WO2010039662A2 - Medical fluid injection system with automated valve manifold - Google Patents

Medical fluid injection system with automated valve manifold Download PDF

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Publication number
WO2010039662A2
WO2010039662A2 PCT/US2009/058681 US2009058681W WO2010039662A2 WO 2010039662 A2 WO2010039662 A2 WO 2010039662A2 US 2009058681 W US2009058681 W US 2009058681W WO 2010039662 A2 WO2010039662 A2 WO 2010039662A2
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WO
WIPO (PCT)
Prior art keywords
injector
manifold
signal
fluid
valve
Prior art date
Application number
PCT/US2009/058681
Other languages
French (fr)
Other versions
WO2010039662A3 (en
Inventor
Frank M. Fago
Original Assignee
Mallinckrodt Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mallinckrodt Inc. filed Critical Mallinckrodt Inc.
Publication of WO2010039662A2 publication Critical patent/WO2010039662A2/en
Publication of WO2010039662A3 publication Critical patent/WO2010039662A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/223Multiway valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14212Pumping with an aspiration and an expulsion action
    • A61M5/1424Manually operated pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073Syringe, piston type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/10General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103General characteristics of the apparatus with powered movement mechanisms rotating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/121General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit interface between cassette and base
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1413Modular systems comprising interconnecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546Front-loading type injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Definitions

  • the invention relates generally to medical fluid injection systems and, more particularly, to valve assemblies or valve manifolds designed for use with such systems.
  • imaging may be enhanced by injecting contrast media into a subject's cardiovascular system.
  • contrast media For example, blood is generally indistinguishable from surrounding tissues in x- rays.
  • radio-opaque contrast media may be injected into a subject's heart to facilitate x-ray imaging.
  • a typical injection procedure may include an injection of contrast media followed by and/or along with an injection of saline.
  • existing injection techniques tend to involve a number of manual steps, which can result in errors.
  • physicians may prefer to inject contrast media by hand in order to achieve a feel for the injection.
  • a first aspect of the present invention is directed to a medical fluid injection system that includes a medical fluid injector having a syringe mounted thereto.
  • This medical fluid injector is designed to be held and supported by at least one hand of a user ⁇ e.g., a hand-held injector).
  • the system includes a first valve fluidly coupled with the syringe and in communication with the medical fluid injector.
  • This first valve is designed to transition between at least first and second conditions (e.g., an open condition and a closed condition) in response to wireless and/or electronic control signals provided by the medical fluid injector.
  • fluidly coupled refers to two or more things being interconnected (i.e., either directly or indirectly connected) in a manner that allows fluid to flow therebetween.
  • in communication refers to two or more things being designed in a manner such that electronic and/or wireless signals (e.g., radio frequency, infrared, cable synchronizing, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, wireless application protocol (WAP), spread-spectrum frequency hopping, half-duplex or full-duplex communication, Bluetooth standards, or the like), or more generally a control signal, can be transmitted therebetween.
  • wireless signals e.g., radio frequency, infrared, cable synchronizing, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, wireless application protocol (WAP), spread-spectrum frequency hopping, half-duplex or full-duplex communication, Bluetooth standards, or the like
  • Some embodiments of the first aspect may include medical tubing.
  • the syringe may be connected to one end of the medical tubing, and the first valve may be connected to another end (e.g., the opposite end) of the medical tubing.
  • medical fluid may flow through the medical tubing between the syringe and the first valve,
  • Some embodiments of the first aspect may include a second valve that is fluidly coupled with a medical fluid container (e.g., a syringe or a medical fluid bag).
  • a medical fluid container e.g., a syringe or a medical fluid bag.
  • This second valve may be designed to transition between at least first and second conditions in response to wireless and/or electronic control signals, or more generally control signals (e.g., from the medical fluid injector or another control signal source),
  • the second valve is fluidly coupled with the first valve.
  • the syringe and the medical fluid container may have medical fluid disposed therein.
  • the medical fluid in the syringe may be the same as or different from the medical fluid in the medical fluid container.
  • the medical fluid(s) in the syringe and container may be any appropriate fluid(s) such as, but not limited to, contrast media (e.g., for use in a medical imaging procedure), a radiopharmaceutical, saline, or any combination thereof.
  • the medical fluid injection system may have radiation shielding disposed about the syringe (e.g., in the form of a radiation-shielded syringe receptacle). This radiation shielding may include any appropriate radiation shielding materia! (e.g., lead, tungsten, tungsten-impregnated plastic, depleted uranium, or any combination thereof).
  • Some embodiments of the first aspect may include a third valve. While this valve is referred to as a
  • third valve the second valve mentioned above may not be present in all embodiments including the third valve.
  • the third valve may be fluidly coupled with the first valve, the second valve, a subject, a medical waste container, or any combination thereof.
  • the third valve may be designed to transition between at least first and second conditions in response to wireless and/or electronic control signals, or more generally control signals
  • One or more of the valves listed above may be disposed within a common housing (e.g., a "cassette").
  • first, second, and third valves are all located within a common housing.
  • a "valve” herein refers to a device for controlling the flow of medical fluid.
  • Some embodiments may include a fluid pump that is fluidiy coupled with at least one valve of the system.
  • the fluid pump may be any appropriate pump mechanism (e.g., peristaltic pump, gear pump, generated rotor (gerotor) pump, eccentric orbit pump, or the like).
  • the system includes a pressure transducer that is configured to monitor the biood pressure of a patient.
  • This pressure transducer may be fluidly coupled with the system (e.g., a valve thereof).
  • the medical fluid injector may be designed such that force utilized to expel medical fluid from the syringe using the medical fluid injector is derived from a user.
  • the user may squeeze a manual trigger, handle, or the like of the medical fluid injector to bias a ram of the medical fluid injector against a plunger of the syringe to expel medical fluid from therein.
  • Some embodiments of the first aspect may include another medical fluid injector in addition to the one that has already been mentioned above.
  • each of the medical fluid injectors may be fluidly coupled with the first valve.
  • One of the medical fluid injectors may be electrically-powered and programmable, and the other of the medical fluid injectors may be designed to be held and supported by a hand of a user.
  • a second aspect of the invention is directed to a method of operation for a medical fluid injection system.
  • a valve assembly is automatically positioned to create a first pathway ⁇ e.g., a first route/course in which fluid may flow) for medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) from a syringe that is mounted to a medical fluid injector.
  • the automatic positioning of the valve assembly occurs in response to a first control signal from the medica! fluid injector.
  • This first control signal may be generally in a wireless or electronic format.
  • the medical fluid injector is completely supported by at least one hand of an operator. As such, an operator may hold the medical fluid injector and completely support it in his/her hand while the valve assembly is being automatically positioned.
  • valve assembly may be automatically positioned to create a second pathway for medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) from a fluid source other than the syringe (e.g., another syringe or a medical fluid bag) in response to a second control signal from the medical fluid injector.
  • This second control signal may, like the first control signal, be in a wireless or electronic format.
  • the valve assembly may be automatically positioned to create a third pathway. While this pathway is referred to as a "third pathway," the second pathway mentioned above may not be present in all embodiments including the third pathway.
  • the third pathway of the valve assembly may enable the syringe to be filled and/or refilled with medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) and may be created in response to a third control signal (e.g., from the medical fluid injector or another appropriate control signal source).
  • This third control signal may, like the first control signal, be in a wireless or electronic format.
  • the valve assembly of this second aspect may be any appropriate valve assembly.
  • the valve assembly may include only a single valve.
  • the valve assembly may include a plurality of valves.
  • the first control signal may cause automatic positioning of only one valve of the assembly, of multiple valves of the assembly, or of all valves of the assembly.
  • the valve(s) associated with the valve assembly of the second aspect may be any appropriate type(s) of valve (e.g., an actuatable stopcock).
  • the blood pressure of a subject may be monitored. For instance, a patient's blood pressure may be monitored while medical fluid is not being expelled from the injector (e.g., not being injected into the patient).
  • a third aspect of the present invention is embodied by a medical fluid injection system.
  • This injection system includes a first injector, a manifold, a first injector conduit, and an injection conduit.
  • the manifold includes a plurality of signal-actuated valves (which hereafter may also be referred to as "manifold valves").
  • the first injector conduit extends between the first injector and the manifold, while the injection conduit extends from the manifold (e.g., to a patient).
  • a number of feature refinements and additional features are applicable to the third aspect of the present invention. These feature refinements and additional features may be used individually or in any combination.
  • the following discussion is applicable to the third aspect, up to the start of the discussion of a fourth aspect of the present invention. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the third aspect.
  • the first injector may be of any appropriate size, shape, configuration, and/or type.
  • the first injector may be in the form of a hand-held injector.
  • Hand-held injectors may be held in the hand of a user and supported entirely by the user during operation of the injector, fluid discharges from the hand-held injector may be based at least in part upon manual forces provided by the user (including where the entire force for affecting a fluid discharge is by a manually-initiated user force), or both.
  • the first injector may also be in the form of a power injector of any appropriate size, shape, configuration, and/or type, including without limitation a programmable power injector.
  • At least one syringe may be installed on the first injector in any appropriate manner.
  • Any appropriate fluid may be used by any injector incorporated by the medical fluid injection system, such as contrast media (e.g., for use in a medical imaging procedure), a radiopharmaceutical, saline, or any combination thereof.
  • Each of the first injector conduit and the injection conduit may be of any appropriate size, shape, configuration, and/or type.
  • the first injector conduit and the injection conduit are each in the form of medical tubing.
  • the injection conduit may include an appropriate vasculature access device (e.g., a catheter), such that fluid directed through the injection conduit may be injected into a patient.
  • Any appropriate signal may be used to actuate each individual manifold valve. The same type of signal may be provided to each manifold valve to actuate the same. One or more different types of signals may be utilized to actuate different ones of the various manifold valves. A fluid-pressure signal may be used to actuate at least one of the manifold valves.
  • Control signals may be used to actuate at least one of the manifold valves (where a "control signal” is a pulse or frequency of electricity or light that represents a control command as it travels over a network, a computer channel, orwirelessly, such that "control signals” encompasses both electrical signals and wireless communications).
  • a first manifold valve is actuated by a fluid-pressure signal
  • a second manifold valve is actuated by a control signal
  • a first manifold valve may be actuated in one manner by a fluid-pressure signal (e.g., moved to a first position) and may be actuated in another manner by a control signal (e.g., moved to a second position).
  • the manifold may include two discrete sections - a manifold drive unit and a cassette that is mounted to the manifold drive unit.
  • the cassette may be mounted to the manifold drive unit in any appropriate manner, including detachably (e.g., where a cassette may be installed on and then subsequently removed from the manifold drive unit).
  • the cassette may include the plurality of signal-actuated valves, while the manifold drive unit may include an actuator for each of the signal-actuated valves (along with other appropriate components, such as a controller that could interact with each of the signal-actuated valves).
  • the cassette is in the form of a disposable and the manifold drive unit is reusable with multiple cassettes (e.g., for multiple injection operations on multiple patients).
  • the medical fluid injection system may utilize a tubing set, where this tubing set includes a manifold connector and a plurality of tubes that each extend from this common manifold connector.
  • This tubing set includes a manifold connector and a plurality of tubes that each extend from this common manifold connector.
  • One or more features may be incorporated by the manifold connector and/or the manifold so that the manifold connector can only be installed in a single orientation relative to the manifold.
  • the manifold connector may interface with the manifold (e.g., the above-noted cassette) in any appropriate manner.
  • the manifold connector of the tubing set may be detachably interconnected with the manifold.
  • both the first injector conduit and a first fluid source conduit extend from the manifold connector and are part of the tubing set.
  • Other tubes may extend from this manifold connector as well, such as a waste container tube (e.g., a tube that extends between the manifold and a waste container).
  • the various tubes may be joined together for some distance as they extend from the manifold connector. In one embodiment, this joined condition of tubes extending from the manifold connector exists for a distance of at least about 24 inches.
  • the first injector may incorporate one or more signaling devices of any appropriate type for signaling one or more of the signal-actuated valves of the manifold.
  • Each signaling device incorporated by the first injector may dispose the signal-actuated valves in different configurations or flowpath arrangements. For instance: 1 ) a certain signaling device/signal may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect the first injector and the injection tube; 2) a certain signaling device/signa!
  • a certain signaling device/signal may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect another injector (e.g., a power injector) and the injection tube; 3) a certain signaling device/signal may used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to allow the first injector to be "loaded" with fluid (e.g., to allow fluid to be directed into a syringe installed on the first injector), which thereafter may be directed through the manifold and into the injection conduit; 4) a certain signaling device/signal may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect the injection conduit with a waste container or the like; and 5) any combination of the foregoing.
  • a flowpath through the manifold e.g., a flowpath configuration
  • each of these various flowpath configurations for the manifold may be achieved in any appropriate manner, in one embodiment the flowpath configurations are realized by repositioning at least one, and possibly at least two, of the manifold valves. In one embodiment, each of the various manifold valves is in the form of a three-way stopcock.
  • the medical fluid injection system may further include a first fluid source and a first fluid source conduit that extends between the first fluid source and the manifold. Any appropriate fluid may be utilized by the first fluid source, including saline.
  • first fluid source including saline.
  • the manifold e.g., the above-noted cassette
  • the manifold may incorporate an appropriate pressure transducer.
  • a first configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a first flowpath from the first injector to the injection conduit, while fluidly isolating the first injector from each of the first fluid source and the pressure transducer, This will allow operation of the first injector to direct fluid through the manifold and into/through the injection conduit ⁇ e.g., for injection into a patient).
  • a second configuration, arrangement, or positioning of the above-noted first, second, and third manifold valves may provide a second flowpath from the first fluid source to the injection tube, while fluidly isolating the first fluid source from each of the first injector and the pressure transducer (e.g., to accommodate a flow from the first fluid source, through the manifold, and into the injection conduit).
  • the manifold may incorporate a pump of any appropriate type to direct a fluid flow from the first fluid source and through the injection tube (e.g., peristaltic pump, gear pump, generated rotor (gerotor) pump, eccentric orbit pump).
  • the drive for such a pump could be incorporated into the above-noted manifold drive unit, while another portion of the pump (e.g., a pump stator and/or rotor) couid be incorporated into the above-noted cassette.
  • a third configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a third flowpath from the injection conduit at least to the pressure transducer, while fluidly isolating the pressure transducer from each of the first fluid source and the first injector. This may allow a patient's blood pressure to be monitored when the injection conduit is in fluid communication with the patient's vasculature.
  • the medical fluid injection system could further include a waste container and a waste container conduit or tube that extends between the waste container and manifold so that the waste container may be fluidly interconnected with the injection conduit via this third flowpath.
  • One or more valves of any appropriate type may be included in the waste container conduit ⁇ e.g., a check valve disposed between the waste container and the pressure transducer) to preclude fluid from flowing from the waste container to the manifold.
  • the medical fluid injection system may further include a second injector.
  • a fourth configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a fourth flowpath from the second injector to the first injector, while fluidly isolating the first injector from each of the pressure transducer and the first fluid source, and further while fluidly isolating the second injector from each of the pressure transducer and the first fluid source. This may allow a fluid transfer from the second injector (e.g., a power injector) to the first injector (e.g., a hand-held injector).
  • the second injector e.g., a power injector
  • the first injector e.g., a hand-held injector
  • a fifth configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a fifth flowpath from the second injector (e.g., a power injector) to the injection conduit, while fluidly isolating the first injector from each of the pressure transducer and the first fluid source, and further while fluidly isolating the first injector from the second injector.
  • this fifth flowpath allows fluid from the second injector to be directed through the manifold and into/through the injection conduit (e.g., for injection into a patient).
  • the medical fluid injection system includes two separate injectors (e.g., a hand-held injector and a power injector).
  • the plurality of signal-actuated valves used by the manifold may include a first manifold valve that controls the fluid communication between the first injector, the second injector, and the injection tube.
  • the first and second injectors may be fluidly interconnected by the first manifold valve being in a first position (e.g., to allow contrast media from a power injector to be transferred to a hand-held injector).
  • the first injector may be fluidly interconnected with the injection conduit, the first injector may be fluidly isolated from the second injector, and the second injector may be fluidly isolated from the injection conduit, all by the first manifold valve being in a second position.
  • the second injector may be fluidly interconnected with the injection conduit, the first injector may be fluidly isolated from the second injector, and the first injector may be fluidly isolated from the injection conduit, all by the first manifold valve being in a third position,
  • a fourth aspect of the present invention is embodied by a medical fluid injection system.
  • This injection system includes a first injector, a first fluid source, a manifold, a tubing set, and an injection tube.
  • the manifold includes a manifold drive unit and a cassette that is detachably mounted to this manifold drive unit.
  • This cassette in turn includes a plurality of signal-actuated valves.
  • the tubing set extends from the cassette and includes a first injector tube (e.g., extending between the first injector and the cassette) and a first fluid source tube (e.g., extending between the first fluid source and the cassette).
  • a fifth aspect of the present invention is embodied by a medical fluid injection system.
  • This injection system includes a first injector, a first fluid source, a manifold, a tubing set, and an injection tube.
  • the manifold includes a plurality of signal-actuated valves.
  • the tubing set includes a manifold connector for mounting the tubing set to the manifold.
