Cassette for holding fluid path components for a fluid injector system

Abstract

A cassette for holding fluid path components for a fluid injector comprises a body defining at least one mechanism for holding at least one fluid path component for the fluid injector, and a connection member for removably connecting the body of the cassette to the fluid injector, the connection member being operably connected to the body, the connection member having at least one pivotable connection mechanism protruding from the body, each of the at least one pivotable connection mechanism configured to removably connect to a corresponding connection mechanism receiver of the fluid injector, such that the body is pivotable relative to the fluid injector between a first unlatched position and a second latched position in which at least one fluid path component of the body of the cassette is arranged to operably connect to a corresponding mechanism of the fluid injector.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 199,010, filed on December 1, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure generally relates to mechanisms associated with a cassette for holding and managing fluid path components for a fluid injector system. The cassette enables easy and compact storage of various fluid path components, which can be easily accessed and engaged with a fluid injector for use in a fluid injection procedure.

Background Art

[0003] Syringe injection systems are one of the medical devices used in medical imaging procedures. Many such syringes operate by being operably connected to an internal plunger and manually advancing a plunger extension to pressurize the fluid within the syringe. However, in many medical injection procedures, accurate control and / or high pressures may be required that cannot be achieved with manual syringe operation. Thus, several syringes and electric injectors have been developed for use with and for use in contrast - enhanced medical imaging procedures such as angiography, computed tomography (CT), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). For example, Patent Document 1 discloses pressure jackets, and front - loading syringes and electric injectors in jacketless configurations, the disclosure of which is incorporated herein by reference.

[0004] To fill the syringe with the contrast fluid, the user normally connects the filling tube and / or spike to the front nozzle or discharge outlet of the syringe, and places the other end of the tube / spike in a bottle or bag of the contrast medium (hereinafter referred to as "contrast agent") or other fluid such as physiological saline or other flushing fluid. Until the desired amount is filled into the syringe, the plunger of the syringe is retracted (usually by the injector piston) to aspirate the contrast agent into the syringe. After the syringe is filled, the syringe can be primed to remove air from the syringe and the fluid path. Then, the various fluid path components can be connected to the patient catheter by a fluid injection procedure.

[0005] Conventional fluid injector systems can utilize multiple components within the fluid path during the filling and delivery procedures. These fluid path components include tubes, spikes, and / or connectors for filling the syringe from a bulk fluid source for the contrast agent and physiological saline and delivering the fluid from the syringe to the patient, air management components for managing the flow of fluid through the fluid path components, valves, and stopcocks, aseptic maintenance components, etc. For example, in certain cases, a fairly long tube is used, which may get tangled during transportation and setup. There is a need for a device for managing the various fluid path components that can be accessed and set up quickly. A loose tube may also be properly installed because the length of the tube that may be loose with respect to the fluid injector is excessive.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0007] In one embodiment, a cassette for holding fluid path components for a fluid injector, the cassette comprising a body defining at least one mechanism for holding at least one fluid path component for the fluid injector, and a connection member for removably connecting the body of the cassette to a receiving surface of the fluid injector, the connection member being operably connected to the body. The connection member may include at least one pivotable connection mechanism protruding from the body, each of the at least one pivotable connection mechanisms being configured to removably connect to a corresponding connection mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first latch release position and a second latch position in which at least one fluid path component of the body of the cassette is operably connected to a corresponding mechanism of the fluid injector.

[0008] In another embodiment, at least one fluid path component is selected from at least one stopcock, at least one air bubble suspension device, one or more fluid line components, at least one fluid path component having an air detection region, and at least one removable end cap for a fluid line. At least one mechanism of the body is at least one extension member protruding from the body, and the at least one extension member is configured to hold a fluid path component of the fluid injector. The at least one extension member includes a retaining tab for holding a fluid path component on the at least one extension member. The at least one extension member comprises a plurality of extension members, each extension member being configured to hold at least one fluid path component of the fluid injector. At least one fluid component comprises at least one stopcock, the stopcock having a first fluid filling position that creates fluid communication between the bulk fluid container and the syringe engaged with the fluid injector, a second fluid delivery position that creates fluid communication between the syringe and the patient tubing set, and a third stop position that blocks fluid communication between the syringe, the bulk fluid container, and the patient tubing set. When the cassette is in the second latch position, the at least one extension member holds at least one stopcock in a position configured to engage at least one stopcock actuator of the fluid injector. The stopcock actuator actuates the stopcock between the first fluid filling position, the second fluid delivery position, and the third stop position in response to a signal from the control unit of the fluid injector. The body further comprises a shielding member that prevents user access to at least one stopcock held by the body of the cassette. At least one fluid component comprises at least one air bubble suspension device fluidly disposed between at least one fluid path component having an air detection region and at least one stopcock, and at least one retaining element holds at least one air bubble suspension device in a position movable between a first priming position and a second injection position as the head of the fluid injector moves between an upright priming position and an injection position at a downward angle.At least one bubble suspension device is configured to prime substantially all of the bubbles from the at least one bubble suspension device when primed in an upright priming position and to at least temporarily suspend the bubbles detected in the injection fluid during a fluid injection procedure when in a downward angle injection position. At least one fluid component comprises at least one fluid path component having an air detection region, and at least one retaining element holds the at least one fluid path component having the air detection region in a position operably engaged with an air detector of a receiving surface of a fluid detector. The air detector detects bubbles in the injection fluid during a fluid injection procedure and, in response to the detection of bubbles in the injection fluid, transmits a signal to a control unit of the fluid injector to cause at least one stopcock actuator to move at least one stopcock from a second fluid delivery position and a third stop position. At least one fluid component comprises at least one removable end cap for a fluid line, and the at least one removable end cap covers and prevents inadvertent contamination of a connector element of the fluid line. The cassette comprises two stopcocks, two bubble suspension devices, a plurality of fluid line components, two fluid path components each having an air detection region, and a plurality of removable end caps from the fluid line. The connection member comprises a lock tab configured to be received in a corresponding lock groove of the fluid injector for removably attaching the receiving surface to the fluid injector. The connection member comprises a latch member configured to removably connect a lock arm of the fluid injector. The identifier may be disposed on the body and is configured to provide information regarding the cassette, including at least one of an assembly date, a number of uses of the cassette, and a position of the cassette. The identifier may comprise a barcode.

[0009] In another embodiment, the fluid injector includes a housing, at least one syringe removably held within the housing, and a cassette for holding fluid path components for the fluid injector, the cassette having a body defining at least one mechanism for holding at least one fluid path component for the fluid injector, and a connection member for removably connecting the body of the cassette to the fluid injector, the connection member being operably connected to the body, the cassette comprising a connection member, the connection member comprising at least one pivotable connection mechanism protruding from the body, each of the at least one pivotable connection mechanisms being configured to removably connect to a corresponding connection mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first unlatch position and a second latch position in which at least one fluid path component of the body of the cassette is disposed for operably connecting to a corresponding mechanism of the fluid injector.

[0010] In another embodiment, at least one fluid path component is selected from at least one stopcock, at least one bubble suspension device, one or more fluid line components, at least one fluid path component comprising an air detection region, and at least one removable end cap for the fluid line. At least one mechanism of the body is at least one extension member protruding from the body, and the at least one extension member is configured to hold the fluid path components of the fluid injector. The at least one extension member includes a retaining tab for holding the fluid path component on the at least one extension member. The body of the cassette may comprise a plurality of retaining elements, each retaining element being configured to hold at least one fluid path component of the fluid injector. The at least one fluid component comprises at least one stopcock, the stopcock having a first fluid filling position that creates fluid communication between the bulk fluid container and the syringe engaged with the fluid injector, a second fluid delivery position that creates fluid communication between the syringe and the patient tubing set, and a third stop position that blocks fluid communication between the syringe, the bulk fluid container, and the patient tubing set, and when the cassette is in the second latch position, the at least one retaining element holds the at least one stopcock in a position configured to engage at least one stopcock actuator of the fluid injector. The stopcock actuator actuates the stopcock between the first fluid filling position, the second fluid delivery position, and the third stop position in response to a signal from the control unit of the fluid injector. The body further comprises a shielding member that prevents user access to at least one stopcock held by the body of the cassette. The at least one fluid component comprises at least one bubble suspension device fluidly disposed between at least one fluid path component comprising an air detection region and at least one stopcock, and the at least one retaining element holds the at least one bubble suspension device in a position movable between a first priming position and a second injection position as the head of the fluid injector moves between an upright priming position and an injection position at a downward angle.At least one bubble suspension device is configured to prime substantially all bubbles from the at least one bubble suspension device when primed in an upright priming position and to at least temporarily suspend bubbles detected in the injection fluid during a fluid injection procedure when in a downward angle injection position. At least one fluid component includes at least one fluid path component having an air detection region, and at least one holding element holds at least one fluid path component having a bubble detection region in a position operably engaged with an air detector on a cassette receiving surface of a fluid detector. The air detector detects bubbles in the injection fluid during a fluid injection procedure and, in response to detection of bubbles in the injection fluid, transmits a signal to a control unit of the fluid injector to cause at least one stop cock actuator to move at least one stop cock from a second fluid delivery position and a third stop position. At least one fluid component includes at least one removable end cap for a fluid line, and the at least one removable end cap covers and prevents inadvertent contamination of a connector element of the fluid line. The cassette includes two stop cocks, two bubble suspension devices, a plurality of fluid line components, two fluid path components each having an air detection region, and a plurality of removable end caps from the fluid line. The connecting member includes a lock tab configured to be received in a corresponding lock groove of the fluid injector for removably attaching the body to the fluid injector. The connecting member includes a latch member configured to removably connect a lock arm of the fluid injector. The identifier may be disposed on the body and is configured to provide information regarding the cassette including at least one of an assembly date, a number of uses of the cassette, and a position of the cassette. The identifier may comprise a barcode.

