as) United States
`a2) Patent Application Publication
`(10) Pub. No.: US 2003/0018252 Al
`
`(43) Pub. Date: Jan. 23, 2003
`Duchonet al.
`
`US 20030018252A1
`
`(54) ANGIOGRAPHIC INJECTOR SYSTEM AND
`METHOD OF USE
`
`(76)
`
`Inventors: Douglas J. Duchon, Chanhassen, MN
`(US); James P. Smith, Watertown, MN
`(US); Katherine H. Anderson, Golden
`Valley, MN (US); Robert F. Wilson,
`Shoreview, MN (US); Jiyan Liu,
`Roseville, MN (US)
`
`Correspondence Address:
`ATTN: James W. Inskeep
`OPPENHEIMER WOLFF & DONNELLY LLP
`Suite 700
`840 Newport Center Drive
`Newport Beach, CA 92660 (US)
`
`(21) Appl. No.:
`
`10/172,674
`
`(22)
`
`Filed:
`
`Jun. 14, 2002
`
`Related U.S. Application Data
`
`(60) Continuation of application No. 09/488,443, filed on
`Jan. 20, 2000, which is a division of application No.
`08/966,088, filed on Nov. 7, 1997, which is a con-
`tinuation-in-part of application No. 08/957,801, filed
`on Oct. 24, 1997, now Pat. No. 6,221,045, which is a
`
`modesof operation directly through the interactive panel.
`
`continuation-in-part of application No. 08/946,293,
`filed on Oct. 7, 1997, now Pat. No. 5,800,397, which
`is a continuation of application No. 08/426,148, filed
`on Apr. 20, 1995, now abandoned.
`
`Publication Classification
`
`Ente C07 cacecccsscssssssssnsssssetistnntsnssstve A61M 5/00
`(ST)
`(52) US. Ch.
`cecescsssssssscnstssssetnsenssstn 600/432; 604/154
`
`(57)
`
`ABSTRACT
`
`An angiographic injector system and a method of control-
`lably delivering medical fluid to a patient from an angio-
`graphic injector system are disclosed. A multiple processor
`control system is used to actively control
`the injection
`process and to monitor sensed functions of the system. The
`multiple processors provide dual redundancy safety circuits
`for critical control functions such as syringe motor drive
`speed and current. A motor/servo-amplifier nested control
`function is also disclosed. A unique method and apparatus
`are disclosed for establishing injection parameter default
`values just prior to an injection procedure that are based on
`physiological values of the patient to be treated. The injector
`system uses an interactive display panel
`that presents
`sequenced set-up screens to the user and which enables the
`user to select injection procedures, parameters and other
`
`1
`
`Sinclair Pharmaetal.
`EUNSUNG-1010
`
`Sinclair Pharma et al.
`EUNSUNG-1010
`
`1
`
`

`

`Jan. 23, 2003 Sheet 1 of 38
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`Patent Application Publication
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`US 2003/0018252 Al
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`Patent Application Publication
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`Jan. 23,2003 Sheet 9 of 38
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`Jan. 23,2003 Sheet 10 of 38.
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`Patent Application Publication
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`Jan. 23,2003 Sheet 22 of 38.
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`Patent Application Publication
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`Jan. 23, 2003 Sheet 23 of 38
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`Jan. 23,2003 Sheet 24 of 38.
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`Patent Application Publication
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`US 2003/0018252 Al
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`Power On
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`Jan. 23,2003 Sheet 25 of 38.
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`Patent Application Publication
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`Jan. 23,2003 Sheet 33 of 38)
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`Patent Application Publication
`
`Jan. 23,2003 Sheet 34 of 38)
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`US 2003/0018252 Al
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`
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`
`© ASPIRATE
`
`
`© PURGE
`
`
`CONTRAST TOTAL :[ Omi]
`PATIENT WEIGHT :[
`110.0 Kgs
`ACIST 3.1.0
`LAST INJECTION :|0.0mL @ 0.0mL/s
`
` © END CASE
`
`FIXEDRATE
`|[___—|[L__—_ [AUTO-REFILL
`
`
`SELECT MODE
`©) INJECT
`
`
`
`FIG. 32
`
`LEFT CORON.ARY
`
`SELECTINJECTION
`@ LCA
`
`© RCA
`
`© LV/Ao
`
`S
`SS Press the desired Flow Rate (mL/s)
`
`.
`
`SELECT MODE
`©) INJECT
`
`tTEEC © swine
`
`© END CASE
`
`CONTRAST TOTAL:[OmL__] PATIENT WIEGHT :[
`LAST INJECTION:
`[0.0mL @ 0.0mL/s
`VARIABLE RATE|[ ——s|[__—_—||AUTO-REFILL
`
`ACIST 3.1.0
`
`110.0 Kgs
`
`© ASPIRATE
`
`© PURGE
`
`FIG. 33
`
`35
`
`35
`
`

