagnetic radiation at a wavelength that exhibits the greatest difference in transmission of saline and contrast medium. In some embodiments, the emitter 312 may be configured to emit electromagnetic radiation at multiple wavelengths (simultaneously or in alternating pulses) to improve the sensitivity of the sensor 310. For example, the emitter 312 may be configured to emit electromagnetic radiation at a first wavelength optimized to distinguish between saline and contrast medium and at a second wavelength optimized to distinguish between concentrations of contrast medium.

[0124] In some embodiments, the wavelength(s) of electromagnetic radiation can be selected to minimize adverse effects of factors on sensor performance, such as alignment of the electromagnetic radiation emitter 312 and detector 314, alignment of the fluid path section 570 relative to the emitter 312 and detector 314; material and shape of the outer wall of the fluid path section 570; exposure of the detector 314 to ambient light. The span of the gap G between the emitter 312 and detector 314 may also be selected to maximize the difference in the detector 314 output signal for various fluids. For example, empirical testing on standard tubing having a nominal outer diameter of 0.188 inches found that a gap G of 0.228 inches was preferred over gaps G of 0.188 inches and 0.208 inches for the ability of the detector 314 to distinguish between air, contrast, and saline within the tubing (see FIGS. 8A and 8B).

[0125] FIG. 3 illustrates the absence of a fluid path section in the gap G, so that the electromagnetic radiation ER must pass only through the air in the gap G to reach the detector 314. FIG. 4 illustrates a fluid path section 570 disposed in the gap G in operative association with the sensor 310. The fluid path section 570 in FIG. 4 is filled with an injection fluid F, as would be expected during a fill operation of an injection procedure in which fluid moves from the bulk fluid containers 19A, 19B to the syringes 10A, 10B. The refractive index of the injection fluid F can focus the electromagnetic radiation ER passing through the fluid path section 570 before reaching the detector 314, thereby causing an increase in the signal strength received and measured by the detector 314. In addition, the injection fluid F (e.g., solute molecules dissolved in an aqueous solution, typical of an aqueous solution, saline flushing fluid, or imaging contrast agent) absorbs a portion of the electromagnetic radiation ER generated by the emitter 312, preventing a portion of the electromagnetic radiation ER from reaching the detector 314. 5 shows fluid path section 570 disposed within gap G in operative association with sensor 310, fluid path section 570 filled with air, as would be expected prior to priming fluid path section 570 or initiating a filling operation of syringes 10A, 10B, or as may occur during an injection procedure if air bubbles are present in injection fluid F. The refractive index of air focuses electromagnetic radiation ER passing through fluid path section 570 before it reaches detector 314, thereby causing a decrease in the signal strength received and measured by detector 314.

[0126] Additionally, the absorption associated with an air-filled fluid path section 570 absorbs less light than a liquid-filled fluid path section 570 (FIG. 4), but absorbs more light than the situation where the fluid path section 570 is not in the gap G due to the absorption of light by the polymeric material of the fluid path section sidewalls (FIG. 3). In certain embodiments, light absorption by the contents between the emitter 312 and the detector 314 can cause a difference in the signal strength measured by the detector 314. For example, in FIG. 3, where there is no fluid path section 570, air has only minimal absorption of light from the emitter 312 (which can be factored into any calculations), so light can pass freely from the emitter 312 to the detector 314 of the sensor 310 with only a minimal reduction in signal strength. When a fluid-filled fluid path section 570 is inserted into the sensor 310, the light signal passing from the emitter 312 to the detector 314 is attenuated by absorption by the fluid in the fluid path section 570 as well as the molecular composition of its sidewalls. With fluid path section 570 filled with air, the light signal passing from emitter 312 to detector 314 is attenuated by absorption due to the molecular composition of the sidewalls of fluid path section 570 (there is no absorption due to unprimed air in the fluid path or large air bubbles). According to various embodiments, detector 312 can use differences in light attenuation resulting from different fluids in the fluid path to distinguish between different contrast agent types or concentrations, or between contrast agent and saline, within fluid path section 570.

[0127] The detector 314 is configured to transmit an output signal (e.g., an output voltage) to the controller 900 based on the signal strength of the detected electromagnetic radiation ER. The output signal thus varies depending on the refractive index and absorption characteristics of the contents of the gap G, allowing the controller 900 to determine whether the fluid path section 570 is not present (FIG. 3), whether the fluid path section 570 is present and filled with an injection fluid F (FIG. 4), or whether the fluid path section 570 is present and at least partially filled with air (FIG. 5). In various embodiments, the controller 900 can determine the type of fluid (e.g., from a known database of commercially available contrast medium solutions) and / or the dilution ratio of the fluid (i.e., the ratio of contrast medium to saline during a dual flow injection) based on the output signal of the detector 314. Specifically, the sensor module 300C (FIG. 2) downstream of the confluence of the patient lines 210A, 210B may be configured to measure the dilution of the contrast medium from the first syringe 10A by the saline from the second syringe 10B. To obtain reliable results, the emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the output signal generated by the detector 314 is sufficiently different between fluid types that the sensor 310 can distinguish between different contrast media types and / or different dilution ratios. For example, if the sensor 310 is intended to distinguish between contrast media and saline, the emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the range of output voltages of the detector 314 when saline is present in the fluid path section 570 does not overlap with the range of output voltages of the detector 314 when contrast media is present in the fluid path section 570. Similarly, if the sensor 310 is intended to distinguish between contrast media types, the emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the range of output voltages of the detector 314 when a particular contrast media type is present in the fluid path section 570 does not overlap with the range of output voltages of the detector 314 when a different contrast media type is present in the fluid path section 570.

[0128] FIG. 23 illustrates an electrical schematic of a sensor 310 according to one embodiment of the present disclosure. As referred to herein, the sensor 310 includes an emitter 312 and a detector 314 arranged such that the detector 314 receives electromagnetic radiation from the emitter 312 and the received electromagnetic radiation is altered by absorption and / or reflection of the fluid path section 570 and its contents. The emitter 312 and the detector 314 are powered by respective power supplies 320, 321. The power supplies 320, 321 may be 5 volts and may be standalone devices or outputs of the controller 900. The power supply 320 associated with the emitter 312 allows the controller 900 to calibrate the emitter 312 by adjusting the supply current. The power supply 321 provides the detector 314 with a fixed reference voltage related to the stability of the resultant output voltage of the sensor 310. The emitter 312 may include one or more LEDs emitting electromagnetic radiation of one or more specific wavelengths with a current limiting resistor 322 arranged in series to maintain a proper forward current through the LED(s). The detector 314 may be one or more phototransistors, photoresistors, or photodiodes having an associated sensor resistor 324. The sensor resistor 324 converts a current generated by the detector 314 in response to detecting electromagnetic radiation into an output voltage signal 326 for passing to the controller 900.

[0129] 6, in some embodiments, the sensor modules 300A, 300B are provided within a manifold housing module 220 associated with the fluid infuser 12. The manifold housing module 220 can define a receiving channel 222 for movably receiving a manifold 500 of the fluid pathway set. The manifold 500 can be a disposable component that serves as a junction for the first syringe line 208A, the first patient line 210A, and the first fill line 216A (FIG. 2). Specifically, the manifold 500 can include a first inlet port 510 connected to or integrally formed with the syringe line 208A, a first outlet port 512 connected to or integrally formed with the patient line 210A, and a first fill port 514 connected to or integrally formed with the fill line 216A. Similarly, the manifold 500 can function as a junction for the second syringe line 208B, the second patient line 210B, and the second fill line 216B (FIG. 2). The manifold 500 can include a second inlet port 520 connected to or integrally formed with the syringe line 208B, a second outlet port 522 connected to or integrally formed with the patient line 210B, and a second fill port 524 connected to or integrally formed with the fill line 216B. The manifold 500 defines a respective fluid path section 570 adjacent each of the fill ports 514, 524 configured to be operatively positioned between the emitter 312 and the detector 314 of the respective sensor module 300A, 300B.