  • the tubing set further includes a first injector tube (e.g., extending between the first injector and the cassette) and a first fluid source tube (e.g., extending between the first fluid source and the manifold) that each extend from the manifold connector.
  • the injection tube extends from the manifold (e.g., to a patient), and may communicate with the tubing set via multiple flowpaths through the manifold and as dictated by the positioning of the various signal-actuated valves.
  • any power injector that may be utilized to provide a fluid discharge may be of any appropriate size, shape, configuration, and/or type.
  • any such power injector may utilize one or more syringe plunger drivers of any appropriate size, shape, configuration, and/or type, where each such syringe plunger driver is capable of at least bi-directionai movement (e.g., a movement in a first direction for discharging fluid; a movement in a second direction for accommodating a loading of fluid or so as to return to a position for a subsequent fluid discharge operation), and where each such syringe plunger driver may interact with its corresponding syringe plunger in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to advance the syringe plunger in at least one direction (e.g., to discharge fluid).
  • each such syringe plunger driver is capable of at least bi-directionai movement (e.g., a movement in a first direction for discharging fluid; a movement in a second direction for accommodating a loading of fluid or so as to return to
  • Each syringe plunger driver may utilize one or more drive sources of any appropriate size, shape, configuration, and/or type. Multiple drive source outputs may be combined in any appropriate manner to advance a single syringe plunger at a given time.
  • One or more drive sources may be dedicated to a single syringe plunger driver, one or more drive sources may be associated with multiple syringe plunger drivers (e.g., incorporating a transmission of sorts to change the output from one syringe plunger to another syringe plunger), or a combination thereof.
  • Representative drive source forms include a brushed or brushless electric motor, a hydraulic motor, a pneumatic motor, a piezoelectric motor, or a stepper motor.
  • Any such power injector may be used for any appropriate application where the delivery of one or more medical fluids is desired, including without limitation any appropriate medical application (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; single photon emission computed tomography or SPECT imaging; positron emission tomography or PET imaging; X-ray imaging; angiographic imaging; optica! imaging; ultrasound imaging).
  • Any such power injector may be used in conjunction with any component or combination of components, such as an appropriate imaging system (e.g., a CT scanner). For instance, information could be conveyed between any such power injector and one or more other components (e.g., scan delay information, injection start signal, injection rate).
  • any appropriate number of syringes may be utilized with any such power injector in any appropriate manner (e.g., detachably; front-loaded; rear-loaded; side-loaded), any appropriate medical fluid may be discharged from a given syringe of any such power injector (e.g., contrast media, a radiopharmaceutical, saline, and any combination thereof), and any appropriate fluid may be discharged from a multiple syringe power injector configuration in any appropriate manner (e.g., sequentially, simultaneously), or any combination thereof, in one embodiment, fluid discharged from a syringe by operation of the power injector is directed into a conduit (e.g., medical tubing set), where this conduit is fluidly interconnected with the syringe in any appropriate manner and directs fluid to a desired location (e.g., to a catheter that is inserted into a patient, for instance for injection).
  • a conduit e.g., medical tubing set
  • each syringe includes a syringe barret and a plunger that is disposed within and movable relative to the syringe barrel. This plunger may interface with the power injector's syringe plunger drive assembly such that the syringe plunger drive assembly is able to advance the plunger in at least one direction, and possibly in two different, opposite directions.
  • Figure 1 is a schematic of one embodiment of a medical fluid injection system fluidly coupled to a patient.
  • Figure 2 is a schematic of a variation of the medical fluid injection system of Figure 1 and fluidly coupled to a patient, and which illustrates at least certain of its components in more detail and with a power injector of the medical fluid injection system being shown in a perspective view,
  • Figure 3 is a cutaway view of a manifold cassette of a manifold used by the medical fluid injection system of Figure 2.
  • Figure 4 is a plan view of a tubing set used by the medical fluid injection system of Figure 2.
  • Figure 5 is a plan view of a manifold drive unit of the manifold used by the medical fluid injection system of Figure 2.
  • Figure 6 is a perspective view of the manifold cassette, part of the tubing set, and the manifold drive unit of Figures 3-5.
  • Figures 7-11 are exemplary configurations of the manifold cassette illustrated in Figure 3 and for the fluid component arrangement of Figure 1.
  • Figure 12 is a plan view of a pump used by the manifold of Figures 3, 5, and 6.
  • Figures 13-14 are plan views of other representative pumps that may be used by the manifold of
  • Figure 15 is a perspective view of one embodiment of an eccentric orbit pump that may be used by the manifold of Figures 3, 5, and 6.
  • Figure 16 presents sequential views that illustrate the pumping action of the eccentric orbit pump illustrated in Figure 15.
  • Figure 17 is a flowchart illustrating a method for injecting medical fluid into a patient using the medical fluid injection system of Figure 1.
  • Figure 18 is a perspective view of another embodiment of a medical fluid injection system.
  • Figure 19 is a plan view of a stopcock used by the medical fluid injection system of Figure 18.
  • Figures 20-21 are plan views of the stopcock of Figure 19, and how the same interfaces with the injector of the medical fluid injection system of Figure 18, DETAILED DESCRIPTION
  • the articles “a”, “an”, and “the” are intended to mean that there are one or more of the elements.
  • the terms “comprising”, “including”, and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.
  • any use of the terms “top”, “bottom”, “above”, “below 11 , and variations of these terms is made for convenience, but does not require any particular orientation of the components.
  • use of the terms “lateral”, “longitudinal”, “vertical”, and variations of these terms is made for convenience, and may refer to relative directions rather than absolute directions.
  • the term “coupled” or the like herein refers to two or more things being interconnected (i.e., either directly or indirectly connected).
  • the various embodiments are each directed to components of a system for injecting medical fluids into a patient.
  • contrast media may be injected into a patient to enable monitoring of fluid flow through the patient's circulatory system and/or to enhance imaging of various tissues of the patient.
  • a radiopharmaceutical may be injected to image tissues (e.g., tumor) and/or treat tissues of a patient. While the following discussion focuses on injection of contrast media, the disclosed embodiments are not intended to be limited to such fluids. Rather, any medical fluid, such as, for example, contrast media, radiopharmaceuticals, saline solution, or a combination thereof, may be utilized in the described embodiments.
  • Embodiments of injection system components described below include: an exemplary valve assembly or valve manifold embodied in the form of an injector-controlled stopcock mechanism; an exemplary injector designed to control the stopcock mechanism; and exemplary pumps for use with the valve manifold.
  • the injector-controlled stopcock mechanism may include a stopcock coupled to a gear that meshes with another gear controlled by the injector.
  • the injector-controlled stopcock mechanism may include what may be characterized as a "cassette" that includes one or more stopcocks within a common housing.
  • the injector-controlled stopcock mechanism may include a manifold drive unit to control the stopcock(s).
  • the injector may include one or more buttons to orient the stopcock(s) in various configurations (e.g., to provide or define various flowpaths through the manifold).
  • the injection system may include a fluid pump, such as an eccentric orbit pump, that is fluidly coupled with and may optionally be a component of the valve manifold. This eccentric orbit pump may be utilized to move fluid therethrough without the use of a tube as commonly utilized in medical pumps. Other embodiments may not include a pump or may include another appropriate pumping mechanism ⁇ e.g., one that is utilized with medical tubing).
  • a medical fluid injection system 10 for injecting medical fluid into a patient 90 is iliustrated.
  • the injection system 10 generally includes a hand-held or hand-assisted injector 12, a power injector 40 (e.g., a fluid source), a contrast media source 72, a saline source 66, and a waste container or bag 62.
  • the components of the injection system 10 may be fluidly coupled with each other and with the patient 90 via a manifold or valve assembly 100 (only schematically illustrated in Figure 1, but shown in more detail in Figures 2-6) of the injection system 10.
  • an appropriate signal may be used to configure or define the flowpath through the manifold 100 (e.g., to fluidly interconnect certain components of the injection system 10 and/or the patient 90).
  • a description of the various flowpaths through the manifold 100 and how the same may be realized will be addressed in more detail below.
  • the hand-held injector 12 includes a syringe 22 and a lever or trigger 20. Manually actuating the lever 20 (e.g., via forces from an operator or user) discharges contrast media from the syringe 22, into a hand-held discharge tube 26, and into the manifold 100. This particular flow from the hand-held injector 12 is introduced into the manifold 100 via a stopcock 122c.
  • the power injector 40 includes a powerhead 42.
  • the power injector 40 may communicate with one or more external or remote devices (e.g., a remote console, a hospital information system) by a communication link 48 of any appropriate type (e.g., a cable as shown; wirelessly).
  • a power injector syringe 46 is installed on the powerhead 42. Operation of the powerhead 42 (e.g., in accordance with one or more injection protocols that each may be in the form of a programmed sequence of any type) discharges contrast media (or any other appropriate fluid) from the power injector syringe 46, into a power injector discharge tube 52 (or more generally a contrast media tube for the iliustrated application), and into the manifold 100. This particular flow from the power injector 40 is introduced into the manifold 100 via the above-noted stopcock 122c.
  • the contrast media source 72 may utilize a container of any appropriate size, shape, configuration, and/or type. Contrast media (or any other appropriate fluid) may be directed out of the contrast media source 72 by a contrast media tube 74. This flow out of the contrast media source 72 is introduced into the manifold 100 via the above-noted stopcock 122c. In the illustrated embodiment, the contrast media tube 74 and the power injector discharge tube 52 merge together. An appropriate connector would allow the power injector discharge tube 52 to join the contrast media tube 72, or the contrast media tube 74 and the power injector discharge tube 52 could be in the form of Y-type tubing.
  • the saline source 66 (more generally, a fluid source) may utilize a container of any appropriate size, shape, configuration, and/or type. Saline (or any other appropriate fluid) may be directed out of the saline source 66 by a saline tube 68. This flow out of the saline source 66 is introduced into the manifold 100 via a stopcock 122b.
  • the waste bag 62 may be of any appropriate size, shape, configuration, and/or type.
  • a waste tube 64 extends between the waste bag 62 and the manifold 100. Flow from the manifold 100, through the waste tube 64, and into the waste bag 62 is controlled by a stopcock 122a.
  • One or more of the stopcocks 122a, 122b, 122c may be repositioned to provide a flowpath through the manifold 100 that fluidly interconnects two or more components of the medical fluid injection system 10 1 or that fluidiy interconnects at least one of the components of the medical fluid injection system 10 with the patient 90.
  • a patient or injection tube 92 extends between the patient 90 and the manifold 100.
  • At least the waste bag 62, waste tube 64, saline source 66, saline tube 68, contrast media source 72, and contrast media tube 74 may be characterized as a tubing set 60.
  • Each of the tubes 64, 68, 74, 52, 26, and 92 may be any appropriate conduit, including in the form of medical tubing.
  • the contrast media source 72 may be utilized to provide contrast media to the power injector 40 and/or the hand-held injector 12. For instance, in preparation for an upcoming imaging procedure, the contrast media source 72 may be utilized to fill one or both of the syringes 22, 46 that are mounted to the injectors 12, 40, respectiveiy, As another example, the contrast media source 72 may be utilized during an imaging procedure to refill one or both of the syringes 22, 46 that are mounted to the injectors 12, 40, respectively (e.g., when additional contrast media is desired for the injection procedure).
  • the contrast media source 72 may be in communication with the power injector 40, such as via radio frequency communication (e.g., to monitor information for patient safety and billing) or by any appropriate communication link.
  • the power injector 40 may be fluidly coupled to the contrast media source 72 in any appropriate manner.
  • the power injector 40 may be fluidiy coupled to the contrast media source 72 using a check valve arrangement (not shown) or an injector-controlled valve (e.g., as in Figures 18-21 ).
  • the contrast media source 72 may be characterized as a bulk contrast media source - having a volume of contrast media that may accommodate multiple injections of multiple patients.
  • One or more of the illustrated components of the injection system 10 may be omitted in other embodiments of the system 10.
  • the power injector 40 may be omitted, and the portion of the tubing set 60 interconnecting the contrast media source 72 with the manifold 100 may not exhibit a "Y" configuration, since there would be no need to allow the power injector 40 to be fluidly coupled with the rest of the injection system 10.
  • the contrast media source 72 may be omitted (e.g., as in the variation illustrated in Figure 2).
  • Figure 2 presents a variation of the medical fluid injection system 10 from Figure 1, and shows more detail regarding the manifold 100. Corresponding components between these two embodiments are identified by the same reference numerals. Those corresponding components that differ in at least some respect are identified by a superscripted "i" notation. In this regard, Figure 2 is characterized as a medical fluid injection system 10'.
  • the hand-held injector 12 1 is illustrated as being of a "single hand” type, versus the "dual hand” type illustrated in Figure 1. In any case, these two injectors 12, 12' may be interchanged, and other hand-held injector configurations may be appropriate as well.
  • the hand-held injector 12 1 also includes various signaling devices 14, 16, and 18 that each may communicate with the manifold 100 via a communication link 24 of any appropriate type (wired in the illustrated embodiment). These signaling devices could also be used by the Figure 1 embodiment or by any other hand-held power injector.
  • the power injector 40 from the injection system 10' of Figure 2 includes a display or graphical user interface 44 (e.g., for displaying a blood pressure of the patient 90; for displaying information regarding one or more aspects of the operation of the power injector 40), and a communication link 50 of any appropriate type (wired in the illustrated embodiment) extends between the power injector 40 and the manifold 100.
  • the power injector discharge tube 52 1 itself extends to the manifold 100 ⁇ i.e., it does not merge with a contrast media tube 74 as in the case of the Figure 1 embodiment), and again may also be characterized as a contrast media tube 52'.
  • the manifold 100 generally includes a cassette 102 (e.g., Figures 3 and 6) having one or more stopcocks 122a, 122b, 122c (more generally, signal-actuated valves), along with a manifold drive unit 130 (e.g. Figures 5 and 6), each described in more detail below.
  • the tubing set 60 1 may be coupled to the manifold 100 to fluidly couple the manifold 100 to one or more of the power injector 40, the saline source 66, the waste bag 62, another component which may be included in the system 10', or any combination thereof.
  • a contrast media source 72 (e.g., as in Figure 1) may be fluidly coupled with the manifold 100 in addition to or in lieu of the power injector 40.
  • the position of the injectors 12' and 40 in the injection system 10' could be switched as well.
  • Either or each of the injectors 12 [ , 40 may include various buttons, switches, levers, knobs, toggles, or the like that function as signaling devices to control one or more of the signal-actuated valves 122a, 122b, 122c of the manifold 100 (e.g., as in Figures 7-11) via, for instance, electronic and/or wireless signals (e.g., radio frequency, infrared, cable synchronizing, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, wireless application protocol (WAP), spread-spectrum frequency hopping, half-duplex or full-duplex communication, Bluetooth standards, or the like), and which may be categorically defined as "control signals.”
  • an electronic and/or wireless signal may be transmitted from either of the injectors 12', 40 to the manifold 100, which in turn controls (e.g., opens, closes, rotates, actuates, or the like) one of more of the signal-actuated valves 122a, 122
  • a signal to the manifold 100 may reposition at least one of the 122a, 122b, 122c to provide a desired flowpath through the manifold 100 (e.g., to fluidly interconnect desired components of the medical fluid injection system 10' and/or patient 90).
  • An exemplary protocol may automatically position one or more of the valves 122a, 122b, 122c in the manifold 100 such that the injector 12 1 or power injector 40 (more specifically their respective syringes 22, 46) is fluidly coupled with the patient 90 in response to an appropriate signal from one of the injectors 12, 40 (e.g., due to depression of a button, squeezing of a lever, toggling of a switch, or the like).
  • a first such protocol could configure the manifold 100 to fluidly interconnect the syringe 22 of the hand-held injector 12' and the patient 90.
  • a second such protocol could configure the manifold 100 to fluidly interconnect the syringe 46 of the power injector 40 and the patient 90.
  • each of these signaling device may provide a different configuration for the manifold 100 (e.g., each such signaling device may provide or define a different flowpath through the manifold 100 to fluidly interconnect different components of the injection system 10 1 and/or the patient 90), may initiate an associated function, or both.
  • a signaling device14 (e.g., in the form of a button) on the hand-held injector 12' may be programmed with a protocol to configure manifold 100 to fluidly interconnect the saiine source 66 and the patient 90, to initiate a flow of saline from the saline source 66 to the patient 90, or both.
  • a signaling device18 (e.g., in the form of a button) on the hand-held injector 12' may be programmed with a protocol to refill the syringe 22 ⁇ e.g., from the power injector 40 to the hand-held injector 12' or from a contrast media source (e.g., contrast media source 72 in Figure 1) to the hand-held injector 12 1 ).
  • a mechanical lever 20 on the hand-held injector 12' may be programmed with a protocol to fluidly couple the injector 12 1 to the patient 90 while the lever 20 advances a plunger within the syringe 22. Moving the lever 20 could result in issuing an appropriate control signal. However, the fluid pressure provided by an actuation of the lever 20 could also provide a fluid-pressure signal to the manifold 100 which could fluidly interconnect the hand-assisted injector 12 1 with the patient 90. In any case, the lever 20 on the hand-assisted injector 12' may provide a more powerful ergo ⁇ omic grip than a common syringe.
