U.S. patent application number 14/777134 was filed with the patent office on 2016-02-11 for self-contained modular analytical cartridge and programmable reagent delivery system.
The applicant listed for this patent is Leslie Don ROBERTS. Invention is credited to Leslie Don Roberts.
Application Number | 20160038942 14/777134 |
Document ID | / |
Family ID | 50272707 |
Filed Date | 2016-02-11 |
United States Patent
Application |
20160038942 |
Kind Code |
A1 |
Roberts; Leslie Don |
February 11, 2016 |
SELF-CONTAINED MODULAR ANALYTICAL CARTRIDGE AND PROGRAMMABLE
REAGENT DELIVERY SYSTEM
Abstract
A modular system for constructing a variety of self-contained
analytical cartridges enabled to perform a number of symmetrical or
asymmetrical tests on a single sample source within a single
device. Said cartridges are embodied as a readily reversible
assemblage of two or more modules that are, in turn, operable to
perform one or more tasks of an analytical test as discrete
articles-of-manufacture. A programmable reagent delivery system
comprising one or more serialized reagent clusters having one or
more wet cells (individually packaged reagents) and zero or more
dry cells (calibrated spacers); wherein, said wet cells are
arranged in a linear series corresponding to prescribed temporal
release sequence and dry cells are interpositioned between wet
cells in a manner that enables two or more test protocols having
asymmetrical release sequences to be synchronized such that a
single mechanism can actuate more than one test protocol
simultaneously.
Inventors: |
Roberts; Leslie Don; (Forth
Worth, TX) |
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Applicant: |
Name |
City |
State |
Country |
Type |
ROBERTS; Leslie Don |
|
|
US |
|
|
Family ID: |
50272707 |
Appl. No.: |
14/777134 |
Filed: |
February 14, 2014 |
PCT Filed: |
February 14, 2014 |
PCT NO: |
PCT/US14/16574 |
371 Date: |
September 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61802408 |
Mar 16, 2013 |
|
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|
Current U.S.
Class: |
436/43 ; 422/503;
422/67 |
Current CPC
Class: |
B01L 2200/16 20130101;
B01L 2400/0481 20130101; B01L 2400/0415 20130101; G01N 35/00
20130101; G01N 35/10 20130101; G01N 2035/00326 20130101; B01L
3/502715 20130101; B01L 2400/082 20130101; B01L 2300/0861 20130101;
G01N 35/0092 20130101; B01L 2200/027 20130101; B01L 2300/0672
20130101; B01L 2200/028 20130101; B01L 2400/0683 20130101; B01L
2200/026 20130101; B01L 2200/10 20130101; G01N 2035/0094 20130101;
B01L 2300/087 20130101; B01L 3/502 20130101; B01L 2300/0832
20130101; G01N 35/1079 20130101; B01L 2300/044 20130101 |
International
Class: |
B01L 3/00 20060101
B01L003/00; G01N 35/00 20060101 G01N035/00; G01N 35/10 20060101
G01N035/10 |
Claims
1. A system of microfluidic modules, comprising: A plurality of
coupling module-types having, At least a first coupling feature for
receiving a next module, An internal structure operable to
communicate fluidically with another module-type, and/or otherwise
enable one or more root-level operational protocols, A cooperative
overall external geometry; and, Operable, in a same total number or
in a different total number, to provide for more than one proper
selection of modules operable to assemble into a complete cartridge
having, A substantially conserved overall operative external
geometry, and Operable to perform one or more distinct root-level
operational protocol.
2. The system of modules of claim 1 further comprising a second
coupling feature for being selectively received by an alternative
module.
3. The system of modules of claim 2 wherein said internal structure
of a possible module-type, namely a specimen module, is one or more
chambers configured to: Receive a primary-input, Enclose said
primary-input, Communicate said primary-input to a next coupling
module, and Provide for one or more means for externally
controlling the internal pressure of said chamber; such as, ports,
vents, pumps, or valves; and, May further contain a mechanical
and/or chemical means intended to prepare said primary-input for
analysis; such as, analytical reagents, membranes, sieves, filters,
or internal physical features operative with a centrifugal
process.
4. The system of modules of claim 3 wherein said chamber further
possesses an opening sealed by a pierceable barrier; such as, a
self-healing stopper, through which said chamber may be evacuated
of atmosphere and set under a vacuum by operable means; and
whereby, said chamber is operable pull a primary-input into said
chamber by forces of equalizing pressure.
5. The system of modules of claim 3 wherein said chamber is coupled
to a mechanical means operable to communicate a specimen into said
chamber; such as, by suction, by placement, or by capillary
action.
6. The system of modules of claim 3 wherein said chamber is made to
possess electrical and/or chemical sensors operable to generate an
output regarding a quality of said primary-input.
7. The system of modules of claim 2 wherein said internal structure
of a possible module-type, namely a reactor module, is one or more
of a type of fluid control structure configured as a
continuous-flow fluidic system operable to: Receive a primary-input
transmitted from a first module, Receive a compliment of
secondary-inputs transmitted from one or more next modules, Process
said primary-input with said secondary-inputs according to said
root-level operational protocol, and May further be enabled to
transmit a liquid signal to a next module, and may further possess
a secondary-input within said structures.
8. The system of modules of claim 7 wherein said type of fluid
control structure is a number of individual mixing chambers
interconnected in operative fluid communication to provide for
plural discriminate pathways of fluid communication between said
chambers; and, Wherein at least a first pathway provides for
communicating a primary-input to said mixing chambers, and An
operable number of secondary pathways provide for communicating a
secondary-input to said mixing chamber according to a root-level,
or a number of concordant subordinate-level operational
protocols.
9. The system of modules of claim 7 wherein said type of fluid
control structure is a flow cytometer comprising: A fluid control
pathway extending into, and opening into a chamber by means of a
flow aperture configured with means; such as electrodes, operative
to establish an electrical field about its opening; and, Wherein a
quality of said primary-input is generated as an output of the
effect of said inputs passage through said electrical filed as said
input is made to flow through said aperture.
10. The system of modules of claim 7 wherein said type of fluid
control structure is one or more chambers made to possess a
semi-solid, or suspended solid, intermedium for processing a
primary-input according to a root-level operational protocol; and
may further possess means operable to establish an electrical field
about such intermedium to influence the electrical qualities of a
primary-input; such as, by providing for continuity in a liquid
conductor, or electrodes.
11. The system of modules of claim 7 wherein said fluid control
structures is a chamber made to possess an electrical and/or
chemical sensor operable to generate an output regarding a quality
of said primary-input.
12. The system of modules of claim 2 wherein said internal
structure of a possible module-type, namely a waste module, is one
or more chambers configured to: Receive a fluid signal transmitted
from a next coupling module, Contain said fluid signal with the
structure of said chamber, Provide for one or more means for
externally controlling the internal pressure of said chamber; such
as, ports, vents, pumps, or valves; and, May further contain an
electrical and/or chemical sensors operable to generate an output
regarding a quality of a primary-input.
13. The system of modules of claim 2 wherein said internal
structure of a possible module-type is an internal slot operable to
receive and house a subassembly.
14. The system of modules of claim 13, wherein said module-type is
a reagent module and said subassembly is a reagent delivery system;
and, Wherein said reagent delivery system is operably configured to
discriminately communicate one or more compliments of a
secondary-input to a next module according to a root-level, or a
number of concordant subordinate-level, operational protocols; and
Whereby, said compliment of secondary-inputs is a number of
individually packaged regents arranged in a temporally calibrated
series defining the time dependent dispensing sequence for each
reagent according a root-level or a number of concordant
subordinate-level operational processes.
15. The system of modules of claim 13, wherein said module-type is
an auxiliary module and said subassembly is a type, or a
combination of: a chemical, electrical, and/or light sensor, meter,
filter; and/or, a photomultiplier; and/or, an electrical storage
device; and/or a computational mechanism.
16. The system of modules of claim 2 wherein a said proper
selection of modules further comprises an operative modular matrix
that is intelligible to said selection of modules to express one or
more operations distinct from said root-level operational
protocol.
17. The system of modules of claim 16 wherein said operative matrix
is encoded in the selection, deposition, distribution, and/or
inherent properties of coupling features between: two or more
modules, to or more groups of modules, or a complete modular
assemblage; and Whereby, such coupling features may include a type
or a combination of, mechanical couplings, mechanical connectors,
cooperating geometries, cooperating interstices, native interfaces,
interfaces manifested by a partial modular assembly, divided
mechanical couplings rendered complete by a partial modular
assembly, divided mechanical connections rendered complete by a
partial modular assembly, the use of appliques or other visual
indicators, and/or divided electrical circuits.
18. The system of modules of claim 17 comprising a first operation;
wherein, said first order operation is expressed as a means for
rendering a proper selection of modules intelligible to
self-discriminate one or more aspects regarding: the selection,
timing, order, and orientation of each module's assembly into a
completed cartridge; and Whereby, such means may be a progressive
process requiring the perfection of a present assembly event may
manifest an operative point-of-attachment for a next assembly
event, leading to a final assembly event that completes a cartridge
by perfecting all point(s)-of-attachment.
19. The system of modules of claim 17 comprising a second order
operation; wherein, said second order operation is expressed as a
means for rendering select modules of a completed cartridge enabled
to operate controllable aspects of the cartridge; and Whereby, a
latent aspect of a mechanical connection providing firstly, for
selective assembly may secondly, allow for one or more modules to
be set in motion relative to other modules of the cartridge.
