U.S. patent application number 15/801009 was filed with the patent office on 2019-05-02 for multi-port control valve for use in blood sampling, blood pressure measurement systems.
This patent application is currently assigned to Edwards Lifesciences Corporation. The applicant listed for this patent is Edwards Lifesciences Corporation. Invention is credited to Mandana Farhadieh, Andrew Nguyen Hoan, Brian Patrick Murphy, Alexander H. Siemons, Jason A. Wine.
Application Number | 20190125232 15/801009 |
Document ID | / |
Family ID | 64500453 |
Filed Date | 2019-05-02 |
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United States Patent
Application |
20190125232 |
Kind Code |
A1 |
Wine; Jason A. ; et
al. |
May 2, 2019 |
MULTI-PORT CONTROL VALVE FOR USE IN BLOOD SAMPLING, BLOOD PRESSURE
MEASUREMENT SYSTEMS
Abstract
Disclosed is a multi-port control valve with multi-lumen paths
diverging flow so that, the multi-port control valve fills and
expels fluid at the same time through the same port for use in a
blood sampling, blood pressure monitoring system that includes a
sampling site, a pressure transducer, and reservoir. The multi-port
control valve may include a rotatable valve member and three ports.
Each of the three ports is connected to one of the sampling site,
the pressure transducer, and the reservoir. In particular, the
rotatable valve member is rotatable, such that, depending upon a
position of the rotatable valve member, one of the three ports is
blocked from fluid communication with the other two ports.
Inventors: |
Wine; Jason A.; (Placentia,
CA) ; Siemons; Alexander H.; (Yorba Linda, CA)
; Hoan; Andrew Nguyen; (Irvine, CA) ; Farhadieh;
Mandana; (Tustin, CA) ; Murphy; Brian Patrick;
(Sunset Beach, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences Corporation |
Irvine |
CA |
US |
|
|
Assignee: |
Edwards Lifesciences
Corporation
Irvine
CA
|
Family ID: |
64500453 |
Appl. No.: |
15/801009 |
Filed: |
November 1, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150221 20130101;
A61M 5/1413 20130101; A61B 5/021 20130101; A61M 39/223
20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/021 20060101 A61B005/021 |
Claims
1. A multi-port control valve with multi-lumen paths diverging flow
so that, the multi-port control valve fills and expels fluid at the
same time through the same port for use in a blood sampling, blood
pressure monitoring system that includes a sampling site, a
pressure transducer, and reservoir, the multi-port control valve
comprising: a rotatable valve member; and three ports, wherein each
of the three ports is connected to one of the sampling site, the
pressure transducer, and the reservoir, wherein, depending upon a
position of the rotatable valve member, one of the three ports is
blocked from fluid communication with the other two ports.
2. The multi-port control valve of claim 1, further comprising a
visual indicator that is visually indicative of one of a plurality
of modes of operation of the control valve based upon the position
of the rotatable valve member.
3. The multi-port control valve of claim 2, wherein the plurality
of modes of operation comprise: a flushing/priming mode, a
monitoring mode, a drawing/re-infusing mode, or a sampling
mode.
4. The multi-port control valve of claim 3, wherein, in the
monitoring mode, the port connected to the reservoir is blocked
from fluid communication with the rest of the other ports.
5. The multi-port control valve of claim 3, wherein, in the
drawing/re-infusing mode, the port connected to the pressure
transducer is blocked from fluid communication with the rest of the
other ports.
6. The multi-port control valve of claim 3, wherein, in the
sampling mode, the port connected to the sampling site is blocked
from fluid communication with the rest of the other ports.
7. The multi-port control valve of claim 3, wherein, in the
flushing/priming mode, all three ports are open to fluid flow.
8. The multi-port control valve of claim 2, further comprising a
valve handle coupled to the rotatable valve member such that the
rotatable valve member rotates in synchrony with the valve handle
and wherein the valve handle includes the visual indicator.
9. A blood sampling, blood pressure monitoring system comprising: a
sampling site; a pressure transducer; a reservoir; and a multi-port
control valve with multi-lumen paths diverging flow so that, the
multi-port control valve fills and expels fluid at the same time
through the same port for use in the blood sampling, blood pressure
monitoring system, the multi-port control valve coupled to the
sampling site, the pressure transducer, and the reservoir, the
multi-port control valve comprising: a rotatable valve member; and
three ports, wherein each of the three ports is connected to one of
the sampling site, the pressure transducer, and the reservoir,
wherein, depending upon a position of the rotatable valve member,
one of the three ports is blocked from fluid communication with the
other two ports.
10. The blood sampling, blood pressure monitoring system of claim
9, further comprising a visual indicator that is visually
indicative of one of a plurality of modes of operation of the
control valve based upon the position of the rotatable valve
member.
11. The blood sampling, blood pressure monitoring system of claim
10, wherein the plurality of modes of operation comprise: a
flushing/priming mode, a monitoring mode, a drawing/re-infusing
mode, or a sampling mode.
12. The blood sampling, blood pressure monitoring system of claim
11, wherein, in the monitoring mode, the port connected to the
reservoir is blocked from fluid communication with the rest of the
other ports.
13. The blood sampling, blood pressure monitoring system of claim
11, wherein, in the drawing/re-infusing mode, the port connected to
the pressure transducer is blocked from fluid communication with
the rest of the other ports.
14. The blood sampling, blood pressure monitoring system of claim
11, wherein, in the sampling mode, the port connected to the
sampling site is blocked from fluid communication with the rest of
the other ports.
15. The blood sampling, blood pressure monitoring system of claim
11, wherein, in the flushing/priming mode, all three ports are open
to fluid flow.
16. The blood sampling, blood pressure monitoring system of claim
10, further comprising a valve handle coupled to the rotatable
valve member such that the rotatable valve member rotates in
synchrony with the valve handle and wherein the valve handle
includes the visual indicator.
