U.S. patent application number 15/803001 was filed with the patent office on 2018-02-22 for biological fluid separation device and biological fluid separation and testing system.
The applicant listed for this patent is Becton, Dickinson and Company. Invention is credited to Daniel J. Marchiarullo, Bradley M. Wilkinson.
Application Number | 20180049686 15/803001 |
Document ID | / |
Family ID | 58804713 |
Filed Date | 2018-02-22 |
United States Patent
Application |
20180049686 |
Kind Code |
A1 |
Marchiarullo; Daniel J. ; et
al. |
February 22, 2018 |
Biological Fluid Separation Device and Biological Fluid Separation
and Testing System
Abstract
A biological fluid separation device that is adapted to receive
a multi-component blood sample is disclosed. After collecting the
blood sample, the biological fluid separation device is able to
separate a plasma portion from a cellular portion. After
separation, the biological fluid separation device is able to
transfer the plasma portion of the blood sample to a point-of-care
testing device. The biological fluid separation device of the
present disclosure also provides a closed separation and transfer
system that reduces the exposure of a blood sample and provides
fast mixing of a blood sample with a sample stabilizer. The
biological fluid separation device is engageable with a blood
testing device for closed transfer of a portion of the plasma
portion from the biological fluid separation device to the blood
testing device. The blood testing device is adapted to receive the
plasma portion to analyze the blood sample and obtain test
results.
Inventors: |
Marchiarullo; Daniel J.;
(North Haledon, NJ) ; Wilkinson; Bradley M.;
(North Haledon, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
|
|
Family ID: |
58804713 |
Appl. No.: |
15/803001 |
Filed: |
November 3, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14251699 |
Apr 14, 2014 |
9833182 |
|
|
15803001 |
|
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|
61811918 |
Apr 15, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/151 20130101;
B01L 2300/0803 20130101; B01L 2200/0621 20130101; B01L 3/502
20130101; A61B 5/150221 20130101; B01L 2400/0688 20130101; A61B
5/150755 20130101; B04B 7/08 20130101; B01L 2300/0672 20130101;
A61B 5/15144 20130101; G01N 33/491 20130101; G01N 2001/4016
20130101; B01L 2300/0627 20130101; A61B 5/150022 20130101; A61M
1/3406 20140204; A61B 5/1411 20130101; A61B 5/157 20130101; A61M
1/36 20130101; A61B 5/150412 20130101; B01L 2200/10 20130101; A61B
5/150442 20130101; B01L 2400/0409 20130101; B01L 2300/0877
20130101; A61B 5/150343 20130101; A61M 1/34 20130101; B01L 2200/027
20130101; G01N 1/4005 20130101; A61B 5/15101 20130101; A61B
5/150213 20130101; A61B 5/150351 20130101; B01L 2400/0406 20130101;
B01L 2400/0478 20130101; A61B 5/150267 20130101; B01L 2200/0684
20130101; G01N 2001/4088 20130101; B01L 2300/0864 20130101; A61B
5/150305 20130101; A61B 5/150435 20130101; B01L 2200/0631 20130101;
B01L 3/50273 20130101; A61B 5/150748 20130101; A61B 5/150778
20130101; B01L 3/5021 20130101; G01N 1/4077 20130101; G01N 1/34
20130101; A61B 5/150969 20130101; G01N 1/28 20130101; A61B 5/15003
20130101; A61B 5/15105 20130101; B01L 2300/0681 20130101; A61B
5/15198 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/151 20060101 A61B005/151; G01N 33/49 20060101
G01N033/49; G01N 1/40 20060101 G01N001/40; G01N 1/34 20060101
G01N001/34; G01N 1/28 20060101 G01N001/28; B04B 7/08 20060101
B04B007/08; B01L 3/00 20060101 B01L003/00; A61M 1/34 20060101
A61M001/34; A61B 5/157 20060101 A61B005/157 |
Claims
1. A biological fluid separation cartridge, comprising: a housing
having an inlet port and a flow channel defined within the housing
in fluid communication with the inlet port; a first collection
chamber defined within the housing in fluid communication with the
flow channel and including a first outlet port having a valve
comprising a deformable wall member and a septum, wherein the
septum covers the first outlet port; and a second collection
chamber defined within the housing in fluid communication with the
flow channel and including a second outlet port, the second
collection chamber isolated from the first collection chamber, and
the second outlet port spaced apart from the first outlet port.
2. The biological fluid separation cartridge of claim 1, wherein
the flow channel has a spiral shape.
3. The biological fluid separation cartridge of claim 1, wherein at
least a portion of the flow channel contains a sample
stabilizer.
4. The biological fluid separation cartridge of claim 1, further
comprising an inlet channel in fluid communication with the inlet
port and the flow channel.
5. The biological fluid separation cartridge of claim 4, wherein at
least a portion of the inlet channel contains a sample
stabilizer.
6. The biological fluid separation cartridge of claim 1, wherein
the biological fluid separation cartridge is receives a
multi-component blood sample.