[0130] The manifold 500 can include at least one connecting beam 550 that, along with the receiving channel 222, orients and positions the manifold 500 to precisely index and interface the fluid path section 570 with the sensor modules 300A, 300B. Thus, the manifold 500 is designed to allow a user to quickly and accurately install a tubing set within the manifold housing module 220 such that the air detection region of the fluid flow path is properly inserted into the reading portion of the sensor modules 300A, 300B. For example, in preparing the fluid injector system 2000 for a new injection procedure, the user need only connect the syringe lines 208A, 208B to the syringes 10A, 10B, snap the manifold 500 into the manifold housing module 220, connect the fill lines 216A, 216B to the bulk fluid sources 19A, 19B (e.g., by pushing the fill lines 216A, 216B into the respective bulk fluid sources 19A, 19B), and the fluid pathway set should be ready for priming. In certain cases, the manifold 500 and manifold housing module 220 may include complementary latch components, for example on at least one connecting beam 550, to releasably engage the manifold 500 with the manifold housing module 220. In certain embodiments, the manifold 500 and associated fluid pathway components may be disposable components configured for use during a single injection procedure or for a series of injection procedures for a single patient. In another embodiment, the manifold 500 and associated fluid path components may be disposable elements of a multi-use portion of a fluid path set, which can be used in conjunction with multiple single-use portions over several fluid injection procedures before being discarded, for example after a set number of injections or after 24 hours of use.

[0131] Each of the fluid path sections 570 includes a sidewall 530 configured to allow passage of electromagnetic radiation from the emitter 312 to the detector 314 when the fluid path sections 570 are disposed in operative association with the sensor modules 300A, 300B. Each of the sidewalls 530 is at least partially transparent to a predetermined wavelength of electromagnetic radiation ER generated by the emitter 312. The sidewalls 530 can be made of an at least partially transparent material, such as a polymer, glass, a transparent composite, quartz, or other suitable material. In certain embodiments, the sidewalls 530 may be constructed of a plastic material, such as polyethylene terephthalate (PET), polycarbonate (PC), or polypropylene (PP), having a predetermined refractive index. In some embodiments, the refractive index of the sidewalls 530 is closer to the refractive index of water than to the refractive index of air. In some embodiments, the sidewalls 530 may be rigid such that the sidewalls 530 cannot deflect, which could change the path of the electromagnetic radiation ER through the fluid path sections 570 and result in unreliable sensor readings. In certain embodiments, the sidewall 530 may be curved, extending circumferentially around the outer surface of the fluid path section 570. In another embodiment, the sidewall 530 may have one or more substantially flat outer and inner surfaces. The one or more substantially flat surfaces may be arranged such that the path of the electromagnetic radiation from the emitter 312 to the detector 314 passes through the one or more substantially flat surfaces. According to these embodiments, the one or more substantially flat surfaces may minimize or eliminate any converging or non-converging lens effects by the surface on the beam of electromagnetic radiation as it passes through the first fluid path section 570. In another embodiment, the sidewall 530 may include or function as a lens to focus or disperse the electromagnetic radiation passing through the fluid path section 570. For example, the sidewall 530 may have one or more flat surfaces that can transmit light more predictably than curved surfaces, and in some embodiments, the sidewall 530 may be a square tube. In some embodiments, the sidewall 530 may have a surface finish to focus or disperse the electromagnetic radiation passing through the fluid path section 570.

[0132] 6, the manifold 500 can include one or more check valves, such as check valves 516, 526 located in the fill ports 514, 524, respectively. The check valves 516, 526 can act to prevent backflow of fluid into the bulk fluid containers 19A, 19B during pressure injection. In some embodiments, additional check valves or actively controlled valves (e.g., stopcocks, pinch valves, etc.) may be located at any of the inlet ports 510, 520, outlet ports 512, 522, and fill ports 514, 524 to selectively control fluid flow through the manifold 500.

[0133] The manifold 500 may include one or more encoded identifiers 580, such as, for example, a bar code, a QR code, an RFID tag, etc., located on at least one connecting beam 550 or a fluid path wall. The fluid injector 12 may have an appropriately positioned reader 280, such as a bar code reader, a QR code reader, an RFID reader, etc., associated with the manifold housing module 220. When the manifold 500 is properly engaged with the manifold housing module 220, the encoded identifier 580 is read by the reader to determine one or more characteristics of the manifold 500 and associated fluid path elements, such as one of: that the manifold 500 is properly inserted, that it is the correct manifold 500 for the injection procedure, that the manufacturing date of the manifold 500 and associated fluid path components is within a required time frame, and to determine whether the manufacturer of the manifold 500 is an approved manufacturer. If the controller 900 determines that the encoded identifier indicates that there may be a problem with the manifold 500, the controller 900 can alert the user and request that the problem be corrected before a fluid injection procedure can be performed.

[0134] With continued reference to FIG. 6, the manifold housing module 220 may include additional sensor modules 300X, 300Y associated with the fluid path sections adjacent to the respective inlet ports 510, 520. The additional sensor modules 300X, 300Y may be generally similar in structure to the sensor modules 300A, 300B. However, various attributes of the additional sensor modules 300X, 300Y may differ from the sensor modules 300A, 300B to facilitate different functions. For example, the additional sensor modules 300X, 300Y may be specifically configured for bubble detection and analysis, as described in International Application US2022 / 017812, filed February 25, 2022, the disclosures of each of which are incorporated herein by this reference. Further details of the structure and function of the manifold 500 and the manifold housing module 220 are provided in International Application US2022 / 017812.

[0135] 7, an embodiment of a sensor module 300A, 300B is shown in operative association with a corresponding syringe tip 16A, 16B to detect fluid in a fluid path section 570 entering the corresponding syringe 10A, 10B during a filling operation. The syringe tip 16A, 16B may itself serve as the fluid path section aligned with the sensor 310, or a separate fluid path section 570 may be attached to the syringe tip 16A, 16B and aligned with the sensor 310. The fluid path section 570 includes a sidewall 530, which may be similar to the sidewall described in connection with FIG. 6, that is at least partially transparent to electromagnetic radiation of the wavelength generated by the emitter 312. The sidewall 530 may be constructed of a plastic material, such as polyethylene terephthalate (PET), polycarbonate (PC), or polypropylene (PP), having a predetermined refractive index. In some embodiments, the refractive index of the sidewall 530 is closer to the refractive index of water than to the refractive index of air. In some embodiments, the sidewall 530 may be rigid such that the sidewall 530 cannot deflect, which could change the path of the electromagnetic radiation ER through the fluid path section 570 and result in an unreliable sensor reading. In some embodiments, the sidewall 530 may include or function as a lens to refract and focus or disperse the electromagnetic radiation passing through the fluid path section 570. In some embodiments, the sidewall 530 may have a surface finish to focus or disperse the electromagnetic radiation passing through the fluid path section 570. The sensor modules 300A, 300B may be freely rotatable about the syringe tips 16A, 16B to allow an operator to freely position the sensor modules 300A, 300B, for example, to avoid certain orientations that receive a large amount of ambient light. An optical filter 318 may be provided between the emitter 312 and the detector 314 to prevent ambient light from affecting the measurements of the detector 314.

