System and method for syringe fluid fill verification and image recognition of power injector system features

Abstract

To allow differentiation between air and / or different types of fluids contained within a syringe of a fluid injector, thereby enhancing the safety by preventing air injections and improving the workflow by preventing technicians from mixing up the fluid types.SOLUTION: The invention provides a fluid injection system and a fluid verification system for confirming that a syringe, containing a fluid for injection, is fully filled with the fluid and neither has free space (i.e., air) near the distal end thereof when the syringe is provided in an upright position nor contains air bubbles. Imaging processing techniques and systems are also provided to determine various injection parameters and to verify the type and certain properties of the fluid that is present within the syringe.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 211,462, filed August 28, 2015, entitled "System and Method for Syringe Fluid Fill Verification and Image Recognition of Power Injector System Features," and to U.S. Provisional Patent Application No. 62 / 259,824, filed November 25, 2015, entitled "System and Method for Syringe Fluid Fill Verification and Image Recognition of Power Injector System Features," the contents of which are incorporated herein by reference.

[0002] The present disclosure relates to systems and methods for verifying that a syringe is filled with a fluid, and in particular for determining the presence of such fluid based on an illumination pattern produced by electromagnetic radiation projected through a portion of a filled syringe. In other aspects, the present disclosure relates to systems and methods for identifying various features and characteristics of the fluid within a syringe. [Background technology]

[0003] In many medical, diagnostic and therapeutic procedures, practitioners, such as physicians, inject medical fluids into patients. In recent years, a number of injector-actuated syringes and power injectors for pressurized injection of fluids, such as contrast agents (often simply called "contrast"), drugs, or saline, have been developed for use in imaging procedures such as angiography, computed tomography, ultrasound, and magnetic resonance imaging. Generally, these power injectors are designed to deliver a preset amount of contrast agent or other fluid at a pre-set flow rate.

[0004] One of the problems associated with using such autoinjector systems to inject fluids into a patient is the possibility of air being present in the syringe or fluid delivery system prior to injection. This problem is of particular concern in injection procedures of contrast media, which are often colorless or colored to only a limited extent. Furthermore, imaging procedures are often performed at relatively low light levels to facilitate reading of x-rays, computer display screens, and the like. Thus, there is an increased concern that air in the syringe will not be identified prior to the injection procedure. It is therefore desirable to easily detect whether the syringe is not filled with fluid or is only partially filled with fluid (i.e., the syringe contains a quantity of air) prior to attempting an injection.

[0005] In some previously provided solutions, the presence of liquid is indicated by a change in the shape of an indicator pattern on the barrel of the syringe, as described, for example, in U.S. Pat. No. 4,452,251 to Heilman and U.S. Pat. No. 5,254,101 to Trombley, III, both of which are incorporated herein by reference. However, there is a need for systems and methods that further help indicate the presence of liquid when the syringe is viewed from a distance, or that allow verification of a filled syringe at a glance. An automated system for verifying that the syringe is completely filled and does not contain air is also desirable.

[0006] Furthermore, because most medical fluids used with power injectors are transparent, it is very difficult for a technician to quickly and easily distinguish between the fluid and air present in a translucent syringe. Thus, there is a need for a system used with a fluid injection device that can distinguish between air and different types of fluid. Additionally, an automated system that can determine various properties of the fluid by analyzing the characteristics and / or changes in the interaction of electromagnetic radiation with the contents of the syringe and communicating those properties to a user, for example, via a display screen, is also desirable. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Pat. No. 4,452,251 [Patent Document 2] U.S. Pat. No. 5,254,101 Summary of the Invention [Problem to be solved by the invention]

[0008] The systems and methods described herein indicate to an operator of a fluid injector the presence of liquid in a syringe when the syringe is viewed from a distance, or allow for verification of a filled syringe at a glance. Additionally, an automated system for verifying that a syringe is completely filled and does not contain air is also provided. Such a system allows for differentiation of air and / or different types of fluid contained within a syringe of a fluid injector, improving safety by preventing air injection and improving workflow by preventing technicians from confusing fluid types. Additionally, in certain embodiments, the system can determine one or more characteristics of the fluid in the syringe and / or the injection procedure. [Means for solving the problem]

[0009] According to one aspect of the disclosure, a syringe is provided that includes a syringe barrel including a proximal end and a distal end including an inclined surface, and a plunger slidably disposed within the syringe barrel and configured to advance through the syringe barrel to expel a fluid therefrom, The plunger includes a transparent or translucent material configured to transmit electromagnetic radiation such that an illuminated identification pattern is formed on a predetermined portion of the distal end of the syringe barrel when the syringe is filled with fluid.

[0010] In one embodiment, the shape of the syringe barrel can be such that when the internal volume of the syringe barrel is completely or partially filled with air, at least one characteristic of the illuminated identification pattern is different compared to when the syringe is completely filled with fluid, The at least one characteristic can include at least one of the presence, size, shape, and brightness of the illuminated identification pattern.

[0011] In one embodiment, the illuminated identification pattern may not be visible when the percentage of the volume of air present at the distal end of the syringe is greater than about 15% of the volume of the distal end of the syringe having the beveled surface. In another embodiment, the illuminated identification pattern may be visible to an observer or sensor when the syringe is viewed from the side in a straight orientation or in a forward or backward tilted orientation. The beveled surface at the distal end of the syringe barrel may have an angle of about 30 degrees to 60 degrees relative to the longitudinal axis of the syringe.

[0012] In one embodiment, the electromagnetic radiation source may include a light bulb, an LED bulb, a photon emitter, an infrared emitter, a laser, or an ambient light. In another embodiment, the at least one reference line or marking may be formed on the distal end of the syringe barrel and extend around the circumference of the distal end of the syringe barrel. The at least one reference line or marking may be formed on the barrel of the syringe by at least one of printing, overmolding, and etching. In one embodiment, a first reference line or marking of the at least one reference line or marking is configured to align with a first predetermined portion of the illuminated identification pattern when a first fluid is present in the syringe, and a second reference line or marking is configured to align with a second predetermined portion of the illuminated identification pattern when a second fluid is present in the syringe. The at least one reference line or marking may be configured to align with a predetermined portion of the illuminated identification pattern when a first fluid is present in the syringe, and may be configured to be located away from the illuminated identification pattern when a second fluid is present in the syringe.

[0013] According to another aspect of the present disclosure, a system is provided for indicating whether a syringe is ready for use to inject a fluid into a patient's body, the system comprising: a syringe with a barrel including a distal end having an inclined surface and defining an interior volume configured to receive a fluid; and an electromagnetic radiation source arranged to emit electromagnetic radiation through at least a portion of the syringe, the syringe being shaped such that when the syringe is filled with fluid, at least a portion of the electromagnetic radiation is affected by interaction of the electromagnetic radiation with at least one interface associated with the fluid and the syringe to form an illuminated identification pattern indicative of the contents of the syringe at a predetermined portion of the syringe.

[0014] In one embodiment, the syringe may be shaped such that when the internal volume is completely or partially filled with air, at least one characteristic of the illuminated identification pattern is different compared to when the internal volume is completely filled with fluid. The at least one characteristic may include at least one of the presence, size, shape, and brightness of the illuminated identification pattern. The illuminated identification pattern may not be visible when the percentage of volume of air present at the distal end of the syringe is greater than about 15% of the volume of the distal end of the syringe having the beveled surface.

[0015] In another aspect, the system may further include at least one sensor configured to measure at least one characteristic of the illuminated identification pattern, if present. The at least one sensor may include at least one of an imaging sensor, an optical sensor, an electromagnetic radiation detector, or a digital camera. In another aspect, the system may also include a fluid injector configured to interface with the syringe to expel fluid from the syringe. The fluid injector may include a controller configured to receive a confirmation signal from the at least one sensor when the measurement of the at least one characteristic of the illuminated identification pattern indicates that the syringe is substantially filled with fluid, the controller configured to activate the injector to perform the injection when the confirmation signal is received.

[0016] In one embodiment, the illuminated identification pattern may be visible to an observer or sensor when the syringe is viewed from the side in a straight-on orientation or in a forward or backward tilted orientation. In another embodiment, the illuminated identification pattern may include an annular shape extending around at least a portion of the distal end of the syringe barrel. In yet another embodiment, the angled surface at the distal end of the barrel may have an angle of about 30 degrees to 60 degrees relative to the longitudinal axis of the syringe. In one embodiment, the electromagnetic radiation source may include a light bulb, an LED bulb, a photon emitter, an infrared emitter, a laser, or ambient light.

[0017] In certain aspects, the syringe may further comprise a plunger, and the electromagnetic radiation source is positioned to project at least a portion of the electromagnetic radiation onto or through the plunger. In one example, at least a portion of the plunger comprises a transparent or translucent material. In another example, at least a portion of the plunger comprises a colored material.

[0018] According to another aspect of the present disclosure, a method for syringe fluid fill verification is provided, the method including emitting electromagnetic radiation through at least a portion of a syringe, identifying whether at least a portion of the electromagnetic radiation produces an illuminated identification pattern in a predetermined portion of the syringe, and determining contents of the syringe based on at least one characteristic of the illuminated identification pattern.

[0019] In one aspect, the at least one characteristic may be at least one of the presence of an illuminated identification pattern, a size of the illuminated identification pattern, a shape of the illuminated identification pattern, and a brightness of the illuminated identification pattern. In another aspect, identifying whether at least a portion of the electromagnetic radiation produces an illuminated identification pattern includes measuring at least one characteristic of the illuminated identification pattern with at least one sensor associated with the syringe and receiving a confirmation signal from the at least one sensor indicative of a value of the at least one characteristic of the illuminated identification pattern. In an additional aspect, emitting the electromagnetic radiation through at least a portion of the syringe includes emitting the electromagnetic radiation through a syringe plunger, at least a portion of which comprises a transparent or translucent material.

[0020] According to another aspect of the disclosure, a fluid injection system is provided that includes a fluid injector, at least one syringe operably engaged with the fluid injector, and an electromagnetic radiation source. The at least one syringe includes a barrel including a distal end having an inclined surface and defining an interior volume configured to receive a fluid. The electromagnetic radiation source is positioned relative to the at least one syringe and emits electromagnetic radiation through at least a portion of the at least one syringe, such that when the syringe is filled with fluid, at least a portion of the electromagnetic radiation is affected by interaction of the electromagnetic radiation with at least one interface associated with the fluid and the syringe to form an illuminated identification pattern indicative of the contents of the at least one syringe on a predetermined portion of the at least one syringe. The fluid injection system also includes an image capture device positioned to capture an image of the illuminated identification pattern, and at least one computing device in communication with the image capture device and the fluid injector. The at least one computing device includes at least one processor configured to determine a distance from a bottom to a top of the illuminated identification pattern in an image of the illuminated identification pattern, compare the distance from the bottom to the top of the illuminated identification pattern to at least one predetermined distance, and based on the comparison of the distance from the bottom to the top of the illuminated identification pattern to the at least one predetermined distance, do at least one of the following: i) display an indication of at least one characteristic of the syringe on a display device in communication with the at least one processor; ii) enable the fluid injector to perform a function; or iii) prevent the fluid injector from performing an operation.

[0021] In one aspect, determining the distance from the bottom to the top of the illuminated identification pattern can include determining a bottom edge of the illuminated identification pattern and determining a top edge of the illuminated identification pattern. The bottom and top edges of the illuminated identification pattern may be determined by determining a change in contrast between adjacent pixels in an image of the illuminated identification pattern.

[0022] In another aspect, the characteristic of the at least one syringe may be the presence of air in the at least one syringe, and the at least one processor may be further configured to provide an indication that air is present in the at least one syringe and prevent the fluid injector from performing the injection procedure if the distance from the bottom to the top of the illuminated identification pattern is less than at least one predetermined distance. Additionally, the at least one processor may be configured to determine a size of the at least one syringe prior to determining the distance from the bottom to the top of the illuminated identification pattern by matching the image of the illuminated identification pattern with a first template of a known illuminated identification pattern of a syringe having a first size. In one aspect, the at least one processor may be further configured to provide an indication that the at least one syringe has a first size if the first template matches the image of the illuminated identification pattern. The at least one processor may be further configured to match the image of the illuminated identification pattern with a second template of a known illuminated identification pattern of a syringe having a second size if the first template does not match the image of the illuminated identification pattern. The at least one processor may be still further configured to provide an indication that the at least one syringe has the second size if the second template matches the image of the illuminated identification pattern.

[0023] In another aspect, the characteristic of the at least one syringe may be a content of the at least one syringe. The at least one predetermined distance may include a first predetermined distance indicative of a first fluid as a content contained in the at least one syringe and a second predetermined distance indicative of a second fluid as a content contained in the at least one syringe. An indication may be provided that the at least one syringe contains a first fluid if a distance from a bottom to a top of the illuminated identification pattern corresponds to the first predetermined distance, and an indication may be provided that the at least one syringe contains a second fluid if a distance from a bottom to a top of the illuminated identification pattern corresponds to the second predetermined distance. If the at least one processor determines that the at least one syringe contains a first fluid, a color of the electromagnetic radiation forming the illuminated identification pattern may be set to a first color, and if the at least one processor determines that the at least one syringe contains a second fluid, a color of the electromagnetic radiation forming the illuminated identification pattern may be set to a second color different from the first color.

[0024] In other embodiments, the at least one syringe may further comprise a plunger, and the electromagnetic radiation source may be positioned to project at least a portion of the electromagnetic radiation through the plunger. In such embodiments, the plunger may comprise a transparent or translucent material. In yet other embodiments, the electromagnetic radiation source may be positioned such that the electromagnetic radiation source reflects through the barrel and off the distal face of the plunger. In such embodiments, the plunger may comprise an opaque colored material. In other embodiments, the electromagnetic radiation source may be positioned adjacent to the barrel of the at least one syringe, and the electromagnetic radiation is reflected off a mirror positioned near a distal end of the barrel and directed toward the distal face of the plunger, and the electromagnetic radiation reflects through the barrel and off the plunger.

[0025] According to an additional aspect of the present disclosure, a fluid injection system is provided that includes a fluid injector; at least one syringe operatively engaged with the fluid injector, the syringe including a barrel including a distal end having an inclined surface and defining an interior volume configured to receive a fluid; an electromagnetic radiation source positioned relative to the at least one syringe and emitting electromagnetic radiation through at least a portion of the at least one syringe, when the syringe is filled with fluid, at least a portion of the electromagnetic radiation being affected by interaction of the electromagnetic radiation with at least one interface associated with the fluid and the syringe to form an illuminated identification pattern indicative of contents of the at least one syringe on a predetermined portion of the at least one syringe; an image capture device positioned to capture an image of the illuminated identification pattern; and at least one computing device in communication with the fluid injector and the image capture device. The at least one computing device comprises at least one processor configured to determine a distance from a bottom to a top of the illuminated identification pattern in an image of the illuminated identification pattern, compare the distance from the bottom to the top of the illuminated identification pattern to a predetermined distance, and if the distance from the bottom to the top of the illuminated identification pattern is less than the predetermined distance, provide an indication that air is present in the at least one syringe and prevent the fluid injector from performing an injection procedure.

[0026] In one aspect, determining the distance from the bottom to the top of the illuminated identification pattern can include determining a bottom edge of the illuminated identification pattern and determining a top edge of the illuminated identification pattern. The bottom and top edges of the illuminated identification pattern may be determined by determining a change in contrast between adjacent pixels in an image of the illuminated identification pattern.

[0027] In another aspect, the at least one processor may be configured to determine a size of the at least one syringe prior to determining the distance from the bottom to the top of the illuminated identification pattern by matching the image of the illuminated identification pattern with a first template of a known illuminated identification pattern of a syringe having a first size. The at least one processor may be further configured to provide an indication that the at least one syringe has a first size if the first template matches the image of the illuminated identification pattern. The at least one processor may be further configured to match the image of the illuminated identification pattern with a second template of a known illuminated identification pattern of a syringe having a second size if the first template does not match the image of the illuminated identification pattern. The at least one processor may be still further configured to provide an indication that the at least one syringe has a second size if the second template matches the image of the illuminated identification pattern.

[0028] According to another aspect of the present disclosure, a fluid injection system is provided that includes a fluid injector, at least one syringe operatively engaged with the fluid injector and configured to be irradiated with an electromagnetic radiation source to irradiate a fluid contained therein, a sensor disposed to capture an image of the irradiated fluid, and at least one computing device in communication with the fluid injector and the sensor, the at least one computing device including at least one processor configured to obtain an image of the irradiated fluid from the sensor, determine at least one of a type of fluid contained within the at least one syringe and whether air is contained within the at least one syringe based on the image of the irradiated fluid, and automatically display, on a display device in communication with the at least one processor, an indication of the type of fluid contained within the at least one syringe and an indication that air is contained within the at least one syringe.

[0029] In certain aspects, the at least one processor may be configured to prevent the fluid injector from performing an injection procedure if air is determined to be contained within the at least one syringe. Brightness measurements made within a region of interest within the illuminated fluid image are utilized to determine at least one of the type of fluid contained within the at least one syringe and whether air is contained within the at least one syringe.

[0030] According to another aspect of the disclosure, a fluid injection system is provided, the fluid injection system comprising: a fluid injector; a syringe operatively engaged with the fluid injector; an image capture device; and at least one computing device in communication with the fluid injector and the image capture device. The syringe comprises a barrel defining an interior volume and at least one feature disposed on the barrel of the syringe. The at least one feature has a different appearance when viewed through different types of fluids contained within the syringe. The image capture device is positioned to capture an image of the at least one feature through the contents of the syringe. The at least one computing device comprises at least one processor configured to obtain an image of the at least one feature through the fluid contained within the syringe, determine an appearance of the at least one feature based on the image of the at least one feature, compare the determined appearance to templates of appearances of the at least one feature when viewed through different types of fluids, and automatically display an indication of a characteristic of the syringe based on the comparison on a display device in communication with the at least one processor.

[0031] In one embodiment, the at least one feature may be formed on the barrel of the syringe by at least one of printing, overmolding, and etching. In another embodiment, the at least one feature may be a fluid dot, a line, a series of lines, or any combination thereof. The appearance of the at least one feature may include at least one of a shape of the at least one feature and an orientation of the at least one feature.

[0032] In one aspect, the characteristic of the syringe may be the presence of air in the syringe, and the at least one processor may be further configured to provide an indication that air is present in the at least one syringe and prevent the fluid injector from performing the injection procedure if the determined appearance matches one of the templates of the appearance of the at least one feature when viewed through air.

[0033] In another aspect, the characteristic of the at least one syringe may be the contents of the at least one syringe, and the at least one processor may be further configured to provide an indication that a first fluid is present in the syringe if the determined appearance matches one of the templates of an appearance of the at least one feature when viewed through the first fluid. In one aspect, the at least one processor may be further configured to provide an indication that a second fluid is present in the syringe if the determined appearance matches one of the templates of an appearance of the at least one feature when viewed through the second fluid.

[0034] According to another aspect of the present disclosure, a fluid injection system is provided, the fluid injection system comprising: a fluid injector; a syringe operably engaged in a vertical direction with the fluid injector, the syringe including a barrel defining an interior volume configured to receive a fluid and at least one object having a density different from a density of the fluid, such that when the fluid is present in the barrel, the at least one object floats; an image capture device arranged to capture images of the barrel; and at least one computing device in communication with the fluid injector and the image capture device. The at least one computing device comprises at least one processor configured to acquire images of the barrel, determine a position of the at least one object within the barrel based on the images of the barrel, and thus determine whether the barrel is either (i) completely filled with fluid or (ii) at least partially filled with air, and based on the determination, provide an indication that air is present in the syringe based on the position of the at least one object, and prevent the fluid injector from performing an injection procedure.

[0035] According to yet another aspect of the present disclosure, a fluid injection system is provided, the fluid injection system comprising: a fluid injector, a syringe operatively engaged with the fluid injector, an image capture device arranged to capture an image of at least a portion of the syringe, and at least one computing device in communication with the fluid injector and the image capture device, the at least one computing device comprising at least one processor configured to obtain an image of at least a portion of the syringe, determine at least one characteristic of an injection procedure performed by the fluid injector based on the at least a portion of the syringe, and adjust the at least one characteristic of the injection procedure performed by the fluid injector to ensure that fluid is delivered to a predetermined region of interest within a patient's body at a particular time such that an actionable image is generated during imaging.

