U.S. patent application number 11/173506 was filed with the patent office on 2005-11-03 for apparatus and method for administration of iv liquid medication and iv flush solutions.
Invention is credited to Baldwin, Brian Eugene.
Application Number | 20050245883 11/173506 |
Document ID | / |
Family ID | 31188002 |
Filed Date | 2005-11-03 |
United States Patent
Application |
20050245883 |
Kind Code |
A1 |
Baldwin, Brian Eugene |
November 3, 2005 |
Apparatus and method for administration of IV liquid medication and
IV flush solutions
Abstract
The present invention provides a medical liquid administration
apparatus and administration method that are particularly apt for
intravenous (IV) applications. More particularly, the
administration apparatus and method may be employed in conjunction
with the administration of liquid medication and one or more flush
solutions from multi-dose sources, wherein fluid interconnections
between at least one flush solution source and the administration
apparatus may be established a single time at the outset of a given
procedure. The administration apparatus may include a valve having
a control member selectively positionable to provide any selected
one of a plurality of closed flow paths through the valve, and a
syringe interconnected to the control member for
clockwise/counterclockwi- se co-rotation therewith (e.g. to
establish the selected flow path). The valve may include a valve
housing have a plurality of ports, wherein in one arrangement at
least two of the ports have corresponding center axes lying in
offset first and second planes. Correspondingly, the control member
may include an internal passageway extending between a plurality of
apertures, wherein at least two of the apertures have center axes
lying in said offset first and second planes. By selectively
rotating the control member, different fluid paths may be
established between different ones of the valve housing ports,
thereby facilitating closed-path passage of a liquid medication and
one or more flush solutions therethrough. In particular, the flush
solution(s) and liquid medication may be passed sequentially into
the interconnected syringe for subsequent manual administration by
medical personnel.
Inventors: |
Baldwin, Brian Eugene;
(Centennial, CO) |
Correspondence
Address: |
MARSH, FISCHMANN & BREYFOGLE LLP
3151 SOUTH VAUGHN WAY
SUITE 411
AURORA
CO
80014
US
|
Family ID: |
31188002 |
Appl. No.: |
11/173506 |
Filed: |
July 1, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11173506 |
Jul 1, 2005 |
|
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10225886 |
Aug 22, 2002 |
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Current U.S.
Class: |
604/246 |
Current CPC
Class: |
Y10T 137/86654 20150401;
F16K 7/06 20130101; A61M 39/223 20130101; F16K 11/022 20130101;
Y10T 137/86863 20150401 |
Class at
Publication: |
604/246 |
International
Class: |
A61M 005/00 |
Claims
What is claimed:
1. A method for medical liquid administration to a patient,
comprising: establishing an interconnection between a flush
solution source and a syringe, and an interconnection between said
syringe and a vascular catheter; drawing flush solution from said
flush solution source into a sterile syringe body of said syringe;
flowing said flush solution from said syringe through said vascular
catheter to a patient utilizing said interconnection between the
syringe and the vascular catheter; infusing a liquid medication
through said vascular catheter to a patient while maintaining said
interconnection between said flush solution source and said
syringe; and maintaining the sterility of said syringe body during
said flowing and infusing steps.
2. A method as recited in claim 1, further comprising: repeating
said drawing, flowing, infusing and maintaining steps a plurality
of times while maintaining said interconnection between said flush
solution source and said syringe.
3. A method as recited in claim 2, wherein said repeating step is
completed while maintaining an interconnection between a source of
said liquid medication and said vascular catheter.
4. A method as recited in claim 2, wherein between successive ones
of said plurality of times, the method further comprises:
disconnecting said syringe and said vascular catheter; and,
reestablishing said interconnection between said syringe and said
vascular catheter.
5. A method as recited in claim 4, wherein said interconnection
between said syringe and said vascular catheter is established
utilizing a tubing line having a connector at one end, and wherein
the method further comprises: covering the connector after said
disconnecting step; uncovering the connector after said covering
step and prior to said reestablishing step; and swabbing the
connector with a disinfectant prior to said reestablishing
step.
6. A method as recited in claim 1, wherein said infusing step is
completed utilizing at least a portion of a tubing line employed
for said interconnection between said syringe and said vascular
catheter.
7. A method as recited in claim 1, further comprising: utilizing
said syringe, at least one of before and after at least one of said
flowing step and said infusing step, to draw fluid into said
vascular catheter from said patient and to then infuse the fluid
back into said patient.
8. A method as recited in claim 7, further comprising: repeating
said drawing, flowing, maintaining, infusing and utilizing steps a
plurality of times while maintaining said interconnection between
said flush solution source and said syringe.
9. A method as recited in claim 8, wherein said infusing step and
said utilizing step are each completed utilizing at least a portion
of a tubing line employed for said interconnection between said
syringe and said vascular catheter.
10. A method as recited in claim 8, wherein said repeating step is
completed while maintaining an interconnection between a source of
said liquid medication and said vascular catheter.
11. A method as recited in claim 1, further comprising: utilizing
said syringe, at least one of before and after each of said flowing
step and said infusing step, to draw fluid into said vascular
catheter from said patient and to then infuse the fluid back into
said patient.
12. A method as recited in claim 1, wherein said syringe is
directly interconnected to a valve, and wherein said establishing
step further comprises: interconnecting said flush solution source
to a first inlet port of a valve, a source of said liquid
medication to a second inlet port of said valve, and said vascular
catheter to an outlet port of said valve.
13. A method as recited in claim 12, wherein said vascular catheter
and said syringe are at least partially interconnected by a tubing
line, and wherein said flowing and said infusing step are each
completed utilizing the tubing line.
14. A method as recited in claim 12, further comprising: repeating
said drawing, flowing, maintaining and infusing steps a plurality
of times while maintaining said interconnection between said flush
solution source and said first inlet port of said valve.
15. A method as recited in claim 14, wherein between successive one
of said plurality of times, the method further comprises:
disconnecting said syringe and said vascular catheter; and
reestablishing said interconnection between said syringe and said
vascular catheter.