20. The system of modules of claim 17 comprising a third order
operation; wherein, said third order operation is expressed as a
means for transforming an external signal into an internal signal;
that may further, Operate controllable aspects of the cartridge for
performing a root-level operational protocol, and/or Convey
programmable attributes to a programmable aspect of the cartridge
for performing a root-level operational protocol, and/or
Communicate coherent pathways for transmitting radiant energy into
or out of the cartridge in a timely manner dependent upon a
root-level operational protocol; and, Whereby, the movement of one
or more modules along slide/slide-guides could: firstly, transform
an linear motion having a nonlinear magnitude and duration, into an
internal signal having a modulated amplitude and frequency that
could be used to control the communication of secondary-inputs
between modules according to a root-level operational protocol;
and/or, secondly serve as a higher order programmable attribute
governing a programmed reagent delivery system; and/or thirdly,
timely provide for transmission pathways for radiant energy into
and/or out of the cartridge by aligning one or more visual openings
of a module housing over a site where a root-level operational
protocol in being performed.
21. The system of modules of claim 2 wherein said root-level
operational protocol is a stepwise process for combining a
primary-input with a complement of secondary-inputs to generate an
output regarding a quality of the primary-input, and may further
accommodate a number of concordant subordinate-level protocols
having distinct stepwise process and/or separate complements of
secondary-inputs to generate separate outputs regarding different
qualities of the primary-input; and, Wherein, said primary-input
may be a biological specimen, and said secondary-inputs may be
liquid, gas, or immobile powder reagents, and said operational
protocol may be performed in a type, or a combination of a: liquid,
semi-solid, suspended-solid environment.
22. The modular system of claim 21 wherein said complements of
secondary-inputs further comprise: One or more individual liquid
reagents individually encapsulated in separate physical containers,
namely wet-cells, One or more of said wet-cells arranged according
to a root-level operational protocol to provide for a timed
dispensing sequence, namely a serialized reagent cluster; and,
Wherein two or more serialized reagent clusters may be arranged in
a parallel series; and, Wherein a discordance between the said
timed dispensing sequence between two or more serialized reagent
clusters may be temporally calibrated by the interpositioning of a
spacer element, namely a dry cell, to introduce a temporal delay
between one or more wet-cells of said two or more serialized regent
clusters so as to synchronize the temporal operation of each
operational protocol when actuated by a single impetus.
23. The system of modules of claim 22 wherein said complement of
secondary-inputs are preconfigured in operative compositions to
express a temporally control dispensing sequence that may be a
type, or a combination, of: Identical compositions; and/or,
Symmetrical compositions having a same number, amount, and timing;
but, differing in one or more of a type; and/or, Asymmetrical
compositions varying in number, amount, timing, and/or type.
24. The system of modules of claim 21 further comprising a type, or
a combination, of means for: interconnecting different types of
modules, and/or controlling the communication of liquids within and
between modules, and/or perform various tasks of a root-level
operational protocol as the circumstances of a protocol dictate;
and Whereby such means may be a type, or a combinations of: Means
capable of directing the assembly of specific modules into specific
cartridge types; such as, unambiguous configurations of cooperative
mechanical attachments, cooperating slide and slide-guides, clips,
appliques; Means to receive, store and/or make available fluids;
such as, chambers, cavities, bladders, and/or prepackaged reagent
cells; Means that enable the communication of a liquid within and
between modules; such as, tubes, channels, or other geometric
configurations of fluid control pathways that facilitate the
movement and possibly separation of fluids; Means to improve the
interrelationship and transfer of fluids between the cooperating
fluid transfer pathways of interconnected modules; such as,
mechanical seals, gaskets, sterile seal barriers, or self-healing
stoppers; Means to improve fluid control; such as, switches, tubes,
valves, choke points, diverters, piercing devices, shunts, ports,
vents, gaskets, compression forms, and/or magnetized or magnetic
material; Means intended to prepare a sample for analysis; such as,
analytical reagents, membranes, sieves, filters, or features that
enable a module to undergo centrifugation; Means that assist in the
acquisition of data pertaining to an analytical procedure; such as,
electrical, chemical, and/or light: sensors, meters, filters,
photomultipliers, polarizers, or light blocking, reflective, or
transparent materials, structures, or appliques; Means that further
enable the operation of the device by means of an electrical
current generated within or about a module or module assembly; such
as, electrical circuits, electrically conductive material, or
electricity storage devices, such as batteries or capacitors; Means
that allow module to move relative to other modules as set forth by
guide paths within or about other modules; such as, plungers,
select module configurations, linear actuators, slides or other
types motion directing or imparting devices; Means that communicate
indications of proper modular assemblages; such as, the specific
disposition and interrelation of one or more physical elements of
cooperative mechanical attachment between cooperating modules,
appliques, or other visual elements that may further possess
information as to the type of module and its operational
parameters; divisions of electrical circuits disposed about
cooperating modules operable to close a circuit when properly
assembled and that may further enable the communication of
information pertaining to the operation of a cartridge to an
analytical instrument designed to operate the cartridge; and Means
such as the ability to vary the physical dimensions and
configurations between of individual modules to meet the
requirements of a specific analytical task while conforming to a
standard overall dimension and mechanism-of-operation of the
finished device form.
25. The system of modules of claim 24 further comprising a proper
selection of said modules properly assembled into a complete
cartridge operably equipped to perform one or more root-level
operational protocols having two or more concordant
subordinate-level operational protocols involving separate
compliments of secondary inputs.
26. The modular system of claim 25 wherein said proper selection of
modules comprises: One or more of a reactor module operable to
receive and process a number of primary- and secondary-inputs
according to a root-level operational protocol and further operable
to establish fluid communication between one or more reagent
modules, zero or more specimen modules, and zero or more waste
modules; and, One or more of a reagent module operable to contain
and dispense a complement of secondary-inputs to said reactor
module; and, Zero or more of a specimen modules operable to contain
and dispense a primary-input to said reactor module; and, Zero or
more of a waste module operable to receive and store processed
inputs and/or input overflow from said reactor module.
27. The modular system of claim 26 wherein said complete cartridge
encloses one or more independently controlled closed
continuous-flow fluidic systems enabled by means to effect the
transmission of a fluid signal along plural discriminate pathways
of fluid communication; and, wherein, A first said pathway is
enabled by a first pneumatic port operably positioned upstream of
an input, and a second pneumatic port operably positioned
downstream of the inputs intended destination, and further operable
to couple with an external mechanical means operable to establish a
pressure gradient upstream and downstream of said input thereby
inducing and directing the input to flow discriminately to an
intended destination; and, A second said pathway is enabled by a
compressive force, generated by two modules articulated against
each other, to elevate the pressure upstream of an input, and said
second or more pneumatic ports operable to couple with an external
mechanical means to lower the internal pressure downstream of the
inputs intended destination thereby inducing and directing the
input to flow discriminately to an intended destination.
28. The modular system of claim 25 wherein said proper selection of
modules comprises: At least one module internally operable to mix a
primary-input and a secondary-input according to a root-level
operational protocol, but not internally operable to provide for
all secondary-inputs, or At least one module operable to internally
provide for a primary- or a secondary-input, but not internally
operable to mix such inputs according to a root-level operational
protocol, or At least one module that neither provides for, nor
mixes, a primary- or secondary-input according to a root-level
operational protocol, but may contain waste liquids spent during
the course of the operational protocol.
29. A programmable reagent delivery system comprising: One or more
volumes of a liquid reagent individually encapsulated in its own
physical container, namely wet-cells, Zero or more temporally
calibrated spacers, namely a dry-cells, having a volume equating a
measured amount of time, A first module having an interior at least
two wet-cells wide and at least one wet-cell deep, an exterior, a
distal end, and a proximal end operable to couple with and transmit
fluidic signals to a next module; A compression form operable to
distribute a mechanical load across one or more wet-cells while
containing such cells in an operable configuration; and, May
further possess a piercing element operable to establish a fluidic
connection between a wet-cell contained in said first module and a
fluid control pathway of said next coupling module; and wherein,
One or more wet-cells are stacked according to a defined dispensing
sequence creating a serialized reagent clusters and two or more
serialized reagent clusters are arranged in a parallel series such
that said dispensing sequence of each reagent cluster may be
actuated by a single impetus.
30. The programmable reagent delivery system of claim 29 further
comprising: One or more temporally calibrated spacers, namely a
dry-cells, having a volume equating a measured amount of time; and,
Wherein said dry cells are operably interpositioned between one or
more wet-cells to introduce a temporal delay in the release
sequence of two or more serialized reagent clusters so as to
synchronize a temporal discordance in the dispensing sequences
between reagent clusters enabling each reagent cluster to be
actuated simultaneously by a single impetus.
31. The programmable reagent delivery system of claim 30 wherein
said dry-cell may be an operable volume of a non-dispensable
material encapsulated in an individual container, or an operable
volume of a non-dispensable material interpositioned between one or
more wet-cells when operative to communicate a programmatic time
delay.
32. The programmable reagent delivery system of claim 29 further
comprising means for actuating fluid communication between a first
module and a next module; wherein such means may be of a type or
combination of: The articulation of said first module into said
next module, wherein said first module has a closed distal end and
said articulation is operable to advance one or more enclosed
wet-cells on to said piercing element, Said first module having an
open distal end, and enclosing one or more wet-cells contained in a
compression form and wherein a force acts directly on, or by means
of an intervening element, to effect a distal side of a wet-cell so
as to move a proximal side of a wet-cell onto a piercing
element.
