U.S. patent application number 14/092483 was filed with the patent office on 2014-03-27 for multi-dose medical fluid injection system having patient-specific tubing set with use indicator.
This patent application is currently assigned to Mallinckrodt LLC. The applicant listed for this patent is Mallinckrodt LLC. Invention is credited to Frank M. Fago.
Application Number | 20140088559 14/092483 |
Document ID | / |
Family ID | 42537831 |
Filed Date | 2014-03-27 |
United States Patent
Application |
20140088559 |
Kind Code |
A1 |
Fago; Frank M. |
March 27, 2014 |
Multi-Dose Medical Fluid Injection System Having Patient-Specific
Tubing Set with Use Indicator
Abstract
A single-use, single-patient, or patient-specific tubing set
(300) is disclosed. The tubing set (300) includes at least one
check valve (304), along with a use indicator (320). This use
indicator (320) provides a visual indication when the tubing set
(300) has been used for an injection. In this regard, a piston
(340) moves from one position to another when exposed to a certain
fluid pressure.
Inventors: |
Fago; Frank M.; (Mason,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mallinckrodt LLC |
Hazelwood |
MO |
US |
|
|
Assignee: |
Mallinckrodt LLC
Hazelwood
MO
|
Family ID: |
42537831 |
Appl. No.: |
14/092483 |
Filed: |
November 27, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13144304 |
Jul 13, 2011 |
8628514 |
|
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PCT/US2010/029895 |
Apr 5, 2010 |
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14092483 |
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61167551 |
Apr 8, 2009 |
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Current U.S.
Class: |
604/508 |
Current CPC
Class: |
A61M 5/14546 20130101;
A61B 6/548 20130101; A61M 39/10 20130101; A61M 5/1408 20130101;
A61M 5/007 20130101; A61M 5/16881 20130101; A61M 2205/273 20130101;
A61M 2005/14553 20130101; A61M 2205/583 20130101; Y10T 137/8326
20150401 |
Class at
Publication: |
604/508 |
International
Class: |
A61M 5/145 20060101
A61M005/145; A61M 5/00 20060101 A61M005/00 |
Claims
1. A method of using a medical fluid injection system, the method
comprising: executing a first interconnecting step comprising
interconnecting a first patient-specific tubing set with a
multi-patient tubing set, wherein said first patient-specific
tubing set comprises a first use indicator; executing a first
directing step comprising directing a medical fluid from said
injection device through said multi-patient tubing set, and then
through said first patient-specific tubing set; executing a first
blocking step comprising blocking a backflow through said first
patient-specific tubing set and into said multi-patient tubing
step; and executing a first inducing step comprising inducing a
single response by said first use indicator to said first directing
step, wherein said single response is a physical change of said
first use indicator.
2. The method of claim 1, wherein said first inducing step
comprises moving a first indicator element from a first position to
a second position.
3. The method of claim 2, further comprising retaining said first
indicator element in said second position after said moving said
first indicator element step.
4. The method of claim 2, wherein said moving said first indicator
element step is initiated without deforming said first indicator
element.
5. The method of claim 2, wherein said moving said first indicator
element step comprises moving said first indicator element into a
visibly observable position.
6. The method of claim 2, wherein said moving said first indicator
element step comprises moving said first indicator element into an
open space.
7. The method of claim 1, further comprising: disconnecting said
first patient-specific tubing set from said multi-patient tubing
set; executing a second interconnecting step comprising
interconnecting a second patient-specific tubing set with said
multi-patient tubing set, wherein said second patient-specific
tubing set comprises a second use indicator; executing a second
directing step comprising directing a medical fluid from said
injection device through said multi-patient tubing set, and then
through said second patient-specific tubing set; executing a second
blocking step comprising blocking a backflow through said second
patient-specific tubing set and into said multi-patient tubing
step; and executing a second inducing step comprising inducing a
single response by said second use indicator to said second
directing step, wherein said single response is a physical change
of said second use indicator.
8. The method of claim 7, wherein said second inducing step
comprises moving a second indicator element from a first position
to a second position.
9. The method of claim 8, further comprising retaining said second
indicator element in said second position after said moving said
second indicator element step.
10. The method of claim 8, wherein said moving said second
indicator element step is initiated without deforming said second
indicator element.
11. The method of claim 8, wherein said moving said second
indicator element step comprises moving said second indicator
element into a visibly observable position.
12. The method of claim 8, wherein said moving said second
indicator element step comprises moving said second indicator
element into an open space.
13. The method of claim 7, wherein said medical fluid for each of
said first and second directing steps is acquired from a common
fluid source.
Description
RELATED APPLICATIONS
[0001] This application is a divisional patent application of U.S.
patent application Ser. No. 13/144,304, filed 13 Jul. 2011, which
is a U.S. National Stage of PCT/US2010/029895, filed 5 Apr. 2010,
which claims priority to and is a non-provisional application of
U.S. Provisional Application Ser. No. 61/167,551 filed on 8 Apr.
2009 entitled "MULTI-DOSE MEDICAL FLUID INJECTION SYSTEM HAVING
PATIENT-SPECIFIC TUBING SET WITH USE INDICATOR". Priority is
claimed to each patent application set forth in this Related
applications section, and the subject matter of each such
application is incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention generally relates to the field of
medical fluid injection systems having a reusable or multi-patient
tubing set (e.g., for use with multiple patients), along with a
disposable or single-use or patient-specific tubing set (e.g., for
use with a single patient).
BACKGROUND
[0003] Various medical procedures require that one or more medical
fluids be injected into a patient. For example, medical imaging
procedures oftentimes involve the injection of contrast media into
a patient, possibly along with saline or other fluids. Other
medical procedures involve injecting one or more fluids into a
patient for therapeutic purposes. Power injectors may be used for
these types of applications.
[0004] A power injector generally includes what is commonly
referred to as a powerhead. One or more syringes may be mounted to
the powerhead in various manners (e.g., detachably; rear-loading;
front-loading; side-loading). Each syringe typically includes what
may be characterized as a syringe plunger, piston, or the like.
Each such syringe plunger is designed to interface with (e.g.,
contact and/or temporarily interconnect with) an appropriate
syringe plunger driver that is incorporated into the powerhead,
such that operation of the syringe plunger driver axially advances
the associated syringe plunger inside and relative to a barrel of
the syringe. One typical syringe plunger driver is in the form of a
ram that is mounted on a threaded lead or drive screw. Rotation of
the drive screw in one rotational direction advances the associated
ram in one axial direction, while rotation of the drive screw in
the opposite rotational direction advances the associated ram in
the opposite axial direction.
[0005] One way to categorize syringes used by power injectors is
the manner in which they are filled or loaded with fluid. Power
injector syringes may be pre-filled--syringes that are filled with
fluid at one facility and then shipped to another facility (e.g.,
an end-use facility). Empty syringes may be shipped to the end-use
facility, and may then be filled with fluid in at least two general
manners. An empty syringe may be filled with fluid at one location
within the end-use facility (e.g., at a filling station), and then
transferred to another location within the end-use facility (e.g.,
an imaging suite) where the fluid-containing syringe is then
installed on a power injector. Alternatively, an empty syringe may
be installed on a power injector at the end-use facility (e.g., in
an imaging suite) and then loaded or filled with fluid.
[0006] Individual empty syringes may be filled in accordance with
the foregoing from what may be characterized as a single dose
container. In this case, the syringe is used for a single injection
on a single patient. Any contrast media remaining in the syringe
after this single injection is thereby wasted. The entire tubing
set extending from the power injector to the patient (including the
various components that may be incorporated into the tubing set,
such as one or more valves and a catheter) is also discarded.
SUMMARY
[0007] As used herein, the phrase "fluidly interconnected" or the
like refers to two or more components or entities being connected
(directly or indirectly) in a manner such that fluid can flow
(e.g., unidirectionally or bidirectionally) between the components
or entities. For example, "an injection device being fluidly
interconnected to a patient" describes a configuration where fluid
can flow from the injection device, through any interconnecting
device(s) (e.g., tubing, connectors), and to the patient (e.g.,
into the vasculature of the patient).
[0008] As used herein, the phrase "fluidly isolated" or the like
describes a relationship between components or entities where it is
intended that fluid be at least temporarily precluded from flowing
between the components or entities. For example, "an injection
device being fluidly isolated from a patient" describes a
configuration where fluid from the injection device is intended to
be at least temporarily precluded from flowing to the patient. Such
an inability to flow may be because no interconnecting device(s)
currently fluidly interconnects the injection device and the
patient or because one or more devices, such as a valve, is
currently in a configuration or position that is intended to
preclude flow between the injection device and the patient.
[0009] As used herein, the phrase "detachably interconnected"
describes a relationship between components or entities where the
components or entities are interconnected yet retain the ability to
be detached or disconnected from each other where, after being
detached or disconnected, at least one of the components or
entities remains in condition for re-use. For example, "a
multi-patient tubing set being detachably interconnected with a
patient-specific tubing set" describes a condition where the
multi-patient tubing set is currently interconnected with the
patient-specific tubing in a manner that allows for the
multi-patient tubing set to be detached or disconnected from the
patient-specific tubing set. Furthermore, after being disconnected,
at least one of the multi-patient tubing set and the
patient-specific tubing set retains the ability to be
interconnected (e.g., detachably) with another component (e.g.,
such that the same multi-patient tubing set may be interconnected
at one time with one patient-specific tubing set, and after being
disconnected therefrom, may be interconnected with another
patient-specific tubing set).
[0010] A first aspect of the present invention is embodied by a
medical fluid injection system that uses an injection device, a
multi-patient tubing set, and a patient-specific tubing set. The
multi-patient tubing set is disposed between the patient-specific
tubing set and the injection device (e.g., by a detachable
interconnection between the multi-patient tubing set and the
patient-specific tubing set). The patient-specific tubing set
includes at least one valve, along with a use indicator that is
movable from a first position to a second position in response to a
flow through the patient-specific tubing set.
[0011] A second aspect of the present invention is embodied by a
medical fluid injection system that uses an injection device, a
multi-patient tubing set, and a patient-specific tubing set. The
multi-patient tubing set is disposed between the patient-specific
tubing set and the injection device (e.g., by a detachable
interconnection between the multi-patient tubing set and the
patient-specific tubing set). The patient-specific tubing set
includes at least one valve, along with a use indicator. The use
indicator includes a housing and a piston that is movably disposed
within the housing, where the piston interfaces with a flowpath
through the housing.
[0012] A number of feature refinements and additional features are
separately applicable to each of the first and second aspects of
the present invention. These feature refinements and additional
features may be used individually or in any combination. As such,
each of the following features that will be discussed may be, but
are not required to be, used with any other feature or combination
of features of the first and second aspects. The following
discussion is separately applicable to each of the first and second
aspects, up to the start of the discussion of a third aspect of the
present invention.
[0013] Any appropriate valve may be utilized by the
patient-specific tubing set, for instance a check valve. First and
second valves (e.g., dual check valves) may be disposed along a
flowpath through the patient-specific tubing set. One or more
valves may be utilized by the patient-specific tubing set to reduce
the potential that contaminants of any type will be able to proceed
beyond such valves and reach the multi-patient tubing set and/or
the injection device. Contamination of the multi-patient tubing set
and/or the injection device could affect the ability of the same to
be used for subsequent injections without first sterilizing the
same (e.g., for different patients).
[0014] Having the use indicator in its second position may be for
purposes of providing a visual indication that the patient-specific
tubing set has been used (e.g., such that it should be discarded;
such that it should not be re-used without first being sterilized).
The use indicator may be locked after being moved into its second
position. The use indicator may be in a protruded configuration in
its second position, and as such the use indicator may be
characterized as a pop-up or pop-out indicator.
[0015] The use indicator may include a housing and a piston that is
movably disposed within the housing, where the piston interfaces
with a flowpath through the housing. As such, fluid within the
flowpath may contact the piston, and the pressure of the fluid
within the flowpath may exert a force on the piston. The piston may
move axially from a first position to a second position, may move
along a path that is orthogonal to a flow through the housing, or
both when the piston is exposed to a certain fluid pressure within
the flowpath through the housing. At least part of the piston may
protrude or extend beyond the housing when the piston is in its
second position. The piston may be characterized as being directed
into an open space when moving from its first position to its
second position (e.g., such that the piston interfaces with this
open space--or such that the piston does not come into physical
contact with another structure (a structure in addition to the use
indicator) by moving from its first position to its second
position). One or more detents or the like may be incorporated into
the housing to lock or restrain the piston after having moved to
its second position. In one embodiment, a fluid pressure of at
least 15 psi is required to move the piston from its first position
to its second position.