[0011] In another embodiment, a method of attaching at least one component to a fluid injector may include attaching at least one component to a cassette, the cassette comprising a body defining at least one opening for holding the at least one component and a connection member operably connected to the body, and connecting the connection member of the cassette operably to a corresponding connection member of the fluid injector to connect the cassette to the housing of the fluid injector, wherein the connection of the cassette to the housing of the fluid injector is configured to place the at least one component in a predetermined position in the housing of the fluid injector.

[0012] In another embodiment, the at least one component is at least one of a stopcock, a bubble suspension device, a fluid line, and a dust cap for the fluid line. The method may include evaluating an identifier attached to the cassette to determine whether the cassette has already been used.

[0013] In another embodiment, a connection interface between a cassette and a fluid injector, the cassette being configured to hold at least one component of the fluid injector, the connection interface including a first connection member provided on the cassette that engages the fluid injector and a second connection member provided on the fluid injector that receives the first connection member, wherein the connection of the first connection member to the second connection member is configured to place the at least one component in a predetermined position in the fluid injector.

[0014] Embodiments of the present invention are also disclosed in the following clauses.

[0015] Clause 1: A cassette for holding fluid path components for a fluid injector, the cassette comprising a body defining at least one mechanism for holding at least one fluid path component for the fluid injector, and a connecting member for removably connecting the body of the cassette to the fluid injector, the connecting member being operably connected to the body, the connecting member comprising at least one pivotable connecting mechanism protruding from the body, each of the at least one pivotable connecting mechanisms being configured to removably connect to a corresponding connecting mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first latch release position and a second latch position where at least one fluid path component of the body of the cassette is operably connected to a corresponding mechanism of the fluid injector.

[0016] Clause 2: The cassette according to clause 1, wherein the at least one fluid path component is selected from at least one stopcock, at least one air bubble suspension device, one or more fluid line components, at least one fluid path component comprising an air detection region, and at least one removable end cap for a fluid line.

[0017] Clause 3: The cassette according to clause 1 or 2, wherein the at least one mechanism of the body is at least one extension member protruding from the body, the at least one extension member being configured to hold a fluid path component of the fluid injector.

[0018] Clause 4: The cassette according to clause 3, wherein the at least one extension member includes a retaining tab for holding a fluid path component on the at least one extension member.

[0019] Clause 5: The cassette according to clause 3 or clause 4, wherein the cassette comprises a plurality of retaining elements, each retaining element being configured to hold a fluid path component of the fluid injector.

[0020] Clause 6: At least one fluid component includes at least one stopcock, the stopcock having a first fluid filling position that creates fluid communication between a bulk fluid container and a syringe engaged with a fluid injector, a second fluid delivery position that creates fluid communication between the syringe and a patient tube set, and a third stop position that blocks fluid communication among the syringe, the bulk fluid container, and the patient tube set. When the cassette is in the second latch position, at least one retaining element holds at least one stopcock in a position configured to engage at least one stopcock actuator of the fluid injector. The cassette according to any one of Clauses 3 to 5.

[0021] Clause 7: The cassette according to Clause 6, wherein a stopcock actuator actuates the stopcock between the first fluid filling position, the second fluid delivery position, and the third stop position in response to a signal from a control unit of the fluid injector.

[0022] Clause 8: The cassette according to any one of Clauses 1 to 7, wherein the body further includes a shielding member that prevents user access to at least one stopcock held by the cassette body.

[0023] Clause 9: At least one fluid component includes at least one bubble suspension device fluidly disposed between at least one fluid path component having an air detection region and at least one stopcock. At least one retaining element holds at least one bubble suspension device in a position movable between a first priming position and a second injection position as the head of the fluid injector moves between an upright priming position and a downwardly angled injection position. The cassette according to any one of Clauses 3 to 5.

[0024] Clause 10: The cassette according to clause 9, wherein at least one bubble suspension device is configured to prime substantially all bubbles from the at least one bubble suspension device when primed in an upright priming position and to at least temporarily suspend bubbles detected in the injection fluid during a fluid injection procedure when in a downward injection position.

[0025] Clause 11: The cassette according to any one of clauses 3 to 10, wherein at least one fluid component comprises at least one fluid path component having an air detection region, and at least one holding element holds the at least one fluid path component having the air detection region in a position operably engaged with an air detector on a receiving surface of a fluid detector.

[0026] Clause 12: The cassette according to clause 11, wherein the air detector detects bubbles in the injection fluid during a fluid injection procedure and, in response to detection of bubbles in the injection fluid, transmits a signal to a control unit of a fluid injector to move at least one stopcock actuator to move at least one stopcock from a second fluid delivery position and a third stop position.

[0027] Clause 13: The cassette according to any one of clauses 3 to 12, wherein at least one fluid component comprises at least one removable end cap for a fluid line, and the at least one removable end cap covers and prevents inadvertent contamination of a connector element of the fluid line.

[0028] Clause 14: The cassette according to any one of clauses 1 to 13, comprising two stopcocks, two bubble suspension devices, a plurality of fluid line components, two fluid path components each having an air detection region, and a plurality of removable end caps from the fluid line.

[0029] Clause 15: The cassette according to any one of Clauses 1 to 14, wherein the connecting member includes a locking tab configured to be received in a corresponding locking groove of the fluid injector to removably attach the body to the fluid injector.

[0030] Clause 16: The cassette according to any one of Clauses 1 to 14, wherein the connecting member includes a latch member configured to removably connect a locking arm of the fluid injector.

[0031] Clause 17: The cassette according to any one of Clauses 1 to 16, further comprising an identifier disposed on the body, the identifier being configured to provide information about the cassette, including at least one of the assembly date, the number of times the cassette has been used, and the position of the cassette.

[0032] Clause 18: The cassette according to Clause 17, wherein the identifier includes a barcode.

[0033] Clause 19: A fluid injector, comprising: a housing; at least one syringe removably held within the housing; a cassette for holding fluid path components for the fluid injector, the cassette including a body defining at least one mechanism for holding at least one fluid path component for the fluid injector; and a connecting member for removably connecting the body of the cassette to the fluid injector, the connecting member being operably connected to the body, the connecting member including at least one pivotable connecting mechanism protruding from the body, each of the at least one pivotable connecting mechanisms being configured to removably connect to a corresponding connecting mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first latch release position and a second latch position where at least one fluid path component of the body of the cassette is operably connected to a corresponding mechanism of the fluid injector.

[0034] Clause 20: The fluid injector according to clause 19, wherein at least one fluid path component is selected from at least one stopcock, at least one air bubble suspension device, one or more fluid line components, at least one fluid path component having an air detection region, and at least one removable end cap for a fluid line.

[0035] Clause 21: The fluid injector according to clause 19 or 20, wherein at least one mechanism of the body is at least one extension member protruding from the body, and at least one extension member is configured to hold a fluid path component of the fluid injector.

[0036] Clause 22: The fluid injector according to clause 21, wherein at least one extension member includes a holding tab for holding a fluid path component on at least one extension member.

[0037] Clause 23: The fluid injector according to clause 21 or clause 22, wherein the cassette includes a plurality of holding elements, and each holding element is configured to hold a fluid path component of the fluid injector.

[0038] Clause 24: The fluid injector according to any one of clauses 21 to 23, wherein at least one fluid component includes at least one stopcock, the stopcock having a first fluid filling position in which fluid communication occurs between a bulk fluid container and a syringe engaged with the fluid injector, a second fluid delivery position in which fluid communication occurs between the syringe and a patient tube set, and a third stop position in which fluid communication between the syringe, the bulk fluid container, and the patient tube set is blocked, and when the cassette is in a second latch position, at least one holding element holds at least one stopcock in a position configured to engage with at least one stopcock actuator of the fluid injector.

[0039] Clause 25: The fluid injector according to clause 24, wherein a stopcock actuator actuates a stopcock between a first fluid filling position, a second fluid delivery position, and a third stop position in response to a signal from a control unit of the fluid injector.

[0040] Clause 26: The fluid injector according to any one of clauses 19 to 25, wherein the main body further comprises a shielding member that prevents a user from accessing at least one stopcock held by the main body of the cassette.

[0041] Clause 27: The fluid injector according to any one of clauses 21 to 23, wherein at least one fluid component comprises at least one bubble suspension device fluidly disposed between at least one fluid path component having an air detection region and at least one stopcock, and at least one holding element holds at least one bubble suspension device in a position movable between a first priming position and a second injection position as the head of the fluid injector moves between an upright priming position and a downwardly angled injection position.