[0036] In one embodiment, the at least one characteristic of the injection procedure can be at least one of a flow rate, a volume of fluid remaining in the syringe, and a capacitance measurement of the syringe.

[0037] These and other features and characteristics, as well as the method of operation, function of associated elements of construction, combination of parts, and economies of manufacture of the presently disclosed system and / or apparatus will become apparent from a consideration of the following description and appended claims with reference to the accompanying drawings, which form a part hereof. Like reference characters indicate corresponding parts in the various views. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the presently disclosed system and / or apparatus. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. [Brief description of the drawings]

[0038] [Figure 1] 1 is a schematic diagram of a fluid injector and fluid verification system according to an aspect of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram of a syringe according to an embodiment of the present disclosure for use with the injector of FIG. 1. [Figure 3A] 1 is a schematic diagram of a syringe having a distal end of one shape with an illuminated identification pattern appearance according to one aspect of the present disclosure. FIG. [Figure 3B] 1 is a schematic diagram of a syringe having an alternatively shaped distal end with an illuminated identification pattern appearance according to one aspect of the present disclosure. FIG. [Figure 3C] 1 is a schematic diagram of a syringe having yet another shape of a distal end with an illuminated identification pattern appearance according to an aspect of the present disclosure. FIG. [Figure 3D] 1 is a schematic diagram of a syringe having yet another shape of a distal end with an illuminated identification pattern appearance according to an aspect of the present disclosure. FIG. [Figure 4A]FIG. 2 is a schematic diagram of a syringe having a mechanism at its distal end for altering the shape and / or size of the illuminated identification pattern. [Figure 4B] FIG. 13 is a schematic diagram of a syringe having an alternative mechanism at its distal end for altering the shape and / or size of the illuminated identification pattern. [Figure 4C] FIG. 13 is a schematic diagram of a syringe having yet another mechanism at its distal end for altering the shape and / or size of the illuminated identification pattern. [Figure 5A] FIG. 3 is a perspective view of a syringe plunger that can be used with the syringe of FIG. 2. [Figure 5B] FIG. 3 is a schematic diagram of a syringe plunger that can be used with the syringe of FIG. 2. [Figure 6] 1 is a schematic diagram of a syringe with a backlit plunger and fluid verification system according to one aspect of the present disclosure. [Figure 7] 7 is a schematic diagram of a syringe completely or partially filled with air during use with the fluid verification system of FIG. 6. [Figure 8] 7 is a schematic diagram of a syringe filled with fluid for use in the fluid verification system of FIG. 6. [Figure 9] 1 is a schematic diagram of another example of a syringe with a backlit plunger and fluid verification system according to an aspect of the present disclosure. [Figure 10] 1 is a schematic diagram of a syringe with a reflective plunger and a fluid verification system. [Figure 11] 1 is a schematic diagram of another embodiment of a syringe with a reflective plunger and fluid verification system. [Figure 12] 1 is a schematic diagram of another embodiment of a syringe and fluid verification system having a reflective plunger and a fiber optic light pipe. [Figure 13] FIG. 1 is a schematic diagram illustrating light rays reflecting within and transmitting through a syringe barrel filled with fluid according to one aspect of the present disclosure. [Figure 14A]1 is a schematic diagram of a portion of a distal end of an embodiment of a fluid-filled syringe for use with a fluid verification system, according to one aspect of the present disclosure. [Figure 14B] 13 is a schematic diagram of a portion of a distal end of an embodiment of a fluid-filled syringe for use with a fluid verification system, according to another aspect of the present disclosure. [Figure 14C] 13 is a schematic diagram of a portion of a distal end of an embodiment of a fluid-filled syringe for use with a fluid verification system, according to yet another aspect of the present disclosure. [Figure 15A] FIG. 1 is a side view of a rolling diaphragm syringe according to one aspect of the present disclosure. [Figure 15B] FIG. 15B is a cross-sectional side view of the rolling diaphragm syringe shown in FIG. 15A taken along line AA. [Figure 16A] FIG. 13 is a perspective view of a rolling diaphragm syringe and pressure jacket according to another aspect of the present disclosure. [Figure 16B] FIG. 16B is a cross-sectional side view of the rolling diaphragm syringe and pressure jacket shown in FIG. 16A. [Figure 16C] FIG. 16B is a perspective view of a rolling diaphragm syringe and cap for use with the pressure jacket shown in FIG. 16A. [Figure 17A] 1 is a perspective cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a first configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. FIG. [Figure 17B] 1 is a cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a first configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. [Figure 18A] 1 is a perspective cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a second configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. FIG. [Figure 18B] 13 is a perspective cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a third configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. FIG. [Figure 19A]13 is a perspective cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a third configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. FIG. [Figure 19B] 11 is a cross-sectional view of a portion of a rolling diaphragm syringe and an engagement mechanism illustrating a third configuration of an electromagnetic radiation source according to one embodiment of the present disclosure. [Figure 20] 13A-13C are cross-sectional views of a rolling diaphragm syringe and portions of an engagement mechanism showing protruding elements according to one aspect of the present disclosure. [Figure 21] 1 is a flow chart of a method for determining the presence of air in a syringe utilizing image processing techniques, according to one aspect of the present disclosure. [Figure 22] FIG. 22 is an exemplary image of the distal end of a syringe used in the method of FIG. 21. [Figure 23] FIG. 22 is another exemplary image of the distal end of a syringe used in the method of FIG. 21. [Figure 24] 22 is a graph showing the correlation between the magnitude of the distance between the meniscus and the halo used in the method of FIG. 21 and the presence of air. [Diagram 25] FIG. 2 is a schematic diagram of an alternative syringe for use with the injector of FIG. 1. [Figure 26] 26 is a flow chart of an alternative method for determining the presence of air in a syringe utilizing image processing techniques and the syringe of FIG. 25 according to an embodiment of the present disclosure. [Figure 27] FIG. 27 is an exemplary image of the distal end of a syringe containing air for use in the method of FIG. 26. [Figure 28] 1A-1C are diagrams of example images used by an image recognition system to determine if air is present in a syringe using brightness measurements, in accordance with aspects of the present disclosure. [Figure 29] 1 is a diagram of an exemplary image used by an image recognition system to determine the type of fluid contained within a syringe, according to one aspect of the present disclosure. [Diagram 30]FIG. 13 is a diagram of another example image used by an image recognition system to determine the type of fluid contained within a syringe, according to an aspect of the present disclosure. [Diagram 31] 11 is a diagram of an alternative exemplary image used by an image recognition system to determine the type of fluid contained within a syringe, according to an aspect of the present disclosure. [Diagram 32] FIG. 13 is a diagram of another alternative exemplary image used by an image recognition system to determine the type of fluid contained within a syringe, according to an aspect of the present disclosure. [Diagram 33] 1 is a diagram of an exemplary image used by an image recognition system to determine the size of a syringe, according to one aspect of the present disclosure. [Diagram 34] FIG. 13 is a diagram of another example image used by an image recognition system to determine the size of a syringe, according to an aspect of the present disclosure. [Diagram 35] 1A-1C are diagrams of example images used by an image recognition system to determine whether a fluid pathway set is connected to a syringe, according to one aspect of the present disclosure. [Diagram 36] FIG. 13 is a diagram of another example image used by an image recognition system to determine whether a fluid pathway set is connected to a syringe, according to an aspect of the present disclosure. [Figure 37] FIG. 1 is a perspective view of a fluid transfer system including a fluid transfer device for transferring fluid from a fluid container to a syringe, according to an aspect of the present disclosure. [Figure 38] 1A-1C are diagrams of exemplary images used by an image recognition system to determine whether a fluid transfer device is connected to a syringe, according to one aspect of the present disclosure. [Figure 39] FIG. 13 is a diagram of another example image used by an image recognition system to determine whether a fluid transfer device is connected to a syringe, according to an aspect of the present disclosure. [Diagram 40] FIG. 1 is a perspective view of a purge vessel connected to a fluid transfer set according to one aspect of the present disclosure. [Diagram 41]FIG. 41 is a perspective view of the purge container of FIG. 40. [Figure 42A] FIG. 41 is a front view of the purge vessel of FIG. 40 with no fluid contained therein. [Figure 42B] FIG. 41 is a front view of the purge vessel of FIG. 40 with fluid contained therein. [Figure 43A] FIG. 41 is a perspective view of an alternative configuration of the purge vessel of FIG. 40 with no fluid contained therein. [Figure 43B] FIG. 43B is a front view of the purge receptacle of FIG. 43A with fluid contained therein. [Figure 44A] FIG. 41 is a perspective view of another alternative configuration of the purge vessel of FIG. 40 having no fluid contained therein. [Figure 44B] FIG. 44B is a front view of the purge vessel of FIG. 44A with fluid contained therein. [Diagram 45] FIG. 2 is a perspective view of an example of a purge vessel connected to a fluid transfer set according to one aspect of the present disclosure. [Figure 46] FIG. 13 is a front view of an end of a tube for use with a fluid transfer set according to one aspect of the present disclosure. [Figure 47] 1 is a schematic diagram of a syringe during an injection procedure showing the syringe stretching and expanding, according to one aspect of the present disclosure. FIG. [Figure 48] 1 is a graph showing delivered volume versus time during an exemplary injection procedure. [Figure 49] 1 is a flow chart of a method for determining the volume of fluid remaining in a syringe utilizing image processing techniques, according to one aspect of the present disclosure. [Figure 50] 2 is a perspective view of an alternative syringe for use in the system of FIG. 1. FIG. [Figure 51] FIG. 51 is a side view of the syringe of FIG. 50. [Figure 52] FIG. 51 is a schematic diagram of the syringe of FIG. 50 delivering fluid at low pressure and a fluid verification system according to one embodiment of the present disclosure. [Figure 53] FIG. 51 is a schematic diagram of the syringe of FIG. 50 delivering fluid at high pressure and a fluid verification system according to one embodiment of the present disclosure. [Figure 54]FIG. 51 is a schematic diagram of the syringe of FIG. 50 aspirating fluid with negative pressure, according to an embodiment of the present disclosure. [Figure 55] FIG. 15B is a schematic diagram of the syringe of FIG. 15A with an associated pressure indication mechanism, according to one embodiment of the present disclosure. [Figure 56A] 1 is a schematic diagram of a syringe for delivering fluid at low pressure and a fluid verification system according to another aspect of the present disclosure. [Figure 56B] FIG. 56B is a schematic diagram of the syringe and fluid verification system of FIG. 56A delivering fluid at high pressure. [Figure 57] FIG. 1 is a schematic diagram of a syringe with an integrated temperature strip according to one aspect of the present disclosure. [Figure 58] FIG. 1 is a front perspective view of a fluid injection system according to one aspect of the present disclosure. [Figure 59] 1 is a schematic diagram of a fluid injection system according to one aspect of the present disclosure. [Figure 60] FIG. 60 is a schematic diagram of a portion of the fluid injector of the fluid injection system of FIG. 59. [Figure 61] FIG. 60 is a schematic diagram of one configuration of the fluid injection system of FIG. 59. [Figure 62] FIG. 60 is a schematic diagram of another configuration of the fluid injection system of FIG. 59. [Figure 63] FIG. 60 is a schematic diagram of yet another configuration of the fluid injection system of FIG. 59. [Figure 64] 2 is a schematic diagram of another alternative syringe for use with the system of FIG. 1; [Figure 65] FIG. 65 is a schematic diagram of the syringe of FIG. 64 filled with air and a fluid verification system according to one embodiment of the present disclosure. [Figure 66] FIG. 65 is a schematic diagram of the syringe of FIG. 64 filled with saline and a fluid verification system according to one embodiment of the present disclosure. [Figure 67] FIG. 65 is a schematic diagram of the syringe of FIG. 64 filled with contrast agent and a fluid verification system according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] For purposes of this description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall refer to the present disclosure as shown in the drawings. When used with respect to a syringe, the term "proximal" refers to the portion of the syringe closest to the injector when the syringe is connected to the injector. The term "distal" refers to the portion of the syringe furthest from the injector. However, it should be understood that the present disclosure may contemplate alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific apparatus and processes illustrated in the accompanying drawings and described below are merely exemplary embodiments of the present disclosure. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0040] One aspect of the present disclosure relates to a fluid injection and fluid verification system that uses image processing techniques to verify that a syringe containing a fluid for injection is completely filled with fluid, has no free space (i.e., air) near the distal end when the syringe is in an upright position, and does not contain any air bubbles. The present disclosure also generally relates to using image processing techniques to determine various injection parameters to verify the type and specific characteristics of the fluid present in the syringe.

[0041] As used herein, fluid and / or medical fluid refers to a liquid substance or solution, such as, but not limited to, contrast media, saline, and therapeutic fluids. In certain aspects, the fluid verification system is configured to emit electromagnetic radiation, such as visible light or infrared light, through at least a portion of the syringe barrel. Electromagnetic radiation refers to radiant energy that propagates through space in the form of one or more electromagnetic waves. Electromagnetic radiation may be visible (e.g., having a wavelength of about 400 nm to 700 nm) or may not be visible to the human eye, such as, for example, in the case of x-rays, radioactive, infrared, and ultraviolet light. Additionally, as used herein, electromagnetic radiation may be ambient light. When the syringe is completely filled with fluid, the electromagnetic radiation is refracted by the fluid and / or the syringe barrel to illuminate the distal end of the syringe to provide a distinctive identification pattern. The illuminated area that defines the identification pattern on the distal end of the syringe is referred to herein as a halo. The term "halo" as used herein includes an illuminated identification pattern that includes a circular colored / illuminated ring around the distal portion or sub-portion of the conical distal end of the syringe. This halo can be easily identified when viewed by an operator from a straight-on, edge-on, or slightly elevated position. In one example, this straight-on or edge-on view is in a plane that is generally parallel to a plane that extends through the central axis of the syringe, and may generally be along a plane that extends through the distal end of the syringe. Also, by illuminating the syringe in the manner described herein, air bubbles present along the sidewall of the syringe barrel can be illuminated, thereby allowing an operator or a sensor to more easily identify the presence of such bubbles.

[0042] In some embodiments, one or more sensors can be configured to capture images of the distal end of the syringe to detect the halo pattern, for example, by automated image processing techniques. If the syringe is completely filled with fluid, a clearly observable halo, for example in the form of an illuminated band on at least a portion of the distal end of the syringe, is illuminated as an identification that the syringe is completely filled with fluid. If the syringe is not completely filled with fluid, such as if the syringe is completely or partially filled with air, the size and / or brightness of the halo is substantially reduced or absent. As used herein, fluid refers to a medical grade liquid configured to be delivered to a patient, such as saline or various types and concentrations of contrast media, as opposed to air or other gases.

[0043] I. Generation of illuminated discrimination patterns A. Exemplary Fluid Injection System 1, a fluid injector 10, such as an automatic fluid injector, is shown adapted to interface and operate with one or more syringes 12 that can be filled with a fluid F, such as contrast media, saline, or any desired medical fluid. The fluid injector 10 can be used during angiography, computed tomography (CT), magnetic resonance imaging (MRI), molecular imaging, or other medical procedures for injecting contrast media and / or common cleaning agents, such as saline, into a patient's body. In some examples, the fluid injector 10 may be at least a dual syringe injector, with two fluid delivery syringes 12 oriented side-by-side or in other spatial relationship and separately actuated by respective linear actuators or piston elements associated with the injector 10.

[0044] The injector 10 can be enclosed within a housing 14 formed from a suitable structural material, such as plastic and / or metal. The housing 14 can be formed in a variety of shapes and sizes depending on the desired application. For example, the injector 10 can be a freestanding structure configured to be placed on a floor, or can be configured to rest on a suitable table or support frame. The injector 10 includes one or more syringe ports 16 for connecting to the proximal ends of one or more syringes 12 and connecting the plungers 26 to the respective piston elements. The syringe ports 16 are typically located on the side of the housing 14, as shown, for example, in FIG. 1. The housing 14 is rotatable so that the syringe ports 16 and the syringes 12 extending therefrom can be oriented vertically, horizontally, or downward. In some examples, the syringes 12 can include at least one identification tag 34, such as a label or bar code, that includes information about the syringe's dimensions, capacity, pressure tolerance, and / or information about the fluid contained in the syringe 12. The at least one identification tag 34 can be read by a sensor 36 disposed or recessed on a side of the housing 14 or within at least a portion of an inner surface of at least one syringe port 16 of the injector 10 .

[0045] Fluid pathway set 17 may interface with syringes 12 for delivery of one or more fluids from syringes 12 to a catheter (not shown) inserted into a vascular access site of a patient. For example, the flow of saline from a first syringe 12 and the flow of contrast from a second syringe 12 may be regulated by a fluid control module (not shown) associated with injector 10. The fluid control module operatively controls flow regulating structures, such as injection rate, pressure, valves and pistons or linear actuators, to regulate the delivery of saline and / or contrast to the patient based on user-selected injection parameters, including injection flow rate, duration, total injection volume, and the ratio of contrast to saline, which may be programmed or entered into the injector fluid control module.

[0046] A front-loading fluid injector suitable for use with the above system is disclosed in U.S. Patent No. 5,383,858 to Reilly et al., which is incorporated herein by reference in its entirety.Other exemplary multi-fluid delivery systems and components are described in U.S. Patent No. 7,553,294 to Lazzaro et al.; U.S. Patent No. 7,666,169 and U.S. Patent No. 9,199,033 to Cowan et al.; U.S. Patent No. 8,173,995 to Tucker et al.; PCT International Application No. 2012 / 155035 to Shearer et al.; U.S. Patent Application Publication No. 2014 / 0027009 to Riley et al., all of which are assigned to the assignee of the present application and whose disclosures are incorporated herein by reference.

[0047] B. Exemplary Syringes for Use with Fluid Injection Devices 1. Details of the syringe body Having described the general structure and function of the fluid injector 10, a detailed description will now be given of the syringe 12 that is connected to the injector 10 and configured to contain a fluid F. With reference to FIG. 2, the syringe 12 includes a substantially cylindrical barrel 18 formed from glass or a suitable medical grade plastic and defining an interior volume 19. For example, the barrel 18 may be formed from medical grade polyethylene terephthalate (PET) or other medical grade plastic material. The barrel 18 has a proximal end 20 and a tapered conical distal end 24 that extends to a nozzle 22. The barrel 18 may be formed from a transparent or translucent material such that a user or system operator may observe the fluid F contained therein and, when used with a fluid verification system, as described herein, may discern a halo on the distal end 24 of the barrel 18. In other examples, only the distal end 24 of the barrel 18 is transparent or translucent, with the remainder of the barrel 18 being formed from an opaque reflective material to increase the transmission of light through the barrel 18. In some embodiments, a shield (not shown) may be provided around the outside of the barrel 18. The shield may be formed of an opaque reflective material to increase the transmission of light through the barrel 18. The fluid F generally has a refractive index greater than that of air and may be different than the material of the barrel 18, thus altering the path of electromagnetic radiation, such as visible light, traveling through the barrel 18 of the syringe 12. For example, the refractive index of air is about 1, the refractive index of saline is about 1.34, the refractive index of contrast media is about 1.46, and the refractive index of PET is about 1.57. Without intending to be bound by theory, the path of travel of the electromagnetic radiation is governed by the reflective and refractive properties of the medium through which the electromagnetic radiation travels.

[0048] The appearance of the illuminated area or halo 120 is determined at least in part based on the angle and / or shape of the tapered distal end 24 of the barrel 18, as shown in Figures 3A-3D. In some embodiments, the tapered distal end 24 of the barrel 18 may taper at an angle ranging from 30 degrees to 60 degrees, and in other embodiments at an angle of 40 degrees to 50 degrees, relative to a horizontal axis or a latitudinal or radial axis extending through the syringe 12. In one example, the angle of the tapered distal end 24 of the barrel 18 is about 45 degrees relative to the horizontal (see Figure 3A). There are also values ​​above and below the low threshold above which the reflected illuminated area or halo is no longer visible. Thus, altering the angle and / or shape of the tapered distal end 24 of the barrel 18 may affect the size and visualization of the halo 120. For example, as the angle of the tapered distal end 24 of the barrel increases, the size of the visualized halo increases (FIG. 3C shows a syringe with a tapered distal end 24 having an angle of 60 degrees with respect to the horizontal). However, the brightness of the halo is generally reduced with such an increase in angle. This may be compensated for by increasing the intensity of the electromagnetic radiation from the source used to generate the halo. In another example, as the angle of the tapered distal end 24 of the barrel 18 decreases, the size of the halo 120 also decreases, as shown in FIG. 3B. Finally, if the distal end 24 of the syringe does not have a sloping surface, such as the dome-shaped syringe shown in FIG. 3D, the halo 120 is not generated. Specific details of how the halo 120 is generated at the distal end of the syringe 12 are provided herein.