[0016] The injection device may be of any appropriate type, for
instance a power injector. The system may include other components.
In one embodiment, the system includes a fluid source that may be
used to "re-load" the injection device (e.g., for providing an
injection to another patient, after switching out the prior
patient-specific tubing set for a new patient-specific tubing
set).
[0017] A third aspect of the present invention is embodied by a
method of using a medical fluid injection system. A first
patient-specific tubing set is interconnected with a multi-patient
tubing set. Fluid is directed through the multi-patient tubing set,
and then through the first patient-specific tubing set. Any
backflow through the first patient-specific tubing set is exposed
to a blocking action, and thereby is not intended to be able to
reach the multi-patient tubing set (e.g., such that the
multi-patient tubing set should not become contaminated so that it
may be re-used on a different patient). The first patient-specific
tubing set may include a first use indicator, and a single response
in the form of a physical change is induced when the first use
indicator is exposed to at least a certain condition.
[0018] A number of feature refinements and additional features are
applicable to the third aspect of the present invention. These
feature refinements and additional features may be used
individually or in any combination. As such, each of the following
features that will be discussed may be, but are not required to be,
used with any other feature or combination of features of the third
aspect. The following discussion is applicable at least to the
third aspect of the present invention.
[0019] The "physical change" of the first use indicator may be of
any appropriate type. Representative physical changes may be a
change in size of the overall first use indicator, a change in
shape of the overall first use indicator, or both. For instance and
for the case where the first use indicator is in the form of a
piston movably disposed relative to a housing, the physical change
may result from a movement of the piston relative to the housing
(e.g., to a protruding or "more protruding" position relative to
the housing). Even though the piston may not deform to provide this
movement, the overall shape of the first use indicator may still be
properly characterized as having changed when the piston moves to a
protruding/more protruded position relative to the housing.
[0020] The single induced response of the first use indicator may
be a movement of a first indicator element from a first position to
a second position. The first indicator element may be retained
after having been moved into its second position. The movement of
the first indicator element is subject to a number of
characterizations. One is that this movement may be initiated
without any deformation of the first indicator element--the first
indicator element itself need not experience a change in size
and/or shape in moving from the first position to the second
position in this characterization. Another is that this movement
may entail moving the first indicator element into a visibly
observable position (e.g., a protruding position). Yet another is
that this movement may entail moving the first indicator element
into an open space. In one embodiment, the first indicator element
is in the form of a piston.
[0021] The first patient-specific tubing set may be disconnected
from the multi-patient tubing set (e.g., after completion of an
injection protocol in relation to a first patient, where fluid is
injected into the first patient), and a second patient-specific
tubing set may be connected with the multi-patient tubing set. The
various steps associated with the first patient-specific tubing set
may be repeated for this second patient-specific tubing set (e.g.,
an injection protocol may be executed in relation to a second
patient, where fluid is injected into the second patient). The
fluid directed through each of the first and second
patient-specific tubing sets may be acquired from a common fluid
source.
[0022] A number of feature refinements and additional features are
separately applicable to each of above-noted first, second, and
third aspects of the present invention. These feature refinements
and additional features may be used individually or in any
combination in relation to each of the above-noted first, second,
and third aspects of the present invention. Any feature of any
other various aspects of the present invention that is intended to
be limited to a "singular" context or the like will be clearly set
forth herein by terms such as "only," "single," "limited to," or
the like. Merely introducing a feature in accordance with commonly
accepted antecedent basis practice does not limit the corresponding
feature to the singular (e.g., indicating that a power injector
includes "a syringe" alone does not mean that the power injector
includes only a single syringe). Moreover, any failure to use
phrases such as "at least one" also does not limit the
corresponding feature to the singular (e.g., indicating that a
power injector includes "a syringe" alone does not mean that the
power injector includes only a single syringe). Use of the phrase
"at least generally" or the like in relation to a particular
feature encompasses the corresponding characteristic and
insubstantial variations thereof (e.g., indicating that a syringe
barrel is at least generally cylindrical encompasses the syringe
barrel being cylindrical). Finally, use of the phrase "in one
embodiment" in relation to one or more features does not limit the
use of the associated feature(s) to a single embodiment.
[0023] An injection device may be used to deliver fluid using the
multi-use fluid set and at least one patient-specific fluid set. In
one embodiment, the injection device is a power injector. Any power
injector that may be utilized to provide a fluid discharge may be
of any appropriate size, shape, configuration, and/or type. Any
such power injector may utilize one or more syringe plunger drivers
of any appropriate size, shape, configuration, and/or type, where
each such syringe plunger driver is capable of at least
bi-directional movement (e.g., a movement in a first direction for
discharging fluid; a movement in a second direction for
accommodating a loading of fluid or so as to return to a position
for a subsequent fluid discharge operation), and where each such
syringe plunger driver may interact with its corresponding syringe
plunger in any appropriate manner (e.g., by mechanical contact; by
an appropriate coupling (mechanical or otherwise)) so as to be able
to advance the syringe plunger in at least one direction (e.g., to
discharge fluid). Each syringe plunger driver may utilize one or
more drive sources of any appropriate size, shape, configuration,
and/or type. Multiple drive source outputs may be combined in any
appropriate manner to advance a single syringe plunger at a given
time. One or more drive sources may be dedicated to a single
syringe plunger driver, one or more drive sources may be associated
with multiple syringe plunger drivers (e.g., incorporating a
transmission of sorts to change the output from one syringe plunger
to another syringe plunger), or a combination thereof.
Representative drive source forms include a brushed or brushless
electric motor, a hydraulic motor, a pneumatic motor, a
piezoelectric motor, or a stepper motor.
[0024] Any such power injector may be used for any appropriate
application where the delivery of one or more medical fluids is
desired, including without limitation any appropriate medical
application (e.g., computed tomography or CT imaging; magnetic
resonance imaging or MRI; single photon emission computed
tomography or SPECT imaging; positron emission tomography or PET
imaging; X-ray imaging; angiographic imaging; optical imaging;
ultrasound imaging). Any such power injector may be used in
conjunction with any component or combination of components, such
as an appropriate imaging system (e.g., a CT scanner). For
instance, information could be conveyed between any such power
injector and one or more other components (e.g., scan delay
information, injection start signal, injection rate).
[0025] Any appropriate number of syringes may be utilized with any
such power injector in any appropriate manner (e.g., detachably;
front-loaded; rear-loaded; side-loaded), any appropriate medical
fluid may be discharged from a given syringe of any such power
injector (e.g., contrast media, a radiopharmaceutical, saline, and
any combination thereof), and any appropriate fluid may be
discharged from a multiple syringe power injector configuration in
any appropriate manner (e.g., sequentially, simultaneously), or any
combination thereof. In one embodiment, fluid discharged from a
syringe by operation of the power injector is directed into a
conduit (e.g., medical tubing set), where this conduit is fluidly
interconnected with the syringe in any appropriate manner and
directs fluid to a desired location (e.g., to a catheter that is
inserted into a patient, for instance for injection). Multiple
syringes may discharge into a common conduit (e.g., for provision
to a single injection site), or one syringe may discharge into one
conduit (e.g., for provision to one injection site), while another
syringe may discharge into a different conduit (e.g., for provision
to a different injection site). In one embodiment, each syringe
includes a syringe barrel and a plunger that is disposed within and
movable relative to the syringe barrel. This plunger may interface
with the power injector's syringe plunger drive assembly such that
the syringe plunger drive assembly is able to advance the plunger
in at least one direction, and possibly in two different, opposite
directions.
BRIEF DESCRIPTION OF THE FIGURES
[0026] FIG. 1 is a schematic of one embodiment of a power
injector.
[0027] FIG. 2A is a perspective view of one embodiment of a
portable stand-mounted, dual-head power injector.
[0028] FIG. 2B is an enlarged, partially exploded, perspective view
of a powerhead used by the power injector of FIG. 2A.
[0029] FIG. 2C is a schematic of one embodiment of a syringe
plunger drive assembly used by the power injector of FIG. 2A.
[0030] FIG. 3A is a perspective view of one embodiment of a
multi-dose injection system.
[0031] FIG. 3B is a perspective view of a bulk fluid container
holder module that may be used by the multi-dose injection system
of FIG. 3A.
[0032] FIG. 4A is a perspective view of a multi-use tubing set that
may be used by the multi-dose injection system of FIG. 3A.
[0033] FIG. 4B is a perspective view of a patient-specific tubing
set that may be used by the multi-dose injection system of FIG.
3A.
[0034] FIG. 5A is a perspective top view of a cassette used by the
multi-dose injection system of FIG. 3A.
[0035] FIG. 5B is a perspective bottom view of the cassette of FIG.
5A.
[0036] FIG. 6 is a flowchart of a method of delivering medical
fluid to a plurality of patients from the multi-dose injection
system.
[0037] FIG. 7 is a schematic of another embodiment of a multi-dose
injection system that uses both a multi-patient tubing set and a
patient-specific tubing set.
[0038] FIG. 8 is a schematic of another embodiment of a multi-dose
injection system that uses both a multi-patient tubing set and a
patient-specific tubing set.
[0039] FIG. 9A is a perspective view of one embodiment of a
patient-specific tubing set that may be used by the multi-dose
injection systems of FIGS. 7-8.
[0040] FIG. 9B is a perspective view of the indicator from the
patient-specific tubing set of FIG. 9A and in its "used"
position.
[0041] FIG. 9C is a cross-sectional view of the indicator from the
patient-specific tubing set of FIG. 9A.
DETAILED DESCRIPTION
[0042] FIG. 1 presents a schematic of one embodiment of an
injection device in the form of a power injector 10 having a
powerhead 12. One or more graphical user interfaces or GUIs 11 may
be associated with the powerhead 12. Each GUI 11: 1) may be of any
appropriate size, shape, configuration, and/or type; 2) may be
operatively interconnected with the powerhead 12 in any appropriate
manner; 3) may be disposed at any appropriate location; 4) may be
configured to provide one or any combination of the following
functions: controlling one or more aspects of the operation of the
power injector 10; inputting/editing one or more parameters
associated with the operation of the power injector 10; and
displaying appropriate information (e.g., associated with the
operation of the power injector 10); or 5) any combination of the
foregoing. Any appropriate number of GUIs 11 may be utilized. In
one embodiment, the power injector 10 includes a GUI 11 that is
incorporated by a console that is separate from but which
communicates with the powerhead 12. In another embodiment, the
power injector 10 includes a GUI 11 that is part of the powerhead
12. In yet another embodiment, the power injector 10 utilizes one
GUI 11 on a separate console that communicates with the powerhead
12, and also utilizes another GUI 11 that is on the powerhead 12.
Each GUI 11 could provide the same functionality or set of
functionalities, or the GUIs 11 may differ in at least some respect
in relation to their respective functionalities.
[0043] A syringe 28 may be installed on the powerhead 12 and, when
installed, may be considered to be part of the power injector 10.
Some injection procedures may result in a relatively high pressure
being generated within the syringe 28. In this regard, it may be
desirable to dispose the syringe 28 within a pressure jacket 26.
The pressure jacket 26 is typically associated with the powerhead
12 in a manner that allows the syringe 28 to be disposed therein as
a part of or after installing the syringe 28 on the powerhead 12.
The same pressure jacket 26 will typically remain associated with
the powerhead 12, as various syringes 28 are positioned within and
removed from the pressure jacket 26 for multiple injection
procedures. The power injector 10 may eliminate the pressure jacket
26 if the power injector 10 is configured/utilized for low-pressure
injections and/or if the syringe(s) 28 to be utilized with the
power injector 10 is (are) of sufficient durability to withstand
high-pressure injections without the additional support provided by
a pressure jacket 26. In any case, fluid discharged from the
syringe 28 may be directed into a conduit 38 of any appropriate
size, shape, configuration, and/or type, which may be fluidly
interconnected with the syringe 28 in any appropriate manner, and
which may direct fluid to any appropriate location (e.g., to a
patient).
