U.S. patent application number 17/752089 was filed with the patent office on 2022-09-08 for power injector device and method of use.
The applicant listed for this patent is Medline Industries, LP. Invention is credited to Kirsten Cleveland, Eric Houde.
Application Number | 20220280717 17/752089 |
Document ID | / |
Family ID | 1000006351557 |
Filed Date | 2022-09-08 |
United States Patent
Application |
20220280717 |
Kind Code |
A1 |
Houde; Eric ; et
al. |
September 8, 2022 |
POWER INJECTOR DEVICE AND METHOD OF USE
Abstract
Automated injection system disclosed in this application
advantageously provides physicians with a simplified interface for
selecting fluid sources, such as saline, contrast, or a mixture of
both, to inject at high pressures. The injector system may comprise
a multi-use subassembly, a single-use subassembly, a fitting to
fluidly connect the multi-use and single-use subassemblies, a hand
held controller, a user interface, and an injector housing.
Inventors: |
Houde; Eric; (Queensbury,
NY) ; Cleveland; Kirsten; (South Glens Fall,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medline Industries, LP |
Northfield |
IL |
US |
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|
Family ID: |
1000006351557 |
Appl. No.: |
17/752089 |
Filed: |
May 24, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14159777 |
Jan 21, 2014 |
11369739 |
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17752089 |
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PCT/US2013/061397 |
Sep 24, 2013 |
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14159777 |
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61754687 |
Jan 21, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2039/0027 20130101;
A61M 5/16827 20130101; A61M 5/1408 20130101; A61M 5/31546 20130101;
A61M 5/14546 20130101; A61M 5/007 20130101; A61M 5/172 20130101;
A61M 5/20 20130101; A61M 5/2066 20130101; A61M 2205/505
20130101 |
International
Class: |
A61M 5/168 20060101
A61M005/168; A61M 5/00 20060101 A61M005/00; A61M 5/20 20060101
A61M005/20; A61M 5/145 20060101 A61M005/145; A61M 5/14 20060101
A61M005/14; A61M 5/172 20060101 A61M005/172; A61M 5/315 20060101
A61M005/315 |
Claims
1-20. (canceled)
21. A method for an operator to inject fluids into a patient using
an injection apparatus, the method comprising: the apparatus
drawing a first fluid through a first valve and into a first
container, drawing a second fluid through a second valve and into a
second container, the first valve being disposed in a first valve
fill position when the first fluid is drawn into the first
container, and the second valve being disposed in a second valve
fill position when the second fluid is drawn into the second
container; and the apparatus injecting the first fluid and the
second fluid into a patient by moving the first valve to a first
inject position, moving the second valve to a second inject
position, displacing the first fluid from the first container and
through the first valve in the first inject position, and
displacing the second fluid from the second container and through
the second valve in the second inject position.
22. A method of claim 21 further comprising the operator specifying
a ratio of an amount of the first fluid displaced from the first
container to the amount of the second fluid displaced from the
second container.
23. A method of claim 21, the first fluid comprising saline and the
second fluid comprising contrast.
24. A method of claim 21, the apparatus comprising a multi-use
subassembly comprising the first valve, the first container, the
second valve, and the second container.
25. A method of claim 24, the apparatus further comprising a
single-use subassembly in fluid connection with the multi-use
subassembly, the single-use subassembly comprising a first line for
receiving the first fluid from the multi-use subassembly, a second
line for receiving the second fluid from the multi-use subassembly,
a junction connected to the first line and the second line and
permitting mixing of the first fluid and the second fluid, and a
patient line connected to the junction and for receiving a mixture
of the first fluid and the second fluid and conveying the mixture
to the patient.
26. A method of claim 24, the apparatus further comprising injector
housing, the multi-use subassembly residing in the injector
housing, the injector housing comprising a first valve actuator for
actuating the first valve and a second valve actuator for actuating
the second valve.
27. A method of claim 21, the apparatus comprising a computer
processor controlling the drawing of the first fluid, the drawing
of the second fluid, the injecting of the first fluid, and the
injecting of the second fluid.
28. An injection apparatus comprising: a multi-use subassembly
comprising a first valve in fluid communication with a first
container, and a second valve in fluid communication with a second
container; an injector housing supporting the multi-use subassembly
and comprising a first valve actuator and a second valve actuator;
and a processor, the processor being configured to control
operations comprising: actuating the first valve actuator to move
the first valve to a first valve fill position, actuating the
second valve actuator to move the second valve to a second valve
fill position, drawing a first fluid through the first valve in the
first valve fill position and into the first container, drawing of
a second fluid through the second valve in the second valve fill
position and into the second container, actuating the first valve
actuator to move the first valve to a first inject position,
actuating the second valve actuator to move the second valve to a
second inject position, displacing the first fluid from the first
container and the through the first valve in the first inject
position, and displacing the second fluid from the second container
and the through the second valve in the second inject position.
29. An apparatus of claim 28, the processor being programed to
control a ratio of an amount of the first fluid displaced from the
first container relative to an amount of the second fluid displaced
from the second container.
30. An apparatus of claim 28, including a supply of the first fluid
and a supply of the second fluid, the first fluid comprising saline
and the second fluid comprising contrast.
31. An apparatus of claim 28, the injector housing further
comprising a first piston for drawing the first fluid into the
first container and displacing the first fluid from the first
container, and a second piston for drawing the second fluid into
the second container and displacing the second fluid from the
second container.
32. An apparatus of claim 28, further comprising a single-use
subassembly in fluid connection with the multi-use subassembly, the
single-use subassembly comprising a first line for receiving the
first fluid from the multi-use subassembly, a second line for
receiving the second fluid from the multi-use subassembly, a
junction connected to the first line and the second line and
permitting mixing of the first fluid and the second fluid, and a
patient line connected to the junction and for receiving a mixture
of the first fluid and the second fluid and conveying the mixture
to a patient.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 119(e) to
U.S. provisional patent application 61/754,687, filed Jan. 21,
2013, and claims priority under 35 U.S.C. 120 as a
continuation-in-part of PCT/US13/61397 filed Sep. 24, 2013, of
which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The disclosure generally relates to fluid dispensing
machines and, more particularly, relates to fluid injection systems
and methods used to automatically inject various fluids, such as
saline, contrast, or a mixture of both, into a patient.
BACKGROUND
[0003] During medical procedures fluids of different types need to
be injected into human tissue and vascular structures. Various
medical procedures require a radiographic image of a vascular
structure to be obtained by injecting radiographic contrast
material through a procedure catheter into a hollow anatomical
structure, such as a blood vessel, artery, vein, or heart chamber.
X-rays are then passed through the region of the body in which the
contrast material was injected. The X-rays are absorbed by the
contrast material causing a radiographic outline or image of the
hollow anatomical structure containing the contrast material. The
x-ray images of the hollow anatomical structures filled with the
contrast material are usually recorded on memory, such as on film
or videotape, and displayed on a fluoroscope monitor. When a series
of different fluids are to be administered, or a series of
injections are required, it is often necessary to flush one fluid
from the injection line before the next fluid is administered. For
example, during angioplasty, the procedure catheter is often
flushed with saline before and/or after the addition of contrast
solution. Further, it is also necessary to purge any injection
lines of air and to prevent the reintroduction of air into the
lines.
[0004] The injection of the contrast or other fluids can be
performed either manually or automatically. In both injection
procedures, a procedure catheter is inserted into a hollow
anatomical structure, which in turn is connected to a fluid line
leading to a valve or manifold which is in fluid communication with
an injector or syringe. The plunger of the injector or syringe is
then either manually or automatically depressed to inject fluid
through the fluid line, through the procedure catheter, and into
the patient.
[0005] The most commonly used apparatus for these types of
procedures involves the connection of a catheter to a valve or
manifold having a number of stopcock valves. Movement of fluids
between selected fluid sources, other apparatus, and to the
procedure catheter and patient is typically accomplished with a
syringe or other manual injection device. The physician is
typically required to selectively open and close the valves or
manifold to control the source, path and direction of the fluid
flow during a procedure. The physician may also be required to draw
fluid, take a blood sample, remove waste, inject medication, or
flush fluid out of the injection device repeatedly during a
procedure.
[0006] Because a physician is required to manipulate a number of
stopcock valves during a procedure to achieve a desired flow path
to or from the procedure catheter, it takes training to learn how
to properly operate one of the prior art manifolds. Further,
because it may not be immediately evident from looking at the
manifold which way the fluid is flowing, it is easy to make an
improper connection resulting in no unintended fluid delivery into
the patient. Because a number of stopcock valves are involved in
the prior art manifolds, the handles must be small so as to not
cause interference with one another. However, the small handles can
be difficult to grasp and manipulate. Additionally, physicians
often develop a "tactile feel" for infusing fluids through
catheters with the syringe or other injection device, maintaining
the infusion pressure within desired pressure ranges to avoid
damaging catheters, vessel dissection, damaging catheter balloons
or unintentional damage to any hollow anatomical structures while
still achieving flows sufficient for contrast-enhanced imaging.
[0007] In certain situations, it is necessary to dilute the
concentration of contrast being injected into a patient. For
example, in those patients with renal insufficiency incapable of
processing concentrated contrast through their system, or in cases
where a large amount of contrast is used, such as complicated
coronary interventions (PTCA) or peripheral (PTA) cases with
runoffs, direct injections of contrasts, are not desired.
Accordingly, it may be necessary to mix the contrasts and saline
prior to injection to arrive at the appropriate dilution
percentage. The goal is to obtain a dilution percentage that is
safe for the patient and still provides a clear image. Such
processes are necessarily slow and are currently difficult to
achieve using known injectors in the art. There is a need in the
art to easily mix contrast and saline in-line and control the
dilatation of the concentration of contrast being injection;
thereby preventing unnecessary contrast from entering the patient's
body and also reducing overall contrast used allowing for a cost
saving by the hospital.
[0008] To address these issues, an improved automated fluid
management system has been developed and is disclosed herein.
Automated injection system disclosed in this application
advantageously provide physicians with a simplified process for
selecting fluid sources to inject into hollow anatomical structures
at high pressures up to 1400, and typically between 900-1200
psi.
[0009] Traditional injection procedures for coronary injections as
commonly known in the art may include the use of a manifold, as
described above, for controlled injections of both saline and
contrast. If high volume injections are then required the manifold
may be removed and the user may have to then attached an automated
injectors to the procedure catheter. Therefore, a need in the art
exists, of which this invention satisfies, for an automated
injector that can be used with controlled injection of both saline
and contrast. An advantage of this system is incorporating the
ability to perform controlled injections historically done by
manifolds together the ability to simultaneously automate injection
of contrast, saline, or a mixture of both in-lines at high
pressures.
SUMMARY OF THE INVENTION
[0010] In accordance with one aspect of the disclosure, an
injection system is provided which may comprise of a multi-use
subassembly, a single-use subassembly, a fitting to fluidly connect
the multi-use and single-use subassemblies, a hand held controller,
a user interface, and an injector. The multi-use subassembly may
comprise a protective shell, at least one power actuated syringe,
and at least one automated rotary valve, a venting system, and high
pressure tubing. The single-use subassembly may comprise high
pressure tubing, pressure protection valve, pressure transducer,
and a catheter connection. In this embodiment, the multi-patient
subassembly may be capable of multiple injections for a single
patient, multiple patients, whereas the single-use subassembly may
be capable of multiple injections for a single patient.
[0011] In accordance with another aspect of the disclosure, an
injection system may also comprise a portable cart and a mounting
system. The mounting system comprises different mounting
subassemblies, including but not limited to, a cart mounting
option, a rail or bed mounting option, and a ceiling or wall
mounting option.
[0012] In yet another embodiment of the invention, the injection
system may comprise a multi-use subassembly, a single-use
subassembly, a hand held controller, a user interface, an injector
housing, and a fitting to fluidly connect the multi-use and
single-use subassemblies for single patient use only. In this
embodiment, the multi-use subassembly and single-use subassembly
may both be capable of multiple injections but for only a single
patient use. The purpose of this embodiment is so the injection
system may be used in combination with a contrast source intended
for single patient use only.
[0013] Key advantages of this invention include an improved
monitor/user interface system to facilitate automated and preset
and/or customizable injections; ability to simultaneously inject a
mixture of fluids (such as a mixture of saline and contrast) in
line and in real time; interchangeable multi-use disposables to
facilitate setup and preparation of injection system; an automated
purge system; a special rotary valve for automated fill and
injection; convex faced syringe barrel; enhanced rear barrel
support means, hand controller providing user with a tactile or
haptic feel during injections, and a side exit port syringe barrel
used to shorten the shell and decrease overall injector
footprint.
DESCRIPTION OF THE DRAWINGS:
[0014] FIG. 1 is a schematic drawing of one embodiment of the
injection system.
