System and method for monitoring tissue samples to be processed by a tissue processor

文档序号:1539463 发布日期:2020-02-14 浏览:13次 中文

阅读说明:本技术 监测待由组织处理器处理的组织样本的系统和方法 (System and method for monitoring tissue samples to be processed by a tissue processor ) 是由 菲奥娜·玛丽·塔尔别特 东查德哈·欧-艾尼尔 于 2018-08-22 设计创作,主要内容包括:一种用于监测待由用于组织病理学工作流的组织处理器处理的组织样本的系统,所述系统包括:与所述组织处理器相关联的扫描仪,所述扫描仪被布置为扫描待由所述组织处理器处理的至少一个组织样本的电子样本标识符;输入模块,所述输入模块被布置为接收组织处理器工作流数据,所述组织处理器工作流数据指示用于待由所述组织处理器中用于处理所述至少一个组织样本的多个处理站中的所选择处理站处理的所述至少一个组织样本的组织处理器工作流;监测模块,所述监测模块被布置为监测在所述处理站中的所选择处理站中的每一个处处理的所述至少一个组织样本的特性,并且与所述电子样本标识符相关联地将所述至少一个组织样本的所述特性记录在用于所述组织处理器工作流的样本记录中;以及输出模块,所述输出模块被布置为将所述样本记录输出到用于在组织病理学工作流中进一步处理所述至少一个组织样本的一个或多个实验室仪器。还提供一种用于组织病理学工作流的用于处理组织样本的组织处理器。还提供一种监测待由用于组织病理学工作流的组织处理器处理的组织样本的方法。(A system for monitoring tissue samples to be processed by a tissue processor for histopathology workflow, the system comprising: a scanner associated with the tissue processor, the scanner arranged to scan an electronic sample identifier of at least one tissue sample to be processed by the tissue processor; an input module arranged to receive tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample; a monitoring module arranged to monitor a characteristic of the at least one tissue sample processed at each of selected ones of the processing stations and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier in a sample record for the tissue processor workflow; and an output module arranged to output the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow. A tissue processor for processing tissue samples for histopathology workflow is also provided. A method of monitoring a tissue sample to be processed by a tissue processor for histopathology workflow is also provided.)

1. A system for monitoring tissue samples to be processed by a tissue processor for histopathology workflow, the system comprising:

a scanner associated with the tissue processor, the scanner arranged to scan an electronic sample identifier of at least one tissue sample to be processed by the tissue processor;

an input module arranged to receive tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample;

a monitoring module arranged to monitor a characteristic of the at least one tissue sample processed at each of selected ones of the processing stations and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier in a sample record for the tissue processor workflow; and

an output module arranged to input the sample records to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

2. The system of claim 1, wherein the sample record further comprises, in association with the electronic sample identifier, the tissue processor workflow data indicating the tissue processor workflow for the at least one tissue sample.

3. The system of claim 2, wherein the sample record further comprises, in association with the electronic sample identifier, a characteristic of the at least one tissue sample expected based on the tissue processor workflow for the at least one tissue sample.

4. The system of any one of claims 1 to 3, further comprising one or more sensors associated with each of the plurality of processing stations in the tissue processor, the one or more sensors arranged to sense the characteristic of the at least one tissue sample being processed.

5. The system of any one of claims 1 to 4, wherein the at least one tissue sample to be processed by the tissue processor is disposed in a cassette, and the electronic sample identifier comprises a cassette identifier.

6. The system of claim 5, wherein the box is disposed in a basket, and the electronic sample identifier further comprises a basket identifier.

7. The system of any of claims 1-6, wherein the electronic sample identifier comprises a barcode label.

8. The system of claim 6 or claim 7 when dependent on claim 6, wherein the at least one sample is associated with the basket identifier when the at least one sample is subjected to preliminary processing.

