System and method for detecting fluid type in tubing for fluid injector apparatus
The fluid injector system uses light-emitting sensors to identify and adjust fluid types and concentrations, addressing the challenge of incorrect administration in medical imaging procedures, enhancing safety and accuracy.
Patent Information
- Application Number
- JP2025067664
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-06-17
- Filing Date
- 2025-04-16
- Publication Date
- 2025-08-13
AI Technical Summary
Existing fluid injectors for medical imaging procedures lack the ability to accurately identify and differentiate between contrast media and saline, ensuring correct fluid types and concentrations are used, which can lead to incorrect administration and potential harm to patients.
A fluid injector system with sensors that emit light through the fluid path section and detect the light to determine fluid identity and concentration, using processors to adjust protocols and provide alerts or interface updates for correct fluid administration.
Ensures accurate identification and adjustment of fluid types and concentrations, minimizing errors and ensuring safe and effective medical fluid delivery.
Smart Images

Figure 2025118668000001_ABST
Abstract
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 herein by reference in its entirety.
[0002] The present disclosure relates to the field of fluid injectors and devices for injecting contrast media for contrast medical imaging procedures. Specifically, embodiments of a system and method for detecting air and fluid type (contrast media and saline) and fluid concentration within the 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 patients. 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, a fluid injector has at least one drive member, such as a plunger or piston, that connects to a 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 medical fluid from a fluid reservoir. The syringe may include a rigid barrel with a syringe plunger slidably disposed within the barrel. The drive member drives the plunger proximally and / or distally relative to the longitudinal axis of the barrel to draw or deliver fluid, respectively, into or from the syringe barrel. In certain applications, medical fluids are injected into the vascular system 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 fluid are injected at the correct time in the injection procedure to minimize or eliminate contrast overinjection, 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 patient harm if administered incorrectly, new methods and devices are needed to verify the type and concentration of fluid loaded into corresponding syringes and to enable the injection system to clearly indicate which syringes contain which injection fluids. 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, based on the electrical signal generated by the detector, at least one of the identity of the at least one fluid present in the fluid path section, the concentration of the at least one fluid in the fluid path section, and at least one characteristic of the fluid path section.
[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 being 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 being 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 the 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.
[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 the fluid originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains the fluid 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 the highest 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 the 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 the 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 the direction of fluid flow 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 may 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, and 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 through at least one fluid path section of a fluid infuser 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, 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.
[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 being positioned to detect fluid entering the first fluid reservoir during a fill operation of the first fluid reservoir, and the second sensor being 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 the 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.
[0036] In some embodiments, the method further includes modifying the injection protocol by configuring the first fluid reservoir to inject a fluid originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject a fluid originally intended to be injected by the first fluid reservoir.
[0037] In some embodiments, the method further includes 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 the fluid originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains the fluid 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 the highest 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, and a second voltage signal when the fluid path section contains saline. The method further includes determining an identity of the 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 at least one fluid path section contains air. The method further includes determining that air is present 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 the 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 the injection rate of the saline solution during the injection procedure to increase the concentration of the contrast medium delivered to the patient.
[0046] In some embodiments, the emitter is positioned to emit light perpendicular to the direction of fluid flow 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 may 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, and 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 pathway 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 pathway section, the at least one sensor comprising an emitter configured to emit light through the at least one fluid pathway section and a detector configured to receive the light emitted through the at least one fluid pathway 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 the at least one fluid present in the fluid pathway section, a concentration of the at least one fluid in the fluid pathway section, and at least one characteristic of the fluid pathway 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 positioned on a first side of the fluid path section and the detector is positioned 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. A fluid injector system as described in 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 the 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 the 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 injector 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. A fluid injector system as described in 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 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 the injection parameters are updated to switch the identification information of the first fluid reservoir and the second fluid reservoir 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 change 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.
[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, 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.
[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 fill rate for at least one fluid reservoir based on at least one identification of the fluid and the concentration of the fluid in at least one fluid pathway section.
[0064] Clause 11. The fluid infuser system of 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 the 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 the concentration of contrast medium in at least one fluid pathway section based on the electrical signal generated by the at least one sensor, and to increase the 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 the concentration of contrast medium in the fluid pathway 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 contrast medium delivered to the patient.
[0070] Clause 17. A fluid injector system according to any one of clauses 1 to 16, wherein the emitter is arranged to emit light perpendicular to the direction of fluid flow 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 in 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 in 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: 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 the infusion fluid present in the 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 positioned on a first side of the fluid path section and the detector is positioned 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, wherein the first sensor is positioned to detect fluid entering the first fluid reservoir during a filling operation of the first fluid reservoir, and the second sensor is 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 the step of 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 the 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 the fluid originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains the fluid 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 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.
[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, and the method further comprises determining 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.