[0015] FIG. 2 is a side perspective view of the injection
system.
[0016] FIG. 3a is a side perspective view of the injector with
cover closed; 3b is a side perspective view of the injector with
the cover open.
[0017] FIG. 4 is a side perspective view of the injector after the
multi-use subassembly has been placed.
[0018] FIG. 5 is a side perspective view of the syringe barrel.
[0019] FIG. 6 is a rear perspective view of the outer protective
shell.
[0020] FIG. 7 is a side top perspective view of the outer
protective shell.
[0021] FIG. 8 is a top cross-section view of the multi-use
subassembly.
[0022] FIG. 9 is a side perspective view of the multi-use
subassembly.
[0023] FIG. 10 is a rear perspective view of the multi-use
subassembly.
[0024] FIG. 11 is an exploded perspective view of the multi-use
subassembly.
[0025] FIG. 12 is a partial top cross-sectional view of the
multi-use subassembly.
[0026] FIG. 13 is a partial top cross-sectional view of the
automated valve in the inject position.
[0027] FIG. 14 is a partial top cross-sectional view of the
automated valve in fill or purge position.
[0028] FIG. 15 is a partial top cross-sectional view of the
automated valve in a closed position.
[0029] FIG. 16 is an exploded view of the multi-use subassembly
highlighting the venting system.
[0030] FIG. 17 is a cross-sectional view of the multi-use
subassembly highlighting the venting system.
[0031] FIG. 18 is a partial perspective cross-sectional view of the
venting system.
[0032] FIG. 19 are partial side cross-sectional views of syringe
barrel and plunger position during venting.
[0033] FIG. 20 is a side perspective view of the injector housing,
specifically the syringe support means.
[0034] FIG. 21 is a top perspective view of the injector housing,
specifically the syringe support means.
[0035] FIG. 22 is a side perspective view of the injector housing,
specifically the syringe support means and the multi-use
subassembly.
[0036] FIG. 23A is a side perspective view of the injector housing,
specifically the syringe support means and the multi-use
subassembly.
[0037] FIG. 23B is a side perspective view of the injector housing,
specifically the syringe support means and the multi-use
subassembly with lift support.
[0038] FIG. 24a is a side perspective view of the quick connect
fitting; FIG. 24b is a top perspective view of the quick connect
fitting; FIG. 24c is an additional side perspective view of the
quick connect fitting.
[0039] FIG. 25 is a side perspective view of the fitting housing in
an open position.
[0040] FIG. 26 is a side perspective view of the fitting housing in
a closed position.
[0041] FIG. 27 is a side perspective view of the fitting housing in
a locked position.
[0042] FIG. 28 is a side view of the single-use subassembly.
[0043] FIG. 29 is an exploded perspective view of the single-use
subassembly.
[0044] FIG. 30 is an exploded perspective view of the pressure
protection valve.
[0045] FIG. 31 is a side cross-sectional view of the pressure
protection valve.
[0046] FIG. 32 is a side perspective view of the hand
controller.
[0047] FIG. 33 is a rear perspective view of the hand
controller.
[0048] FIG. 34 is an exploded perspective view of the hand
controller.
[0049] FIG. 35 is a side perspective view of the mounting
system.
[0050] FIG. 36 is a side perspective view of the mounting system
securely attached to a bed.
[0051] FIG. 37 is a partial side perspective view of the mounting
system.
[0052] FIG. 38 is a partial side perspective view of the mounting
system being attached to the injector housing.
[0053] FIG. 39 is a partial side perspective view of the mounting
system being attached to the injector housing.
[0054] FIG. 40 is a partial side perspective view of the mounting
system securely attached the injector housing.
[0055] FIG. 41A is a schematic of the interface system of the
system of FIG. 2.
[0056] FIG. 41B is an illustration of a Start Screen of the display
of the system of FIG. 2.
[0057] FIG. 42 is an illustration of a Setup Screen of the display
of the system of FIG. 2.
[0058] FIG. 43 is a diagrammatic flow chart illustrating the
process used to attach the multiple-use subassembly to the
injection housing of the system of FIG. 2.
[0059] FIG. 44 is a diagrammatic flow chart illustrating the
process used to fill and vent the syringes of the multiple-use
subassembly of the system of FIG. 2.
[0060] FIG. 45 is a diagrammatic flow chart illustrating the
process used to fill and prime the tubing and transducer of the
single-use subassembly of the system of FIG. 2.
[0061] FIG. 46 is a diagrammatic flow chart illustrating the
process used to select the procedure type for the system of FIG.
2.
[0062] FIG. 47 is a diagrammatic flow chart illustrating the
process to automatically fill the syringes of the multiple-use
subassembly of the system of FIG. 2.
[0063] FIG. 48 is an illustration of a Dashboard Screen of the
display of the system of FIG. 2.
[0064] FIG. 49 is an illustration of an Armed Dashboard Screen of
the display of the system of FIG. 2.
[0065] FIG. 50 is an illustration of a Shell Option Screen of the
display of the system of FIG. 2.
[0066] FIG. 51 is an illustration of a Source Options Screen of the
display of the system of FIG. 2.
[0067] FIG. 52 is an illustration of a Patient Options Screen of
the display of the system of FIG. 2.
[0068] FIG. 53 is an illustration of a Summary Screen of the
display of the system of FIG. 2.
[0069] FIG. 54 is a diagrammatic flow chart illustrating the
process to remove the multiple-use subassembly of the system of
FIG. 2.
[0070] FIG. 55 is an illustration of a Settings Screen of the
display of the system of FIG. 2.
[0071] FIG. 56 is an illustration of a Help Screen of the display
of the system of FIG. 2.
DETAILED EMBODIMENTS
[0072] As seen in FIG. 1, a schematic of the automated fluid
injection system 1 is shown. The injector system 1 is comprised of
various components or subassemblies that may be combined together
to form the overall system 1. The injector system 1 may allow the
user to monitor invasive pressures or vascular blood pressure
monitoring and perform dual injections of contrast, saline, a
mixture of contrast and saline, or any other fluid, with the
ability for variable mixing during medical procedures. The
injection system 1 is capable of injecting fluids from the barrel
35 at both low and high pressures, for example any pressure up to
1,400 PSI or the pressure required by maximum catheter
specifications as currently known in the art. The injector system 1
may include, but is not limited to, the user interface 7, a hand
controller 9, at least one injector ram 15, at least one fluid
source 23, a multi-use subassembly 3, a fitting housing 4, and a
single-use subassembly 5. The hand controller 9 may further
comprise, but is not limited to, a selector 303, an actuator 301, a
sensor 313, and a feedback means 311. The multi-use subassembly 3
may further comprise, but is not limited to, at least one syringe
barrel 35, an air purge or venting system 43, at least one
automated valve 45. The fitting housing 4 may further comprise, but
is not limited to, a fitting 133 and an air sensor 155. The
single-use subassembly 5 may further comprise, but is not limited
to, a dual lumen high pressure line 209, a tubing junction 211, a
pressure protection valve 207, a disposable pressure transducer
203, a single lumen high pressure line 213, a stopcock 215 and a
catheter connection 219. The single-use subassembly 5 may be in
fluid connection with a procedure catheter (not shown). As
described in more detail below, the various components and
subassemblies shown in the schematic of FIG. 1 may change depending
on the needs of the user.
[0073] FIGS. 2-4 depicts one embodiment of the injector system 1.
The injector system 1 may comprise of various components or
subassemblies including, but not limited to, a multi-use
subassembly 3, a single-use subassembly 5, a user interface 7, a
hand controller 9, an injector housing 13, fluid source 23, a foot
pedal 10, cover 6, locking handles 31, and a cart 19. For the sole
purpose of clarity the cover 6 has been removed from FIGS. 2 and 4.
The injector system 1 may also comprise a mount finger 14, a
mounting plate 407, a connection arm 17, and a motorized base 409.
The connection arm 17 is used to securely attach the injector
housing 13 to a mount plate 407. A key feature of the injector
system 1 is the interchangeable mounting system, described in more
detail below, that allows the injector to be secured to various
securement structures including, but not limited to, a cart 19, a
bed rail 411 (as seen FIGS. 35-40), or a ceiling or wall mount (not
shown).
[0074] The fluid sources 23 containing either saline or contrast
may be secured to the housing 13 with a source arm 25. The arm 25
may be hinged or pivotally connected to the housing 13. The arm 25
may be collapsible or foldable to allow the user to reduce the
footprint of the injector housing 13 when not in use. The user
interface 7 may be securely attached to the housing 13 by an
interface arm 11 that pivotally extends or retracts. It is
advantageous that the user interface 7 is able to swing, pivot, or
otherwise be manipulated in multiple directions during a procedure.
It is common for the injector housing 13 to be placed away from the
user during a procedure due to limited space, for example on the
opposite side of the bed, so having the ability to manipulate the
interface 7 in various directions is an advantage over injectors
currently known in the art. The interface may have an
identification card swipe 8. The hand controller 9 may be connected
to the user interface 7 using various techniques, as described
below, including a control cable 305. Similarly, the foot pedal 10
may be connected to user interface 7 using various techniques
including a control cable 18.
[0075] The interface 7 is intended to control and display various
aspects of operating the injector including, but not limited to,
setting injection parameters, automated purging of system,
automated injection, displaying real time injection status, and
providing a user friendly interface for injector. Various selection
tabs on the interface 7 may become highlighted, flash, grayed out,
or have a visual indicator in order to depict and verify to the
user that tab has been selected. An advantage of user interface7 is
that it reduces the user learning curve by programming the
interface 7 to make it easier for users to navigate the system and
simplify or automate the purging and injection sequences so to
reduce possible user error. The interface 7 may be interactive via
a touch screen so that user can select an option simply by pressing
a visual aid on the screen. Alternatively, interface 7 may be voice
activated or controlled via voice commands so instead of physically
pressing a screen or tablet computer a user may control interface 7
using a head set or other similar voice command device.
[0076] The interface 7 may be software based and incorporated onto
a touch screen tablet, PC, or a digital application used on a smart
phone. Additionally, interface 7 may provide a shorter or faster
setup time allowing for more time to conduct procedures. Interface
7 may provide for automatic syringe refill and air purging. The
automatic refill option minimizes waste by allowing user to input a
required amount of contrast, saline, or other fluid to be used per
case. User may also be able to define a maximum limit for total
contrast or saline that can be injected into the patient with
integrated warning signals to notify user when maximum has been
reached.
[0077] The interface 7 may have a card swipe 8 or identification
card reader as known in the art, as seen in FIG. 2. The purpose of
the card swipe 8 is to allow the user to simply swipe their
hospital identification card and the interface will automatically
bring up preset settings. These settings may be changed at any time
but having the ability to automatically call up preset settings may
save the user time.
[0078] As seen in FIG. 3a-FIG. 4, housing 13 has a loading area 12
that the multi-use subassembly 3 may be placed or inserted into
during setup. FIG. 3a shows the loading area 12 without the
multi-use subassembly 3 in place. The loading area 12 has at least
one valve actuator 16. The valve actuator 16 is designed so that
the tab 46 of the automated valve 45 (see FIG. 4) may fit securely
within the valve actuator 16. The movement of the valve actuator 16
is controlled by the interface 7 or hand controller 9. As described
in more detail below, when the valve actuator 16 moves or rotates
it simultaneously moves or rotates the valve tab 46 thereby
controlling the position automated valve 45. The loading area 12
also may comprise a fitting housing 4 used to securely enclose the
fitting that connects the multi-use assembly 3 to the single-use
assembly 5. The loading area 12 may also comprise visual
identifiers (not shown). The visual identifiers may include at
least one light or LED (not shown) used to provide visual
identification to the user of the current status of the injector.
For example, the loading area 12 may have two visual identifiers in
the form of different colored LEDs (not shown), one color to
represent contrast and one color to represent saline. Each LED may
be placed adjacent to the automated valve 16. Each LED may light up
and provide user notice during injection of fluid or filing,
purging, or venting of a barrel. For example, if just saline is
being injected then only the corresponding LED is activated; if
just contrast is being injected then only the corresponding LED may
be activated; if both contrast and saline is being injected both
LEDs may be activated.
[0079] Multi-use subassembly 3 may be inserted into loading area 12
and secured to the injector via a locking means such as a cover 6.
To load the multi-use subassembly 3 into the loading area 12 the
user must unlock the cover 6 by rotating the locking handles 31 and
lifting the cover 6 away from the loading area 12, as seen in FIG.
3b. Once the cover 6 has been lifted, the user may place the
multi-use subassembly 3 on the loading area 12 of the injector
housing 13. The multi-use subassembly 3 is secured to the loading
area 12 and injector housing 13 by placing the securement ridge 59
of barrels 35 into the rear barrel support means 79, as described
in more detail below. Once the multi-use subassembly 3 is in place
on the loading area 12 the user may close the cover 6 and rotate
the locking handles 31 to securely enclose the multi-use
subassembly 3 to the injector housing, as seen in FIG. 4.
