Source: http://www.google.com/patents/US8034610?dq=6,243,373
Timestamp: 2017-05-01 02:52:30
Document Index: 265410615

Matched Legal Cases: ['Application No. 60', 'Application No. 06', 'Application No. 200680022409', 'Application No. 200680022409', 'Application No. 200680022461', 'Application No. 200680022554', 'Application No. 06']

Patent US8034610 - Parallel processing fluidic method and apparatus for automated rapid ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA sample processing system that may be configured to achieve parallel or coincidental sample processing such as histochemical processing may involve a plurality of samples arranged for coincidental movement perhaps by use of angular microscopic slide movements to cause processing activity that may include...http://www.google.com/patents/US8034610?utm_source=gb-gplus-sharePatent US8034610 - Parallel processing fluidic method and apparatus for automated rapid immunohistochemistryAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS8034610 B2Publication typeGrantApplication numberUS 11/912,273PCT numberPCT/US2006/015269Publication dateOct 11, 2011Filing dateApr 21, 2006Priority dateApr 21, 2005Fee statusPaidAlso published asCA2623199A1, CA2623235A1, CA2623241A1, CA2623251A1, CN101203596A, CN101203597A, CN101203598A, CN101203762A, EP1877787A2, EP1877788A2, EP1880223A2, EP1880239A2, US7838283, US8058010, US8178350, US20080194034, US20080213804, US20080286753, US20090004691, WO2006116035A2, WO2006116035A3, WO2006116037A2, WO2006116037A3, WO2006116039A2, WO2006116039A3, WO2006116199A2, WO2006116199A3Publication number11912273, 912273, PCT/2006/15269, PCT/US/2006/015269, PCT/US/2006/15269, PCT/US/6/015269, PCT/US/6/15269, PCT/US2006/015269, PCT/US2006/15269, PCT/US2006015269, PCT/US200615269, PCT/US6/015269, PCT/US6/15269, PCT/US6015269, PCT/US615269, US 8034610 B2, US 8034610B2, US-B2-8034610, US8034610 B2, US8034610B2InventorsPage A. Erickson, Michael R. Everman, Michael S. Bell, Kevin S. Edberg, Matthew M. BotkeOriginal AssigneeCelerus Diagnostics, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (162), Non-Patent Citations (24), Referenced by (2), Classifications (11), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetParallel processing fluidic method and apparatus for automated rapid immunohistochemistry
US 8034610 B2Abstract
A sample processing system that may be configured to achieve parallel or coincidental sample processing such as histochemical processing may involve a plurality of samples arranged for coincidental movement perhaps by use of angular microscopic slide movements to cause processing activity that may include repeated elimination and reapplication of a fluidic substance perhaps through the action of capillary motion in order to refresh a microenvironment adjacent to a sample such as a biopsy or other such sample. Snap in antibody and other substances may be included to ease operator actions and to permit location specific substance applications perhaps by including single container multiple chamber multiple fluidic substance magazines, linearly disposed multiple substance source, and primary antibody cartridges. Through refreshing of a microenvironment, depletion of the microenvironment is avoided and the time necessary for slide processing may be dramatically shortened.
This invention relates to the field of automated sample testing such as may be used in biochemistry, perhaps including cytochemistry, histochemistry, and the like. Specifically, it relates to systems and devices that may be used to achieve results in a more rapid fashion, are easier to use, and can accomplish processing in a parallel manner. Such systems and devices may be particularly appropriate for use in a surgical or operative environment, where rapids results may be necessary. Furthermore, this application addresses only certain aspects of the technology disclosed. Other aspects are addressed in the concurrently filed applications entitled: “Enhanced Fluidic Method and Apparatus for Automated Rapid Immunohistochemistry” filed this same day and accorded serial number PCT/US2006/015020, “Method and Apparatus for Automated Rapid Immunohistochemistry” filed this same day and accorded serial number PCT/US2006/015023, and “Wicking Cassette Method and Apparatus for Automated Rapid Immunohistochemistry” filed this same day and accorded serial number PCT/US 2006/015017. Each of these are hereby incorporated by reference as well as the priority filing (which this filing claims the benefit of), U.S. Provisional Application No. 60/673,486 entitled “Method and Apparatus for Automated Rapid Immunohistochemistry”.