`

`Patent Application Publication
`
`Jan. 23,2003 Sheet 35 of 38)
`
`US 2003/0018252 Al
`
`SELECTINJECTION
`@ LCA
`
`
`FLOW RATE|VOLUME PRESSURE
`
`LEFT CORONARY :
`
`9
`
`mL/sec
`
`733
`
`PSI
`
`© RCA
`
`© LV/Ao
`
`SELECT MODE
`© INJECT
`
`© SALINE
`
`© ASPIRATE
`
`© PURGE
`
`SN|INDICATORS
`[VARIABLE RATE|| sd{,Ss [MANUAL REFILL]|© END CASE
`
`PATIENT WEIGHT :[_
`CONTRASTTOTAL :[OmL.|
`LAST INJECTION :
`[0.0mL @ 0.0mL/s
`VARIABLE RATE|[ ss [MANUAL REFILL]|© END CASE
`
`ACIST 3.x
`
`110.0 Kgs
`
`FIG. 34
`
`PHYSICIAN:
`| CONTRAST TOTAL:|47mL_|
`LAST INJECTION:
`|8.0mL @ 4.0mL/s
`
`|DR. WILSON
`
`|
`
`FIG. 35
`
`36
`
`SELECT INJECTION
`
`@ LCA
`
`© RCA
`
`© LV/Ao
`
`SELECT MODE
`© INJECT
`
`©) SALINE
`
`© ASPIRATE
`
`© PURGE
`
`ACIST 1.0
`© DISPLAY
`
`36
`
`

`

`Patent Application Publication
`
`Jan. 23,2003 Sheet 36 of 38)
`
`US 2003/0018252 Al
`
`
`
`0
`
`0
`
`10 20 30 40 50 60 70 80 90 100110120130 140
`Weight (kg)
`
`FIG. 36A
`
`s=& 2& =S
`
`i“
`
` oS
`
`0
`
`10 20 30 40 50 60 70 80 90 100110120 130 140
`Weight (kg)
`
`o=— 2& ==
`
`FIG. 36B
`
`Ro2
`
`15
`
`10 FlowRate(mli/sec) 0
`
`
`
`0
`
`10 20 30 40 50 60 70 80 90 100110120 130 140
`Weight (kg)
`
`FIG. 36C
`
`37
`
`37
`
`

`

`Patent Application Publication
`
`Jan. 23,2003 Sheet 37 of 38.
`
`US 2003/0018252 Al
`
`(ml) 0
`Volume
`
`Q
`
`10 20 30 40 50 60 70 80 90 100110120 130 140
`Weight (kg)
`
`FIG. 37A
`
`M—~NoCoACANO
` Volume
`(ml)
`
`0 10 20 30 40 50 60 70 80 90 100110120 130 140
`Weight (kg)
`
`FIG. 37B
`
`(ml)—DoCoROODSBOQOoooooe
`Volume
`
`0
`
`10 20 30 40 50 60 70 80 90 100110120 130140
`Weight (kg)
`
`FIG. 37€
`
`38
`
`38
`
`

`

`Patent Application Publication
`
`Jan. 23,2003 Sheet 38 of 38.
`
`US 2003/0018252 Al
`
`Setup Process
`
`531
`
`Enter
`Patient Weight
`
`530
`
`
`Calculatejection
`and Display
`LOA
`
`
`
`
`
`Patient Weight
`
`Button Selected
`
`
`RCA
`LV/Ao
`Injection Selected
`
`Main Screen
`
`533
`
`FIG. 38
`
`39
`
`39
`
`

