U.S. patent application number 10/948921 was filed with the patent office on 2005-02-17 for injector.
This patent application is currently assigned to Mallinckrodt Inc.. Invention is credited to Fago, Frank M., Gibbs, Jonathon D., Neer, Charles.
Application Number | 20050038389 10/948921 |
Document ID | / |
Family ID | 31187636 |
Filed Date | 2005-02-17 |
United States Patent
Application |
20050038389 |
Kind Code |
A1 |
Fago, Frank M. ; et
al. |
February 17, 2005 |
Injector
Abstract
An injector 20 that may be used to deliver radiographic contrast
media and/or flushing solution into a patient's vascular system for
the purposes such as obtaining enhanced diagnostic x-ray images.
The injector includes the following features: (1) a syringe mount
26 for attachment of a syringe 28 to the injector 20; (2) display
34 and controls 90 for volume and flow rates; (3) automatic
limiting of the operating pressure of the injector 20 as determined
by the selection of a flow rate; (4) a syringe cradle 48 having a
warming capability; (5) a purge/retract trigger 36 for control of
the injection procedure having intuitive direction (i.e., forward
for injecting, reverse for filing), non-contact control
transmission through the housing of an injector 20 for an improved
seal integrity, a speed lock, and/or the ability to change the
concentration and/or flow rate of media or other fluid during an
injection procedure; (6) a switch to determine when the drive ram
46 is in a "home" position; (7) a "soft" on/off power switch
separate from the injector; and (8) a structure to prevent rotation
of the drive ram 46 about its axis of symmetry 76. Additionally,
the injector system includes software for the control of various
components.
Inventors: |
Fago, Frank M.; (Mason,
OH) ; Neer, Charles; (Cincinnati, OH) ; Gibbs,
Jonathon D.; (Mason, OH) |
Correspondence
Address: |
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI
OH
45202
US
|
Assignee: |
Mallinckrodt Inc.
St. Louis
MO
Liebel-Flarsheim Company
|
Family ID: |
31187636 |
Appl. No.: |
10/948921 |
Filed: |
September 24, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10948921 |
Sep 24, 2004 |
|
|
|
10211726 |
Aug 2, 2002 |
|
|
|
Current U.S.
Class: |
604/187 |
Current CPC
Class: |
A61M 5/007 20130101;
A61M 2205/3331 20130101; A61M 2205/702 20130101; A61M 2005/14553
20130101; A61M 5/31525 20130101; A61B 6/548 20130101; A61M 5/1458
20130101; Y02A 90/10 20180101; A61M 2205/3317 20130101; A61M
2205/3561 20130101; A61M 5/445 20130101; A61M 2005/1402 20130101;
A61M 2205/3653 20130101; A61M 5/172 20130101; A61M 2005/1403
20130101; A61M 5/16827 20130101; Y02A 90/26 20180101; A61M 5/14566
20130101; A61M 2205/3569 20130101; A61M 5/14546 20130101 |
Class at
Publication: |
604/187 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. An injector for injecting fluids from a syringe into an animal
subject comprising: a drive ram bidirectionally movable along a
longitudinal axis of said drive ram; a motor drivingly coupled to
said drive ram to selectively advance and retract said drive ram
along said longitudinal axis; and a syringe mount engageable with a
syringe to position said syringe relative to said injector to
permit said drive ram to engage and move a plunger within said
syringe; wherein said syringe mount includes first and second
members, said first member being pivotable toward and away from
said second member such that said first member may be placed in a
first position or a second position.
2. The injector of claim 1 wherein said first member is in said
first position when said syringe mount is not engaged with said
syringe.
3. The injector of claim 1 wherein said first member is in said
second position when said syringe mount is engaged with said
syringe.
4. The injector of claim 1 wherein said first and second members
each have an arcuate surface
5. The injector of claim 4 wherein said first member is biased
toward said second member when said first member is in said second
position and said first and second members grip a sidewall of said
syringe between said first and second members to engage said
syringe with said syringe mount.
6. The injector of claim 1 further comprising a housing, said
syringe mount being adapted to mount a syringe external to said
housing.
7. The injector of claim 1 wherein said syringe mount includes
first and second movable members, said first and second movable
members being pivotable toward and away from one another such that
said first and second members may be in a first position or a
second position.
8. The injector of claim 7 wherein said first and second movable
members are in said first position when said syringe mount is not
engaged with said syringe.
9. The injector of claim 7 wherein said first and second movable
members are in said second position when said syringe mount is
engaged with said syringe.
10. The injector of claim 1 wherein said first and second movable
members each have an arcuate surface.
11. The injector of claim 10 wherein said first and second movable
members are biased toward one another when in said second position
and grip a sidewall of said syringe between the first and second
movable members to engage said syringe with said syringe mount.
12 The injector of claim 7 further comprising a housing, said
syringe mount being adapted to mount a syringe external to said
housing.
13. The injector of claim 1, further comprising: a housing; and a
heating element, wherein said heating element further comprises an
extension operatively connected to said injector external to said
housing.
14. The injector of claim 13 wherein said heating element is
adapted to interact with a syringe and directly and/or indirectly
alter the temperature of contents in said syringe.
15. The injector of claim 13 wherein said heating element is
adapted to interact with a syringe and directly and/or indirectly
maintain the temperature of contents in said syringe.
16. The injector of claim 14 wherein the temperature of contents in
said syringe is raised to approximate the temperature of a subject
to be injected.
17. The injector of claim 15 wherein the temperature of contents in
said syringe is maintained at approximately the temperature of a
subject to be injected.
18. The injector of claim 1, further comprising: a housing; and a
detector disposed within said housing for determining whether a
first end of said proximal drive ram is in a first position
proximal to the forward end of a housing of said injector, wherein
said detector operates in concert with a signal emitting device
disposed on said drive ram to detect signals emitted from said
signal emitting device.
19. The injector of claim 18 wherein said signal emitting device is
a magnet.
20. The injector of claim 18 wherein a signal emitted by said
signal emitting device is a magnetic field.
21. The injector of claim 18 further including at least one sensor
disposed on said housing of said injector.
22. The injector of claim 21 wherein said drive ram is moveable in
a forward or a reverse direction along its longitudinal axis.
23. The injector of claim 22 wherein said drive ram is movable in a
reverse direction along its longitudinal axis at a first velocity
when said detector does not detect any signals from a signal
emitting device disposed on said drive ram.
24. The injector of claim 23 wherein said detector includes a
calibrated value corresponding to said first position of said drive
ram.
25. The injector of claim 24 wherein said drive ram is movable in a
reverse direction along its longitudinal axis at a second velocity
when said detector detects signals from a signal emitting device,
but said signals do not equal said calibrated value.
26. The injector of claim 24 wherein said detector operatively
causes said drive ram to halt at said first position when said
detector detects a signal emitted by a signal emitting device, and
said signal is equal to said calibrated value.
27. The injector of claim 1, wherein said drive ram has a
cross-section of a first shape taken perpendicular to said
longitudinal axis; said injector further comprising a housing; a
plate disposed within said housing; and an orifice disposed through
said plate, said orifice having said first shape, and said drive
ram being disposed through said orifice; whereby said first shape
prevents rotation of said drive ram about said longitudinal
axis.
28. The injector of claim 1, further comprising: a console
operatively connected to said injector, said console generating a
console control signal for said motor such that said drive ram
moves along said longitudinal axis in a first ram direction,
wherein said console control signal is delivered remotely to said
motor from said console.
29. The injector of claim 28, wherein said drive ram moves in said
second ram direction when a second console control signal is
delivered remotely to said motor from said console.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of and claims priority to
U.S. application Ser. No. 10/211,726, by Frank M. Fago et al.,
entitled "Injector," filed on Aug. 2, 2002, the disclosure of which
is hereby incorporated by reference in its entirety.
FIELD OF INVENTION
[0002] The present invention relates to injectors for injecting
fluid into animal subjects, including humans.
BACKGROUND OF THE INVENTION
[0003] During many medical procedures, various fluids are injected
into patients for purposes of diagnosis or treatment. An example of
one such fluid is contrast media used to enhance angiography or CT
imaging. Such fluids may also be used in other modalities, such as
intravenous pyelogram (IVP) and cardiology. The injectors used in
these procedures are often automated devices that expel the fluid
from a syringe, through a tube, and into the subject.
[0004] Injectors suitable for these applications generally include
relatively large volume syringes and are capable of producing
relatively large flow rates and injection pressures. For these
reasons, injectors for such applications typically include large,
high mass injection motors and drive trains. These are typically
housed in an injection head, which is supported by a floor, wall,
or ceiling mounted arm. Certain such injectors include the CT9000
ADV and the Optistar MR Injection System (K948088). Such devices
are generally designed to meet both the ordinary needs of the
market as well as advanced needs.
[0005] There exist many drawbacks to the large injector units
described above, which are presently used to inject contrast media
and other media. For example, these large power injectors generally
are only available at a high cost. In many instances, this cost is
prohibitive in that it prices many of these injectors out of the
range of some small hospitals, and out of the range of developing
and third world markets. This results in patients that either (1)
do without tests and treatments which may be necessary, or (2)
endure the burden of travel, often over long distances, to reach
those facilities with the necessary injection capabilities. Also,
this results in injection procedures wherein the contrast media, or
other fluid, is delivered by a hand syringe, which is ergonomically
unsafe and can lead to cumulative stress disorders for the user.
Further, the use of a hand syringe provides inferior images as
compared to those generated when using a power injector.
Additionally, many costly, large injector units may include a
number of features which may not be necessary for the purposes for
which they are to be used at some smaller hospitals and other
medical facilities. Such facilities may be better served by an
injector which does not include all the numerous features of large
injectors, but which might thereby be more affordable.
[0006] In addition to the cost concerns discussed above, safety
concerns can arise due to the use of these large, and often
complex, injectors. First, these injectors operate at a relatively
high pressures, as described above. Many current power injectors
have a maximum pressure limit in order to provide safety to the
components of the power injector. This prevents the injector from
being damaged by being subjected to forces greater than its
components are rated to withstand. These injectors also allow the
operator to reduce the set maximum pressure limit to provide safety
to a patient or other subject to be injected. For example, access
ports are inserted into patients who need medication intravenously,
but whose veins cannot tolerate multiple needle sticks. Access
ports that are implanted into patients cannot tolerate many of the
high pressures capable of being generated by these large injectors.
High flow rates and pressures can cause the implanted catheter
portion of the access port to break and require surgery to remove.
For example, 100 psi is generally a threshold of pressure that a
typical access port is able to withstand. However, a typical large
CT injector can attain pressures during delivery of media of 300
psi at all flow rates. Thus, unless the pressure of such an
injector is manually reduced, the access ports in a patient can be
become over-pressured and possibly fail. Limiting the pressure for
the injection of fluid into an access port for a contrast study
requires a technologist to reprogram the injector to reduce the
pressure limit. If the technologist forgets to reset the limit to
the higher setting once the application has been performed, the
desired flow rates may not be achieved during injections for
subsequent patients. This can result in ineffective injections and
a waste of media, among other costs attendant to repeating the
injection procedure.
[0007] A second safety concern regards the structure and function
of the triggers of injectors. Injectors, as described above, may
include a trigger lever which may be manipulated by an operator in
order to dispel media or other fluid from a syringe into a subject
or to pull fluid from a container and into a syringe. The triggers
of these large power injectors may often operate only at a constant
set speed. Once the injection has begun, it may automatically
proceed to completion at a set pressure and flow rate. An operator
may be generally unable to change the injection speed or rate or
pressure as an injection is occurring, without actually halting the
injection procedure. This lack of control over the pressure and
flow rates at which an injection proceeds may raise safety issues
for the patient or other subject being injected, should an
incorrect pressure limit or flow rate be programmed. Likewise,
halting an injection procedure can result in ineffective injections
and waste of media, among other costs.
[0008] Additional problems arise when attaching a syringe to an
injector. Many current injectors include a face plate, which is
disposed at the forward end of the injector. To replace the
syringe, the front face plate, which facilitates coupling between
the syringe plunger and the plunger drive ram, is moved, the used
syringe detached, and a fresh syringe attached. The syringes may be
pre-filled or may be initially empty, to be filled after being
attached to the injector. The plunger drive ram of the injector is
disposed within the injector housing on one side of the face plate,
while the syringe is attached to, and extends from, the opposite
side of the face plate. When the syringe is connected to the face
plate, it is substantially co-axially aligned with the plunger
drive ram. The face plates used in operatively connecting the
syringe to the injector may be cumbersome and time-consuming to
operate.
[0009] Additionally, many injectors may include a separate console
for controlling the injector. The console typically includes
programmable circuitry which can be used for automatic programmed
control of the injector. This may be beneficial in that the
operation of the injector can be made predictable and operate in
concert with the operations of other medical equipment. Thus, at
least a part of the injection process may be automatically
controlled. However, any filling procedure, and typically some part
of the injection procedure may be performed by an operator using
hand-operated movement controls on the injector head. Typically the
hand-operated movement controls may include buttons for reverse and
forward movement of the injector drive ram, to respectively fill
and empty the syringe. In some cases, a combination of buttons is
used to initiate movement of the ram or to control ram movement
speed. The injector head also typically includes a gauge or display
for indicating injection parameters to the operator. Unfortunately,
operators have found it cumbersome to use the hand-operated
movement buttons and to read the injector head gauges and
displays.
[0010] Another problem that arises concerns the temperature of the
media or other fluid as it is injected. It is often important,
during injection procedures, that the fluid to be injected have a
temperature approaching the body temperature of the subject to be
injected. To accomplish this, in large injectors as described
above, a warming unit may be included in the injector to raise and
maintain the temperature of a fluid to a predetermined level.
Often, media will be maintained at a particular temperature in a
separate warming unit and subsequently attached to the injecting
unit. However, any lag time involved in removing the media from its
warming cradle, and attaching the syringe, and injecting the media,
may result in a decrease of the temperature of the media.
[0011] Another drawback with presently used injectors is that they
are generally incapable of communicating with other injectors. As a
result this only allows for one injector to be programmed and/or
used at a time. Thus, there is generally no ability for different
injectors to operate automatically in a sequential fashion. This
situation reduces the overall safety in injection procedures by
requiring a technician or other medical personnel to operate and
monitor potentially several different injections simultaneously or
in overlapping fashion. This increases the potential for error in
an injection procedure.
[0012] Additional problems with current injectors arise due to the
use of multiple components which must communicate with one another
during an injection procedure. Often, several components, such as
the injector, a console, and a power supply, must all communicate
with one another in order to correctly perform an injection.
[0013] Another problem that arises from the structure of current
injectors is in attempting to maintain the correct placement of the
drive ram in order to facilitate the loading and unloading of
syringes to the injector. Many prior art injectors use
potentiometers and/or encoders on the motor, either separately or
as redundant systems, to track the location of the drive ram in
relation to the housing of the injector. It is important to be able
to track the position of the drive ram so that an operator can
remove and replace syringes during a series of injections, while
being able to rely on the drive ram being in the correct location.