  • a signaling device 18 (e.g., a smaller lever or trigger) on the hand-held injector 12 1 may be programmed with a protocol to fluidly interconnect the patient 90 with the waste bag 62, to eject fluid and air into the waste bag 62 that may have been pulled in by a catheter or other vasculature access device included with the patient or injection tube 92, or both (e.g., for an air purge operation).
  • the hand-held injector 12 1 may include a signaling device programmed with a protocol to start or stop injection of contrast media from the power injector 40 to the patient 90. Other common protocols may be programmed into the hand-held injector 12 1 . Each of these signaling devices/protocols may be incorporated by the power injector 40 as well.
  • the manifold 100 of the injection system 10 1 may be in the form of a two-part structure - a cassette 102 (e.g., Figures 3 and 6) and a manifold drive unit 130 (e.g., Figures 4 and 6).
  • the cassette 102 could be in the form of a disposable structure (e.g., for a single procedure or injection), while the manifold drive unit 130 could be a multi-use or reusable structure (e.g., for use with multiple injections to multiple patients).
  • the cassette 102 generally includes a plurality of signal-actuated or manifold valves 122a, 122b, 122c (e.g., three-way stopcocks), which may be arranged in various configurations/positions to control fluid flow in the injection system 10 1 and/or to the patient 90.
  • signal-actuated or manifold valves 122a, 122b, 122c e.g., three-way stopcocks
  • manifold valves 122a, 122b, 122c any appropriate number of manifold valves may be utilized by the cassette 102 and these valves may be disposed in any appropriate arrangement.
  • one or more valves of any appropriate type may be used by the cassette 102 and may be repositioned in response to an appropriate signal or combination of signals to provide a certain flowpath through the manifold 100 - to fluidly interconnect one or more components of the medical fluid injection system 10 1 , the patient 90, or any combination thereof.
  • each manifold valve 122a, 122b, 122c is in the form of a stopcock and includes a stopcock flow channel 124 having three accesses or ports (e.g., a T-shaped structure in the illustrated embodiment). Moreover, each manifold valve 122a, 122b, 122c has a drive feature 126 (e.g., in the form of a projection) to enable rotation of the manifold valves 122a, 122b, 122c as described below.
  • a drive feature 126 e.g., in the form of a projection
  • the stopcock 122c may be fluidly coupled with the stopcock 102b, an injector connector 104 (e.g., a standard Luer connector) on the cassette 102, and a contrast media line or flow channel 120 within the cassette 102.
  • the stopcock 102b may be fluidly coupled with the stopcock 122a, the stopcock 122c, and a saline line or flow channel 114 within the cassette 102.
  • a saline pump 116 for moving saline from the saline source 66 to the patient 90 may be situated in or communicate with the saline line 114.
  • the saline pump 116 is illustrated in more detail in Figure 12, and is discussed below.
  • saline pump 116 may utilize any appropriate drive feature (e.g., pump shaft 118) to enable its rotation by the manifold drive unit 130.
  • the stopcock 122a is fluidly coupled with the stopcock 122b, a patient connector 106 (e.g., a standard Luer connector) on the cassette 102, and a waste line or flow channel 108 within the cassette 102.
  • a pressure transducer 110 of any appropriate type (e.g., to monitor the blood pressure of the patient 90 on a scale of approximately 3-5 psi) and a check valve 112 (e.g., to block a flow of waste from the waste bag 62 to the patient 90).
  • the check valve 112 may open only at higher pressures than those associated with blood pressure (e.g., greater than 10 psi). Pressure from operation of either of the injectors 12, 40 may be adequate to open the check valve 112, thereby enabling waste to be deposited in the waste bag 62 (e.g., for an air purge operation).
  • the tubing set 60 1 illustrated in Figures 2 and 4 generally includes three tubes or conduits (e.g., power injector discharge tube 52 1 , saline tube 68, and waste tube 64) corresponding to the contrast media line or flow channel 120, the saline line or flow channel 114, and the waste line or flow channel 108 of the cassette 102, respectively.
  • any number of signal-actuated valves may be utilized by the cassette 102, and accordingly any number of tubes may make up the tubing set 60 1 .
  • the manifold 100 may have a signal-actuated valve for each tube being used by the tubing set 60', although such may not always be the case, [0081 ]
  • the power injector discharge tube 52 1 , saline tube 68, and waste tube 64 interface with a common connector 78 which may couple the tubing set 60' to the manifold 100, more specifically the cassette 102.
  • the connector 78 may be referred to as a "manifold connector 78.”
  • the manifold connector 78 thereby simultaneously fluid interconnects multiple tubes (tubes 52 1 , 68, and 64 in the illustrated embodiment) with the manifold 100 (more specifically with the lines 120, 114, and 108, respectively).
  • the manifold connector 78 may be configured to enable the manifold 100 to clamp or otherwise securely maintain the tubing set 60' in place within the cassette 102, as described below.
  • the manifold connector 78 could also be integrally formed with or separately attached to the cassette 102 in a non-detachable relation (i.e., so that the manifold connector 78 is not intended to be removed from the cassette 102 such that the tubing set 60' and cassette 102 could be dispersed of as a single unit).
  • Allowing multiple fluid interconnections to be simultaneously made with the cassette 102 reduces the time/complexity to set up the medical fluid injection system 10 ⁇
  • One or more features may be utilized to reduce the potential that the manifold connector 78 wiil be incorrectly installed on the cassette 102.
  • the tubing set 60', the manifold connector 78, and/or the cassette 102 may be color-coded, labeled, or configured to facilitate proper connection of the fluid lines fluid lines 120, 114, and 108 of the cassette 102 to the tubes 52 1 , 68, and 64, respectively, of the tubing set 60 ⁇
  • One or more features could be incorporated by the manifold connector 78 and/or the cassette 102 such that the manifold connector 78 may only be installed when in a single orientation relative to the cassette 102 ⁇ i.e., a positional registration feature or features may be utilized such that the manifold connector 78 may only go on "one way" to the cassette 102).
  • individual connectors could be provided at corresponding ends of the individual tubes 64, 68, 52 1 to separately fluidly couple each tube 64, 68, 52' with a particular one of the various fluid lines or flow channels 108, 114, 120 of the cassette 102.
  • the opposite end of one or more of these tubes 64, 68, 52 j may include an appropriate connector as well.
  • one end of the power injector tube 54' may include a connector 54 (e.g., a standard Luer connection) for fluidly coupling the contrast line 52 1 with the power injector syringe 46 and/or contrast media source 72 ⁇ Figure 1 ).
  • a saline spike 70 may be disposed at one end of the saline tube 68 to connect the saline source 66, such as a saline bag, to the saline tube 68.
  • the waste bag 62 may be integral with the tubing set 60' or otherwise "pre-connected" to the waste tube 64, or the waste tube 64 may terminate in a spike similar to the saline spike 70 (or any other appropriate connector) to enable connection of the waste tube 64 to a separate waste bag 62, [0084]
  • Another feature of the tubing set 60* is directed to facilitating the set-up of the medical fluid injection system 10 1 .
  • the tubing set 60 1 includes a section 76 where the tubes 64, 68, and 52 1 are joined together or are otherwise maintained in a fixed position relative to each other, and which may be done in any appropriate manner.
  • This joined section 76 extends from the manifold connector 78 of the tubing set 60 1 .
  • the joined section 76 has a length of at least about 24 inches, Having the joined section 76 may reduce the potential for individual tubes of the tubing set 60 1 becoming tangled during and after incorporating the same in the medical fluid injection system 10'.
  • Figures 5 and 6 present views of the manifold drive unit 130 of the manifold 100.
  • the manifold drive unit 130 may receive the cassette 102 and control the position of the signal-actuated valves 122a, 122b, 122c of the cassette 102 based upon an appropriate signal from the hand-held injector 12 or the power injector 40.
  • the manifold drive unit 130 generally includes electrical and/or mechanical control elements (e.g., drives, motors, gears, or the like) for positioning/configuring the stopcocks 122a, 122b, 122c, operating the saline pump 116, and reading the pressure transducer 110.
  • stopcock actuators 132 of the manifold drive unit 130 may be coupled to the stopcocks 122a, 122b, 122c of the cassette 102 to enable the manifold drive unit 130 to rotate the stopcocks 122a, 122b, 122c into desired positions (e.g., to provide different flowpaths through the manifold 100).
  • each stopcock actuator 132 is associated with a different one of the stopcocks 122a, 122b, 122c. Any appropriate way of interfacing or interconnecting each stopcock actuator 132 with its corresponding stopcock 122a, 122b, 122c may be utilized.
  • each stopcock actuator 132 incorporates a drive feature 134 (e.g., an A-shaped recess) that mechanically couples with the drive feature 126 (e.g , an A-shaped projection) of the corresponding stopcock 122a, 122b, 122c to ensure that the stopcocks 122a, 122b, 122c may only be coupled to the stopcock actuators 132 in a predictable manner (e.g., the projections 126 only fit into the recesses 134 one way, like a key).
  • Other ways of realizing a predictable alignment between the stopcocks 122a, 122b, 122c and their corresponding stopcock actuator 132 may be utilized.
  • the manifold drive unit 130 includes a pump drive 136 (e.g., a motor) for controlling/operating the saline pump 116 in the cassette 102 (e.g., Figures 3 and 5).
  • the pump drive 136 may be coupled to the saline pump 116 in any appropriate manner (e.g., a recess 138 in the pump drive 136 may receive an end of a drive shaft 118 of the pump 116 (or a coupling or other structure on the end of such a drive shaft 118), such that the pump drive 136 rotates the shaft 118 of the pump 116).
  • the pump shaft 118 and the recess 138 may be complimentary-shaped such that rotation of the pump drive 136 is mechanically communicated to the pump 116 (e.g., a hex-shaped end of the pump shaft 118 may be disposed within a hex-shaped recess 138 such that the pump drive 136 and the pump 116 rotate together when coupled).
  • the manifold drive unit 130 additionally includes pressure transducer contacts 140 to read/transmit information (e.g., blood pressure of the patient 90 as in Figure 2) from the pressure transducer 110 in the cassette 102.
  • the pressure transducer contacts 140 on the manifold drive unit 130 may be utilized to communicate pressure signals from the pressure transducer 110 to one or more signal-processing devices that will ultimately determine (e.g., calculate) the blood pressure of the patient 90.
  • the blood pressure of the patient 90 may be relayed to the power injector 40 or any other appropriate device and displayed (e.g., on the display 44 as shown in Figure 2).
  • the medical fluid injection system 10' may utilize appropriate communication links 24 and/or 50 (e.g., means for receiving and/or transmitting signals, such as interface cables, a wireless transmitter and/or receiver arrangement, or the like). Due to the signal-actuated control of the manifold 100, the manifold 100 may be smaller than a traditiona! manual manifold in which clearance must typically be provided for hand operation.
  • Figure 6 is a perspective view of the cassette 102, manifold drive unit 130, and part of the tubing set 60' illustrated in Figures 2-5.
  • the cassette 102 and the tubing set 60 1 are assembled such that the fluid lines 108, 114, 120 are fluidly coupled with the tubes 64, 68, 52', respectively.
  • the cassette 102 may be coupled with the manifold drive unit 130 (e.g , the drive features 126 of the stopcocks 122a, 122b, 122c may be aligned with and coupled with the drive features 134 of the stopcock actuators 132; the pump shaft 118 of the saline pump 116 may be aligned with and inserted into the recess 138 of the pump drive 136; the pressure transducer contacts 140 may be aligned with the pressure transducer 110; or the like).
  • the manifold drive unit 130 e.g , the drive features 126 of the stopcocks 122a, 122b, 122c may be aligned with and coupled with the drive features 134 of the stopcock actuators 132; the pump shaft 118 of the saline pump 116 may be aligned with and inserted into the
  • the position of the cassette 102 may also be "registered" to the manifold drive unit 130 in any appropriate manner.
  • the cassette 102 may be substantially blocked from lateral or longitudinal movement (e.g., along axis 146 and/or axis 148) with respect to the manifold drive unit 130.
  • a lip 128 protruding from the cassette 102 may be inserted in a slot or groove 144 in the manifold drive unit 130, thereby blocking vertical movement (e.g., along axis 150) of the cassette 102 relative to the manifold drive unit 130.
  • the manifold drive unit 130 may also include a connector or clamp 142 which receives the manifold connector 78 of the tubing set 60' (e.g., via a snap-lock or press-fit interaction) to secure the cassette 102 to trie manifold drive unit 130.
  • the clamp 142 in conjunction with the slot 144, at least substantially locks the cassette 102 and the tubing set 60' onto the manifold 130.
  • Figures 7-11 illustrate exemplary configurations into which the stopcocks 122a, 122b, 122c may positioned to provide various flowpaths through the manifold 100 for the case of the medical fluid injection system 10 of Figure 1 (e.g., to fluidly interconnect different components of the medical fluid injection system 10 and/or the patient 90). Only certain components of the injection system 10 from Figure 1 are included for context in Figures 7-11. It should be appreciated that these same configurations may be used by the medical fluid injection system 10 1 of Figure 2 (including where the power injector 40 is replaced by the contrast media source 72), and that these same configurations could also be used by other variations of the medical fluid injection system 10 of Figure 1 as well, for instance where the power injector 40 is not utilized (not shown).
  • Figure 7 illustrates a manual contrast injection configuration 160 by which contrast media may be supplied from the hand-held injector 12 to the patient 90. That is, a fluid pathway or flowpath extends from the hand-held injector 12 to the patient 90 through each of the stopcocks 122a, 122b, 122c of the manifold 100. Moreover, the stopcock 122c is positioned to fluidly isolate the hand-held injector 12 from each of the contrast media source 72 and the power injector 40, the stopcock 122b is positioned to fluidiy isolate the hand-held injector 12 from the saline source 66, and the stopcock 122a is positioned to fluidly isolate the hand-held injector 12 from the waste bag 62.
  • Figure 8 illustrates a power injector contrast injection configuration 164 by which contrast media may be supplied from the power injector 40 to the patient 90. That is, a fluid pathway or flowpath extends from the power injector 40 to the patient 90 through each of the stopcocks 122a, 122b, 122c of the manifold 100.
  • Figure 9 illustrates a saline injection configuration 168 and a syringe refill configuration 172. These configurations 168, 172 may be used independently of each other or in combination with each other as desired/required.
  • saline injection configuration 168 saline may be pumped to the patient 90 from the saline source 66.
  • a fluid pathway or flowpath extends from the saline source 66 to the patient 90 through the stopcocks 122a and 122b of the manifold 100 (the stopcock 122c is not in this flowpath, and therefore its position may be characterized as being irrelevant to the saline injection configuration 168).
  • the stopcock 122b is positioned to fluidly isolate each of the patient 90 and the saline source 66 from each of the contrast media source 72, the power injector 40, and the hand-held injector 12.
  • contrast media from the contrast source 72 and/or the power injector 40 may be supplied to refill the hand-held injector 12. That is, a fluid pathway extends from the contrast media source 72 and/or the power injector 40 to the hand-held injector 12 through the stopcock 122c of the manifold 10O (the stopcocks 122a and 122b are not in this flowpath, and therefore their respective positions may be characterized as being irrelevant to the syringe refill configuration 172).
  • Figure 10 illustrates a pressure-reading configuration 176 and a saline flush configuration 180. These configurations 176, 180 may be used independently of each other or in combination with each other as desired/required.
  • the blood pressure of the patient 90 may be monitored. That is, the stopcock 122a may be positioned such that the patient 90 is in fluid communication with the pressure transducer 110 within the cassette 102 (and which senses pressure in the waste line or flow channel 108 of the cassette 102) (the stopcocks 122b, 122c are not in this flowpath, and therefore their respective positions may be characterized as being irrelevant to the pressure-reading configuration 176). Moreover, the stopcock 122a may be positioned to fluidly isolate each of the patient 9O 1 the pressure transducer 110, and the waste bag 62 from each of the saiine source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12.
  • the pressure-reading configuration 176 may be a default position for the stopcock 122a, where the stopcock 122a returns to the pressure-reading configuration 176 any time the stopcock 122a is not in use in another configuration.
  • the stopcocks 122a, 122b may be positioned to provide a flowpath from the saline source 66 to the hand-assisted injector 12 (the stopcock 122a is not in this flowpath, and therefore its position may be characterized as being irrelevant to the saline flush configuration 180).
  • the stopcock 122b fluidly isolates each of the saline source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12 from each of the patient 90 and the waste bag 62.
  • the saline flush configuration 180 it may be desirable to flush the hand-held injector 12 after contrast media has been injected into the patient 90 to ensure that all of the contrast media is injected into the patient 90, to clean out the syringe 22 of the hand-held injector 12 ( Figure 1) before disposal, or both.
  • Figure 11 illustrates an air purge configuration 184 by which fluid and/or air may be pushed into the waste bag 62 from the hand-held injector 12. That is, a fluid pathway or flowpath extends from the hand-held injector 12 to the waste bag 62 through each of the stopcocks 122a, 122b, and 122c. Moreover, the stopcock 122a is positioned to fluidly isolate the patient 90 from each of the waste bag 62, the saline source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12. It should be appreciated that the stopcock 122c in Figure 11 could be disposed in the position shown in Figure 8 to provide an air purge configuration for the power injector 40. Other configurations not illustrated here may be utilized to perform further tasks, and configurations other than those illustrated may be used to perform described tasks. Finally, the described configurations may be combined, where possible, to perform multiple tasks simultaneously (e.g., as in Figures 9 and 10).