9. A tissue processor for processing tissue samples for a histopathology workflow, the tissue processor comprising:

a scanner arranged to scan an electronic sample identifier of at least one tissue sample to be processed by the tissue processor;

a plurality of processing stations arranged to process the at least one tissue sample;

an input module arranged to receive tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of the plurality of processing stations;

a monitoring module arranged to monitor a characteristic of the at least one tissue sample processed at each of selected ones of the processing stations and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier in a sample record for the tissue processor workflow; and

an output module arranged to input the sample records to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

10. The tissue processor of claim 9 wherein the sample record further comprises, in association with the electronic sample identifier, the tissue processor workflow data indicating the tissue processor workflow for the at least one tissue sample.

11. The tissue processor of claim 10, wherein the sample record further comprises, in association with the electronic sample identifier, a characteristic of the at least one tissue sample expected based on the tissue processor workflow for the at least one tissue sample.

12. The tissue processor of any one of claims 9 to 11, further comprising one or more sensors associated with each of the plurality of processing stations in the tissue processor, the one or more sensors arranged to sense the characteristic of the at least one tissue sample being processed.

13. The tissue processor of any of claims 9-12, wherein the at least one tissue sample to be processed by the tissue processor is disposed in a cassette, and the electronic sample identifier comprises a cassette identifier.

14. The tissue processor of claim 13 wherein the cassette is disposed in a basket and the electronic specimen identifier further comprises a basket identifier.

15. The tissue processor of any of claims 9-14, wherein the electronic sample identifier comprises a barcode label.

16. The tissue processor of claim 14 or claim 15 when dependent on claim 14, wherein the at least one sample is associated with the basket identifier when the at least one sample is subjected to preliminary processing.

17. The tissue processor of any of claims 9-16, further comprising a display, wherein information indicative of the sample record is displayed to a user of the tissue processor on the display.

18. A method of monitoring tissue samples to be processed by a tissue processor for a histopathology workflow, the method comprising:

receiving, from a scanner associated with the tissue processor, an electronic sample identifier of at least one tissue sample to be processed by the tissue processor;

receiving tissue processor workflow data indicating a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample;

monitoring a characteristic of the at least one tissue sample processed at each of the selected ones of the processing stations;

recording the characteristic of the at least one tissue sample in a sample record for the tissue processor workflow in association with the electronic sample identifier; and

inputting the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

Technical Field

The present invention relates to a system and method of monitoring tissue samples to be processed by a tissue processor for histopathological workflow. The invention has particular, but not exclusive, application to: monitoring a characteristic of the tissue sample being processed and recording the characteristic in the sample record in association with the electronic sample identifier; the sample record is output for use by a laboratory instrument that further processes the tissue sample in a histopathology workflow.

Background

Biological tissue samples (in particular histological tissue samples) are often required in the fields of human and veterinary medicine, in particular as microscope preparation specimens for the evaluation of cells and their environment. For microscopic examination, thin sections of tissue samples must be prepared for evaluation by an expert under a microscope with incident or transmitted light.

Producing thin sections (e.g., using a microtome) requires that the tissue sample have a certain strength so that a knife can be used to produce transparent thin sections with a thickness in the order of microns. For this purpose, the tissue sample must first undergo a treatment process in which it is fixed, dehydrated, cleaned and then infiltrated with a carrier material (preferably molten paraffin). These processes are typically performed sequentially in a single unit called an "organization processor"; for this purpose, this tissue processor comprises closable process chambers, called "autoclaves", which receive various reagents (in particular process media) in order to carry out the process steps at suitable temperatures and pressures.

These processes for processing tissue samples in a tissue processor are typically provided as a tissue processor workflow. The tissue processor workflow defines the processes to be applied by selected laboratory workstations (such as a reaction kettle) in the tissue processor. In addition, in the case where tissue samples are to be analyzed for histopathological or histological evaluation, the tissue processor workflow forms part of a histopathological workflow.