Some previous injectors have used linear potentiometers; others
have used rotary potentiometers. However, the use of these
potentiometers and redundant systems increases the required size
and cost of the injectors.
[0014] Another problem found in current injectors is in the
structure for ensuring that the drive ram does not rotate about its
axis of symmetry during injection. If the drive ram should rotate
away from its original position, it is possible that an operator
would then be unable to remove and discard old syringes, and/or
attach new syringes to the injector. To reduce this problem,
previous injectors generally have used a cam follower operatively
connected to the drive ram which moves back and forth along with
the drive ram and tracks in a groove located in an inner wall of
the housing of the injector in order to prevent rotation of the
drive ram. However, this structure increases friction which may
result in an unsmooth movement of the injector drive ram.
Additionally, any groove in the housing may become blocked which
also may disrupt the injection procedure.
SUMMARY OF THE INVENTION
[0015] Accordingly, to improve power injectors, there is need for
an injector system including an injector in which pressure limits
may be easily set within safety thresholds. It would be further
desirable to provide an injector which allows for manipulation of
injection speeds, rates, and/or pressures during the injection
procedure. Further, it would be desirable to provide an injector
which reduces or eliminates power connections to the injector
itself. It would also be desirable to provide an injector to
facilitate attachment of a syringe. Further, it would be desirable
to provide an injector which has the capability of warming and/or
maintaining the temperature of the media or other fluid to be
injected. Additionally, it would be desirable to provide an
injector which is capable of communicating with other injectors.
Further, it would be desirable to provide an injector which is
capable of tracking the location of the drive ram while reducing
the overall size, and thus the cost, of the injector. Also, it
would be desirable to provide an injector which includes a uniform
or "soft" power switch associated with a peripheral component, such
as a remote console. Further, it would be desirable to provide an
injector which prevents rotation of the drive ram. Also, it would
be desirable to provide an injector which improves the ease of its
operation. And finally, it would be desirable to provide such an
injector at low cost in order to provide such injectors to
currently unavailable markets.
[0016] The present invention also provides less cumbersome features
than those injectors of the prior art, and thereby may provide
injectors and injector systems at lower cost. Accordingly, the
apparatus of the present invention includes an injector system
having an injector which overcomes and eliminates the drawbacks of
injector systems and injectors as described above in the background
of the invention. The term "injector system", as used herein,
generally applies to any number of injectors, consoles, power
supplies, interconnections, and other peripherals used to complete
an injection procedure, while the term "injector" generally refers
to the particular equipment which directly discharges fluid, such
as media, from a syringe. However, the terms "injector" and
"injector system" may be used interchangeably herein.
[0017] The injector of the present invention may be used to deliver
radiographic contrast media and/or flushing solution into a
patient's vascular system for the purpose of obtaining enhanced
diagnostic x-ray images. However, the injector is not limited to
this purpose, and may be used to deliver other media for other
applications. In one aspect, the invention provides an ergonomic,
light-weight powerhead injector that may be hand-held. This allows
the injector to be more portable and economical than current large
mounted injectors. Such a handheld injector is amenable for use in
facilities which rely upon hand injection, or for use in
combination with a mounted single powerhead to provide a dual
syringe capability in CT applications. The injector of the present
invention may deliver radiographic contrast media at a controlled
flow rate and volume into a patient's vascular system for the
purpose of obtaining enhanced diagnostic images. The injector of
the present invention is made up generally of at least the
following components:
[0018] (1) A powerhead--The powerhead includes a drive system, a
syringe mount for attachment and holding of a syringe, a main
microprocessor, control electronics, a control keypad for
programming and initiating injection protocols, a status display,
and a purge/retract trigger.
[0019] (2) A power pack--The power pack includes a power supply and
an interface. The interface is made up of a plurality of relays and
optical couplings that provide communication between various
devices. One use for the interface is to harmonize two injectors in
one injection system so as to provide greater volume capability or
to provide a flushing solution.
[0020] The present invention may also include an optional remote
console which communicates with the powerhead to program and
initiate injection protocols, displays the injection status, and
displays a timer.
[0021] The present invention may thus include, but is not limited
to, the following features: (1) a syringe mount for attachment of a
syringe to the injector; (2) display and controls for volume and
flow rates; (3) automatic limiting of the operating pressure of the
injector as determined by the selection of a flow rate; (4) a
syringe cradle having a warming capability; (5) a purge/retract
trigger including a trigger lever for control of the injection
procedure having intuitive direction (i.e., forward for injecting,
reverse for filing) coupled with variable velocity of the drive
ram, non-contact control transmission through the housing of an
injector for an improved seal integrity, a speed lock, and/or the
ability to change the concentration and/or flow rate of media or
other fluid during an injection procedure; (6) a switch to
determine when the drive ram is in a "home" position; (7) a "soft"
on/off power switch separate from the injector; and (8) a structure
to prevent rotation of the drive ram about its axis of symmetry.
Additionally, the injector system may include software for the
control of various components. It will be apparent to those of
skill in the art that many of the features of the injector of the
present invention may also be applicable to the large ceiling,
floor, or wall mounted injectors described above in the background
of the invention.
[0022] The injector of the present invention delivers media, such
as contrast media for example, under pressure, into a patient for
the purpose of obtaining contrast enhanced diagnostic images. As
described above in the background of the invention, many current
markets are served by larger, more permanent injector systems which
are mounted to the exam table suspended from the ceiling, or fitted
to a pedestal-type mobile stand, as described above in the
background of the invention. These previous injectors may only be
available at a cost that is prohibitive in many markets. In one
aspect, the injector of the present invention may be small and
light weight, thus allowing the user the option of holding the
injector by hand during injections, thus allowing for a greater
level of control. Such a small handheld injector requires less
materials and may therefore be produced at a lower cost. This
reduction in the overall price of such an injector increases the
ability of smaller hospitals and third world markets to purchase
such injectors, and thus allows patients in those areas access to a
greater range of medical procedures. The injector of the present
invention is designed to meet ordinary needs of the medical market
and is therefore less expensive, smaller, and less complicated to
operate. Features such as stored protocols, multi-phasic
injections, high flow rate, and optional printer may be omitted
from the injector of the present invention in order to reduce costs
and simplify the user interface. With an optional
injector-to-injector interface, the injector of the present
invention may be joined with other compatible injectors in order to
deliver multi-phasic injections, greater volume capability, or a
flushing solution (normally saline) in a similar manner as some
other injection systems, such as the Optistar MR injection
system.
[0023] A greater level of control is also provided by the
purge/retract trigger of the present invention, which includes an
intuitive trigger lever. This trigger lever may be in the form of a
variable speed rocker switch. Pushing on the front of the trigger
of the injector of the present invention will extend the drive ram
into the syringe thereby discharging any fluid contained therein.
Pushing the back of the trigger will retract the ram from the
syringe. The trigger of the injector of the present invention
allows the operator to vary the speeds at which fluids are being
injected. It does so by providing a proportional speed control for
the drive ram motions of extension and retraction. The speed of the
drive ram is dependent on the amount of trigger activation compared
to the program speed. Thus, the further an operator displaces the
trigger from its original, or home, position when pushing on the
front of the lever, the faster the movement of the drive ram and
thus the injection flow rate. The same speed control may be
provided when retracting the drive ram.
[0024] Another aspect of the injector of the present invention is
the use of noncontact control associated with the trigger in order
to reduce power connections through the housing in order to seal
the housing. In one embodiment, such non-contact control may occur
through a series of magnets associated with the trigger, the
magnets being sensed by a magnetic sensor that is operatively
connected to a circuit board within the housing of the injector.
Additionally, the injector of the present invention may include a
speed lock associated with the trigger. This allows an operator to
operate injection and filling functions of the injector at constant
speeds by engaging the speed lock, or alternatively at variable
speeds by disengaging the speed lock.
[0025] Another aspect of the injector of the present invention is
the integrity of the connection between the injector and the
syringe to be loaded into the injector. To that end, the injector
of the present invention provides a syringe mount including first
and second gripping members that are designed to be substantially
circumferential around the cylindrical body of a syringe when the
syringe is loaded into the injector. These gripping members are
biased towards the longitudinal axis of the syringe so that as a
syringe is placed into the injector, the gripping members bias
toward and clamp around the cylindrical body of the syringe.
[0026] In another aspect, the handheld injector of the present
invention may include a warming cradle that is operatively
connected to the injector. This warming cradle allows the contents
of a syringe to be maintained at a particular desired temperature
while the syringe is attached to the injector. In one embodiment,
the warming unit may be a cradle present on a hanger which can be
associated with the injector of the present invention. In use, the
injector (including syringe) is operatively connected to the hanger
with the syringe oriented in a downward fashion. This brings the
cylindrical body of the syringe into proximity with the cradle such
that the media within the syringe is warmed. This configuration
reduces and eliminates any cooling problems present with the use of
previous separate warming units and injectors.
[0027] As described above, the present invention also allows for
limitation of the pressure supplied by the injector. Since low flow
rates require less pressure, the injector of the present invention
automatically assigns the pressure limit based on the flow rate.
The pressure limit value is thus high enough to achieve the
programmed flow rate under normal conditions, but won't allow high
pressure to develop in the event of unexpected restriction or
blockage within the syringe or tube or access port. By
automatically assigning a pressure limit based on the flow rate, an
operator does not need to remember to alter the pressure limit each
time the injector is used. Thus, the injector is able to deliver
media at desired rate, but does not allow too much reserved
pressure to build in the event that a blockage occurs. This
increases the safety of the injector of the present invention over
that of injectors of the prior art.
[0028] The injector of the present invention may also be adapted to
be used with other injectors. These other injectors may include,
but are not limited to, handheld injectors, ergonomic lightweight
powerhead injectors, or other CT injectors, and may utilize
multiple device communication links. In one particular embodiment
of the present invention the communication format used is a
Controller Area Network (CAN). However, the injector could
potentially use any communication format. The communication may
occur through wires, fiber optic cable, or may occur through
wireless communication.
[0029] The injector of the present invention also includes a ram
home detector. The ram home detector accurately detects both when
the ram is a certain distance from the home position and when the
ram is at the home position. This detection may be achieved through
the use of magnets. This allows the elimination of secondary analog
position devices such as a potentiometer. As described above in the
background of the invention many present injectors use
potentiometers and/or encoders on the motor as redundant systems to
track the location of the drive ram of an injector. The injector of
the present invention does not include such a system. Rather, the
injector of the present invention includes a magnet disposed on the
ram that interacts with sensors along the inner part of the
injector to detect the location of the ram. When reversing the ram
to its home position, for example, this allows the ram to run
quickly in reverse mode until it is a certain distance from its
home position. During its operation, the injector of the present
invention calibrates a value which it assigns to the ram when the
ram is in its home position, generally flush with the outer edge of
the front surface of the injector. In this way, the ram can be run
and reversed such that it always comes to a rest in the same home
position. This is necessary in being able to remove and replace
various syringes, into and out of the drive ram when in the correct
location. Thus, when in reverse mode, the injector may reverse the
ram at a relatively rapid rate until it recognizes that it is close
to the home position. The rate of reversal of the ram is then
slowed until the injector recognizes that it has reached the
pre-calibrated home position. Movement of the ram is then halted
such that syringes may be removed from and/or inserted into the
injector.
[0030] Additionally, the injector of the present invention also
includes an on/off power switch, referred to as a "soft" power
switch, located on the remote console which is present in addition
to the switch located on the power supply and/or on the injector
itself. Consoles used in injection procedures generally have an off
switch for DC power while the AC power of the power supply remains
active. The on/off switch of the injector of the present invention
communicates with the console such that if the console is in its
off position, the injector and console will automatically be turned
on when the power supply reads that the console has been turned on.
In particular, this switch includes a normally closed/normally open
contact that communicates with a processor inside the console of
the injector. When the contact is open, the processor communicates
with a communication component within the injector to cause the
power supply to turn off. Software may be included in the injector
of the present invention to ensure that the switch does not start
the actual running of an injection procedure.
[0031] The injector of the present invention also includes a
structure to prevent rotation of the drive ram. In particular, this
prevents the ram from. rotating about its axis of symmetry during
an injection procedure. The anti-rotation of the ram is caused by
the shape of the drive ram itself. In one embodiment, a
cross-section of the drive ram taken perpendicular to the
longitudinal axis of the drive ram is in the shape of back to back
D's, having a flat surface across the top of the ram, a flat
surface across the bottom of the ram and a curved surface on both
sides of the ram. This drive ram inserts through a similarly shaped
orifice 134 in a plate in the end of the housing of the injector of
the present invention nearest the syringe. Due to the flat surfaces
on the top and the bottom of the drive ram, the ram is thus unable
to rotate as it moves forward. This is important in keeping a
coupling element that is disposed at the end of the drive ram
aligned in an upward facing direction so that syringes may be
removed and replaced into the injector.
[0032] The aforementioned and other principles and advantages of
the present invention may explained and/or be apparent from the
accompanying drawings which are incorporated in and constitute a
part of this specification, along with the general description of
the invention given above and the detailed description of the
embodiments given below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1 is a perspective view of the injector of the present
invention, depicting the intuitive trigger and the syringe mount in
accordance with principles of the present invention and also
including a power supply and a remote console;
[0034] FIG. 1A is a perspective view of an embodiment of the
present invention including two injectors, two remote consoles, and
two power supplies;
[0035] FIG. 2 is a cross-sectional view of the injector of the
present invention taken along lines 2-2 of FIG. 1, and depicting
the intuitive trigger of the present invention;
[0036] FIG. 3 is a cross-sectional view of the intuitive trigger of
the present invention depicting the trigger in a forward
position;
[0037] FIG. 4 is a cross-sectional view of the intuitive trigger of
the present invention depicting the trigger in a reverse
position;
[0038] FIG. 5 is a cross-sectional view of the syringe mount taken
along line 5-5 of FIG. 2 depicted without a syringe attached to the
injector;
[0039] FIG. 6 is a cross-sectional view of the syringe mount
depicting a syringe attached to the injector of the present
invention;
[0040] FIG. 7 is a perspective view of the hanger of the injector
in accordance with the principles of the present invention;
[0041] FIG. 7A is a perspective view of the injector of the present
invention, including a hanger with a syringe attached to the
injector and associated with the hanger;
[0042] FIG. 8 is a perspective view of the hanger and warming
cradle of the injector in accordance with the principles of the
present invention;
[0043] FIG. 8A is a perspective view of the injector of the present
invention including a hanger and warming cradle with a syringe
attached to the injector and associated with the hanger and warming
cradle;
[0044] FIG. 9 is a graph demonstrating the limits of pressure
versus flow rates in the injector of the present invention.
[0045] FIG. 10 is a schematic of the control board of the remote
console in accordance with the principles of the present
invention;
[0046] FIG. 11 is a schematic of the control board of the remote
console in accordance with the principles of the present invention;
and
[0047] FIG. 12 is a schematic of the power supply interconnect
board in accordance with the principles of the present
invention.
