U.S. patent application number 16/093002 was filed with the patent office on 2019-07-11 for device system and method for blood sample collection.
This patent application is currently assigned to Integrated Nano-Technologies, Inc.. The applicant listed for this patent is Integrated Nano-Technologies, Inc.. Invention is credited to Konstantin Aptekarev, Dennis M. Connolly, Richard S. Murante, Nathaniel E. Wescott.
Application Number | 20190209065 16/093002 |
Document ID | / |
Family ID | 60041939 |
Filed Date | 2019-07-11 |
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United States Patent
Application |
20190209065 |
Kind Code |
A1 |
Connolly; Dennis M. ; et
al. |
July 11, 2019 |
DEVICE SYSTEM AND METHOD FOR BLOOD SAMPLE COLLECTION
Abstract
A blood collection assembly to facilitate the assay of a blood
sample, comprising: (i) an absorptive media configured to collect
and release the blood sample, (ii) a cartridge defining a cavity
and a blood-sampling end configured to hold the absorptive media
against a dermal membrane containing the blood sample; (iii) a
lancet disposed within the cavity and having a lance at one end
thereof; and (iv) a plunger configured to extend and retract the
lancet through the absorptive media to lance the dermal membrane
and collect the blood sample within the absorptive media. The
cartridge containing the blood-filled, absorptive media is
configured to be placed into a blood assay device for extraction of
the blood sample from the absorptive media.
Inventors: |
Connolly; Dennis M.;
(Rochester, NY) ; Murante; Richard S.; (Rochester,
NY) ; Wescott; Nathaniel E.; (West Henrietta, NY)
; Aptekarev; Konstantin; (Santa Cruz, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Integrated Nano-Technologies, Inc. |
Henrietta |
NY |
US |
|
|
Assignee: |
Integrated Nano-Technologies,
Inc.
Henrietta
NY
|
Family ID: |
60041939 |
Appl. No.: |
16/093002 |
Filed: |
April 14, 2017 |
PCT Filed: |
April 14, 2017 |
PCT NO: |
PCT/US2017/027648 |
371 Date: |
October 11, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62322840 |
Apr 15, 2016 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 1/14 20130101; A61B
5/15113 20130101; A61B 5/150396 20130101; A61B 5/15144 20130101;
A61B 5/150022 20130101; A61B 5/150305 20130101; A61B 5/150732
20130101; A61B 5/150503 20130101; G01N 2001/1056 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/151 20060101 A61B005/151 |
Claims
1. A blood assay system for the assaying a blood sample,
comprising: an absorptive media configured to collect and release
the blood sample; a blood collection assembly defining a cavity and
a blood-sampling end configured to hold the absorptive media
against a dermal membrane containing the blood sample; a lancet
disposed within the cavity and having a lance at one end thereof; a
plunger configured to extend and retract the lancet through the
absorptive media to lance the dermal membrane and collect the blood
sample within the absorptive media; and a disposable assay
cartridge configured to assay the blood sample for detecting the
presence of a particular attribute, the disposable cartridge having
at least one sample chamber disposed in fluid communication with at
least one other assay chamber and containing at least one assay
chemical operative to detect the particular attribute; wherein the
blood collection assembly is configured to be placed into and
sealed against the at least one sample chamber to elute the blood
sample from the blood collection assembly and combine the eluted
blood with the at least one assay chemical to detect for the
presence of the attribute.
2. The blood assay system of claim 1 wherein the absorptive media
is a cellulose fiber filter comprising cotton linters which have
been treated to achieve an alpha cellulose content greater than
ninety-eight (98%.)
3. The blood assay system of claim 1 wherein the absorptive media
includes an aperture facilitating the passage of the lance upon
activation of the plunger.
4. The blood assay system of claim 1 wherein the assembly includes
at least one aperture through a wall of the assembly into the
cavity to facilitate elution of the blood sample from the
absorptive media.
5. The blood assay system of claim 1 wherein the plunger includes a
finger-receiving flanges projecting laterally from the assembly to
hold the absorptive media against the dermal membrane.
6. The blood assay system of claim 1 wherein the plunger includes:
(i) a piston portion defining a first surface slidably guided along
and internal wall of the cavity, defining a second surface
coaxially aligned with first surface, and (ii) a trigger portion
disposed through an aperture of the assembly and having an internal
bore telescopically mounting to the second surface of the piston
portion, the trigger portion projecting outwardly of the cavity to
an extended position in response to spring-biasing of the piston
portion of the plunger; and wherein the lancet mounts to the piston
portion to lance the dermal membrane when the trigger portion is
depressed.
7. The blood assay system of claim 6 wherein the lancet retracts
automatically within the cavity in response to axial displacement
of the trigger portion relative to the piston portion of the
plunger.
8. The blood assay system of claim 7 wherein the plunger includes a
coil spring disposed between the blood sampling end of the assembly
and the piston portion of the plunger.
9. The blood assay system of claim 8 wherein the trigger portion
telescopes relative to the piston portion such that the trigger
portion remains depressed following retraction of the lancet.
