Note: Descriptions are shown in the official language in which they were submitted.
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FLUID OPTIMIZATION AND CONTAMINANT CONTAINMENT DEVICE AND
METHOD USING DISPLACEABLE PLUG
CROSS-REFERENCE TO RELATED APPLICATIONS
[00011 This application claims the benefit of U.S. Provisional Application
No. 63/033,196,
filed June 1, 2020. This application is incorporated herein by reference in
its entirety.
BACKGROUND
[0002] Bacteraemia is the presence of microorganisms in the blood.
Sepsis, on the other
hand, is bacteraemia in the presence of clinical symptoms and signs such as
fever, tachycardia,
tachypnea and hypotension. Bacteraemia and sepsis are associated with a high
mortality and an
increased incidence and duration of hospital stay and associated costs. Many
bacteraemias,
sepsis, fungaemias and other pathogens actually occur within a hospital or
other healthcare
settings with catheters and venipunctures being a source of contamination as
potential carriers of
these pathogens.
[0003] Blood cultures are the standard test used to detect microbial
pathogens related to
bacteraemia and sepsis in a patient's blood. The term blood culture refers to
a single
venipuncture, either from a peripheral site or central or arterial line, with
the blood inoculated
into one or more blood culture bottles or containers. One bottle is considered
a blood culture
where two or more are considered a set. Multiple sets may be obtained from
multiple
venipunctures and are associated with different sites on the patient.
[0004] These methods allow for microbial identification and
susceptibility testing to be
performed, which is a critical component to managing sepsis, however the lack
of rapid results
and decreased sensitivity for fastidious pathogens has led to the development
of improved
systems and adjunctive molecular or proteomic testing.
[0005] Collection of blood samples for conducting blood cultures is a
critical component of
modem patient care and can either positively affect the patient outcome by
providing an accurate
diagnosis, or can adversely affect the outcome by prolonging unnecessary
antimicrobial therapy,
the length of hospital stays, and increasing costs.
[0006] One outcome of collection of blood cultures is contamination.
Blood culture
contamination can lead to a false positive culture result and/or significant
increase in healthcare
related costs. Sources of blood culture contamination include improper skin
antisepsis, improper
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collection tube disinfection, and contamination of the initial blood draw
which may then skew
results.
10007] Blood culture collection kits generally consist of a "butterfly"
set, infusion set, or
other type of venipuncture device as offered by companies like BD, Smiths, B.
Braun and others,
.. and aerobic and anaerobic blood culture bottles. Various different bottles
are also available
depending on the test requirements. These bottles are specifically designed to
optimize recovery
of both aerobic and anaerobic organisms. In conventional kits, a bottle used
is known generally
as a "Vacutainer," which is a blood collection tube formed of a sterile glass
or plastic tube with a
closure that is evacuated to create a vacuum inside the tube to facilitate the
draw of a
i() predetermined volume of liquid such as blood.
[0008] False positive blood cultures are typically a result of poor
sampling techniques. They
cause the use of antibiotics when not needed, increasing hospital costs and
patient anxiety.
Blood cultures are drawn from. a needlestick into the skin, and then a
Vacutainer is attached to
capture a sample of blood. Contamination may occur from improper or incomplete
disinfection
.. of the skin area in and around the puncture site. It may also occur from
the coring of the skin by
the needle during insertion, with the cored skin cells and any associated
contamination being
pulled into the sample.
[0009] Blood flow through a hypodermic needle is laminar, and as such, a
velocity gradient
can be developed over the flow tube as a pressure drop is applied to the
hypodermic needle.
Either forceful aspiration of blood, or using a very small hypodermic needle,
can cause lysis and
a release of potassium from the red blood cells, thereby rendering the blood
samples abnormal.
[0010] In other instances, some patients have delicate veins that can
collapse under a
pressure drop or vacuum, particularly as applied by a syringe's plunger that
is drawn too quickly
for the patient's condition. Since such condition is impossible to know
beforehand, such vein
collapses are a risk and very difficult to control.
[0011] Various strategies have been implemented to decrease blood culture
contamination
rates, e.g. training staff with regard to aseptic collection technique,
feedback with regard to
contamination rates and implementation of blood culture collection kits.
Although skin antisepsis
can reduce the burden of contamination, 20% or more of skin organisms are
located deep within
the dermis and are unaffected by antisepsis. Changing needles before bottle
inoculation is not
advisable as it increases the risk to acquire needle stick injuries without
decreasing
contamination rates.
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[0012] Some conventional systems and techniques for reducing blood
culture contamination
include discarding the initial aliquot of blood taken from central venous
catheters, venipunctures,
and other vascular access systems. However, these systems require the user to
mechanically
manipulate an intravascular device, or require a complex series of steps that
are difficult to
ensure being followed.
[0013] Recent innovations have proposed novel approaches to reduce blood
contaminants by
utilizing methods based on US Patent No. 9,820,682. The '682 patent utilized
the patient's own
blood pressure to manage blood contamination by allowing the initial aliquot
of blood to flow
into a channel that vents to atmosphere. While this approach works well, if a
patient's blood
pressure is too low it can lead to long fill times of the contaminant
containment reservoir.
[0014] Another approach disclosed in US Patent Publication No.
2019/0365303, which
appears inspired by the concepts of the '682 patent, makes use of vacuum
pressure from a
syringe or vacuum bottle, and dissolving membranes, flow controllers or flow
restrictors, and
other mechanical moving parts to reduce blood sample contamination. This
approach, while
possibly eliminating extended fill times of the contaminant containment
reservoir that may occur
with reliance on patient blood pressure as the driving mechanism, presents
other problems in the
second channel, the sampling channel. First, dissolving materials may impact
sample test results
and understanding all the potential testing variations that may occur is
difficult to assess.
Second, flow controllers or flow restrictors as described in the '303
publication impede flow, and
such restrictions may create hemolysis which can negatively impact test
results. Further, flow
restrictions come with a potential addition of wait time to fill a fluid
collection device, which is
also undesirable.
SUMMARY
[001.5] This document describes a non-venting bodily fluid sample
optimization device and
system, for use in a blood sampling or blood culture collection system. In
accordance with
implementations described herein, a device has no permanently-attached,
statically positioned
moving parts, such as valves, state-transitioning switches or diverters, or
other mechanisms that
move, shift or transition from one operating mode to another operating mode,
or from one state
to another state.
[001.6] In one aspect, a fluid sample optimization device is described for
optimizing a fluid
sample collected by a fluid collection device from a fluid source, where a
first portion of the fluid
sample potentially has contaminants. The fluid sample optimization device
includes an inlet
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configured to connect with the fluid source, an outlet configured to connect
with the fluid
collection device, and a sample path connected between the inlet and the
outlet. The fluid
sample optimization device further includes a contaminant containment
reservoir connected
between the inlet and the outlet. The contaminant containment reservoir has an
air permeable
fluid resistor proximate the outlet, and is arranged to receive, when a
pressure differential is
applied between the inlet and the outlet, a first portion of the fluid sample
from the fluid source
to displace air therein through the air permeable fluid resistor and the
outlet, such that upon
receipt of the first portion of the fluid sample and containment of the
contaminants in the
contaminant containment reservoir, subsequent portions of the fluid sample can
be conveyed by
the sample path from the inlet to the outlet when subsequent pressure
differentials are applied
between the inlet and the outlet. The fluid sample optimization device can
further include a
displaceable plug between the inlet and the sample path, or in the sample
path, that can be
displaced by the subsequent pressure differentials to allow the subsequent
portions of the fluid to
be conveyed through the sample path.
[001.7] In another aspect, a fluid sample optimization device includes an.
inlet configured to
connect with the fluid source, and an outlet configured to connect with the
fluid collection device
that provides a negative pressure differential between the inlet and the
outlet. The fluid sample
optimization device further includes a sample path connected between the inlet
and the outlet, a
junction between the inlet and the sample path having a displaceable plug that
is configured to
inhibit at least a part of the first portion of the fluid sample and the
contaminants from entering
the sample path. The fluid sample optimization device further includes a
contaminant
containment reservoir connected between the inlet and the outlet, and that
includes an. air
permeable fluid resistor proximate the outlet. The contaminant containment
reservoir is arranged
to receive, when a pressure differential is applied between the inlet and the
outlet, the first
portion of the fluid sample from the fluid source to displace air therein
through the air permeable
fluid resistor and the outlet, such that upon receipt of the first portion of
the fluid sample and
containment of the contaminants in the contaminant containment reservoir,
subsequent portions
of the fluid sample can move the displaceable plug and be conveyed by the
sample path from the
inlet to the outlet when subsequent pressure differentials are applied between
the inlet and the
outlet.
[0018] The
details of one or more embodiments are set forth in the accompanying drawings
and the description below. Other features and advantages will be apparent from
the description
and drawings, and from the claims.
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BRIEF DESCRIPTION OF THE DRAWINGS
100191 These and other aspects will now be described in detail with
reference to the
following drawings.
[0020] FIG. I illustrates a blood sample optimization system.
100211 FIG. 2 illustrates a blood sample optimization system in accordance
with an
alternative implementation.
[0022] FIG. 3 illustrates a blood sample optimization system in
accordance with another
alternative implementation.
100231 FIG. 4 illustrates a blood sample optimization system in
accordance with another
alternative implementation.
[0024] FIG. 5 illustrates a blood sample optimization system in
accordance with another
alternative implementation.
[00251 FIG. 6 illustrates a blood sample optimization system in
accordance with an
alternative implementation.
[0026] FIG. 7 is a flowchart of a method for optimizing a quality of a
blood culture.
[00271 FIGS. 8A - 8E illustrate a blood sequestration system for non-
contaminated blood
sampling, in accordance with some implementations.
[0028] FIG. 9 illustrates a pathway splitter for use in a blood
sequestrations system.
[00291 FIGS. 10A - 10D illustrate a blood sequestration system for non-
contaminated blood
sampling, in accordance with alternative implementations.
[0030] FIGS. 11A - 11E illustrate a blood sequestration system for non-
contaminated blood
sampling, in accordance with other alternative implementations.
[0031] FIGS. 12A-12D illustrate a blood sample optimization system.
including a blood
sequestration device in accordance with yet other alternative implementations.
[0032] FIGS. 13A-13D illustrate a blood sample optimization system 1300 in
accordance
with yet another alternative implementations.
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[00331 FIGS. 14A-14E illustrate yet another implementation of a blood
sampling system to
sequester contaminates of an initial aliquot or sample to reduce false
positives in blood cultures
or tests performed on a patient's blood sample.
100341 FIGS. 15A-15G illustrate a blood sequestration device and method of
using the same,
in accordance with yet another implementation.
[0035] FIGS. 16A-16D illustrate a blood sequestration device in accordance
with yet another
implementation.
[0036] FIGS. 17A ¨ 17E illustrate a bottom member of a housing for a blood
sequestration
device.
[0037] FIGS. 18A ¨ 18F illustrate a top member of a housing for a blood
sequestration
device.
[0038] FIGS. 19A and 19B illustrate a blood sequestration device having a
top member
mated with a bottom member.
[00391 FIG. 20 shows a blood sample optimization system including a blood
sequestration
device.
[0040] FIG. 21 illustrates a non-vented blood sequestration device using a
wicking material
chamber.
[0041] FIGS. 22A and 22B illustrate a material makeup of a filter for
sequestering blood in a
sequestration chamber of a blood sequestration device.
[0042] FIGS. 23A ¨ 23E illustrate another implementation of a blood
sequestration device
that uses a vacuum force from a blood collection device.
[00431 FIGS. 24A ¨ 24D illustrate another implementation of a blood
optimization system
and blood sequestration device.
[0044] FIGS. 25A ¨ 25D illustrate another implementation of a blood
optimization system
and blood sequestration device.
[0045] FIGS. 26A ¨ 26E illustrate another implementation of a blood
optimization system
and blood sequestration device.
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[0046] FIGS. 27A - 27D illustrate another implementation of a blood
optimization system
and blood sequestration device.
10047] FIGS. 28A --- 28F illustrate another implementation of a blood
optimization system
and blood sequestration device.
[0048] FIGS. 29A - 29C illustrate another implementation of a blood
optimization system
and blood sequestration device.
[00491 FIGS. 30A - 30G illustrate another implementation of a blood
optimization system
and blood sequestration device.
[0050] FIG. 31 illustrates a non-venting fluid contaminant sample
optimization devices, in
accordance with implementations described herein;
[0051] FIGS. 32A - 32C illustrate a fluid sample optimization device
having a housing, an
air-permeable fluid barrier, and a displaceable plug, consistent with
implementations described
herein.
10052] FIGS. 33A --- 33D illustrate a fluid sample optimization device
consistent with
implementations described herein.
[0053] FIGS. 34A 34C illustrate various alternative implementations of a
displaceable plug
or stopper, shown in the form of a ball or rounded object.
[00541 FIGS. 35A and 35B illustrate various alternative implementations
of a displaceable
plug or stopper, shown in the form of a disk.
[0055] FIGS. 36A - 36C illustrate further various alternative
implementations of a
displaceable plug or stopper, consistent with the devices described herein.
[0056] FIGS. 37A and 37B show a variation of a fluid path for fluid flow
after displacement
of a plug; and
[0057] FIGS. 38A - 38C illustrate another fluid sample optimization
device consistent with
implementations described herein.
[0058] Like reference symbols in the various drawings indicate like
elements.
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DETAILED DESCRIPTION
100591 This document describes fluid sample optimization systems and
methods for reducing
or eliminating contaminates in collected blood samples, which in turn reduces
or eliminates false
positive readings in blood cultures or other testing of collected blood
samples. In some
implementations, a blood sample optimization system includes a patient needle
for vascular
access to a patient's bloodstream, a sample needle for providing a blood
sample to a blood
collection container, such as an evacuated blood collection container or tube
like a VacutainerTm
or the like, or other sampling device, and a fluid sample optimization device,
for containing
possible contaminants in a first amount of a fluid sample, such as a blood
sample. Subsequent
amounts of the fluid sample are allowed to bypass the first amount, thereby
containing any
contaminants in the first amount while providing less to zero contaminates in
fluid samples in the
subsequent amounts of the fluid.