[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 the concentration of the contrast medium in at least one fluid pathway section based on the electrical signal generated by the at least one sensor, and increasing the 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 the concentration of the contrast medium in at least one fluid pathway section based on the electrical signal generated by the at least one sensor, and reducing the injection rate of the saline solution 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 the direction of fluid flow through the 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 from 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 review of the following detailed description of the various examples in conjunction with the accompanying drawings. [Brief explanation of the drawings]
[0108] [Figure 1] 1 is a perspective view of a fluid injector system according to one embodiment of the present disclosure; [Figure 2] 1 is a schematic diagram of a fluid injector system according to one embodiment of the present disclosure. [Figure 3] FIG. 1 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. [Figure 5] FIG. 4 is a front cross-sectional view of the sensor module of FIG. 3. [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. 1 is a side cross-sectional view of a syringe tip, a fluid path section, and a sensor module according to one embodiment of the present disclosure. [Figure 8A] 10 is a histogram of sensor output voltages 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] 10 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using infrared light, according to an embodiment of the present disclosure. [Figure 10] 10 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] 10 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] 10 is a graph of relative electromagnetic transmission for various contrast media within a fluid path section, according to an embodiment of the present disclosure. [Figure 13] 10 is a graph of relative electromagnetic transmission for various contrast media within a fluid path section, according to an embodiment of the present disclosure. [Figure 14] 10 is a graph of relative electromagnetic transmission for various contrast media within a fluid path section, according to an embodiment of the present disclosure. [Figure 15] 10 is a graph of relative electromagnetic transmission for various contrast media within a fluid path section, according to an embodiment of the present disclosure. [Figure 16] FIG. 10 is a cross-sectional front view of an eccentric fluid path section. [Figure 17] FIG. 10 is a side cross-sectional view of a fluid path section having a draft. [Figure 18] FIG. 10 is a cross-sectional side view of a fluid path section having a surface finish. [Figure 19] FIG. 10 is a front cross-sectional view of a non-circular fluid path section. [Figure 20] FIG. 10 is a cross-sectional front view of a fluid path section having burrs. [Figure 21A] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21B]10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21C] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21D] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21E] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21F] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21G] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 21H] 10 is a graph illustrating detector output voltage as a function of emitter current, according to one embodiment of the disclosure. [Figure 22] 10 is a graph of sensor output voltage versus time for various conditions and configurations of syringe caps. [Figure 23] FIG. 1 is a circuit diagram of a sensor according to one embodiment of the disclosure. [Figure 24] FIG. 1 is a perspective view of a syringe tip, a manifold, and a sensor module according to one embodiment of the disclosure. DETAILED DESCRIPTION OF THE INVENTION
[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," etc., relate to the invention as shown 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 including 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 encompass 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 beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less. Ranges and / or ratios disclosed herein represent average values across the specified range and / or ratio. Terms such as "first," "second," etc., do not refer to a particular order or chronological order, but are intended to refer to different conditions, properties, or elements.
[0111] All documents referred to herein are "incorporated by reference" in their entirety.
[0112] The term "at least" is synonymous with "or greater than." 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 reference to a syringe, the term "proximal" refers to the portion of the syringe closest to the piston element that engages the end wall of the syringe and delivers fluid from the syringe. When used in reference 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 reference to a syringe, the term "distal" refers to the portion of the syringe closest to the delivery nozzle. When used in reference 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 a 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 a direction around the inner or outer surface of the sidewall of the syringe. The term "axial" refers to a direction along the longitudinal axis of the syringe, extending between the proximal and distal ends.
[0114] It is to be understood that the present disclosure may contemplate alternative variations and step sequences unless expressly specified otherwise. It is also to 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 limiting.
[0115] Referring to the drawings, in which like reference numerals refer to like parts throughout the several views, the present disclosure provides systems, components, devices, and methods for detecting and analyzing the fluid contents of a fluid pathway 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. Various contrast compounds at different concentrations are known in the art. Fluid is infused from fluid reservoirs 10A, 10B through a series of fluid path elements connecting fluid reservoirs 10A, 10B to a catheter 110 inserted into a patient's vascular system. 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. System 2000 includes a fluid path set including a first syringe line 208A in fluid communication with the tip or nozzle 16A of first syringe 10A, a first fill line 216A in fluid communication with first bulk fluid container 19A, and a first patient line 210A in fluid communication with 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 by a manifold or a T-joint (see, for example, 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, syringe line 208B, fill line 216B, and / or patient line 210B are fluidly connected by a manifold or T-joint (see, e.g., FIGS. 6 and 24). The fluid path set arrangement allows fluid to be drawn from first bulk fluid container 19A into first syringe 10A via first fill line 216A and first syringe line 208A. Fluid can be infused into the patient from first syringe 10A via first syringe line 208A, patient line 210A, and catheter 110. Similarly, fluid may be drawn from second bulk fluid container 19B into second syringe 10B via second fill line 216B and second syringe line 208B. Fluid can be injected into the patient from the second syringe 10B via the second syringe line 208B, the second patient line 210B, and the catheter 110. 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 region, and the mixing chamber, may be rigid. While the fluid injector 12 shown in FIGS. 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 the associated flushing fluid. According to these embodiments, the fluid injector 12 may engage only 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 a single fluid injection procedure. Alternatively, a fluid injector (not shown) configured to engage only a single syringe may utilize various embodiments of the sensor modules and methods described herein.
[0116] Syringes, tubing and fluid path components, shut-off valves, pinch valves, controllers, and further details of a suitable, non-limiting power injector system, including an air detector; Examples include 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 / US2018 / 034613, and PCT / US2020 / 049885. 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 , injector system 2000 includes a first piston 13A and a second piston 13B associated with each of syringes 10A and 10B, respectively. Each of pistons 13A and 13B is configured to drive a respective plunger 14A and 14B within the barrel of each of syringes 10A and 10B. Fluid injector system 2000 includes a controller 900 in electronic communication with various components of system 2000 to perform an injection procedure. Specifically, controller 900 may include at least one processor programmed or configured to operate pistons 13A and 13B and various other components of injector system 2000 to deliver medical fluid 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 syringes 10A and 10B and determining fluid identity and / or 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 syringe identification information in the injection protocol so that the correct fluid is identified in 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 contrast concentration on the display; adjusting the injection protocol to inject the correct ratio of contrast and saline when an incorrect contrast concentration is loaded into the contrast syringe; switching the color of one or more light emitting elements (e.g., LED lights) associated with the syringe to provide an alert to the user that one or more errors occurred during the fluid filling operation, such as the incorrect fluid being filled into the syringe, the bulk fluid container being empty because only air was drawn into the syringe, or changing the incorrect contrast concentration injection protocol.The controller 900 may include a computer-readable medium, such as a memory, on 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 an injection procedure. The fluid injector system 2000 may further include at least one graphical user interface (GUI) 11 through which an operator can interact with the controller 900 to view and control the status of an 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 the correct fluid type is flowing through the correct fluid path elements based on the associated bulk fluid container. If the fluid type is incorrect, 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 infusion fluid F (e.g., imaging contrast medium or flushing fluid) from a 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 fill lines 216A, 216B to control the filling of the syringes 10A, 10B with the appropriate infusion fluid F. As described herein, during a fill operation, the fluid flowing through fill lines 216A, 216B is monitored by fluid sensors described herein to identify one or more characteristics of the fluid in fill line 216A or 216B, and if necessary, 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 fill line 216A or 216B.