17. A method for utilizing a multi-port control valve with
multi-lumen paths diverging flow so that, the multi-port control
valve fills and expels fluid at the same time through the same port
for use in a blood sampling, blood pressure monitoring system that
includes a sampling site, a pressure transducer, and reservoir, the
method comprising: rotating a rotatable valve member to one of
three ports of the multi-port control valve, wherein each of the
three ports is connected to one of the sampling site, the pressure
transducer, and the reservoir; and wherein, depending upon the
position that the rotatable valve member is rotated to, one of the
three ports is blocked from fluid communication with the other two
ports.
18. The method of claim 17, further comprising rotating a visual
indicator that is visually indicative of one of a plurality of
modes of operation of the control valve based upon the position of
the rotatable valve member.
19. The method of claim 18, wherein the plurality of modes of
operation comprise: a flushing/priming mode, a monitoring mode, a
drawing/re-infusing mode, or a sampling mode.
20. The method of claim 19, wherein, in the monitoring mode, the
port connected to the reservoir is blocked from fluid communication
with the rest of the other ports.
21. The method of claim 19, wherein, in the drawing/re-infusing
mode, the port connected to the pressure transducer is blocked from
fluid communication with the rest of the other ports.
22. The method of claim 19, wherein, in the sampling mode, the port
connected to the sampling site is blocked from fluid communication
with the rest of the other ports.
23. The method of claim 19, wherein, in the flushing/priming mode,
all three ports are open to fluid flow.
24. The method of claim 18, wherein a valve handle is coupled to
the rotatable valve member such that the rotatable valve member
rotates in synchrony with the valve handle and wherein the valve
handle includes the visual indicator.
Description
BACKGROUND
Field
[0001] The present invention relates to blood sampling, blood
pressure measurement systems, and, in particular, to a multi-port
control valve for use in a blood sampling, blood pressure
measurement system.
Relevant Background
[0002] In a hospital setting there is always the need to monitor
patient health through the evaluation of a blood chemistry profile.
The simplest method employed in the hospital is to use a syringe
carrying a sharpened cannula at one end and insert that cannula
into a vein or artery to extract a blood sample from the patient.
Patients that are in critical care units or the operating room
sometimes require as many as twelve samples a day. Such frequent
sampling injections potentially expose the patient to airborne
bacteria and viruses which can enter the bloodstream through the
opening made by the sharpened cannula.
[0003] One way to obtain a blood sample is to draw the blood from a
catheter that is already inserted in the patient, either in a
central venous line, such as one placed in the right atrium, or in
an arterial line. Typically, existing access sites for arterial or
venous or pressure monitoring lines are used to take periodic blood
samples from the patient. Conventional mechanisms for drawing blood
from the lines used for infusion or pressure monitoring utilize a
plurality of stopcock mechanisms that preclude flow from the
infusion fluid supply or from the pressure column drip supply,
while allowing blood to flow from the patient into a collecting
syringe connected to a proximal port formed in one of the
stopcocks.
[0004] Earlier systems required a two-step operation where a first
sample of fluid, generally about 5 ml in volume for intensive care
environments was withdrawn into the sampling syringe and discarded.
This first sample potentially included some of the infusion fluid
and thus would be an unreliable blood chemistry measurement sample.
After the initial sample had been discharged, the second sample was
pure blood from the artery or vein.
[0005] In response to the drawbacks associated with earlier
two-step sampling systems, closed systems were developed.
Commercial closed systems such as the Venous Arterial blood
Management Protection (VAMP) system feature a reservoir in the
tubing line from the patient that can draw fluid past a sampling
port. The clearing volume is held in the in-line reservoir, and
set-aside in a syringe for re-infusion later. The sampling systems
are often used in conjunction with a pressure monitor having a
transducer continually or periodically sensing pressure within the
sampling line except during the draw of a blood sample.
[0006] The VAMP system conveniently utilizes a reservoir with
one-handed operability, and includes a line from the patient into
and out of the reservoir and to a proximal source of flushing fluid
and a pressure transducer. (The standard directional nomenclature
is that proximal is toward the clinician, or away from the patient,
and distal is toward the patient). A pressure transducer in the
line proximal to the reservoir senses fluid pressure within the
line and conveys the signal to a monitor. One exemplary pressure
transducer is a Disposable Pressure Transducer (DPT).
[0007] When a blood sample is to be taken, the nurse or clinician
withdraws an amount of fluid into the reservoir chamber and distal
line sufficient to pull pure blood past one or more fluid sampling
sites. After full retraction of the plunger, the stopcock valve
closes off the reservoir from the patient and a sample of blood is
taken at one or the other sampling sites. Subsequently, the
clinician manipulates the stopcock valve so that the volume within
the reservoir can be reinfused back into the patient by depressing
the plunger, and the flushing drip and pressure monitoring
resumes.
SUMMARY
[0008] Embodiments of the invention may relate to a multi-port
control valve with multi-lumen paths diverging flow so that, the
multi-port control valve fills and expels fluid at the same time
through the same port for use in a blood sampling, blood pressure
monitoring system that includes a sampling site, a pressure
transducer, and reservoir. The multi-port control valve may include
a rotatable valve member and three ports. Each of the three ports
is connected to one of the sampling site, the pressure transducer,
and the reservoir. In particular, the rotatable valve member is
rotatable, such that, depending upon a position of the rotatable
valve member, one of the three ports is blocked from fluid
communication with the other two ports.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a diagram illustrating an example blood sampling
system in an example blood sampling, blood pressure monitoring
system as may be set up in a hospital room and connected to a
patient.
[0010] FIGS. 2A-2B are diagrams illustrating a front view and a
cross-section view of an example of a multi-port control valve,
according to embodiments of the invention.
[0011] FIGS. 3A-3D are diagrams illustrating perspective views of
the multi-port control valve in various modes of operation,
according to embodiments of the invention.
[0012] FIGS. 4A-4D are diagrams illustrating cross-section views of
the multi-port control valve in various modes of operation,
according to embodiments of the invention.