[0136] The emitter 312 and detector 314 may be disposed within the expanding diameter section Dw of the fluid path section 570. This arrangement allows the electromagnetic radiation emitted by the emitter 312 to pass through a relatively large diameter of fluid, allowing for more absorption and / or refraction of the electromagnetic radiation by the fluid. Empirical testing has shown that the larger the diameter of the fluid, the more absorption occurs and the greater the difference in the detector output signal between the fluid types. Thus, an increase in the diameter of the fluid path section 570 through which the electromagnetic radiation travels can result in a more reliable and improved determination of the fluid characteristics within the fluid path section 570 by the controller 900. In some empirically tested embodiments, an increase in the diameter of the fluid path section 570 accentuates the difference in absorption in a squared relationship. That is, a small increase in the diameter of the fluid path section has a relatively large effect on the fluid's absorption of the electromagnetic radiation.

[0137] The sensor modules 300A, 300B may include a collimating aperture 350 associated with the emitter 312 and / or a collimating aperture 352 associated with the detector 314. The collimating aperture 350 associated with the emitter 312 may restrict the electromagnetic radiation leaving the emitter 312 to a substantially straight trajectory toward the detector 314. The collimating aperture 352 associated with the detector 314 may restrict the peripheral field of view of the detector 314 such that only electromagnetic radiation coming from the direction of the emitter 312 can reach the detector 314. Thus, the collimating aperture 352 may shield the detector 314 from ambient light sources. In some embodiments, the collimating apertures 350, 352 may have a length that is less than a diameter. In some embodiments, the collimating apertures 350, 352 may have a length that is greater than a diameter.

[0138] The sensor module 300A, 300B may include one or more additional sensors 410, 410' configured to provide further analysis of the fluid path section 570. The additional sensors 410, 410' may be generally similar in structure to the sensor 310, and therefore any features of the sensor 310 described herein may be equally applicable to the additional sensors 410, 410'. However, various attributes of the additional sensors 410, 410' may differ from the sensor 310 to facilitate different functions. For example, the additional sensors 410, 410' may be specifically configured for the detection and analysis of air bubbles. Examples of additional sensors for the detection and determination of analysis of air bubbles are provided in International Application US2022 / 017812. The emitters 412, 412' of each of the additional sensors 410, 410' may be configured to emit electromagnetic radiation at the same or different wavelengths as the sensor 310. In the embodiment shown in FIG. 7, the additional sensor 410, 410′ is located downstream of the sensor 310. In another embodiment, the additional sensor 410, 410′ may be located upstream of the sensor 310 or at a completely different point in the fluid path set. The sensor 310 and the additional sensor 410, 410′ may be configured to distinguish between air and fluid (e.g., saline and contrast medium) in the fluid path section 570. In some embodiments, the additional sensor 410, 410′ may be configured to act in conjunction with the controller 900 to detect air bubbles in the fluid path section 570, determine a flow velocity of the detected air bubbles, and / or determine a volume of the detected air bubbles. The controller 900 may be configured to determine a flow velocity of such detected air bubbles based on a time offset between the air bubbles being detected by the proximal detector 414 and the distal detector 414′.

[0139] 24, in another embodiment, a manifold 600 including a fluid path section 670 may be attached to each syringe tip 16A, 16B, and the sensor module 300A, 300B may be disposed in operative association with the fluid path section 670 of the manifold 600. The manifold 600 and associated sidewall 630 may clip or otherwise engage corresponding features of the tips 16A, 16B of the syringes 10A, 10B by a clip engagement mechanism such as described in International Application Publication No. US2021 / 018523, the disclosure of which is incorporated by reference herein. The manifold 600 includes an inlet port 610 configured for connection with the syringe tips 16A, 16B, with or without flexible tubing (i.e., corresponding syringe lines 208A, 208B) (as shown). Manifold 600 further includes an outlet port 612 configured for connection with a corresponding patient line 210A, 210B and a fill port 614 configured for connection with a corresponding fill line 216A, 216B. Fluid pathway section 670 includes a sidewall 630, which may be substantially similar to sidewall 530 shown and described in connection with FIGS.

[0140] 1, 2, 6, 7, and 24, in certain embodiments, the sensor modules 300A, 300B may be utilized for gross air detection in the fill lines 216A, 216B during angiography (CV) or computed tomography (CT) procedures corresponding to refilling of an in-use syringe 10A, 10B from a bulk fluid container 19A, 19B. As mentioned herein, the sensor modules 300A, 300B may be used to distinguish between an injection fluid F and air in the fluid path section 570, to distinguish between two types of injection fluids common to MR, CV, or CT injection procedures (i.e., contrast media type and saline), to distinguish between the type and / or concentration of the contrast medium, to determine whether the fluid path section 570 has been inserted into the sensor modules 300A, 300B, and to determine the presence or absence of the fluid path section 570 itself. Specifically, the controller 900 may be configured to automatically identify the fluid contents of each syringe 10A, 10B based on the output signal of the detector 314. The controller 900 may display the contents of the syringes 10A, 10B to the operator, for example, via a message or graphic on the GUI 11 or by a color associated with the fluid type (e.g., green or purple for contrast medium, blue for saline or other flushing solution). For example, the GUI 11 may graphically depict the syringes 10A, 10B and show each in a predetermined color depending on the contents of the syringes 10A, 10B. Assuming that the syringes 10A, 10B are filled as expected, with the first syringe 10A containing contrast medium and the second syringe 10B containing saline, the GUI 11 may show the first syringe 10A in green or purple and the second syringe 10B in blue. It is understood that other colors may be used to represent particular fluid types and sensor modules 300A, 300B when air is present.

[0141] In some embodiments, the controller 900 can illuminate the syringes 10A, 10B or other portions of the system 2000 to indicate the contents of the syringes 10A, 10B as determined by the sensor modules 300A, 300B and the controller 900. For example, the controller 900 can illuminate a light source optically connected to each syringe 10A, 10B, which can act as a light tube to display a color (e.g., green for contrast medium, blue for saline) indicative of the filled contents of the syringes 10A, 10B. The plungers 14A, 14B can be backlit as described in U.S. Patent Application Publication No. 2017 / 0056603, the entire disclosure of which is incorporated herein by reference, to indicate the contents of the syringes 10A, 10B as determined by the sensor modules 300A, 300B.

[0142] In some embodiments, the controller 900 may be configured to communicate a warning to the operator, for example on the GUI 11 or in the form of a warning alarm (e.g., audible or visual), if there is an error in fluid placement with respect to the requirements of a prescribed injection protocol. In some embodiments, the controller 900 may utilize a visual indication, such as an electronic sign to indicate the absence of the fluid path section 570 in an operational position in the sensor module 300A, 300B (e.g., a yellow warning light), the presence of air in the fluid path section 570 (e.g., a red stop injection light), the presence of saline in the fluid path section 570 (a blue light), or the presence of contrast medium in the fluid path section 570 (e.g., a green light). In certain embodiments, if air is detected in the fluid path section 570, the controller 900 may be configured to withhold the injection procedure, either automatically by the controller 900 or under the direction of the operator, until a purge operation is performed and no further air is detected in the tubing.