For example, immunohistochemical staining and in situ nucleic acid analysis are existing means for histological diagnosis and histomorphological studies that are part of a typical histopathological workflow. Immunohistochemical staining relies on the specific binding affinity of antibodies to epitopes in tissue samples, as well as the increasing availability of antibodies that specifically bind to unique epitopes present only in certain types of diseased cell tissues. Immunohistochemical staining involves a series of processing steps performed on a tissue sample (usually a section) mounted on a glass slide to highlight certain morphological indicators of disease status by selective staining.

Typical processing steps for immunohistochemical staining include: pre-processing the tissue sample using a tissue processor to reduce non-specific binding; antibody treatment and incubation; enzyme-labeled secondary antibody treatment and incubation; reacting the substrate with an enzyme to produce a fluorophore or chromophore that highlights regions of the tissue sample having epitopes bound by the antibody; counterdyeing, and the like. Between each processing step, the tissue sample must be rinsed to remove unreacted residual reagents from the previous step. Most processing steps involve an incubation period that is typically performed at ambient temperatures of about 25 ℃ up to about 40 ℃, while cell conditioning steps are typically performed at slightly higher temperatures (e.g., 90 ℃ to 100 ℃). In situ DNA analysis relies on the specific binding affinity of probes (DNA binding proteins) to unique nucleotide sequences in cell or tissue samples and similarly involves a series of process steps performed under a variety of reagent and process temperature requirements. Some specific reactions involve temperatures as high as 120 ℃ to 130 ℃. Thus, pre-processing the tissue sample in the tissue processor introduces a large amount of variability, which is likely to affect further processing of the tissue sample in other laboratory instruments in the rest of the histopathology workflow.

Some automation has been attempted in laboratory instruments used to process tissue samples in histopathology workflow. In existing applications, for example, automated tissue sample staining equipment is employed to process tissue samples disposed on slides for immunological applications. In this example, the automated staining apparatus implements multiple laboratory modules in a single instrument that process tissue samples with reagents and then stain the samples disposed on slides. In the example, processing a sample using such an apparatus includes: one or more robots are configured to dip the slides into the dewaxing solution and then dispense reagents to the samples on the slides in a predetermined order according to a staining protocol. However, automated tissue sample staining apparatus have limited or no knowledge of previous tissue sample processing steps, which in some cases can negatively impact the quality of the staining.

In addition, while most modern laboratory instruments are automated to some extent and computer control is becoming common, each instrument may have a unique operating system and communicate using different data patterns and control signals.

Disclosure of Invention

Accordingly, one aspect of the present invention provides a system for monitoring tissue samples to be processed by a tissue processor for histopathological workflow, the system comprising: a scanner associated with the tissue processor, the scanner arranged to scan an electronic sample identifier of at least one tissue sample to be processed by the tissue processor; an input module arranged to receive tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample; a monitoring module arranged to monitor a characteristic of the at least one tissue sample processed at each of selected ones of the processing stations and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier in a sample record for the tissue processor workflow; and an output module arranged to output the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

In this aspect, the system comprises a module arranged to monitor the tissue samples processed by the tissue processor with respect to tissue processor usage for histopathological workflow. One or more of the modules may be arranged, for example, in a client-server arrangement. For example, the input module, monitoring module, and output module are provided by a server in data communication with one or more tissue processors, and the scanner may be co-located with each tissue processor.

Another aspect of the invention provides a tissue processor for processing tissue samples for a histopathology workflow, the tissue processor comprising: a scanner arranged to scan an electronic sample identifier of at least one tissue sample to be processed by the tissue processor; a plurality of processing stations arranged to process the at least one tissue sample; an input module arranged to receive tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of the plurality of processing stations; a monitoring module arranged to monitor a characteristic of the at least one tissue sample processed at each of selected ones of the processing stations and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier in a sample record for the tissue processor workflow; and an output module arranged to output the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

In this aspect, the tissue processor incorporates a module for monitoring tissue samples being processed for a histopathology workflow.

The plurality of processing stations arranged to process the at least one tissue sample may comprise reaction vessels for processing tissue samples with different reagents. It will be understood by those skilled in the art that the reaction kettle may be used to perform a number of processing steps that may otherwise be performed in a number of processing stations, such as fixation with formalin, dehydration with alcohol, cleaning with xylene, and addition of paraffin to the sample.

