Fluid injection system

Abstract

The present invention relates to a fluid injection system comprising: a fluid injector, a fluid path set, a purge container, an image capture device, 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 one feature through a fluid contained within a container body of the purge container; determine a distance from a top edge of the fluid contained within the container body to the at least one feature; compare the distance from the top edge of the fluid contained within the container body to the at least one feature to at least one predetermined distance; and based on the comparison of the distance from the top edge of the fluid contained within the container body to the at least one feature to the at least one predetermined distance, display an indication on a display device in communication with the at least one processor that the fluid path set has been purged and primed and the fluid injector is ready for a fluid injection procedure.

Description

[0001] This application is a divisional application of patent application 202110811779.5 entitled “System and method for image recognition of features of syringe fluid filling verification and power injector system”, filed on August 24, 2016. Technical Field

[0002] This disclosure relates to systems and methods for verifying that a syringe is filled with fluid, and particularly to systems and methods for confirming the presence of such fluid based on an illumination pattern produced by electromagnetic radiation projected through a portion of the filled syringe. In other aspects, this disclosure relates to systems and methods for identifying various characteristics and properties of fluids within a syringe. Background Technology

[0003] In many medical, diagnostic, and therapeutic procedures, medical practitioners, such as physicians, administer medical fluids to patients. In recent years, numerous syringe-actuated syringes and powered injectors have been developed for pressurized injection of fluids such as contrast mediums (often simply referred to as "contrast agents"), pharmaceuticals, or saline solutions, for use in imaging procedures such as angiography, computed tomography, ultrasound, and magnetic resonance imaging. Generally, these powered injectors are designed to deliver a predetermined amount of contrast agent or other fluid at a preset flow rate.

[0004] One of the problems involved in using such automated syringe systems to inject fluids into patients is the possibility of air being present in the syringe or fluid delivery system before injection. This is particularly concerning during the injection of contrast agent media, which are typically colorless or only partially stained. Furthermore, imaging procedures are often performed at relatively low light levels to facilitate reading X-rays, computer screens, etc. This increases the concern that air in the syringe may not be detected before the injection process. Therefore, it is desirable to be able to easily detect whether the syringe is not yet filled with fluid or is only partially filled with fluid (i.e., the syringe contains a certain amount of air) before attempting injection.

[0005] Several solutions have been previously provided, including, for example, those discussed in Heilman's U.S. Patent No. 4,452,251 and Trombley, III's U.S. Patent No. 5,254,101 (each of which is incorporated herein by reference in its entirety), indicating the presence of liquid by changing the shape of a marking pattern on the syringe barrel. However, systems and methods are needed to further aid in indicating the presence of liquid when the syringe is viewed from a distance, or to allow for immediate verification of a filled syringe. Automated systems for verifying that the syringe is fully filled and contains no air are also desired.

[0006] Further, since most medical fluids used with power injectors are clear, it is difficult for a technician to quickly and easily distinguish between the fluid and air present in a semi-transparent syringe. Accordingly, a system for use with a fluid injection device that is capable of distinguishing between air and different types of fluids is desirable. Further, an automated system that can determine various properties of a fluid, for example, by analyzing the nature and / or changes in the interaction of electromagnetic radiation with the contents of a syringe, and communicate these properties to a user, for example, via a display screen, is also desirable. SUMMARY

[0007] The systems and methods discussed herein provide an indication that a liquid is present in a syringe when the syringe is viewed from a distance, or allow for a quick glance to verify a filled syringe. Further, an automated system for verifying that a syringe is completely filled and does not contain any air is also provided. Such a system allows for a distinction between air and / or different types of fluids contained within a syringe of a fluid injector, thereby improving safety by preventing air injection and facilitating an improved workflow by preventing a technician from confusing fluid types. Additionally, in certain aspects, the system can determine one or more properties of a fluid within a syringe and / or injection process.

[0008] According to one aspect of the disclosure, a syringe is provided that includes a syringe barrel including a proximal end and a distal end, the distal end including an angled surface, and a plunger slidably disposed in the syringe barrel and configured to be advanced through the barrel to expel fluid therefrom. The plunger includes a transparent or translucent material configured to transmit electromagnetic radiation therethrough such that, when the syringe is filled with fluid, an illuminated identification pattern is formed at a predetermined portion of the distal end of the syringe barrel.

[0009] In one aspect, the syringe barrel can be shaped such that at least one property of the illuminated identification pattern is different when the interior volume of the syringe barrel is completely or partially filled with air as compared to when the syringe is completely filled with fluid. The at least one property can include at least one of the presence, size, shape, and brightness of the illuminated identification pattern.

[0010] In one aspect, the illuminated identification pattern can be invisible when the percentage of the volume of air present in the distal end of the syringe is greater than about 15% of the volume of the distal end of the syringe having the angled surface. In another aspect, the illuminated identification pattern can be visible to an observer or a sensor when the syringe is viewed from the side in a straight-on orientation or in an orientation that is tilted forward or tilted backward. The angled surface of the distal end of the syringe barrel can have an angle of about 30 to 60 degrees relative to a longitudinal axis of the syringe.

[0011] In one aspect, the electromagnetic radiation source can include a light bulb, an LED light bulb, a photon emitter, an infrared emitter, a laser, or ambient light. In another aspect, at least one reference line or marker can be formed on the distal end of the syringe barrel and extend around a circumference of the distal end of the syringe barrel. The at least one reference line or marker can be formed on the barrel of the syringe by at least one of printing, overmolding, and etching. In one aspect, a first reference line or marker of the at least one reference line or at least one marker is configured to align with a first predetermined portion of the illuminated identification pattern if a first fluid is present within the syringe, and a second reference line or marker is configured to align with a second predetermined portion of the illuminated identification pattern if a second fluid is present within the syringe. The at least one reference line or marker can be configured to align with a predetermined portion of the illuminated identification pattern if a first fluid is present within the syringe, and can be configured to be positioned away from the illuminated identification pattern if a second fluid is present within the syringe.

[0012] According to another aspect of the disclosure, a system for indicating whether a syringe is ready for use in injecting a fluid therein into a patient is provided. The system includes a syringe including a barrel including a distal end having an angled surface and defining an interior volume configured to receive a fluid, and an electromagnetic radiation source positioned to emit electromagnetic radiation through at least a portion of the syringe. 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 the electromagnetic radiation and an interaction with at least one interface associated with the fluid and the syringe to form an illuminated identification pattern that indicates contents of the syringe on a predetermined portion of the syringe.

[0013] In one aspect, the syringe can be shaped such that, when the interior volume is completely or partially filled with air, at least one property of the illuminated identification pattern is different compared to when the interior volume is completely filled with the fluid. The at least one property can include at least one of a presence, a size, a shape, and a brightness of the illuminated identification pattern. The illuminated identification pattern can be invisible when a percentage of a volume of air present in the distal end of the syringe is greater than about 15% of a volume of the distal end of the syringe having the angled surface.

[0014] In another aspect, the system can further include at least one sensor configured to measure at least one property of the illumination identification pattern, when present. The at least one sensor can include at least one of an imaging sensor, an optical sensor, an electromagnetic radiation detector, or a digital camera. In another aspect, the system can further include a fluid syringe configured to interface with the syringe to expel fluid from the syringe. The fluid syringe can include a controller configured to receive a confirmation signal from the at least one sensor when the measurement of the at least one property of the illumination identification pattern indicates that the syringe is substantially filled with fluid, and the controller configured to actuate the syringe to perform an injection when the confirmation signal is received.

[0015] In one aspect, the illumination identification pattern can be visible to an observer or a sensor when the syringe is viewed from the side in a heads-up orientation or in an orientation that is tilted forward or tilted backward. In another aspect, the illumination identification pattern can include an annular shape that extends around at least a portion of a distal end of a barrel of the syringe. In yet another aspect, an angled surface of the distal end of the barrel can have an angle of about 30 degrees to 60 degrees relative to a longitudinal axis of the syringe. In one aspect, the electromagnetic radiation source can include a light bulb, an LED light bulb, a photon emitter, an infrared emitter, a laser, or ambient light.

[0016] In certain aspects, the syringe can further include a plunger, and the electromagnetic radiation source is positioned to project at least a portion of the electromagnetic radiation to reflect off of or transmit through the plunger. In one example, at least a portion of the plunger includes a transparent or translucent material. In one example, at least a portion of the plunger includes a colored material.

[0017] According to another aspect of the present disclosure, a method for syringe fluid fill verification is provided, including: emitting electromagnetic radiation through at least a portion of a syringe; identifying whether at least a portion of the electromagnetic radiation produces an illumination identification pattern on a predetermined portion of the syringe; and determining contents of the syringe based on at least one property of the illumination identification pattern.

[0018] In one aspect, the at least one property can be at least one of a presence of the illumination identification pattern, a size of the illumination identification pattern, a shape of the illumination identification pattern, and a brightness of the illumination identification pattern. In another aspect, the step of identifying whether at least a portion of the electromagnetic radiation produces the illumination identification pattern can include: measuring the at least one property of the illumination identification pattern by at least one sensor associated with the syringe; and receiving a confirmation signal from the at least one sensor indicating a value of the at least one property of the illumination identification pattern. In an additional aspect, emitting the electromagnetic radiation through at least a portion of the syringe can include emitting the electromagnetic radiation through a plunger of the syringe, at least a portion of the plunger including a transparent or translucent material.

[0019] According to another aspect of the present disclosure, a fluid injection system is provided, comprising: a fluid injector; at least one syringe in operable engagement with the fluid injector; and an electromagnetic irradiation source. The at least one syringe includes a barrel including a distal end having an angled surface and defining an interior volume configured to receive a fluid. The electromagnetic irradiation source is positioned relative to the at least one syringe to emit electromagnetic irradiation through at least a portion of the at least one syringe such that, when the syringe is filled with the fluid, at least a portion of the electromagnetic irradiation is affected by an interaction of the electromagnetic irradiation and at least one interface associated with the fluid and the syringe to form an illuminated identification pattern that indicates contents of the at least one syringe on a predetermined portion of the at least one syringe. The fluid injection system further 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 the 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, at least one of: i) display an indication of a characteristic of the at least one syringe on a display device in communication with the at least one processor; ii) enable the fluid injector to perform a function; and iii) disable the fluid injector from performing an action.

[0020] 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 can be determined by determining a change in contrast between adjacent pixels in the image of the illuminated identification pattern.

[0021] In another aspect, the characteristic of the at least one syringe can be the presence of air in the at least one syringe, and the at least one processor can be further configured to provide an indication of the presence of air in the at least one syringe and disable the fluid injector from performing an injection procedure if the distance from the bottom to the top of the illumination recognition pattern is less than the at least one predetermined distance. Further, the at least one processor can 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 illumination recognition pattern by matching a first template of a known illumination recognition pattern for a syringe having a first size to the image of the illumination recognition pattern. In one aspect, the at least one processor can be further configured to provide an indication that the at least one syringe has the first size if the first template matches the image of the illumination recognition pattern. The at least one processor can be further configured to match a second template of a known illumination recognition pattern for a syringe having a second size to the image of the illumination recognition pattern if the first template does not match the image of the illumination recognition pattern. The at least one processor can be 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 illumination recognition pattern.

[0022] In another aspect, the characteristic of the at least one syringe can be contents of the at least one syringe. The at least one predetermined distance can include a first predetermined distance and a second predetermined distance, the first predetermined distance indicating a first fluid as a content contained in the at least one syringe, and the second predetermined distance indicating a second fluid as a content contained in the at least one syringe. An indication of the first fluid contained in the at least one syringe can be provided if the distance from the bottom to the top of the illumination recognition pattern corresponds to the first predetermined distance, and an indication of the second fluid contained in the at least one syringe can be provided if the distance from the bottom to the top of the illumination recognition pattern corresponds to the second predetermined distance. A color of the electromagnetic radiation forming the illumination recognition pattern can be set to a first color if the at least one processor determines that the first fluid is present in the at least one syringe, and the color of the electromagnetic radiation forming the illumination recognition pattern can be set to a second color different from the first color if the at least one processor determines that the second fluid is present in the at least one syringe.

[0023] In other aspects, the at least one syringe can further include a plunger, and the source of electromagnetic radiation can be positioned to project at least some of the electromagnetic radiation through the plunger. In such aspects, the plunger can include a transparent or translucent material. In yet other aspects, the source of electromagnetic radiation can be positioned such that the source of electromagnetic radiation reflects off of a distal surface of the plunger through the barrel of the at least one syringe. In such aspects, the plunger can include an opaque, colored material. The source of electromagnetic radiation can be positioned adjacent to the barrel of the at least one syringe, and the electromagnetic radiation reflects off of a mirror positioned proximate to a distal end of the barrel and is directed toward the distal surface of the plunger such that the electromagnetic radiation reflects off of the plunger through the barrel.

[0024] According to an additional aspect of the disclosure, a fluid injection system is provided, comprising: a fluid injector; at least one syringe in operable engagement with the fluid injector, the syringe comprising a barrel comprising a distal end having an angled surface and defining an interior volume configured to receive a fluid; an electromagnetic irradiation source positioned relative to the at least one syringe to emit electromagnetic irradiation through at least a portion of the at least one syringe such that, when the syringe is filled with the fluid, at least a portion of the electromagnetic irradiation is affected by an interaction of the electromagnetic irradiation and at least one interface associated with the fluid and the syringe to form an illuminated identification pattern that indicates 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 the 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 provide an indication that air is present in the at least one syringe and disable the fluid injector from performing an injection procedure if the distance from the bottom to the top of the illuminated identification pattern is less than the predetermined distance.

[0025] In one aspect, determining the distance from the bottom to the top of the illuminated identification pattern can comprise determining a bottom edge of the illuminated identification pattern and determining a top edge of the illuminated identification pattern. The bottom edge and the top edge of the illuminated identification pattern can be determined by determining a change in contrast between adjacent pixels in the image of the illuminated identification pattern.

[0026] In another aspect, the at least one processor can be configured to determine a size of the at least one syringe by matching a first template of a known illuminated identification pattern for a syringe having a first size to the image of the illuminated identification pattern prior to determining the distance from the bottom to the top of the illuminated identification pattern. The at least one processor can be further configured to provide an indication that the at least one syringe has the first size if the first template matches the image of the illuminated identification pattern. The at least one processor can be further configured to match a second template of a known illuminated identification pattern for a syringe having a second size to the image of the illuminated identification pattern if the first template does not match the image of the illuminated identification pattern. The at least one processor can be 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.

[0027] According to another aspect of the disclosure, a fluid injection system is provided that includes a fluid injector; at least one syringe in operable engagement with the fluid injector and configured to be illuminated with an electromagnetic radiation source to illuminate a fluid contained therein; a sensor positioned to capture an image of the illuminated fluid; and at least one computing device in communication with the fluid injector and the sensor. The at least one computing device includes at least one processor configured to: obtain the image of the illuminated fluid from the sensor; determine, based on the image of the illuminated fluid, at least one of: a type of the fluid contained within the at least one syringe; and whether air is contained within the at least one syringe; and automatically display, on a display device in communication with the at least one processor, one of: an indication of the type of the fluid contained within the at least one syringe; and an indication that air is contained within the at least one syringe.

[0028] In certain aspects, the at least one processor can be configured to disable the fluid injector from performing an injection procedure if it is determined that air is contained within the at least one syringe. A luminance measurement can be made in a region of interest in the image of the illuminated fluid for determining at least one of: the type of the fluid contained within the at least one syringe; and whether air is contained within the at least one syringe.

[0029] According to another aspect of the disclosure, a fluid injection system is provided that includes a fluid injector; a syringe in operable engagement 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 includes a barrel and defines an interior volume and at least one feature provided on the barrel of the syringe. The at least one feature has a different appearance when viewed through different types of fluid contained within the syringe. The image capture device is positioned to capture an image of the at least one feature through contents of the syringe. The at least one computing device includes at least one processor configured to: obtain the image of the at least one feature through the fluid contained within the syringe; determine, based on the image of the at least one feature, an appearance of the at least one feature; compare the determined appearance to a template of appearances of the at least one feature when viewed through different types of fluid; and based on the comparison, automatically display, on a display device in communication with the at least one processor, an indication of a characteristic of the syringe.

[0030] In one aspect, the at least one feature can be formed on the barrel of the syringe by at least one of printing, overmolding, and etching. In another aspect, the at least one feature is a dot, a line, a series of lines, or any combination thereof. The appearance of the at least one feature can include at least one of a shape of the at least one feature and an orientation of the at least one feature.

[0031] In one aspect, the characteristic of the syringe can be the presence of air in the syringe, and the at least one processor can be further configured to provide an indication of the presence of air in the at least one syringe and disable the fluid injector from performing an injection procedure if the determined appearance matches one of the templates of appearances of the at least one feature when viewed through air.

[0032] In another aspect, the feature of the at least one syringe can be contents of the at least one syringe, and the at least one processor can be further configured to provide an indication of the presence of a first fluid within the syringe if the determined appearance matches at least one of the templates of appearances of the at least one feature when viewed through the first fluid. In one aspect, the at least one processor can be further configured to provide an indication of the presence of a second fluid within the syringe if the determined appearance matches at least one of the templates of appearances of the at least one feature when viewed through the second fluid.

[0033] According to yet another aspect of the present disclosure, a fluid injection system is provided, comprising: a fluid injector; a syringe operatively engaged with the fluid injector in a vertical orientation, the syringe including a barrel and defining an interior volume configured to receive a fluid and at least one object having a density other than that of the fluid such that the at least one object floats if the fluid is present within the barrel; an image capture device positioned to capture an image 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 includes at least one processor configured to: obtain the image of the barrel; determine, based on the image of the barrel, a position of the at least one object within the barrel and thereby determine whether the barrel is one of (i) completely filled with the fluid and (ii) at least partially filled with air; based on the determination, provide an indication of the presence of air in the syringe based on the position of the at least one object; and disable the fluid injector from performing an injection procedure.

[0034] According to yet another aspect of the present disclosure, a fluid injection system is provided, comprising: a fluid injector; a syringe operatively engaged with the fluid injector; an image capture device positioned 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 includes at least one processor configured to: obtain the image of the at least portion of the syringe; determine, based on the at least portion of the syringe, at least one characteristic of an injection procedure performed by the fluid injector; and adjust the at least one characteristic of the injection procedure performed by the fluid injector to ensure that a fluid is delivered to a predetermined region of interest in a patient's body at a particular time such that a workable image is produced during an imaging procedure.

[0035] In one aspect, the at least one characteristic of the injection process can be at least one of a flow rate, a volume of fluid remaining within the syringe, and a volumetric measurement of the syringe.

[0036] These and other features and characteristics of the system and / or device of the present disclosure, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate similar parts in the various figures. It is to be expressly understood, however, that the drawings are for purposes of illustration only and are not intended as a definition of the limits of the system and / or device of the present disclosure. As used in the specification and in the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. BRIEF DESCRIPTION OF DRAWINGS

[0037] Figure 1 is a schematic view of a fluid injector and fluid verification system in accordance with aspects of the present disclosure;

[0038] Figure 2 is a schematic view of a syringe for use with the injector of Figure 1 ;

[0039] Figures 3A-3D is a schematic view of a syringe having various shapes of distal ends along with the appearance of the illuminated identification pattern;

[0040] Figures 4A-4C is a schematic view of a syringe having various features provided on the distal end of the syringe to change the shape and size of the illuminated identification pattern;

[0041] Figures 5A-5B are perspective and schematic views, respectively, of a syringe plunger that can be used with the syringe of Figure 2 ;

[0042] Figure 6 is a schematic view of a syringe and fluid verification system containing a backlit plunger in accordance with aspects of the present disclosure;

[0043] Figure 7 is a schematic view of a syringe that is completely filled with air or partially filled with air for use with the fluid verification system of Figure 6 ;

[0044] Figure 8 is a schematic view of a fluid-filled syringe for use with the fluid verification system of Figure 6 ;

[0045] Figure 9This is a schematic diagram of another example of a syringe and a fluid verification system with a backlit plunger according to aspects of this disclosure;

[0046] Figure 10 This is a schematic diagram of a syringe and a fluid verification system with a reflective plunger;

[0047] Figure 11 This is a schematic diagram of another embodiment of a syringe and a fluid verification system with a reflective plunger;

[0048] Figure 12 This is a schematic diagram of another embodiment of a syringe and a fluid verification system with a reflective plunger and an optical fiber guide.