[0143] In some embodiments, the controller 900 may be configured to perform safety checks and / or adjust parameters of the injection procedure if a fault is detected before or during the injection. For example, the controller 900 may monitor the fluid path section 570 during a fill operation in which contrast medium is drawn from the bulk fluid container 19A into the syringe 10A via the sensor module 300A associated with the first syringe 10A. The controller 900 may monitor the output signal of the detector 314 of the sensor module 300A to determine whether the first syringe 10A is actually receiving contrast medium or is instead being filled with saline because, for example, an operator has mistakenly connected the bulk fluid containers 19A, 19B to the wrong syringes 10A, 10B. Similarly, the controller 900 may monitor the output signal of the detector 314 of the sensor module 300B to determine whether the second syringe 10B intended to be filled with saline is instead being filled with contrast medium. If one or both conditions are true, the controller 900 may alert the operator via a message displayed on the GUI 11 and / or automatically stop the filling procedure. In some embodiments, the controller 900 continues the filling procedure and adjusts the injection protocol and GUI display so that the first syringe 10A is indicated as a saline syringe (i.e., by highlighting the syringe in blue on the GUI) and the controller is configured to inject saline from the syringe 10A using parameters programmed for saline and originally intended to be used by the second syringe 10B. Similarly, the controller 900 may adjust the injection protocol and GUI display so that the second syringe 10A is indicated as a contrast syringe (i.e., by highlighting the syringe in green on the GUI) and the controller injects contrast from the syringe 10B using parameters programmed for a contrast injection fluid and originally intended to be used by the first syringe 10A.In such an embodiment, the controller 900 may be configured to update the display of the GUI to indicate this reversal of which syringe delivers which medical fluid. The ability to proceed with an injection procedure even if the syringes 10A, 10B are incorrectly filled can reduce waste because the incorrectly loaded injection fluid is discarded and the fill operation does not have to be repeated.

[0144] In some embodiments, the controller 900 can be configured to adjust the injection ratio of contrast medium to saline if the sensor module 300A detects that the concentration of the contrast medium in the first syringe 10A is different than the concentration required by the injection protocol. If the controller 900 determines, based on the output signal of the sensor module 300A, that the contrast medium in the syringe 10A is more concentrated than specified by the injection protocol, the controller 900 can alert the operator and / or automatically increase the ratio of saline injected during the procedure to dilute the concentration of the contrast medium delivered to the patient. Similarly, in a dual flow procedure, the controller 900 can reduce the injection rate of saline during the injection procedure to increase the concentration of the contrast medium, for example, if the contrast medium in the first syringe 10A is less concentrated than specified by the injection protocol.

[0145] According to various embodiments, when a fluid path section is not present in one or both of the sensor modules 300A, 300B, the resulting output signal from the corresponding detector 314 can be used by the controller 900 as a calibration point from which the controller 900 can access subsequent output signals from the detector 314. When the fluid path section 570 contains air or air bubbles, a lower level of light transmission through the fluid path section occurs, for example, by absorption or scattering of light by the sidewalls 530, such that less light reaches the detector 314, resulting in a lower detector output voltage. Alternatively, when a fluid is present in the fluid path section 570, the light absorption properties and / or refractive index of the fluid will absorb and / or refract light as it travels through the fluid path section 570, resulting in an even lower level of light reaching the detector 314 compared to air in the fluid path section 570. The type of fluid affects the light transmission properties. For example, saline, due to the solutes (salts) dissolved in the aqueous solution, will absorb / refract a first amount of light to the detector 314 that is greater than the amount of light absorbed / refracted by the air-filled fluid path section 570, resulting in a first voltage reading that is lower than that of air or in the absence of the fluid path section 570. A contrast medium, due to the type of solutes (contrast molecules) dissolved in the aqueous solution, will absorb / refract a second amount of light to the detector 314 that is greater than the amount of light absorbed / refracted by the saline or air-filled fluid path section 570, or in the absence of the fluid path, resulting in a lower voltage reading. While the above description relates increased light transmission to a higher detector 314 voltage output and increased light absorption to a lower voltage output, this relationship is a function of the actual circuitry driving the sensor 310 such that some embodiments may exhibit a decrease in detector voltage output at higher light transmission.

[0146] As described herein, according to certain embodiments, the sensitivity of the detector 314 may also allow for differentiation of different types of contrast agents and / or different concentrations of the same contrast medium. For example, different concentrations of the same contrast medium may have different densities due to different amounts of solutes dissolved in the solution, resulting in different refractive indices and / or different amounts of light absorption. Thus, the fluid may allow different levels of electromagnetic radiation to reach the detector 314, resulting in different detector output voltage signals. In some embodiments, the controller 900 may be calibrated or configured to reference a database associated with output voltages of different contrast agent types or different contrast agent concentrations, for example in a look-up database programmed into the controller 900. Thus, the controller 900 may determine what brand, type, and / or concentration of contrast medium is in the first syringe 10A (or in the second syringe 10B if the second syringe 10B is erroneously filled with contrast medium) and update the GUI as necessary or alert the user that the wrong contrast agent or the wrong contrast agent concentration has been loaded into the syringe 10A.

[0147] In some embodiments, the controller 900 can determine the type of fluid in the fluid path sections to optimize the fill time of the syringes 10A, 10B. By identifying the type of fluid in the fill fluid lines 216A, 216B, the controller 900 can set a predetermined safe fill rate for the syringes 10A, 10B, i.e., a flow rate into the syringes 10A, 10B that minimizes the syringe fill time while reducing the occurrence of air bubbles generated in the fluid by an excessive flow rate of the fluid into the syringes. For example, the controller 900 can store and utilize the results of the air detection and correlate the results of the air detection with a particular fill rate such that an optimal fill rate (maximum rate) that prevents or reduces the introduction of air bubbles into the fluid in the syringes 10A, 10B can be determined. For example, the predetermined safe fill rate of saline may be higher than the predetermined safe fill rate of the contrast medium.

[0148] Referring to FIG. 8A, histogram 2100 illustrates empirically observed output voltages of detector 314 for various fluids in fluid path section 570 operatively associated with sensor 310. The wavelength of light utilized in FIGS. 8A and 8B was 890 nm. Voltages were measured in 0.188 inch outer diameter tubing with infrared light generated by emitter 312 and a sensor gap G of 0.228 inches. A gap G of 0.228 inches was found to be an optimal size to obtain a signal difference with 0.188 inch tubing. As can be seen from FIG. 8A, the detector 314 output voltages observed for an empty tube (i.e., only air in fluid path section 570) were in the range of 0 to 0.25 volts. The detector 314 output voltages observed for no tube (i.e., no fluid path section 570 disposed in operative association with sensor 310) were in the range of 1 to 1.25 volts. The detector 314 output voltage observed for saline in fluid path section ranged from 3.75 volts to 4.25 volts, and the detector 314 output voltage observed for contrast agent in fluid path section 570 ranged from 4.75 volts to 5 volts. The clustering of voltage outputs exhibited by the various fluids (or lack thereof) in fluid path section 570 indicates that sensor 310 can reliably distinguish between these fluid types based on the detector 314 output voltage.