10. A blood collection assembly facilitating the assay of a blood
sample, comprising: an absorptive media configured to collect and
release the blood sample; a body defining a cavity and a
blood-sampling end configured to hold the absorptive media against
a blood-containing membrane; a lancet disposed within the cavity
and having a lance at one end thereof; a plunger configured to
extend and retract the lancet through the absorptive media to lance
the membrane and collect the blood sample within the absorptive
media; and wherein the body containing the absorptive media is
configured to be placed into and sealed against a chamber of a
blood assay device for extraction of the blood sample from the
absorptive media.
11. The blood collection assembly of claim 10 wherein the
absorptive media is a cellulose fiber filter comprising cotton
linters which have been treated to achieve an alpha cellulose
content greater than ninety-eight (98%.)
12. The blood collection assembly of claim 10 wherein the
absorptive media includes an aperture facilitating the passage of
the lance upon activation of the plunger.
13. The blood collection assembly of claim 10 wherein the plunger
includes a finger-receiving flanges projecting laterally from the
assembly to hold the absorptive media against the membrane.
14. The blood collection assembly of claim 10 wherein the plunger
includes: (i) a piston portion defining a first surface slidably
guided along and internal wall of the cavity, defining a second
surface coaxially aligned with first surface, and (ii) a trigger
portion disposed through an aperture of the assembly and having an
internal bore telescopically mounting to the second surface of the
piston portion, the trigger portion projecting outwardly of the
cavity to an extended position in response to spring-biasing of the
piston portion of the plunger; and wherein the lancet mounts to the
piston portion and lances the a dermal membrane when the trigger
portion is retracted from the extended position to a depressed
position.
15. The blood collection assembly of claim 14 wherein the lancet
retracts automatically within the cavity in response to axial
displacement of the trigger portion relative to the piston portion
of the plunger.
16. The blood collection assembly of claim 14 wherein the plunger
includes a coil spring disposed between the blood sampling end of
the assembly and the piston portion of the plunger.
17. The blood collection assembly of claim 14 wherein the trigger
portion telescopes relative to the piston portion such that the
trigger portion remains depressed following retraction of the
lancet.
18. A method of collecting a blood sample, comprising the steps of:
providing a blood collection assembly having a media-retaining end
and a plunger/lancet assembly; loading the media-retaining end with
an absorptive media capable of absorbing a quantity of blood;
placing the absorptive media of the assembly into contact with the
skin of a patient, activating the plunger/lancet assembly to cause
a lancet thereof to penetrate the skin to effect collection of the
quantity of blood into the absorptive media; and placing the blood
collection assembly and the absorptive media into a blood assaying
device and sealing the blood collection assembly against a chamber
of the blood assaying device.
19. The method of claim 18 further comprising the step of:
automatically retracting the lancet into cavity when a plunger is
activated.
20. The method of claim 18 further comprising the step of:
inhibiting a second activation of the lancet by the plunger/lancet
assembly following an initial activation by the plunger/lancet
assembly.
21. A blood collection assembly for obtaining and testing blood
samples from a patient, comprising: an assembly body having an
upper body portion defining a plunger end and a pair of
finger-receiving flanges projecting outwardly of the upper body
portion, a lower body portion defining a blood-sampling end and an
opening, and a cavity defining a cylindrical bore defined by the
upper and lower body portions; a plunger disposed between the
finger-receiving flanges and capable of axial displacement relative
to the assembly, the plunger having: (i) a piston portion defining
a first cylindrical surface slidably guided along the cylindrical
bore of the cavity and defining a second cylindrical surface
coaxially aligned with cylindrical bore of the cavity, and (ii) a
trigger portion slideably guided by an aperture in the upper body
portion of the assembly and having an internal bore telescopically
mounting over the second cylindrical surface of the piston portion,
the trigger and piston portions being spring-biased from a
depressed position to a retracted position, an absorptive media
disposed within the opening; a lancet disposed within the cavity of
the assembly, having one end affixed to the piston portion of the
plunger and another end defining a skin-penetrating lance facing
the media-retaining opening of the absorptive media; wherein, the
blood collection assembly is placed against a dermal membrane to
collect a sample of blood by activation of the lancet and
absorption of a sample of blood by the absorptive media and is
placed into a blood sampling device for elution and testing of the
blood sample from the absorptive media.
22. The blood collection assembly of claim 21 wherein the
absorptive media is a cellulose fiber filter comprising cotton
linters which have been treated to achieve an alpha cellulose
content greater than ninety-eight (98%.)
23. The blood collection assembly of claim 21 wherein the
absorptive media includes an aperture facilitating the passage of
the skin-penetrating lance upon activation of the plunger.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Non-Provisional Utility Patent
application which claims priority from a first U.S. Provisional
Patent Application Ser. No. 62/322,840, filed Apr. 15, 2016
entitled "Blood Sample Device" and U.S. Provisional Patent
Application Ser. No. 62/322,843, filed Apr. 15, 2016 entitled "Food
Sample Device." The contents of the aforementioned applications are
hereby incorporated by reference in their entirety.
[0002] This application relates to U.S. patent application Ser. No.
15/157,584 filed May 18, 2016 entitled "Method and System for
Sample Preparation" which is a continuation of U.S. Non-Provisional
patent application Ser. No. 14/056,603, filed Oct. 17, 2013, now
U.S. Pat. No. 9,347,086, which claims priority to U.S. Provisional
Patent Application Ser. No. 61/715,003, filed Oct. 17, 2012, which
is a continuation-in-part of U.S. patent application Ser. No.