[0042] Clause 28: The fluid injector according to clause 27, wherein at least one bubble suspension device is configured to prime substantially all bubbles from at least one bubble suspension device when primed in an upright priming position and to suspend at least temporarily bubbles detected in the injection fluid during a fluid injection procedure when in a downwardly angled injection position.

[0043] Clause 29: The fluid injector according to any one of clauses 21 to 28, wherein at least one fluid component comprises at least one fluid path component having an air detection region, and at least one holding element holds at least one fluid path component having an air detection region in a position operably engaged with an air detector on a receiving surface of a fluid detector.

[0044] Clause 30: The fluid injector according to clause 29, wherein the air detector is configured to detect air bubbles in the injection fluid during the fluid injection procedure, and in response to the detection of air bubbles in the injection fluid, transmit a signal to the control unit of the fluid injector to move at least one stopcock to at least one stopcock actuator. Move one stopcock from the second fluid delivery position and the third stop position.

[0045] Clause 31: The fluid injector according to any one of clauses 21 to 30, wherein at least one fluid component comprises at least one removable end cap for the fluid line, and at least one removable end cap covers and prevents inadvertent contamination of the connector element of the fluid line.

[0046] Clause 32: The fluid injector according to any one of clauses 19 to 31, wherein the cassette comprises two stopcocks, two air suspension devices, a plurality of fluid line components, two fluid path components each having an air detection region, and a plurality of removable end caps from the fluid line.

[0047] Clause 33: The fluid injector according to any one of clauses 19 to 32, wherein the connecting member comprises a locking tab configured to be received in a corresponding locking groove of the fluid injector for removably attaching the body to the fluid injector.

[0048] Clause 34: The fluid injector according to any one of clauses 19 to 32, wherein the connecting member comprises a latch member configured to removably connect the locking arm of the fluid injector.

[0049] Clause 35: The fluid injector according to any one of clauses 19 to 34, further comprising an identifier disposed on the body, the identifier being configured to provide information about the cassette including at least one of the assembly date, the number of uses of the cassette, and the position of the cassette.

[0050] Clause 36: The fluid injector according to clause 35, wherein the identifier comprises a barcode.

[0051] Clause 37: A method of attaching at least one component to a fluid injector, the method comprising attaching at least one component to a cassette, the cassette comprising a body defining at least one opening for holding at least one component, and a connection member operably connected to the body, and connecting the cassette to the housing of the fluid injector by operably connecting the connection member of the cassette to a corresponding connection member of the fluid injector, wherein the connection of the cassette to the housing of the fluid injector is configured to place at least one component in a predetermined position in the housing of the fluid injector.

[0052] Clause 38: The method of clause 37, wherein at least one component is at least one of a stopcock, a bubble suspension device, a fluid line, and a dust cap for a fluid line.

[0053] Clause 39: The method of clause 37 or clause 38, further comprising evaluating an identifier attached to the cassette to determine whether the cassette has been previously used.

[0054] Clause 40: A connection interface between a cassette and a fluid injector, the cassette being configured to hold at least one component of the fluid injector, the connection interface comprising a first connection member provided on the cassette that engages the fluid injector, and a second connection member provided on the fluid injector that receives the first connection member, wherein the connection of the first connection member to the second connection member is configured to place at least one component in a predetermined position in the fluid injector.

[0055] The various mechanisms described herein are described in detail in the appended claims. However, such mechanisms can be preferably understood by reference to the following description in conjunction with the accompanying drawings, both as to their construction and manner of operation.

Brief Description of the Drawings

[0056]

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[0057] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. The illustrative mechanisms shown in the detailed description, drawings, and claims are not meant to be limiting. Other mechanisms may be utilized and other changes may be made without departing from the scope of the subject matter presented herein.

[0058] Before detailing the various aspects of the cassette, its interaction with the injector components, and their various mechanisms, it should be noted that the various aspects disclosed herein are not limited in detail to the structure and configuration of the components shown in the accompanying drawings and description in their application or use. Rather, the disclosed devices may be arranged or incorporated into other devices, their variations, and modifications, and may be implemented or executed in various ways. Accordingly, the aspects of the cassette and fluid injector mechanisms disclosed herein are exemplary in nature and are not meant to limit their scope or application. Further, unless otherwise indicated, the terms and expressions used herein are selected for the purpose of describing the various aspects of the cassette and fluid injector mechanisms for the convenience of the reader and do not limit their scope. Further, it should be understood that any one or more of the cassette and fluid injector mechanisms, their expressions, and / or any one or more of their example components, without limitation, may be combined with any one or more of other components, their expressions, and / or any one or more of their examples.

[0059] Also, in the following description, terms such as front, rear, inner, outer, top, bottom, etc. are for convenience and should not be construed as limiting terms. The terms used herein are not meant to be limiting insofar as the device or a part thereof described herein can be attached or utilized in other orientations. The various aspects of the cassette and fluid injector mechanisms will be described in detail with reference to the drawings.

[0060] Referring to FIGS. 1-5, a disposable cassette 2 is shown and described that simplifies the installation of disposable fluid path components to an electric medical fluid injector 4, such as for use in contrast enhanced angiography (CV), computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound, and similar imaging procedures. The cassette may include a skeletal mechanism, such as a retaining element for holding various fluid path components in proper positions for alignment and interaction with various components of, for example, a fluid injector head, a patient fluid line, and / or a bulk fluid source. The various fluid path components may be held in proper position and orientation by one or more retaining elements. According to various embodiments, the cassette and the various fluid path components may be manufactured, assembled, processed in a sterilization process, and packaged for shipment to an end user at a manufacturing facility. According to various embodiments, the cassette and the fluid path components, together with a plurality of separate single patient fluid path components used for each injection procedure and discarded prior to a subsequent fluid injection procedure, may be utilized as a plurality of patient fluid path sets that are used only over a series of fluid injection procedures. In other embodiments, the cassette and the fluid path components may be utilized in a single use manner where the cassette and the fluid path components are discarded after a single injection procedure and a new cassette / fluid path component assembly is installed for subsequent injections.

[0061] The cassette and the fluid path component assembly may be configured to be easily installed on a receiving surface of a head of a fluid injector, as described herein. Thus, the cassette assembly is designed to minimize the time between injection procedures and may perform a number of injection procedures over a period of time. In addition, since all fluid path components are assembled in the correct positions and alignments and the cassette can engage the receiving surface of the fluid injector only in a single possible orientation, the cassette may reduce or eliminate user setup errors.

[0062] According to one embodiment of the present disclosure, the disposable cassette 2 simplifies the installation of disposable fluid path components of a fluid injector, such as, but not limited to, the CV injector 4 (FIG. 10), by integrating mounting points for the cassette and fluid path components having corresponding mechanisms of the fluid injector 4 while maintaining various fluid path components in an organized and compact configuration. The cassette 2 can be used to simplify and manage fluid path components by changing the orientation of various components, for example, by appropriately inserting one or more of the air detection regions of the fluid path components into an air detector associated with the fluid injector to enable priming and / or bubble suspension, by changing the orientation to attach a bubble suspension device in a position enabling priming and / or bubble suspension, by inserting a stopcock into a corresponding stopcock actuator of the fluid injector, by appropriately inserting one or more compressible pinch valve regions of the fluid path components into one or more corresponding pinch clamps of the fluid injector, by managing tubes or other fluid path components, by managing male or female connector components and / or spikes at the ends of the fluid path in an appropriate orientation and / or proximity for connection to corresponding male or female connector components of the fluid injector components or fluid path components, and by managing one or more removable end caps for fluid lines. The cassette 2 is provided to the user as a single device or scaffold having various fluid path components disposed or connected at appropriate locations of the cassette 2, and the cassette 2 and associated fluid path components can be easily installed on the receiving surface 11 of the fluid injector 4 with a single operation or a simple series of operations. The single operation or simple series of operations for installing the cassette 2 replaces several complex operations of installing multiple fluid path components in a conventional fluid injector and minimizes the possibility of incorrect installation of one or more of the multiple fluid path components that can lead to errors in the fluid injection procedure.The cassette 2 may also be designed to be installed in only a single predetermined orientation relative to the fluid injector 4, thereby minimizing confusion, delays, and errors during setup and ensuring that various fluid path components are properly positioned for quick connection to one or more syringes attached to the fluid injector 4.

[0063] According to one embodiment of the present disclosure, the cassette 2 includes a body 6 configured to hold various fluid path components in positions for operably connecting to corresponding mechanisms of the fluid injector 4, disposable components such as syringes attached to the fluid injector, and / or components attachable to cassette fluid path components such as patient fluid lines, bulk fluid sources, etc. The body 6 may define various openings, compartments, and a plurality of retaining elements for holding the various fluid path components. In one example, the cassette 2 is configured to hold at least one fluid line 8 used to deliver a medical fluid from the fluid injector 4 (i.e., the syringe of the fluid injector 4) to a patient. In one example, the cassette 2 may be configured to hold two separate fluid lines 8, each fluid line 8 being configured to deliver various medical fluids to the patient. For example, one fluid line 8 may deliver saline to the patient, and the other fluid line 8 may deliver a contrast agent or other liquid pharmaceutical formulation to the patient.