[0149] Referring to FIG. 8B, graph 2150 shows the standard deviation of detector output voltage over several test measurements of various fluids in fluid path section 570, also using infrared light and a gap G of 0.228 inches as shown in FIG. 8A. The fluids for which data are shown include saline (three sets of data were analyzed) and the following commercially available contrast media solutions: Ultravist® 370, Ultravist® 300, Omnipaque™ 240, Omnipaque™ 350, Isovue® 370, Isovue® 300, and Isovue® 250. For all fluids except Isovue® 370 and one example of saline, the standard deviation of the detector output voltage was less than 0.01 volts. The low standard deviations for these fluids indicate that the detector 314 output voltage is consistent for each particular fluid, again indicating that the sensor 310 can reliably distinguish between contrast media solutions based on the detector output voltage. Based on this or similar empirical data, the controller 900 can be programmed with predefined thresholds, such as upper and lower limits associated with air, saline, and various types of contrast media. During an injection procedure, if the output signal from the detector 314 is within the upper and lower limits associated with air, the controller 900 determines that air is present in the fluid path section 570. Similarly, if the output signal of the detector is within the upper and lower limits associated with contrast media, the controller 900 determines that contrast media is present in the fluid path section 570. In some embodiments, only an upper limit or only a lower limit may be used as one of the predefined thresholds. For example, the controller 900 may not have an upper limit associated with air, since the output voltage signal of saline or contrast media never falls below the output voltage signal of air. In some embodiments, the controller 900 may interpret an output signal that is significantly outside the range of expected values ​​as a fault condition and may alert the operator (e.g., via a message displayed on the GUI 11) and / or automatically stop the injection procedure.For example, in this embodiment, if the output signal exceeds 5 volts and is greater than the expected output voltage for any fluid in the fluid path section 570 as evident from the histogram 2100, the controller 900 can determine that a fault has occurred.

[0150] 9, graph 2200 shows empirically observed detector output signal voltages for water, contrast medium, and a 50:50 solution of water and contrast medium for emitter 312 also operating at 1450 nm. In this embodiment, the average detector output voltage for water in fluid path section 570 is between 150 millivolts (mV) and 200 mV, the average detector output voltage for a 50:50 solution of contrast medium and water in fluid path section 570 is between 200 mV and 250 mV, and the average detector output voltage for contrast medium in fluid path section 570 is between 250 mV and 300 mV.

[0151] 10, graph 2300 shows empirically observed detector output signal voltages for water, contrast medium, and a 50:50 solution of water and contrast medium in an embodiment where emitter 312 produces electromagnetic radiation in the ultraviolet spectrum at 395 nm. In this embodiment, the average detector output voltage for water in fluid path section 570 is between 1600 mV and 1800 mV, the average detector output voltage for the 50:50 solution of contrast medium and water in fluid path section 570 is between 1400 mV and 1600 mV, and the average detector output voltage for contrast medium in fluid path section 570 is approximately 1200 mV.

[0152] 11, graph 2400 shows empirically observed detector output signal voltages for various dilutions of contrast medium to water, also in an embodiment where emitter 312 produces electromagnetic radiation on the UV spectrum at about 395 nm. In this embodiment, the average detector output voltage for 100% contrast medium in fluid path section 570 is approximately 1200 mV, and the average detector output voltage gradually increases at 75% contrast medium, 50% contrast medium, 25% contrast medium, and 0% contrast medium (100% water). Thus, in this embodiment, the percentage of contrast medium in solution has an inverse effect on the detector 314 output voltage.

[0153] 8A-11 show data for only a few embodiments having particular configurations of the sensor 310. Other configurations that may use different types of emitters 312 or detectors 314, different circuitry associated with the emitters 312 or detectors 314, different gap spacing between the emitters 312 and detectors 314, different tubing diameters, different intensities of electromagnetic radiation, different optical lenses or filters may produce different output voltages when detecting the same fluids as shown in FIGS. 8A-11. In some embodiments, for example, the detector 314 may output a voltage of approximately 1.609 volts when the fluid path section is not present, approximately 0.609 volts when the fluid path section is filled with air, approximately 3.43 volts when the fluid path section is filled with saline, and approximately 4.65 volts when the fluid path section is filled with contrast medium. In another embodiment, the detector 314 may output a voltage of approximately 5.0 volts when the fluid path section is not present, approximately 2.5 volts when the fluid path section is filled with air, and approximately 1.0 volts when the fluid path section is filled with contrast medium. The detector output voltage can be manipulated to some extent through calibration (e.g., changing resistors 322, 324 in the sensor circuit of FIG. 23) to output an output voltage with greater sensitivity.

[0154] 12-15, graphs 2500-2800 show various empirically observed transmissions of electromagnetic radiation through various commercially available contrast medium solutions as a function of wavelength generated by emitter 312. Referring to FIG. 12, graph 2500 shows experimental data collected on the relative transmission of electromagnetic radiation through various dilutions of Ultravist® 370 contrast medium in a 10 millimeter (mm) glass cuvette. The transmission of electromagnetic radiation through water in a 10 mm glass cuvette is also shown as a baseline value, with essentially 100% transmission. The graphed dilutions include pure Ultravist® 370 and 1:1, 2:1, and 3:1 ratios of water to Ultravist® 370. As can be seen from graph 2500, the largest differences in relative transmission between the various dilutions occur in or near the UV spectrum, for example in the region from 370 to 390 nm, and in this embodiment specifically around 379 nm.

[0155] The difference in relative transmission at a given wavelength can be used to distinguish between saline (similar to water) and contrast agent, and between various dilutions of contrast agent with water. Specifically, as the detector 314 detects electromagnetic radiation passing through the fluid in the fluid path section 570, differences in the transmission of the various dilutions will cause different amounts of electromagnetic radiation to reach the detector 314. As a result, the resulting output signal generated by the detector 314 will be different for water and dilutions of contrast agent, which have different transmissions at a given wavelength. By using an emitter 312 that emits electromagnetic radiation at a predetermined wavelength, for example, approximately 379 nm, the controller 900 can determine approximately what dilution of Ultravist® 370 is present in the fluid path section 570 based on the output signal of the detector 314. Specifically, the controller 900 may be configured to match the output voltage of the detector 314 to known output voltages associated with various dilutions of Ultravist® 370. In some embodiments, the controller 900 may be configured to reference a database of known output voltages associated with various diluents. In some embodiments, the controller 900 may be configured to interpolate a dilution ratio for the Ultravist® 370 based on the output voltage of the detector 314.

[0156] Referring to FIG. 13, graph 2600 shows the transmission of electromagnetic radiation having wavelengths between 350 and 450 nm through various commercially available contrast medium solutions including Isovue® 128, Isovue® 250, Isovue® 370, Omnipaque™ 300, and Ultravist® 370. Graph 2700 in FIG. 14 shows the same data as graph 2600, but the electromagnetic radiation is expanded to have wavelengths between about 200 and about 1020 nm. Graph 2800 in FIG. 15 shows the transmission of the same commercially available contrast medium solutions for electromagnetic radiation having wavelengths between 900 nm and 1050 nm. As shown in FIG. 12, the difference in relative transmission at a given wavelength can be used to distinguish between various contrast medium solutions. As can be seen from FIGS. 13-15, the largest difference in the transmittance of various contrast medium solutions may occur in or near the infrared and ultraviolet regions of the electromagnetic spectrum. Thus, the emitter 312 may be configured to generate electromagnetic radiation in or near the infrared and ultraviolet spectrum to take advantage of this difference. In another embodiment, the emitter 312 may be configured to generate electromagnetic radiation in the visible spectrum. In another embodiment, the emitter 312 may be capable of generating electromagnetic radiation at two or more different wavelengths, such as two wavelengths in the infrared region of the electromagnetic spectrum, two wavelengths in the ultraviolet region of the electromagnetic spectrum, or a wavelength in the infrared region and a wavelength in the ultraviolet region of the electromagnetic spectrum. Thus, the emitter 312 may pulse electromagnetic radiation of different wavelengths through the fluid path section 570 to collect several absorption / transmission data points on the fluid in the fluid path section 570 to more accurately determine the identity of the fluid in the fluid path section 570. In some embodiments, the controller 900 can be configured to determine which contrast medium solution is present in the fluid path section 570 based on the output signal of the detector 314. In particular, the controller 900 may be configured to match the output voltage of the detector 314 to known output voltages associated with various commercially available contrast medium solutions.In some embodiments, the controller 900 may be configured to reference a database of known output voltages associated with various commercially available contrast medium solutions.

