Programmable injector control

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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Details

C600S431000, C600S458000, C604S890100, C604S892100, C604S019000

Reexamination Certificate

active

06643537

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention generally relates to powered injectors and syringes for use therewith, and more particularly, to methods and apparatus for automatically controlling the same.
A number of injector-actuated syringes and powered injectors for use in medical procedures such as angiography, computed tomography, ultrasound and NMR/MRI have been developed. U.S. Pat. No. 4,006,736, for example, discloses an injector and syringe for injecting fluid into the vascular system of a human being or an animal. Typically, such injectors comprise drive members such as pistons that connect to a syringe plunger. For example, U.S. Pat. No. 4,677,980, discloses an angiographic injector and syringe wherein the drive member of the injector can be connected to, or disconnected from, the syringe plunger at any point along the travel path of the plunger via a releasable mechanism. A front-loading syringe and injector system is also disclosed in U.S. Pat. No. 5,383,858.
U.S. Pat. No. 5,494,036 discloses a patient infusion system adapted for use in MRI. The infusion system is designed to be substantially non-reactive with the magnetic field generated by the magnetic resonance imaging system for producing diagnostic images.
Medrad has also developed a control arrangement (“SPECTRIS”) for an MRI infusion system that uses two syringes, namely, one for the introduction of contrast medium into a patient and the other for a flushing medium. As is known conventionally, it is often desirable to flush from the tubing of an infusion system a residual quantity of contrast medium that remains there after a given infusion procedure, as contrast medium tends to be expensive and its efficient use, without waste, is often seen as a top priority. The “SPECTRIS” control arrangement will thus not only account for the residual contrast medium left in the tubing, and aim to use it in an infusion procedure, but will utilize a much cheaper flushing medium, such as a saline solution, in order to serve the purpose of pushing the residual contrast medium through the tubing and even through the patent's body (so as to “push” and deliver contrast medium to a region of interest in the body). Other advantageous purposes have also been recognized in connection with such flushing media, such as maintaining a flow through tie patient's veins for a predetermined period of time in order that the veins will be better prepared to subsequently receive a new infusion of contrast medium.
The “SPECTRIS” control arrangement is a pre-programmable arrangement for establishing a precise protocol for the infusion of contrast medium followed by flushing medium. At the time that the “SPECTRIS” system was established, needs in the industry were generally such that only some very simple protocols were desired. Thus, the “SPECTRIS” system addressed such needs by permitting protocols in which one or two “phases” of contrast medium took place followed by zero, one or two “phases” of flushing medium infusion. “Phase” refers to the application of a given quantity of a given medium at, for example, a fixed flowrate for a fixed period of time. Thus, up to two phases each of contrast medium and flushing medium, for example, were permitted by the “SPECTRIS” system, in order to provide a patient with different modes of infusion one after the other to serve particular purposes.
Of late, however, some disadvantages have been noted in connection with the “SPECTRIS” control system and other related systems. Not the least of these is the lack of flexibility in developing and administering infusion protocols to a patient, as the “SPECTRIS” system would allow no more than two distinct phases for each medium, and no single phase of flushing medium infusion could take place between two different phases of contrast medium infusion.
A further disadvantage has been recognized in that the aforementioned phases will typically be administered one after the other without the opportunity for an intermediate pause or hold between phases. This would appear to limit the convenience and utility of the system in question in many respects.
Nemoto and Co., Ltd., of Tokyo, Japan has also developed a control system for an MR injector. However, this appears to be even less flexible than the “SPECTRIS” system in that only protocols consisting of no more than one contrast medium infusion and no more than one flushing medium infusion appear to be permitted.
In the realm of CT (computed tomography) injection technology, Medrad has developed the “ENVISION” control system. As flushing media have generally not been hitherto employed in CT injector systems, the “ENVISION” system, much as any conventional CT injector control system, contemplates only the use of a single syringe for patient infusion, and solely for use with contrast medium. The “ENVISION” system permits protocols that employ up to eight different phases of contrast medium infusion, wherein each phase may employ a different infusion flowrate, infusion quantity and/or infusion duration. Pre-programmed pauses between infusion phases are also conceivable within such a context.
Evolving needs have thus been recognized in connection with providing an injection control system that is much more readily adaptable to a wider range of contexts.
SUMMARY OF THE INVENTION
Generally, at least one presently preferred embodiment of the present invention broadly contemplates a fluid injection arrangement, in the context of patient imaging systems, in which phases of contrast medium injection and flushing medium injection can be freely and selectably ordered so as to make available to the operator and patient a vast array of possible protocols that has hitherto been essentially unattainable.
The present invention also broadly contemplates the use of a “hold” phase, involving an indefinite pause between phases of a protocol, in connection with such imaging systems. One advantage of a “hold” phase is that it permits some time for the operator to render supplementary judgments, following the administration of the phase(s) before the “hold”, that could be of value when administering the phase(s) that occur(s) after the “hold”. For example, the “hold” phase could permit an operator to alter the parameters for the phases not yet undertaken.
In addition, the present invention broadly contemplates the use of “pattern recognition,” through recognizing a graphical or iconic pattern of words, numbers, geometric shapes, and possibly other visual stimuli that in sum correspond to a given protocol, to permit an operator to quickly and efficiently recognize the makeup of a given protocol.
In one aspect, the present invention provides an apparatus and method for operating an injector providing stimuli corresponding to an injection protocol. The method includes perceiving the stimuli, recognizing a pattern provided by the stimuli, correlating the recognized pattern to the injection protocol, and interacting with the injector based on the recognized pattern.
The stimuli provided by the injector may, in a preferred embodiment of the present invention, comprise visual stimuli including, but not limited to, words, numbers, shapes and colors.
Also broadly contemplated herein is the use of a “pause” phase in which a pause of fixed duration is pre-programmed into the protocols of MRI injector systems.
In further summary, at least one presently preferred embodiment of the present invention broadly embraces fluid injection apparatus comprising: at least one drive mechanism; at least two fluid containers operably associated with the at least one drive mechanism, one fluid container containing a contrast medium and the other fluid container containing a flushing medium; and a control device operably associated with the at least one drive mechanism; wherein the control device is operable to: selectively program a plurality of phases of an injection procedure, at least one phase comprising one of: a contrast medium phase, a flushing medium phase, a pause phase and a hold phase; and selectively modify at least one phase of the injection p

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