7. The biological fluid separation cartridge of claim 6, wherein
the multi-component blood sample comprises a cellular portion and a
plasma portion.
8. The biological fluid separation cartridge of claim 7, wherein
the flow channel comprises a separation element that separates the
cellular portion and the plasma portion of the multi-component
blood sample.
9. The biological fluid separation cartridge of claim 8, wherein
the separation element comprises a plurality of posts.
10. The biological fluid separation cartridge of claim 6, wherein
the single inlet port includes a connecting portion that engages a
blood collection device and the single inlet port receives the
multi-component blood sample via connection to the blood collection
device.
11. The biological fluid separation cartridge of claim 7, wherein
the first collection chamber receives at least a portion of the
plasma portion therein and the second collection chamber receives
at least a portion of the cellular portion.
12. The biological fluid separation cartridge of claim 11, further
comprising a one-way mechanism for preventing the cellular portion
from entering the first collection chamber.
13. The biological fluid separation cartridge of claim 7, wherein
the first outlet port comprises a connection portion that engages a
point-of-care testing device for closed transfer of a portion of
the plasma portion from the first collection chamber to the
point-of-care testing device.
14. The biological fluid separation cartridge of claim 13, further
comprising a connection portion that engages a drive device,
wherein with the drive device connected to the biological fluid
separation cartridge, the drive device causes flow of the plasma
portion from the first collection chamber to the point-of-care
testing device.
15. A biological fluid separation and testing system for a
multi-component blood sample, the biological fluid separation and
testing system comprising: a biological fluid separation cartridge
adapted to receive the multi-component blood sample, the biological
fluid separation cartridge comprising: a housing having an inlet
port and a flow channel defined within the housing in fluid
communication with the inlet port; a first collection chamber
defined within the housing in fluid communication with the flow
channel and including a first outlet port having a valve comprising
a deformable wall member and a septum, wherein the septum covers
the first outlet port; and a second collection chamber defined
within the housing in fluid communication with the flow channel and
including a second outlet port, the second collection chamber
isolated from the first collection chamber, and the second outlet
port spaced apart from the first outlet port; and a blood testing
device having a receiving port adapted to receive the first outlet
port of the biological fluid separation cartridge for closed
transfer of a portion of a component of the multi-component blood
sample from the first collection chamber to the blood testing
device.
16. The biological fluid separation and testing system of claim 15,
wherein the multi-component blood sample comprises a first cellular
portion component and a second plasma portion component.
17. The biological fluid separation and testing system of claim 16,
further comprising a connection portion that engages a drive
device, wherein with the drive device connected to the biological
fluid separation cartridge, the drive device causes flow of the
plasma portion from the first collection chamber to the blood
testing device.
18. The biological fluid separation and testing system of claim 15,
wherein the blood testing device comprises a point-of-care testing
device.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 14/251,699, filed Apr. 14, 2014, entitled
"Biological Fluid Separation Device and Biological Fluid Separation
and Testing System", which claims priority to U.S. Provisional
Application No. 61/811,918, filed Apr. 15, 2013, entitled "Medical
Device for Collection of a Biological Sample", the entire
disclosures of each of which are hereby incorporated by reference
in their entirety.
BACKGROUND OF THE INVENTION
1. Field of the Disclosure
[0002] The present disclosure relates generally to devices,
assemblies, and systems adapted for use with vascular access
devices. More particularly, the present disclosure relates to
devices, assemblies, and systems adapted for collecting biological
samples for use in point-of-care testing.
2. Description of the Related Art
[0003] Blood sampling is a common health care procedure involving
the withdrawal of at least a drop of blood from a patient. Blood
samples are commonly taken from hospitalized, homecare, and
emergency room patients either by finger stick, heel stick, or
venipuncture. Blood samples may also be taken from patients by
venous or arterial lines. Once collected, blood samples may be
analyzed to obtain medically useful information including chemical
composition, hematology, or coagulation, for example.
[0004] Blood tests determine the physiological and biochemical
states of the patient, such as disease, mineral content, drug
effectiveness, and organ function. Blood tests may be performed in
a clinical laboratory or at the point-of-care near the patient. One
example of point-of-care blood testing is the routine testing of a
patient's blood glucose levels which involves the extraction of
blood via a finger stick and the mechanical collection of blood
into a diagnostic cartridge. Thereafter, the diagnostic cartridge
analyzes the blood sample and provides the clinician a reading of
the patient's blood glucose level. Other devices are available
which analyze blood gas electrolyte levels, lithium levels, and
ionized calcium levels. Some other point-of-care devices identify
markers for acute coronary syndrome (ACS) and deep vein
thrombosis/pulmonary embolism (DVT/PE).