In some embodiments, the sample record further includes, in association with the electronic sample identifier, the tissue processor workflow data indicating the tissue processor workflow for the at least one tissue sample. Additionally, in some embodiments, the sample record further includes, in association with the electronic sample identifier, a characteristic of the at least one tissue sample expected based on the tissue processor workflow for the at least one tissue sample.

In some embodiments, the system further comprises one or more sensors associated with each of the plurality of processing stations in the tissue processor, the one or more sensors arranged to sense the characteristic of the at least one tissue sample being processed. In some embodiments, the tissue processor further comprises one or more sensors associated with each of the plurality of processing stations in the tissue processor, the one or more sensors being arranged to sense the characteristic of the at least one tissue sample being processed. Preferably, the characteristics of the at least one tissue sample being processed include: fixation period, tissue thickness, tissue type, protocol step, protocol duration, reagent concentration, reagent batch number, reactor temperature, cycle number, and reagent residual amount (carryover). Some characteristics may also be derived from the sensed characteristics. The concentration of the agent to be used for treating the tissue is calculated according to the residual quantity. Residual volume is defined as the amount of reagent carried over from previous steps in the process and from multiple cassettes, baskets, tissue and biopsy constraints in the current processing run. This is calculated from both instrument input and user input.

In some embodiments, the at least one tissue sample to be processed by the tissue processor is disposed in a cassette, and the electronic sample identifier comprises a cassette identifier. Additionally, the cartridge may be disposed in a basket, and the electronic sample identifier may further include a basket identifier. Still further, the electronic sample identifier (e.g., the box identifier or basket identifier) may include a bar code label. For example, in these embodiments, the at least one sample may be associated with the basket identifier when performing a preliminary processing (sizing) on the at least one sample. Preferably, the barcode label is a two-dimensional data matrix digital barcode with human readable text. Alternatively, the basket identifier is a radio frequency identification technology (RFID) tag.

Those skilled in the art will appreciate that other electronically readable identifiers may be used, such as but not limited to: printed text, bar codes (one, two or three dimensional), data glyphs, Optical Character Recognition (OCR) codes, integrated circuits disposed on the identifier or identifier support, radio frequency identification technology (RFID) tags, and electronic ink. The electronically readable identifier may also be communicatively coupled (via a communication infrastructure such as the internet, Wi-Fi or other communication network, bluetooth, RFID, cellular, etc.) with the tissue processor or other monitoring device.

In some embodiments, the system can record software and/or sensor data for automating tissue processing and use the software and/or sensor data to provide information to a histopathology laboratory user.

In one example, the tissue sample is initially processed by chopping and placing the tissue sample into a box, and then placing the box in a basket. The user of the tissue processor may then associate the basket with a tissue processor workflow for the tissue sample when the tissue sample is loaded into the basket and then into the tissue processor. The tissue processor receives the tissue processor workflow data and scans the electronic sample identifier in the form of a basket barcode label using the scanner to identify the sample being processed according to the tissue processor workflow. As above, the characteristics of the tissue sample being processed are then recorded in a sample record in association with the electronic sample identifier for output to one or more further laboratory instruments for further processing of the tissue sample in a histopathology workflow.

The tissue processing protocol and reagents form part of a validation record for advanced staining optimization in the laboratory. In one example, the advanced staining process is altered based on the sample record to re-validate the staining technique based on a processing output, such as the macroscopic and/or microscopic appearance of the tissue or some other characteristic (e.g., tissue quality).

In some embodiments, the tissue processor further comprises a display such that information indicative of the sample record is displayed to a user of the tissue processor on the display. Alternatively, the system may further include a display associated with the server such that information indicative of the sample record is displayed to a user monitoring tissue samples being processed by one or more tissue processors. In these embodiments, the user may visually determine whether the tissue treatment meets the necessary treatment criteria.