  • the cassette 102 discussed in relation to the medical fluid injection system 10' again incorporates a saline pump 116.
  • An enlarged view of this saline pump 116 is presented in Figure 12.
  • the saline pump 116 may be characterized as a generated rotor (gerotor) pump.
  • the pump 116 generally includes an external rotor 240 having a pump cavity 242.
  • An internal rotor 244 is disposed within this pump cavity 242.
  • the rotational axis of the external rotor 240 is offset from the rotational axis of internal rotor 244. Relative rotation of the eccentrically- arranged internal rotor 244 and external rotor 240 creates a vacuum at an inlet 246 of the pump 116 and forces fluid out of the pump 116 through an outlet 248.
  • FIG. 13 illustrates a peristaltic pump 116 1 (e.g., operating on the order of approximately 30 psi).
  • the peristaltic pump 116' generally includes a tube 220 through which saline flows as facilitated by rollers 222 disposed along a rotor 224.
  • the tube 220 is disposed between a raceway 118 of a stator (not shown) and the rotor 224 having the plurality of rollers 222 rotatably mounted thereon.
  • FIG. 14 illustrates an external gear pump 116".
  • the external gear pump 116" generally includes a drive gear 232 and a following or driven gear 234 that are engaged with each other and that are disposed within a pump cavity of a stator or pump housing 230.
  • Driving the drive gear 232 rotates each of the drive gear 232 and the following gear 234 to pump fluid from an inlet 236, around the perimeter of the gears 232 and 234, to an outlet 238.
  • FIG 15 illustrates one embodiment of what may be characterized as an eccentric orbit pump 116 iN , and again which may be used by the cassette 102 in place of the pump 116, or for any other appropriate application.
  • the eccentric orbit pump 116 » ' generally includes an outer housing 252 surrounding an inner cavity 254.
  • a drive shaft 256 e.g., a rotating shaft
  • An eccentric shaft 258 (e.g., not centered around the drive shaft 256) is appropriately coupled to the drive shaft 256 such that rotation of the drive shaft 256 rotates the eccentric shaft 258 eccentrically in the inner cavity 254 (e.g., the center of the eccentric shaft 258 moves relative to the center of the inner cavity 254 during rotation of the eccentric shaft 258).
  • a follower or rotor 260 is mounted on and moves at least substantially within a reference plane in conjunction with the eccentric shaft 258 (e.g., eccentrically relative to the outer housing 252). That is, the eccentric shaft 258 may rotate relative to the follower 260, but the translation of the rotational axis of the eccentric shaft 258 also causes the follower 260 to translate (e.g., move within a reference plane).
  • the follower 260 is prevented from fully rotating by an extension 262 of the outer housing 252 projecting into a slot 264 in the foilower 260.
  • the positive displacement motion of the eccentric orbit pump 116 1 " 1 is illustrated in Figure 16. Movement of the follower 260 in the inner cavity 254 creates a space 266 between the follower 260 and the outer housing 252 within the inner cavity 254.
  • a fluid 268 e.g., saline
  • the space 266 enlarges as the foilower 260 moves in the inner cavity 254, thereby sucking the fluid 268 into the pump 116 » ' using a vacuum action.
  • the space 266 may become closed off from the inlet 270.
  • the space 266 may then be fluidly coupled with an outlet 272.
  • the fluid 268 may be pushed out of the space 266 through the outlet 272.
  • Figure 17 illustrates an exemplary process 274 for setting up and using the injection system 10 (e.g., as in Figure 1).
  • the recited steps may be performed in orders otherthan that listed herein, and various steps may be omitted or repeated, depending upon the requirements of a given procedure.
  • the tubing set 60 may be mounted to the cassette 102 via the manifold connector 78 (Block 276).
  • the cassette 102 and attached tubing set 60 may then be installed on the manifold drive unit 130 (Block 278).
  • the saline source 66 e.g., a saline bag or bottle
  • the waste bag 62 may be fluidiy interconnected with the tubing set 60 (e.g., if the waste bag 62 is not integral with the tubing set 60).
  • the contrast media source 72 and/or the power injector 40 may be fluidly interconnected with the tubing set 60 (e.g., sequentially, simultaneously) (Block 282). If the power injector 40 and/or the contrast media source 72 is not required for a given procedure (e.g., if only one of the power injector 40 or the contrast media source 72 is needed), the action(s) associated with Block 282 may be revised accordingly. If only the hand-held injector 12 is needed, the action(s) associated with Block 282 may be eliminated.
  • the hand-held injector 12 may be fluidly interconnected with the cassette 102 via the connector 50 on the cassette 102 (Block 284).
  • An air purge operation may be undertaken in relation to the hand-held injector 12 and/or the power injector 40, where air may be directed through the manifold 100 and into the waste bag 62 (e.g., as in Figure11) or the air may be ejected through the patient connector 106 on the manifold 100 while not connected to the patient 90 (Block 286).
  • the syringe 22 of the hand-held injector 12 may then be filled with contrast media (e.g., manually or automatically) from the power injector 40 and/or the contrast media source 72 (Block 288).
  • contrast media e.g., manually or automatically
  • pressing a button on the injector 12, 40 may send a control signal to the manifold 100 to orient the stopcock 122c such that contrast media (e.g., from the power injector 40 and/or the contrast media source 72) may be directed into the syringe 22 on the hand-held injector 12 (e.g., as in Figure 9).
  • the hand-held injector 12 may be omitted from the injection system 10, and the syringe 46 on the power injector 40 may be filled with contrast media from the contrast media source 72 in Block 288. This would not require a fluid line or a flowpath through the manifold 100.
  • another air purge application may be undertaken (e.g., by pushing the air into the waste bag 62 or ejecting the air through the patient connector 106 while not connected to the patient 90) (Block 290).
  • the manifold 100 may be connected to the patient 90 (e.g., by fluidly coupling the patient connector 106 on the cassette 102 with a catheter inserted in the patient 90, via the injection tubing 92) (Block 292).
  • blood pressure monitoring may commence (e.g., the stopcock 122a may fluidly couple the patient 90 with the pressure transducer 110, as in Figure 10) (Block 294).
  • the default position of the stopcock 122a may be to enable monitoring of the blood pressure of the patient 90 when fluids are not being injected into the patient 90 or the waste bag 62 (e.g., as in FigurelO). Contrast media or saline may then be injected into the patient 90 via the manifold 100.
  • contrast media may be injected from the hand-held injector 12 (e.g., as in Figure 7) (Block 296), This step enables a caregiver to have manual control over injection of the contrast media, as well as to receive tactile feedback.
  • the syringe 22 of the hand-held injector 12 may then be refilled with contrast media (e.g., as in Figure 9) (Block 298).
  • contrast media may be injected from the power injector 40 (e.g., as in Figure 8) (Block 300). If the power injector 40 is fluidly connected to the contrast media source 72, the syringe 46 on the power injector 40 may be refilled after the injection (Block 302).
  • saline may be injected into the patient 90 from the saline source 66 (e.g., as in Figure 9) (Block 304).
  • the system 306 generally includes a power injector 308, an injector- controlled valve assembly 310, and a medical fluid source 312 (e.g., containing contrast media, a radiopharmaceutical, saline, or the like).
  • the medical fluid source 312 may include radiation shielding to substantially contain the radiation from a radiopharmaceutical.
  • fluid may be routed from the injector 308 and/or the fluid source 312 to the patient 314 (e.g., for injection) and/or from the fluid source 312 to the injector 308 (e.g., to fill the injector 308) via the valve assembly 310.
  • the valve assembly 310 is illustrated in more detail in Figure 19, and may include a valve (e.g., a three- way stopcock 316), a connector (e.g., a three-way tube connector 318), and a valve drive (e.g., a stopcock actuator 320). It should be noted that while the illustrated embodiment includes a three-way stopcock, other types of valves may be appropriate.
  • the tube connector 318 may include three tube connections 322, 324, and 326 (e.g., standard Luer connections) which fluidly couple the valve assembly 310 to the injector 308, the fluid source 312, and the patient 314, respectively (e.g., as in Figure18).
  • the stopcock actuator 320 may rotate the stopcock 316 with respect to the tube connector 318 (e.g., to fluidly couple different elements with one another).
  • the injector 308 may include a motor 328 coupled to a drive gear 330 which meshes with the stopcock actuator 320.
  • the stopcock 316 may be rotated automatically (e.g., in response to electronic and/or wireless control signals) upon movement of a plunger 334 disposed within a syringe 336 installed on the injector 308 (e.g., by movement of a ram 309 of the injector 308).
  • an electronic and/or wireless signal may be sent to the motor 328, thereby initiating rotation of the drive gear 330.
  • the drive gear 330 may be actuated mechanically by movement of the plunger 334.
  • the stopcock actuator 320 rotates with the drive gear 330 to position the stopcock 316 in an injection configuration 338 (e.g., the injector 308 is fluidly coupled with the patient 314, as in Figure 20) when the plunger 334 is depressed.
  • withdrawal of the plunger 334 may automatically rotate the stopcock 316 into a fill configuration 240 (e.g., the injector 308 is fluidly coupled with the fluid source 312, as in Figure 21).
  • the syringe 336 may then be filled with medical fluid (e.g., contrast media, radiopharmaceutical, saline, or the like) from the fluid source 312, enabling another injection into the subject 314 without requiring the syringe 336 to be disconnected from the system 306.
  • medical fluid e.g., contrast media, radiopharmaceutical, saline, or the like

Abstract

Among other things, disclosed is an injection assembly that includes a medical fluid injector (12i) and a valve assembly (100) fluidly coupled with a syringe (22) that is mounted to the injector. This valve assembly may include one or more valves (122a, 122b, 122c) designed to transition between at least first and second (e.g., open and closed) conditions in response to wireless and/or electronic control signals provided by the injector via a communication link (24).

Description

MEDICAL FLUID INJECTION SYSTEM WITH AUTOMATED VALVE MANIFOLD
RELATED APPLICATIONS
[0001] This application claims priority to US provisional application serial number 61/194,778 filed on 30 September 2008 entitled "Medical Fluid Injection System with Automated Valve Manifold".
FIELD OF THE INVENTION
[0002] The invention relates generally to medical fluid injection systems and, more particularly, to valve assemblies or valve manifolds designed for use with such systems.
BACKGROUND
[0003] In the fields of cardiology and angiography, imaging may be enhanced by injecting contrast media into a subject's cardiovascular system. For example, blood is generally indistinguishable from surrounding tissues in x- rays. Accordingly, radio-opaque contrast media may be injected into a subject's heart to facilitate x-ray imaging. A typical injection procedure may include an injection of contrast media followed by and/or along with an injection of saline. Unfortunately, existing injection techniques tend to involve a number of manual steps, which can result in errors. Furthermore, physicians may prefer to inject contrast media by hand in order to achieve a feel for the injection. These hand injections tend to be physically challenging and may exceed the limits of ergonomic standards, thus potentially resulting in uneven flow rates of contrast media and less than desirable x-ray images. The inability to achieve a desired flow rate can lead to inferior x-ray images. Also, the use of smaller syringes in a hand injector may require the physician to disconnect the syringe in order to refill it, increasing the possibility of introducing air into the syringe.
SUMMARY
[0004] A first aspect of the present invention is directed to a medical fluid injection system that includes a medical fluid injector having a syringe mounted thereto. This medical fluid injector is designed to be held and supported by at least one hand of a user {e.g., a hand-held injector). In addition, the system includes a first valve fluidly coupled with the syringe and in communication with the medical fluid injector. This first valve is designed to transition between at least first and second conditions (e.g., an open condition and a closed condition) in response to wireless and/or electronic control signals provided by the medical fluid injector. Incidentally, "fluidly coupled," "fluidly interconnected," or the like herein refers to two or more things being interconnected (i.e., either directly or indirectly connected) in a manner that allows fluid to flow therebetween. Further, "in communication," "operatively interconnected," or the like refers to two or more things being designed in a manner such that electronic and/or wireless signals (e.g., radio frequency, infrared, cable synchronizing, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, wireless application protocol (WAP), spread-spectrum frequency hopping, half-duplex or full-duplex communication, Bluetooth standards, or the like), or more generally a control signal, can be transmitted therebetween. [0005] A number of feature refinements and additional features are applicable to the above-noted first aspect of the present invention. These refinements and additional features may exist individually or in any combination in relation to the first aspect. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the first aspect.
[0006] Some embodiments of the first aspect may include medical tubing. In such embodiments, the syringe may be connected to one end of the medical tubing, and the first valve may be connected to another end (e.g., the opposite end) of the medical tubing. As such, medical fluid may flow through the medical tubing between the syringe and the first valve,
[0007] Some embodiments of the first aspect may include a second valve that is fluidly coupled with a medical fluid container (e.g., a syringe or a medical fluid bag). This second valve may be designed to transition between at least first and second conditions in response to wireless and/or electronic control signals, or more generally control signals (e.g., from the medical fluid injector or another control signal source), In some embodiments, the second valve is fluidly coupled with the first valve.
[0008] The syringe and the medical fluid container may have medical fluid disposed therein. In such a case, the medical fluid in the syringe may be the same as or different from the medical fluid in the medical fluid container.
Moreover, the medical fluid(s) in the syringe and container may be any appropriate fluid(s) such as, but not limited to, contrast media (e.g., for use in a medical imaging procedure), a radiopharmaceutical, saline, or any combination thereof. In the event that the syringe has a radiopharmaceutical disposed therein, the medical fluid injection system may have radiation shielding disposed about the syringe (e.g., in the form of a radiation-shielded syringe receptacle). This radiation shielding may include any appropriate radiation shielding materia! (e.g., lead, tungsten, tungsten-impregnated plastic, depleted uranium, or any combination thereof).
[0009] Some embodiments of the first aspect may include a third valve. While this valve is referred to as a
"third valve," the second valve mentioned above may not be present in all embodiments including the third valve.
In any event, the third valve may be fluidly coupled with the first valve, the second valve, a subject, a medical waste container, or any combination thereof. The third valve may be designed to transition between at least first and second conditions in response to wireless and/or electronic control signals, or more generally control signals
(e.g., from the medical fluid injector or another control signal source).
[0010] One or more of the valves listed above may be disposed within a common housing (e.g., a "cassette").
For example, in some embodiments the first, second, and third valves are all located within a common housing.
Incidentally, a "valve" herein refers to a device for controlling the flow of medical fluid.
[0011] Some embodiments may include a fluid pump that is fluidiy coupled with at least one valve of the system. In such embodiments, the fluid pump may be any appropriate pump mechanism (e.g., peristaltic pump, gear pump, generated rotor (gerotor) pump, eccentric orbit pump, or the like).
[0012] In some embodiments, the system includes a pressure transducer that is configured to monitor the biood pressure of a patient. This pressure transducer may be fluidly coupled with the system (e.g., a valve thereof).
[0013] In some embodiments, the medical fluid injector may be designed such that force utilized to expel medical fluid from the syringe using the medical fluid injector is derived from a user. For example, the user may squeeze a manual trigger, handle, or the like of the medical fluid injector to bias a ram of the medical fluid injector against a plunger of the syringe to expel medical fluid from therein.
[0014] Some embodiments of the first aspect may include another medical fluid injector in addition to the one that has already been mentioned above. In such embodiments, each of the medical fluid injectors may be fluidly coupled with the first valve. One of the medical fluid injectors may be electrically-powered and programmable, and the other of the medical fluid injectors may be designed to be held and supported by a hand of a user. [0015] A second aspect of the invention is directed to a method of operation for a medical fluid injection system. In this method, a valve assembly is automatically positioned to create a first pathway {e.g., a first route/course in which fluid may flow) for medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) from a syringe that is mounted to a medical fluid injector. The automatic positioning of the valve assembly occurs in response to a first control signal from the medica! fluid injector. This first control signal may be generally in a wireless or electronic format. In the case of the second aspect, the medical fluid injector is completely supported by at least one hand of an operator. As such, an operator may hold the medical fluid injector and completely support it in his/her hand while the valve assembly is being automatically positioned. [0016] A number of feature refinements and additional features are applicable to the above-noted second aspect of the present invention. These refinements and additional features may exist individually or in any combination in relation to the second aspect. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the second aspect. [0017] In some embodiments, the valve assembly may be automatically positioned to create a second pathway for medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) from a fluid source other than the syringe (e.g., another syringe or a medical fluid bag) in response to a second control signal from the medical fluid injector. This second control signal may, like the first control signal, be in a wireless or electronic format.
[0018] In some embodiments, the valve assembly may be automatically positioned to create a third pathway. While this pathway is referred to as a "third pathway," the second pathway mentioned above may not be present in all embodiments including the third pathway. In any event, the third pathway of the valve assembly may enable the syringe to be filled and/or refilled with medical fluid (e.g., contrast media, radiopharmaceutical, saline, or a combination thereof) and may be created in response to a third control signal (e.g., from the medical fluid injector or another appropriate control signal source). This third control signal may, like the first control signal, be in a wireless or electronic format.