16. A method as recited in claim 12, further comprising: repeating
said drawing, flowing, maintaining and infusing steps a plurality
of times while maintaining said interconnection between said flush
solution source and said first inlet port of said valve and said
interconnection between said source of said liquid medication and
said second inlet port of said valve.
17. A method as recited in claim 12, wherein said drawing step
comprises: controlling said valve to selectively establish a first
flow path therethrough between said first inlet port and said
syringe.
18. A method as recited in claim 17, wherein said flowing step
comprises: controlling said valve to selectively establish a second
flow path therethrough between said syringe and said outlet
port.
19. A method as recited in claim 18, wherein said infusing step
comprises: controlling said valve to selectively establish a third
flow path therethrough between said second inlet port and said
outlet port.
20. A method as recited in claim 19, further comprising:
interconnecting a second flush solution source to a third inlet
port of said valve; controlling said valve to selectively establish
a fourth flow path therethrough between said third inlet port and
said syringe; drawing a second flush solution from said second
flush solution source into said syringe body; and flowing said
second flush solution from said syringe through said vascular
catheter to a patient.
21. A method as recited in claim 18, further comprising: utilizing
said syringe, at least one of before and after at least one of said
flowing step and said infusing step, and with said second flow path
established, to draw fluid into said vascular catheter from said
patient and to infuse said fluid, back into said patient.
22. A method as recited in claim 21, further comprising: repeating
said drawing, flowing, maintaining, infusing and utilizing steps a
plurality of times while maintaining said interconnection between
said flush solution source and said first inlet part of said
valve.
23. A method as recited in claim 21, wherein said syringe further
comprises a plunger, wherein said drawing and flowing steps include
selectively retracting and advancing, respectively, said plunger
relative to said syringe body, and wherein said utilizing step
comprises selectively retracting and advancing said plunger
relative to said syringe body.
24. A method as recited in claim 12, further comprising: packaging
said syringe and said valve in a fixedly interconnected condition
within an enclosure prior to said establishing step; sterilizing
said fixedly interconnected syringe and valve; and, removing said
sterilized fixedly interconnected syringe and valve from said
enclosure prior to said establishing step.
25. A method as recited in claim 24, wherein said packaging step
further comprises: packaging one or more tubing lines, for use in
establishing one or more of said interconnections, with said
fixedly interconnected syringe and valve within said enclosure.
26. A method for medical liquid administration to a patient,
comprising: establishing an interconnection between a flush
solution source and a syringe, an interconnection between said
syringe and a vascular catheter, and an interconnection between a
source of liquid medication and said vascular catheter; drawing
flush solution from said flush solution source into a sterile
syringe body of said syringe; flowing said flush solution from said
syringe through said vascular catheter to a patient; infusing a
liquid medication from said source of liquid medication through
said vascular catheter to a patient while maintaining said
interconnection between said flush source and said syringe; and
utilizing said syringe, at least one of before and after at least
one of said flowing step and said infusing step, to draw fluid into
said vascular catheter from said patient and to infuse said fluid
back into said patient.
27. A method as recited in claim 26, further comprising: utilizing
said syringe, at least one of before and after each of said flowing
step and said infusing step, to draw fluid into said vascular
catheter from said patient and to infuse said fluid back into said
patient.
28. A method as recited in claim 26, wherein said syringe further
comprises a plunger, wherein said drawing and flowing steps include
selectively retracting and advancing, respectively, said plunger
relative to said syringe body, and wherein said utilizing step
comprises selectively retracting and advancing said plunger
relative to said syringe body.
29. A method as recited in claim 26, wherein said infusing step is
completed utilizing at least a portion of a tubing line employed
for said interconnection between said syringe and said vascular
catheter.
30. A method as recited in claim 26, further comprising:
maintaining the sterility of said syringe body during said flowing
and infusing steps.
31. A method as recited in claim 30, further comprising: repeating
said drawing, flowing, maintaining, infusing and utilizing steps a
plurality of times while maintaining said interconnection between
said flush solution source and said syringe.
32. A method as recited in claim 31, wherein between successive
ones of said plurality of time, the method further comprises:
disconnecting said syringe and said vascular catheter; and,
reestablishing said interconnection between said syringe and said
vascular catheter.
33. A method as recited in claim 31, wherein said repeating step is
completed while maintaining said interconnection between a source
of said liquid medication and said vascular catheter.
34. A method as recited in claim 26, wherein said syringe is
directly interconnected to a valve, and wherein said establishing
step further comprises: interconnecting said flush solution source
to a first inlet port of a valve, said source of said liquid
medication to a second inlet port of said valve, and said vascular
catheter to an outlet port of said valve.
35. A method as recited in claim 34, wherein said vascular catheter
and said syringe are at least partially interconnected by a tubing
line, and wherein said flowing, and utilizing infusing steps are
each completed utilizing the tubing line.
36. A method as recited in claim 34, further comprising: repeating
said drawing, flowing, maintaining, infusing and utilizing steps a
plurality of times while maintaining said interconnection between
said flush solution source and said first inlet port of said
valve.
37. A method as recited in claim 36, wherein between successive
ones of said plurality of times, the method further comprises:
disconnecting said syringe and said vascular catheter; and,
reestablishing said interconnection between said syringe and said
vascular catheter.
38. A method as recited in claim 34, repeating said drawing,
flowing, maintaining, infusing and utilizing steps a plurality of
times while maintaining said interconnection between said flush
solution source and said first inlet port of said valve and said
interconnection between said source of said liquid medication and
said second inlet port of said valve.
39. A method as recited in claim 34, wherein said drawing step
comprises: controlling said valve to selectively establish a first
flow path therethrough between said first inlet port and
syringe.
40. A method as recited in claim 39, wherein said flowing step
comprises: controlling said valve to selectively establish a second
flow path therethrough between said syringe and said outlet
port.