Preferably, the sample records are provided as collated reports that can be filtered by a user and viewed by the user on the organization processor. Additionally, in some embodiments, the sample records are output over USB in CSV format for use by other laboratory instruments in the histopathology workflow. In addition, the sample record may be output using a common architecture of the laboratory instrument, such as a Laboratory Information System (LIS). It will be appreciated by those skilled in the art that other options for packaging the sample record and allowing the user to export the sample record may be provided. The sample records may be provided as raw data, tabulated data, as report collations, specify filter conditions (e.g., filtering by date, user, event, etc.), and may be in a variety of formats (e.g., html, csv files for use in excel, pdf, etc.). The user may access the sample records through a variety of channels; for example, the sample records may be viewed on an instrument display, manually exported by a user (e.g., via USB or other connection type), or automatically accessed (e.g., via ethernet for use in LIS). It should also be understood that typical data entry, data recording and sample tracking (e.g., barcoded samples at preliminary processing) of the types described above, tissue processing instruments do not have this provision. Thus, the process and control is manual, which makes it difficult to track patient samples throughout the tissue treatment process, and makes any troubleshooting (e.g., in the case of sub-optimal tissue treatment) difficult and impractical.

Another aspect of the invention provides a method of monitoring a tissue sample to be processed by a tissue processor for histopathological workflow, the method comprising: receiving, from a scanner associated with the tissue processor, an electronic sample identifier of at least one tissue sample to be processed by the tissue processor; receiving tissue processor workflow data indicating a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample; monitoring a characteristic of the at least one tissue sample processed at each of the selected ones of the processing stations; recording the characteristic of the at least one tissue sample in a sample record for the tissue processor workflow in association with the electronic sample identifier; and outputting the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

Drawings

The present invention will now be described in more detail with reference to the appended drawings, in which like features are represented by like numerals. It should be understood that the illustrated embodiments are examples only, and should not be taken as limiting the scope of the invention as defined by the appended claims. Embodiments are described with reference to the accompanying drawings, in which:

fig. 1 is a schematic diagram of a system for monitoring tissue samples to be processed by a tissue processor for histopathology workflow, according to an embodiment of the present invention;

fig. 2 is another schematic diagram of a system for monitoring tissue samples to be processed by a tissue processor for histopathology workflow, according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of a system for processing a tissue sample according to an embodiment of the present invention;

FIG. 4 is a representation of a tissue processor for histopathological workflow according to an embodiment of the present invention;

FIG. 5 is a flow diagram of processing a sample by a laboratory instrument in a system for processing tissue samples according to an embodiment of the present invention; and

fig. 6 is a flow diagram of a method of monitoring a tissue sample to be processed by a tissue processor for a histopathology workflow, according to an embodiment of the invention.

Detailed Description

Embodiments of the invention are discussed herein with reference to the accompanying drawings, which are not to scale and are intended merely to aid in the explanation of the invention.

An embodiment of a system 10 for monitoring tissue samples to be processed by a tissue processor for histopathology workflow is shown in fig. 1. The system 10 comprises a scanner 12 associated with the tissue processor, said scanner 12 being arranged to scan an electronic sample identifier 13 of at least one tissue sample to be processed by the tissue processor. As discussed, the system 10 may be implemented in a client-server arrangement in which a plurality of modules for monitoring tissue samples being processed by a tissue processor are implemented by a server. In this manner, the system 10 can be used to monitor tissue samples processed by many tissue processors, and can be applied to existing tissue processors that are in data communication with a server over a network.

These modules, implemented by the server, include: an input module 14, the input module 14 being arranged to receive tissue processor workflow data 15, the tissue processor workflow data 15 being indicative of a tissue processor workflow for at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of a tissue processor for processing at least one tissue sample. That is, the tissue processor comprises a plurality of processing stations, discussed in more detail below, arranged to process tissue samples according to a tissue processor workflow.