[0013] FIGS. 5A-5D are diagrams illustrating various perspective,
cross-section, and other views of the multi-port control valve and
a reservoir, according to embodiments of the invention.
[0014] FIGS. 6A-6C are diagrams illustrating various views of a
bracket having a clip to mount the multi-port control valve and the
reservoir to a sensor holder, according to embodiments of the
invention.
DETAILED DESCRIPTION
[0015] Embodiments of the invention may relate to a multi-port
control valve with multi-lumen paths diverging flow so that, the
multi-port control valve fills and expels fluid at the same time
through the same port for use in a blood sampling, blood pressure
monitoring system that includes a sampling site, a pressure
transducer, and reservoir. The multi-port control valve may include
a rotatable valve member and three ports. Each of the three ports
is connected to one of the sampling site, the pressure transducer,
and the reservoir. In particular, the rotatable valve member is
rotatable, such that, depending upon a position of the rotatable
valve member, one of the three ports may be blocked from fluid
communication with the other two ports. The modes of operation may
comprise: a flushing/priming mode, a monitoring mode, a
drawing/re-infusing mode, and a sampling mode. As will be described
in more detail hereafter, the multi-port control valve and the
reservoir include a unique structure comprising various fluid flow
dividers and directors in the multi-port control valve and the
reservoir that provide for a complete flushing of residual blood
from the reservoir during the flush operation.
[0016] As an example, a clinician may rotate the rotatable valve
member through a valve handle that is connected thereto. The valve
handle may have a visual indicator on it that is visually
indicative of one of the plurality of modes of operation (e.g., a
flushing/priming, mode, a monitoring mode, a drawing/re-infusing
mode, and a sampling mode). Therefore, a system and method for
indicating to the clinician, in an intuitive manner, the present
mode of operation based upon rotating the valve handle, as well as,
for assisting the clinician in correctly turning the rotating valve
handle to the next desired position (which corresponds to the next
desired mode of operation) is provided. Various examples of these
implementations will be hereafter described in more detail
[0017] FIG. 1 illustrates an example blood sampling system 120 in
an example blood sampling, blood pressure monitoring system 100 as
may be set up in a hospital room and connected to a patient 110.
The blood sampling system 120 comprises a conduit line having a
distal segment 122 toward the patient 110 and a proximal segment
124. The conduit line is primarily medical grade pressure tubing.
The distal segment 122 may terminate in a male luer connector 126
for attaching to a female luer connector (not shown) of an
injection site, or other conduit leading to the patient 110. A
reservoir 130 connects to the conduit line via a multi-port control
valve 132 interposed between the distal segment 122 and the
proximal segment 124. The multi-port control valve 132 externally
resembles a stopcock and controls fluid flow between the conduit
line and the reservoir 130.
[0018] The proximal segment 124 extends from the multi-port control
valve 132 and terminates in a female luer connector 134 attached to
a stopcock 136 of a pressure transducer 138 (e.g., a disposable
pressure transducer (DPT)). The reservoir 130 and pressure
transducer 138 removably mount to a bracket 140 which, in turn, may
be secured to a conventional pole support 142 with the reservoir
130 in a vertical orientation.
[0019] As mentioned above, the blood sampling system 120 forms a
portion of the blood sampling, blood pressure monitoring system
100, and the pressure transducer 138 may be a DPT. However, it
should be appreciated that any type of pressure monitoring device
may be utilized.
[0020] A supply of flush solution 144 connects to a flush port 146
of the transducer 138 via tubing 148. Typically, the flush solution
144 comprises a bag of physiological fluid such as saline
surrounded by a pressurized sleeve that squeezes the fluid and
forces it through the tubing 148. In addition, an infusion fluid
supply (not shown) may be provided in communication with an
infusion port 150 of the stopcock 136. The pressure transducer 138
is thus placed in fluid communication with the arterial or venous
system of the patient 110 through the conduit line, and includes a
cable and plug 152 to connect to a suitable display monitor (e.g.,
patient monitor 160). The pressure transducer 138 is shown
positioned within the proximal segment 124.
[0021] A fluid sampling site 161 that includes a Z-shaped flow
passage adjacent a pre-slit septum may be utilized to sample blood.
The septum preferably comprises an elastomeric disc which accepts a
blunt cannula and reseals after each sample is drawn, reducing the
potential for contamination and eliminating the danger of needle
sticks. However, any type of fluid sampling site may be
utilized.
[0022] The blood sampling reservoir 130 may include a syringe-type
variable volume chamber 162, though other reservoirs that have
constant volume chambers or other receptacles for receiving fluid
may be used. The reservoir 130 is of a type that includes a channel
through the variable volume chamber 162 for passage of flushing
fluid there through.
[0023] In one mode of operation of the sampling system 120, a
reduced pressure is created within the variable volume chamber 162
by withdrawing the plunger 164 such that a fluid sample from the
distal segment 122 is drawn into the chamber 162. The chamber 162
may have a sufficient volume, e.g., 12 ml, to draw blood from the
patient 110 past the sampling site 161. The clinician can then take
a sample of undiluted blood from the sampling site 161.
Subsequently, the blood and other fluids drawn into the reservoir
130 during the sampling operation are re-infused by depressing the
plunger 164. It should be noted that the pressure transducer 138
may include a flow restrictor or flow control means to prevent
flushed solution from going proximally through the sensor rather
than back to the patient 110. For instance, the stopcock 136 may be
used to close off the fluid path through the pressure transducer
138 prior to re-infusing the reservoir clearance volume.
[0024] The entire sampling system 120 is thus closed as the
"priming" volume that ensures a pure sample of blood reaches the
sampling site 161 remains within the sampling system 120 and is
reinfused into the patient.
[0025] With additional reference to FIGS. 2A-2B, an example of the
multi-port control valve 132 of the sampling system 120, will be
described. As has been described, the multi-port control valve 132
for use in the blood sampling, blood pressure monitoring system 100
that includes a sampling site 161, a pressure transducer 138, and a
reservoir 130, may include a rotatable valve 170 and three ports
172, 174, and 176. Port 172 may be connected to appropriate tubing
to the sampling site 161. Port 174 may be connected to appropriate
tubing to the pressure transducer 138. Port 176 may be connected to
the reservoir 130.