[0080] The multi-use subassembly 3 may comprise of at least one
syringe barrel 35 as seen in FIG. 5. Barrel 35 may further comprise
a front end 51, back end 53, a first port 55, a second port 57, a
securement ridge 59, an alignment nub 63, and anti-rotation means.
The front end section 51 of syringe barrel 35, and similarly the
front end section 64 of protective shell 61 as seen in FIG. 6-7,
may be a semi-spherical convex, rounded, or bullet shape. An
advantage of front end sections 51 having a semi-spherical or
convex front profile is a reduction in stress points or risers.
Stress risers occur at corners and/or sharp angles on
injection-molded devices. By eliminating the sharp corners present
in a conical shaped barrel, the component will be less prone to
premature, stress-induced failures under high pressure conditions
generated by power injection. An advantage of this design is an
increase in strength that allows barrel 35 to be used multiple
times under high pressure conditions. The front face 51 of barrel
35 also shortens overall barrel length--relative to standard
conical shaped syringe barrels known in the art-allowing for
smaller multi-use subassembly 3 and small injector footprint. It is
advantageous for the injector to have a reduced footprint and
overall smaller size because the procedure room in which injector
is user becomes very crowded and space becomes limited. The design
of this embodiment helps reduce overall size of injector thereby
providing more room around the injector for hospital personnel to
freely move. Syringe barrel 35 may be made from various materials
able to withstand high temperatures or pressures including, but not
limited to, clear polycarbonate, clear abs, or ultem.
[0081] The securement ridge 59 may be located towards the back end
53 of the barrel and extend radially a selected distance around the
barrel 35. The securement ridge 59 may be injection molded together
with barrel 35 to create a single piece component. Securement ridge
59 is shaped to fit within the rear barrel support means, as
described in more detail below. The purpose of the securement ridge
59 is to provide additional support to the barrel 35 and also a
means for securely connecting or attaching the barrel 35 to the
injector housing 13. During injections the barrel 35 may come under
high forces so it is important that the securement ridge 59 can
withstand such forces because the ridge 59 may be the connection
point for securely attaching barrel 35 to injector.
[0082] The first port 55 is used to fill and inject fluids from the
syringe barrel 35. The first port 55 can be located along the front
end 51 of syringe barrel 35 and provides a fluid communication
channel between the automated valve and interior of barrel body. In
one embodiment, as shown in FIGS. 5 and 8, the first port 55 is
positioned towards the front end 51 and bottom wall 54 and below
the center axis of barrel 35.
[0083] First port 55 may be positioned on the front face 51 near
the transition zone 65 between the barrel body and the front face
51. An advantage of positioning the first port 55 along the side
wall of syringe barrel 35 is shortening the overall barrel length,
thereby allowing for a smaller multi-use subassembly 3.
Additionally, when the first port 55 is positioned along the side
wall of barrel 35 the port 55 may be located a selected distance
proximal to the tapering zone 65, an area along front end 51 of
syringe where barrel 35 transitions from straight side wall to
shaped end face, thereby reducing the risk of barrel cracking or
fatigue. First port 55 of syringe barrel 35 may be inverted into
the barrel 35, as seen in FIG. 12. An advantage of this design
allows barrel 35 to be front loaded into the shell 61, as will be
described in detail later.
[0084] The second port 57 located on top surface of securement
ridge 59 is used for purging or venting the barrel 35 of unwanted
air, as described in more detail below. The second port 57 may be
located along the top of the securement ridge 59 as seen in FIG. 5.
The second port 57 may provide fluid communication between inside
the barrel chamber and a one-way check valve 113a, 113b of the
venting system, as described in more detail below. Alternatively,
the second port 57 may be located on the top wall 56 of the barrel
35 towards the back end 53 of the syringe barrel 35.
[0085] Referring now to FIG. 6-7, the system may include an outer
protective shell 61 as a means of additional support intended to
prevent syringe barrel 35 from over expansion, cracking, leaking or
bursting during use. The protective shell 61 may include, but not
limited to, a convex shaped front end 64, port holes 58,
anti-rotation grooves 52 along the inner wall 60, alignment holes
62, placement tabs 68, connection arms 70, and the bottom half 92
of the fill chamber. Shell 61 may comprise two separate enclosure
containers 66. The shell 61 is designed so each barrel 35 may be
independently placed inside an enclosure container 66. Each
container 66 has a port hole 58 that aligns with the first port 55
of the barrel 35. At least one connection arm 70 extending off each
container 66 may securely attach to the bottom half 92 of the fill
chamber, thereby connecting both containers 66 to form a single
shell 61. The fill chamber 92 is part of the venting system 43 and
is described in more detail below. Each container 66 may have a
placement tab 68 so user may grip or hold the shell 61 during
insertion or removal from injection housing 13. Shell 61 may be
made from various materials able to withstand high temperatures or
pressures including, but not limited to, clear polycarbonate or
ultem.
[0086] The multi-use subassembly 3 may contain anti-rotation means
to prevent the barrel 35 from twisting or rotating out of alignment
during an injection or manufacture/assembly of the multi-use
subassembly 3. As seen in FIG. 5-7, the barrel 35 and shell 61 are
separate components and the anti-rotation means is used to ensure
that the barrel 35 remains aligned within the shell 61 during use.
The anti-rotation means on the barrel 35 may include an alignment
nub 63 along the front end 51 and raised notches 50 along the outer
surface of the barrel 35. The anti-rotation means of the shell 61
may include an alignment hole 62 along the front end 64 and groove
52 on inner wall 60, as seen in FIG. 6-7. The alignment nub 63 is
designed to align with and abut or be received into a corresponding
alignment hole 62 of the shell 61. Similarly, the raised notch 50
along barrel 35 outer surface aligns and fits within grooves 52 of
shells 61 inner wall 60, thus properly aligning the outer surface
of barrel 35 and inner wall 60 of shell 61. While it is important
to prevent the barrel 35 from become out of alignment, an expansion
gap may exist between the outer diameter of the barrel 35 and inner
wall 60 of the shell 61 to permit certain expansion that may occur
during use. For example, as seen in FIG. 8 an expansion gap 72 may
exist towards front end of barrel. The purpose for an expansion gap
72 is to allow the barrel 35 to expand or stretch a predetermined
amount during injections but prevent the barrel 35 from
overexpansion or overstretching to the point of failure. Therefore
the size of expansion gap 72 may vary depending on how much room
the syringe barrel 35 needs to expand or stretch but yet still be
reinforced by shell 61 to prevent failure.
[0087] Referring to FIGS. 9-11, one embodiment of the entire
multi-use subassembly 3 with all of its components is shown. The
multi-use subassembly 3 of this embodiment may comprise two syringe
barrels 35 securely enclosed within an outer protective shell 61, a
venting system 43, automated valves 45, and tubing lines 47, 41.
The ridges 59 are not enclosed by the shell 61 because the ridges
59 may attach to the rear securement means 79, as described in more
detail below. The automated valves 45 fluidly connect the barrels
35 to the fill tubing 41 or connection tube 107 and injection
tubing 47. The fill tubing 41, connection tube 107 and injection
tubing 47 may incorporate flexible, large inner diameter high
pressure tubing to enable user to visualize any trapped air in
tubing sets and achieve desired high pressure flow rates while
maintaining flexibility. The fill tube 41 may contain bag spikes 40
as known in the art to fluidly connect the fill tubes 41 with the
fluid sources. Injection tubing 47 may be fluidly connect the
barrels 35 to the fitting 133. Dedicated fluid lines may minimize
fluid waste and injection fluid lag. The tubing lines 41, 47 may be
either clear or have a specific color to represent the type of
fluid present. For example, the tube carrying saline may have a
blue line or tint along its length so the user may easily visualize
the tubing line corresponding to the delivery of saline.
[0088] As seen in FIG. 11, plunger 36 may comprise of a plunger
body 37, cover 39 and securement nub 34. As described in more
detail below, the securement nub 34 along the rear wall of body 37
may be used when securing the multi-use subassembly 3 to the
injector housing 13. Plunger cover 39 may be sized so it can freely
slide along inner wall of barrel 35 while all sides of cover 39
converge on or abut against the inner wall of barrel 35.
[0089] As seen in FIG. 12-15, the multi-use subassembly 3 may
include specially designed automated valves 45. Automated valve 45
may be a Y-shaped rotary valve. The automated valves 45 may include
a valve stem 42, valve tab 46, and may be comprised of three
different channel elements: a fill channel 44, an injection channel
38, and a barrel channel 48. Valve stem 42 is inserted and securely
attached to first port 55 of the barrel 35. Stem 42 may be secured
by adhesive or other known methods in the art. The barrel channel
48 connects to first port 55 of barrel 35 via valve stem 42. The
fill channel 44 of one barrel 35 may be connected to tubing line 41
which may be in fluid connection to fluid source 23 (saline,
contrast, and other fluid being injected) or a fill chamber 90. For
example, barrel 35 containing saline may have fill channel 44
fluidly connected to tubing line 41 which is in direct fluid
communication with saline source. Alternatively, the fill channel
44 of other barrel 35, such as barrel 35 containing contrast fluid,
may be in fluid communication with connection tube 107 which in
turn is in fluid communication with fill chamber outlet port 97, as
described in more detail below. The injection channel 39 may be
connected to injection tubing 47.
[0090] The valve 45 must be able to withstand high pressures during
injection of fluids. The Y-shaped valve 45 as shown may have angles
up to one hundred and twenty degrees between the fill channel 44,
injection channel 38, and barrel channel 48. This valve 45 design
is an improvement upon valves commonly used in the art, which may
be known as "T-valves" or "90 degree valves" which have ports
separated by only ninety degrees. An advantage of valve 45 is to
maximize the ceiling surface area between fluid paths over a
traditional ninety degree valve. For example, the Y-shaped valve 45
is an increase of the ceiling surface area between first port
barrel channel 48 and injection channel 38 and between fill channel
44 and barrel channel 48 because each port is separated by at least
one hundred and twenty degrees. This greater ceiling surface
provides superior protection against valve 45 failure during high
pressure injections because stress on the valve may be more evenly
dispersed. Also, unlike a traditional T-shaped or ninety degree
valve, which may require fluid to take a sharp ninety degree turn
during an injection, the Y-shaped valve 45 may provide for a less
severe and smoother transition or turn for fluid to travel. Thus,
Y-shaped valve 45 has less of a chance for leaking, cracking, or
failure during high pressure fluid flow because stress on valve 45
is more evenly distributed and flow of fluid is less turbulent.
[0091] The valve 45 has an injection setting, a fill setting, or a
closed setting. The movement of the tab 46 controls changing
between the settings. The tab 46 is controlled by the valve
actuator 16 (see FIG. 3a), which in turn is controlled by the user
interface 7. As the user selects a certain function on the
interface 7 this causes the valve actuator 16 to automatically
rotate. As the actuator 16 rotates this causes the tab 46 to
simultaneously rotate, thereby changing the valve setting. As seen
in FIG. 13, the valve 45 is shown in the injection position with
open fluid communication between the barrel channel 48 and the
injection channel 38. The injection position allows for fluid to be
injected into the patient by establishing a flow path from the
barrel 35 through the injection channel 48 to the injection tubing
47 which is in fluid communication with fitting and single-use
subassembly. As seen in FIG. 14, the valve 45 is in the fill
position with open fluid communication between the fill channel 44
and barrel chamber. The fill position is used to fill the barrel
chamber by allowing fluid to travel from the fluid source 23 or
fill chamber 90 into the barrel 35 and may also be used during
venting. As seen in FIG. 15, the valve 45 is in a closed position
with no open fluid communication between any of the ports. A closed
position may be used when the single-use subassembly needs to be
changed or when injector is shut down for an extended time.
[0092] Referring to FIGS. 11 and 16-18, the multi-use subassembly
also includes a venting system 43 used to purge barrel 35 of
trapped or unwanted air. The injection system must be primed before
use to avoid any air being injected into the patient. The priming
stage includes filling the syringe barrel 35 of the multi-use
subassembly 3 with fluid from the fluid reservoirs and then filling
the single-use subassembly with fluid. During priming air may
become trapped within the syringe barrel 35 or in any the fluid
lines, therefore it is important to remove this air through the
venting system 43 prior to injecting fluid into the patient.
[0093] The venting system 43 comprises a fill chamber having a top
half 91 and bottom half 92, the fill chamber may have several ports
including: an inlet port 99, an outlet port 97, and an overflow
port 95. Venting system may also include a waste chamber 96 having
a top half 94 and bottom half 93, and several ports including a
first inlet port 101, a second inlet port 103, a third inlet port
105, and an outlet port 117.