[0005] Despite the rapid advancement in point-of-care testing and
diagnostics, blood sampling techniques have remained relatively
unchanged. Blood samples are frequently drawn using hypodermic
needles or vacuum tubes attached to a proximal end of a needle or a
catheter assembly. In some instances, clinicians collect blood from
a catheter assembly using a needle and syringe that is inserted
into the catheter to withdraw blood from a patient through the
inserted catheter. These procedures utilize needles and vacuum
tubes as intermediate devices from which the collected blood sample
is typically withdrawn prior to testing. These processes are thus
device intensive, utilizing multiple devices in the process of
obtaining, preparing, and testing blood samples. Each additional
device increases the time and cost of the testing process.
[0006] Point-of-care testing devices allow for a blood sample to be
tested without needing to send the blood sample to a lab for
analysis. Thus, it is desirable to create a device that provides an
easy, safe, reproducible, and accurate process with a point-of-care
testing system.
SUMMARY OF THE INVENTION
[0007] The present disclosure provides a biological fluid
separation device, such as a blood separation device, that is
adapted to receive a multi-component blood sample, for example,
having a cellular portion and a plasma portion. After collecting
the blood sample, the blood separation device is able to separate
the plasma portion from the cellular portion. After separation, the
blood separation device is able to transfer the plasma portion of
the blood sample to a point-of-care testing device. The blood
separation device of the present disclosure also provides a closed
separation system that reduces the exposure of a blood sample and
provides fast mixing of a blood sample with a sample stabilizer,
which could be an anticoagulant, or a substance designed to
preserve a specific element within the blood such as, for example,
RNA, protein analyte, or other element. The blood separation device
is engageable with a blood testing device for closed transfer of a
portion of the plasma portion from the blood separation device to
the blood testing device. The blood testing device is adapted to
receive the plasma portion to analyze the blood sample and obtain
test results.
[0008] Some of the advantages of the blood separation device and
the biological fluid separation and testing system of the present
disclosure over prior systems are that it is a closed system which
reduces blood sample exposure, it provides passive and fast mixing
of the blood sample with a sample stabilizer, it facilitates
separation of the blood sample without transferring the blood
sample to a separate device, and it is capable of transferring pure
plasma to a point-of-care testing device. The blood separation
device of the present disclosure enables integrated blood
collection and plasma creation in a closed system without
centrifugation. The clinician may collect and separate the blood
sample and then immediately transfer the plasma portion to the
point-of-care testing device without further manipulation. This
enables collection and transfer of plasma to the point-of-care
testing device without exposure to blood. In addition, the blood
separation device of the present disclosure minimizes process time
by processing the blood within the blood separation device and
without external machinery. Further, for tests which only require
small amounts of blood, it eliminates the waste associated with
blood collection and plasma separation with an evacuated tube.
[0009] In accordance with an embodiment of the present invention, a
biological fluid separation cartridge, such as a blood separation
cartridge, includes a housing having an inlet port and a flow
channel defined within the housing in fluid communication with the
inlet port, a first collection chamber defined within the housing
in fluid communication with the flow channel and including a first
outlet port, and a second collection chamber defined within the
housing in fluid communication with the flow channel and including
a second outlet port. The second collection chamber is isolated
from the first collection chamber, and the second outlet port is
spaced apart from the first outlet port.
[0010] In certain configurations, the flow channel has a spiral
shape. At least a portion of the flow channel may include a sample
stabilizer. In certain arrangements, the cartridge may include an
inlet channel in fluid communication with the inlet port and the
flow channel, with the inlet channel including a sample stabilizer.
The biological fluid separation cartridge may be adapted to receive
a multi-component blood sample. The multi-component blood sample
may include a cellular portion and a plasma portion.
[0011] The cartridge may include a flow channel having a separation
element adapted to separate the cellular portion and the plasma
portion of the multi-component blood sample. The separation element
may include a plurality of posts. In certain configurations, the
inlet port may be adapted to receive the multi-component blood
sample via connection to a blood collection device. The first
collection chamber may be adapted to receive at least a portion of
the plasma portion therein, and the second collection chamber may
be adapted to receive at least a portion of the cellular portion.
In some cases, the cellular portion is prevented from entering the
first collection chamber. The first outlet port may be adapted for
connection to a point-of-care testing device for closed transfer of
a portion of the plasma portion from the first collection chamber
to the point-of-care testing device. In other configurations, a
portion of the blood separation cartridge is adapted for connection
with a drive device. When the drive device is connected to the
blood separation cartridge, the drive device causes flow of the
plasma portion from the first collection chamber to the
point-of-care testing device.
[0012] In accordance with another embodiment of the present
invention, a biological fluid separation device is adapted to
receive a multi-component blood sample. The blood separation device
includes a separation cartridge having an inlet port and a flow
channel defined within the cartridge in fluid communication with
the inlet port. The flow channel contains a separation element
adapted to separate the multi-component blood sample into at least
a first component and a second component. A first collection
chamber defined within the cartridge in fluid communication with
the flow channel includes a first outlet port, and a second
collection chamber defined within the cartridge in fluid
communication with the flow channel includes a second outlet port,
with the second collection chamber isolated from the first
collection chamber.
[0013] In certain configurations, the first component is a cellular
portion of the multi-component blood sample and the second
component is a plasma portion of the multi-component blood sample.