[0026] As can be particularly seen in FIG. 2B, rotatable valve
member 170 may be approximately cylindrical-shaped on top--with a
rectangular divider below, and may be rotated around, such that, as
will be described in more detail hereafter, depending upon a
position of the rotatable valve member 170, one of the three ports
172, 174, and 176 may be blocked by the cylindrical-shaped surface
of the rotatable valve member 170 from fluid communication with the
other two ports. Further, port 176 may have a divider 178 that
divides fluid flow to and from the reservoir 130 below. As will be
described in more detail hereafter, the port from the multi-port
control valve 132 that connects to the reservoir 130 includes a
unique structure comprising a fluid flow divider 178 in the
multi-port control valve (e.g., with rotatable valve member 170)
that interacts with a fluid flow director of reservoir 162 that
provides for a complete flushing of residual blood from the
reservoir during the flush operation.
[0027] As can be seen in FIGS. 2A and 2B, a visual indicator that
is visually indicative of one of the plurality of modes of
operation controlled by the control valve 132, based upon the
position of the rotatable valve member 170, is shown. In one
embodiment, this visual indicator may be shown on a valve handle
180 that is connected to the rotatable valve member 170. In
particular, the valve handle 180 may be coupled to the rotatable
valve member 170 such that the rotatable valve member 170 rotates
in synchrony with the valve handle 180. It should be appreciated
that valve handle 180 may be connected to rotatable valve member
170 by any suitable connection means or the valve handle 180 and
rotatable valve member 170 may be one singular component.
[0028] The valve handle 180 may show a visual indicator indicative
of the mode of operation (e.g., a flushing/priming mode, a
monitoring mode, a drawing/re-infusing mode, and a sampling mode),
as will be described in more detail hereafter. The valve handle 180
may have a centered circular portion 182, a plurality of arrows 184
extending from the circular portion that are used to align with
ports, and a long rectangular handle member 185 that is actuated by
a clinician for rotation. In particular, the handle 185 has an OFF
indicator 186 (with an arrow) that is used to select and indicate
the mode of operation (e.g., a flushing/priming mode, a monitoring
mode, a drawing/re-infusing mode, and a sampling mode), as will be
described in more detail hereafter. Therefore, the OFF visual
indicator 186 on the handle 185 can be used by the clinician to
choose the mode of operation. Also, the plurality of arrows 184
align with the ports. It should be noted that, when the OFF
indicator 186 is particularly positioned with a port, this is an
indication that that port is closed by the rotatable valve member
170.
[0029] As examples, when the OFF indicator 186 of the handle 185 is
pointed to the reservoir port 176, this indicates that the blood
pressure monitoring mode is activated and that the reservoir port
176 is blocked from fluid communication with the other two ports
172 and 174. When the OFF indicator 186 of the handle 185 is
pointed to the pressure transducer port 174, this indicates that a
drawing/re-infusing mode is activated and that the pressure
transducer port 174 is blocked from fluid communication with the
other two ports 172 and 176. When the OFF indicator 186 of the
handle 185 is pointed to the sampling port 172, this indicates a
sampling mode is activated and that the sampling site port 172 is
blocked from fluid communication with the other two ports 174 and
176. Further, when the OFF indicator 186 of the handle 185 is
pointed up, this indicates a flushing/priming mode and all of the
ports 172, 174, and 176 are all open for fluid communication.
[0030] As an example, a clinician may rotate handle 185 of valve
handle 180 that is connected to rotatable valve member 170 to
select a desired operational mode. In particular, the OFF indicator
186 of handle 185 provides a visual indicator that is visually
indicative of the desired mode of operation (e.g., a
flushing/priming mode, a monitoring mode, a drawing/re-infusing
mode, and a sampling mode), as will be described in more detail
hereafter. Further, the arrows 184 align with ports to further
indicate the correct positioning and mode. Therefore, a system and
method is provided for indicating to the clinician, in an intuitive
manner, the present mode of operation based on rotating the handle
185 of the valve handle 180 that is very useful in assisting the
clinician in correctly turning the rotating valve handle 180 to a
next desired position, which corresponds to the next desired mode
of operation. Various examples of these implementations will be
hereafter described in more detail.
[0031] With additional reference to FIGS. 3A-3D and 4A-4D, various
modes of operation will be described. Looking at these figures, it
should be appreciated that pressure transducer port 174 connects to
appropriate tubing to support fluid flow to pressure transducer
138; sampling port 172 connects to appropriate tubing to support
fluid flow to sampling site 161; and reservoir port 176 is
connected to reservoir 130, as previously described.
[0032] As has been previously described, when handle 185 is rotated
to a desired position for a desired operational mode (e.g., a
flushing/priming mode, a monitoring mode, a drawing/re-infusing
mode, and a sampling mode), rotatable valve member 170 is rotated
to the proper position to block fluid flow from any one of the
three ports 172, 174, 176 with fluid flow communication with the
other two ports, or may allow fluid flow communication between all
three ports 172, 174, and 176 (e.g., flushing/priming mode). When a
port of the control valve 132 is blocked by the rotatable valve
member 170 from fluid communication with the other two ports, it
can be referred to as being closed; otherwise, it can be referred
to as being open.