[0094] The fill chamber may be used to fill one of the syringe
barrels 35 with fluid, such as contrast, and prevent back pressure
buildup within the fluid source. It is common for contrast fluid
sources to be packaged in hard glass medical grade containers that
may be susceptible to a buildup of reverse or negative pressure
leading to leaks or cracking in the fluid connection. For example,
if the barrel 35 containing contrast was in direct fluid
communication with contrast source then during the purging sequence
pressure from the syringe barrel 35 may build and travel back up
stream towards the contrast fluid source. Since the contrast fluid
source may be a hard glass container that does not allow for
expansion, any buildup of negative pressure may lead to leaks or
damaging the fluid connection between the injector and contrast
source. Therefore, the fill chamber 91 acts as a pressure release
or pressure buffer to prevent the unwanted pressure buildup within
the contrast fluid source. Conversely, the saline fluid source is
commonly packaged in a flexible medical grade pouch or bag that is
expandable and able to withstand reverse or negative pressure
without causing leakage or failure in fluid connections. Therefore,
it is possible for the barrel 35 containing saline to be in direct
fluid communication with saline source because any negative
pressure during purging will simply expand the flexible saline bag
and not impact the connections between saline source and
injector.
[0095] To more clearly understand the function of the fill chamber
the process of filling the barrel 35 with contrast will now be
described in detail. As seen in FIG. 17, the fill line 41 for fluid
source, preferably contrast, is connected to the fill chamber inlet
port 99 having a one-way check valve 116. As the plunger 36 of the
contrast barrel 35 retracts back during the venting sequence, as
described in more detail below, negative pressure is created within
the barrel 35. The negative pressure draws and pulls the contrast
from its source along the fill tubing 41 before passing through the
fill one-way check valve 116 and into the fill chamber 92. The
negative pressure within barrel 35 will pull or force contrast
collected within fill chamber to pass through the fill chamber
outlet port 97, through a connection tube 107 into the valve fill
channel 45 and then through first port 55 into the barrel 35, as
seen in FIG. 12. Referring back to FIG. 17, the inlet port 99 may
have a standard one-way check valve 116 preventing air from exiting
the inlet port 99 and traveling back up line towards the contrast
source, thereby preventing the unwanted buildup of negative
pressure within the contrast fluid source. During venting it may be
necessary for any excess contrast in the fill chamber 92 to be
forced through the fill chamber overflow port 95 and one-way check
valve 115 then along the overflow connection tube 109 and into the
first inlet port 101 of waste chamber 96. The reason the excess
contrast will back flow through the fill chamber overflow port 95
rather than through the fill line 41 to the contrast fluid source
is because the one-way check valve 116 prevents reverse flow from
the fill chamber 92 to fluid sources, thereby protecting against
additional waste of the entire fluid source.
[0096] The waste chamber 96 is intended to allow air to escape from
the barrel while also collecting any saline, contrast, or other
fluid that is removed during the purging process. If the injector 1
is tilted at a range of 5-40 degrees relative to the horizontal
axis of the base, as shown in FIG. 2, any air remaining within
barrel will be forced to the top rear of the syringe barrel 35,
near the location of the second port 57. Referring to FIG. 16, air
is forced through the second port 57 of barrel 35, through a waste
one-way check valve 113(a), 113(b) along waste connection tubing
111(a), 111(b) and then into either the second 103 or third 105
waste chamber inlet ports. Then excess air passes through the waste
chamber outlet port 117 which is open to atmosphere. The waste
chamber outlet port 117 may have a standard one-way check valve
118, as shown in FIG. 17, to only allow air to escape from the
waste chamber 96 and prevent unwanted air from entering the system
through the outlet port 117.
[0097] The waste chamber 96 may contain multiple fluid columns 119
to increase the total surface area of the waste chamber 96, as seen
in FIG. 18. The purpose of the multiple fluid columns 119 is to
increase the overall surface area of the waste chamber 96 while
thereby increasing the amount of fluid the waste chamber 96 is able
to hold without increasing the overall size of the waste chamber
96. The fluid columns 119 increase overall distance the fluid must
travel before it enters the waste chamber 96, thereby increasing
total waste capacity without increasing the size of the waste
chamber 96. As fluid enters the waste chamber it must travel up and
down each fluid column 119 before it actually enters the chamber
and collects along the bottom surface 93.
[0098] During the automated injection sequence the system may stop
plunger before it reaches the front end 51 of barrel 35, thereby
leaving a reservoir of predetermined volume of fluid (5-10 mL)
within barrel chamber captured between the plunger and the front
end 51 of the barrel 35, as seen in step 123 of FIG. 19. The
purpose of this reservoir of predetermined volume of fluid is if
any excess air is trapped inside barrel chamber after purging the
air will be forced along the top wall 56 of the barrel 35 because
injector housing 13 may be tilted at a 5-40 degree angle along the
horizontal axis.
[0099] As seen in FIG. 19, the method of injecting fluid into a
hollow anatomical structure using the injector system disclosed
herein may include several steps. The movement of air or fluid
inside the barrel 35 chamber is controlled by the movement of the
plunger 36. The movement of the plunger 36 may be controlled by the
injector ram. For example, the plunger securement nub 34 may be
securely attached to the rear support means and in turn the
injector ram, as described in more detail below, so plunger
movement is controlled as injector ram advances forward or retracts
back. The purging sequence 121 may start with plunger 36 at
proximal most end of barrel 35 and the valve 45 is rotated into the
inject position, as seen in FIG. 13, so the barrel channel 48 is in
fluid communication with the injection channel 38. The barrels 35
may be purged prior to being connected to the procedure catheter.
Next, plunger 36 is pushed forward 123 towards front of barrel 35
causing any trapped air in barrel 35 to be expelled through first
port 55 and through valve 45 and tubing 47 and then fitting 133, as
also seen in FIG. 12, which is open to atmosphere. Next, the valve
45 is rotated to fill position, as seen in FIG. 14, so the barrel
channel 48 is in fluid communication with the fill channel 44.
Plunger 36 is then retracted to a first purge position 127 which is
a first selected distance proximal from the second port 57. While
plunger 36 is in first purge position 127 fluid may be filling the
syringe barrel 35 through port 55. The rate at which fluid fills
syringe barrel 35 depends on the fluid's viscosity, for example
contrast may take a longer time to fill syringe barrel 35 than
saline due to contrast's higher viscosity. Once fluid has filled
the syringe barrel 35 the plunger 36 may be advanced forward
slightly to a second purge position 129 a second selected distance
proximal from second port 57. While plunger 36 is in second purge
position 129 any trapped air still remaining in barrel 35 will be
forced out of barrel 35 through second port 57. After all air has
been removed the valve 45 is rotated into the inject position, as
seen in FIG. 13, and the plunger 36 is advanced distally beyond the
second port 57 to the inject position 130. During injection,
plunger 36 is advanced distally causing fluid to be advanced
through port 55 into lines 47, as show in FIG. 12. After injection
is complete 132 the user may select to either refill the barrel 35
or put the injector in standby mode. If the user elects to refill
the barrel 35 then the valve 45 may be rotated to fill position, as
seen in FIG. 14, and injector would repeat fill and purge steps
123, 127, 129 and 130. Alternatively, if user elects to put
injector in standby mode then valve 45 may be moved to closed or
off position, as seen in FIG. 15. Standby mode may be used between
procedures of multiple patients or if the injector is not going to
be used for an extended period of time.
[0100] As seen in FIGS. 20-23, the injector system 1 may comprise a
rear barrel support means 79. The purpose of the rear barrel
support means 79 is to securely attach and hold the securement
ridge 59 of barrel 35 to the injector housing 13. The rear barrel
support means 79 may comprise multiple support flanges 85, 83, a
plunger lock means 88, and a top flange (not shown). The rear
barrel support means 79 may be part of the injector housing 13 and
adjacent to the injector rams 15.
[0101] The injector rams 15 may be a mechanism capable of advancing
and withdrawing the plunger inside the barrel chamber. The injector
rams 15 may be mechanical arms or pistons that push and retract the
plunger 36 of barrel 35. For example, in this embodiment the
injector rams 15 may be motorized pistons that are advanced forward
toward the front face of the barrel during an injection and are
withdrawn back towards rear support means 79 during a fill or purge
sequence. The movement of the injector rams 15 may be controlled by
electronic signals sent from either the user interface or the hand
controller. For example, the user may input injection parameters
into the user interface or choose different selections on hand
controller and then an electronic signal is sent from user
interface or hand controller to the injector rams 15. Depending on
the type of electronic signal sent the movement of the injector
rams 15 may be either forward or rearward. The injector rams 15 may
include a sensor 87 to measure how much force or pressure is being
transferred to the plunger 36 as the plunger 36 is moved forward
and rearward. The ram sensor 87 may measure the amount of force
exerted onto the barrel 35 by the rams 15. The ram sensor 87 may be
comprised of a known sensor in the art. This sensor 87 is in
electronic communication with the user interface 7. The interface 7
uses the information from sensor 87 to measure at what pressure or
force the injector is operating and ensuring this is correctly
correlated with the user inputs.
[0102] The support flanges may include, but not limited to, a top
flange (not shown), at least one bottom flange 83, and at least two
side flanges 85. If a top flange (not shown) is used, it may be
connected to support means 79 via a hinge so during setup the top
flange is able to be lifted up and away from the side flanges 85
and bottom flange 83. The flanges 83, 85 are intended to be shaped
and size to securely enclose the securement ridge 59 of barrel 35,
as shown in FIG. 20. The flanges 83, 85 may have a barrel groove 86
and a shell groove 82. Grooves 82, 86 may consist of an indent or
step along the ends of the flanges 83, 85. The sides of the
securement ridge 59 may align with and be slid into the ridge
grooves 86 of the side flanges 85.
[0103] Additionally, the shell 61 may have a rear ridge 28 that
securely fits within shell groove 82. The bottom flange 83 may also
have a groove 80 that aligns with the bottom of the securement
ridge 59. In addition to flanges for support, the rear barrel
support means 79 may also include a plunger lock means 88. The
plunger lock means 88 is intended to securely attach to the plunger
securement nub 34 on the rear end of the plunger body 37. The lock
means 88 may have a notch 84 that is shaped to receive the
securement nub 34.
[0104] As seen in FIG. 22-23A, the rear support means 79 is
intended to simplify system setup. The system allows the user to
simply align the securement ridge 59 over the rear barrel support
means 79 and then push the multi-use subassembly 3 in place. First,
the user may hold onto the side tabs 68 of shell 61 and align the
securement ridge 59 with ridge grooved 86 and shell ridge 28 with
shell groove 82 of side flanges 85. Next, the multi-use subassembly
may be push downward to align the plunger securement nub 34 with
the notch 84 of the plunger lock means 88. Finally, the user may
continue to push down on the multi-use subassembly 3 until the
bottom side of the securement ridge 59 is aligned with the grooved
80 of bottom flange 83. An advantage of the rear support means is
that once the user aligns the securement ridge 59 with the rear
barrel support means 79 all of the other components of the
multi-use subassembly 3 are automatically align into proper
position making the setup process faster and overall injector more
user friendly. For example, once the securement ridge 59 is over
the rear barrel support means 79 the valve tabs 46 will also be
aligned over the valve actuator 16. Upon proper placement of the
multi-use subassembly 3 into the rear barrel support means 79 the
user may hear an audio feedback, such as a sound or a "click", or
have a tactile feedback response. After multi-use subassembly 3 has
been positioned inside the rear barrel support means 79 the user
may push down or close the top flange (not shown) or the cover 6,
thereby locking and securing the multi-use subassembly 3 to the
injector.
[0105] As seen in FIG. 23B, the shell ridge 28 may further comprise
a lift support 29. The lift support 29 provides the user with a
means for lifting the shell 61 from the injector housing. For
example, after a high powered injection the shell 61 may be
difficult to remove and replace. Therefore, the life support 29 may
provide the user with an additional area to grasp onto and assist
the user with faster removal of the shell. The lift support 29 may
be a separate piece of material that is securely attached to the
shell ridge 28 by ordinary means known in the art. The lift support
29 may take the form of a ring, key hole, circle, or other shape
that allows a user to easily grasp onto.
[0106] Referring now to FIG. 24-27, the multi-use subassembly 3 and
single-use subassembly 5 may be connected by a specially designed
fitting 133. It is known in the art to use standard luer type
connectors for injection systems. Such standard luer connections
require the user to twist or rotate a luer at each connection
point. The purpose of the fitting 133 for this injection system is
to allow the user to quickly connect the multi-use assembly to the
single-use assembly. The connection makes the setup simpler, more
reliable, and decreases overall setup time. Rather than using
standard luer type connection the injection system may use a
specially designed "snap fit" or "quick connect" fitting 133 to
connect the multi-use subassembly 3 and the single-use subassembly
5. The fitting 133 may also comprise a dust cap or other protective
means for preventing contamination of the fluid lines.