33. The programmable reagent delivery system of claim 30 wherein
said physical container further possesses one or more qualities
that may be a type, or a combination of: an elastic quality
operable to contain a liquid under tension; a self-sealing quality
operable to be pierced through by a piercing element without
significant leakage; an elastic quality operable to deform and
distribute a mechanical load between a series of wet-cells without
rupturing; and may further possess means of interconnecting two
cells such as male/female connectors, or bonding surfaces; and may
be made of light impenetrable material.
34. The programmable reagent delivery system of claim 30 wherein
said piercing element may be a hollow cannula sharpened at one or
more ends and operable to transmit a fluid signal through its
interior, or may be a sharpened extension of a fluid control
pathway provided by said next coupling module.
35. A method for programming a reagent delivery system to
synchronize symmetrical and/or asymmetrical reagent systems
comprising: A. Selecting a step-wise root-level operational
protocol for processing a primary-input with a compliment of
secondary-inputs to generate an output that communicates a quality
of the primary-input; whereby, said root-level operational protocol
may further encapsulate a number of subordinate-level operational
protocols having separate secondary-inputs to generate separate
outputs the communicate separate qualities of the primary input;
and whereby, said primary-input may be a biological specimen that
is liquid, or a solid, or gas, in a liquid suspension, and said
secondary-inputs may be liquid reagents, B. Assess each operative
aspects of each operational protocol: 1. If each operational
protocol is identical then, skip forward to step C, 2. If each
operational protocol has a same overall operational time-cycle and
a same total volume of secondary-inputs then, skip forward to step
C, 3. If one said operational protocols differs in time cycle
and/or a total volume of secondary-inputs and skip forward to step
D; C. Arranging a prescribed volume of each secondary-input(s)
encapsulated in separate physical containers, namely a wet-cell, in
order of a prescribed dispensing sequence to create a serialized
reagent cluster for each protocol, while operably orienting two or
more serialized reagent cluster in a parallel series according to
the root-level operational protocol, and then continue to step E;
D. Perform the operational process prescribed in step C (see above)
in addition to interpositioning one or more temporally calibrated
spacer within said serialized reagent cluster according to the
requirements of each protocol: 1. If one protocol has an overall
shorter operational time cycle due to a lesser total volume of
secondary inputs, and/or a shorter time to yield an output, then
interposition a temporally calibrated spacer: In a first position
to delay the initiation of said protocol such that the protocol
concludes later, or In a last position to initiate and conclude
such protocol earlier, or In a first position and a last position
to conclude the protocol between other protocols; and/or 2. If a
protocol presents asymmetrical order of operation involving a
temporal delay between the administration of two or more
secondary-inputs; such as a timed incubation cycle, then
Interposition a temporally calibrated spacer between such wet-cells
to delay the dispensing cycles between said reagents, 3. And then
continue to step E; E. Calibrate the actuation of each serialized
reagent cluster for either continuous or incremental actuation;
whereby, continuous actuation provides for programming the
dispensing sequence of each input in a constant or variable rate;
whereas incremental actuation provides for programming the
dispensing sequence to incorporate timed stops intermittently
during, or between, an active dispensing event; and then
communicate said operating instructions to an operative instrument,
or individual, to be executed.
36. A method of encoding operation within the modular matrix of a
modular cartridge having three or more modules, said method
comprising: A. Quantifying the final operative configuration of a
modular cartridge, B. Selecting an operable type of coupling
element to be divided and/or distributed between two or more
modules; whereby, different types of coupling can provide for
selectivity during assembly and later different types of movability
once assembled; and, C. Distributing individual aspects of said
element between said modules, D. Disposing said aspects on said
modules to be selective for a specific module when one or modules
exist in a specific configuration; and Whereby, useful elements may
include a type, or a combination of: selective mechanical couplings
between two or more modules; multipart selective mechanical
connections between modules; imperfecting a part of a multi-part
mechanical connection and distributing different aspects between
select modules which perfect said part in a timely manner when
properly assembled; cooperating geometries between two or more
modules; cooperating interstices; one or more native interface(s)
between two or more modules; one or more manifested interface(s) of
a partial modular assembly; and/or, any one of the previous element
positioned in an intentionally conflicting configuration so as to
prevent an improper assemble event.
37. A method for operating a modular analytical cartridge having a
programmable reagent delivery system, comprising: A. First, induce
a metered volume of specimen to flow into an intended destination
by establishing a pressure gradient upstream of a specimen and
downstream of an intended destination for a measured amount of
time, B. Second, induce one or more or a metered volume of reagent
to flow to said intended destination by mechanically articulating
one or more reagent modules according to a preprogrammed
configuration of an enclosed reagent to induce a reagent container
to be pierced by a piercing device in fluid communication with a
pathway operable to communicate said reagent to said intended
destination, while maintaining a favorable negative pressure
downstream of said intended destination thereby establishing fluid
communication between said reagent container and an intended
destination in a manner that directs and may augment the flow of
such reagents into said intended destination.
38. An apparatus for operating a modular analytical cartridge
having a programmable reagent delivery system, comprising: Means
for receiving an a modular analytical cartridge; such a as a
mechanical stage, or a carousel, A pneumatic pump configured to
operably couple with said cartridge by means and communicate
pneumatic signals for selectively effecting the internal pressure
of select modules, A means for mechanically articulating one or
more modules of said cartridge; such as a type of a linear
actuator.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT
[0003] Not Applicable
REFERENCE TO A SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM
LISTING COMPACT DISK APPENDIX
[0004] Not Applicable
BACKGROUND OF THE INVENTION
[0005] 1. Field of the Invention
[0006] The field of the current invention relates to self-contained
single-use fluidically-operated analytical devices considered to be
portable and operable to perform one or more analytical test
requiring a liquid or semi-solid environment. Applications related
to the present invention are realized fields employing analytical
testing such as environmental testing, food safety, national
defense, research tools, drug development, and medical
diagnostics.
[0007] 2. Description of Related Art
[0008] A microfluidic device is a solid-state mixing device enabled
by a fixed-configuration continuous-flow fluid control network
physically disposed within an appropriate substrate. This fluid
control network enables the mixing of small volumes of analytical
material in a controlled manner without external user assistance
and by doing so possesses the potential to enable the automation of
many complex analytical procedures. A broad spectrum of
microfluidic devices exist ranging from simple mixing manifolds to
fully integrated self-contained analytical systems. Each type of
device varies in the degree of its self-containment, the quantity
and types of test it can perform, its fluid management, and its
method of manufacture. The subject of the present invention
pertains most closely to fully integrated analytical systems
embodied as portable self-contained fluidically controlled
cartridges operable to facilitate one or more quantitative or
qualitative analytical tests within a liquid or semi-solid
environment.
[0009] To meet the requirements of portability and self-containment
these devices must be easily transportable and operable in the
field at the point of sample collection. These devices must also be
enabled to store, dispense, and facilitate the controlled mixing of
one or more analytical materials without external assistance and
retain the collective volumes of spent solutions used during the
course of the analytical test. Such devices are generally
manufactured as singularly-indivisible holistically self-contained
articles of manufacture fabricated by advanced lithography
techniques or laminating progressive stencil layers to form the
requisite fluid control structures of a fluid control network.
These structures are then loaded with the requisite analytical
materials needed to carry out a test, and then the device is sealed
to form a closed system. With a few exceptions this is a contiguous
manufacturing process that generates a device having inseparable
constituent parts. Such devices are generally operated by
establishing a pressure gradient force within the device that
induces the movement of fluid through the device from regions of
elevated pressure to regions of lower pressure. An operable
pressure gradient force can be generated directly by pneumatic,
hydraulic, or peristaltic pumps which add a gas or immiscible
liquid to one or more inlets while subtracting a proportional
amount from an outlet or, by the elevation in pressure generated by
releasing materials from blister packaging integrated into the
fluid control network. Such a force can also be generated by
indirect means through the use of plunger systems, squeeze blubs,
and centrifuges; and, it is also possible to exploit the
electrochemomotive properties of charged molecules within an
electrical field. These devices generally control the mixing of
fluids by simultaneously releasing multiple fluids along
individually calibrated paths that vary in length and diameter;
and/or, by releasing each fluid in a temporal sequence by
selectively establishing an operable motive force at one or more
fluid reservoirs strategically positioned about the device.
Briefly, different analytical reagents exhibit different flow and
mixing rates and weak forces such as capillary action and surface
tension, generally overlooked in large volumes, become dominate
forces in the fluid dynamics of small volumes. Likewise, different
tests require different types and volumes of reagents administered
in differing temporal sequences. The act of designing an operable
fluid control network to store, mix ,and retain the collective
volumes of materials in a temporally controlled manner typically
renders a highly specialized device specific for a given test;
meaning, a new device is required for each test or combination of
tests.