`

`US 2003/0018252 Al
`
`Jan. 23, 2003
`
`ANGIOGRAPHIC INJECTOR SYSTEM AND
`METHOD OF USE
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application is a continuation-in-part of U.S.
`
`patent application Ser. No.
`filed on Oct. 24, 1997,
`entitled ANGIOGRAPHIC INJECTOR SYSTEM WITH
`AUTOMATIC HIGH/LOW PRESSURE SWITCHING
`which is a continuation-in-part of U.S. patent application
`Ser. No. 08/946,293, filed on Oct. 7, 1997, which is a file
`wrapper continuation application of U.S. patent application
`Ser. No. 08/426,148 filed on Apr. 20, 1995, which are all
`herein incorporated by reference. This application also
`incorporates by reference the contents of the following U.S.
`
`patent applications: Ser. No.
`, entitled Dual Port
`
`Syringe, filed on Oct. 24, 1997; Ser. No.
`, entitled
`Pneumatic Controller and Method, filed on Nov. 6, 1997;
`and Design application Ser. No.
`; entitled Hand-Held
`Pneumatic Control Device, filed on Nov. 6, 1997; all three
`of which are owned by a commonassignee of this applica-
`tion.
`
`FIELD OF THE INVENTION
`
`[0002] This invention relates generally to angiography
`and/or particularly to an improved injector system for inject-
`ing medical fluids such as radiographic contrast fluids into
`living organisms.
`
`BACKGROUND OF THE INVENTION
`
`[0003] Angiography is a procedure used in the treatment
`of cardiovascular conditions including abnormalities or
`restrictions in blood vessels towards, the network of pas-
`sageways through which bloodtravels in a humanor animal
`body. During angiography, a radiographic contrast material
`is injected through a catheter into a vein or artery, which then
`passes to vascularstructures in fluid communication with the
`vein or artery. When X-rays are passed through the region of
`the body into which the contract material is injected, they are
`absorbed by the contrast material, providing radiographic
`imagesof the desired vascularstructure(s). The images can
`be recorded on film or video tape and/or displayed on a
`fluoroscope monitor. The images can be used for many
`purposes, as for example, diagnostics and for operative
`procedures such as angioplasty, wherein a balloon is inserted
`into a vascular system and inflated to open a stenosis.
`
`[0004] The contrast material can be injected into the
`catheter by either manual or automated injection systems.
`While the apparatus for injecting the contrast material can
`vary, most current systems include a syringe operatively
`connected with the catheter. The syringe has a chamber for
`holding the contrast material and a plunger reciprocally
`moveable within the chamber. The contrast material
`is
`suctioned into the chamber when the plunger is moved to
`create a partial vacuum within the chamber. A reversal of the
`plungerdirection first forces air out of the chamber and then
`delivers the contrast material to the catheter at a rate and
`
`volume determined by the speed of movement of the
`plunger.
`
`In a manual system the user or operator loads the
`[0005]
`syringe and ejects air from the chamber before connecting
`the syringe to the catheter. The user of a manual system
`
`adjusts the rate and volume of injection by altering the
`manualforce applied to the plunger. The maximum injection
`pressure for manual systemsis typically limited to 150 p.s.1.
`(i.e. the maximum pressure that can be applied by the human