[0107] As seen in FIG. 24, the fitting 133 may comprise of a
multi-use connector 137 and a single-use connector 139. The
multi-use connector 137 may be attached to the multi-use connector
137 which is in fluid communication with the barrel, as seen in
FIG. 12. The single-use connector 139 may be attached to the single
use tubing set 209, as seen in FIG. 28. The multi-use connector 137
may have securement grooves 141, alignment ridge143, and female
tubing connections 145. The single-use connector 139 may have
securement tabs 147, alignment ridge 148, male tubing connections
149, tubing seals 153, and an anti-rotation means 151. The
alignment ridges 143, 148 are designed to provide the user with
tactile surface when grasping the fitting 133. The alignment ridges
143 of multi-use connector 137 and the alignment ridge 148 of the
single-use connector 139 may both have convex, concave, or other
mirrored shapes so the user knows by touch or feel that the
connectors 137, 139 are properly aligned when connected. The male
tubing connections 149 may comprise a tubing seals 153, such as a
standard 0-ring, to prevent leaking and ensure a fluid tight seals
within the fitting 133. The anti-rotation means 151 may be
comprised of an additional protrusion or flange extending from the
single-use connector 139 that aligns with a slot (not shown) in the
multi-use connector 137. The purpose of the anti-rotation means 151
is to provide additional connective support or structure to fitting
133 and prevent unwanted twisting or rotation during high pressure
injections.
[0108] During use, the user may use the curvature of the alignment
ridges 143, 148 to provide tactile feedback that the single-use
connector 139 and multi-use connector 137 are properly aligned. As
the user pushes the connectors 137, 139 together the male tubing
connection 149 will automatically align with the female tubing
connection 145 creating a tactile and audio feedback; similarly the
anti-rotation means 151 automatically slides within corresponding
slot in multi-use connector 137. The securement tabs 147 of the
single-use connector 139 slide along the securement grooves 144 of
the multi-use connector 137 until the user hears a "click" sound
and feels a haptic response that the fitting 133 has been properly
connected. To disconnect the fitting 133 the user simply needs to
push the tabs 147 in towards the center of the fitting 133 and the
pull apart the connectors 137, 139. In an alternative embodiment,
the securely tabs 147 may comprise a foot 142 having a notch (not
shown). The notch may align with a corresponding tab or extension
(not shown) protruding within securement grooves 141 of the
multi-use connector 137. When securement tabs 147 are aligned with
securement grooves 141 and are pushed together the notch on foot
142 may fit within the protruding tab or extension. This notch and
groove fitting may provide additional connective support or
structure to fitting by eliminating twisting or rotational movement
of the foot 142 and tab 147.
[0109] FIG. 25-27 illustrates the placement of the connection 133
within the housing base 153. House base 153 extends from the
injector housing and is used to securely hold the fitting 133 and
air sensor 155. Housing base 153 may comprise a seat for the
fitting 133, a seat for an air sensor 155, a housing door 157, a
viewing window 159, and a locking clamp 161. The purpose of the
viewing window 159 is to provide user with visibility of the
fitting 133 connection during use. The air sensor 155 may be
standard bubble detectors as known in the art and may use
ultrasound to detect small amounts of air trapped in tubing 209 of
single-use subassembly. If air is detected by sensor 155 in system
after purging is complete interface 7 may automatically stop
injection to prevent air from being injected into patient. The
sensors 155 may include tubing channels 144 to permit proper
placement of the single use tubing 209. The housing door 157 may
include raised bumps 158 along the inside wall of the door 157.
These bumps 158 are designed to align with the tubing channels of
the sensor 155 so when the door 157 is closed and in a locked
position the bumps 158 ensure the single use tubing 209 remain
securely inside slots 144 ensuring the sensors 155 obtain an
accurate reading.
[0110] The housing door 157 may be connected to housing base 153
via a hinged connector 163 that allows the door 157 to swing open
and close. When door 157 is in an open position the fitting 133 may
be placed into base 153 and single patient tubing 209 may be placed
into air sensor 155 slots 144. After fitting 133 is properly in
place the door 157 may be closed and securely locked to base 153
using the clamp 161. The clamp 161 may also be connected to base
153 via a hinged connection 165. The clamp 161 may include a
locking means 167 that is connected to the clamp 161 via another
hinged connection 169. When the clamp 161 is hinged or pulled
upwards into an open position, as seen in FIG. 26, the locking
means 167 may align with a notch 171 on the top surface of the
housing door 157. As the clamp 161 is pushed downwards the locking
means 167 grasps along the door notch 171 and securely locks the
door 157 to the base 153, as seen in FIG. 27.
[0111] As seen in FIGS. 28-31, the injector system includes a
single-use disposable subassembly 5. This single-use subassembly 5
is intended to connect the multi-use subassembly 3 with the
procedure catheter (not shown) via fitting 133. The single-use
subassembly 5 may comprise a single-use connection 139, pressure
transducer 203, pressure monitoring line 205, pressure protection
valve 207, co-extruded high pressure tubing 209, a tubing junction
211, high pressure tubing 213, a distal high pressure stopcock 215,
catheter connection tubing 217, and a procedure catheter connection
219. An advantage of using the single-use subassembly 5 is to
eliminate the risk of infection or contamination of the multi-use
subassembly 3. An advantage of single-use 5 subassembly is it may
be detached and discarded after each patient, whereas multi-use
subassembly may be used for multiple patients, saving user both
time and money.
[0112] The single-use connection 139 is connected to and in fluid
communication with co-extruded high pressure tubing 209 which is
able to withstand injection pressure of at least 1,400 psi. Tubing
209 may be a co-extruded dual lumen fused component designed to
avoid tangling of individual lines. Proximal end of tubing 209 may
be aligned with air sensor 155 to prevent unwanted air being
injected into patient. Distal end of tubing 209 is connected to and
in fluid communication with a tubing junction 211. The tubing
junction 211 is connected to and in fluid communication with both a
pressure protection valve 207 and single lumen high pressure
braided tubing 213 rated up to at least 1,400 psi. The high
pressure braided tubing 213 is connected to and in fluid
communication with a distal high pressure stopcock 215. The
stopcock 215 may be used to deliver fluids to the catheter, draw
blood samples, or remove waste from the system.
[0113] The single-use 5 subassembly is able to mix contrast and
saline in-line. The co-extruded dual lumen tubing 209 may have
separate lumens for contrast fluid and saline fluid. When the
co-extruded dual lumen tubing 209 reaches the tubing junction 211
it is at this point that the saline fluid and contrast fluid may be
mixed together into the single lumen high pressure braided tubing
213 to form a diluted or mixed solution. For example, if user
elects to inject a solution having the ratio of 50% contrast and
50% saline then equal amounts of contrast and saline will be
injected from the barrels of multi-use subassembly and travel along
the co-extruded dual lumen tubing 209 until the fluids reach tubing
junction 211 at which point the two fluids may mix together to form
a diluted solution. Alternatively, the user may inject a highly
diluted contrast solution, such as 20% contrast and 80% saline, and
still be able to achieve high quality images. An advantage of this
system is providing the user the able to dilute contrast fluid and
still achieve high quality images. Therefore, diluting contrast
being injected into the patient with a mixture of saline means less
contrast solution may be used during a procedure, and over time
this can lead to huge savings in both wasted contrast and money
spent on contrast.
[0114] These various tubing junctions and connections between
different components of the single-use disposable subassembly 6,
together with the multi-use subassembly 3, may be permanently
secured by various methods known in the art, including, but not
limited to, UV bonding, adhesive material, or ultrasound bonding,
and intended to withstand injecting pressures of at least 1,500
psi.
[0115] The pressure protection valve 207, pressure monitoring line
205 and pressure transducer 203, are described in U.S. Pat. No.
6,896,002, entitled PRESSURE TRANSDUCER PROTECTION VALVE, and U.S.
Pat. No. 6,986,742, entitled PRESSURE TRANSDUCER PROTECTION VALVE,
and both are incorporated herein by reference. The pressure
protection valve 207 is intended for a two-way connection and fluid
communication between tubing junction 211 and a disposable pressure
transducer 203. Pressure transducer measures the patient's blood
pressure. Referring to FIGS. 30-31, the pressure protection valve
207 includes a cap 221, a flexible diaphragm 223, a stem 225, a
sealing surface 227, a body 229, a housing 231, source fluid
channel 233 and a pressure transducer tubing connection. The
pressure protection valve 207 is activated when a pressure
fluctuation exists between source fluid channel 233 and a pressure
transducer tubing connection 235 causing the compliant flexible
diaphragm 223 to deflect away from its original position towards
the channel 233. The top of the integrated stem 225 is connected to
the diaphragm 223 and the bottom of the stem 225 is connected to
the body 229. The deflection of the diaphragm 223 moves the
integrated stem 225 away from the channel 233, causing the body 229
to engage a sealing surface 227 and create pressure isolation
between channel 233 and disposable transducer 203. This seal
protects the disposable transducer 203 from excessive pressure
which may damage or impact the transducer 203. The pressure
protection valve 207 may create a seal to protect transducer 203
before fluid pressure in channel reaches a pressure sufficient to
damage the transducer. Once pressure of fluid flow through channel
223 is lowered the diaphragm 223 moves back to its original
position, thereby separating the body 229 from the sealing surface
227 and re-establishing or opening fluid communication between the
transducer 203 and channel 223.
[0116] In yet another embodiment of this invention, there may be a
need in the art for both the single-use subassembly 5 and multi-use
subassembly 3 to be single patient use only. For example, if the
fluid source 23, such as the contrast container, is indicated as a
single use only then each component of the injector that contacts
the fluid may need to be changed after each use. In this
embodiment, the components of both the single-use subassembly 5 and
multi-use subassembly 5 may remain the same as above except for the
fitting 133. In place of the quick connect or snap fit fitting 133
of the previous embodiment, this embodiment may use a standard luer
type connection as known in the art or be directly bonded together.
The standard fitting connection would fluidly connect the injector
tubing 47 of the multi-use subassembly and the proximal end of
tubing 210 of the single-use subassembly 5.
[0117] As is shown in FIGS. 32-34, a controller 9 of the invention
may include a handle 300, a front actuator 301, rear flush button
302, a selector 303 for selecting a fluid source from which to
inject fluid within a patient, a puff button 307 for injection of a
small controlled amount of fluid, and a visual identifier 309 to
notify user of the type of fluid selected to inject. Controller 9
may also include various internal components including, but not
limited to, a tactile feedback means 311 for providing a tactile or
haptic response, and a sensor 313 for measuring position of
actuator 301. The rear flush button 302 may be used to inject a
predetermined amount of fluid, such as saline, to flush the system
or procedure catheter. Controller 9 may be used to control the
start and stop of injections, flush the tubing lines, deliver a
"puff" or selected amount of contrast, select the type of fluid to
be injected into the patient, and warn the user when an injection
may be dangerous to the patient or system.
[0118] FIG. 32 depicts a controller 9 according to certain
embodiments of the invention. The controller 9 communicates with
the user interface 7 via control cable 305. In certain embodiments,
the controller 9 can be connected and disconnected from the control
cable 305 via a first connector (not shown) that matches up to a
second connector (not shown) on the cable 305. The connection
between the first and second connectors can be made using any
suitable connection means known in the art, for example male and
female mini-DIN connectors. Alternatively, in certain embodiments,
the controller 9 communicates wirelessly with user interface 7. Any
suitable wireless protocol may be used in the invention, including
802.11(a, b, g, or n) and any other suitable protocols used in the
art. In certain embodiments, the controller 9 may be connected to
user interface 7 via a network connection, including over the
internet. Accordingly, in certain embodiments, controller 9
includes hardware and/or software for transmitting and receiving
signals over a network, including wirelessly.
[0119] Controller 9 is, in certain embodiments, composed of
materials that can be sterilized once or more than once, for
example by autoclaving, irradiation, or alcohol swab or immersion,
or may be kept sterile during the procedure by placing a protective
disposable sleeve over controller 9 during use.
[0120] The front actuator 301 may have a finite distance to travel
within the controller 9. The user may move or press down on the
front actuator 301 in order to cause a corresponding movement of
fluid between the injection system and a patient. The depression of
the actuator 301 may send an electronic signal to either the user
interface or the injector. The relationship between how much the
user moves the front actuator 301 and the quantity of fluid that is
infused into a patient may be any useful or advantageous
relationship, and may depend upon, among other things, the
application for which the automated fluid management system is
used, the injection mechanism employed by the automated fluid
management system, the inputs user selected on the user interface
7, or the preference or selection of the user. In certain
embodiments, the mapping between the amount a user moves the front
actuator 301 and the quantity of fluid infused is linear (i.e. the
transfer function is linear), advantageously permitting the
controller to function similarly to an infusion syringe and in a
manner that is familiar to physicians and easier to learn. In other
embodiments, the mapping between the amount of movement of the
front actuator 301 and the quantity infused is non-linear (i.e. the
transfer function is nonlinear), permitting the tailoring of fluid
delivery to specific uses. For example, if a high power injection
of contrast agent is desired, the mapping may be linear over a
portion of the travel of the front actuator 301, then exponential
over another portion, then linear again.