The separation element may include a plurality of posts. In certain
embodiments, the flow channel has a spiral shape. The inlet channel
may be provided in fluid communication with the inlet port and the
flow channel, with the inlet channel including a sample stabilizer.
In certain embodiments, the second component is a plasma portion of
the multi-component blood sample.
[0014] In specific arrangements, the first collection chamber is
adapted to receive at least a portion of the second component
therein and the second collection chamber is adapted to receive at
least a portion of the first component. The first component may be
a cellular portion of the multi-component blood sample and the
second component may be a plasma portion of the multi-component
blood sample. In certain embodiments, the cellular portion is
prevented from entering the first collection chamber. Optionally,
at least a portion of the flow channel includes a sample
stabilizer. The second component may be a plasma portion of the
multi-component blood sample.
[0015] In certain configurations, the inlet port is adapted to
receive the multi-component blood sample via connection to a blood
collection device. The first outlet port may be adapted for
connection to a point-of-care testing device for closed transfer of
a portion of the second component of the multi-component blood
sample from the first collection chamber to the point-of-care
testing device. A portion of the blood separation device may be
adapted for connection with a drive device. When the drive device
is connected to the blood separation device, the drive device
causes flow of the second component of the multi-component blood
sample from the first collection chamber to the point-of-care
testing device.
[0016] In accordance with yet another embodiment of the present
invention, a biological fluid separation and testing system, such
as a blood separation and testing system, for a multi-component
blood sample includes a blood separation cartridge adapted to
receive the multi-component blood sample. The blood separation
cartridge includes a housing having an inlet port and a flow
channel defined within the housing in fluid communication with the
inlet port. The cartridge further includes a first collection
chamber defined within the housing in fluid communication with the
flow channel and including a first outlet port, and a second
collection chamber defined within the housing in fluid
communication with the flow channel and including a second outlet
port. The second collection chamber is isolated from the first
collection chamber, and the second outlet port is spaced apart from
the first outlet port. The system further includes a blood testing
device having a receiving port adapted to receive the first outlet
port of the blood separation cartridge for closed transfer of a
portion of a component of the multi-component blood sample from the
first collection chamber to the blood testing device.
[0017] In certain configurations, the multi-component blood sample
includes a first cellular portion component and a second plasma
portion component. A portion of the blood separation cartridge may
be adapted for connection with a drive device. When the drive
device is connected to the blood separation cartridge, the drive
device causes flow of the plasma portion from the first collection
chamber to the blood testing device. The blood testing device may
include a point-of-care testing device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The above-mentioned and other features and advantages of
this disclosure, and the manner of attaining them, will become more
apparent and the disclosure itself will be better understood by
reference to the following descriptions of embodiments of the
disclosure taken in conjunction with the accompanying drawings,
wherein:
[0019] FIG. 1 is a perspective view of a biological fluid
separation device in accordance with an embodiment of the present
invention.
[0020] FIG. 2 is a top view of a biological fluid separation device
in accordance with an embodiment of the present invention.
[0021] FIG. 3 is a perspective view of a biological fluid
separation device in accordance with an embodiment of the present
invention, with a first biological fluid collection device.
[0022] FIG. 4 is a perspective view of a biological fluid
separation device in accordance with an embodiment of the present
invention, with a second biological fluid collection device.
[0023] FIG. 5 is a cross-sectional, top view of a biological fluid
separation cartridge in accordance with an embodiment of the
present invention.
[0024] FIG. 6 is a detailed, fragmentary view of a portion of FIG.
5.
[0025] FIG. 7 is a perspective view of a biological fluid
separation device and a point-of-care testing device in accordance
with an embodiment of the present invention.
[0026] FIG. 8 is a cross-sectional view of a septum of a biological
fluid separation device in accordance with an embodiment of the
present invention, with the septum in a closed position.
[0027] FIG. 9 is a cross-sectional view of a septum of a biological
fluid separation device in accordance with an embodiment of the
present invention, with the septum in an open position.
[0028] FIG. 10 is a side elevation view of a biological fluid
separation device in accordance with an embodiment of the present
invention.
[0029] FIG. 11 is a side elevation view of a biological fluid
separation device in accordance with an embodiment of the present
invention, with a first component being removed from a second
component.
[0030] Corresponding reference characters indicate corresponding
parts throughout the several views. The exemplifications set out
herein illustrate exemplary embodiments of the disclosure, and such
exemplifications are not to be construed as limiting the scope of
the disclosure in any manner.
DETAILED DESCRIPTION
[0031] The following description is provided to enable those
skilled in the art to make and use the described embodiments
contemplated for carrying out the invention. Various modifications,
equivalents, variations, and alternatives, however, will remain
readily apparent to those skilled in the art. Any and all such
modifications, variations, equivalents, and alternatives are
intended to fall within the spirit and scope of the present
invention.
[0032] For purposes of the description hereinafter, the terms
"upper", "lower", "right", "left", "vertical", "horizontal", "top",
"bottom", "lateral", "longitudinal", and derivatives thereof shall
relate to the invention as it is oriented in the drawing figures.