[0044] The powerhead 12 includes a syringe plunger drive assembly
or syringe plunger driver 14 that interacts (e.g., interfaces) with
the syringe 28 (e.g., a plunger 32 thereof) to discharge fluid from
the syringe 28. This syringe plunger drive assembly 14 includes a
drive source 16 (e.g., a motor of any appropriate size, shape,
configuration, and/or type, optional gearing, and the like) that
powers a drive output 18 (e.g., a rotatable drive screw). A ram 20
may be advanced along an appropriate path (e.g., axial) by the
drive output 18. The ram 20 may include a coupler 22 for
interacting or interfacing with a corresponding portion of the
syringe 28 in a manner that will be discussed below.
[0045] The syringe 28 includes the plunger or piston 32 that is
movably disposed within a syringe barrel 30 (e.g., for axial
reciprocation along an axis coinciding with the double-headed arrow
B). The plunger 32 may include a coupler 34. This syringe plunger
coupler 34 may interact or interface with the ram coupler 22 to
allow the syringe plunger drive assembly 14 to retract the syringe
plunger 32 within the syringe barrel 30. The syringe plunger
coupler 34 may be in the form of a shaft 36a that extends from a
body of the syringe plunger 32, together with a head or button 36b.
However, the syringe plunger coupler 34 may be of any appropriate
size, shape, configuration, and/or type.
[0046] Generally, the syringe plunger drive assembly 14 of the
power injector 10 may interact with the syringe plunger 32 of the
syringe 28 in any appropriate manner (e.g., by mechanical contact;
by an appropriate coupling (mechanical or otherwise)) so as to be
able to move or advance the syringe plunger 32 (relative to the
syringe barrel 30) in at least one direction (e.g., to discharge
fluid from the corresponding syringe 28). That is, although the
syringe plunger drive assembly 14 may be capable of bi-directional
motion (e.g., via operation of the same drive source 16), the power
injector 10 may be configured such that the operation of the
syringe plunger drive assembly 14 actually only moves each syringe
plunger 32 being used by the power injector 10 in only one
direction. However, the syringe plunger drive assembly 14 may be
configured to interact with each syringe plunger 32 being used by
the power injector 10 so as to be able to move each such syringe
plunger 32 in each of two different directions (e.g., in different
directions along a common axial path).
[0047] Retraction of the syringe plunger 32 may be utilized to
accommodate a loading of fluid into the syringe barrel 30 for a
subsequent injection or discharge, may be utilized to actually draw
fluid into the syringe barrel 30 for a subsequent injection or
discharge, or for any other appropriate purpose. Certain
configurations may not require that the syringe plunger drive
assembly 14 be able to retract the syringe plunger 32, in which
case the ram coupler 22 and syringe plunger coupler 34 may not be
desired. In this case, the syringe plunger drive assembly 14 may be
retracted for purposes of executing another fluid delivery
operation (e.g., after another pre-filled syringe 28 has been
installed). Even when a ram coupler 22 and syringe plunger coupler
34 are utilized, these components may or may not be coupled when
the ram 20 advances the syringe plunger 32 to discharge fluid from
the syringe 28 (e.g., the ram 20 may simply "push on" the syringe
plunger coupler 34 or on a proximal end of the syringe plunger 32).
Any single motion or combination of motions in any appropriate
dimension or combination of dimensions may be utilized to dispose
the ram coupler 22 and syringe plunger coupler 34 in a coupled
state or condition, to dispose the ram coupler 22 and syringe
plunger coupler 34 in an un-coupled state or condition, or
both.
[0048] The syringe 28 may be installed on the powerhead 12 in any
appropriate manner. For instance, the syringe 28 could be
configured to be installed directly on the powerhead 12. In the
illustrated embodiment, a housing 24 is appropriately mounted on
the powerhead 12 to provide an interface between the syringe 28 and
the powerhead 12. This housing 24 may be in the form of an adapter
to which one or more configurations of syringes 28 may be
installed, and where at least one configuration for a syringe 28
could be installed directly on the powerhead 12 without using any
such adapter. The housing 24 may also be in the form of a faceplate
to which one or more configurations of syringes 28 may be
installed. In this case, it may be such that a faceplate is
required to install a syringe 28 on the powerhead 12--the syringe
28 could not be installed on the powerhead 12 without the
faceplate. When a pressure jacket 26 is being used, it may be
installed on the powerhead 12 in the various manners discussed
herein in relation to the syringe 28, and the syringe 28 will then
thereafter be installed in the pressure jacket 26.
[0049] The housing 24 may be mounted on and remain in a fixed
position relative to the powerhead 12 when installing a syringe 28.
Another option is to movably interconnect the housing 24 and the
powerhead 12 to accommodate installing a syringe 28. For instance,
the housing 24 may move within a plane that contains the
double-headed arrow A to provide one or more of coupled state or
condition and an un-coupled state or condition between the ram
coupler 22 and the syringe plunger coupler 34.
[0050] One particular power injector configuration is illustrated
in FIG. 2A, is identified by a reference numeral 40, and is at
least generally in accordance with the power injector 10 of FIG. 1.
The power injector 40 includes a powerhead 50 that is mounted on a
portable stand 48. A pair of syringes 86a, 86b for the power
injector 40 are mounted on the powerhead 50. Fluid may be drawn
into and/or discharged from the syringes 86a, 86b during operation
of the power injector 40.
[0051] The portable stand 48 may be of any appropriate size, shape,
configuration, and/or type. Wheels, rollers, casters, or the like
may be utilized to make the stand 48 portable. The powerhead 50
could be maintained in a fixed position relative to the portable
stand 48. However, it may be desirable to allow the position of the
powerhead 50 to be adjustable relative to the portable stand 48 in
at least some manner. For instance, it may be desirable to have the
powerhead 50 in one position relative to the portable stand 48 when
loading or drawing fluid into one or more of the syringes 86a, 86b,
and to have the powerhead 50 in a different position relative to
the portable stand 48 for performance of an injection procedure. In
this regard, the powerhead 50 may be movably interconnected with
the portable stand 48 in any appropriate manner (e.g., such that
the powerhead 50 may be pivoted through at least a certain range of
motion, and thereafter maintained in the desired position).
[0052] It should be appreciated that the powerhead 50 could be
supported in any appropriate manner for providing fluid. For
instance, instead of being mounted on a portable structure, the
powerhead 50 could be interconnected with a support assembly, that
in turn is mounted to an appropriate structure (e.g., ceiling,
wall, floor). Any support assembly for the powerhead 50 may be
positionally adjustable in at least some respect (e.g., by having
one or more support sections that may be repositioned relative to
one or more other support sections), or may be maintained in a
fixed position. Moreover, the powerhead 50 may be integrated with
any such support assembly so as to either be maintained in a fixed
position or so as to be adjustable relative the support
assembly.
[0053] The powerhead 50 includes a graphical user interface or GUI
52. This GUI 52 may be configured to provide one or any combination
of the following functions: controlling one or more aspects of the
operation of the power injector 40; inputting/editing one or more
parameters associated with the operation of the power injector 40;
and displaying appropriate information (e.g., associated with the
operation of the power injector 40). The power injector 40 may also
include a console 42 and powerpack 46 that each may be in
communication with the powerhead 50 in any appropriate manner
(e.g., via one or more cables), that may be placed on a table or
mounted on an electronics rack in an examination room or at any
other appropriate location, or both. The powerpack 46 may include
one or more of the following and in any appropriate combination: a
power supply for the injector 40; interface circuitry for providing
communication between the console 42 and powerhead 50; circuitry
for permitting connection of the power injector 40 to remote units
such as remote consoles, remote hand or foot control switches, or
other original equipment manufacturer (OEM) remote control
connections (e.g., to allow for the operation of power injector 40
to be synchronized with the x-ray exposure of an imaging system);
and any other appropriate componentry. The console 42 may include a
touch screen display 44, which in turn may provide one or more of
the following functions and in any appropriate combination:
allowing an operator to remotely control one or more aspects of the
operation of the power injector 40; allowing an operator to
enter/edit one or more parameters associated with the operation of
the power injector 40; allowing an operator to specify and store
programs for automated operation of the power injector 40 (which
can later be automatically executed by the power injector 40 upon
initiation by the operator); and displaying any appropriate
information relation to the power injector 40 and including any
aspect of its operation.
[0054] Various details regarding the integration of the syringes
86a, 86b with the powerhead 50 are presented in FIG. 2B. Each of
the syringes 86a, 86b includes the same general components. The
syringe 86a includes plunger or piston 90a that is movably disposed
within a syringe barrel 88a. Movement of the plunger 90a along an
axis 100a (FIG. 2A) via operation of the powerhead 50 will
discharge fluid from within the syringe barrel 88a through a nozzle
89a of the syringe 86a. An appropriate conduit (not shown) will
typically be fluidly interconnected with the nozzle 89a in any
appropriate manner to direct fluid to a desired location (e.g., a
patient). Similarly, the syringe 86b includes plunger or piston 90b
that is movably disposed within a syringe barrel 88b. Movement of
the plunger 90b in a first direction along an axis 100b (FIG. 2A)
via operation of the powerhead 50 will discharge fluid from within
the syringe barrel 88b through a nozzle 89b of the syringe 86b.
Movement of the plunger 90b in a direction opposite from the first
direction along axis 100b (FIG. 2A) via operation of the powerhead
50 may, where the powerhead 50 is fluidly interconnected to a
source of fluid, load fluid into the syringe barrel 88b through the
nozzle 89b of the syringe 86b. An appropriate conduit (not shown)
will typically be fluidly interconnected with the nozzle 89b in any
appropriate manner to direct fluid to a desired location (e.g., a
patient) and/or load fluid from a desired location (e.g., a fluid
container).
[0055] The syringe 86a is interconnected with the powerhead 50 via
an intermediate faceplate 102a. This faceplate 102a includes a
cradle 104 that supports at least part of the syringe barrel 88a,
and which may provide/accommodate any additional functionality or
combination of functionalities. A mounting 82a is disposed on and
is fixed relative to the powerhead 50 for interfacing with the
faceplate 102a. A ram coupler 76 of a ram 74 (FIG. 2C), which are
each part of a syringe plunger drive assembly or syringe plunger
driver 56 (FIG. 2C) for the syringe 86a, is positioned in proximity
to the faceplate 102a when mounted on the powerhead 50. Details
regarding the syringe plunger drive assembly 56 will be discussed
in more detail below in relation to FIG. 2C. Generally, the ram
coupler 76 may be coupled with the syringe plunger 90a of the
syringe 86a, and the ram coupler 76 and ram 74 (FIG. 2C) may then
be moved relative to the powerhead 50 to move the syringe plunger
90a along the axis 100a (FIG. 2A). It may be such that the ram
coupler 76 is engaged with, but not actually coupled to, the
syringe plunger 90a when moving the syringe plunger 90a to
discharge fluid through the nozzle 89a of the syringe 86a.
[0056] The faceplate 102a may be moved at least generally within a
plane that is orthogonal to the axes 100a, 100b (associated with
movement of the syringe plungers 90a, 90b, respectively, and
illustrated in FIG. 2A), both to mount the faceplate 102a on and
remove the faceplate 102a from its mounting 82a on the powerhead
50. The faceplate 102a may be used to couple the syringe plunger
90a with its corresponding ram coupler 76 on the powerhead 50. In
this regard, the faceplate 102a includes a pair of handles 106a.
Generally and with the syringe 86a being initially positioned
within the faceplate 102a, the handles 106a may be moved to in turn
move/translate the syringe 86a at least generally within a plane
that is orthogonal to the axes 100a, 100b (associated with movement
of the syringe plungers 90a, 90b, respectively, and illustrated in
FIG. 2A). Moving the handles 106a to one position moves/translates
the syringe 86a (relative to the faceplate 102a) in an at least
generally downward direction to couple its syringe plunger 90a with
its corresponding ram coupler 76. Moving the handles 106a to
another position moves/translates the syringe 86a (relative to the
faceplate 102a) in an at least generally upward direction to
uncouple its syringe plunger 90a from its corresponding ram coupler
76.
[0057] The syringe 86b is interconnected with the powerhead 50 via
an intermediate faceplate 102b. A mounting 82b is disposed on and
is fixed relative to the powerhead 50 for interfacing with the
faceplate 102b. A ram coupler 76 of a ram 74 (FIG. 2C), which are
each part of a syringe plunger drive assembly 56 for the syringe
86b, is positioned in proximity to the faceplate 102b when mounted
to the powerhead 50. Details regarding the syringe plunger drive
assembly 56 again will be discussed in more detail below in
relation to FIG. 2C. Generally, the ram coupler 76 may be coupled
with the syringe plunger 90b of the syringe 86b, and the ram
coupler 76 and ram 74 (FIG. 2C) may be moved relative to the
powerhead 50 to move the syringe plunger 90b along the axis 100b
(FIG. 2A). It may be such that the ram coupler 76 is engaged with,
but not actually coupled to, the syringe plunger 90b when moving
the syringe plunger 90b to discharge fluid through the nozzle 89b
of the syringe 86b.