The modules further comprise a monitoring module 16, the monitoring module 16 being arranged to monitor a characteristic of at least one tissue sample processed at each of the selected ones of the processing stations in accordance with the tissue processor workflow, and to record the characteristic of the at least one tissue sample in association with the electronic sample identifier 13 in a sample record 17 for the tissue processor workflow. In addition, the output module 18 is arranged to output the sample record 17 to one or more laboratory instruments for further processing of the at least one tissue sample in the histopathology workflow.

Fig. 5 shows an example of a histopathological workflow. It can be seen here that the steps of preliminary processing of the tissue sample, processing of the tissue sample using a tissue processor, and embedding the tissue sample occur just before the advanced staining step. It will therefore be appreciated that the quality of the tissue processing step affects the advanced staining and therefore the diagnosis of tissue samples in the histopathology workflow.

Fig. 2 shows an alternative embodiment of a tissue processor 20, the tissue processor 20 incorporating the above-mentioned modules to monitor tissue samples being processed by the tissue processor 20 for histopathological workflow. That is, the tissue processor 20 comprises a scanner 12 co-located with the tissue processor 20, said scanner 12 being arranged to scan an electronic sample identifier 13 of at least one tissue sample to be processed by the tissue processor 20.

For example, the electronic sample identifier is a barcode label. In one embodiment, the bar code label is applied to a basket containing tissue samples that have been shredded and placed into a cassette that is placed into the basket for batch processing of the samples in the cassette. In another embodiment, the identifier is applied to the cassette. Additionally, the cassette may have a cassette identifier in addition to the basket identifier to further identify the sample being processed by tissue processor 20.

The tissue processor 20 comprises a plurality of processing stations 22, the plurality of processing stations 22 being arranged to process at least one tissue sample according to a tissue processor workflow. One of the processing stations 22 is a reaction vessel for processing tissue samples with different reagents. The organization processor workflow includes detailed information of which of the stations 22 are to be used to process the samples and in what order. These stations 22 will be described in more detail below.

Tissue processor 20 also includes a CPU 11 (or other microprocessor), which CPU 11 is configured to implement the above-mentioned modules for monitoring tissue samples being processed by tissue processor 20. The CPU 11 is configured to execute the modules by executing program codes stored on the memory 24 for each of the modules. Those skilled in the art will appreciate that the client-server arrangement described above also implements the modules using program code, and this code may be stored in a memory in data communication with the server processor.

Specifically, the modules implemented by the CPU 11 of the tissue processor 20 shown in fig. 2 include: an input module 14, the input module 14 being arranged to receive tissue processor workflow data 15, the tissue processor workflow data 15 being indicative of a tissue processor workflow for samples processed by a selected one of the plurality of processing stations 22. In processing the samples by the tissue processor 20, the monitoring module 16 is arranged to monitor characteristics of the tissue samples processed at each of the processing stations 22 and to record these characteristics in the sample record 17 for the tissue processor workflow in association with the electronic sample identifier 13. In addition, the tissue processor 20 comprises an output module 18, said output module 18 being arranged to output the sample records 17 to one or more laboratory instruments for further processing of the tissue samples in the histopathology workflow.

An example of another laboratory instrument for further processing of tissue samples in a histopathology workflow includes an automated tissue staining apparatus. Fig. 3 shows a representation of tissue processor 20 in data communication over network 34 with instrument a 26 having instrument ID 28 (e.g., an automated tissue staining apparatus) and instrument B30 having instrument ID 32, which form a system 36 for processing tissue samples according to an embodiment of the invention. Sample records 17 are transmitted over network 34 in a format understood by laboratory instruments a 26 and laboratory instruments B30 for further processing of tissue samples in a histopathology workflow. In association with the electronic sample identifier, the sample record 17 includes tissue processor workflow data indicative of a tissue processor workflow for at least one tissue sample. The sample record 17 also includes characteristics of at least one tissue sample expected based on the tissue processor workflow for the at least one tissue sample. Automated tissue staining equipment (e.g., instrument a 26), such as, for example, uses these characteristics to modify its workflow to ensure higher quality staining.