However, it is to be understood that the invention may assume
alternative variations and step sequences, except where expressly
specified to the contrary. It is also to be understood that the
specific devices and processes illustrated in the attached
drawings, and described in the following specification, are simply
exemplary embodiments of the invention. Hence, specific dimensions
and other physical characteristics related to the embodiments
disclosed herein are not to be considered as limiting.
[0033] Various point-of-care testing devices are known in the art.
Such point-of-care testing devices include test strips, glass
slides, diagnostic cartridges, or other testing devices for testing
and analysis. Test strips, glass slides, and diagnostic cartridges
are point-of-care testing devices that receive a blood sample and
test that blood for one or more physiological and biochemical
states. There are many point-of-care devices that use cartridge
based architecture to analyze very small amounts of blood bedside
without the need to send the sample to a lab for analysis. This
saves time in getting results over the long run but creates a
different set of challenges versus the highly routine lab
environment. Examples of such testing cartridges include the
i-STAT.RTM. testing cartridge from the Abbot group of companies.
Testing cartridges such as the i-STAT.RTM. cartridges may be used
to test for a variety of conditions including the presence of
chemicals and electrolytes, hematology, blood gas concentrations,
coagulation, or cardiac markers. The results of tests using such
cartridges are quickly provided to the clinician.
[0034] However, the samples provided to such point-of-care testing
cartridges are currently manually collected with an open system and
transferred to the point-of-care testing cartridge in a manual
manner that often leads to inconsistent results, or failure of the
cartridge leading to a repeat of the sample collection and testing
process, thereby negating the advantage of the point-of-care
testing device. Accordingly, a need exists for a system for
collecting and transferring a sample to a point-of-care testing
device that provides safer, reproducible, and more accurate
results. Accordingly, a point-of-care collecting and transferring
system of the present disclosure will be described hereinafter. A
system of the present disclosure enhances the reliability of the
point-of-care testing device by: 1) incorporating a more closed
type of sampling and transfer system; 2) minimizing open exposure
of the sample; 3) improving sample quality; 4) improving the
overall ease of use; and 5) separating the sample at the point of
collection.
[0035] FIGS. 1-11 illustrate an exemplary embodiment of the present
disclosure. Referring to FIGS. 1-11, a biological fluid separation
device, such as a blood separation device 10, of the present
disclosure is adapted to receive a blood sample 12 having a
cellular portion 14 and a plasma portion 16. After collecting the
blood sample 12, the blood separation device 10 is able to separate
the plasma portion 16 from the cellular portion 14. After
separation, the blood separation device 10 is able to transfer the
plasma portion 16 of the blood sample 12 to a point-of-care testing
device. The blood separation device 10 of the present disclosure
also provides a closed separation system that reduces the exposure
of a blood sample and provides fast mixing of a blood sample with a
sample stabilizer.
[0036] FIG. 7 illustrates an exemplary embodiment of the present
disclosure. Referring to FIG. 7, a biological fluid separation and
testing system, such as a blood separation and testing system 20 of
the present disclosure, includes a blood separation device 10 and a
blood testing device or point-of-care testing device 22 engageable
with the blood separation device 10 for closed transfer of a
portion of the plasma portion 16 (FIG. 6) from the blood separation
device 10 to the blood testing device 22. The blood testing device
22 is adapted to receive the plasma portion 16 to analyze the blood
sample and obtain test results.
[0037] Some of the advantages of the blood separation device and
the blood separation and testing system of the present disclosure
over prior systems are that it is a closed system which reduces
blood sample exposure, it provides passive and fast mixing of the
blood sample with a sample stabilizer, it facilitates separation of
the blood sample without transferring the blood sample to a
separate device, and it is capable of transferring pure plasma to a
point-of-care testing device. The blood separation device of the
present disclosure enables integrated blood collection and plasma
creation in a closed system without centrifugation. The clinician
may collect and separate the blood sample and then immediately
transfer the plasma portion to the point-of-care testing device
without further manipulation. This enables collection and transfer
of plasma to the point-of-care testing device without exposure to
blood. In addition, the blood separation device of the present
disclosure minimizes process time by processing the blood within
the blood separation device and without external machinery.
Further, for tests which only require small amounts of blood, it
eliminates the waste associated with blood collection and plasma
separation with an evacuated tube.
[0038] Referring to FIGS. 1-11, a blood separation device 10
includes a first component or biological fluid separation
cartridge, such as a blood separation cartridge 11 and a second
component or drive device 13 that is removably connected to the
blood separation cartridge 11. The blood separation cartridge 11 is
adapted to receive a blood sample 12 having a cellular portion 14
and a plasma portion 16. In one embodiment, a blood separation
cartridge 11 is a disposable component and connects with a reusable
drive device 13 that is in the shape of a standard pipette which
drives the flow of blood through the blood separation cartridge 11
and drives the flow of plasma into a point-of-care testing device
22.
