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.
Claims
1-35. (canceled)
36. A system of microfluidic modules comprising: a plurality of microfluidic modules characterized by a basic module type possessing elements that complement and cooperate with a corresponding module of the same basic type, comprising: a substrate containing plural perpendicular exterior surfaces that provide for a first surface and a second surface; said first surface further containing: a fluidic connector intersecting said first surface that links and enables fluid communication between cooperating microfluidic modules; a first coupling element that establishes a coincident interface that links and enables fluidic connection between cooperating microfluidic modules; a second coupling element that links and establishes a collinear axis enabling translational motion between cooperating modules to effect fluid communication between cooperating microfluidic modules; an internal fluidic feature; and a flow path through said substrate connecting the internal fluidic feature, the first surface via the fluidic connector, and the second surface; and, further characterized by a basic cartridge type comprising plural linked microfluidic modules of the same basic type further characterized by at least: a coincident interface of complementary first surfaces corresponding to a first microfluidic module and a second microfluidic module so as to enable fluidic communication; and, the ability to translate a first microfluidic module inwardly, enveloping at least one coincident interface of complimentary first surfaces while partially enveloping the substrate of a second microfluidic module so as to effect fluidic communication.
37. The system of microfluidic modules of claim 36, wherein said second module further comprises the same basic module type as previously set forth further characterized by: the substrate possessing a height, a width, and a depth sufficient to be enveloped by said first module; and, the fluidic connector characterized by an outwardly extended flow path with a sharpened tip protruding from the module substrate.
38. The system of microfluidic modules of claim 36, wherein said first module further comprises the same basic module type as previously set forth further characterized by: the substrate having a height, a width, and a depth sufficient to envelop said second module; the second surface having a position opposite the first surface; the fluidic connector characterized by a sharpened hollow tube shaped so as to establish a fluid tight connection when inserted into said flow channel; and, the internal fluidic feature comprising a actuatable liquid dispensing apparatus that further contains: a slot having a cavity opening to said first surface, and a backplane sharing a common wall with the second surface; a compressible substrate having the characteristics of a solid foam, having plural perpendicular faces coincident with said slot that provide for: a dispending face coincident with the first surface, and an actuating face opposite the dispensing face and coincident with the backplane; and, a wet-cell characterized by a packaged liquid reagent store individually encapsulated in a flexible thin-wall pierceable material suitable for packaging liquids; a dry-cell characterized by a compressible spacer element possessing a selected length; a serialized reagent cluster characterized by one or more wet-cells and one or more dry-cells linked in a linear series having a first wet-cell or dry-cell aligned proximally to the dispensing face and a last wet-cell or dry-cell aligned proximally to the actuating face; and, a mechanical linkage of coincident surfaces that communicate and external mechanical force from the second surface; through the actuating face; into the compressible substrate; through the last wet-cell or dry-cell, the serialized reagent cluster, and the first wet-cell or dry-cell; out of the compressible substrate; across the dispensing face and said first surface of the present module; and, through the first surface and into the previously established second module; said serialized reagent cluster further characterized by one or more dry-cells having a selected length corresponding to an intended displacement of one or more wet-cells a linear distance over one or more asynchronous time intervals.
39. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface and the second surface, and one or more additional surfaces.
40. The system of microfluidic modules of claim 36 wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface and a second surface opposite the first surface.
41. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface; and a second surface on an perpendicular plane adjacent to the first surface.
42. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface, a second surface on an perpendicular plane adjacent to the first surface, and a third surface on a plane opposite the first surface and adjacent to the second surface.
43. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface; a second surface adjacent to the first surface, a third surface opposite the second surface, and a fourth surface opposite the first and adjacent to the second and third surface.
44. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, and a fourth surface adjacent to the first, second, and third surfaces.
45. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, and a fourth surface adjacent to the first, second, and third surfaces, and a fifth surface opposite the fourth surface.
46. The system of microfluidic modules of claim 36, wherein the internal fluidic feature further comprises: an internal reservoir connected by the flow channel to the first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, a fourth surface adjacent to the first, second, and third surfaces, a fifth surface opposite the fourth surface, and a sixth surface adjacent to the first, second, fourth and fifth surfaces.
47. A microfluidic cartridge building kit comprising: a basic module type providing plural elements that cooperatively interrelate with corresponding modules of the same basic module type comprising: a substrate containing plural perpendicular exterior surfaces that provide for a first surface and a second surface; said first surface further containing: a fluidic connector intersecting said first surface positioned to engage a complementary element on a corresponding module of a same basic module type to link and enable fluid communication between cooperating modules; a first coupling element positioned to engage a complementary element on a corresponding module of a same basic module type creating a coincident interface that links and establishes a fluidic connection between cooperating modules; and a second coupling element characterized by a cooperating slide or slide-guide positioned to engage a complementary element on a corresponding modules of a same basic module type that links and enables translational motion between cooperating modules to effect fluid communication between cooperating modules; an internal fluidic feature; and, a flow path through said substrate connecting the internal fluidic feature, the first surface via the fluidic connector, and the second surface.
48. The microfluidic cartridge building kit of claim 47, wherein the first coupling element is the operator or the receiver element of a box-coupling.
49. The microfluidic cartridge building kit of claim 47, wherein the first coupling element is the clip or the groove of a clip and groove coupling.
50. The microfluidic cartridge building kit of claim 47, wherein the second coupling element is the slide or the slide-guide of a prismatic joint.