DETAILED DESCRIPTION
[0048] As described above in the summary of the invention, the
present invention provides an injector which overcomes and
eliminates the drawbacks of injectors as described above. With
reference to the Figures, an injector 20 of the illustrated
embodiment of the present invention may be provided in a "wand"
shape in order to be hand held. The injector 20 of the present
invention is designed to meet ordinary needs of the medical market
and is therefore less expensive, smaller, and less complicated to
operate. Features such as stored protocols, multi-phasic
injections, high flow rate, and optional printer may be omitted in
order to reduce costs and simplify the user-injector interface 30.
With an optional injector-injector interface 31 (FIG. 1A), the
injector 20 of the present invention may be joined with other
compatible injectors in order to deliver greater volume injections,
or a flushing solution (normally saline) in a similar manner as
some other injection systems such as the Optistar MR injection
system. It will, however, be recognized by those of skill in the
art that many of the features of the present invention are amenable
for use on larger injectors, such as wall, ceiling, or floor
mounted CT injectors. The injector 20 of the present invention may
deliver radiographic contrast media at a controlled flow rate and
volume into a patient's vascular system for the purpose of
obtaining enhanced diagnostic images. As described above, the
injector 20 of the present invention is made up generally of at
least the following components:
[0049] (1) A powerhead 22--The powerhead 22 includes a drive system
24 which may be electromechanical, a syringe mount 26 for the
attachment and holding of a syringe 28, a main microprocessor,
control electronics, a user-injector interface 30 including a
control keypad 32 for programming and initiating injection
protocols, a status display 34, and a purge/retract trigger 36.
[0050] (2) A power pack 38--The power pack 38 includes a power
supply 40 and a power-injector interface 42. In general, the power
pack 38 may supply DC power to the powerhead 22 from AC mains. The
power-injector interface 42 is made up of a plurality of relays and
optical couplings that provide communication between devices such
as the powerhead 22 and power pack 38. One use for these interfaces
such as the injector-injector interface 31 is to harmonize two
injectors in an injection system so as to provide greater volume
capability or to provide a flushing solution.
[0051] The present invention may also include an optional remote
console 44 which communicates with the powerhead 22 to allow a user
to program and initiate injection protocols and control injections,
such as by starting and stopping an injection. The remote console
44 also may include a user-console interface 45 which may display
injection parameters such as volume and flow rate while injecting,
may display the injection status, and may display a timer.
[0052] Certain features of the injector 20 of the present invention
may include, but are not limited to, the following. The injector 20
of the present invention may include a syringe mount 26 on the
injector 20 in order to facilitate attachment of a syringe 28 to
the injector 20 in alignment with a drive ram 46. The injector 20
may include a cradle 48 having a warming capability. Further, the
injector 20 of the present invention may include a purge/retract
trigger 36 having intuitive direction capabilities. These include
pushing the trigger 36 in a forward direction for injecting, and
pushing the trigger 36 in a reverse direction for filling.
Additionally, the velocity of the drive ram 46 may be varied,
depending on the degree of deflection of the trigger 36 away from a
"home" position. The trigger 36 also may include a non-contact
control transmission through a housing 47 of the injector. The
trigger 36 also may include a speed lock which allows a user to
have the ability to change the concentration or flow rates of the
fluid being injected during the actual operation of an injection
procedure. The utility of an injector 20 that may be small and
light weight along with the ability to dynamically adjust the flow
rate while performing an injection gives the user greater levels of
control over the injection. Further, the pressure generated by the
injector 20 of the present invention may be automatically limited
by the selection of a particular flow rate. The injector 20 of the
present invention also may include a ram home detector 50 that is
used to determine when the drive ram 46 of the injector 20 is
located in a "home" position. The injector 20 of the present
invention also may include an on/off power switch 52 on the remote
console 44 which is separate from other power switches. Finally,
the injector 20 of the present invention may also include the drive
ram 46 having a particular structure that operates to prevent
rotation of the drive ram 46 about its axis of symmetry 76.
[0053] As mentioned previously, the injector 20 of the present
invention operates in combination with a syringe 28. Proximal to
the forward end 56 of the injector housing 47, positioned between
the injector 20 and the syringe 28, is a syringe mount 26 to
facilitate attachment of the syringe 28 to the injector 20. In
certain embodiments (not shown), a pressure jacket, preferably
transparent, may extend outwardly from the forward end 56 of the
housing 47, in order to receive a replaceable syringe 28. The
syringe 28 and pressure jacket are constructed such that they
withstand the injection pressures created by the injector 20 during
an injection operation. It is not necessary that the injector 20
include a pressure jacket that surrounds the syringe 28. In an
alternate embodiment (not shown), a cradle may extend outwardly
from the forward end 56 of the housing 47, in order to support the
syringe 28. As will be discussed below, such a cradle may have a
heating capability, in order to warm the contents of the syringe
28. However, it is not necessary that the injector 20 include a
cradle to support the syringe 28. In yet another embodiment, the
syringe 28 may simply extend freely from the injector 20, with no
structure for its support other than its connection to the injector
20 itself. The syringe 28 may include a syringe plunger.
[0054] With reference to FIGS. 1-4, the syringe 28 for use with the
injector 20 of the present invention generally includes a body 54
which may be in the form of an exterior cylindrical barrel, which
at its forward end 55 is integral with a conical front wall section
58. A neck 60, terminating in a discharge tip 62, generally extends
forwardly from and may be integral with the conical front wall
section 58. The body 54 of the syringe 28 may engage the interior
wall of a pressure jacket or a cradle, as described above, when
such a pressure jacket or cradle is present on the injector 20.
However, the illustrated embodiment depicts a syringe 28 extending
freely from the front of the injector 20. The syringe 28, as used
in conjunction with the injector 20 of the present invention,
includes a syringe mating section 64, which may be in the form of a
radially outwardly extending flange. This syringe mating section 64
is positioned in a plane perpendicular to the axis of symmetry 66
of the syringe 28 and integral with the rear end 67 of the
cylindrical barrel of the body 54 of the syringe 28. This flange
may be annular. The syringe mating section 64 is arranged, when the
syringe 28 is located in conjunction with the injector 20, to align
proximal to cooperating members of a syringe mount 26 located on
the forward end 56 of the injector housing 47. In this manner, the
syringe mating section 64 and syringe mount 26 facilitate the
connection of the syringe 28 to the injector 20, as will be
discussed in greater detail below.
[0055] The discharge tip 62 of the syringe 28 generally contains an
orifice 68 in its remote end which may communicate with an internal
syringe cavity 70 formed within the neck 60, the conical front wall
58, and the body 54 of the syringe 28. The rear end of the cavity
70 may be further defined by a forward facing surface 72 of a
syringe plunger 74. In one particular embodiment, this surface 72
is conical. The conical surface 72 is of a slope which conforms to
the slope of the interior of the conical front wall 58. The syringe
plunger 74 may be snugly slidable within the body 54 of the syringe
28 such that the cavity 70 is of variable volume.
[0056] Referring now to FIGS. 2-4, the syringe plunger 74 can be
seen more clearly within the cylindrical barrel of the body 54 of
the syringe 28. The syringe plunger 74, when the syringe 28 is
attached to the injector 20, is located proximal to and in
substantial alignment with the plunger drive ram 46 of the injector
20. The plunger drive ram 46 is driven by a motor to move in a
forward or rearward motion along its longitudinal axis of symmetry
76 to deploy the plunger drive ram 46 and thus the syringe plunger
74 in a forward or rearward motion along the axis of symmetry 66 of
the syringe 28 to inject fluid into a human or animal subject or
fill the syringe 28 with fluid, respectively. For example, one may
load a pre-filled syringe into the injector 20 of the present
invention, and by deploying the plunger 74 in a forward direction,
may thereby expel fluid from the syringe 28. In so doing, the fluid
may be injected into the human or animal subject. Alternatively, an
empty syringe 28 may be loaded into the injector 20 and deploy the
syringe plunger 74 to its forward-most position. Thereafter fluid
may be loaded into the syringe 28 by operatively connecting the
syringe 28 to a source of fluid and retracting the syringe plunger
74 in a rearward direction in order to pull fluid into the syringe
28.
[0057] In general, in the injector system of the present invention,
the injector 20 involves single phase injections to deliver fluid
such as x-ray contrast agents, flushing solutions, and other media
for purposes such as enhancing diagnostic imaging in humans. The
injector 20 may include a protocol which may be programmed for a
single phase injection. The injector 20 of the present invention
also may include a manual X-ray scan delay timer which operates for
a maximum period of twenty minutes. The syringe drive system 24 may
be electromechanical and the injector 20 may be used either with
pre-filled syringes or may be used with empty syringes which may
then be filled. In one embodiment, in filling an unfilled syringe
with the injector 20 of the present invention, the syringe filling
rate is generally in the range of about 1 ml/second to about 8
ml/second. The flow rate during an injection is generally in the
range of about 0.1 ml/second to about 6 ml/second. This same flow
rate may be used for a flushing fluid. The maximum pressure limit
of the injector 20 in one embodiment of the present invention is
about 250 psi. The injector 20 of the present invention may be
designed to operate within an ambient temperature range of about
15EC to about 45EC. Further, the injector 20 may be designed to
withstand an ambient storage temperature range of about -20EC to
about 60EC. The injector 20 may be designed to operate properly
within about 1 hour of being in ambient operating temperatures
after being subjected to storage temperatures. Additionally, the
injector 20 may be designed to operate up to a relative humidity of
about 90%. The injector 20 of the present invention may also
include a post-injection readout on an LED display 34, and a safety
stop mechanism which provides for an electrical stop when the
injection parameters are outside the specification of the injection
protocol.
[0058] The user-injector interface 30 of the injector 20 of the
present invention includes a purge/retract trigger 36 in order to
control filling and expelling fluid from the syringe 28 and may
include a remote console 44. Programming injections may be
controlled by controls 90, such as buttons, on the console 44
and/or the powerhead 22 of the injector 20. A display screen 34 on
the powerhead 22 may, in one embodiment, provide information
regarding the volume of fluid remaining in the syringe 28. The
display screen 34 may also provide information regarding the flow
rate at which the injection is proceeding. The user-injector
interface 30 may be provided in plastic and/or metal form, or a
combination of plastic and metal.
[0059] In one embodiment of the present invention, the plunger
drive ram 46 may include a first coupling element 80 in order to
engage a second coupling element 82 disposed on the syringe plunger
74. This allows the syringe plunger 74 to be coupled to the drive
ram 46. Thus, once the syringe plunger 74 has been deployed, the
plunger drive ram 46 may be retracted, at the same time retracting
the syringe plunger 74 within the cylindrical body 54 of the
syringe 28. In one embodiment, and referring to FIGS. 2-4, the
coupling between the drive ram 46 and syringe plunger 74 is
passive. In the illustrated embodiment, the first coupling element
80 of the drive ram 46 includes a slot 84 on an end of the drive
ram 46 most proximal to the forward end 56 of the housing 47 of the
injector. This slot 84 is sized and shaped to match and receive the
second coupling element 82, which may be in the form of a
rearwardly-facing extension 88 disposed on the syringe plunger 74.
While the slot 84 and extension 88 of the illustrated embodiment
are mushroom-shaped, it will be recognized by those of skill in the
art that any shape which facilitates coupling may be used.
Additionally, while the illustrated embodiment depicts first and
second coupling elements 80, 82 that result in a passive coupling,
those of skill in the art will recognize that first and second
coupling elements that result in an active coupling (one which
involves some degree of positive gripping) may be used.
[0060] As described previously, the injector 20 of the present
invention may receive pre-filled syringes. Alternatively, the
injector 20 of the present invention may receive empty syringes
which must then be filled prior to injecting fluid into a human or
other animal subject. In one embodiment, the injector 20 of the
present invention is adapted to receive 125 ml pre-filled syringes,
such as the Ultraject syringe, commercially available from
Mallinckrodt Inc. of St. Louis, Mo. Such syringes are used for
injecting contrast media to a patient. These 125 ml syringes may be
pre-filled with varying amounts of fluid, such as 50 ml, 75 ml, 100
ml or 125 ml, for example. However, alternatively, the injector 20
may receive empty 125/130 ml syringes for indications such as
coronary angiography. In another embodiment, the injector 20 of the
present invention is adapted to receive 130 ml syringes available
from Liebel Flarsheim (part no. 600172). In yet other embodiments,
the injector 20 of the present invention may receive 50 ml, 75 ml
or 100 ml syringes. In yet another alternative embodiment, the
injector 20 of the present invention may be adapted to receive
syringes of other sizes.
[0061] Referring to FIGS. 1-4, the injector 20 of the present
invention includes a powerhead 22 which is operatively connected to
a power pack 38 including a power supply 40. In alternative
embodiments, the injector system can be expanded to include at
least one remote console 44 having a console interface 89 to the
injector 20, to allow for remote control of the injection. This
will be discussed in greater detail below.
[0062] Referring now to FIG. 1, the injector 20 of the illustrated
embodiment includes a user-injector interface 30 having a plurality
of controls 90 which are used to control the operation of the
injector powerhead 22. These may include controls including, but
not limited to, "start", "stop", "pause", "flow rate increment",
"flow rate decrement", "volume increment", and "volume decrement".
The powerhead 22 of the injector 20 also may include a display
screen 34 to relay information about an injection procedure to an
operator. This information indicates to the operator when an
injection is enabled and when an injection is in progress. In one
embodiment, the display 34 may include two numeric displays, one
for displaying volume information and one for displaying flow rate
information. In this embodiment, the volume display displays the
programmed volume when the injector 20 is in a programming mode,
and displays the injection volume when injecting. Similarly, in
this embodiment, the flow rate display displays the programmed flow
rate when the injector 20 is in a programming mode, and displays
the injection flow rate when in injection mode. The injector 20 of
the present invention may also include a visual indicator 91 to
indicate: (1) when the injector 20 is enabled and ready to inject,
(2) when an injection is in progress, and (3) when an injection is
complete. Additionally, if the flow rate is reduced during an
injection, the visual indicator 91 may signal this as well.
Further, if the injector 20 detects an injector 20 fault condition,
the visual indicator 91 may signal this information. This visual
indicator 91 may appear on the display screen 34 of the user
interface 30, or may be separate from the display screen 34. In the
illustrated embodiment, the visual indicator 91 may include an LED
display.
[0063] Referring now to FIGS. 2-6, the combination of the syringe
28 being operatively connected to the injector 20 of the present
invention, by way of the syringe mount 26, is more clearly shown.