[0049] In some examples, at least a portion of the distal end 24 of the syringe barrel 18 can include one or more elements configured to enhance the appearance of the halo 120. The one or more elements can be in the form of a scallop or ridge 24A extending circumferentially around the exterior surface of the distal end 24 of the barrel 18. The scallop or ridge 24A can be positioned to refract at least a portion of the halo 120, making it visible over a range of viewing angles and user positions. The scallop or ridge 24A can be used to create a multi-part lens, such as a Fresnel lens. This type of lens allows light passing through the portion of the syringe 12 where the halo 120 is visualized to be redirected onto a more direct path toward a detector or viewer. Such lenses can also be used to transmit light farther and appear brighter at more viewing angles. Additionally, the scallop or ridge 24A can improve visualization of the halo 120 or other features within the syringe 12. The geometry of the ridges 24A may be determined by the internal reflection of light and the combination or convergence of corresponding light rays at the viewer's eye. With reference to Figures 4A-4C, different arrangements of scallops or ridges 24A at the distal end 24 are shown that lead to different shapes or sizes of the generated halo 120.

[0050] Returning to FIG. 2 , in some examples, an annular flange, often referred to as a drip flange 28, extends radially outward from a location near the proximal end 20 of the syringe barrel 18. When the syringe 12 is inserted into the injector 10 (shown in FIG. 1 ), the drip flange 28 is positioned against a distal opening of the syringe port 16 (shown in FIG. 1 ) to prevent excess fluid expelled from the syringe 12 from entering the port 16. The portion of the syringe barrel 18 between the drip flange 28 and the proximal end 20 of the barrel 18 (referred to herein as an insert 30) is sized and adapted to be inserted into the syringe port 16 of the injector 10. Thus, in some examples, the insert 30 of the barrel 18 includes one or more locking structures, such as a locking flange 32, extending radially outward from the barrel 18. The locking flange 32 may be adapted for locking engagement with a corresponding protrusion or locking structure in the syringe port 16 to releasably maintain the syringe 12 within the syringe port 16 while the injector 10 is in use. Alternatively, the insert 30 may include one or more latches, locking mechanisms, or radially extending ribs for connecting to a corresponding portion of the syringe port 16.

[0051] Exemplary syringes suitable for use with the injector 10 shown in Figure 1, which may be used with a fluid verification system, are described in U.S. Patent No. 5,383,858 to Reilly et al., U.S. Patent Nos. 7,666,169 and 9,199,033 to Cowan et al., and U.S. Patent No. 8,173,995 to Tucker et al., all of which are assigned to the assignee of the present application and the disclosures of which are incorporated herein by reference in their entireties. Further exemplary syringes are described in U.S. Patent No. 6,322,535 to Hitchins et al. and U.S. Patent No. 6,652,489 to Trocki et al., each of which are assigned to the assignee of the present application and the disclosures of which are incorporated herein by reference in their entireties.

[0052] 2. Examples of Plungers for Use with Exemplary Syringes 2 , the proximal end 20 of the syringe barrel 18 may be sealed with a plunger or plunger cover 26 slidably disposed within the syringe barrel 18. The plunger or plunger cover 26 may have a distal surface 26A. The plunger or plunger cover 26 forms a fluid-tight seal against a sidewall of the barrel 18 as the barrel 18 is advanced or retracted therethrough. The plunger or plunger cover 26 may include an interior cavity 27 and a proximal opening 29 configured to receive and engage a distal end of a piston rod (not shown) extending from the injector 10 (shown in FIG. 1 ). The piston rod is advanced or retracted through the syringe barrel 18 by the injector 10 to drive the plunger or plunger cover 26 through the interior 19 of the syringe barrel 18 to expel a fluid F therefrom or deliver a fluid F to the syringe barrel 18.

[0053] In some examples, the plunger or plunger cover 26 is at least partially formed from a substantially transparent or translucent material and is configured to pass electromagnetic radiation, such as visible light, ambient light, infrared light, or ultraviolet light, or to emit electromagnetic radiation from a portion of the plunger or plunger cover 26. For example, the plunger or plunger cover 26 may include a transparent or translucent central portion surrounded by an annular elastomeric ring that provides a seal between the plunger cover 26 and the inner surface of the barrel 18. The emitted electromagnetic radiation radiates, propagates, or travels substantially axially within and / or through the syringe barrel 18 toward the distal end 24 of the syringe barrel 18, while other electromagnetic radiation is emitted non-axially, while at least a portion of the electromagnetic radiation is reflected from the inner surface of the syringe barrel 18 toward the distal end 24. It also propagates non-axially from the plunger or plunger cover 26, a portion of which is reflected from the sidewall of the syringe barrel 18 toward the distal end 24 of the syringe 12. The electromagnetic radiation beam can be scattered as it passes through the transparent or translucent material of the plunger or plunger cover 26, contributing to the appearance of a halo. The plunger or plunger cover 26 can be clear or colored white, although in certain applications a more striking color can be useful. For example, the plunger material can be colored a conspicuous color, such as bright red or bright green, to color the halo. Coloring the halo brightly and visibly helps a system operator recognize the halo when it is present. For example, the plunger or plunger cover 26 may be colored green or blue (e.g., green is often understood to indicate a ready state) for increased visibility and to confirm that the syringe 12 is ready for use. Alternatively, the electromagnetic radiation passing through the plunger or plunger cover 26 can have a color from a light source, such as red, green, blue, or other color, to define a colored halo.

[0054] Alternatively, or in addition to including transparent or translucent portions, in other embodiments, the plunger or plunger cover 26 can include one or more windows or openings 31 that allow electromagnetic radiation to pass through. For example, the plunger or plunger cover 26 can include a pattern of windows disposed along the portions of the cover 26 that contribute to the formation of the halo. The windows or openings 31 can be covered with a transparent or translucent material or film to ensure that the plunger or plunger cover 26 is fluid-tight. Other portions of the plunger or plunger cover 26 can be formed from an opaque material and need not be able to pass light, unlike the previous examples. In one example, selective illumination through these windows or openings 31 can be used to change the pattern of the visible halo 120 or the color of the halo 120 based on certain system conditions or conditions. For example, some of the windows or openings 31 can be configured to have red light emerge therethrough, while other windows or openings 31 can be configured to emit yellow light therethrough. Thus, halo 120 may have a red color when only the red light is on, a yellow color when only the yellow light is on, and an orange color when all lights are on. The particular color of halo 120 may provide an indication of the operation of a particular system condition or state, such as, but not limited to, the type of fluid being used, the size of the syringe, the volume of fluid in the syringe, the pressure in the syringe, the presence of air in the syringe, etc.

[0055] In another example, the plunger or plunger cover 26 may be formed from or coated with a reflective or colored material rather than a translucent or transparent material. The reflective or colored material or surface reflects light directed distally through the syringe barrel 18 to the plunger or plunger cover 26 to create a halo. An exemplary fluid verification system including a reflective plunger is shown in Figures 10-12 and described in detail herein.

[0056] In yet another example, as shown in FIGS. 5A and 5B, the plunger or plunger cover 26 may be formed from or coated with a reflective material having a plurality of different colored stripes 38. The reflective material forming the stripes 38 reflects light directed distally through the syringe barrel 18 to the plunger or plunger cover 26 to create a halo. As the plunger or plunger cover 26 moves through the barrel, the light reflects off different stripes 38 depending on the position of the plunger or plunger cover 26 within the syringe barrel 18. Because each stripe 38 of the plunger or plunger cover 26 is a different color, the color and / or appearance of the halo changes depending on the stripes 38, and light is reflected on the stripes 38 as the plunger or plunger cover 26 advances or retracts through the syringe barrel 18 during an injection or filling procedure. A sensor, such as an image capture device, can be positioned to capture an image of the halo as the plunger or plunger cover 26 advances or retracts through the syringe barrel 18 and detects a change in color of the halo. A processor operatively coupled to the sensor and appropriately programmed can then be used to determine the amount remaining in the syringe based on the color / appearance of the halo. While the example shown in Figures 5A and 5B shows eight different colored stripes, this should not be construed as limiting the invention and any suitable number of stripes can be utilized. Alternatively, the plunger or plunger cover 26 may be configured to emit different colored light at certain portions of the syringe to produce different colored halos depending on the amount of fluid remaining in the syringe. Additionally, patterns other than colored stripes can be used to encode information on the plunger as seen in the halo 120. One example of such a pattern is a bar code.

[0057] C. Generation of an illuminated identification pattern with an exemplary syringe Having generally described various aspects of the structure of the syringe 12 and plunger or plunger cover 26 with reference to FIG. 6, components of an example fluid verification system 110 will now be described in detail. The fluid verification system 110 includes an electromagnetic radiation source 112 for generating a beam of radiation that forms a halo 120. The electromagnetic radiation source 112 may be a light bulb, an LED bulb, a visible light emitter, an infrared emitter, a laser, other electromagnetic radiation source, or ambient light provided to project a beam of electromagnetic radiation into the interior 19 of the syringe 12. In certain aspects, the electromagnetic radiation source 112 emits electromagnetic radiation in a generally axial direction through the syringe barrel 18 toward the distal end of the syringe.

[0058] 1. An electromagnetic radiation source placed under the plunger For example, as shown in FIG. 6, the electromagnetic radiation beam B travels through a translucent or transparent plunger or plunger cover 26 toward the distal end 24 of the barrel 18. The electromagnetic radiation source 112 can be configured to enhance the conspicuousness of the halo 120 or tailor the halo 120 for a particular sensor or electromagnetic radiation detector. In one example, the electromagnetic radiation source 112 includes a laser of a particular wavelength, such as a laser having a wavelength of about 532 nm in one embodiment (e.g., a green laser). Lasers that emit electromagnetic radiation at other wavelengths within the visible range are also envisioned. A laser electromagnetic radiation source 112 can be used with a neutral color or transparent plunger and still produce a halo 120 of a conspicuous color. In other examples, the electromagnetic radiation source 112 can emit electromagnetic radiation outside the visible spectrum, provided the system includes a sensor or camera that can detect radiation within the emitted wavelength (e.g., the halo 120). In yet other examples, the electromagnetic radiation source 112 can be configured to emit polarized or filtered light of a particular wavelength that can be more easily distinguished from ambient light. In other examples, the electromagnetic radiation source 112 may be configured to emit pulses of light according to a predetermined, identifiable sequence that may be identified by a system operator or automatically detected by a sensor.

[0059] 6, the electromagnetic radiation source 112 is disposed on the underside of the plunger or plunger cover 26 to backlight the plunger or plunger cover 26. For example, an LED bulb or other electromagnetic radiation emitting device can be attached to the base, piston, actuator, or syringe port of the syringe receiving stand that is configured to receive the syringe 12 and positioned to emit an electromagnetic radiation beam, for example, axially through the syringe barrel 18. Thus, in some examples, the electromagnetic radiation source 112 can be integrated with the injector 10 (shown in FIG. 1). For example, the electromagnetic radiation source 112 can be located on the syringe port 16 (shown in FIG. 1) adjacent the drip flange 28 of the syringe barrel 18, or in another convenient location on the injector adjacent the syringe port.

[0060] In other examples, fluid verification system 110 may be a stand-alone structure that includes a base or holder for receiving syringe 12 to be inspected. An electromagnetic radiation source 112, such as an LED or a standard light bulb, may be located on or adjacent to the base or holder. In this case, syringe 12 is verified to ensure that it is properly filled with fluid F. After verification is complete, syringe 12 is removed from the base or holder and transferred to an injector, such as fluid injector 10, to deliver fluid F to a patient.

[0061] Electromagnetic radiation passing through the plunger or plunger cover 26 radiates substantially through the syringe barrel 18 and forms a halo 120 when the syringe is filled with fluid. With particular reference to FIG. 7, when the syringe 12 is filled with air or partially filled with air, the electromagnetic radiation beam passes through the syringe barrel 18 but does not form the characteristic illuminated portion or halo 120 near its distal end 24. In contrast, as shown in FIG. 8, when the syringe 12 is completely filled with fluid F, the electromagnetic radiation beam is refracted by the fluid F and the syringe barrel walls, producing a halo 120 near the distal end 24 of the syringe 12. As described in more detail herein in connection with the methods and steps for syringe verification, a system operator or an automated image reader or optical device (e.g., sensor 114) can identify whether the halo 120 is present and, if so, whether it is of the correct shape and size. If the halo 120 is too small, not bright enough, or not present at all, this may indicate that the syringe is not filled with enough fluid or contains air, and the system operator may add additional fluid F to the syringe 12 to ensure it is completely filled before injection into the patient. If a halo 120 having the correct size, shape, and brightness is identified, the verification that the syringe is full of fluid is complete, and the fluid contents of the syringe 12 are ready to be administered to the patient. Thus, the fluid verification system 110 provides an adequate visual indication of whether the syringe 12 is full of fluid or whether even a small amount of air is present within the syringe interior 19.

[0062] Additionally, as shown in FIGS. 7 and 8, the line 40 may be formed on the distal end 24 of the syringe barrel 18 and extend around the circumference of the distal end 24 of the syringe barrel 18. The line 40 may be formed on the barrel 18 using any suitable method, such as, but not limited to, printing, overmolding, and etching. The line 40 is configured to interface with the halo 120 to provide the operator with a quick and visual indication of the type of fluid in the syringe 12. For example, the halo 120 may be sized differently depending on the type of fluid present in the syringe due to the different properties of different fluids. Thus, the line 40 may be formed on the syringe 12 and aligned with a particular portion of the halo 120, such as the bottom end shown in FIG. 8, when a first fluid is present in the syringe 12, aligned with a second predetermined portion of the halo 120, such as the middle portion, when a second fluid is present in the syringe 12, or may be positioned away from the halo 120 when a second fluid is present in the syringe 12. In this manner, the operator can quickly and easily visually determine the position of line 40 relative to halo 120 and, based on this information, determine the type of fluid present in syringe 12.

[0063] 9, another example of a syringe 12 and fluid verification system 110 is shown that includes a backlit translucent or transparent plunger or plunger cover 26. The syringe 12 is attached to the syringe port 16 of the injector 10. The piston rod 124 of the injector 10 has one or more electromagnetic radiation sources 112, such as LEDs, attached or embedded at the distal end thereof. Upon actuation, the piston rod 124 advances toward and is received within a cavity 27 defined by the plunger or plunger cover 26. The LEDs emit light axially through the plunger cover 26 to generate a halo 120 adjacent the distal end 24 of the syringe barrel 18 as described above. The halo 120 can be identified by a sensor 114 positioned adjacent the distal end 24 of the syringe barrel 18.

[0064] 2. A source of electromagnetic radiation positioned so that radiation is reflected from the surface of the plunger 10, the radiation source 112 can also be positioned such that energy or electromagnetic radiation reflects axially from the distal surface 26A of the plunger or plunger cover 26 through the syringe barrel 18 to form the halo 120. For example, the electromagnetic radiation source 112 described herein can be positioned outside the barrel, such as near the distal end 24 of the barrel 18, to project electromagnetic radiation or light beam B toward the distal surface 26A of the plunger or plunger cover 26 through the syringe barrel 18. The electromagnetic radiation or light beam B then reflects distally off the plunger or plunger cover 26 with any attendant refraction / reflection by the fluid and / or syringe wall material to form a visible halo at the distal end of the syringe.

[0065] 3. An electromagnetic radiation source disposed adjacent to a surface of the injector. In another example, as shown in FIG. 11, the system 110 can include an electromagnetic radiation source 112 disposed adjacent a surface of the injector 10 and / or syringe port 16 (shown in FIG. 1). The electromagnetic radiation source 112 described herein can be configured to focus and reflect a light or radiation beam B from a mirror 122 or other reflective element disposed near the distal end 24 of the syringe barrel 18. The mirror 122 directs the light or electromagnetic radiation beam toward a distal surface 26A of the plunger or plunger cover 26 such that when the syringe is filled with fluid, the radiation or light can reflect off the plunger or plunger cover 26 to form a halo 120. The halo 120 can be visually identified by an operator or by a detector or sensor 114.

[0066] 4. Electromagnetic radiation sources including optical fibers 12, in another example, a fiber optic light pipe 126 is used to provide light or electromagnetic radiation from the electromagnetic radiation source 112 toward the distal end 24 of the barrel 18, e.g., the radiation source is associated with the injector body and shines or directs light toward the distal face 26A of the plunger or plunger cover 26. In one example, the light pipe 126 can be embedded within the syringe barrel 18 itself. Alternatively, the light pipe 126 can be embedded within a pressure jacket that surrounds the syringe barrel 18. Light can then be directed from the electromagnetic radiation source 112, e.g., located at the syringe port 16 of the injector 10, through the light pipe 126 to the distal end 24 of the barrel 18. Light emitted from light pipe 126, as shown by light beam B, is directed toward distal surface 26A of plunger or plunger cover 26 and can be reflected therefrom in the manner described in connection with the examples shown in Figures 10 and 11 to form a halo at the distal end of the syringe when the syringe is filled with fluid.

[0067] 5. Illuminated identification pattern or halo With reference to FIG. 13, the details of how electromagnetic radiation is refracted by the fluid F and / or the material of the walls of the barrel 18 to produce the halo 120 will be described in greater detail. As shown in FIG. 13, light rays 130 (generally designated 130) that are scattered in multiple directions as they pass through the plunger or plunger cover 26 (shown in FIGS. 6 and 9) travel in a generally axial direction A towards the distal end 24 of the syringe barrel 18. Some of the light rays 130 exit the syringe barrel 18 through the transparent or translucent sidewalls of the syringe barrel 18, meaning that the illuminated plunger 26 is visible to an observer 200. Some of the light rays 130 reach the tapered cone-shaped distal end 24 of the barrel 18 directly without contacting the sidewalls of the barrel 18. The light rays 130 that directly illuminate the distal end 24 of the barrel 18 are visible to an observer 200 looking at the top of the syringe 12 from an elevated position. Some light rays 130 are focused by total or partial internal reflection from the syringe barrel 18 to the distal end 24 of the syringe barrel 18, as indicated by reference numeral 132. For example, light rays 130 directed to one side of the tapered conical distal end 24 of the syringe barrel 18 are reflected by total internal reflection, as indicated by reference numeral 133, towards the opposite side of the tapered distal end 24 when the syringe is filled with fluid and the difference in the refractive index of the fluid, syringe wall material and the air outside the syringe are different, causing internal reflection. If the syringe barrel 18 is completely filled with air or only partially filled with fluid F, the light rays 130 will not be sufficiently internally reflected and focused to the distal conical end, and will be little, if any, visible to the observer 200 over the region of the syringe 12 filled with air. Without intending to be limited by any theory, it is believed that the majority of the light rays traveling through a volume of the syringe that contains air are not internally reflected off the syringe barrel walls, but instead exit the syringe through the side walls. Because there is no substantial internal reflection, the light rays are not focused at the distal end of the syringe, creating an observable halo. In particular, the focused light rays 130 are not visible as a halo when viewing the syringe barrel 18 in a straight-on or edge-on position when air is present in the syringe.Thus, when the syringe barrel 18 is not completely filled with fluid, the halo 120 appears to be absent.

[0068] However, as shown in FIG. 13, when the syringe 12 is filled with fluid F, the light beam 130 that is reflected toward and focused at the tapered distal end 24 of the barrel 18 is refracted as shown by line 131 due to the difference in the refractive index of the fluid relative to the ambient air and the syringe wall material. Specifically, as described herein, the refractive index of air is substantially 1. In contrast, the refractive index of saline is approximately 1.34, the refractive index of the contrast agent is approximately 1.46, and the refractive index of PET is approximately 1.57. The refracted light beam 130 exiting the syringe barrel 18 is visible to the observer 200 at a lower angle compared to when the syringe barrel 18 is only partially filled with fluid F. Furthermore, due to refraction, the light beam 130 may be further focused to increase the intensity of the light halo observed by the observer 200. Thus, when viewing the fluid-filled syringe 12 straight on, from an edge-on, or slightly elevated position, an observer 200 sees an illuminated halo 120 that has a characteristic appearance.