41. A method as recited in claim 40, wherein said infusing step
comprises: controlling said valve to selectively establish a third
flow path therethrough between said second inlet port and said
outlet port.
42. A method as recited in claim 41, further comprising:
interconnecting a second flush solution source to a third inlet
port of said valve; controlling said valve to selectively establish
a fourth flow path therethrough between said third inlet port and
said syringe; drawing a second flush solution from said second
flush solution source into said syringe body; and flowing said
second flush solution from said syringe through said vascular
catheter to a patient.
43. A method as recited in claim 34, further comprising: packaging
said syringe and said valve in a fixedly interconnected within an
enclosure prior to said establishing step; sterilizing said fixedly
interconnected syringe and valve; and, removing said sterilized
fixedly interconnected syringe and valve from said enclosure prior
to said establishing step.
44. A method as recited in claim 43, wherein said packaging step
further comprises: packaging one or more tubing lines, for use in
establishing one or more of said interconnections, with said
fixedly interconnected syringe and valve within said enclosure.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of and claims
priority to U.S. patent application Ser. No. 10/225,886, filed on
Aug. 22, 2002, and entitled "ADMINISTRATION OF IV LIQUID MEDICATION
AND IV FLUSH SOLUTIONS, APPARATUS AND METHOD FOR", the disclosure
of which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of medical liquid
administration, and more particularly, to an administration
apparatus and method for administering multiple medical liquids
during one or repeated periods. The administration apparatus and
method are particularly apt for use in successive intravascular
(IV) administrations of liquid medication and one or multiple flush
solutions over an extended time period, wherein the liquid
medication and flush solution(s) may be alternately infused through
a closed system requiring only a single vascular catheter fluid
interconnection per sequence.
BACKGROUND OF THE INVENTION
[0003] Numerous techniques are employed for the administration of
"medical liquids" (e.g. liquid medication and flush solutions) to a
patient. In particular, where repeated medication infusions are
required, medical liquids are often administered via the use of a
vascular access catheter that is fluidly interconnected or
interconnectable to one or more medical liquid sources via an
associated tubing line set. Typically, the catheter is inserted
into the vein of a patient and left there for multiple intravenous
(IV) infusions during an extended course of medication therapy. By
way of example, the time period between IV drug infusions may be
between about 4 to 24 hours, wherein the IV liquid medication
source is typically replaced after each dose infusion. In the
course of extended medication therapy a given tubing line set may
be repeatedly employed, and a number of tubing line sets may be
successively employed. For example, it is typical to replace a
given tubing line set every two or three days.
[0004] During extended therapy applications, a desirable practice
is to disconnect the vascular catheter from a medical liquid source
and tubing line set between infusions. In this regard, most
patients receiving IV medication therapy are ambulatory to some
degree and benefit from not being continuously connected.
[0005] In conjunction with the repeated connection/disconnection of
a vascular catheter and liquid medication source and tubing line
set, it is usual practice to purge the vascular catheter with a
flush solution (e.g. a saline solution) prior to and at the
completion of a given liquid medication infusion. Pre-infusion
flushing verifies that the vascular catheter is primed and clear of
obstructions. Post infusion flushing not only flushes through any
remaining liquid medication to achieve the desired therapeutic
effect, but also reduces any chance that the vascular catheter may
become blocked in-between infusions, e.g. by a blood clot that may
otherwise form in the vascular catheter. In relation to infusion
procedures, it is also common practice to verify the proper
functioning of a vascular catheter via aspiration. This is
typically done prior to pre-infusion flushing and after liquid
medication infusion. The procedure entails using the flush solution
syringe or liquid medication syringe to drain a small amount of a
patient's blood through the vascular catheter, thereby permitting
visual verification of proper vascular catheter functionability,
then advancing the blood back through the vascular catheter using
the syringe. By way of example, such procedure assures that the
vascular catheter is not blocked by a blood clot and is otherwise
properly inserted into a patient's vascular system.
[0006] A number of approaches are currently utilized for the noted
flushing procedures. Such techniques generally entail the usage of
flush solutions packaged in large volume, multi-dose reservoirs
(e.g. about 250 ml. or more) or pre-filled unit dose syringes (e.g.
having volumes of 2, 3, 5 or 10 ml.).
[0007] Where a unit dose syringe is utilized, medical personnel
must generally remove the syringe from packaging, remove a cap from
the syringe, remove any air in the syringe, swab a vascular
catheter access port with an antibacterial material, interconnect
the syringe to a vascular catheter access port, optionally aspirate
the vascular catheter, advance the syringe plunger to infuse the
flush solution (e.g. at a rate of about 5 to 10 ml. over about 15
to 30 seconds), remove the syringe from the vascular catheter
access port and discard the used syringe with its wrapper. As may
be appreciated, such steps may need to be repeated numerous times
over the course of extended medication therapy, e.g. after each
infusion and vascular catheter access port reconnection, thereby
entailing significant medical personnel time and resulting in
substantial medical waste. Further, while unit dose syringes
provide good sensitivity for aspiration purposes they are not
particularly pressure sensitive for flushing purposes.
[0008] Where multi-dose flush solution reservoirs are employed,
medical personnel typically utilize an empty unit dose syringe to
draw the flush solution from the reservoir, then follow the same
basic procedure noted above in an administering the flush solution.
Again, such procedure may be followed a number of times during a
medication therapy. Further, contamination concerns may arise when
a unit dose syringe is filled from a multi-dose reservoir at the
point of use. To address such concern, unit dose syringes are often
filled from a multi-dose reservoir within a pharmacy department of
a medical care facility utilizing a hepa-filter air hood. However,
significant syringe handling is required. Moreover, labeling
becomes a further need when a delay is expected between the filling
of a unit dose syringe and the usage of the filled syringe.