[0058] The faceplate 102b may be moved at least generally within a
plane that is orthogonal to the axes 100a, 100b (associated with
movement of the syringe plungers 90a, 90b, respectively, and
illustrated in FIG. 2A), both to mount the faceplate 102b on and
remove the faceplate 102b from its mounting 82b on the powerhead
50. The faceplate 102b also may be used to couple the syringe
plunger 90b with its corresponding ram coupler 76 on the powerhead
50. In this regard, the faceplate 102b may include a handle 106b.
Generally and with the syringe 86b being initially positioned
within the faceplate 102b, the syringe 86b may be rotated along its
long axis 100b (FIG. 2A) and relative to the faceplate 102b. This
rotation may be realized by moving the handle 106b, by grasping and
turning the syringe 86b, or both. In any case, this rotation
moves/translates both the syringe 86b and the faceplate 102b at
least generally within a plane that is orthogonal to the axes 100a,
100b (associated with movement of the syringe plungers 90a, 90b,
respectively, and illustrated in FIG. 2A). Rotating the syringe 86b
in one direction moves/translates the syringe 86b and faceplate
102b in an at least generally downward direction to couple the
syringe plunger 90b with its corresponding ram coupler 76. Rotating
the syringe 86b in the opposite direction moves/translates the
syringe 86b and faceplate 102b in an at least generally upward
direction to uncouple its syringe plunger 90b from its
corresponding ram coupler 76.
[0059] As illustrated in FIG. 2B, the syringe plunger 90b includes
a plunger body 92 and a syringe plunger coupler 94. This syringe
plunger coupler 94 includes a shaft 98 that extends from the
plunger body 92, along with a head 96 that is spaced from the
plunger body 92. Each of the ram couplers 76 includes a larger slot
that is positioned behind a smaller slot on the face of the ram
coupler 76. The head 96 of the syringe plunger coupler 94 may be
positioned within the larger slot of the ram coupler 76, and the
shaft 98 of the syringe plunger coupler 94 may extend through the
smaller slot on the face of the ram coupler 76 when the syringe
plunger 90b and its corresponding ram coupler 76 are in a coupled
state or condition. The syringe plunger 90a may include a similar
syringe plunger coupler 94 for interfacing with its corresponding
ram coupler 76.
[0060] The powerhead 50 is utilized to discharge fluid from the
syringes 86a, 86b in the case of the power injector 40. That is,
the powerhead 50 provides the motive force to discharge fluid from
each of the syringes 86a, 86b. One embodiment of what may be
characterized as a syringe plunger drive assembly or syringe
plunger driver is illustrated in FIG. 2C, is identified by
reference numeral 56, and may be utilized by the powerhead 50 to
discharge fluid from each of the syringes 86a, 86b. A separate
syringe plunger drive assembly 56 may be incorporated into the
powerhead 50 for each of the syringes 86a, 86b. In this regard and
referring back to FIGS. 2A-B, the powerhead 50 may include
hand-operated knobs 80a and 80b for use in separately controlling
each of the syringe plunger drive assemblies 56.
[0061] Initially and in relation to the syringe plunger drive
assembly 56 of FIG. 2C, each of its individual components may be of
any appropriate size, shape, configuration and/or type. The syringe
plunger drive assembly 56 includes a motor 58, which has an output
shaft 60. A drive gear 62 is mounted on and rotates with the output
shaft 60 of the motor 58. The drive gear 62 is engaged or is at
least engageable with a driven gear 64. This driven gear 64 is
mounted on and rotates with a drive screw or shaft 66. The axis
about which the drive screw 66 rotates is identified by reference
numeral 68. One or more bearings 72 appropriately support the drive
screw 66.
[0062] A carriage or ram 74 is movably mounted on the drive screw
66. Generally, rotation of the drive screw 66 in one direction
axially advances the ram 74 along the drive screw 66 (and thereby
along axis 68) in the direction of the corresponding syringe 86a/b,
while rotation of the drive screw 66 in the opposite direction
axially advances the ram 74 along the drive screw 66 (and thereby
along axis 68) away from the corresponding syringe 86a/b. In this
regard, the perimeter of at least part of the drive screw 66
includes helical threads 70 that interface with at least part of
the ram 74. The ram 74 is also movably mounted within an
appropriate bushing 78 that does not allow the ram 74 to rotate
during a rotation of the drive screw 66. Therefore, the rotation of
the drive screw 66 provides for an axial movement of the ram 74 in
a direction determined by the rotational direction of the drive
screw 66.
[0063] The ram 74 includes a coupler 76 that that may be detachably
coupled with a syringe plunger coupler 94 of the syringe plunger
90a/b of the corresponding syringe 86a/b. When the ram coupler 76
and syringe plunger coupler 94 are appropriately coupled, the
syringe plunger 90a/b moves along with ram 74. FIG. 2C illustrates
a configuration where the syringe 86a/b may be moved along its
corresponding axis 100a/b without being coupled to the ram 74. When
the syringe 86a/b is moved along its corresponding axis 100a/b such
that the head 96 of its syringe plunger 90a/b is aligned with the
ram coupler 76, but with the axes 68 still in the offset
configuration of FIG. 2C, the syringe 86a/b may be translated
within a plane that is orthogonal to the axis 68 along which the
ram 74 moves. This establishes a coupled engagement between the ram
coupler 76 and the syringe plunger coupler 96 in the above-noted
manner.
[0064] The power injectors 10, 40 of FIGS. 1 and 2A-C each may be
used for any appropriate application, including without limitation
for medical imaging applications where fluid is injected into a
subject (e.g., a patient). Representative medical imaging
applications for the power injectors 10, 40 include without
limitation CT imaging, MRI, SPECT imaging, PET imaging, X-ray
imaging, angiographic imaging, optical imaging, and ultrasound
imaging. The power injectors 10, 40 each could be used alone or in
combination with one or more other components. The power injectors
10, 40 each may be operatively interconnected with one or more
components, for instance so that information may be conveyed
between the power injector 10, 40 and one or more other components
(e.g., scan delay information, injection start signal, injection
rate).
[0065] Any number of syringes may be utilized by each of the power
injectors 10, 40, including without limitation single-head
configurations (for a single syringe) and dual-head configurations
(for two syringes). In the case of a multiple syringe
configuration, each power injector 10, 40 may discharge fluid from
the various syringes in any appropriate manner and according to any
timing sequence (e.g., sequential discharges from two or more
syringes, simultaneous discharges from two or more syringes, or any
combination thereof). Multiple syringes may discharge into a common
conduit (e.g., for provision to a single injection site), or one
syringe may discharge into one conduit (e.g., for provision to one
injection site), while another syringe may discharge into a
different conduit (e.g., for provision to a different injection
site). Each such syringe utilized by each of the power injectors
10, 40 may include any appropriate fluid (e.g., a medical fluid),
for instance contrast media, a radiopharmaceutical, saline, and any
combination thereof. Each such syringe utilized by each of the
power injectors 10, 40 may be installed in any appropriate manner
(e.g., rear-loading configurations may be utilized; front-loading
configurations may be utilized; side-loading configurations may be
utilized).
[0066] FIG. 3A is a perspective view of one embodiment of a
multi-dose injection system 108. The multi-dose injection system
108 may include the power injector 40 (the powerhead 50 of the
power injector 40 is illustrated in FIG. 3A; other portions of the
power injector 40 are not illustrated in FIG. 3A). The multi-dose
injection system 108 may include a multi-use tubing or tube set 110
(described with reference to FIG. 4A) and a patient-specific tubing
or tube set 112 (described with reference to FIG. 4B, and which may
also be characterized as a "per-patient disposable 112").
Furthermore, the multi-dose injection system 108 may include a
cassette 114 (described with reference to FIGS. 5A and 5B) and a
bulk fluid container holder module 116. In the multi-dose injection
system 108, a fluid may be transferred from the bulk fluid
container holder module 116, through the multi-use tubing set 110,
through the patient-specific tubing set 112, and into a patient
(e.g., into the vasculature of the patient through a catheter 260
or the like). The multi-dose injection system 108 may be operable
to transfer and/or mix fluids from one or more bulk containers to
one or more patients. In this regard, the multi-dose injection
system 108 may allow for safe and easy use of bulk containers as
well as multiple uses (e.g., across multiple patients) of a saline
syringe 126, a contrast syringe 127 and the multi-use tubing set
110.
[0067] For use in the multi-dose injection system 108, the syringes
126, 127 may be provided empty. Furthermore, each syringe 126, 127
may be of any appropriate configuration. As shown in FIG. 3A, the
saline syringe 126 (the syringe fluidly interconnected to a saline
bottle 118) may be of the same configuration as the contrast
syringe 127 (the syringe fluidly interconnected to a contrast
bottle 120). Accordingly, generic empty syringes may be supplied
that are operable to be installed in either of the syringe mounting
locations on the powerhead 50 and used as either a saline syringe
126 or a contrast syringe 127.
[0068] The bulk fluid container holder module 116 may be operable
to hold the saline bottle 118 and the contrast bottle 120 for
delivery of saline and/or contrast to a single patient and/or to a
plurality of patients. Such a configuration may be used, for
example, in delivering contrast and saline in connection with an
imaging procedure such as MRI and CT imaging. In other embodiments,
the bulk fluid container holder module 116 may be configured to
hold any appropriate type and number of bulk containers. The number
and/or type of bulk containers may correspond to a particular
medical fluid delivery procedure. Any appropriate fluid may be
contained in each individual bulk container installed on the bulk
fluid container holder module 116.
[0069] The bulk fluid container holder module 116 may be supported
by a support 122. The support 122 may be adjustable such that the
height of the bulk fluid container holder module 116 may be
adjusted. The support 122 may generally be adjusted such that the
bulk fluid container holder module 116 is disposed at a level
higher than the powerhead 50. Such positioning allows flow from the
bulk fluid container holder module 116 to the powerhead 50 to be
assisted by gravity. The support 122 may, for example, be in the
form of a vertical pole. The support 122 may be a stand-alone unit
or it may be attachable to, and supportable by, another component
of the multi-dose injection system 108, such as the portable stand
48 for the powerhead 50.
[0070] The bulk fluid container holder module 116 may include two
container holders: a saline container holder 124 and a contrast
container holder 125. As shown in FIG. 3A, the container holders
124, 125 may correspond to the shapes of the saline bottle 118 and
the contrast bottle 120, respectively. For example, as shown in
FIG. 3A, the container holders 124, 125 may comprise recesses to
accommodate the bottle 118, 120, respectively, and the recesses may
be shaped to correspond to the shapes of the bottles 118, 120. The
container holders 124, 125 may cradle (e.g., support the bottles
118, 120 by contacting them with portions of the container holders
124, 125 that correspond to the shape of portions of the bottles
118, 120) the containers (e.g., saline bottle 118, contrast bottle
120) disposed therein. The saline bottle 118 and the contrast
bottle 120 may, for example, each be 500 milliliter bottles or of
any other appropriate size. The saline bottle 118 and the contrast
bottle 120 may be held such that the openings of the bottles 118,
120 are facing downward. The openings may be fluidly interconnected
to the cassette 114.
[0071] While the multi-dose injection system is generally described
herein employing the bottles 118, 120 as fluid sources, other types
of fluid sources are contemplated. For example, differently shaped
bottles, fluid bags and/or any other appropriate type of fluid
source and/or bulk fluid container may be substituted for one or
both of the bottles 118, 120. In such embodiments, the container
holders 124, 125 may be shaped to correspond to the different
shaped bottles, fluid bags, or other appropriate type of fluid
source and/or bulk fluid container. Such containers may be of any
appropriate configuration, volume and/or shape. Each container
holder 124, 125 may be configured to hold a bulk container in a
predetermined position such that a fluid outlet of the bulk
container is downwardly disposed. Moreover, in systems that include
multiple container holders, each container holder may be
specifically configured for a particular bulk container (e.g., one
or more of the container holders may be configured differently from
one or more other container holders in a particular multi-dose
injection system 108). For example, the saline bottle 118 may be
shaped such that it is inoperable to be installed into the contrast
container holder 125. Furthermore, the container holders 124, 125
may be adjustable to accommodate different types of bulk
containers.