[0119] Following the fill and priming operations (in which 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 perform 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 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 meet 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, system 2000 includes one or more sensors and / or sensor modules configured to detect air and / or fluid in fluid path elements associated with each syringe 10A, 10B, such as fill lines 216A, 216B. As shown in Figures 1 and 2, a first sensor module 300A is disposed in operative communication with first syringe tip 16A, and a second sensor module 300B is disposed in operative communication with second syringe tip 16B. Alternatively or additionally, first and second sensor modules 300A, 300B may be associated with 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 pathway section 570 (associated with the fluid lines 208A, 208B, 216A, and / or 216B) based on signals transmitted by the sensor modules 300A, 300B. For example, based on signals transmitted by the sensor modules 300A, 300B, the controller 900 may be configured to determine the identity of the fluid in the fluid pathway section 570, the concentration of the medical fluid in the fluid pathway section 570, the presence of air in the fluid pathway section 570, the priming state of the fluid pathway section 570, characteristics of the fluid pathway 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 other 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, the third sensor module 300C being 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 to define a gap G within which an operably 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. Additionally, 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 reaching the detector 314 due to the refractive index of the fluid and the fluid path section 570. The measured difference in absorption and / or refraction can be used to distinguish between an empty sensor 310, where the fluid path section 570 is operably inserted into the field of the sensor 310, 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 within the sensor module 300A, 300B, 300C, the sensor module 300A, 300B, 300C can then use the measured difference in refraction 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 then 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 particular embodiments, about 1450 nm. In other embodiments, 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 particular embodiments, about 890 nm.In another embodiment, the electromagnetic radiation emitted by 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 particular embodiments, about 395 nm. In some embodiments, emitter 312 can be configured to emit acoustic energy, such as ultrasonic energy, and 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 electromagnetic radiation does not require acoustic coupling (e.g., compressive contact) between fluid path section 570 and 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 signals 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 a second wavelength optimized to distinguish between concentrations of contrast medium.
[0124] In some embodiments, the wavelength(s) of the electromagnetic radiation can be selected to minimize the adverse effects of factors on sensor performance, such as the alignment of the electromagnetic radiation emitter 312 and detector 314, the alignment of the fluid path section 570 relative to the emitter 312 and detector 314; the material and shape of the outer wall of the fluid path section 570; and the 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 preferable to gaps G of 0.188 inches and 0.208 inches in terms of the detector 314's ability to distinguish between air, contrast agent, and saline within the tubing (see FIGS. 8A and 8B).
[0125] FIG. 3 illustrates the absence of a fluid path section within gap G, such that electromagnetic radiation ER must pass only through the air within gap G to reach detector 314. FIG. 4 illustrates fluid path section 570 disposed within gap G in operative association with sensor 310. Fluid path section 570 in FIG. 4 is filled with infusion fluid F, as would be expected during the fill operation of an injection procedure in which fluid moves from bulk fluid containers 19A, 19B to syringes 10A, 10B. The refractive index of infusion fluid F can focus electromagnetic radiation ER passing through fluid path section 570 before reaching detector 314, thereby causing an increase in signal strength received and measured by detector 314. Additionally, infusion fluid F (e.g., aqueous solutions, solute molecules dissolved in aqueous solutions typical of saline flushing fluids or imaging contrast agents) can absorb a portion of the electromagnetic radiation ER generated by emitter 312, preventing some of the electromagnetic radiation ER from reaching detector 314. 5 shows fluid path section 570 disposed within gap G in operative association with sensor 310, fluid path section 570 being 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 reaching 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 when the fluid path section 570 is not in gap G (FIG. 3) due to light absorption by the polymer material of the fluid path section sidewalls. In certain embodiments, light absorption by the contents between the emitter 312 and the detector 314 can cause differences in the signal strength measured by the detector 314. For example, in FIG. 3, where the fluid path section 570 is absent, air has only minimal absorption of light from the emitter 312 (which can be incorporated into any calculations), so light can pass freely from the emitter 312 to the detector 314 of the sensor 310 with only 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 molecular composition of the fluid within the fluid path section 570 as well as its sidewalls. With fluid path section 570 filled with air, the optical signal passing from emitter 312 to detector 314 is attenuated by absorption by the molecular composition of the sidewalls of fluid path section 570 (there is no absorption by unprimed air in the fluid path or large bubbles). According to various embodiments, detector 312 can use the difference in optical 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] Detector 314 is configured to send an output signal (e.g., an output voltage) to controller 900 based on the signal strength of the detected electromagnetic radiation ER. Thus, the output signal varies depending on the refractive index and absorption characteristics of the contents of gap G, allowing controller 900 to determine whether fluid path section 570 is absent ( FIG. 3 ), whether fluid path section 570 is present and filled with injection fluid F ( FIG. 4 ), or whether fluid path section 570 is present and at least partially filled with air ( FIG. 5 ). In various embodiments, controller 900 can determine the type of fluid (e.g., from a known database of commercially available contrast medium solutions) and / or the fluid dilution ratio (i.e., the ratio of contrast medium to saline during dual-flow injection) based on the output signal of detector 314. Specifically, sensor module 300C ( FIG. 2 ), downstream of the confluence of patient lines 210A, 210B, may be configured to measure the dilution of contrast medium from first syringe 10A by saline from second syringe 10B. To obtain reliable results, emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the output signal generated by detector 314 is sufficiently different between fluid types that sensor 310 can distinguish between different contrast agent types and / or different dilutions. For example, if sensor 310 is intended to distinguish between contrast medium and saline, emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the range of output voltages of detector 314 when saline is present in fluid path section 570 does not overlap with the range of output voltages of detector 314 when contrast medium is present in fluid path section 570. Similarly, if sensor 310 is intended to distinguish between contrast medium types, emitter 312, detector 314, and fluid path section 570 are selected and positioned such that the range of output voltages of detector 314 when a particular contrast agent type is present in fluid path section 570 does not overlap with the range of output voltages of detector 314 when a different contrast medium type is present in fluid path section 570.