[0064] According to some embodiments of the present disclosure, the cassette 2 may include a plurality of mechanisms for attaching various tube types thereon. According to various embodiments, the cassette 2 may include fluid path components such as a fluid line 8 that may include a fill tube, a patient line tube, and other fluid path components (e.g., U.S. Provisional Application No. 63 / 212,055 filed on June 17, 2021, and U.S. Provisional Application No. 63 / 222,605 filed on July 16, 2021, and International Application PCT / US 2021 / 018523 filed on February 18, 2021, International Application PCT / US 2021 / 022421 filed on March 15, 2021, International Application PCT / US 2021 / 022321 filed on March 15, 2021, International Application PCT / US 2021 / 029963 filed on April 29, 2021, and International Application PCT / US 2021 / 01507 filed on February 25, 2021), an in-line bubble suspension component (International Application PCT / US 2021 / 037623 filed on June 16, 2021), and a priming / purge tube (International Application PCT / US 2021 / 045689 filed on August 13, 2021), and can operably hold each of these, and the disclosure of each of these is hereby incorporated by reference in its entirety. In various embodiments, the cassette 2 may be designed for a single syringe setup (e.g., when only contrast agent is injected) or as a dual syringe setup (e.g., including a first syringe containing contrast agent and a second syringe containing a flushing fluid such as saline or lactated Ringer's solution). According to embodiments, a single set of mechanisms may be used for all of these, or separate mechanisms may be used for each fluid line 8.

[0065] In certain embodiments, for example, as shown in FIGS. 17 and 18, one or more posts 10 may project from the surface of the cassette 2 such that the fluid line 8 is wound therearound. For example, a long patient fluid line 8 may be wound or engaged around one or more posts to keep the patient fluid line 8 in a compact position and minimize tangling during transport and / or setup for fluid infusion. In certain embodiments, one or more posts 10 may be designed to apply a spring force to the fluid line 8 to ensure tension of the fluid line 8 when held on the post 10. The post 10 and / or the cassette 2 may also have one or more grooves or protrusions for positioning the fluid line 8 when held on the post 10. In certain embodiments, a lid or cap (not shown) may be disposed on one or more posts 10 or all of the posts 10 to hold the fluid line 8. The lid may be removably or permanently attached. In one non-limiting embodiment of the present disclosure, the post 10 may be inclined outwardly to generate tension in the fluid line 8 wound around the post 10. The fluid line(s) associated with one or more posts 10 may include, for example, a patient fluid line and / or a bulk fluid line, with or without an associated spike member for spiking a bulk fluid source.

[0066] According to non-limiting embodiments, as shown in FIGS. 4, 19, and 20, one or more spools or reels 12 may be disposed on the top, bottom, or side of the cassette 2 to hold various portions of the fluid line 8 prior to installation and to allow the fluid line 8 to be drawn out. In certain embodiments, the spool 12 may be wound from the end or center of a tube section. In certain embodiments, the spool 12 may be removably attachable to the fluid injector 4 such that, during setup, the spool 12 is unwound by the fluid injector 4, or by a biasing element such as a spring, and rewound after use. The spool 12 may be rotatable within the cassette 2 freely, or with resistance such as friction or click claws. Rotation allows for easy removal of the fluid line 8 from the spool 12. One or more spools 12 may be nested or stackable such that multiple spools 12 may be used in one cassette 2. In certain embodiments, the spool 12 may include a spring or other biasing member for retracting the fluid line 8, such as by click claws and release of spring-driven winding that return the fluid line 8 onto the spool or reel 12 at the completion of a fluid injection procedure. The spool 12 may have a removable end cap or tube holder molded onto the spool 12 for holding the fluid line 8 thereon. In one non-limiting embodiment of the present disclosure, the spool 12 may also define a retaining groove 13 for receiving and holding the fluid line 8 when wound around the spool 12.

[0067] According to non-limiting embodiments, one or more pockets or wells may be molded into the cassette 2, and the fluid line 8 may be wound into the cassette 2 prior to setup. The fluid line 8 may be placed in this pocket such that, prior to use with the fluid injector 4, the fluid line 8 can be drawn straight and unwind itself. The cassette 2 may also have additional connectors that are firmly attached such that other fluid line connections are easily accessible.

[0068] According to one embodiment of the present disclosure, as shown in FIGS. 1-5, the body 6 of the cassette 2 may also include at least one extension member 14 that helps hold the distal end of the fluid line 8 to the cassette 2. For example, the at least one extension member 14 may be configured to hold the distal end of the fluid line 8. In one example, the cassette 2 may include a plurality of extension members 14 such that the distal end of each fluid line 8 can be held on a separate extension member 14 at a location where it is attached to the patient fluid line. The extension member 14 may include a retaining tab 16 to which a fluid path component such as the fluid line 8 can be removably secured. The retaining tab 16 may include a groove defined in the extension member 14 such that the fluid line 8 can be press-fitted into the groove for retention on the extension member 14. In another embodiment shown in FIG. 20, the cassette 2 may omit the extension member 14 and, instead, the fluid line 8 may extend from the front face of the cassette 2 without support from an extension member or retaining element.

[0069] According to various embodiments, the upper and / or lower surfaces of the cassette 2 may include a plurality of retaining elements for holding various fluid path components in the proper position and configuration of the cassette 2, e.g., in the correct position and / or orientation for engaging corresponding components of a fluid injector or in the proper orientation for steps of an injection procedure. For example, in various embodiments, the retaining elements may include one or more catch members for engaging corresponding mechanisms of the fluid path components. At least one retaining element may be configured such that the fluid path component is removably held by the at least one retaining element, or at least one retaining element may be configured such that the fluid path component is non-removably held by the at least one retaining element.

[0070] Referring to FIGS. 1-6B, according to various embodiments of the present disclosure, the cassette 2 may define a holder 18 configured to hold one or more removable end caps 20 operably connected to the proximal and / or distal ends of one or more fluid lines 8. The removable end cap 20 may be provided to prevent dust and other microbial contaminants from entering and contaminating the fluid moving through the pre-sterilized fluid path components. Examples of suitable removable end caps may be, for example, those described in U.S. Provisional Patent Application No. 63 / 222,605 or commercially available end caps. In certain embodiments, the removable end cap 20 may include a sterilizing element such as an alcohol swab element that maintains the sterility of the connector element at the end of the fluid line. The removable end cap 20 may be operably connected to the fluid line 8 using a rotational connection, a press-fit or friction fit connection, or a snap-lock connection. According to various embodiments, the removable end cap 20 may be configured to engage one or more flexible locking legs of the corresponding connector element of the fluid line 8, as described, for example, in PCT Application No. PCT / US 2021 / 018523, which is hereby incorporated by reference, or U.S. Patent No. 11,083,882. Each of the removable end caps 20 may have a tab 22 that can be easily grasped by the user to remove the removable end cap 20 from the connector of the fluid line 8 to allow fluid access to the fluid line 8. In one embodiment, the holder 18 defines at least one slot 24 for receiving each tab 22 of the removable end cap 20, whereby the removable end cap 20 and the corresponding connector end of the fluid line 8 may be held in a defined position during transportation and installation into the fluid injector. Alternatively, the holder 18 may be configured to hold another portion of the removable end cap 20.According to various embodiments, the slot 24 may be sized or configured to receive the tab 22 in a friction fit to hold the removable end cap 20 to the holder 18 such that the end of the fluid line 8 and the connector element are adjacent to or near the corresponding mechanism of the injector, such as the connector element at the distal end of the syringe inserted into the fluid injector 4. As described herein, after the cassette 2 is installed on the fluid injector 4 and the operator is ready to connect the fluid line 8 to the connector element at the distal end of the syringe on the fluid injector 4, the removable end cap 20 is pulled from the holder 18 and removed from the fluid line 8 to enable connection of the fluid line 8 to the fluid injector 4. Similar to the removable end cap 20, the opposing end of the fluid line 8 held by the extension member 14 may also have a removable end cap 26 provided on the extension member 14 to prevent contamination of the fluid line 8. Referring to FIG. 6B, according to another embodiment of the present disclosure, the tab 22 of the removable end cap 20 may include a large tab section that may be press-fitted into the holder 18 for connection to the cassette 2.

[0071] Referring to FIGS. 1-5, FIGS. 6A and 6B, and FIG. 21 according to various embodiments of the present disclosure, the cassette 2 is arranged to have at least one air detection region 29 for alignment with one or more air detectors 129 on the receiving surface 11 of the fluid injector 4 (see FIGS. 10 and 21). The cassette 2 may also include a holding element configured to hold at least one air detection region 29 of the fluid path. According to various embodiments, the cassette 2 and the fluid line 8 may include two air detection regions 29, a first air detection region 29 of the contrast agent fluid path and a second air detection region 29 of the saline fluid path. According to certain embodiments, each air detection region 29 interacts with a corresponding air detector 129 of the fluid injector 4, whereby any air bubbles flowing through the fluid path of at least one air detection region 29 may be detected by the air sensor of the air detector 129. The advantage of the defined scaffold of the cassette 2 is that at least one air detection region 29 is accurately positioned within the corresponding region of the air detector 129 to ensure that any air bubbles passing through the fluid path within at least one air detection region 29 are detected by the air detector 129. The air detector 129 is configured to detect one or more air bubbles in the injection fluid during a fluid injection procedure. In response to the detection of air bubbles in the injection fluid, the air detector 129 may transmit a signal indicating that air bubbles have been detected in the fluid line to the control unit of the fluid injector. As will be understood by those skilled in the art, the injection of air into a patient's vasculature can potentially cause serious and harmful health effects to the patient. Particularly in angiography procedures, as well as in other contrast agent injection procedures such as CT, PET, and MR, it is important to minimize or eliminate the possibility of injecting a critical amount of air (defined as the minimum amount of air that can cause harmful effects if injected into the patient) during a particular procedure. As used herein, the cassette 2 is configured to accurately align at least one air detection region 29 with one or more corresponding air detectors 129 to eliminate the possibility of operator error or manufacturing defects that could cause misalignment between at least one air detection region 29 and the air detector 129, and to ensure accurate detection of any air that may pass through the fluid line 8.