[0049] Figure 13 This is a schematic diagram illustrating light reflected within a fluid-filled syringe barrel and transmitted through the fluid-filled syringe barrel according to an embodiment of the present disclosure;

[0050] Figures 14A-14C This is a schematic diagram of the distal portion of an embodiment of a fluid-filled syringe used with a fluid validation system according to aspects of this disclosure;

[0051] Figure 15A This is a side view of a rolling diaphragm syringe according to one aspect of the present disclosure;

[0052] Figure 15B yes Figure 15A The side view of the cross section taken along line AA of the rolling diaphragm syringe is shown in the figure;

[0053] Figure 16A This is a perspective view of a rolling diaphragm syringe and a pressure sheath according to another aspect of this disclosure;

[0054] Figure 16B yes Figure 16A The image shows a cross-sectional side view of the rolling diaphragm syringe and pressure sheath.

[0055] Figure 16C Is with Figure 16A A perspective view of a rolling diaphragm syringe and cap used together with a pressure sheath, shown in the figure;

[0056] Figure 17A and 17B The figures are perspective cross-sectional views and cross-sectional views of portions of the rolling diaphragm syringe and coupling mechanism according to aspects of this disclosure, illustrating a first configuration of the electromagnetic irradiation source;

[0057] Figure 18A and 18B This is a perspective cross-sectional view of a portion of the rolling diaphragm syringe and the coupling mechanism according to aspects of this disclosure, illustrating a second and a third configuration of the electromagnetic irradiation source;

[0058] Figure 19A and 19B is a perspective cross-sectional view and cross-sectional view of portions of a rolling diaphragm syringe and engagement mechanism illustrating a third configuration of an electromagnetic radiation source according to aspects of the present disclosure;

[0059] Figure 20 is a cross-sectional view of portions of a rolling diaphragm syringe and engagement mechanism illustrating a protruding element according to aspects of the present disclosure;

[0060] Figure 21 is a flowchart of a method of determining the presence of air within a syringe using image processing techniques according to aspects of the present disclosure;

[0061] Figure 22 and 23 is an illustration of an exemplary image of a distal end of a syringe used in the method of Figure 21 ;

[0062] Figure 24 is a graph illustrating a correlation between the size of the distance between the presence of air and a meniscus and a halo used in the method of Figure 21 ;

[0063] Figure 25 is a schematic of an alternative syringe for use with the syringe of Figure 1 ;

[0064] Figure 26 is a flowchart of an alternative method of determining the presence of air within a syringe using image processing techniques and the syringe of Figure 25 ;

[0065] Figure 27 is an illustration of an exemplary image of a distal end of an air-containing syringe used in the method of Figure 26 ;

[0066] Figure 28 is an illustration of an exemplary image used by an image recognition system to determine whether air is present within a syringe using luminance measurements according to aspects of the present disclosure;

[0067] Figure 29 and 30 is an illustration of an exemplary image used by an image recognition system to determine the type of fluid contained within a syringe according to aspects of the present disclosure;

[0068] Figure 31 and 32 is an illustration of an alternative exemplary image used by an image recognition system to determine the type of fluid contained within a syringe according to aspects of the present disclosure;

[0069] Figure 33 and34 This is an illustration of an exemplary image used by an image recognition system to determine the size of a syringe according to aspects of this disclosure;

[0070] Figure 35 and 36 This is an illustration of an exemplary image used by an image recognition system to determine whether a fluid path kit is connected to a syringe, according to aspects of this disclosure;

[0071] Figure 37 This is a perspective view of a fluid transport system including a fluid transport device for transferring fluid from a fluid container to a syringe, according to aspects of this disclosure.

[0072] Figure 38 and 39 This is an illustration of an exemplary image used by an image recognition system to determine whether a fluid delivery device is connected to a syringe, according to aspects of this disclosure;

[0073] Figure 40 This is a perspective view of a purge container connected to a fluid transfer kit according to aspects of this disclosure;

[0074] Figure 41 yes Figure 40 A 3D view of the drain container;

[0075] Figure 42A yes Figure 40 The main view of the drain container, which does not contain any fluid;

[0076] Figure 42B yes Figure 40 The front view of the drain container, which contains fluid;

[0077] Figure 43A yes Figure 40 A perspective view of an alternative configuration of the drain container, in which no fluid is contained;

[0078] Figure 43B yes Figure 43A The front view of the drain container, which contains fluid;

[0079] Figure 44A yes Figure 40 A perspective view of another alternative configuration of the drain container, in which no fluid is contained;

[0080] Figure 44B yes Figure 44A The front view of the drain container, which contains fluid;

[0081] Figure 45This is a perspective view of an example of a drain container connected to a fluid transfer kit according to aspects of this disclosure;

[0082] Figure 46 This is a front view of the end of a conduit used with a fluid transfer kit according to aspects of this disclosure;

[0083] Figure 47 This is a schematic diagram of a syringe during an injection process according to aspects of this disclosure, illustrating the manner in which the syringe is stretched and expanded;

[0084] Figure 48 This is a diagram illustrating the volume delivered versus time during an exemplary injection procedure;

[0085] Figure 49 This is a flowchart of a method for determining the volume of residual fluid in a syringe using image processing techniques according to aspects of this disclosure;

[0086] Figure 50 Is with Figure 1 A three-dimensional diagram of an alternative syringe used in the system;

[0087] Figure 51 yes Figure 50 A side view of the syringe;

[0088] Figure 52 Delivery of fluid under low pressure according to aspects of this disclosure Figure 50 A schematic diagram of a syringe and fluid verification system;

[0089] Figure 53 Delivery of fluid under high pressure according to aspects of this disclosure Figure 50 A schematic diagram of a syringe and fluid verification system;

[0090] Figure 54 It is based on aspects of this disclosure regarding the extraction of fluid under negative pressure. Figure 50 A schematic diagram of a syringe;

[0091] Figure 55 It is based on the aspects of this disclosure that have the same Figure 15A The pressure indication mechanism associated with the syringe. Figure 15A A schematic diagram of a syringe;

[0092] Figure 56A This is a schematic diagram of a syringe and fluid verification system for delivering fluid under low pressure, according to another aspect of this disclosure;

[0093] Figure 56B It delivers fluid under high pressure. Figure 56A A schematic diagram of a syringe and fluid verification system;

[0094] Figure 57This is a schematic diagram of a syringe having a temperature strip integrated with the syringe according to aspects of this disclosure;

[0095] Figure 58 This is a front perspective view of a fluid injection system according to aspects of this disclosure;

[0096] Figure 59 This is a schematic diagram of a fluid injection system according to aspects of this disclosure;

[0097] Figure 60 Is with Figure 59 A schematic diagram of the fluid injector portion of a fluid delivery system;

[0098] Figures 61-63 yes Figure 59 Schematic diagrams of various configurations of the fluid injection system;

[0099] Figure 64 Is with Figure 1 A diagram illustrating another alternative syringe used in the system;

[0100] Figure 65 It is filled with air according to aspects of this disclosure. Figure 64 A schematic diagram of a syringe and fluid verification system;

[0101] Figure 66 It is filled with physiological saline according to aspects of this disclosure. Figure 64 A schematic diagram of the syringe and fluid verification system; and

[0102] Figure 67 It is filled with contrast agent according to aspects of this disclosure. Figure 64 A schematic diagram of the syringe and fluid verification system. Detailed Implementation

[0103] For the purposes described herein, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives will refer to this disclosure as oriented as shown in the accompanying drawings. When referring to the use of a syringe, the term “near” refers to the portion of the syringe closest to the syringe when the syringe is attached to the syringe. The term “far” refers to the portion of the syringe furthest from the syringe. However, it should be understood that alternative variations and sequences of steps may be assumed in the invention unless explicitly specified to the contrary. It should also be understood that the specific apparatus and processes shown in the drawings and described in the following description are merely exemplary embodiments of this disclosure. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0104] One aspect of the present disclosure relates to fluid injection systems and fluid verification systems to confirm, using image processing techniques, that a syringe containing fluid for injection is completely filled with fluid and does not have free space (i.e., air) or contain air bubbles near its distal end when the syringe is provided in an upright position. The present invention also generally relates to using imaging processing techniques to determine various injection parameters to verify the type and certain properties of the fluid present within a syringe.

[0105] 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 liquids. In certain aspects, the fluid verification system is configured to emit electromagnetic radiation, such as visible 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 can be visible to the human eye (e.g., having a wavelength of between approximately 400 m to 700 m) or invisible (as is the case, for example, with x-rays, radio frequency rays, infrared radiation, and ultraviolet radiation). Further, as used herein, the electromagnetic radiation can 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 unique identification pattern. The illuminated area that defines the identification pattern on the distal end of the syringe is referred to herein as a halo. As used herein, the term "halo" encompasses an illuminated identification pattern that includes a colored / illuminated ring around the distal portion of the conical distal end of the syringe or a conical sub-portion of the distal portion of the conical distal end of the syringe. This halo can be easily identified by an operator when viewed in a level, true side view, or slightly elevated position. In one example, the level or true side view can be in a plane that is generally parallel to a central axis extending through the syringe and generally along a plane extending through the distal end of the syringe. Illuminating the syringe in the manner described herein can also cause any air bubbles present along the sidewall of the syringe barrel to be illuminated, thereby allowing an operator or sensor to more easily identify the presence of such air bubbles.

[0106] In some aspects, one or more sensors can be configured to capture an image of the distal end of the syringe to detect the halo pattern, for example, via automated image processing techniques. If the syringe is completely filled with fluid, a distinct observable halo (e.g., in the form of a band of light 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 when the syringe is completely or partially filled with air), the size and / or brightness of the halo is substantially reduced or disappears. 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.

[0107] I. Generation of the illuminated identification pattern

[0108] A. Exemplary fluid injector system

[0109] Reference Figure 1 A fluid injector 10, such as an automated or powered fluid injector, is shown adapted to engage with and actuate one or more syringes 12, which can be filled with a fluid F, such as a contrast media, a saline solution, or any desired medical fluid. The fluid injector 10 can be used to inject contrast media and / or a common flushing agent, such as saline, into a patient during an angiography, computed tomography (CT), magnetic resonance imaging (MRI), molecular imaging, or other medical procedure. In some examples, the fluid injector 10 can be at least a dual-syringe injector, in which two fluid delivery syringes 12 are oriented in a side-by-side or other spatial relationship and are separately actuated by respective linear actuators or piston elements associated with the injector 10.

[0110] The injector 10 can be enclosed within an outer housing 14 formed of a suitable structural material, such as plastic and / or metal. The outer housing 14 can be formed in various shapes and sizes, depending on the desired application. For example, the injector 10 can be a free-standing structure configured to be placed on the floor, or can be configured to be placed on a suitable table or support frame. The injector 10 includes one or more syringe ports 16 to connect to the proximal ends of the one or more syringes 12 and to connect plungers 26 to respective piston elements. The syringe ports 16 are generally located on the side of the outer housing 14, for example as shown in Figure 1 The outer housing 14 can be rotatable to direct the syringe ports 16 and the syringes 12 to extend therefrom in a vertical, horizontal, or downward direction. In some examples, the syringes 12 can include at least one identification tag 34, such as a label or barcode, that includes information about the syringe size, volume, 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 positioned on or recessed in the side of the outer housing 14, or within at least a portion of the inner surface of at least one syringe port 16 of the injector 10.

[0111] The fluid path set 17 can interface with the syringes 12 to deliver one or more fluids from the syringes 12 to a catheter (not shown) inserted into a patient at a vascular access site. For example, a saline solution stream from a first syringe 12 and a contrast media stream from a second syringe 12 can be regulated by a fluid control module (not shown) associated with the injector 10. The fluid control module operably controls injection rates, pressures, valves, and flow regulating structures such as pistons or linear actuators to regulate delivery of saline solution and / or contrast media to a patient based on user-selected injection parameters such as injection flow rate, duration, total injection volume, and ratio of contrast media to saline, which can be programmed or otherwise input into the injector fluid control module.

[0112] A suitable front-loaded fluid injector for use with the above-described 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 found in U.S. Patent Nos. 7,553,294 to Lazzaro et al., 7,666,169 and 9,199,033 to Cowan et al., 8,173,995 to Tucker et al., PCT Publication No. WO 2012 / 155035 to Shearer et al., and U.S. Patent Application Publication No. 2014 / 0027009 to Riley et al., all assigned to the assignee of the present application, and the disclosures of which are incorporated herein by reference.

[0113] B. Exemplary Syringes for Use with Fluid Injector Devices

[0114] 1. Details of the Syringe Body

[0115] Having described the overall structure and function of the fluid injector 10, the syringes 12 configured for connection to the injector 10 and containing fluid F will now be discussed in detail. Reference is made to Figure 2The syringe 12 includes a substantially cylindrical body 18 formed of glass or a suitable medical-grade plastic and defining an internal volume 19. For example, the body 18 may be formed of medical-grade polyethylene terephthalate (PET) or other medical-grade plastic materials. The body 18 has a proximal end 20 and a tapered, conical distal end 24 extending to a nozzle 22. The body 18 may be formed of a transparent or translucent material, allowing the user or system operator to observe the fluid F contained therein, and, as discussed herein, to identify a halo on the distal end 24 of the body 18 when used with a fluid verification system. In other examples, only the distal end 24 of the body 18 is transparent or translucent, while the rest of the body 18 is formed of an opaque, reflective material to increase light transmission through the body 18. In some aspects, a shield (not shown) may be provided around the outer circumference of the body 18. The shield can be formed of an opaque reflective material to increase light transmission through the syringe 18. The fluid F generally has a refractive index greater than that of air and can be made of a different material than the syringe 18, thus altering the path of electromagnetic radiation, such as visible light, traveling through the syringe 18. For example, the refractive index of air is approximately 1, that of saline is approximately 1.34, that of contrast agents is approximately 1.46, and that of PET is approximately 1.57. Unwilling to be bound by theory, the reflection and refraction properties of the medium through which the electromagnetic radiation travels govern its path.

[0116] At least in part based on such Figures 3A-3D The angle and / or shape of the tapered distal end 24 of the shown syringe 18 determines the appearance of the illuminated area or halo 120. In some respects, the tapered distal end 24 of the syringe 18 may taper at an angle ranging from 30 to 60 degrees, and in other respects, at an angle ranging from 40 to 50 degrees relative to a horizontal, latitudinal, or radial axis extending through the syringe 12. In one example, the angle of the tapered distal end 24 of the syringe 18 is approximately 45 degrees relative to the horizontal (see [link to article]). Figure 3A There are also high and low thresholds, in which the reflected illumination area or halo becomes invisible. Therefore, changing the angle and / or shape of the tapered distal end 24 of the cylinder 18 may affect the size and visibility of the halo 120. For example, as the angle of the tapered distal end 24 of the cylinder increases, the size of the visible halo increases (see...). Figure 3Cthat has an angle of 60 degrees relative to the horizontal plane. However, the brightness of the halo generally decreases as such angles increase. This can be compensated for by increasing the intensity of the electromagnetic radiation from the source used to produce 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 Figure 3B Finally, if the distal end 24 of the needle barrel has no angled surface, such as a domed needle barrel shown in Figure 3D , no halo 120 is produced. Specific details of the manner in which the halo 120 is produced at the distal end of the needle barrel 12 are provided herein.

[0117] In some examples, at least a portion of the distal end 24 of the needle barrel 18 can contain 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 outer 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 to be visible over a range of viewing angles and user positions. The scallop or ridge 24A can be used to manufacture a multi-part lens, such as a Fresnel lens. This type of lens can allow light passing through the halo 120 of the needle barrel 12 to be redirected into a more direct path toward the detector or viewer at the portion where the halo 120 is visualized. Such a lens can also be used to transmit light over greater distances and appear brighter at a greater number of viewing angles. In addition, the scallop or ridge 24A allows for enhanced visualization of the halo 120 or other features within the needle barrel 12. The geometry of the ridge 24A can be determined by the internal reflection of light and the corresponding rays combining or converging at the viewer’s eye. Referring to Figures 4A-4C , different arrangements of the scallop or ridge 24A at the distal end 24 that result in different shapes or sizes of the halo 120 produced are shown.

[0118] Returning to Figure 2 In some examples, an annular flange, commonly referred to as a drip flange 28, extends radially outward from the needle barrel 18 at a location proximate to the proximal end 20 of the needle barrel 18. When the needle barrel 12 is inserted into the syringe 10 (shown in Figure 1 , the distal opening of the needle barrel port 16 (shown in The drip flange 28 is positioned (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 the insertion portion 30) is sized and adapted to be inserted into the syringe port 16 of the syringe 10. Thus, in some examples, the insertion portion 30 of the barrel 18 includes one or more locking structures, such as locking flanges 32, that extend radially outward from the barrel 18. The locking flanges 32 can be adapted to form a locking engagement with corresponding protrusions or locking structures in the syringe port 16 to releasably retain the syringe 12 in the syringe port 16 when the syringe 10 is in use. Alternatively, the insertion portion 30 can include one or more latches, locking mechanisms, or radially extending ribs to connect to corresponding portions of the syringe port 16.

[0119] Syringes suitable for use with the Figure 1 Exemplary syringes for use with the syringe 10 depicted in FIG. 1 and that can be adapted for use with a fluid verification system are assigned to the assignee of the present application and the disclosures of which are incorporated by reference in their entireties. Additional exemplary syringes are disclosed in U.S. Patent Nos. 6,322,535 to Hitchins et al. and 6,652,489 to Trocki et al., each of which is assigned to the assignee of the present application and the disclosures of which are incorporated by reference in their entireties.

[0120] 2. Examples of plungers for use with exemplary syringes

[0121] With continued reference to Figure 2 The proximal end 20 of the syringe barrel 18 can be sealed with a plunger or plunger cap 26 that is slidably disposed within the syringe barrel 18. The plunger or plunger cap 26 can have a distal surface 26A. The plunger or plunger cap 26 forms a fluid-tight seal against the sidewall of the barrel 18 as it is advanced or withdrawn through the barrel 18. The plunger or plunger cap 26 can include an internal cavity 27 and a proximal opening 29 that are configured to receive and engage a distal end of a piston rod (not shown) that extends from the syringe 10 (shown in FIG. 1). The piston rod is advanced or retracted through the syringe barrel 18 by the syringe 10 to drive the plunger or plunger cap 26 through the interior 19 of the syringe barrel 18 to expel fluid F therefrom or to deliver fluid F into the syringe barrel 18. Figure 1

[0122] ​In some examples, the plunger or plunger cover 26 is at least partially formed of a substantially transparent or translucent material and is configured to allow electromagnetic radiation, such as visible light, ambient light, infrared light, or ultraviolet light, to pass through or be emitted from portions of the plunger or plunger cover 26. For example, the plunger or plunger cover 26 can include a transparent or translucent central portion enclosed 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 is radiated, propagated, or travels within the syringe barrel 18 and / or through the syringe barrel 18 in a substantially axial direction toward the distal end 24 of the syringe barrel 18, while other electromagnetic radiation is emitted in a non-axial direction, but at least portions of the electromagnetic radiation are reflected off the inner surface of the syringe barrel 18 toward the distal end 24. It also propagates from the plunger or plunger cover 26 in a non-axial direction, and portions thereof are reflected off the sidewall of the syringe barrel 18 toward the distal end 24 of the syringe 12. The beam of electromagnetic radiation can be scattered as it passes through the transparent or translucent material of the plunger or plunger cover 26, which contributes to the appearance of the halo. While the plunger or plunger cover 26 can be transparent or tinted white, in certain applications, certain more pronounced colors can be useful. For example, the plunger material can be tinted a pronounced color, such as bright red or bright green, to impart a color to the halo. Imparting a bright, pronounced color to the halo can help a system operator to identify the halo when it is present. For example, the plunger or plunger cover 26 can be tinted green or blue to increase visibility and confirm that the syringe 12 is ready for use (e.g., green is generally understood to indicate a "go" or "proceed" ready state. 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 colors) to define a colored halo.