[0128] FIG. 23 shows an electrical schematic diagram 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, which are positioned such that the detector 314 receives electromagnetic radiation from the emitter 312 and alters the received electromagnetic radiation due to absorption and / or reflection by 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 resulting 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 an appropriate forward current through the LED(s). The detector 314 may be one or more phototransistors, photoresistors, or photodiodes with an associated sensor resistor 324. The sensor resistor 324 converts the 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, sensor modules 300A, 300B are provided within a manifold housing module 220 associated with fluid infuser 12. Manifold housing module 220 may define a receiving channel 222 for movably receiving a manifold 500 of a fluid pathway set. Manifold 500 may be a disposable component that serves as a junction for first syringe line 208A, first patient line 210A, and first fill line 216A (FIG. 2). Specifically, manifold 500 may include a first inlet port 510 connected to or integrally formed with syringe line 208A, a first outlet port 512 connected to or integrally formed with patient line 210A, and a first fill port 514 connected to or integrally formed with fill line 216A. Similarly, manifold 500 can serve as a junction for second syringe line 208B, second patient line 210B, and second fill line 216B (FIG. 2). Manifold 500 can include a second inlet port 520 connected to or integrally formed with syringe line 208B, a second outlet port 522 connected to or integrally formed with patient line 210B, and a second fill port 524 connected to or integrally formed with fill line 216B. Manifold 500 defines a respective fluid path section 570 adjacent each of fill ports 514, 524 configured to be operatively positioned between emitter 312 and detector 314 of respective sensor modules 300A, 300B.
[0130] Manifold 500 can include at least one connecting beam 550 that, together with receiving channel 222, orients and positions manifold 500 and precisely indexes and interfaces fluid path section 570 with sensor modules 300A, 300B. Manifold 500 is therefore designed to allow a user to quickly and accurately install a tubing set within manifold housing module 220 so that the air detection region of the fluid flow path is properly inserted into the reading portion of sensor module 300A, 300B. For example, in preparing fluid injector system 2000 for a new injection procedure, a user need only connect syringe lines 208A, 208B to syringes 10A, 10B, snap manifold 500 into manifold housing module 220, connect fill lines 216A, 216B to bulk fluid sources 19A, 19B (e.g., by pushing fill lines 216A, 216B into their respective bulk fluid sources 19A, 19B), and the fluid pathway set should be ready for priming. In certain cases, manifold 500 and manifold housing module 220 may include complementary latching components, for example, on at least one connecting beam 550, to releasably engage manifold 500 with manifold housing module 220. In certain embodiments, 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 fluid path section 570 includes a sidewall 530 configured to allow passage of electromagnetic radiation from the emitter 312 to the detector 314 when the fluid path section 570 is disposed in operative association with the sensor module 300A, 300B. Each sidewall 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 so that they cannot deflect; deflection could alter the path of the electromagnetic radiation ER through the fluid path section 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 other embodiments, the sidewall 530 may have one or more substantially flat outer and inner surfaces. The one or more substantially flat surfaces may be positioned such that the path of 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 de-converging lensing effects of the surfaces on the beam of electromagnetic radiation as it passes through the first fluid path section 570. In other embodiments, the sidewall 530 may include or function as a lens to focus or disperse 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; 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 electromagnetic radiation passing through the fluid path section 570.
[0132] 6, manifold 500 can include one or more check valves, such as check valves 516, 526 located in fill ports 514, 524, respectively. Check valves 516, 526 can act to prevent backflow of fluid into bulk fluid containers 19A, 19B during pressure injection. In some embodiments, additional check valves or actively controlled valves (e.g., stopcocks, pinch valves, etc.) can be located at any of inlet ports 510, 520, outlet ports 512, 522, and fill ports 514, 524 to selectively control fluid flow through manifold 500.