By the arrangement shown, the syringe 28 is inserted into the
injector 20 such that a syringe mating system 64, which may be in
the shape of a flange circumferential about a distal end of the
cylindrical barrel of the syringe 28, communicates with an engaging
slot 84 disposed in the forward end 56 of the injector powerhead
housing 47. As the syringe 28 is positioned in proximity to the
slot 84 and moved downwardly toward the base of the injector 20 so
as to be inserted in the slot 84, it engages a first member 92 and
a second member 94 which may each be gripping members and may each
be movable about a pivot point 96 and are biased toward the
longitudinal axis of symmetry 76 of the plunger drive ram 46. In
the illustrated embodiment, the gripping first and second members
92, 94 may further include an internal groove 98 disposed in the
first and second gripping members 92, 94. This groove 98 may
communicate with the slot 84 to thereby form a retention area to
aid in connection of the syringe 28 to the injector 20. As the
syringe 28 is moved into insertion with the slot 84 and groove 98,
the engagement of the syringe 28 with the first and second gripping
members 92, 94 of the syringe mount 26 may cause the first and
second gripping members 92, 94 to be spread outwardly by the body
54 of the syringe 28 as the syringe 28 slides past the gripping
members 92, 94. As the syringe 28 continues to slide into engaging
relationship with the injector 20, the biased nature of the first
and second gripping members 92, 94 may move them back toward the
longitudinal axis 76 of the plunger drive ram 46. Additionally, the
force provided by the cylindrical barrel of the body 54 of the
syringe 28 against the base of the gripping members 92, 94
facilitates movement of the first and second gripping members 92,
94 toward the longitudinal axis 76 of the plunger drive ram 46.
Thus, the first and second gripping members 92, 94 move into
gripping relationship circumferentially around the body 54 of the
syringe 28 to thereby couple the syringe 28 to the injector 20 in
proximity to and in substantially co-axial alignment with the
plunger drive ram 46. This alignment allows for subsequent forward
translation of the drive ram 46 to express contrast media or other
fluid from the cylindrical body 54 of the syringe 28, through the
discharge tip 62 of the syringe 28, and into an animal subject,
such as a human. The syringe plunger 74 is connected to the plunger
drive ram 46 by the first and second coupling elements 80, 82 as
described previously.
[0064] In the illustrated embodiment of the present invention, the
first and second gripping members 92, 94 are diametrically opposite
one another, about the axis of symmetry 76 of the plunger drive ram
46, so that the first and second gripping members 92, 94 have
circumferential portions on opposed faces 100, 102 that are
diametrically opposite one another and exterior to the cylindrical
barrel of the syringe 28. Upon attachment of the syringe 28 to the
forward end 56 of the injector 20, the first and second biased
movable gripping members 92, 94 of the injector 20 engage the side
surface of the exterior cylindrical body 54 of the syringe 28, as
described above, to hold the syringe 28 in place against and in
alignment with the drive ram 46 of the injector 20 of the present
invention.
[0065] As described briefly above, the syringe mount 26 of the
injector 20 of the present invention includes first and second
gripping members 92, 94 having opposed faces 100, 102, which are
preferably arcuately shaped. In one embodiment, the arcuate opposed
faces 100, 102 may further include a metal ridge (not shown) in
order to "bite" into the body of the syringe to facilitate gripping
of the syringe. Alternately, in yet another embodiment, each
arcuate face of the first and second gripping members may bear a
plurality of ridges of teeth (not shown). Such teeth may be on the
first and second members, or may be included on any metal ridges.
The pivotal movement of the first and second gripping members
alters the distance between their arcuate faces, as they pivot
toward and away from one another. In the illustrated embodiment,
these first and second gripping members are each movable. However,
in alternative embodiments (not shown), it is possible to use a
single movable member disposed in spaced relation to a nonmovable
arcuate stop or abutment toward which the movable gripping member
is biased.
[0066] The first and second movable gripping members 92, 94 may
each be pivotally mounted about shafts or pivot pins 104, which, in
certain embodiments may also include bias springs 106 associated
with each of the first and second gripping members 92, 94. In such
an embodiment, one end of each of the bias springs 106 is in
contact with its respectively associated gripping member, and the
opposite end of each bias spring 106 seats or bears against
portions of the housing 47 of the injector 20. The bias springs 106
are journalled about the pins 104 which form the pivot axes of the
first and second gripping members 92, 94.
[0067] The first and second gripping members 92, 94 as described
above are biased toward the axis of symmetry 76 of the plunger
drive ram 46 by the bias springs 106. Stated differently, the bias
springs 106 bias the first and second gripping members 92, 94 such
that their confronting faces 100, 102 are urged toward each other.
In certain embodiments, once the cylindrical body 54 of the syringe
28 is inserted into the syringe mount 26, it cannot be extracted by
lifting the syringe 28 away from the syringe mount 26. In fact, any
such movement of the syringe 28 away from the syringe mount 26 in
such an embodiment of the invention may result in intensified
gripping of the cylindrical body 54 of the syringe 28 by the first
and second gripping members 92, 94. However, it will be recognized
by those of skill in the art that it is not necessary that the
gripping intensity of the first and second members 92, 94 is such
that any movement intensifies the gripping. Additionally, it will
be apparent to those of skill in the art that bias springs 106 are
not necessary for the coupling of syringe 28 to injector 20.
Rather, in certain embodiments, the positive force of the syringe
barrel against the first and second gripping members 92, 94 will
retain the syringe 28 within the gripping members 92, 94. In such
an embodiment, the syringe 28 is connected to the injector 20
through a friction fit that supplies enough force to retain the
syringe 28 during an injection procedure, but which releases the
syringe 28 upon positive movement of the syringe 28 away from the
injector 20.
[0068] It will be appreciated by those of skill in the art that, in
alternate embodiments of the invention, first and second gripping
members 92, 94 are not necessary for the gripping function. In such
alternative embodiments, a single gripping member may be used to
grip the syringe, thereby operatively connecting the syringe to the
injector. In this alternate embodiment, the gripping member must be
of a curved shape and cover enough of the circumference of the
syringe when in contact with the cylindrical barrel in order to
hold the syringe against the injector. In such an embodiment, each
arm extending from the center point of the gripping member has a
degree of elasticity such that the arms may splay outwardly and
inwardly to allow for the insertion and/or removal of a
syringe.
[0069] Thus, the various embodiments of the syringe mount 26 of the
injector 20 of the present invention, including those using one
gripping member and those using more than one gripping member, may
include, but are not limited to, the following: (1) a syringe mount
26 that holds the cylindrical barrel of the syringe 28 on a
contiguous 210E of the syringe circumference; (2) a metal spring
clip that allows a contiguous 230E contact area with the
circumference of the cylindrical barrel of the syringe 28 and
provides a sharp edge to bite into the syringe 28; (3) first and
second gripping members 92, 94 having opposing faces 100, 102, each
contacting 45E of the circumference of the cylindrical barrel of
the syringe 28 for a total of 90E of contact area; (4) first and
second gripping members 92, 94, each of the arcuate faces 100, 102
having 80E of contact area with the circumference of the
cylindrical body 54 of the syringe 28 for a total of 160E of
contact with the syringe body 54; (5) first and second gripping
members 92, 94, each arcuate face having 150E of contact area with
the cylindrical barrel of the syringe 28 for a total of 300E of
contact with the syringe body 54. In the illustrated embodiments
showing two first and second gripping members 92, 94, the gripping
members 92, 94 may include or be made of a metal, such as stainless
steel, so they bite into the cylindrical body 54 of the syringe
28.
[0070] After a syringe 28 has been operatively connected to the
injector 20 by way of the syringe mount 26 such that the axes of
symmetry 66, 76 of the syringe 28 and the plunger drive ram 46 are
substantially coaxial, a motor of the injector 20 may be used to
deploy the plunger drive ram 46 into the syringe cavity 70 to expel
fluid from the syringe 28. After advancement of the syringe plunger
74 by movement of the drive ram 46 through the interior cavity 70
of the syringe body 54, the drive ram 46 may be retracted from the
distal end of the syringe 28. Once the plunger drive ram 46 is
fully retracted, the syringe 28 may be removed from the syringe
mount 26 in one embodiment of the injector 20 through the use of a
release catch (not shown in the illustrated embodiment) which moves
the first and second biased movable gripping members 92, 94 away
from and out of engagement with the exterior cylindrical body 54 of
the syringe 28. Alternatively, when loading an initially empty
syringe into the syringe mount 26 of the injector 20, the plunger
drive ram 46 may first be extended into the syringe cavity 70. It
may then be retracted in order to draw fluid into the syringe 28.
This fluid may then be injected into a subject by once again
translating the plunger drive ram 46 in a forward direction. After
subsequently retracting the plunger drive ram 46, the syringe 28
may be released by operating the release catch. In an alternate
embodiment, the syringe mount 26 may not include a release catch,
but rather may connect the syringe 28 to the injector 20 through a
friction fit that supplies enough force to retain the syringe 28
during an injection procedure, but which releases the syringe 28
upon positive movement of the syringe 28 away from the injector
20.
[0071] Referring now to FIGS. 2-4, the injector 20 of the present
invention also features a hand-operated purge/retract trigger 36
which facilitates operator control of the injector 20. The trigger
36 allows a user to purge air from the syringe 28 and to retract
the drive ram 46 after an injection. Additionally, the trigger 36
allows a user to dynamically vary the flow rate while injecting or
retracting. This aspect of the present invention includes a trigger
36 movable between home, forward, and reverse positions. Movement
of the trigger 36 to the forward position causes the injector 20 to
move the plunger drive ram 46 forward to expel fluid from the
syringe 28, and movement of the trigger 36 to the reverse position
causes the injector 20 to move the drive ram 46 in reverse to
potentially draw fluid into the syringe 28, or to retract the drive
ram 46 from the syringe 28 prior to removing the syringe 28 from
the injector 20. The intuitive trigger 36 is designed such that it
allows for variable injection speeds and also may include a locking
mode which allows for hands free injection.
[0072] More specifically, in one embodiment of the injector 20 of
the present invention, the trigger 36 is mounted on a pivot 110,
and is biased to the home position by at least first and second
springs 112, 114 positioned on opposite sides of the trigger 36.
Rotation of the trigger 36 away from the home position
progressively compresses the springs 112, 114 to an increasing
degree at increasing angles of lever rotation. Sensors 116 located
in the interior of the housing 47 and associated with the trigger
36 then detect the angle of the trigger 36 so that this angle can
be used to control the speed of motion of the plunger drive ram 46.
Using this structure and control, the relative position of the
trigger 36 can be made proportional to the flow rate of fluid into
or out of the syringe 28 which is attached to the injector 20,
thereby providing the operator with intuitive feedback on the
operation of the injector 20.
[0073] The trigger 36 is rotatable on an axis of rotation 118. When
the hand operated trigger 36 is left in its home position, no
motion of the drive ram 46 is generated by the powerhead 22.
However, when the hand operated trigger 36 is rotated toward the
syringe 28 (i.e., to forward position), forward motion of the drive
ram 46 is generated by the powerhead 22, thereby expelling fluid or
air from the syringe 28. Alternatively, when the trigger 36 is
rotated away from the syringe 28 (i.e., to a reverse position),
reverse motion of the drive ram 46 is generated by the powerhead
22, thereby filling the syringe 28 with fluid or air.
[0074] Still referring to FIGS. 2-4, the structure of the injector
20 to allow non-contact control of the injection procedure by use
of the intuitive trigger 36 is more clearly shown. The injector 20
of the present invention generally may include a compact modular
design facilitating manufacture as a hand-held injector 20 in one
embodiment. In particular, control circuitry of the injector 20 of
the present invention may be incorporated onto a printed circuit
board 120. One feature of the injector 20 of the present invention
is the use of magnetic conductors 122 to channel magnetic field
energy from magnets 124 positioned in the intuitive trigger 36
through the injector housing 47 and into the vicinity of magnetic
sensors 116 operatively connected to the circuit board 120. In one
embodiment, by using magnetic conductors 122 to carry magnetic
fields through the injector housing 47, circuit board mountable
magnetic sensors 116 can be used thereby reducing the overall cost
as compared to individually packaged sensors for mounting in an
injector housing. The use of such non-contact control also
eliminates the need for wiring through the housing 47, thereby
enhancing seal integrity.
[0075] To determine the direction and degree of rotation of the
trigger 36, a plurality of magnets 124 may be disposed on or in the
trigger 36, so that rotation of the trigger 36 increases or
decreases distances between magnets 124 on the controls of the
trigger 36 and in the injection housing 47, creating a changing
magnetic field that can be detected by the magnetic sensors 116
associated with the control circuitry of the powerhead 22. In
particular, the injector 20 of the present invention may use a
Hall-effect sensor in one embodiment. The function of the Hall
sensor is based on the principle of the Hall effect: namely, that a
voltage is generated transversely to the current flow direction in
an electric conductor if a magnetic field is applied
perpendicularly to the conductor. In certain embodiments of the
invention, since the Hall effect is most pronounced in
semiconductors, one suitable Hall element is a small platelet made
of semiconductor material. A Hall plate with current terminals and
taps for the Hall voltage may be arranged on a surface of the
sensor. This sensor elements detects the components of the magnetic
flux perpendicular to the surface of a chip and emits a
proportional electrical signal which is processed in the evaluation
circuits integrated in the circuit board 120. In a particular
embodiment of the present invention, the injector 20 includes
analog, or linear sensors. Linear Hall sensors generate an analog
output voltage which is proportional to the magnetic flux
perpendicular through the Hall plate. Thus, the sensors operatively
connected to the circuit board 120 of the injector 20 of the
present invention can determine from the magnetic flux the degree
to which the trigger 36 has been rotated away from the home
position, and adjust the electrical output and thus the velocity of
the plunger drive ram 46 accordingly.
[0076] When the trigger 36 is rotated forward, the sensors 116
associated with the control circuitry detect this rotation from
signals produced by the magnetic field, and causes the plunger
drive ram 46 to move forward, i.e., outward from the powerhead
housing 47, at a velocity proportional to the angle of deflection
of the trigger 36 away from the home position. Alternatively, when
the trigger 36 is rotated in a reverse direction, the control
circuitry detects this rotation from signals produced by the
magnetic field, and causes the plunger drive ram 46 to move
backward, i.e., into the powerhead housing 47, at a velocity
proportional to the angle of deflection of the trigger 36 away from
the home position.
[0077] As described above, the power injector may also include
first and second springs 112, 114 associated with the control
trigger 36 which engage the housing 47 of the injector 20 and
produce torque tending to return the shaft to the home position.
When the trigger 36 is in its home position, the springs 112, 114
apply opposing torques to the trigger 36, tending to hold the
trigger 36 in the home position. In this position, the sensors 116
produce a signal indicating that the trigger 36 is in the home
position. In this position, the control circuit of the powerhead 22
can determine that no motion of the drive ram 46 is being requested
through hand operated movement control of the trigger 36.
[0078] When the trigger 36 is rotated away from the home position,
the sensors 116 produce a signal, which may be an analog signal,
indicating that the trigger 36 is away from the home position. As
this occurs, the control circuit may read the signal produced by
the magnets 124 to determine the position of the trigger 36 and
produce the appropriate motion of the plunger drive ram 46.