[0010] How a device configures its fluid control pathways and the
mode of operation it employs determines the number and types of
test it can perform. Devices configured to perform more than one
test can be classified either as a homogenous or heterogeneous
testing platforms; and, the difference between, and within, these
two classes can lead to some confusion depending on whether "a
test" is referred to by its sample source, the variable it is
measuring or, both. For purposes of clarity, "a test", "multiple
tests", or "one or more test" as may be used herein, is intended to
be interchangeable with "one or more of a type of test". A
homogenous testing platform can perform multiple tests in at least
one of two ways; it can hold the test protocol constant and vary
the sample being tested or it can hold the sample constant and vary
a type of reagent used in the test protocol without altering its
volume or sequence of administration. In the first example a number
of sample sources are tested for the same compound and, in the
second example a single sample source is tested for multiple
compounds. Regardless how you define "a test", in both examples,
the volumes and temporal sequence of administering each fluid is
held constant which allows one fluid control network to be
calibrated for the type of test and then symmetrical replicated for
the number of tests desired which enables all test to be actuated
simultaneously in a uniform fashion. Due to the symmetry of the
system, the means (ports, electrodes, plungers, etc) that actuate
the motive force to move these fluids can be placed predictably
about various iterations of the device while also conserving the
overall dimension of the device. This in turn, enables multiple
devices to be operated by a common analytical instrument and, doing
so, has a high commercial value. The term "analytical instrument",
as used herein, is intended to generically refer to a second
instrument specially enabled to operate and analyze data acquired
from the device. Heterogeneous testing platforms, on the other
hand, integrate different types of tests involving different types,
volumes, and temporal release sequence of reagents. While these
testing platforms derive greater commercial value from the
diversity of test they can perform on a single sample source, due
to their asymmetry they are easily orders of magnitudes more
difficult to design and operate compared to homogenous testing
platforms. While some simultaneously actuated heterogeneous testing
platforms exist, their commercial utility is generally limited to a
small number of tests. Heterogeneous testing platforms that perform
a commercially relevant number of tests generally require
differentially configured fluid control networks actuated
independently of each other. This generally precludes the
predictable placement of means (ports, electrodes, plungers, etc.)
to actuate the motive force needed to move fluids within the
system. This in turn, leads to the need for different analytical
instruments or the use of complex adaptors to operate these
systems, neither of which is commercially favorable.
[0011] In addition to being difficult to design and operate, being
singularly-indivisible and holistically self-contained, most of
these devices have poor fault tolerances and are difficult to
manufacture. For example, the shelf-life of a device possessing
numerous analytical reagents would be defined by those reagents
with the shortest life expectancy. From a production standpoint, it
would be favorable to maximize the operational life-expectancy of
each device by strategically pairing the tests on any single device
to ones with compatible shelf-lives and storage conditions. Doing
so diversifies the number of devices needed to perform the
equivalent number of tests which limits the full utility of such a
device. As a device that is inseparable into constituent parts the
individual elements of the device cannot be individually
fault-tested which, when coupled to a contiguous manufacturing
process, results in an incrementing risk profile as the device is
assembled which increases the cost of sacrificing the entire device
if any single element fails to conform to specification. Likewise,
without the ability to interchange defective components, entire
production lots are placed at risk when an analytical reagent,
sensor, or other material reaches its life-expectancy or, is found
to expire prematurely or malfunction post-manufacture.
[0012] As previously mentioned, it is commercially favorable to
perform as many types of tests as possible from a single sample
source and employ different iterations of devices to diversify the
testing capability of the system employing a common analytical
instrument. In order to do so, each device iteration must have both
a conserved mechanism-of-operation and overall dimension so as to
operably interface with a common analytical instrument. This means
that, depending on the circumstances of the tests, the fluid
control network must be scaled up or down to accommodate the total
reaction volumes of the aggregate number of tests being performed
and as more tests are integrated into the system the total reactant
volumes per test must be scaled-down in order to free-up physical
space. While the physical layout of the fluid control network is
largely a design issue that is self-limiting; the total reactant
volume of a test, the sample volume in-particular, can only be
decrease so much before it ceases to meaningfully represent the
larger system. Therefore, in circumstances where low abundance
targets are present in dilute environments, as is the case in most
bioanalytics, an adequate sample size must be tested meaning. Thus,
fluid control systems must be scaled-up to handle larger reactant
volumes which limits the total number of tests the device can
perform. This again, is commercially unfavorable. It would
therefore be commercially favorable to reduce the physical
foot-print by simplifying the fluid control network needed to
perform a given tests.
[0013] While not an exhaustive list, a commercially viable
microfluidic cartridge design should be able to perform multiple
types of tests on an adequate sample size with precision,
sensitivity and reproducibility. The fluid control network should
be simplified and standardized in order to be adaptable to new test
and test combinations without significant retooling. The mode of
operation and overall device dimension should be such that enables
multiple devices to be operated by a single analytical instrument,
and the device should be easy to manufacture at commercial scales
and provide improved fault testing and fault tolerances.
SUMMARY OF THE INVENTION
[0014] The subject of the present invention pertains to the use of
a modular system to create a plurality of possible analytical
cartridges, a method to create a modular analytical cartridge
derived from a common continuous-flow fluid control network, a
plurality of possible module types that can be rendered operable to
perform one or more steps of an analytical task, a plurality of
possible modular assemblages operable to perform an analytical task
as a self-contained device, the use of individually packaged
reagents in an analytical cartridge, the use of a serialized
reagent cluster in an analytical cartridge, a method of programming
the release sequence of a dispensable material to an analytical
task, and a method to temporally synchronize the release sequences
of a variety of dispensable materials to two or more analytical
tasks.
[0015] Certain aspects of the present invention pertain to various
aspects of a fluidically controlled system. Within the context of
the present disclosure the terms "fluid control network", "fluid
control structure", and "fluid control pathway" are used as
follows: "Fluid control pathways" refer to structures that define a
path enabling the transfer of a fluid material between two
structures; "fluid control structure" pertains to various
structural elements that comprise a fluid control network; such as,
reservoirs, analytical chambers, etc.; "fluid control network"
refers to the fluid control system in aggregate comprising and
referring to among other things the physical disposition of various
fluid control pathways and fluid control structures and may enable
the controlled mixing of analytical materials. Similarly, the term
"mode-of-operation", "mechanism-of-operation", and
"method-of-operation" are used as follows: "mode-of-operation"
references the type of gradient force employed within various
modules or modular assemblages; for example by, centrifugational
force, pressure-gradient force, or electrochemomotive force, etc.;
"mechanism-of-operation" references the means used to establish a
gradient force; for example, linear actuators, centrifuges,
pneumatic or peristaltic pumps, or the flow of a electrical
current, etc.; and, "method-of-operation" references how the
cartridge is operated and generally refers to an automated, a
manual, or a combination of an automated and manual process that
may be facilitated by a computer assisted device programmed or
mechanical configured to automate a predetermined step-wise
process, and/or the use of a human hand that may grasp and
otherwise operate a device.
[0016] It is realized that many articles can be employed to
interconnect different types of modules, control the movement of
fluids, and perform various tasks essential to the operation of a
cartridge as the circumstances of a specific test dictate. Such
articles may be unambiguous configurations of cooperative
mechanical attachment, cooperating slide and slide guides, clips,
appliques or other means capable of directing the assembly of
specific modules into specific cartridge types; means to receive,
store and/or make available fluids by means of cavities, bladders,
and/or prepackaged reagent cells; means enabling fluid transfer
within and between modules in the form of tubes or channels or
other geometric configurations that facilitate the transfer and
possibly separation of fluids; means to improve the
interrelationship and transfer of fluids between the cooperating
fluid transfer pathways of interconnected modules, such as
mechanical seals, gaskets, sterile seal barriers, or self healing
stoppers; means to improve fluid control, such as switches, tubes,
valves, choke points, diverters, piercing devices, shunts, ports,
vents, gaskets, compression forms, and/or magnetized or magnetic
material; mechanical or chemical means intended to prepare a sample
for analysis, such as analytical reagents, membranes, sieves,
filters, or features that enable a module to undergo
centrifugation; means to assist in the acquisition of data
pertaining to an analytical procedure, such as electrical,
chemical, and/or light: sensors, meters, filters, photomultipliers,
polarizers, or light blocking, reflective, or transparent
materials, structures, or appliques; means that further enable the
operation of the device by means of an electrical current generated
within or about a module or module assembly, such as electrical
circuits, electrically conductive material, or electricity storage
devices, such as batteries or capacitors; and, means that allow
module to move relative to other modules as set forth by guide
paths within or about other modules, such as plungers, select
module configurations, linear actuators, slides or other types
motion directing or imparting devices.
[0017] One aspect of the present invention provides for a modular
system enabled to create a wide variety of analytical cartridges
operable to perform one or more analytical test in a liquid or
semi-solid environment. Various aspects of this modular system
enables a conserved overall dimension and mechanism-of-operation
for a number of possible modular assemblages in their final
assembled state. This enables a common analytical instrument to
operate multiple types of cartridges derived from said system.
Other aspects of the modular system provide for functional
groupings of fluid control structures to be manufactured as
discrete modules enabled to be rendered operable to perform one or
more steps of an analytical process as a functionally
self-contained unit. This provides for a segmented manufacturing
process that can uncouple the production cost of modules requiring
specialized facilities, such as clean rooms, from less specialized
modules while also improving the scalability of manufacturing
various modules at a commercially meaningful scales of production.