SUMMARY OF THE INVENTION
[0009] In view of the foregoing, a primary objective of the present
invention is to reduce the number of steps and associated time
required by medical personnel for the infusion of medical liquids
in conjunction with IV procedures. A related objective is to
facilitate the utilization of multi-dose flush solution sources in
conjunction with IV liquid medication administration procedures
occurring over an extended course of therapy.
[0010] An additional objective of the present invention is to
provide the noted medical liquid administration efficiencies in a
manner that also enhances the maintenance of sterility.
[0011] A further objective of the present invention is to
facilitate the utilization of different types of flush solutions,
including the use of two different flush solutions in conjunction
with IV procedures for a given patient.
[0012] Yet another objective of the present invention is to reduce
medical waste associated with the IV administration of flush
solutions.
[0013] In addressing the noted objectives, the present inventors
have recognized the desirability of providing an apparatus that
fluidly interconnects fluid lines from multiple medical liquid
sources to a single fluid line that is selectively interconnectable
to a vascular catheter access port. More particularly, the
inventors have recognized that desirability of providing an
apparatus that allows a liquid medication source and multiple flush
solutions to be administered in a closed system through a single
fluid line that entails only a single interconnection to a vascular
catheter access port.
[0014] As such, one or more of the above objectives and additional
advantages may be realized by an inventive medical liquid
administration apparatus that comprises a valve having a control
member selectively positionable to provide any selected one of a
plurality of flow paths through the valve, and a syringe, fluidly
interconnected to a syringe port of the valve, for receiving and
dispensing medical liquid through the valve.
[0015] In one aspect, the syringe may be fixedly interconnected to
the control member for clockwise and counterclockwise co-rotation
therewith. In this regard, the control member may be positionable
so that in a first position a first flow path between a first inlet
port of the valve and the syringe port is provided. The control
member may be further positionable in a second position to provide
a second flow path between the syringe and an outlet port of the
valve. Such selective positioning facilitates the drawing of a
first medical liquid (e.g. a first flush solution) into the syringe
through the first inlet port when the control member is in the
first position, and the subsequent administration of such medical
liquid from the syringe through the outlet port of the valve when
the control member is in the second position, e.g. administration
via a vascular catheter access port.
[0016] Further, the control member may be provided for selective
positioning in a third position wherein a third flow path is
defined between a second inlet port and the needle-less syringe.
Such functionality allows for the use of the syringe to draw a
second medical liquid (e.g. a second flush solution) through the
second inlet port when the control member is in the third position,
and the subsequent administration of the medical liquid through the
outlet port of the valve when the control member is in the second
position.
[0017] Of note, the valve may also include a third inlet port,
wherein when the control member is in the second position a fourth
flow path is defined to allow a third medical liquid (e.g. a liquid
medication or drug) to be passed directly through the third inlet
port to the outlet port of the valve, wherein the third medical
liquid is administered to a patient, e.g. via a vascular catheter
access port. In such an arrangement the second and fourth flow
paths are fluidly interconnected and partially overlap.
[0018] In another aspect, a valve may be provided which includes a
plurality of valve ports, including the syringe port and first and
second valve inlet ports having corresponding center axes in offset
first and second planes, respectively. Further, the control member
may be positionable to provide any selected one of a plurality of
flow paths between a corresponding plurality of different sets of
the valve ports. More particularly, the control member may be
provided with an internal passageway extending between a plurality
of apertures in the control member, wherein a first aperture and a
second aperture have corresponding center axes lying in said offset
first and second planes, respectively. That is, the center axes of
the first valve port and first aperture may be disposed within a
common first plane, and the center axes of the second valve port
and second aperture may be disposed within a common second plane.
Moreover, the first and second planes may be substantially
parallel. Such an arrangement allows multiple flow paths to be
defined in a relatively simple manner. For example, in one
embodiment at least a portion of the control member may be
rotatably disposed in the valve, wherein such portion includes the
first and second apertures.
[0019] In conjunction with this aspect, a first set of valve ports
may be disposed in a first relative relationship and a different
second set of valve ports may be disposed in a second relative
relationship, said first and second relative relationships being
different. Correspondingly, a first set of control member apertures
may be disposed in said first relative relationship and a second
set of control member apertures may be disposed in a said second
relative relationship. Further, the first and second sets of
apertures may each include at least one aperture in common.
[0020] As should be noted, the described administration apparatus
allows up to three different medical liquid sources to be
concurrently interconnected to three different inlet ports and
separately administered through a common outlet port in a closed
system, wherein the interconnected syringe is employable for the
receipt and administration of the medical liquids. In the later
regard, the outlet port may be selectively interconnected to a
vascular catheter access port (e.g. via an interconnected tubing
line having a male luer connector). By way of primary example, the
invention allows for the sequential administration of a liquid
medication, or drugs, and two different flush solutions via a
closed system and pursuant to the establishment of a single
vascular catheter interconnection.
[0021] Additional features may be provided in combination with the
above noted apparatus. For example, the syringe port and an end
aperture of the control member may be disposed in opposing, aligned
relation on the center axis of the valve. Further, the control
member may be provided with a plurality of side apertures that may
be selectively aligned with different ones of a plurality of valve
side ports. As will be appreciated, the side apertures of the
control member may be disposed for selective blockage by internal
sidewalls of the valve in certain positions.
[0022] Additionally, the medical liquid administration apparatus
may include one or more indicators for identifying the optional
fluid flow paths through the valve. For example, such indicator(s)
may include visual path identifiers (e.g. corresponding with
intended liquid medication and first/second solution source
interconnections) located in spatial relation to inlet/outlet ports
of the valve. The syringe may also be oriented transverse to a
center axis of the valve, wherein the syringe may be selectively
positioned in substantial alignment with a given one of the valve
ports to affect a desired fluid flow path through the valve.
[0023] In yet another feature, the syringe of the administration
apparatus may include a syringe body, a plunger having a bottom end
disposed in a top end of the syringe body, and a sealing member for
sealing the top end of the syringe body to the plunger. More
particularly, the sealing member may extend from a top end of the
syringe body to a top end of the plunger. By way of example, the
sealing member may comprise a flexible membrane that functions in a
bellows-like manner.