12/785,864, filed May 23, 2010, now U.S. Pat. No. 8,663,918, which
claims priority to U.S. Provisional Patent Application Ser. No.
61/180,494, filed May 22, 2009, and which is also a
continuation-in-part of U.S. patent application Ser. No.
12/754,205, filed Apr. 5, 2010, now U.S. Pat. No. 8,716,006, which
claims priority to U.S. Provisional Patent Application Ser. No.
61/166,519, filed Apr. 3, 2009. The contents of the aforementioned
applications are hereby incorporated by reference in their
entirety.
TECHNICAL FIELD
[0003] This invention relates to a device, system, and method for
analyzing biological samples. In one embodiment, a device, system
and method for collecting samples is disclosed for use in
combination with multi-chambered disposable cartridges for use in
assaying blood samples. In another embodiment, a system and method
is disclosed for use in combination with multi-chambered disposable
cartridges for use in assaying food samples.
BACKGROUND
[0004] There is continuing interest to improve testing
methodologies, facilitate collection and decrease the time
associated with clinical laboratories. Particular testing requires
that a sample be disrupted to extract nucleic acid molecules such
as DNA or RNA.
[0005] The number of diagnostic tests performed annually has
increased exponentially in the past decade. The use of molecular
diagnostics and gene sequencing in research and medical diagnostics
is also rapidly growing. For example, DNA testing has also exploded
in view of the growing interest in establishing and tracking the
medical history and/or ancestry of a family. Many, if not all of
these assays, could benefit from a rapid sample preparation process
that is easy to use, requires no operator intervention, is cost
effective and is sensitive to a small sample size.
[0006] Sample collection and preparation is a major cost component
of conducting real-time Polymerase Chain Reaction (PCR), gene
sequencing and hybridization testing. In addition to cost, delays
can lead to the spread of infectious diseases, where time is a
critical component to its containment/abatement. In addition to
delaying the test results, such activities divert much-needed
skilled resources from the laboratory to the lower-skilled
activities associated with proper collection, storage and
delivery.
[0007] For example, a portable molecular diagnostic system could be
operated by minimally trained personnel (such as described in US
2014/0099646 A1) and have value with regard to disease
surveillance. However, the adoption of such portable systems can be
limited/constrained by current methods of sample collection, which
require trained personnel to permit safe and effective handling of
blood and/or food samples for analysis.
[0008] A need, therefore, exists for an improved device, system and
method for collection, preparation and testing of fluid samples,
facilitates the use of minimally-trained personnel, facilitates the
testing of both blood and food samples, and may be used in
combination with a portable molecular diagnostic system.
SUMMARY
[0009] The present disclosure relates to a sample
collection/carrier device and method for using the same when
assaying fluid samples, such as blood and food samples.
[0010] In one embodiment, a blood collection assembly is provided
to facilitate the assay of a blood sample, comprising: (i) an
absorptive media configured to collect and release the blood
sample, (ii) a cartridge defining a cavity and a blood-sampling end
configured to hold the absorptive media against a dermal membrane
containing the blood sample, (iii) a lancet disposed within the
cavity and having a lance at one end thereof, and (iv) a plunger
configured to extend and retract the lancet through the absorptive
media to lance the dermal membrane and collect the blood sample
within the absorptive media. The cartridge containing the
blood-filled, absorptive media is configured to be placed into a
blood assay device for extraction or elution of the blood sample
from the absorptive media.
[0011] In another embodiment, a device is provided to facilitate
the assay of a fluid sample, comprising: (i) an absorptive media
configured to collect and release the fluid sample, and (ii) a
carrier configured to: (a) hold the absorptive media in contact
with the fluid sample during collection, (b) carry the absorptive
media into an apparatus for assaying the fluid sample, and (c)
produce a fluid-retaining barrier with the apparatus while assaying
the fluid sample.
[0012] In another embodiment, a dual-barrel syringe is provided to
facilitate the preparation of a diagnostic fluid sample,
comprising: (i) a first syringe operative to draw a quantity of the
fluid sample, (ii) a second syringe containing a lysis buffer, the
first and second syringes defining first and second barrels,
respectively, which are juxtaposed and share a common wall, and
(iii) a valve mechanism containing a nozzle which may be rotated
into in fluid communication with an opening in each of the first
and second barrels.
[0013] In yet another embodiment, a food assay system is provided
to facilitate the assay of a fluid sample, comprising: an
absorptive media configured to collect and release the fluid
sample, and a disposable assay cartridge configured to assay the
fluid sample for detecting the presence of a select attribute. The
disposable cartridge has least one sample chamber disposed in fluid
communication with at least one assay chamber containing at least
one assay chemical facilitating the detection of the select
attribute. The food assay system comprises, a fluid collection
carrier configured to: (i) hold the absorptive media in contact
with the fluid sample during collection, (ii) carry the absorptive
media into the disposable assay cartridge for assaying the fluid
sample, and (iii) produce a fluid-retaining barrier with the
disposable assay cartridge while assaying the fluid sample. The
fluid collection carrier is configured to be placed into the sample
chamber such that the assay chemical is disposed in combination
with the fluid sample to determine whether the select attribute is
present.