[0069] The structure and geometry of the syringe 12, particularly the tapered conical distal end, are selected such that the halo 120 is readily visible at a predetermined portion of the barrel 18 (i.e., the distal end 24) from a particular set position or orientation. For example, in some embodiments, the injector 10 holds the syringe 12 in an oblique orientation (e.g., tilted upwards or downwards between about 0 degrees and about 30 degrees relative to the plane of the injector). To account for the oblique orientation of the syringe 12, the shape of the barrel 18 and the distal end 24 of the barrel 18 can be selected to enhance the visibility of the halo 120 when viewed in an oblique position. When the syringe 12 is held by the injector 10 in a substantially straight (e.g., untilted) position, the syringe 12 is shaped such that the halo 120 is readily visible when the syringe 12 is viewed straight on or edge-on.

[0070] More specifically, with reference to FIGURE 14A, when the syringe 12 is oriented for general viewing from a straight-on or tilted (e.g., 10-30 degree tilt) orientation, the angle 23 of the tapered distal end 24 of the barrel 18 is about 30-60 degrees with respect to the horizontal, and in certain embodiments, about 45 degrees. An angle of about 45 degrees creates a halo 120 that is more easily seen than at a straight-on viewing angle. In particular, as shown in FIGURE 14A, the viewer 200 can see the light rays 130 that form the halo 120 at a significantly lower orientation.

[0071] In contrast, for a syringe 12 having a distal end 24 with a steeper angle 23, as shown in FIG. 14B, the halo 120 is visible to the observer 200 at a higher (e.g., downward) orientation. A higher vantage point may be appropriate if the syringe 12 is expected to be viewed in a tilted forward position. In some instances, the distal end 24 of the barrel 18 may also have a dome shape. However, in most situations, the halo 120 may be easier to see through a tapered distal end 24 rather than a dome-shaped distal end 24.

[0072] In another example, as shown in FIG. 14C, the distal end of the syringe 12 includes a distal portion 24 that includes a curved, angled portion that extends from the barrel 18 to the nozzle 22 or tip. A distal portion 24 with such a curved, angled portion creates a halo 120 that is visible from a wider range of viewing angles. In particular, as shown in FIG. 14C, the light beam 130 can be viewed by an observer 200 in either a straight-on or more downwardly directed orientation. Thus, with a syringe 12 having a distal portion 24 as shown in FIG. 14C, the halo 120 is visible regardless of whether the injector 10 is holding the syringe 12 in a slightly tilted or straight position.

[0073] 6. Operation of an Exemplary Syringe-Based Fluid Injection System 1, 2, and 6, in use, the operator inserts the proximal end 20 of the barrel 18 into the corresponding syringe port 16. The operator may need to apply some force to each syringe 12 so that the locking flange 32 of the syringe 12 engages with a corresponding locking structure (not shown) on the syringe port 16 to form a proper connection. In certain instances, the operator continues to push the syringe 12 into the port 16 until the insert 30 of the syringe barrel 18 is fully inserted. In some cases, an audible or tactile signal, such as a click, indicates that the syringe barrel is fully inserted, locked, and ready for use.

[0074] The syringe 12 may be preloaded with the fluid F. Alternatively, the injector 10 may automatically or manually draw the fluid F into the syringe barrel 18 from an external fluid source. When the syringe 12 is inserted into the port 16 and filled with the fluid F, the electromagnetic radiation source 112 is turned on and a light beam is projected through the plunger or plunger cover 26. Alternatively, the electromagnetic radiation or light may be reflected axially therefrom toward the distal surface 26A of the plunger cover 26, as described herein with respect to the exemplary system shown in FIGS. 10-12. In some examples, the syringe insertion and halo identification may be coordinated such that the electromagnetic radiation source 112 is automatically turned on each time the syringe 12 is loaded into the injector 10. Alternatively, the system operator may manually turn on the electromagnetic radiation source 112, for example, by entering a command via a user interface or by pressing an activation button. When the electromagnetic radiation source 112 is activated, the presence or absence of the irradiated portion or halo 120 (shown in FIGS. 6 and 9) can be identified and / or detected by a technician or automatically by a sensor. Specifically, when the syringe 12 is completely filled with fluid F, the halo 120 appears. When the syringe 12 is filled with air or only partially filled with fluid, the halo 120 is either less noticeable or not present at all. For example, as soon as air is introduced into the syringe, the halo 120 begins to become less noticeable (i.e., smaller in size and / or less bright) and continues to weaken until it disappears completely when approximately 5 mL of air is present in the syringe 12 at the distal end of the syringe when a syringe such as the syringe shown in FIG. 2 is utilized in the system. In another example, the halo 120 is not visible when the percentage of the volume of air present at the distal end 24 of the syringe 12 is greater than about 15% of the volume of the conical distal end 24 of the syringe 12. In yet another example, the halo 120 is not visible when the percentage of the volume of air present at the distal end 24 of the syringe 12 is greater than about 10% of the volume of the conical distal end 24 of the syringe 12.In yet other examples, the halo 120 is not visible when the percentage of volume of air present at the distal end 24 of the syringe 12 is greater than about 20% of the volume of the conical distal end 24 of the syringe 12. In some examples, a system operator manually verifies, such as by visual verification, that the halo 120 is present prior to actuating the injector 10.

[0075] Alternatively, according to another aspect of the present disclosure, the illuminated halo 120 can be automatically detected by one or more sensors 114, such as a digital camera. More specifically, one or more images of the distal end 24 of the barrel 18 can be acquired by the one or more sensors 114. The obtained images can be analyzed by a processor using image processing techniques (as described in more detail herein). For example, as described in more detail herein, pattern recognition algorithms can be used to identify the expected structure and other characteristics of the syringe 12, the fluid fill, the fluid characteristics, the shape and / or location of the halo 120, and other characteristics and features. Pattern recognition can also be used to identify information about the syringe 12, such as the syringe fluid capacity or preferred injection parameters for a particular syringe size and geometry. An end-to-end distance calculation algorithm can be used to identify the location and length of the halo 120. An end-to-end distance calculation algorithm can also be used to determine the length of the meniscus formed by the fluid F contained in the syringe 12. Knowledge of the position and size of the meniscus can be used to determine the fluid volume contained in the syringe 12 and the free space (i.e., air volume), if any, between the meniscus and the syringe nozzle. A brightness determination algorithm can be used to determine the intensity of the halo 120. As previously mentioned, the brightness of the halo 120 may be used as an indicator of the amount of air present within the syringe 12. Thus, the processing algorithm can be configured to ensure that the brightness of the halo exceeds a certain pre-determined threshold indicating that a threshold amount of air within the syringe is not exceeded.

[0076] In some examples, the injector 10 can be configured to "unlock / lock" based on whether the halo 120 is identified. For example, if the halo 120 is not identified, the injector 10 can enter a "locked" state that prevents the injection from proceeding and / or requests that the tested syringe be replaced with a new syringe. If the halo 120 is identified, the injector 10 can "unlock" and allow the operator to access other functions of the injector 10 user interface to proceed with the injection procedure. Similarly, the injector 10 can be configured to cancel or stop a scheduled injection procedure if the sensor 114 fails to identify the halo 120 or if the halo 120 is identified but is not of sufficient brightness. If the halo 120 is present, the injector 10 can be configured to automatically begin the injection procedure. Upon actuation of the injector 10, the linear actuator advances the piston rod 124 distally to contact and engage the plunger or plunger cover 26. Distal advancement of the plunger or plunger cover 26 through the barrel 18 expels the fluid F from the syringe 12 and injects the fluid F into a patient through any known injection structure, such as IV tubing or a needle accessory.

[0077] D. Alternative Exemplary Syringes for Use with Fluid Injection Systems 1. Alternative Exemplary Syringe Constructions 15A and 15B show alternative exemplary syringes that may be utilized with the fluid injector 10. More specifically, these figures show a rolling diaphragm syringe 135 according to another embodiment of the present disclosure. Various features of the rolling diaphragm syringe are described in detail in PCT Publication WO 2015 / 164783, the disclosure of which is incorporated by reference. FIG. 15B is a cross-sectional side view of the rolling diaphragm syringe 135 shown in FIG. 15A along line AA. Referring initially to FIG. 15A, the rolling diaphragm syringe 135 generally includes a hollow body including a forward or distal end 137, a rearward or proximal end 139, and a flexible sidewall 134 extending therebetween. The sidewall 134 of the rolling diaphragm syringe 135 defines a soft, pliable, flexible, self-supporting body configured to roll on itself as a "rolling diaphragm" under the action of the piston 138 (shown in FIGS. 18A and 18B) of the fluid injector 10. In particular, the sidewall 134 of the rolling diaphragm syringe 135 is configured to rotate such that its outer surface folds and inverts radially inward when the piston 138 is moved distally, and deploys radially outward in the opposite direction when the piston 138, e.g., a piston releasably attached to a proximal end of an end wall 136 of the rolling diaphragm syringe 135, is retracted proximally.

[0078] The rolling diaphragm syringe 135 may be made of any suitable medical grade plastic or polymeric material. In various embodiments, the transparent plastic material is capable of withstanding sterilization procedures, such as exposure to ethylene oxide or electromagnetic radiation sterilization procedures.

[0079] 15B and with continued reference to FIG. 15A, the distal end 137 of the rolling diaphragm syringe 135 has an open-ended discharge neck 140 having a corresponding connecting member, such as connecting member 140a for connecting to the cap of FIG. 17 described herein, which may be connected to a fluid path set (not shown). The discharge neck 140 is axially spaced apart from the sidewall 134 by a thickness T 2A first sidewall thickness T that is greater than 1 The thickness T 1 is selected such that the drain neck 140 can be sufficiently rigid to allow connection to a corresponding connecting member of a fluid pathway set (not shown) without substantially deforming the drain neck 140, for example, during an injection procedure. 2 is selected such that the sidewall 134 of the rolling diaphragm syringe 135 is flexible to allow for the rollover and deployment of the sidewall 134 as described herein. The proximal end 139 of the rolling diaphragm syringe 135, such as the closed end wall 136, may be reinforced to prevent deformation during rollover of the sidewall 134, or in certain embodiments, deployment of the sidewall 134. In some embodiments, the proximal end 139 of the rolling diaphragm syringe 135 is configured to engage with the piston 138.

[0080] The end wall 136 can have a central portion 276 having a substantially dome-shaped configuration and a piston-engaging portion 244 extending proximally from the central portion 276, such as approximately at the midpoint of the central portion 276. In some embodiments, the distal-most end of the central portion 276 can be substantially flat. The piston-engaging portion 244 is configured to engage an engagement feature on the piston 138 of the fluid injector 10. The proximal end 139 of the rolling diaphragm syringe 135 can have one or more ribs 278 that project radially outward from the piston-engaging portion 244 along the proximal surface of the ramp 272.

[0081] FIG. 16A is a perspective view of a syringe assembly 204 having a rolling diaphragm syringe 135 (shown in FIG. 16B) and a pressure jacket 210 according to the present disclosure. The syringe assembly 204 includes a pressure jacket 210 that removably interfaces with an injector 10 (shown in FIG. 1) as described herein. The pressure jacket 210 has a distal end 216, a proximal end 218, and a sidewall 219 that extends between the distal end 216 and the proximal end 218 along a longitudinal axis of the pressure jacket 210 and defines an internal throughbore 221 (shown in FIG. 16B). In some embodiments, the sidewall 219 of the pressure jacket 210 is shaped to receive at least a portion of the rolling diaphragm syringe 135 (shown in FIG. 16B) within the throughbore 221. The sidewall 219 of the pressure jacket 210 has a first distal portion 360a for receiving at least a portion of the rolling diaphragm syringe 135 and a second proximal portion 360b in contact with the injector 10. The first distal portion 360a may have an open end configured to releasably receive a cap 390 that encloses the interior of the pressure jacket 210. The second proximal portion 360b may have an open end that allows the piston 138 of the fluid injector 10 to extend through the open end and engage the rolling diaphragm syringe 135 held within the throughbore 221. The rolling diaphragm syringe 135 may be inserted through the open end of the first distal portion 360a or the second proximal portion 360b.

[0082] In some embodiments, the second proximal portion 360b has a locking lug or lip 370 that projects radially outward from an outer surface of the second proximal portion 360b. The locking lug or lip 370 can extend continuously or discontinuously around the circumference of the second proximal portion 360b. The locking lug or lip 370 is configured to interact with a corresponding feature on the fluid injector 10 to releasably lock the pressure jacket 210 to the fluid injector 10. In some embodiments, the locking lug or lip 370 can have a connecting member for releasably securing the pressure jacket 210 to a corresponding locking feature of the fluid injector 10 described in U.S. Pat. Nos. 5,383,858; 5,873,861; 6,652,489; 9,173,995; and 9,199,033, which are incorporated herein by reference. Other connection members between the pressure jacket 210 and the fluid injector 10 are described in International Application No. PCT / US2015 / 057751, filed October 28, 2015, or International Application No. PCT / US2015 / 057747, filed October 28, 2015, which are incorporated herein by reference.

[0083] 16B and with continued reference to FIG. 16A, the pressure jacket 210 can have a cap 390 releasably secured to the distal end 216. In some embodiments, the cap 390 can be secured by threaded engagement, a bayonet fit, or another mechanical fastening arrangement with the distal end 216 of the pressure jacket 210. For example, as shown in FIGS. 16B and 16C, the cap 390 can have at least one protrusion 430 that is received inside at least one groove 440 on the pressure jacket 210, and the cap 390 can be locked with the pressure jacket 210 by aligning the at least one protrusion 430 to fit within the groove 440. The cap 390 can have an inner element 400 having a nozzle 410. The nozzle 410 can be in fluid communication with (or formed directly in) the interior volume of the rolling diaphragm syringe 135 to deliver fluid into or from the rolling diaphragm syringe 135. The nozzle 410 can have a connection member 420 for removably connecting to a connector of the fluid path set 17 (shown in FIG. 1).

[0084] The annular sidewall 460 can have one or more gripping elements 470 (shown in FIG. 16C ) that facilitate gripping the cap 390 when the cap 390 is connected to and / or removed from the pressure jacket 210. The cap 390 can have a radial flange 480 extending radially outward from a proximal portion of the annular sidewall 460.

[0085] 16C, at least a portion of the rolling diaphragm syringe 135 may be removably secured to a cap 390. In some embodiments, the cap 390 may have a connection member that corresponds to and connects to the connection member 140a (shown in FIG. 15A) of the rolling diaphragm syringe 135. As further shown in FIG. 16C, the rolling diaphragm syringe 135 may initially be in a compressed configuration in which the rolling diaphragm syringe 135 is rolled over on itself. Providing the rolling diaphragm syringe 135 initially in a compressed configuration may provide economic benefits during packaging and shipping by requiring less packaging material per syringe setup and / or allowing more syringe setups to be packaged.

[0086] 2. Generation of illuminated identification patterns with alternative exemplary syringes Having generally described the structure of the rolling diaphragm syringe 135, a system for generating an illuminated identification pattern on the rolling diaphragm syringe 135 to determine the fill status of the rolling diaphragm syringe 135 will now be described in detail. In one example, with reference to FIGS. 17A and 17B, the piston 138 of the fluid injector 10 can have one or more electromagnetic radiation sources 212, such as an LED, attached or embedded at its distal end. When actuated, the piston 138 advances toward and engages the piston-engaging portion 244 of the rolling diaphragm syringe 135. The LED emits light axially through the piston-engaging portion 244 to generate an illuminated identification pattern on the distal end 137 of the rolling diaphragm syringe 135.

[0087] The wavelength of the LED's electromagnetic radiation is selected to match the material used to form the rolling diaphragm syringe to allow for the best transfer of energy. For example, car windows are made of materials that do not allow UV light to pass through to prevent sunburn while driving. The same principle applies in the present application. The LED's wavelength may be selected to match the material used to manufacture the syringe to ensure maximum transmission through the material of the piston-engaging portion 244 and / or the wall thickness of the syringe. Alternatively, instead of selecting a wavelength that matches the material, a wavelength of the LED may be selected that is best visible to the human eye when combined with the halo effect described herein. For example, green light is located in the middle of the visible spectrum (about 532 nm), making light with such wavelengths easily visible to technicians. Also, depending on the solute concentration of the fluid contained in the syringe, the compounds present, and their chemical properties, the LED's wavelength may be selected to be selectively absorbed or transmitted by the fluid, or to have the desired reflection / dispersion properties. Thus, the wavelength of the LED can be selected such that the light generated by the LED is dispersed by the fluid to produce more light, or the light can be absorbed / transmitted by the fluid and pass through similar to how the halo 120 described herein is formed.

[0088] In other examples, the electromagnetic radiation source may be located in various other locations, such as, but not limited to, the piston-engaging portion 244 of the rolling diaphragm syringe 135, the pressure jacket 210 external to the fluid injector 10 similar to the configuration shown in FIGS. 10 and 11, a heat maintenance device associated with the pressure jacket 210, or any other suitable location. In one example, with reference to FIGS. 18A and 18B, the electromagnetic radiation source 212 may be located in another portion of the fluid injector, such as a clamp 213 located at the distal end of the syringe 135 used to secure the syringe 135 within the fluid injector. For example, with reference to FIG. 18A, the electromagnetic radiation source 212 may be located around the side of the clamp 213 to direct light through the side of the pressure jacket 210 to the syringe 135. Alternatively, with reference to FIG. 18B, the electromagnetic radiation source 212 may be located on the top surface of the clamp 213 to direct light downward through the syringe 135.

[0089] In one example, an end of the piston-engaging portion 244 may be configured to expose an LED of the piston 138 when the piston 138 engages the piston-engaging portion 244. More specifically, the piston-engaging portion 244 may be configured to release a cover (not shown) to expose the LED when the piston 138 engages the piston-engaging portion 244.

[0090] The piston-engaging portion 244 of the rolling diaphragm syringe 135 may be shaped to collect light from the LED and direct the light through the interior volume 214 of the rolling diaphragm syringe 135 to its distal end. For example, the piston-engaging portion 244 may have a convex lens shaped portion to focus the light generated by the electromagnetic radiation source 212 and direct the light onto the piston-engaging portion 244. Additionally, if the source of the electromagnetic radiation source is collimated, the shape of the particular portion of the piston-engaging portion 244 may be flat or any other suitable geometric shape.

[0091] The piston engaging portion 244 may also have a textured surface to enhance its light gathering and transmitting capabilities. Additionally, the central portion 276 of the end wall 136 may also include a textured surface to enhance the transmission of light to the distal end 137 of the rolling diaphragm syringe 135 when the rolling diaphragm syringe 135 is filled with fluid, and may diffuse light when the rolling diaphragm syringe 135 is filled with air or partially filled with air. Alternatively, the central portion 276 of the end wall 136 may be configured as a lens to enhance the transmission of light to the distal end 137 of the rolling diaphragm syringe 135.

[0092] In another example, as shown in Figures 19A and 19B, the pressure jacket 210 can include an electromagnetic radiation source 212 as described herein disposed at its proximal end 218. In such a case, light generated by the electromagnetic radiation source 212 is directed upward through the pressure jacket 210, and internal reflections within the pressure jacket 210 generate an identification pattern illuminated on the conical distal end 137 of the rolling diaphragm syringe 135 when the syringe is filled with fluid. In another embodiment, the pressure jacket 210 can be coated with a material that creates a "one-way mirror" that appropriately distributes the internal reflections of the electromagnetic radiation while still allowing observation by a technician. Additionally or alternatively, the electromagnetic radiation source and pressure jacket 210 can be deflected so that the electromagnetic radiation does not exit the pressure jacket 210.

[0093] The electromagnetic radiation is collected and directed to the distal end 137 of the rolling diaphragm syringe 135 to generate an illuminated identification pattern when filled with fluid. The inside of the distal end 137 of the rolling diaphragm syringe 135 may be angled similar to the distal end 24 of the syringe 12 described herein to generate the halo 120 in a similar manner. Alternatively or additionally, a protruding piece 224 may be incorporated or positioned on the distal end 137 of the rolling diaphragm syringe 135 to distribute light and generate the halo 120, as shown in FIG. 20. The protruding piece 224 may have a variety of configurations for a variety of purposes. For example, the protruding piece 224 may be a reflective surface that reflects light in different directions to improve visualization of the halo 120 or to provide another indication that fluid is present. The protruding parts 224 may be prisms, mirrors, textured surfaces, or other shapes / materials to disperse / absorb light in a manner that allows for indication of the presence of fluid, type of fluid, or other characteristics of the syringe 135.