100601 FIG. 1 illustrates a blood sample optimization system in
accordance with some
implementations. The system includes a patient needle 1 to puncture the skin
of a patient to
access the patient's vein and blood therein. The system further includes a
sample needle (i.e., a
resealably closed needle for use with VacutainersTm or the like) 5, which may
be contained
within and initially sealed by a resealable boot 10, a Liter activated valve,
or another collection
interface or device. The resealable boot 10 can be pushed aside or around the
sample needle 5 by
application of a VacutainerTm bottle (not shown) for drawing the patient's
blood. The system can
further include a low volume chamber 30 that leads to the sample needle 5, but
also includes an
orifice or one or more channels 45 that lead to a sequestration chamber 55
formed by a housing
50.
[0061] The sequestration chamber 55 is a chamber, channel, pathway, lock,
or other structure
for receiving and holding a first aliquot of the patient's blood, which may be
in a predetermined
or measured amount, depending on a volume of the sequestration chamber 55. The
first draw of
blood typically contains or is more susceptible to containing organisms that
cause bacteraemia
and sepsis or other pathogens than subsequent blood draws. The sequestration
chamber 55 can
be a vessel encased in a solid housing, formed in or defined by the housing
itself, or can be
implemented as tubing or a lumen. The sequestration chamber 55, regardless how
formed and
implemented, may have a predetermined volume. In some implementations, the
predetermined
volume may be based on a volume of the patient needle, i.e. ranging from less
than the volume of
the patient needle to any volume up to or greater than 20 times or more of the
volume of the
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patient needle. The predetermined volume of the sequestration chamber 55 may
also be
established to economize or minimize an amount of blood to be sequestered and
disposed of.
10062] The sequestration chamber 55 can be formed, contained or housed in
a chamber
housing 50, and can be made of plastic, rubber, steel, aluminum or other
suitable material. For
example, the sequestration chamber 55 could be formed of flexible tubing or
other elastomeric
materials. The sequestration chamber 55 further includes an air permeable
blood barrier 20 that
allows air to exit the sequestration chamber 55. As used herein the term "air
permeable blood
barrier" means an air permeable but substantially blood impermeable substance,
material, or
structure. Examples may include hydrophobic membranes and coatings, a
hydrophilic
membrane or coating combined with a hydrophobic membrane or coating, mesh, a
filter, a
mechanical valve, antimicrobial material, or any other means of allowing air
to be displaced from
the sequestration chamber 55 as it is filled with blood. In various exemplary
embodiments, an air
permeable blood barrier may be formed by one or more materials that allow air
to pass through
until contacted by a liquid, such material then becomes completely or
partially sealed to prevent
or inhibit the passage of air and/or liquid. In other words, prior to contact
with liquid, the
material forms a barrier that is air permeable. After contact with a liquid,
the material
substantially or completely prevents the further passage of air and/or liquid.
[0063] The orifice or channel 45 can be any desired length, cross-
sectional shape or size,
and/or can be formed to depart from the low volume chamber 30 at any desired
angle or
orientation. The orifice or channel 45 may also include a one-way flap or
valve 60 that maintains
an initial aliquot of blood sample within the sequestration chamber 55. In
some specific
implementations, the orifice or channel 45 can include a "duck bill" or
flapper valve 60, or the
like, for one-way flow of blood from low volume chamber 30 to the
sequestration chamber 55.
The air permeable blood barrier 20 can also be constructed of a material that
allows air to exit but
then seals upon contact with blood, thereby not allowing external air to enter
sequestration
chamber 55. This sealing would eliminate the need for a valve.
10064] Valve 60 can be any type of valve or closing mechanism. Chamber 30
is designed to
hold virtually no residual blood, and can be designed to be adapted to hold or
allow pass-through
of a particular volume or rate of blood into sequestration chamber 55.
Likewise, sequestration
chamber 55 may also include any type of coating, such as an anti-microbial
coating, or a coating
that aids identification and/or diagnosis of components of the first,
sequestered blood draw.
[0065] Housing 50 and 40 can be formed of any suitable material,
including plastic, such as
acrylonitrile butadiene styrene (ABS) or other thermoplastic or polymeric
material, rubber, steel,
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or aluminum. The air permeable blood barrier 20 can include a color-providing
substance, or
other signaling mechanism, that is activated upon contact with blood from the
initial blood draw,
or when air displacement is stopped, or any combination of events with blood
in the
sequestration chamber 55. The air permeable barrier may also include an outer
layer such as a
hydrophobic membrane or cover that inhibits or prevents the inadvertent or
premature sealing of
the filter by an external fluid source, splash etc. Sequestration chamber 55
can also be
translucent or clear to enable a user to visually confirm the chamber is
filled.
[0066] FIG. 2 illustrates a blood sample optimization system in
accordance with some
alternative implementations. In the implementation shown in FIG. 2, a
sequestration chamber
55, or waste chamber, surrounds the patient needle I, with an open-ended cuff
or housing
connected with the waste chamber and encircling the sample needle housing base
and housing.
The patient needle 1 and sample needle 5 are connected together by a boot 56,
which forms a
continuous blood draw channel therethrough. The boot 56 includes a single
orifice or channel
leading from the blood draw channel into sequestration chamber 55. The device
can include
more than one single orifice or channel, in other implementations. Each
orifice or channel can
include a one-way valve, and can be sized and adapted for predetermined amount
of blood flow.
[0067] The sequestration chamber 55 includes an air permeable blood
barrier. The filter can
further include a sensor or indicator to sense and/or indicate, respectively,
when a predetermined
volume of blood has been collected in the sequestration chamber 55. That
indication will alert a
user to attach an evacuated blood collection tube or bottle, such as a
VacutainerTm to the sample
needle 5. The housing for the sequestration chamber 55 can be any size or
shape, and can
include any type of material to define an interior space or volume therein.
The interior space is
initially filled only with air, but can also be coated with an agent or
substance, such as a
decontaminate, solidifying agent, or the like. Once evacuated blood collection
tube is attached to
the sample needle 5, blood will flow automatically into the patient needle I,
through the blood
draw channel and sample needle 5, and into the bottle. The sample needle 5 is
covered by a
resealable boot, coating or membrane that seals the sample needle when a blood
collection bottle
is not attached thereon or thereto.
[0068] FIG. 3 illustrates a blood sample optimization system in
accordance with some
alternative implementations. In the implementation shown, a sample needle 5 is
surrounded by a
resealable boot or membrane, and is further connected with a patient needle I.
A blood flow
channel is formed through the sample needle and the patient needle. The
connection between the
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sample needle and patient needle includes a "T" or "Y" connector 102, st%
IliCh includes a channel,
port or aperture leading out from the main blood flow channel to a
sequestration chamber 104.
10069] The
T or Y connector 102 may include a flap or one-way valve, and have an opening
that is sized and adapted for a predetermined rate of flow of blood. The
sequestration chamber
104 can be formed from tubing, or be formed by a solid housing, and is
initially filled with air.
The sequestration chamber 104 will receive blood that flows out of a patient
automatically, i.e.
under pressure from the patient's own blood pressure. The sequestration
chamber 104 includes
an air permeable blood barrier 106, preferably at the distal end of tubing
that forms the
sequestration chamber 104, and which is connected at the proximal end to the T
or Y connector
102. The T or Y connector 102 can branch off at any desired angle for most
efficient blood flow,
and can be formed so as to minimize an interface between the aperture and
channel and the main
blood flow channel, so as to minimize or eliminate mixing of the initial
aliquot of blood with
main blood draw samples.
100701 In
some alternative implementations, the sample needle may be affixed to a tubing
of
any length, as shown in FIG. 4, connecting at its opposite end to the T or Y
connector 102. The
sequestration chamber 104 can be any shape or volume so long as it will
contain a predetermined
amount of blood sample in the initial aliquot. The T or Y connector 102 may
also include an
opening or channel that is parallel to the main blood flow channel. The air
permeable blood
barrier may further include an indicator 107 or other mechanism to indicate
when a
predetermined amount of blood has been collected in the sequestration chamber,
or when air
being expelled reaches a certain threshold, i.e. to zero. The tubing can also
include a clip 109 that
can be used to pinch off and prevent fluid flow therethrough.
[0071.] Once the air permeable blood barrier and primary chamber are
sealed the initial
aliquot of blood is trapped in the sequestration chamber 104, an evacuated
blood collection tube,
such as a VacutainerTm bottle may be attached to the sample needle 5 to obtain
the sample. The
blood collection tube can be removed, and the sample needle 5 will be
resealed. Any number of
follow-on blood collection tubes can then be attached for further blood draws
or samples. Upon
completion of all blood draws, the system can be discarded, with the initial
aliquot of blood
remaining trapped in the sequestration chamber 104.
[0072] FIG. 5 illustrates a blood sample optimization system in accordance
with some
alternative implementations. In the implementation shown, a sample needle 5 is
connected with
a patient needle by tubing. A "T' or "Y" connector 120 is added along the
tubing at any desired
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location, and includes an aperture, port or channel leading to a sequestration
chamber 204,
substantially as described above.
10073j FIG. 6 illustrates a blood sample optimization system in
accordance with some
alternative implementations, in which a sequestration chamber 304, formed as a
primary
collection channel, receives an initial aliquot of blood, and is provided
adjacent to the blood
sampling channel. The sequestration chamber 304 can encircle the blood
sampling channel, the
patient needle 1, and/or the sample needle 5. The primary collection channel
can include a T or
Y connector 120, or other type of aperture or channel. The sequestration
chamber 304 includes
an air permeable blood barrier, which can also include an indicator of being
contacted by a fluid
such as blood, as described above.
[0074] In some implementations, either the patient needle 1 or the sample
needle 5, or both,
can be replaced by a Luer lock male or female connector. However, in various
implementations,
the connector at a sample needle end of the blood sample optimization system
is initially sealed
to permit the diversion of the initial aliquot of blood to the sequestration
chamber, which is
pressured at ambient air pressure and includes the air outlet of the air
permeable blood barrier. In
this way, the system passively and automatically uses a patient's own blood
pressure to
overcome the ambient air pressure of the sequestration chamber to push out air
through. the air
permeable blood barrier and displace air in the sequestration chamber with
blood.
[0075] FIG. 7 is a flowchart of an exemplary method for optimizing the
quality of a blood
culture. At 702, a clinician places a needle into a patient's vein. At 704,
blood then flows into a
sequestration chamber, pushing the air in the sequestration chamber out of the
sequestration
chamber through an air permeable blood barrier. In some implementations, the
volume of the
sequestration chamber is less than 0.1 to more than 5 cubic centimeters
(cc's), or more. The
sequestration chamber is sized and adapted to collect a first portion of a
blood sample, which is
more prone to contamination than secondary and other subsequent portion of the
blood sample or
subsequent draws. Since the sequestration chamber has an air-permeable blood
barrier through
which air can be displaced by blood pushed from the patient's vein, such blood
will naturally and
automatically flow into the sequestration chamber before it is drawn into or
otherwise enters into
a Vacutainer or other bottle for receiving and storing a blood sample.
[0076] When the sequestration chamber fills, the blood will gather at or
otherwise make
contact with the air permeable blood barrier, which will inhibit or prevent
blood from passing
therethrough. At 706, when the blood comes into contact with the entire
internal surface area of
the air permeable blood barrier, the air permeable blood barrier is then
closed and air no longer
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flows out or in. At 708, the clinician may be provided an indictor or can see
the full chamber, to
indicate the evacuated blood collection tube, such as a VacutainerTm can be
attached. The
indicator can include visibility into the primaiy chamber to see whether it is
full, the blood
barrier changing color, for example, or other indicator. The fill time of the
sequestration
chamber may be substantially instantaneous, so such indicator, if present, may
be only that the
sequestration chamber is filled.
[0077] Prior to an evacuated blood collection tube being attached,
communication between
the needle, sampling channel, and the sequestration chamber is restricted by
the sealing of the
sequestration chamber blood barrier thereby not permitting air to reenter the
system through the
sequestration. Sealing the communication path could also be accomplished with
a mechanical
twist or other movement, a small orifice or tortuous pathway, eliminating the
need for a separate
valve or mechanical movement or operation by the clinician. At 710, once the
evacuated blood
collection tube is removed, the self-sealing membrane closes the sample
needle, and at 712,
additional subsequent evacuated blood collection tubes may be attached. Once
samples have
been taken, at 714 the device is removed from the patient and discarded.
[00781 FIGS. 8A - 8E illustrate an exemplary blood sample optimization
system 800 for
non-contaminated blood sampling, in accordance with some implementations. The
blood sample
optimization system 800 includes an inlet port 802 that can be connected to
tubing, a patient
needle (or both), or other vascular or venous access device, and a pathway
splitter 804 having a
first outlet to a sequestration chamber tubing 806 and a second outlet to
sample collection tubing
808. One or both of the sequestration chamber tubing 806 and the sample
collection tubing 808
can be formed of tubing. In some implementations, the sequestration chamber
tubing 806 is
sized so as to contain a particular volume of initial blood sample. The sample
collection tubing
808 will receive a blood sample once the sequestration chamber tubing 806 is
filled. The sample
collection tubing 808 can be connected to a VacutainerTm base or housing 810,
or other blood
sample collection device.
10079] The blood sequestration system 800 further includes a blood
sequestration device 812
which, as shown in more detail in FIGS. 8B - 8D, includes a housing 818 that
includes a
sampling channel 820 defining a pathway for the non-contaminated sample
collection tubing 808
or connected at either end to the non-contaminated sample collection tubing
808. The sampling
channel 820 can be curved through the housing 818 so as to better affix and
stabilize the housing
818 at a location along the non-contaminated sample collection tubing 808.
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[00801 The blood sequestration device 812 further includes a
sequestration chamber 822
connected with the sequestration chamber tubing 806 or other chamber. The
sequestration
chamber 822 terminates at an air permeable blood barrier 824. The air
permeable blood barrier
824 can also include a coloring agent that turns a different color upon full
contact with blood, as
an indicator that the regular collection of blood samples (i.e. the non-
contaminated blood
samples) can be initiated. Other indicators may be used, such as a small
light, a sound generation
mechanism, or the like. In some implementations, the air permeable blood
barrier is positioned
at a right angle from the direction of sequestration chamber 822, but can be
positioned at any
distance or orientation in order to conserve space and materials used for the
housing 818. The
housing 818 and its contents can be formed of any rigid or semi-rigid material
or set of materials.
[00811 FIG. 9 illustrates a pathway splitter 900 for use in a blood
sequestrations system, such
as those shown in FIGS. 8A ¨ 8E, for example. The pathway splitter 900
includes an inlet port
902, a main line outlet port 904, and a sequestration channel outlet port 906.