[0019] The valve assembly of this second aspect may be any appropriate valve assembly. For instance, in some embodiments, the valve assembly may include only a single valve. In other embodiments, the valve assembly may include a plurality of valves. In the case where the valve assembly includes a plurality of valves, the first control signal may cause automatic positioning of only one valve of the assembly, of multiple valves of the assembly, or of all valves of the assembly. The valve(s) associated with the valve assembly of the second aspect may be any appropriate type(s) of valve (e.g., an actuatable stopcock). [0020] In some embodiments of the method, the blood pressure of a subject may be monitored. For instance, a patient's blood pressure may be monitored while medical fluid is not being expelled from the injector (e.g., not being injected into the patient).
[0021] A third aspect of the present invention is embodied by a medical fluid injection system. This injection system includes a first injector, a manifold, a first injector conduit, and an injection conduit. The manifold includes a plurality of signal-actuated valves (which hereafter may also be referred to as "manifold valves"). The first injector conduit extends between the first injector and the manifold, while the injection conduit extends from the manifold (e.g., to a patient).
[0022] A number of feature refinements and additional features are applicable to the third aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the third aspect, up to the start of the discussion of a fourth aspect of the present invention. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the third aspect.
[0023] The first injector may be of any appropriate size, shape, configuration, and/or type. For instance, the first injector may be in the form of a hand-held injector. Hand-held injectors may be held in the hand of a user and supported entirely by the user during operation of the injector, fluid discharges from the hand-held injector may be based at least in part upon manual forces provided by the user (including where the entire force for affecting a fluid discharge is by a manually-initiated user force), or both. The first injector may also be in the form of a power injector of any appropriate size, shape, configuration, and/or type, including without limitation a programmable power injector. In any case, at least one syringe may be installed on the first injector in any appropriate manner. Any appropriate fluid may be used by any injector incorporated by the medical fluid injection system, such as contrast media (e.g., for use in a medical imaging procedure), a radiopharmaceutical, saline, or any combination thereof.
[0024] Each of the first injector conduit and the injection conduit may be of any appropriate size, shape, configuration, and/or type. In one embodiment, the first injector conduit and the injection conduit are each in the form of medical tubing. The injection conduit may include an appropriate vasculature access device (e.g., a catheter), such that fluid directed through the injection conduit may be injected into a patient. [0025] Any appropriate signal may be used to actuate each individual manifold valve. The same type of signal may be provided to each manifold valve to actuate the same. One or more different types of signals may be utilized to actuate different ones of the various manifold valves. A fluid-pressure signal may be used to actuate at least one of the manifold valves. Control signals may be used to actuate at least one of the manifold valves (where a "control signal" is a pulse or frequency of electricity or light that represents a control command as it travels over a network, a computer channel, orwirelessly, such that "control signals" encompasses both electrical signals and wireless communications). In one embodiment, a first manifold valve is actuated by a fluid-pressure signal, while a second manifold valve is actuated by a control signal, In one embodiment, a first manifold valve may be actuated in one manner by a fluid-pressure signal (e.g., moved to a first position) and may be actuated in another manner by a control signal (e.g., moved to a second position). [0026] The manifold may include two discrete sections - a manifold drive unit and a cassette that is mounted to the manifold drive unit. The cassette may be mounted to the manifold drive unit in any appropriate manner, including detachably (e.g., where a cassette may be installed on and then subsequently removed from the manifold drive unit). The cassette may include the plurality of signal-actuated valves, while the manifold drive unit may include an actuator for each of the signal-actuated valves (along with other appropriate components, such as a controller that could interact with each of the signal-actuated valves). In one embodiment, the cassette is in the form of a disposable and the manifold drive unit is reusable with multiple cassettes (e.g., for multiple injection operations on multiple patients).
[0027] The medical fluid injection system may utilize a tubing set, where this tubing set includes a manifold connector and a plurality of tubes that each extend from this common manifold connector. One or more features may be incorporated by the manifold connector and/or the manifold so that the manifold connector can only be installed in a single orientation relative to the manifold. The manifold connector may interface with the manifold (e.g., the above-noted cassette) in any appropriate manner. For instance, the manifold connector of the tubing set may be detachably interconnected with the manifold.
[0028] Installing the above-noted manifold connector on the manifold may simultaneously fluidly interconnect multiple tubes from the tubing set with the manifold (e.g., with different ones of the signal-actuated valves). That is, the manifold connector may be used to reduce the potential that tubes extending to multiple components will be incorrectly installed on the manifold. In one embodiment, both the first injector conduit and a first fluid source conduit extend from the manifold connector and are part of the tubing set. Other tubes may extend from this manifold connector as well, such as a waste container tube (e.g., a tube that extends between the manifold and a waste container). In any case, the various tubes may be joined together for some distance as they extend from the manifold connector. In one embodiment, this joined condition of tubes extending from the manifold connector exists for a distance of at least about 24 inches.
[0029] The first injector may incorporate one or more signaling devices of any appropriate type for signaling one or more of the signal-actuated valves of the manifold. Each signaling device incorporated by the first injector may dispose the signal-actuated valves in different configurations or flowpath arrangements. For instance: 1 ) a certain signaling device/signal may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect the first injector and the injection tube; 2) a certain signaling device/signa! may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect another injector (e.g., a power injector) and the injection tube; 3) a certain signaling device/signal may used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to allow the first injector to be "loaded" with fluid (e.g., to allow fluid to be directed into a syringe installed on the first injector), which thereafter may be directed through the manifold and into the injection conduit; 4) a certain signaling device/signal may be used to configure a flowpath through the manifold (e.g., a flowpath configuration for the manifold) to fluidly interconnect the injection conduit with a waste container or the like; and 5) any combination of the foregoing. Although each of these various flowpath configurations for the manifold may be achieved in any appropriate manner, in one embodiment the flowpath configurations are realized by repositioning at least one, and possibly at least two, of the manifold valves. In one embodiment, each of the various manifold valves is in the form of a three-way stopcock.
[0030] The medical fluid injection system may further include a first fluid source and a first fluid source conduit that extends between the first fluid source and the manifold. Any appropriate fluid may be utilized by the first fluid source, including saline. Consider the case where there are three signal-actuated valves being utilized by the manifold - a first manifold valve, a second manifold valve, and a third manifold valve. The manifold (e.g., the above-noted cassette) may incorporate an appropriate pressure transducer. A first configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a first flowpath from the first injector to the injection conduit, while fluidly isolating the first injector from each of the first fluid source and the pressure transducer, This will allow operation of the first injector to direct fluid through the manifold and into/through the injection conduit {e.g., for injection into a patient).
[0031] A second configuration, arrangement, or positioning of the above-noted first, second, and third manifold valves may provide a second flowpath from the first fluid source to the injection tube, while fluidly isolating the first fluid source from each of the first injector and the pressure transducer (e.g., to accommodate a flow from the first fluid source, through the manifold, and into the injection conduit). Further in this regard, the manifold may incorporate a pump of any appropriate type to direct a fluid flow from the first fluid source and through the injection tube (e.g., peristaltic pump, gear pump, generated rotor (gerotor) pump, eccentric orbit pump). The drive for such a pump could be incorporated into the above-noted manifold drive unit, while another portion of the pump (e.g., a pump stator and/or rotor) couid be incorporated into the above-noted cassette.
[0032] A third configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a third flowpath from the injection conduit at least to the pressure transducer, while fluidly isolating the pressure transducer from each of the first fluid source and the first injector. This may allow a patient's blood pressure to be monitored when the injection conduit is in fluid communication with the patient's vasculature. The medical fluid injection system could further include a waste container and a waste container conduit or tube that extends between the waste container and manifold so that the waste container may be fluidly interconnected with the injection conduit via this third flowpath. One or more valves of any appropriate type may be included in the waste container conduit {e.g., a check valve disposed between the waste container and the pressure transducer) to preclude fluid from flowing from the waste container to the manifold.
[0033] The medical fluid injection system may further include a second injector. A fourth configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a fourth flowpath from the second injector to the first injector, while fluidly isolating the first injector from each of the pressure transducer and the first fluid source, and further while fluidly isolating the second injector from each of the pressure transducer and the first fluid source. This may allow a fluid transfer from the second injector (e.g., a power injector) to the first injector (e.g., a hand-held injector). A fifth configuration, arrangement, or positioning of the first, second, and third manifold valves may provide a fifth flowpath from the second injector (e.g., a power injector) to the injection conduit, while fluidly isolating the first injector from each of the pressure transducer and the first fluid source, and further while fluidly isolating the first injector from the second injector. As such, this fifth flowpath allows fluid from the second injector to be directed through the manifold and into/through the injection conduit (e.g., for injection into a patient).
[0034] Consider the case where the medical fluid injection system includes two separate injectors (e.g., a hand-held injector and a power injector). The plurality of signal-actuated valves used by the manifold may include a first manifold valve that controls the fluid communication between the first injector, the second injector, and the injection tube. The first and second injectors may be fluidly interconnected by the first manifold valve being in a first position (e.g., to allow contrast media from a power injector to be transferred to a hand-held injector). The first injector may be fluidly interconnected with the injection conduit, the first injector may be fluidly isolated from the second injector, and the second injector may be fluidly isolated from the injection conduit, all by the first manifold valve being in a second position. The second injector may be fluidly interconnected with the injection conduit, the first injector may be fluidly isolated from the second injector, and the first injector may be fluidly isolated from the injection conduit, all by the first manifold valve being in a third position,
[0035] A fourth aspect of the present invention is embodied by a medical fluid injection system. This injection system includes a first injector, a first fluid source, a manifold, a tubing set, and an injection tube. The manifold includes a manifold drive unit and a cassette that is detachably mounted to this manifold drive unit. This cassette in turn includes a plurality of signal-actuated valves. The tubing set extends from the cassette and includes a first injector tube (e.g., extending between the first injector and the cassette) and a first fluid source tube (e.g., extending between the first fluid source and the cassette). The injection tube extends from the manifold (e.g., to a patient), and may communicate with the tubing set via multiple flowpaths through the manifold and as dictated by the positioning of the various signal-actuated valves. The above-noted discussion of a particular component used by the third aspect, and which is also used by the fourth aspect, is equally applicable to this fourth aspect. [0036] A fifth aspect of the present invention is embodied by a medical fluid injection system. This injection system includes a first injector, a first fluid source, a manifold, a tubing set, and an injection tube. The manifold includes a plurality of signal-actuated valves. The tubing set includes a manifold connector for mounting the tubing set to the manifold. The tubing set further includes a first injector tube (e.g., extending between the first injector and the cassette) and a first fluid source tube (e.g., extending between the first fluid source and the manifold) that each extend from the manifold connector. The injection tube extends from the manifold (e.g., to a patient), and may communicate with the tubing set via multiple flowpaths through the manifold and as dictated by the positioning of the various signal-actuated valves. The above-noted discussion of a particular component used by third aspect, and which is also used by the fifth aspect, is thereby equally applicable to this fifth aspect. [0037] A number of feature refinements and additional features are separately applicable to each of above- noted first, second, third, fourth, and fifth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the above-noted first, second, third, fourth, and fifth aspects of the present invention. Any feature of any other various aspects of the present invention that is intended to be limited to a "singular" context or the like will be clearly set forth herein by terms such as "only," "single," "limited to," or the like. Merely introducing a feature in accordance with commonly accepted antecedent basis practice does not limit the corresponding feature to the singular {e.g., indicating that a power injector includes "a syringe" alone does not mean that the power injector includes only a single syringe). Moreover, any failure to use phrases such as "at least one" also does not limit the corresponding feature to the singular {e.g., indicating that a power injector includes "a syringe" alone does not mean that the power injector includes only a single syringe). Finally, use of the phrase "at least generally" or the like in relation to a particular feature encompasses the corresponding characteristic and insubstantial variations thereof (e.g., indicating that a syringe barrel is at least generally cylindrical encompasses the syringe barrel being cylindrical). [0038] Any power injector that may be utilized to provide a fluid discharge may be of any appropriate size, shape, configuration, and/or type. Any such power injector may utilize one or more syringe plunger drivers of any appropriate size, shape, configuration, and/or type, where each such syringe plunger driver is capable of at least bi-directionai movement (e.g., a movement in a first direction for discharging fluid; a movement in a second direction for accommodating a loading of fluid or so as to return to a position for a subsequent fluid discharge operation), and where each such syringe plunger driver may interact with its corresponding syringe plunger in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to advance the syringe plunger in at least one direction (e.g., to discharge fluid). Each syringe plunger driver may utilize one or more drive sources of any appropriate size, shape, configuration, and/or type. Multiple drive source outputs may be combined in any appropriate manner to advance a single syringe plunger at a given time. One or more drive sources may be dedicated to a single syringe plunger driver, one or more drive sources may be associated with multiple syringe plunger drivers (e.g., incorporating a transmission of sorts to change the output from one syringe plunger to another syringe plunger), or a combination thereof. Representative drive source forms include a brushed or brushless electric motor, a hydraulic motor, a pneumatic motor, a piezoelectric motor, or a stepper motor.
[0039] Any such power injector may be used for any appropriate application where the delivery of one or more medical fluids is desired, including without limitation any appropriate medical application (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; single photon emission computed tomography or SPECT imaging; positron emission tomography or PET imaging; X-ray imaging; angiographic imaging; optica! imaging; ultrasound imaging). Any such power injector may be used in conjunction with any component or combination of components, such as an appropriate imaging system (e.g., a CT scanner). For instance, information could be conveyed between any such power injector and one or more other components (e.g., scan delay information, injection start signal, injection rate).
[0040] Any appropriate number of syringes may be utilized with any such power injector in any appropriate manner (e.g., detachably; front-loaded; rear-loaded; side-loaded), any appropriate medical fluid may be discharged from a given syringe of any such power injector (e.g., contrast media, a radiopharmaceutical, saline, and any combination thereof), and any appropriate fluid may be discharged from a multiple syringe power injector configuration in any appropriate manner (e.g., sequentially, simultaneously), or any combination thereof, in one embodiment, fluid discharged from a syringe by operation of the power injector is directed into a conduit (e.g., medical tubing set), where this conduit is fluidly interconnected with the syringe in any appropriate manner and directs fluid to a desired location (e.g., to a catheter that is inserted into a patient, for instance for injection). Multiple syringes may discharge into a common conduit (e.g., for provision to a single injection site), or one syringe may discharge into one conduit (e.g., for provision to one injection site), while another syringe may discharge into a different conduit (e.g., for provision to a different injection site). In one embodiment, each syringe includes a syringe barret and a plunger that is disposed within and movable relative to the syringe barrel. This plunger may interface with the power injector's syringe plunger drive assembly such that the syringe plunger drive assembly is able to advance the plunger in at least one direction, and possibly in two different, opposite directions.
BRtEF DESCRIPTION OF THE FIGURES
[0041] Figure 1 is a schematic of one embodiment of a medical fluid injection system fluidly coupled to a patient.
[0042] Figure 2 is a schematic of a variation of the medical fluid injection system of Figure 1 and fluidly coupled to a patient, and which illustrates at least certain of its components in more detail and with a power injector of the medical fluid injection system being shown in a perspective view,
[0043] Figure 3 is a cutaway view of a manifold cassette of a manifold used by the medical fluid injection system of Figure 2.
[0044] Figure 4 is a plan view of a tubing set used by the medical fluid injection system of Figure 2.
[0045] Figure 5 is a plan view of a manifold drive unit of the manifold used by the medical fluid injection system of Figure 2.
[0046] Figure 6 is a perspective view of the manifold cassette, part of the tubing set, and the manifold drive unit of Figures 3-5.
[0047] Figures 7-11 are exemplary configurations of the manifold cassette illustrated in Figure 3 and for the fluid component arrangement of Figure 1.
[0048] Figure 12 is a plan view of a pump used by the manifold of Figures 3, 5, and 6.
[0049] Figures 13-14 are plan views of other representative pumps that may be used by the manifold of
Figures 3, 5, and 6.
[0050] Figure 15 is a perspective view of one embodiment of an eccentric orbit pump that may be used by the manifold of Figures 3, 5, and 6.
[0051] Figure 16 presents sequential views that illustrate the pumping action of the eccentric orbit pump illustrated in Figure 15.
[0052] Figure 17 is a flowchart illustrating a method for injecting medical fluid into a patient using the medical fluid injection system of Figure 1.
[0053] Figure 18 is a perspective view of another embodiment of a medical fluid injection system.
[0054] Figure 19 is a plan view of a stopcock used by the medical fluid injection system of Figure 18.
[0055] Figures 20-21 are plan views of the stopcock of Figure 19, and how the same interfaces with the injector of the medical fluid injection system of Figure 18, DETAILED DESCRIPTION
[0056] One or more specific embodiments of the present invention of medical fluid injection systems will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business- related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure. [0057] When introducing elements of various embodiments of the present invention, the articles "a", "an", and "the" are intended to mean that there are one or more of the elements. The terms "comprising", "including", and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. Moreover, any use of the terms "top", "bottom", "above", "below11, and variations of these terms is made for convenience, but does not require any particular orientation of the components. Similarly, use of the terms "lateral", "longitudinal", "vertical", and variations of these terms is made for convenience, and may refer to relative directions rather than absolute directions. As used herein, the term "coupled" or the like herein refers to two or more things being interconnected (i.e., either directly or indirectly connected).