[0157] 16-20, various tubing shapes and manufacturing imperfections that may be present within the fluid path section associated with the sensor 310 are illustrated. FIG. 16 illustrates an eccentricity where the lumen 580 of the fluid path section is not concentric with the sidewall 530. FIG. 17 illustrates a draft where the inner and / or outer diameter of the sidewall 530 tapers in a proximal to distal direction. FIG. 18 illustrates a surface finish 582 applied to the sidewall 530. Certain surface finishes may be intended to manipulate the convergence and / or divergence of electromagnetic radiation passing through the sidewall 530. However, other surface finishes and / or inconsistently applied surface finishes may adversely affect sensor readings. FIG. 19 illustrates an oval shaped tube where the inner and / or outer diameter of the sidewall 530 is not perfectly round. FIG. 20 illustrates the inclusion of whiskers 584 on the sidewall 530, e.g., a substrate or mold line imparted during manufacturing. Each of the features shown in Figures 16-20 can cause electromagnetic radiation passing through the fluid path section to behave in an unexpected way, resulting in spurious and unreliable output signals from detector 314. In empirical testing, differentiation between types of contrast medium requires the highest sensitivity, and therefore tubing irregularities of the type shown in Figures 16-20 may have the most significant effect on this type of differentiation. Alternatively, differentiation between air and contrast medium, air and saline, and contrast medium and saline may require less sensitivity, and therefore tubing irregularities in Figures 16-20 may have less or negligible effect on these determinations.

[0158] In some embodiments, the controller 900 may be configured to perform test measurements prior to the injection and / or syringe filling procedure to establish the presence and potential effect of these geometric features / defects on the output signal from the detector 314. The controller 900 may use the results of the test measurements to configure the detector 314 and / or calculate one or more correction factors based on the effect of the features / defects in one or both of the contrast injection fluid path and the flushing fluid path. During the filling and / or injection procedure, the controller 900 may apply the correction factors to the output signal from the detector 314 to compensate for the manufacturing features / defects.

[0159] An additional manufacturing issue that may affect the sensor readings is the inner diameter of the sidewall 530 differing from the expected value. This may occur due to manufacturing tolerances and / or the use of third-party fluid path set components. An unexpected inner diameter of the sidewall 530 may particularly affect the bubble volume calculation, since the controller 900 may utilize a predetermined diameter constant corresponding to the inner diameter to convert the detected length of the bubble to a volume. If the actual inner diameter of the sidewall 530 differs from the predetermined diameter constant, the bubble volume calculation may be inaccurate. In some embodiments, the controller 900 may be configured to perform a test measurement prior to the injection procedure to establish the outer diameter, inner diameter, and thickness of the sidewall based on the detected deflection of the empty fluid path section. Based on the test measurement, the controller 900 may apply a correction factor to the subsequent output signal from the detector 314.

[0160] 21A-21H, in some embodiments, the controller 900 can be configured to manipulate the intensity and / or wavelength of the electromagnetic radiation generated by the emitter 312 to improve sensitivity and / or gather additional information from the sensor 310. Specifically, the controller 900 can increase the current to the emitter 312 causing the emitter 312 to emit light at a high intensity or decrease the current to the emitter 312 causing the emitter 312 to emit light at a lower intensity. In some embodiments, the controller 900 can power the emitter 312 at a known predetermined intensity to saturate the detector 314. When the detector 314 is at its saturation limit, the output voltage of the detector 314 is at a maximum and further increasing the intensity of light from the emitter 312 will not produce a higher output voltage from the detector 314. FIGS. 21A-21D show the detector output voltage as a function of emitter current for any embodiment of the sensor 310. As shown in FIG. 21A, the detector 314 has a dark level corresponding to a minimum output voltage and a saturation limit corresponding to a maximum output voltage. FIG. 21A shows a first emitter current 702 selected to generate a first detector output voltage 802 between the dark level and the saturation limit of the detector 314. FIG. 21B shows a second emitter current 704 that is greater than the first emitter current 702, thereby causing the detector 314 to generate a second detector output voltage 804 that is greater than the first output voltage 802. In this case, the second detector output voltage 804 is still below the saturation limit of the detector 314. FIG. 21C shows a third emitter current 706 that is greater than the second emitter current 704, thereby causing the detector 314 to generate a third detector output voltage 806 that is greater than the second detector output voltage 804. In this case, the third emitter current 706 produces enough light intensity that the detector 314 saturates, and therefore the third detector output voltage 806 is at its saturation limit. Figure 21D shows a fourth emitter current 708 that is greater than the third emitter current 706. Because the detector 314 has already reached its saturation limit, the fourth detector output voltage 808 produced by the fourth emitter current 708 is substantially equal to the third detector output voltage 806.Further increases in the emitter current similarly do not result in an increase in the output voltage of detector 314 .

[0161] The saturation limit of a given detector 314 is substantially constant. Because the refractive index and absorption properties of the contents between the emitter 312 and the detector 314 affect the amount and / or intensity of light that reaches the detector 314, the refractive index and absorption properties of the fluid in the fluid path section (and the fluid path section itself) determine the emitter current required to reach the saturation limit of the detector 314. The controller 900 can utilize the known saturation limit of the detector 314 to distinguish between fluids, e.g., air, saline, and contrast agent, as well as to distinguish between types and / or concentrations of contrast agents. For example, the controller 900 can drive the emitter 312 with a current that would be sufficient to saturate the detector 314 if only air was present in the fluid path section. If the detector output voltage does indeed reach its saturation limit in response to this emitter current, the controller 900 can determine that only air is present in the fluid path section. However, if the detector output voltage does not reach its saturation limit in response to this emitter current, the controller 900 can determine that another fluid is present. In some embodiments, the controller 900 may continue to modulate the current to the emitter 312 to further infer the type and / or concentration of fluid within the fluid path section. For example, the controller 900 may drive the emitter 312 with a current sufficient to saturate the detector 314 if the fluid within the fluid path section includes less than a predetermined ratio of contrast agent to saline. If the detector output voltage reaches a saturation limit in response to this emitter current, the controller 900 may determine that the fluid within the fluid path section has less than a predetermined ratio of contrast agent to saline.

[0162] 21E-21H illustrate a method for determining the fluid contents of a fluid path section by gradually increasing the emitter current. In FIG. 21E, the controller 900 drives the emitter 312 with a fifth emitter current 750, which corresponds to a known current that will not saturate the detector 314 even if only air is present in the fluid path section. At this emitter current, the detector output voltage associated with air 850, the detector output voltage associated with the first contrast solution 852, the detector output voltage associated with the second contrast solution 854, and the detector output voltage associated with the third contrast solution 856 are all below the saturation limit of the detector 314. Nonetheless, the detector output voltage associated with air 850 is sufficiently distinct from the detector output voltages associated with the contrast solutions 852, 854, 856 that the controller 900 can conclude that air is present in the fluid path section based on the actual measured detector output voltages of the detector 314. It should be noted that at the fifth emitter current 750, the detector output voltages associated with the second and third contrast agent solutions 854, 856 are substantially at the dark level of the detector 314, and therefore the controller 900 cannot effectively distinguish between the second and third contrast agent solutions 854, 856 at the fifth emitter current 750.