[0024] Various capabilities accommodated by the inventive
administration apparatus may be implemented in an inventive method
for medical liquid administration. In one aspect, the inventive
method includes the steps of fluidly interconnecting a first flush
solution source to a first inlet port of an administration
apparatus, a second flush solution source to a second inlet port of
the administration apparatus, and a liquid medication source to a
third inlet port of the administration apparatus. The method
further includes the step of passing a selected one of the flush
solutions into a syringe of the administration apparatus. Of
course, the inventive method may further include the step of
flowing the selected flush solution from the syringe through an
outlet port of the administration apparatus for administration to a
patient, e.g. via a vascular catheter access port to a patient.
Additionally, the method may include the step of infusing liquid
medication by passing the liquid medication from the liquid
medication source into the third inlet port and out of outlet port
of the administration apparatus for administration to a patient,
e.g. via a vascular catheter access port to a patient. Of note, a
common outlet port is utilized for both flush solution and liquid
medication administration.
[0025] As may be appreciated, the inventive method may further
include the steps of passing and flowing of a selected flush
solution both prior to and after the liquid medication infusing
step. In this regard, the first flush solution may be selected for
said passing and flowing steps prior to the infusing step, and the
second flush solution may be selected for the passing and flowing
steps after said infusing step. More particularly, the first flush
solution may include a saline solution and the second flush
solution may comprise a heparin solution.
[0026] In multiple-dose applications, the inventive method may
include repeating the passing, flowing and infusing steps a desired
number of times, while maintaining at least one of the fluid
interconnections at the first, second and third inlet ports of the
medical liquid administration apparatus. Moreover, the passing,
flowing and infusing steps may be repeated any number of times
while maintaining all three of the medical liquid source/inlet port
interconnections. The maintenance of such interconnections yields
sterility benefits as well as reduced procedural requirements.
[0027] In conjunction with multiple-dose applications, the
inventive method may further include the steps of interconnecting
the outlet port of the administration apparatus to a vascular
catheter access port to a patient, completing the flowing and
infusing steps noted above, and disconnecting the outlet port of
the medical liquid administration apparatus from the vascular
catheter access port to the patient. In turn, the interconnecting,
completing and disconnecting steps may be repeated a number of
times. As will be appreciated, such steps accommodate the
ambulatory needs of a patient receiving medication therapy over an
extended time period, while also reducing the overall member of
vascular catheter interconnections/disconnections required for
liquid medication infusion and pre/post flushing procedures.
[0028] In relation to the step of passing a selected flush solution
into the syringe, such step may include a selected one of
establishing: (i) a first closed flow path between the first inlet
port and syringe, and (ii) a second closed path between the second
inlet port and the syringe. Further, the step of flowing the
selected flush solution to a vascular catheter access port may
provide for the establishment of a third flow path between the
syringe and the outlet port. The noted methodology may be
implemented so that only one of the first, second or third flow
paths is establishable at a given time. Further, the noted
establishment of first, second or third flow paths may be
selectively established via the rotation of a control member within
a valve of the administration apparatus. Further, such rotating
step may include the alignment of the syringe with one of the
first, second and third inlet ports to establish a corresponding
selected one of the first, second and third flow paths. Visual path
identifiers (as noted above) may also be obscured in conjunction
with the selection of a desired flow path.
[0029] In completing the step of passing a selected flush solution
into the syringe of the administration apparatus, the selected
flush solution may be drawn by the retraction of a plunger relative
to a barrel of the syringe. In turn, the step of flowing the
selected flush solution out the outlet port, e.g. to a vascular
catheter access port, may entail advancement of the plunger
relative to the barrel of the syringe.
[0030] As may be appreciated, the method may further provide for
the retraction of the syringe plunger relative to the syringe
barrel after at least one or both of the steps of flowing the
selected flush solution or infusing the liquid medication. In
conjunction with such retraction, the method may also include the
step of observing fluid drawn from a patient towards a vascular
catheter access port, wherein a proper fluid interconnection at the
vascular catheter may be confirmed.
[0031] Additional aspects and advantages of the present invention
will become apparent to those skilled in the art upon consideration
of the further description provided hereinbelow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] FIG. 1A is perspective view of one medical liquid
administration apparatus embodiment comprising the present
invention.
[0033] FIG. 1B is a top view of the administration apparatus
embodiment of FIG. 1A.
[0034] FIG. 1C is a front view of the administration apparatus
embodiment of FIG. 1A.
[0035] FIG. 1D is a side view of the administration apparatus
embodiment of FIG. 1A.
[0036] FIG. 2 is a cross-sectional side view of the administration
apparatus embodiment of FIG. 1A, with a syringe thereof shown in a
first position.
[0037] FIGS. 3A and 3B are perspective and top views of the
administration apparatus embodiment of FIG. 1A, as interconnected
to a liquid medication source and a first flush solution source,
with two flow paths being defined by the medical liquid
administration apparatus.
[0038] FIG. 3C is a side cross-sectional view of the administration
apparatus embodiment and liquid medication source shown in FIGS. 3A
and 3B, as taken along line AA of FIG. 3A.
[0039] FIGS. 4A and 4B are perspective and top views of the
administration apparatus embodiment of FIG. 1A, as interconnected
to a liquid medication source and a first flush solution source,
with another flow path being defined by the administration
apparatus.
[0040] FIGS. 5A and 5B are perspective and top views of the
administration apparatus embodiment of FIG. 1A, as interconnected
to a liquid medication source and first and second flush solution
sources, with yet another flow path being defined by the
administration apparatus.
[0041] FIGS. 6A-6H are schematic illustrations showing various
selected flow paths definable by the administration apparatus
embodiment of FIG. 1A in accordance with one method embodiment of
the present invention.