[0058] The various embodiments are each directed to components of a system for injecting medical fluids into a patient. For example, in cardiology and angiography, contrast media may be injected into a patient to enable monitoring of fluid flow through the patient's circulatory system and/or to enhance imaging of various tissues of the patient. Similarly, in nuclear medicine, a radiopharmaceutical may be injected to image tissues (e.g., tumor) and/or treat tissues of a patient. While the following discussion focuses on injection of contrast media, the disclosed embodiments are not intended to be limited to such fluids. Rather, any medical fluid, such as, for example, contrast media, radiopharmaceuticals, saline solution, or a combination thereof, may be utilized in the described embodiments.
[0059] Embodiments of injection system components described below include: an exemplary valve assembly or valve manifold embodied in the form of an injector-controlled stopcock mechanism; an exemplary injector designed to control the stopcock mechanism; and exemplary pumps for use with the valve manifold. In some embodiments, the injector-controlled stopcock mechanism may include a stopcock coupled to a gear that meshes with another gear controlled by the injector. In some embodiments, the injector-controlled stopcock mechanism may include what may be characterized as a "cassette" that includes one or more stopcocks within a common housing. Further, the injector-controlled stopcock mechanism may include a manifold drive unit to control the stopcock(s). The injector may include one or more buttons to orient the stopcock(s) in various configurations (e.g., to provide or define various flowpaths through the manifold). In some embodiments, the injection system may include a fluid pump, such as an eccentric orbit pump, that is fluidly coupled with and may optionally be a component of the valve manifold. This eccentric orbit pump may be utilized to move fluid therethrough without the use of a tube as commonly utilized in medical pumps. Other embodiments may not include a pump or may include another appropriate pumping mechanism {e.g., one that is utilized with medical tubing). [0060] Referring to Figure 1 , a medical fluid injection system 10 for injecting medical fluid into a patient 90 is iliustrated. The injection system 10 generally includes a hand-held or hand-assisted injector 12, a power injector 40 (e.g., a fluid source), a contrast media source 72, a saline source 66, and a waste container or bag 62. The components of the injection system 10 may be fluidly coupled with each other and with the patient 90 via a manifold or valve assembly 100 (only schematically illustrated in Figure 1, but shown in more detail in Figures 2-6) of the injection system 10. Generally, an appropriate signal may be used to configure or define the flowpath through the manifold 100 (e.g., to fluidly interconnect certain components of the injection system 10 and/or the patient 90). A description of the various flowpaths through the manifold 100 and how the same may be realized will be addressed in more detail below.
[0061] The hand-held injector 12 includes a syringe 22 and a lever or trigger 20. Manually actuating the lever 20 (e.g., via forces from an operator or user) discharges contrast media from the syringe 22, into a hand-held discharge tube 26, and into the manifold 100. This particular flow from the hand-held injector 12 is introduced into the manifold 100 via a stopcock 122c.
[0062] The power injector 40 includes a powerhead 42. The power injector 40 may communicate with one or more external or remote devices (e.g., a remote console, a hospital information system) by a communication link 48 of any appropriate type (e.g., a cable as shown; wirelessly). A power injector syringe 46 is installed on the powerhead 42. Operation of the powerhead 42 (e.g., in accordance with one or more injection protocols that each may be in the form of a programmed sequence of any type) discharges contrast media (or any other appropriate fluid) from the power injector syringe 46, into a power injector discharge tube 52 (or more generally a contrast media tube for the iliustrated application), and into the manifold 100. This particular flow from the power injector 40 is introduced into the manifold 100 via the above-noted stopcock 122c.
[0063] The contrast media source 72 (more generally, a fluid source) may utilize a container of any appropriate size, shape, configuration, and/or type. Contrast media (or any other appropriate fluid) may be directed out of the contrast media source 72 by a contrast media tube 74. This flow out of the contrast media source 72 is introduced into the manifold 100 via the above-noted stopcock 122c. In the illustrated embodiment, the contrast media tube 74 and the power injector discharge tube 52 merge together. An appropriate connector would allow the power injector discharge tube 52 to join the contrast media tube 72, or the contrast media tube 74 and the power injector discharge tube 52 could be in the form of Y-type tubing. Each of the contrast media tube 74 and the power injector discharge tube 52 may be characterized as extending to the manifold 100 for the illustrated configuration (albeit using a common section in the illustrated embodiment). Moreover, the power injector discharge tube 52 could also be characterized as a contrast media tube for the case where it is delivering contrast media to the manifold 100. [0064] The saline source 66 (more generally, a fluid source) may utilize a container of any appropriate size, shape, configuration, and/or type. Saline (or any other appropriate fluid) may be directed out of the saline source 66 by a saline tube 68. This flow out of the saline source 66 is introduced into the manifold 100 via a stopcock 122b. [0065] The waste bag 62 may be of any appropriate size, shape, configuration, and/or type. A waste tube 64 extends between the waste bag 62 and the manifold 100. Flow from the manifold 100, through the waste tube 64, and into the waste bag 62 is controlled by a stopcock 122a.
[0066] One or more of the stopcocks 122a, 122b, 122c may be repositioned to provide a flowpath through the manifold 100 that fluidly interconnects two or more components of the medical fluid injection system 101 or that fluidiy interconnects at least one of the components of the medical fluid injection system 10 with the patient 90. In the latter regard, a patient or injection tube 92 extends between the patient 90 and the manifold 100. [0067] At least the waste bag 62, waste tube 64, saline source 66, saline tube 68, contrast media source 72, and contrast media tube 74 may be characterized as a tubing set 60. Each of the tubes 64, 68, 74, 52, 26, and 92 may be any appropriate conduit, including in the form of medical tubing.
[0068] The contrast media source 72 may be utilized to provide contrast media to the power injector 40 and/or the hand-held injector 12. For instance, in preparation for an upcoming imaging procedure, the contrast media source 72 may be utilized to fill one or both of the syringes 22, 46 that are mounted to the injectors 12, 40, respectiveiy, As another example, the contrast media source 72 may be utilized during an imaging procedure to refill one or both of the syringes 22, 46 that are mounted to the injectors 12, 40, respectively (e.g., when additional contrast media is desired for the injection procedure). As represented by the series of arcs shown in Figure 1 , the contrast media source 72 may be in communication with the power injector 40, such as via radio frequency communication (e.g., to monitor information for patient safety and billing) or by any appropriate communication link. The power injector 40 may be fluidly coupled to the contrast media source 72 in any appropriate manner. For instance, the power injector 40 may be fluidiy coupled to the contrast media source 72 using a check valve arrangement (not shown) or an injector-controlled valve (e.g., as in Figures 18-21 ). The contrast media source 72 may be characterized as a bulk contrast media source - having a volume of contrast media that may accommodate multiple injections of multiple patients.
[0069] One or more of the illustrated components of the injection system 10 may be omitted in other embodiments of the system 10. For example, if the power injector 40 is not needed for a procedure, the power injector 40 may be omitted, and the portion of the tubing set 60 interconnecting the contrast media source 72 with the manifold 100 may not exhibit a "Y" configuration, since there would be no need to allow the power injector 40 to be fluidly coupled with the rest of the injection system 10. As another example, if only a relatively small volume of contrast media is needed for a given procedure, the contrast media source 72 may be omitted (e.g., as in the variation illustrated in Figure 2).
[0070] Minus the contrast media source 72, Figure 2 presents a variation of the medical fluid injection system 10 from Figure 1, and shows more detail regarding the manifold 100. Corresponding components between these two embodiments are identified by the same reference numerals. Those corresponding components that differ in at least some respect are identified by a superscripted "i" notation. In this regard, Figure 2 is characterized as a medical fluid injection system 10'.
[0071] At least certain additional details are shown in Figure 2. For instance, the hand-held injector 121 is illustrated as being of a "single hand" type, versus the "dual hand" type illustrated in Figure 1. In any case, these two injectors 12, 12' may be interchanged, and other hand-held injector configurations may be appropriate as well. The hand-held injector 121 also includes various signaling devices 14, 16, and 18 that each may communicate with the manifold 100 via a communication link 24 of any appropriate type (wired in the illustrated embodiment). These signaling devices could also be used by the Figure 1 embodiment or by any other hand-held power injector. [0D72] The power injector 40 from the injection system 10' of Figure 2 includes a display or graphical user interface 44 (e.g., for displaying a blood pressure of the patient 90; for displaying information regarding one or more aspects of the operation of the power injector 40), and a communication link 50 of any appropriate type (wired in the illustrated embodiment) extends between the power injector 40 and the manifold 100. The power injector discharge tube 521 itself extends to the manifold 100 {i.e., it does not merge with a contrast media tube 74 as in the case of the Figure 1 embodiment), and again may also be characterized as a contrast media tube 52'. [0073] The manifold 100 generally includes a cassette 102 (e.g., Figures 3 and 6) having one or more stopcocks 122a, 122b, 122c (more generally, signal-actuated valves), along with a manifold drive unit 130 (e.g. Figures 5 and 6), each described in more detail below. In addition, the tubing set 601 may be coupled to the manifold 100 to fluidly couple the manifold 100 to one or more of the power injector 40, the saline source 66, the waste bag 62, another component which may be included in the system 10', or any combination thereof. For example, a contrast media source 72 (e.g., as in Figure 1) may be fluidly coupled with the manifold 100 in addition to or in lieu of the power injector 40. The position of the injectors 12' and 40 in the injection system 10' could be switched as well.
[0074] Either or each of the injectors 12[, 40 may include various buttons, switches, levers, knobs, toggles, or the like that function as signaling devices to control one or more of the signal-actuated valves 122a, 122b, 122c of the manifold 100 (e.g., as in Figures 7-11) via, for instance, electronic and/or wireless signals (e.g., radio frequency, infrared, cable synchronizing, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, wireless application protocol (WAP), spread-spectrum frequency hopping, half-duplex or full-duplex communication, Bluetooth standards, or the like), and which may be categorically defined as "control signals." For example, an electronic and/or wireless signal may be transmitted from either of the injectors 12', 40 to the manifold 100, which in turn controls (e.g., opens, closes, rotates, actuates, or the like) one of more of the signal-actuated valves 122a, 122b, 122c of the manifold 100. Generally, a signal to the manifold 100 may reposition at least one of the 122a, 122b, 122c to provide a desired flowpath through the manifold 100 (e.g., to fluidly interconnect desired components of the medical fluid injection system 10' and/or patient 90).
[0075] An exemplary protocol may automatically position one or more of the valves 122a, 122b, 122c in the manifold 100 such that the injector 121 or power injector 40 (more specifically their respective syringes 22, 46) is fluidly coupled with the patient 90 in response to an appropriate signal from one of the injectors 12, 40 (e.g., due to depression of a button, squeezing of a lever, toggling of a switch, or the like). A first such protocol could configure the manifold 100 to fluidly interconnect the syringe 22 of the hand-held injector 12' and the patient 90. A second such protocol could configure the manifold 100 to fluidly interconnect the syringe 46 of the power injector 40 and the patient 90. In the case of this second protocol, it could also initiate automatic injection of contrast media from the power injector 40 to the patient 90 if desired. [0076] Various signaling devices are incorporated by the hand-held injector 121 shown in Figure 2. Activating each of these signaling device may provide a different configuration for the manifold 100 (e.g., each such signaling device may provide or define a different flowpath through the manifold 100 to fluidly interconnect different components of the injection system 101 and/or the patient 90), may initiate an associated function, or both. A signaling device14 (e.g., in the form of a button) on the hand-held injector 12' may be programmed with a protocol to configure manifold 100 to fluidly interconnect the saiine source 66 and the patient 90, to initiate a flow of saline from the saline source 66 to the patient 90, or both. A signaling device18 (e.g., in the form of a button) on the hand-held injector 12' may be programmed with a protocol to refill the syringe 22 {e.g., from the power injector 40 to the hand-held injector 12' or from a contrast media source (e.g., contrast media source 72 in Figure 1) to the hand-held injector 121). A mechanical lever 20 on the hand-held injector 12' may be programmed with a protocol to fluidly couple the injector 121 to the patient 90 while the lever 20 advances a plunger within the syringe 22. Moving the lever 20 could result in issuing an appropriate control signal. However, the fluid pressure provided by an actuation of the lever 20 could also provide a fluid-pressure signal to the manifold 100 which could fluidly interconnect the hand-assisted injector 121 with the patient 90. In any case, the lever 20 on the hand-assisted injector 12' may provide a more powerful ergoπomic grip than a common syringe. A signaling device 18 (e.g., a smaller lever or trigger) on the hand-held injector 121 may be programmed with a protocol to fluidly interconnect the patient 90 with the waste bag 62, to eject fluid and air into the waste bag 62 that may have been pulled in by a catheter or other vasculature access device included with the patient or injection tube 92, or both (e.g., for an air purge operation). Further, the hand-held injector 121 may include a signaling device programmed with a protocol to start or stop injection of contrast media from the power injector 40 to the patient 90. Other common protocols may be programmed into the hand-held injector 121. Each of these signaling devices/protocols may be incorporated by the power injector 40 as well.
[0077] The manifold 100 of the injection system 101 may be in the form of a two-part structure - a cassette 102 (e.g., Figures 3 and 6) and a manifold drive unit 130 (e.g., Figures 4 and 6). The cassette 102 could be in the form of a disposable structure (e.g., for a single procedure or injection), while the manifold drive unit 130 could be a multi-use or reusable structure (e.g., for use with multiple injections to multiple patients). In any case and referring now primarily to Figures 3 and 6, the cassette 102 generally includes a plurality of signal-actuated or manifold valves 122a, 122b, 122c (e.g., three-way stopcocks), which may be arranged in various configurations/positions to control fluid flow in the injection system 101 and/or to the patient 90. It should be noted that while the illustrated embodiment includes three manifold valves 122a, 122b, 122c, any appropriate number of manifold valves may be utilized by the cassette 102 and these valves may be disposed in any appropriate arrangement. Generally, one or more valves of any appropriate type may be used by the cassette 102 and may be repositioned in response to an appropriate signal or combination of signals to provide a certain flowpath through the manifold 100 - to fluidly interconnect one or more components of the medical fluid injection system 101, the patient 90, or any combination thereof.
[0078] In the illustrated embodiment, each manifold valve 122a, 122b, 122c is in the form of a stopcock and includes a stopcock flow channel 124 having three accesses or ports (e.g., a T-shaped structure in the illustrated embodiment). Moreover, each manifold valve 122a, 122b, 122c has a drive feature 126 (e.g., in the form of a projection) to enable rotation of the manifold valves 122a, 122b, 122c as described below. The stopcock 122c may be fluidly coupled with the stopcock 102b, an injector connector 104 (e.g., a standard Luer connector) on the cassette 102, and a contrast media line or flow channel 120 within the cassette 102. The stopcock 102b may be fluidly coupled with the stopcock 122a, the stopcock 122c, and a saline line or flow channel 114 within the cassette 102. A saline pump 116 for moving saline from the saline source 66 to the patient 90 may be situated in or communicate with the saline line 114. The saline pump 116 is illustrated in more detail in Figure 12, and is discussed below. Other pumps that may be used in place of the saline pump 116 are illustrated below in Figures 13-16 and are discussed in more detail below as well. Similar to the stopcocks 122a, 122b, 122c, the saline pump 116 may utilize any appropriate drive feature (e.g., pump shaft 118) to enable its rotation by the manifold drive unit 130.
[0079] The stopcock 122a is fluidly coupled with the stopcock 122b, a patient connector 106 (e.g., a standard Luer connector) on the cassette 102, and a waste line or flow channel 108 within the cassette 102. Disposed within or otherwise associated with the waste line 108 may be a pressure transducer 110 of any appropriate type (e.g., to monitor the blood pressure of the patient 90 on a scale of approximately 3-5 psi) and a check valve 112 (e.g., to block a flow of waste from the waste bag 62 to the patient 90). In order to prevent blood pressure from opening the check valve 112, the check valve 112 may open only at higher pressures than those associated with blood pressure (e.g., greater than 10 psi). Pressure from operation of either of the injectors 12, 40 may be adequate to open the check valve 112, thereby enabling waste to be deposited in the waste bag 62 (e.g., for an air purge operation).
[0080] The tubing set 601 illustrated in Figures 2 and 4 generally includes three tubes or conduits (e.g., power injector discharge tube 521, saline tube 68, and waste tube 64) corresponding to the contrast media line or flow channel 120, the saline line or flow channel 114, and the waste line or flow channel 108 of the cassette 102, respectively. As noted above, any number of signal-actuated valves may be utilized by the cassette 102, and accordingly any number of tubes may make up the tubing set 601. The manifold 100 may have a signal-actuated valve for each tube being used by the tubing set 60', although such may not always be the case, [0081 ] In the illustrated embodiment, the power injector discharge tube 521, saline tube 68, and waste tube 64 interface with a common connector 78 which may couple the tubing set 60' to the manifold 100, more specifically the cassette 102. As such, the connector 78 may be referred to as a "manifold connector 78." The manifold connector 78 thereby simultaneously fluid interconnects multiple tubes (tubes 521, 68, and 64 in the illustrated embodiment) with the manifold 100 (more specifically with the lines 120, 114, and 108, respectively). The manifold connector 78 may be configured to enable the manifold 100 to clamp or otherwise securely maintain the tubing set 60' in place within the cassette 102, as described below. The manifold connector 78 could also be integrally formed with or separately attached to the cassette 102 in a non-detachable relation (i.e., so that the manifold connector 78 is not intended to be removed from the cassette 102 such that the tubing set 60' and cassette 102 could be dispersed of as a single unit). [0082] Allowing multiple fluid interconnections to be simultaneously made with the cassette 102 reduces the time/complexity to set up the medical fluid injection system 10Λ One or more features may be utilized to reduce the potential that the manifold connector 78 wiil be incorrectly installed on the cassette 102. The tubing set 60', the manifold connector 78, and/or the cassette 102 may be color-coded, labeled, or configured to facilitate proper connection of the fluid lines fluid lines 120, 114, and 108 of the cassette 102 to the tubes 521, 68, and 64, respectively, of the tubing set 60\ One or more features could be incorporated by the manifold connector 78 and/or the cassette 102 such that the manifold connector 78 may only be installed when in a single orientation relative to the cassette 102 {i.e., a positional registration feature or features may be utilized such that the manifold connector 78 may only go on "one way" to the cassette 102).