[0079] As previously described, the velocity of motion of the
plunger drive ram 46 is proportional to the extent of the movement
or rotation of the trigger 36 away from the home position. As this
occurs, the mechanical structure of the first and second springs
112, 114 insures that a return torque is being applied to the
trigger 36 as the trigger 36 is rotated to increasing angles away
from the home position. Depending on the stiffness of the springs
112, 114 and the range of motion of the trigger 36, this return
torque may be approximately equal at all deflection angles, or may
increase or decrease over increasing and decreasing deflection
angles. An increasing return torque compared to the deflection
angle may provide the operator with additional feedback on the
velocity of the drive ram 46. Additionally, and as described above,
the first and second springs 112, 114 also offer a degree of
tension to bias the trigger 36 in the home position. This assists
in preventing accidental deflection of the trigger 36 away from its
home position when it casually abuts another object, such as when
the injector 20 is laid down on a table.
[0080] Additionally, the injector 20 may include other mechanisms
to ensure that the trigger 36 is not accidentally displaced from
the home position. In certain embodiments, the trigger 36 may be
designed so the user has to intentionally enable the trigger
mechanism to operate the injector 20.
[0081] As described above, when filling a syringe 28 or discharging
the contents of a syringe 28, there may be an ideal maximum speed
at which fluid can be drawn into the syringe 28 and expelled from
the syringe 28 due to safety considerations. Additionally, any such
optimal injection flow rate may be dependent on the particular
procedure and/or the fluid to be injected. To control the filling
and discharge of fluid from syringes, and to maintain the safety of
those involved in the injection procedure, the operator should have
feedback as to when an ideal speed has been reached, so that
syringes can be filled or discharged at this optimal speed.
Additionally, the injector 20 may include a mechanism to prevent
the discharge of fluids above certain speeds. One purpose of the
first and second springs 112, 114 described above is to provide the
operator with mechanical feedback of the angle of deflection of the
trigger 36, which may correspond approximately to the ideal fill
speed. More specifically, the control circuit of the powerhead 22
may establish that the plunger drive ram 46 will move near to the
ideal speed when the trigger 36 has been rotated to a certain
position. Accordingly, an operator wishing to fill a syringe 28 at
the ideal speed, can rotate the trigger lever until the increasing
torque is noted and then hold the trigger lever at that location to
fill the syringe 28.
[0082] Additionally, the injector 20 of the present invention may
include a speed lock associated with the trigger 36 of the injector
20. This speed lock allows an operator to program in and inject or
retract the drive ram 46 at a particular flow rate. This injection
may occur at a particular flow rate regardless of the extent to the
depression of the trigger 36 itself or, alternatively, may be
programmed to inject at a particular flow rate unless that program
is overridden by a change in the deflection of the trigger 36. In
one embodiment, the trigger speed lock may be located on the
control panel of the injector 20. It operates to lock in the
current speed of the drive ram 46, whether retracting or injecting,
when the speed lock is activated. In one particular embodiment of
the injector 20 of the present invention, any plunger drive ram 46
movement may be halted when any other control 90 or the trigger 36
itself is depressed while the lock is active. While in the
illustrated embodiment, it is noted that the controls for the
trigger speed lock are located on the injector powerhead 22, it
will be appreciated by those skilled in the art that the speed lock
controls may be located on the remote console 44, or any other
component of the injector system.
[0083] In certain embodiments, the injector 20 of the present
invention may be enabled to allow the speed lock feature to be
activated while expelling contrast media or other fluid from a
syringe 28 associated with the injector 20. If the injector 20 is
speed locked on a particular flow rate, and any of the powerhead 22
switches are activated, or the purge/retract trigger 36 is
reactivated, the injector 20 may be designed to unlock the flow
rate and run at the flow rate determined by the purge/retract
trigger 36. Additionally, when retracting, the injector 20 may
activate the flow rate speed lock feature when the purge/retract
trigger 36 is fully engaged in the retract direction for a minimum
period of time, such as for two seconds. When retracting and the
flow rate speed lock is activated, the injector 20 may be
deactivate the speed lock if the purge/retract trigger 36 is
reactivated or the injector ram reaches its home position.
[0084] Referring to FIGS. 2-6, the injector 20 of the present
invention also includes a structure to prevent rotation of the
drive ram 46. This prevents the drive ram 46 from rotating about
its axis of symmetry 76 during an injection procedure. The
anti-rotation of the drive ram 46 is achieved by the shape of the
drive ram 46 itself. In the illustrated embodiment, a cross-section
of the drive ram 46 taken perpendicular to the axis of symmetry 76
of the drive ram 46 is in the shape of back to back "D"s, having a
first flat surface 126 across the top of the ram, a second flat
surface 128 across the bottom of the ram and two curved surfaces
130, 132, one on each side of the ram 46. This drive ram 46 inserts
through a similarly shaped orifice 134 in a plate 136 located in
the forward end 56 of the housing 47 of the injector 20 of the
present invention nearest the syringe 28. During movement of the
drive ram 46 in either forward or reverse directions, the drive ram
46, at all times, remains disposed through the similarly shaped
orifice 134 in the plate 136. The orifice 134 in the plate 136 is
sized such that the drive ram 46 may move freely within the orifice
134, but will cause the drive ram 46 to abut the edge of the
orifice 134 should the drive ram 46 begin to rotate about its
longitudinal axis 76. In the illustrated embodiment, due to the
flat surfaces 126, 128 on the top and the bottom of the drive ram
46, the ram 46 is thus unable to rotate as it moves forward. This
is important in keeping the first coupling element 80, disposed at
the forward end 56 of the drive ram 46, properly aligned, such as
in an upward facing direction, so that syringes 28 may be removed
and replaced into the injector 20. While the illustrated embodiment
depicts a back-to-back "D" shape, those of skill in the art will
recognize that other shapes may be used. The injector 20 of the
present invention also includes a ram home detector 50 which
operates to determine whether an end of the drive ram 46 is
proximal to the forward end 56 of the injector housing 47. This
position is the "home" position of the drive ram 46. The ram home
detector 50 accurately detects both when the drive ram 46 is a
certain distance from the home position (such as 1/2 inch) and when
the ram 46 is at the home position. This detection may be achieved
through the use of magnets 138. This allows the elimination of
secondary analog position devices, such as a potentiometer. For
example, a magnet 138 may be disposed on the surface of the drive
ram 46 and a magnetic sensor 140 may be positioned in the housing
47. The magnetic sensor 140 can detect a magnetic field produced by
the magnet 138. This magnetic field will increase in intensity as
the magnet 138 on the drive ram 46 approaches the sensor 140. The
intensity of the magnetic field can be calibrated to determine when
the drive ram 46 is at its home location.
[0085] As described above in the background of the invention, many
present injectors use potentiometers and/or encoders on the motor
as redundant systems to track the location of the drive ram of an
injector. The injector 20 of the present invention does not include
such a system. Rather, the injector 20 of the present invention
includes a magnet 138 disposed on the ram that interacts with
sensors 140 along the inner part of the injector 20 to detect the
location of the ram 46. When reversing the ram 46 to its home
position, for example, this allows the ram 46 to run quickly in
reverse mode until it is a certain distance from its home position.
During its operation, the injector 20 of the present invention
calibrates a value which it assigns to the ram 46 when the ram 46
is in its home position flush with the outer edge of the forward
end 56 of the injector 20. In this way, the ram 46 can be run and
reversed such that it always comes to a rest in the same home
position. This is necessary in being able to remove and replace
various syringes, into and out of the drive ram 46, when in the
correct location. Thus, when in reverse mode the injector 20 may
reverse the ram 46 at a relatively rapid rate until it recognizes
that it is close to the home position. The rate of reversal of the
ram 46 is then slowed until the injector 20 recognizes that it has
reached the pre-calibrated home position. Movement of the ram 46 is
then halted such that syringes 28 may be removed from and/or
inserted into the injector 20.
[0086] Referring now to FIGS. 7, 7A, 8, and 8A, the injector 20 of
the present invention may also include a warming cradle 48. In the
illustrated embodiment, this warming cradle 48 includes an annular
plastic section 142 and a molded plastic base 144. In one
embodiment (FIG. 1A), this warming cradle 48 may be integral with
the injector 20 such as by extending from the forward end 56 of the
housing 47 of the injector 20. In an alternative embodiment, the
warming cradle 48 may be part of a hanger 146 to which the injector
20 and syringe 28 are operatively connected prior to starting an
injection procedure. The plastic section 142 may extend from the
hanger 146 in such a manner as to be disposed proximally to and in
confronting relationship with the syringe 28 when the syringe 28
and injector powerhead 22 are operatively connected to the hanger
146 and warming cradle 48. The plastic section 142 of the warming
cradle 48 includes a filament of wire 148 which generates heat when
an electrical current is driven through it via a suitable electric
power source. The filament 148 may extend throughout the region of
an annular portion of the plastic section 142 which is in contact,
or in confronting relationship, with the syringe 28 and/or pressure
jacket, and terminates at either end in electrical leads (not
shown) which may be encased in an insulating cable (not shown)
which can be operatively connected to the control circuitry of the
powerhead 22. Such connection may occur directly through an
aperture in the housing 47 of the powerhead 22, or may occur
through electrical contacts disposed on the exterior of the
powerhead housing 47 which contact electrical contacts disposed on
the exterior of the cradle 48 or hanger 146. When current from the
powerhead 22 is forced through the leads in the cable and through
the filament 148, the filament 148 generates an even heat which
warms fluid inside the syringe 28, or maintains the temperature of
fluid in a pre-warmed syringe 28. Those having skill in the art
will recognize that any alternate, suitable method of generating
heat in the warming cradle 48 may be used.
[0087] As described above, and referring to FIG. 9, the present
invention also allows for limitation of the pressure supplied by
the injector 20. Since low flow rates require less pressure, the
injector 20 of the present invention automatically assigns the
pressure limit based on the flow rate. The pressure limit value is
thus high enough to achieve the programmed flow rate under normal
conditions, but won't allow high pressure to develop in the event
of unexpected restriction or blockage within the syringe 28 or tube
or access port. By automatically assigning a pressure limit based
on the flow rate, an operator does not need to remember to alter
the pressure limit each time the injector 20 is used. Thus, the
injector 20 is able to deliver media at desired rate, but does not
allow too much reserved pressure to build in the event that a
blockage occurs. This increases the safety of the injector 20 of
the present invention over that of injectors of the prior art.
[0088] In use, a user may program a flow rate into the injector 20.
However, if that flow rate would exceed the pressure limit of the
injector 20, the flow rate would be decreased and/or the injection
halted for safety purposes. Thus, the injector 20 of the present
invention further includes a stop circuit to terminate the
injection if the fluid injection pressure exceeds a predetermined
limit. Alternatively, the stop circuit may terminate the injection
when the fluid injection pressure exceeds a predetermined limit for
a predetermined period of time.
[0089] In one particular embodiment of the present invention, the
predetermined pressure limit is 250 psi. The injector 20 may be
designed so that the user cannot adjust the pressure limit
function. The pressure limiting function may thus be internally
programmed and set prior to injecting. In one embodiment, the
pressure limit may be based on the flow rate selected by the user
as specified in the equation: Pressure Limit (psi)=(78)(selected
Flow Rate ml/s)+50. If the selected flow rate exceeds 2.5 ml/s, the
pressure limit may be fixed at a maximum of 250 psi. If the
injection pressure approaches the pressure limit, the injector 20
may reduce the flow rate as necessary to keep the injection
pressure from exceeding the pressure limit.
[0090] As discussed above, in one embodiment as depicted in FIG. 1,
the injector 20 of the present invention may include an optional
remote console 44 for operating injection procedures by remote
control. The remote console 44 is an accessory that connects to the
power pack 38 and may be used to monitor and control an injection
from a remote location, such as a control room. The user can
program, start, stop, and resume an injection as well as
dynamically adjust the flow rate while an injection is in progress,
all from the remote console 44. The remote console 44 may also
contain a timer on the user-console interface 45 for displaying the
elapsed time from the start of an injection until the ram is
retracted. The timer is present to assist the user in determining
when to start an x-ray scan after injecting to achieve optimal
image contrast. Thus, a functional remote console 44 for the
injector 20 of the present invention may generally be a chargeable
console 44 having features and abilities including, but not limited
to: (1) starting the injection, (2) stopping or pausing the
injection, (3) setting and changing the injection parameters,
and/or (4) providing a timer that can be started at the onset of an
injection to time the injection. In one embodiment, this timer will
have a minimum duration of twenty minutes. However, those of skill
in the art will recognize that a timer of any particular minimum
duration may be used.
[0091] Also in an alternate embodiment and referring to FIG. 1A, a
second injector 20' can be added to an injection system via an
optional interface cable. The first and second injectors 20, 20'
can then be configured to communicate with one another in order to
provide a saline push or to provide for a larger volume injection
capability. In this embodiment, the first and second injectors 20,
20' can be configured to communicate in order to provide a saline
push or a larger volume capability. This is because, often,
injection procedures will require a greater volume of fluid to be
injected than is contained by a single syringe 28. Additionally,
during certain injection procedures, it may also be desirable to
follow an injection with a saline push which may be used to ensure
that the entire injection has been received by a subject. When both
units are ready to inject, the second injector 20' may be
programmed to inject at the completion of the injection of the
first injector 20. In this embodiment, a second remote console 44'
that connects to a second power pack 38' may be added to facilitate
remote control of the second injector 20'. A second power-injector
interface 42' and a second console-power interface 89' may be used
to interconnect these devices.
[0092] A power supply 40 may be connected to the injector 20
through a power-injector interface 42, which may include an
extension cable connected via prefabricated connectors. An
alternate connection may be provided to allow such an injector
extension cable to be shortened to facilitate installation in a
particular location while avoiding excess wiring or cable, which
may create a safety hazard. In one embodiment, and as used, a 10'
coiled cable with connectors at both end, may connect the powerhead
22 to a wall plate (not shown). A 75' extension cable may connect
between the wall plate and the power pack 38. This extension cable,
in one embodiment, may be a plenum type cable. The connection at
the power pack 38 for the 75' extension cable may incorporate a
connection scheme that allows the extension cable to be shortened
to facilitate a neat installation. The power supply 40 includes a
console-power interface 89 in order to communicate with any remote
console 44. In one particular embodiment of the present invention,
the power supply 40 senses a line voltage during the powerup phase
and automatically configures for voltages ranging from about 100
VAC to about 240 VAC, plus or minus about 10% at about 50 HZ to
about 60 HZ, plus or minus about 3 HZ. A 10' Ethernet type cable
with RJ-11 type connectors may be used to connect the power pack 38
to the remote console 44.
[0093] The present invention also may include a method for
controlling DC power to the injector powerhead 22 and/or remote
console 44. In this embodiment of the present invention, a start
injection wire may be used to turn on the power and a two-wire
serial communication may be used to turn off the power.
[0094] As described above in the background of the invention, in
previous injectors, generally including a power supply 40, a
powerhead 22 and a remote console 44, the remote console 44
generally includes a low-voltage on/off switch. This switch
generally includes wires connected to the power pack 38 to control
DC power (generally 24 volts) to the console 44 and the powerhead
22. The DC voltage in the power pack 38 may always be present as
long as a main power switch is on. The connector size in the
console 44 of the larger injectors described in the background of
the invention is generally at a minimum 15 pins, and thus these
connectors allow for dedicated wires for the power on/off function.