[0123] Alternatively, or in addition to including a transparent or translucent portion, in other aspects, 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 positioned along a portion of the cover 26 that help to form a halo. The windows or openings 31 can be covered by 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 of an opaque material and, unlike the previously described examples, need not be capable of allowing light to pass through. In one example, selective lighting through these windows or openings 31 can be used to change the pattern on the visible halo 120 or the color of the halo 120 based on certain system conditions or states. For example, some of the windows or openings 31 can be configured to have red light shining through them, while other windows or openings 31 can be configured to have yellow light shining through them. Thus, if only the red lights are on, the halo 120 can have a red color, if only the yellow lights are on, the halo 120 can have a yellow color, or if all of the lights are on, the halo 120 can have an orange color. Certain colors of the halo 120 can provide an indication of the operation of certain system conditions or states, 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 within the syringe, the volume of fluid within the syringe, the presence of air within the syringe, etc.

[0124] In another example, the plunger or plunger cover 26 can be formed of, or coated with, a reflective or colored material instead of a translucent or transparent material. The reflective or colored material or surface will reflect light directed toward the plunger or plunger cover 26 in a distal direction through the syringe barrel 18 to create a halo. Figures 10-12 FIG. 13 illustrates an example fluid verification system including a reflective plunger, which is discussed in detail herein.

[0125] In yet another example, as Figure 5A and 5BAs shown, the plunger or plunger cover 26 can be formed of or coated with a reflective material having a plurality of different colored stripes 38. The reflective material forming the stripes 38 reflects light directed toward the plunger or plunger cover 26 in a distal direction through the syringe barrel 18 to produce a glow. As the plunger or plunger cover 26 moves through the barrel, depending on the position of the plunger or plunger cover 26 within the syringe barrel 18, light is reflected from a different stripe 38. Because each of the stripes 38 of the plunger or plunger cover 26 is a different color, the color and / or appearance of the glow changes during the injection or filling process depending on which stripe 38 the light is reflected off of as the plunger or plunger cover 26 is advanced or retracted through the syringe barrel 18. As the plunger or plunger cover 26 is advanced or retracted through the syringe barrel 18, a sensor, such as an image capture device, can be positioned to capture images of the glow and detect changes in the color of the glow. A processor, which can be operably coupled to the sensor and suitably programmed, can then be used to determine the volume of fluid remaining within the syringe based on the color / appearance of the glow. While the example shown in FIGS. 1-3 illustrates the plunger or plunger cover 26 having a plurality of different colored stripes 38, it should be understood that this is not intended to be limiting. For example, the plunger or plunger cover 26 can be configured to emit different colors of light at particular portions of the syringe to produce a different colored glow depending on the volume of fluid remaining in the syringe. Further, in addition to colored stripes, other patterns can be used to encode information into the plunger in the manner observed in the glow 120. One example of such a pattern is a bar code. Figure 5A and Figure 5B The example shown in FIGS. 1-3 illustrates eight (8) different colored stripes, but this should not be construed as limiting the present disclosure as any suitable number of stripes can be used. Alternatively, the plunger or plunger cover 26 can be configured to emit different colors of light at particular portions of the syringe to produce a different colored glow depending on the volume of fluid remaining in the syringe. Further, in addition to colored stripes, other patterns can be used to encode information into the plunger in the manner observed in the glow 120. One example of such a pattern is a bar code.

[0126] C. Producing an illumination identification pattern with an example syringe

[0127] Having generally described various aspects of the structure of the syringe 12 and the plunger or plunger cover 26, components of one example of a fluid verification system 110 will now be discussed in detail. Figure 6 The fluid verification system 110 includes an electromagnetic radiation source 112 for producing an irradiance beam that forms the glow 120. The electromagnetic radiation source 112 can be a light bulb, LED bulb, visible light emitter, infrared emitter, laser, other electromagnetic radiation source, or ambient light that provides an electromagnetic radiation beam that is projected through the interior 19 of the syringe 12. In certain aspects, the electromagnetic radiation source 112 emits electromagnetic radiation generally in an axial direction through the syringe barrel 18 toward the distal end of the syringe.

[0128] 1. Electromagnetic radiation source positioned below the plunger

[0129] For example, as Figure 6As shown, the beam of electromagnetic radiation B passes through the translucent or transparent plunger or plunger cover 26 and toward the distal end 24 of the barrel 18. The electromagnetic radiation source 112 can be configured to increase the prominence of the halo 120 or to tailor the halo 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 wavelength of about 532 nm in one embodiment (e.g., a green laser). Lasers emitting electromagnetic radiation of other wavelengths within the visible region are also contemplated. The laser electromagnetic radiation source 112 can be used with a neutral colored plunger or a transparent plunger and still produce a prominent colored halo 120. In other examples, the electromagnetic radiation source 112 can emit electromagnetic radiation outside the visible spectrum, provided that the system contains a sensor or camera capable of detecting the radiation (e.g., the halo 120) within the emitted wavelength. In yet other examples, the electromagnetic radiation source 112 can be configured to emit polarized light or filtered light of certain wavelengths that can be more easily distinguished from ambient light. In other examples, the electromagnetic radiation source 112 can be configured to emit pulses of light according to a predetermined and identifiable sequence that can be identified by a system operator or automatically detected by a sensor.

[0130] With continued reference to Figure 6 , the electromagnetic radiation source 112 is disposed below the plunger or plunger cover 26 to provide backlighting for the plunger or plunger cover 26. For example, an LED bulb or other electromagnetic radiation emitting device can be mounted to a base portion of a syringe receiving stand, a plunger, an actuator, or a syringe port configured to receive the syringe 12 and positioned to emit a beam of electromagnetic radiation through the syringe barrel 18, for example, in an axial direction. Accordingly, in some examples, the electromagnetic radiation source 112 can be integrated with the syringe 10 (shown in Figure 1 ). For example, the electromagnetic radiation source 112 can be positioned on the syringe port 16 (as shown in Figure 1 ), adjacent to the drip flange 28 of the syringe barrel 18, or at some other convenient location on the syringe adjacent to the syringe port.

[0131] In other examples, the fluid verification system 110 can be a standalone structure that includes a base or holder for receiving a syringe 12 to be tested. The electromagnetic radiation source 112, such as an LED or standard bulb, can be positioned on or adjacent to the base or holder. In that case, the syringe 12 is verified to ensure that it is properly filled with fluid F. After verification is complete, the syringe 12 is removed from the base or holder and transferred to a syringe, such as the fluid syringe 10, to deliver the fluid F to a patient.

[0132] When the syringe is filled with fluid, the electromagnetic radiation passing through the plunger or plunger cover 26 substantially radiates through the syringe barrel 18 to form the halo 120. With particular reference to Figure 7When the syringe 12 is filled or partially filled with air, the electromagnetic radiation beam passes through the syringe barrel 18, but does not form a distinct illuminated portion or halo 120 near the distal end 24 thereof. In contrast, as shown in Figure 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 wall, which creates a halo 120 near the distal end 24 of the syringe 12. As discussed in more detail with respect to the methods and steps for syringe verification herein, a system operator or automated image reading or optical device (e.g., sensor 114) can identify whether the halo 120 is present, and if so, whether it is the correct shape and size. If the halo 120 is too small, not bright enough, or not present at all, this can indicate that the syringe is not filled with enough fluid or contains air, and the system operator can add additional fluid F to the syringe 12 to completely fill before injection into a patient. If a halo 120 of the correct size, shape, and brightness is identified, the syringe is verified to be filled with fluid and the fluid contents of the syringe 12 are ready for administration to a patient. Thus, the fluid verification system 110 provides a proper visual indication of whether the syringe 12 is full of fluid or whether a small amount of air is present in the interior 19 of the syringe.

[0133] Further, as shown in Figure 7 and 8 The line 40 can 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 using any suitable method, such as but not limited to printing, overmolding, and etching. The line 40 is configured to work in conjunction with the halo 120 to provide a quick visual indication to an operator of the type of fluid within the syringe 12. For example, due to the different properties of different fluids, the halo 120 will be a different size depending on the type of fluid present within the syringe. Thus, the line 40 can be formed on the syringe 12 so as to align with a particular portion of the halo 120, such as the bottom edge shown in Figure 8 when a first fluid is present within the syringe 12, and align with a second predetermined portion of the halo 120, such as the middle portion, if a second fluid is present within the syringe 12, or can be positioned away from the halo 120 if a second fluid is present within the syringe 12. In this manner, an operator can quickly and easily visually determine the position of the line 40 relative to the halo 120 and determine the type of fluid present within the syringe 12 based on this information.

[0134] Referring to Figure 9The illustration shows another example of a syringe 12 comprising a backlit translucent or transparent plunger or plunger cap 26 and a fluid verification system 110. The syringe 12 is mounted to the syringe port 16 of the syringe 10. One or more electromagnetic irradiation sources 112 (such as LEDs) are mounted to or embedded in the distal end of the piston rod 124 of the syringe 10. When actuated, the piston rod 124 is advanced toward and received within a cavity 27 defined by the plunger or plunger cap 26. The LED emits light axially through the plunger cap 26 to generate a halo 120 adjacent to the distal end 24 of the syringe barrel 18 in the manner described above. The halo 120 can be identified by a sensor 114 positioned adjacent to the distal end 24 of the syringe barrel 18.

[0135] 2. Position the electromagnetic irradiation source so that irradiation is reflected from the surface of the plunger.

[0136] refer to Figure 10 The irradiation source 112 can also be arranged or positioned such that energy or electromagnetic radiation is axially reflected from the distal surface 26A of the plunger or plunger cap 26 through the syringe barrel 18 to form a halo 120. For example, an electromagnetic irradiation source 112, as described herein, can be positioned outside the barrel (e.g., near the distal end 24 of the barrel 18) to project electromagnetic radiation or a beam of light B through the syringe barrel 18 toward the distal surface 26A of the plunger or plunger cap 26. The electromagnetic radiation or beam of light B is then reflected from the plunger or plunger cap 26 in a distal direction, with accompanying refraction / reflection by the fluid and / or syringe wall material, to form a visible halo at the distal end of the syringe.

[0137] 3. Electromagnetic radiation source positioned adjacent to the surface of the syringe

[0138] In another example, such as Figure 11 As shown, system 110 may include an electromagnetic irradiation source 112, which is positioned relative to syringe 10 and / or syringe port 16 (e.g., Figure 1 The surfaces (shown) are adjacent. An electromagnetic irradiation source 112, such as that described herein, can be configured to focus and reflect a light beam or irradiation beam B from a mirror 122 or other reflective element located near the distal end 24 of the syringe barrel 18. The mirror 122 directs the light or electromagnetic irradiation beam toward the distal surface 26A of the plunger or plunger cap 26, such that when the syringe is filled with fluid, the irradiation or light can be reflected from the plunger or plunger cap 26 to form a halo 120. The halo 120 can be visually identified by an operator or by a detector or sensor 114.

[0139] 4. Electromagnetic radiation sources containing optical fibers

[0140] refer to Figure 12In another example, shown, a fiber optic light guide 126 is used to provide light or electromagnetic radiation from an electromagnetic radiation source 112 associated with the syringe body toward the distal end 24 of the barrel 18 and to shine or direct light toward the distal surface 26A of the plunger or plunger stopper 26. In one example, the light guide 126 can be embedded in the syringe barrel 18 itself. Alternatively, the light guide 126 can be embedded in a pressure jacket that surrounds the syringe barrel 18. In that case, light can be directed from an electromagnetic radiation source 112 located in, for example, the syringe port 16 of the syringe 10, through the light guide 126 toward the distal end 24 of the barrel 18. As shown by the light beam B, the light emitted from the light guide 126 is shown or directed toward the distal surface 26A of the plunger or plunger stopper 26 and is allowed to reflect from it in the manner discussed with respect to the examples shown in Figure 10 and Figure 11 to form a halo of light at the distal end of the syringe when the syringe is filled with fluid.

[0141] 5. Illuminating identification patterns or halos

[0142] Referring now to Figure 13 the details of how electromagnetic radiation is refracted by the fluid F and / or the material in the walls of the barrel 18 to produce the halo 120 will now be discussed in detail. As shown in Figure 13 generally as 130, when passing through the plunger or plunger stopper 26, as in Figure 6 and 9When the light rays 130 are scattered in multiple directions, the light rays collectively travel in the axial direction A toward the distal end 24 of the barrel 18. Some of the light rays 130 pass through the transparent or translucent sidewall of the barrel 18 out of the barrel 18, meaning that the illuminated plunger 26 is visible to the observer 200. Some light rays 130 directly reach the tapered, conical distal end 24 of the barrel 18 without contacting the sidewall of the barrel 18. For an observer 200 looking at the top of the syringe 12 from an elevated position, the light rays 130 directly shining on the distal end 24 of the barrel 18 will be visible. Some light rays 130 are focused by total internal reflection or partial internal reflection (as shown by reference numeral 132) from the barrel 18 to the distal end 24 of the barrel 18. For example, when the syringe is filled with fluid and the difference in refractive indices between the fluid, the syringe wall material, and the air outside the syringe is different to cause internal reflection, the light rays 130 directed to one side of the tapered, conical distal end 24 of the barrel 18 are reflected by total internal reflection (as shown by reference numeral 133) toward the opposite side of the tapered distal end 24. If the barrel 18 is completely filled with air or only partially filled with fluid F, the light rays 130 are not sufficiently internally reflected or focused to the distal conical end, and will only be faintly visible, if at all, to the observer 200 over the air-filled region of the syringe 12. Without intending to be bound by any theory, it is believed that a large percentage of the light rays traveling through the air-containing volume of the syringe do not internally reflect at the barrel wall but pass through the sidewall out of the syringe; and because there is no significant internal reflection, the light rays are not focused to the distal end of the syringe to produce an observable halo. In particular, when air is in the syringe, the focused light rays 130 will not be visible as a halo when looking at the barrel 18 from a level position or a true side view. Thus, the halo 120 appears to be absent when the barrel 18 is not completely filled with fluid.

[0143] However, as in the Figure 13As shown, when syringe 12 is filled with fluid F, light rays 130 reflected and focused toward the tapered distal end 24 of syringe 18 are refracted, as indicated by line 131, due to the difference in refractive index between the fluid and the external air and syringe wall material. Specifically, as discussed herein, air has a refractive index of approximately 1. In contrast, saline has a refractive index of approximately 1.34, contrast agents approximately 1.46, and PET approximately 1.57. Compared to when syringe 18 is only partially filled with fluid F, the refracted light beam 130 exiting syringe 18 is visible to observer 200 at a lower angle. Furthermore, due to refraction, light ray 130 can also be focused to increase the intensity of the halo of light observed by observer 200. Therefore, when observer 200 looks at the fluid-filled syringe 12 from a level, true side, or slightly elevated position, observer 200 sees an illumination halo 120 with a unique appearance.

[0144] The structure and geometry of the syringe 12, and particularly the tapered, conical distal end, are chosen to ensure that the halo 120 is readily visible from a set of specific positions or orientations at a predetermined portion (i.e., distal end 24) of the barrel 18. For example, in some embodiments, the syringe 10 holds the syringe 12 in an inclined orientation (e.g., tilted upwards or downwards relative to the plane of the syringe from about 0 degrees to about 30 degrees). To accommodate the inclined orientation of the syringe 12, the shape of the syringe body 18 and the shape of the distal end 24 of the barrel 18 can be chosen to increase the visibility of the halo 120 when viewed from an inclined position. If the syringe 12 is held in a substantially straight (e.g., non-tilted) position by the syringe 10, then the syringe 12 is shaped such that the halo 120 is readily visible when the syringe 12 is viewed from a level or true side-view orientation.

[0145] More specifically, see reference Figure 14A If the syringe 12 is oriented such that it is typically viewed from a level or tilted (e.g., a tilt of 10 to 30 degrees) orientation, the angle 23 of the tapered distal end 24 of the syringe 18 is from approximately 30 to 60 degrees, and in some embodiments approximately 45 degrees relative to the horizontal. An angle of approximately 45 degrees produces a halo 120 that is more easily seen than from a level view. Specifically, as... Figure 14A As shown, observer 200 can see the light 130 forming the halo 120 at a fairly low orientation.

[0146] On the contrary, such as Figure 14BAs shown, for a syringe 12 with a steeper distal end 24 of angle 23, halo 120 is visible to observer 200 at a higher (e.g., downward) orientation. A higher observation point may be appropriate if it is desired to observe syringe 12 from a forward-tilted position. In some examples, the distal end 24 of syringe 18 may also have a dome shape. However, in most cases, halo 120 is more easily seen through the tapered distal end 24 rather than the dome-shaped distal end 24.

[0147] In another example, such as Figure 14C As shown, the distal end of the syringe 12 includes a distal portion 24, which comprises a curved and angled portion extending from the syringe body 18 to the nozzle 22 or tip. This curved and angled distal portion 24 produces a halo 120 that can be seen from a wider range of viewing angles. Specifically, as... Figure 14C As shown, observer 200 can see beam 130 at eye level or at a more downward-oriented orientation. Therefore, for those with... Figure 14C The halo 120 is visible in the distal portion 24 of the syringe 12 shown, whether the syringe 10 holds the syringe 12 in a slightly tilted position or an upright position.

[0148] 6. Operation of a fluid injection system with an exemplary syringe

[0149] Refer again Figure 1 , Figure 2 and Figure 6 In use, the operator inserts the proximal end 20 of the syringe 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 the corresponding locking structure (not shown) of the syringe port 16 to form a proper connection. In some examples, the operator continues to press the syringe 12 into the port 16 until the insertion portion 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.

[0150] Syringe 12 may be pre-loaded with fluid F. Alternatively, syringe 10 may automatically or manually draw fluid F from an external fluid source into syringe barrel 18. Once syringe 12 is inserted into port 16 and filled with fluid F, electromagnetic irradiation source 112 is turned on, causing a beam of light to be projected through plunger or plunger cap 26. Alternatively, as incorporated herein... Figures 10 to 12As discussed in the exemplary system illustrated, electromagnetic irradiance or light can be directed toward the distal surface 26A of the plunger cap 26 and reflected therefrom in the axial direction. In some examples, syringe insertion and halo recognition can be coordinated such that the electromagnetic irradiance source 112 automatically turns on each time the syringe 12 is loaded into the syringe 10. Alternatively, the system operator can manually turn on the electromagnetic irradiance source 112 by, for example, entering a command via a user interface or pressing an activation button. Once the electromagnetic irradiance source 112 is activated, the presence or absence of an illuminating portion or halo 120 (in...) Figure 6 and Figure 9 (As shown in the diagram) can be identified and / or detected by a technician, or automatically identified and / or detected by a sensor. Specifically, if syringe 12 is fully filled with fluid F, a halo 120 appears. If syringe 12 is filled with air or only partially filled with fluid, the halo 120 is less noticeable or not present at all. For example, when using systems such as Figure 2 When the syringe shown is used, once air is introduced into the syringe, the halo 120 begins to become less noticeable and continues to fade (i.e., smaller and / or less bright) until it is completely absent when approximately 5 mL of air is present in the syringe 12. In other examples, the halo 120 is invisible when the percentage of the volume of air present in the distal end 24 of the syringe 12 is greater than approximately 15% of the volume of the conical distal end 24 of the syringe 12. In yet another example, the halo 120 is invisible when the percentage of the volume of air present in the distal end 24 of the syringe 12 is greater than approximately 10% of the volume of the tapered distal end 24 of the syringe 12, and in yet another example, the halo 120 is invisible when the percentage of the volume of air present in the distal end 24 of the syringe 12 is greater than approximately 20% of the volume of the tapered distal end 24 of the syringe 12. In some examples, the system operator manually confirms (e.g., visually verifies) the presence of the halo 120 before actuating the injector 10.