In addition, the sample record 17 serves as a troubleshooting means to determine if there are any causes (such as due to processing or reagent problems) that cause errors in tissue processing. The sample record 17 also serves as a Quality Control (QC) record that may need to be shown at the time of auditing.

Fig. 4 shows an embodiment of the tissue processor 20 and its processing station 22 described above. Tissue processor 20 includes two processing stations 22 as reaction vessel 21A and reaction vessel 21B for simultaneously processing tissue samples with different reagents. In reaction vessels 21A and 21B, the tissue sample undergoes a plurality of process steps. It will be understood by those skilled in the art that while reaction vessels 21A and 21B are performing these various steps, reaction vessels 21A and 21B themselves form various processing stations 22.

One such process is a fixation process in which formalin is typically used. This process preferably occurs first in the organization process workflow. The dehydration process is then completed using various purity alcohol solutions. During the subsequent cleaning process, alcohol residues are removed from the tissue sample and the tissue sample is prepared for absorbing the carrier material. Xylene or similar media is typically used in this cleaning process. Paraffin or waxes of various compositions are preferably suitable as carrier materials. The individual or multiple process steps may be subdivided into process sub-steps in which the tissue sample is exposed to the aforementioned reagents having different purities.

Once these process steps have been performed in the tissue processor workflow, a process of cleaning reaction vessels 21A and 21B is performed using the aforementioned or additional reagents; for example, by performing the foregoing process steps in reverse order without a tissue sample in reaction vessels 21A and 21B. The tissue processor 20 includes a cabinet 23 having two drawers for containers 25 for reagents necessary for various processes, including a fixing process, a dehydration process, and/or a cleaning process.

A work area is provided on the desktop of the tissue processor 20, as well as a display 27. It should be understood that the CPU 11 and memory 24 are provided by the tissue processor 20 to control the processing of tissue samples according to the tissue processor workflow, as well as to monitor the tissue samples being processed. The display 27 is configured by the CPU 11 to display information indicative of the sample record 17 to a user of the tissue processor 20. For example, the sample records 17 are shown on the display 27 as collated reports that may be filtered by the user.

Reaction vessels 21A and 21B are embodied in tissue processor 20 as sealable chambers having openings for receiving tissue samples in the baskets, and are shown in a closed position. Inside one of the reaction vessels 21A, various reagents (e.g. paraffin, which is important for the infiltration process) can act on the tissue sample by means of pressure, vacuum and/or temperature. The interior of reaction vessel 21A is connected by a valve arrangement to a line extending from reagent vessel 25 through an electrically controllable valve. For example, one line is connected to the contents of the reaction tank 21A through a valve so that liquid paraffin is delivered from the corresponding reagent vessel 25 under the control of the valve. The further lines are connected to further reagent containers 25 for reagents required for the fixing process, the dewatering process and/or the cleaning process etc. In addition, another line is connected to a distributor that distributes the liquid paraffin under the control of a valve. The paraffin may be contained in a paraffin replenishment station or in one of the reagent containers 25. In another embodiment, the distributor is connected to a line connecting the distributor to the container 25 containing the liquid paraffin with increasing purity.

In the embodiment described, as the distributor is heated, the lines are also heated, and depending on the reagents used, the valve arrangement is also heated, in order to ensure that the paraffin is always maintained in a liquid state (e.g. at 65 ℃) and does not solidify during operation. The same applies to some of the reaction vessels 21A and 21B and their parts and supply stations and vessels.

A sensor 29 is disposed on tissue processor 20 to sense a characteristic of the tissue sample being processed (see, e.g., fig. 2). These sensors 29 are associated with each of the plurality of processing stations 22 (such as autoclaves 21A and 21B) in tissue processor 20 and are arranged to sense characteristics of the tissue samples as they are processed.