[0072] In one embodiment shown in FIG. 21, the cassette 2 may be designed and structured to apply a load to the fluid line 8 of the air detection region 29. The shape and thickness of the cassette 2 may be formed to act as a spring and apply a continuous force to the fluid line 8 of the air detection region 29, ensuring contact between the fluid line 8 of the air detection region 29 and the corresponding air detector 129 and eliminating problems with tolerances in manufacturing. For example, when the fluid line 8 of the air detection region 29 is inserted into the cassette 2, the shape of the cassette 2, in particular the protrusion or retaining element of the cassette 2, may be configured to apply pressure to the fluid line 8 to press the air detection region 29 of the fluid line 8 against the air detector 129, ensuring accurate reading of the fluid and any air passing through the fluid line 8. By ensuring that the cassette 2 is configured to apply this pressure to the fluid line 8, problems with tolerances that occur during manufacturing and / or during the manufacture of the air detection region 29 can be reduced.

[0073] In various embodiments, cassette 2 may define at least one holder 28 configured to receive and hold a bubble suspension device 30. In one example, the bubble suspension device 30 may be in fluid connection with the fluid line 8 downstream of the air detection region 29 to at least temporarily interrupt and delay bubbles that may be detected within the fluid passing through the upstream air detection region 29 of the fluid line 8. For example, an air detector 129 notifies the control unit of the fluid injector 4 of detecting air, stops the fluid injection procedure, and stops the flow of fluid to the patient, for at least sufficient time, by moving a shut-off valve, such as a pinch valve or stopcock described herein, to a closed position. At least one bubble suspension device 30 may be configured to at least temporarily interrupt and delay the flow of one or more detected bubbles within the bubble suspension region. In this way, even a small amount of air can be detected and the injection procedure stops before the high fluid flow and system capacitance carry the air to the patient. In one example, cassette 2 may define two holders 28 each configured to receive and hold a separate bubble suspension device 30, each in fluid communication with a single fluid line 8 (e.g., a contrast fluid line and a saline line). In one embodiment, the bubble suspension device 30 may be an in-line bubble suspension device as disclosed in PCT International Patent Application PCT / US 2021 / 037623. Other connection configurations that allow the bubble suspension device 30 to be removably attached to the cassette 2 may use a latch or snap-fit connection such that the bubble suspension device 30 can be held in the cassette 2. Referring to FIGS. 7A and 7B, according to a particular embodiment of the present disclosure, the bubble suspension device 30 may be held in the cassette 2 using a push tab 31 configured to be inserted into an opening defined in the holder 28. The push tab 31 is configured to expand outwardly to prevent the push tab 31 from moving back through the opening of the holder 28 when the push tab 31 is pushed through the opening.

[0074] As shown in FIGS. 13 and 14, the cassette 2 can be configured to be attached to the fluid injector 4 such that the cassette 2 and the fluid injector 4 can pivot between an upright priming position (FIG. 13) and a downward injection position (FIG. 14). A retaining element associated with at least one bubble suspension device 30 of the cassette 2 can align and orient the at least one bubble suspension device 30 such that substantially all of the air within the bubble suspension device 30 can be primed from the bubble suspension device 30 and the fluid line prior to the injection procedure at a first priming position, and the bubble suspension device 30 is oriented to temporarily hold bubbles within the fluid path during the injection procedure at a second injection position. The movement of the head of the fluid injector 4 between the upright priming position and the downward angled injection position moves one or more bubble suspension devices 30 between a priming position where air is removed from the bubble suspension device 30 and an injection position where air within the injection fluid is retained within the bubble suspension device 30.

[0075] According to one embodiment of the present disclosure, as shown in FIGS. 1-5 and 8, the cassette 2 may also define at least one holder 32 for receiving and holding a fluid control valve 34 used to control the flow of fluid through the fluid line 8. In one embodiment, the cassette 2 may define two holders 32 for receiving and holding the fluid control valves 34 respectively. In one example, the fluid control valve 34 may be a stopcock valve such as a three-way stopcock. The fluid control valve 34 may be removably held in the holder via a snap-fit connection, a friction fit, or any other removable connection configuration that allows insertion and removal of the fluid control valve 34 into and from the holder 32. In one embodiment, a fluid control valve 34 such as a three-way stopcock is movable by the fluid injector 4 between at least three different positions. In a first fluid filling position, the fluid control valve 34 may direct fluid through the fluid line 8 to create fluid communication between the bulk fluid source and the syringe held by the fluid injector 4 while preventing fluid communication with the patient fluid line. In a second fluid delivery position, the fluid control valve 34 may be arranged to create direct fluid communication from the syringe held by the fluid injector 4 into the patient fluid line and thus into the patient via the fluid line 8 while preventing fluid communication with the bulk fluid source. In a third stop position, the fluid control valve 34 prevents fluid communication through the fluid line 8 between the syringe, the bulk fluid source, and the patient. The cassette operably positions the stopcock using a corresponding stopcock actuator 134 of the fluid injector 4 such that the stopcock actuator 134 can actuate the corresponding stopcock and move the stopcock between the first, second, and third positions in response to a signal from the control unit of the fluid injector 4. For example, when a fluid injection protocol requires filling of the syringe, the control unit may send a signal to the stopcock actuator 134 to move the stopcock to the first fluid filling position and allow fluid to be drawn from the bulk fluid source into the syringe.Next, the control unit may send a signal to the stopcock actuator 134 to move the stopcock to the second fluid delivery position to enable priming of the system, and then initiate a fluid injection procedure. The control unit may send a signal to the stopcock actuator 134 to move the stopcock to the third stop position when: a) the fluid injection procedure is temporarily stopped to prevent dripping of fluid from the system; b) the fluid injection procedure is completed; or c) the air detector 129 notifies the control unit that one or more bubbles have been detected in the fluid flowing through the air detection region 29 of the fluid path. In the latter case, the air detector operates in cooperation with the bubble suspension device 30, the control unit, and the stopcock and stopcock actuator 134 to detect air in the fluid path, temporarily interrupt the air in the bubble suspension device 30, notify the control unit of the detected air, and notify and activate the control unit to move the stopcock actuator 134 to the third stop position within a time period sufficient to stop the fluid flow before the air passes through the bubble suspension device 30 and the downstream patient (via the stopcock). The cassette 2 is configured to accurately align the stopcock with the stopcock actuator 134, thereby preventing air from moving through the system into the patient.

[0076] According to one embodiment, the fluid control valve 34 may be one or more pinch valves of the fluid injector 4 operably arranged to interact with one or more fluid lines 8 such as a bulk fluid line and / or a patient fluid line held within the cassette. In certain embodiments, the pinch valve may be, for example, a double pinch valve designed to control the flow through two separate fluid lines between the bulk fluid line and / or the patient fluid line. A pinch valve suitable for incorporation into the fluid injector 4 is described in PCT International Application PCT / US 2021 / 029963, such as the double pinch valve described therein. For example, in certain embodiments, the double pinch valve may include a first pinch valve for controlling the flow of fluid between the bulk fluid source and the syringe, and a second pinch valve for controlling the flow of fluid between the syringe and the patient fluid line. According to certain embodiments, the cassette 2 may be configured to align the various fluid lines 8 with the pinch valve. In certain embodiments, when the cassette is operably engaged with the fluid injector 4, the cassette 2 may be configured to apply a force to the fluid line 8 to bias the fluid line 8 into an engagement interaction (i.e., insert the fluid line tube into the pinch region of the pinch valve).

[0077] According to one embodiment, the body 6 of the cassette 2 may include a guard member 35 that covers at least one fluid control valve 34. The guard member 35 is configured to protect and / or prevent the handle of at least one fluid control valve 34 from becoming detached during transportation or handling by an operator. In one embodiment, a notch 37 may be provided in the guard member 35 to allow visual recognition of the handle of the fluid control valve 34 and to determine the position of the handle.