[0014] In yet another embodiment, a method for collecting a blood
sample is provided comprising the steps of: providing a cartridge
having a media-retaining end and a plunger/lancet assembly, loading
the media-retaining end with an absorptive media capable of
absorbing a quantity of blood and placing the absorptive media of
the assembly into contact with the skin of a patient. The method
further comprises the steps of: activating the plunger/lancet
assembly to cause a lancet thereof to penetrate the skin to effect
collection of the quantity of blood into the absorptive media, and
placing the assembly and the blood-filled, absorptive media into a
blood assaying device.
[0015] In yet another embodiment, a method is provided for
preparing a diagnostic fluid sample for use with a fluid assay
system. The method comprises the steps of: amplifying the fluid
sample to increase the number of cells being tested, drawing a
first volume of the fluid sample into a first syringe of a
dual-barrel syringe and dispensing the first volume of the fluid
sample through a media filter. The method further comprises the
steps of: placing the media filter into a lysis module, dispensing
a first portion of a lysis buffer into the lysis module from the
second syringe of the dual-barrel syringe, and dispensing a second
portion of the lysis buffer through the media filter into a
disposable cartridge of a fluid assay system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The present invention is disclosed with reference to the
accompanying drawings, wherein:
[0017] FIG. 1 is a perspective view of a portable diagnostic assay
system operative to accept one of a plurality of disposable
cartridges configured to test fluid samples of collected blood or
food samples.
[0018] FIG. 2 is an exploded perspective view of one of the
disposable cartridges configured to test the biological
samples.
[0019] FIG. 3 is a top view of the one of the disposable cartridges
illustrating a variety of assay chambers including a central assay
chamber, one of which contains an assay chemical suitable to
breakdown the fluid sample to detect a particular blood
attribute.
[0020] FIG. 4 is a bottom view of the disposable cartridge shown in
FIG. 3 illustrating a variety of channels operative to move at
least a portion of the fluid sample from one chamber to another the
purpose of performing multiple operations on the fluid sample.
[0021] FIGS. 5 and 6 are perspective and profile views,
respectively, of a novel blood collection assembly according to one
embodiment of the disclosure including: a cartridge body, a
blood-collection end configured to secure an absorptive media, and
a trigger operative to activate the extension and retraction of a
lancet disposed within a cavity of the assembly body and projecting
through an aperture in the absorptive media to effect the
collection of a blood sample.
[0022] FIG. 7 is an exploded view of the blood collection assembly
including an upper body including a pair of laterally projecting
finger-flanges, a lower body including a blood-retention end, a
trigger portion, a piston portion, an absorptive media and a coil
spring.
[0023] FIG. 8 depicts the blood collection assembly being placed
into a disposable cartridge of a portable diagnostic assay
system.
[0024] FIG. 9 depicts the blood collection assembly seated in the
disposable cartridge of the portable diagnostic assay system.
[0025] FIG. 10 depicts an isolated perspective view of the trigger
and piston portions of the plunger each having a plurality of
mating teeth and a telescopic mounting surface for permitting
relative motion between the trigger and piston portions.
[0026] FIG. 11 depicts the cavity of the upper and lower body
portions for mounting the plunger and absorptive media of the blood
collection assembly.
[0027] FIG. 12 depicts an enlarged internal view of the cavity
depicting guide and retention surfaces for axial translation of the
plunger, auto-retraction of the piston portion, and a locking
feature of the trigger portion in a depressed or retracted
position.
[0028] FIG. 13 depicts a novel fluid collection device including an
absorptive media disposed at the tip end of a carrier configured
to: (i) hold the absorptive media in contact with the fluid sample
during collection, (ii) carry the absorptive media into a portable
fluid assaying system, and (iii) produce a fluid-tight or
fluid-retaining seal/barrier with the portable fluid assaying
system while performing an analysis of the fluid sample.
[0029] FIG. 13a depicts an alternate embodiment of the carrier
including a plug functionally replacing a cap to produce the
fluid-tight or fluid-retaining seal barrier with the portable fluid
assaying system.
[0030] FIG. 14 depicts the fluid collection device being placed
into, and seated within, a disposable cartridge of a portable
diagnostic assay system.
[0031] FIG. 15 depicts a perspective view of a dual-barrel syringe
facilitating the preparation of a diagnostic fluid sample,
including a first syringe operative to draw a quantity of the fluid
sample, a second syringe juxtaposed with and sharing a common wall
with the first syringe, the second syringe containing a lysis
buffer, and a valve mechanism containing a nozzle which may be
rotated into fluid communication with an opening in each barrel of
the first and second syringe.
[0032] FIGS. 16-19 depict the dual-barrel syringe in various
operating positions including drawing, dispensing, exposing and
rinsing/flushing the fluid sample in preparation for assay testing
within a portable biological assay system.
[0033] Corresponding reference characters indicate corresponding
parts throughout the several views. The examples set out herein
illustrate several embodiments of the invention but should not be
construed as limiting the scope of the invention in any manner.
DETAILED DESCRIPTION
[0034] A blood collection assembly is described for use in
combination with a portable/automated assay system such as that
described in commonly-owned, co-pending U.S. patent application
Ser. No. 15/157,584 filed May 18, 2016 entitled "Method and System
for Sample Preparation" which is hereby included by reference in
its entirety. The blood collection assembly may be used in
combination with a variety of blood diagnostic cartridges which may
be used to detect any of a variety of diseases which may be found
in a blood specimen. For example, such blood diagnostic cartridges
may be dedicated cartridges useful for detecting Hepatitis,
Autoimmune Deficiency Syndrome (AIDS/HIV), Diabetes, Leukemia,
Graves, Lupus, Multiple Myeloma, etc., just naming a small fraction
of the various blood borne diseases that the portable/automated
assay system may be configured to detect.