[0033] With brief additional reference to FIGS. 5A and 5B, as has
been described, the multi-port control valve 132 may be connected
to the blood sampling reservoir 130. The blood sampling reservoir
130 may include a syringe-type variable volume chamber 162. In
particular, the reservoir port 176 may connect within an
approximately circular receiving portion 177 of the chamber 162. As
has been described, a reduced pressure is created within the
chamber 162 by withdrawing the plunger 164 (e.g., having a
push/pull handle 157, a rod 158, and a head 159) such that a fluid
sample is drawn into the chamber 162. The chamber 162 may have a
sufficient volume, e.g., 12 ml, to draw blood from the patient 110
past the sampling site 161. The clinician can then take a sample of
undiluted blood from the sampling site 161. Subsequently, the blood
and other fluids drawn into the reservoir 130 during the sampling
operation are re-infused by depressing the plunger 164. Also, the
volume chamber 162 may have a pair of protruding rectangular
sections 187. As will be described, and as shown in FIG. 5B, by
utilizing a divider 178 in the reservoir port 176 of the multi-port
control valve 132 that mates with a divider 188 in the chamber 162
of the reservoir 130, a fluid circuit is created from multi-port
control valve 132 through the reservoir 130 and back to the
multi-port control valve 132. As will be described, by utilizing
the divider 178 in the reservoir port 176 of the multi-port control
valve 132 that mates with the divider 188 in the volume chamber
162, a complete flushing of residual blood from the reservoir may
be achieved.
[0034] With particular reference again to FIGS. 3A and 4A, the
clinician may rotate handle 185 to the top position as shown in
FIGS. 3A and 4A such that the OFF indicator 186 is pointed upwards.
This corresponds to the flushing/priming mode of operation, meaning
that all fluid communications are open. In particular, when the OFF
indicator 186 of the handle 185 is pointed up, the rotatable valve
member 170 is pointed up, such that all of the ports: sample site
port 172, pressure transducer port 174, and reservoir port 176; are
all open for fluid communication. During the flushing/priming mode
of operation, the reservoir 130, sample sites 161, and tubes can be
flushed, cleared, and de-bubbled. Also, a snap tab of the pressure
transducer 138 may be pulled to flush saline and clear air bubbles.
In this mode of operation, portions of the blood sampling, blood
pressure monitoring system 100 may be cleared for operation.
[0035] With reference to FIGS. 3B and 4B, when blood pressure
monitoring is desirable by the blood pressure transducer 138, the
clinician may rotate handle 185 to another position, which
corresponds to the blood pressure monitoring mode. In this
position, when the OFF indicator 186 of the handle 185 is pointed
downward to the reservoir port 176, this indicates that the blood
pressure monitoring mode is activated. In this position, the
rotatable valve member 170 blocks fluid communication from the
reservoir port 176 with the pressure transducer port 174 and the
sampling site port 172 such that fluid communication from the
reservoir 130 is blocked from the pressure transducer 138 and
sampling site 161. In this way, the reservoir 130 is closed from
fluid communication to isolate the reservoir 130 from the blood
pressure monitoring system so that it does not interfere with blood
pressure measurement. In particular, in this configuration, there
is a direct high fidelity fluid link between the patient 110
through the tubes to pressure transducer 138 for blood pressure
measurement.
[0036] When the clinician would like a blood sample, the clinician
should engage in a drawing/re-infusing mode operation. With
reference to FIGS. 3C and 4C, the clinician may rotate handle 185
to another position, which corresponds to the drawing/re-infusing
mode. In this position, when the OFF indicator 186 of the handle is
pointed to the pressure transducer port 174, this indicates the
drawing/re-infusing mode is activated. In this position, the
rotatable valve member 170 blocks fluid communication from the
pressure transducer port 174 with the reservoir port 176 and
sampling site port 172 such that fluid communication from pressure
transducer 138 is blocked from the reservoir 130 and the sampling
site 161. In this way, in the drawing/re-infusing mode operation, a
clearing volume can be pulled from the distal segment of the
patient 110 through the tube by pulling plunger 164 of the
reservoir 130 downward such that a mixture of blood and saline is
pulled by the plunger 164 into the chamber 162 of the reservoir
130. Based upon this, a sampling mode can be initiated.
[0037] Next, when the clinician wishes to obtain a blood sample,
the clinician should engage in a sampling mode operation. With
reference to FIGS. 3D and 4D, the clinician may rotate handle 185
to another position, which corresponds to the sampling mode. In
this position, when the OFF indicator 186 of the handle is pointed
to the sampling port 172, this indicates the sampling mode is
activated. In this position, the rotatable valve member 170 blocks
fluid communication from the sampling port 172 with the reservoir
port 176 and pressure transducer port 174 such that fluid
communication from sampling site 161 is blocked from the reservoir
130 and the pressure transducer 138. In this way, in the sample
mode operation, fluid may be drawn from the sampling site 161 that
comes purely from the patient 110 and not from the reservoir 130 or
other areas (e.g., such as, the pressure transducer 138). Thus,
blood can be withdrawn from the sampling site 161 with pure blood
in a secure manner, as previously described.
[0038] Continuing with these modes of operation, once the blood
sample is drawn, the clinician may rotate handle 185 to the
drawing/re-infusing mode position (FIGS. 3C and 4C). In this
position, when the OFF indicator 186 of the handle is pointed to
the pressure transducer port 174, this indicates the
drawing/re-infusing mode is activated, as previously described. In
this position, the rotatable valve member 170 blocks fluid
communication from the pressure transducer port 174 with the
reservoir port 176 and sampling site port 172 such that fluid
communication from pressure transducer 138 is blocked from the
reservoir 130 and the sampling site 161. In the drawing/re-infusing
mode operation (e.g., with additional reference to FIG. 1), the
plunger 164 may be pushed up by the clinician at a slow rate until
the plunger 164 latches onto the closed and locked position of the
reservoir 130 such that the clearing volume (e.g., saline and blood
mixture) is pushed back through the appropriate tubing back to the
patient 110. Next, the clinician may rotate handle 185 to the top
position (FIGS. 3A and 4A), such that the OFF indicator 186 is
pointed upwards to the flushing/priming mode operation such that
all fluid communications are open. During the flushing/priming mode
operation, the reservoir 130, sample sites 161, and tubes can be
flushed, cleared, and de-bubbled. Also, a snap tab of the pressure
transducer 138 may be pulled to flush saline and clear air bubbles.