[0078] According to various embodiments, the cassette 2 includes a mechanism that enables proper placement of the cassette 2 relative to the receiving surface 11 of the head of the fluid injector 4, and a connection configuration 36 for facilitating installation of the cassette 2 onto the fluid injector 4 and aligning various fluid path components of the cassette 2 using the associated mechanisms of the fluid injector 4. According to various embodiments, as shown in FIGS. 10-14, the cassette 2 is hingedly engagable with the fluid injector 4 so as to align the fluid line 8, the bubble suspension device 30, the air detection region 29, and the fluid control valve 34 with their corresponding actuators of the fluid injector 4, while the end of the fluid line 8 may be disposed adjacent to the corresponding connection mechanisms of the fluid injector 4 and the patient fluid line. Thus, the cassette 2 can enhance efficiency and shorten the time between injection procedures while minimizing operator installation errors or delays. In certain embodiments, the cassette 2 may be provided in a sterile package or provided as a single packaged disposable unit having all associated disposable fluid path components, similar to a sterile fluid path component (i.e., the internal portions of the various fluid path components are sterilized and then sealed and packaged). The cassette 2 can be removed from the package and quickly engaged with the fluid injector 4 such that all fluid path components of the cassette 2 are ready for a subsequent injection procedure.

[0079] Various methods for placing, engaging, and latching the cassette 2 to the fluid injector 4 are shown in FIGS. 10-12, incorporating a fixed pivot point into the fluid injector 4 and disposed on the receiving surface 11 of the head of the fluid injector 4, and incorporating a fixed latch mechanism for holding the cassette 2 after engagement. When the cassette 2 is attached to and engaged with the mechanism of the fluid injector 4, the user can access the various fluid path components, remove the associated removable end caps 20, and then use the appropriate mechanisms of the fluid injector 4 (e.g., syringe nozzle, spike of the bulk fluid source, patient fluid line, etc.) to connect connector elements to the distal and proximal ends of the fluid path to prepare the system for a fluid injection procedure.

[0080] Referring to FIGS. 1-5 and FIGS. 10-12, according to certain embodiments of the present disclosure, the cassette 2 may include a connection configuration 36 that includes at least one hinge member 38. In various examples, two hinge members 38 are provided on opposite sides of the proximal end of the cassette 2. Each hinge member 38 may include a round member 40 and a latch member 42. In one embodiment, the hinge member 38 is configured to be received within a corresponding groove 44 defined in the cassette receiving surface 11 of the fluid injector 4. In one example, the hinge member 38 may be disposed on the cassette 2 such that the hinge member 38 can only be inserted into the groove 44 of the receiving surface 11 of the fluid injector 4 at a predetermined orientation or insertion / removal angle with respect to the receiving surface 11, thereby eliminating the risk that an operator or user installs the cassette 2 in an undesirable position of the fluid injector 4. The groove 44 may be defined to have a shape corresponding to the hinge member 38. To install the cassette 2 onto the fluid injector 4, the round member 40 of the hinge member 38 may first be inserted into the groove 44 of the fluid injector 4. Once the round member 40 is inserted into the groove 44, the cassette 2 may be rotated downward relative to the fluid injector 4 to move the cassette 2 toward the fluid injector 4 and move the latch member 42 of the hinge member 38 into the groove 44. It is also contemplated that the cassette 2 may be press-fitted onto the fluid injector 4 instead of a rotational fit.

[0081] As shown in FIGS. 10-12, according to various embodiments of the present disclosure, after the hinge member 38 is inserted into the groove 44, the cassette 2 may be rotated completely toward the fluid injector 4 in order to fully connect the cassette 2 to the fluid injector 4. When the cassette 2 rotates toward the fluid injector 4, the flexible lock tab 46 provided at the distal end of the cassette 2 is bent, pressed, and lock-engaged with a lock groove 48 defined in the receiving surface 11 of the head of the fluid injector 4. The lock tab 46 may snap-engage with the lock groove 44 to hold the hinge member 38 within the corresponding groove 48 so that the cassette 2 remains removably engaged with the fluid injector 4. After the cassette 2 is locked in a predetermined position of the fluid injector 4, the fluid path components held in the cassette 2 are arranged in a predetermined orientation of the fluid injector 4 in order to be easily connected to the corresponding fluid path components of the fluid injector 4 and / or the patient fluid line. For example, at the engagement lock position, the cassette 2 positions the proximal connector end of the fluid line 8, and the associated removable end cap 20, in proximity to the distal end of the syringe, whereby the proximal connector end may be removed from the removable end cap 20 and the connector engaged with the syringe to create fluid communication between the interior of the syringe and the fluid line 8. In one embodiment of the present disclosure, to remove the cassette 2 from the fluid injector 4 after use, the lock tab 46 is flexibly pressed toward the cassette 2 to release the connection with the lock groove 48 of the fluid injector 4, whereby the cassette is rotated upward to the insertion / removal angle by the rotation of the rounded member 40 of the hinge member 38 within the groove 44, such that the fluid path components are disengaged from the corresponding mechanism of the fluid injector 4 and the cassette 2 may be released from the fluid injector 4. Thereafter, the cassette 2 may be discarded, and a new sterile cassette 2 may be installed for subsequent fluid injection procedures.

[0082] When set up, the cassette 2 can provide a rigid attachment point to the fluid injector 4 to enable one-handed connection of the patient fluid line 8. As described above, a mechanism may be added to the cassette 2 to store the removable end cap 20. According to certain embodiments, these mechanisms may include a removable end cap 20 that is directly molded onto the cassette 2. Additional embodiments may include an additional sterile removable end cap 20 for maintaining the sterility of the connector end, e.g., the connector end attached to the patient fluid line, after priming of the plurality of patient fluid lines 8 and during the patient infusion procedure. In an alternative embodiment, the cassette 2 may include a sterilization element such as an alcohol swab mechanism or function for accessing UV light on the fluid injector 4 to enable sterilization of the distal connector end of the fluid line 8 of the cassette 2 during the patient infusion procedure. The cassette 2 may also function as a storage location for the used removable end cap 20 from setup, which helps to maintain an organized work space and ensure disposal of the removable end cap 20 using the disposable cassette 2. The removable end cap 20 may also be retained by the cassette 2 after being removed from the fluid line 8 to ensure that the removable end cap 20 does not fall from the cassette 2.

[0083] When one or a series of multiple patient fluid infusions are completed, removal of the cassette 2 from the fluid injector 4 is simplified because the cassette 2 enables one-handed removal of one or more, for example, all, of the multiple fluid path components associated with the cassette 2 in one step. The cassette 2 remains attached to the fluid injector and syringe, for example, with the fluid control valve 34 in the third stop position, during this process and can minimize dripping of fluid between infusion procedures in a multiple patient infusion setup or during disassembly steps. The combined syringe and cassette assembly can then be discarded as a unit. In certain embodiments, the used syringe and cassette assembly may be recycled. Further, by maintaining the fluid control valve 34 in the third stop position and maintaining upstream components such as the syringe and other upstream fluid path components in the pressurized position, it is possible to reduce fluid volume delivery errors resulting from the release and uptake of system capacitance (i.e., expansion of system components under infusion pressure, uptake of slack in the system) between patient infusion procedures in a multiple patient infusion setup.

[0084] According to some non-limiting embodiments, the cassette 2 may have one or more components that separate when the cassette 2 is removed and render the cassette 2 and associated fluid path components no longer usable. For example, in certain embodiments, the flexible lock tab 46 or the connection configuration 36 may be configured to break or deform when disengaged from the fluid injector 4. This avoids accidental reuse of the cassette 2 and associated fluid path components and thus prevents potential cross-contamination and other safety issues associated with multiple uses other than the recommended and approved use of the cassette 2 and fluid path components.

[0085] According to some non-limiting embodiments, one or more deformable parts or shields (not shown) of the cassette 2 may be used to position components during transportation and installation of the cassette 2 and prevent inadvertent movement of fluid path components such as stopcock handles or engagement mechanisms. For example, during shipping or installation, the stopcock engagement mechanism may be inadvertently moved, thereby no longer being in a predetermined position for engaging the associated stopcock actuator, and the shield may prevent access to the engagement mechanism and minimize the possibility of inadvertent movement. As described herein, these deformable parts may be designed to bend without getting in the way when the cassette 2 is installed, thereby allowing the control unit to accurately move the stopcock between the first, second, and third positions, enabling the control unit to identify a specific rotational position of the stopcock while allowing a fluid injector 4 mechanism such as an actuator to interface with the fluid path component, such as the stopcock actuator being able to engage and operate with the stopcock handle.

[0086] According to some non-limiting embodiments, a portion of the cassette 2 may be illuminated via one or more lights 50 of the fluid injector 4. These lights 50 may include area lighting where the light is projected onto at least a particular portion, or all, of the cassette 2. This may also be directional lighting, such as "light piping", where the cassette 2 is designed such that light reaches internally through one or more portions of the fluid path or cassette skeletal mechanism. In certain embodiments, the cassette 2 may be made of a transparent or translucent plastic, and the lights 50 are closely coupled to the cassette 2 of the fluid injector 4. Lights may be used to indicate to the user that the cassette 2 is properly installed in the injector 4, and / or that the fluid path components are primed, and / or that the fluid path components are ready for a fluid injection procedure, and / or which fluid type (e.g., contrast agent or saline) is associated with a particular fluid path. The light mechanism may also be used to indicate whether the fluid control valve 34 is in a first filling position, a second fluid delivery position, and a third stop position by using lights of various colors for each position. The cassette 2 may be made of a light-transmissive material such that when the cassette 2 is fully loaded, light from the emitter is transmitted to the transmitter to indicate that the cassette 2 is fully loaded.