[0121] The controller 9 also includes a selector 303 for selecting
one of a plurality of fluid reservoirs within the automated fluid
management system from which to infuse fluid into a patient or into
which to deposit fluid from a patient. In preferred embodiments,
the injector system includes reservoirs for saline and contrast,
and the selector permits users to select one of these reservoirs or
a mixture of both reservoirs that are mixed inline during fluid
delivery.
[0122] Controller 9 may provide the user with feedback as to the
status of a patient or the automated fluid management system.
Feedback may be sent to and received by user in various forms
including, but not limited to, audio feedback, visual feedback 309,
such as LEDs or flashing lights, tactile or haptic such as
resistance in front actuator 301 or vibrations. In one embodiment,
front actuator 301 provides the user with position-based feedback
as to the level of fluid in the barrel 35 of the multi-use
subassembly 3 selected with the selector. The front actuator 301
has a finite travel within the controller, and the position of the
actuator along its travel corresponds to the fluid level within the
selected barrel 35. The fluid level can be measured in absolute
terms, for example in mL, or in relative terms, e.g. percent
fullness. In certain embodiments, the fluid level in the barrel 35
maps linearly to the position of the front actuator 301 along its
travel, i.e. the transfer function is a linear function. These
embodiments permit a user of the controller 9 to receive tactile or
haptic feedback from the actuator 301 in a manner similar to the
plunger of an infusion syringe in a manual injection system known
in the art. For example, tactile or haptic feedback may be felt if
distal end of catheter is occluded preventing fluid to flow from
injector. These embodiments may advantageously permit new users to
rapidly learn how to use controllers 9 of the invention. However,
in other embodiments the fluid level will map in a non-linear (e.g.
exponential) manner, i.e. the transfer function is non-linear.
These embodiments may permit users of controllers to tailor the
feedback information provided by the actuator to specific
applications.
[0123] In certain embodiments, the position of the front actuator
301 and the degree of movement map to fluid level and fluid
displacement, respectively, in the same way. For example, the
controller 9 may be configured to behave as a 10 cc syringe, so
that movement of the actuator 301 along 10% of its total travel
results in the infusion of 1 cc of fluid into or out of a patient,
and when the actuator 301 is positioned at the midpoint of its
travel, the selected barrel 35 will contain 5 ml of fluid. It
should be noted that, in an embodiment such as this one, after a
user moves the front actuator 301 to cause fluid to be infused into
a patient, the user may let go of the front actuator 301 and the it
will remain in the position in which the user left it. In other
embodiments, however, the mapping of the fluid level in the
selected reservoir to the position of the front actuator 301 for
the provision of feedback may be different than the mapping of the
position of the front actuator 301 to the amount of fluid that is
infused into a patient. In these embodiments, after the user
releases the front actuator 301, or after the user has stopped
applying force to the front actuator 301, the actuator 301 changes
position based on the fluid level within the selected barrel to
provide position-based feedback of fluid levels. In other
embodiments the position of the front actuator 301 and the degree
of movement map to velocity based control. For example, the
controller 9 may be configured so that at rest and no movement
equals zero velocity and full depression on front actuator 301
equates to full velocity of injection. The velocity is based off of
flow rates, so if the maximum flow rate is set at 5 mL/sec when
front actuator 301 is completely depressed fluid is delivered at
the maximum flow rate of 5 mL/sec.
[0124] The front actuator 301 of the controller may provide
feedback in other ways and for other parameters. In certain
embodiments, in addition to providing position-based feedback to
users, the front actuator 301 also provides resistance-based
feedback to users. The resistance-based feedback may in the form of
vibrations, resistance in movement of the front actuator 301, or
providing the user with a haptic response such as shaking or
jarring of the controller 9. The haptic or tactile feedback, such
as vibrations, shaking, or jarring of controller 9, may be
generated by the tactile feedback means 311 as seen in FIG. 34.
Preferably, resistance based feedback is provided based on a level
of fluid pressure within the injector system. For example, the font
actuator 301 may resist movement from rest to a relatively high
degree, or the controller 9 may begin to vibrate, if the fluid
pressure is relatively high within the injector system. For
example, if injection begins to approach max pressure limits, the
vibrations may increase in frequency and/or intensity. Similarly,
front actuator 301 may resist movement from rest very little or not
at all, or the controller 9 may begin to vibrate, if the fluid
pressure is relatively low. The degree of resistance may be
determined by the controller based on relative pressure values or
absolute pressure values and, as discussed above, the mapping
between pressure and resistance applied may be linear or
non-linear. For instance, in certain embodiments, the resistance
may be set to a maximum when the pressure reaches or exceeds a
certain value, and may be set to zero when the pressure reaches or
drops below another value, advantageously mimicking the kind of
resistance provided by a standard infusion syringe and catheter
set-up, which is familiar to physicians and easy to learn.
Alternatively, the resistance may be zero below a particular
threshold value, then maximum above that threshold value.
[0125] In certain embodiments, the controller 9 provides additional
or secondary feedback via other mechanisms, including visual
identifiers 309 including LEDs or display screens, and audio
feedback including audible alerts.
[0126] Controller 9 of the invention can be made any suitable size
or shape, and have any suitable actuator mechanism. Controllers 9,
actuator 301, and selector 303 may have any suitable form factors.
For example, actuators 301 may be made in form factors including
plungers, joysticks, rocker switches, toggle switches, paired
buttons, scissor handles, trackballs, computer mice, touch wheels,
scroll wheels, etc.
[0127] In one embodiment (not shown) the controller 9 may have a
form factor resembling infusion syringes generally used in the art.
It includes multiple ergonomic finger holes into which a user can
place fingers or thumbs to advantageously achieve comfortable
leverage over the actuator 301. The actuator 301 may be shaped like
a syringe plunger, and is operated in a manner similar to the
plunger of an infusion syringe: the actuator 301 is pushed inward
to cause the system in infuses fluid from a reservoir into a
patient.
[0128] In yet another embodiment of the controller 9, as seen in
FIG. 32, the front actuator 301 may be a depressible button.
Controller 9 once again includes a handle300 optionally
ergonomically shaped, permitting users to grip the handle 300 with
their fingers and palm while operating the actuator 301, 302 and
the selector 303. The front actuator 301 may include a depressible
button that may be operatively moveable by the user's thumb. For
example, the user may depress or press down on front actuator 301
to cause infusion. The controller 9 may also have a finger-operated
rear button actuator 302, as seen in FIG. 33. The rear button
actuator 302 may be used in place or in conjunction with front
actuator 301, and may cause infusion when depressed by user. The
selector 303 preferably includes a button allowing user to choose
various options for selecting saline, contrast, or mixture of both.
Additionally, the controller 9 may have a puff button 307 that
allows the user to inject a defined pre-set amount of fluid,
contrast, saline or a mixture of both, every time it is pressed to
help visualize where the catheter tip is located in the body. The
actuators 301, 302 of this embodiment may provide position-based
feedback or resistance-based feedback as disclosed above. The
feedback may be created by a motor or spring in the controller body
that provides resistance to the actuator. For example, the actuator
301, 302 of this embodiment may be spring loaded so that after
being depressed by user the actuator is forced in an upward motion
returning to its original state.
[0129] Referring now to FIGS. 35-40, the injector system may also
include a mounting system. The purpose of the mounting system is to
assist the user when transferring the injector housing 13 from a
body unit 409 to another surface. In many facilities that use an
automated injector system space is limited and many medical
personnel are in the room around the injector. Therefore, an
advantage of the mounting system is to assist the user in securing
the injector housing 13 to a stationary surface, such as a bed 410,
wall mount, or ceiling mount, without obstructing the movement of
the medical personnel in the room.
[0130] The bed mount 403 may include, but not limited to, rail
connectors 413, mounting support 415, mount locks 417, mount brace
419, bed support 421, and adjustment means 423. The rail connectors
413 are designed to securely attach the bed mount 403 to the bed
rails 411. It is understood that there are many different types or
brands of hospital beds 410 and each many have different sized
rails 411, therefore it is an advantage of this invention that the
rail connectors 413 may be adjustable and able to change sizes to
fit various sized bed rails 411. Alternatively, rails connectors
413 may interchangeably fit with the same mounting supports 415
allowing specialized rail connectors 413 to fit a single bed mount
403. The mounting supports 415 are bars or arms that securely
connect the rail connectors 413 with the actual bed support 421.
The bed support 421may be comprised of at least one flat bar or arm
that extends the width of the bed 410. The bed support 421 may also
need to be customized in order to fit various brands or sizes of
hospital beds 410, therefore the bed support 421 may have an
adjustment means 423 allowing the support to extend or retract for
proper fitting. The adjustment means 423 may be a series of screws
or bolts that unlock to allow for the bed support 421 to either be
extended or retracted and then lock back in place thereby securing
the bed support 421. The bed mount 403 may be securely attached to
the bed 410 by using the mount locks 417. Mount locks 417 may
include, but not limited to, levers, screw locks, or other
tightening locks known in the art. The mount brace 419 is used to
securely hold and embrace the mounting finger 14, as described in
more detail below.
[0131] To properly place the bed mount 403 the user may use the
adjustment means 423 to extend or retract the bed support 421 so it
is properly sized to the bed 410. Next, the rail connectors 413 may
be adjusted and slid onto the bed rails 411. The user may use the
mounting locks 417 on the rail connector 417 to securely attach the
mount 403 to bed 410. For example, as seen in FIG. 37, the mounting
locks 417 may include a knob 419 and a locking plate 420. The knob
419 may be turned or rotated which forces the locking plate 420 to
move closer to the rail 411, thereby securing the rail connector
413 to the rail 411.
[0132] After the mount 403 had been securely attached to the bed
410 the user may then securely attached the injector housing 13 to
the mount 403. The top of the connection arm 17 may be securely
attached to the bottom of the injector housing 13 (see FIG. 2) and
the bottom of the connection arm 17 may be securely attached to the
top of the mounting plate 407. The bottom of the mounting plate 407
may be connected to the top of the housing base 405. The mounting
plate 407 may have a mounting finger 14 extending off its side. The
mounting finger 14 is intended to be sized to securely fit within
slot 427 of the mounting brace 419. The mounting finger 14 may have
supports 433 extending from the housing base 405 to provide lateral
support to finger 14.
[0133] An advantage of this device is the cart 19, as seen in FIG.
2, may have a motorized body 409 or telescoping body, as known in
the art, that can extends up and down. As seen in FIG. 40, the top
wall 408 of the motorized body 409 may have a base finger 431 that
extends into a slot (not shown) of the housing base 405. The base
finger 431 may be securely attached to base housing 405 via base
locks 429, which may include, but not limited to, levers, screw
locks, or other tightening locks known in the art. The user may use
the motorized body 409 of the cart 19 to raise the injector housing
13 so the mounting finger 14 is above the mount brace 419. Since
the cart 19 may have wheels the user may easily push the cart close
to the bed 410 and effortlessly position the mounting finger 14 in
place so the tip of the finger 14 is aligned with slot 427 of
mounting brace 419, as seen in FIG. 38. Next, the user may lower
the motorized body 409 of cart 19 thereby lowering the finger 14
into position so the entire finger 14 is captured within the
mounting brace 419, as seen in FIG. 39. Once the finger 14 is
positioned inside the brace 419 the user may use the injector locks
425 to securely fasten the finger in place, thereby securing the
injector housing 13 to the bed mount 403. After the injector
housing 13 is secured to bed mount 403 the user may unlock or
loosen the base lock 429 so the motorized body 409 of cart 19 may
be lowered down even further, as seen in FIG. 40, completely
removing the base finger 431 from the housing base 405.
[0134] Once removed, the cart 19 may be moved and stored away
providing more free space around the injector for doctors and
nurses to walk and work. When the injector housing 13 needs to be
moved to another bed the cart 19 may be positioned so the base
finger 431 aligns with slot (not shown) of housing base 405. The
motorized body 409 may be raised and base finger 431 extends fully
into slot. User may secure housing base 405 to body 409 by using
the base locks 429. Next, user may unlock the injector locks 425
freeing the mounting plate 407 from the bed mount 403. Finally,
user may continue to raise the motorized body 409 until the
mounting finger 14 is completely free of mount brace 419, allowing
the cart 19 and injector housing 13 to be moved.