[0039] Referring to FIGS. 1-11, the blood separation cartridge 11
generally includes a housing 30, an inlet port 32, a flow channel
34 having an inlet channel 36 and an exit channel 38, a first
collection chamber 40 defined within the housing 30 and in fluid
communication with the flow channel 34 and including a first outlet
port 42, a second collection chamber 44 defined within the housing
30 and in fluid communication with the flow channel 34 and
including a second outlet port 46, and a valve or septum 86
disposed at the first outlet port 42. In one embodiment, the second
collection chamber 44 is isolated from the first collection chamber
40 and the second outlet port 46 is spaced apart from the first
outlet port 42. Referring to FIG. 6, the flow channel 34 includes a
separation element 50 that is adapted to separate the cellular
portion 14 and the plasma portion 16 of the blood sample 12. In one
embodiment, the separation element 50 includes a plurality of posts
52. The inlet channel 36 is in fluid communication with the inlet
port 32.
[0040] In one embodiment, the blood separation cartridge 11 is
connectable with the drive device 13 to allow vacuum or pressure to
drive flow of a blood sample within the blood separation cartridge
11. The connection between the blood separation cartridge 11 and
the drive device 13 does not allow blood contact with the drive
device 13. For example, the use of materials that only let air to
pass, or one way valves, ensures that blood does not come in
contact with the drive device 13.
[0041] In one embodiment, the flow channel 34 has a spiral shape
for inertial separation of blood cells, e.g., a cellular portion
14, from a plasma portion 16 as shown in FIG. 6. In one embodiment,
the flow channel 34 includes a plurality of posts 52 arranged to
enhance plasma separation by filtering and directing the cellular
portion 14 to the outside of the flow channel 34, which is the same
direction the inertial forces drive the cellular portion 14. The
posts 52 can be of any suitable shape, such as rounded, and may
have a generally circular cross-section. In another configuration,
the posts 52 may have any polygon shape, such as a polygon
cross-sectional shape.
[0042] At the end of the flow channel 34, e.g., a junction point
48, the flow channel 34 splits into a first collection chamber 40
for collecting the plasma portion 16 and a second collection
chamber 44 for collecting the cellular portion 14. The first
collection chamber 40 and the second collection chamber 44 includes
no posts 52 to take advantage of laminar flow properties in a
microfluidic channel. In one embodiment, to increase throughput,
multiple spirals can be fabricated that operate in parallel to
generate sufficient plasma volume for a downstream application. The
first collection chamber 40 includes the first outlet port 42 which
interfaces with a point-of-care testing device 22 or storage vessel
as discussed in more detail below. The second outlet port 46
provides an outlet for the cellular portion 14 of the blood sample
12. In one embodiment, the junction point 48 contains a mechanism
for substantially preventing the cellular portion 14 from entering
the first collection chamber 40. For example, the junction point 48
may contain a filter or one-way valve or other mechanism.
[0043] In one embodiment, at least a portion of the flow channel 34
is adapted to contain a sample stabilizer to provide passive and
fast mixing of a blood sample with the sample stabilizer. The
sample stabilizer can be an anticoagulant, or a substance designed
to preserve a specific element within the blood such as, for
example, RNA, protein analyte, or other element. In other
embodiments, the sample stabilizer is provided in other areas of
the housing 30 of the blood separation cartridge 11 such as the
inlet channel 36. In this manner, as a blood sample 12 flows
through the inlet port 32 and into the flow channel 34, the blood
separation device 10 provides passive and fast mixing of the blood
sample 12 with the sample stabilizer.
[0044] Referring to FIGS. 1-4, in one embodiment, the drive device
13 may comprise an electronic durable component that is in the
shape of a standard pipette which drives the flow of blood through
the blood separation cartridge 11 and drives the flow of plasma
into a point-of-care testing device 22. In one embodiment, the
drive device 13 drives flow by vacuum or pressure and can actuate
any required valves on the blood separation cartridge 11. The drive
device 13 can be battery operated or plugged into a wall outlet in
some embodiments or, like some automated pipettes, use induction or
plug-in charging with an internal rechargeable battery. In one
embodiment, the drive device 13 may include an actuation member 60
and flow in or out is controlled by pressing the actuation member
60 on the top of the drive device 13 in a similar location to a
plunger on a standard laboratory pipette. In other embodiment, the
actuation member 60 or buttons may be located in a trigger position
on the handle similar to automated serological pipettes.
[0045] The blood separation cartridge 11 and the drive device 13
are removably connectable theretogether such that significant
relative movement between the blood separation cartridge 11 and the
drive device 13 is prevented. Referring to FIG. 11, in one
embodiment, the blood separation cartridge 11 and the drive device
13 are removably connectable theretogether via engagement of a
first securement portion 47 of the blood separation cartridge 11
with a second securement portion 62 of the drive device 13. In
other embodiments, similar connection mechanisms may be used. For
example, a snap fit engagement mechanism or a friction fit
engagement mechanism may be used. With the blood separation
cartridge 11 and the drive device 13 connected, the blood
separation cartridge 11 is adapted to receive a blood sample 12
therein. In one embodiment, the inlet port 32 of the blood
separation cartridge 11 is adapted to receive the blood sample upon
actuation of the actuation member 60 of the drive device 13 as
discussed in more detail below.