[0133] Manifold 500 may include one or more encoded identifiers 580, such as a barcode, QR code, RFID tag, etc., located on at least one connecting beam 550 or a fluid path wall. Fluid injector 12 may have an appropriately positioned reader 280, such as a barcode reader, QR code reader, RFID reader, etc., associated with manifold housing module 220. When manifold 500 is properly engaged with manifold housing module 220, encoded identifier 580 is read by the reader to determine one or more characteristics of manifold 500 and associated fluid path elements, such as one of: that manifold 500 is properly inserted; that it is the correct manifold 500 for the injection procedure; that the manufacturing dates of manifold 500 and associated fluid path components are within a required timeframe; and whether the manufacturer of manifold 500 is an approved manufacturer. If the controller 900 determines that the coded 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] Continuing with reference to FIG. 6 , the manifold housing module 220 can include additional sensor modules 300X, 300Y associated with 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 air bubble detection and analysis, as described in International Application No. US2022 / 017812, filed February 25, 2022, the disclosures of each of which are incorporated herein by reference. Further details of the structure and function of the manifold 500 and the manifold housing module 220 are provided in International Application No. US2022 / 017812.
[0135] Referring to FIG. 7 , one 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 function 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 so that it cannot deflect; deflection could alter the path of the electromagnetic radiation ER through the fluid path section 570, resulting in unreliable sensor readings. 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, allowing an operator to freely position the sensor modules 300A, 300B, for example, to avoid certain orientations that receive large amounts 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 positioned 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 greater absorption and / or refraction of the electromagnetic radiation by the fluid. Empirical testing has shown that the larger the fluid diameter, the greater the absorption and the greater the difference in detector output signal between fluid types. Therefore, increasing the diameter of the fluid path section 570 through which the electromagnetic radiation travels can result in more reliable and improved determination by the controller 900 of the fluid characteristics within the fluid path section 570. In some empirically tested embodiments, increasing the diameter of the fluid path section 570 accentuates the absorption difference in a square-law 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 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 electromagnetic radiation leaving the emitter 312 to a substantially straight-line 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 so 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 shorter than their diameter. In some embodiments, the collimating apertures 350, 352 may have a length that is longer than their diameter.
[0138] The sensor modules 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 equally apply 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 detecting and analyzing air bubbles. Examples of additional sensors for detecting and determining the analysis of air bubbles are provided in International Application Publication No. US 2022 / 017812. The emitters 412, 412' of the respective additional sensors 410, 410' may be configured to emit electromagnetic radiation at the same or different wavelengths as the sensor 310. 7, the additional sensors 410, 410′ are positioned downstream of the sensor 310. In another embodiment, the additional sensors 410, 410′ may be positioned upstream of the sensor 310 or at an entirely different point in the fluid path set. The sensor 310 and the additional sensors 410, 410′ may be configured to distinguish between air and fluid (e.g., saline and contrast medium) within the fluid path section 570. In some embodiments, the additional sensors 410, 410′ may be configured to act in conjunction with the controller 900 to detect air bubbles within the fluid path section 570, determine the flow velocity of the detected air bubbles, and / or determine the volume of the detected air bubbles. The controller 900 may be configured to determine the 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 sensor modules 300A, 300B may be disposed in operative association with fluid path section 670 of manifold 600. Manifold 600 and associated sidewall 630 may clip or otherwise engage corresponding features on tips 16A, 16B of syringes 10A, 10B via a clip engagement mechanism such as described in International Application Publication No. US 2021 / 018523, the disclosure of which is incorporated by reference. Manifold 600 includes inlet ports 610 configured for connection with 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 can be utilized for gross air detection within the fill lines 216A, 216B during angiography (CV) or computed tomography (CT) procedures corresponding to the refilling of an in-use syringe 10A, 10B from a bulk fluid container 19A, 19B. As mentioned herein, the sensor modules 300A, 300B can be used to distinguish between an injection fluid F and air within the fluid path section 570, distinguish between two types of injection fluids common to MR, CV, or CT injection procedures (i.e., contrast media type and saline), distinguish between the type and / or concentration of the contrast media, determine whether the fluid path section 570 is inserted into the sensor modules 300A, 300B, and 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 indicate each with a predetermined color depending on the contents of the syringes 10A, 10B. Assuming 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 indicate 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 coupled to each syringe 10A, 10B, and the syringes 10A, 10B can function as light tubes to display a color indicative of the filled contents of the syringes 10A, 10B (e.g., green for contrast medium or blue for saline). The plungers 14A, 14B may 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 the 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 refrain from 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 can 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 a 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 whether it 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 a 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 can alert the operator via a message displayed on the GUI 11 and / or automatically stop the fill procedure. In some embodiments, the controller 900 continues the fill procedure and adjusts the injection protocol and GUI display so that the first syringe 10A is designated as a saline syringe (i.e., by highlighting the syringe in blue on the GUI) and the controller is configured to inject saline from syringe 10A using the 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 designated as a contrast syringe (i.e., by highlighting the syringe in green on the GUI) and the controller injects contrast from syringe 10B using the 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 GUI display 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, eliminating the need to repeat the fill operation.
[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 differs from 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 proportion 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 absent 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 bubbles, a low level of light transmission through the fluid path section occurs, for example, due to 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 fluid is present in the fluid path section 570, the light absorption properties and / or refractive index of the fluid 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 solutes (salts) dissolved in the aqueous solution, absorbs / refracts a first amount of light to the detector 314 that is greater than the amount of light absorbed / refracted by an air-filled fluid path section 570, resulting in a first voltage reading that is lower than that of air or the absence of the fluid path section 570. A contrast medium, due to the type of solutes (contrast molecules) dissolved in the aqueous solution, absorbs / refracts a second amount of light to the detector 314 that is greater than the amount of light absorbed / refracted by a saline or air-filled fluid path section 570 or the absence of the fluid path, resulting in a lower voltage reading. While the preceding 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 rates.