[0035] More specifically, and referring to FIGS. 1 and 2, the
system employs the use of a portable assay system 10 which receives
any one of a variety of disposable assay cartridges 20, each
selectively configured for detecting a particular attribute of a
fluid sample. The portable assay system 10 includes one or more
linear and rotary actuators operative to move fluids into, and out
of, various compartments or chambers of the disposable assay
cartridge 20 for the purpose of identifying or detecting a fluid
attribute. More specifically, a signal processor 14, i.e., a PC
board, controls a rotary actuator (not shown) of the portable assay
system 10 so as to align one of a variety of ports 16, disposed
about a cylindrical rotor 18, with a syringe barrel 22 of the assay
cartridge 20. Furthermore, the processor 14 controls a Linear
Variable Displacement Transducer (LVDT) 24, to displace a shaft 26
for the purpose of developing pressure i.e., positive or negative
(vacuum) in the syringe barrel 22. That is, the shaft 26 displaces
a plunger 28 within the syringe 22 to move and or admix fluids
contained in one or more of the chambers 30, 32.
[0036] The disposable cartridge 20 provides an automated process
for preparing the fluid sample for analysis and/or performing the
fluid sample analysis. The sample preparation process allows for
disruption of cells, sizing of DNA and RNA, and
concentration/clean-up of the material for analysis. More
specifically, the sample preparation process of the instant
disclosure prepares fragments of DNA and RNA in a size range of
between about 100 and 10,000 base pairs. The chambers can be used
to deliver the reagents necessary for end-repair and kinase
treatment. Enzymes may be stored dry and rehydrated in the
disposable cartridge, or added to the disposable cartridge, just
prior to use. The use of a rotary design allows for a single
plunger to draw and dispense fluid samples without the need for a
complex system of valves to open and close at various times. This
greatly reduces potential for leaks and failure of the device
compared to conventional systems. It will also be appreciated that
the system greatly diminishes the potential for human error.
[0037] In FIGS. 3 and 4, the cylindrical rotor 18 includes a
central chamber 30 and a plurality of assay chambers 32, 34
surrounded, and separated by, one or more radial or circumferential
walls 36. In the described embodiment, the central chamber 30
receives the fluid sample while the surrounding chambers 32, 34 may
contain a premeasured assay chemical or reagent for the purpose of
detecting an attribute of the fluid sample. The chemical or
reagents may be initially dry and rehydrated immediately prior to
conducting a test. Some of the chambers 32, 34 may be open to allow
the introduction of an assay chemical while an assay procedure is
underway or in process. The chambers 30, 32, 34 are disposed in
fluid communication, e.g., from one of the ports 16 to one of the
chambers 30, 32, 34, by channels 40, 42 molded in an underside
surface 42 of the rotor 18. For example, a port 16, corresponding
to aperture 42, may be in fluid communication with the central
chamber 30, via aperture 50.
Blood Collection Assembly
[0038] In FIGS. 5-8, an embodiment of a novel blood collection
assembly 100 comprises: (i) a body 104 having a blood-sampling end
106 configured to hold an absorptive media or filter 108, (ii) a
lancet 112 disposed within a cavity 116 (See FIG. 7) of the body
104 and having a lance 118 at one end thereof, and (iii) a plunger
or plunger assembly 120 configured to extend and retract the lancet
112 through the absorptive media or filter 108 to lance a dermal
membrane, (i.e., the skin of a patient), and collect a blood sample
within the absorptive media or filter 108. Once a blood sample has
been collected, the assembly body 104 containing the blood-filled,
absorptive media or filter 108 is configured to be placed into a
blood assay device 10, i.e., the fluid sample chamber 30 of the
disposable cartridge 20. This step may be performed immediately, or
involve the sterile packaging/storing and/or transport of the blood
sample, for subsequent analysis. Notwithstanding the time between
collection and analysis, the blood collection assembly 100 is
configured to be placed into a blood assay device 10 to elute the
blood from the absorptive media 108. Furthermore, the blood
collection assembly closes the sample chamber, i.e., produces a
fluid-tight seal or fluid barrier, such that fluids may flow
between ports 16 as pressure is developed in the various chambers
30, 32, 34 and channels 40, 42 of the disposable cartridge 20.
[0039] In the described embodiment, the assembly body 104 includes
an upper body portion 104a and a lower body portion 104b which
collectively define the cavity 116. The body 104 is split to allow
assembly of the plunger or plunger assembly 120 for insertion into
the cavity 116, or to facilitate the replacement/removal of the
absorptive media 108. While the absorptive media 108 may be
replaced following use, the blood collection assembly of the
present disclosure is intended to be disposable, similar to the
disposable cartridge that it supplies.
[0040] The upper body portion 104a includes a pair of
finger-receiving flanges 136, 138 projecting laterally from the
assembly body 104 to facilitate handling of the assembly 100 while
placing the absorptive media 108 against the dermal membrane or
skin The lower body portion 104b is configured to secure the
absorptive media 108 within an annular groove or recess formed at
the tip-end of the lower body portion 104b, i.e., at the tip of the
blood-sampling end 106 of the assembly body 104.