[0046] Referring to FIGS. 3 and 4, the inlet port 32 of the blood
separation cartridge 11 is adapted to be connected to a blood
collection set or blood collection device 100 to allow for the
collection of a blood sample 12 into the blood separation device
10. The inlet port 32 may be sized and adapted for engagement with
a separate device, such as a needle assembly or IV connection
assembly and, therefore, may include a mechanism for such
engagement as is conventionally known. For example, in one
embodiment, the inlet port 32 may include a luer lock or luer tip
for engagement with an optional separate luer mating component of
such a separate device for attachment therewith. For example,
referring to FIGS. 3 and 4, the blood collection set 100 may
include a luer component 102 for engagement with the inlet port 32
of the blood separation device 10. In this manner, the inlet port
32 is connectable to the blood collection set 100 for the
collection of a blood sample into the blood separation device 10.
In addition, a mechanism for locking engagement between the inlet
port 32 and the blood collection set 100 may also be provided. Such
luer connections and luer locking mechanisms are well known in the
art. The blood collection set 100 may include a needle assembly, an
IV connection assembly, a PICC line, an arterial indwelling line,
or similar blood collection means.
[0047] The inlet port 32 may also include a resealable septum that
is transitionable between a closed position and an open position.
With the septum in an open position, a blood sample 12 may flow
through the inlet port 32 to the flow channel 34 via the inlet
channel 36.
[0048] The blood separation cartridge 11 also may include a valve
or septum 86 (FIGS. 8 and 9) at the first outlet port 42. The first
outlet port 42 is adapted for connection to a point-of-care testing
device 22 for closed transfer of a portion of the plasma portion 16
from the blood separation device 10 to the point-of-care testing
device 22 via the first outlet port 42 as described in more detail
below. The valve or septum 86 at the first outlet port 42 is
transitionable between a closed position and an open position. With
the valve or septum 86 in an open position (FIG. 9), the plasma
portion 16 of the blood sample 12 may flow through the first outlet
port 42 to a blood testing device or a point-of-care testing device
22 (FIG. 7).
[0049] Referring to FIG. 7, a blood testing device or point-of-care
testing device 22 includes a receiving port 24 adapted to receive
the first outlet port 42 of the blood separation device 10. The
blood testing device 22 is adapted to receive the first outlet port
42 of the blood separation device 10 for closed transfer of a
portion of the plasma portion 16 (FIG. 6) from the blood separation
device 10 to the blood testing device 22. The blood testing device
22 is adapted to receive the plasma portion 16 to analyze the blood
sample and obtain test results.
[0050] As discussed above, the first outlet port 42 of the blood
separation device 10 may include a valve or septum 86 that is
transitionable between a closed position and an open position. With
the valve or septum 86 in an open position (FIG. 9), the plasma
portion 16 of the blood sample 12 may flow through the first outlet
port 42 to a blood testing device or a point-of-care testing device
22 (FIG. 7).
[0051] In one embodiment, referring to FIGS. 8 and 9, the valve 86
may generally include a transfer channel 90, a bellows or
deformable wall member 92, and a septum or barrier 94 having a
first barrier wall 96 and a second barrier wall 98. Referring to
FIG. 8, the valve 86 is in a closed position to prevent the plasma
portion 16 of the blood sample 12 from flowing through the first
outlet port 42. In this manner, the plasma portion 16 is sealed
within the blood separation device 10. Referring to FIG. 9, the
valve 86 is in an open position so that the plasma portion 16 of
the blood sample 12 may flow through the first outlet port 42 to a
blood testing device or a point-of-care testing device 22 (FIG.
7).
[0052] Referring to FIG. 9, with the plasma portion 16 received
within the first outlet port 42 of the blood separation device 10,
the first outlet port 42 of the blood separation device 10 is then
positioned over the receiving port 24 of the point-of-care testing
device 22. Pushing down in the direction of arrow B compresses the
deformable wall member 92 and opens up the first barrier wall 96
and the second barrier wall 98 of the septum 94 as shown in FIG. 9.
With the valve 86 in the open position, the plasma portion 16 of
the blood sample 12 is allowed to flow through the first outlet
port 42 and the receiving port 24 to the point-of-care testing
device 22 in a closed manner, reducing exposure to the clinician
and the patient.
[0053] The valve 86 of the blood separation device 10 only opens
when the first outlet port 42 is pressed upon the receiving port 24
of the point-of-care testing device 22. This releases the isolated
plasma portion 16 directly into the receiving port 24 of the
point-of-care testing device 22, thus mitigating unnecessary
exposure to the patient's blood.