[0151] Alternatively, in accordance with another aspect of the present disclosure, the illumination halo 120 can be automatically detected by one or more sensors 114, such as a digital camera. More specifically, an image or images of the distal end 24 of the barrel 18 can be obtained by the one or more sensors 114. The obtained images can be analyzed by a processor using image processing techniques (as will be discussed in greater detail herein). For example, and as will be discussed in detail herein, pattern recognition algorithms can be used to identify the expected structure of the syringe 12 and other properties (the fluid fill volume, the fluid properties, and the shape and / or location of the halo 120, among other properties and features). Pattern recognition can also be used to identify information about the syringe 12, such as the syringe fluid volume for a particular syringe size and geometry or preferred injection parameters. Edge-to-edge distance calculation algorithms can be used to identify the location and length of the halo 120. Edge-to-edge distance calculation algorithms can also be used to determine the length of the meniscus formed by the fluid F contained in the syringe 12. The identification of the meniscus location and size can be used to determine the fluid volume contained in the syringe 12 as well as the free space (i.e., the air volume) between the meniscus and the syringe nozzle, if present. Brightness determination algorithms can be used to determine the intensity of the halo 120. As previously discussed, the brightness of the halo 120 can be used as an indicator of the amount of air present in the syringe 12. Accordingly, the processing algorithms can be configured to ensure that the halo brightness exceeds certain predetermined thresholds, indicating that a threshold amount of air in the syringe has not been exceeded.

[0152] 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, preventing the injection from proceeding and / or requesting that the tested syringe be replaced with a new syringe. If the halo 120 is identified, the injector 10 can be "unlocked," and allow the operator to access other features of the user interface of the injector 10 and allow the injection process to proceed. Similarly, if the sensor 114 fails to identify the halo 120 or if the halo 120 is identified but the brightness is not sufficient, the injector 10 can be configured to cancel or pause the scheduled injection process. If the halo 120 is present, the injector 10 can be configured to automatically initiate the injection process. Activation of the injector 10 causes the linear actuator to advance the piston rod 124 in the distal direction to contact and engage the plunger or plunger cap 26. Advancing the plunger or plunger cap 26 in the distal direction through the barrel 18 causes the fluid F to be expelled from the syringe 12, thereby injecting the fluid F into the patient through any known injection structure (e.g., an IV tube or a needle fitting).

[0153] D. Alternative example syringes for use with fluid injection systems

[0154] 1. Structure of alternative example syringes

[0155] Figure 15A and 15B Alternative example syringes that can be used with fluid injector 10 are shown. More specifically, these figures illustrate a rolling diaphragm syringe 135 according to another aspect of the present disclosure. Various features of rolling diaphragm syringes are described in detail in International PCT Application Publication No. WO 2015 / 164783, the disclosure of which is incorporated herein by reference. Figure 15B is Figure 15A A cross-sectional side view of rolling diaphragm syringe 135 shown in Figure 15A , taken along line A-A. Referring first to Figure 18A and Figure 18B , rolling diaphragm syringe 135 generally comprises a hollow body that includes a front or distal end 137, a rear or proximal end 139, and a flexible sidewall 134 extending therebetween. Sidewall 134 of rolling diaphragm syringe 135 defines a soft, pliable, or flexible yet self-supporting body that is configured to roll itself as a "rolling diaphragm" under the action of a piston 138 (shown in

[0156] Rolling diaphragm syringe 135 can be made of any suitable medical grade plastic or polymeric material. In various aspects, the transparent plastic material can withstand sterilization processes, such as exposure to ethylene oxide or electromagnetic radiation sterilization processes.

[0157] Referring to Figure 15B and with continued reference to Figure 15AThe distal end 137 of the rolling diaphragm syringe 135 has an open ended discharge neck 140 having a connecting member 140a for connecting to a corresponding connecting member of a fluid path set (not shown), such as the cap of FIG. 17 as described herein. The discharge neck 140 has a first sidewall thickness T1 that is greater than a thickness T2 of the sidewall 134. The thickness T1 is selected so that the discharge neck 140 can have sufficient rigidity to allow connection to a corresponding connecting member of a fluid path set (not shown) without substantially deforming the discharge neck 140, for example, during an injection procedure. The thickness T2 is selected so that the sidewall 134 of the rolling diaphragm syringe 135 is flexible to allow rolling and spreading over the sidewall 134 as described herein. The proximal end 139 of the rolling diaphragm syringe 135, such as the closed end wall 136, can be reinforced to prevent deformation during rolling over the sidewall 134 or spreading of the sidewall 134 as described herein. In some aspects, the proximal end 139 of the rolling diaphragm syringe 135 is configured to engage with the plunger 138.

[0158] The end wall 136 can have a central portion 276 having a substantially dome-shaped configuration and a plunger engagement portion 244 extending proximally from the central portion 276, such as an approximate midpoint of the central portion 276. In some aspects, a distal most end of the central portion 276 can be substantially flat. The plunger engagement portion 244 is configured for engagement with an engagement mechanism on the plunger 138 of the fluid injector 10. The proximal end 139 of the rolling diaphragm syringe 135 can have one or more ribs 278 protruding radially outward from the plunger engagement portion 244 along a proximal surface of the ramp 272.

[0159] Figure 16A is a perspective view of a syringe assembly 204 having a rolling diaphragm syringe 135 (shown in Figure 16B ) and a pressure jacket 210 according to the present disclosure. The syringe assembly 204 includes the pressure jacket 210 that is removably interfaced with an injector 10 (shown in Figure 1 ) as described herein. The pressure jacket 210 has a distal end 216, a proximal end 218, and a sidewall 219 extending between the distal end 216 and the proximal end 218 along a longitudinal axis of the pressure jacket 210 to define an internal through bore 221 (shown in Figure 16B ). In some aspects, the sidewall 219 of the pressure jacket 210 is shaped to receive the rolling diaphragm syringe 135 (shown in Figure 16BAt least a portion of the rolling diaphragm syringe 135 within the through-hole 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 for interfacing with the syringe 10. The first distal portion 360a can have an open end configured to releasably receive a cap 390 enclosing the interior of the pressure jacket 210. The second proximal portion 360b can have an open end to allow the piston 138 of the fluid syringe 10 to extend through the open end and engage the rolling diaphragm syringe 135 held within the through-hole 221. The rolling diaphragm syringe 135 can be inserted through the open end of the first distal portion 360a or the second proximal portion 360b.

[0160] In some aspects, the second proximal portion 360b has a locking lug or lip 370 protruding radially outward from an outer surface of the second proximal portion 360b. The locking lug or lip 370 can extend continuously or discontinuously around an outer circumference of the second proximal portion 360b. The locking lug or lip 370 is configured for interaction with a corresponding feature on the fluid syringe 10 to releasably lock the pressure jacket 210 with the fluid syringe 10. In some aspects, the locking lug or lip 370 can have a connecting member to releasably secure the pressure jacket 210 to a locking mechanism of the fluid syringe 10 described in U.S. Patent Nos. 5,383,858, 5,873,861, 6,652,489, 9,173,995, and 9,199,033, which are hereby incorporated by reference. Other connecting members between the pressure jacket 210 and the fluid syringe 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 hereby incorporated by reference.

[0161] Referring to Figure 16B and with continued reference to Figure 16A The pressure jacket 210 can have a cap 390 releasably secured to the distal end 216. In some aspects, the cap 390 can be secured with the distal end 216 of the pressure jacket 210 by a threaded engagement, a bayonet fitting, or another mechanical fastening arrangement. For example, as shown in FIG. 6, the cap 390 can have a threaded outer surface 392 that is configured to threadably engage a threaded inner surface 394 of the distal end 216 of the pressure jacket 210. In some aspects, the cap 390 can be secured to the distal end 216 of the pressure jacket 210 by a snap-fit arrangement. For example, as shown in FIG. 7, the cap 390 can have a snap-fit protrusion 396 that is configured to snap-fit with a corresponding snap-fit recess 398 of the distal end 216 of the pressure jacket 210. Figure 16B and 16CAs shown in FIG. 39, the cap 390 can have at least one protrusion 430 that is received within at least one groove 440 on the pressure jacket 210, such that 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 member 400 with a nozzle 410. The nozzle 410 can be in fluid communication with (or directly formed on) the inner volume of the rolling diaphragm syringe 135 to deliver fluid into or from the rolling diaphragm syringe 135. The nozzle 410 can have a connecting member 420 to removably connect to a connector of the fluid path set 17 (shown in FIG. 40). Figure 1

[0162] The annular sidewall 460 can have one or more gripping elements 470 (shown in FIG. 41) to facilitate gripping the cap 390 when the cap 390 is connected to and / or disconnected 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. Figure 16C

[0163] Referring to FIG. 42, at least a portion of the rolling diaphragm syringe 135 can be removably secured to the cap 390. In some aspects, the cap 390 can have a connecting member that corresponds to and connects with the connecting member 140a (shown in FIG. 43) of the rolling diaphragm syringe 135. As further shown in FIG. 44, the rolling diaphragm syringe 135 can initially be in a compressed configuration, where the rolling diaphragm syringe 135 is rolled upon itself. Providing the rolling diaphragm syringe 135 in the initial compressed configuration can provide economic benefits during packaging and shipping by requiring less packaging material for each syringe set and / or allowing more syringe sets to be packaged. Figure 16C Figure 15A Figure 16C

[0164] 2. Producing an illumination identification pattern with an alternative exemplary syringe

[0165] Having generally described the structure of the rolling diaphragm syringe 135, a system for producing an illumination identification pattern with the rolling diaphragm syringe 135 to determine a fill status of the rolling diaphragm syringe 135 will now be discussed in detail. In one example, referring to FIGS. 45-47, the piston 138 of the fluid injector 10 can have one or more sources of electromagnetic radiation 212, such as LEDs, mounted to or embedded in a distal end thereof. When actuated, the piston 138 is advanced toward and engages the piston engagement portion 244 of the rolling diaphragm syringe 135. The LEDs emit light in an axial direction through the piston engagement portion 244 to produce an illumination identification pattern at the distal end 137 of the rolling diaphragm syringe 135. Figure 17A 17B ​​​​​​​

[0166] The wavelength of the electromagnetic radiation of the LED is selected to match the material used to form the rolling diaphragm syringe to allow optimal energy transfer. For example, the windows of a car are made of a material that prevents UV light from passing through to prevent sunburn while driving. The same principle holds true in the present application. The wavelength of the LED can be selected to match the material used to manufacture the syringe to ensure maximum transmissivity through the material of the piston engagement portion 244 and / or the wall thickness of the syringe. Alternatively, instead of selecting a wavelength to match the material, the wavelength of the LED can be selected that is most visible to the human eye when combined with the halo effect described herein. For example, green light is in the middle of the visible spectrum (approximately 532 nm) allowing a technician to easily see light having this wavelength. Additionally, depending on the solute concentration of the fluid contained within the syringe along with the compounds present and their chemical properties, the wavelength of the LED can be selected to be selectively absorbed or transmitted by the fluid or have the desired reflection / dispersion properties. Thus, the wavelength of the LED can be selected such that the light produced by the LED is dispersed by the fluid and more light is produced therein or similar to how the halo 120 is formed as described herein, the light can be absorbed / transmitted by the fluid and pass through.

[0167] In other examples, the electromagnetic radiation source can be positioned in various other locations such as, but not limited to, the piston engagement portion 244 of the rolling diaphragm syringe 135, the pressure jacket 210, the exterior of the fluid injector 10 similar to the arrangement shown in Figure 10 and Figure 11 the arrangement shown in FIGS. 1 1 and 12, a heat sink associated with the pressure jacket 210, or any other suitable location. In one example, referring to Figure 18A and 18B the electromagnetic radiation source 212 can be positioned within another portion of the fluid injector such as a clamp 213 positioned at the distal end of the syringe 135 that is used to secure the syringe 135 within the fluid injector. For example, referring to Figure 18A the electromagnetic radiation source 212 can be positioned around the circumference of the side of the clamp 213 to direct light through the side of the pressure jacket 210 to the syringe 135. Alternatively, referring to Figure 18B the electromagnetic radiation source 212 can be positioned on the top surface of the clamp 213 to direct light downward through the syringe 135.

[0168] In one example, the end of the piston engagement portion 244 can be configured to expose the LED of the piston 138 when the piston 138 engages the piston engagement portion 244. More particularly, the piston engagement portion 244 can be configured to disengage a cover (not shown) to expose the LED when the piston 138 engages the piston engagement portion 244.

[0169] The piston engagement portion 244 of the rolling diaphragm syringe 135 can be shaped in a manner that collects light from the LED and directs the light through the interior volume 214 of the rolling diaphragm syringe 135 toward its distal end. For example, the piston engagement portion 244 can have a lenticular portion such that the portion focuses the light produced by the electromagnetic radiation source 212 and directs the light up the piston engagement portion 244. Additionally, if the light source of the electromagnetic radiation source is collimated, the shape of certain portions of the piston engagement portion 244 can be flat or any other appropriate geometry.

[0170] The piston engagement portion 244 can also have a textured surface to enhance its ability to collect and transmit light. Additionally, the central portion 276 of the end wall 136 can also contain 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 to 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 can be configured as a lens to enhance the transmission of light to the distal end 137 of the rolling diaphragm syringe 135.

[0171] In another example, as shown in Figure 19A and 19B The pressure jacket 210 can contain the electromagnetic radiation source 212 positioned at its proximal end 218 as mentioned herein. In this case, the light produced by the electromagnetic radiation source 212 can be directed up through the pressure jacket 210 and, when the syringe is filled with fluid, the internal reflections within the pressure jacket 210 produce an illuminated identification pattern at the conical distal end 137 of the rolling diaphragm syringe 135. In another aspect, the pressure jacket 210 can be coated with a substance that produces a "one-way mirror" to appropriately distribute the internal reflections of the electromagnetic radiation while allowing the technician to view. Additionally or alternatively, the electromagnetic radiation source and the pressure jacket 210 can be polarized to prevent the electromagnetic radiation from exiting the pressure jacket 210.

[0172] The electromagnetic radiation is collected and directed toward the distal end 137 of the rolling diaphragm syringe 135 to produce an illuminated identification pattern when filled with fluid. The inside of the distal end 137 of the rolling diaphragm syringe 135 can be angled similar to the distal end 24 of the syringe 12 discussed herein to produce a halo 120 in a similar manner. Alternatively or additionally, as shown in Figure 20As shown in FIG. 1, the protruding member 224 can be integrated in or positioned near the distal end 137 of the rolling diaphragm syringe 135 to cause light distribution to create the light halo 120. The protruding member 224 can have various configurations for various purposes. For example, the protruding member 224 can be a reflective surface that reflects light in various directions to enhance visualization of the light halo 120 or to show another indication of fluid presence. The protruding member 224 can be a prism, a mirror, a textured surface, or some other geometric / material alteration to diffuse / absorb light, thereby allowing an indication of fluid presence, fluid type, or other characteristics of the syringe 135.

[0173] Since the cap 390 can be used with the rolling diaphragm syringe 135 as described herein, the cap 390 can be made of a translucent or transparent material so that the light halo can be observed through the cap material. When electromagnetic radiation is transmitted to the distal end 137 of the rolling diaphragm syringe 135, it causes such a transparent or translucent cap 390 to be illuminated. As described herein, the intensity of the illumination of the cap 390 varies depending on the fluid contained within the syringe. For example, if a fluid is provided within the syringe, the cap 390 is illuminated much brighter than if air is present within the syringe.

[0174] II. Image recognition of illuminated identification patterns and various other aspects of fluid injection systems

[0175] Having discussed various examples of irradiation sources, syringes, how electromagnetic radiation or light beams are directed through the syringes to form illuminated identification patterns, the sensor 114 (shown in FIG. 1) for recognizing the illuminated identification patterns and for monitoring or controlling operation of the syringe 10 based on recognition of the illuminated identification patterns will now be discussed in detail, as well as various other aspects of the fluid syringe 10. Figure 1 Although the systems and methods discussed herein will be discussed with reference to a fluid syringe 10 that includes a syringe 12, all of the concepts discussed herein can also be used with the rolling diaphragm syringe 135.

[0176] Referring to Figure 1 , Figure 6 and Figures 9-12In one example, 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 at least to distal end 24 of syringe 12, a central processing unit 116 including a controller operably connected to sensor 114 and configured to process images obtained from sensor 114 using appropriate image processing software, and a display 118 operably connected to central processing unit 116 for displaying results of image processing by the central processing unit. In one example, the image processing software can be Insight Explorer software from Cognex Corporation of Natick, Massachusetts, and sensor 114 can be a DataMan 100 camera also from Cognex Corporation. Further, at least one sensor 114 and central processing unit 116 can be integrated into a single component or provided as separate components. Additionally, at least one sensor 114, fluid injector 10, display 118, and / or central processing unit 116 can communicate wired or wirelessly, such as via Bluetooth, WiFi, or other conventional wireless communication techniques.

[0177] In another example, sensor 114 can be an alternative type of optical sensor, such as an electromagnetic radiation detector or other appropriate sensor known in the art. In some examples, at least one sensor 114 is a digital camera that can be configured to obtain a digital image of at least distal end 24 of barrel 18 when electromagnetic radiation source 112 is turned on. In other examples, at least one sensor 114 can be an infrared radiation detector, an ultraviolet light detector, an ultrasound imaging device, or any other appropriate sensor for identifying electromagnetic radiation emitted from electromagnetic radiation source 112.

[0178] As will be appreciated by one of ordinary skill in the art, at least one sensor 114 or detector can be specifically adapted to identify the wavelength of electromagnetic radiation or light associated with electromagnetic radiation source 112 and the illumination identification pattern produced thereby. For example, at least one sensor 114 can include various filters, or tuned or attenuated optical elements, to identify only radiation within the expected wavelength (e.g., electromagnetic radiation within the wavelength emitted by electromagnetic radiation source 112). Further, syringe 12 itself can be used as a filter by altering material properties (e.g., color, molecular alignment, pigment additives, polarizing surfaces) to filter light of a given wavelength, thereby enabling optimized user visualization. Alternatively, image processing techniques known in the art can be used to remove portions of the obtained image outside of the expected wavelength, thereby reducing the effects of ambient light and increasing the sensitivity of the illumination identification pattern.

[0179] Using the features of the fluid verification system 110 described herein, various aspects of the fluid injection process can be monitored prior to and during delivery of the fluid to provide the technician with information about the details of the injection process in an obvious manner quickly. These details of the injection will be discussed herein.

[0180] A. Air Detection

[0181] 1. Image of Illumination Identification Pattern

[0182] All current syringe systems rely on a technician's personal inspection to determine whether air is present in the syringe prior to the start of the injection process. The fluid verification system 110 is configured to provide detection of air using at least one sensor 114 and image recognition software executed by the central processing unit 116 to allow the technician to have additional corroboration of his / her conclusion about the state of the syringe. In addition, the technician can manually determine whether air is present by observing the syringe to determine whether the illumination identification pattern is present, providing an alternative or backup approach to air detection.