DETAILED DESCRIPTION
[0042] FIGS. 1A-1D and 2 illustrate one medical liquid
administration apparatus embodiment comprising various features of
the present invention. The administration apparatus 1 includes a
valve 10 and a syringe 70 fluidly interconnected to the valve 10.
As best shown by FIG. 2, the valve 10 includes a control member 20
rotatably disposed within a valve housing 30. The control member 20
may be selectively rotated relative to valve housing 30 to provide
a number of flow paths through the valve 10.
[0043] In this regard, valve housing 30 is provided with side ports
32, 34, 36, 38, as well as a syringe port 40. Control member 20
includes an internal passageway 50 that extends between apertures
52, 54 and 56. As will be further described, apertures 54 and 56
are disposed to provide for the selective passage of medical
liquids between side ports 34 and 38, and syringe port 40.
Apertures 52 and 56 are disposed to provide for the selective
passage of medical liquids between syringe port 40 and side port
36. Apertures 52 and 54 are further disposed to provide for the
direct passage of a medical liquid between side port 32 and side
port 36.
[0044] The syringe 70 may be fixedly interconnected through syringe
port 40 to the control member 20, e.g. via an interconnection
member 60, for clockwise and counterclockwise co-rotation with the
control member 20. In one arrangement, a cylindrical end of control
member 20 may be located and adhered within a complimentary,
annular groove of the interconnection member 60 to achieve
interconnection. A fluid opening 62 may be defined through the
interconnection member 60 to fluidly interconnect aperture 56 and a
fluid port 72 of the syringe 70.
[0045] As noted, various flow paths through valve 10 may be
selectively established. Such capability allows medical liquid
administration apparatus 1 to be utilized for the administration of
three (3) different medical liquids, e.g. via an interconnectable
vascular catheter access port. Furthermore, integration of syringe
70 in medical liquid administration apparatus 1 facilities the
administration of a medical liquid from one or a plurality of
interconnected sources (e.g. containing different flush solutions)
on a successive, repeated basis during the course of medication
therapy for a given patient. In particular, medical liquid
administration apparatus 1 may be employed for the successive
administration of a catheter flush solution, such as a saline
solution and/or heparin solution, before and/or after liquid
medication infusions, wherein at least one of the flush solutions
is contained in an interconnectable reservoir of sufficient volume
to dispense multiple flush solution dosages.
[0046] Referring now to FIGS. 1A-1D and 2, the spatial
relationships between valve ports 32, 34, 36, 38, 40 and apertures
52, 54 and 56 of control member 20 will be described. In
particular, valve side ports 32, 34, 38 have corresponding center
axes disposed in a common first plane, and valve side port 36 has a
center axis disposed in a second plane offset from and parallel to
the first plane. Correspondingly, control member 20 is disposed
within valve housing 30 so that the center axes of apertures 52, 54
are disposed in said offset first plane and second plane,
respectively. Further, valve port 40 and aperture 56 are disposed
in opposing aligned relation on a center axis of valve housing
30.
[0047] In connection with the foregoing, and as best shown in FIG.
1B and FIG. 2 it should also be noted that the center axes of the
valve side ports 32, 34, 36, 38 and the center axes of apertures
52, 54 of control member 20 are disposed to facilitate various
aligned relationships therebetween. In particular, the center axes
of coplanar ports 32, 34 and 38 are offset at 90.degree. intervals
about the center axis of valve housing 30. On the other hand,
apertures 52 and 54 of control member 20 are offset 180.degree.
about the center axis of valve housing 30.
[0048] By virtue of noted relative relationships, control member 20
may be rotatably positioned relative to valve housing 30 to
selectively provide for the passage of liquid between port 34 and
port 40 in a first position, between port 38 and port 40 in a
second position, and between port 40 and port 36 in a third
position. Additionally, when in the third position control member
20 also provides for direct passage of liquid between port 32 and
port 36. Further in this regard, it should be noted that when the
control member 20 is positioned in each of the first and second
positions, aperture 52 is blocked by an internal sidewall of valve
housing 30, thereby preventing the passage of liquid
therethrough.
[0049] In addition to the above-noted features, administration
apparatus 1 may further include flow path indication, sterility
maintenance and fluid interconnection features. In particular,
administration apparatus 1 may include visual representations
disposed in spatial relation to valve side ports 32, 34, 36 and 38
that correspond with the intended fluid interconnections. For
example, as shown in FIGS. 1A and 1B the letters "S", "A" and "H"
may be disposed in spatial relation to ports 34, 32 and 38,
respectively, wherein the "S" port 34 is intended for fluid
interconnection with a saline flush solution source, the "A" port
32 is intended for fluid interconnection with a liquid medication
source, and the "H" port 38 is intended for fluid interconnection
with a heparin flush solution source. As further shown by FIGS. 1A
and 1B, the visual representation "Cath" is provided in spatial
relation to valve side port 36, wherein the "Cath" port 36 is
intended for fluid interconnection with a patient, e.g. a vascular
catheter access port to a patient. In medical liquid administration
apparatus 1, the various visual representations noted above are
provided on web members 80. Certainly, other embodiments may
utilize alternate visual representations disposed in other
locations, e.g. directly on port extension members.
[0050] In conjunction with the foregoing, it should also be noted
that syringe 70 is disposed transverse to the center axis of the
valve 10 (e.g. substantially parallel to the center axes of the
various valve side ports 32, 34, 36, 38), wherein syringe 70 is
rotatable about the center axis of the valve 10 to obtain the
desired flow path through valve 10. That is, by rotating syringe 70
over and into an aligned relation with a given one of the valve
side ports 32, 34 and 38, the fluid flow path corresponding with
such valve side port may be achieved. In this regard, valve 10 may
be provided so as to mechanically restrict the rotatable
positioning of control member 20 to an arc that extends between
ports 32, 34 and 38 (e.g. at least 180.degree.) but which does not
extend by port 36. For example, and as best shown by FIG. 1D, valve
housing 30 may include an upstanding stop member 39 that extends
into a cut-out region of a bottom skirt 62 of interconnection
member 60. In turn, rotation of the interconnection member 60 and
control member 20 is limited to the arc defined by the cut-out
region of interconnection member 60. To facilitate aligned
positioning of control member 20, valve housing 30 may also include
an upstanding detent member 39 having a rounded top end for receipt
by a complimentary depression (e.g. hemispherical) in the bottom
skirt 62 of the interconnection member 60. As will be appreciated,
when control member is rotatably positioned into the above-noted
third position (e.g. to define passageways between ports 40 and 36
and between ports 32 and 36), the rounded top end of detent member
39 will slidably pass into the complimentary depression of bottom
skirt 62.