In this mode of operation, portions of the blood sampling, blood
pressure monitoring system 100 may be cleared for operation.
[0039] With particular reference to FIGS. 5A-5D, structural
features of the multi-port control valve 132 and the reservoir 130
will be described that provide for the complete flushing of
residual blood from the top part of the chamber 162 of the
reservoir 130 when the head 159 of the plunger 164 latches onto the
closed and locked position of the reservoir 130 after the
re-infusing mode operation and when the flush mode operation has
been engaged in. In particular, by utilizing a divider 178 in the
reservoir port 176 of the multi-port control valve 132 that mates
with a divider 188 in the volume chamber 162 of the reservoir 130,
a fluid circuit is created from the multi-port control valve 132
through the reservoir 130 and back to the multi-port control valve
132. By utilizing the divider 178 in the reservoir port 176 of the
multi-port control valve 132 that mates with the divider 188 in the
volume chamber 162, in combination with a fluid director 200 (as
will be described) attached to divider 188, a complete flushing of
residual blood from the area between the head 159 of the plunger
164 and the area of the chamber 162 (i.e., the top area 202 and the
outside circumference 204 of the chamber 162), and the head 159
itself, may be achieved during the flush operation. As an example,
there may only be a 0.01 inch height between the head 159 of the
plunger 164 and the top area 202 of the chamber 162. In one
example, the fluid director 200 may be approximately H-shaped
having two opposed bars 210 and 212. However, this is only one
example shape of a fluid director and any suitable shape to guide
fluid to clean the interior of the chamber 162 may be used (e.g.,
Y-shapes, W-shapes, etc.)
[0040] With particular reference to FIGS. 5C and 5D, during a flush
mode operation, saline is flushed through the pressure transducer
port 174 down first channel 220 divided by dividers 178 and 188
such that the saline flows against the head 159 of the plunger 164
and is guided by the opposed bars 210 and 212 of the H-shaped fluid
director 200 against the outside circumference 204 and the top area
202 of the chamber 162 around the inside of the chamber (e.g.,
following lines 230 and 232) such that the fluid is then flushed
out of the chamber up second channel 222 divided by dividers 178
and 188 through the sampling site port 172 back to the tubing and
the patient. In the flush operation, the reservoir 130, sample
sites 161, and tubes can be flushed, cleared, and de-bubbled.
However, by the particularly described structure, a sufficient,
suitable, adequate, or complete flushing of residual blood from the
area between the head 159 of the plunger 164 and the area of the
chamber 162 (i.e., the top area 202 and the outside circumference
204 of the chamber 162), and the head 159 itself, may be achieved
during the flush operation.
[0041] With reference again to FIGS. 3A-3D and 4A-4D, next the
clinician may again enable blood pressure monitoring mode by
rotating handle 185 back the blood pressure monitoring position, in
which, the OFF indicator 186 of the handle 185 is pointed downward
to the reservoir port 176 (FIGS. 3B and 4B). As has been described,
in the blood pressure monitoring mode, the reservoir port 176
towards the reservoir 130 is closed from fluid communication to
isolate the reservoir 130 from the blood pressure monitoring system
so that it does not interfere with blood pressure measurement. In
particular, in this configuration, there is a direct high fidelity
fluid link between the patient 110 through the tubes to pressure
transducer 138 for blood pressure measurement.
[0042] As has been described, all of the modes of operation (e.g.,
a flushing/priming mode, a monitoring mode, a drawing/re-infusing
mode, and a sampling mode) may be activated by a clinician in a
very straight forward manner by rotating handle 185 such that the
OFF indicator 186 is in an appropriate position to inform the
clinician as to what mode of operation the blood sampling, blood
pressure monitoring system 100 is operating in. Also, it should be
appreciated that because the pressure transducer 138 contains a
small orifice in the normal state, fluid flow is restricted, such
that, although all fluid communications are open when the valve
member 170 is in the flushing position, all the fluid flow pulled
into the reservoir 130 should come from the patient side. Because
of this, the flushing/priming mode may be used in some instances,
instead of the drawing/re-infusing mode.
[0043] As has been described, a clinician may rotate handle 185 of
valve handle 180 that is connected to rotatable valve member 170 to
select a desired operational mode. In particular, the OFF indicator
186 of handle 185 provides a visual indicator that is visually
indicative of the desired mode of operation (e.g., a
flushing/priming mode, a monitoring mode, a drawing/re-infusing
mode, and a sampling mode). Further, the arrows 184 align with
ports to further indicate the correct positioning and mode. Thus, a
system and method is provided for indicating to the clinician, in
an intuitive manner, the present mode of operation based on
rotating the handle 185 of the valve handle 180 that is very useful
in assisting the clinician in correctly turning the rotating valve
handle 180 to a next desired position, which corresponds to the
next desired mode of operation. With the assistance of the visual
indication assembly, confusion as to the present mode of operation
of the control valve and to the correct way to rotate the valve
member/handle for the next desired mode of operation may be
reduced, and the work efficiency of the clinician improved.
[0044] It should be noted that the OFF indicator 186 with the arrow
indicates that the blocking member of the rotatable valve member
170 is present and that the port (if one is present) is closed.
However, the other arrows 184 indicate that the ports are open
(i.e., the rotatable valve member is not blocking fluid) and
further that the lines 187 between the arrows 184 indicate an open
fluid path. Therefore, each of the previously described modes of
operation (the flushing/priming mode, the monitoring mode, the
drawing/re-infusing mode, and the sampling mode), that are easily
selectable by the clinician, via the OFF indicator 186, the arrows
184, and the lines 187, indicate what port is closed (OFF indicator
186), what ports are open (arrows 184), and the directions of the
fluid flow (lines 187).