[0146] As described herein, according to certain embodiments, the sensitivity of detector 314 can also allow for differentiation between different types of contrast agents and / or different concentrations of the same contrast medium. For example, different concentrations of the same contrast medium have different densities due to different amounts of solutes dissolved in solution, resulting in different refractive indices and / or different amounts of light absorption. Thus, the fluid allows different levels of electromagnetic radiation to reach detector 314, resulting in different detector output voltage signals. In some embodiments, controller 900 may be calibrated or configured to reference a database associated with output voltages for different contrast agent types or different contrast agent concentrations, for example, in a lookup database programmed into controller 900. Thus, controller 900 can determine which brand, type, and / or concentration of contrast medium is in first syringe 10A (or second syringe 10B, if second syringe 10B is incorrectly 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 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 syringe fill time while reducing the generation of air bubbles generated in the fluid due to excessive flow rates of the fluid into the syringes. For example, the controller 900 can store and utilize air detection results and correlate the air detection results with specific fill rates so that an optimal fill rate (maximum rate) can be determined that prevents or reduces the introduction of air bubbles into the fluid in the syringes 10A, 10B. For example, the predetermined safe fill rate for saline may be higher than the predetermined safe fill rate for contrast medium.
[0148] Referring to FIG. 8A, histogram 2100 shows the empirically observed output voltage 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. Voltage was 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 the optimal size for obtaining a signal difference with 0.188-inch tubing. As can be seen from FIG. 8A, the observed detector 314 output voltage for empty tubing (i.e., only air in fluid path section 570) ranged from 0 to 0.25 volts. The observed detector 314 output voltage for no tubing (i.e., no fluid path section 570 operatively associated with sensor 310) ranged from 1 to 1.25 volts. The detector 314 output voltage observed for saline in fluid path section 570 was in the range of 3.75 to 4.25 volts, and the detector 314 output voltage observed for contrast agent in fluid path section 570 was in the range of 4.75 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 the detector output voltage across several test measurements of various fluids in fluid path section 570, also using infrared light and a 0.228 inch gap G 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 for Isovue® 370 and one example of saline, the standard deviation of the detector output voltage was less than 0.01 volts. The low standard deviation for these fluids indicates that the detector 314 output voltage is consistent for each particular fluid, again demonstrating that 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 predetermined 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 detector output signal 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 predetermined thresholds. For example, because the output voltage signal for saline or contrast media never falls below the output voltage signal for air, the controller 900 may not have an upper limit associated with 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 fluid path section 570 as evident from histogram 2100, 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 the 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 the 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 generates electromagnetic radiation in the UV spectrum at approximately 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 output voltage of detector 314.
[0153] 8A-11 show data for only a few embodiments having specific configurations of sensor 310. Other configurations, which 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, or 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, detector 314 may output a voltage of approximately 1.609 volts when no fluid path section is 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, or approximately 4.65 volts when the fluid path section is filled with contrast medium. In another embodiment, detector 314 may output a voltage of approximately 5.0 volts when no fluid path section is 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 transmittances 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 transmittance of electromagnetic radiation through various dilutions of Ultravist® 370 contrast medium in a 10 millimeter (mm) glass cuvette. The transmittance of electromagnetic radiation through water in a 10 mm glass cuvette is also shown as a baseline value, with essentially 100% transmittance. 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 greatest differences in relative transmittance between the various dilutions occur in or near the UV spectrum, e.g., the 370 to 390 nm region, specifically approximately 379 nm in this embodiment.
[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 in water. Specifically, because detector 314 detects electromagnetic radiation passing through the fluid in fluid path section 570, differences in the transmittance of the various dilutions will result in different amounts of electromagnetic radiation reaching detector 314. As a result, the resulting output signal generated by detector 314 will be different for water and dilutions of contrast agent, which have different transmittances at a given wavelength. By using emitter 312 that emits electromagnetic radiation at a predetermined wavelength, for example, approximately 379 nm, controller 900 can determine approximately which dilution of Ultravist® 370 is present in fluid path section 570 based on the output signal of detector 314. Specifically, controller 900 may be configured to match the output voltage of 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 the dilution ratio of the Ultravist® 370 based on the output voltage of the detector 314.
[0156] Referring to FIG. 13 , graph 2600 shows the transmittance 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 transmittance of the same commercially available contrast medium solutions for electromagnetic radiation having wavelengths between 900 and 1050 nm. As shown in FIG. 12 , differences 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 greatest difference in transmittance of various contrast medium solutions may occur in or near the infrared and ultraviolet regions of the electromagnetic spectrum. Therefore, emitter 312 can be configured to generate electromagnetic radiation in or near the infrared and ultraviolet regions of the electromagnetic spectrum to take advantage of this difference. In another embodiment, emitter 312 may be configured to generate electromagnetic radiation in the visible spectrum. In another embodiment, 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 and one in the ultraviolet region of the electromagnetic spectrum. Thus, emitter 312 can pulse electromagnetic radiation of different wavelengths through fluid path section 570 to collect several absorption / transmission data points on the fluid in fluid path section 570 to more accurately determine the identity of the fluid in 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. Specifically, 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 illustrate various tubing shapes and manufacturing defects that may exist within the fluid path section associated with the sensor 310. FIG. 16 illustrates 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 designed 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 oval-shaped tubing, where the inner and / or outer diameter of the sidewall 530 is not perfectly round. FIG. 20 illustrates whiskers 584 on the sidewall 530, such as the inclusion of 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 can 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 can require lower sensitivity, and therefore tubing irregularities in Figures 16-20 can have less or negligible effect on these determinations.
[0158] In some embodiments, controller 900 may be configured to perform test measurements prior to an injection and / or syringe filling procedure to establish the presence and potential effect of these geometric features / defects on the output signal from detector 314. Controller 900 may use the results of the test measurements to configure detector 314 and / or calculate one or more correction factors based on the effect of features / defects in one or both of the contrast injection fluid path and the flushing fluid path. During the fill and / or injection procedure, controller 900 may apply the correction factors to the output signal from detector 314 to compensate for manufacturing features / defects.