51. The microfluidic cartridge building kit of claim 47 further characterized by: the substrate having a height, a width, and a depth sufficient to envelop said second module; the second surface positioned opposite the first surface; the fluidic connector constituting a piercing element characterized by a sharpened hollow tube shaped so as to establish a fluid tight connection when inserted into said flow channel; and, the internal fluidic feature comprising a actuatable liquid dispensing apparatus that further contains: a slot having a cavity opening to said first surface, and a backplane sharing a common wall with the second surface; a compressible substrate having the characteristics of a solid foam, having plural perpendicular faces coincident with said slot that provide for: a dispending face coincident with the first surface, and an actuating face opposite the dispensing face and coincident with the backplane; and, a wet-cell characterized by a packaged liquid reagent store individually encapsulated in a flexible thin-wall pierceable material suitable for packaging liquids; a dry-cell characterized by a compressible spacer element possessing a selected length; a serialized reagent cluster characterized by one or more wet-cells and one or more dry-cells linked in a linear series having a first wet-cell or dry-cell aligned proximally to the dispensing face and a last wet-cell or dry-cell aligned proximally to the actuating face; and, a mechanical linkage of coincident surfaces that communicate and external mechanical force from the second surface; through the actuating face; into the compressible substrate; through the last wet-cell or dry-cell, the serialized reagent cluster, and the first wet-cell or dry-cell; out of the compressible substrate; across the dispensing face and said first surface of the present module; and, through the first surface and into a corresponding module.
52. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to the first surface and the second surface; and one or more additional surfaces.
53. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface; and a second surface opposite the first surface.
54. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface; and a second surface on an perpendicular plane adjacent to the first surface.
55. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface, a second surface on an perpendicular plane adjacent to the first surface, and a third surface on a plane opposite said first surface and adjacent to said second surface.
59. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface, a second surface adjacent to the first surface, a third surface opposite said second surface, and a fourth surface opposite the first and adjacent to the second and third surface.
57. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, and a fourth surface adjacent to the first, second, and third surfaces.
58. The microfluidic cartridge building kit of claim 47, wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, a fourth surface adjacent to the first, second, and third surfaces, and a fifth surface opposite the fourth surface.
59. The microfluidic cartridge building kit of claim 47 wherein the internal fluidic feature further comprises: an internal reservoir connected by said flow channel to said first surface, a second surface opposite the first surface, a third surface adjacent to the first surface and the second surface, a fourth surface adjacent to the first, second, and third surfaces, a fifth surface opposite the fourth surface, and a sixth surface adjacent to the first, second, fourth and fifth surfaces.
60. An actuatable liquid dispensing apparatus comprising: a substrate containing plural perpendicular exterior surfaces providing for a first surface, and a second surface opposite the first surface; an internal fluidic feature comprising: a slot having a cavity opening to said first surface, and a backplane sharing a common wall with the second surface; a compressible substrate having the characteristics of a solid foam, having plural perpendicular faces coincident with said slot that provide for: a dispending face coincident with the first surface, and an actuating face opposite the dispensing face and coincident with the backplane; and, a wet-cell characterized by a packaged liquid reagent store individually encapsulated in a flexible thin-wall pierceable material suitable for packaging liquids; a dry-cell characterized by a compressible spacer element possessing a selected length; a serialized reagent cluster characterized by one or more wet-cells and one or more dry-cells linked in a linear series further characterized by a first wet-cell or dry-cell aligned proximally to the dispensing face, and a last wet-cell or dry-cell aligned proximally to the actuating face; and, a mechanical linkage of coincident surfaces connecting the actuating face, the first wet-cell or dry-cell, the serialized reagent cluster, the last wet-cell or dry-cell, and the dispensing face.
61. The actuatable liquid dispensing apparatus of claim 60 further comprising a fluidic connector characterized by a sharpened hollow tube shaped so as to establish a fluid tight connection when inserted into a flow channel.
62. The actuatable liquid dispensing apparatus of claim 60 further comprising one or more serialized reagent clusters further characterized by one or more dry-cells having a selected length corresponding to an intended displacement of one or more wet-cells a linear distance over one or more asynchronous time intervals
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0024] FIG. 1A: Illustrates a possible module comprising: module 1, reservoir 11, boxed slide guides 12, flange 13, a cannula 14 and pneumatic port 15.
[0025] 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.
[0026] FIG. 2: Illustrates a possible module comprising: module 2, reservoir 21, cylindrical slide-guides 22, flange 23, cannula 24, and pneumatic port 25.
[0027] FIG. 3: Illustrates a possible module comprising: module 3, open slot 31, cylindrical slide 32, box slide 33, and boxed slide-guide(s) 34.
[0028] FIG. 4: Illustrates a possible module comprising: module 4, closed structure 41, cylindrical slide 42, and box slide 43.
[0029] 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.
[0030] FIG. 6: Is an exploded perspective illustrating the assembly pattern of those modules illustrated in FIG. 1-5 comprising: 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 350 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.
[0031] 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.
[0032] FIG. 7B illustrates modules 1-5 in a resting assembled state.
[0033] 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.
[0034] 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.
[0035] 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 as open box for purposes of clarity and the operable assembly of the various elements into a reagent module 88.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] FIG. 12A 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.
[0040] FIG. 13A illustrates select aspects pertaining to the operation of the embodiment described in FIG. 12A. 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.
[0041] 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.
[0042] 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
[0043] 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 bulb 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] 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) 64 and 65 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.
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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:
[0057] Item 101/86.1: x1=incubation, x2=square, x3=circle, x4=incubation, x5=triangle, x6=circle.
[0058] Item 102/86.2: x1=star, x2=incubation, x3=incubation, x4=incubation, x5=star, x6=triangle.
[0059] Item 103/86.3: x1=circle, x2=incubation, x3=square, x4=circle, x5=circle, x6=incubation.
[0060] Item 104/86.4: x1=square, x2=star, x3=incubation, x4=square, x5=square, x6=incubation.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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 anyway.