[0045] As previously described examples, when the OFF indicator 186
of the handle 185 is pointed to the reservoir port 176, this
indicates that the blood pressure monitoring mode is activated and
that the reservoir port 176 is blocked from fluid communication
with the other two ports 172 and 174, and that the sampling port
172 and the pressure transducer port 174 are open (arrows 184 point
to them), and fluid flows between the ports as indicated by the
lines 187 and arrows 184 (FIG. 3B). When the OFF indicator 186 of
the handle 185 is pointed to the pressure transducer port 174, this
indicates that a drawing/re-infusing mode is activated and that the
pressure transducer port 174 is blocked from fluid communication
with the other two ports 172 and 176, and that the sampling port
172 and the reservoir port 176 are open (arrows 184 point to them),
and fluid flows between the ports as indicated by the lines 187 and
arrows 184 (FIG. 3C). When the OFF indicator 186 of the handle 185
is pointed to the sampling port 172, this indicates a sampling mode
is activated and that the sampling site port 172 is blocked from
fluid communication with the other two ports 174 and 176, and that
the pressure transducer port 172 and the reservoir port 176 are
open (arrows 184 point to them), and fluid flows between the ports
as indicated by the lines 187 and arrows 184 (FIG. 3D). Further,
when the OFF indicator 186 of the handle 185 is pointed up, this
indicates a flushing/priming mode and all of the ports (pressure
transducer port 174, reservoir port 176, and sampling site port
172) are open (arrows 184 point to them) for fluid communication,
and fluid flows between the ports as indicated by the lines 187 and
arrows 184 (FIG. 3A).
[0046] As can be particularly seen in FIGS. 3A-3D, particular
implementations of the arrows 184, lines 187, and OFF indicators
186, will now be described. As has been described, the arrows 184,
lines 187, and OFF indicators 186 are put on the three-port control
valve 132 that are different than typical stopcock valves and
provide a clear indication of the fluid path directions and what
operational mode the multi-port control valve 132 is in. As can be
seen in FIGS. 3A-3D, the indicators (the arrows 184, the lines 187,
the OFF indicator 186) may be slightly raised or elevated relative
to the rest of the rotatable handle 185. As one example, the
indicators (the arrows 184, the lines 187, the OFF indicator 186)
may be molded into the handle (e.g., embossed), and hot foil
stamped directly on the raised surface to provide contrast (e.g.,
color) from the rotatable handle 185. As one example, the rotatable
handle may be white and the color of the indicators (the arrows
184, the lines 187, the OFF indicator 186) may be black. However,
any suitable colors may be utilized.
[0047] Also, in one implementation, the top of the multi-port
control valve 132 may have a rectangular visual indicator 195 and
the top of the rotatable handle may have a pair of aligned
rectangular lines 197. When, the multi-port control valve 132 and
the system are in the blood pressure monitoring mode, FIG. 3B, the
alignment of the pair of aligned rectangular lines 197 with the
rectangular visual indicator 195 (along with the OFF indicator 186
pointing down), provides a very clear indicator to the clinician
that the system is set for the blood pressure monitoring mode. In
some examples, the pair of aligned rectangular lines 197 and the
rectangular visual indicator 195 may be colored (e.g., green, red,
yellow, any color) for further visual indication to the clinician.
The colors of the rectangular lines and the rectangular visual
indicator may be the same colors or different colors. Further, any
sort distinguishing color, shape, design, etc., may be used to
increase the visual indication to the clinician. Also, in one
example, the top and bottom of the rotatable hand 185 may include
aligned raised rectangular lines 199 to provide indicators and
grabbing ease to the clinician's fingers to rotate the rotatable
handle.
[0048] It should be appreciated that although various visual
indicator types (e.g., arrows, terminology (e.g., OFF), handles,
structures, etc.) to indicate the various operational modes have
been described in detail, that these are just examples, and that
any suitable visual indicator type may be utilized to inform the
clinician of the operational mode of the blood sampling, blood
pressure monitoring system 100.
[0049] It should be appreciated that previously described design
structures allow for the use of the multi-port control valve 132 to
allow for the isolation of the reservoir 130 during blood pressure
monitoring that enhances the frequency response of the blood
pressure monitoring device, which further allows for the increase
of working length (e.g., increased working length tubing). In
particular, the isolation of the reservoir maintains a high
fidelity of the frequency response--allowing for the longer working
tubing length. The increased working length may be useful for use
in the operating room. Further, the previously described design
structures allow for the flushing of all unwanted blood from the
reservoir 130 during flushing.
[0050] With reference to FIGS. 6A-6C, as will be described, the
multi-port control valve 132 and the reservoir 130 (e.g., the
device 304) may be mounted to a sensor holder 300 with a bracket
302 having a clip that automatically engages the sensor holder 300
upon installation. When the clinician intends to remove the device
304, the clinician simply needs to disengage the clip in order to
remove the device 304 from the sensor holder 300. The bracket 302
with the clip, as will be described, holds the device 304 in a
fixed manner to avoid movement and falling--while allowing easy
mounting and demounting by a clinician without discomfort to the
clinician.
[0051] In particular, with reference to FIGS. 6A-6C, the bracket
302 for mounting the multi-port control valve 132 and the reservoir
130 (e.g., the device 304) to the sensor holder 300 will be more
particularly described hereafter. Looking at the sensor holder 300,
the sensor holder 300 may be approximately rectangular shaped and
may be mountable to an IV pole--as sensor holders typically are
(e.g., see FIG. 1). In particular, sensor holder 300 may include a
plurality of mounting sections 310 that include two-opposed
rectangular portions 312 and 314 that each have slots 320 and
bottoms 322. As will be described, the slots 320 and bottoms 322
may receive flanges of the bracket 302 and clips. Also, the
mounting sections 320 may include guide rails 321 that may be used
by devices.