[0163] Referring to FIG. 21F, the controller 900 can increase the current to the emitter 312 to improve the ability to distinguish between the fluids, particularly the first, second, and third contrast solutions 852, 854, 856. To do so, the controller 900 can drive the emitter 312 at a sixth emitter current 752, which is greater than the fifth emitter current 750. At the sixth emitter current 752, the detector output voltage associated with the air 850 is at the saturation limit of the detector 314. The detector output voltage associated with the second contrast solution 854 has moved out of the dark level and is therefore within the effective resolution of the detector 314. At the sixth emitter current 752, the controller 900 may be able to distinguish, particularly between the first and second contrast solutions 852, 852, based on the output voltage of the detector 314. Furthermore, the removal method allows the contrast solution 856 to be removed as if it were still within the dark level.

[0164] 21G, the controller 900 can again increase the current to the emitter 312 to improve the ability to distinguish between the fluids, particularly the second and third contrast solutions 854, 856. At the seventh emitter current 754, the detector output voltages associated with the air 850 and the first contrast solution 852 are at the saturation limit of the detector 314. The detector output voltage associated with the third contrast solution 856 has moved away from the dark level. In addition, the spread between the detector output voltages associated with the second and third contrast solutions 854, 856 has increased, making it easier and / or more certain to distinguish between the second and third contrast solutions 854, 856 at the seventh emitter current 754 compared to the sixth emitter current 752.

[0165] The controller 900 can again increase the current to the emitter 312 to an eighth emitter current 758. At the eighth emitter current 758, the detector output voltages associated with the air 850, the first contrast solution 852, and the second contrast solution 854 are at the saturation limit of the detector 314. Thus, the controller 900 can determine that the third contrast solution 856 is present in the fluid path section when the actual detector output voltage of the detector 314 is any value below the saturation limit. The controller 900 can be configured to incrementally modulate the current driving the emitter 312 at predetermined time intervals to analyze the fluid contents of the fluid path section, as described in connection with FIGS. 21A-21H.

[0166] 22, a graph of an exemplary output signal of the detector 314 is shown for the sensor 310 operably associated with syringe tips 16A, 16B (as shown in FIG. 7 or FIG. 24) of three different inner diameters (0.122 inch syringe cap "A", 0.165 inch syringe cap "B", and 0.210 inch syringe cap "C"). Three different conditions were tested for each of the syringe caps "A", "B", and "C": syringe cap not operably associated with the sensor module 300A, 300B; syringe cap operably associated with the sensor module 300A, 300B and filled with air; syringe cap operably associated with the sensor module 300A, 300B and filled with water. The output signal from the detector 314 enables the controller 900 to distinguish between these three conditions, regardless of the inner diameter of the syringe cap. Across measurements made for all three syringe cap diameters, the average output signal for syringe caps not operatively associated with a sensor ranged from 4.110 to 4.111 volts, the average output signal for syringe caps filled with air ranged from 2.120 to 2.665 volts, and the average output signal for syringe caps filled with water ranged from 1.102 to 1.283 volts. For the test results shown in FIG. 22, emitter 312 was operated at a wavelength of 1450 nm.

[0167] Although various examples of the present invention have been provided in the foregoing description, those skilled in the art can make modifications and variations to these examples without departing from the scope and spirit of the present disclosure. Therefore, the above description is intended to be illustrative rather than limiting. The disclosure described above is defined by the appended claims, and all changes to the disclosure that come within the meaning and range of equivalence of the claims should be embraced therein. [Explanation of symbols]

[0168] 10A First Fluid Reservoir (Syringe) 10B Second fluid reservoir (syringe) 11 Graphical User Interface (GUI) 12 Fluid injector 13A First Piston 13B Second piston 14A Plunger 14B Plunger 16A Tip or Nozzle 16B Tip or Nozzle 19A First Bulk Fluid Container (Reservoir) 19B Second bulk fluid container (reservoir) 110 Catheter 208A First Syringe Line 208B Second Syringe Line 210A First Patient Line 210B Second Patient Line 216A First filling line 216B Second Filling Line 220 Manifold Housing Module 222 Receptor Channel 280 Leader 300A First Sensor Module 300B Second Sensor Module 300C 3rd Sensor Module 300X Additional Sensor Module 300Y Additional Sensor Module 310 Sensors 312 Emitter 314 Detector 318 Optical Filters 320 power supply 321 Power supply 324 Sensor resistor 326 Output voltage signal 350 Collimating Aperture 352 Collimating Aperture 410 Additional Sensors 410' Additional Sensors 500 Manifold 510 First inlet port 512 First Exit Port 514 First Fill Port 516 Check valve 520 Second Inlet Port 522 Second Exit Port 524 Second Fill Port 526 Check valve 530 Side wall 550 Connecting Beam 570 Fluid Path Section 580 lumen 584 Beard 600 Manifold 610 Inlet port 612 Exit Port 614 Filling port 630 Side wall 670 Fluid Path Section 702 First emitter current 704 Second emitter current 706 Third emitter current 708 4th emitter current 750 5th emitter current 752 6th emitter current 754 Seventh emitter current 758 8th emitter current 802 First detector output voltage 804 Second detector output voltage 806 Third detector output voltage 808 4th detector output voltage 850 Air 852 First contrast agent solution 854 Second contrast solution 856 Third contrast solution 900 Controller 2000 Fluid Injector System 2100 Histogram 2150 Graph 2200 Graph 2300 Graph 2400 Graphs 2500 graphs 2600 Graphs 2700 Graph 2800 graphs

Claims

1. 1. A fluid injector system comprising: at least one injector for pressurizing and delivering at least one fluid from the first fluid reservoir and the second fluid reservoir; a first fluid path section providing fluid communication between a first bulk fluid container and the first fluid reservoir, and a second fluid path section providing fluid communication between a second bulk fluid container and the second fluid reservoir, the first fluid reservoir being a first syringe connected to the at least one injector, and the second fluid reservoir being a second syringe connected to the at least one injector; a first sensor disposed along the first fluid path section and a second sensor disposed along the second fluid path, each of the first sensor and the second sensor comprising an emitter and a detector; a first emitter associated with the first sensor and a second emitter associated with the second sensor configured to emit light through each of the first and second fluid path sections; a first detector associated with the first sensor and a second detector associated with the second sensor configured to receive the light emitted through each of the first and second fluid path sections and generate an electrical signal based on at least one characteristic of the received light. a first sensor and a second sensor; Based on the electrical signals generated by the first detector and the second detector, an identity of the at least one fluid present in at least one of the first fluid path section and the second fluid path; a concentration of the at least one fluid in at least one of the first fluid path section and the second fluid path; and At least one characteristic of at least one of the first fluid path section and the second fluid path. at least one processor programmed or configured to determine at least one of: Equipped with the at least one processor is programmed or configured to determine, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir and that the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir; adjusting an injection protocol to ensure that injection parameters are updated to switch the identities of the first fluid reservoir and the second fluid reservoir such that the first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir; Fluid injector system.