[0041] The lancet 112 comprises a conventional tubular shaft having
an end which is cut at a shallow angle, i.e., inclined, to produce
a pointed tip end 118. The tip may be machined at an angle to
produce a piercing tip, or sharpened to produce a razor-sharp lance
118. One end of the lancet 112 is embedded within a piston portion
of the plunger or plunger assembly 120, discussed in greater detail
below, while the other end of the lancet 112 faces the absorptive
media 108 while disposed within the cavity 116 of the blood
collection assembly 100.
[0042] The absorptive media 108 may be any material that absorbs
and retains a liquid sample (paper, cellulose matrix, etc.) The
material can be cut, pleated or woven in any manner to adjust the
collected volume. In one embodiment, the absorptive media 108
includes a cellulose fiber filter having cotton linters treated to
achieve an alpha cellulose content greater than about ninety-eight
percent (98%). Filter materials suitable for use include Whatman
Brand filters such as the Whatman FTA Elute series of paper
products which facilitates: (i) long-term room temperature DNA
preservation, (ii) multiple amplifications from a single sample,
and (iii) ease of elution.
[0043] In the described embodiment, the absorptive media 108 is an
annular ring having an aperture 142 for receiving the lancet 112
upon activation of the plunger 120. While an annular ring is
described, the absorptive media may have any shape provided it
allows the lancet to penetrate or pass through a portion of the
media material.
[0044] In one embodiment, the plunger 120 is spring-biased within
the cavity 116 of the assembly body 104 to be retracted and
extended relative to the assembly body 104. Furthermore, since the
lancet 112 is connected to the plunger 120, the lancet 112 may also
extend and retract within the cavity 116 to urge the lance 118
through the opening or aperture 142 in the absorptive media 108. In
the described embodiment, a coil spring 160 abuts a raised
ring-shaped shoulder 162 formed along the outer circumference of
the trigger 120, allowing the trigger 120 to be depressed from, and
returned to, an extended position. As mentioned in the preceding
sentence, inasmuch as the lancet 112 is mounted to the trigger 120,
the lancing end 118 may also extend and retract through the opening
142 in the absorptive media 108.
[0045] In FIGS. 10-12, the plunger or plunger assembly 120 includes
a piston portion 122 and a trigger portion 124. The piston portion
122 (i) defines a first cylindrical surface 126 slidably guided
along an internal cylindrical bore or surface 144 of the cavity
116, (ii) defines a second cylindrical surface 128 telescopically
mounting within a bore 134 of the trigger portion 124, and (iii)
includes a pair of arrow-shaped radial protrusions 154 (FIG. 10) to
axially guide the piston portion 122 within axial channels 156,
while preventing rotation of the piston portion 122 about an
elongate axis 100A (FIG. 11) of the assembly 100. The trigger
portion 124 is: (i) disposed between the finger-receiving flanges
136, 138 of the upper body portion 104a of the assembly 100, (ii)
slideably guided within a bore 135 in the upper body portion 104a,
and (iii) axially guided within the bore 142 (see FIG. 12) by the
raised linear guide 156 within the cavity 116.
[0046] The piston and trigger portions 122, 124 include first and
second crown-shaped teeth 164, 166, respectively, which facilitate
the transfer of axial motion between the piston and trigger
portions 122, 124 while imparting rotational motion as a
consequence of engagement between the inclined surfaces of the
crown-shaped teeth 164, 166. Inasmuch as the piston portion 122
employs anti-rotation protrusions 154, the piston portion travels
axially within the guide 156 while the trigger portion 124 rotates
into a shoulder notch 170. The trigger portion 124 only moves into
the notch 170 as the trigger portion 124 moves axially past notch
170 or as the trigger portion 124 moves past a threshold axial
location.
[0047] The relative rotation between the piston and trigger
portions 122, 124 causes the piston portion 122 to recede into the
trigger portion 124 as a consequence of the telescopic mount
between the piston and trigger portions portion 122, 124.
Furthermore, inasmuch as the lancet 112 is seated within the piston
portion 124, the lancet 112 "auto-retracts" when the trigger
portion 124 rotates under the notch 170. Furthermore, when the
trigger portion 124 rotates beneath the notch 170, it is no longer
capable of retraction and extension. Accordingly, the trigger
piston 124 is "locked" and incapable of a second use. This feature
may be desirable to prevent cross-contamination of the blood
sample. Alternatively, the lancet 122 may move into a position
where it is locked by a housing shoulder to prevent the lancet 112
and the blood collection assembly 100 from being used a second
time.
[0048] Once a blood sample has been taken, the blood collection
assembly 100 is placed within the sample chamber 30 of the
disposable cartridge 20. The blood collection assembly 100 may
include a sealing ring (not shown) at the tip end of the assembly
to facilitate the formation of a fluid-tight seal. Additionally, to
augment release and elution of the blood from the absorptive media
108, one or more apertures 172 (see FIG. 6) may be formed in the
body 104 to facilitate fluid flow through the absorptive media
108.