[0135] As seen in FIG. 41-56, the injector system may comprise of
an interactive user interface 7. The interface 7 is intended to
control and display various aspects of the injector including, but
not limited to, setting injection parameters, automated purging of
system, automated injection, displaying real time injection status,
and providing a user friendly interface. An advantage of user
interface 7 may include a simplified setup procedure or simplified
injection procedure. The interface 7 may provide step-by-step
prompts or notices that are intended to guide the user through the
simplified setup procedures or simplified injection procedures.
This simplified setup and injection procedure may decrease the
learning curve compared to manual injection systems with manifolds
or currently known automated systems. The purpose of the simplified
setup procedure or simplified injection procedure is to minimize
user interaction with system and automate as many features as
possible. The simplified setup procedure may include, but is not
limited to, priming the system, steps for attaching the multi-use
and single-use subassemblies, and venting the system. The
simplified injection procedure may include, but it not limited to,
steps for injection of fluids into a patient, auto refill of
syringes, and changing system sub-assemblies for the next patient
case.
[0136] An advantage of minimizing user interaction and automation
of system features is to save the user time and also reduce
possible user error. Also, by automating certain features, such as
priming the system, venting the system, and adjusting contrast to
saline ratio, this may minimize the amount of contrast or saline
used, thereby decreasing overall contrast waste. The interface 7
may be capable of full automation for certain features, however for
safety concerns the interface 7 may require user to confirm certain
tasks have in fact been completed. For example, the interface 7 may
be capable of fully automating the venting and air purging process,
as described below in more detail; however interface 7 may still
require user to confirm they have visually inspected all fluid
lines and syringes to ensure that no air is present. The purpose of
the user confirmation is to provide an additional level of patient
safety but still saving user time by automating the process.
[0137] Another advantage of interface 7 is to help user be able to
adjust contrast to saline mix ratio based on individual patient
requirements in order to minimize amount of contrast injected into
the patient while achieving clinically acceptable images. Reduction
in amount of contrast injected into a patient may help minimize
potential for contrast included nephropathy (CIN). In addition, the
interface 7 is intended to help user reduce the total contrast used
during injection procedures, thereby resulting in total cost
savings of over 25% in contrast related expenses for the hospital
or user. Another advantage of the interface 7 system is the user
has the ability to set patient specific injection parameters, as
described in more detail below, which may trigger warning
mechanisms when fluid injection maximums have been reached.
[0138] The interface 7 may provide the user with multiple mounting
options. For example, the interface 7 may be a touchscreen computer
housed in a display unit 510 (see FIG. 2). The display unit 510 may
be mounted on the injector assembly housing 13 (as seen in FIG. 2)
or attached to a hospital bed used for imaging. The display unit
510 may also be attached to a movable arm 11 that folds onto itself
to reduce injector footprint when being stored or not in use. The
moveable arm 11 may be attached to the injector assembly housing 13
(as seen in FIG. 2) or attached to a hospital bed used for imaging.
If the display unit 510 is attached to a moveable arm 11 this may
allow interface to be pulled across the patient bed or closer to
the user for ease of use and be able to manipulate display unit 510
at varying angles. The display unit 510 may be made of plastics,
metals, or various other materials known in the art. The display
unit 510 may be capable of contacting various fluids, such as
water, saline, contrast, blood, and will withstand high
temperatures, resist cracking or damage during normal usage. The
display unit 510 may be capable of being cleaned or disinfected
with commonly used hospital practices.
[0139] For purposes of this application, the terms "code",
"software", "program", "application", "software code", "software
module", "module", and "software program" are used interchangeably
to mean software instructions that are executable by a computer
processor as known in the art. The "user" can be a physician or
other medical professional.
[0140] The interface 7 may be in the form of software that is
preloaded onto a touchscreen computer, an application that may be
compatible with a smartphone or other portable device, or software
that may be transferred onto a touchscreen computer, hospital
network, PC or desktop computer. The interface 7 may have
backlights that change in brightness so the user can see the
interface 7 in a dark room with little or no lighting. The
brightness of the backlights may be changed manually by the user or
may automatically change depending on the amount of light in the
room. The interface 7 may be powered by the injection system and
also have a battery backup. The interface 7 may also have an
electrical port (such as a USB port as known in the art) or be
connected to the internet (either wirelessly or being connected to
an Ethernet cable) so that information on the interface 7 may be
exported or transferred to another system. For example, the
interface 7 may keep a history or summary of injections, as
described in more detail below, and user may have ability to copy
this injection summary to a portable memory storage unit (such as a
USB) or transfer the injection summary over the internet or
intranet.
[0141] In one embodiment, the interface 7 is on a touchscreen
computer with a display screen. The user may control the interface
7 by manually pressing tabs or buttons on the display screen, by
remote control, by an application that is compatible with a
smartphone or other portable electronic device, or by voice
commands. Tabs or buttons may change or alter its appearance to
indicate to user that the tab or button has been selected, for
example the tabs or buttons upon selection may become highlighted,
greyed out, blinking, flashing, or become a visual icon as known in
the art. The user may be able to calibrate the interface 7 to
change sensitivity levels of the touchscreen display so that system
is able to detect the user's touch when wearing gloves, fluids
(such as contrast, saline, or blood) is on the screen, or user's
hands have become wet. Alternatively, interface 7 may be voice
activated or controlled via voice commands so instead of physically
pressing a screen or tablet computer user may control interface 7
using a head set.
[0142] As seen in FIG. 41A, a schematic of one embodiment of the
interface 7 is shown. The interface 7 may further comprise of an
internal memory 502, data storage 504, and a processor 506 or CPU.
The internal memory 502 may be used to store user's inputs 500 or
selections and transfer this data to the processor 506.
Additionally, the user's inputs 500 may also be save in the data
storage 504. The data storage 504 may be exported or transferred
via an external storage device, such as a USB device, or through an
Ethernet cable. After the user's input 500 has been entered and
stored a processor 506 may then control the injection parameters
508 of the injection system, as described in more detail below.
[0143] The interface 7 may also provide user with visual
notifications. For example, the interface 7 software may have
integrated visual status notifications that alert user when a
change to the system has occurred. The integrated visual status
notification may include flashing visual elements on the interface
7 screen, icons or pictures on the interface 7 screen, an LED
mounted on the interface 7 housing, or audio notifications. The
visual notifications may be used to inform user that the disposable
sub-assembly has been properly installed, visualization of the
syringes being filled or injected, the system has been armed, the
system is injecting, the system has been disarmed, the system has
been armed for high flow rate or high volume injections, or that
the system is approaching preset maximum flow rate or volume
injections based on specific patient criteria.
[0144] As seen in FIG. 41B, the start screen 501 is shown having a
start tab 503, recent cases tab 505, and a system status tab 507.
The recent case tab 505 may include additional text or information
about the previous injections performed by the injector. For
example, the recent cases tab 505 may include statistics about the
previous injections on the start screen 501 and provide user with
short summary of the previous injections, such as time of each
previous case and number of injections. If the user selects the
recent cases tab 505 the display screen may transition the
interface 7 to a summary page, as described in more detail below
and seen on FIG. 53. The system status tab 507 may include
information about which part of the injection system is ready for
the procedure. The text in the system status tab 507 may be
highlighted or bold to indicate that the particular subassembly has
been properly setup. Additionally, the user may be able to select
the particular subassembly listed on the status tab 507 to move
directly to the setup screen controlling that particular
subassembly. Selecting the start tab 503 may transition the
interface to the setup screen 509, as seen in FIG. 42.
[0145] Referring now to FIG. 42, the setup screen 509 may comprise
several functional tabs, including but not limited to, a setup tab
511, a case tab 513, a summary tab 515, a settings tab 517, and a
help tab 719. When the setup tab 511 is selected, as shown in FIG.
42, the tab 511 may become highlighted, greyed out, blink, or
otherwise visually indicate to the user that the setup tab 511 has
been selected. Upon selection of the setup tab 511 the interface 7
begins a series of prompts to help guide the user in setting up the
injector system for use. The prompts may be listed in the check
list box 521 containing the individual steps required for properly
setting up the injector system for a procedure. For example, the
check list box 521 may include, but is not limited to; the
following setup prompts, load shell and connect controls 523,
connect fluid sources 525, and connect patient tubing 527.
Additionally, each individual step may have a corresponding image
box 513. The image box 513 may contain a picture, graphic,
illustration, or other visual aid to help the user associate the
particular step with the injector subassembly or component
requiring setup.
[0146] Referring now to FIG. 43, if the user selects the load shell
and connect controls 523 prompt the interface will next guide the
user through a series of steps as described in the flow chart. Each
step in the flow chart may be a separate notice screen, popup
window, or other visual aid that is intended to guide the user
through various steps in the correct sequence. The interface will
prompt user to perform step or will notify user of a step
automatically being performed by interface 7. For example, when the
load shell and connect controls 523 prompt is selected the first
step the interface may indicate the user to perform is open the
cover 529. After use has correctly opened the cover, the interface
will instruct with the injector system to retract the pistons 531
thereby simultaneously retracting the plungers which are connected
to the pistons. Once the pistons have been retracted the interface
may inform user to place shell 533 on the injector (as seen in FIG.
22-23A). Once the user has placed the shell 533 on the injector the
system will check to determine if the shell sensor has been
activated 535. The shell sensor (not shown) may be located on the
injector housing and ensures that the user has correctly aligned
and placed the shell or detect if any fluid is in the shell. If the
sensor fails to detect the presence of the shell the interface will
notify user and inform user to remove and replace shell 539.
Alternatively, if the sensor detects the presence of fluid in the
shell the interface will notify user and inform user to remove and
replace shell 539. After sensor has indicated shell is properly in
place the interface 7 may notify user to close cover 537 and
trigger injector to begin purging or removing air from shells 541.
A sensor may detect closing the cover or securement of the
latch.
[0147] Referring now to FIG. 44, if the user selects connect fluid
sources 525 prompt the interface may guide the user through a
series of steps as described in the flow chart. Each step in the
flow chart may be a separate notice screen, popup window, or other
visual aid that is intended to guide the user through various
steps. The interface may notify user to access source fluid
containers 545, then open spike stopcocks 547, and then specify
sources 551. The sources may be either saline 549, contrast 553, or
any other source (not shown). Once the type of source is selected
the user will be prompted to enter either a saline source volume
555 or contrast source volume 559. User may enter volume based on
presets or patient specific parameters. After user has entered a
source volume 555, 559 the user may select to fill syringe 557. The
interface will automatically fill each syringe with the user
selected volume. After syringes have been filled to selected
volumes the interface may trigger automatic venting of syringes 561
or alternatively the user may manually select to vent syringes on
interface (not shown). The system will check for air in syringes
and if air is present 559 the system may repeat venting 561 until
no air is present 656 at which time interface may notify user to
connect patient tubing 557.
[0148] Referring now to FIG. 45, if the user selects the connect
patient tubing 527 prompt the interface may guide the user through
a series of steps as described in the flow chart. Each step in the
flow chart may be a separate notice screen, popup window, or other
visual aid that is intended to guide the user through various
steps. First the interface may notify the user to open the quick
connect cover 563, then connect patient tubing set to shell and
depress tubing into bubble sensor 565, then close quick connect
cover and secure latch 567. Once the system has detected the latch
has been secured, for example detection by a sensor, the interface
may prompt the user to indicate if the transducer is used with the
tubing set 569. If a transducer is being used with the tubing set
the interface may then prompt user or system to prime transducer
571, open the stopcock on transducer 573, close the three-way
stopcock on the injector 575, prime transducer line with saline
577, and check for air in the transducer line 579. If air is
present in the transducer line 581 the interface may prompt user to
manually re-prime transducer line until it is free of air 583. If
no air is present in transducer line 585, or no transducer is being
used with the tubing set, the interface may then prompt system to
prime the patient line 585, zero balance the transducer with
hemodynamics system 587, close the stopcock on transducer 589,
close the three-way stopcock to transducer line 591, prime patient
tubing line with saline 593, and determine if there is any air in
the patient tubing set 595. If air is present in tubing set 597,
interface will prompt system to remove air from appropriate tubing
line(s) by flushing saline and/or contrast 598. Once no air is
present in tubing line 596 the case is ready to start 599 upon
users command.
[0149] Now referring to FIG. 46, after the injection system and
single patient tubing set has been primed the interface may be
prompted to help user select the details on the case 600. User may
select to start case 599 and interface may prompt to set fluid
maximums for patient 601. User may input contrast maximum 603 and
saline maximum 605. For example, if the patient suffers from
contrast included nephropathy and can only safely withstand a 50 mL
of contrast fluid in a 24 hour period then the interface 7 provides
user with ability to set the maximum total volume of contrast the
system will inject during the procedure to be no more than 50 mL.
User may input volume with an onscreen keyboard that indicates.