[0072] The bulk fluid container holder module 116 may include
componentry operable to warm one or more bulk containers disposed
therein. Any appropriate means for heating the bulk containers may
be utilized. For example, the bulk fluid container holder module
116 may include one or more resistive elements disposed along one
or more surfaces of the container holders 124, 125 such that heat
generated by the one or more resistive elements may be transferred
to the bulk containers, thus heating the fluid therein. In this
regard, the container holders 124, 125 may cradle (e.g., surfaces
of the container holders 124, 125 may correspond to portions of the
shape of the bottles 118, 120) bottles 118, 120 inserted therein,
resulting in a contact area that may aid the transfer of heat from
the container holders 124, 125 to the bottles 118, 120. The bulk
fluid container holder module 116 may include sensors operable to
sense the temperature of various members such as, for example,
fluid contained within the bulk containers and/or surfaces of the
container holders 124, 125. The temperature to which the bulk
containers may be heated may be adjustable. The bulk fluid
container holder module 116 may, for example, be operable to warm
any one or more of the bulk containers disposed therein to level at
or near body temperature.
[0073] The bulk fluid container holder module 116 may be configured
such that the cassette 114 may be removably and replaceably fixed
to the bulk fluid container holder module 116. For example, the
bulk fluid container holder module 116 may contain features that
allow the cassette 114 to be snapped into the bulk fluid container
holder module 116. It may be such that the cassette 114 can be both
detachably installed on and removed from the bulk fluid container
holder module 116 by hand--without the use of any tools. Other
types of mechanisms, such as screws, spring-loaded pins, magnets,
or any other appropriate mechanism may be used to removably and
replaceably fix the cassette 114 to the bulk fluid container holder
module 116.
[0074] As used herein, the term "detachably installed" describes a
relationship between components where the components are
interconnected yet retain the ability to be detached from each
other where after detaching, at least one of the components remains
in a usable condition.
[0075] The bulk fluid container holder module 116 may include one
or more radio frequency identification (RFID) tag readers capable
of reading RFID tags. The one or more RFID tag readers may be
operable to read a bottle RFID tag 128 disposed on each container
(e.g., both the saline bottle 118 and the contrast bottle 120)
installed in the bulk fluid container holder module 116. The
information read from the bottle RFID tag 128 may be used in a
plurality of different ways including, for example, verification of
correct bulk container, notification of a change of a bulk
container, and tracking of the length of time a bulk container has
been connected to the bulk fluid container holder module 116. The
information read from the bottle RFID tag 128 may include, for
example, lot number, expiration date and/or time, contents,
concentration, and/or fill volume. The information read from the
bottle RFID tag 128 may be forwarded to the power injector 40
and/or other devices interconnected to the multi-dose injector
injection 108. The one or more RFID tag readers may be operable to
distinguish which bottle 118, 120 is in which container holder 124,
125. In this regard, the one or more RFID tag readers may be
operable to detect a misplaced bottle (e.g., the saline bottle 118
placed in the contrast container holder 125).
[0076] The one or more RFID tag readers may be operable to read an
RFID tag disposed on the cassette 114. In this regard, the
multi-dose injection system 108 may be operable to determine when
the cassette 114 has been removed and/or when a new cassette 114
has been installed. The multi-dose injection system 108 may also be
operable to determine when a change of cassette 114 is needed and
may indicate such a situation (e.g., via the GUI 52 and/or via an
audible alert) to an operator (e.g., medical personnel) of the
multi-dose injection system 108.
[0077] Other appropriate methods of bottle 118, 120 and/or cassette
114 identification and information handling, either singularly or
in cooperation, may be employed by the multi-dose injection system
108. For example, machine-readable labels (e.g., barcodes) and/or
human-readable labels may be employed to perform some of the
functions of the RFID tags and readers discussed above.
[0078] The bulk fluid container holder module 116 may include
color-coding and/or other visual indicators to aid the operator in
setting up the multi-dose injection system 108. For example, the
saline bottle 118 may include a purple portion (e.g., on the label,
attached to the bottle) that coincides with a purple portion
disposed within the saline container holder 124 where the saline
bottle 118 is to be installed. In this regard, the operator may
match the saline bottle 118 (that includes the purple portion) to
the saline container holder 124 (that includes the purple portion).
Similarly, the contrast bottle 120 and corresponding contrast
container holder 125 may be color-coded with, for example, yellow
features. Of course, any appropriate colors and/or symbols may be
used as visual indicators to aid the operator in setting up the
multi-dose injection system 108.
[0079] Turning briefly to FIG. 5B, the cassette 114 may include a
saline valve 176 and a contrast valve 178. The bulk fluid container
holder module 116 may include valve actuators 130, 131 (FIG. 3B)
operable to actuate the valves 176, 178 of the cassette 114. Each
valve 176, 178 may be actuatable by rotating a female hexagonal
member associated with the particular valve 176, 178. The valves
176, 178 may be of any appropriate configuration (e.g., stop-cock
type valves) and operable to control the flow of fluid
therethrough. In this regard, the valves 176, 178 may be operable
to be continuously adjustable from a fully closed position to a
fully opened position.
[0080] The bulk fluid container holder module 116 and/or the
cassette 114 may include features that enable the multi-dose
injection system 108 to determine the positions of the valves 176,
178 after the cassette 114 has been installed onto the bulk fluid
container holder module 116. For example, the valves 176, 178 may
feature hard stops that prevent the female hexagonal members from
freely rotating through 360 degrees. Accordingly, the valve
actuators 130, 131 may drive the valves 176, 178 until the valves
176, 178 bump up against the hard stops, at which time the
positions of the valves 176, 178 would be known. In another
example, the cassette 114 may include switches (and associated
electrical connections) that may be actuated when the valves 176,
178 are in a particular position (e.g., open or closed) and the
multi-dose injection system 108 may be able to read the actuated
switches to determine the position of the valves 176, 178. In still
another example, the valves 176, 178 may include indicators (e.g.,
visual, magnetic) as to their position and the bulk fluid container
holder module 116 may include sensors operable to determine the
position of the valves 176, 178 based on sensing the
indicators.
[0081] FIG. 3B is a perspective view of the bulk fluid container
holder module 116 with the cassette 114, saline bottle 118 and
contrast bottle 120 removed. The saline valve actuator 130 and the
contrast valve actuator 131 of the bulk fluid container holder
module 116 may comprise hexagonal male protrusions operable to
interface with the corresponding female hexagonal members of the
corresponding valves 176, 178. The valve actuators 130, 131 may
each include a motor or any other appropriate mechanism to rotate
the hexagonal male protrusions to adjust the valves 176, 178.
Although shown in FIGS. 5B and 3B as hexagonally keyed, any
appropriate method of mechanically interfacing the valve actuators
130, 131 of the bulk fluid container holder module 116 with the
valves 176, 178 of the cassette 114 may be incorporated into the
multi-dose injection system 108. Furthermore, any other appropriate
method of actuation of the valves 176, 178 of the cassette 114 may
be utilized.
[0082] Returning to FIG. 3A, the bulk fluid container holder module
116 may include one or more sensors operable to detect a fluid
level within the saline bottle 118 and/or contrast bottle 120. For
example, optical sensors may be disposed close to the opening of
the saline bottle 118 and/or contrast bottle 120 to detect when the
saline bottle 118 and/or contrast bottle 120 is empty or close to
empty. Any appropriate type of sensor or sensors disposed in any
appropriate location or locations may be utilized by the bulk fluid
container holder module 116. The sensors may be disposed to
generally detect fluid volume levels within the attached saline
bottle 118 and/or contrast bottle 120, or the sensors may be
disposed to detect when the volume within saline bottle 118 and/or
contrast bottle 120 reaches a certain level (e.g., close to
empty).
[0083] The bulk fluid container holder module 116 may be operable
to communicate with other portions of the multi-dose injection
system 108. In this regard, the various features of the bulk fluid
container holder module 116 discussed herein may be controlled by
and/or directed by components located in other portions of the
multi-dose injection system 108 (e.g., the powerhead 50 and/or GUI
52 of the power injector 40). For example, actuation of the valve
actuators 130, 131 may be controlled by, and synchronized with, the
powerhead 50. The bottle heaters of the bulk fluid container holder
module 116 may be controlled by the powerhead 50 (e.g., a user may
turn on and off the bottle warmer(s) and set the set temperature of
the bottle warmer(s) from the GUI 52). Moreover, the bulk fluid
container holder module 116 may communicate RFID tag information
obtained from the bottles 118, 120 and/or cassette 114 installed
into the bulk fluid container holder module 116 to the powerhead 50
or other appropriate component of the multi-dose injection system
108. The bulk fluid container holder module 116 may communicate
fluid level information (e.g., obtained from the sensors discussed
above). The communications between the bulk fluid container holder
module 116 and other components of the multi-dose injection system
108 may be via any appropriate method or technology, including a
direct electrical connection (e.g., wired) or a wireless
connection.
[0084] The illustrated bulk fluid container holder module 116 and
accompanying discussion related to the bulk fluid container holder
module 116 describe container holders 124, 125 designated for the
saline bottle 118 and a contrast bottle 120. However, the bulk
fluid container holder module 116 may be configured to hold any
appropriate number of containers for a particular application or
procedure. For example, an embodiment of a multi-dose injection
system 108 may include a single container holder for procedures
where only a single fluid source is needed. For a further example,
an embodiment of a multi-dose injection system 108 may include
three or more container holders for procedures where three or more
different fluid sources may be required. In still a further
example, an embodiment of a multi-dose injection system 108 may
include three or more container holders where some of the container
holders hold separate bulk containers containing the same type of
fluid. Such a system may be used to aid in bulk container
replacement and/or to be operable to continue to deliver fluids
when one of the bulk containers becomes empty or close to
empty.
[0085] The bulk fluid container holder module 116 in conjunction
with the powerhead 50 may be operable to transfer fluids from
either bottle 118, bottle 120, or from both bottle 118 and bottle
120. Such transfers may be done sequentially or simultaneously. For
example, a particular patient may only receive contrast during a
particular procedure, in which case contrast from the contrast
bottle 120 would be loaded into the contrast syringe 127 installed
on the powerhead 50. In another example, a patient may first
receive a dose of saline, followed by a dose of contrast (or vice
versa), in which case contrast from the contrast bottle 120 would
be loaded into the contrast syringe 127 installed on the powerhead
50 and saline from the saline bottle 118 would be loaded into the
saline syringe 126 installed on the powerhead 50. In another
example, a patient may receive a dose of saline and simultaneously
receive a dose of contrast, in which case contrast from the
contrast bottle 120 could be loaded into the contrast syringe 127
installed on the powerhead 50 and saline from the saline bottle 118
could be loaded into the saline syringe 126 installed on the
powerhead 50. The two fluids may mix together in the multi-use
tubing set 110, effectively delivering a diluted dose of contrast
to the patient.
[0086] FIG. 4A is a perspective view of the multi-use tubing set
110 and FIG. 4B is a perspective view of the patient-specific
tubing set 112. The multi-use tubing set 110, as illustrated in
FIG. 4A, may be permanently interconnected to the cassette 114. In
this regard, the multi-use tubing set 110 and the cassette 114 may
be packaged together and replaced as a single unit. Alternatively,
the cassette 114 and the multi-use tubing set 110 may be separate
items that may be interconnected to each other (e.g., using Luer
connectors, barbs).
[0087] Fluidly interconnected to the cassette 114 are two fluid
tubes: a saline tube 132 and a contrast tube 134. The tubes 132,
134 may be of any appropriate construction for directing the flow
of fluid between various locations. The tubes 132, 134 may fluidly
interconnect the cassette 114 with the corresponding nozzles of the
syringes 126, 127 on the powerhead 50. In this regard, the saline
tube 132 may be fluidly interconnected to a saline connector 142.
The saline connector 142 may be in the form of a Luer type
connector operable to directly connect to the nozzle of the saline
syringe 126 on the powerhead 50. The contrast tube 134 may be
fluidly interconnected to a contrast connector 144. The contrast
connector 144 may be in the form of a Luer type connector operable
to directly connect to the nozzle of the contrast syringe 127 on
the powerhead 50. For the connections between the saline tube 132
and the contrast tube 134 and their corresponding nozzle, any
appropriate fluid connector may be substituted for the Luer
connectors described herein.