[0159] An additional manufacturing issue that can affect sensor readings is when the inner diameter of the sidewall 530 differs from the expected value. This can occur due to manufacturing tolerances and / or the use of third-party fluid path set components. Because the controller 900 can utilize a predetermined diameter constant corresponding to the inner diameter to convert the detected length of the bubble to volume, an unexpected inner diameter of the sidewall 530 can particularly affect the bubble volume calculation. 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 refraction of the empty fluid path section. Based on the test measurement, the controller 900 can apply a correction factor to subsequent output signals 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 higher 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 increases in the intensity of light from the emitter 312 do 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 to saturate the detector 314, 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 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 reaching the detector 314, the refractive index and absorption properties of the fluid within 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, such as air, saline, and contrast agent, as well as to distinguish between the type and / or concentration of contrast agent. 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 were present within the fluid path section. If the detector output voltage indeed reaches its saturation limit in response to this emitter current, the controller 900 can determine that only air is present within 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 estimate 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 contains 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, controller 900 drives emitter 312 at a fifth emitter current 750, which corresponds to a known current that will not saturate detector 314 even if only air is present in the fluid path section. At this emitter current, the detector output voltages associated with air 850, first contrast agent solution 852, second contrast agent solution 854, and third contrast agent solution 856 are all below the saturation limit of detector 314. Nevertheless, the detector output voltage associated with air 850 is sufficiently distinct from the detector output voltages associated with contrast agent solutions 852, 854, and 856 that controller 900 can conclude that air is present in the fluid path section based on the actual measured detector output voltages of 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 fluids, particularly the first, second, and third contrast agent solutions 852, 854, 856. To do so, the controller 900 can drive the emitter 312 at a sixth emitter current 752 that is greater than the fifth emitter current 750. At the sixth emitter current 752, the detector output voltage associated with air 850 is at the saturation limit of the detector 314. The detector output voltage associated with the second contrast agent solution 854 has moved away from 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 agent solutions 852, 852, based on the output voltage of the detector 314. Furthermore, a removal method allows the contrast agent 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 agent solutions 854, 856. At the seventh emitter current 754, the detector output voltages associated with the air 850 and the first contrast agent solution 852 are at the saturation limit of the detector 314. The detector output voltage associated with the third contrast agent solution 856 has moved away from the dark level. Additionally, the spread between the detector output voltages associated with the second and third contrast agent solutions 854, 856 has increased, making it easier and / or more reliable to distinguish between the second and third contrast agent 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 agent solution 852, and the second contrast agent solution 854 are at the saturation limit of the detector 314. Thus, the controller 900 can determine that the third contrast agent 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] Referring to FIG. 22, a graph of exemplary detector 314 output signals is shown for sensor 310 operably associated with syringe tips 16A, 16B (as shown in FIG. 7 or FIG. 24) with 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 syringe caps "A", "B", and "C": syringe cap not operably associated with sensor module 300A, 300B; syringe cap operably associated with sensor module 300A, 300B and filled with air; and syringe cap operably associated with sensor module 300A, 300B and filled with water. The output signal from detector 314 enables controller 900 to distinguish between these three conditions, regardless of the inner diameter of the syringe cap. Across measurements taken 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 operated at a wavelength of 1450 nm.
[0167] While 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. Accordingly, the above description is intended to be illustrative rather than limiting. The above-described disclosure is defined by the appended claims, and all changes to the present disclosure that come within the meaning and range of equivalency of the claims are to 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 Third Sensor Module 300X Additional Sensor Modules 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 Fourth Emitter Current 750 5th emitter current 752 6th emitter current 754 Seventh Emitter Current 758 Eighth 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 agent solution 900 Controller 2000 Fluid Injector System 2100 Histogram 2150 graph 2200 graphs 2300 graphs 2400 graphs 2500 graphs 2600 graphs 2700 graphs 2800 graphs
Claims
1. 1. A fluid injector system comprising: a first fluid path section providing fluid communication between a first bulk fluid container and a first fluid reservoir, the first fluid reservoir being a first syringe connected to at least one injector; a first sensor disposed along the first fluid path section, the first sensor comprising: a first emitter configured to emit light through the first fluid path section; a first detector configured to receive the light emitted through the first fluid path section and to generate an electrical signal based on at least one characteristic of the received light; a first sensor comprising: at least one processor programmed or configured to determine, based on the electrical signal generated by the first detector, the identity of the at least one fluid present in the first fluid path section or that the first fluid path section contains air instead of a fluid; Equipped with the at least one processor is programmed or configured to determine whether the fluid filling the first fluid reservoir is the correct fluid based on the electrical signal generated by the first sensor; adjusting an injection protocol to ensure that injection parameters are updated according to the identity of the first fluid reservoir so that the correct fluid is associated with the first fluid reservoir; Fluid injector system.
2. 10. The fluid injector system of claim 1, a second fluid path section providing fluid communication between a second bulk fluid container and a second fluid reservoir, the second fluid reservoir being a second syringe connected to the at least one injector; a second sensor disposed along the second fluid path section, the second sensor comprising: a second emitter configured to emit light through the second fluid path section; and a second detector configured to receive the light emitted through the second fluid path section and generate a second electrical signal based on at least one characteristic of the received light; a second sensor comprising: Further provided with the at least one processor is programmed or configured to determine whether the fluid filling the second fluid reservoir is the correct fluid based on the electrical signal generated by the second sensor; adjusting the injection protocol to ensure that injection parameters are updated according to the identity of the second fluid reservoir so that the correct fluid is associated with the second fluid reservoir; Fluid injector system.