`hand), and the maximum quantity of fluid is about 12 cc.
`Such manual systems typically do not accommodate any
`safety features such as the restriction or prevention of
`injections outside of predetermined injection parameters
`(such as rate or pressure), and generally do not include
`active sensors or alarms to detect air bubbles or other
`hazards.
`
`[0006] Angiography can include the injection of fluids
`other than the contrast material. For example, a saline flush
`and/or the injection of fluid medications may be desired.
`One of the most commonly used manual injection systems
`includes a valve mechanism having a plurality of manually
`activated valves that
`the operator selectively opens and
`closes to direct flow of the desired fluids into or out of fluid
`
`channels connected to the syringe or catheter. When the
`operator aspirates or injects the contrast fluid into or out of
`the syringe chamber,the fluid flows through the path ofleast
`resistance as directed by the relative positions of the valves.
`Whenchanging the valve positions, one or more fluids may
`be selectively injected.
`
`[0007] A number of motorized and automated injection
`systems have appeared in the art, to address the limitations
`and dangers associated with the manual injection systems.
`Most such automated systems use a syringe with a linear
`actuator whose movementis regulated by an electronically
`controlled motor. For a description of such typical systems,
`the reader is referred to U.S. Pat. No. 4,812,724 issued on
`Mar. 14, 1989 and to U:S. Pat. No. 4,854,324 issued on Aug.
`8, 1989. Such automated injection systems are generally
`fixed rate injection systems, wherein an operator enters a
`parameter representing the desired fixed volumeof contrast
`material and the desired fixed rate of injection into the
`system. Such systems typically include an initial specified
`rate of flow increase leading to a final rate of injection, until
`the entire volumeof contrast material is injected. There is no
`interactive control between the operator and the system,
`except to start or stop the injection. Any changeofflow rate
`must occur by stopping the injector and resetting the param-
`eters. The automated nature of such machines, however,
`offers the addition of injection speed and volume limit
`control features that were not available with the earlier
`manual injection systems.
`
`[0008] Since the optimal flow rate can vary considerably
`between patients, the lack of ability of such prior art systems
`to vary the rate of injection during an injection procedure
`can result in suboptimal quality of angiographic studies. In
`cardiovascular systems,
`the rate and volume of contrast
`injection depends on the volume and flow rate within the
`blood vessel or other cardiovascular chamberbeinginjected.
`In many or most cases, these parameters are not known
`precisely and can change rapidly during the injection pro-
`cedure as the patient’s cardiovascular system conditions
`change in response to such things as, for example, drugs,
`illness or normal physiology. Consequently,
`the initially
`selected volumeor flow rate parameters for an injection of
`contrast material may be insufficient to outline a desired
`structure on an X-ray image, thereby necessitating another
`injection. Conversely, an excessive flow rate may injure the
`cardiovascular vessel being injected, cause the catheter to be
`40
`
`40
`
`