The inlet port 902
can be connected to main tubing that is in turn connected to a patient needle
system, or directly
to a patient needle. The main line outlet port 904 can be connected to main
line tubing to a blood
sampling system, such as a vacutainer base or housing, or directly to such
blood sampling
system. The sequestration channel outlet port 906 can be connected to
sequestration tubing for
receiving and sequestering a first sample of blood, up to a measured amount or
predetermined
threshold. Alternatively, the sequestration channel outlet port 906 can be
connected to a
sequestration chamber. The sequestration channel outlet port 906 is preferably
20-70 degrees
angled from the main line outlet port 904, which in turn is preferably in-line
with the inlet port
902. Once the predetermined amount of initial blood sample is sequestered in
the sequestration
tubing or chamber, in accordance with mechanisms and techniques described
herein, follow-on
blood samples will flow into the inlet port 902 and directly out the main line
outlet port 904,
without impedance.
[0082] FIGS. 10A 10D illustrate a blood sequestration device 1000 in
accordance with
alternative implementations. The blood sequestration device 1000 includes an
inlet port 1002, a
main outlet port 1004, and a sequestration channel port 1006. The inlet port
1002 can be
connected to a patient needle or related tubing. The main outlet port 1004 can
be connected to a
blood sample collection device such as a Vacutainer, associated tubing, or a
Luer activated valve,
or the like. The sequestration channel port 1006 splits off from the main
outlet port 1004 to a
sequestration chamber 1008. In some implementations, the sequestration chamber
1008 is
formed as a helical channel within a housing or other container 1001.
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[0083] The sequestration chamber 1008 is connected at the distal end to
an air permeable
blood barrier 1010, substantially as described above. Air in the sequestration
chamber 1008 is
displaced through the air permeable blood barrier 1010 by an initial aliquot
of blood that is
guided into the sequestration channel port 1006. Once the sequestration
chamber 1008 is filled,
further blood draws through the main outlet port 1004 can be accomplished,
where these samples
will be non-contaminated.
[0084] FIGS. 11A - 11E illustrate a blood sequestration device 1100 in
accordance with
other alternative implementations. The blood sequestration device 1100
includes an inlet port
1102, similar to the inlet ports described above, a main outlet port 1104, and
a sequestration
channel port 1106 that splits off from the main outlet port 1104 and inlet
port 1102. The
sequestration channel port is connected to a sequestration chamber 1108. In
the implementation
shown in FIGS. 11A - I 1E, the blood sequestration device includes a base
member 1101 having
a channel therein, which functions as the sequestration chamber 1108. The
channel can be
formed as a tortuous path through the base member 1101, which is in turn
shaped and formed to
rest on a limb of a patient.
[00851 A portion of the sequestration chamber 1108 can protrude from the
base member or
near a top surface of the base member, just before exiting to an air permeable
blood barrier 1110,
to serve as a blood sequestration indicator 1109. The indicator 1109 can be
formed of a clear
material, or a material that changes color when in contact with blood.
10086j In some implementations, the blood sequestration device 1100 can
include a blood
sampling device 1120 such as a normally closed needle, VacutainerTm shield or
other collection
device. The blood sampling device 1120 can be manufactured and sold with the
blood
sequestration device 1100 for efficiency and convenience, so that a first
aliquot of blood that may
be contaminated by a patient needle insertion process can be sequestered.
Thereafter, the blood
sampling device 1120 can draw non-contaminated blood samples to reduce the
risk of false
positive testing and ensure a non-contaminated sample.
[0087] FIGS. 12A-12D illustrate a blood sample optimization system. 1200
in accordance
with yet other alternative implementations. The system 1200 includes a blood
sequestration
device 1202 for attaching to a blood sampling device 1204, such as a
VacutainerTm or other
collection and sampling device. The blood sequestration device 1202 is
configured and arranged
to receive, prior to a VacutainerTM container or vial being attached to a
collection needle of the
blood sampling device 1204, a first aliquot or amount of blood, and sequester
that first aliquot or
amount in a sequestration channel of the blood sequestration device 1202.
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[0088] In some implementations, the blood sequestration device 1202 can
include an inlet
port 1212, a main outlet port, and a sequestration channel port. The inlet
port 1212 can be
connected to a patient needle or related tubing. The main outlet port 1214 can
be connected to a
normally closed needle or device to enable connection with an evacuated blood
collection
container or other collection device such as a VacutainerTm, associated
tubing, luer connectors,
syringe, a Luer activated valve, or the like. The sequestration channel port
splits off from the
main outlet port to a sequestration chamber 1218.
[0089] In some implementations, the sequestration chamber 1218 is formed
as a channel
within the body of a sequestration device 1202. The sequestration chamber 1218
can be a
winding channel, such as a U-shaped channel, an S-shaped channel, a helical
channel, or any
other winding channel. The sequestration device 1202 can include a housing or
other containing
body, and one or more channels formed therein. A.s shown in FIGS. 12A. and
12B, the
sequestration device 1202 includes a main body 1206 and a cap 1208. The main
body 1206 is
formed with one or more cavities or channels, which are further formed with
one or more arms
1210 that extend from the cap 1208, and which abut the cavities or channels in
the main body
1206 to form the primary collection port and main outlet port.
[0090] FIGS. 13A-13D illustrate a blood sample optimization system. 1300
in accordance
with yet other alternative implementations. The system 1300 includes a blood
sequestration
device 1302 for attaching to a blood sampling device 1304; such as a
Vacutainer or other bodily
fluid collection and sampling device. The blood sequestration device 1302 is
configured and
arranged to receive, prior to a Vacutainer container or vial being attached to
a collection needle
of the blood sampling device 1304, a first aliquot or amount of blood, and to
sequester that first
aliquot or amount of blood or other bodily fluid in a sequestration channel of
the blood
sequestration device 1302.
[0091] The blood sequestration device 1302 includes a housing 1301 having
an inlet port
1314, a main outlet port 1312, and a sequestration channel port 1316. The
inlet port 1314 can be
connected to a patient needle or associated tubing. The main outlet port 1312
can be connected
to a normally closed needle or device to enable connection with an evacuated
blood collection
container or other collection device such as a Vacutainer, associated tubing,
luer connectors,
syringe, a Luer activated valve, or the like. The sequestration channel port
1316 splits off from
the main inlet port 1314 to a sequestration chamber 1318.
[0092] In the implementation shown in FIGS. 13A-D, the sequestration
chamber 1318 is
formed as a cavity or chamber within housing 1301 or formed by walls that
define housing 1301.
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The sequestration chamber 1318 can be a winding channel, such as a U-shaped
channel, an S-
shaped channel, a helical channel, or any other winding channel, that is
defined by the
cooperation and connection of housing 1301 with cap 1307 which cap 1307 can
include a
protrusion 1305 that provides one or more walls or directors for the winding
channel in the
sequestration chamber 1318. The protrusion 1305 from the cap 1307 can be
straight or curved,
and may have various channels, apertures or grooves embedded therein, and can
extend from the
cap 1307 any angle or orientation. When the cap 1307 is connected with the
housing 1301 to
complete the formation of the sequestration chamber 1318, the protrusion 1305
forms at least
part of the winding channel to sequester a first aliquot or amount of blood or
other bodily fluid in
a sequestration channel formed in the sequestration chamber 1318 and by the
winding channel.
100931 The sequestration chamber 1318 includes an air permeable blood
barrier 1310,
substantially as described above. Air in the sequestration chamber 1318 is
displaced through the
air permeable blood barrier 1310 by an initial aliquot of blood that is
provided into the
sequestration chamber 1318 by the blood pressure of the patient. Once the
sequestration
chamber 1318 is filled and the air in the sequestration chamber 1318
displaced, the blood
pressure of the patient will be insufficient to drive or provide further blood
into the blood
sequestration device 1302, and in particular the outlet port 1312, until a
force such as a vacuum
or other pressure, such as provided by the blood sample collection device like
Vacutainer is
provided to draw out a next aliquot or amount of blood or bodily fluid.
Further blood draws
through the main outlet port 1312 can be accomplished, where these samples
will be non-
contaminated since any contaminants would be sequestered in the sequestration
chamber 1318
with the first aliquot of blood.
100941 FIGS. 14A-14E illustrate yet another implementation of a blood
sampling system
1400 to sequester contaminates of an initial aliquot or sample to reduce false
positives in blood
cultures or tests performed on a patient's blood sample. The blood sampling
system 1400
includes a blood sequestration device 1401 that can be connected between a
blood sample
collection device 1403 and a patient needle (not shown). The blood sample
collection device
1403 can be a Vacutainer or the like. The blood sequestration device 1401
includes an inlet port
1402 that can be connected with a patient needle that is inserted into a
patient's vascular system
for access to and withdrawing of a blood sample. The inlet port 1402 may also
be connected
with tubing or other conduit that is in turn connected with the patient
needle.
[0095] The inlet port 1402 defmes an opening into the blood sequestration
device 1401,
which opening can be the same cross sectional dimensions as tubing or other
conduit connected
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with the patient needle or the patient needle itself. For instance, the
opening can be circular with
a diameter of approximately 0.045 inches, but can have a diameter of between
0.01 inches or less
to 0.2 inches or more. The blood sequestration device 1401 further includes an
outlet port 1404,
which defines an opening out of the blood sequestration device 1401 and to the
blood sample
collection device 1403. The outlet port 1404 may also be connected with tubing
or other conduit
that is in turn connected with the blood sequestration device 1403. The outlet
port 1404 can
further include a connector device such as a threaded cap, a Luer connector
(male or female), a
non threaded interference or glue joint fitting for attachment of various
devices including but not
limited to tubing, or the like.
100961 The blood sequestration device 1401 further includes a sampling
channel 1406
between the inlet port 1402 and the outlet port 1404, and which functions as a
blood sample
pathway once a first aliquot of blood has been sequestered. The sampling
channel 1406 can be
any sized, shaped or configured channel, or conduit. In some implementations,
the sampling
channel 1406 has a substantially similar cross sectional area as the opening
of the inlet port 1402.
In other implementations, the sampling channel 1406 can gradually widen from.
the inlet port
1402 to the outlet port 1404.
[00971 The blood sequestration device 1401 further includes a
sequestration chamber 1408
that is connected to and split off or diverted from the sampling channel 1406
at any point
between the inlet port 1402 and the outlet port 1404, but preferably from a
proximal end of the
sampling channel 1406 near the inlet port 1402. The sequestration chamber 1408
is at first
maintained at atmospheric pressure, and includes an air outlet 1412 at or near
a distal end of the
sequestration chamber 1408 opposite the diversion point from the sampling
channel 1406. The
air outlet 1412 includes an air permeable blood barrier 1412. As shown in FIG.
14B, the air
permeable blood barrier 1412 can be overlaid with a protective cover 1416. The
protective cover
1416 can be sized and configured to inhibit a user from touching the air
permeable blood barrier
1412 with their finger or other external implement, while still allowing air
to exit the air
permeable blood barrier 1412 as the air is displaced from the sequestration
chamber 1408 by
blood being forced into the sequestration chamber 1408 by a patient's own
blood pressure. In
addition the protective cover 1416 can be constructed to inhibit or prevent
accidental exposure of
the air permeable blood barrier to environmental fluids or splashes. This can
be accomplished in
a variety of mechanical ways including but not limited to the addition of a
hydrophobic
membrane to the protective cover.
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[0098] As shown in FIGS. 14C and 14D, the sampling channel 1406 can be
cylindrical or
fnisto-conical in shape, going from a smaller diameter to a larger diameter,
to minimize a
potential to lyse red blood cells. Likewise, the sampling channel 1406 is
formed with a minimal
amount of or no sharp turns or edges, which can also lyse red blood cells. The
sampling channel
1406 splits off to the sequestration chamber 1408 near the inlet port 1402 via
a diversion
pathway 1409. The diversion pathway 1409 can have any cross-sectional shape or
size, but is
preferably similar to the cross-sectional shape of at least part of the inlet
port 1402.
[0099] In some implementations, the sampling channel 1406 and the
sequestration chamber
1408 are formed by grooves, channels, locks or other pathways formed in
housing 1414. The
housing 1414 can be made of plastic, metal or other rigid or semi-rigid
material. The housing
1414 can have a bottom member that sealably mates with a top member. One or
both of the
bottom member and the top member can include the sampling channel 1406 and the
sequestration chamber 1408, as well as the diversion pathway 1409, the inlet
port 1402, and the
outlet port 1404. In some other implementations, one or more of the diversion
pathway 1409, the
inlet port 1402, and/or the outlet port 1404 can be at least partially formed
by a cap member that
is connected to either end of the housing 1414. In some implementations, the
top member and
the bottom member, as well as the cap member(s), can be coupled together by
laser welding, heat
sealing, gluing, snapping, screwing, bolting, or the like. In other
implementations, some or all of
the interior surface of the diversion pathway 1409 and/or sequestration
chamber 1408 can be
coated or loaded with an agent or substance, such as a decontaminate,
solidifying agent, or the
like. For instance, a solidifying agent can be provided at the diversion
pathway 1409 such that
when the sequestration chamber 1408 is filled and the initial aliquot of blood
backs up to the
diversion pathway 1409, that last amount of sequestered blood could solidify,
creating a barrier
between the sequestration chamber 1408 and the sampling channel 1406.
[0100] FIGS. 15A-15G illustrate a blood sequestration device 1500. The
blood sequestration
device 1500 can be connected to a normally closed needle or device to enable
connection with an
evacuated blood collection container or other collection device such as a
Vacutaineirm,
associated tubing, luer connectors, syringe, a Luer activated valve, or the
like.
[01011 The blood sequestration device 1500 includes an inlet port 1502
that can be connected
with a patient needle that is inserted into a patient's vascular system for
access to and
withdrawing of a blood sample. The inlet port 1502 may also be connected with
tubing or other
conduit that is in turn connected with the patient needle. The inlet port 1502
defines an opening
into the blood sequestration device 1500, which opening may be the same cross
sectional
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dimensions as tubing or other conduit connected with the patient needle or the
patient needle
itself. For instance, the opening can be circular with a diameter of
approximately 0.045 inches,
but can have a diameter of between 0.01 inches or less to 0.2 inches or more.
101021 The inlet port 1502 can also include a sealing or fluid-tight
connector or connection,
such as threading or Luer fitting, or the like. In some implementations,
tubing or other conduit
associated with the patient needle can be integral with the inlet port 1502,
such as by co-molding,
gluing, laser weld, or thermally bonding the parts together. In this manner,
the blood
sequestration device 1500 can be fabricated and sold with. the patient needle
as a single unit,
eliminating the need for connecting the patient needle to the blood
sequestration device 1500 at
the time of blood draw or sampling.