[0054] Referring to FIGS. 10 and 11, a blood separation system of
the present disclosure will now be discussed. In one embodiment,
the drive device 13 is connectable with any number of blood
separation cartridges 11. In this manner, a blood separation
cartridge 11 is a replaceable single use component. As will be
described below, after use of a blood separation cartridge 11, the
blood separation cartridge 11 can be removed from the drive device
13, as shown in FIG. 11, and the blood separation cartridge 11 can
be disposed of into a biological hazard container. When it is
desired to use the blood separation device 10 again, a new and
clean blood separation cartridge 11 can be selected and used with
the drive device 13. One advantage of the blood separation system
of the present disclosure is that a plurality of blood separation
cartridges 11 can be used with the drive device 13. The drive
device 13 can be repeatedly used.
[0055] Referring to FIGS. 1-11, use of a blood separation device
and blood separation and testing system of the present disclosure
will now be described. Referring to FIGS. 3 and 4, the inlet port
32 of the blood separation device 10 is adapted to be connected to
a blood collection set 100 to allow for the collection of a blood
sample 12 into the blood separation device 10 as discussed above.
Once the blood collection set 100 is connected to a patient, the
actuation member 60 of the drive device 13 is activated, e.g., a
power switch is pushed down, to draw the blood sample into the flow
channel 34 of the blood separation cartridge 11. As the blood
sample 12 slowly fills the blood separation device 10, it is
collected and stabilized over a layer of sample stabilizer.
Referring to FIG. 6, the blood sample 12 may then flow through the
flow channel 34 for inertial separation of the cellular portion 14
from the plasma portion 16. Inside of the flow channel 34, the
series of posts 52 are arranged to enhance plasma separation by
filtering and directing the cellular portion 14 to the outside of
the flow channel 34, which is the same direction that the inertial
forces drive the cellular portion 14.
[0056] At the end of the flow channel 34, e.g., the junction point
48, the flow channel 34 splits into a first collection chamber 40
for collecting the plasma portion 16 and a second collection
chamber 44 for collecting the cellular portion 14. The first
collection chamber 40 and the second collection chamber 44 include
no posts 52 to take advantage of laminar flow properties in a
microfluidic channel. In one embodiment, to increase throughput,
multiple spirals can be fabricated that operate in parallel to
generate sufficient plasma volume for a downstream application. The
first collection chamber 40 includes the first outlet port 42 which
interfaces with a point-of-care testing device 22 or storage
vessel.
[0057] After disconnecting the blood separation device 10 from the
blood collection set 100 or other blood collection line, the blood
separation device 10 may be engaged with a blood testing device 22.
Next, the first outlet port 42 is placed over the receiving port 24
of the point-of-care testing device 22 as shown in FIG. 7. Then,
the actuation member 60 of the drive device 13 may be activated or
depressed to advance the plasma portion 16 and to transfer the
collected plasma portion 16 to the point-of-care testing device 22.
The blood testing device 22 is adapted to receive the first outlet
port 42 of the blood separation device 10 for closed transfer of a
portion of the plasma portion 16 from the blood separation device
10 to the blood testing device 22. The blood testing device 22 is
adapted to receive the plasma portion 16 to analyze the blood
sample and obtain test results. After that, the blood separation
cartridge 11 can be removed from the drive device 13, as shown in
FIG. 11, and the blood separation cartridge 11 can be disposed of
into a biological hazard container.
[0058] Current systems for blood collection use centrifugation of
blood collection tubes often in a centralized lab to generate
plasma. This limits the ability to use plasma for point-of-care
testing. The blood separation system of the present disclosure
relies on inertial forces and a gentler filtration to generate
plasma. The filtration posts are made of the same material as the
device so analyte bias and passivation is the same for the posts as
the parent device. By using the two methods to drive the cellular
portion into a separate flow stream, less filtration should be
required to generate the same quality plasma.
[0059] Some of the other advantages of the blood separation device
and the blood separation and testing system of the present
disclosure over prior systems are that it is a closed system which
reduces blood sample exposure, it provides passive and fast mixing
of the blood sample with a sample stabilizer, it facilitates
separation of the blood sample without transferring the blood
sample to a separate device, and it is capable of transferring pure
plasma to the point-of-care testing device 22. The blood separation
device of the present disclosure enables integrated blood
collection and plasma creation in a closed system without
centrifugation. The clinician may collect and separate the blood
sample and then immediately transfer the plasma portion to the
point-of-care testing device 22 without further manipulation. This
enables collection and transfer of plasma to the point-of-care
testing device 22 without exposure to blood. In addition, the blood
separation device of the present disclosure minimizes process time
by processing the blood within the blood separation device and
without external machinery. Further, for tests which only require
small amounts of blood, it eliminates the waste associated with
blood collection and plasma separation with an evacuated tube.
[0060] While this disclosure has been described as having exemplary
designs, the present disclosure can be further modified within the
spirit and scope of this disclosure. This application is therefore
intended to cover any variations, uses, or adaptations of the
disclosure using its general principles. Further, this application
is intended to cover such departures from the present disclosure as
come within known or customary practice in the art to which this
disclosure pertains and which fall within the limits of the
appended claims.
* * * * *