[0183] 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 to determine whether a halo 120 has been created in the syringe 12 using the sensor 114 by the electromagnetic radiation source 212, and using image recognition software of the central processing unit 116 to vet and analyze the image to measure one or more properties of the halo 120 or illumination identification pattern to determine whether the syringe is properly filled with fluid prior to injection. More specifically, according to one aspect and with reference to Figure 21 At step 300, the at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12 containing the halo 120 or other illumination identification pattern. Thereafter, and with reference to Figure 22 and Figure 23At step 302, the system 110 measures or determines the bottom edge 301 of the meniscus of the fluid contained within the syringe 12 and / or the bottom edge 303 of the halo 120. 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 be able to detect edges by a variety of different methods. One method is to determine a change in contrast between adjacent pixels in the image of the edge. Alternatively, a change in contrast over several adjacent pixels can indicate the presence of an edge. This change is indexed over each pixel in a search window to find areas where the change in contrast reaches a threshold. For example, if the image recognition software finds a point where a light pixel is adjacent to a dark pixel, the change is flagged. If several pixels in a row are found to cross this threshold, particularly oriented in a predetermined direction, the image processing software determines that this is an "edge". In this particular application, the diffusion of light caused by the lensing effect of the meniscus creates a darkened area of the fluid at the location of the meniscus. Specifically, as most clearly shown in Figure 23 the top and bottom of the meniscus are edges that can be found.

[0184] Figure 22 is an image of the syringe 12 with no air present, and Figure 23 is an image obtained by the sensor 114 of the presence of air in the syringe 12. As can be seen from these images, when there is no air, the halo 120 is larger, as shown in Figure 22 This allows for the use of imaging processing techniques, as discussed in more detail herein, to determine the presence of air.

[0185] At step 304, the 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 is determined, the location of this edge in space can be found. Specifically, as long as the syringe 12 and the sensor 114 are not moved, the bottom edge 303 of the halo 120 can be determined and this bottom edge 303 of the halo 120 always remains fixed. Thus, the image processing software is then able to determine the distance from the bottom edge 301 of the meniscus to the bottom edge 303 of the halo 120.

[0186] At step 306, the distance 305 determined in step 304 is compared to a predetermined distance. The predetermined distance is created by creating a curve, such as Figure 24The curve is obtained by taking a full syringe 12 and replacing known increments of fluid with equal volumes of air. An image is then taken after each increment of fluid is replaced, and the distance from the bottom edge of the meniscus to the bottom edge of the halo 120 is measured using image recognition software on the central processing unit 116. The curve is then plotted and an equation is fitted. This equation is then provided to the logic algorithm where, Figure 24 the data from the curve is implemented to calculate the volume of air present based on the distance between the two edges.

[0187] If the measured distance 305 is greater than the predetermined distance, it can be determined that substantially no air is present and the syringe can be primed to continue with the injection process 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 disabled from the injection process at step 312. Alternatively, if air is present, the fluid injector 10 can be put through a purging process to purge the air from the syringe, and then repeat Figure 21 the measurement process of FIG. 3. The purging process can be repeated until the measurement process indicates that substantially no air is present in the syringe and the injection process can continue.

[0188] 2. Using details provided on the barrel of the syringe

[0189] An alternative approach to detecting air in the syringe using image processing techniques is to obtain an image of certain features provided on the barrel of the syringe. In particular, and with reference to Figure 25 and Figure 26 , the syringe 12 can include at least one fluid dot 339 on the surface of the syringe 12 that is visible by the sensor through the fluid contained within the syringe 12. The use of fluid dots is described in U.S. Patent No. 5,254,101 to Trombley, III, the disclosure of which is incorporated by reference herein in its entirety. Due to the different properties of different fluids, this dot 339 will have a different appearance based on the fluid contained within the syringe. Accordingly, if the syringe 12 contains air, 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, at step 340, at least one sensor 114 is positioned to capture an image of at least a portion of the syringe 12 containing the fluid dot 339 through the fluid contained within the syringe 12. Thereafter, and with reference to Figure 27 , at step 342, the fluid dot 339 is identified in the image using a pixel contrast threshold. In particular, the fluid dot 339 is identified by detecting the edges of the fluid dot 339 in a manner similar to determining the bottom edge of the meniscus as described herein.

[0190] Next, at step 344, since the shape of the fluid dot 339 is known when various fluids are provided within the syringe, pattern matching techniques can be utilized to determine whether air or fluid is within the syringe 12. Thus, the template of the fluid dot 339 when fluid is present within the syringe can be matched to the image obtained in step 340. If the template matches the image obtained in step 340, then it can be determined that no air is present, and the fluid injector 10 can be primed to continue the injection at step 348. On the other hand, if the template does not match, then an indication that air can be present within the syringe 12 is provided at step 350, and the fluid injector 10 is disabled from the injection process at step 352 until a repeated analysis step indicates that the air has been removed, for example, by purging.

[0191] While described herein as utilizing a fluid dot 339, various other shapes can be utilized and imaged to determine whether air is present within the syringe. This is due to the fact that the cylindrical syringe barrel acts as a lens in effect. If air or fluid is present within the syringe 12, the curvature of the barrel wall can be utilized to capture an image that will appear different to the at least one sensor 114. This phenomenon can be used to detect whether gross air is present within the syringe. Furthermore, the relative size of the image can allow for a determination of the type of fluid within the syringe (e.g., a larger image will be seen through contrast media, while a small image will be seen through saline, for example, due to differences in the 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 is stretched in the horizontal axis. Thus, the elliptical fluid dot 339 is stretched horizontally without affecting the vertical height. The elliptical fluid dot 339 on an empty syringe becomes circular or more circular on a filled syringe to the sensor 114. The sensor can measure the change in the fluid dot 339 on the horizontal width to determine various characteristics of the fluid contained within the syringe. Due to this principle, various different shapes can be used to achieve the above-described effect of the fluid dot 339, for example, by measuring the difference in non-vertical features of the fluid dot 339.

[0192] 3. Use of Brightness Measurements

[0193] According to other aspects, air detection is also possible by imaging a portion of the syringe having electromagnetic radiation from an electrical measurement radiation source passing therethrough and determining an average pixel brightness value (e.g., a halo as described herein) of a region of interest, such as a portion of the distal end 24 of the syringe. Such an arrangement is shown in Figure 28 , for example, Figure 28 A syringe 12 is shown, the syringe 12 filled with contrast media, the contrast media having electromagnetic radiation passing therethrough, the electromagnetic radiation in the form of a laser beam 354 of a particular wavelength. From Figure 28As can be seen, when the syringe is filled with contrast agent, a clear path of the laser beam 354 can be seen as the laser beam 354 passes through the contrast agent. Without being bound by any theory, it is believed that the dissolved contrast agent agent in the solution scatters the electromagnetic radiation in the laser beam 354, providing an observable laser beam path. If the syringe 12 is filled with air, no such laser beam exists (see Figure 27 ). Accordingly, as shown in Figure 28 , the average pixel intensity (e.g., 0-255 intensity units) in the image of the portion of the distal end 24 of the syringe 12 is much higher when filled with fluid than when the syringe is filled with air, as evidenced by the presence of the laser beam 354 due to laser scattering. Thus, by illuminating the laser electromagnetic radiation through a portion of the syringe barrel, obtaining an image of the syringe through which the electromagnetic radiation passes, the intensity can be used to determine the presence of air or contrast agent; determining a region of interest of the syringe, such as proximate to the distal end 24; determining an average pixel intensity value for the region of interest by assigning a 0-255 intensity unit value to each 8-bit pixel within the region of interest, and then averaging the intensity values; and comparing the average intensity value to a known intensity value to determine whether fluid or air is present within the syringe 12. In contrast to the non-scattering of air, the scattering of the laser by contrast agent can be observed by illuminating the laser through any portion of the fluid in the syringe barrel. In the aspects described herein, the laser can be displayed through the distal end of the syringe due to the particular location of the at least one sensor relative to the syringe barrel. Those skilled in the art will recognize that other locations of the at least one sensor can be used to determine the intensity of the laser, depending on the location of the path of the laser.

[0194] B. Fluid Differentiation

[0195] All of the above image processing techniques for differentiating air from fluid within a syringe can also be used to identify the type of fluid contained within the syringe. For example, due to the manner in which different fluids interact with light, the above imaging processing techniques can be used to precisely separate contrast agent from saline from one another, and different types of contrast agent can be precisely distinguished from one another. With particular reference to Figure 29 and 30 , the scattering of the laser can differ depending on the fluid within the syringe. For example, the laser beam path 354 exhibits a weak intensity passing through saline, as compared to the intensity of the laser beam path 354 passing through contrast agent in the syringe.

[0196] 1. Identify Mode with Illumination

[0197] With further reference to Figure 29 and 30According to the fluid verification system 110 of the various aspects herein, the system 110 can determine whether the syringe contains saline or contrast by taking an image of the halo 120 produced by the electromagnetic radiation source 112 in the syringe 12 using the sensor 114 and using image recognition software of the central processing unit 116 to determine whether the syringe contains saline or contrast. While other methods for distinguishing between saline and contrast are described in detail herein, the same techniques can be used to distinguish between 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 containing the halo 120. Thereafter, the distance between the bottom edge 301 of the meniscus at the air / fluid interface within the syringe 12 and the bottom edge 303 of the halo 120 is measured by the system 110. These edges 301, 303 are identified in the image by software provided on the central processing unit 116 according to a pixel contrast threshold, as described herein. Figure 29 is an image of a syringe 12 containing saline obtained by the sensor 114, and Figure 30 is an image of the presence of contrast in the syringe 12 obtained by the sensor 114. From these images, it can be seen that the distance between the edges 301 and 303 when saline is present in the syringe ( Figure 29 ) is greater than the distance between the edges 301 and 303 when contrast is present in the syringe ( Figure 30 ). Figure 30 With respect to the distinction between contrast, depending on the type of contrast present in the syringe, the halo 120 will also be different sizes. This allows for the use of image processing techniques as discussed in more detail herein to distinguish between the type of fluid contained in the syringe - saline as well as various contrast agents.

[0198] As described herein, the distance between the bottom edge 301 of the meniscus at the air / fluid interface and the bottom edge 303 of the halo 120 is determined using image processing software provided on the central processing unit 116. 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 that saline is contained in the syringe 12, and if the distance corresponds to a second predetermined distance for a particular contrast, an indication 358 is automatically displayed on the display 118 that the particular contrast is contained in the syringe 12.

[0199] 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 on the central processing unit 116 can determine the height of the halo 120 from the bottom of the threads of the hub 22 to the bottom edge of the halo 120, and based on that height determine the presence of a fluid and the type of fluid. In addition, by taking training images of syringes that have been known to contain a particular contrast agent therein, the image processing software can also be programmed to recognize particular contrast agents or other fluids using image recognition. The training images record the full dimensions of the halo 120 including the height. The image processing software then compares the full features of images it captures later to the training images for comparison. If the images exceed a threshold of similarity, then the system will provide an indication that the syringe 12 contains a contrast agent other than the one it has been trained for or saline.

[0200] 2. Using details provided on the syringe barrel

[0201] An alternative approach to using image processing techniques to determine the type of fluid contained within the syringe is to obtain an image of certain features provided on the syringe. In particular, and with reference to Figure 27 Figure 31 and Figure 32 , the syringe 12 can contain at least one fluid dot 339 that is visible by the sensor passing through the air or fluid contained within the syringe as described herein. Due to the different properties of air and different fluids, this dot 339 will have a different appearance (particularly along the horizontal axis) based on the air or fluid contained within the syringe, as seen by comparing the fluid dot 339 as seen by passing through a syringe 12 containing air, Figure 27 the fluid dot 339 as seen by passing through a syringe 12 containing saline, Figure 31 and the fluid dot 339 as seen by passing through a syringe 12 containing a contrast agent, Figure 32 Thus, if the syringe 12 contains air within, the fluid dot 339 will have a shorter distance in the horizontal direction when viewed by the sensor, if the syringe 12 contains saline within, the fluid dot 339 will have a certain configuration when viewed in the image, and if the syringe 12 contains a contrast agent within, the fluid dot 339 will have a certain configuration (i.e., a longer distance in the horizontal direction) when viewed in the image. Thus, the type of fluid contained within the syringe can be detected as follows.

[0202] ​First, the positioning sensor 114 is used to capture an image of at least a portion of the fluid point 339 or other landmark feature on the needle cylinder 12 containing the fluid contained within the needle cylinder 12. Thereafter, the fluid point 339 is identified in the image using a pixel contrast threshold as described herein. Next, at step 344, since the shape of the fluid point 339 is known when various fluids are provided within the needle cylinder, a pattern matching technique can be utilized to determine whether air, saline, or contrast is present within the needle cylinder 12. For example, a template of the fluid point 339 when saline is present within the needle cylinder can be matched to the image. If the template matches the image, then it can be determined that saline is present and an indication 356 is provided on the display 116 that saline is present in the needle cylinder 12. On the other hand, if the template does not match, then a template of the fluid point 339 when contrast is present within the needle cylinder can be matched to the image. If the template matches the image, then it can be determined that contrast is present and an indication 358 is provided on the display 118 that contrast is present in the needle cylinder 12. Additionally, if the templates for saline or various contrasts do not match, then a template of the fluid point 339 when air is present within the needle cylinder can be matched to the image. If it is determined that air is present in the needle cylinder, then the injection process can be automatically paused.

[0203] Various other shapes besides the elliptical fluid point 339 can be utilized and imaged to determine the type of fluid contained within the needle cylinder, as described in greater detail herein.

[0204] 3. Using Brightness Measurements

[0205] According to certain aspects, fluid differentiation can also be possible by imaging a portion of the needle cylinder having electromagnetic radiation passing therethrough from an electromagnetic radiation source and determining the average pixel brightness value of the region of interest, such as the portion of the distal end 24 of the needle cylinder. Returning to Figure 27 、 Figure 29 and Figure 30 A clear laser beam path 354 can be seen when the needle cylinder is filled with contrast (see Figure 30 ). If the needle cylinder 12 contains saline (see Figure 20), the laser beam path 354 is much less distinct, and when passing through a syringe filled with air, the laser beam path 354 is essentially indiscernible. According to certain embodiments, a laser that emits light having a wavelength within the green region of the visible spectrum can be used. Accordingly, the average pixel intensity (e.g., 0-255 intensity units) in the 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, by obtaining an image of a syringe that is irradiated with electromagnetic radiation, the type of fluid contained within the syringe can be determined; a region of interest of the syringe, such as near the distal end 24 (although other regions of the syringe can be used) is determined; the average pixel intensity value of the region of interest is determined by assigning a brightness value of 0-255 intensity units to each 8-bit pixel within the region of interest, and then averaging the brightness values; and the average brightness value is compared to known brightness values to determine whether contrast agent, saline, or air is present within the syringe 12. This method can also be used to distinguish between different types of contrast agent (e.g., brand or solute concentration).

[0206] C. Fluid Source Status

[0207] According to other aspects, various information regarding the fluid source status can be obtained by using at least one sensor 114 to obtain images of various portions of the fluid injector 10. For example, an image of a fluid container, such as a saline bag or a contrast bottle, and its contents can be obtained, and image processing techniques can be used to determine the amount of fluid within the bottle. This information can be provided to the central processing unit, and the bottle can be displayed on the display 118 showing the amount of fluid present or remaining within the bottle. In addition, optical character recognition can be used to determine the type of fluid contained within the bottle, and this information can also be displayed on the display 118. Further, in certain aspects, the fluid remaining in the bottle can be constantly monitored before, during, and after an injection procedure, and an updated remaining volume can be displayed on the display 118 in real time. In yet other aspects, if one or more of the volumes of contrast or saline are insufficient to complete an injection procedure, the central processing unit 116 can monitor the remaining volumes and provide a warning. This feature can be combined with a patient schedule of a series of patients to provide real-time feedback of the required volumes of contrast and / or saline, so that the technician can ensure that he has sufficient supplies on hand to complete all scheduled injection procedures, and, for example, when a contrast warmer is used, can ensure that the contents of the current bottle are nearly depleted when the subsequent container(s) of contrast are at the desired injection temperature.

[0208] More specifically, the same methods employed to identify the size of the halo 120 using the pattern recognition techniques described herein can be used to determine the fluid source status. For example, the image processing software looks for geometric components in the image to compare to training images with known objects. In one example, if the image processing software is trained to know what the letters of the alphabet look like, and the threshold for size and angle of recognition is lowered, the image processing software can effectively read the label on the vial and determine the manufacturer, the contrast agent type, the expiration date, etc. Additionally, the fluid level within the vial can be identified using the edge detection techniques described herein, and the image processing software can be programmed to calculate the volume remaining in the vial until it needs to be replaced by the user. This aspect utilizes calculations similar to the volume of air present in the syringe, as described herein. Specifically, a curve can be generated and an equation fit or algorithm can be developed for the size and shape of each vial to determine the volume remaining.

[0209] D. Syringe Type Determination (Size / Presence)

[0210] In certain aspects, the fluid verification system 110 can also be used to determine various properties or parameters of the syringe 12 inserted into the injector prior to a 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 can be used to identify the syringe and manufacturer, determine whether the syringe has been previously used, and determine the expected flow rate, pressure, volume, etc. In one example, reference is made to the syringe 12 and the fluid verification system 110 determines 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. Figure 33 and Figure 34, the size of the syringe can be determined as follows. First, the 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. Since the position of the at least one sensor 114 is known, the position of certain features of the syringe 12 of a first size, such as the nozzle 22 or the halo 120, and the position of certain features of the syringe 12 of a second size, such as the nozzle 22 or the halo 120, in the image of the distal end 24 of the syringe are also known. With this fact, pattern matching techniques can be utilized to determine the size of the syringe 12 used with the fluid injector 10. 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, the central processing unit 116 can determine that the syringe is a 150 mL syringe and provide an indication 367 of the size of the syringe 12 on the 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, the central processing unit 116 can determine that the syringe is a 200 mL syringe and provide an indication 367 of the size of the syringe 12 on the display 118. If none of the stored templates match, an indication can be provided on the display 118 that no syringe is present or that the identity of the syringe cannot be determined. In another aspect, the at least one sensor 114 can be positioned to image at least one identification mark on the syringe 12, such as a bar code containing information about the syringe, such as, for example, the manufacturer, date of manufacture or batch, one or more syringe parameters, a special identity / security code that can be confirmed by the central processing unit to determine whether the syringe is authentic or can be reused, etc., and send the image of the identification mark to the central processing unit 116 for deconvolution.

[0211] E. Tubing presence flag

[0212] Similar to the determination of the syringe type, in other aspects, imaging processing techniques can also be used to determine the presence or absence of the fluid path set 17 connected to the syringe 12. If the operator inadvertently attempts to begin an injection procedure without connecting the fluid path set 17 to the nozzle 22 of the syringe or if the fluid path set has not been primed, the central processing unit 116 can use this information to disable the injector. In one example, with reference to Figure 35 and Figure 36, the positioning sensor 114 to capture an image of the nozzle 22 of the syringe 12. Since the position of the sensor 114 is known, the position of certain features of the syringe 12 in the image of the syringe 12, such as the nozzle 22 and the fluid path set 17 if connected to the nozzle 22, are also known. With this fact, a pattern matching technique can be utilized to determine whether the fluid path set 17 is connected to the syringe 12. For example, a template 373 of a syringe 12 with a fluid path set 17 connected to the syringe 12 can be applied to the image. If the template matches the image, the central processing unit 116 can determine that the fluid path set 17 is connected to the syringe 12 and provide an indication 375 on the display 118 that the fluid path set 17 is present (see Figure 31 ). On the other hand, if the template 373 does not match, the central processing unit 116 can determine that the fluid path set 17 is not present and provide an indication 377 on the display 118 that the fluid path set 17 is not present.