[0103] The blood sequestration device 1500 further includes an outlet
port 1504, which
defmes an opening out of the blood sequestration device 1500 and to the blood
sample collection
device. The outlet port 1504 may also be connected with tubing or other
conduit that is in turn
connected with the blood sequestration device, and may also include a sealing
or fluid-tight
connector or connection, such as threading or Luer fitting, or the like.
Accordingly, as discussed
above, the blood sequestration device 1500 can be fabricated and sold with the
patient needle
and/or tubing and the blood sample collection device as a single unit,
eliminating the need for
connecting the patient needle and the blood sample collection device to the
blood sequestration
device 1500 at the time of blood draw or sampling.
101041 The blood sequestration device 1500 further includes a sampling
channel 1506
between the inlet port 1502 and the outlet port 1504, and which functions as a
blood sample
pathway once a first aliquot of blood has been sequestered. The sampling
channel 1506 can be
any sized, shaped or configured channel or conduit. In some implementations,
the sampling
channel 1506 has a substantially similar cross sectional area as the opening
of the inlet port 1502.
In other implementations, the sampling channel 1506 can gradually widen from
the inlet port
1502 to the outlet port 1504.
[0105] The blood sequestration device 1500 further includes a
sequestration chamber 1508
that is connected to and split off or diverted from the sampling channel 1506
at any point
between the inlet port 1502 and the outlet port 1504, but preferably from a
proximal end of the
sampling channel 1506 near the inlet port 1502. In some implementations, the
diversion includes
a Y-shaped junction. The sequestration chamber 1508 is preferably maintained
at atmospheric
pressure, and includes a vent 1510 at or near a distal end of the
sequestration chamber 1508. The
vent 1510 includes an air permeable blood barrier 1512. FIG. 15C illustrates
the blood
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sequestration device 1500 with the sequestration chamber 1508 filled with a
first aliquot or
sample of blood from the patient.
101.06j The air permeable blood barrier 1512 can be covered with a
protective cover 1516.
The protective cover 1516 can be sized and configured to inhibit a user from
touching the air
permeable blood barrier 1512 with their finger or other external implement,
while still allowing
air to exit the air permeable blood barrier 1512 as the air is displaced from
the sequestration
chamber 1508 by blood being forced into the sequestration chamber 1508 by a
patient's own
blood pressure. The protective cover 1516 can be constructed to inhibit or
prevent accidental
exposure of the filter to environmental fluids or splashes. This can be
accomplished in a variety
of mechanical ways including but not limited to the addition of a hydrophobic
membrane to the
protective cover.
[0107] FIG. 158 is a perspective view of the blood sequestration device
1500 from the outlet
port 1504 and top side of a housing 1501 of the blood sequestration device
1500 that includes the
vent 1510, and illustrating an initial aliquot of blood filling sequestration
chamber 1508 while the
sampling channel 1506 is empty, before a sample collection device is
activated. FIG. 15G is a
perspective view of the blood sequestration device 1500 from the outlet port
1504 and bottom
side of the housing 1501 of the blood sequestration device 1500, and
illustrating the initial
aliquot of blood filling sequestration chamber 1508 while the sampling channel
1506 is empty,
before the sample collection device is activated. FIG. 15C is another
perspective view of the
blood sequestration device 1500 from the inlet port 1502 and top side of a
housing 1501 of the
blood sequestration device 1500 that includes the vent 1510, and illustrating
blood now being
drawn through sampling channel 1506 while the sequestered blood remains
substantially in the
sequestration chamber 1508.
[0108] FIG. 15D is a cross section of the blood sequestration device 1500
in accordance with
some implementations, showing the housing 1501 that defmes the sampling
channel 1506 and
the sequestration chamber 1508. FIGS. 15E and 15F illustrate various form
factors of a housing
for a blood sequestration device, in accordance with one or more
implementations described
herein.
[0109] The sequestration chamber 1508 can have a larger cross-sectional
area than the
sampling channel 1506, and the cross-sectional area and length can be
configured for a
predetermined or specific volume of blood to be sequestered or locked. The
sampling channel
1506 can be sized to be compatible with tubing for either or both of the
patient needle tubing or
the blood collection device tubing.
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[0110] The housing 1501 can be formed of multiple parts or a single,
unitary part. In some
implementations, and as illustrated in FIG. 15D, the housing 1501 includes a
top member 1520
and a bottom member 1522 that are mated together, one or both of which having
grooves,
channels, locks, conduits or other pathways pre-formed therein, such as by an
injection molding
process or by etching, cutting, drilling, etc. The top member 1520 can be
connected with the
bottom member 1522 by any mating or connection mechanism, such as by laser
welding, thermal
bonding, ultrasonic welding, gluing, using screws, rivets, bolts, or the like,
or by other mating
mechanisms such as latches, grooves, tongues, pins, flanges, or the like.
[011.1] In some implementations, such as shown in FIG. 15D, the top member
1520 can
.. include the grooves, channels, locks; conduits or other pathways, while the
bottom member 1522
can include a protrusion 1524 that is sized and adapted to fit into at least
one of the grooves,
channels, locks or other pathways of the top member 1520. The protrusion 1524
can provide a
surface feature, such as a partial groove or channel, for instance, to
complete the formation of
either the sampling channel 1506 and/or the sequestration chamber 1508. In
some
implementations, the protrusion 1524 can. be formed with one or more angled
sides or surfaces
for a tighter fit within the corresponding groove, channel, lock or other
pathway. In yet other
implementations, both the top member 1520 and the bottom member can include
grooves,
channels, locks or other pathways, as well as one or more protrusions 1524.
[0112] In some implementations, the sampling channel 1506 and the
sequestration chamber
1508 are formed by grooves, channels, locks or other pathways formed in
housing 1501. The
housing 1501 can be made of any suitable material, including rubber, plastic,
metal or other
material. The housing 1501 can be formed of a clear or translucent material,
or of an opaque or
non-translucent material. In other implementations, the housing 1501 can be
mostly opaque or
non-translucent, while the housing surface directly adjacent to the sampling
channel 1506 and/or
.. the sequestration chamber 1508 is clear or translucent, giving a
practitioner a visual cue or sign
that the sequestration chamber 1508 is first filled to the extent necessary or
desired, and/or then a
visual cue or sign that the sequestered blood remains sequestered while a
clean sample of blood
is drawn through the sampling channel 1506. Other visual cues or signs of the
sequestration can
include, without limitation: the air permeable blood barrier 1512 turning a
different color upon
contact, saturation, or partial saturation with blood; a color-coded tab or
indicator at any point
along or adjacent to the sequestration chamber; an audible signal; a vibratory
signal; or other
signal.
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101131 After a venipuncture by a patient needle of a patient (not shown),
which could gather
a number of pathogens from the patient's skin, a first amount of the patient's
blood with those
pathogens will make its way into the inlet port 1502 blood sequestration
device 1500 and flow
into the sequestration chamber 1508 by following the path of least resistance,
as the patient's
own blood pressure overcomes the atmospheric pressure in the sequestration
chamber 1508 to
displace air therein through the air permeable blood barrier 1512. The
patient's blood pressure
will not be sufficient to overcome the air pressure that builds up in the
sealed sampling channel
1506. Eventually, the sequestration chamber 1508, which has a predetermined
volume, is filled
with blood that displaces air through the air permeable blood barrier 1512.
Once the blood hits
the air permeable blood barrier, the blood interacts with the air permeable
blood barrier 1512
material to completely or partially seal the vent 1510. A signal or indication
may be provided
that the practitioner can now utilize the Vacutainer capsule or other blood
sample collection
device to acquire a next amount of the patient's blood for sampling. The blood
in the
sequestration chamber 1508 is now effectively sequestered in the sequestration
chamber.
[01.1.41 Upon filling the blood sequestration pathway 1508 but prior to use
of the Vacutainer
or other blood sample collection device, the patient's blood pressure may
drive compression of
the air in the sampling channel 1506, possibly resulting in a small amount of
blood moving past
the diversion point to the sequestration chamber 1508 and into the sampling
channel 1506,
queuing up the uncontaminated blood to be drawn through the sampling channel
1506.
101151 In some instances, as shown in FIG. 15H, an inlet port 1532 can
include a male luer
connector for connecting to a removable patient needle, and an outlet port
11534 can include a
female luer connector for connecting with a syringe. This implementation of
the inlet port and
outlet port can be used with any device described herein, for avoiding a
propensity of a
Vacutainer-type device collapsing a patient's vein. In this implementation, a
clinician can use
the syringe in a modulated fashion to obtain a blood sample. In operation, the
syringe is attached
to the outlet port 1004, and the needle is attached to the inlet port 1002. A
venipuncture is
performed with the needle, and without the clinician pulling on the syringe.
An initial aliquot of
blood fills a sequestration chamber, and then the syringe can be used to draw
a sample of blood
through the collection channel, bypassing the sequestered blood in the
sequestration chamber.
[01161 FIGS. 16-19 illustrate yet another implementation of a blood
sequestration device.
FIGS. 16A-16D illustrate a blood sequestration device 1600 that can be
connected between a
blood sample collection device, such as an evacuated blood collection
container like a
Vacutainer Tm (not shown), and a patient needle (not shown) and/or associated
tubing. FIG. 17
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illustrates a bottom member of the blood sequestration device, and FIG. 18
illustrates a top
member of the blood sequestration device, which top member and bottom member
can be mated
together to form. an inlet port, and outlet port, a sequestration chamber and
a sampling channel,
as explained more fully below. FIGS. 19A and B show the top member and bottom
member
mated together. It should be understood that FIGS. 16-19 illustrate one
exemplary manner of
constructing a blood sequestration device as described herein, and other forms
of construction are
possible.
[01.1.71 Referring to FIGS. 16A. ¨ D, the blood sequestration device 1600
includes an inlet
port 1602 that can be connected with a patient needle that is inserted into a
patient's vascular
system for access to and withdrawing of a blood sample. The inlet port 1602
may also be
connected with tubing or other conduit that is in turn connected with the
patient needle. The inlet
port 1602 defines an opening into the blood sequestration device 1600, which
opening can be the
same cross sectional dimensions as tubing or other conduit connected with the
patient needle or
the patient needle itself. For instance, the opening can be circular with a
diameter of
approximately 0.045 inches, but can have a diameter of between 0.01 inches or
less to 0.2 inches
or more.
[01 1 81 The inlet port 1602 can also include a sealing or fluid-tight
connector or connection,
such as threading or Luer fitting, or the like. In some implementations,
tubing or other conduit
associated with the patient needle can be integral with the inlet port 1602,
such as by co-molding,
gluing, laser weld, or thennally bonding the parts together. In this manner,
the blood
sequestration device 1600 can be fabricated and sold with the patient needle
and/or tubing as a
single unit, eliminating the need for connecting the patient needle to the
blood sequestration
device 1600 at the time of blood draw or sampling.
[01191 The blood sequestration device 1600 further includes an outlet
port 1604; which
defmes an opening out of the blood sequestration device 1600 and to the blood
sample collection
device. The outlet port 1604 may also be connected with tubing or other
conduit that is in turn
connected with the blood sequestration device; and may also include a sealing
or fluid-tight
connector or connection, such as threading or Luer fitting, or the like.
Accordingly, as discussed
above, the blood sequestration device 1600 can be fabricated and sold with the
patient needle
and/or tubing and the blood sample collection device as a single unit,
eliminating the need for
connecting the patient needle and the blood sample collection device to the
blood sequestration
device 1600 at the time of blood draw or sampling.
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[0120] The blood sequestration device 1600 further includes a sampling
channel 1606
between the inlet port 1602 and the outlet port 1604, and a sequestration
chamber 1608 that is
connected to and split off or diverted from the sampling channel 1606 at any
point between the
inlet port 1602 and the outlet port 1604. The sampling channel 1606 functions
as a blood
sampling pathway once a first aliquot of blood has been sequestered in the
sequestration chamber
1608. The sampling channel 1606 can be any sized, shaped or configured
channel, or conduit.
In some implementations, the sampling channel 1606 has a substantially similar
cross sectional
area as the opening of the inlet port 1602. In other implementations, the
sampling channel 1606
can gradually widen from the inlet port 1602 to the outlet port 1604. The
sequestration chamber
1608 may have a larger cross section to form a big reservoir toward the
sequestration channel
path so that the blood will want to enter the reservoir first versus entering
a smaller diameter on
the sampling channel 1606, as is shown more fully in FIGS. 17 and 19.
[0121] In some exemplary implementations, the diversion between the
sampling channel
1606 and the sequestration chamber 1608 is by diverter junction 1607. Diverter
junction 1607
may be a substantially Y-shaped, T-shaped, or U-shaped. In some preferred
exemplary
implementations, and as shown in FIG. 17A - 17B, the diverter junction 1607 is
configured such
that the flow out of the inlet port 1602 is preferentially directed toward the
sequestration chamber
1608. The sequestration chamber 1608 may also include or form a curve or ramp
to direct the
initial blood flow toward and into the sequestration chamber 1608.
[0122] The sequestration chamber 1608 is preferably maintained at
atmospheric pressure,
and includes a vent 1610 at or near a distal end of the sequestration chamber
1608. The vent
1610 may include an air permeable blood barrier 1612 as described above.
[0123] The blood sequestration device 1600 can include a housing 1601
that can be formed
of multiple parts or a single, unitary part. In some implementations, and as
illustrated in FIGS.
17A - 17E and FIGS. 18A - 18F, the housing 1601 includes atop member 1620 and
a bottom
member 1622 that are mated together. The blood sequestration device 1600 can
also include a
gasket or other sealing member (not shown) so that when the top member 1620 is
mechanically
attached with the bottom member 1622, the interface between the two is sealed
by the gasket or
sealing member. The FIGS. 17A - 17E illustrate a bottom member 1622 of a
housing for a blood
sequestration device 1600. The bottom member 1622 can include grooves,
channels, locks,
conduits or other pathways pre-formed therein, such as by an injection molding
process or by
etching, cutting, drilling, etc., to form the sampling channel 1606, the
sequestration chamber
1608, and diverter junction 1607.
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[0124] The sequestration chamber 1608 may have a larger cross section
than the sampling
channel 1606 so that the blood will preferentially move into the sequestration
chamber first
versus entering a smaller diameter on the sampling channel 1606.