[0083] Notwithstanding the benefits of the above-noted manifold connector 78, individual connectors could be provided at corresponding ends of the individual tubes 64, 68, 521 to separately fluidly couple each tube 64, 68, 52' with a particular one of the various fluid lines or flow channels 108, 114, 120 of the cassette 102. In any case, the opposite end of one or more of these tubes 64, 68, 52j may include an appropriate connector as well. For instance, one end of the power injector tube 54' may include a connector 54 (e.g., a standard Luer connection) for fluidly coupling the contrast line 521 with the power injector syringe 46 and/or contrast media source 72 {Figure 1 ). A saline spike 70 may be disposed at one end of the saline tube 68 to connect the saline source 66, such as a saline bag, to the saline tube 68. The waste bag 62 may be integral with the tubing set 60' or otherwise "pre-connected" to the waste tube 64, or the waste tube 64 may terminate in a spike similar to the saline spike 70 (or any other appropriate connector) to enable connection of the waste tube 64 to a separate waste bag 62, [0084] Another feature of the tubing set 60* is directed to facilitating the set-up of the medical fluid injection system 101. The tubing set 601 includes a section 76 where the tubes 64, 68, and 521 are joined together or are otherwise maintained in a fixed position relative to each other, and which may be done in any appropriate manner. This joined section 76 extends from the manifold connector 78 of the tubing set 601. In one embodiment, the joined section 76 has a length of at least about 24 inches, Having the joined section 76 may reduce the potential for individual tubes of the tubing set 601 becoming tangled during and after incorporating the same in the medical fluid injection system 10'.
[0085] Figures 5 and 6 present views of the manifold drive unit 130 of the manifold 100. The manifold drive unit 130 may receive the cassette 102 and control the position of the signal-actuated valves 122a, 122b, 122c of the cassette 102 based upon an appropriate signal from the hand-held injector 12 or the power injector 40. The manifold drive unit 130 generally includes electrical and/or mechanical control elements (e.g., drives, motors, gears, or the like) for positioning/configuring the stopcocks 122a, 122b, 122c, operating the saline pump 116, and reading the pressure transducer 110. For example, stopcock actuators 132 of the manifold drive unit 130 may be coupled to the stopcocks 122a, 122b, 122c of the cassette 102 to enable the manifold drive unit 130 to rotate the stopcocks 122a, 122b, 122c into desired positions (e.g., to provide different flowpaths through the manifold 100). In the illustrated embodiment, each stopcock actuator 132 is associated with a different one of the stopcocks 122a, 122b, 122c. Any appropriate way of interfacing or interconnecting each stopcock actuator 132 with its corresponding stopcock 122a, 122b, 122c may be utilized. In the illustrated embodiment, each stopcock actuator 132 incorporates a drive feature 134 (e.g., an A-shaped recess) that mechanically couples with the drive feature 126 (e.g , an A-shaped projection) of the corresponding stopcock 122a, 122b, 122c to ensure that the stopcocks 122a, 122b, 122c may only be coupled to the stopcock actuators 132 in a predictable manner (e.g., the projections 126 only fit into the recesses 134 one way, like a key). Other ways of realizing a predictable alignment between the stopcocks 122a, 122b, 122c and their corresponding stopcock actuator 132 may be utilized. [0086] The manifold drive unit 130 includes a pump drive 136 (e.g., a motor) for controlling/operating the saline pump 116 in the cassette 102 (e.g., Figures 3 and 5). The pump drive 136 may be coupled to the saline pump 116 in any appropriate manner (e.g., a recess 138 in the pump drive 136 may receive an end of a drive shaft 118 of the pump 116 (or a coupling or other structure on the end of such a drive shaft 118), such that the pump drive 136 rotates the shaft 118 of the pump 116). The pump shaft 118 and the recess 138 may be complimentary-shaped such that rotation of the pump drive 136 is mechanically communicated to the pump 116 (e.g., a hex-shaped end of the pump shaft 118 may be disposed within a hex-shaped recess 138 such that the pump drive 136 and the pump 116 rotate together when coupled).
[0087] The manifold drive unit 130 additionally includes pressure transducer contacts 140 to read/transmit information (e.g., blood pressure of the patient 90 as in Figure 2) from the pressure transducer 110 in the cassette 102. The pressure transducer contacts 140 on the manifold drive unit 130 may be utilized to communicate pressure signals from the pressure transducer 110 to one or more signal-processing devices that will ultimately determine (e.g., calculate) the blood pressure of the patient 90. The blood pressure of the patient 90 may be relayed to the power injector 40 or any other appropriate device and displayed (e.g., on the display 44 as shown in Figure 2). To enable communication between the manifold drive unit 130 and either or both of the injectors 12', 40 (e.g., to relay control signals from the injectors 12, 40 and operating information from the manifold 100), the medical fluid injection system 10' may utilize appropriate communication links 24 and/or 50 (e.g., means for receiving and/or transmitting signals, such as interface cables, a wireless transmitter and/or receiver arrangement, or the like). Due to the signal-actuated control of the manifold 100, the manifold 100 may be smaller than a traditiona! manual manifold in which clearance must typically be provided for hand operation. [0088] Figure 6 is a perspective view of the cassette 102, manifold drive unit 130, and part of the tubing set 60' illustrated in Figures 2-5. In the illustrated embodiment, the cassette 102 and the tubing set 601 are assembled such that the fluid lines 108, 114, 120 are fluidly coupled with the tubes 64, 68, 52', respectively. The cassette 102 may be coupled with the manifold drive unit 130 (e.g , the drive features 126 of the stopcocks 122a, 122b, 122c may be aligned with and coupled with the drive features 134 of the stopcock actuators 132; the pump shaft 118 of the saline pump 116 may be aligned with and inserted into the recess 138 of the pump drive 136; the pressure transducer contacts 140 may be aligned with the pressure transducer 110; or the like). [0089] The position of the cassette 102 may also be "registered" to the manifold drive unit 130 in any appropriate manner. For instance, the cassette 102 may be substantially blocked from lateral or longitudinal movement (e.g., along axis 146 and/or axis 148) with respect to the manifold drive unit 130. A lip 128 protruding from the cassette 102 may be inserted in a slot or groove 144 in the manifold drive unit 130, thereby blocking vertical movement (e.g., along axis 150) of the cassette 102 relative to the manifold drive unit 130. The manifold drive unit 130 may also include a connector or clamp 142 which receives the manifold connector 78 of the tubing set 60' (e.g., via a snap-lock or press-fit interaction) to secure the cassette 102 to trie manifold drive unit 130. The clamp 142, in conjunction with the slot 144, at least substantially locks the cassette 102 and the tubing set 60' onto the manifold 130.
[0090] Figures 7-11 illustrate exemplary configurations into which the stopcocks 122a, 122b, 122c may positioned to provide various flowpaths through the manifold 100 for the case of the medical fluid injection system 10 of Figure 1 (e.g., to fluidly interconnect different components of the medical fluid injection system 10 and/or the patient 90). Only certain components of the injection system 10 from Figure 1 are included for context in Figures 7-11. It should be appreciated that these same configurations may be used by the medical fluid injection system 101 of Figure 2 (including where the power injector 40 is replaced by the contrast media source 72), and that these same configurations could also be used by other variations of the medical fluid injection system 10 of Figure 1 as well, for instance where the power injector 40 is not utilized (not shown).
[0091] Figure 7 illustrates a manual contrast injection configuration 160 by which contrast media may be supplied from the hand-held injector 12 to the patient 90. That is, a fluid pathway or flowpath extends from the hand-held injector 12 to the patient 90 through each of the stopcocks 122a, 122b, 122c of the manifold 100. Moreover, the stopcock 122c is positioned to fluidly isolate the hand-held injector 12 from each of the contrast media source 72 and the power injector 40, the stopcock 122b is positioned to fluidiy isolate the hand-held injector 12 from the saline source 66, and the stopcock 122a is positioned to fluidly isolate the hand-held injector 12 from the waste bag 62.
[0092] Figure 8 illustrates a power injector contrast injection configuration 164 by which contrast media may be supplied from the power injector 40 to the patient 90. That is, a fluid pathway or flowpath extends from the power injector 40 to the patient 90 through each of the stopcocks 122a, 122b, 122c of the manifold 100. Moreover, the stopcock 122c is positioned to fluidly isolate the power injector 40 from the hand-held power injector 12, the stopcock 122b is positioned to fluidly isolate the power injector 40 from the saline source 66, and the stopcock 122a is positioned to fluidly isolate the power injector 40 from the waste bag 62, [0093] Figure 9 illustrates a saline injection configuration 168 and a syringe refill configuration 172. These configurations 168, 172 may be used independently of each other or in combination with each other as desired/required. In the saline injection configuration 168, saline may be pumped to the patient 90 from the saline source 66. That is, a fluid pathway or flowpath extends from the saline source 66 to the patient 90 through the stopcocks 122a and 122b of the manifold 100 (the stopcock 122c is not in this flowpath, and therefore its position may be characterized as being irrelevant to the saline injection configuration 168). Moreover, the stopcock 122b is positioned to fluidly isolate each of the patient 90 and the saline source 66 from each of the contrast media source 72, the power injector 40, and the hand-held injector 12.
[0094] In the syringe refill configuration 172 shown in Figure 9, contrast media from the contrast source 72 and/or the power injector 40 may be supplied to refill the hand-held injector 12. That is, a fluid pathway extends from the contrast media source 72 and/or the power injector 40 to the hand-held injector 12 through the stopcock 122c of the manifold 10O (the stopcocks 122a and 122b are not in this flowpath, and therefore their respective positions may be characterized as being irrelevant to the syringe refill configuration 172). [0095] Figure 10 illustrates a pressure-reading configuration 176 and a saline flush configuration 180. These configurations 176, 180 may be used independently of each other or in combination with each other as desired/required. In the pressure-reading configuration 176, the blood pressure of the patient 90 may be monitored. That is, the stopcock 122a may be positioned such that the patient 90 is in fluid communication with the pressure transducer 110 within the cassette 102 (and which senses pressure in the waste line or flow channel 108 of the cassette 102) (the stopcocks 122b, 122c are not in this flowpath, and therefore their respective positions may be characterized as being irrelevant to the pressure-reading configuration 176). Moreover, the stopcock 122a may be positioned to fluidly isolate each of the patient 9O1 the pressure transducer 110, and the waste bag 62 from each of the saiine source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12. The pressure-reading configuration 176 may be a default position for the stopcock 122a, where the stopcock 122a returns to the pressure-reading configuration 176 any time the stopcock 122a is not in use in another configuration. [0096] In the saline flush configuration 180 shown in Figure 10, the stopcocks 122a, 122b may be positioned to provide a flowpath from the saline source 66 to the hand-assisted injector 12 (the stopcock 122a is not in this flowpath, and therefore its position may be characterized as being irrelevant to the saline flush configuration 180). Moreover, the stopcock 122b fluidly isolates each of the saline source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12 from each of the patient 90 and the waste bag 62. With regard to the saline flush configuration 180, it may be desirable to flush the hand-held injector 12 after contrast media has been injected into the patient 90 to ensure that all of the contrast media is injected into the patient 90, to clean out the syringe 22 of the hand-held injector 12 (Figure 1) before disposal, or both.
[0097] Figure 11 illustrates an air purge configuration 184 by which fluid and/or air may be pushed into the waste bag 62 from the hand-held injector 12. That is, a fluid pathway or flowpath extends from the hand-held injector 12 to the waste bag 62 through each of the stopcocks 122a, 122b, and 122c. Moreover, the stopcock 122a is positioned to fluidly isolate the patient 90 from each of the waste bag 62, the saline source 66, the contrast media source 72, the power injector 40, and the hand-held injector 12. It should be appreciated that the stopcock 122c in Figure 11 could be disposed in the position shown in Figure 8 to provide an air purge configuration for the power injector 40. Other configurations not illustrated here may be utilized to perform further tasks, and configurations other than those illustrated may be used to perform described tasks. Finally, the described configurations may be combined, where possible, to perform multiple tasks simultaneously (e.g., as in Figures 9 and 10).
[0098] The cassette 102 discussed in relation to the medical fluid injection system 10' again incorporates a saline pump 116. An enlarged view of this saline pump 116 is presented in Figure 12. The saline pump 116 may be characterized as a generated rotor (gerotor) pump. The pump 116 generally includes an external rotor 240 having a pump cavity 242. An internal rotor 244 is disposed within this pump cavity 242. The rotational axis of the external rotor 240 is offset from the rotational axis of internal rotor 244. Relative rotation of the eccentrically- arranged internal rotor 244 and external rotor 240 creates a vacuum at an inlet 246 of the pump 116 and forces fluid out of the pump 116 through an outlet 248.
[0099] Any appropriate pump may be used in place of the above-described saline pump 116. Representative pump configurations are shown in Figures 13-15. Figure 13 illustrates a peristaltic pump 1161 (e.g., operating on the order of approximately 30 psi). The peristaltic pump 116' generally includes a tube 220 through which saline flows as facilitated by rollers 222 disposed along a rotor 224. The tube 220 is disposed between a raceway 118 of a stator (not shown) and the rotor 224 having the plurality of rollers 222 rotatably mounted thereon. As the rotor 224 rotates, the rollers 222 progressively occlude the tube 220 against the raceway 118 to at least some degree, which in turn displaces fluid in the tube 220, thereby moving the fluid from an inlet 226 to an outlet 228. [00100] Figure 14 illustrates an external gear pump 116". The external gear pump 116" generally includes a drive gear 232 and a following or driven gear 234 that are engaged with each other and that are disposed within a pump cavity of a stator or pump housing 230. Driving the drive gear 232 rotates each of the drive gear 232 and the following gear 234 to pump fluid from an inlet 236, around the perimeter of the gears 232 and 234, to an outlet 238.
[00101] Figure 15 illustrates one embodiment of what may be characterized as an eccentric orbit pump 116iN, and again which may be used by the cassette 102 in place of the pump 116, or for any other appropriate application. The eccentric orbit pump 116»' generally includes an outer housing 252 surrounding an inner cavity 254. A drive shaft 256 (e.g., a rotating shaft) may be disposed at the center of the inner cavity 254. An eccentric shaft 258 (e.g., not centered around the drive shaft 256) is appropriately coupled to the drive shaft 256 such that rotation of the drive shaft 256 rotates the eccentric shaft 258 eccentrically in the inner cavity 254 (e.g., the center of the eccentric shaft 258 moves relative to the center of the inner cavity 254 during rotation of the eccentric shaft 258). A follower or rotor 260 is mounted on and moves at least substantially within a reference plane in conjunction with the eccentric shaft 258 (e.g., eccentrically relative to the outer housing 252). That is, the eccentric shaft 258 may rotate relative to the follower 260, but the translation of the rotational axis of the eccentric shaft 258 also causes the follower 260 to translate (e.g., move within a reference plane). The follower 260 is prevented from fully rotating by an extension 262 of the outer housing 252 projecting into a slot 264 in the foilower 260. [00102] The positive displacement motion of the eccentric orbit pump 1161"1 is illustrated in Figure 16. Movement of the follower 260 in the inner cavity 254 creates a space 266 between the follower 260 and the outer housing 252 within the inner cavity 254. A fluid 268 (e.g., saline) enters the space 266 via an inlet 270. The space 266 enlarges as the foilower 260 moves in the inner cavity 254, thereby sucking the fluid 268 into the pump 116»' using a vacuum action. As the follower 260 continues to move around the inner cavity 254, the space 266 may become closed off from the inlet 270. The space 266 may then be fluidly coupled with an outlet 272. As the follower 260 continues moving around the inner cavity 254, the fluid 268 may be pushed out of the space 266 through the outlet 272.
[00103] Figure 17 illustrates an exemplary process 274 for setting up and using the injection system 10 (e.g., as in Figure 1). The recited steps may be performed in orders otherthan that listed herein, and various steps may be omitted or repeated, depending upon the requirements of a given procedure. First, the tubing set 60 may be mounted to the cassette 102 via the manifold connector 78 (Block 276). The cassette 102 and attached tubing set 60 may then be installed on the manifold drive unit 130 (Block 278). The saline source 66 (e.g., a saline bag or bottle) may be fluidly interconnected with the tubing set 60 via the spike 70 (Block 280). In addition, the waste bag 62 may be fluidiy interconnected with the tubing set 60 (e.g., if the waste bag 62 is not integral with the tubing set 60). The contrast media source 72 and/or the power injector 40 may be fluidly interconnected with the tubing set 60 (e.g., sequentially, simultaneously) (Block 282). If the power injector 40 and/or the contrast media source 72 is not required for a given procedure (e.g., if only one of the power injector 40 or the contrast media source 72 is needed), the action(s) associated with Block 282 may be revised accordingly. If only the hand-held injector 12 is needed, the action(s) associated with Block 282 may be eliminated.