[0213] F. Spike or transfer set presence flag

[0214] Referring to Figure 37 , according to certain aspects, the fluid transfer device 46 is often used to fill the syringe 12 from the fluid container 44. The transfer device 46 typically includes a spike 48 having at least one fluid path and, in certain aspects, an air passageway for piercing the seal of the fluid container 44, a container holder or cup 50 for holding the fluid container 44 on the spike 48, a valve (not shown), such as a check valve, for allowing fluid to enter the syringe 12, and a syringe support member or sleeve 54 for holding the syringe 12 relative to the transfer device 46.

[0215] During the filling process, after the syringe 12 is mounted on 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 can then be inserted onto the fluid container 44 so that the spike 48 pierces the seal of the fluid container 44. The syringe support member 54 of the transfer device 46 can 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 the valve to open a passageway for fluid to flow from the container 44 to the syringe 12. To draw the contents of the fluid container 44 into the syringe 12, the injector plunger (not shown) retracts the plunger 26 of 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 the at least one sensor 114 to ensure accurate filling of the syringe.

[0216] Once filling is complete, it can be desirable to provide an indication to the operator that the fluid transfer device 46 has been removed. This can be done automatically using the fluid verification system 110 described herein. In particular, with reference to Figure 38 and Figure 39 , the at least one sensor 114 is positioned to capture an image of the nozzle 22 of the syringe 12. Since the position of the at least one sensor 114 is known, the position of certain features of the syringe 12 in the image of the syringe 12, such as the nozzle 22 and the fluid transfer device 46 if connected to the nozzle 22, are also known. With this fact, pattern matching techniques can be utilized to determine whether the fluid transfer device 46 is connected to the syringe 12. For example, a template 383 of a syringe 12 with a fluid transfer device 46 connected to the syringe 12 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 provide an indication 385 on the display 118 that the fluid transfer device 46 is present (see Figure 38 ). This information can also be displayed on the touch screen controller 82 of the fluid injector system 600 as shown in Figure 58 . On the other hand, if the template 383 does not match, the central processing unit 116 can determine that the fluid transfer device 46 is not present and provide an indication 387 on the display 118 that the fluid transfer device 46 is not present (see Figure 39 ).

[0217] G. Line Purge Indicator

[0218] With reference to Figure 40 , in certain aspects of the fluid injectors 10 described herein, a purge container 550 can be configured to be connected to an end of a connector 552 of a fluid path set 17 that delivers contrast media or other fluid to a patient during a purge process prior to an injection. When the fluid path set 17 is primed or purged of air prior to an injection process, the purge container 550 can collect a discharge of contrast media from the end of the fluid path set 17 that delivers media to a patient when the syringe 12 and fluid path set 17 are purged and primed, and provide an indication that the purge is acceptable based on the amount of contrast contained therein. In certain aspects, an operator can visually inspect the purge container 550 to determine that an acceptable amount of contrast is contained therein and determine that the purge is acceptable and that the syringe and fluid path are primed with fluid. However, in certain aspects, this process can be automated by capturing an image of the purge container 550 with the at least one sensor 114 and processing the image using image processing techniques discussed herein.

[0219] For example, with reference to Figure 41 , Figure 42A and Figure 42BFluid point 554, similar to fluid point 339 discussed herein, or other markings, may be formed or provided on the surface of the drain container 550. At least one sensor 114 is positioned such that it will image the fluid point 554 through any fluid contained within the drain container 550. Due to the different properties of different fluids (such as refractive index) and / or the selected curvature of the drain container 550, the point 554 will have different appearances based on the syringe and the fluid contained within the drain container 550. Thus, if the drain container 550 contains air, the fluid point 554 will have a first configuration when viewed in the image, for example, according to one aspect shown in Figure 42, and if the drain container 550 contains a fluid such as a contrast agent or saline, the fluid point 554 will have a second configuration, for example, as shown in Figure 42. Figure 42B As shown in the diagram, the configuration of the fluid point 554 can be detected as follows. First, at least one sensor 114 is positioned to capture an image of at least a portion of the drain container 550 containing the fluid point 554, passing through the fluid contained within the drain container 550 after the syringe and tubing kit 17 has been filled or purged of air. Then, since the shape of the fluid point 554 is known when various fluids are supplied within the drain container 550, pattern matching techniques can be used to determine whether air or fluid is present within the drain container 550. Therefore, a template of the fluid point 554 when a fluid such as contrast agent or saline is present in the drain container 550 can be matched with the image of the fluid point 554 obtained by the sensor 114. If the template matches the image, it can be determined that no air is present in the syringe and tubing kit 17, and that the drain container 550 contains sufficient fluid to indicate that the system has been filled, and a signal that the fluid path kit 17 has been properly purged and filled can be sent to the fluid injector 10. The display 118 may also provide an indication that the fluid path kit 17 has been properly emptied and filled and that the syringe is ready for the injection process. According to some aspects, the filling and emptying of the syringe and fluid path kit can be monitored in real time. In this aspect, at least one sensor 114 monitors the fluid point 554 on the empty container 550 as the configuration of the fluid point 554 changes during the injection process, thereby monitoring changes in the volume of the empty container 550 and indicating when sufficient fluid has been filled into the system and no additional air remains in the system. According to one aspect, an algorithm can be used to confirm the completion of the filling operation, which correlates the volume change in the empty container 550 with the fluid flow through the tubing kit 17.

[0220] Alternatively, according to another aspect, refer to Figure 43A and Figure 43BRather than using the fluidic dot 554, one or more reference lines 556 can be formed or provided on the surface of the vented container 550. The reference lines 556 can be printed on the surface of the vented container 550, molded onto the surface of the vented container 550, or formed or provided on the surface of the vented container 550 in any other suitable manner. The at least one sensor 114 is positioned so that it will image the reference lines 556 through any fluid contained within the vented container 550. Once an image of the vented container 550 is obtained, the image processing software provided on the central processing unit 116 uses a pixel contrast threshold as described herein to identify the top edge 558 of the fluid F contained within the vented container 550 along with the reference lines 556. The distance 560 from the top edge 558 of the fluid F contained within the vented container 550 to the reference lines 556 is determined using the 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 venting procedures to determine whether the venting is acceptable and whether the system is primed. Again, as the syringe and fluid path set 17 are primed, the venting / priming operation and the change in volume in the vented container 550 can be monitored in real time to ensure accurate priming of the system.

[0221] In yet another alternative, reference is made to Figure 44A and Figure 44BWith the shape shown, a marker line 562 can be formed or provided on the surface of the purging container 550. The marker line 562 can be printed on the surface of the purging container 550, molded onto the surface of the purging container 550, or formed or provided on the surface of the purging container 550 in any other suitable manner. The positioning sensor 114 is positioned such that it will image the marker line 562 through any fluid contained within the purging container 550. Due to the properties of different fluids and / or the selected curvature of the purging container 550, the marker line 562 appears a different length in the image when fluid is present than when air is present. As well, the marker line 562 can have a brighter appearance when viewed in air than when viewed in fluid. Thus, image processing software on the central processing unit 116 can perform pattern matching techniques and / or brightness level measurements on the image of the marker line 562 to determine whether fluid or air is present within the purging container 550. Based on this determination, the central processing unit 116 can determine the acceptability of the purging and provide an indication to the operator via the display 118. Again, as the syringe and fluid path 17 are filled, the purging / filling operation and the change in volume in the purging container 550 based on the change in the marker line 562 can be monitored in real time to ensure accurate filling of the system. Those skilled in the art will recognize that other configurations of the marker line 562 are possible, and the image recognition software and algorithms described herein can monitor the change in the configuration of the marker line 562 during the purging / filling operation and indicate to the technician that the system has been properly filled and is ready for use in an injection procedure. Such other configurations are within the scope of the present disclosure.

[0222] Referring to Figure 45An alternative configuration of the drain container 550 is shown. The drain container 550 is also configured to connect to the end of a connector 552 of a fluid pathway kit 17 during the draining process, the fluid pathway kit 17 being designed to deliver contrast agent media or other fluids to the patient during subsequent diagnostic injection procedures. The drain container 550 comprises a cylindrical body 563 having a proximal end 564 and a tapered distal end 565, the tapered distal end 565 being similar to the tapered distal end 24 of the syringe 12 described herein. An electromagnetic irradiation source 566, such as an LED, is positioned below the proximal end 564 of the cylindrical body 563. Thus, when the drain container 550 is filled with an appropriate amount of fluid, a halo 567 is generated in a manner similar to the halo 120 formed within the syringe 12 as described herein. This allows the operator to quickly and easily determine whether an acceptable amount of contrast agent is contained therein, and if a halo 567 is present, to determine that draining is acceptable and that the syringe and fluid pathway kit 17 have been properly filled. Furthermore, the process can be automated and, in some respects, monitored in real time by capturing one or more images of the halo 567 generated within the clearing container 550 using at least one sensor 114 and processing the images using the image processing techniques discussed herein.

[0223] refer to Figure 46 According to one aspect, the fluid path kit 17 can be modified to allow image recognition of the piping image obtained by at least one sensor 114 to determine whether the fluid path kit 17 has been adequately drained. For example, as Figure 46 As shown, the conduit of the fluid path kit 17 may include an optical fiber cable 610 positioned adjacent to it. The optical fiber cable 610 may also be co-extruded with the conduit of the fluid path kit 17, such that the optical fiber cable 610 is embedded within the conduit, or it may be placed inside the conduit of the fluid path kit 17. In another example, a reflective surface may be provided on the inside or outside of the conduit of the fluid path kit 17 to transmit light via internal reflection throughout the length of the conduit, or alternatively, the fluid path material may be selected to have a refractive index suitable for internal reflection as described herein. When fluid is present, this will allow light to be reflected throughout the length of the conduit of the fluid path kit 17 (similar to how a light guide works), resulting in a visible indication that the conduit of the fluid path kit 17 is drained and filled with fluid. This visual indication may be an illumination element at the end of the conduit kit, which may be identified by sensor 114 or simply by an operator. If air is present in the fluid path kit 17 (e.g., when the pipe is not fully filled), internal reflection of light will not occur, and the “light guide” effect will not be observed.

[0224] Additionally, the tubing of the fluid path set 17 can be configured to have a connector (not shown) on its end that attaches to the syringe 10 or is positioned at a location where the electromagnetic radiation source fires through a segment of the connector. Then, according to this embodiment, the entire connector will only light up if it is filled with fluid, indicating that the air of the tubing of the fluid path set 17 is completely purged and primed and ready for use. The electromagnetic radiation source can be wireless, battery powered, or connected to a power source on the syringe. This means that it can have direct or indirect contact with the tubing of the fluid path set 17 and can be disposable or reusable depending on the particular aspect.

[0225] In yet another example, the image processing software provided on the central processing unit 116 can be used to determine the volume of fluid needed to purge the fluid path set 17. More specifically, the system can use any of the methods described herein to determine how much air is present in the barrel 12. The image processing software on the central processing unit 116 can then use pattern matching techniques as described herein to determine the type of fluid path set 17 connected to the barrel. Using this information, the central processing unit 116 can calculate the volume of fluid needed to purge / prime the fluid path set 17. Using this information, the central processing unit 116 can instruct the syringe 10 to operate the barrel to move the plunger a distance corresponding to the calculated volume of air in the barrel and fluid path set 17. The plunger can move an additional distance to dislodge further volume to ensure complete priming of the system.

[0226] In another configuration of the purge container 550, one or more sensors can be associated therewith. More particularly, a component (not shown) can be provided in the purge container 550 that moves when fluid enters (meaning the purge tubing). The moving component can be detected by the sensor 114 or the moving component is a visual indicia to the operator and the volume of fluid entering the purge container 550 can be determined to confirm when priming of the barrel and fluid path set 17 is complete.

[0227] For example, in one aspect, the component can be an air filter (such as a Porex brand filter) that allows air to pass through as priming occurs and then comes into contact with the fluid, builds pressure, breaks the friction with the surface and is driven forward to a position that can be detected by the sensor 114 or the operator. The component can also be a floating ball that rises and falls in relation to the presence of fluid and the density of the present fluid, as discussed in more detail herein with respect to positioning such a ball in the barrel.

[0228] H. Capacitance measurement based on inflation and stretching of at least a portion of the barrel

[0229] Volume is defined, for example, as a change in volume of a fluid path element, elements, or the entire system as a result of a change in pressure on the system when the internal pressure of the system is increased by operation of the plunger to pressurize the system during an injection process. The total system expansion volume, capacity, or volume of compliance represents the total amount or volume of suppressed fluid (i.e., backflow volume) trapped in the expansion of the injector system components due to the applied pressure. The total system volume of compliance and volume of compliance are inherent to each fluid injection system and depend on a number of factors, including the injector configuration, the mechanical properties of the materials used to construct the syringe, the plunger, the pressure jacket surrounding the syringe, the pressure jacket and the constraining movement or deflection, the fluid density, compressibility, and / or viscosity, the change in flow rate at constant pressure, the fluid lines delivering contrast and saline to the flow mixing device, the starting pressure, the ending pressure, etc. For example, in a dual syringe injector, the amount of backflow or reverse flow increases when the relative velocity difference between the two plungers of the injection system is large and the pressure required is high, which can occur when the fluid flow is simultaneously through a small restriction, the velocity of the total fluid injection is large, and / or the viscosity of the fluid is high. Backflow or reverse flow can prevent the simultaneous delivery of fluids of different ratios in certain injections, which can be disadvantageous for all dual syringe type injector systems, such as fluid injector 10.

[0230] Volume of compliance measurements can be used to dynamically correct for changing delivery flow rates and volumes to enhance clinical imaging practices. More specifically, in medical procedures, such as intravenous infusion of contrast media for contrast-enhanced radiographic imaging, it is often desirable to introduce a "sharp bolus" of fluid in which the drug and / or diagnostic fluid is introduced under increasing pressure to be delivered quickly into a specific location in the body. In the case of contrast-enhanced radiographic imaging, at a predetermined time, sufficient contrast must be present in the specific location or region of interest in the body to take diagnostic quality images during the procedure. Thus, the accuracy of the amount or volume of contrast media delivered to the patient and the time at which that volume of contrast media reaches the specific point in the patient's body is important. The "sharp bolus" of contrast media in practice can be defined as a clear or defined column of liquid having well-defined relative ends or boundaries. Thus, the accuracy of the amount of fluid delivered intravenously to a patient is often important in medical treatment and diagnostic procedures, and such accuracy can be reduced by the volume of compliance expansion of the fluid delivery path components when the fluid delivery system is under pressure. Further details of volume of compliance measurements and volume of compliance corrections are described in U.S. Patent No. 8,403,909 to Spohn et al., which is hereby incorporated by reference in its entirety.

[0231] Referring Figure 47 As the fluid portion of the syringe 12 is delivered, the syringe 12 will expand and stretch due to the increase in internal pressure during the injection process. According to aspects of the present disclosure, the volume of the bolus can then be determined as follows. This expansion and stretching can be detected in real-time by the at least one sensor 114 and the extent thereof 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. 5. The central processing unit 116 can then integrate the different outer diameter measurements along the length of the barrel 18 above the bottom seal of the plunger 26 to dynamically determine the precise volume within the syringe 12. Thereafter, the expected volume if the syringe 12 did not have the bolus is subtracted from the determined dynamic volume and this results in the remaining volume corresponding to the bolus volume. Once the bolus 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 to ensure delivery of the sharp bolus. Figure 47

[0232] Referring Figure 48 FIG. 5 shows a volume versus time plot of an injection process by the fluid injector 10, where line 501 represents the volume of fluid that the fluid injector 10 has been programmed to believe has been delivered without any correction for the bolus; line 503 represents the volume of fluid that has actually been delivered to the patient; and line 505 represents the difference between the volume of fluid believed to have been delivered due to the system bolus and the volume of fluid that has actually been delivered. The scanner (not shown) used to capture images for diagnostic purposes is activated and directed to begin capturing images at the precise time interval that the desired drug is expected to pass through the particular portion of the body that is expected to be imaged. This time is based on the amount of fluid that the fluid injector 10 believes to have been introduced over a certain time period (i.e., line 501 in FIG. 5). Since the actual amount of fluid is delivered later than expected, the scanner can capture images in some instances when the fluid (i.e., contrast) has not been fully introduced to the portion of the body being imaged. This is due to the bolus or expansion of the syringe and tubing set with pressure as described herein. To correct for this, most operators introduce an estimated delay to try to compensate for the bolus. However, by determining the flow rate and the bolus based on the expansion and stretch segments as described herein, the controller of the fluid injector 10 can automatically make this delay for the operator and capture the best quality images for diagnostic purposes. Figure 48

[0233] I. Determination of the Remaining Volume

[0234] ​​In one example, the fluid verification system 110 can be arranged such that the at least one sensor 114 can capture images of the syringe 12 containing the syringe barrel 18 and plunger 26 such that the position of the plunger 26 in each image can be determined. Based on these images, the volume of contrast or saline remaining within the syringe 12 can be determined. In particular, with reference to Figure 49 At step 570, an image of the syringe 12 is obtained by the sensor 114. Then, at step 572, the image processing software identifies the plunger 26 in the image by using image recognition based on training images as discussed herein. Next, at step 574, the image processing software determines the position of the plunger 26 within 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 within the barrel 18 of the syringe 12 is determined, this position can be compared at step 576 to a known position corresponding to the volume of fluid remaining within the syringe 12. Then at step 578, the central processing unit 116 sends a signal to display the volume remaining to the display 118. The volume remaining can be displayed as a numerical value, or a graphical representation of the syringe 12 can be displayed that illustrates the real-time volume remaining within the syringe. The images are taken continuously and the display of the volume remaining is updated continuously until the injection process is determined to be complete at step 580. Correction of the volume of the syringe remaining by measuring the syringe expansion due to tonicity during the injection can also be integrated into the protocol. Thus, the at least one sensor can measure the change in the outer diameter of the syringe, for example, by comparing the image to a reference template, and calculate the volume resulting from tonicity. This tonicity volume can be monitored in real-time and sent to the central processing unit where an algorithmic analysis can allow for compensation for tonicity to adjust fluid delivery and provide delivery of a bolus.

[0235] In an alternative embodiment, if utilizing Figure 5A and Figure 5Bplunger 26 can be formed of or coated with a reflective material having a plurality of different colored stripes 38. The reflective material forming the stripes 38 reflects light directed toward the plunger 26 in a distal direction through the syringe barrel 18 to produce a halo. As the plunger 26 moves through the barrel, light is reflected from different stripes 38 depending on the position of the plunger or plunger cover 26 within the syringe barrel 18. Because each of the stripes 38 of the plunger 26 is a different color, the color and / or appearance of the halo changes depending on which stripe 38 the light is reflected off of as the plunger 26 is advanced or retracted through the syringe barrel 18 during an injection or filling process. At least one sensor 114 can be positioned to capture images of the halo as the plunger is advanced or retracted through the syringe barrel 18. Image processing software provided on the central processing unit 116 detects changes in the color of the halo. The central processing unit is configured to then determine the position of the plunger 26 within the syringe barrel 18 based on the color of the halo. Once the position of the plunger 26 is determined by the central processing unit 116, the volume of fluid remaining within the syringe is determined. The central processing unit 116 then sends a signal to display the volume of fluid remaining on the display 116. The volume of fluid remaining can be displayed as a numerical value, or a graphical representation of the syringe 12 can be displayed that illustrates the volume remaining within the syringe. In an alternative embodiment, different colored LED lights can be positioned in the piston to transmit light through a translucent or transparent plunger material in similar concentric circles on the plunger.

[0236] J. Pressure feedback based on syringe expansion and stretching

[0237] In another example, image processing techniques can be utilized to determine the pressure of the fluid within the syringe 12 being delivered to a patient during a fluid injection process due to the expansion and stretching of portions of the syringe 12, such as portions of the distal end 24, during the injection process. The degree of this expansion and stretching is known to correspond to the pressure of the fluid exerted within the syringe at any given time.