Next, interface may prompt user to select initial procedure type
607 by choosing a procedure 609. The interface may be preloaded
with various types of common procedures the injection system may be
used for. The interface may provide user with an option of
peripheral cases 611, cardiac cases 615, physician case list 613 or
other 617 cases. Cardiac cases 615 may include various preset
injection parameters depending on the specific type of case, for
example interface may prompt user to select from aortagram presets
619, coronary presets 621, and a left ventriculography presets 623.
These are merely examples of the type of cardiac preset parameters
available to choose from, it is within the scope of this invention
that additional procedures may be included in the preset parameter
options including, but not limited to, cardiac, catheterization,
selective coronary angiography, coronary intervention, coronary
angiogram, Chronic Total Occlusion, Transcatheter Aortic Valve
Replacement (TAVI/TAVR), and coronary bypass graft angiography.
Examples of peripheral cases 611 may include, but not limited to,
intravascular ultrasound (IVUS), peripheral angiogram, endovascular
aneurism repair, Y-90 mapping, CT cone beam studies, interventions,
and any other procedure requiring X-ray imaging of the peripheral.
The preset parameter options is intended to be guide for setting up
the injection system; each case is unique and may require specific
injection parameters so as described in more detail below the user
will have the option to change the preset parameters on the
dashboard screen prior to starting the case. The physician list 613
may include preset parameters for various physicians using the
injector system. Each physician may have unique preset case
parameters that they wish to use as defaults. The physician list
613 presets may be changed or updated frequently. Alternatively,
interface 7 may provide user an option to skip select case 609 and
go directly to dashboard and manually enter injection
parameters.
[0150] Referring now to FIG. 47, the system may also include an
auto refill option. The purpose of the auto refill option is to
provide user with the ability to input minimum syringe barrel
volumes at which the system will automatically replenish the
syringes with fluid from the sources. The auto refill option may
provide user with ability to set maximum fluid volumes. The auto
refill option may also provide user with ability to set minimum
volumes for each syringe. For example, if the user selects the auto
refill option so each syringe has a minimum volume of 25 mL and
after 5 injections the contrast syringe volume falls to 15 mL the
system will detect that the total volume in contrast syringe has
dropped below 25 mL and automatically refill the contrast syringe
to either the total possible volume syringe is capable of holding,
such as 100 mL, or with 10 mL of fluid. The interface 7 may notify
user that the auto refill is taking place but because the user has
preprogrammed the auto refill option the contrast syringe will be
filled automatically. An advantage to the auto refill feature is to
save the user time between injections and provide the user with the
ability quickly do additional injections that may not have been
planned at end of the procedure if needed. Also, if user is
performing multiple large volume injections the auto refill option
pervades user with ability to continue performing such injections
without stopping the case to manually fill syringes. Another
advantage of the auto refill option is to provide the ability to
continue performing injections once the desired volume in syringe
has been met.
[0151] To set the auto refill option the interface may first check
auto refill 625 has been selected by user. If user does intend to
use auto refill option, the interface may prompt system to
determine if syringe is filled enough to perform the intended
operation 627. If so, the procedure may continue 629 and there is
no need for refill. If not, the interface may prompt system to
confirm auto refill has been enabled 631. If auto fill has not been
enabled the interface may notify user 633. If auto fill has been
enabled the system may determine which syringe is not full 635. If
contrast is not full 637 the system may be prompted to fill
contrast syringe from contrast source 643 until proper volume has
been reached. If saline is not full 639 the system may be prompted
to fill saline syringe from saline source 641. The interface may
then prompt user to determine if user wants to abort auto fill 645,
if so the system will stop filing syringe 647, if not system will
continue to fill syringes from source until complete 649.
[0152] After the injector system has been set up, primed, case
selected, and the user is ready to begin the procedure, the user
interface will transition to a dashboard screen 651 as shown in
FIG. 48. The parameters on the dashboard screen 651 may be preset
depending on the type of procedure user selects 609 during
injection setup (as seen in flowchart of FIG. 46). The dashboard
screen 651 provides user with the option to change all of the
injection parameters previously described above and additional
parameters including, but not limited to, fixed 657 or variable 659
injection speeds, the type of procedure 655, the contrast ratio
661, the flow rate 663, the volume 665, the pressure 667, the rise
time 669, source options 683, shell options 685, patient options
687, summary 515, help 689, puff injection 693, end case 691, or
arm 671 the system for injection. The dashboard screen 652 may also
provide a parameter summary box 675 that provides user with
clarification on the currently set injection parameters.
[0153] Advantages of the dashboard screen 651 include providing the
user with the ability to easily and quickly modify various preset
parameters of the injection that were populated based on type of
case selected, determine if the system is armed or disarmed, and
visually see what the current volume status is of each syringe
and/or source. The dashboard screen 651 may include the type of
case, for example if user selected a cardiac case and specifically
a coronary procedure then the case type 653 may be depicted as a
coronary procedure. Also included may be a specific case type tab
655 indicating the type of case about to be performed, for example
if user is going to perform a left coronary artery injection. User
may have the option to perform either fixed 657 or variable 659
speed injections. The dashboard screen 651 may provide user with
visualization and accessibility to control various injection
parameters, including but not limited to, contrast ratio 661, flow
rate 663, volume 665, pressure 667, and rise time 669. Each
injection parameter may include arrows or other markers indicating
the user's ability to easily change the preset or previously set
parameter. For example, if the preset parameter for a coronary
procedure of contrast ratio is 50% contrast and 50% saline, but a
patient is susceptible to complications arising from excess
contrast, such as contrast included nephropathy (CIN) as described
above, the user may decide to change the contrast ratio 661 to 20%
contrast and 80% saline thereby decreasing amount of contrast
needed during the injection but enough contrast to still provide a
clear medical image. To accomplish this change the user may press
the arrows or markers contained within the contrast ratio 661 tab
and interface may prompt user with a pop-up window that will allow
user to change the contrast to saline ration from 50/50 to the
desired ratio. The injection system is capable of injecting 100%
contrast and 0% saline, 100% saline and 0% contrast, or any other
conceivable ratio of contrast and saline therebetween. The
dashboard screen 651 may include a tab detailing the sources 667
and options 683 to change the source ranges, shell 679 and options
685 to change the shell ranges, and patient 681 and options to
change the patient ranges, as described in more detail below and
seen in FIG. 50-52. Dashboard screen 651 may also include a help
tab 689, an end case tab 691, a puff tab 693, and an inject tab
695. The system provides for a hand controller, as previously
described above, to control puff and fluid injections, however the
user may also use the puff tab 693 or inject tab 695 in place of
the hand controller. The dashboard may also include an arm tab 671
that the user may press once the injection parameters have been
properly set and the system is now ready to start the
procedure.
[0154] Referring now to FIG. 49, upon arming the system the
interface may change to an armed dashboard screen 699. The armed
dashboard screen 699 may have many of the same features and tabs as
the previously described unarmed dashboard screen 651; however the
armed screen 699 may include a notification bar 697 upon the top
portion of the screen. The notification bar 697 and inject button
695 may be highlighted, blinking, flashing, include flashing text
or visual indications, or otherwise indicate the system has been
armed and is ready for injection. The armed dashboard screen 669
may also include a disarm tab 701 when selected would cause
interface to switch back to the unarmed dashboard screen 651 of
FIG. 48.
[0155] Referring now to FIG. 50-FIG. 52, the interface allows user
to change various aspects of the shell option screen 685, source
option screen 683, and patient option screen 687. The shell option
screen 685 may include an information tab 703 indicating how long
ago the current shell of the multiple-use subassembly was installed
or the number of cases the shell has performed. For example, if
each shell is intended to be used for either up to 100 hours or a
total of 5 patient cases, the information tab 703 may be changed or
customized to indicate the appropriate indicator. The shell of the
multi-use subassembly may include a limit on number of uses, for
example up to five patients, or limit on total usage time, for
example up to 12 hours. The limit on shell usage may be preset from
the manufacturer or changed by the user. Other shell options
include changing the saline vent 705, purge 707, or fill 709
parameters, and changing the contrast vent 711, purge 713, or fill
715 parameters. The saline vent 705, contrast vent 711, include
retracting the plunger in the saline or contrast syringe to various
positions in order to vent each syringe of air, as described in
more detail above and seen in FIG. 19. The purge 707, 713 options
may flush system with fluid to remove any trapped air in-line and
fill lines with desired fluid. The fill 709, 715 options includes
filling either the contrast syringe or saline syringe with fluid
from the fluid source. Shell option screen 685 may also allow user
to change the status of the auto refill option 719, which was
previously discussed, or indicate to the system that the shell is
to be removed 721. Source option screen 683 provide user with
ability to edit parameters 723 of saline source or edit parameters
725 of the contrast source, such as the volume of new contrast or
saline source, or indicate sources need to be replaced 727. Patient
option screen 687 allows user to change parameters for amount of
maximum saline volume 729 or maximum contrast volume 731 the system
can inject into the patient.
[0156] Referring now to FIG. 53, one embodiment of the summary
screen 515 is shown. The summary screen 515 may include a current
injection summary 733, past injections summary 735, fluid summary
737 and an injection history 738. The current injection summary 733
may include time/date and number of injections for the current
case, the past injection summary 735 may include time/date and
number of injections for previous cases. The fluid summary 737 may
include details about the saline and contrast for either the
current injection summary 733 or past injection summary 735; such
details may include as total amount of fluid used, total amount of
fluid delivered to patient, total amount of fluid wasted (i.e., not
delivered to patient but still used), and total usage time. The
injection history 738 may include a table or chart depicting the
injection parameters compared with what the injection system
actually performed, the table may be sortable and include, but is
not limited to, the number of injection performed, ratio of
contrast, flow, volume, date of injection, time of injection, name
of procedure type, patient characteristics, and pressure and rise
time for each injection. The injection history 739 may also be
exported 739 to any computer readable format or mobile application.
The summary screen 515 may be access from the setup screen 509, the
dashboard screen 651, or the armed dashboard screen 699.
[0157] Referring now to FIG. 54, after the case is complete the
user may select to end case 691 from either dashboard 651 or armed
dashboard 699 screen. After case has been ended the interface 7
will then the user through the sequence of post procedure steps, in
which in which the interface 7 may guide the user to first
disconnect the tubing set from the patient 741. Next, open quick
connect cover and disconnect patient tubing set from shell 743,
dispose patient tubing set in proper manner 745, place a sterile
end-cap on the shell fitting 747, press end case button 691 (as
seen in FIG. 48-49) 749, and switch to connect patient tubing
screen 751 to prepare for next case. Alternatively, if injection
system is intended for single patient use only the sequence to end
case 691 may include removal of the patient tubing and multi-use
subassembly. Additionally, the interface 7 may notify user that
after a certain number of patient uses, injections or total usage
time the multi-use subassembly needs to be replaced.
[0158] Referring now to FIG. 55, the setting screen 517 is shown
having a category tab 752 and a detailed information tab 761. The
purpose of the setting screen 517 is to provide user with access to
the current injector setting information and the ability to modify
the settings. Possible system settings that may be modified through
setting screen 517 may include auto fill status, minimum auto fill
volumes, volume level, and system interface settings such as screen
brightness, voice command, and default language. The setting screen
517 may have a category tab 752 which may include a general
information selection tab 753 (which when selected prompts the
generation information tab 761 as shown); a rates and volume tab
755, a physical content tab 757, and a procedure preset tab 759.
Additionally, setting screen 517 options may be password protected
to prevent unintended changes to presets. For example, system may
prevent selected users from changing settings including, but not
limited to, fill rate, priming volumes, procedure types, preset
injection parameters for individual physicians, or any other preset
injection parameter.
[0159] Referring now to FIG. 56, the help screen 518 is shown
having a topics tab 763 and a detailed information tab 765. The
topics tab 763 may include various topics or aspects of the
injector that user may need help with. The detailed information tab
765 may contain a user manual, or other helpful hints, tips and
help information to walk user through general issues or
troubleshooting topics. Detailed information may include videos,
audio step-by-step instructions, or live user support.
[0160] The phrase "and/or," as used herein should be understood to
mean "either or both" of the elements so conjoined, i.e., elements
that are conjunctively present in some cases and disjunctively
present in other cases. Other elements may optionally be present
other than the elements specifically identified by the "and/or"
clause, whether related or unrelated to those elements specifically
identified unless clearly indicated to the contrary. Thus, as a
non-limiting example, a reference to "A and/or B," when used in
conjunction with open-ended language such as "comprising" can
refer, in one embodiment, to A without B (optionally including
elements other than B); in another embodiment, to B without A
(optionally including elements other than A); in yet another
embodiment, to both A and B (optionally including other elements);
etc.
[0161] It will be apparent to those skilled in the art that various
modifications and variations can be made in the structure and
methodology of the present invention. Thus, it is intended that the
present invention cover such modifications and variations provided
that they come within the scope of the appended claims and their
equivalents.
* * * * *