[00104] The hand-held injector 12 may be fluidly interconnected with the cassette 102 via the connector 50 on the cassette 102 (Block 284). An air purge operation may be undertaken in relation to the hand-held injector 12 and/or the power injector 40, where air may be directed through the manifold 100 and into the waste bag 62 (e.g., as in Figure11) or the air may be ejected through the patient connector 106 on the manifold 100 while not connected to the patient 90 (Block 286). The syringe 22 of the hand-held injector 12 may then be filled with contrast media (e.g., manually or automatically) from the power injector 40 and/or the contrast media source 72 (Block 288). For example, pressing a button on the injector 12, 40 may send a control signal to the manifold 100 to orient the stopcock 122c such that contrast media (e.g., from the power injector 40 and/or the contrast media source 72) may be directed into the syringe 22 on the hand-held injector 12 (e.g., as in Figure 9). In another embodiment, the hand-held injector 12 may be omitted from the injection system 10, and the syringe 46 on the power injector 40 may be filled with contrast media from the contrast media source 72 in Block 288. This would not require a fluid line or a flowpath through the manifold 100. In any case and when the syringe 22 is filled with contrast media, another air purge application may be undertaken (e.g., by pushing the air into the waste bag 62 or ejecting the air through the patient connector 106 while not connected to the patient 90) (Block 290). When the air has been purged, the manifold 100 may be connected to the patient 90 (e.g., by fluidly coupling the patient connector 106 on the cassette 102 with a catheter inserted in the patient 90, via the injection tubing 92) (Block 292).
[00105] When the system 10 is fluidiy coupled with the patient 90, blood pressure monitoring may commence (e.g., the stopcock 122a may fluidly couple the patient 90 with the pressure transducer 110, as in Figure 10) (Block 294). In addition, the default position of the stopcock 122a may be to enable monitoring of the blood pressure of the patient 90 when fluids are not being injected into the patient 90 or the waste bag 62 (e.g., as in FigurelO). Contrast media or saline may then be injected into the patient 90 via the manifold 100. For example, contrast media may be injected from the hand-held injector 12 (e.g., as in Figure 7) (Block 296), This step enables a caregiver to have manual control over injection of the contrast media, as well as to receive tactile feedback. The syringe 22 of the hand-held injector 12 may then be refilled with contrast media (e.g., as in Figure 9) (Block 298). Instead of or in addition to injecting the contrast media via the hand-held injector 12, contrast media may be injected from the power injector 40 (e.g., as in Figure 8) (Block 300). If the power injector 40 is fluidly connected to the contrast media source 72, the syringe 46 on the power injector 40 may be refilled after the injection (Block 302). Finally, saline may be injected into the patient 90 from the saline source 66 (e.g., as in Figure 9) (Block 304). [00106] Turning now to Figure 18, another embodiment of a medical fluid injection system 306 for injecting medical fluid into a patient 314 is illustrated. The system 306 generally includes a power injector 308, an injector- controlled valve assembly 310, and a medical fluid source 312 (e.g., containing contrast media, a radiopharmaceutical, saline, or the like). The medical fluid source 312 may include radiation shielding to substantially contain the radiation from a radiopharmaceutical. In any case, fluid may be routed from the injector 308 and/or the fluid source 312 to the patient 314 (e.g., for injection) and/or from the fluid source 312 to the injector 308 (e.g., to fill the injector 308) via the valve assembly 310.
[00107] The valve assembly 310 is illustrated in more detail in Figure 19, and may include a valve (e.g., a three- way stopcock 316), a connector (e.g., a three-way tube connector 318), and a valve drive (e.g., a stopcock actuator 320). It should be noted that while the illustrated embodiment includes a three-way stopcock, other types of valves may be appropriate. The tube connector 318 may include three tube connections 322, 324, and 326 (e.g., standard Luer connections) which fluidly couple the valve assembly 310 to the injector 308, the fluid source 312, and the patient 314, respectively (e.g., as in Figure18). The stopcock actuator 320 may rotate the stopcock 316 with respect to the tube connector 318 (e.g., to fluidly couple different elements with one another). [00108] As illustrated in Figures 20 and 21 , the injector 308 may include a motor 328 coupled to a drive gear 330 which meshes with the stopcock actuator 320. The stopcock 316 may be rotated automatically (e.g., in response to electronic and/or wireless control signals) upon movement of a plunger 334 disposed within a syringe 336 installed on the injector 308 (e.g., by movement of a ram 309 of the injector 308). That is, when the plunger 334 is moved, an electronic and/or wireless signal may be sent to the motor 328, thereby initiating rotation of the drive gear 330. In another embodiment, the drive gear 330 may be actuated mechanically by movement of the plunger 334. The stopcock actuator 320 rotates with the drive gear 330 to position the stopcock 316 in an injection configuration 338 (e.g., the injector 308 is fluidly coupled with the patient 314, as in Figure 20) when the plunger 334 is depressed. Similarly, withdrawal of the plunger 334 may automatically rotate the stopcock 316 into a fill configuration 240 (e.g., the injector 308 is fluidly coupled with the fluid source 312, as in Figure 21). The syringe 336 may then be filled with medical fluid (e.g., contrast media, radiopharmaceutical, saline, or the like) from the fluid source 312, enabling another injection into the subject 314 without requiring the syringe 336 to be disconnected from the system 306.
[00109] While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the figures and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.

Claims

1. A medical fluid injection system, comprising: a syringe comprising a barrel and a plunger disposed within and movable relative to the barrel, wherein the barrel has an open rearward end and a closed forward end having a discharge opening defined therein; a medical fluid injector on which the syringe is mounted, wherein the medical fluid injector is designed to cause movement the plunger of the syringe relative to the barrel of the syringe, wherein the medical fluid injector is designed to be held and supported by a hand of a user; and a first valve fluidly coupled with the discharge opening of the syringe, wherein the first valve is designed to transition between at least first and second conditions in response to wireless and/or electronic control signals provided by the medical fluid injector.
2. The system of claim 1 , further comprising medical tubing, wherein the discharge opening of the syringe is connected to one end of the medical tubing, and wherein the first valve is connected to another end of the medical tubing.
3. The system of any of claims 1-2, further comprising contrast media for use in a medical imaging procedure disposed within the syringe.
4. The system of any of claims 1-2, further comprising a radiopharmaceutical disposed within the syringe.
5. The system of claim 4, further com prising radiation shielding disposed about the syringe.
6. The system of any preceding claim, further comprising a second valve fluidly coupled with a medical fluid container.
7. The system of claim 6, wherein the second valve is designed to transition between at least first and second conditions in response to wireless and/or electronic control signals.
8. The system of claim 6, wherein the first and second valves are disposed within a common manifold.
9. The system of any of claims 7-8, wherein the first valve is fluidly coupled with the second valve.
10. The system of any of claims 7-9, wherein the medical fluid container is a medical fluid bag.
11. The system of any of claims 7-10, further comprising saline disposed within the medical fluid container.
12. The system of any preceding claim, further comprising a third valve fluidly coupled with at least one of the first valve, the second valve, a subject, and a medical waste container.
13. The system of claim 12, wherein the third valve is designed to transition between at least first and second conditions in response to wireless and/or electronic control signals.
14. The system of claim 12, wherein each of the first, second, and third valves comprise a stopcock.
15. The system of any of claims 12-14, wherein the first, second, and third valves are disposed within a common housing.
16. The system of any preceding claim, further comprising a pump fluidly coupled with at least one valve of the system.
17. The system of any preceding claim, further comprising a pressure transducer configured to monitor blood pressure of a patient, wherein the pressure transducer is fluidly coupled with at least one valve of the system.
18. The system of any of claims 1-17, wherein the medical fluid injector is designed such that force utilized to expel medical fluid from the syringe using the medical fluid injector is derived from a user.
19. The system of any preceding claim, wherein the medical fluid injector comprises a switch, the activation of which causes a control signal to be sent to the first valve to orient the first valve in at least one of a plurality of preset configurations.
20. The system of any of claims 1-19, further comprising another medical fluid injector, wherein the medical fluid injector and the another medical fluid injector are both fluidly coupled with the first valve.
21. The system of claim 20, wherein the another medical fluid injector is an electrically-powered, programmabie injector.
22. A method of operation for a medical fluid injection system, the method comprising: automatically positioning a valve assembly to create a first pathway for medical fluid from a syringe that is mounted to a medical fluid injector, wherein the automatically positioning occurs in response to a first control signal from the injector, and wherein the first control signal is wireless or electronic, wherein the medical fluid injector is completely supported by the hand of an operator during the automatic positioning of the valve assembly.
23. The method of claim 22, further comprising automatically positioning the valve assembly to create a second pathway for medical fluid from a fluid source other than the syringe in response to a second control signal from the medical fluid injector, wherein the second control signal is wireless or electronic.
24. The method of any of claims 22-23, further comprising automatically positioning the valve assembly to create a third pathway for at least one of filling and refilling the syringe with medical fluid in response to a third control signal, wherein the third control signal is wireless or electronic.
25. The method of any of claims 22-24, further comprising automatically positioning a plurality of valves of the valve assembly in response to the first control signal.
26. The method of any of claims 22-25, further comprising monitoring blood pressure of a subject when fluid is not being expelled from the medical fluid injector.
27. The method of any of claims 22-26, wherein each of the medical fluids is selected from the group consisting of contrast media, radiopharmaceuticals, saline, and combinations thereof.
28. A medical fluid injection system, comprising: a first injector; a manifold comprising a plurality of signal-actuated valves; a first injector conduit extending between said first injector and said manifold; and an injection conduit extending from said manifold.
29. The system of claim 28, wherein said first injector is selected from the group consisting of a hand-held injector and a power injector,
30. The system of any one of claims 28-29, further comprising a first syringe installed on said first injector.
31. The system of any one of claims 28-30, wherein a signal provided to each of said plurality of signal-actuated valves is selected from the group consisting of a fluid-pressure signal, an electrical signal, a wireless signal, or any combination thereof.
32. The system of any one of claims 28-30, wherein said plurality of signal-actuated valves comprises first and second valves, wherein said first valve is actuated by a fluid-pressure signal, and wherein said second valve is actuated by a control signal.
33. The system of any one of claims 28-32, wherein said manifold comprises a manifold drive unit and a cassette mounted to said manifold drive unit and which comprises said plurality of signal-actuated valves.
34. The system of claim 33, wherein said cassette is disposable and said manifold drive unit is reusable.
35. The system of any one of claims 33-34, further comprising a tubing set that in turn comprises a manifold connector and a plurality of tubes that extend from said manifold connector, wherein said manifold connector is detachably interconnected with said cassette.
36. The system of claim 35, wherein said plurality of tubes are joined together for at least a certain distance extending from said manifold connector.
37. The system of any one of claims 35-36, wherein said plurality of tubes comprises a first fluid source conduit and said first injector conduit.
38. The system of claim 37, wherein said plurality of tubes further comprises a waste container conduit.
39. The system of any one of claims 33-38, wherein said manifold drive unit comprises a separate actuator for each of said plurality of signal-actuated valves.
40. The system of any one of claims 33-39, wherein said manifold further comprises a controlier operatively interconnected with each of said plurality of signal-actuated valves.
41. The system of any one of claims 28-40, wherein said first injector comprises a first signaling device, wherein operating said first signaling device disposes said plurality of signal-actuated valves in a first flowpath configuration.
42. The system of any one of claims 28-40, wherein said first injector comprises first and second signaling devices, wherein operating said first signaling device disposes said plurality of signal-actuated valves in a first flowpath configuration, and wherein operating said second signaling device disposes said plurality of signal- actuated valves in a second flowpath configuration.
43. The system of any one of claims 28-40, wherein said first injector comprises first, second, and third signaling devices, wherein operating said first signaling device disposes said plurality of signal-actuated valves in a first flowpath configuration, wherein operating said second signaling device disposes said plurality of signal-actuated valves in a second flowpath configuration, and wherein operating said third signaling device disposes said plurality of signal-actuated valves in a third flowpath configuration.
44. The system of any one of claims 28-43, wherein a first signal provided to said manifold disposes said plurality of signal-actuated valves in a first flowpath configuration by repositioning at least one of said plurality of signal-actuated valves.
45. The system of claim 44, wherein a second signal provided to said manifold disposes said plurality of signal-actuated valves in a second flowpath configuration by repositioning at least one of said plurality of signal-actuated valves.
46. The system of claim 45, wherein a third signal provided to said manifold disposes said plurality of signal-actuated valves in a third flowpath configuration by repositioning at least one of said plurality of signal-actuated valves.
47. The system of any one of claims 2846, wherein said manifold further comprises a pump.
48. The system of any one of claims 28-47, wherein each of said plurality of signal-actuated valves comprises 3-way stopcock.
49. The system of any one of claims 28-48, further comprising: a first fluid source; and a first fluid source conduit extending from said first fluid source to said manifold, wherein said plurality of signal-actuated valves comprises first, second, and third valves, and wherein said manifold further comprises a pressure transducer.
50. The system of claim 48, wherein a first configuration of said first, second, and third valves provides a first flowpath from said first injector to said injection conduit and fluidly isolates said first injector from each of said first fluid source and said pressure transducer.
51. The system of claim 50, wherein a second configuration of said first, second, and third valves provides a second flowpath from said first fluid source to said injection conduit and fluidly isolates said first fluid source from each of said first injector and said pressure transducer.
52. A system of claim 51 , wherein said manifold further comprises a pump associated with said second flowpath.
53. The system of claim 52, wherein said pump is selected from the group consisting of a peristaltic pump, a gear pump, a generated rotor pump, and an eccentric orbit pump.
54. The system of any one of claims 51-53, wherein said first fluid source comprises a saline source.
55. The system of any one of claims 50-54, wherein a third configuration of said first, second, and third valves provides a third flowpath from said injection conduit to said pressure transducer and fluidly isolates said pressure transducer from each of said first fluid source and said first injector.
56. The system of claim 55, further comprising: a waste container; and a waste container conduit extending from said waste container to said manifold, wherein said third flowpath extends to said waste container conduit.
57. The system of any one of claims 50-56, further comprising: a second injector.
58. The system of claim 57, wherein a fourth configuration of said first, second, and third valves provides a fourth flowpath from said first injector to said second injector, fluidly isolates said first injector from each of said pressure transducer and said first fluid source, and fluidly isolates said second injector from each of said pressure transducer and said first fluid source.
59. The system of claim any one of claims 57-58, wherein a fifth configuration of said first, second, and third valves provides a fifth flowpath from said second injector to said injection conduit, fluidly isolates said second injector from each of said pressure transducer and said first fluid source, fluidly isolates said first injector from each of said injection conduit, said pressure transducer, and said first fluid source, and fluidiy isolates said first injector from said second injector.
60. The system of claim any one of claims 57-59, wherein a sixth configuration of said first, second, and third valves provides a sixth flowpath from said first injector to said injection conduit, fluidly isolates said first injector from each of said pressure transducer and said first fluid source, fluidly isolates said second injector from each of said injection conduit, said pressure transducer, and said first fluid source, and fluidly isolates said second injector from said first injector.
61. The system of any one of claims 57-60, wherein one of said first and second injectors is a hand-held injector and the other of said first and second injectors is a power injector.
62. The system of any one of claims 2848, further comprising: a second injector.
63. The system of claim 62, wherein one of said first and second injectors is a hand-held injector and the other of said first and second injectors is a power injector.
64. The system of any one of claims 62-63, wherein said plurality of signal-actuated valves comprises a first valve that controls fluid communication between said first injector, said second injector, and said injection conduit.
65. The system of claim 64, wherein having said first valve in a first position fluidly interconnects said first and second injectors, wherein having said first vatve in a second position fluidly interconnects said first injector with said injection conduit, fluidiy isolates said first injector from said second injector, and fluidly isolates said second injector from said injection conduit, and wherein having said first valve in a third position fluidly interconnects said second injector with said injection conduit, fluidly isolates said first injector from said second injector, and fluidly isolates said first injector from said injection conduit.
66. A medical fluid injection system, comprising: a first injector; a first fluid source; a manifold comprising a manifold drive unit and a cassette detachably mounted to said manifold drive unit and comprising a plurality of signal-actuated valves; a tubing set connected to said cassette and comprising a first injector tube and a first fluid source tube; and an injection tube extending from said cassette.
67. A medical fluid injection system, comprising: a first injector; a first fluid source; a manifold comprising a plurality of signal-actuated valves; a tubing set comprising a manifold connector along with a first injector tube and a first fluid source tube that each extend from said manifold connector, wherein said manifold connector is detachably engaged with said manifold; and an injection tube extending from said manifold.
PCT/US2009/058681 2008-09-30 2009-09-29 Medical fluid injection system with automated valve manifold WO2010039662A2 (en)

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