[0087] According to some non-limiting embodiments, the cassette 2 may include one or more identification labels 52 such as RFID, barcodes, QR codes, or other machine-readable identification labels, and the identification labels 52 may be scanned by the fluid injector 4 or by other components of the fluid injector system such as a control unit, a handheld identification label reader, or a computer associated with the fluid injector 4. The identification labels 52 may be on one or both of the cassette 2 and the cassette package. According to various embodiments, the identification labels 52 may be used for various purposes. When setting up the fluid injector 4 to operate with various components and characteristics (workflow, prime volume, compliance information, number of patients, etc.) of a disposable set, the identification label 52 may be utilized. According to these embodiments, the cassette 2 may be configured to include various fluid path components according to the specifications of the infusion protocol. The identification label 52 enables the fluid injector 4 to recognize the mechanism, characteristics, and components of a particular cassette 2 and related fluid path components, determine whether the cassette 2 is the appropriate cassette for the selected fluid infusion procedure, and configure the fluid infusion procedure according to the characteristics and components of the cassette 2. The identification label 52 may further be used to prevent reuse of the cassette beyond its approved lifespan or prevent use of the cassette, and / or may include information about the manufacture of the cassette such as the manufacturing date, usable lifespan, etc.

[0088] The identification label 52 may also be provided to ensure that a compatible, non-counterfeited disposable set is used with the fluid injector 4. The fluid injector 4 may notify the user that the cassette 2 may cause one or more errors during the fluid infusion procedure when the fluid path components included in the cassette 2 are used, that the cassette 2 is not compatible or is not an approved disposable set, or that it is not from an approved manufacturer with appropriate quality control protocols. When the identification label 52 is read, the control unit may be able to indicate to the user that the cassette 2 is not suitable or not approved for the associated infusion procedure and may further prevent the use of the cassette and related fluid path components during the infusion procedure.

[0089] The identification label 52 can be used to record the use of the cassette 2 and / or the fluid injector 4 for a patient or multiple patients in a hospital record system. If the cassette 2 includes multiple patient fluid path configurations, the identification label 52 can enable communication and data transfer with a hospital record system or other tracking system to ensure that the cassette 2 and associated components are used according to specifications. When a disposable set for multiple patients approaches or reaches its maximum usage amount (maximum number of injections or maximum total usage time), or when the end of its storage life or expiration date is reached, the identification label 52 can also be used to warn the user and instruct the user on the need to replace the cassette 2 and / or proper disposal. In another embodiment, an indicator may be provided on the fluid injector 4 to notify the operator when the fluid control valve 34 is fully engaged, indicating that the fluid injector 4 is ready to operate.

[0090] Referring to FIGS. 16A - 16C, according to one non - limiting embodiment of the present disclosure, an alternative connection configuration 54 for connecting the cassette 2 to the fluid injector 4 is shown and described. The connection configuration 54 can include a lock tab 56 disposed on the cassette 2 and a lock groove 58 disposed on the fluid injector 4. To connect the cassette 2 to the receiving surface 11 of the fluid injector 4, the lock tab 56 is inserted into the lock groove 58 of the receiving surface 11, and the cassette 2 can be rotated toward the fluid injector 4. As the cassette 2 rotates toward the fluid injector 4, the cassette 2 engages a latch mechanism 60 to releasably lock the cassette 2 to the fluid injector 4.

[0091] Referring to FIG. 15, according to one non-limiting embodiment of the present disclosure, after the fluid path component is attached to the cassette 2, the entire assembled cassette 2 is inserted into a press-forming container and / or at least partially covered with plastic using a non-permeable or semi-permeable polymer material, or any other known method, or may be packaged within the package 62. In one example, the patient fluid line may be wound around a coil and placed in an associated tube receptacle outside the package to maintain an organized package. The fluid line 8 may be bundled, individually packaged, or placed in a sterile package. In addition to using removable end caps 20, 26 to cover the opposing ends of the fluid line 8, this packaging method may be used to maintain a sterile fluid path rather than a completely sterile cassette 2. In another embodiment, a package may be formed using a cassette 2 provided with two protective covers on the top and bottom of the cassette 2 to seal the internal components of the cassette 2 from contamination. In one example, the sides of the body 6 of the cassette 2 may form the sides of the package.

[0092] According to one embodiment of the present disclosure, a method of attaching at least one component to a fluid injector 4 is described. The method can include attaching at least one component to a cassette 2, the cassette 2 including a body 6 defining at least one opening for holding at least one component, and a connection configuration or member 36 operably connected to the body 6. The method can include connecting the cassette 2 to the housing of the fluid injector 4 by operably connecting the connection configuration or member 36 of the cassette 2 to a corresponding connection configuration or member 36 of the fluid injector 4. The connection of the cassette 2 to the housing of the fluid injector 4 is configured to place at least one component at a predetermined location of the housing of the fluid injector 4. The at least one component can be at least one of a stopcock 34, a bubble suspension device 30, a fluid line 8, and a removable end cap 20 for the fluid line 8. The method can also include evaluating an identifier 52 attached to the cassette 2 to determine whether the cassette 2 has already been used.

[0093] It is worth noting that references to "one embodiment" or "an embodiment" mean that the particular mechanism, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. The particular mechanisms, structures, or characteristics can be combined in any suitable way in one or more embodiments.

[0094] One skilled in the art will recognize that the components (e.g., operations), devices, objects, and accompanying descriptions described herein are used as examples for clarity of concept, and that various configuration changes are contemplated. Accordingly, as used herein, the specific examples and accompanying descriptions provided are intended to represent their general classes. In general, the use of any particular exemplification is intended to represent that class and should not be construed as limiting to the exclusion of particular components (e.g., operations), devices, and objects.

[0095] Regarding the use of any plural and / or singular terms herein, one skilled in the art can convert from plural to singular and / or from singular to plural depending on context and / or application. Various singular / plural substitutions are not explicitly described herein for clarity.

[0096] The subject matter described herein may refer to various components that are included within or connected to other various components. It should be understood that the architectures shown in that way are merely illustrative, and in fact, many other architectures that achieve the same functions may be implemented. In a conceptual sense, any configuration of components for achieving the same function is effectively "associated" so that the desired function is achieved. Therefore, any two components of this specification combined to achieve a specific function can be considered to be "associated" with each other so that the desired function is achieved, regardless of the architecture or intermediate components. Similarly, any two components associated in that way can be considered to be "operably connected", and any two components that can be associated in that way can also be considered to be "operably connectable" to each other to achieve the desired function. Specific examples of operably connectable include, but are not limited to, components that can physically fit together and / or physically interact, and / or components that can wirelessly interact, and / or components that logically interact, and / or components that can logically interact.

[0097] Some aspects may be described using the terms "coupled" and "connected" along with their derivatives. It should be understood that these terms are not intended to be synonyms for each other. For example, some aspects may describe using the term "connected" to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may describe using the term "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other but still cooperate or interact with each other.

[0098] In some examples, one or more components may be referred to herein as “configured,” “operable,” “adapted,” etc. One of ordinary skill in the art will recognize that “configured” can generally include, without further context if not otherwise required, components in an active state, and / or components in an inactive state, and / or components in a standby state.

[0099] While particular aspects of the subject matter described herein have been illustrated and described, based on the teachings herein, changes and modifications can be made without departing from the subject matter described herein and its broader aspects, and thus it will be apparent to those skilled in the art that the appended claims are intended to cover all such changes and modifications that fall within the scope of the subject matter described herein. Generally, the terms used in this specification, particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be construed as “non-limiting” terms (e.g., the term “including” should be construed as “including but not limited to”, the term “having” should be construed as “having at least”, the term “includes” should be construed as “includes but not limited to”, etc.). It will be understood by those skilled in the art that when an introduction of a specific number of recited claims is intended, such intent is explicitly recited in the claims, and when there is no such recitation, such intent does not exist. For example, for purposes of illustration, the following appended claims may include the use of introductory phrases “at least one” and “one or more” to introduce the recitation of claims. However, the use of such phrases should not be construed to mean that the introduction of a claim recitation by the indefinite article “a” or “an” limits any particular claim containing such recitation to a claim containing only one such recitation, as the same claim may contain both an introductory phrase such as “one or more” or “at least one” and an indefinite article such as “a” or “an” (e.g., “a” and / or “an” should be construed as normally meaning “at least one” or “one or more”), and this also applies to the use of definite articles used to introduce claim recitations.

[0100] Furthermore, even if the description of a specific number of introduced claims is explicitly stated, one of ordinary skill in the art will recognize that such description should normally be construed to mean at least the number described (e.g., a raw description of "two listings" without other modifiers normally means at least two listings, or two or more listings). Further, when a convention similar to "at least one of A, B, and C, etc." is used, generally, such a configuration is intended in a sense that one of ordinary skill in the art will understand the convention (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, a system having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together). When a convention similar to "at least one of A, B, or C, etc." is used, generally, such a configuration is intended in a sense that one of ordinary skill in the art will understand the convention (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, a system having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together). Disjunctive words and / or phrases presenting two or more alternative terms are usually understood by one of ordinary skill in the art to contemplate the possibility of including one of the terms, any of the terms, or both terms, regardless of whether in the description, claims, or drawings, unless the context indicates otherwise. For example, the phrase "A or B" is usually understood to include the possibilities of "A" or "B" or "A and B".