3. 3. The fluid injector system of claim 2, wherein when the at least one processor determines that a first fluid is associated with the second fluid reservoir and a second fluid is associated with the first fluid reservoir, the at least one processor is programmed or configured to modify the injection protocol by configuring the first fluid reservoir to inject the fluid originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject the fluid originally intended to be injected by the first fluid reservoir.
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 to indicate that the first fluid reservoir contains the fluid originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains the fluid originally intended to be injected by the first fluid reservoir.
5. 4. The fluid injector system of claim 3, wherein the at least one processor is programmed or configured to illuminate a first light source associated with the first fluid reservoir and illuminate a second light source associated with the second fluid reservoir to indicate that the first fluid reservoir contains the fluid originally intended to be infused by the second fluid reservoir and that the second fluid reservoir contains the fluid originally intended to be infused by the first fluid reservoir.
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 the at least one fluid in 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 fluid infuser system of claim 2 .
7. 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 at least one processor is programmed or configured to determine that air is present 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 at least one processor determines that the first fluid path section or the second fluid path section contains air, the at least one processor is 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. 3. The fluid injector system of claim 2, wherein the at least one processor is programmed or configured to determine, based on the electrical signal, whether the first fluid path section or the second fluid path section is between the first emitter and the first detector of the first sensor or between the second emitter and the second detector of the second sensor.
10. the first detector is configured to output a first voltage signal when the first fluid path section contains a contrast medium; the first detector is configured to output a second voltage signal when the first fluid path section contains saline; the at least one processor is programmed or configured to determine the identity of the fluid in the first fluid path section based on a difference between the first voltage signal and the second voltage signal. The fluid infuser system of claim 1 .
11. the first detector is configured to output a third voltage signal when the first fluid path section contains air; the at least one processor is programmed or configured to determine that air is present in the first 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 10.
12. 12. The fluid injector system of claim 11, wherein when the at least one processor determines that the first fluid path section contains air, the at least one processor is configured to provide an alert to a user that the first bulk fluid container is empty.
13. 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 is present between the first emitter and the first detector of the first sensor.
14. 1. A method for determining one or more fluid characteristics of an injection fluid flowing within a first fluid path section of a fluid injector system, the fluid injector system comprising: a first fluid reservoir for delivering a first infusion fluid; a first bulk fluid container in fluid communication with the first fluid reservoir through the first fluid path section; a first sensor associated with the first fluid path section; Equipped with The method comprises: 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; determining an identity of an infusion fluid present in the first fluid pathway section based on the electrical signal generated by the first detector; determining whether the injection fluid flowing from the first bulk fluid container into the first fluid reservoir was originally intended to fill the first fluid reservoir based on the electrical signal generated by the first sensor, and based on the result of the determination: adjusting an injection protocol to ensure that injection parameters are updated to correctly identify the injection fluid in the first fluid reservoir; and notifying a user if the injection fluid in the first fluid reservoir is incorrect; and performing at least one of: A method comprising:
15. 15. The method of claim 14, wherein the fluid infuser system comprises: a second fluid reservoir for delivering a second infusion fluid; a second bulk fluid container in fluid communication with the second fluid reservoir through the first fluid path section; a second sensor associated with the second fluid path section; Further provided with The method comprises: emitting light from a second emitter of the second sensor through the second fluid path section; detecting light that has passed through the second fluid path section with a second detector of the second sensor; determining an identity of an infusion fluid present in the second fluid pathway section based on the electrical signal generated by the second detector; determining, based on the electrical signals generated by the first sensor and the second sensor, whether the injection fluid flowing from the first bulk fluid container into the first fluid reservoir was originally intended to fill the first fluid reservoir, and whether the injection fluid flowing from the second bulk fluid container into the second fluid reservoir was originally intended to fill the second fluid reservoir; adjusting an injection protocol to ensure that injection parameters are updated to correctly identify the injection fluid in the first fluid reservoir and the injection fluid in the second fluid reservoir based on the result of determining that the injection fluid flowing from the first fluid reservoir is the second injection fluid, injecting the second injection fluid into the first fluid reservoir using the injection protocol originally for the second fluid reservoir, and injecting the first injection fluid into the second fluid reservoir using the injection protocol originally for the first fluid reservoir; The method further comprises:
16. 16. The method of claim 15, further comprising the step of adjusting a display of a graphical user interface to indicate that the first fluid reservoir contains the second infusion fluid and that the second fluid reservoir contains the first infusion fluid if the infusion fluid flowing from the first fluid reservoir is the second infusion fluid and the infusion fluid flowing from the second fluid reservoir is the first infusion fluid.
17. 16. The method of claim 15, further comprising illuminating a first light source associated with the first fluid reservoir and illuminating a second light source associated with the second fluid reservoir to indicate that the first fluid reservoir contains the second injection fluid originally intended to be injected by the second fluid reservoir and that the second fluid reservoir contains the first injection fluid originally intended to be injected by the first fluid reservoir.
18. 16. The method of claim 15, 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 an 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 infusion fluid including saline; The method further includes determining the identity of the infusion fluid in the first fluid pathway section or the second fluid pathway section based on a difference between the first voltage signal and the second voltage signal. method.
19. 20. The method of claim 18, 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 includes 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. method.
20. 16. The method of claim 15, determining, based on the electrical signal, whether the first fluid path section exists between the first emitter and the first detector of the first sensor, and determining whether the second fluid path section exists between the second emitter and the second detector of the second sensor. method.
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