[0238] Reference Figure 50 and Figure 51 According to one embodiment, to enhance this expansion and stretching, an alternative example of a syringe 12 having a flexible section 590 positioned at the distal end 24 of the syringe 12 can be utilized. Figure 50 and Figure 51 Many of the components of the syringe 12 shown in Figure 2 are substantially similar to the components of the syringe 12 described herein with reference to Figure 50 and Figure 51 The reference numerals in Figure 2 are used to illustrate components that are the same as the corresponding reference numerals in Figure 2The previous discussion of the syringe 12 generally shown in Figure 50 and 51 shown in

[0239] In one aspect, the flexible segment 590 can be configured to expand during an injection process when the internal pressure of the syringe 12 increases. The flexible segment 590 can be insert molded from a material that is more flexible than the syringe barrel 18. The material that forms the flexible segment 590 can be any suitable flexible material such as, but not limited to, TPU, TPE, polypropylene, polyethylene, and thermoplastic elastomers. In addition, the flexible material 590 can be a transparent or translucent material such that it can be illuminated with the electromagnetic radiation source 112 and show the halo feature as described herein.

[0240] While the flexible segment 590 is illustrated in Figure 50 and 51 as being positioned at the distal end 24 of the syringe 12, this is not to be construed as limiting the disclosure as the flexible segment 590 can be applied to many areas of the syringe 12. Factors to consider for better pressure resolution include minimizing fluid capacity at maximum expansion.

[0241] Referring to Figure 52 and Figure 53 and with continued reference to Figure 50 and Figure 51 the fluid verification system 110 including at least one sensor 114, a central processing unit 116, and a display 118 according to this aspect can be positioned such that the sensor 114 is able to capture images of the flexible segment 590 during an injection process. Once an image of the flexible segment 590 is obtained, the image processing software of the central processing unit 116 measures the increased diameter of the flexible segment 590 and correlates the increased diameter to the syringe internal pressure. For example, Figure 52 illustrates the flexible segment 590 with a small increase in diameter corresponding to a small syringe internal pressure, while Figure 53 illustrates the flexible segment 590 with a large increase in diameter corresponding to a large syringe internal pressure. The central processing unit 116 can be configured to display this syringe internal pressure on the display 118 and control the fluid injector 10 to allow active pressure control within the syringe during an injection process.

[0242] Thus, the flexible segment 590 provides a "live" or real-time readout of the pressure within the barrel 18 of the syringe 12 during an injection process. Referring to Figure 54 , the negative pressure created during a fill process causes the flexible segment 590 to move inward. The change in size of the flexible segment 590 can be measured using the sensor 114 and image processing software provided on the central processing unit 116 and the subsequent vacuum level can then be determined.

[0243] This negative pressure can be important for the rolling diaphragm syringe 135 described herein, as having a high vacuum level can crush or deform the walls of the syringe 135 during filling of such a syringe 135. Accordingly, with reference to Figure 55 , one embodiment of the rolling diaphragm syringe 135 can be adapted to include a flexible segment or diaphragm 591 provided on the connector 592 attached to the distal end 137 of the rolling diaphragm syringe 135 or in the cap 390 (not shown). The outer diameter of the flexible segment 591 can 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 the measurement of the diameter of the flexible segment 590. As the vacuum level within the rolling diaphragm syringe increases during the filling process, the outer diameter of the flexible segment 591 decreases. Thus, the size of the outer diameter of the flexible segment 591 can be used to determine the vacuum level within the rolling diaphragm syringe 135. Thereafter, the vacuum level can be maintained below a specified threshold by adjusting the rate of withdrawal of the plunger 138 to prevent crushing of the rolling diaphragm syringe 135.

[0244] With reference to Figure 56A and 56B , according to aspects, the determination of the pressure within the syringe 12 can also be obtained by positioning the electromagnetic irradiance source 212 such that its reflection passes through at least a portion of the sidewall of the syringe barrel 18. The light that is illuminated through the sidewall of the syringe barrel 18 is visualized at the bottom of the light halo 120, as shown by lines 121a and 121b. For example, if there is no light illuminating the sidewall of the syringe barrel 18, that area will appear as a dark line (121b). Placing the electromagnetic irradiance source 212 underneath the syringe 12 facing upward toward the sidewall of the syringe barrel 18 such that the line at the bottom of the light halo 120 appears illuminated (see element 121a in Figure 56A , because the light travels up the inside of the sidewall of the syringe barrel 18 and is portrayed in the light halo 120.

[0245] When the syringe 12 is subjected to pressure, for example, during an injection process, the syringe 12 expands, pushing the walls of the syringe 12 outward, as shown in Figure 56B . This removes the straight-line path of the light from the electromagnetic irradiance source 212 to the bottom of the light halo 120. As the syringe 12 expands (i.e., the pressure increases), the line fades from light to dark (see Figure 56BThe electromagnetic radiation source 212 can also be placed such that the light will be completely extinguished when the pressure limit of the syringe is reached (i.e., the syringe is inflated enough to block the light). Alternatively, the intensity can be determined as a function of pressure (i.e., inflation) and used to determine the pressure. For example, image recognition software can be used to monitor changes in the intensity of the line to provide real-time feedback on the syringe capacity.

[0246] K. Flow Rate Feedback

[0247] Feedback on the flow rate of the fluid being delivered by the fluid injector can also be provided to the operator using many of the concepts described herein. More specifically, the axial position of the plunger 26 within the syringe barrel 18 can be monitored during the injection process by the sensor 114 and image processing software. A curve can then be created showing the position of the plunger versus time during the injection process. An equation fitting the curve can then be derived. This equation is then provided to a logic algorithm where data from the curve is implemented to calculate the flow rate of the fluid being delivered by the injector. This flow rate can be displayed to the operator on the display 118.

[0248] L. Syringe Fill Feedback

[0249] When filling the syringe 12 with contrast or saline, it has been observed that the halo or illumination recognition pattern 120 described in detail herein only exists if the syringe is filled at an appropriate rate. For example, using a syringe such as the syringe 12, an appropriate fill rate is approximately 4 mL / sec because this is the fastest fill rate that can be achieved for the thickest fluid before a vacuum head is drawn into the syringe. However, the fastest specified fill rate will depend on the particular limitations of the fluid injection system in question. Depending on the fluid injection system being used, the piston should be pulled back so that the syringe is filled as quickly as possible. This is accomplished using the concepts described herein by dynamically checking the halo 120 during the fill process using the sensor 114 and image processing software provided on the central processing unit 116. As long as the halo 120 is determined to be fully present, then the vacuum has not reached the threshold to create a vacuum head (i.e., air) in the syringe. As described herein, the halo 120 is recognized using the sensor 114 and image processing software provided on the central processing unit 116 and the position of the top edge of the halo 120 relative to the bottom edge of the halo 120 is detected. If the top edge of the halo 120 begins to move down, an indication can be provided to the operator that air is being drawn into the syringe 12. In addition, the fluid injector 10 can be controlled to adjust the rate at which the piston 124 pulls the plunger 26 back to reestablish the appropriate size of the halo 120. This allows the fluid injector 10 to achieve the fastest fill rate possible regardless of the size of the syringe, the type of fluid, or the fill rate.

[0250] In other words, if the syringe is filled too quickly, causing air to be introduced into the syringe, the halo 120 will not be present. Accordingly, the sensor 114 can be positioned to capture an image of the halo 120 during the filling process. Image processing software of the central processing unit 116 processes the image 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.

[0251] Other features of the syringe that can be identified using image processing

[0252] Several other features of the syringe 12 can be imaged using the fluid validation system 110, and information obtained thereby can be provided to the fluid injector 10. For example, an operator or technician must typically validate the syringe prior to performing an injection. Validation can include confirming that the syringe is acceptable for use with the injector, as well as determining various characteristics of the syringe and fluid contained therein. For example, the operator must verify that the identification information, such as the syringe size (e.g., diameter, length, and liquid volume) and the fluid contents, are correct for the process being performed. In addition, the operator can be required to provide certain information about the syringe, such as the manufacturing date, origin, friction characteristics between the plunger and the syringe barrel, fluid viscosity, etc. (generally referred to herein as "syringe injection parameters") to the fluid injector or the injector operating system to control the piston force and acceleration to deliver the fluid at the desired flow rate. The identification information can be contained on or associated with a machine-readable identification tag, such as a bar code. Accordingly, an image of such a bar code can be obtained by the sensor 114. Image processing software provided on the central processing unit 116 can then be configured to read the identification information from the bar code and provide that information to the fluid injector 10. In certain examples, the bar code can be backlit by the electromagnetic radiation source 112, thereby making it more clearly visible to the sensor 114.

[0253] Furthermore, the cylindrical syringe barrel 18 is effectively a lens itself. With the curvature of the barrel wall, the captured and recognized image looks different to the image processing software provided on the central processing unit 116 if there is air in the syringe 12 or if there is fluid in the syringe 12. If there is air in the syringe 12, the image of the barcode received by the sensor 114 looks a first size and / or orientation. If there is fluid in the syringe 114, the image of the barcode looks a second size and is inverted. Thus, in one example, the barcode can be encoded with information such that when the information is read by the sensor 114 when there is air in the syringe 12, the code tells the system that the syringe 12 is present, the size of the syringe 12, and that there is air in the syringe 12. When there is fluid within the syringe 12, the barcode image is inverted, and the image processing software provided on the central processing unit 116 recognizes the new code, which provides a signal to the system that there is fluid within the syringe 12. Furthermore, the relative size of the barcode provides an indication of the type of fluid within the syringe 12 (i.e., saline, contrast, or type of contrast).

[0254] In another example, referring to Figure 57 , a temperature strip 58 can be added to the syringe 12 to provide an indication to the operator of the temperature of the contents of the syringe 12. This temperature strip 58 can be imaged by the sensor 114 and automatically read by the image processing software. In particular, 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 as the temperature changes, or have some other method of indicating temperature. The image processing software is configured to detect this change in color and determine the temperature based on the change in color. Thereafter, the temperature information can be provided to the fluid injector. In certain examples, both the temperature strip and the barcode can be provided on the label applied to the syringe 12.

[0255] N. Exemplary fluid injection system utilizing image recognition technology

[0256] Referring to Figures 58-60Exemplary fluid injection system 600 includes fluid injector 10, which can have a housing formed of a suitable structural material, such as plastic, composite, and / or metal. The housing 14 can have various shapes and sizes depending on the desired application. For example, fluid injection system 600 can be a freestanding structure having a support portion 70 connected to a base 72 having one or more casters or wheels so that fluid injector 10 is movable over the ground. Fluid injector 10 can include at least one syringe port 16 to releasably connect at least one syringe 12 to a corresponding piston rod 124. In various examples, the at least one syringe includes at least one syringe retention member configured to retain the syringe within the syringe port 16 of the fluid injector 10. In non-limiting examples, the at least one syringe retention member is configured to operably engage a locking mechanism provided on or in the syringe port 16 of the fluid injector 10 to facilitate self-orienting loading of the syringe into and / or removal of the syringe from the injector 10. The syringe retention member and the locking mechanism together define a connection interface for connecting the syringe to the fluid injector 10. Examples of various connection interfaces are described in U.S. Patent No. 9,173,995, the disclosure of which is incorporated by reference herein in its entirety.

[0257] In certain non-limiting examples, it is desirable to temporarily rotate and / or invert the injector housing 14 that includes the syringe port between a substantially vertical position (i.e., the syringe port(s) point upwardly) that can facilitate, for example, loading of a syringe into the syringe port or filling the syringe with a medical fluid, and an inverted position that can facilitate, for example, removing air bubbles in a medical fluid contained within the syringe or conducting an injection procedure. Accordingly, in non-limiting examples of the present disclosure, the housing 14 can be rotatably connected to the support portion 70 so that the housing 14 is rotatable relative to the support portion 70 and the retractable pole 74.

[0258] Fluid injection system 600 can also include a lower support member 76 that can extend or retract in a vertical direction to adjust the height of the fluid injector 10. An operator can push down on handle 78 to release a locked connection between the lower support member 76 and a fluid warmer 80 provided on the lower support member 76. When the handle 78 is depressed, the operator can raise or lower the fluid warmer 80 to adjust the height of the fluid injector 10.

[0259] In non-limiting examples, the at least one fluid path set 17 can be fluidically coupled with the distal end of the at least one syringe to deliver medical fluid from the at least one syringe to a catheter, needle, or other fluid delivery connection (not shown) inserted into a patient at a vascular access site. Fluid flow from the at least one syringe can be regulated by a fluid control module operated by the controller, such as a detachable touchscreen controller 82 or any suitable device. The fluid control module can operate various pistons, valves, and / or flow regulating devices based on one or more user-selected injection parameters, such as injection flow rate, duration, total injection volume, and / or ratio of contrast media and saline, to regulate delivery of medical fluid, such as saline solution and contrast media, to a patient.

[0260] The controller 82 can include one or more processors, memory, network interfaces, etc., and can be configured to control a display including a graphical user interface ("GUI"), which can allow a user to view and / or interact with various injection parameters through graphical icons and visual indicia produced on the display. The controller 82 can include a central processing unit 116 having image processing software provided thereon or on a separate unit. In non-limiting examples, the controller 82 can be formed as a detachable touchscreen controller. The controller 82 can also be non-removably attached to the fluid injector 10. The controller 82 can be used to monitor one or more injection parameters, including, for example, patient-specific information (age, weight, gender, organ to be imaged, dosage of imaging agent, etc.), which can be input by a user or called / downloaded from a database, network, memory, or another controller in communication with the system through a wired or wireless communication process. The controller 82 can also be configured to control various injection parameters, which can be input by a user and / or calculated based on data downloaded from a database and / or data input by a user through one or more algorithmic calculations by the controller 82, fluid control devices, and / or another controller or processor in communication with the fluid control devices and / or the controller 82.

[0261] With specific reference to Figure 59 and Figure 60 , the example fluid injection system 600 utilizes the illumination recognition patterns and image processing techniques discussed herein. As described above, the system 600 includes a fluid injector 10 with a needle 12 and a syringe 14, which can be used to inject a patient with a medical fluid, such as saline solution and / or contrast media. The system 600 also includes a controller 82, which can be used to control the fluid injection system 600, including the fluid injector 10, and can include a central processing unit 116 having image processing software provided thereon or on a separate unit. In non-limiting examples, the controller 82 can be formed as a detachable touchscreen controller. The controller 82 can also be non-removably attached to the fluid injector 10. The controller 82 can be used to monitor one or more injection parameters, including, for example, patient-specific information (age, weight, gender, organ to be imaged, dosage of imaging agent, etc.), which can be input by a user or called / downloaded from a database, network, memory, or another controller in communication with the system through a wired or wireless communication process. The controller 82 can also be configured to control various injection parameters, which can be input by a user and / or calculated based on data downloaded from a database and / or data input by a user through one or more algorithmic calculations by the controller 82, fluid control devices, and / or another controller or processor in communication with the fluid control devices and / or the controller 82. Figure 1The described fluid injector is similar to fluid injector 10. Fluid injector 10 is configured to engage pairs of syringes 12. Syringes 12 are mounted to syringe ports 16 of fluid injector 10. A number of electromagnetic radiation sources 112, such as LEDs, are mounted to or embedded in the distal end of plunger rod 124 of injector 10. The LEDs are configured to illuminate in a first color when a first fluid is detected within syringe 12 and to illuminate in a second color when a second fluid is detected within syringe 12. When actuated, plunger rod 124 is advanced toward and received within a cavity (not shown) defined by plunger 26. The LEDs emit light in an axial direction through plunger cover 26 to create a halo 120 adjacent to distal end 24 of syringe barrel 18 in the manner described above. Sensor 114 can be removably provided on support portion 602 of fluid injection system 600 so that sensor 114 is positioned behind syringe 12 when syringe 12 is filled with fluid from a multi-dose fluid bottle or bag. As described herein, fluid injection system 600 can be configured to use image processing techniques to identify the type of fluid being directed into syringe 12 or the level of fluid in each syringe 12. Based on the information identified by the imaging processing techniques, injector 10 can adjust its operating parameters to achieve the desired fill and injection parameters.

[0262] As discussed herein, electromagnetic radiation sources 112 can be light bulbs, LED bulbs, visible light emitters, infrared emitters, or lasers positioned to project a beam of electromagnetic radiation through the interior of syringe 12. The electromagnetic radiation sources generally emit electromagnetic radiation in an axial direction through syringe 12. For example, the beam of electromagnetic radiation can pass through a translucent or transparent plunger or plunger cover 26 and toward distal end 24 of barrel 12.

[0263] As discussed in greater detail herein, electromagnetic radiation sources 112 can be configured to increase the salience of halo 120 or tailor the halo for a particular sensor or electromagnetic radiation detector. In one example, electromagnetic radiation sources 112 include a laser with a wavelength of about 532 nm (e.g., a green laser). The green laser electromagnetic radiation source can be used with a plunger that is neutral or transparent in color and still produce a salient colored halo. In other examples, electromagnetic radiation sources 112 can emit electromagnetic radiation outside of the visible spectrum, provided that the system includes a sensor or camera capable of detecting the radiation (e.g., halo) within the emitted wavelength. In one such aspect, an infrared sensor can be provided to detect the radiation on syringe 12. In yet other examples, the electromagnetic radiation sources can be configured to emit polarized light or filtered light of certain wavelengths that can be more easily distinguished from ambient light. In other examples, the electromagnetic radiation sources can be configured to emit pulses of light according to a predetermined and identifiable sequence that can be identified by a system operator or automatically detected by a sensor.

[0264] Light or electromagnetic radiation passing through the plunger or plunger cap 26 essentially irradiates through the syringe 12 to form a halo 120. When the syringe 12 is empty or only partially filled, the electromagnetic radiation beam passes through the syringe 12, but close to... Figure 8 The distal end 24 shown does not form a distinct illumination portion or halo 120. In contrast, when the syringe 12 is fully 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. The system operator or an automated image reading device or optical device (such as sensor 114) can identify whether the halo (if present) is of the correct shape and size. If the halo is too small, insufficiently bright, or completely absent, the system operator can add additional fluid to the syringe 12 to complete the filling. If a halo with the correct size, shape, and brightness is identified, verification is complete and the fluid contents of the syringe 12 are ready for administration to the patient.

[0265] In some examples, system 600 can also determine whether two syringes 12 are present simultaneously on the fluid injector 10 by using image recognition. Furthermore, system 600 detects whether the syringe 12 is filled with fluid or air. System 600 also uses images obtained from sensor 114 to visualize features on the syringe barrel 18, visualize the height difference of the halo 120, or visualize laser light passing through the fluid to detect which of the two syringes 12 contains contrast agent and which contains saline, as described in more detail herein. Once determined, system 600 can send a signal to an electromagnetic irradiation source 112 on a piston rod 124 positioned below a translucent plunger on the syringe head. This signal can alarm the electromagnetic irradiation source to illuminate an LED in a first color (such as green) below the syringe 12 determined to contain contrast agent and in a second color (such as blue) below the syringe 12 determined to contain saline. This light will illuminate the halo 120, which will also have a color corresponding to the LED color for visualization by the operator.

[0266] The system can also signal to the operator via visual, audible, or any other method of sensory cueing to alert the operator to the type of fluid. For example, once the syringe 12 has been determined by image recognition technology to contain contrast, a visual cue (LED, laser, graphic, text) and / or an audible cue (alarm, chime, whistle, other sound) alerts the operator to the fact that the particular syringe 12 contains contrast. For example, a green colored overlay feature can be used on one side of the injector 10 designated for contrast. A green LED can be used to illuminate a halo 120 on the syringe 12 that has been determined to have contrast, regardless of which side the syringe 12 is located. This would be accomplished with a circuit having two LED colors (green and blue) where the green would be illuminated if contrast is determined to be present and the blue would be illuminated if normal saline is determined to be present. It is also possible to send a message to the operator in the control room alerting them to which syringe is on which side and whether it conflicts with the protocol prescribed by the attending physician.