However, due to the physically smaller size of the console 44 for
embodiments of the injector 20 of the present invention, the
connector may generally include only 8 pins. This 8 pin
configuration does not allow for any extra dedicated wires for the
separate power on/off function on the console 44.
[0095] In view of the above, and referring now to FIGS. 10-12, the
separate "soft" power on/off switch may be provided on a remote
console 44 as follows. As described above the basic elements of the
injector 20 are the powerhead 22, the power pack 38, and the remote
console 44. The powerhead 22 is the primary device, needing a
supply of generally about 24 volts to function as a stand-alone
injector. The remote console 44, as described above, includes the
same controls and displays as the powerhead 22 but further includes
an injection timer 152 (such as may be used for manually starting a
CT scanner) and an on/off switch. The power pack 38 includes a
24-volt power supply 40 as well as an injector to injector
interface and a power on/off control. In the particular embodiment
of the present invention, the injector to injector interface and
on/off circuitry is only functional when a remote console 44 is
attached to the system and uses an 12C serial interface to control
these features. The powerhead 22 and the console 44 may communicate
by a serial communication referred to herein as Controller Area
Network (CAN). This CAN communication is used for real time control
between the powerhead 22 and console 44. As a redundant system in
running an injection, the interconnecting cabling may include a
wire which allows all the devices to identify that a start command
has been activated from the console 44. In such a configuration,
this injection signal must be supported by the CAN interface. If it
is not supported, it will be ignored or reported as an error to the
remaining components of the injection apparatus and no injection
will occur.
[0096] In use and in reference to FIGS. 10-12, the communication
may operate as follows. For purposes of the following description,
one may assume that the main power switch of the power pack 38 is
"on" and that 24 volts are present in the power pack 38. Activation
of the remote on/off switch will connect a "start out" signal to
ground. This wire will turn on the 24 volts for the system power
when it is switched to ground. The circuitry used to implement this
is flip-flop U4:B, transistor Q4 and relay K4. The remote on/off
switch in the console 44 is the only component that can activate
this line when the system power is off. When the system power is
on, the console 44 start switch and the remote on/off switch may
activate this line, which will attempt to turn on system power that
is already on. When this happens, no change occurs.
[0097] When the system power is on and the remote on/off switch is
activated, the remote switch will attempt to turn on the power but
at the same time it sends a start signal to the powerhead 22 (which
will be ignored) and a signal to the console microprocessor. The
software in the processor will wait until the switch depression
ends, then delay an appropriate amount of time (in general less
than one second). After the delay, the processor sends a power off
serial command to the 12C Parallel I/O chip which will toggle the
flip-flop U4:B and consequently turn off the system power through
K4. If the powerhead 22 or second console are to be used to turn
off the power, such a command should be requested through the CAN
interface to the first console 44.
[0098] The display screen 34 on the injector 20 relays all
information regarding the injection procedure to an operator. These
parameters include the program flow rate, the real time flow rate
for injection while the injection is running, a program volume, the
remaining available volume when the injection is running, and a
timer to count up from the start of injection to display up to 19
minutes and 59 seconds. This timer will reset when the drive ram 46
is pulled back or after 20 minutes.
[0099] The powerhead 22 of the injector 20 of the present invention
includes software which, in one embodiment, includes four modes of
operation: (1) a manual mode, (2) an auto-inject mode, (3) a
syringe size selection mode, and (4) a manufacturing mode. The
powerhead 22 also includes a power-on self-test (POST), to check
for proper injector operation, and a safe state which the powerhead
22 can enter in the event of serious injector malfunction. When
power is applied, the powerhead 22 of the injector 20 of the
present invention performs an initialization of the microcontroller
and system resources. After this initialization, the powerhead
software automatically runs a POST. If the powerhead 22 passes all
POST tests, the software then may check for the manufacturing mode.
The powerhead software enters the manufacturing mode only if the
user activates the volume increment and volume decrement at the
same time while the software version number is displayed. If the
user alternatively activates the purge/retract trigger 36 while the
powerhead software is displaying the software version number, the
software proceeds automatically into manual mode.
[0100] The powerhead software is equipped to perform a POST of the
microcontroller CPU. Following that first self-test, the POST may
perform a cyclical-redundancy check (CRC) test of the program Flash
Program Read Only Memory (PROM), a CRC test of the data Flash PROM,
and a memory test of all data and program RAM. Following those
tests, the POST may perform a test of all peripherals internal to
the microcontroller which may be used during operation of the
injector 20 of the present invention. The POST then may illuminate
all visual indicators, including all digits and segments in the LED
displays for a minimum of three seconds. Further, the POST may
check the power supply voltages for the +24 volt +/-4 volt and +5
volt +/-0.5 volt power supplies. The POST also may check for proper
motor cutout relay operation and may check the calibration voltage
of all purge/retract trigger sensors 116 to be within +/-0.2 volts.
The POST may also activate an audible enunciator for a minimum of
500 milliseconds. The POST also detects whether or not an external
start signal is active. If the POST detects an external start
signal as being active, the software displays a code indicating an
active external start signal and stays in the POST mode until that
external start signal becomes inactive.
[0101] Upon completion of the POST, the powerhead 22 of the
injector 20 of the present invention sends the self-test status to
the remote console 44. Upon successful completion of the POST, the
powerhead software displays the current software version on the
display 34 for a minimum of three seconds. After displaying the
powerhead software version number, the powerhead software checks
the sensor 140 of the ram home detector 50 to verify that the ram
46 is fully retracted. If the sensor 140 indicates that the ram 46
is not at the home position, the powerhead software then allows the
ram 46 to move in the retract direction only and at the same time
displays alternating dashes on all digits of the seven segment LED
displays. These alternating dashes will continue to be displayed
until the ram 46 is moved to the home position. If any of the
self-tests fail, the powerhead software transitions to the safe
state.
[0102] As described briefly above, the powerhead software contains
a manual mode. In this manual mode, the software allows the user to
program a volume and flow rate for an injection. When entering the
manual mode, the powerhead software will recall and display the
previously programmed flow rate and volume.
[0103] The user interface 30 of the powerhead 22 includes a control
panel keypad 32 which may include a volume increment push button
and volume decrement push button for programming the injection
volume. In one embodiment, the user activates and releases the
volume increment button, the powerhead software increments the
volume 1 ml. When the user activates and holds the volume increment
button, the powerhead software increments the volume 1 ml at a rate
of 1 ml per 0.5 seconds +/-0.1 seconds. If the user holds the
volume increment button for more than 3 seconds, the powerhead
software increments the volume 1 ml at an accelerating rate. If the
user holds the volume increment button and the maximum volume is
reached, the powerhead 22 holds the program volume at the maximum
value and gives an audible beep. If the user holds the volume
decrement button and the minimum volume is reached, the powerhead
22 holds the program volume rate at the minimum value and gives an
audible beep. The volume decrement button may operate in the same
way as the volume increment button except it decrements the program
volume. If a 125 ml syringe size is selected, then the program
volume ranges from 125 ml down to 1 ml. If the 100 ml syringe size
is selected, the program volume ranges from 100 ml down to 1 ml.
This programming volume may alternate, depending on the syringe
size selected for the powerhead 22. The powerhead software will not
allow the user to program more volume than the maximum programmable
volume. The maximum programmable volume will be determined to be
the syringe size volume or the remaining volume, whichever is less.
If a user attempts to program more volume than the maximum
programmable volume, the powerhead software will hold the display
volume at the maximum programmable value and give an audible
beep.
[0104] The control panel keypad 32 of the powerhead 22 may include
a flow rate increment push button and a flow rate decrement push
button for programming the injection flow rate. In one embodiment,
when the user activates and releases the flow rate increment
button, the powerhead software may increment the flow rate 0.1
ml/s. When the user activates and holds the flow rate increment
button, the powerhead software may initially increment the flow
rate 0.1 ml/s and hold for 1 second. If the user continues to hold
the flow rate increment button, the powerhead software may
increment the flow rate 0.1 mi/s at a rate of 0.5 seconds. If the
user holds the flow rate increment button for more than 4 seconds,
the powerhead software may increment the flow rate 0.1 ml at an
accelerating rate. The flow rate decrement button may operate in
the same way as the flow rate increment button except it decrements
the program flow rate. The powerhead 22 may allow the programmed
flow rate to range from 6.0 ml/s down to 0.1 ml/s. If the user
holds the flow rate increment button and the maximum flow rate is
reached, the powerhead 22 may hold the program flow rate at the
maximum value and give an audible beep. If the user holds the flow
rate decrement button and the minimum flow rate is reached, the
powerhead 22 may hold the program flow rate at the minimum value
and give an audible beep.
[0105] The powerhead software may enter a pre-filled syringe
selection mode if the injector 20 is in manual mode and the user
activates and holds the volume increment button for more than 3
seconds when the volume displayed is at the maximum programmed
volume. When entering the pre-filled syringe selection mode, the
powerhead software may continually flash an indicating signal, such
as "PF", at the slow rate in the flow rate display, and display,
without flashing, the pre-filled syringe sizes in the volume
display. The "PF", or other indicating signal, is to inform the
user that the injector 20 is in the pre-filled syringe selection
mode. The fast flash rate, in one embodiment, may be 750 ms on and
250 ms off. When entering the pre-filled syringe selection mode,
the powerhead software may display the previously selected syringe
size in the volume display. The powerhead software may allow the
user to increment to the next larger syringe size by activating the
volume increment button. The syringe size may increment to the next
larger syringe size for each activation of the volume increment
button. The selectable syringe sizes may be 50 ml, 75 ml, 100 ml,
125 ml, and 130 ml. The powerhead software may ignore further
syringe size increments when the largest syringe size is displayed.
If the user activates the volume decrement button, the powerhead
software may decrement the syringe size to the next smaller size.
The syringe size may decrement to the next smaller size for each
activation of the volume decrement button. The powerhead software
may ignore further syringe size decrements when the smallest
syringe size is displayed. The powerhead software may select the
displayed syringe size and exit from syringe size selection mode
and transition to the manual mode if the user: (1) activates the
flow rate increment or decrement push-button, (2) activates the
start push-button, (3) activates the purge/retract trigger 36, or
(4) opens and closes the syringe mount 26. The powerhead software
may have a syringe size selection mode time-out feature wherein
after 10 seconds of inactivity, the software may select the
displayed syringe size and exit to the manual mode. When exiting
from syringe size selection mode, the software may store the
selected syringe size in non-volatile memory.
[0106] As described above, the powerhead 22 contains a
purge/retract trigger 36 to allow the user to vary the flow rate
when purging air from the syringe 28 or to retract the ram 46 after
an injection. The powerhead software may activate the injector
motor in the "expel" direction if the purge/retract trigger 36 is
activated in the expel direction. When the purge/retract trigger 36
is activated in the "expel" direction, the powerhead software may
decrement the volume display 1 ml for every 1 ml of fluid expelled.
The powerhead software may activate the injector motor in the
"retract" direction if the purge/retract trigger 36 is activated in
the retract direction. When the purge/retract trigger 36 is
activated in the "retract" direction, the powerhead software may
increment the volume display 1 ml for every 1 ml that the ram 46 is
retracted. The powerhead software may control the flow rate in
proportion to the distance to which the user displaces the trigger
36 away from its home position. The powerhead software may not move
the injector ram 46 when the purge/retract trigger 36 is in the
home position.
[0107] The powerhead software may adjust the range of the
purge/retract trigger 36 so that the maximum achievable flow rate
may be limited to the user programmed flow rate or the flow rate
allowed when the pressure is being limited. For example, if the
user programmed a flow rate of 2.0 ml/s, the injector 20 should
adjust the range of the purge/retract trigger 36 so that a flow
rate of 2.0 ml/s is achieved when the trigger 36 is fully engaged
in the forward direction. If the user programmed a flow rate of 3.5
ml/s, then the injector 20 should adjust the range of the
purge/retract trigger 36 so that a flow rate of 3.5 ml/s is
achieved when the trigger 36 is fully engaged in the forward
direction. When the purge/retract trigger 36 is fully engaged in
the forward direction, the software may control the injector motor
to deliver the maximum achievable flow rate. The powerhead software
may correlate the flow rate to the purge/retract trigger 36
position as shown in Table 1. The position tolerance may be +/-2%
of fully engaged.
1 TABLE 1 Flow Rate (ml/s) % of Fully Engaged 0 0 to 12 (Dead Band)
0.1 to 0.5 12 to 50 0.6 to Programmed Flow Rate 50 to 90 Programmed
Flow Rate 90 to 100
[0108] The powerhead software may adjust the range of the
purge/retract trigger 36 during retraction. The no-load retract
speed may be a minimum of 6.0 ml/s. Thus, if the injector 20 is
operating at this minimum of 6.0 ml/s, the injector 20 should
adjust the range of the purge/retract trigger 36 so that a rate of
6.0 ml/s is achieved when the trigger 36 is fully engaged in the
reverse direction. When the purge/retract trigger 36 is fully
engaged in the reverse direction, therefore, the software may
control the injector motor to deliver this minimum rate. The
correlation of flow rate to the purge/retract trigger 36 position
may be as shown in Table 2. The no-load retract speed may be a
minimum of 6.0 ml/s. The position tolerance may be +/-2% of fully
engaged.
2 TABLE 2 Flow Rate (ml/s) % of Fully Engaged 0 0 to 12 (Dead Band)
0.1 to 0.5 12 to 50 0.6 to 6.0 50 to 90 6.0 90 to 100
[0109] The powerhead software may display the volume position, by
counting up as the ram 46 moves toward the home position. The
powerhead software may additionally display the flow rate by
calculating the average flow rate averaged over the previous 0.5
second. When the user releases the purge/retract trigger 36, the
flow rate display may return to the programmed flow rate and the
volume display may show the maximum programmable volume. The
powerhead software may limit the reverse movement to a maximum flow
rate of 1 ml/s for the first 1 ml. If the ram 46 is extended 20 ml
or more and the operator engages the purge/retract trigger 36 at
90% to 100% in the reverse direction, the powerhead software may
lock in the retract function so the operator can release the flow
rate trigger switch while the injector 20 continues to retract. If
the ram 46 is not extended 20 ml or more, the powerhead software
may not lock in the flow rate in the retract direction. When
retracting the ram 46, if the flow rate is locked in and the user
activates the purge/retract trigger 36, the powerhead software may
deviate the lock-in feature and control the motor to the
purge/retract trigger 36.
[0110] Pre-filled syringes, such as those commercially available
from Mallinckrodt, may contain an extra 3 ml of contrast media or
other fluid, over the labeled syringe size, to allow the user to
purge air from the syringe and tubing and still have the fully
labeled syringe volume available to inject. For example, a 125 ml
syringe may contain 128 ml of contrast media. When the user inserts
a new syringe 28 into the injector 20, the powerhead 22 may display
the labeled syringe size selected and allow the user to purge up to
3 ml before the volume display decrements. If the user purges more
than 3 ml, then the powerhead 22 may decrement the volume display 1
ml for every 1 ml of contrast expelled.