[0051] To facilitate repeated use of the syringe 70 during a given
medication therapy, syringe 70 is provided with a sealing member 74
for maintaining sterility. More particularly, the sealing member 74
may extend over the top end of the plunger 76 and interconnected
with the syringe body 78, e.g. via a securing ring 90
interconnected to a top end of the syringe body 78. Sealing member
74 may be a collapsible membrane that functions in a bellows-like
manner to facilitate advancement and retraction of plunger 76
relative to syringe body 78. As will be appreciated, the provision
of sealing member 74 maintains the sterility of the inside surfaces
of the syringe body 78 during use.
[0052] More generally in this regard, it may be appreciated that
the medical liquid administration apparatus 1 may be packaged in a
sterile condition. For example, the administration apparatus 1 may
be assembled, packaged in a heat-sealed enclosure, and sterilized
via exposure to gamma radiation.
[0053] As shown in phantom in FIG. 2, a catch member 92 may also be
provided with administration apparatus 1. For example, catch member
92 may be interconnected to or comprise a further feature of
securing ring 90. In use, the catch member 92 may be employed to
selectively restrict retraction of plunger 76 relative to syringe
body 78. Such feature may be of particular use during use of the
administration apparatus 1 for liquid medication administration. Of
course, catch member 92 may also be deflected outward to permit use
of the plunger 76, as will be described.
[0054] As indicated, the medical liquid administration apparatus 1
may be further provided with a number of features to facilitate
various intended fluid interconnections. In particular, and as best
shown by FIGS. 1A-1D, 3A, 4A and 5A, administration apparatus 1 may
be provided with a tubing line 122 connected to valve side port 34.
In turn, tubing line 122 may be directly connected to a first flush
solution source 120 (e.g. a saline solution reservoir) or may be
provided with a spike member 124 for selective interconnection to a
vial or other reservoir containing a first flush solution (e.g.
saline flush solution). Administration apparatus 1 may also be
provided with a lure connector 102 (e.g. a female luer connector
having a removable cap) connected to valve side port 32 for
selective interconnection with a complimentary lure connector 104
(e.g. a male luer connector) that is provided at one end of a
tubing line 106 fluidly interconnected to a liquid medication
source 100. A clip 108 may be provided on tubing line 106 for
selective occlusion of tubing line 106. Administration apparatus 1
may also be provided with a lure connector 142 (e.g. a female luer
connector having a removable cap) connected to valve side port 38
for selective interconnection with a complementary lure connector
146 (e.g. a male luer connector) provided at one end of a tubing
line 144 interconnected with a second flush solution source 140
(i.e. a heparin flush solution). Finally, administration apparatus
1 may also be provided with a tubing line 162 connected to valve
side port 36 and having a male lure connector 164, e.g. provided
for selective interconnection with a complementary female luer
connector comprising a vascular catheter access port 160 to a
patient.
[0055] Such various fluid interconnection features will now be
further described in relation to intended exemplary applications.
With specific reference to FIGS. 3A, 3B and 3C, the administration
apparatus 1 is shown with syringe 70 located in a position to
define a flow path between the liquid medication source 100 and
vascular catheter access port 160 via valve ports 32 and 36. To
administer liquid medication, the liquid medication source 100 may
be controlled to infuse the medical liquid into the vascular
catheter access port 160. For example, when liquid medication
source 100 comprises a syringe, the plunger may be advanced
relative to the barrel thereof to achieve administration. In one
approach, the liquid medication source 100 may be mounted in an
automated device 110 for automated dispensation of pre-selected
dosage amounts. As noted above, during liquid medication
administration the optional catch member 92 may be positioned to
restrict retraction of the syringe plunger 76. Preferably, clip 108
is manipulated to occlude, or close, tubing line 106 during all
periods between liquid medication administrations.
[0056] When syringe 70 is located in the position shown in FIGS.
3A, 3B and 3C, a flow path is also defined between syringe 70 and
vascular catheter access port 160 via valve ports 40 and 36. As
will be described, such position is employed to administer first or
second flush solution amounts drawn into syringe 70.
[0057] In that regard, and referring now to FIGS. 4A and 4B,
syringe 70 is shown in a position that provides a fluid flow path
between the first flush solution source 120 and syringe 70 via
valve ports 34 and 40. To facilitate the passage of the first flush
solution into the syringe 70, plunger 76 is retracted so as to draw
the flush solution through the tubing line 122 and valve 10 into
the syringe body 78. To administer the first flush solution from
the syringe body 78, syringe 70 is rotated into the position shown
in FIG. 3A-3C. Thereafter, plunger 76 may be advanced so as to flow
the flush solution through valve ports 40, 36 to the vascular
catheter access port 160.
[0058] A similar procedure may be followed for optional usage of
the second flush solution source 140. More particularly, and
referring now to FIGS. 5A and 5B, syringe 70 is shown in a position
that provides a fluid path between the second flush solution source
140 and syringe 70 via valve ports 38 and 40. In this position
plunger 76 of syringe 70 may be retracted to draw flush solution
from source 140. Then, syringe 70 may be rotated to the position
shown in FIGS. 3A-3C for infusion of the second flush solution
through vascular catheter access port 160.