[0094] As the cap 390 may be used with the rolling diaphragm syringe 135 described herein, the cap 390 may be fabricated from a translucent or transparent material such that a halo may be observed through the cap material. Electromagnetic radiation, when transmitted to the distal end 137 of the rolling diaphragm syringe 135, illuminates such a transparent or translucent cap 390. The intensity of the illumination of the cap 390 varies depending on the fluid contained within the syringe described herein. For example, when a fluid is provided within the syringe, the cap 390 is illuminated much more brightly than when air is present within the syringe.

[0095] II. Various Other Aspects of the Image Recognition of Illuminated Identification Patterns and Fluid Injection System Having described various examples of the radiation source, the syringe, and how the electromagnetic radiation or light beam passes through the syringe to form the projected identification pattern, a sensor 114 for identifying the projected identification pattern and for monitoring or controlling operation of the injector 10 (shown in FIG. 1 ) based on identification of the projected identification pattern, as well as various other aspects of the fluid injector 10 will now be described in detail. The systems and methods described herein are described with reference to a fluid injector 10 that includes a syringe 12, although all of the concepts described herein may also be utilized with a rolling diaphragm syringe 135.

[0096] 1, 6, and 9-12, the fluid verification system 110 is configured as an image recognition system including at least one sensor 114, such as an image capture device positioned to have a field of view directed toward at least the distal end 24 of the syringe 12, a central processing unit 116 operably connected to the sensor 114 and including a controller configured to process images obtained from the sensor 114 using suitable image processing software, and a display 118 operably connected to the central processing unit 116 for displaying results of the image processing performed by the central processing unit. In one example, the image processing software may be Insight Explorer software from Cognex Corporation of Natick, Massachusetts, and the sensor 114 may be a DataMan 100 camera from Cognex Corporation. Additionally, the at least one sensor 114 and the central processing unit 116 may be integrated into a single component or provided as separate components. Additionally, at least one sensor 114, the fluid injector 10, the display 118, and / or the central processing unit 116 may be in wired communication or may be in wireless communication, for example via Bluetooth, WiFi, or other conventional wireless communication technologies.

[0097] In another example, the sensor 114 may be an alternative type of optical sensor, such as an electromagnetic radiation detector or other suitable sensor known in the art. In some examples, the at least one sensor 114 is a digital camera that may be configured to capture a digital image of at least the distal end 24 of the barrel 18 when the electromagnetic radiation source 112 is turned on. In other examples, the at least one sensor 114 may be an infrared detector, an ultraviolet detector, an ultrasound imager, or other suitable sensor for identifying electromagnetic radiation emitted from the electromagnetic radiation source 112.

[0098] As will be appreciated by those skilled in the art, the at least one sensor 114 or detector may be specifically adapted to identify wavelengths of electromagnetic radiation or light associated with the electromagnetic radiation source 112 and the illuminated identification pattern generated therewith. For example, the at least one sensor 114 may include various filters or tuned or attenuated optical elements to identify only radiation within expected wavelengths (e.g., electromagnetic radiation within the wavelengths emitted by the electromagnetic radiation source 112). Additionally, the syringe 12 itself may be used as a filter by modifying material properties (e.g., color, molecular arrangement, dye additives, polarization plane) to filter light of a given wavelength to achieve optimized visualization by the user. Alternatively, image processing techniques known in the art may be used to remove portions of the obtained image outside of expected wavelengths to reduce the effect of ambient light on the illuminated identification pattern and increase sensitivity.

[0099] Using the features of the fluid verification system 110 described herein, various aspects of a fluid injection procedure can be monitored before and during fluid delivery to quickly provide detailed information about the injection procedure to the technician in a readily apparent manner, as will be described herein.

[0100] A. Air detection 1. Use of images of illuminated identification patterns All current injector systems rely on a technician's personal inspection to determine if air is present in the syringe prior to the start of an injection procedure. The fluid verification system 110 is configured to provide detection of air using at least one sensor 114 and image recognition software executed by a central processing unit 116, allowing the technician to further corroborate a conclusion regarding the condition of the syringe. Additionally, the technician can manually determine if air is present by viewing the syringe to determine if an illuminated identification pattern is present, providing an alternative or two-pronged approach to air detection.

[0101] In one example, the fluid verification system 110 determines whether air is present by taking an image of the distal end of the syringe 12, determines whether a halo 120 has been created in the syringe 12 by the electromagnetic radiation source 212 with the sensor 114 using image recognition software in the central processing unit 116, and reviews and analyzes the image to measure one or more characteristics of the halo 120 or illuminated identification pattern to determine whether the syringe is properly filled with fluid prior to injection. More specifically, according to one embodiment, with reference to FIG. 21, in step 300, at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12 including the halo 120 or other illuminated identification pattern. Thereafter, with reference to FIGS. 22 and 23, in step 302, a bottom edge 301 of the meniscus of the fluid contained in the syringe 12 and / or a bottom edge 303 of the halo 120 are measured or determined by the system 110. These edges 301, 303 are identified in the image by software provided on the central processing unit 116. More specifically, the image processing software executed by the central processing unit 116 can detect edges by a variety of different methods. One method is to determine the change in contrast between adjacent pixels in the image of the edge. Alternatively, a change in contrast over several adjacent pixels may indicate the presence of an edge. This change is indexed across each pixel in a search window to find an area where the change in contrast reaches a threshold. For example, if the image recognition software finds a spot where a light colored pixel is adjacent to a dark pixel, this change is flagged. If this threshold is found to intersect with several pixels in a row that is specifically oriented in a given direction, the image processing software determines that this is an "edge". In this particular application, the dispersion of light caused by the lensing effect of the meniscus causes a dark area of ​​fluid at the meniscus location. Specifically, there is an edge that can be seen at the top and bottom of the meniscus, as most clearly shown in FIG. 23.

[0102] Figure 22 is an image of the syringe 12 without the presence of air, and Figure 23 is an image obtained by the sensor 114 when air is present in the syringe 12. As can be seen from these images, the halo 120 is larger when no air is present, as shown in Figure 22. This allows air to be determined using image processing techniques that are described in more detail herein.

[0103] In step 304, a distance 305 from the bottom edge 301 of the meniscus to the bottom edge 303 of the halo 120 is determined using image processing software provided on the central processing unit 116. Once the bottom edge 301 of the meniscus has been determined, the position of this edge in space can be found. In particular, the bottom edge 303 of the halo 120 can be determined, and this bottom edge 303 of the halo 120 always remains fixed as long as the syringe 12 and the sensor 114 do not move. Thus, the image processing software can determine the distance from the bottom edge 301 of the meniscus to the bottom edge 303 of the halo 120.

[0104] In step 306, the distance 305 determined in step 304 is compared to a predetermined distance. The predetermined distance was found by creating a curve such as the curve shown in FIG. 24. This curve was created by taking a filled syringe 12 and replacing known increments of fluid with an equal volume of air. An image was then taken after each increment of fluid was replaced and the distance from the bottom edge of the meniscus to the bottom edge of the halo 120 was measured using image recognition software on the central processing unit 116. The curve is plotted and an equation is fitted. This equation is provided to a logic algorithm which is implemented such that the data for the curve in FIG. 24 calculates the volume of air present based on the distance between the two ends.

[0105] If the measured distance 305 is greater than the predetermined distance, it can be determined that substantially no air is present, and the injector can be activated to proceed with the injection, at step 308. On the other hand, if the measured distance 305 is less than the predetermined distance, an indication that air is present in the syringe 12 is provided, at step 310, and the fluid injector 10 is prevented from performing the injection procedure, at step 312. Alternatively, if air is present, the fluid injector 10 can perform a purging process to purge the air from the syringe and then repeat the measurement procedure of FIG. 21. This purging process is repeated until the measurement process indicates that substantially no air is present in the syringe, and the injection procedure can proceed.

[0106] 2. Use of the details provided on the syringe barrel Another approach to detecting air in a syringe using image processing techniques is to obtain an image of a particular feature on the barrel of the syringe. Specifically, referring to FIG. 25 and FIG. 26, the syringe 12 can include at least one fluid dot 339 on the surface of the syringe 12, which is visible by a sensor through the fluid contained in the syringe 12. The use of fluid dots is described in U.S. Pat. No. 5,254,101 to Trombley, III, the disclosure of which is incorporated herein by reference in its entirety. Due to the different properties of different fluids, this dot 339 will have a different appearance based on the fluid contained in the syringe. Thus, if air is contained in the syringe 12, the fluid dot 339 will have a particular configuration, such as an oval shape, when viewed in the image, which can be detected as follows. First, in step 340, at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12, including the fluid dot 339, through the fluid contained in the syringe 12. 27, in step 342, the fluid dots 339 are identified in the image using a pixel contrast threshold. Specifically, the fluid dots 339 are identified by detecting their edge in a manner similar to how the bottom edge of the meniscus is determined as described herein.

[0107] Next, in step 344, because the shape of the fluid dot 339 when various fluids are provided in the syringe is known, pattern matching techniques can be utilized to determine if air or fluid is present in the syringe 12. Thus, a template of the fluid dot 339 when fluid is present in the syringe can be matched to the image obtained in step 340. If the template matches the image obtained in step 340 in step 346, it can be determined that no air is present and the injector can be activated in step 348 to proceed with the injection. On the other hand, if the template does not match, an indication is provided in step 350 that air may be present in the syringe 12 and the fluid injector 10 is prevented from performing the injection procedure in step 352 until repeated analysis steps indicate that the air has been removed, for example by purging.

[0108] Although described herein as utilizing a fluid dot 339, various other shapes can be utilized and imaged to determine if air is present within the syringe. This is due to the fact that the cylindrical syringe barrel is effectively a lens itself. The curvature of the barrel wall can be utilized to capture an image that appears different to at least one sensor 114 if there is air or fluid within the syringe 12. This phenomenon can be utilized to detect the presence of total air inside the syringe. Additionally, the relative size of the images can allow for the determination of the type of fluid within the syringe (e.g., a large image is seen through contrast agent while a small image is seen through saline due to the difference in refractive index between the fluids). More specifically, since the syringe barrel 18 acts as a cylindrical lens when filled with fluid, the fluid dot 339 spreads out on the horizontal axis. Thus, the elliptical fluid dot 339 spreads out horizontally without affecting its vertical height. This is how an elliptical fluid dot 339 on an empty syringe becomes circular or more circular relative to the sensor 114 on a filled syringe. The sensor can measure the change in horizontal width of the fluid dot 339 to determine various features of the fluid contained within the syringe. Because of this principle, a variety of different shapes can be used to achieve the above-mentioned effects of the fluid dot 339, for example, by measuring the difference in the non-vertical features of the fluid dot 339.

[0109] 3. Using Luminance Measurement According to other embodiments, air detection is also possible by imaging a portion of the syringe having electromagnetic radiation from a radiation source passing therethrough to determine the average pixel brightness value of a region of interest, such as a portion of the distal end 24 of the syringe, e.g., a halo region as described herein. Such a configuration is shown in FIG. 28, which illustrates a syringe 12 filled with contrast agent having electromagnetic radiation in the form of a passing laser light beam 354, e.g., having a particular wavelength. As seen in FIG. 28, when the syringe is filled with contrast agent, a distinct laser beam 354 path can be seen as it passes through the contrast agent. Without being limited to any theory, it is believed that the contrast agent dissolved in solution scatters the electromagnetic radiation in the laser beam 354, providing an observable laser beam path. When the syringe 12 is filled with air, no such laser beam is present (see FIG. 27). Thus, as shown in FIG. 28, the average pixel brightness (e.g., 0-255 intensity units) in an image of a portion of the distal end 24 of the syringe 12 when filled with fluid is much higher than when the syringe is filled with air, as evidenced by the presence of a laser beam 354 due to scattered laser light. Thus, the brightness can be used to determine the presence of air or contrast agent by shining laser electromagnetic radiation through a portion of the syringe barrel and obtaining an image of the syringe through which the electromagnetic radiation passes; determining a region of interest, such as near the distal end 24 of the syringe; determining an average pixel brightness value for the region of interest by assigning each 8-bit pixel in the region of interest a brightness value of 0-255 intensity units and then averaging these brightness values; and comparing the average brightness value to a known brightness value to determine whether fluid or air is present in the syringe 12. The scattering of laser light by the contrast agent, as compared to the non-scattering of air, can be observed by shining laser light through any portion of the fluid in the syringe barrel. In the embodiments described herein, the laser light may be presented through the distal end of the syringe due to a particular location of the at least one sensor relative to the syringe barrel. Those skilled in the art will appreciate that other locations of the at least one sensor may be used to determine the intensity of the laser light depending on the location of the path of the laser light.

[0110] B. Fluid Distinction All of the image processing techniques described above for distinguishing air from fluid in a syringe can also be utilized to identify the type of fluid contained within the syringe. For example, the image processing techniques described above due to the way different fluids interact with light can be used to accurately distinguish contrast agent from saline, and different types of contrast agents from each other. With particular reference to Figures 29 and 30, the scattering of the laser light may differ depending on the fluid within the syringe. For example, laser beam path 354 displays a weaker intensity passing through saline compared to the intensity of laser beam path 354 passing through the contrast agent in the syringe.

[0111] 1. Use of illuminated identification patterns 29 and 30, a fluid verification system 110 according to various aspects of the present disclosure can determine whether the syringe contains saline or contrast by capturing an image of the halo 120 created in the syringe 12 by the electromagnetic radiation source 112 with the sensor 114 and using image recognition software on the central processing unit 116. Other methods for distinguishing between saline and contrast are described in detail herein, but the same techniques can be used to distinguish different types or concentrations of contrast. First, at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12 including the halo 120. The distance between the bottom edge 301 of the meniscus at the air / fluid interface in the syringe 12 and the bottom edge 303 of the halo 120 is then measured by the system 110. These edges 301, 303 are identified in the image by software provided on the central processing unit 116 from pixel contrast thresholds as described herein. FIG. 29 is an image obtained by the sensor 114 of the syringe 12 containing saline, and FIG. 30 is an image obtained by the sensor 114 when contrast agent is present in the syringe 12. As can be seen from these images, the distance between the ends 301 and 303 is greater when saline is present in the syringe (FIG. 29) compared to the distance between the ends 301 and 303 when contrast agent is present in the syringe (FIG. 30). With regard to contrast agent differentiation, the halo 120 will also be of different magnitudes depending on the type of contrast agent present in the syringe. This allows differentiation of the type of fluid contained in the syringe, i.e. saline and various contrast agents, using image processing techniques described in more detail herein.

[0112] The distance from the bottom edge 301 of the meniscus between the air / fluid interface and the bottom edge 303 of the halo 120 is determined using image processing software provided in the central processing unit 116 as described herein. This distance can then be compared to various predetermined distances corresponding to various fluids contained within the memory of the central processing unit 116. If the distance corresponds to a first predetermined distance for saline, an indication 356 is automatically displayed on the display 118 indicating that the syringe 12 contains saline, and if the distance corresponds to a second predetermined distance for a particular contrast agent, an indication 358 is automatically displayed on the display 118 indicating that the syringe 12 contains a particular contrast agent.

[0113] Alternatively, pattern matching techniques based on the size of the halo 120 can be utilized to determine whether the syringe contains air, saline, or various contrast agents. For example, as described in detail herein, image processing software provided in the central processing unit 116 can determine the height of the halo 120 from the bottom of the threads of the nozzle 22 to the bottom end of the halo 120 and determine the presence and type of fluid based on the height. Additionally, the image processing software can be programmed for a particular contrast agent or other fluid using pattern recognition by capturing a training image of a syringe known to have a particular contrast agent contained therein. This training image records all dimensions of the halo 120, including the height. The image processing software then compares all features of the image after capture to the training image for comparison. If the image exceeds a threshold of similarity, the system provides an indication that the syringe 12 contains a contrast agent or saline other than the trained contrast agent.

[0114] 2. Use of the details provided on the syringe barrel Another approach to using image processing techniques to determine the type of fluid contained in a syringe is to obtain an image of a particular feature provided on the syringe. Specifically, referring to Figs. 27, 31, and 32, the syringe 12 may include at least one fluid dot 339 that is viewed by a sensor through the air or fluid contained in the syringe described herein. Due to the different properties of air and different fluids, this dot 339 has a different appearance, especially along the horizontal axis, based on the air or fluid contained in the syringe, as can be seen by comparing the fluid dot 339 in Fig. 27 seen through a syringe 12 containing air, the fluid dot 339 in Fig. 31 seen through a syringe 12 containing saline, and the fluid dot 339 in Fig. 32 seen through a syringe 12 containing contrast agent. Thus, if air is contained within the syringe 12, the fluid dots 339 will have a shorter horizontal distance when viewed by the sensor, if saline is contained within the syringe 12, the fluid dots 339 will have a particular configuration when viewed in the image, and if contrast agent is contained within the syringe 12, the fluid dots 339 will have a particular configuration (i.e., a longer horizontal distance) when viewed in the image. Thus, the type of fluid contained within the syringe can be detected as follows:

[0115] First, the sensor 114 is positioned to capture an image of at least a portion of the syringe 12, including a fluid dot 339 or other indicator feature on the syringe barrel through the fluid contained within the syringe 12. The fluid dot 339 is then identified in the image using a pixel contrast threshold as described herein. Next, in step 344, because the shape of the fluid dot 339 when various fluids are provided in the syringe is known, pattern matching techniques can be utilized to determine whether air, saline, or contrast is present in the syringe 12. For example, a template of the fluid dot 339 when saline is present in the syringe can be matched to the image. If the template matches the image, it can be determined that saline is present, and an indication 356 is provided on the display 118 indicating the presence of saline in the syringe 12. On the other hand, if the template does not match, a template of the fluid dot 339 when contrast is present in the syringe can be matched to the image. If the template matches the image, then it can be determined that contrast agent is present and an indication 358 is provided on the display 118 indicating that contrast agent is present in the syringe 12. Additionally, if the templates for saline or various contrast agents do not match, then a template of fluid dots 339 when air is present in the syringe can be matched to the image. If air is determined to be in the syringe, the injection procedure can be automatically stopped.

[0116] A variety of other shapes besides the oval shaped fluid dot 339 can be utilized and imaged to determine the type of fluid contained within the syringe, as described in more detail herein.

[0117] 3. Using Luminance Measurement According to certain aspects, differentiation of fluids may also be possible by imaging a portion of the syringe with electromagnetic radiation from a radiation source passing through it to determine an average pixel brightness value of a region of interest, such as a portion of the distal end 24 of the syringe. Returning to Figures 27, 29, and 30, when the syringe is filled with contrast agent (see Figure 30), a separate laser beam path 354 is visible. When the syringe 12 contains saline (see Figure 29), the laser beam path 354 is much less distinct and is essentially indistinguishable when passing through an air-filled syringe. According to certain embodiments, a laser can be used that emits light having a wavelength within the green region of the visible light spectrum. Thus, the average pixel brightness (e.g., 0-255 intensity units) in an image of the portion of the distal end 24 of the syringe 12 when filled with contrast agent is much higher than when the syringe is filled with saline or air. Thus, the type of fluid contained within the syringe may be determined by acquiring an image of the syringe through which electromagnetic radiation passes; determining a region of interest, such as near the distal end 24 of the syringe (although other regions of the syringe may be used); determining an average pixel brightness value for the region of interest by assigning each 8-bit pixel within the region of interest a brightness value between 0 and 255 intensity units and then averaging these brightness values; and comparing the average brightness value to known brightness values ​​to determine whether contrast agent, saline, or air is present within the syringe 12. This methodology may also be used to distinguish between different types (e.g., different brands or solute concentrations) of contrast agents.

[0118] C. Fluid source condition According to other embodiments, various information regarding the status of the fluid source can be obtained by using at least one sensor 114 to obtain images of various portions of the fluid injector 10. For example, images of a fluid container, such as a saline bag or contrast bottle, and its contents can be obtained, and image processing techniques can be used to determine the amount of fluid in the bottle. This information can be provided to a central processing unit, and the bottle may be displayed on a display 118 indicating the amount of fluid present or remaining in the bottle. Additionally, optical character recognition can be used to determine the type of fluid contained in the bottle, and this information can be displayed on the display 118. Additionally, in certain embodiments, the fluid remaining in the bottle may be constantly monitored before, during, and after an injection procedure, and an updated remaining amount may be displayed in real time on the display 118. In still other embodiments, the central processing unit 116 can monitor the remaining amount and provide a warning if the volume of one or more contrast or saline is not sufficient to complete the injection procedure. This mechanism, combined with patient schedules for a series of patients, can provide real-time feedback of the required amount of contrast and / or saline so that the technician can be sure they have sufficient supplies on hand to complete all scheduled injection procedures or, for example, if a contrast warmer is used, can ensure that the subsequent contrast container or containers are at the desired injection temperature when the contents of the currently used bottle are nearly depleted.