Other aspects of this system provides for the fault-testing of
individual modules independently of the final assembled device form
while also providing for improved fault-tolerances of the final
assembled device. For example, if a module fails to meet
operational specifications at any point prior to the initialization
of a test, the module can be readily disconnected from the device
and replaced with a functioning module without undue hardship or
the need to sacrifice the entire device. Still other aspects of
this modular system enable a unique mechanism-of-operation. In
certain modular assemblages a module may be positioned internally
to another module and made to move relative to that module. While
many types of cartridges enabled by this system employ
pneumatically driven pressure gradients to induce the movement of
fluid within and between modules, certain embodiments that possess
this type of modular configuration may also employ mechanical force
to leverage the compressive force imparted by the movement of two
objects inwardly relative to each other in order to operate
additional aspects provided for by the present system. Other
aspects of the present modular system provide for means that direct
an unambiguous assembly pattern of a number of cooperating modules
derived from a common fluid control network into a specific modular
assemblage that may also enable the operation of the final
assembled device. This may be favorable when employing a modular
system that presents a possibility of misassembling a device at one
or more locations. Such means may include the specific disposition
and interrelation of one or more physical elements of cooperative
mechanical attachment between cooperating modules, and/or
appliques, or other visual elements that provide visual indications
of proper modular assemblages that may further possess information
as to the type of analytical device and its specific operational
parameters. Such means may also be divisions of electrical circuits
disposed about cooperating modules enabled to close a circuit when
properly assembled that may further enable the communication of
information pertaining to the operation of a cartridge to an
analytical instrument designed to operate the cartridge. Other
aspects of the present system are found in the ability to vary the
physical dimensions and configurations between of individual
modules to meet the requirements of a specific analytical task
while conforming to a standard overall dimension and
mechanism-of-operation of the finished device form. This provides
high adaptability of the present modular system in performing a
wide-variety of analytical tasks while relying on a common
analytical instrument.
[0018] Another aspect of the present invention provides for a
method for creating a modular analytical device operable to perform
an analytical test as a closed system. The method describes the
steps of selecting of one or more analytical tests to be performed
on a sample; designing a continuous-flow fluid control network
operable to perform the select analytical tests accounting for,
among other things, the requisite fluid control structures operably
interconnected by fluid control pathways; dividing the fluid
control network into function groupings that are favorable to
manufacture as a number of discrete articles of manufacture that
possess sufficient cooperative modularity to be reassembled and
reconstruct the original fluid control network. The selection of
fluid control structures to be included within a functional
division may vary depending on the circumstances of each test but
it is realized that creating functional division of fluid control
structures having a similar function may be favorable from a
manufacturing and operational standpoint. For example, a functional
division possessing only analytical chambers may be favorable as a
distinct article of manufacture if said chambers are made to hold
an analytical reagent that must be kept sterile. In this example, a
single module could be rendered operable in a sterile environment,
sealed and transported to a separate facility where it could be
joined with additional modules having other elements needed to
perform the analytical test. However, it is realized that different
combinations of fluid control structures may be collocated within a
single module as is favorable for specific circumstances, such as
the inclusion of a waste reservoir in the previously mentioned
module embodiment.
[0019] Another aspect of the present invention provides for a
number of possible modules that may also be rendered operable to
perform one or more steps of an analytical test by the inclusion of
requisite analytical material needed to perform said tests. The
following selection of possible embodiments is provided to
illustrate a variety of aspects of a number of possible module
embodiments manifested in a variety of operational contexts. The
inclusion or exclusion of possible embodiments is not intended to
be limiting in any way but rather provided so as to communicate the
broader context of various aspects of select module embodiments.
One aspect of these modules may be the inclusion of one or more
fluid control structures that has been functionally reduced and
individualized from a common fluid control network enabled to
perform one or more analytical tasks. The use of the term
"functionally reduced" is intended to communicate the consolidation
of one or more fluid control structures, their corresponding fluid
control pathways, and any other requisite equipment or materials
into consolidated functional division of a select fluid control
network. Similarly the term "individualized" is intended to
communicate that an operable functional division is physically
separated from the fluid control network and disposed in an
undivided operable state within the context of an individual
module. For example, such a fluid control structure may be a type
of reservoir enabled to store, dispense, and/or retain an
analytical reagent, a sample, or the waste solutions spent during
the course of an analytical test. Another example may be a mixing
chamber and/or an analytical chamber made to mix various materials
in a controlled fashion or serve as a site that enables the
collection of information pertaining to the test being performed.
Another aspect of a module may possess a functional structure,
embodied as a substantially solid structure, a compartment, or a
slot made to house module subassemblies that may embody other fluid
control structures, electrical storage devices, sensors, or simply
serve to conserve the overall dimension and/or mode-of operation of
the device. Other examples may include multi-use structures that
consolidate two or more functions into a single structure such as a
dual mixing/sample reservoir. Many types and configurations of
fluid control structures are realized and the inclusion of such
structures depends on the circumstances of the test being
performed. Each module may also include equipment that enables
different types of analytical tasks, such as a flow aperture
enabled to perform flow cytometry, electrodes to establish an
electrical current enabling electrophoretic separation of
electrically charged materials, or ports that enable the addition
or subtraction of a gas or liquid from various modules enabling a
pressure gradient to be established within and between modules.
Other aspects of modules may include mechanical means that may be
used to direct a specific assembly pattern between two or more
modules that may also function to enable the operation of a module
assemblage. Other aspects of these modules may possess one or more
elements of cooperative mechanical attachment disposed about the
module in coordination with a one or more select cooperating
modules. For example, an element of a cooperative mechanical
attachment may be the tooth of a tooth and groove clip; wherein,
the tooth is positioned on one module and the groove on a
cooperating module and the positioning of both components is
selective for each module. Another example may be a slide/slide
guide assembly; wherein a slide is present on one module and the
slide-guide on a cooperating module and the geometric configuration
of the assembly, such as a box-slide, barrel-slide, or
triangle-slide, is selective for a cooperating module. In certain
embodiments of these modules one or more fluid control pathways are
disposed to open to one or more sides of the module. These opening
may be inlets and/or outlets depending on the type of modular
embodiment. Another aspect of these fluid control pathways is that
the physical disposition of these inlets or outlets must coordinate
and cooperate with fluid control pathways of cooperating modules.
Likewise, certain embodiments of these modules must possess the
ability to be sealed in order to contain materials within the fluid
control structures resident within the module. An aspect of this
seal is that it must be reversible in order to allow fluid
communication between modules. There are many ways to achieve this.
For example, a first module could be made to possess a piercing
device operatively recessed within a fluid control pathway thereby
allowing an adhesive barrier placed over its opening and a second
cooperating module could then be made to possess a protrusion
having an operable diameter and extending from the second module
that could also be sealed by an adhesive barrier. When the two
modules are assembled in a preoperational configuration the two
pathway would be operably opposed but not interconnected and when
actuated to perform an analytical task the protrusion from the
second module could be made to pierce the adhesive barrier of the
first module while adhesive barrier of the second module would be
pierced by the piercing device recessed within the fluid control
pathway of the first module. Alternatively, a first module could be
made to possess a self-healing stopper and a second module an
exposed piercing device. In this configuration the two modules
could be actuated in a manner that inserts and removes the piercing
device one or more times depending on the operational parameters of
the test being performed. Again, these are just a few possible
means to establish fluid communication between one or more sealed
modules and provide context for an operational aspect that may be
necessarily required for the operation of certain embodiments of
the present invention.
[0020] The present invention also provides for the use of
individually prepackaged reagents in an analytical cartridge. In
this aspect of the present invention select volumes of analytical
reagents are embodied as individual articles of manufacture,
referred to as "wet cells". Wet cells differ from blister packaging
and preloaded reagents in that they are physically separable from
the device, not integrated into the fluid control network and, have
an internal volume that is defined by their packaging not the fill
volume of a fixed reservoir in which they would otherwise be
placed. They are self-contained individual articles of manufacture
that may be made by means to interconnect into reagent clusters.
Such means may include snaps, threaded connectors, adhesives, or
simply grouped together. There are many advantages and utilities of
employing individually prepackaged reagents. Select volumes of
reagents can be manufactured in bulk and incorporated into an
analytical device at later times and locations and since they are
individually packaged they eliminate complex fluid containment
strategies needed to prevent diffusion in resting fluids and allow
reagents to be co-localized within different modules of various
modular assemblages while providing for a simplified reagent
release mechanism. They reduce waste, can be readily interchanged
if they malfunction or reach the term of their life-expectancy, and
can be specially packaged to extend the shelf-life of select
reagents; such as, light impenetrable materials to encapsulate
photosensitive reagents. Additional aspects of these wet cells
provide that single-use or multi-use volumes of analytical material
may be contained within a wet cell as the circumstances of a test
may dictate.
[0021] Another aspect of the present invention provides for
programmable reagent delivery system physically embodied as a
serialized reagent cluster. An aspect of this serialized reagent
cluster translates the operational protocol of an analytical test
into a prescribed physical arrangement of wet cells that contain a
dispensable material needed to perform an analytical test. Said wet
cells are arranged in linear series corresponding to the first,
second, third, etc., reagent employed by an analytical test. This
serial arrangement provides for the linear insertion of a cannula
sequentially into each cell of said series in a temporally
controlled manner allowing the contents of each cell to be
dispensed through said cannula. Other aspects of this serialized
reagent cluster provide for exploiting a mechanism-of-operation
provided for by other aspects of the present invention; such as the
generation of a compressive force provided for by the movement of
two modules relative to each other as previously described, modules
that may be made to possess slots to house other modular
sub-assemblies, or the use of such a system in a syringe-like
analytical system having a dual function plunger system which will
be discussed later on.
[0022] Another aspect of the present invention pertains to a
compression form. Depending on the mechanism-of-operation for
actuating the present system, certain embodiments may require the
use of a compression form. A compression form is a structure made
to possess openings enabled to receive and operably orient a
serialized reagent cluster relative to a cannula in the formation
of a reagent assemblage. The function of a compression form is to
provide a space in which the cells of a reagent cluster may be
compressed by the application of a compressive force to an end of
the reagent cluster operable to compress each cell in said series.