[0088] The saline tube 132 may be interconnected to the saline
connector 142 via a saline Y connector 138 (or any other
appropriate connector), or the saline connector 142 may simply be
associated with a short extension tube that leads into the saline
tube 132. The saline Y connector 138 may also be fluidly
interconnected to a saline and contrast tubes Y connector 150.
Positioned between the saline Y connector 138 and the saline and
contrast tubes Y connector 150 may be a saline tube one-way check
valve 146. The saline tube one-way check valve 146 may be operable
to only permit fluid flow in the direction from the saline Y
connector 138 to the saline and contrast tubes Y connector 150. The
saline tube one-way check valve 146 may require a pressure equal to
or greater than a cracking pressure (e.g., the minimum upstream
pressure at which the saline tube one-way check valve 146 will
operate) to be present upstream of the saline tube one-way check
valve 146 before the saline tube one-way check valve 146 will open
and allow fluid to flow. Similarly, the contrast tube 134 may be
interconnected to the contrast connector 144 via a contrast Y
connector 140 (or any other appropriate connector), or the contrast
connector 144 may simply be associated with a short extension tube
that leads into the contrast tube 134. The contrast Y connector 140
may also be fluidly interconnected to the saline and contrast tubes
Y connector 150. Positioned between the contrast Y connector 140
and the saline and contrast tubes Y connector 150 may be a contrast
tube one-way check valve 148. The contrast tube one-way check valve
148 may be configured similarly to the saline tube one-way check
valve 146 and may be operable to only permit fluid flow in the
direction from the contrast Y connector 140 to the saline and
contrast tubes Y connector 150. Together the saline tube one-way
check valve 146 and contrast tube one-way check valve 148 permit
fluid to flow from the saline syringe 126 and contrast syringe 127
of the powerhead 50 to the patient, while at least attempting to
prevent backflow in the opposite direction.
[0089] As illustrated in FIG. 4A, the saline tube 132 and the
contrast tube 134 may be joined together (although not fluidly
joined together) in a joined tube section 136. Such an arrangement
helps to reduce tangling of tubes such as may occur if the saline
tube 132 and the contrast tube 134 were completely separate from
each other. The saline tube 132 and the Contrast tube 134 may be of
any appropriate length. For example, the tubes 132, 134 may be of a
length such that the cassette 114, attached to the bulk fluid
container holder module 116, may be positioned above the powerhead
50 such that gravity may aid in the flow of saline and contrast
from the bulk fluid container holder module 116 down to the
powerhead 50.
[0090] The saline tube 132 may be configured with an internal
diameter appropriate for the viscosity of saline and the flow rate
and pressure expected therein during medical fluid delivery
procedures. Furthermore, the saline tube 132 wall thickness and
material of the saline tube 132 may be selected, inter alia, based
on expected pressures during fluid delivery procedures. Similarly,
the contrast tube 134 may be configured with an internal diameter
appropriate for the viscosity of the contrast to be used and the
flow rate and pressure expected therein during medical fluid
delivery procedures. The contrast tube 134 wall thickness and
material of the contrast tubes 134 may be selected, inter alia,
based on expected pressures during fluid delivery procedures.
[0091] The saline connector 142 and the contrast connector 144 may
be color-coded or otherwise marked to aid in the setting up of the
multi-dose injection system 108. For example, continuing the color
scheme discussed above with respect to the marking of the saline
bottle 118, the saline connector 142 may be color-coded purple.
Furthermore the nozzle and/or other portion of the saline syringe
126 on the powerhead 50 may also be color-coded purple. Along these
same lines, the contrast connector 144 and the corresponding nozzle
and/or other portion of the contrast syringe 127 on the powerhead
50 may be color-coded yellow. Furthermore, the saline connector 142
and the contrast connector 144 may be uniquely configured (e.g.,
uniquely keyed, uniquely sized) such that each of the connectors
142, 144 is only operable to be attached to its corresponding
nozzle from the corresponding syringe 126, 127.
[0092] Interconnected to the saline and contrast tubes Y connector
150 may be an extension tube 152. The extension tube 152 may be
coiled to aid in the handling of the extension tube 152 and to
reduce tangling. The extension tube 152 may be of any appropriate
length. For example, the extension tube 152 may be of a length to
accommodate the typical distance between the powerhead 50 and the
patient-specific tubing set 112 that may be seen before, during,
and after an imaging procedure utilizing the multi-dose injection
system 108.
[0093] At the end of the extension tube 152 opposite from the
saline and contrast tubes Y connector 150 may be a needle-free
swabable female Luer connector 154. Catheters, such as catheter 260
(FIG. 3A), inserted into a patient typically have a female Luer
connector (e.g., catheter interface female Luer 262). By having a
female Luer connector 154 at the end of the extension tube 152,
accidental attachment of the female Luer 154 directly to a catheter
installed in a patient should be prevented (e.g., due to the
inability of the catheter interface female Luer 262, connected to
the catheter 260, to directly connect to the female Luer connector
154 at the end of the extension tube 152). Thus, the chances of
contaminating the multi-use tubing set 110 with patient fluids
should be reduced. In this regard, a unique tubing set with male
Luer connectors on each end, such as the patient-specific tubing
set 112 described below, is required to interconnect the extension
tube 152 to the catheter interface female Luer 262. Furthermore,
the female Luer connector 154 is swabable and therefore may be
cleaned before being fluidly interconnected to a new
patient-specific tubing set 112.
[0094] As noted, and referring now to FIG. 4B, the patient-specific
tubing set 112 may include two male luer connections: a male Luer
156 operable to interconnect to the female Luer 154 (from the
multi-use tubing set 110) and a patient interface male Luer 162
operable to interconnect to, for example, the catheter interface
female Luer 262 and the catheter 260 (FIG. 3A) inserted into the
patient. The patient-specific tubing set 112 may include an
alternate access port such as access Luer 158. The access Luer 158
may be used, for example, to check the patency of the catheter 260
inserted into the patient and connected via the patient interface
male Luer 162. The access Luer 158 may be used to, for example,
deliver alternate fluids (e.g., alternate to the saline or
contrast) to the patient. The access Luer 158 may be used for any
other appropriate procedure and/or fluid delivery. Any other
appropriate type of fluid access device may be added to or
substituted for the access Luer 158.
[0095] The patient-specific tubing set 112 may also include dual
one-way check valves 160. The dual one-way check valves 160 may
prevent fluid flow in a direction from the patient interface male
Luer 162 toward the male Luer 156. In this regard, the dual one-way
check valves 160 may reduce the potential for contamination of the
multi-use tubing set 110 with fluids from the patient. This then
should enable the use of the multi-use tubing set 110 to supply
fluid to several patients by reducing the potential of fluid from a
particular patient mixing with fluids from another patient. The
dual one-way check valves 160 may comprise two serially-disposed
individual one-way check valves. Such an arrangement provides a
level of redundancy in that if one of the one-way check valves
fails, the other one-way check valve may remain functional and
reduce the potential of backflow of fluids from the patient into
the multi-use tubing set 110.
[0096] The dual one-way check valves 160 of the patient-specific
tubing set 112 are positioned downstream (e.g., relative to the
normal flow of fluids through the patient-specific tubing set 112)
of a Y connector 164. In alternate configurations, the dual one-way
check valves 160 may be disposed upstream of the Y connector 164
between the Y connector 164 and the male Luer 156. In another
arrangement, one one-way valve of the dual one-way check valves 160
may be disposed on each side of the Y connector 164. Any other
appropriate configuration of the one-way check valves of the dual
one-way check valves 160 may be utilized in the patient-specific
tubing set 112.
[0097] Returning briefly to FIG. 3A, the patient-specific tubing
set 112 may be fluidly interconnected to the catheter 260 that may
be inserted into the patient. In this regard, the catheter
interface female Luer 262 may be operable to fluidly connect to the
patient interface male Luer 162. The catheter 260 may include a
fluid outlet port 261 through which fluid from the multi-dose
injection system 108 may flow into the vasculature of a patient and
thereafter mix with fluids of the patient.
[0098] FIG. 5A is a perspective top view of the cassette 114 used
by the multi-dose injection system 108. FIG. 5B is a perspective
bottom view of the cassette 114 of FIG. 5A. The cassette 114 may be
selectively securable to the bulk fluid container holder module
116. The cassette 114 may include features that correspond to
features on the bulk fluid container holder module 116 so that the
cassette 114 may be secured to the bulk fluid container holder
module 116. For example, the cassette 114 may snap into the bulk
fluid container holder module 116. Clips, screws or the like may be
used to secure the cassette 114. Any other appropriate means of
selectively securing the cassette 114 to the bulk fluid container
holder module 116 may be employed.
[0099] The cassette 114 may include an identification feature such
as a cassette RFID tag 174. The bulk fluid container holder module
116 may include an RFID tag reader (not shown) operable to read the
RFID tag 174 attached to the cassette 114. In this regard, the bulk
fluid container holder module 116 may be operable to determine
information regarding the cassette 114. Such information may
include, for example, cassette 114 part number, cassette 114 serial
number, and cassette 114 configuration information. Such
information may be communicated to other components of the
multi-dose injection system 108. Such information may, for example,
be used for operational, validation, or recordation purposes.
Furthermore, using the cassette RFID tag 174 to track the presence
of the cassette 114 attached to the bulk fluid container holder
module 116 and tracking the flow of fluid from the bulk fluid
containers interconnected to the cassette 114, a usage history of
the cassette 114 may be developed. Such a usage history may be used
to determine, for example, when to replace the cassette 114 (and
optionally also the multi-use tubing set 110 connected to the
cassette 114) and/or when to replace the saline bottle 118 and/or
contrast bottle 120. Moreover, the RFID tag reader may be operable
to detect when a particular cassette 114 is removed and/or replaced
with a different cassette 114.
[0100] The cassette RFID tag 174 may be disposed in any appropriate
location on the cassette 114. The RFID tag reader may be disposed
in any appropriate location on the bulk fluid container holder
module 116 or on any other appropriate component of the multi-dose
injection system 108.
[0101] As illustrated, the cassette 114 includes two bulk fluid
container fluid interfaces in the form of a saline spike 170 and a
contrast spike 172. The spikes 170, 172 may be vented to allow air
to flow into the bottles 118, 120 as fluid flows out of the bottles
118, 120. Where appropriate, for example where the bulk fluid
containers are collapsible, the spikes 170,172 may not include
vents. The cassette 114 may include an appropriate number of bulk
fluid container fluid interfaces. The spikes 170, 172 may be
fixedly secured to the cassette 114 and disposed such that they are
pointing upward from the cassette 114 when the cassette 114 is
secured to the bulk fluid container holder module 116. In this
regard, fluid containers such as the saline bottle 118 (FIG. 3A)
may be fluidly interconnected to the cassette 114 by pressing
and/or lowering the saline bottle 118 onto the saline spike 170.
The fluid interconnection may be achieved by the saline spike 170
piercing a septum or other pierceable barrier of the saline bottle
118 as the saline bottle 118 is lowered onto the saline spike 170.
The saline bottle 118 may be removed from the cassette 114 by
pulling upward on the saline bottle 118. Additionally, when fluidly
interconnected to the saline spike 170, additional securement
features, such as clips, twist locks, snaps, or any other
appropriate securement device or devices, may be used to further
secure the saline bottle 118 onto the saline spike 170. The
contrast bottle 120 may be secured to the contrast spike 172 in a
similar manner.
[0102] The saline spike 170 may be fluidly interconnected to the
saline valve 176 that is in turn fluidly interconnected to the
saline tube 132. The saline valve 176 may be a stop-cock type valve
operable to vary between a fully open (e.g., no restriction to
fluid flow between the saline spike 170 and the saline tube 132)
and a fully closed (e.g., no flow between the saline spike 170 and
the saline tube 132) position. The saline valve 176 may also be
operable to be positioned in intermediate positions allowing
partial fluid flow therethrough. The saline valve 176 may be
disposed within a housing 115 of the cassette 114. The housing 115
may also contain a portion of the saline spike 170 and fluid
passages fluidly interconnecting the saline tube 132 to the saline
valve 176 and the saline spike 170 to the saline valve 176. The
contrast spike 172 and the contrast tube 134 may be fluidly
interconnected to a similarly configured contrast valve 178. The
contrast valve 178 may be configured similarly to the saline valve
176.