[0119] More specifically, the same methodology utilized to recognize the size of the halo 120 using the pattern recognition techniques described herein can be utilized to determine the status of the fluid source. For example, the image processing software looks for geometric components in the image and compares it to training images with known objects. In one example, if the image processing software is trained to know what letters of the alphabet look like and the size and angle thresholds for recognition are reduced, the image processing software can effectively read the label on the bottle and determine the manufacturer, type of contrast agent, expiration date, etc. Additionally, the fluid level in the bottle can be identified using the edge detection techniques described herein, and the image processing software can be programmed to calculate the amount remaining in the bottle until it needs to be replaced by the user. This aspect utilizes a calculation similar to the volume of air present in a syringe as described herein. Specifically, an equation, or algorithm, can be developed to generate a curve and fit each size and shape of the bottle to determine the amount remaining.

[0120] D. Determine type (size / presence) of syringe In certain embodiments, the fluid verification system 110 may be utilized to determine various characteristics or parameters of the syringe 12 to be inserted into the injector prior to the fluid injection procedure, such as the syringe type, size, manufacturer, date of manufacture or lot number, suitability for a particular injection procedure, prior use, remaining useful life, maximum pressure, etc. This information may be used to identify the syringe and manufacturer, determine if the syringe has been used previously, determine the desired flow rate, pressure, volume, etc. In one example, with reference to FIGS. 33 and 34, the syringe size may be determined as follows. First, at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12, such as the distal end 24 of the syringe 12. Because the location of the at least one sensor 114 is known, the location of a particular feature of the syringe 12 of a first size, such as the nozzle 22 or halo 120, and the location of a particular feature of the syringe 12 of a second size, such as the nozzle 22 or halo 120, in the image of the distal end 24 of the syringe are also known. This fact can be utilized to determine the size of syringe 12 to be used with fluid injector 10 using pattern matching techniques. For example, a template 365 of a syringe of a first size (e.g., 150 mL) can be applied to the image. If the template matches the image, central processing unit 116 determines that the syringe is a 150 mL syringe and an indication 367 of the size of syringe 12 is provided on display 118. On the other hand, if the template 365 does not match, a template 369 of a syringe of a second size (e.g., 200 mL) can be applied to the image. If the template matches the image, central processing unit 116 determines that the syringe is a 200 mL syringe and an indication 367 of the size of syringe 12 is provided on display 118. If none of the stored templates match, an indication can be provided on display 118 indicating that the syringe is not present or that the identity of the syringe cannot be determined.In another embodiment, at least one sensor 114 can be positioned to image at least one identification marking on the syringe 12, such as a barcode containing information about the syringe, such as the manufacturer, manufacturing date or lot, one or more syringe parameters, a specific identification / security code that can be verified by the central processing unit to determine whether the syringe is authentic or potentially reused, and transmit the image of the identification marking to the central processing unit 116 for deconvolution.

[0121] E. Indicators of tube presence Similar to determining the syringe type, in other embodiments, the presence or absence of a fluid path set 17 connected to the syringe 12 may be determined using image processing techniques. This information can be utilized by the central processing unit 116 to prevent the injector from operating if an operator inadvertently attempts to begin an injection procedure without the fluid path set 17 connected to the nozzle 22 of the syringe, or if the fluid path set is not primed. In one example, referring to FIGS. 35 and 36, the sensor 114 is positioned to capture an image of the nozzle 22 of the syringe 12. Since the location of the sensor 114 is known, the location of certain features of the syringe 12, such as the nozzle 22 and the fluid path set 17, in the image of the syringe 12, when connected to the nozzle 22, is also known. This fact can be utilized to determine whether the fluid path set 17 is connected to the syringe 12 using pattern matching techniques. For example, a template 373 of the syringe 12 with the fluid path set 17 connected can be applied to the image. If the template matches the image, the central processing unit 116 can determine that a fluid pathway set 17 is connected to the syringe 12, and an indication 375 is provided on the display 118 indicating that the fluid pathway set 17 is present (see FIG. 31 ). On the other hand, if the template 373 does not match, the central processing unit 116 can determine that the fluid pathway set 17 is not present, and an indication 377 is provided on the display 118 indicating that the fluid pathway set 17 is not present.

[0122] F. Indicators of the presence of a spike or transfer set 37, according to certain embodiments, a fluid transfer device 46 is often used to fill a syringe 12 from a fluid container 44. The transfer device 46 typically includes a spike 48 having at least one fluid path and, in certain embodiments, an airway for piercing a seal of the fluid container 44, a cup 50 for holding the fluid container 44 on the spike 48, a valve (not shown), such as a check valve, to allow fluid to enter the syringe 12, and a syringe support member or sleeve 54 for holding the syringe 12 against the transfer device 46.

[0123] During the filling procedure, after the syringe 12 is attached to the fluid injector 10, the plunger 26 is advanced to expel air from the syringe 12. The syringe 12 is then ready to be filled with fluid. The transfer device 46 may then be inserted onto the fluid container 44 such that the spike 48 pierces the seal of the fluid container 44. The syringe support member 54 of the transfer device 46 may then be placed over the nozzle 22 of the syringe 12. Within the support member 54, the luer tip of the syringe 12 engages and actuates a valve, opening a passage for fluid to flow from the container 44 to the syringe 12. The injector piston (not shown) retracts the plunger 26 of the syringe 12 to aspirate the contents of the fluid container 44 into the syringe 12. After the syringe 12 is filled, the fluid container 44 is removed from the transfer device 46. The filling of the syringe with fluid can be monitored, for example in real time, by at least one sensor 114 to ensure accurate filling of the syringe.

[0124] Once filling is complete, it may be desirable to provide an indication to the operator as to whether the fluid transfer device 46 has been removed. This can be done automatically using the fluid verification system 110 described herein. Specifically, with reference to FIGS. 38 and 39, at least one sensor 114 is positioned to capture an image of the nozzle 22 of the syringe 12. Because the location of the at least one sensor 114 is known, the location in the image of the syringe 12 of certain features of the syringe 12, such as the nozzle 22 and the fluid transfer device 46, when connected to the nozzle 22, is also known. This fact can be utilized to determine whether the fluid transfer device 46 is connected to the syringe 12 using pattern matching techniques. For example, a template 383 of the syringe 12 with the fluid transfer device 46 connected can be applied to the image. If the template matches the image, the central processing unit 116 can determine that the fluid transfer device 46 is connected to the syringe 12, and an indication 385 indicating the presence of the fluid transfer device 46 is provided on the display 118 (see FIG. 38). This information may also be displayed on the touch screen controller 82 of the fluid injection system 600, as shown in Figure 58. On the other hand, if the template 383 does not match, the central processing unit 116 may determine that the fluid transfer device 46 is not present, and an indication 387 is provided on the display 118 indicating that the fluid transfer device 46 is not present (see Figure 39).

[0125] G. Purged Tube Indicator 40, in certain embodiments of the fluid injector 10 described herein, a purge container 550 may be configured to be connected to an end of a connector 552 of a fluid pathway set 17 that delivers contrast or other fluid to a patient during a pre-injection purge procedure. When the fluid pathway set 17 is primed or purged with air prior to an injection procedure, the purge container 550 collects contrast agent discharged from the end of the fluid pathway set 17 and delivers that contrast agent to the patient as the syringe 12 and fluid pathway set 17 are purged and primed, providing an indication that the purge was acceptable based on the amount of contrast agent contained therein. In certain embodiments, an operator may visually inspect the purge container 550 to determine that it contains an acceptable amount of contrast agent and that the purge is acceptable and the syringe and fluid pathway are primed with fluid. However, in certain embodiments, this process can be automated by capturing images of the purge vessel 550 with at least one sensor 114 and processing the images using image processing techniques described herein.

[0126] For example, with reference to Figures 41, 42A, and 42B, a fluid dot 554 or other indicator marking similar to the fluid dot 339 described herein may be formed or provided on a surface of the purge container 550. At least one sensor 114 is positioned to image the fluid dot 554 through any fluid contained within the purge container 550. Due to different properties, such as refractive index of different fluids, and / or the selected curvature of the purge container 550, the dot 554 has a different appearance based on the fluid contained within the syringe and the purge container 550. Thus, if air is contained within the purge container 550, the fluid dot 554 has a first configuration as viewed in the image, for example, according to one embodiment as shown in Figure 42A, and if a fluid, such as contrast agent or saline, is contained within the purge container 550, the fluid dot 554 has a second configuration as shown in Figure 42B. The configuration of the fluid dot 554 may be detected as follows: First, the at least one sensor 114 is positioned to capture an image of at least a portion of the purge container 550, including the fluid dots 554 through the fluid contained therein, after the syringe and tubing set 17 has primed and purged the air. Thereafter, since the shapes of the fluid dots 554 when various fluids are provided in the purge container 550 are known, pattern matching techniques can be utilized to determine whether air or fluid is present in the purge container 550. Thus, a template of the fluid dots 554 when a particular fluid, such as contrast or saline, is present in the purge container 550 can be matched to the image of the fluid dots 554 obtained by the sensor 114. If the template matches the image, it can be determined that there is no air in the syringe and tubing set 17 and that the purge container 550 contains sufficient fluid, which indicates that the system is primed and a signal can be sent to the fluid injector 10, indicating that the fluid path set 17 is properly purged and primed. An indication may be provided on the display 118 that the fluid pathway set 17 is properly purged and primed and the injector is ready for an injection procedure.According to certain embodiments, the priming and purging of the syringe and fluid pathway set may be monitored in real time. In this embodiment, at least one sensor 114 monitors the fluid dots 554 on the purge reservoir 550 as the configuration of the fluid dots 554 changes during the priming procedure, and thus the change in volume of the purge reservoir 550, indicating when sufficient fluid has been primed into the system and that no additional air remains in the system. According to one embodiment, an algorithm may be utilized that correlates the fluid flow through the tubing set 17 with the volume change in the purge reservoir 550 to verify completion of the priming operation.

[0127] Alternatively, according to another embodiment, and referring to FIGS. 43A and 43B, instead of using fluid dots 554, one or more reference lines 556 can be formed or provided on the surface of the purge vessel 550. The reference lines 556 can be printed on the surface of the purge vessel 550, molded on the surface of the purge vessel 550, or formed or provided on the surface of the purge vessel 550 in any other suitable manner. At least one sensor 114 is positioned to image the reference lines 556 through any fluid contained within the purge vessel 550. Once an image of the purge vessel 550 is obtained, image processing software provided on the central processing unit 116 uses a pixel contrast threshold described herein to identify a top end 558 of the fluid F contained within the purge vessel 550 along with the reference lines 556. A distance 560 from the top end 558 of the fluid F contained within the purge vessel 550 to the reference lines 556 is determined using image processing software provided on the central processing unit 116. The central processing unit 116 compares this distance 560 to various predetermined distances corresponding to acceptable and unacceptable purge processes to determine if the purge is acceptable and the system is primed. Again, to ensure accurate priming of the system, the purge / priming operation and the change in volume in the purge vessel 550 can be monitored in real time as the syringe and fluid path set 17 is primed.

[0128] In yet another alternative, referring to Figs. 44A and 44B, an indicator line 562 having the shape shown may be formed or provided on the surface of the purge vessel 550. The indicator line 562 may be printed on the surface of the purge vessel 550, molded onto the surface of the purge vessel 550, or formed or provided on the surface of the purge vessel 550 in any other suitable manner. The sensor 114 is positioned to image the indicator line 562 through any fluid contained within the purge vessel 550. Due to the different fluid properties and / or the selected curvature of the purge vessel 550, the indicator line 562 appears to be a different length in the image when fluid is present compared to when air is present. Furthermore, the indicator line 562 may have a brighter appearance when viewed in air than when viewed in fluid. Thus, pattern matching techniques and / or brightness level measurements of the indicator line 562 may be performed on the image of the indicator line 562 by image processing software on the central processing unit 116 to determine whether fluid or air is present in the purge vessel 550. Based on this determination, the central processing unit 116 can determine the acceptability of the purge and provide an indication to the operator via the display 118. Again, to ensure accurate priming of the system, the purge / priming operation and the change in volume of the purge vessel 550 can be monitored in real time based on the change in the indicator line 562 as the syringe and fluid path 17 are primed. Those skilled in the art will appreciate that other configurations of the indicator line 562 are possible and that the image recognition software and algorithms described herein will monitor the change in the configuration of the indicator line 562 during the purge / priming operation to indicate to the technician that the system is properly primed and ready for use in an injection procedure. Such other configurations are within the scope of the present disclosure.

[0129] 45, another configuration of a purge container 550 is shown. This purge container 550 is also configured to be connected during a purge procedure to an end of a connector 552 of a fluid path set 17 designed to deliver contrast or other fluids to a patient during a subsequent diagnostic injection procedure. The purge container 550 includes a cylindrical body 563 having a proximal end 564 and a tapered distal end 565 similar to the tapered distal end 24 of the syringe 12 described herein. A source of electromagnetic radiation 566, such as an LED, is disposed below the proximal end 564 of the cylindrical body 563. Thus, when the purge container 550 is filled with an appropriate amount of fluid, a halo 567 is generated similar to the halo 120 formed in the syringe 12 described herein. This allows an operator to quickly and easily determine whether an acceptable amount of contrast agent is contained therein, that the purge was acceptable if halo 567 is present, and that the syringe and fluid pathway set 17 is properly primed. Furthermore, this process may be automated, and in certain embodiments may be monitored in real time, by capturing one or more images of the halo 567 created in the purge vessel 550 with at least one sensor 114 and processing the images using image processing techniques described herein.

[0130] 46, according to one embodiment, the fluid path set 17 may be modified to allow image recognition of the image of the tube obtained by at least one sensor 114 to determine if the fluid path set 17 has been sufficiently purged. For example, as shown in FIG. 46, the tube of the fluid path set 17 may include a fiber optic cable 610 disposed adjacent thereto. The fiber optic cable 610 may be extruded simultaneously with the tube of the fluid path set 17 such that the fiber optic cable 610 is embedded within the tube or disposed within the tube of the fluid path set 17. In another example, the tube of the fluid path set 17 may be provided with a reflective surface on the inside or outside to transmit light by internal reflection throughout the length of the tube, or the fluid path material may be selected to have a suitable index of refraction for internal reflection as described herein. This will cause light to be reflected throughout the length of the tube of the fluid path set 17 when fluid is present (similar to the operation of a light pipe) providing a visual indicator that the tube of the fluid path set 17 has been purged and is filled with fluid. This visual indicator may be an illuminated component at the end of the tube set that can be recognized by the sensor 114 or simply by the operator. If air is present within the fluid path set 17, for example when the tubes are not fully primed, no internal reflection of light occurs and the "light pipe" effect is not observed.

[0131] Additionally, the tubing of the fluid path set 17 may be configured to have a connector (not shown) at its end attached to the injector 10 or positioned in a location where the electromagnetic radiation source emits through a section of the connector. According to this embodiment, the entire connector will only light up when filled with fluid, indicating that the tubing of the fluid path set 17 is completely purged of air, primed, and ready for use. The electromagnetic radiation source may be wireless, battery powered, or connected to a power source on the injector; that is, it may be in direct or indirect contact with the tubing of the fluid path set 17 and may be disposable or reusable according to certain aspects.

[0132] In yet another example, image processing software provided on the central processing unit 116 can be used to determine the amount of fluid required to purge the fluid path set 17. More specifically, the system can determine how much air is present in the syringe 12 using any of the methods described herein. The image processing software on the central processing unit 116 can then determine the type of fluid path set 17 connected to the syringe using the pattern matching techniques described herein. Using this information, the central processing unit 116 can calculate the amount of fluid required to purge / prime the fluid path set 17. Using this information, the central processing unit 116 can direct the injector 10 to actuate the syringe to move the plunger a sufficient distance to accommodate the amount of air calculated to be in the syringe and fluid path set 17. The plunger can be moved further to expel an additional volume to ensure complete priming of the system.

[0133] In another configuration of the purge receptacle 550, one or more sensors may be associated with it. More specifically, a component (not shown) may be provided within the purge receptacle 550 that moves when fluid enters (meaning the tube is being purged). The moving component may be detected by the sensor 114 or may be a visual indicator to the operator, and the amount of fluid entering the purge receptacle 550 may be determined when priming of the syringe and fluid path set 17 is complete.

[0134] For example, in one aspect, the component may be an air filter (e.g., a Porex brand filter) that allows air to pass as priming occurs, which then contacts the fluid, increasing pressure, reducing friction with the surface, and is driven forward to a position detectable by the sensor 114 or an operator. The component may also be a float ball that rises and falls in response to the presence of fluid and the density of the fluid present, as described in more detail herein with respect to placing such a ball within a syringe.

[0135] H. Capacitance Measurements Based on the Expansion and Stretching of at Least a Portion of a Syringe Capacitance is defined as the change in volume of a fluid path element, element, or entire system as a result of a change in pressure on the system, for example, when the internal pressure of the system is increased by the action of a plunger, pressurizing the system during the injection process. Total system expansion capacity, volume, or capacitance capacity represents the total amount or volume of constrained fluid captured upon expansion of the injector system components due to the applied pressure (i.e., backflow volume). Total system capacitance and capacitance capacity are unique to each fluid injection system and depend on multiple factors, including mechanical properties of the materials used to construct the injector structure, syringe, piston, pressure jacket surrounding the syringe, constrained motion or flexure, fluid density, compressibility, and / or viscosity, change in flow rate under constant pressure, fluid lines delivering contrast and saline to the flow mixer, start pressure, end pressure, etc. For example, in a dual syringe injector, when the relative velocity difference between the two pistons of the injection system is large and the required pressure is high, the amount of backflow increases, which can occur when the simultaneous fluid flow is through a small restriction, the velocity of the total fluid injection is high, and / or the viscosity of the fluid is high. Backflow can prevent different ratios of fluids injected simultaneously in a particular injection, which can be detrimental to any two-syringe injector system, such as fluid injector 10.

[0136] Capacitance measurements can be used to correct for altered flow rates and dynamically delivered flow rates to improve diagnostic imaging. More specifically, in medical procedures such as intravenous injection of contrast media for contrast-enhanced radiography, it is often desirable to introduce a "sharp bolus" of fluid, where a drug and / or diagnostic fluid is introduced at elevated pressure, for rapid delivery to a specific location in the body. For contrast-enhanced radiography, sufficient contrast media must be present at a specific location or region of interest in the body at a given time for a diagnostic quality image to be taken during the procedure. Thus, the amount or volume of contrast media delivered to the patient and the precision of the time at which this volume of contrast media reaches a specific point in the patient's body are important. A "sharp bolus" of contrast media can be defined in practice as a clear or defined column of liquid with well-defined opposing ends or boundaries. Thus, accuracy of the amount of fluid delivered into a patient's veins is often important in medical treatment and diagnostic procedures, and such accuracy can be degraded by the expansion of the capacitance capacity of the fluid delivery pathway components when the fluid delivery system is under pressure. Further details of capacitance measurement and capacitance compensation are described in U.S. Patent No. 8,403,909 to Spohn et al., which is incorporated herein by reference in its entirety.

[0137] Referring to FIG. 47, as fluid is delivered, the increased internal pressure during the injection procedure causes portions of the syringe 12 to expand and stretch. According to an embodiment of the present disclosure, the capacitance volume can be determined as follows. This expansion and stretching can be detected in real time by at least one sensor 114, and the extent can be measured using image processing software provided on the central processing unit 116. For example, the outer diameter of the syringe 12 along the length of the barrel 18 of the syringe 12 can be determined as shown in FIG. 47. The central processing unit 116 can then integrate over different outer diameter measurements above the bottom seal of the plunger 26 along the length of the barrel 18 to dynamically determine the exact volume within the syringe 12. The expected volume if the syringe 12 had no capacitance is then subtracted from the dynamically determined volume, resulting in a residual volume that corresponds to the capacitance volume. Once the capacitance volume is known, the fluid injector 10 can be controlled to control the piston 124 to compensate for the expansion of the barrel 18 under pressure and ensure the delivery of a rapid bolus dose.