Fluid Sample Carrier
[0049] In FIGS. 13, 13a, and 14, a novel food assay system and
fluid sample carrier 200 includes an absorptive media 208
configured to collect and release or elute a fluid sample when
disposed in combination with a disposable cartridge 20 of a food
assay system 10. The disposable assay cartridge 20 is essentially
the same as was previously described, i.e., the arrangement of
chambers, channels, ports, and plungers etc. The principal
difference between the disposable assay cartridges 20 relates to
the types of biological agents or attributes being assayed. For
example, a cartridge 20 may be configured to assay for salmonella,
E. coli, mad-cows disease, and other food borne pathogens.
Additionally, the assembly can be configured to assay West Nile
Virus or Lime Disease.
[0050] The fluid collection carrier 200 of this embodiment,
includes a sample collection end 202, a protective handle 204, and
a connecting shaft 206 disposed therebetween. The sample collection
end 202 includes a media or media filter 220 suitable for absorbing
and carrying fluids which are suspected of containing a hazardous
or dangerous pathogen.
[0051] The absorptive media 208 may be any material that absorbs
and retains a liquid sample (paper, cellulose matrix, etc.). In one
embodiment, the absorptive media 208 includes a cellulose fiber
having cotton linters treated to achieve an alpha cellulose content
greater than about ninety-eight percent (98%). Fiber media
materials suitable for use include Whatman Brand filters such as
the Whatman FTA Elute series of paper products which facilitates
long-term room temperature preservation and ease of elution.
[0052] In the described embodiment, the absorptive media 208 will
have an elliptical shape and be sized to collect a select volume of
fluid. While an ellipse is depicted, the absorptive media 208 may
have any shape suitable for swabbing a surface or absorbing a
standing fluid.
[0053] In one embodiment, the carrier 200 comprises a sealing
member or cap 210 disposed between the shaft 206 and the protective
handle 204. The cap 210 is configured to be disposed over a rim 216
(FIG. 14) of the sample chamber 30 of the disposable cartridge 20
and form a fluid-tight or fluid-retaining seal or barrier between
it and the disposable cartridge 20. In the described embodiment,
the cap 210 defines a cavity 218 to accept the rim 216 of the
disposable cartridge 20. Similar to the previously-described blood
collection assembly 100, the carrier 200 forms a seal or barrier
with the sample chamber 30 such that the absorptive media 208 may
elute the fluid to assay for food-borne diseases, hazardous
biological agents, and/or dangerous pathogens.
[0054] In another embodiment depicted in FIG. 13a, an elastomer
plug 220 functionally replaces the cap 210 to produce the seal or
barrier with the sample chamber 30. In this embodiment, the plug
220 is received within the sample chamber 30 and forms a seal with
the internal periphery of the sample chamber 30.
[0055] In another embodiment, the sealing member 210, 220 forms a
fluid-tight seal with a vial 230 configured to maintain the purity
or sterility of the fluid sample, both before and after collection.
Furthermore, the vial 230 may be filled with a sterile fluid before
and/or after sample collection.
[0056] The fluid collection carrier 200 is configured to: (i) hold
the absorptive media 208 in contact with the fluid sample so as to
cause the absorptive media 208 to collect a quantity of the fluid
sample; (ii) carry the absorptive media 208 into the disposable
assay cartridge 20, and (iii) close an end of the sample chamber 30
to prevent the egress of assay fluids and/or assay chemicals during
assay testing.
[0057] In the described embodiment, the protective handle 204
includes a flange 212 projecting laterally outboard from an axis
206A defined by the shaft 206. The flange 212 is disposed axially
aft, or rearward of, the sealing member 210 and functions to
protect a handler from exposure to the food-borne diseases,
hazardous biological agents, and/or dangerous pathogens carried
within the absorptive media 208.
Dual-Barrel Syringe for Preparation of a Food Sample
[0058] Many diagnostic tests, particularly food safety testing,
require bacterial growth or amplification of the sample, prior to
testing. This is due to the fact that certain agents, particularly
those in food, often present very low levels of the biological
attribute sought to be tested or detected in a sample. To enhance
the probability of detecting the biological attribute, i.e., a test
sample with a low Colony Forming Unit (CFU) count, a large sample
size, i.e., typically more than ten milliliters (10 ml) can be
required. This requirement, however, runs counter to many
diagnostic assay systems which are designed for much smaller sample
inputs, i.e., typically less than about fifty micro-liters (50
.mu.l.)
[0059] To integrate these competing requirements, a multi-barrel
syringe 300 in combination with a selector valve 304 may be
employed to draw, dispense, expose, and rinse/flush the fluid
sample from an initial quantity of a food sample which has been
amplified immediately prior to conducting an assay test.
[0060] More specifically, and referring to FIGS. 15 and 16, the
syringe 300 comprises first and second barrels 308, 312 having
first and second syringe plungers 318, 322, and a selector valve
326 rotatably mounted to an end of the syringe 300 about an axis of
rotation 304A and having a syringe nozzle 330. The first and second
barrels 308, 312 are juxtaposed, share a common wall 332, and
define first and second apertures 338, 342 at an end of each of the
first and second barrels 308, 312, respectively.
[0061] The first barrel 308 of the dual-barrel syringe 300 is
larger than the second barrel 312, and in the described embodiment,
the volume of the first barrel 308 is between about five (5) to
one-hundred (100) times larger than the volume of the second barrel
312. Furthermore, the first barrel 308 of the dual-barrel syringe
300 is initially empty to allow the first barrel 308 to draw a
fluid sample from a biological sample 350 (FIG. 16) which has been
amplified/colonized to increase the CFU concentration. The second
barrel 312 of the dual-barrel syringe 300 is initially filled with
a lysis buffer which is useful for breaking-down the assay sample.