[0267] With specific reference Figure 59 , the system 600 has determined that, as shown, the contrast syringe 12a is mounted on the right and the normal saline syringe 12b is mounted on the left. On the display 118, "C" is displayed at the right and "S" is displayed at the left to indicate that the image processing software of the central processing unit 116 has identified the contents of the syringe on the left as normal saline and the contents of the syringe on the right as contrast. With reference to Figure 61 , as shown, the contrast syringe 12a has been moved to the left position and the normal saline syringe 12b has been moved to the left position. On the display 118, "C" is now displayed at the left and "S" is now displayed at the right to indicate that the image processing software of the central processing unit 116 has identified the contents of the syringe on the left as contrast and the contents of the syringe on the right as normal saline. With reference to Figure 62 , the fluid injector 10 is shown without the syringes 12a, 12b present. On the display 118, "A" is now displayed at both the left and the right to indicate that the image processing software of the central processing unit 116 has identified that air is present at both locations. With reference to Figure 63 , empty syringes 12 have been mounted in the left position and another empty syringe 12 has been mounted in the right position, as shown. On the display 118, "A" is now displayed at both the left and the right to indicate that the image processing software of the central processing unit 116 has identified that air is present in both syringes.

[0268] O. Use of syringes with floating elements

[0269] With reference to Figure 64FIG. 12 shows another alternative example of a syringe 12 that can be used with the fluid injector 10 and the fluid verification system 110 to determine the type of fluid within the syringe 12. This syringe 12 is similar to the syringe 12 of FIG. 11, except that it contains a plurality of objects, such as floating balls 650a, 650b, and 650c, positioned between the distal end 24 of the syringe 12 and the plunger. Figure 2

[0270] The floating balls 650a, 650b, and 650c operate on the principle of buoyancy for contrast and saline differentiation. Buoyancy is the upward force on an object that is opposite to its downward weight. 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, and 650c is greater than the density of the fluid by a sufficient margin, the weight overcomes the buoyancy and the balls 650a, 650b, and 650c sink to the bottom. If the density of the balls 650a, 650b, and 650c is less than the density of the fluid by a sufficient margin, the balls 650a, 650b, and 650c float.

[0271] Saline and contrast have different densities. For example, saline can have a density of around 1 g / mL, while a denser contrast can have a density of around 17 g / mL. In one example, the ball 650b has a density of 0.5 g / mL, while the ball 650c has a density of 5 g / mL. Referring to FIG. 12, when the syringe 12 is filled with air and positioned upright, all of the floating balls 650a, 650b, and 650c sit at the bottom of the syringe 12 due to gravity. Thus, the syringe 12 filled with air does not have floating balls near its distal end 24. Referring to FIG. 13, when the syringe 12 is filled with saline, based on the principles described above, the ball with a density of 0.5 g / mL (i.e., the ball 650b) floats to the distal end 24 of the syringe 12, while the ball with a density of 5 g / mL (ball 650c) remains at the bottom as the buoyancy does not overcome its weight. Referring to the ball 650a, which can also be positioned within the syringe 12, has a density less than 0.5 g / mL. This ball 650a also floats to the distal end 24 of the syringe 12 when saline is present within the syringe 12. Thus, the syringe 12 filled with saline has two balls floating near its distal end 24. Referring to FIG. 14, when the syringe 12 is filled with contrast, based on the principles described above, the ball with a density of 0.5 g / mL (i.e., the ball 650b) sinks to the bottom of the syringe 12, while the ball with a density of 5 g / mL (ball 650c) floats to the distal end 24 of the syringe 12 as the buoyancy overcomes its weight. Referring to the ball 650a, which can also be positioned within the syringe 12, has a density less than 0.5 g / mL. This ball 650a also sinks to the bottom of the syringe 12 when contrast is present within the syringe 12. Thus, the syringe 12 filled with contrast has one ball floating near its distal end 24. Figure 65 Figure 66 Figure 67 ​​​When the syringe 12 is filled with contrast agent having a density of 17 g / mL, all three balls 650a, 650b, and 650c float to the top because each ball has a density less than the density of the fluid in which they are immersed.

[0272] With continued reference to Figures 65-67 , the positioning sensor 114 is positioned to capture an image of the distal end 24 of the syringe 12. Thereafter, image processing software on the central processing unit 116 can detect the presence or absence of the balls 650a, 650b, and 650c in the image. If the image processing software on the central processing unit 116 determines that the balls are not present, a signal can be sent to the display 118 to display that air is present within the syringe 12. If the image processing software on the central processing unit 116 determines that the balls 650a and 650b are present, a signal can be sent to the display 118 to display that saline is present within the syringe 12. Finally, if the image processing software on the central processing unit 116 determines that all three balls are present, a signal can be sent to the display 118 to display that contrast agent is present within the syringe 12. This principle applies to any number of balls in the syringe as long as the balls have the appropriate corresponding densities. A further application is several different balls having varying densities, the varying densities corresponding to varying densities of different brands and different contrast agent concentrations. This principle can be used to determine the different types of contrast agent present using image recognition of the floating balls. In addition, the balls 650a, 650b, and 650c can have different sizes to provide another characteristic to allow the image processing software to distinguish between contrast agent and saline.

[0273] Figure 64The syringe 12 can also be used to determine the temperature of the fluid contained within the syringe 12. The floating balls 650a, 650b, and 650c are again operated based on the principle of buoyancy. Buoyancy is the upward force on an object that is in a fluid that opposes the weight of the object and tends to keep it submerged. 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, and 650c is greater than the density of the fluid by a sufficient margin, the weight overcomes the buoyancy and the balls 650a, 650b, and 650c sink to the bottom. If the density of the balls 650a, 650b, and 650c is less by a sufficient margin, the balls float. In this application, the density changes with temperature. As the fluid contained within the syringe 12 is heated, its volume tends to increase, lowering its density. Therefore, the floating balls 650a, 650b, and 650c can have incremental densities (e.g., 0.5 g / mL, 0.6 g / mL, 0.7 g / mL for normal saline, 15 g / mL, 15.5 g / mL, 16 g / mL for contrast) such that as the temperature of the fluid increases, the corresponding decrease in density will cause a particular ball 650a, 650b, and 650c to float or sink. The sensor 114 can be used to image the distal end 24 of the syringe 12, and image processing software on the central processing unit 116 can determine the number of balls present in the image. Once the number of balls is determined, the central processing unit 116 can correlate the number of balls to the temperature of the fluid. The diameter of the balls 650a, 650b, and 650c can also vary to correspond to their density / temperature relationship, such that the image processing software on the central processing unit 116 can measure the diameter and correlate it to the density and from the density to the temperature of the fluid.

[0274] Figure 64 The syringe 12 can also be used as a pressure limiting tool. More specifically, one of the balls 650a, 650b, and 650c can be configured to have a slight positive buoyancy at zero pressure when submerged in the fluid. Therefore, this ball floats when the syringe is not injecting fluid and is filled with fluid. As injection begins, the pressure inside the syringe increases. Since the air in the floating ball is more compressible than the fluid contained within the syringe, the volume of the ball decreases, increasing its density. Therefore, the floating ball can be designed to sink at a particular internal pressure within the syringe. For example, the ball can be designed to fall to the bottom of the syringe at a pressure greater than 325 psi. The fallen ball is then captured in an image taken by the sensor 114 and detected by the image processing software. A signal is then sent to the fluid injector to limit the pressure of the injection.

[0275] Fluid injection systems according to other embodiments of the present application are set forth in the following clauses:

[0276] Clause 1 : A fluid injection system, comprising: a fluid injector; at least one syringe in operable engagement with the fluid injector, the syringe comprising a barrel comprising a distal end having an angled surface and defining an interior volume configured to receive a fluid; an electromagnetic radiation source positioned relative to the at least one syringe to emit electromagnetic radiation through at least a portion of the at least one syringe such that, when the syringe is filled with the fluid, at least a portion of the electromagnetic radiation is affected by an interaction of the electromagnetic radiation and at least one interface associated with the fluid and the syringe to form an illuminated identification pattern that indicates 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 image capture device and the fluid injector, the at least one computing device comprising at least one processor configured to: determine a distance from a bottom to a top of the illuminated identification pattern in the 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, at least one of: i) display an indication of a characteristic of the at least one syringe on a display device in communication with the at least one processor; ii) enable the fluid injector to perform a function; and iii) disable the fluid injector from performing an action.

[0277] Clause 2: The fluid injection system of clause 1, wherein determining the distance from the bottom to the top of the illuminated identification pattern comprises determining a bottom edge of the illuminated identification pattern and determining a top edge of the illuminated identification pattern.

[0278] Clause 3: The fluid injection system of clause 2, wherein the bottom edge and the top edge of the illuminated identification pattern are determined by determining a change in contrast between adjacent pixels in the image of the illuminated identification pattern.

[0279] Clause 4: The fluid injection system of clause 1, wherein the characteristic of the at least one syringe is presence of air in the at least one syringe, and the at least one processor is further configured to, if the distance from the bottom to the top of the illuminated identification pattern is less than the at least one predetermined distance, provide an indication of presence of air in the at least one syringe and disable the fluid injector from performing an injection procedure.

[0280] Clause 5: The fluid injection system of clause 4, wherein the at least one processor is configured to determine a size of the at least one syringe prior to determining the distance from a bottom to a top of the illumination recognition pattern by matching a first template of a known illumination recognition pattern of a syringe having a first size to the image of the illumination recognition pattern.

[0281] Clause 6: The fluid injection system of clause 5, wherein the at least one processor is further configured to provide an indication that the at least one syringe has the first size if the first template matches the image of the illumination recognition pattern.

[0282] Clause 7: The fluid injection system of clause 5, wherein the at least one processor is further configured to match a second template of a known illumination recognition pattern of a syringe having a second size to the image of the illumination recognition pattern if the first template does not match the image of the illumination recognition pattern.

[0283] Clause 8: The fluid injection system of clause 7, wherein the at least one processor is 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 illumination recognition pattern.

[0284] Clause 9: The fluid injection system of clause 1, wherein the characteristic of the at least one syringe is a content of the at least one syringe.

[0285] Clause 10: The fluid injection system of clause 9, wherein the at least one predetermined distance includes a first predetermined distance and a second predetermined distance, the first predetermined distance indicating a first fluid as the content contained in the at least one syringe, the second predetermined distance indicating a second fluid as the content contained in the at least one syringe.

[0286] Clause 11: The fluid injection system of clause 10, wherein an indication that the at least one syringe contains the first fluid is provided if the distance from a bottom to a top of the illumination recognition pattern corresponds to the first predetermined distance, and an indication that the at least one syringe contains the second fluid is provided if the distance from a bottom to a top of the illumination recognition pattern corresponds to the second predetermined distance.

[0287] Clause 12: The fluid injection system of clause 11, wherein if the at least one processor determines that the first fluid is present in the at least one syringe, a color of the electromagnetic radiation forming the illuminated identification pattern is set to a first color, and if the at least one processor determines that the second fluid is present in the at least one syringe, the color of the electromagnetic radiation forming the illuminated identification pattern is set to a second color that is different from the first color.

[0288] Clause 13: The fluid injection system of clause 1, wherein the at least one syringe further comprises a plunger, and wherein the source of electromagnetic radiation is positioned to project at least some of the electromagnetic radiation through the plunger.

[0289] Clause 14: The fluid injection system of clause 13, wherein the plunger comprises a transparent or translucent material.

[0290] Clause 15: The fluid injection system of clause 1, wherein the at least one syringe further comprises a plunger, wherein the source of electromagnetic radiation is positioned such that the electromagnetic radiation reflects from a distal surface of the plunger through the barrel.

[0291] Clause 16: The fluid injection system of clause 15, wherein the plunger comprises an opaque, colored material.

[0292] Clause 17: The fluid injection system of clause 1, wherein the at least one syringe further comprises the plunger, and wherein the source of electromagnetic radiation is positioned adjacent to the barrel of the at least one syringe, and wherein the electromagnetic radiation is reflected from a mirror located proximate a distal end of the barrel and directed toward a distal surface of the plunger such that the electromagnetic radiation reflects from the plunger through the barrel.

[0293] Clause 18: A fluid injection system, comprising: a fluid injector; at least one syringe in operable engagement with the fluid injector, the at least one syringe including a barrel including a distal end having an angled surface and defining an interior volume configured to receive a fluid; an electromagnetic radiation source positioned relative to the at least one syringe to emit electromagnetic radiation through at least a portion of the at least one syringe such that, when the syringe is filled with the fluid, at least a portion of the electromagnetic radiation is affected by an interaction of the electromagnetic radiation and at least one interface associated with the fluid and the syringe to form an illuminated identification pattern that indicates 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 including at least one processor configured to: determine a distance from a bottom to a top of the illuminated identification pattern in the 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 disable the fluid injector from performing an injection procedure.

[0294] Clause 19: The fluid injection system of clause 18, wherein determining the distance from the bottom to the top of the illuminated identification pattern includes determining a bottom edge of the illuminated identification pattern and determining a top edge of the illuminated identification pattern.

[0295] Clause 20: The fluid injection system of clause 19, wherein the bottom edge and the top edge of the illuminated identification pattern are determined by determining a change in contrast between adjacent pixels in the image of the illuminated identification pattern.

[0296] Clause 21 : The fluid injection system of clause 18, wherein the at least one processor is configured to, prior to determining the distance from the bottom to the top of the illuminated identification pattern, determine a size of the at least one syringe by matching a first template of a known illuminated identification pattern of a syringe having a first size to the image of the illuminated identification pattern.

[0297] Clause 22: The fluid injection system of clause 21, wherein the at least one processor is further configured to, if the first template matches the image of the illuminated identification pattern, provide an indication that the at least one syringe has the first size.

[0298] Clause 23: The fluid injection system of clause 21, wherein the at least one processor is further configured to match a second template of a known illumination identification pattern of a syringe having a second size to the image of the illumination identification pattern if the first template does not match the image of the illumination identification pattern.

[0299] Clause 24: The fluid injection system of clause 23, wherein the at least one processor is 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 illumination identification pattern.

[0300] Clause 25: A fluid injection system, comprising: a fluid injector; at least one syringe in operable engagement with the fluid injector and configured to be illuminated with an electromagnetic radiation source to illuminate a fluid contained therein; a sensor positioned to capture an image of the illuminated fluid; and at least one computing device in communication with the fluid injector and the sensor, the at least one computing device comprising at least one processor configured to: obtain the image of the illuminated fluid from the sensor; determine, based on the image of the illuminated fluid, at least one of: a type of the fluid contained within the at least one syringe; and whether air is contained within the at least one syringe; and automatically display, on a display device in communication with the at least one processor, one of: an indication of the type of the fluid contained within the at least one syringe; and an indication that air is contained within the at least one syringe.

[0301] Clause 26: The fluid injection system of clause 25, wherein the at least one processor is configured to disable the fluid injector from performing an injection procedure if it is determined that air is contained within the at least one syringe.

[0302] Clause 27: The fluid injection system of clause 25, wherein a luminance measurement made in a region of interest in the image of the illuminated fluid is used to determine at least one of: the type of the fluid contained within the at least one syringe; and whether air is contained within the at least one syringe.

[0303] Clause 28: A fluid injection system, comprising: a fluid injector; a syringe operably engaged with the fluid injector, the syringe including a barrel and defining an interior volume and at least one feature provided on the barrel of the syringe, the at least one feature having a different appearance when viewed through different types of fluid contained within the syringe; an image capture device positioned to capture an image of the at least one feature through contents 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 including 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 a template of appearances of the at least one feature when viewed through different types of fluid; and based on the comparison, automatically display an indication of a characteristic of the syringe on a display device in communication with the at least one processor.

[0304] Clause 29: The fluid injection system of clause 28, wherein the at least one feature is formed on the barrel of the syringe by at least one of printing, overmolding, and etching.

[0305] Clause 30: The fluid injection system of clause 28, wherein the at least one feature is a dot of fluid, a line, a series of lines, or any combination thereof.

[0306] Clause 31 : The fluid injection system of clause 28, wherein the appearance of the at least one feature includes at least one of a shape of the at least one feature and an orientation of the at least one feature.

[0307] Clause 32: The fluid injection system of clause 28, wherein the characteristic of the syringe is a presence of air in the syringe, and the at least one processor is further configured to provide an indication of a presence of air in the syringe and disable the fluid injector from performing an injection procedure if the determined appearance matches one of the template of appearances of the at least one feature when viewed through air.

[0308] Clause 33: The fluid injection system of clause 28, wherein the characteristic of the syringe is contents of the syringe.

[0309] Clause 34: The fluid injection system of clause 33, wherein the at least one processor is further configured to provide an indication of a presence of a first fluid within the syringe if the determined appearance matches at least one of the template of appearances of the at least one feature when viewed through the first fluid.

[0310] Clause 35: The fluid injection system of clause 34, wherein the at least one processor is further configured to provide an indication that the second fluid is present within the syringe if the determined appearance matches at least one of the templates of the appearance of the at least one feature when viewed through the second fluid.

[0311] III. Other Concepts

[0312] In another example, the source 112 can emit light of a given wavelength, and the speed at which the light travels through the syringe can be measured by the detector and processor and indicate the type of fluid contained within the syringe 12.

[0313] It should be noted that although all of the concepts described herein are described with reference to a syringe and a fluid injector, this should not be interpreted as limiting the invention, as these concepts can be used with any fluid container. For example, these concepts can be used in a beverage filling set up to ensure that each bottle manufactured contains the correct volume of liquid and the correct liquid. The bottles can be provided with a colored translucent or transparent bottom and an angled neck. After the bottles are filled, an electromagnetic radiation source is positioned below the bottles to provide light through the bottles and create a halo of light near the neck of the bottles. This halo can be identified using the sensors and image processing software described herein. If the halo is not present or is of an inappropriate size, a signal can be generated that the bottles are not properly filled.

[0314] While the disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred implementations, it is understood that such detail is solely for that purpose and that the disclosure is not limited to the disclosed implementations, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the scope of the appended claims. For instance, it is to be understood that the 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.

[0315] Cross Reference to Related Applications

[0316] 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 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 each of which are incorporated herein by reference.

Claims

1. A fluid injection system, comprising: a fluid injector; a fluid path set comprising tubing having a connector with an end; a purge container configured to be connected to the end of the connector during a purge process prior to an injection process, the purge container configured to collect a discharge of contrast media from the end of the connector when the fluid path set is purged and primed, and to provide an indication that the purge is acceptable based on an amount of contrast media contained in the purge container, the purge container comprising a container body defining an interior volume and at least one reference line provided on a surface of the container body; an image capture device positioned to capture an image of the at least one reference line through contents of the container body; 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 the at least one reference line through fluid contained within the container body of the purge container; determine a distance from a top edge of the fluid contained within the container body to the at least one reference line; compare the distance from the top edge of the fluid contained within the container body to the at least one reference line to a plurality of predetermined distances, the plurality of predetermined distances corresponding to acceptable and unacceptable purge processes; and based on the comparison of the distance from the top edge of the fluid contained within the container body to the at least one reference line to the plurality of predetermined distances, display an indication on a display device in communication with the at least one processor whether the purge process is acceptable or unacceptable.

2. The fluid injection system of claim 1, wherein the top edge of the fluid contained within the container body and the at least one reference line are determined by determining a change in contrast between adjacent pixels in the image of the at least one reference line.

3. The fluid injection system of claim 1, wherein the at least one reference line is formed on the container body of the purge container by at least one of printing, overmolding, and etching. ​ ​

Images