[0052] Looking particularly at the bracket 302, the bracket 302 may
include a curved backside 330 and two extending sidewalls 332 with
curved portions that extend therefrom to surround, hold, and mount
the chamber 162 of the reservoir 130 therein. Further, extending
downward with the two extending sidewalls 332 with curved portions
are engagement areas 350 having two indicator lines 351. Also,
bracket 302 may include a base table 336 to abut the bottom of the
reservoir including one of the protruding rectangular sections 187
to hold the reservoir in place. Furthermore, the backside 330 may
include an approximately rectangular opening 331 to accept one of
the protruding rectangular sections 187 mounted against the base
table 336 for further mounting stability. Moreover, bracket 302 may
include a pair of one-way clips 342 that clip into place when the
bracket 302 is mounted into a mounting section 310 of the sensor
holder 300 by a clinician, as will be described. The clips 342
extend as flanges from the engagement areas 350. Additional flanges
340 extend from the sidewalls 332 and the engagement areas 350,
respectively.
[0053] Also, bracket 302 may include a downward extending plunger
section 360 with sidewalls 362 and a base portion 366 that tapers
downward from the base table 336. The plunger section 360 may be
used to partially cover and protect the push-pull handle 157 and
rod 158 of the plunger 164. As can be seen in FIG. 6A, the
push-pull handle 157 may also have an L-shaped thumb feature 370
including two rectangular indicators for easy pushing and pulling
by the clinician. The base portion 366 may prevent the push-pull
handle 157 from over extending.
[0054] In particular, when the bracket 302 firmly holding device
304 is mounted by the clinician to the sensor holder 300, the
mounting sections 310 with the two opposed rectangular portions 312
and 314 having slots 320 and bottoms 322 receive the flanges 340 of
the bracket 302 including the clips 342. When the bracket 302 is
placed by the clinician in the mounting section 310, the flanges
340 of the bracket are received by the slots 320 and the flange's
bottoms abut the bottoms 322 of the two opposed rectangular
portions 312 and 314 and the clips 342 clip around the bottoms 322
of the two opposed rectangular portions 312 and 314, such that the
bracket 302 is mounted in place with audible and visual cues. On
the other hand, to remove the bracket 302, the clinician actuates
the two engagement areas 350 (easily findable by the clinician by
two indicator lines 351) to thereby deflects the clips 342 inward
to allow for disengagement of the clips 342 from the mounting
section 310 of the sensor holder 300. With the clips 342 deflected
inward, the clips 342 are disengaged from the bottoms 322 of the
two opposed rectangular portions 312 and 314, allowing the
clinician to easily remove the bracket 302 and the device 304 by
pulling the bracket 302 upwards and out of the mounting section 310
of the sensor holder 300. The clips 342 can be manually actuated to
allow removal of the bracket from the sensor holder 300, in such
manner that prevents obstruction of the clinicians hand upon
removal from sensor holder 300.
[0055] With the previously described structure of the sensor holder
300 and bracket 302, the two one-way clips 342 may easily snap into
place when the bracket 302 holding the device 304 is pushed into
place by the clinician into the mounting section 310, such that,
the clips snap around the bottoms of the opposed rectangular
portions. On the other hand, when the clinician intends to remove
the bracket 302 holding the device 304, the clinician simply
actuates the clips 342 by deflecting the two engagement areas 350.
In particular, this may be achieved by deflecting the two
engagement areas 350 (easily findable by the clinician by two
indicator lines 351) to allow for the disengagement of the clips
342 from the bottoms of the opposed rectangular portions, such
that, the bracket 302 holding the device 304 is easily moveable in
the reverse direction (e.g. opposite of installation) out of the
mounting section 310. By utilizing this structure, the clinician
does not experience obstacles in removing the bracket 302 holding
the device 304, and it is easy to remove. Also, this structure
enables easy one-handed mounting and removal of the bracket 302 and
device 304 by the clinician. Further, when the bracket 302 is
locked into place, the clips 342 are connected to the sensor holder
300 in a very secure manner, by the clips 342 wrapping around the
bottom portions of the two opposed rectangular portions, such that
the bracket 302 holding the device 304 is securely mounted. In this
way, the bracket 312 and the device 304 are very limited as to
movement in response to being bumped, manipulated, and are much
less susceptible to falling.
[0056] It should further be appreciated that although various types
of valves, ports, and various other mechanical structures and
components have been described, that these are only examples, and
other types of mechanical components may be utilized to perform the
same or similar functions. It should further be appreciated that
the previously described mechanical structures and components may
be made of any material, such as: plastic, metal, rubber, polymer,
polyvinyl chloride, or any suitable material.
[0057] The various illustrative logical blocks, processors,
modules, and circuitry described in connection with the embodiments
disclosed herein may be implemented or performed with a general
purpose processor, a specialized processor, circuitry, a
microcontroller, a digital signal processor (DSP), an application
specific integrated circuit (ASIC), a field programmable gate array
(FPGA) or other programmable logic device, discrete gate or
transistor logic, discrete hardware components, or any combination
thereof designed to perform the functions described herein. A
processor may be a microprocessor or any conventional processor,
controller, microcontroller, circuitry, or state machine. A
processor may also be implemented as a combination of computing
devices, e.g., a combination of a DSP and a microprocessor, a
plurality of microprocessors, one or more microprocessors in
conjunction with a DSP core, or any other such configuration.
[0058] The steps of a method or algorithm described in connection
with the embodiments disclosed herein may be embodied directly in
hardware, in a software module/firmware executed by a processor, or
any combination thereof. A software module may reside in RAM
memory, flash memory, ROM memory, EPROM memory, EEPROM memory,
registers, hard disk, a removable disk, a CD-ROM, or any other form
of storage medium known in the art. An exemplary storage medium is
coupled to the processor such the processor can read information
from, and write information to, the storage medium. In the
alternative, the storage medium may be integral to the
processor.
[0059] The previous description of the disclosed embodiments is
provided to enable any person skilled in the art to make or use the
present invention. Various modifications to these embodiments will
be readily apparent to those skilled in the art, and the generic
principles defined herein may be applied to other embodiments
without departing from the spirit or scope of the invention. Thus,
the present invention is not intended to be limited to the
embodiments shown herein but is to be accorded the widest scope
consistent with the principles and novel features disclosed
herein.
* * * * *