[0101] In summary, many advantages resulting from using the concepts described herein are described. The foregoing disclosure is presented for purposes of illustration and explanation. It is not intended to be exhaustive or to limit to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The claims submitted with this specification are intended to define the overall scope of this disclosure.

Description of Reference Numerals

[0102] 2 Disposable Cassette 4 Electric Medical Fluid Injector 6 Main Body 8 Fluid Line 10 Post 11 Receiving Surface 12 Spool or Reel 13 Retaining Groove 14 Extension Member 16 Retaining Tab 18 Holder 20 End Cap 22 Tab 24 Slot 26 End Cap 28 Holder 29 Air Detection Region 30 Bubble Suspension Device 31 Push Tab 32 Holder 34 Fluid Control Valve 35 Guard Member 36 Connection Configuration 37 Notch 38 Hinge Member 40 Round Member 42 Latch Member 44 Groove 46 Flexible Lock Tab 48 Lock Groove 50 Light 52 Identification Label 54 Connection Configuration 56 Lock Tab 58 Lock Groove 60 Latch Mechanism 129 Air Detector 134 Stopcock Actuator

Claims

1. A cassette for holding fluid path components for a fluid injector, the cassette comprising: a body defining a plurality of holding elements for holding at least one fluid path including at least one fluid path component for engaging with the fluid injector, the at least one fluid path component comprising at least one bubble suspension device held on the body by at least one of the plurality of holding elements, the at least one bubble suspension device being fluidly disposed between a fluid path component having at least one air detection region and a fluid path component having at least one stopcock, a body; at least one connecting member for removably connecting the body to the fluid injector; the at least one connecting member comprising at least one pivotable connecting mechanism protruding from the body; each of the at least one pivotable connecting mechanisms being configured to removably connect to a corresponding connecting mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first latch release position and a second latch position where the at least one fluid path component of the body is operably connected to a corresponding mechanism of the fluid injector. A cassette.

2. further comprising at least one extension member protruding from the body, the at least one extension member being configured to hold at least one of the at least one fluid path component of the fluid injector; the at least one fluid path component is further selected from at least one of at least one second stopcock, at least one second bubble suspension device, one or more fluid lines, at least one fluid path component having a second air detection region, and at least one removable end cap for the one or more fluid lines. The cassette according to claim 1.

3. The cassette according to claim 2, wherein the at least one extension member includes a retaining tab for retaining the fluid path component on the at least one extension member.

4. The at least one stop cock includes a first fluid filling position that creates fluid communication between the bulk fluid container and a syringe engaged with the fluid injector, a second fluid delivery position that creates fluid communication between the syringe and the patient tube set, and a third stop position that blocks fluid communication between the syringe, the bulk fluid container, and the patient tube set. The cassette according to claim 1, wherein when the cassette is in the second latch position, at least one of the plurality of retaining elements holds the at least one stop cock in a position configured to engage at least one stop cock actuator of the fluid injector.

5. The cassette according to claim 4, wherein the body further includes a shielding member that prevents user access to at least one stop cock held by the body.

6. The cassette according to claim 1, wherein at least one of the plurality of retaining elements holds the at least one air bubble suspension device in a position movable between a first priming position and a second injection position as the head of the fluid injector moves between an upright priming position and a downwardly angled injection position.

7. The cassette according to claim 6, wherein the at least one air bubble suspension device is configured to prime substantially all air bubbles from the at least one air bubble suspension device when primed in the upright priming position and to at least temporarily suspend air bubbles detected in the injection fluid during a fluid injection procedure when in the downwardly angled injection position.

8. The at least one fluid path component includes at least one fluid path component having an air detection region. The cassette according to claim 4, wherein at least one of the plurality of holding elements holds at least one fluid path component having an air detection region in a position operably engaged with an air detector on a receiving surface of the fluid injector.

9. The cassette according to claim 8, wherein the air detector detects air bubbles in the injection fluid during a fluid injection procedure, and in response to detection of the air bubbles in the injection fluid, transmits a signal to a control unit of the fluid injector to cause the at least one stopcock actuator to move the at least one stopcock from the second fluid delivery position and the third stop position.

10. The cassette according to claim 2, comprising two stopcocks, two air bubble suspension devices, a plurality of fluid line components, two fluid path components each having an air detection region, and a plurality of removable end caps from the fluid line.

11. The cassette according to claim 1, wherein the at least one connection member includes a flexible lock tab configured to be received in a corresponding lock groove of the fluid injector for removably attaching the body to the fluid injector.

12. The cassette according to claim 1, wherein the at least one pivotable connection mechanism of the at least one connection member includes at least one hinge member configured to be removably connected to at least one groove on a corresponding connection mechanism receptacle on a receiving surface of the fluid injector.

13. The cassette according to claim 1, further comprising an identification label disposed on the body, the identification label configured to provide information regarding the cassette, including at least one of an assembly date, a number of uses of the cassette, and a position of the cassette.

14. A fluid injector system comprising a fluid injector and a cassette, wherein the fluid injector includes a housing, At least one syringe removably held within the housing, comprising, a cassette for holding fluid path components for a fluid injector, a body defining a plurality of holding elements for holding at least one fluid path including at least one fluid path component for engaging with the fluid injector, the at least one fluid path component comprising at least one bubble suspension device held on the body by at least one of the plurality of holding elements, the at least one bubble suspension device being fluidly disposed between a fluid path component having at least one air detection region and a fluid path component having at least one stopcock, and at least one connecting member for removably connecting the body to the fluid injector, wherein the at least one connecting member comprises at least one pivotable connection mechanism protruding from the body, each of the at least one pivotable connection mechanisms being configured to removably connect to a corresponding connection mechanism receptacle of the fluid injector, whereby the body is pivotable relative to the fluid injector between a first latch release position and a second latch position where the at least one fluid path component of the body is operably connected to a corresponding mechanism of the fluid injector, a fluid injector system.

15. The fluid injector system according to claim 14, wherein the at least one fluid path component is further selected from at least one second stopcock, at least one second bubble suspension device, one or more fluid lines, at least one fluid path component having a second air detection region, and at least one removable end cap for one or more fluid lines.

16. Further comprising at least one stopcock actuator, The at least one stopcock has a first fluid filling position that creates fluid communication between the at least one bulk fluid container and at least one syringe engaged with the fluid injector, a second fluid delivery position that creates fluid communication between the at least one syringe and a patient tubing set, and a third stop position that blocks fluid communication between the at least one syringe, the at least one bulk fluid container, and the patient tubing set. The fluid injector system according to claim 15, wherein when the cassette is in the second latch position, the at least one stopcock is held in a position configured to engage with the at least one stopcock actuator of the fluid injector by at least one of the plurality of retaining elements. **Claim 17** The fluid injector system according to claim 16, wherein the at least one stopcock actuator actuates the at least one stopcock between the first fluid filling position, the second fluid delivery position, and the third stop position in response to a signal from a control unit of the fluid injector. **Claim 18** The fluid injector further comprises a head movable between an upright priming position and an injection position at a downward angle. As the head of the fluid injector moves between the upright priming position and the injection position at a downward angle, the at least one bubble suspension device is held in a position movable between a first priming position and a second injection position by at least one of the plurality of retaining elements. The fluid injector system according to claim 15. **Claim 19** The fluid injector further comprises at least one air detector on a receiving surface of the fluid injector. The fluid injector system according to claim 16, wherein the at least one fluid path component comprises at least one fluid path component including an air detection region held in a position operably engaged with the at least one air detector by at least one of the plurality of retaining elements. **Claim 20** The at least one air detector detects air bubbles in the injection fluid during a fluid injection procedure and, in response to detection of the air bubbles in the injection fluid, transmits a signal to a control unit of the fluid injector to cause the at least one stopcock actuator to move the at least one stopcock from the second fluid delivery position and the third stop position, the fluid injector system according to claim 19.

21. The fluid injector system according to claim 14, further comprising at least one locking groove, wherein the at least one connecting member comprises a flexible locking tab configured to be received in the corresponding at least one locking groove for removably attaching the body to the fluid injector.

22. The fluid injector further comprises at least one groove on the corresponding connection mechanism receptacle of the receiving surface of the fluid injector, The fluid injector system according to claim 14, wherein the at least one pivotable connection mechanism of the at least one connecting member comprises at least one hinge member configured to be removably connected to the at least one groove.

23. A method of attaching at least one fluid path to a fluid injector, the method comprising: operatively connecting at least one connecting member of a cassette to a corresponding connection mechanism receptacle on a receiving surface of the fluid injector to removably connect the cassette to a housing of the fluid injector; wherein the cassette is a body comprising a plurality of holding elements for holding at least one fluid path including at least one fluid path component for engaging the fluid injector, the at least one fluid path component comprising at least one air bubble suspension device held on the body by at least one of the plurality of holding elements, the at least one air bubble suspension device being fluidly disposed between a fluid path component comprising at least one air detection region and a fluid path component comprising at least one stopcock; a body at least one connecting member having at least one pivotable connecting mechanism protruding from the body; comprising By connecting the cassette to the housing of the fluid injector, the at least one fluid path component is arranged at a predetermined position on the housing of the fluid injector. method.

24. The method according to claim 23, further comprising the step of evaluating an identification label attached to the cassette to determine whether the cassette has already been used.

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