[0111] The powerhead software may enter the enabled state when the
following sequence occurs: (1) the user opens and closes the
syringe mount 26 when the ram 46 is in the home position; (2) the
powerhead software verifies that all injection start signals are
inactive, including start switches of the powerhead 22 and the
external start signal; and (3) the user purges (i.e., expels) a
minimum of 1 ml with the purge/retract trigger 36 and then releases
the purge/retract trigger 36. When entering the enabled state, the
powerhead software may illuminate the visual indicator 91 a first
color, such as green. The injector 20 may remain in the enabled
state if the user changes the injection parameters. The injector 20
may remain in the enabled state if the user retracts the ram 46
less than 5 ml. If the injector 20 is enabled and the user retracts
the ram 46 greater than 5 ml, the powerhead software may disable
the injection.
[0112] In one embodiment, when an injection is enabled and the user
activates a start button on the powerhead control panel keypad 32
or when the injector 20 is enabled and a start command is received
from the remote console 44, the powerhead 22 may start and run the
programmed injection. While injecting, the powerhead software may
display the programmed flow rate if the actual flow rate is within
the flow rate performance tolerance. While injecting, the powerhead
software may display the average flow rate if the actual flow rate
is not within the flow rate performance tolerance. While injecting,
the powerhead software may display the volume remaining for the
programmed injection. While injecting, the powerhead software may
sweep a tri-colored visual indicator 91 through the color spectrum
to indicate that the injector 20 is running.
[0113] If the user activates the flow rate, volume, or start
buttons on the powerhead control panel or remote console 44 while
the injector 20 is running an injection, the powerhead software may
pause the injection. If an injection is paused, the powerhead 22
may flash, at the fast rate, the programmed flow rate and the
remaining programmed volume on the display activates an audible
beep and flash the visual indicator 91, such as a tri-colored LED,
in a second color, such as amber. For example, if 100 ml of a 125
ml syringe were programmed and the injector 20 was paused after 75
ml had been injected, then the injector 20 should display 25 ml for
the volume remaining. If an injection is paused and the user
activates the purge/retract trigger 36 in the "retract" direction,
the powerhead 22 may disable auto injection mode, and transition to
manual mode. If an injection is paused and the user activates the
purge/retract trigger 36 in the "expel" direction, the powerhead 22
may display the actual flow rate and the remaining syringe volume
without flashing and sweep the tri-color LED of the visual
indicator 91 through the color spectrum while the ram 46 moves
forward. When the user releases the purge/retract trigger 36, the
powerhead software may display the programmed flow rate and the
maximum programmable volume and flash the tri-color LED of the
visual indicator 91 amber in color. If an injection is paused and
the user activates the flow rate or volume buttons, the powerhead
22 may disable auto injection mode and transition to the manual
mode. If the injection is paused and the user activates an
injection start button on the powerhead 22 or remote console 44
before activating any of the other controls 90 or the purge/retract
trigger 36, the powerhead software may resume the injection from
where is was paused. If the user activates the purge/retract
trigger 36 while in auto inject mode, the powerhead software may
pause the injection.
[0114] When an injection is completed, the powerhead software may
flash, at a slow rate, the average achieved flow rate and achieved
volume values on the powerhead display. The cycle of the slow rate
flash may be "on" for 1.5 seconds and "off" for 0.5 seconds. When
an injection completes, the powerhead software may disable the
injector 20 and turn off the tri-colored LED of the visual
indicator.
[0115] After an injection completes and (1) the user activates the
flow rate increment, flow rate decrement, volume increment, volume
decrement, or start controls 90 on the powerhead control panel
keypad 32 or remote console 44, (2) there is greater than 1 ml of
volume remaining in the syringe 28, and (3) the user has not
retracted the ram 46, the powerhead software may: (1) display the
programmed flow rate and maximum programmable volume, (2) re-enable
the injection, and (3) activate the tri-color LED, of the visual
indicator 91, the first color, such as green. If the user activates
the purge/retract trigger 36 in the "expel" direction, the
powerhead 22 may display the actual flow rate and the remaining
syringe volume without flashing and sweep the tri-color LED, of the
visual indicator 91, through the color spectrum while the ram 46
moves forward.
[0116] When the user releases the purge/retract trigger 36 the
powerhead software may display the programmed flow rate and the
maximum programmable volume and activate the tri-color LED, of the
visual indicator 91, the first color. After an injection completes
and there is 1 ml or less volume remaining in the syringe 28 the
powerhead software may disable the injection.
[0117] An external start signal from the remote console 44 to the
powerhead 22 is part of the console interface 89 between the
powerhead 22 and remote console 44. The external start signal is
used in conjunction with an injection start message from the remote
console 44 to start an injection from the remote console 44. The
powerhead software may start a programmed injection from the
external start signal only if the following conditions are met: (1)
the injection is enabled, (2) the external start signal activates,
and (3) a message from the remote console 44 is received by the
powerhead software within 500 milliseconds of the external start
signal activation. If the powerhead software detects an external
start signal activation and the injector 20 is not enabled, the
powerhead software may ignore the external start signal, activate
an audible beep and display a user error code for injection not
enabled. If the powerhead software detects the external start
signal and does not receive a start message, the powerhead software
may disable auto inject mode and display the injector 20 failure
code for injection start.
[0118] The powerhead 22 further includes a sensor for detecting
when the user opens and closes the syringe mount 26.
[0119] If the user activates the purge/retract trigger 36 in the
expel direction with the syringe mount 26 open the powerhead
software may: (1) not allow the ram 46 to move in the expel
direction, (2) display a user error code for the syringe clamp
open, and (3) restore the original display when the user releases
the purge/retract trigger 36 or closes the syringe mount 26.
[0120] If the powerhead software detects the syringe mount 26
opening during an injection, the software may stop injecting and
flash, at a fast rate, an injector 20 fault code for syringe mount
26 open on the powerhead display 34 and disable the auto inject
mode. If the user closes the syringe mount 26, the powerhead
software may transition to manual mode and display the programmed
flow rate and maximum programmable volume.
[0121] The powerhead software may correlate injector motor current
to syringe pressure. In one embodiment, the powerhead software will
not allow the syringe pressure to exceed 250 psi when the ram 46 is
moving in the forward direction. If syringe pressure is approaching
the pressure limit the powerhead software may reduce the flow rate
of the injection to keep from exceeding the pressure limit. If the
flow rate is reduced due to pressure limiting, the powerhead
software may provide continual beeps from the audible annunciator
and flash the flow rate on the display 34 at the fast rate while
injecting. When a pressure limited injection completes, the
powerhead software may stop the audible annunciator from beeping
and flash the volume and flow rate at the slow rate. When
retracting the ram 46, the powerhead software may limit the
pressure. In one embodiment, the pressure during retraction of the
ram 46 may be limited to a maximum of 100 psi.
[0122] The remote console 44 includes a timer for timing the
elapsed time from the start of an injection to when the injector
ram is retracted. The purpose of the timer is to assist the user in
determining when to start an imaging scan after injecting contrast.
The powerhead 22 may send messages to the remote console 44
containing injection elapsed time information for the remote
console 44 to display on the injection timer. The powerhead 22 may
not start the timer unless the injector 20 is first enabled.
[0123] It is expected that a user would typically use the auto
inject feature to run an injection. In this scenario the user would
first purge the injector 20 and stop. The injector 20 would be
enabled at this point. The user would then start the injection
using the start button on the powerhead 22 or the remote console
44. The timer would start timing when the start button is pressed.
The powerhead 22 may reset and start the timer when an auto
injection starts. During the injection the powerhead 22 may send
messages to the remote console 44 with the injection elapsed time
information to display on the timer.
[0124] In a different scenario, after purging and enabling the
injector 20, a user could "manually" perform the injection by using
the purge/retract trigger 36 instead of using the auto inject
feature. In this scenario, the timer would start timing as soon as
the ram 46 moved forward after being enabled. However, the timer
should not display the time until a minimum of 10 ml volume was
injected without stopping. If the user stopped injecting before 10
ml, the timer would reset to zero. When the user moves the injector
ram 46 forward with the purge/retract trigger 36, the powerhead 22
may start the timer but send a message to the remote console 44 to
display dashes until a minimum of 10 ml is expelled without
stopping. If the user moves the ram 46 forward more than 10 ml,
without stopping, the powerhead 22 may send the elapsed time to the
remote console 44 to display on the timer. If the user stops
expelling before 10 ml of contrast media or other fluid is expelled
the powerhead 22 may stop the timer and send a message to the
remote console 44 to continue to display dashes for the time.
[0125] In another scenario, the user may perform a "scout"
injection prior to starting an auto injection. In this scenario the
user would first purge and enable the injector 20, then manually
inject a small amount of contrast, or other media, to verify proper
needle placement. Several scout injections may be done before
proper needle placement is verified. Once proper needle placement
is verified the user then starts the injection using the start
button on the powerhead 22 or the remote console 44. This scenario
is covered in the above requirements for auto and manual injection.
If the user performs a scout injection of less than 10 ml the timer
display will remain with displayed dashes until the start button is
pressed. If the user injects more than 10 ml, the timer will start
and display time but reset to zero when the user starts the
injection with the start button.
[0126] If an injection is paused, the powerhead 22 may allow the
timer to continue to run and send messages to the remote console 44
with the injection elapse time. The powerhead 22 may stop the timer
and send a message to the remote console 44 to display dashes when
the ram 46 is retracted more than 5 ml.
[0127] The remote console 44 may include a momentary contact switch
that the user may activate to turn 24 volt power "on" or "off" to
the remote console 44 and the powerhead 22. When the remote console
44 detects the activation of this "soft" power switch 52, it sends
a message to the powerhead 22 that 24 volt power is turning off.
When the powerhead 22 receives a power down message from the remote
console 44 the powerhead 22 may transition to the safe state.
[0128] The powerhead software contains a safe state to which the
software transitions if an injector failure is detected. While in
the safe state the injector 20 is prohibited from functioning in an
unsafe manner. It is intended that, if possible, the ram 46 be
retracted to the home position so the syringe 28 may be able to be
removed from the injector 20. While in the safe state the powerhead
software may not allow the injector ram 46 to move in the forward
direction. The powerhead software may allow the user to retract the
ram 46 to the home position at a maximum rate of 1 ml/s. While in
the safe state the powerhead software may activate a periodic
audible beep at the rate of on for one second and off for two
seconds. While in the safe state the powerhead software may display
the failure code of any detected injector malfunction. If more than
one failure occurs the powerhead software may continually cycle
through and display each failure code for at least 2 seconds. If
the powerhead software enters the safe state it may stay in the
safe state until power is cycled. Apart from the self-tests
conducted at power-on, the powerhead software performs run time
checks on hardware components to verify safe operation. An LED is
connected to the microcontroller I/O line for the software to
toggle on/off so that a manufacturing technician has a visual
indicator that the microcontroller is running. The powerhead
software may toggle the "Alive" LED on and then off so that a
manufacturing technician has a visual indicator that the
microcontroller is running. If the microcontroller is reset, the
powerhead software may display the microcontroller failure code and
transition to the safe state.
[0129] The powerhead software may verify that the +24 volt power
supply is between +20 volts and +28 volts within 500 milliseconds
after starting an injection. If the +24 volt power supply is
outside the tolerance range, the powerhead software may stop the
motor and transition to the safe state. The powerhead software may
verify that the +5 volt power supply is between +4.5 volts and +5.5
volts at a minimum every 30 seconds. If the +5 volt power supply is
outside the tolerance range, the powerhead software may transition
to the safe state.
[0130] The powerhead software may verify that the microcontroller
is receiving motor encoder pulses whenever the software runs the
motor. If the powerhead software does not detect any motor encoder
pulses within 100 milliseconds of running the motor, the powerhead
software may transition to the safe state.
[0131] The powerhead control panel keypad 32 may include two
injection start switches that are activated by the user as one
push-button for injection start. Two switches are used to as a
redundant safety feature to avoid having a false start signal from
a bad switch start an injection. If both start switches indicate an
activation of the start button and the injector 20 is enabled, the
powerhead software may activate the injector motor in the forward
direction at the programmed values. If the injection completes and
one of the start switches is active then the powerhead software
may, until both start switches are inactive: (1) remain in the
injection complete state, (2) display a start switch failure code,
(3) allow the user to retract the ram 46 with the purge/retract
trigger 36, and (4) not allow the user to move the ram 46
forward.
[0132] The powerhead motor assembly contains an encoder that
provides position information back to the powerhead
microcontroller. The encoder, however, does not provide absolute
position information. Thus, when power is turned off and back on,
the position information from the encoder is lost. Therefore, the
powerhead 22 includes a ram home detector 50 that indicates when
the ram 46 is at the fully retracted position or home position.
When the ram 46 is being retracted, and the powerhead software
determines from the encoder counts that the home position has been
reached, and the sensor 140 of the home position detector 46 has
not indicated a home position within +/-2 ml, the powerhead
software may stop the motor and transition to the safe state. When
the ram 46 is being retracted and the powerhead software determines
the sensor 140 of the home position detector 50 indicates a home
position while the encoder counts does not indicate a home position
within +/-2 ml, the powerhead software may stop the motor and
transition to the safe state.
[0133] The purge/retract trigger 36 includes sensors 116 that
detect how much the user moves the trigger 36. If a zero point of
the sensors drifts out of tolerance, the software could interpret
the drift as a purge/retract trigger 36 activation. When the
powerhead software detects purge/retract trigger 36 activation in
the forward direction the software may check that all trigger
sensors 116 indicate activation of the trigger 36 in the forward
direction. When the powerhead software detects activation of the
purge/retract trigger 36 in the reverse direction, the software may
check that all trigger sensors 116 indicate activation of the
trigger 36 in the reverse direction. If a purge/retract trigger
sensor is out of tolerance, the powerhead software may transition
to the safe state.
[0134] After an injection completes and the achieved average flow
rate is not within the tolerance for a non-pressure limited
injection, the powerhead software may alternate between displaying
the achieved flow rate and the flow rate out of tolerance failure
code until the user activates the purge/retract trigger 36 or any
of the powerhead controls 90.
[0135] If the achieved volume is not within a specified tolerance,
the powerhead software may alternate between displaying the
achieved volume and the volume out of tolerance failure code until
the user activates the purge/retract trigger 36 or any of the
powerhead controls 90.