[0059] Of note, it should be appreciated that, prior to or after
the infusion of a liquid medication or flush solution,
administration apparatus may be conveniently employed for effective
vascular catheter aspiration. In particular, syringe plunger 76 may
be retracted to manually draw a small amount of blood through an
interconnected vascular catheter and into tubing line 166 to allow
medical personnel to confirm proper catheter placement and/or the
absence of blood clotting. Then, syringe plunger 76 may be advanced
to return the blood.
[0060] An exemplary procedure using the medical liquid
administration apparatus 1 will now be presented. To begin the
procedure the liquid administration apparatus 1 is removed from
sterile packaging and set-up procedures completed. In particular,
and with reference to FIGS. 3A, 4A and 5A, a vascular catheter
access port 160 may be fluidly interconnected to the medical liquid
administration apparatus 1 via male luer connector 164, tubing line
162 and valve side port 36. Further, liquid medication source 100
may be fluidly interconnected to side port 32 of the medical liquid
administration apparatus 1, and source 100 may be optionally
positioned within an automated infusion device 110 as deemed
appropriate by medical personnel. To complete the set-up procedure,
a saline flush solution source 120 and/or heparin flush solution
source 140 may be fluidly interconnected to valve side port 34
and/or valve side port 38 of the medical liquid administration
apparatus 1. At this point, all necessary fluid interconnections
have been made to allow for the use of medical liquid
administration apparatus 1 on a repeated basis over the course of
an extended medication therapy.
[0061] Following setup, various tubing lines comprising the various
fluid interconnections may be primed by sequentially positioning
and control of syringe 70 to define and draw liquid through the
desired fluid flow path to be primed both upstream of the medical
liquid administration apparatus 1 and downstream thereof. Tubing
line 106 may be primed by manipulation or automated control of
liquid medication source 100. Next, a vascular catheter (not shown)
interconnected via tubing line 166 to vascular catheter access port
160 may be inserted into a patient. Then, syringe 70 may be
employed to aspirate the vascular catheter.
[0062] Reference is now made to FIG. 1A and FIGS. 6A-6H. When
medical personnel determine that it is an appropriate time to
provide a dose of liquid medication, the syringe 70 may be aligned
with port 34 to define a fluid flow path between the saline flush
solution source 120 and the syringe 70 via valve 10, see FIG. 6A.
Medical personnel may then pass a desired volume of the saline
flush solution into the syringe 70 via retraction of plunger 76.
Next, medical personnel may locate the syringe 70 into an aligned
orientation with port 36, see FIG. 6B. The plunger 76 may then be
advanced to flow the saline flush solution through the valve 10 and
into the vascular catheter access port 160 to the patient. Of note,
plunger 76 may then be retracted a sufficient amount to allow
medical personnel to visually confirm a blood return into the
vascular catheter access port tubing line 166, see FIG. 6C. Upon
such confirmation, plunger 76 may be advanced to push the blood
back into the patient.
[0063] Next, medical personnel may position the syringe 70 in an
aligned orientation with valve side port 32, see FIG. 6D.
Concomitantly, clip 108 may be positioned to open the tubing line
106 and a predetermined, desired amount of liquid medication may be
passed from liquid medication source 100 into vascular catheter
access port 160 via manipulation or automated control of liquid
medication source 100. Clip 108 may then be repositioned to occlude
tubing line 106. Again, plunger 76 may be retracted a sufficient
amount to allow medical personnel to visually confirm a blood
return into the vascular catheter access port tubing line 166. Upon
such confirmation, plunger 76 may be advanced to push the blood
back into the patient.
[0064] When the desired liquid medication infusion is complete,
medical personnel may rotate the syringe 70 into an aligned
position with port 34, see FIG. 6F. A desired volume saline flush
solution may be drawn from source 120 into the syringe 70. Syringe
70 may then be rotated back into an aligned position with port 32,
see FIG. 6G, and plunger 76 advanced to affect passage of the
saline flush solution through the administration apparatus 1 to
vascular catheter access port 160. Medical personnel may then
slightly retract plunger 76 to again visually confirm a blood
return within the vascular access port tubing 166, as per FIG. 6C,
and thereafter push the blood back into the patient.
[0065] As may be appreciated, when use of the heparin flush
solution from source 140 is desired, the syringe 70 may be oriented
in an aligned relation with a port 38, see FIG. 6H. Thereafter, the
heparin flush solution may be passed into the syringe 70 and
subsequently infused by rotating the syringe 70 into an aligned
orientation with port 32, see FIG. 61, and advancing plunger
76.
[0066] After a given infusion of liquid medication is completed,
the valve side port 36 of medical liquid administration apparatus 1
may be selectively disconnected from the vascular catheter access
port 160, e.g. male luer connector 164 may be disconnected and
covered. For example, the male luer connector 164 may be
temporarily docked within a docking apparatus such as that
described in U.S. patent application Ser. No. 10/226,183, entitled
"STERILE DOCKING APPARATUS AND METHOD", filed Aug. 22, 2002, hereby
incorporated by reference in its entirety.
[0067] When a further infusion of liquid medication is desired, the
male lure connector 164 may be uncovered. The male luer connector
164 and vascular catheter access port 160 may then be swabbed with
an appropriate anti-bacterial solution and reconnected. Thereafter,
the procedure may continue as per the description accompanying
FIGS. 6A-6H above.
[0068] In accordance with described arrangement, multiple infusions
of liquid medication may be completed utilizing medical liquid
administration apparatus 1, while maintaining fluid
interconnections between the medical liquid administration
apparatus 1 and saline flush solution source 120, liquid medication
source 100 and/or heparin flush solution source 140. As may be
appreciated, the maintenance of one or more such interconnections
simplifies the overall procedure for medical personnel, results in
reduced waste relative to prior techniques, and enhances the
maintenance of sterile interconnections.
[0069] The embodiments described above are for exemplary purposes
only and is not intended to limit the scope of the present
invention. Various adaptations, modifications and extensions of the
described system/method will be apparent to those skilled in the
art and are intended to be within the scope of the invention as
defined by the claims which follow.
* * * * *