[01251 FIGS. 18A ¨ 18F illustrate the top member 1620, which can be
connected with the
bottom member 1622 by any mating or connection mechanism, such as by laser
welding, thermal
bonding, gluing, using screws, rivets, bolts, or the like, or by other mating
mechanisms such as
latches, grooves, tongues, pins, flanges, or the like. The top member 1620 can
include some or
all of the grooves, channels, locks, conduits or other pathways to form the
sampling channel
1606, the sequestration chamber 1608, and the diverter junction 1607. In yet
other
i() implementations, both the top member 1620 and the bottom member 1622
can include the
grooves, channels, locks or other pathways.
[0126] in some implementations, the sampling channel 1606 and the
sequestration chamber
1608 are formed by grooves, channels, locks or other pathways formed in
housing 1601. The
housing 1601 can be made of rubber, plastic, metal or any other suitable
material. The housing
1601 can be formed of a clear or translucent material, or of an opaque or non-
translucent
material. In other implementations, the housing 1601 can be mostly opaque or
non-translucent,
while the housing surface directly adjacent to the sampling channel 1606
and/or the sequestration
chamber 1608 may be clear or translucent, giving a practitioner a visual cue
or sign that the
sequestration chamber 1608 is first filled to the extent necessary or desired,
and/or then a visual
cue or sign that the sequestered blood remains sequestered while a clean
sample of blood is
drawn through the sampling channel 1606. Other visual cues or signs of the
sequestration can
include, without limitation: the air permeable blood barrier 1612 turning a
different color upon
contact, saturation, or partial saturation with blood; a color-coded tab or
indicator at any point
along or adjacent to the sequestration chamber; an audible signal; a vibratory
signal; or other
signal.
[01.27] As shown in FIGS. 18A ¨ 18F, the air permeable blood barrier 1612
can be covered
with, or surrounded by, a protective member 1616. The protective member 1616
can be sized
and configured to inhibit a user from touching the air permeable blood barrier
1612 with their
finger or other external implement, while still allowing air to exit the air
permeable blood barrier
1612 as the air is displaced from the sequestration chamber 1608. In some
implementations, the
protective member 1616 includes a protrusion that extends up from atop surface
of the top
member 1620 and around the air permeable blood barrier 1612. The protective
member 1616
can be constructed to inhibit or prevent accidental exposure of the filter to
environmental fluids
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or splashes. This can be accomplished in a variety of mechanical ways
including but not limited
to the addition of a hydrophobic membrane to the protective cover.
101.28j In use, the blood sequestration device 1600 includes a sampling
channel 1606 and a
sequestration chamber 1608. Both pathways are initially air-filled at
atmospheric pressure, but
the sampling channel 1606 is directed to an outlet port 1604 that will be
initially sealed by a
Vacutainer or other such sealed blood sampling device, and the sequestration
chamber 1608
terminates at a vent 1610 to atmosphere that includes an air permeable blood
barrier 1612.
101.29j After a venipuncture by a patient needle of a patient (not shown),
which could gather
a number of pathogens from the patient's skin, a first amount of the patient's
blood with those
pathogens will pass through inlet port 1602 of blood sequestration device
1600. This initial
volume of potentially contaminated blood will preferentially flow into the
sequestration chamber
1608 by finding the path of least resistance. The patient's own blood pressure
overcomes the
atmospheric pressure in the vented sequestration chamber 1608 to displace air
therein through
the air permeable blood bather 1612, but is not sufficient to overcome the air
pressure that builds
up in the sealed sampling channel 1606. In various exemplary embodiments, the
sequestration
chamber 1608 and sampling channel 1606 can be configured such that the force
generated by the
patient's blood pressure is sufficient to overcome any effect of gravity,
regardless of the blood
sequestration device's orientation.
101.301 Eventually, the sequestration chamber 1608 fills with blood that
displaces air through
the air permeable blood barrier 1612. Once the blood contacts the air
permeable blood barrier,
the blood interacts with the air permeable blood barrier 1612 material to
completely or partially
seal the vent 1610. A signal or indication may be provided that the
practitioner can now utilize
the Vacutainer or other blood sampling device.
101311 Upon filling the blood sequestration pathway 1608 but prior to use
of the Vacutainer
or other blood sample collection device, the patient's blood pressure may
drive compression of
the air in the sampling channel 1606, possibly resulting in a small amount of
blood moving past
the diversion point into the sampling channel 1606, queuing up the
uncontaminated blood to be
drawn through the sampling channel 1606.
[0132] FIG. 19A is a side view, and FIG. 19B is a cross-sectional view,
of the blood
sequestration device 1600, illustrating the top member 1620 mated with the
bottom member
1622.
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[0133] FIG. 20 shows a blood sample optimization system 2000 that
includes a patient
needle 2002 for vascular access to a patient's bloodstream, a blood sample
collection device
2004 to facilitate the collecting of one or more blood samples, and a conduit
2006 providing a
fluid connection between the patient needle 2002 and the blood sample
collection device 2004.
In some implementations, the blood sample collection device 2004 includes a
protective shield
that includes a sealed collection needle on which a sealed vacuum-loaded
container is placed,
which, once pierced by the collection needle, draws in a blood sample under
vacuum pressure or
force through the conduit 2006 from the patient needle 2002.
[0134] The blood sample optimization system 2000 further includes a blood
sequestration
1() .. device 2008, located at any point on the conduit 2006 between the
patient needle 2002 and the
blood sample collection device 2004 as described herein.
[0135] FIG. 21 illustrates a non-vented blood sequestration device 2100
using a wicking
material chamber. The blood sequestration device 2100 includes a housing 2101
that has a
sampling channel 2104 that is at least partially surrounded or abutted by a
sequestration chamber
2102 that is filled with a wicking material. An initial aliquot of blood is
drawn in from the
patient needle into the sampling channel 2104 where it is immediately wicked
into the wicking
material of the sequestration chamber 2102. The wicking material and/or
sequestration chamber
2102 is sized and adapted to receive and hold a predetermined amount of blood,
such that follow-
on or later blood draws pass by the wicking material and flow straight through
the sampling
channel 2104 to a sampling device such as a Vacutainer. The wicking material
can include a
substance such as a solidifler, a decontaminate, or other additive.
[0136] As described herein, an air permeable blood barrier may be created
using a wide
variety of different structures and materials. As shown in FIGS. 22A and 22B,
an air permeable
blood barrier 2202 of a blood sequestration device 2200 can include a polymer
bead matrix 2204,
.. in which at least some beads are treated to make them hydrophilic. The air
permeable blood
barrier 2202 further includes a self-sealing material 2206, such as
carboxymethyl cellulose
(CMC) or cellulose gum, or other sealing material. The air permeable blood
barrier 2202 can
further include voids 2208 that permit air flow before contact or during
partial contact with a
fluid such as blood. As shown in FIG. 22B, contact with a fluid causes the
self-sealing material
2206 to swell and close off the voids 2208, occluding air flow through the
voids 2208 and
creating a complete or partial seal.
[0137] FIGS. 23A and 23B illustrate yet another implementation of a blood
sequestration
device 2300, having an inlet port 2302 to connect with a patient needle, an
outlet port 2304 to
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connect with a blood sample collection device, a sequestration chamber 2306,
and a sampling
channel 2308 that bypasses the sequestration chamber 2306 once the
sequestration chamber is
filled to an initial aliquot of potentially contaminated blood to be
sequestered. The sequestration
chamber 2306 includes a hydrophobic plug 2312 at a distal end of the
sequestration chamber
2306 that is farthest from the inlet port 2302. A vacuum or other drawing
force applied from the
outlet port 2304, such as from a Vacutainer or the like, draws in blood into
the inlet port 2302
and directly into the sequestration chamber 2306, where the initial aliquot of
blood will contact
the hydrophobic plug 2312 and cause the initial aliquot of blood to back up
into the sequestration
chamber 2306 and be sequestered there. A small amount of blood may make its
way into the
sampling channel 2308, which is initially closed off by valve 2308. Upon
release of the valve
2308, and under further force of the vacuum or other force, follow-on amounts
of blood will flow
into inlet port 2302, bypass the sequestration chamber 2306, and flow into and
through sampling
channel 2308 toward the outlet port 2304 and to the collection device.
[0138] The sampling channel 2308 can have any suitable geometry and can
be formed of
plastic tubing or any other suitable material. Valve 2308 can be a clip or
other enclosing device
to pinch, shunt, bend or otherwise close off the sampling channel 2308 before
the initial aliquot
of blood is sequestered in the sequestration chamber 2306. For instance, valve
2308 can also be
formed as a flap, door or closable window or barrier within the sampling
channel 2308.
[0139] FIGS. 23C 23E illustrate an alternative implementation of the
blood sequestration
device 2300', in which a sequestration chamber 2320 branches off from a main,
collection
channel 2322 between an inlet port 2316 to connect with a patient needle and
an outlet port 2318
to connect with a blood sample collection device, such as a Vacutainer, a
syringe, or the like.
The sequestration chamber 2320 includes an air-permeable, blood impermeable
blood barrier
2324, such as a hydrophobic plug of material, or a filter formed of one or
more layers, for
example. A valve 2324 closes off and opens the collection channel 2322, and
the device 2300'
can be used similarly as described above.
10140j FIG. 24A --- 24D illustrate a blood sample optimization system
2400 that includes a
patient needle 2402 for vascular access to a patient's bloodstream, a blood
sample collection
device 2404 to facilitate the collecting of one or more blood samples for
blood testing or blood
cultures, and a conduit 2406 providing a fluid connection between the patient
needle 2402 and
the blood sample collection device 2404. In some implementations, the blood
sample collection
device 2404 includes a protective shield that includes a sealed collection
needle on which a
sealed vacuum-loaded container is placed, which, once pierced by the
collection needle, draws in
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a blood sample under vacuum pressure or force through the conduit 2006 from
the patient needle
2402.
101411 The blood sample optimization system 2400 further includes a blood
sequestration
device 2408, located at any point on the conduit 2406 between the patient
needle 2402 and the
blood sample collection device 2404. The location of the blood sequestration
device 2408 can be
based on a length of the conduit between the blood sequestration device 2408
and the patient
needle 2402, and the associated volume that length provides.
101421 The blood sequestration device 2408 includes an inlet port 2412
for being connected
to the conduit 2406 toward the patient needle 2402, and an outlet port 2414
for being connected
to the conduit 2406 toward the blood sample collection device 2404, and a
housing 2416. The
housing 2416 can be any shape, although it is shown in FIGS. 24A ¨ D as being
substantially
cylindrical, and includes the inlet port 2412 and outlet port 2414, which can
be located anywhere
on the housing although shown as being located on opposite ends of the housing
2416.
101431 The blood sequestration device 2408 further includes a blood
sequestration chamber
2418 connected with the inlet port 241.2. The blood sequestration chamber 2418
is defined by an
inner chamber housing 2419 that is movable from a first position to receive
and sequester a first
aliquot of blood, to a second position to expose one or more apertures 2424 at
a proximal end of
the inner chamber housing 2419 to allow blood to bypass and/or flow around the
inner chamber
housing 2419 and through a blood sample channel 2422 defined by the outer
surface of the inner
chamber housing 2419 and the inner surface of the housing 2416. The blood
sequestration
chamber 2418 includes an air permeable blood barrier 2420 at a distal end of
the blood
sequestration chamber 2418.
[01.441 In operation, the inner chamber housing 2419 is in the first
position toward the inlet
port 2412, such that the one or more apertures 2424 are closed, and the blood
sequestration
chamber 2418 is in a direct path from the patient needle. Upon venipuncture of
a patient, and
drawing of blood by way of a syringe or Vacutainer, or other blood collection
device 2404, the
initial aliquot of blood flows into the blood sequestration chamber 2418. A.s
the initial aliquot of
blood flows into the blood sequestration chamber, it displaces air therein and
eventually the
blood contacts the blood barrier 2420, forcing the inner chamber housing to
the second position.
The inner chamber housing 2419 and/or housing 2416 can include a locking
mechanism of one
or more small tabs, grooves, detents, bumps, ridges, or the like, to maintain,
the inner chamber
housing 2419 in the first position until the blood sequestration chamber 2418
is filled, providing
force to overcome the locking mechanism to enable movement of the inner
chamber housing
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2419 to the second position. Once in the second position, the initial aliquot
of blood is
sequestered in the blood sequestration chamber 2418 and the one or more
apertures 2424 are
opened to create a pathway from the inlet port 2412 to the blood sampling
channel 2422,
bypassing and/or flowing around the blood sequestration chamber 2418.
[0145] As described above, the housing 2416 and/or inner chamber housing
2419 can be
formed as cylindrical and concentric, but can be any shape, such as squared,
rectangular,
elliptical, oval, or other cross-sectional shape. The outer surface of the
distal end of the inner
chamber housing 2419 can have one or more outwardly projecting tangs 2421with
gaps
therebetween. The tangs 2421 contact the inner surface of the housing 2416 to
help define the
blood sampling channel 2422 therebetween, and to help stop the inner chamber
housing 2419 in
the second position. The gaps between the tangs 2421 enable blood to flow
through the blood
sampling channel 2422 and to the outlet port 2414. When the inner chamber
housing 2419 is in
the second position and the blood sequestration chamber 2418 is filled with
the first aliquot of
blood, further blood samples will automatically flow through the inlet port
2412, through the one
or more apertures 2424, through the blood sampling channel 2422, through the
gaps between the
tangs 2421, and ultimately through the outlet port 2414 to be collected by a
blood sampling
device 2404.
[0146] FIGS. 25A ¨ D show a blood optimization system 2500 and blood
sequestration
device 2502, formed substantially as described in FIGS. 15, 16, 17, 18 and 19,
but being formed
to inhibit a user or other object from touching or blocking an air venting
mechanism from a
blood sequestration chamber 2520. Air initially in the blood sequestration
chamber 2520 is
displaced by an initial aliquot of blood upon venipuncture, where a patient's
blood pressure
overcomes the ambient air pressure in the blood sequestration chamber 2520.
The air venting
mechanism includes an air permeable blood barrier 2506, such as a porous
material or set of
materials that allows air to escape but blocks blood from leaving the blood
sequestration chamber
2520.