Frequently during surgery, tissue biopsy samples may be removed from a patient and sent from the operating room to a pathology laboratory for analysis, for example by frozen tissue section diagnosis. In addition, methodology for frozen tissue section diagnosis may consist of freezing tissue in a pathology lab, sectioning the frozen tissue, and performing standard Hematoxylin and Eosin (H&E) staining. H&E may be a general-purpose stain for helping a medical pathologist diagnose tissue pathologies. However, H&E staining may have a number of limitations, for example that it may be a non-specific tissue stain, and may not identify specific proteins in tissue. Such identification of specific proteins in tissue, for example by using a procedure sometimes referred to as immunohistochemistry (IHC), may help a pathologist diagnose numerous intraoperative tissue pathologies. Examples may include sentinel lymph node biopsies (for potential metastatic carcinomas and melanomas), undifferentiated tumors (potential carcinomas, lymphomas, and melanomas), and biopsies of margins (looking at the edges of excised tissue to see if the entire tumor has been removed).
3. SUMMARY DISCLOSURE OF THE INVENTION
In embodiments, the present invention involves a self contained rapid sample processing system such as shown in FIG. 1. This system can be used to perform rapid IHC and may be easily used for even a few samples. Embodiments can overcome problems that have seemed insurmountable perhaps by approaching the problem from a very different perspective. The present invention presents systems in a variety of embodiments through which sample processing can be accomplished in a variety of biochemical contexts and in a dramatically shorter time period and in a manner that is easier for the operator. In fact, the present invention shortens tests that have previously taken 60 or 90 or even 120 minutes to an intraoperative time frame such as 20 minutes or the like. Embodiments of the invention overcome what may have been previously considered a physical requirement, namely, that many particular biochemistries involved simply required a long time. Embodiments of the invention also permit coincidental processing of all samples at once. Furthermore, by creating particular conditions within the system, the desired amount of chemical interactions can be accomplished in a far shortened timeframe. In embodiments, the invention acts to replenish a microenvironment on an exterior sample area of a sample so that binding or more generally, other interaction, can occur more rapidly. Embodiments of the present invention overcome the longer binding times previously perhaps taken as a physical constant. Embodiments realize that by acting in a manner to replenish a microenvironment, not just move fluid on a sample, can significantly shorten the time needed for a particular amount of interaction. Rather than using a completely new application of reagents or the like, the present invention acts in a manner where the microenvironment is replenished and a shortened interaction is achieved. Some embodiments of the invention achieve this by removing, perhaps mixing, and reapplying the same fluid so that the fluid and the substance in the microenvironment immediately adjacent the sample is not depleted. Embodiments provide snap in reagents and snap in wicking elements to facilitate operator use of the system.
FIG. 1 shows a depiction of outer view of a self contained system according to one embodiment of the invention.
As mentioned earlier, the present invention includes a variety of aspects, which may be combined in different ways. The following descriptions are provided to list elements and describe some of the embodiments of the present invention. These elements are listed with initial embodiments, however it should be understood that they may be combined in any manner and in any number to create additional embodiments. The variously described examples and embodiments should not be construed to limit the present invention to only the explicitly described systems, techniques, and applications. Further, this description should be understood to support and encompass descriptions and claims of all the various embodiments, systems, techniques, methods, devices, and applications with any number of the disclosed elements, with each element alone, and also with any and all various permutations and combinations of all elements in this or any subsequent application.
As mentioned earlier, a sample processing system (2) can act to facilitate accomplishing a variety of different test sequences or test processes. Applying embodiments that permit rapid processing, the system may be configured to accomplish rapid immunohistochemistry, immunocytochemistry, in situ hybridization, fluorescent in situ hybridization, chromosomal identification, staining, antigen retrieval, cytochemical, molecular chemical, epitope retrieval, or even pretreatment processes. These different types of processes can also be applied to a great variety of samples. Thus by obtaining a particular type of sample and perhaps placing that sample in a sample holder—perhaps such as a microscopic slide sample holder (9)—the sample processor or perhaps the automatically sequenced test processor (3) can be configured to process a variety of differing samples. These can samples can be biologic, cellular, tissue, biopsy, carcinoma related, melanoma related, lymphoma related, margin testing related, epithelial cell, lymph node, undifferentiated tumor cell, pediatric cell, mohs mapping cells, h.pylori cells, an chronic villi tissue cells, neonatal herpes cells, proteomics cells, or other types of samples. As such, the processor can be any one of these types of processors through appropriate programming to achieve a test and act on samples of the type mentioned. The entire sample processing system (2) can provide a detection indication of the presence of some type of biological substance within the sample (1). This detection, may include a detection indication of the presence of a carcinomic, tumor, phagocytic, lymph node, transplant procedure, tumor differentiation, pediatric pathology, mohs mapping, margin, margin indicative, h.pylori diagnosis, therapeutic marker, chronic villi tissue, neonatal herpes, virally, bacterially, infectious diagnostic, or just a molecular indicative type of substance within the sample.