In the described embodiment, the second barrel 312 may contain
approximately three hundred micro-liters (300 .mu.l) of a lysis
buffer.
[0062] The method for preparing the fluid sample for subsequent use
in a portable assay sample system will be described in greater
detail herein below. Suffice to say at this juncture that, of the
various components provided as part of an aggregate kit, i.e., a
kit for identifying a particular attribute of a fluid/food sample,
a dual-barrel syringe 300 will be provided wherein: (i) the first
barrel 308 is significantly larger in volume than the second barrel
312, (ii) the first barrel 308 is initially empty to allow it to be
used for drawing and dispensing an assay sample through a lysis
filter, and (iii) the second barrel 312 is completely filled with a
lysis buffer and dispensed in stages to properly prepare the assay
sample.
[0063] Returning to FIG. 16, a first step of the preparation method
involves preparing the biological food sample 350 in a conventional
manner such that the biological food sample 350 is
amplified/colonized to increase its Colony Forming Unit (CFU) count
or concentration. In a second step, the plunger 318 of the first
barrel is depressed to its bottom position and the selection valve
304 is rotated to align the aperture 338 of the first barrel 308
with the nozzle passageway of the selector valve 304. The nozzle
330 of the selector value 304 is then placed in the
prepared/pre-treated food sample 350, and the plunger 318 is raised
to draw the fluid/food sample into the first barrel 308.
[0064] In FIG. 17, a third, or subsequent step, involves depressing
the plunger 318 of the first barrel 308 to dispense the entire
contents/volume of the first barrel 308 through a lysis filter 354
within a lysis module 360. The filter media 354 contains a filter
material of appropriate porosity to extract the bacterial content
of the fluid/food sample with high efficiency. Once all of the
assay sample has been captured by the lysis filter 354, the
selector valve 304 is rotated from the aperture 338 associated with
the first barrel 308 to the aperture 342 associated with the second
barrel 312.
[0065] In FIG. 18, a fourth step involves dispensing a portion of
the lysis buffer from second barrel 312 into the lysis module 360.
In the described embodiment, about one-half of the lysis buffer is
dispensed in the lysis module 360. Further, the lysis module 360 is
closed in this step to allow the module 360 to hold the contents of
the syringe 300, i.e., the lysis buffer, for a predetermined
minimum period of time. In the described embodiment, the filtered
contents of the lysis filter 354 are exposed into the lysis buffer
for a period of at least five minutes (5 mins.), and preferably for
as much as fifteen minutes (15 mins.) The lysis buffer breaks-down
and liberates the nucleic acids within the lysed material for
subsequent analysis. In certain embodiments, the time period of
exposure may be automated such that the timing is controlled by
computer software. In yet other embodiments, the lysis module 360
may be heated to facilitate and accelerate the lysis reactions.
[0066] In FIG. 19, a fifth, and final, step involves
flushing/rinsing the remaining portion of the lysis buffer, i.e.,
the remaining one-hundred and fifty micro-liters (150 .mu.l,)
through the lysis module 360 into the sample chamber 30 of the
disposable cartridge 20. In other embodiments, the fluid/food
sample could be purged into any suitable sample container based on
the subsequent analysis to be provided/envisioned.
[0067] As mentioned above, this method allows for the detection of
samples having a low CFU concentration in a sample by providing
higher concentrations depending on the relative size of the syringe
300 and the lysis module 360. This method has the added benefit of
extracting the relevant sample from the high salt broths often used
in cultured food samples which have, in the past, been problematic
for DNA purification and subsequent Polymerase Chain Reactions
(PCRs.)
EXAMPLE
[0068] In one example, a particular attribute of a food/fluid
sample was to be detected based on a desired Colony Forming Unit
(CFU)/ml. A ten milliliter (10 ml) sample was extracted from a
broth produced by growing bacteria from a twenty-five gram (25 g)
sample of ground beef. The selector valve 304 is switched to flow
the 10 ml sample through a one hundred and fifty micro-liter (150
.mu.l) lysis module 360 containing a filter medium 354 to extract
the bacterial content in the sample. After extraction, one hundred
and fifty micro-liters (150 .mu.l) of a lysis buffer was injected
into the to the lysis module 360 and allowed to react for
approximately 5 minutes. After the prescribed time period, another
one hundred and fifty micro-liters (150 .mu.l) of the lysis buffer
is dispensed through the filter medium 354 to cause the entire 300
micro-liters (300 .mu.l) to be flushed into the sample chamber 30
of the disposable cartridge 20. The lysed DNA material is then
flushed through into an assay cartridge
[0069] While the invention has been described with reference to
particular embodiments, it will be understood by those skilled in
the art that various changes may be made and equivalents may be
substituted for elements thereof without departing from the scope
of the invention. In addition, many modifications may be made to
adapt a particular situation or material to the teachings of the
invention without departing from the scope of the invention.
[0070] Therefore, it is intended that the invention not be limited
to the particular embodiments disclosed as the best mode
contemplated for carrying out this invention, but that the
invention will include all embodiments falling within the scope and
spirit of the appended claims.
* * * * *