[0138] Referring to FIG. 48, a graph of volume versus time during an injection procedure performed by the fluid injector 10 is shown, where line 501 represents the volume of fluid that the fluid injector 10 was programmed to believe was delivered without capacitance compensation, line 503 represents the volume of fluid that was actually delivered to the patient, and line 505 represents the difference due to system capacitance between what was believed to be delivered and what was actually delivered. A scanner (not shown) used to capture images for diagnostic purposes is activated and instructed to begin capturing images at precise time intervals when the agent is expected to pass through a particular part of the body desired to be imaged. That time is based on the amount of fluid that the fluid injector 10 believes to be introduced over a particular period of time (i.e., line 501 in FIG. 48). Because the actual amount of fluid is delivered slower than expected, the scanner may sometimes capture images when the fluid (i.e., contrast agent) is not fully introduced into the part of the body being imaged. This is due to the capacitance or expansion of the syringe and tubing with pressure as described herein. To compensate for this, most operators introduce an estimated delay to try to compensate for the capacitance. However, by determining the flow rate and capacitance based on the expansion and contraction sections as described herein, the controller of the fluid injector 10 can automate this delay for the operator and capture the highest quality images for diagnostic purposes.

[0139] I. Determining the remaining amount In one example, the fluid verification system 110 may be positioned such that at least one sensor 114 can capture images of the syringe 12, including the syringe barrel 18 and plunger 26, to determine the position of the plunger 26 in each image. Based on these images, the amount of contrast or saline remaining in the syringe 12 can be determined. Specifically, with reference to FIG. 49, in step 570, an image of the syringe 12 is acquired by the sensor 114. Next, in step 572, the image processing software identifies the plunger 26 in the image by using pattern recognition based on the training images as described herein. Next, in step 574, the image processing software determines the position of the plunger 26 in the barrel 18 of the syringe 12 by determining the change in position of the plunger 26 relative to a reference point. Once the position of the plunger 26 in the barrel 18 of the syringe 12 is determined, this position can be compared to a known position corresponding to the volume of fluid remaining in the syringe 12 in step 576. The central processing unit 116 then sends a signal to display the remaining volume on the display 118 in step 578. The remaining volume may be displayed as a numerical value or a graphical display of the syringe 12 may be displayed showing the real-time volume remaining in the syringe. Images are continuously captured and the display of the remaining volume is continuously updated until the injection procedure is completed as determined in step 580. Correction of the remaining volume in the syringe by measuring the syringe expansion during injection due to capacitance may also be incorporated into the protocol. Thus, at least one sensor may measure the change in the outer diameter of the syringe, for example by comparing the image to a reference template, and calculate the volume due to capacitance. This capacitance volume may be monitored in real time and transmitted to the central processing unit, allowing algorithmic analysis to compensate for the capacitance and adjust the fluid delivery to provide for the delivery of a rapid bolus dose.

[0140] In another example, if the plunger 26 of FIGS. 5A and 5B is utilized, the remaining volume in the syringe 12 can be determined using only an image of the halo 120. More specifically, the plunger 26 may be formed from or coated with a reflective material having a plurality of differently colored stripes 38. The reflective material forming the stripes 38 reflects light directed distally through the syringe barrel 18 to the plunger 26 to produce the halo. As the plunger or plunger cover 26 moves through the barrel, the light reflects off different stripes 38 depending on the position of the plunger 26 within the syringe barrel 18. Because each stripe 38 on the plunger 26 is a different color, the color and / or appearance of the halo changes depending on the stripe 38 from which the light is reflected as the plunger 26 advances or retracts through the syringe barrel 18 during an injection or filling procedure. At least one sensor 114 may be positioned to capture an image of the halo as the plunger advances or retracts through the syringe barrel 18. Image processing software provided on the central processing unit 116 detects the change in color of the halo. The central processing unit is then configured to determine the position of the plunger 26 within the syringe barrel 18 based on the color of the halo. Once the central processing unit 116 determines the position of the plunger 26, the amount of fluid remaining in the syringe is determined. The central processing unit 116 then sends a signal to display the amount of fluid remaining on the display 118. The amount of fluid remaining may be displayed as a numerical value or a graphical representation of the syringe 12 showing the amount remaining in the syringe. In an alternative embodiment, different colored LED lights may be placed within the piston to transmit light through a translucent or transparent plunger material in similar concentric circles on the plunger.

[0141] J. Pressure Feedback Based on Syringe Expansion and Extension In another example, due to the fact that portions of the syringe 12, such as a portion of the distal end 24, expand and stretch during an injection procedure, image processing techniques can be utilized to determine the pressure at which the fluid within the syringe 12 is delivered to the patient during a fluid injection procedure. The degree of this expansion and stretching is known to correspond to the pressure that the fluid exerts within the syringe at any given time.

[0142] 50 and 51, according to one embodiment, an alternative embodiment of the syringe 12 may be utilized having a flexible section 590 disposed at its distal end 24 to facilitate this expansion and stretching. Many of the components of the syringe 12 shown in FIGS. 50 and 51 are substantially similar to the components of the syringe 12 described herein with reference to FIG. 2. Reference numbers in FIGS. 50 and 51 are used to indicate components that are identical to the corresponding reference numbers in FIG. 2. The above description of the syringe 12 generally shown in FIG. 2 is applicable to the embodiment shown in FIGS. 50 and 51, and therefore only the relevant differences between these systems will be described herein.

[0143] In one embodiment, the flexible section 590 may be configured to expand when the internal pressure of the syringe 12 increases during an injection procedure. The flexible section 590 may be insert molded from a more flexible material than the syringe barrel 18. The material forming the flexible section 590 may be any suitable flexible material, such as, but not limited to, TPU, TPE, polypropylene, polyethylene, and thermoplastic elastomers. Additionally, the flexible material 590 may be a transparent or translucent material such that it can be illuminated with the electromagnetic radiation source 112 and exhibit the halo features described herein.

[0144] 50 and 51 as being located at the distal end 24 of the syringe 12, this should not be construed as limiting the present disclosure as the flexible section 590 can be applied to many areas of the syringe 12. Factors to consider include maximizing expansion for better pressure resolution while minimizing fluid capacitance.

[0145] 52 and 53 and continuing reference to FIGS. 50 and 51, a fluid verification system 110 with at least one sensor 114, a central processing unit 116, and a display 118 according to this embodiment may be positioned such that the sensor 114 can capture an image of the flexible section 590 during an injection procedure. Once an image of the flexible section 590 is obtained, image processing software in the central processing unit 116 measures the increased diameter of the flexible section 590 and correlates the increased diameter with an internal syringe pressure. For example, FIG. 52 shows a flexible section 590 with a small increased diameter corresponding to a small internal syringe pressure, and FIG. 53 shows a flexible section 590 with a large increased diameter corresponding to a large internal syringe pressure. The central processing unit 116 may be configured to display this internal syringe pressure on the display 118 and control the fluid injector 10 to enable active pressure control in the syringe during an injection procedure.

[0146] Thus, flexible section 590 provides a "live" or real-time readout for the pressure within barrel 18 of syringe 12 during the injection procedure. Referring to Fig. 54, the negative pressure created during the filling procedure causes flexible section 590 to move inward. The dimensional change of flexible section 590 can be measured using sensor 114 and image processing software provided on central processing unit 116, and the subsequent vacuum level can then be determined.

[0147] Such negative pressure may be important for the rolling diaphragm syringes 135 described herein because having a high vacuum level during filling of such a syringe 135 may fracture or deform the walls of the syringe 135. Thus, with reference to FIG. 55, one embodiment of a rolling diaphragm syringe 135 may be adapted to include a flexible section or diaphragm 591 attached to the distal end 137 of the rolling diaphragm syringe 135 or on a connector 592 provided on a cap 390 (not shown). The outer diameter of the flexible section 591 may be dynamically measured in real time using at least one sensor 114 and image processing software provided on the central processing unit 116 as described herein with respect to measuring the diameter of the flexible section 590. The outer diameter of the flexible section 591 decreases as the vacuum in the rolling diaphragm syringe increases during the filling procedure. Thus, the size of the outer diameter of the flexible section 591 can be used to determine the vacuum level within the rolling diaphragm syringe 135. The vacuum level can then be maintained below a particular threshold by adjusting the rate at which the piston 138 is withdrawn to prevent the rolling diaphragm syringe 135 from fracturing.

[0148] 56A and 56B, according to one embodiment, a determination of the pressure within the syringe 12 is also obtained by positioning the electromagnetic radiation source 212 such that it reflects through at least a portion of the sidewall of the syringe barrel 18. Light shining through the sidewall of the syringe barrel 18 is visualized at the bottom of the halo 120 as shown by lines 121a and 121b. For example, if there is no light shining on the sidewall of the syringe barrel 18, this area appears as a black line (121b). When the electromagnetic radiation source 212 is positioned below the syringe 12 pointing up towards the sidewall of the syringe barrel 18, the line at the bottom of the halo 120 appears to light up (see element 121a in FIG. 56A) as the light travels inside the sidewall of the syringe barrel 18 and is painted into the halo 120.

[0149] When the syringe 12 is subjected to pressure, for example during an injection procedure, the walls of the syringe 12 are pushed outward and the syringe 12 expands as shown in FIG. 56B. This removes the straight line path of light from the electromagnetic radiation source 212 to the bottom of the halo 120. This line becomes darker and less intense as the syringe 12 expands (i.e., pressure increases) (see element 121b in FIG. 56B). The electromagnetic radiation source 212 may also be positioned such that the light disappears completely when the pressure limit of the syringe is reached (i.e., when the syringe is expanded enough to block the light). Alternatively, the intensity may be determined as a function of pressure (i.e., expansion) and used to determine the pressure. For example, image recognition software may be used to monitor changes in the intensity of the line to provide real-time feedback on the syringe capacitance.

[0150] K. Flow velocity feedback Feedback regarding the flow rate of the fluid delivered by the fluid injector may be provided to the operator using many of the concepts described herein. More specifically, the position of the axial plunger 26 within the syringe barrel 18 may be monitored by the sensor 114 and image processing software during the injection procedure. A curve may then be created that shows the position of the plunger versus time during the injection procedure. An equation may then be derived that fits the curve. This equation is provided to a logic algorithm that is implemented such that data from the curve calculates the flow rate of the fluid delivered by the injector. This flow rate may be displayed to the operator on the display 118.

[0151] L. Syringe Filling Feedback When filling the syringe 12 with contrast or saline, it has been observed that the halo or illuminated identification pattern 120 described in detail herein is only present if the syringe is filled at the proper rate. For example, when using a syringe such as the syringe 12, the proper fill rate is approximately 4 mL / sec, as this is the fastest fill rate with the thickest fluid that can be achieved before the vacuum head is drawn into the syringe. However, the fastest particular fill rate will depend on the particular limitations of the fluid injection system in question. The piston should be pulled back so that the syringe is filled as quickly as possible, depending on the fluid injection system being utilized. This is accomplished by dynamically inspecting the halo 120 with the sensor 114 and image processing software provided on the central processing unit 116 during the filling procedure using the concepts described herein. As long as the halo 120 is determined to be fully present, the vacuum has not reached a threshold at which a vacuum head (i.e., air) is created in the syringe. The halo 120 is recognized using the sensor 114 and image processing software provided on the central processing unit 116 described herein to detect the position of the upper end of the halo 120 relative to the lower end of the halo 120. When the upper end of the halo 120 begins to move downward, an indication can be provided to the operator that air is being drawn into the syringe 12. Additionally, the fluid injector 10 can adjust the rate at which the piston 124 is retracting the plunger 26 to reset the appropriate size of the halo 120. This allows the fluid injector 10 to achieve the fastest possible fill speed regardless of syringe size, fluid type, or fill speed.

[0152] In other words, if the syringe is filled too quickly, air will be introduced into the syringe and therefore the halo 120 will not be present. Thus, the sensor 114 can be positioned to capture images of the halo 120 during the filling procedure. Image processing software in the central processing unit 116 processes the images to determine the presence of the halo 120. If the halo 120 is not present, a signal is sent to the fluid injector 10 to stop the filling process and adjust the rate at which the piston rod 124 retracts the plunger 26 so that the halo 120 is present throughout the filling process.

[0153] M. Other Syringe Features That Can Be Identified by Image Processing Several other features of the syringe 12 may be imaged using the fluid verification system 110, and the information obtained thereby may be provided to the fluid injector 10. For example, before an injection is performed, an operator or technician is often required to verify the syringe. Verification may include making sure that the syringe is acceptable to the injector, as well as determining various characteristics of the syringe and the fluid contained therein. For example, the operator must verify that identification information, such as the syringe's dimensions (e.g., diameter, length, and fluid volume) and fluid contents, are correct for the procedure being performed. Additionally, the operator may be required to provide specific information about the syringe, such as date of manufacture, source, frictional characteristics between the plunger and the syringe barrel, fluid viscosity, etc. (generally referred to herein as "syringe injection parameters") to the fluid injector or injector actuation system to control piston force and acceleration to deliver the fluid at a desired flow rate. The identification information may be contained in or associated with a machine-readable identification tag, such as a barcode. Thus, an image of such a barcode may be acquired by the sensor 114. Image processing software provided on central processing unit 116 may then be configured to read the identification information from the barcode and provide this information to fluid injector 10. In certain examples, the barcode may be backlit by electromagnetic radiation source 112, thereby allowing sensor 114 to more clearly view the barcode.

[0154] Moreover, the cylindrical syringe barrel 18 is, in effect, a lens itself. Taking advantage of the curvature of the barrel walls, the image captured and recognized will look different to the image processing software provided on the central processing unit 116 if air is present in the syringe 12 or if fluid is present in the syringe 12. If air is present in the syringe 12, the image of the barcode received by the sensor 114 will appear at a first magnitude and / or orientation. If fluid is present in the syringe 112, the image of the barcode will appear at a second magnitude and inverted. Thus, in one example, the barcode may be encoded with information to be read by the sensor 114 when air is present in the syringe 12, the code informing the system that the syringe 12 is present, the size of the syringe 12, and that air is present in the syringe 12. When fluid is present in the syringe 12, the barcode image will be inverted and the image processing software provided on the central processing unit 116 will recognize a new code that provides a signal to the system that fluid is present in the syringe 12. Additionally, the relative size of the barcode provides an indication of the type of fluid within the syringe 12 (ie, saline, contrast, or a type of contrast).

[0155] In another example, referring to FIG. 57, a temperature strip 58 can be added to the syringe 12 to provide an operator with an indication of the temperature of the contents of the syringe 12. This temperature strip 58 is imaged by a sensor 114 and automatically read by image processing software. Specifically, the sensor 114 is positioned to capture an image of the temperature strip 58 on the syringe barrel 18. The temperature strip 58 is configured to change color with temperature or have some other method of indicating temperature. The image processing software is configured to detect this color change and determine the temperature based on the color change. The temperature information can then be provided to the fluid injector. In a particular example, the temperature strip and barcode may both be provided on a label affixed to the syringe 12.

[0156] N. Exemplary Fluid Injection System Utilizing Image Recognition Technology 58-60, an exemplary fluid injection system 600 includes a fluid injector 10 that may have a housing 14 formed from a suitable structural material, such as plastic, composite, and / or metal. The housing 14 may be of various shapes and sizes depending on the desired application. For example, the fluid injection system 600 may be a freestanding structure having a support 70 connected to a base 72 having one or more rollers or wheels such that the fluid injector 10 is movable over a floor portion. The fluid injector 10 may include at least one syringe port 16 for releasably connecting at least one syringe 12 to a respective piston rod 124. In various examples, the at least one syringe includes at least one syringe retaining member configured to retain the syringe within the syringe port 16 of the fluid injector 10. In a non-limiting example, at least one syringe retaining member is configured to operatively engage a locking mechanism provided on or within syringe port 16 of fluid injector 10 to facilitate loading and / or removal of a syringe from self-oriented fluid injector 10. The syringe retaining member and locking mechanism together define a connection interface for connecting a syringe to fluid injector 10. Examples of various connection interfaces are described in U.S. Pat. No. 9,173,995, the disclosure of which is incorporated herein by reference in its entirety.

[0157] In certain non-limiting examples, it may be desirable to temporarily rotate and / or invert the injector housing 14, including the syringe ports, between a substantially vertical position (i.e., with one or more syringe ports facing upward), which may, for example, facilitate loading a syringe into the syringe port or filling the syringe with a medical fluid, and an inverted position, which may, for example, facilitate removing air bubbles in the medical fluid contained within the syringe or performing an injection procedure. Thus, in a non-limiting example of the present disclosure, the housing 14 may be connected to the support 70 in a rotatable manner such that the housing 14 is rotatable relative to the support 70 and the retractable pole 74.

[0158] The fluid injection system 600 may further include a lower support member 76 that may be vertically extended or retracted to adjust the height of the fluid injector 10. An operator may depress a handle 78 to release a locking connection between the lower support member 76 and a fluid warmer 80 mounted on the lower support member 76. When the handle 78 is depressed, the operator may raise or lower the fluid warmer 80 to adjust the height of the fluid injector 10.

[0159] In a non-limiting example, the at least one fluid pathway set 17 may be fluidly connected to a distal end of at least one syringe for delivering medical fluid from the at least one syringe to a catheter, needle, or other fluid delivery connection (not shown) that has been inserted into the patient at the vascular access site. The flow of fluid from the at least one syringe may be regulated by a fluid control module operated by a controller, such as a removable touch screen controller 82 or any suitable device. The fluid control module may operate various pistons, valves, and / or flow rate regulators to regulate the delivery of medical fluids, such as saline and contrast, to the patient based on one or more user-selected injection parameters, such as, for example, injection flow rate, duration, total injection volume, and / or contrast to saline ratio.

[0160] The controller 82 may include one or more processors, memory, network interfaces, etc., and may be configured to control a display including a graphical user interface (GUI) that allows a user to view and / or interact with various injection parameters via graphical icons and visual indicators generated on the display. The controller 82 may include the central processing unit 116 provided with image processing software, or may be provided in a separate unit. In a non-limiting example, the controller 82 may be formed as a removable touch screen controller. The controller 82 may also be non-removably attached to the fluid injector 10. The controller 82 may be used to monitor one or more injection parameters, including, for example, patient-specific information (age, weight, sex, organs imaged, dose of contrast agent, etc.), which may be entered by a user or may be recalled / downloaded from a database, a network, a memory, or another controller in communication with the system by wired or wireless communication processes. The controller 82 may be further configured to control various injection parameters, which may be entered by a user and / or calculated by one or more algorithmic calculations performed by the controller 82, the fluid control device, and / or another controller or processor in communication with the fluid control device and / or the controller 82 based on data downloaded from a database and / or data entered by a user.

[0161] With particular reference to Figs. 59 and 60, an exemplary fluid injection system 600 utilizes the illuminated identification pattern and image processing techniques described herein. As mentioned above, the system 600 includes a fluid injector 10 similar to the fluid injector described with reference to Fig. 1. The fluid injector 10 is configured to engage a pair of syringes 12. The syringes 12 are attached to syringe ports 16 of the fluid injector 10. A distal end of a piston rod 124 of the injector 10 has a plurality of electromagnetic radiation sources 112, such as LEDs, attached thereto or embedded therein. The LEDs are configured to illuminate a first color when a first fluid is detected within the syringes 12 and a second color when a second fluid is detected within the syringes 12. When actuated, the piston rod 124 advances toward and is received within a cavity (not shown) defined by the plunger 26. The LED emits light axially through the plunger cover 26 to generate the halo 120 adjacent the distal end 24 of the syringe barrel 18 as described above. The sensor 114 may be removably mounted to the support 602 of the fluid injection system 600 such that the sensor 114 is positioned behind the syringe 12 when the syringe 12 is being filled with fluid from a multi-dose fluid bottle or bag. As described herein, the fluid injection system 600 may be configured to use image processing techniques to identify the type of fluid being directed to the syringes 12 or the fluid level within each syringe 12. Based on the information identified by the image processing techniques, the injector 10 may adjust its operating parameters to achieve the desired filling and injection parameters.