10147] The air venting mechanism includes an inner wall 2516 that at
least partially
circumscribes or surrounds the air permeable blood barrier 2506, and an outer
wall 2504 spaced
apart from the inner wall 2516. The outer wall 2504 can. have one or more air
vents 2514 formed
therein. The outer wall 2504 extends higher upward than the inner wall 2516,
such that a lid
2510, such as a cap, plug, cover, etc., can be attached to the outer wall 2504
and be displaced by
a small distance from the top of the inner wall 2516. A seal 2508 in the form
of a silicone wafer,
or other elastomeric material, fits within the outer wall 2504 to cover the
air permeable blood
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barrier 2506 and abut the top of the inner wall 2516. The seal 2508 covers and
seals the air
permeable blood bather 2506 and inhibits air from entering the blood
sequestration chamber
2520 through the air permeable blood barrier 2506. A. fulcrum 2512 on an
underside of the lid
2510 allows the seal 2508 to flexibly disconnect from the top of the inner
wall 2516 when
pushed by air displaced from the blood sequestration chamber 2520, to allow
air to vent from the
air permeable blood barrier 2506 and through the one or more air vents 2514 in
the outer wall
2504.
[01.48] FIG. 26A ¨ E illustrate a blood sample optimization system 2600
that includes a
patient needle 2602 for vascular access to a patient's bloodstream, a blood
sample collection
device 2604 to facilitate the collecting of one or more blood samples for
blood testing or blood
cultures, and a conduit 2606 providing a fluid connection between the patient
needle 2602 and
the blood sample collection device 2604. The conduit 2606 can include flexible
tubing. In
preferred implementations, the blood sample collection device 2604 includes a
protective shield
2605 that includes a sealed collection needle on which a sealed vacuum-loaded
container is
placed, which, once pierced by the collection needle, draws in a blood sample
under vacuum
pressure or force through the conduit 2006 from the patient needle 2602.
[0149] The blood sample optimization system 2600 further includes a blood
sequestration
device 2608, located at any point on the conduit 2606 between the patient
needle 2602 and the
blood sample collection device 2604. The location of the blood sequestration
device 2608 can be
.. based on a length of the conduit between the blood sequestration device
2608 and the patient
needle 2602, and the associated volume that length provides.
[0150] The blood sequestration device 2608 includes an inlet port 2612
for being connected
to the conduit 2606 toward the patient needle 2602, and an outlet port 2614
for being connected
to the conduit 2606 toward the blood sample collection device 2604. The blood
sequestration
device 2608 includes an outer housing 2616 and an inner housing 2617, both
having a cylindrical
form., and being connected concentrically. The outer housing 2616 includes an
outer wall 2618
and an inner conduit 2620 that defines a blood sampling channel 2622 to convey
blood through
the conduit 2606 to the blood sampling device 2604. The inner housing 2617
fits snugly
between the inner conduit 2620 and the outer wall 2618 of the outer housing,
and is rotatable in
relation to the outer housing 2616. The fit between the outer housing 2616 and
the inner housing
2617 can be a friction fit that maintains the housings in a particular
position. The inner housing
2617 defmes a blood sequestration chamber 2624, preferably a helical or
corkscrew channel
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around the outer surface of inner conduit 2620 of the outer housing 2616, and
which terminates
at an air vent 2628 having an air permeable blood barrier, as shown in FIG.
26E.
101511 The blood sequestration chamber 2624 is connected with the blood
sampling channel
2622 via diversion junction 2624 fortned in the inner conduit 2620, when the
blood sequestration
device in a first state, illustrated in FIG. 26C. The protective shield 2606
on the collection needle
2604 provides a block for air or blood, enabling a diversion of an initial
aliquot of blood into the
blood sequestration chamber 2624 as the patient's blood pressure overcomes the
ambient air
pressure in the blood sequestration channel 2624 to displace air therefrom
through air vent 2628.
101521 When the inner housing 2617 is rotated relative to the outer
housing 2616, or vice
versa, to a second state, as illustrated in FIG. 26D, the blood sequestration
chamber 2624 is shut
off from diversion junction 2624, enabling a direct path from the patient
needle through the
conduit 2606 to the collection needle 2604, via blood sampling channel 2622.
The outer housing
2616 and/or inner housing 2617 can include ridges or grooves formed within a
portion of their
surfaces, to facilitate relative rotation from the first state to the second
state.
[01531 FIGS. 27A ¨ D illustrate a blood optimization system 2700 and blood
sequestration
device 2702, formed substantially as described with reference to at least
FIGS. 15, 16, 17, 18, 19,
and 25, but being formed to inhibit a user or other object from touching or
blocking an air
venting mechanism from a blood sequestration chamber 2720. Air initially in
the blood
sequestration chamber 2720 is displaced by an initial aliquot of blood upon
venipuncture, where
a patient's blood pressure overcomes the ambient air pressure in the blood
sequestration chamber
2720. The air venting mechanism includes an air permeable blood barrier 2706,
such as a porous
material or set of materials that allows air to escape but blocks blood from.
leaving the blood
sequestration chamber 2720.
101541 The air venting mechanism includes an inner wall 2716 that at
least partially
circumscribes or surrounds the air permeable blood barrier 2706, and an outer
wall 2704 spaced
apart from the inner wall 2716. A cap 2722 is positioned on the air venting
mechanism,
preferably by having a lower cap wall 2728 that fits between the inner wall
2716 and the outer
wall 2704 of the air venting mechanism, and frictionally abutting either the
the inner wall 2716
or the outer wall 2704 or both. The cap 2722 further includes one or more vent
holes 2724 or
slits, apertures, openings, or the like, which extend through an upper surface
of the cap 2722
around a downwardly extending plug 2726. The plug 2726 is sized and adapted to
fit snugly
within the space defined by inner wall 2716.
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[0155] In a first position, as illustrated in FIG. 27C, the cap 2722 is
extended from the air
venting mechanism to allow air from the blood sequestration chamber 2720 to
exit through the
air permeable blood barrier 2706 and through the one or more vent holes 2724.
Once the air
from the blood sequestration chamber 2720 has been displaced, i.e., when the
blood
sequestration chamber 2720 is filled with the first aliquot of potentially
tainted blood from the
patient, then the cap 2722 can be pushed down on the air venting mechanism in
a second position
as shown in FIG. 27D, so that the plug 2726 fits within the inner wall 2716
over the air
permeable blood barrier 2706 to seal the air venting mechanism. In either the
first position or the
second position, the cap 2722 protects the air permeable blood barrier 2706
from outside air or
from. being touched by a user.
[01561 FIGS. 28A - F illustrate a blood optimization system 2800 and
blood sequestration
device 2802, formed substantially as described with reference to at least
FIGS. 15, 16, 17, 18, 19,
25 and 26, but utilizing a multi-layered filter, and in some implementations,
a filter with trapped
reactive material, for an air permeable blood barrier. As shown in FIGS. 28C
and D, an air
permeable blood barrier 2803 includes a first layer 2804 of an air permeable
but blood
impermeable material, and a second layer 2806 that includes a reactive
material, such as a
hydrophobic material, for repelling blood while still allowing air to pass
through both layers. As
shown in FIGS. 28E and F, the air permeable blood barrier 2803 can include any
number of
layers, such as a third layer 2808 formed of the same air permeable but blood
impermeable
material as first layer 2804, while a second layer 2806 includes trapped or
embedded blood
reactive material.
10157] FIGS. 29A --- 29C illustrate a blood optimization system 2900 and
blood sequestration
device 2902, formed substantially as described with reference to at least
FIGS. 15, 16, 17, 18, 19,
and 26, but in which a blood sequestration chamber 2904 is at least partially
filled with a
25 blood-absorptive material 2906. The blood-absorptive material 2906 can
act as a wicking
material to further draw in blood to be sequestered upon venipuncture of the
patient, and prior to
use of a blood drawing device such as a Vacutainerm or a syringe, or the like.
[01581 FIGS. 30A - G illustrate a blood optimization system 3000 and
blood sequestration
device 3002, formed substantially as described with reference to at least
FIGS. 15, 16, 17, 18, 19,
25 and 26. The blood sequestration device 3000 includes an inlet port 3002
that can be
connected with a patient needle that is inserted into a patient's vascular
system for access to and
withdrawing of a blood sample. The inlet port 3002 may also be connected with
tubing or other
conduit that is in turn connected with the patient needle. The inlet port 3002
defines an opening
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into the blood sequestration device 3000, which opening can be the same cross
sectional
dimensions as tubing or other conduit connected with the patient needle or the
patient needle
itself. For instance, the opening can be circular with a diameter of
approximately 0.045 inches,
but can have a diameter of between 0.01 inches or less to 0.2 inches or more.
[0159] The inlet port 3002 can also include a sealing or fluid-tight
connector or connection,
such as threading or Luer fitting, or the like. In some implementations,
tubing or other conduit
associated with the patient needle can be integral with the inlet port 3002,
such as by co-molding,
gluing, laser weld, or thermally bonding the parts together. In this manner,
the blood
sequestration device 3000 can be fabricated and sold with the patient needle
and/or tubing as a
single unit, eliminating the need for connecting the patient needle to the
blood sequestration
device 3000 at the time of blood draw or sampling.
[0160] The blood sequestration device 3000 further includes an outlet
port 3004, which
defines an opening out of the blood sequestration device 3000 and to the blood
sample collection
device. The outlet port 3004 may also be connected with tubing or other
conduit that is in turn
connected with the blood sequestration device, and may also include a sealing
or fluid-tight
connector or connection, such as threading or Luer fitting, or the like.
Accordingly, as discussed
above, the blood sequestration device 3000 can be fabricated and sold with the
patient needle
and/or tubing and the blood sample collection device as a single unit,
eliminating the need for
connecting the patient needle and the blood sample collection device to the
blood sequestration
device 3000 at the time of blood draw or sampling.
[01611 The blood sequestration device 3000 further includes a sampling
channel 3006
between the inlet port 3002 and the outlet port 3004, and a sequestration
chamber 3008 that is
connected to and split off or diverted from the sampling channel 3006 at any
point between the
inlet port 3002 and the outlet port 3004. The sampling channel 3006 functions
as a blood
sampling pathway once a first aliquot of blood has been sequestered in the
sequestration chamber
3008. The sampling channel 3006 can be any sized, shaped or configured
channel, or conduit.
In some implementations, the sampling channel 3006 has a substantially similar
cross sectional
area as the opening of the inlet port 3002. In other implementations, the
sampling channel 3006
can gradually widen from the inlet port 3002 to the outlet port 3004. The
sequestration chamber
3008 may have a larger cross section to form a big reservoir toward the
sequestration channel
path so that the blood will want to enter the reservoir first versus entering
a smaller diameter on
the sampling channel 3006.
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[0162] In some exemplary implementations, the diversion between the
sampling channel
3006 and the sequestration chamber 3008 is by diverter junction 3007. Diverter
junction 3007
may be a substantially Y-shaped, T-shaped, or U-shaped. In some preferred
exemplary
implementations, and as shown in FIG. 17A ¨ 17B, the diverter junction 3007 is
configured such
.. that the flow out of the inlet port 3002 is preferentially directed toward
the sequestration chamber
3008. The sequestration chamber 3008 may also include or form a curve or ramp
to direct the
initial blood flow toward and into the sequestration chamber 3008.
[01.63] The sequestration chamber 3008 is preferably maintained at
atmospheric pressure,
and includes a vent 3010 at or near a distal end of the sequestration chamber
3008. The vent
3010 may include an air permeable blood barrier 3012 as described above.
[0164] The blood sequestration device 3000 can include a housing 3001
that can be formed
of multiple parts or a single, unitary part. In some implementations, and as
illustrated FIG. 30F,
the housing 3001 includes a top member 3020 and a bottom member 3022 that are
mated
together. The blood sequestration device 3000 can also include a gasket or
other sealing member
(not shown) so that when the top member 3020 is mechanically attached with the
bottom
member 3022, the interface between the two is sealed by the gasket or sealing
member. The
bottom member 3022 can. include grooves, channels, locks, conduits or other
pathways pre-
formed therein, such as by an injection molding process or by etching,
cutting, drilling, etc., to
form the sampling channel 3006, the sequestration chamber 3008, and diverter
junction 3007.
10165j The sequestration chamber 3008 may have a larger cross section than
the sampling
channel 3006 so that the blood will preferentially move into the sequestration
chamber first
versus entering a smaller diameter on the sampling channel 3006.
[01.66] In some implementations, the sampling channel 3006 and the
sequestration chamber
3008 are formed by grooves, channels, locks or other pathways formed in
housing 3001. The
.. housing 3001 can be made of rubber, plastic, metal or any other suitable
material. The housing
3001 can be formed of a clear or translucent material, or of an opaque or non-
translucent
material. In other implementations, the housing 3001 can be mostly opaque or
non-translucent,
while the housing surface directly adjacent to the sampling channel 3006
and/or the sequestration
chamber 3008 may be clear or translucent, giving a practitioner a visual cue
or sign that the
sequestration chamber 3008 is first filled to the extent necessary or desired,
and/or then a visual
cue or sign that the sequestered blood remains sequestered while a clean
sample of blood is
drawn through the sampling channel 3006. Other visual cues or signs of the
sequestration can
include, without limitation: the air permeable blood barrier 3012 turning a
different color upon
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contact, saturation; or partial saturation with blood; a color-coded tab or
indicator at any point
along or adjacent to the sequestration chamber; an audible signal; a vibratory
signal; or other
signal.
101671 The air permeable blood barrier 3012 can be covered with, or
surrounded by, a cap
3032. The cap 3032 can be sized and configured to inhibit a user from touching
the air
permeable blood barrier 3012 with their finger or other external implement,
while still allowing
air to exit the air permeable blood barrier 3012 as the air is displaced from
the sequestration
chamber 3008. The cap 3032 can be constructed to inhibit or prevent accidental
exposure of the
filter to environmental fluids or splashes. This can be accomplished in a
variety of mechanical
ways including but not limited to the addition of a hydrophobic membrane to
the protective
cover.
[0168] The air venting mechanism includes a wall 3030 that at least
partially circumscribes
or surrounds the air permeable blood barrier 3012. The wall 3030 can have one
or more air vents
formed therein. The cap 3032 covers wall 3030 and can be snapped, glued, or
otherwise attached
in place. A seal 3017 in the form of a silicone wafer, or other elastomeric
material, fits within
the wall 3030 to cover the air permeable blood barrier 3012 and abut the top
of the wall 3030.
The seal 3017 covers and seals the air permeable blood barrier 3012 and
inhibits air from
entering the blood sequestration chamber 3008 through the air permeable blood
barrier 3012. A
fulcrum 3012 on an underside of the cap 3032 allows the seal 3008 to flexibly
disconnect from
the top of the inner wall 3016 when pushed by air displaced from the blood
sequestration
chamber 3008, to allow air to vent from the air permeable blood barrier 3012
and through the one
or more air vents in the wall 3030 and/or cap 3032.