Certain embodiments of this compression form may be manufactured
from a rigid material that resist deformation of the walls of said
opening when acted on by the compression of a serialized reagent
cluster by the compressive force. Other embodiments of the
compression form may be manufactured from a material possessing
qualities of operable compression and resilience that is also
operable to resist the deformation of one or more serialized
reagent clusters as both the compression form and serialized
reagent cluster are compressed by a compressive force. Such a
compression form may also possess operable absorptive qualities to
absorb spillage of dispensable materials within the apparatus.
Also, certain embodiments of this reagent assemblage may directly
possess and position a cannula while in other embodiments it may be
more favorable to locate the cannula elsewhere about the device.
Another aspect of a serialized reagent cluster provides for the
ability to communicate multiple fluids along a single fluid
communication pathway which dramatically simplifies the fluid
control network of devices enabled by the present invention, which
in turn frees up more space for more tests.
[0023] Another aspect of the present invention provides for a
method for programming the operational protocol of one or more
analytical tests through the use of serialized reagent cluster
possessing both wet cells and dry cells. Dry cells, which lack a
dispensable content, function to provide for incubation cycles by
creating a physical separation between wet cells; the greater the
separation, provided by the internal volume of the dry cell, the
longer the incubation period. By allowing for incubation cycles
between treatment cycles, dry cells allow multiple serialized
reagent clusters to be temporally synchronized enabling multiple
analytical tests to be performed in parallel. This could be
achieved by actuating reagent clusters individually or collectively
and in a manner that is incremental or continuous. The use of this
methodology and apparatus allows one or more analytical tests to be
configured in a way that is largely independent of the physical
configuration of a fluid control network. This provides a highly
degree of adaptability to performing different types of tests
involving equivalent operational protocols, or highly diverse
operational protocols that differ in the types, volumes, and timing
of administration of various analytical reagents.
[0024] Another aspect of the present invention provides for a
number of possible modular assemblages that may be also be rendered
operable to perform one or more analytical tests within the context
of a single device by the inclusion of requisite analytical
material needed to perform said tests. The following selections of
possible embodiments have been provided to illustrate the present
invention in a variety of context. The inclusion or exclusion of
possible embodiments is not intended to be limiting in any way but
rather serve to communicate the broader context of the present
invention. A number of possible modular assemblages are realized
and enabled to perform one or more analytical tests as a
self-contained system in either a liquid, semi-solid,
suspended-solid, or combination thereof; said systems may be a
modular assemblage of two or more modules possessing a closed
continuous-flow systems operable to perform one or more analytical
tests, syringe based systems, electrophoresis systems, cell culture
systems, and others.
[0025] Many applications for the present invention are realized and
encompass technical fields that employ fluid based analytics or
analytics in semi-solid or suspended-solids environments. The
embodiments provided herein are intended to illustrate the general
utility of the present invention in a few select contexts and is
not intended as an exhaustive list of each possible module
configuration, cartridge embodiment, or all possible utilities of
the present invention. The number and type of functional elements
described herein are not intended to be limiting as it may be
preferable to include different numbers and types of functional
structures as specific analytical procedures dictate and not all
functional structures, variations, or possible configurations are
described herein.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0026] FIG. 1A: Illustrates a possible module comprising: module 1,
reservoir 11, boxed slide guides 12, flange 13, a cannula 14 and
pneumatic port 15.
[0027] FIG. 1B: Illustrates an alternative embodiment of the module
described in FIG. 1A comprising: module 1, cannula 14, and bulb
assembly in its depressed state 16 and relaxed state 17.
[0028] FIG. 2: Illustrates a possible module comprising: module 2,
reservoir 21, cylindrical slide-guides 22, flange 23, cannula 24,
and pneumatic port 25.
[0029] FIG. 3: Illustrates a possible module comprising: module 3,
open slot 31, cylindrical slide 32, box slide 33, and boxed 340
slide-guide(s) 34.
[0030] FIG. 4: Illustrates a possible module comprising: module 4,
closed structure 41, cylindrical slide 42, and box slide 43.
[0031] FIG. 5: Illustrates a possible module comprising: module 5,
boxed slide(s) 51, mixing chambers 52, inlet(s) 53 and 54,
outlet(s) 55 and 56, and a point of mechanical attachment 57 that
could be present symmetrically on the opposing side of the module
but not shown for visual clarity.
[0032] FIG. 6: Is an exploded perspective illustrating the assembly
pattern of those modules illustrated in FIG. 1-5 comprising:
[0033] a first attachment between module(s) 2 and 5 by route of
path 61 forming assemblage 2:5, a second and third attachment
between assemblage 2:5 and modules 3 and 4 by route of path(s) 62
and 63 forming assemblage 2:5:3:4, a fourth attachment between
assemblage 2:5:3:4 and module 1 forming the final assemblage
2:5:3:4:1. Note that the various slide-guides provide compounding
specificity to the assembly of additional modules into an operable
final form. For example, the interconnection of module 5 with
modules 3 and 4 would preclude module 2 from the assemblage. This
is due to the cylindrical nature of the slide guides present on
module 3 and 4 which require said modules to be inserted into the
slide guides present on module 2 in a specific manner.
[0034] FIG. 7A is the first of a four part composite illustration
describing the interconnection and operation of a 5 module
assemblage: comprising, modules 1-5, four paths of interconnection
generally represented as Arrows 70-73, and port(s) 74 and 75.
[0035] FIG. 7B illustrates modules 1-5 in a resting assembled
state.
[0036] FIG. 7C is a transparent view of modules 1-5 as depicted in
FIG. 7B illustrating the hypothetical orientation and configuration
of various internal structures within such a module.
[0037] FIG. 7D is the final part of FIG. 7: comprising arrows 76
and 77 that illustrate how modules 3 and 4 could be made to move
inward relative to module 5 (dotted line). This movement would
result in the compression of any materials located with modules 3
and 4.
[0038] FIG. 8 provides for a possible reagent module illustrated
but not described in FIG. 7C. Said module comprises: a series of
cannula 81, and compression form 82, wet cells 83 containing a
geometric shape indicating the presence of dispensable content, dry
cells 84 black boxes indicating the absence of a dispensable
content, various serialized reagent clusters 85 oriented to perform
six analytical protocols 85.1 - 85.6 and temporally synchronized 86
into four stage(s) of actuation 86.1-86.4, a module housing 87
indicated as open box for purposes of clarity and the operable
assembly of the various elements into a reagent module 88.
[0039] FIG. 9 illustrates a possible reactor module 90 possessing
plural paths of fluid communication. A first path of fluid
communication originates at inlet 91 extends through a series of
mixing chambers 95 and terminates at outlet 92, a second path of
fluid communication originates at inlet(s) 93 pass through
individual mixing chambers 95 and terminates at outlet 94.
[0040] FIG. 10 illustrates how reagent module described in FIG. 8
and the reactor module of FIG. 9 could operate by moving the
reagent module inward relative to the reactor module as previously
described in FIG. 7D and provided for in item(s) 100-104. Item 100
illustrates the operable interfacing of said reactor and reagent
module in a resting state in addition to several identified and
unidentified elements previously described in other images. In
circumstances where an element is referred to by number but
unidentified in the present image please refer to the first number
of the numerical identifier associated with an element to locate
the figure depicting the specific element; for example, item 81
would be located in FIG. 8, etc. Said elements comprise: cannula 81
and compression form 82 aligned with inlets 93 of the reactor
module on one side and serialized reagent cluster(s) 85.1-85.6 on
the other side. Note that the reactor module sits inside the
reagent module in a movable configuration as provided for by boxed
slides 51 of the reactor module and slide guides 34 of the reagent
module as previously described. Item 101 illustrates a first
incremental advancement of the reagent module relative to the
reactor module. This results in the cannula piercing the first
temporal sequence of cells 86.1 and the release of any dispensable
contents into individual mixing chambers. Item 102-104 illustrates
the incremental advancement and sequential release of temporal
sequence 86.2-86.4 along with the corresponding discharge 105 of
spent material through outlet 94.
[0041] FIG. 11 illustrates and alternative method of accessing the
various reagent clusters. Similar to FIG. 10, items 110-113
illustrate how reagent clusters could be pressed onto a cannula 81
by means of a slide plunger 110.1 or screw plunger 110.2.
[0042] FIG. 12 Illustrates another possible modular assemblage 120;
comprising, a plunger depressor 121, plunger shaft 122,
bi-directional plunger with a vented flexible diaphragm 123, a
reagent module 124 a dual function sample/reactor module 125, a
threaded male connector 126, and a cap 127. Said reagent module
further comprising a vented reagent module housing 124.1, a
serialized reagent cluster 124.2, and cannula and reagent housing
124.3.
[0043] FIG. 13 illustrates select aspects pertaining to the
operation of the embodiment described in FIG. 12. Item 130 depicts
a device 120, a sample source 130.1, and a plunger apparatus in a
closed state. Item 131 illustrates the upward pulling motion 131.1
of a plunger depressor 121, an expansion between the plunger system
and the reagent module 131.2, the formation of a vacuum 131.3, and
the movement of a sample 131.4 into the dual function
sample/reactor module. Item 132 illustrates the application 132.2 a
cap 124 to the device and points out that in this configuration the
opening 132.2 of the reagent module is visible.
[0044] FIG. 13B illustrates additional aspects pertaining to the
operation of the device described in FIG. 13A. Item 133 depicts the
depression 133.1 of the plunger depressor 120, the separation of
the dual function plunger system into a stationary vented diaphragm
133.2 and a plunger 133.3 and the opening to the reagent module
132.2. Item 134 illustrates that the continued advancement of the
plunger system 134.1 presses the plunger against the reagent
cluster 134.2 against the cannula provided within the reagent
module 134.3 which sequentially dispenses the contents of the cell
into the dual function sample/reactor module 134.4.