`

`US 2003/0018252 Al
`
`Jan. 23, 2003
`
`displacedrelative to the patent or lead to toxic effects (such
`as abnormal heart rhythm) from contrast material overdose.
`Ourprior cross-referenced applications, hereby fully incor-
`porated by reference, address theprior art’s lack ofability to
`vary the injection parameters during an injection procedure.
`
`[0009] While the prior automated systems have signifi-
`cantly improved the accuracy and reliability of angiography
`injection procedures, the known systems have not been as
`user friendly as desired, have not had automated capability
`to determine default
`injection parameters unique to the
`physiology or other values of the patent to be treated, and
`have not
`incorporated pro-active safety features in their
`system designs.
`
`[0010] All automated systems necessarily require some
`type of calibration and start-up procedure to be conducted
`prior to initializing an injection procedure with the system
`on a patient. Heretofore, such automated systems have not
`been particularly user friendly, but have required the opera-
`tor or set-up technicians using the system to follow a set-up
`setup and initialization procedure according to instructions
`in a user manual. Besides the nuisancefactor associated with
`
`it is possible to
`the care and handling of such manuals,
`mistake a manual of one injector with that of another or to
`use an outdated manual
`that does not include the most
`current initialization procedures and/or parameters. A further
`shortcoming of prior automated systemsis that such systems
`do not maintain and display to the operator the actual
`real-time injection parameters existing at any instant of the
`injection procedure, or the cumulative amount of contrast
`material that has been administered to a patient from the
`beginning of the injection procedure, to the present. Here-
`tofore, accumulating and maintaining a record of such
`cumulative information for an injection procedure has been
`a responsibility of the operator.
`
`typically
`[0011] Known automated injection systems
`require entry of the following injection parameters:
`the
`volumeof contrast material to be injected, the flow rate of
`injection, the maximum permitted injection pressure and the
`rate of change of injection flow rate (i.e. the rise time). Since
`the three parameters of flow, volume and duration are
`related, if any two are known, the third can be calculated.
`Knownsystems either require the operator to determine the
`desired parameters for an injection procedure, or allow the
`operator to recall parameters that the operator has stored in
`the system’s memory from a prior procedure. Some injec-
`tion systems also include stored default settings for the
`parameters associated with different types of injection pro-
`cedures that can be used by the operator. A deficiency of
`such prior systems, however, is that such default and stored
`parameter values are arbitrarily determined and are not
`generally determined using unique properties or values or
`characteristics of the patient being treated.
`
`[0012] Known automated injection systems also have not
`incorporated pro-active safety features in their system
`designs. While a microprocessor has been used in prior
`systems for providing primary automated control of the
`syringe plunger movement, back-up safety systems for
`checking on the multiprocessor’s effectiveness have not
`been of a pro-active nature, but have been of a type that
`simply have the capability of interrupting or stopping an
`injection if the safety system determined that the injection
`procedure is being performed outside of one or moreof the
`
`predetermined injection parameters. The present invention
`addresses these and other deficiencies of known automated
`
`angiographic injection systems.
`
`SUMMARYOF THE INVENTION
`
`[0013] This invention provides an automated angiographic
`injection system that is extremely flexible and user friendly
`and which providesreal-time instantaneous injection param-
`eter information to the operator. The system features a liquid
`crystal display screen that displays a sequenceof calibration
`and start-up instructions to the operator without requiring
`additional manuals or hard copy instructions during such
`procedures. User communication with the system’s micro-
`processor(s) is readily and accurately permitted through
`touch-responsive pads on the visual display. Since the sys-
`tem microprocessor(s) always includes the most updated
`system intelligence, there is no chance of operator error as
`a result of using outdated manuals. As the injection proce-
`dure progresses,
`the system microprocessor(s)
`instanta-
`neously communicates with the operator, providing the
`operator with real-time information including the instanta-
`neous value of the injection parameters and the cumulative
`volume of contrast material that has been injected into the
`patient. Such information prevents administration of toxic
`doses of the contrast material
`to the patient
`that might
`otherwise occur as a result of successive injections during an
`extended diagnostic or treatment procedure.
`
`[0014] This invention further employs an injection param-
`eter determination procedure that calculates the preferred
`injection parameter default values before the initiation of
`each injection procedure. The preferred injection parameter
`default values are calculated using algorithms that use
`physiological values or information such as weight, age,
`wellness, cardiovascular peculiarities, etc. that are unique to
`the patient being treated. Such determination procedure
`enables the factoring in of changes that may have occurred
`to the patient since the patient’s last injection procedure, and
`does not simply rely on outdated previous memory-stored
`information on the patient. According to one aspect of the
`invention, such algorithmically determined parameters are
`employed in either an automated fixed rate or operator
`initiated variable rate injection mode of operation to opti-
`mally deliver the contrast material to the patient.
`
`[0015] This invention further contemplates the system
`incorporating a plurality of active intelligence systems such
`as microprocessors, for providing simultaneousservicing of
`system sensors and dual redundancy safety feature for
`critical safety injection procedures. Such system enables
`redundant active decision-making capability that does not
`simply require termination of a function in the event of
`errant signals generated by one microprocessor. According
`to one aspect of the invention an injector system is provided
`that simultaneously uses an embedded core operating system
`particularly configured for sensing and hardware control,
`along with a personal computer (PC) based operating system
`that readily provides operator interface capabilities,
`for
`providing a multiple redundantintelligence control system.
`
`[0016] According to yet a further aspect of the invention,
`control of the prime moverof the contrast material injecting
`syringe plungeris accurately and efficiently achieved with a
`commercially available servo amplifier and the use of
`unique nested control loops.
`A1
`
`41
`
`