[0103] The cassette 114 may include saline indicia 180 to assist
the user in determining the proper location for installation of the
saline bottle 118. The saline indicia 180 may be in the form of a
symbol, such as the letter S. Furthermore, the saline indicia 180
may be color-coded purple (or any other appropriate color). The
cassette 114 may include contrast indicia 182, such as the letter
C. The contrast indicia 182 may be color-coded yellow (or any other
appropriate color).
[0104] Valve 176, 178 operation will be now be described in the
exemplary configuration where the contrast valve 178 is fluidly
interconnected to the contrast syringe 127 on the powerhead 50. It
will be appreciated that the flow of saline may be controlled in a
similar manner and that a particular fluid source (e.g., saline
bottle 118, contrast bottle 120) may be fluidly interconnected to
any appropriate syringe 126, 127 on the powerhead 50. The contrast
valve 178 may be used in conjunction with the movement of the
contrast syringe 127 on the powerhead 50 to achieve the transfer of
contrast from the contrast bottle 120 through the cassette 114, the
multi-use tubing set 110, the patient-specific tubing set 112 and
into the patient. To achieve such a flow, the contrast valve 178
may be disposed in an open position during the retraction of a
plunger of the contrast syringe 127. During such retraction, a
vacuum force may be generated in the contrast syringe 127 and
communicated to the attached contrast tube 134, thereby loading
fluid from the contrast bottle 120 into the contrast syringe 127.
The contrast tube one-way check valve 148 may prevent fluid from
portions of the multi-use tubing set 110 downstream of the contrast
tube one-way check valve 148 from flowing into the contrast syringe
127. Once a satisfactory amount of fluid has been loaded into the
contrast syringe 127, the contrast valve 178 may be closed and the
plunger of the contrast syringe 127 may be advanced. The closed
contrast valve 178 may prevent contrast from flowing back into the
contrast bottle 120. Meanwhile, the contrast tube one-way check
valve 148 may permit flow therethrough from the contrast syringe
127 into the extension tube 152, the patient-specific tubing set
112 and into the patient. Similar manipulation of the saline valve
176 and the corresponding saline syringe 126 of the powerhead 50
may be operable to facilitate transfer of saline from the saline
bottle 118 into the patient.
[0105] The valves 176, 178 may include features to facilitate their
actuation by the bulk fluid container holder module 116. As
illustrated in FIG. 5B, valves 176, 178 may each include a female
hex. Such female hexes may be operable to interface with
corresponding male hex protrusions (not shown) of the bulk fluid
container holder module 116. The male hex protrusions may engage
with the female hexes on the cassette 114 as the cassette 114 is
inserted into the bulk fluid container holder module 116.
Accordingly, the bulk fluid container holder module 116 may include
members (e.g., motors) operable to drive (e.g., rotate) the male
hex protrusions in order to actuate (e.g., open, close) the valves
176, 178. Such actuation of the valves 176, 178 may be controlled
by a control member (e.g., hardware and/or software) disposed in
any appropriate component or combination of components of the
multi-dose injection system 108. For example, the control member
may be disposed within the powerhead 50. Thus synchronization
between movement of the plungers of the syringes 126, 127 on the
powerhead 50 and the positions of the valves 176, 178 may be
achieved. Any other appropriate means of actuating the valves 176,
178 may be utilized by the multi-dose injection system 108. For
example: protrusions shaped differently than hexes may be used; the
locations of the male and female protrusions may be reversed; other
types of interfaces such as a magnetic interface may be used; or
the cassette 114 may include valve position driving members (e.g.,
motors) and may be controlled through an electronic interface
(e.g., electrical contacts) between the bulk fluid container holder
module 116 and the valves 176, 178.
[0106] FIG. 6 is a flowchart of a method 190 of delivering medical
fluid to a plurality of patients from the multi-dose injection
system 108. The first step 192 in the method 190 may be to
communicatively interconnect the bulk fluid container holder module
116 to an injection device (e.g., powerhead 50) via a
communications link. The communications link may be a hardwired
electrical cable, a wireless connection, or any other appropriate
communications link. The remainder of the present method 190 is
described in the context of delivering saline using the saline
syringe 126 on the powerhead 50 and contrast using the contrast
syringe 127 on the powerhead 50. It will be appreciated that the
syringes 126, 127 may be reversed or that, in other embodiments,
other types of fluids may be delivered.
[0107] The following step 194, may be to attach a new multi-use
tubing set 110 to the bulk fluid container holder module 116 and
the powerhead 50. The multi-use tubing set 110 may be pre-connected
to the cassette 114. This attachment may include inserting the
cassette 114 into a corresponding receiving location in the bulk
fluid container holder module 116. The next portion of the current
step 194 may be to interconnect the saline connector 142 to the
corresponding nozzle of the saline syringe 126 of the powerhead 50.
This may be followed by interconnecting the contrast connector 144
to the nozzle of the contrast syringe 127. The current step 194 may
also include reading the cassette RFID tag 174 with an RFID tag
reader. The multi-dose injection system 108 may verify that the
correct cassette 114 has been installed for the procedure to be
performed by the multi-dose injection system 108. Furthermore, the
current step 194 may include determining the position of the valves
176, 178 by the multi-dose injection system 108 using the
components of the bulk fluid container holder module 116 and/or the
cassette 114 discussed above. The current step 194 may also include
actuating the valves 176, 178 such that they are in a predetermined
configuration (e.g., closed to prevent flow between the bottles
118, 120 and the multi-use tubing set 110).
[0108] This may be followed by the step 196 of fluidly attaching
the saline bottle 118 and the contrast bottle 120 to the cassette
114. The user may be aided in this step 196 by color-coding on the
bottles 118, 120, container holders 124, 125, and/or the cassette
114. For example, the saline bottle 118, the saline container
holder 124, and saline indicia 180 indicator on the cassette 114
may all be color-coded purple to assist the user. Similarly,
contrast-related components may be color-coded yellow. Any other
appropriate color-coding scheme may be used. The attaching of the
bottles 118, 120 may comprise lowering the bottles 118, 120 onto
corresponding spikes 170, 172 of the cassette 114.
[0109] The next step 198 may be to warm the fluids in the bottles
118, 120. This may be accomplished by energizing resistive heating
elements disposed in the container holders 124, 125. The fluids in
the bottles 118, 120 may be heated to a preset temperature (e.g.,
the internal temperature of the patient who is to receive the
fluids). Alternatively, any appropriate method of heating fluid
within the bottles 118, 120 may be used. The bottles 118, 120 may
be heated to any appropriate target temperature. The bottles 118,
120 may each be heated to the same temperature, or each bottle 118,
120 may be heated to a different target temperature.
[0110] The next step, step 200, may include attaching the
patient-specific tubing set 112 to the multi-use tubing set 110.
This may include swabbing (e.g., with an alcohol swab) the swabable
female Luer connector 154 of the multi-use tubing set 110 to clean
and/or sterilize the female Luer connector 154. This may be
followed by interconnecting the swabable female Luer connector 154
to the male Luer 156.
[0111] The next step 202 may be to initialize fluid delivery
components (e.g., the syringes 126, 127, the tubing of the
multi-use tubing set 110, and the patient-specific tubing set 112).
This step 202 may include orienting the powerhead 50 such that it
is pointing upward (e.g., so the nozzles of the syringes 126, 127
are pointing upward). Next the valves 176, 178 may be opened and
the plungers of the syringes 126, 127 retracted to load fluid from
the bottles 118, 120 into the multi-use tubing set 110 and into the
syringes 126, 127. The air within the syringes 126, 127 may
accumulate at the top of the syringes 126, 127. Next, the valves
176, 178 may be closed and the plungers of the syringes 126, 127
extended to force the air and fluid within the syringes 126, 127
past the one-way check valves 146, 148, through the extension tube
152, and through the patient-specific tubing set 112. This process
may be repeated until at least substantially all air has been
expelled from the tubing through the patient interface male Luer
162. The saline tube 132 and the contrast tube 134 may be
individually or simultaneously purged using such a process.
Moreover, the multi-use tubing set 110 could be purged prior to
attaching the patient-specific tubing set 112 (which would
thereafter have to be purged). The multi-use tubing set 110 should
not have to be re-purged until the bottles 118, 120 are replaced,
or until the multi-use tubing set 110 is replaced, although the
patient-specific tubing set 112 should be purged each time it is
replaced.
[0112] The next step 204 may be to connect the patient interface
male Luer 162 of the patient-specific tubing set 112 to a
corresponding female Luer (e.g., catheter interface female Luer
262) interconnected to the catheter 260 that has been inserted into
the patient. The patency of the catheter 260 may then be verified
through the access Luer 158.
[0113] The next step 206 may be to inject fluid from the multi-dose
injection system 108 to the patient through the fluid outlet port
261 of the catheter 260. This may include placing the powerhead 50
in a downward-pointing position. In this regard, any air within the
syringes 126, 127 or any air that enters the syringes 126, 127 may
be trapped within the syringes 126, 127.
[0114] The remainder of step 206 and the method 190 will be
described in the context of injecting contrast into the patient
using the contrast syringe 127 on the powerhead 50. It should be
understood that the procedure for injecting saline may be similar.
Furthermore, either syringe 126, 127 of the powerhead 50 may be
used for the injection of any appropriate fluid.
[0115] Continuing with step 206, the contrast valve 178 may be
opened and the plunger of the contrast syringe 127 may be retracted
to load contrast from the contrast bottle 120 into the contrast
syringe 127. During this step, the contrast tube one-way check
valve 148 should prevent fluid downstream of the contrast tube
one-way check valve 148 from entering the contrast syringe 127.
Next, the contrast valve 178 is closed and the plunger of the
contrast syringe 127 is extended. The closed contrast valve 178
should prevent fluid from flowing into the contrast bottle 120 and
the contrast tube one-way check valve 148 permits flow therethrough
as the pressure in the contrast tube 134 elevates due to the
movement of the plunger of the contrast syringe 127. In this
regard, contrast may flow past the contrast tube one-way check
valve 148, into the extension tube 152, through the patient
specific tubing set 112, through the catheter 260, and into the
patient.
[0116] The sequence of contrast valve 178 opening and closing
coupled with retraction and extension of the plunger of the
contrast syringe 127 may be repeated until the patient has received
a predetermined dose of contrast. Accordingly, the next step 208
may be to inquire/determine if the patient has received the full
desired dose of contrast. If the patient has not received the full
dose, the step 206 of injecting contrast may continue. If the
patient has received the full dose, the next step 210 may be to
stop the injection process. It should be appreciated that an
injection protocol for a particular patient may utilize any
appropriate number of phases, and that each phase may use any
appropriate fluid (e.g., an injection protocol may entail
alternating injections of contrast and saline, may include at least
one injection of contrast and at least one injection of saline, or
the like).
[0117] Once the injection process has been stopped, the next step
212 may be to disconnect the multi-use tubing set 110 from the
patient-specific tubing set 112 by disconnecting the swabable
female Luer connector 154 from the male Luer 156.
[0118] The next step 214 may be to determine if the saline bottle
118 and contrast bottle 120 contain enough fluid for performance of
fluid delivery to a subsequent patient. If it is determined that
the saline bottle 118, the contrast bottle 120, or both need to be
replaced, the next step 215 may be to load any fluid contained in
the bottle 118 and/or 120 to be replaced into the appropriate
syringe 126 and/or 127. In this regard, the fluid may be available
for injection into the next patient. The next step 216 may be to
remove the appropriate bottle and move on to step 196 and fluidly
attach a new bottle. The process 190 may then be continued for the
subsequent patient using a new patient-specific tubing set 112. If
it is determined that the bottles 118, 120 do not need to be
replaced, the next step in the process 190 may be to move to step
200 and continue the process on the subsequent patient using a new
patient-specific tubing set 112.
[0119] Once it is determined that the multi-use tubing set 110 is
to be replaced, the process 190 may be halted and the multi-use
tubing set 110 replaced. The used multi-use tubing set 110 may then
be discarded or refurbished (e.g., cleaned and/or sterilized). The
determination that the multi-use tubing set 110 is to be replaced
may, for example, be based on a predetermined length of time that
the multi-use tubing set 110 has been in service, a predetermined
volume of fluids moving therethrough, suspected contamination
and/or damage, or any other appropriate criteria.