[0045] FIG. 14 Provides for a method of dividing a hypothetical
fluid control network into functional divisions operable to be
manufactured as individual modules. Item 140 provides for a
hypothetical closed continuous-flow fluid control network operable
to perform an analytical task consisting of a sample S reservoir, a
mixing chamber M, a waste container W, and four reservoirs for
storing analytical reagents r1, r2, r3, r4; as well as, a first
path of fluid communication solid arrows and a second path of fluid
communication dotted arrows. The illustration of solid or dotted
wavy arrows pointing at said network communicates the placement of
means that push fluids through the present network (such as high
pressure), whereas, the illustration of solid or dotted wavy arrows
pointing away from the network communicates the placement of means
that pull fluids through the present network (such a low pressure).
Item 141 illustrates four possible functional divisions of the
present network A, B, C, D. Item 142 illustrates how the present
network could be further functionally reduced and provides four
possible functional divisions A', B', C', D'.
DETAILED DESCRIPTION
[0046] FIG. 1A Illustrates the various functional elements that
might be present on a first module 1 said module comprising a
sample tube 14, a port 15 and, a cavity 11 enclosed within the
substrate of the module and two independent pairs of reversible
mechanical attachments 12 and 13 enabled to receive mechanical
attachments from two cooperating modules. Referring to the cavity
11, said cavity could be used to store a volume of fluid material;
such as, used or unused analytical reagents or a sample. Said fluid
material could be stored in this cavity by placing the supply tube
14 in fluid communication with a source of material and then
subtracting a gas or other material from the cavity by way of the
port 15. This would establish a pressure gradient spanning the
cavity resulting in the fluid material being drawn into the cavity.
However, other options are available and may be more preferable for
a specific analytical test. For example, said cavity could be set
under a vacuum (not shown) by extracting all contents of the cavity
and then sealing said cavity with a pierceable barrier. Then by
means of interfacing said supply tube with a material source on one
end and puncturing said seal with the other end induce fluid
material to flow into said cavity as the internal pressure of the
chamber moves toward equilibrium. Alternatively, FIG. 1B
illustrates yet another method-of-operation to establish a pressure
gradient across this cavity involving a squeeze bulb 16 operably
interfaced with said cavity of the module 1. The contents of the
cavity could be evacuated by manually compressing the squeeze bulb
16 then the sample tube 14 could be interfaced with a material
source and then by releasing the squeeze blub fluid material would
be drawn into the cavity as the squeeze bulb restored itself to its
original state 17. There are numerous methods for establishing a
pressure gradient across said cavity in order to fill said cavity
without departing from the context of the present invention. The
methods listed herein are a few examples selected for illustrative
purpose only. Some mechanical features that might be present on a
module are various embodiments of reversible mechanical attachment
such as the pair of slide-guides 12 for receiving a slide (not
shown) from a cooperating module on either side and the protruding
flange 13 that could be adapted to fit into a groove of a
cooperating module or could be made to possess an element of a clip
such as a tooth that could interface with a groove on a cooperative
module. This is an example of how a single module could be adapted
to receive three additional modules to create an assemblage of four
modules. It is understood that analytical cartridges containing 2
or more modules may be preferable for different analytical task and
still be consummate within the context of the present
invention.
[0047] FIG. 2 Illustrates the various functional elements that
might be present on a second module 2 said module comprising a
sample tube 24, a port 25 and, a cavity 21 enclosed within the
substrate of the module and two independent pairs of reversible
mechanical attachments 12 and 23 enabled to receive mechanical
attachments from two cooperating modules.
[0048] FIG. 3 Illustrates the various functional elements that
might be present on a third module 3. Said module comprising a slot
31 a first pair of reversible mechanical attachments 34 embodied as
a pair of slide-guides set internal to the module for receiving a
cooperating module within the slot and a second set of reversible
mechanical attachments embodied as geometrically distinct slides 32
and 33 providing for the unambiguous attachment of a different
cooperating module on each slide.
[0049] FIG. 4 Illustrates the various functional elements that
might be present on a fourth module 4. Said module may be devoid of
functional structures pertaining to a fluid control network and
rather provide a specific geometry needed to convey a specific
overall dimension to the final assembled form of the device. Such a
module could also be used to house a battery, capacitor, resistors
or other electrical device (not shown) intended to store, provide,
or condition energy to the analytical cartridge.
[0050] FIG. 5 Illustrates the various functional elements that
might be present in a fifth module 5. Said module possessing a
fluid control network comprising a series of inlets 53 and 54 and
outlets 55 and 56 arranged about the perimeter of the module, a
series of mixing chambers 52, an element of reversible mechanical
attachment in the form of a groove 57 to connect a cooperating
module at one end, in addition to four sets of slides 51 for
providing a reversible connection to cooperating modules along each
side. Additional elements to receive additional modules could be
present about said module but are not included for purposes of
visual clarity of the illustration. Likewise, the configuration of
the fluid control network is for illustrative purposes only. A
multitude of possible configurations could be employed depending on
the quantity and type(s) of analytical procedures intended to be
performed. An operational aspect of the fluid control network
presently depicted are plural paths of fluid communication through
mixing chambers 52. The primary path originates at inlet 54, passes
through each of the mixing chambers, and terminates at outlet 55.
The secondary path(s) originate at individual inlets 53, pass
through an individual mixing chamber, and terminate at individual
outlets 56. In the present configuration, a sample could be drawn
through the first path into each of the mixing chambers while the
plurality of secondary paths could be used to introduce a number of
analytical reagents to the mixing chamber.
[0051] FIG. 6 Illustrates how a cartridge possessing five modules
might be assembled. This figure illustrates the first module 1,
second module 2, third module 3, fourth module 4, and fifth module
5 as previously set forth further interrelated by dotted lines
62-64 representing how each module could be assembled by means of
the various reversible mechanical attachments as previously set
forth. The order of assembly depicted in the present example is
unambiguous in that a first connect between module(s) 5 and 2 along
path 61 must be established to allow the connection of module(s) 3
to 5, and module(s) 4 to 5 along paths 62 thereby creating a three
module assembly. Doing so presents the path(s) 63 and 64 for module
1 to connected to module assemblage 2, 3, 4, and 5. This particular
embodiment was selected as an example to convey how a multiple
module assemblage could be bestowed with physical elements that
direct the assembly of specific modules into a specific assemblage.
This would be preferable for an array of analytical devices
composed of modules having similar physical configuration but
possessing different analytical tests that might be improperly
assembled without these selective means. Among other structural
elements of interest in this illustration is the manner in which
the fluid control pathways are preferably configured to terminate
about the perimeter of the module forming an open system enabled to
interface with the fluid control pathways of cooperating modules.
Additionally, the straight lined fluid control pathways 53 and 56
as depicted could be favorable in allowing direct access to the
mixing chambers 52 which could enable a smaller diameter device to
be inserted through said pathways and provide a means to automate
the introduction of analytical reagents into the module prior to
cartridge assembly.
[0052] FIG. 7 is a four part illustration A, B, C, and D
illustrating the assembly and operation of a possible five module
cartridge assemblage receptive to both pneumatic and mechanical
mechanism-of-operation emphasizing the utility of various
slide/slide-guide as previously set forth in FIG. 1-6. The utility
of a diagnostic cartridge having a generally conserved overall
dimension and mechanism-of-operation is advantageous in
consolidating the operation of a plurality of possible cartridge
configurations to a single analytical device type. Accordingly, a
device possessing similar numbers and forms of modules may promote
ambiguity in selecting the correct modules for a final target
assemblage. The present illustration depicts the use of a variety
of mechanical attachments in a manner that is both cooperative and
selective to promote an unambiguous assembly pattern for specific
modules. The utility of this assembly schema is for illustrative
purposes only. Alternative configurations exist that can achieve an
equivalent result, and the use of ambiguous elements of mechanical
assembly across cartridge types may be favorable in some
situations. Likewise, the weighted reliance on a five module
assemblage was selected to provide a modular cartridge of
intermediate complexity and is not intended to imply or otherwise
limit the present invention to the present cartridge dimension. It
is realized that the modularity of the present invention lends to
many possible configurations of operable diagnostic cartridges and
depending on the field of use and the types and quantity of tests
needed and it may be preferable to employ modular assemblages
possessing two or more modules as the circumstances dictate.
[0053] FIG. 7A Illustrates the five modules as previously set forth
in FIG. 1-5, and the assembly pattern as depicted in FIG. 6. In the
present example configuration the assembly of this cartridge would
begin with the interconnection of the waste module 2 and the
reactor module 5 by path 70, referring to FIG. 6 in this
configuration the waste module provides the points of attachment
(in the form of slides) needed to receive each reagent module,
which would be interconnected to reagent module 4 by path 71, then
reagent module 3 by path 72. In this configuration the two reagent
modules and the reactor module provide the points of attachment
needed to receive the sample module.
[0054] FIG. 7B shows a top view of the five modules in an assembled
state and emphasizes the two ports located on the sample module 74
and waste module 75 for use in, among other things, establishing a
pressure gradient across the reactor module. Such a pressure
gradient could be used as a first mechanism-of-operation to induce
the movement of a sample resident within the sample module into and
through the reactor modules by adding a gas or liquid through port
74 while simultaneous subtracting a gas or liquid from port 75.