As mentioned earlier, one of the aspects of an embodiment of the invention may counter a depletion of a substance (5) as it interacts with the sample (1). As shown in FIG. 3, a sample can be subjected to the substance (5) through some type of fluidic environment. This fluidic environment may be a restrictively confined fluidic environment (17). Within any type of fluidic environment, restricted or not, there may be contained a microenvironment (28) which may exist immediately next to the sample (1). This microenvironment (28) may also be immediately adjacent or next to the sample (1). A microenvironment many contain elements of the substance (5) which actually interact with the sample (1). When elements of substance (5) become depleted, the amount of interaction may slow down. An aspect of embodiments of the present invention may be the fact that this microenvironment (28) can be replenished without replacing the entire fluid. Specifically, as can be understood from FIG. 4, by eliminating the fluidic substance (1) from within the microenvironment (28), the fluidic substance source (11) can be replenished and subsequently replaced. Through appropriate arrangements, the sample processing system (2) can include a sample interface microenvironment affirmative depletion avoidance element (29). This sample interface microenvironment affirmative depletion avoidance element (29) may be a combination of programming and perhaps hardware that acts to achieve the appropriate activity. This action may be as simple as merely accomplishing substantial mixing within the sample interface microenvironment (29). Interestingly, while air knifes and the like have been used, these appear to have not achieved the level of mixing necessary in the microenvironment (28) in order to afford substantially reduced process times as embodiments of the present invention can now achieve. In fact, existing systems (which may even use air knife systems) still retain the old processing times of an hour or perhaps even 90 or 120 minutes whereas the present invention affords significantly shorter process times—times that are less than an intraoperative 20 minute guideline.
As mentioned earlier, a motive force element (23) can cause angular or other movement between a first surface relative to its second surface. Angular movement can be seen by comparing the movements shown in FIGS. 4, and 11 through 14. It can be seen that the sample processing system (2) may be considered to include first and second surface angular movement element. This element can act to displace a first surface relative to and in close proximity to a second surface. While different aspects of these movements are shown in FIGS. 4, and 11 through 14, it should be understood that the ultimate sequencing achieved by an automatically sequenced test processor (3) can include many variations of these movements. As shown in FIG. 6 a specialized sequence of movements can be achieved to accomplish a particular application that subjects the sample to a substance, transiently eliminates that substance, mixes the substance, reapplies the substance, and ultimately withdraws the substance from a sample (1). As indicated, various step timings and sequences can be achieved. For example as shown in step three and four, an initial sequence of ways to mix a primary antibody can be achieved followed by a wave sequence that may permit significant incubation time periods in general. It can also be noticed through FIG. 6 that an entire detection sequence can be achieved in less than 15 minutes—a significantly reduced time period as compared to most existing systems.
FIG. 4B shows the microscopic slides (8) in an intermediate position. As can be understood, the fluidic substance (10) may be pulled along the area in between a microscopic slide (8) and may pass across the exterior sample area (4). FIG. 4C shows how in one embodiment the microscopic slides (8) may be moved to a closed position and are in close proximity to each other. First, it can be understood that the fluidic substance (10) may now be fully covering all appropriate areas between the microscopic slides (8). Furthermore, in the Figure it can be seen that the microscopic slides may not actually be perfectly parallel to each other when they are in the closed position. The microscopic slides (8) may have attached to themselves some type of identifier. This identifier, shown in FIG. 4 as labels (50) can cause spacing through their own thickness. In instances where the identifiers or perhaps labels (50) are relatively thick, it is possible that the microscopic slides (8) do not become fully parallel and the spacing may even be narrower at the other end. This is shown in FIG. 4C as one possibility. Minimizing spacing can serve not only to reduce fluid but also to permit the use of existing label arrangements—even if not optimum.