[0169] In use, the blood sequestration device 3000 includes a sampling
channel 3006 and a
sequestration chamber 3008. Both pathways are initially air-filled at
atmospheric pressure, but
the sampling channel 3006 is directed to an outlet port 3004 that will be
initially sealed by a
Vacutainer or other such sealed blood sampling device, and the sequestration
chamber 3008
terminates at a vent 3010 to atmosphere that includes an air permeable blood
barrier 3012.
101701 After a venipuncture by a patient needle of a patient (not shown),
which could gather
a number of pathogens from the patient's skin, a first amount of the patient's
blood with those
pathogens will pass through inlet port 3002 of blood sequestration device
3000. This initial
volume of potentially contaminated blood will preferentially flow into the
sequestration chamber
3008 by finding the path of least resistance. The patient's own blood pressure
overcomes the
atmospheric pressure in the vented sequestration chamber 3008 to displace air
therein through
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the air permeable blood barrier 3012, but is not sufficient to overcome the
air pressure that builds
up in the sealed sampling channel 3006. In various exemplary embodiments, the
sequestration
chamber 3008 and sampling channel 3006 can be configured such that the force
generated by the
patient's blood pressure is sufficient to overcome any effect of gravity,
regardless of the blood
sequestration device's orientation.
[0171] Eventually, the sequestration chamber 3008 fills with blood that
displaces air through
the air permeable blood barrier 3012. Once the blood contacts the air
permeable blood barrier,
the blood interacts with the air permeable blood barrier 3012 material to
completely or partially
seal the vent 3010. A signal or indication may be provided that the
practitioner can now utilize
the Vacutainer or other blood sampling device.
[0172] Upon filling the blood sequestration pathway 3008 but prior to use
of the Vacutainer
or other blood sample collection device, the patient's blood pressure may
drive compression of
the air in the sampling channel 3006, possibly resulting in a small amount of
blood moving past
the diversion point into the sampling channel 3006, queuing up the
uncontaminated blood to be
drawn through the sampling channel 3006.
[0173] In yet another aspect, the blood sequestration chamber and/or
blood sampling
channel, or other component, of any of the implementations described herein,
can provide a
visually discernable warning or result in a component adapted for operative
fluid communication
with the flash chamber of an introducer for an intravenous catheter into a
blood vessel of a
patient. The device and method provides a visually discernable alert when
blood from the patient
communicates with a test component reactive to communicated blood plasma, to
visually change.
The reaction with the blood or the plasma occurs depending on one or a
plurality of reagents
positioned therein configured to test for blood contents, substances or
threshold high or low
levels thereof, to visually change in appearance upon a result.
10174] In yet other aspects, the blood sequestration chamber and/or blood
sampling channel
can be sized and adapted to provide a particular volumetric flow of blood,
either during the
sequestration process and/or the sampling process.
[0175] In still yet other aspects, a non-venting bodily fluid sample
optimization device and
system, for use in a blood sampling or blood culture collection system, is
shown and described.
In accordance with implementations described herein, a bodily fluid sample
optimization device
overcomes problems in prior devices that include permanently-attached, fixed-
positioned moving
parts, such as valves, state-transitioning switches or diverters, or other
mechanisms that move,
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shift or transition from one operating mode to another operating mode, or from
one state to
another state.
101761 As illustrated in FIG. 31, a fluid sample optimization device 3100
includes an inlet
3112 and an outlet 3114. The inlet 3112 can include an inlet port, connector
or interface, for
connecting to an external device such as tubing or interface thereof. The
inlet 3112 can be
connected with a patient or a patient's fluid source, such as via a
venipuncture needle, in which
fluid is provided at pressure PI and which can be the patient's blood pressure
(which can vary
between 0 and 150 mmHg or more).
101771 The outlet 3114 can include an outlet port, connector or
interface, for connecting to an
external device such as tubing or an interface thereof. For instance, the
outlet 3114 can be
connected with a fluid collection device, such as an evacuated tube like a
Vacutainerf, or a
syringe, in which fluid is drawn by the fluid collection device from the fluid
source by a pressure
P2 that is lower than pressure PI, i.e. a negative pressure. The differential
pressure between PI
and P2 can provide a motive force for fluid which then allows the fluid sample
optimization
device 3100 to be closed to atmosphere and atmospheric pressure, i.e. where
the fluid sample
optimization device 3100 need not include any vent or pathway to outside
atmosphere at least
when in use.
[01.781 The fluid sample optimization device 3100 further includes a
contaminant
containment reservoir 3116 connected with the inlet 3112 and with the outlet
3114, and having
an air permeable fluid resistor 3117 between a distal end of the contaminant
containment
reservoir 3116 and the outlet 3114. As further described herein, the
contaminant containinent
reservoir 3116 can. be sized for holding a desired amount of fluid, and may
contain an absorbent
material that at least partially fills the contaminant containment reservoir
3116. Also as further
described herein, the contaminant containment reservoir 3116 can be configured
as a tortuous
path, a series of chambers of differing cross sections and volumes, and/or
contain rifling or
baffles extending from an inner surface therein to minimize backflow, i.e. a
flow toward the inlet
3112.
[01791 The air permeable blood resistor 3117 allows air to pass through
and be displaced by
a first portion, amount or aliquot of fluid such as blood in the inlet 3112
and sequestration
chamber 3116 when a pressure differential is applied between the inlet 3112
and outlet 3114, i.e.
a negative pressure at the outlet 3114 is lower than the pressure at the inlet
3112. Once the fluid
contacts the air permeable fluid resistor 3117 the flow of fluid into the
contaminant containment
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reservoir 3116 is at least partially stopped, maintaining at least a portion
of the fluid in the
contaminant contaiiunent reservoir 3116.
101.80j The fluid sample optimization device 3100 further includes a
sample path 3118 also
connected with the inlet 3112 and the outlet 3114. The sample path 3118
includes a displaceable
plug or stopper 3119 provided in a seat proximate the inlet 3112 in a junction
between the inlet
and the sample path 3118. The seat can be a portion of the junction, and the
displaceable plug
3119 can be friction-fit into the seat. Alternatively, the seat can include a
ridge or flange, and the
plug can abut such ridge or flange until it is displaced, deflected or
compressed by a pressure
differential. At the same time the pressure P2 is drawing the first portion or
amount of fluid into
the contaminant containment reservoir 3116, the displaceable plug 3119 is
configured to resist,
inhibit, limit or prohibit a flow of the fluid into the sample path 18 until
the first portion or
amount of fluid has entered into the contaminant containment reservoir 3116,
and/or blocked the
air permeable fluid resistor 3117.
101811 As described further herein, the displaceable plug 3119 is
configured such that after
the first portion or amount of fluid has entered into the contaminant
containment reservoir 3116
and/or blocked the air permeable fluid resistor 17, the pressure differential
increases across the
displaceable plug 3119. The higher pressure on the inlet side of the
displaceable plug 3119 will
cause the displaceable plug 3119 to deflect, at least in some portion of an
outer surface, and to
dislodge or become loose, and allowing it to get displaced or moved out of its
seat and to plug
retainer 20. The plug retainer 3120 can be a cavity or chamber that is sized
to receive the plug
3119 after it has been displaced, or an extending member that extends from an
inner wall of the
sample path 3118. The plug retainer 3120 is sized and configured to allow
fluid flow without
restriction beyond a unifomi cross-sectional area of the sample path 3118.
Once the displaceable
plug 3119 is removed from its seat, a second and/or subsequent portions or
amounts of fluid are
allowed to flow from the inlet 3112 through the sample path 3118 to the outlet
3114, still under
force of the pressure differential between P2 and P1.
10182] A displaceable plug described herein can be formed of any
compressible or
elastomeric material, such as silicone, EPDM (ethylene propylene diene
monomer), or PVC
(polyvinyl chloride). The plug can also be made from a more rigid polymer,
such as
polycarbonate, ABS, acetal, etc. with thin enough walls to form a seal and be
deflected from its
seat. In addition, the surfaces of the plug that seal against the seat can be
lubricated (or the
material itself can be impregnated with a lubricious material) to reduce the
friction required to
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displace the plug from its seat when exposed to the pressure differential. Any
suitable rubber,
*nthetic rubber, thermoplastic, or other elastomers can be used.
101831 In some implementations, the fluid sample optimization device 3110
can include an
acceleration portion between the inlet 3112 and the contaminant containment
reservoir 3116 over
or near the displaceable plug 3119, to increase the velocity of the fluid,
thereby reducing the
pressure of the fluid moving through it. This can further help in
preferentially directing the first
portion or amount of fluid from the inlet to the contaminant containinent
reservoir by reducing
the pressure differential across the displaceable plug prior to complete
filling of the contaminant
containment reservoir.
[0184] FIGS. 32A ¨ 32C illustrate another implementation of a fluid sample
optimization
device 3200 having just three basic components: 1) a housing 3220, which
houses, forms, or
defmes an inlet 3202, an outlet 3204, a contaminant containment reservoir
3206, and a sampling
channel 3208; 2) an air-permeable fluid barrier 3212, positioned in or at a
first conduit
(hereinafter "first conduit") between the contaminant containment reservoir
3206 and the
sampling channel 3208 proximate the outlet 3204; and 3) a displaceable plug
3214, positioned in
or at a second conduit (hereinafter "second conduit") between the contaminant
containment
reservoir 3206 and the sampling channel 3208 proximate the inlet 3202.
[0185] The inlet 3202 can include an inlet port for connecting to a fluid
source, such as a
patient needle and tithing. The inlet port can itself include a port
connector, such as a Luer
locking member, threading, truncated conical opening for a friction fit, or
the like. Similarly, the
outlet 3204 can include an outlet port for connecting to a fluid collector,
such as a Vacutainer ,
a syringe, a pump, and associated tubing. The fluid collector provides at the
outlet 3204 a
vacuum or negative pressure relative to the inlet 3202. The inlet port can
itself include a port
connector, such as a Luer locking member, threading, truncated conical opening
for a friction fit,
or the like. Alternatively, the inlet 3202 and/or outlet 3204 can be
permanently connected with
tubing, such as by glue, heat weld, laser weld, or the like.
[01861 The contaminant containment reservoir 3206 is fluidically
connected with the inlet
3202, and can include a main reservoir or main basin, and any conduit,
channel, pathway
between the main reservoir or basin and the inlet 3202. In some instances, the
contaminant
containment reservoir 3206 is formed of a single elongated chamber having an
opening
connected with the inlet 3202. The contaminant containment reservoir 3206 is
fluidically
isolated from the outlet 3204 or the sampling channel 3208 proximate the
outlet by the air
permeable fluid barrier 3212 at the first conduit between the contaminant
containment reservoir
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3206 and the outlet 3204 or sampling channel 3208 proximate the outlet 3204,
and as explained
further below, the air permeable fluid barrier will seal upon contact with a
first portion of fluid
that enters into the contaminant containment reservoir 3206 to displace air
therein through the air
permeable fluid barrier 3212.
[0187] The sampling channel 3208 is fluidically connected with the outlet
3204, and is at
least initially sealed from, or not fluidically connected, with the inlet
3204, as the displaceable
plug blocks, inhibits, restricts or seals the second conduit between the
sampling channel 3208
and the inlet 3202 or the contaminant containment reservoir 3206 proximate the
inlet 3202.
Preferably, the sampling channel 3208 is formed of or defined as a tube,
channel or pathway
having any sized- or shaped-cross section or geometry. The sampling channel
3208 can include
a protrusion or tang above the displaceable plug 3214, for receiving an
holding the displaceable
plug 3214 once it is displaced from. the second conduit by a pressure
differential between the
outlet 3204 and the inlet 3202 when the contaminant containment reservoir 3206
receives and
contains the first amount of fluid, as will be described in further detail
below. Further, the
sampling channel 3208 can include one or more blocks, recesses, side channels,
cavities, or the
like, for receiving the plug 3214.
[0188] In some implementations, the housing 3220 can include, or be
formed of, a lower
housing portion 3222 mated with an upper housing portion 3224, in accordance
with an
orientation of the device 3200 as shown. The lower housing portion 3222 can
include, form, or
define the contaminant containment reservoir 3206, the inlet 3202, and a first
portion of the first
and second conduits. The upper housing portion 3224 can include, form, or
define the sampling
channel 3208, the outlet 3204, and a second portion of the first and second
conduits. The lower
housing portion 3222 and upper housing portion 3224 can be mated together and
the fluid paths
sealed by glue, thermal welding (ultrasonic, laser, friction, etc.), screws,
bolts or any other
connecting mechanism or process.
[01.891 As shown in FIG. 2A, when a negative pressure differential is
applied between the
outlet 3204 and the inlet 3202, a first amount of fluid, which is likely to
have contaminants, is
"pulled" into the inlet 3202 by the negative pressure and into or toward the
contaminant
containment reservoir 3206, since the sampling channel 3208 is initially
blocked or restricted by
displaceable plug 3214. And, because of the presence of the displaceable plug
3214 in the
second conduit to the sampling channel 3208, the first amount of fluid
bypasses the displaceable
plug 3214 and the sampling channel 3208. The negative pressure differential
will continue to
pull fluid into the contaminant containment reservoir 3206 until all the air
therein is displaced by
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fluid, and the fluid contacts the air permeable fluid barrier 3212,
effectively sealing it off from
the negative pressure.
101.90j Once the contaminant containment reservoir 3206 is filled with the
first portion of
fluid and the air permeable fluid barrier 3212 is sealed, the full pressure
differential between the
inlet and outlet is applied across the displaceable plug 3214 (see FIG. 2B) ,
applying a force to
the plug 3214 to defonn, collapse inward, loosen and then move it from the
second conduit to the
sampling channel 3208, as shown in FIG. 2C. Once displaced from the second
conduit to the
sampling channel 3208, and into the proximal end of the sampling channel 3208,
displacement of
the displaceable plug 3214 can be maintained by a protrusion or tang on an
inside surface of the
sampling channel 3208 above the second conduit, as shown in FIG. 2C.
Displacement of the
displaceable plug 3214 then allows subsequent amounts of fluid to bypass the
first amount of
fluid, enter into and through the sampling channel 3208, and pulled out the
outlet 3204. A flow
or drawing of the subsequent amounts of fluid from the inlet 3202 into and
through the sampling
channel 3208 work to keep the plug displaced away from the second conduit. For
instance, the
displaceable plug 3214 can. have a bottom surface that is planar and circular,
or slightly curved,
so as to facilitate displacement from the second conduit. The curvature can be
concave or
convex. In some implementations, the bottom surface of the displaceable plug
3214 can be
coated with a hydrophobic layer, to facilitate flow of the first portion of
fluid past the plug 3214,
as well as facilitate flow past the plug 3214 and through the sampling channel
3208 when the
plug 3214 is displaced.