[0136] In one particular embodiment, if the powerhead software
detects injector failure the software may display an indication
code, such as "F", in the flow rate display and a number
corresponding to the failure type in the volume display. In a
particular embodiment, the failure codes are created and may be
interpreted as follows. The hundred's digit represents the
subsystem where the failure occurred. The number "0" in the
hundred's digit represents the powerhead 22, a "1" represents
remote console 44 (if connected), and a "3" represents the power
pack 38. For example the failure code "F 004" is for the powerhead
RAM memory failure while the failure code "F 104" is for the remote
console 1 RAM memory failure. The failure codes in this particular
embodiment of the software are as follows:
[0137] F X01 Microcontroller CPU Failure
[0138] F X02 Program Flash Memory CRC Failure
[0139] F X03 Data Flash Memory CRC Failure
[0140] F X04 RAM Memory Failure
[0141] F X05 Quad Timer Failure
[0142] F X06 AID Converter Failure
[0143] F X07 PWM Failure
[0144] F X08 Interrupt Controller Failure
[0145] F X09 Clock PLL Failure
[0146] F X10 Microcontroller Watchdog Reset
[0147] F X20 +24V Power Supply failure (+24V Power Supply out of
tolerance)
[0148] F X21 +5V Power Supply failure (+5V Power Supply out of
tolerance)
[0149] F 030 Encoder failure (no encoder counts when motor
activated)
[0150] F 031 Encoder failure (encoder counts detected when motor
not enabled)
[0151] F 032 Motor Relay failure (cut-out relay failure, relay
stuck open or closed)
[0152] F 033 Motor failure (motor over current detected)
[0153] F 034 Motor failure (current detected when motor not
enabled)
[0154] F X40 Start switch failure (one or both start switches are
active)
[0155] F 050 Home sensor failure (no home position signal detected
when ran encode indicates that the injector ram is at the home
position)
[0156] F 051 Purge/Retract Trigger failure (zero position out of
tolerance)
[0157] F 060 Achieved Flow Rate Out of Tolerance F 061 Achieved
Volume Out of Tolerance
[0158] F 070 Powerhead--Remote Console Communication Failure
[0159] F 075 Remote Console--Power Pack Communication Failure
[0160] F 370 Dual Injector Interface failure
[0161] If the user attempts to operate the injector 20 in an unsafe
manner, the powerhead software may display an indicating signal,
such as "ER", in the flow rate display and a number corresponding
to the error type in the volume display. In one embodiment of the
injector 20, these codes may be as follows:
[0162] ER 001 User attempts to start an injection from the
powerhead when the injector is not enabled
[0163] ER 101 User attempts to start an injection from remote
console when the injector is not enabled
[0164] ER 002 User attempts to move the ram forward with the
syringe clamp open
[0165] The manufacturing mode may allow personnel to perform
diagnostics tests, calibrate sensors, and perform a burn-in cycle.
The powerhead software may allow the manufacturing person to run
diagnostic tests. The diagnostic tests at a minimum may run all the
tests performed during power-on self-test. The powerhead
manufacturing mode may allow calibration of the following
sensors:
[0166] Purge/Retract Trigger Sensors
[0167] Pressure Limit
[0168] Ram Home Position Sensor
[0169] Syringe Clamp Sensor
[0170] The powerhead software may allow the calibration values to
be sent out via interfaces 42, 89.
[0171] The manufacturing mode may allow the manufacturing person to
select a "burn-in cycle" sub-mode where the powerhead software
continuously runs an injection at a predetermined injection
parameters.
[0172] The injector powerhead 22 may interface to the remote
console 44 through a network and send messages to the remote
console 44 with the following information:
[0173] Volume Display
[0174] Flow Rate Display
[0175] Timer Display
[0176] Audible Tone Frequency
[0177] Audible Tone Volume
[0178] Tri-Color LED Red Duty Cycle
[0179] Tri-Color LED Blue Duty Cycle
[0180] Tri-Color LED Green Duty Cycle
[0181] The powerhead 22 may send messages to the remote console 44
as the event occurs or at a minimum of once per second. The
powerhead 22 may receive messages from the remote console 44 with
the following information:
[0182] Volume Increment/Decrement Button activation status and
activation duration
[0183] Flow Rate Increment/Decrement Button activation status and
activation duration
[0184] Injection Start Button activation
[0185] Soft Power Off Button activation
[0186] The injector powerhead 22 may also interface to a second
system when a remote console 44 is connected.
[0187] As described above, the injector 20 of the present invention
may include a remote console 44. The purpose of the remote console
44 is to provide the user a way to control and display the status
of the powerhead 22 from a remote location, such as an imaging
control room. The remote console 44 allows the user to program or
change programmed parameters. When the powerhead 22 is enabled for
an injection, the user can start the injector 20 or stop an
injection in progress from the remote console 44.
[0188] The remote console 44 is based on a "master/slave"
architectural design such that the remote console 44 functions as a
"slave" to the powerhead 22 when the powerhead 22 is in the manual,
auto inject, and syringe size selection modes. That is, the remote
console 44 displays the flow rate and volume of the powerhead 22
and not what the user enters at the remote console 44. If the user
changes the injection parameters from the remote console 44, the
remote console 44 sends messages to the powerhead 22 reflecting the
changes. The powerhead 22 implements the changes and sends messages
back to the remote console 44 with the new information. This design
reduces the possibility of the remote console 44 displaying
something other than what the powerhead 22 is actually doing.
[0189] The remote console 44 includes software that functions as a
"slave" to the powerhead 22. If the remote console 44 is powered on
with no powerhead connection, the remote console 44 displays a
powerhead-remote console communication fault code. The remote
console 44 has a power-on self-test (POST) to check for proper
remote console operation, and the safe state for serious injector
malfunction. When power is applied, the remote console 44 performs
an initialization of the microcontroller and system resources.
After initialization, the remote console software runs a POST.
[0190] The POST then performs a CRC test of the program Flash
memory and the data Flash memory. The POST then performs a memory
test of all data and program RAM. The POST then performs a check of
all microcontroller peripherals internal to the microcontroller
used during the operation of the remote console 44. The remote
console 44 POST checks for dual injector interface communication
operation by sending a message to the dual injector interface to
send status information over the remote console-power pack
interface. If the remote console 44 does not receive a response
from the dual injector interface, it fails the communication test.
The POST checks the +24 power supply 40 for proper supply voltages
of +24VDC +/-4 volts and the +5 power supply 40 for +5VDC +/-0.5
volts power supplies. The POST illuminates all visual indicators
including all digits and segments in the 7-segment LED displays for
a minimum of 3 seconds. The POST may activate the audible
annunciator for a minimum of 500 milliseconds.
[0191] Upon successful completion of the POST, the remote console
software may display the current software version on the LED
display for a minimum of 3 seconds. If all self-tests pass, the
remote console 44 may then check for the manufacturing mode. The
remote console 44 will enter the manufacturing mode only if the
user activates the volume increment and volume decrement at the
same time within 3 seconds after POST completes. If the user
activates any other button while the remote console software is
checking for the manufacturing mode, the software skips the
manufacturing mode check and proceeds to the operational mode. If
any of the self-tests fail, the remote console 44 transitions to
the safe state.
[0192] The remote console 44 may receive messages from the
powerhead 22 with flow rate information and display the flow rate
information on the remote console flow rate display. The remote
console 44 may receive messages from the powerhead 22 with volume
information and display the volume information on the remote
console volume display. If the powerhead 22 sends a message to the
remote console software to illuminate the injecting LED, the remote
console 44 will illuminate the injecting LED on the remote console
44. If the powerhead 22 sends a message with an active error code,
the remote console 44 may flash the error code at 500 milliseconds
on and 200 milliseconds off. If the powerhead 22 sends a message
with an active error code, the remote console 44 may activate the
audible tone for one second on and one second off for three times.
The remote console software may send any remote console control
button activation to the powerhead 22. Controls 90 may include, but
are not limited to, buttons for flow rate increment, flow rate
decrement, volume increment, volume decrement, and injection start
buttons.
[0193] The remote console 44 may include at least two injection
switches that are activated by the user as one injection start
push-button for starting an enabled injection. Two switches are
used as a redundant safety feature to avoid having a false start
signal from a bad switch to start an injection. The remote console
44 sends an injection start message to the powerhead 22 when the
user activates the injection start button. When the user activates
the injection start button, the remote console software verifies:
(1) that both injection switches have been activated, and (2) that
both injection switches have transitioned to the inactive state
since the last activation. Following verification, the remote
console software sends an injection start message to the powerhead
22.
[0194] When the user activates the volume increment button, the
remote console software may send a message to the powerhead 22
indicating a volume increment button activation. When the user
releases the volume increment button, the remote console software
may send a message to the powerhead 22 indicating that the volume
button is deactivated. The volume decrement button may operate in
the same way as the volume increment button, except the remote
console 44 sends messages to the powerhead 22 when the volume
decrement button is activated or released.
[0195] When the user activates the flow rate increment button, the
remote console software may send a message to the powerhead 22
indicating a flow rate increment button activation. When the user
releases the flow rate increment button, the remote console
software may send a message to the powerhead 22 indicating that the
flow rate button is deactivated. The flow rate decrement button may
operate in the same way as the flow rate increment button, except
the remote console 44 sends messages to the powerhead 22 when the
flow rate decrement button is activated or released.
[0196] The remote console software may display and flash an
indicator, such as "PF", in the flow rate display when the
powerhead 22 sends a message to display "PF". The "PF" indicator
signals to the user that the injector 20 is in the pre-filled
syringe selection mode. The remote console 44 may flash the "PF" at
the rate sent from the powerhead 22.
[0197] An LED visual indicator may be connected to the
microcontroller I/O line for the software to toggle on/off so that
a manufacturing technician has a visual indicator that the
microcontroller is running. The remote console software may toggle
the "Alive" LED on and then off so that a manufacturing technician
has a visual indicator that the microcontroller is running.
[0198] The remote console software may control the state of the
tri-color LED visual indicator according to the message received
from the powerhead 22. The states for the tri-color LED visual
indicator may be: green, amber, red, blue, white, color sweep, and
blank (no illumination).
[0199] Some imaging protocols require a delay of seconds, while
others may require a delay of minutes, before starting the imaging
scan. The remote console 44 includes a timer to assist the user in
determining when to start an imaging scan after injecting contrast.
The remote console 44 may include a timer for timing elapsed time
from the start of an injection to when the injector ram is
retracted. While the remote console 44 is on and the timer is not
timing, the timer may display dashes in the minutes, tens of
seconds, and seconds seven-segment LED display (i.e., "--: ----").
The remote console 44 may display the elapsed time in a minutes and
seconds format with a colon mark between the minutes and seconds.
The remote console timer may range from 0 minutes, 0 seconds (0:00)
to 19 minutes and 59 seconds (19:59). If the timer is less than 10
minutes, then the remote console 44 may blank the tens of minutes
digit (for example, 9:59). If the timer is less than 1 minute, then
the remote console 44 may display a zero in the minutes digit (for
example, 0:09).
[0200] If the remote console 44 receives a message from the
powerhead 22 to start the timer, the remote console 44 may reset
the time to zero and start the time. The remote console 44 may
continue to display dashes until the powerhead 22 sends a message
to the remote console 44 to display the time.
[0201] The remote console 44 may stop the timer and display dashes
when the remote console 44 receives a message from the powerhead 22
to stop the timer. If the timer reaches 19 minutes and 59 seconds
(19:59) the timer may hold the time at 19 minutes and 59 seconds
and flash the time display at the fast rate.
[0202] The remote console 44 further includes a momentary contact
switch that the user may activate to turn 24 volt power on or off
to the remote console 44 and the powerhead 22. The soft power
switch 52 is not connected to power but to a microprocessor I/O
line in the remote console 44. If the remote console 44 is powered
up, the microprocessor can detect when the user toggles the soft
power switch 52 to turn power off. The remote console 44 then sends
a message over the remote console-power pack interface to turn 24
volt power off. If the remote console 44 is powered off, the
microprocessor will be unable to detect user switch activation.
However, a hardware circuit in the power pack 38 can detect switch
activation through a hardware signal between the remote console 44
and the power pack 38. During this procedure, the power remains on
in the power pack 38. The detection circuit then switches 24 volt
power back on to the remote console 44 and powerhead 22.
[0203] When the remote console 44 is powered on and the user
activates the soft power on/off switch 52, the remote console 44
may send a message over the remote console-power pack interface to
disconnect 24 volt power to the powerhead 22 and remote console 44.
The remote console 44 may delay a minimum of 20 milliseconds from
when the user releases the soft power switch 52 until the power off
message is sent over the remote console-power pack interface. When
the remote console 44 is powered on and the user activates the soft
power on/off switch 52, the remote console 44 may send a message to
the powerhead 22 over the powerhead-remote console interface that
24 volt power is being disconnected. The soft power on/off feature
may not be active before the remote console POST is completed. The
soft power on/off feature may function while the injector 20 is in
the safe mode. This assumes that the associated hardware for the
soft power on/off is functional.
[0204] If the remote console 44 detects a communication failure
with the powerhead 22, the remote console 44 may repeatedly attempt
to communicate with the powerhead 22. If, after 5 seconds, the
repeated attempts fail, the remote console 44 may display a
communication failure and transition to the safe state.
[0205] The remote console 44 may display injector 20 failure codes
sent from the powerhead 22. Further, the remote console 44 may
display injector 20 user error codes sent from the powerhead
22.
[0206] The remote console software includes a safe state where the
software transitions if a remote console failure is detected. While
in the safe state, the remote console 44 is prohibited from
functioning in an unsafe manner. Once in the safe state, the
software may not exit from the safe state as long as power is
applied to the remote console 44. While in the safe state, the
software may not communicate with the powerhead 22. While in the
safe state, the remote console software may send messages to the
power pack 38 to disable all dual injector 20 relay outputs. While
in the safe state, the remote console software may display the
failure code of any detected remote console malfunction.
[0207] The injector 20 of the present invention has the ability to
connect a second injector 20' together through the dual injector
interface. This second injector 20' may be hand-held or may be
wall, floor, or ceiling mounted. The interface 42 allows for the
two injectors to work in tandem for delivering back to back
injections. Typical use for two injectors includes a "saline push"
where the first injector 20 delivers contrast followed by saline
from the second injector 20'.
[0208] The dual injector interface is located in the power pack 38.
Since the cable connecting the power pack 38 to the powerhead 22
does not include any spare signals to accommodate the dual injector
interface directly, the remote console 44 serves as the link
between the dual injector interface and the powerhead 22.
Therefore, the remote console 44 includes a remote console-power
pack interface. The remote console 44 polls the status of the dual
injector interface via the remote console-power pack interface and
sends messages to the powerhead 22 via the powerhead-remote console
interface.
[0209] When the remote console 44 receives a message from the
powerhead 22 to check for dual injector configuration, the remote
console 44 may query the dual injector interface via the remote
console-power pack interface. If another injector is connected to
the dual injector interface, and the other injector is enabled, the
remote console 44 may send the information to the powerhead 22
connected to the remote console 44.
[0210] The remote console 44 includes a microprocessor having
internal non-volatile memory to store the software program and data
constants. Manufacturing will need to update or change the contents
of the non-volatile program and data memory. The manufacturing mode
software may allow the manufacturing technician to reprogram the
contents of the non-volatile program and data memory in the
microprocessor.
[0211] Additional advantages and modifications will readily appear
to those skilled in the art. The invention in its broader aspects
is therefore not limited to the specific details, representative
apparatus and methods, and illustrative examples shown and
described. Accordingly, departures may be made from such details
without departing from the scope or spirit of Applicant's general
inventive concept.
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