FIGS. 11 through 14 and FIGS. 9 and 16, show that chemical interaction may occur where the surfaces are, or at least one surface is, in an untilted orientation. By establishing an untilted surface, it may be easier to facilitate reagent dispensing on a surface such as a microscopic slide (8) such as by extending and retracting a reagent container (55) relative to a desired position or the like. The substance (5) may then be dispensed perhaps drop-wise or in an appropriate metered amount. At times when it is desirable to withdraw a particular fluidic substance (10) from an exterior sample area (4) from proximity to the sample (1), it may be desirable to facilitate this withdrawal of the substance in some manner. This can be facilitated in a variety of ways. In one embodiment this may include orienting a surface to facilitate the withdrawal of the substance away from proximity to the sample. As shown in FIG. 15, this orientation may involve establishing a tilted surface or perhaps tilting the surface to facilitate the wicking away of the substance. This orientation, or perhaps tilting, can occur at a variety of angles and can establish either an upper or lower surface at a given angle or perhaps a bisected angle at a given angle relative to horizontal. This bisected angle may actually be a line in between the two surfaces and may be oriented at a particular angle. As shown in FIG. 15 in one embodiment the orientation may be the tilting of a bisected angle (54) at an angle such as 45°. In this configuration, the surface, perhaps a lower glass microscope slide (45), may be established at perhaps greater than 30° or even 22½°. Similarly the upper surface such as the upper glass microscope slide (43) may be established at a different angle perhaps 60° or 67.5°. In this fashion it can be understood that the withdrawal of the fluidic substance by something such as the perpendicular wicking roll (52) as shown in FIGS. 15, 25, and 26 or perhaps the more general substance withdrawal element (53) such as perhaps a wicking cassette or the like may be moved into position to withdraw a liquid that has collected closer to the hinged movement element (47). Of course, 90° could be used for any surface or perhaps even for the bisected angle (54). In some configurations it may be appropriate to establish a tilted bisected angle (54) between the two surfaces while accomplishing the step of wicking or more generally withdrawing a substance (5) from proximity to the sample (1). This may also occur with one surface untilted such as might be desired to eliminate some movement element or motor or the like.
Further, each of the various elements of the invention and claims may also be achieved in a variety of manners. Additionally, when used or implied, an element is to be understood as encompassing individual as well as plural structures that may or may not be physically connected. This disclosure should be understood to encompass each such variation, be it a variation of an embodiment of any apparatus embodiment, a method or process embodiment, or even merely a variation of any element of these. Particularly, it should be understood that as the disclosure relates to elements of the invention, the words for each element may be expressed by equivalent apparatus terms or method terms—even if only the function or result is the same. Such equivalent, broader, or even more generic terms should be considered to be encompassed in the description of each element or action. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled. As but one example, it should be understood that all actions may be expressed as a means for taking that action or as an element which causes that action. Similarly, each physical element disclosed should be understood to encompass a disclosure of the action which that physical element facilitates. Regarding this last aspect, as but one example, the disclosure of a “dispenser” should be understood to encompass disclosure of the act of “dispensing”—whether explicitly discussed or not—and, conversely, were there effectively disclosure of the act of “dispensing”, such a disclosure should be understood to encompass disclosure of a “dispenser” and even a “means for dispensing.” Such changes and alternative terms are to be understood to be explicitly included in the description.
With regard to claims now or later presented for examination, it should be understood that for practical reasons and so as to avoid great expansion of the examination burden, the applicant may at any time present only initial claims or perhaps only initial claims with only initial dependencies. Support should be understood to exist to the degree required under new matter laws—including but not limited to European Patent Convention Article 123(2) and United States Patent Law 35 USC 132 or other such laws—to permit the addition of any of the various dependencies or other elements presented under one independent claim or concept as dependencies or elements under any other independent claim or concept. In drafting any claims at any time whether in this application or in any subsequent application, it should also be understood that the applicant has intended to capture as full and broad a scope of coverage as legally available. To the extent that insubstantial substitutes are made, to the extent that the applicant did not in fact draft any claim so as to literally encompass any particular embodiment, and to the extent otherwise applicable, the applicant should not be understood to have in any way intended to or actually relinquished such coverage as the applicant simply may not have been able to anticipate all eventualities; one skilled in the art, should not be reasonably expected to have drafted a claim that would have literally encompassed such alternative embodiments.
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