101911 FIGS. 33A ¨ 33D illustrate an alternative implementation of a
fluid sample
optimization device 3300, having an inlet 3302, an outlet 3304. The fluid
sample optimization
device 3300 further includes a contaminant containment reservoir 3306
fluidically coupled with
the inlet 3302 and connected with the outlet 3304 via a first conduit having
an air permeable
fluid barrier 3312. The fluid sample optimization device 3300 further includes
a sampling
channel 3308 fluidically coupled with the outlet and connected with the inlet
via a second
conduit having a displaceable plug 3314 that initially seals the second
conduit. The outlet 3304
is fluidically connected with a fluid sampling device that provides a vacuum
or negative pressure
at the outlet 3304. The inlet is fluidically connected with a fluid source,
such as a patient needle
configured for venipuncture of a patient.
[0192] Upon activation of the vacuum or negative pressure at the outlet
3304, a negative
pressure differential is formed between the outlet 3304 and the inlet 3302. As
shown in FIG. 3B,
the negative pressure from the outlet 3304 draws in fluid into the inlet 3302
and into the
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contaminant containment reservoir 3306, displacing air through the air
permeable membrane
3312 and bypassing the second conduit between the inlet 3302, as the second
conduit is blocked
by displaceable plug 3314.
101931 Once the initial amount of fluid flows into, and is contained in,
the contaminant
containment reservoir 3306, the still-present vacuum or negative pressure at
the outlet 3304 by a
fluid sampling device causes the plug 3314 to be squeezed or otherwise
collapsed, which pulls
the plug 3314 from the second conduit to open it, as shown in FIG. 3C. This
allows subsequent
amounts of fluid to be pulled into the inlet 3302, through the second conduit
and into the
sampling channel 3308, toward and out the outlet 3304.
[01941 FIG. 3D illustrates a plug 3314 having a post 3332 that has a cross-
sectional area that
is smaller than a cross-sectional area of the second conduit. The plug 3334
further includes a
hollow or tubular top portion 3334, which is collapsible upon application of a
negative pressure
on a side of the plug opposite the post 3332. The plug 3334 is configured to
collapse upon a
minimal threshold of pressure. The collapsing under pressure can be configured
by a length of
the top portion 3334, a thickness of walls of the top portion 3334, an
elasticity of the material
that forms the plug 3314, or any combination thereof The plug 3314 can further
include a set of
vertical ribs 3336 or protrusion, or the like, for creating a space or conduit
therebetween to
ensure fluid flow therethrough upon displacement of the plug 3314.
101951 FIGS. 34A ¨ 34C illustrate various alternative implementations of
a displaceable plug
3402 or stopper, shown in the form of a ball or rounded object (i.e. oblong,
or egg-shaped), but
which can be any shape, such as cylindrical, bullet-shaped, disk-shaped, a
curved cap or planar
plug, or any other shape. The plug 3402 is held in place in a junction 3410 of
the device by a
seat 3404 or seating member until displaced by a pressure differential. The
seat can be
elastomeric, semi-rigid or rigid. For example, the seat 3404 can be an o-ring
for a plug with a
circular or semi-circular cross-section (FIG. 34A), a thin sheet with a hole
or aperture (FIG.
34B), or a short segment of tubing that holds the plug 3402 in place until
displaced (FIG. 34C).
The seat 3404 can be held stationary between upper and lower housing members
of the device.
[01961 In some cases, particularly such as shown in FIGS. 34A and 34B, a
feature such as a
shelf 3412 or lip in the housing or the sample path or sampling channel can
cooperate with the
seating member to keep the plug in place, i.e. not allow reverse displacement
toward the inlet or
contaminant containment reservoir. The dimensions and geometry of the plug,
seating member,
and/or path in which the seating member and plug reside, can be designed such
that the plug will
not be pulled through too early ¨ i.e. while the contaminant containment
reservoir.is filling ¨ but
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when the contaminant containment reservoir is full and the pressure
differential increases across
the stopper, the plug will be pulled upward and allow flow past the seating
member through the
path.
101971 FIGS. 35A and 35B illustrate various alternative implementations
of a displaceable
plug 3502 or stopper, shown in the form of a disk with a shoulder 3503, 3505
that holds it in
place within a junction 3510 or path between the inlet and the sample path or
sampling channel,
until the pressure differential overcomes the force of the shoulder 3503, 3505
in the junction
3510 to allow the plug 3502 to be displaced and exit its seat in the junction
3510. The path
between the inlet and the sample path or sampling channel can include a
protrusion 3504, such as
a small ring or one or more small tangs or flanges, that mate with the
shoulder of the plug until
such mating is overcome by pressure.
[0198] FIG. 35A illustrates the plug as a one-piece elastomer disk with
an enlarged diameter
shoulder 3503 that keeps the plug from moving in the path until the pressure
differential is
applied. FIG. 35B shows the plug as a disk with a thin flexible sheet 3505
attached that would
deform when pushed upward. Accordingly, the plug can be formed of one unitary
piece of
material, or several pieces of material each having different durometers,
elasticities or flexibility.
For instance, the disk of FIG. 35B can be formed of a rigid material, which
can be hollow or
solid, and the larger-diameter flexible sheet can be formed of a highly
flexible material that is
tuned to flex upon exertion of a certain range of pressure on it or the disk.
101991 While FIGS. 35A and 35B illustrate a rounded disk shape, it should
be understood
that the plug can have any cross-sectional geometry or shape. For example, in
some
implementations, the flexible sheet or extended ridge can be rounded, while
the upper disk or
plug member can have one or more angled surfaces, such as a pyramid, square,
cone, or the like,
that is configured to fit into a corresponding receptacle in the sample path
of a similar shape,
such as with a friction fit or the like.
102001 FIGS. 36A -- 36C illustrate further various alternative
implementations of a
displaceable plug or stopper, consistent with the devices described herein.
FIG. 36A shows a
plug in the shape of a thin elastomeric disk, or membrane, with a
circumferential 0-ring member,
such as a gasket, where the circumferential 0-ring member has a thickness or
cross-section that is
larger than a thickness of the disk, and abuts or is set within a seat. In
some implementations, the
disk can be in the shape of an umbrella. When subjected to a differential
pressure (i.e. a
relatively higher or positive pressure on the underside of the plug than on
the top side of the
plug), the membrane will deform and the entire plug will be displaced from its
seat. The
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membrane can be curved, such as curved upward. In some implementations, the
plug can
include only one or more peripheral abutments or sections.
10201] FIG. 36B shows a plug 3602 being formed as a hollowed-out
elastomeric stopper
which deforms easily under a threshold amount of pressure, to release the plug
3602 for
displacement from its seat. FIG. 36C shows a plug 3602 formed as a soft,
compressible material
such as a closed-cell foam, and which is press-fit or friction-fit into the
junction or path. The
plug 3602 can also be formed from an open-cell foam, but preferably covered by
a fluid barrier.
10202] One challenge of a device as described herein is providing a
location or member to
which the plug or stopper can move or couple with so that it does not block
the flow through the
sample path or move downstream into a collection device, such as a Vacutainer
bottle. In some
implementations, a screen or grate can be used or positioned in the sample
path downstream from
the junction or path seat, and which can catch the stopper after it is
displaced from the seat.
Alternatively, the shape of the sample path can be configured so as to have a
uniform cross-
sectional area along the sample path, but which changes shape so as to not
allow the plug or
stopper to traverse the length of the sample path.
[0203] FIGS. 37A and 37B show a variation of a junction into the sample
path in which a
stopper 3702 or plug, which is not permanently attached to any wall or other
structure of the
device, moves to a position that allows flow through an alternate path,
created by a divider 3710
within the sample path or sampling channel. In some implementations, the
housing of the device
can be formed to allow a free movement of the stopper 3702 or plug from a seat
within a junction
between the inlet and the sample path, and a receptacle such as a recess,
cavity, pin, or other
protrusion, formed on an inner surface of the sample path. Preferably, once
the stopper or plug is
displaced, the resultant path through the sample path is configured to allow a
free flow of fluid,
i.e. unimpeded or unrestricted, from the inlet through the sample path.
10204] FIG. 38A is a side cross-sectional view, FIG. 38B is front-to-back
cross-sectional
view, and FIG. 38C is an exploded view of another implementation of a fluid
sample
optimization device 3800 having: I) a housing 3820, which houses, forms, or
defines an inlet
3802, an outlet 3804, a contaminant containment reservoir 3806, and a sampling
channel 3808;
2) an air-permeable fluid barrier 3812, positioned in or at a first conduit
between the contaminant
containment reservoir 3806 and the sampling channel 3808 proximate the outlet
3804; and 3) a
displaceable plug 3814, positioned in or at a second conduit between the
contaminant
containment reservoir 3806 and the sampling channel 3808 proximate the inlet
3802.
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[0205] The inlet 3802 can include an inlet port for connecting to a fluid
source, such as a
patient needle and tubing. The inlet port can itself include a port connector,
such as a Luer
locking member, threading, truncated conical opening for a friction fit, or
the like. Similarly, the
outlet 3804 can include an outlet port for connecting to a fluid collector,
such as a Vacutainer ,
a syringe, a pump, and associated tubing. The fluid collector provides at the
outlet 3804 a
vacuum or negative pressure relative to the inlet 3802. The inlet port can
itself include a port
connector, such as a Luer locking member, threading, truncated conical opening
for a friction fit,
or the like. Alternatively, the inlet 3802 and/or outlet 3804 can be
permanently connected with
tubing, such as by glue, heat weld, laser weld, or the like.
102061 The contaminant containment reservoir 3806 is fluidically connected
with the inlet
3802, and can include a main reservoir and associated conduit, channel, or
pathway between the
main reservoir and the inlet 3802. In som.e instances, the contaminant
containment reservoir
3806 is formed of a single elongated chamber having an opening connected with
the inlet 3802.
The contaminant containment reservoir 3806 is fluidically isolated from the
outlet 3804 or the
sampling channel 3808 proximate the outlet 3804 by the air permeable fluid
barrier 3812 at the
first conduit between the contaminant containment reservoir 3806 and the
outlet 3804 or
sampling channel 3808 proximate the outlet 3804, and as explained further
below, the air
permeable fluid barrier will seal upon contact with a first portion of fluid
that enters into the
contaminant containment reservoir 3806 to displace air therein through the air
permeable fluid
barrier 3812.
[0207] The sampling channel 3808 is fluidically connected with the outlet
3804, and is at
least initially sealed from, or not fluidically connected, with the inlet
3804, as the displaceable
plug blocks, inhibits, restricts or seals the second conduit between the
sampling channel 3808
and the inlet 3802 or the contaminant containment reservoir 3806 proximate the
inlet 3802.
Preferably, the sampling channel 3808 is formed of or defined as a tube,
channel or pathway
having any sized- or shaped-cross section or geometry. The sampling channel
3808 can include
a protrusion or tang above the displaceable plug 3814, for receiving an
holding the displaceable
plug 3814 once it is displaced from the second conduit by a pressure
differential between the
outlet 3804 and the inlet 3802 when the contaminant containment reservoir 3806
receives and
contains the first amount of fluid, as will be described in further detail
below. Further, the
sampling channel 3808 can include one or more blocks, recesses, side channels,
cavities, or the
like, for receiving the plug 3814.
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[02081 In some implementations, the housing 3820 can include, or be
formed of, a lower
housing portion 3822 mated with an upper housing portion 3824, in accordance
with an
orientation of the device 3800 as shown.. The lower housing portion 3822 can
include, form, or
define the contaminant containment reservoir 3806, the inlet 3802, and a first
portion of the first
.. and second conduits. The upper housing portion 3824 can include, form, or
define the sampling
channel 3808, the outlet 3804, and a second portion of the first and second
conduits. The lower
housing portion 3822 and upper housing portion 3824 can be mated together and
the fluid paths
sealed by glue, thermal welding (ultrasonic, laser, friction, etc.), screws,
bolts or any other
connecting mechanism or process.
10209] As with the device shown in FIG. 32A and 32B, when a negative
pressure differential
is applied between the outlet 3804 and the inlet 3802, a first amount of
fluid, which is likely to
have contaminants, is "pulled" into the inlet 3802 by the negative pressure
and into or toward the
contaminant containment reservoir 3806, since the sampling channel 3808 is
initially blocked or
restricted by displaceable plug 3814. And, because of the presence of the
displaceable plug 3814
in the second conduit to the sampling channel 3808, the first amount of fluid
bypasses the
displaceable plug 3814 and the sampling channel 3808. The negative pressure
differential will
continue to pull fluid into the contaminant containment reservoir 3806 until
all the air therein is
displaced by fluid, and the fluid contacts the air permeable fluid barrier
3812, effectively sealing
it off from the negative pressure.
102101 Once the contaminant containment reservoir 3806 is filled with the
first portion of
fluid and the air permeable fluid barrier 3812 is sealed, the full pressure
differential between the
inlet and outlet is applied across the displaceable plug 3814 (similar to what
is shown in FIGS.
32A ¨ 32C) , applying a force to the plug 3814 to deform, collapse inward,
loosen and then move
it from. the second conduit to the sampling channel 3808. Once displaced from.
the second
.. conduit to the sampling channel 3808, and into the proximal end of the
sampling channel 3808,
displacement of the displaceable plug 3814 can be maintained by a protrusion
or tang on an
inside surface of the sampling channel 3808 above the second conduit.
Displacement of the
displaceable plug 3814 then allows subsequent amounts of fluid to bypass the
first amount of
fluid, enter into and through the sampling channel 3808, and pulled out the
outlet 3804.
[0211] A flow or drawing of the subsequent amounts of fluid from the inlet
3802 into and
through the sampling channel 3808 work to keep the plug displaced away from
the second
conduit. For instance, the displaceable plug 3814 can have a bottom surface
that is planar and
circular, or slightly curved, so as to facilitate displacement from. the
second conduit. The
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curvature can be concave or convex. In some implementations, the bottom
surface of the
displaceable plug 3814 can be coated with a hydrophobic layer, to facilitate
flow of the first
portion of fluid past the plug 3814, as well as facilitate flow past the plug,
3814 and through the
sampling channel 3808 when the plug 3814 is displaced.
[02121 Although a variety of embodiments have been described in detail
above, other
modifications are possible. Other embodiments may be within the scope of the
following claims.
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