For example, some of the sensors 29 are located between the reagent container 25 and the reaction vessels 21A and 21B and between the distributor and its valves. Another sensor provides for obtaining a measurement value representative of a characteristic property of the paraffin, in particular the purity of the paraffin currently flowing through the pipeline. It is therefore possible to ascertain the different purity of the paraffin currently used before and after processing the tissue sample, when pumping the paraffin to the reaction vessels 21A and 21B and back to the container 25. In this example, the sample record includes tissue processor workflow data indicating the step of processing with paraffin and detailed information of the purity of the paraffin used in this processing step. This information in the sample record 17 can be used for auditing, troubleshooting, inspection instrument use and maintenance, inspection reagent use, and reordering of reagents for inventory management and reagent use optimization.

Examples of sensors 29 include optical sensors configured to sense turbidity or staining of the paraffin (the paraffin may be treated with a colorant in order to ascertain its purity). In addition, with this type of sensor, it is possible to ascertain the density or conductivity of the paraffin, from which the purity of the paraffin can then be ascertained.

Subsequent steps in the fixing process involve pumping a continuous process medium from the other reagent containers 25 through the connectors to the reaction vessels 21A and 21B by, for example, applying pressure to these reagent containers 25. These reagent containers 25 contain corresponding process media of different purity. Thus, other sensors in sensors 29 of tissue processor 20 include density sensors and pressure sensors to sense the density of the process media currently flowing to reaction vessels 21A and 21B. The purity of the process media can be determined based on its density. Thus, density sensors and pressure sensors are used to obtain measurements indicative of the purity of the process media. The density sensor is particularly suitable for ascertaining the purity of the alcohol or xylene used in this process step.

In addition, the process media stored in the reagent vessel 25 encompass, for example: fixing agents, in particular alkaline fixing agents, such as formalin; and dehydrating agents, in particular alcohols, in particular ethanol; an intermediate medium, such as isopropanol or an aromatic compound, in particular xylene; and/or cleaning agents, in particular distilled water. In addition, the fixing agent, the dehydrating agent and/or the intermediate medium may also be used for cleaning, and may also be referred to as a cleaning agent in this context. One or more other sensors 29 may also be provided for sensing characteristic characteristics of all process media used. These characteristic properties can be measured using the following sensors, but are not limited to these: a photosensor, a conductivity sensor, and a pH sensor.

Referring now to fig. 6, there is shown an overview of a method 40 of monitoring tissue samples to be processed by a tissue processor for histopathology workflow, the method comprising: receiving 42, from a scanner associated with the tissue processor, an electronic sample identifier of at least one tissue sample to be processed by the tissue processor; receiving 44 tissue processor workflow data indicative of a tissue processor workflow for the at least one tissue sample to be processed by a selected processing station of a plurality of processing stations of the tissue processor for processing the at least one tissue sample; monitoring 46 a characteristic of the at least one tissue sample processed at each of the selected ones of the processing stations; recording 48 the characteristic of the at least one tissue sample in a sample record for the tissue processor workflow in association with the electronic sample identifier; and outputting 50 the sample record to one or more laboratory instruments for further processing of the at least one tissue sample in a histopathology workflow.

Further aspects of the method will be apparent from the above description of system 10 and tissue processor 20. Those skilled in the art will also appreciate that the methods may be embodied in program code. Program code may be provided in a variety of ways, for example, on a memory of the organization processor 20, or on a tangible computer-readable medium, or as a data signal or file transfer for the organization processor 20.

It will also be appreciated that various alterations, additions and/or modifications may be made to the parts previously described without departing from the scope of the invention, and that the invention may be implemented in software, firmware and/or hardware in a variety of ways, in view of the above teachings, as will be appreciated by those skilled in the art.

It is also to be understood that the following claims are provided by way of example only and are not intended to limit the scope of what may be claimed in any future application. Features may be added to or deleted from the claims at a later date in order to further define or redefine one or more of the inventions.

This description includes discussion of documents, acts, materials, devices, articles and the like, merely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

When any or all of the terms "comprises/comprising" are used in this specification, including the claims, they are to be interpreted as specifying the presence of the stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps or components.

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