2. the emitter is disposed on a first side of at least one of the first fluid path section and the second fluid path; the detector is disposed on a second side of at least one of the first fluid path section and the second fluid path; the second side of at least one of the first fluid path section and the second fluid path is approximately 180° opposite the first side of at least one of the first fluid path section and the second fluid path.

10. The fluid infuser system of claim 1.

3. 2. The fluid injector system of claim 1, wherein the at least one processor is programmed or configured to modify the injection protocol by configuring the first fluid reservoir to inject the fluid that was originally intended to be injected by the second fluid reservoir by the injection protocol, and by configuring the second fluid reservoir to inject the fluid that was originally intended to be injected by the first fluid reservoir by the injection protocol.

4. 4. The fluid injector system of claim 3, wherein the at least one processor is programmed or configured to adjust a display of a graphical user interface or illuminate a first light source associated with the first fluid reservoir and a second light source associated with the second fluid reservoir to indicate that the first fluid reservoir contains the fluid that was originally intended to be injected by the second fluid reservoir by the injection protocol and that the second fluid reservoir contains the fluid that was originally intended to be injected by the first fluid reservoir by the injection protocol.

5. The fluid infuser system of any one of claims 1 to 4, wherein the at least one processor is programmed or configured to determine an optimal fill rate for at least one of the first fluid reservoir and the second fluid reservoir based on at least one identification information of the at least one fluid and a concentration of the at least one fluid in at least one of the first fluid path section and the second fluid path.

6. each of the first detector and the second detector configured to output a first voltage signal when the first fluid path section or the second fluid path section contains a contrast medium; each of the first detector and the second detector configured to output a second voltage signal when the first fluid path section or the second fluid path section contains saline; the at least one processor is programmed or configured to determine the identity of at least one fluid in the first fluid path section and the second fluid path section based on a difference between the first voltage signal and the second voltage signal. A fluid injector system according to any one of claims 1 to 5.

7. each of the first detector and the second detector configured to output a third voltage signal when the first fluid path section or the second fluid path section contains air; the at least one processor is programmed or configured to determine that there is air in the first fluid path section or the second fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal. The fluid infuser system of claim 6.

8. 8. The fluid injector system of claim 7, wherein when the detector determines that there is air in the first fluid path section or the second fluid path section, the at least one processor is programmed or configured to provide an alert to a user that at least one of the first bulk fluid container and the second bulk fluid container is empty.

9. The at least one processor: determining a concentration of contrast medium in the first fluid path section or the second fluid path section based on the electrical signal generated by the at least one sensor; Increasing the rate at which an infusion fluid, including saline, is injected during an injection procedure to dilute the concentration of the contrast medium delivered to a patient, or decreasing the rate at which an infusion fluid, including saline, is injected during an injection procedure to increase the concentration of the contrast medium delivered to a patient.

10. The fluid injector system of claim 1, programmed or configured to:

10. 2. The fluid injector system of claim 1, wherein the at least one processor is programmed or configured to determine, based on the electrical signal, that the first fluid path section or the second fluid path section is present between the first emitter of the first sensor and the first detector and the second detector of the second sensor.

11. 10. The fluid injector system of claim 1, wherein the first emitter and the second emitter are each configured to emit light in the ultraviolet spectrum.

12. 1. A method for determining one or more fluid characteristics of an injection fluid flowing within at least one fluid path section of a fluid injector system, comprising: The fluid injection system comprises: a first fluid reservoir and a second fluid reservoir for delivering a first infusion fluid and a second infusion fluid, respectively; a first fluid path section of the at least one fluid path section, the first fluid path section providing fluid communication between a first bulk fluid container of the at least one bulk fluid container and the first fluid reservoir, the first fluid path section having a first sensor; a second fluid path section of the at least one fluid path section providing fluid communication between a second bulk fluid container of the at least one bulk fluid container and the second fluid reservoir, the second fluid path section having a second sensor; Equipped with The method comprises: emitting light from a first emitter of the first sensor through the first fluid path section; and emitting light from a first emitter of the first sensor through the first fluid path section. detecting light that has passed through the first fluid path section with a first detector of the first sensor and detecting light that has passed through the second fluid path section with a second detector of the second sensor; based on the electrical signal generated by the first detector and the electrical signal generated by the second detector, Identification of the injection fluid present in the first fluid path section and the injection fluid present in the second fluid path section; and At least one characteristic of the first fluid path section and the second fluid path section. determining at least one of: based on the electrical signal generated by the first sensor and the electrical signal generated by the second sensor; whether the injection fluid flowing from the first bulk fluid container into the first fluid reservoir was originally intended by the injection protocol to fill the second fluid reservoir, and whether the injection fluid flowing from the second bulk fluid container into the second fluid reservoir was originally intended by the injection protocol to fill the first fluid reservoir; and based on the result of the determination, adjusting an injection protocol to ensure that injection parameters are updated to switch the identities of the first and second fluid reservoirs such that the first injection fluid is associated with the first fluid reservoir and the second injection fluid is associated with the second fluid reservoir; and adjusting the injection protocol by configuring the first fluid reservoir to inject the injection fluid that was originally intended to be injected by the second fluid reservoir according to the injection protocol and configuring the second fluid reservoir to inject the injection fluid that was originally intended to be injected by the first fluid reservoir according to the injection protocol; A method comprising:

13. 13. The method of claim 12, further comprising adjusting a display of a graphical user interface or illuminating a first light source associated with the first fluid reservoir and a second light source associated with the second fluid reservoir to indicate that the first fluid reservoir contains the injection fluid that was originally intended to be injected by the second fluid reservoir by the injection protocol and that the second fluid reservoir contains the injection fluid that was originally intended to be injected by the first fluid reservoir by the injection protocol.

14. 13. The method of claim 12, further comprising determining an optimal fill rate for at least one of the first fluid reservoir and the second fluid reservoir based on the identity of at least one of the injection fluids and the concentration of the fluid in the at least one fluid pathway section.

15. each of the first detector and the second detector is configured to output a first voltage signal when the first fluid path section and the second fluid path section contain the infusion fluid including a contrast medium; each of the first detector and the second detector is configured to output a second voltage signal when the first fluid path section or the second fluid path section contains an injection fluid that includes saline; The method further includes determining the identity of the at least one infusion fluid of at least one of the first fluid path section or the second fluid path section based on a difference between the first voltage signal and the second voltage signal. The method of claim 12.

16. 16. The method of claim 15, wherein each of the first detector and the second detector is configured to output a third voltage signal when the first fluid path section or the second fluid path section contains air, the method further comprising determining that there is air in the first fluid path section or the second fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.

17. determining a concentration of the infusion fluid including contrast medium in the first fluid pathway section or the second fluid pathway section based on the electrical signal generated by the first sensor or the second sensor; increasing the rate at which the infusion fluid, including saline, is injected during an injection procedure to dilute the concentration of the contrast medium delivered to the patient; or reducing a rate at which the injection fluid, including saline, is injected during an injection procedure to increase the concentration of the contrast medium delivered to the patient; Either one of the steps, The method of claim 12 further comprising:

18. 13. The method of claim 12, further comprising determining, based on the electrical signal, that the first fluid path section is between the first emitter and the first detector, and determining that the second fluid path section is between the second emitter and the second detector.

19. The method of claim 12, wherein emitting light from the first emitter and the second emitter includes emitting at least one of light in the ultraviolet spectrum, light in the infrared spectrum, and light in the visible spectrum.

Images