[0120] The multi-dose injection system 108 may also be operable to
perform certain functions related to the changing of the saline
bottle 118 and/or contrast bottle 120. For example, when the
contrast bottle 120 is near empty, the powerhead 50 may load any
remaining contrast into the contrast syringe 127. The user may then
replace the contrast bottle 120. The plunger of the contrast
syringe 127 may then be extended with the contrast valve 178 open
so that any air in the contrast tube 134 is forced into the new
contrast bottle 120. Thus, the purge step 202 may be avoided or the
amount of purging required may be reduced. In this regard, the
contrast bottle 120 may be expandable, have an air pocket, or have
any other appropriate feature (e.g., a vent) to allow fluids to be
forced therein from the contrast syringe 127.
[0121] Additionally, when not injecting fluids into a patient, one
or both of the saline valve 176 and the contrast valve 178 may be
left in an open position. This may prevent undesired pressure from
being built up in the syringes 126, 127 of the powerhead 50.
[0122] FIG. 7 presents another embodiment of an injection system
220 (e.g., a multi-dose injection system; a medical fluid injection
system; a multi-dose medical fluid injection system). A first fluid
source 222 is fluidly interconnected with a first injection device
226 by first fluid source tubing 224. A second fluid source 228 is
fluidly interconnected with a second injection device 232 by second
fluid source tubing 230. Any appropriate fluid may be utilized by
each of the first fluid source 222 and the second fluid source 228.
In one embodiment, the first fluid source 222 utilizes contrast
media, while the second fluid source 228 utilizes saline or any
other appropriate biocompatible flushing media. Each of the first
fluid source 222 and the second fluid source 228 may have a fluid
volume that is sufficient for multiple injections or injection
procedures (e.g., for multiple patients).
[0123] The first injection device 226 and the second injection
device 232 each may be of any appropriate size, shape,
configuration, and/or type (e.g., a power injector). The first
fluid source tubing 224 and the second fluid source tubing 230 each
may be in the form of any appropriate conduit (e.g., medical
tubing). Any appropriate component or combination of components may
be incorporated in either one or each of the first fluid source
tubing 224 and the second fluid source tubing 230 (e.g., one or
more valves of any appropriate type).
[0124] A multi-use or multi-patient tubing set 234 is fluidly
interconnected with each of the injection devices 226, 232. There
are three different parts or sections of the multi-patient tubing
set 234--first injection device tubing 236 that extends from the
first injection device 226, second injection device tubing 238 that
extends from the second injection device 232, and common discharge
tubing 240. Fluid discharged from the first injection device 226 is
directed into the first injection device tubing 236, and then into
the common discharge tubing 240. Fluid discharged from the second
injection device 232 is directed into the second injection device
tubing 238, and then into the common discharge tubing 240.
[0125] The first injection device tubing 236, the second injection
device tubing 238, and the common discharge tubing 240 may be
integrally formed, or one or more appropriate connectors may be
utilized to fluidly interconnect adjacent sections of the
multi-patient tubing set 234. An appropriate connector may be used
to install the first injection device tubing 236 to the first
injection device 226, while an appropriate connector may be used to
install the second injection device tubing 238 to the second
injection device 232. A connector 242 of any appropriate type may
be provided at a free end of the common discharge tubing 240.
[0126] A disposable, single-use, single-patient, or
patient-specific tubing set 244 is fluidly interconnected with the
common discharge tubing 240 of the multi-patient tubing set 234 by
a connector 246 of any appropriate type. The single-patient tubing
set 244 includes tubing 248. An appropriate vasculature access
device (e.g., a catheter) 250 may be appropriately interconnected
with the tubing 248 (e.g., via an appropriate connector).
[0127] Any appropriate component or combination of components may
be incorporated in either one or each of the multi-patient tubing
set 234 and the single-patient tubing set 244 (e.g., one or more
valves of any appropriate type). The tubing utilized by each of the
multi-patient tubing set 234 and the single-patient tubing set 244
may be of any appropriate type (e.g., medical tubing).
[0128] FIG. 8 presents another embodiment of an injection system
260 (e.g., a multi-dose injection system; a medical fluid injection
system; a multi-dose medical fluid injection system). The injection
system 260 includes a first fluid source 262, a second fluid source
266, a power injector 270, a reusable or multi-patient tubing set
276, and the above-discussed single-patient tubing set 244. The
first fluid source 262 is fluidly interconnected with a first
syringe 272 installed on the power injector 270 by first fluid
source tubing 278 (which may be part of the multi-patient tubing
set 276). The second fluid source 266 is fluidly interconnected
with a second syringe 274 installed on the power injector 270 by
second fluid source tubing 280 (which may be part of the
multi-patient tubing set 276). Any appropriate fluid may be
utilized by each of the first fluid source 262 and the second fluid
source 266. In one embodiment, the first fluid source 262 utilizes
contrast media, while the second fluid source 266 utilizes saline
or any other appropriate biocompatible flushing media. Each of the
first fluid source 262 and the second fluid source 266 may have a
fluid volume that is sufficient for multiple injections or
injection procedures (e.g., for multiple patients). The first fluid
source tubing 278 and the second fluid source tubing 280 each may
be in the form of any appropriate conduit (e.g., medical tubing).
Any appropriate component or combination of components may be
incorporated in either one or each of the first fluid source tubing
278 and the second fluid source tubing 280 (e.g., one or more
valves of any appropriate type).
[0129] The multi-patient tubing set 276 includes first syringe
tubing 282 that extends from the first syringe 272 on the power
injector 270, second syringe tubing 284 that extends from the
second syringe 274 on the power injector 270, and common discharge
tubing 286. Fluid discharged by the power injector 270 from the
first syringe 272 is directed into the first syringe tubing 282,
and then into the common discharge tubing 286. Fluid discharged by
the power injector 270 from the second syringe 274 is directed into
the second syringe tubing 284, and then into the common discharge
tubing 286.
[0130] The first fluid source tubing 278, the second fluid source
tubing 280, the first syringe tubing 282, the second syringe tubing
284, and the common discharge tubing 286 may be integrally formed,
an appropriate connector may be utilized to fluidly interconnect
each pair of adjacent sections of the multi-patient tubing set 276,
or part of the multi-patient tubing set 276 may be integrally
formed with one or more other portions of the multi-patient tubing
set 276 being incorporated by one or more connectors. An
appropriate connector may be used to install the first syringe
tubing 282 to the first syringe 272, while an appropriate connector
may be used to install the second syringe tubing 284 to the second
syringe 274. A connector 290 of any appropriate type may be
provided at a free end of the common discharge tubing 286.
[0131] Any appropriate component or combination of components may
be incorporated in either one or each of the multi-patient tubing
set 276 and the single-patient tubing set 244 as previously noted
(e.g., one or more valves of any appropriate type). For instance,
each of the first syringe tubing 282 and the second syringe tubing
284 may include an appropriate valve 288 (e.g., a stopcock) to
allow fluid from the fluid sources 262, 266 to be loaded into the
respective syringes 272, 274 without being directed into the
single-patient tubing set 244. The tubing utilized by the
multi-patient tubing set 276 may be of any appropriate type (e.g.,
medical tubing).
[0132] The single-patient tubing set 244 used by each of the
injection systems 220, 260 may be in the form, or at least utilize,
the above-noted patient specific tubing set 112 of FIG. 4B. The
single-patient tubing set 244 may also be in the form of, or at
least may utilize, the single-patient tubing set 300 illustrated in
FIGS. 9A-C, and which will now be addressed (e.g., the
single-patient-tubing set 300 may or may not define the entirety of
the single-patient tubing set 244).
[0133] The single-patient tubing set 300 of FIGS. 9A-C includes
tubing 302 of any appropriate type (e.g. medical tubing). An
appropriate connector 310a, 310b is provided on each end of the
single-patient tubing set 300. A multi-patient tubing set (e.g.,
234, 276) may be interconnected with the single-patient tubing set
300 by the connector 310a, while a vasculature access device (e.g.,
250) may be interconnected with the single-patient tubing set 300
by the connector 310b. The single-patient tubing set 300 may define
any portion of the single-patient tubing set 244 (including the
tubing set 112), or could define the entirety thereof. As such, the
connectors 310a, 310b could interface with connectors other than
those noted above (e.g., the single-patient tubing set 300 could
define an end segment of the multi-patient tubing set 244 at its
multi-patient tubing set end; the single-patient tubing set 300
could define an end segment of the multi-patient tubing set 244 at
its vasculature access device end; the single-patient tubing set
300 could define an intermediate segment of the multi-patient
tubing set 244).
[0134] The single-patient tubing set 300 includes a pair of check
valves 304 that are disposed in series along the tubing 302. Each
of the check valves 304 allow a fluid flow through the
single-patient tubing set 300 in the direction indicated by the
arrows in FIG. 9A (e.g., a flow from the connector 310a to the
connector 310b). The check valves 304 each could be disposed at any
appropriate location between the connectors 310a, 310b, and need
not be adjacent to one another as illustrated. One or more access
ports may be provided for the single-patient tubing set 300, for
instance via a needle-free valve 308 and an appropriate connector
306 (e.g., to allow a syringe to direct fluid into the
single-patient tubing set 300).
[0135] The single-patient tubing set 300 also incorporates what may
be characterized as a "use" indicator 320. Generally, this use
indicator 320 provides a visual indication that the single-patient
tubing set 300 has been used. Use indicator 320 includes a housing
322 and a piston 340 that is movably disposed within the housing
322. A flowpath 324 extends through the housing 322, and includes
an inlet port 326, an outlet port 328, and an inner chamber 330.
The tubing 302 may be mounted to oppositely disposed plugs through
which the inlet port 326 and the outlet port 328 extend.
[0136] The piston 340 is movably disposed within the housing 322,
and includes a head 342. This head 342 interfaces with the inner
chamber 330. Therefore, the head 342 of the piston 340 is exposed
to the flowpath 324 (e.g., interfaces with the flowpath; fluid in
the flowpath 324 contacts/interfaces with the head 342). The
development of a certain fluid pressure within the inner chamber
330 will cause the piston 342 to move from the position illustrated
in FIGS. 9A and 9C, to the position illustrated in FIG. 9B. Note
that in the FIG. 9A/9C configuration, an end surface 344 of the
piston 340 may be flush with or recessed relative to (e.g., spaced
inwardly) an end surface 334 of the housing 322 that is disposed
about the perimeter of the piston 340. In the deployed position of
FIG. 9B, the end surface 344 of the piston 340 is now disposed
beyond the end surface 334 of the housing 322 (e.g., a protruded or
extended position for the piston 340). The housing 322 may
incorporate a detent 332 or any other appropriate locking mechanism
(e.g., a snap-lock type feature) to retain the piston 340 in its
protruded position, once the position has moved from the position
of FIGS. 9A and 9C to the protruded position of FIG. 9B. As such,
the use indicator 320 may be characterized as a pop-up or pop-out
indicator 320. In one embodiment, a minimum pressure of 15 psi is
required to move the piston 340 to the protruded or extended
position of FIG. 9B. Other minimum pressure values may be
appropriate.
[0137] There are a number of observations that may be made in
relation the use indicator 320. The use indicator 320 may provide a
visual indication that the single-patient tubing set 300 has been
used in an injection protocol--more specifically that the
single-patient tubing set 300 has been exposed to at least a
certain pressure. The pressure at which the use indicator 320
responds could be set or established in any appropriate manner.
[0138] A single response may be induced when the use indicator 320
is exposed to a certain pressure in the flowpath 324--the piston
340 moves. This movement of the piston 340 may be into an open
space--the movement is not undertaken for purposes of having the
piston 340 engage another structure ("another" being in relation to
the use indicator 320 as a whole) to provide an additional
response. The piston 340 may move along an axial path to provide a
visual indication that the single-patient tubing set 300 has been
used. The piston 340 may also be characterized as being movable
orthogonally to a fluid flowing through the use indicator 320
(specifically through the flowpath 324).
[0139] The foregoing description of the present invention has been
presented for purposes of illustration and description.
Furthermore, the description is not intended to limit the invention
to the form disclosed herein. Consequently, variations and
modifications commensurate with the above teachings, and skill and
knowledge of the relevant art, are within the scope of the present
invention. The embodiments described hereinabove are further
intended to explain best modes known of practicing the invention
and to enable others skilled in the art to utilize the invention in
such, or other embodiments and with various modifications required
by the particular application(s) or use(s) of the present
invention. It is intended that the appended claims be construed to
include alternative embodiments to the extent permitted by the
prior art.
* * * * *