[0055] FIG. 7C is a transparency view of the inner structures of
each module and intended to illustrate how the fluid control
pathways of each possible module would operably interrelate to form
a closed continuous-flow fluid control network specific for one or
more select analytical task.
[0056] FIG. 7D illustrates how modules 3 and 4 could be made to
move inward relative to module 5 along the slides/slide guides
provided by modules 1, 2, 3, 4, and 5. This motion could provide a
second mechanism-of-operation by compress a content held within a
slot present within module 3 or 4 as described in FIG. 3 and
generally evident by the motion as illustrated inferring the
encapsulation of module 5 (dotted lines) by module 3 and 4. In this
example, the inward motion of modules 3 and 4 would completely
obstruct the mixing chambers of module 5 if it were not for the
windows provided by both module 3 and 4 (semi-circular cut outs).
The use of such windows would be favorable in acquiring information
pertaining to an analytical reaction where an unobstructed view
into each mixing chamber was beneficial.
[0057] FIG. 8 Illustrates a possible configuration of a module and
a corresponding reagent assemblage. For illustrative purposes only,
said module is depicted to comprise six cannule 81 operably
positioned above a six compartment compression form 82 and a
plurality of individualized cells having a select internal volume.
Said cells composed of dry cells 85 (black boxes lacking a
dispensable content) and wet cells 86 (white boxes containing a
geometric shape symbolizing a dispensable content). Said cells are
then arranged in series corresponding to six hypothetical
analytical protocols 85.1, 85.2, 85.3, 85.4, 85.5, 85.6. Each cell
series is then inserted into the compression form wherein the cell
corresponding to the first stage of each protocol is oriented
closest to the cannula. Doing so orients each cells series into
temporally synchronized stages 86.1, 86.2, 86.3, 86.4. The reagent
assemblage comprising the cannula 81, compression form 82, and
serial arrangements of reagents 85 is then inserted into a module
87 possessing an operable slot for receiving said assemblage
(depicted as a boxed line for simplicity) to form an assembled
reagent module 88. Again any number of analytical procedures could
be programmed utilizing this methodology; the examples presented
herein illustrate one possible configuration.
[0058] FIG. 9 Illustrates a possible reactor module 90 possessing
plural flow paths of fluid communication passing through at a
series of mixing chambers 95. For the purposes of this example, a
first flow paths originates at inlet 91 passes through each mixing
chamber and terminates at outlet 92, the second flow path
originates at each individual inlets 93 passes through one mixing
chamber and terminates at outlet 94. For simplicity this
illustration does not depict the use of a fluid control device with
the illustrated fluid control network however such devices (e.g.
choke points, valves, gates, diaphragms valves either active and/or
passive) may be present within the various types of modules subject
to the present invention.
[0059] FIG. 10 comprises a sequence of illustrations, item(s) 100,
101, 102, 103, 104, to demonstrate how a possible reagent
assemblage employing a uniform form of actuation could dispense
individual reagents to distinct analytical procedures in a
temporally control manner. Item 100 depicts the four temporally
synchronized stages 86.1, 86.2, 86.3, 86.4 of the six analytical
reactions previously described in FIG. 8 as well as outlet 94 and
the fluid control network previously described in FIG. 9. Item 105
signifies the discharge of spent solutions through outlet 94. For
the purposes of this example, a pressure gradient across the mixing
chambers would be established by compressing the reagent module
against the reactor module while lowering the pressure at outlet 94
to decrease the internal pressure of the mixing chamber. As item
101 illustrates, the compression of the reagent module against the
reactor module compresses the serialized reagent cluster thereby
raising the internal pressure of each cell and actuates the
insertion of a cannula into the first cell of each reagent series
86.1. This, in conjunction with lowered pressure at outlet 94,
would promote the flow of any dispensable content held within the
cells to flow down the pressure gradient through the cannula and
into the mixing chambers. Reading left to right across the mixing
chambers `xN` signifies individual chambers followed by a
hypothetical analytical reagent. Image(s) 101, 102, 103, and 104
illustrates the sequential release of each reagent sequence as the
reagent module is compressed into the reactor module:
[0060] Item 101/86.1: x1=incubation, x2=square, x3=circle,
x4=incubation, x5=triangle, x6=circle.
[0061] Item 102/86.2: x1=star, x2=incubation, x3=incubation,
x4=incubation, x5=star, x6=triangle.
[0062] Item 103/86.3: x1=circle, x2=incubation, x3=square,
x4=circle, x5=circle, x6=incubation.
[0063] Item 104/86.4: x1=square, x2=star, x3=incubation, x4=square,
x5=square, x6=incubation.
[0064] Note that the administration of each successive reagent
provides the requisite positive pressure to displace spent
reagent(s) 105 out of the mixing chamber and through port 94 and
into a waste module (not shown) but a number of alternatives are
also apparent for collecting waste material. For example, the
internal structure of the reactor module, separate from the mixing
chambers and other fluid control pathways, could be dedicated to
storing spent solutions. Likewise, multiple waste modules could be
positioned about the perimeter of the reactor module to enable
alternate configurations of discharge outlets for different fluid
control networks. As previously stated, this example is
illustrative only. Any number of reactions, reagent configurations,
and fluid control architecture could be employed to perform
different analytical procedures as the circumstances dictate.
Likewise, the present illustration depicts the pressing of a
cannula onto a cell but a similar result could be achieved by
pressing the cells onto a cannula as is illustrated in FIG. 11.
[0065] FIG. 11 is a four part composite illustration of images 110,
111, 112, 113 which illustrates how a threaded screw or plunger
could be employed to depress a cell arrangement onto a cannula,
which is the inverse motion set forth in FIG. 10. Item 110 depicts
a cannula 81, compression form 82, wet cells 83, dry cells 84,
reagent module 87, and cell series as previously described in FIG.
8 with the addition of a plunger 110.1, threaded screw 110.2 or
other similar type of linear actuator such as a human finger (not
shown). Item 111 demonstrates how operable force or twisting motion
if applied to the plunger 110.1 or threaded screw 110.2 would
result in pressing the cell series through the compression form and
onto a cannula. Items 112 and 113 depict how multiple reagents
could be controlled by the same motion. The use of such a
configuration may be advantageous in providing additional
flexibility in performing one or more test protocols. Likewise, the
use of serialized reagents in the programmable reagent delivery
system as previously set forth may be employed in a more simplified
fluidically controlled analytical system.
[0066] FIG. 12A illustrates a possible two-module analytical
cartridge 120 possessing a simplified fluidic control system. It
comprises a plunger depressor 121, plunger shaft 122, bi-direction
plunger with vented flexible diaphragm 123, a reagent module 124, a
dual function sample/reactor module with graduations for measuring
sample volume 125, a threaded male connector 126, and a threaded
cap 127. The reagent module is vented and designed to be inserted
into the analytical cartridge, while positioning a reagent cell
series within a compression form having a cannula, as set forth in
previous figures. This configuration could be used to perform a
single test on a liquid sample derived from a number of
sources.
[0067] FIG. 13A illustrates how the device 120 described in FIG. 12
might operate to collect a sample. Item 130 illustrates how the
device with the bi-directional plunger in a operably depressed
position 130.2 might interface with a liquid sample 130.1. Item 131
illustrates how pulling upward 131.1 on the plunger 121 will
retract the vented diaphragm of the bi-direction plunger 131.2
resulting in a vacuum 131.3 that would induce the movement of the
sample into the dual function sample/reactor module 131.4. Item 132
illustrates how a screw cap 124 could be secured 123.1 to the
device once an adequate sample has been collected. Additionally,
the illustration emphasizes that the lifting of the plunger reveals
the opening of the reagent module 132.2.
[0068] FIG. 13B illustrates how the device 120 could be operated to
perform a test on a sample. Item 133 illustrates how the depression
133.1 of the bi-directional plunger would separate the vented
flexible diaphragm 133.2 from the plunger 133.3 leaving the
diaphragm in a stationary position pressed against the internal
wall of the device. The vents illustrated on the flexible diaphragm
133.2 provide for the equalization of atmosphere between the upper
133.4 and lower 133.5 compartments formed by the diagram as the
plunger 133.3 interfaces with the reagent cell series seated into
the opening of the reagent compartment 133.6. Item 134 illustrates
how further depressing the plunger 134.1 would result in the
plunger entering into the reagent module and sequentially compress
each reagent cell 134.3 onto a cannula releasing the contents into
the mixing compartment 134.4. Again the present illustration is not
intended to be limiting a wide range of modular configurations and
configurations of reagent cells are envisioned having unique
advantages to different test protocols. The utility of a non-vented
diaphragm in sealing contents within the device is realized for
applications where it would be preferable to prevent spillage of
contents from the device.
[0069] FIG. 14 illustrates how to create a continuous-flow modular
diagnostic cartridge. Item 140 illustrates a possible closed fluid
control network enable to perform an analytical task involving a
sample reservoir S, four distinct analytical reagent containers r1,
r2, r3, r4 having a defined temporal sequence of administration
defined by flow path dotted arrows. Each reagent must travel to
reach a mixing chamber M, and a waste reservoir W. Item 141
illustrates an aspect of the present invention pertaining to how a
fluid control network could be divided into functional groupings A,
B, C, D that could be manufactured as individual modules. Item 142
illustrates another aspect of the present invention pertaining to
how the same fluid control network could be reconfigured and
divided into functional grouping that are functionally reduced A',
B', C', D'.
[0070] The present illustrations are representative only and
provide only a few possible contexts in which the present invention
could be employed are not intended to limit the scope of all
possible applications for the present invention in any way.
* * * * *