[0162] As described herein, the electromagnetic radiation source 112 may be a light bulb, an LED bulb, a visible light emitter, an infrared emitter, or a laser positioned to project a beam of electromagnetic radiation through the interior of the syringe 12. The electromagnetic radiation source emits electromagnetic radiation generally axially through the syringe 12. For example, the electromagnetic radiation beam may pass through a translucent or transparent plunger or plunger cover 26 toward the distal end 24 of the syringe 12.

[0163] As described in more detail herein, the electromagnetic radiation source 112 can be configured to enhance or tailor the conspicuousness of the halo 120 to a particular sensor or electromagnetic radiation detector. In one example, the electromagnetic radiation source 112 includes a laser (e.g., a green laser) having a wavelength of about 532 nm. A green laser electromagnetic radiation source can be used with a neutral colored or transparent plunger and still produce a halo of a noticeable color. In another example, the electromagnetic radiation source 112 can emit electromagnetic radiation outside the visible spectrum, provided that the system includes a sensor or camera capable of detecting radiation (e.g., a halo) within the emitted wavelength. In one such embodiment, an infrared sensor can be provided to detect the radiation on the syringe 12. In yet another example, the electromagnetic radiation source can be configured to emit specific wavelengths of polarized or filtered light that can be more easily distinguished from ambient light. In another example, the electromagnetic radiation source can be configured to emit pulses of light according to a predetermined identifiable sequence that can be identified by a system operator or automatically detected by a sensor.

[0164] Light or electromagnetic radiation passing through the plunger or plunger cover 26 radiates substantially through the syringe 12 to form a halo 120. If the syringe 12 is empty or only partially filled, the electromagnetic radiation beam passes through the syringe 12 but does not form the characteristic illuminated portion or halo near its distal end, as shown in FIG. 8. In contrast, when the syringe 12 is completely filled with fluid, the electromagnetic radiation beam is refracted by the fluid, producing a halo 120 near the distal end 24 of the syringe 12. A system operator, or an automated image reading or optical device such as the sensor 114, can identify whether the halo, if present, is of the correct shape and size. If the halo is too small, not bright enough, or not present at all, the system operator can add more fluid to the syringe 12 for a complete fill. If a halo of the correct size, shape, and brightness is identified, verification is complete and the fluid contents of the syringe 12 are ready to be administered to the patient.

[0165] In a particular example, the system 600 can also use image recognition to determine whether two syringes 12 are simultaneously present on the fluid injector 10. Additionally, the system 600 detects whether the syringes 12 are filled with fluid or air. The system 600 can also use images obtained from the sensor 114 to visualize features on the syringe barrel 18, visualize differences in the height of the halo 120, or visualize laser light passing through the fluid, as described in more detail herein, to detect which of the two syringes 12 has contrast and which has saline. Once this is determined, the system 600 can send a signal to the electromagnetic radiation source 112 located on the piston rod 124 below the translucent plunger on the injector head. This signal can alert the electromagnetic radiation source to illuminate an LED of a first color, such as green, under the syringe 12 determined to have contrast and illuminate an LED of a second color, such as blue, under the syringe 12 determined to have saline. This light illuminates a halo 120, which also has a color corresponding to the color of the LEDs, for visualization by the operator.

[0166] The system may also send signals to alert the operator of the type of fluid by other methods of visual, audible, or sensory cues. For example, if the image recognition technology determines that the syringe 12 contains contrast, then visual cues (LEDs, laser lights, graphics, text) and / or audible cues (alarms, bells, whistles, other sounds) alert the operator to the fact that the particular syringe 12 contains contrast. For example, a green overlay feature may be used on the side of the injector 10 designated for contrast. A green LED may be used to illuminate a halo 120 on the syringe 12 that has been determined to have contrast regardless of which side of the syringe 12 it is on. This is accomplished by having a circuit for both LED colors (green and blue), with green illuminating if contrast is determined to be present and blue illuminating if saline is determined to be present. It may also be possible to send a message to an operator in the control room alerting which side the syringe is on and if it conflicts with the protocol prescribed by the attending physician.

[0167] With particular reference to FIG. 59, as shown, the system 600 has determined that the contrast syringe 12a is located on the right side and the saline syringe 12b is located on the left side. The display 118 displays a "C" on the right and an "S" on the left, indicating that the image processing software of the central processing unit 116 has identified the contents of the left syringe as saline and the contents of the right syringe as contrast. With reference to FIG. 61, as shown, the contrast syringe 12a has been moved to a left position and the saline syringe 12b has been moved to a right position. The display 118 now displays a "C" on the left and an "S" on the right, indicating that the image processing software of the central processing unit 116 has identified the contents of the left syringe as contrast and the contents of the right syringe as saline. With reference to FIG. 62, the fluid injector 10 is shown without the syringes 12a, 12b present. The display 118 displays an "A" on the left and right to indicate that the image processing software of the central processing unit 116 has identified air present in both locations. Referring to Fig. 63, an empty syringe 12 is placed in the left location and another empty syringe 12 is placed in the right location as shown. The display 118 displays an "A" on the left and right to indicate that the image processing software of the central processing unit 116 has identified air present in both syringes.

[0168] O. Use of a Syringe with a Float Element 64, another alternative example of a syringe 12 that may be used with the fluid injector 10 and fluid verification system 110 to determine the type of fluid in the syringe 12 is shown. This syringe 12 is similar to the syringe 12 of FIG. 2, except that it includes a plurality of objects, such as float balls 650a, 650b, 650c, disposed between the distal end 24 of the syringe 12 and the plunger. The densities of the balls 650a, 650b, 650c are different such that ball 650b floats in saline (density 1.0 g / ml or less) and ball 650c sinks in saline but floats in contrast agent (density greater than 1.1 g / ml but less than the minimum concentration of contrast agent).

[0169] The float balls 650a, 650b, and 650c for distinguishing between contrast and saline operate on the principle of buoyancy, which is an upward force opposing an object in a fluid with a weight exerted downward. The driving variable for this phenomenon is density, specifically the density of the fluid and the weight immersed in the fluid. If the density of the balls 650a, 650b, 650c is sufficiently higher than the density of the fluid, the weight overcomes the buoyancy force and the balls 650a, 650b, 650c sink to the bottom. If the density of the balls 650a, 650b, 650c is sufficiently low, the balls 650a, 650b, 650c float.

[0170] The saline and the contrast agent have different densities. For example, the saline may have a density of about 1 g / mL, while the thicker contrast agent has a density of about 17 g / mL. In one example, ball 650b has a density of 0.5 g / mL, and ball 650c has a density of 5 g / mL. With reference to FIG. 65, when the syringe 12 is filled with air and upright, all the floating balls 650a, 650b, 650c stay at the bottom of the syringe 12 due to gravity. Thus, the air-filled syringe 12 does not have any floating balls near its distal end 24. With reference to FIG. 66, when the syringe 12 is filled with saline based on the above principle, the ball with density 0.5 g / mL (i.e., ball 650b) floats to the distal end 24 of the syringe 12, while the ball with density 5 g / mL (ball 650c) stays at the bottom because the buoyancy force cannot overcome its weight. The reference ball 650a may be placed in a syringe 12 having a density of less than 0.5 g / mL. This ball 650a also floats to the distal end 24 of the syringe 12 when saline is present in the syringe 12. Thus, a syringe 12 filled with saline will have two balls floating near its distal end 24. Referring to FIG. 67, when the syringe 12 is filled with contrast agent having a density of 17 g / mL, all three balls 650a, 650b, 650c will float to the top because each immersed ball has a density less than the density of the fluid.

[0171] With continued reference to FIGS. 65-67, the sensor 114 may be positioned to capture an image of the distal end 24 of the syringe 12. The image processing software on the central processing unit 116 may then detect the presence or absence of balls 650a, 650b, 650c in the image. If the image processing software on the central processing unit 116 determines that no balls are present, a signal may be sent to the display 118 to indicate that air is present in the syringe 12. If the image processing software on the central processing unit 116 determines that balls 650a and 650b are present, a signal may be sent to the display 118 to indicate that saline is present in the syringe 12. Finally, if the image processing software on the central processing unit 116 determines that all three balls are present, a signal may be sent to the display 118 to indicate that contrast agent is present in the syringe. This principle holds true for any number of balls in a syringe, so long as they have the appropriate corresponding density. In a more in-depth application, there are several balls of various densities corresponding to the different densities of different brands or different concentrations of contrast agent. This principle can be used to determine the different types of contrast agents present using image recognition of the float balls. Additionally, the balls 650a, 650b, 650c may have different sizes to provide another characteristic that allows the image processing software to distinguish between contrast agent and saline.

[0172] The syringe 12 of FIG. 64 may also be utilized to determine the temperature of a fluid contained within the syringe 12. The temperature measuring float balls 650a, 650b, 650c again operate on the principle of buoyancy, which is an upward force opposing an object in a fluid with a weight exerted downward. The driving variable for this phenomenon is density, specifically the density of the fluid and the weight immersed in the fluid. If the density of the balls 650a, 650b, 650c is sufficiently higher than the density of the fluid, the weight overcomes the buoyancy force and the balls 650a, 650b, 650c sink to the bottom. If the density of the balls 650a, 650b, 650c is sufficiently low, the balls float. In this application, density changes with temperature. When the fluid contained within the syringe 12 is heated, its volume tends to increase and its density to decrease. Thus, the float balls 650a, 650b, 650c may have incremental densities (e.g., 0.5 g / mL, 0.6 g / mL, 0.7 g / mL for saline, 15 g / mL, 15.5 g / mL, 16 g / mL for contrast), so that as the temperature of the fluid increases, the corresponding decrease in density will cause certain balls 650a, 650b, 650c to float or sink. The distal end 24 of the syringe 12 may be imaged using the sensor 114, and image processing software on the central processing unit 116 may determine the number of balls present in the image. Once the number of balls is determined, the central processing unit 116 may correlate the number of balls to the temperature of the fluid. The diameters of the balls 650a, 650b, 650c may change to correspond to their density / temperature relationship, and image processing software on the central processing unit 116 may measure the diameter and correlate it to density, and from density to the temperature of the fluid.

[0173] The syringe 12 of FIG. 64 may be utilized as a pressure limiting tool. More specifically, one of the balls 650a, 650b, 650c may be configured to have a slight positive buoyancy at zero pressure when submerged in a fluid. Such a ball would therefore float when the syringe is not injecting fluid and is filled with fluid. When injection begins, the pressure in the syringe increases. The air in the float ball is more compressible than the fluid contained in the syringe, so the volume of the ball decreases, thereby increasing its density. Thus, the float ball can be designed to sink at a certain internal pressure in the syringe. For example, the ball can be designed to fall to the bottom of the syringe at a pressure above 325 psi. The falling ball is then captured in an image taken by the sensor 114 and detected by image processing software. A signal is then sent to the fluid injector to limit the pressure of the injection.

[0174] III. Other Concepts In another example, the source 112 can emit light of a given wavelength, and the rate at which the light passes through the syringe can be measured by a detector and processor to indicate the type of fluid contained within the syringe 12.

[0175] It should be noted that while all of the concepts described herein are described with reference to syringes and fluid injectors, these concepts are not intended to limit the present invention as they may be utilized with any fluid container. For example, these concepts may be utilized with a beverage bottle set to ensure that each bottle produced contains the correct amount and correct liquid. The bottle may be provided with a colored translucent or transparent bottom and a sloping neck. After the bottle is filled, a source of electromagnetic radiation is placed under the bottle and provides light through the bottle to create a halo near the neck of the bottle. This halo may be identified using the sensors and image processing software described herein. If the halo is absent or improperly sized, it may generate a signal that the bottle is not filled correctly.

[0176] While the present disclosure has been described in detail for purposes of explanation based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only and that the present disclosure is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment. [Explanation of symbols]

[0177] 10 Fluid injector 12 Syringe 12a Contrast syringe 12b Saline Syringe 14 Housing 16 Syringe port 17 Fluid Path Set, Tube Set 18 Syringe Barrel 19 Internal volume, internal 20 Proximal end 22 Nozzle 23 angle 24 Distal end 24A Scallop or Ridge 26 Plunger, plunger cover 26A distal surface 27 Cavity 28 Drip flange 29 Proximal opening 30 Insertion section 31 Opening 32 Lock flange 34 Identification Tag 36 Sensors 40 Line 44 Fluid container 46 Transfer device 48 Spike 50 cups 54 Syringe support member, sleeve 58 Temperature Strips 70 Support part 72 Base 74 Retractable Pole 76 Lower support member 78 Handle 80 Fluid warmer 82 Touchscreen Controller 110 Fluid Verification System 112 Electromagnetic Radiation Source 114 Sensors 116 Central Processing Unit 118 Display 120 Halo or illuminated identification pattern 122 Mirror 124 Piston rod, piston 126 Light Pipe 130 Rays of light, beams of light 132 Internal reflection 134 Side wall 135 Rolling Diaphragm Syringe 136 End Wall 137 Distal end 138 Piston 139 Proximal end 140 Discharge neck 140a Connection member 200 Observer 204 Syringe Assembly 210 Pressure Jacket 212 Electromagnetic Radiation Source 213 Clamp 214 Internal volume 216 Distal end 218 Proximal end 219 Side wall 221 Through Bore 224 Protruding parts 244 Piston engagement part 272 Lamp 276 Central part 278 Ribs 301 Lower end 303 Lower end 305 distance 339 Fluid Dot 354 Laser beam, laser light beam, laser beam path 356 displays 358 displays 360a Distal part 360b Proximal part 365 Templates 367 views 369 Templates 370 Locking lugs or lips 373 Templates 375 displays 377 displays 383 Templates 385 displays 387 displays 390 Cap 400 inner elements 410 Nozzle 420 Connection parts 430 Protrusion 440 Groove 460 Annular sidewall 470 Gripping element 480 Radial Flange 550 Purge vessel 552 Connector 554 Fluid Dot 556 Reference Line 558 Upper end 560 distance 562 Indicator Lines 563 Cylindrical body 564 Proximal end 565 Tapered Distal End 566 Electromagnetic Radiation Source 567 Hello 590 Flexible section, flexible material 591 Flexible Section, Diaphragm 592 Connector 600 Fluid Injection System 602 Support part 610 Fiber Optic Cable 650a Float Ball 650b Float Ball 650c float ball

Claims

1. a syringe barrel having a proximal end and a distal end including a beveled surface; a plunger slidably disposed within the syringe barrel and configured to advance through the syringe barrel to expel fluid therefrom; A syringe comprising: the plunger comprises a transparent or translucent material configured to transmit electromagnetic radiation such that an illuminated identification pattern is formed at a predetermined portion of the distal end of the syringe barrel when the syringe is filled with the fluid; Syringe.

2. 2. The syringe of claim 1, wherein the shape of the syringe barrel is such that when the internal volume of the syringe barrel is completely or partially filled with air, at least one characteristic of the illuminated identification pattern is different compared to when the syringe is completely filled with the fluid.

3. The syringe of claim 2 , wherein the at least one characteristic includes at least one of a presence, a size, a shape, and a brightness of the illuminated identification pattern.

4. 2. The syringe of claim 1, wherein the illuminated identification pattern is not visible if the percentage of volume of air present at the distal end of the syringe is greater than about 15% of the volume of the distal end of the syringe having the inclined surface.

5. 10. The syringe of claim 1, wherein the illuminated identification pattern is visible to an observer or sensor when the syringe is viewed from the side in a straight orientation or in a forward or backward tilted orientation.

6. 10. The syringe of claim 1, wherein the beveled surface at the distal end of the syringe barrel is at an angle of about 30 degrees to 60 degrees relative to a longitudinal axis of the syringe.

7. 10. The syringe of claim 1, wherein the electromagnetic radiation source comprises a light bulb, an LED bulb, a photon emitter, an infrared emitter, a laser, or ambient light.

8. 10. The syringe of claim 1, further comprising at least one reference line or marking formed in and extending around a circumference of the distal end of the syringe barrel.

9. 9. The syringe of claim 8, wherein the at least one reference line or marking is formed on the syringe barrel of the syringe by at least one of printing, overmolding, and etching.

10. 9. The syringe of claim 8, wherein a first reference line or marking of the at least one reference line or marking is configured to align with a first predetermined portion of the illuminated identification pattern when a first fluid is present in the syringe, and a second reference line or marking is configured to align with a second predetermined portion of the illuminated identification pattern when a second fluid is present in the syringe.

11. 9. The syringe of claim 8, wherein the at least one reference line or marking is configured to align with a predetermined portion of the illuminated identification pattern when a first fluid is present in the syringe and is configured to be located away from the illuminated identification pattern when a second fluid is present in the syringe.

12. 1. A system for indicating whether a syringe is ready for use to inject a fluid therein into a patient, the system comprising: a syringe comprising a barrel including a distal end having a beveled surface, the barrel defining an interior volume configured to receive the fluid; an electromagnetic radiation source positioned to emit electromagnetic radiation through at least a portion of the syringe; Equipped with the syringe is shaped such that, when the syringe is filled with the fluid, at least a portion of the electromagnetic radiation is affected by interaction of the electromagnetic radiation with at least one interface associated with the fluid and the syringe to form an illuminated identification pattern on a predetermined portion of the syringe indicative of the contents of the syringe. system.

13. 13. The system of claim 12, wherein the syringe is shaped such that when the internal volume is completely or partially filled with air, at least one characteristic of the illuminated identification pattern is different compared to when the internal volume is completely filled with the fluid.

14. 14. The system of claim 13, wherein the at least one characteristic includes at least one of a presence, a size, a shape, and a brightness of the illuminated identification pattern.

15. 14. The system of claim 13, wherein the illuminated identification pattern is not visible if the percentage of volume of air present at the distal end of the syringe is greater than about 15% of the volume of the distal end of the syringe having the beveled surface.

16. 14. The system of claim 13, further comprising at least one sensor configured to measure the at least one characteristic of the illuminated identification pattern when the illuminated identification pattern is present.

17. The system of claim 16 , wherein the at least one sensor includes at least one of an imaging sensor, an optical sensor, an electromagnetic radiation detector, or a digital camera.

18. 17. The system of claim 16, further comprising a fluid injector configured to interface with the syringe to expel the fluid from the syringe.

19. the fluid injector comprising a controller configured to receive a confirmation signal from the at least one sensor when measurement of the at least one characteristic of the illuminated identification pattern indicates that the syringe is substantially filled with the fluid; the controller is configured to activate the injector to perform an injection when the confirmation signal is received.

17. The system of claim 16.

20. 13. The system of claim 12, wherein the illuminated identification pattern is visible to an observer or sensor when the syringe is viewed from the side in a straight-up orientation or in a forward or backward tilted orientation.

21. 13. The system of claim 12, wherein the illuminated identification pattern comprises an annular shape extending around at least a portion of the distal end of the syringe barrel.

22. 13. The system of claim 12, wherein the beveled surface at the distal end of the syringe barrel is at an angle of about 30 degrees to 60 degrees relative to a longitudinal axis of the syringe.

23. 13. The system of claim 12, wherein the electromagnetic radiation source comprises a light bulb, an LED bulb, a photon emitter, an infrared emitter, a laser, or ambient light.

24. 13. The system of claim 12, wherein the syringe further comprises a plunger, and the electromagnetic radiation source is positioned to project at least a portion of the electromagnetic radiation onto or through the plunger.

25. 25. The system of claim 24, wherein at least a portion of the plunger comprises a transparent or translucent material.

26. 25. The system of claim 24, wherein at least a portion of the plunger comprises a coloring material.

27. emitting electromagnetic radiation through at least a portion of the syringe; identifying whether at least a portion of the electromagnetic radiation produces an irradiated identification pattern on a predetermined portion of the syringe; determining the contents of the syringe based on at least one characteristic of the illuminated identification pattern; 16. A method for syringe fluid fill verification comprising:

28. 28. The method of claim 27, wherein the at least one characteristic is at least one of the presence of the illuminated identification pattern, the size of the illuminated identification pattern, the shape of the illuminated identification pattern, and the brightness of the illuminated identification pattern.

29. 28. The method of claim 27, wherein identifying whether the at least some of the electromagnetic radiation produces the illuminated identification pattern comprises measuring the at least one characteristic of the illuminated identification pattern with at least one sensor associated with the syringe; and receiving a confirmation signal from the at least one sensor indicative of a value of the at least one characteristic of the illuminated identification pattern.

30. 30. The method of claim 27, wherein emitting electromagnetic radiation through at least a portion of the syringe comprises emitting electromagnetic radiation through a syringe plunger, at least a portion of the syringe plunger comprising a transparent or translucent material.

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