`

`US 2003/0018252 Al
`
`Jan. 23, 2003
`
`[0017] According to one aspect of the invention there is
`provided a method of controllably delivering medical fluid
`from an angiographic injection apparatus to a patient, com-
`prising: (a) providing the angiographic injection apparatus
`with a fluid delivery mechanism for injecting the medical
`fluid into a patient; and (b) controlling the medical fluid
`injection from the fluid delivery mechanism with at lest two
`computers operatively connected with said fluid delivery
`mechanism. According to preferred configurations of the
`invention one of the computers is preferably of a PC-type
`and one is preferably of an embedded core type. Such
`control of the injection procedure with at least two comput-
`ers provides independent dual redundancy control of key
`operative functions of the delivery mechanism by separate
`ones of the computers.
`
`[0018] According to yet a further aspect of the invention
`there is provided an angiographic injector system, compris-
`ing: (a) a device for injecting a medical fluid into a patient;
`(b) drive means operatively connected with said device for
`causing the device to inject the medical fluid; and (c) a
`plurality of computers operatively connected with the drive
`meansfor actively controlling the drive means. According to
`a further feature of the invention, the computers actively
`control the drive means to control key injection parameters
`of the device including such parameters as flow rate and
`volume of the medical fluid. According to a preferred
`configuration of the invention,
`the injection device com-
`prises a syringe having a moveable piston and the drive
`means includes a motor operatively connected to move the
`piston. In such configuration, the computer(s) actively moni-
`tor operable parameters of the motor such as motor speed
`and motorcurrent to provide dual redundancy safety control
`circuits for the system.
`
`[0019] According to yet a further aspect of the invention,
`there is provided a control system for use in combination
`with an angiographic injection system of the type having a
`syringe apparatus for discharging a medical fluid into a
`patient, a syringe control network operatively connected to
`the syringe apparatus for causing the syringe apparatus to
`controllably discharge said fluid, comprising: at least two
`computers of a type having independent intelligence pro-
`cessing capability, operatively connected to the syringe
`control network for monitoring operation of the syringe
`apparatus and the syringe control network, for indepen-
`dently providing control signals to the syringe control net-
`work.
`
`[0020] According to yet a further aspect of the invention
`there is provided a method for injection of medicalfluid into
`a patient, comprising the steps of: (a) providing an angio-
`graphic injection machine; (b) entering at least one patient
`value into the machine prior an injection; (c) calculating
`within the machine at
`least one injection parameter in
`responseto said entered patient value; and (d) displaying the
`calculated injection parameter to a user of the machine prior
`to the injection. The invention further includes the step of
`entering the calculated injection parameter into the machine
`as a default value for the injection parameter, which is usable
`by the machine in performing an injection, and further the
`step of actually performing an injection with the machine,
`using the entered injection parameter. According to a pre-
`ferred algorithm determination,
`the patient value used in
`determining the calculated injection parameter is patient
`weight, and the determined injection parameter can include
`
`injection flow rate of the medical fluid, volume of the
`medical fluid, rise time of the injection flow rate and a
`pressure limit for the medical fluid during an injection
`procedure.
`
`[0021] According to yet a further aspect of the invention
`there is provided an angiographic injector system, compris-
`ing: (a) a device for injecting a medical fluid into a patient;
`(b) control means operatively connected with the device for
`controllably causing the device to inject the medical fluid in
`responseto at least one injection parameter; (c) input means
`suitable for receiving an input signal corresponding to a
`patient physiological value and for providing a patient value
`signal in response thereto; (d) calculating means operatively
`connected to receive the patient value signal and for deter-
`mining a patient related injection parameter in response
`thereto; and (e) display means operatively connected with
`the calculating means for displaying the patient related
`injection parameter external of the injection system. Such
`injection system further contemplates means operatively
`connected with the calculating means and with the control
`means for delivering the patient related injection parameter
`to the control means, wherein the control meanscontrols the
`device at least partially in response to the patient related
`injection parameter.
`
`[0022] According to yet a further aspect of the invention
`there is provided an angiographic injector system, compris-
`ing: (a) a device for injecting a medical fluid into a patient;
`(b) drive means operatively connected with a device for
`causing the device to inject the medical fluid; (c) at least one
`computer operatively connected with the drive means for
`actively controlling the drive means to cause the device to
`controllably inject the medical fluid; (d) a user interface
`display operatively coupled with the computer for receiving
`input signals from a user and for displaying information to
`the user; and (e) means operatively connecting the user
`interface display with the computer to provide the input
`signals to the computer and for providing information from
`the computer to the display. According to yet a