EP-4736171-A1 - SYSTEMS AND METHODS FOR PROCESSING A PATHOLOGY SPECIMEN

Abstract

Systems and methods for processing tissue samples are provided. Tissue samples are obtained and disposed into individual compartments of a cassette with an embedded barcode identifier, which is scanned to generate a display screen of digital images and a reference table. Cassettes with tissue samples are stored and shipped in one formalin filled jar to a pathology facility, where the cassettes are removed and wiped of formalin. Digital images of lidless cassettes are generated and measured by a pathology information system. The ends of each tissue sample are color coded and the tissue samples dehydrated. The tissue samples and an orientation dot are embedded in a paraffin block, which is trimmed and mounted to a slide. Digital images of the tissue samples on the slide are generated and stored by the pathology information system. The digital images may be analyzed by a doctor and/or artificial intelligence programs for abnormal pathology.

Inventors

• LU, JIM

Assignees

• Gopath Laboratories LLC

Dates

Publication Date

20260506

Application Date

20240618

Claims (20)

1. 1. A system for processing pathology specimens, the system comprising: a sample collection module comprising one or more tissue sample cassettes each having a plurality of compartments with each compartment configured to receive a tissue sample, wherein each of the one or more tissue sample cassettes comprises a cassette identifier affixed to the tissue sample cassette, the cassette identifier being one of a barcode and a quick response code (QRC); a sample shipping module comprising a storage container configured to enclose the one or more tissue cassettes and a shipping container configured to receive and protect the shipping container; a sample receiving module comprising a pathology information system receiving station configured to scan a cassette identifier of each of the one or more tissue sample cassettes and a cassette printer configured to print a patient label to be affixed to each of the one or more tissue sample cassettes; a tissue grossing module comprising a digital imaging system configured to take digital images of the tissue samples within the one or more tissue sample cassettes and a pathology information system gross description module configured to measure and record a length and a width of each tissue sample; a tissue processing module comprising a tissue processor configured to receive the one or more tissue sample cassettes and to dehydrate contents of the tissue sample cassettes; a tissue embedding module comprising an embedding mold configured to receive processed tissue samples from one of the one or more tissue sample cassettes and an embedding medium covering the processed tissue samples and an orientation indicator; a tissue cutting module comprising one or more slides configured to receive one or more blocks of hardened embedding medium, each block comprising a set of the processed tissue samples and the orientation indicator; and a digital scanning and management module comprising a scanning system configured to create digital images of the one or more slides and store the digital images as files in the pathology information system.
2. 2. The system of claim 1 , wherein each of the one or more tissue sample cassettes comprises three compartments, wherein each compartment is configured to receive a prostrate tissue core.
3. 3. The system of claim 1 , wherein each of the one or more tissue sample cassettes comprises four compartments, wherein each compartment is configured to receive a gastrointestinal tissue sample.
4. 4. The system of claim 1 , further comprising a cassette holder configured to support the one or more tissue sample cassettes in place.
5. 5. The system of claim 1 , wherein the sample collection module includes a display screen based on a computerized scan of the one or more tissue sample cassettes, the display screen comprising: a digital representation of each of the one or more tissue sample cassettes; and a definition table corresponding to locations and contents of each compartment of the one or more tissue sample cassettes.
6. 6. The system of claim 1 , wherein the storage container of the sample shipping module is a jar containing a storage medium and a lid, the jar configured to receive the one or more tissue sample cassettes within the storage medium and to be sealed by the lid.
7. 7. The system of claim 1 , wherein the storage container comprises at least one of: a patient identifier affixed to the storage container and comprising a label with text information; and a container label affixed to the storage container and comprising one of a barcode and a quick response code (QRC).
8. 8. The system of claim 1 , wherein the tissue processing module comprises an embedding station configured to solidify a fixing medium added to each compartment of the one or more tissue sample cassettes and covering each tissue sample.
9. 9. The system of claim 1 , wherein the tissue embedding module comprises an embedding station configured to soften a solidified fixing medium covering each tissue sample.
10. 10. The system of claim 1 , wherein each of the one or more slides comprises a patient identifier comprising any of text, a bar code and a QRC.
11. 11. A method of preparing pathology specimens, the method comprising: obtaining a plurality of tissue samples from a patient; placing each obtained tissue sample in a separate compartment of a tissue sample cassette; scanning a cassette identifier of the tissue sample cassette; generating a display screen comprising a digital representation of the tissue sample cassette and a definition table corresponding to locations and contents of each compartment of the tissue sample cassette; placing the tissue sample cassette within a storage container containing a storage medium and sealing the storage container; placing the sealed storage container in a shipping container; and sending the shipping container to a pathology processing facility.
12. 12. The method of claim 11 , wherein the tissue sample cassette is coupled to a cassette holder configured to hold a plurality of tissue sample cassettes, and wherein the tissue sample cassette is removed from the cassette holder prior to being placed within the storage container.
13. 13. The method of claim 11 , wherein the cassette identifier is embedded on the tissue sample cassette, the cassette identifier being one of a barcode and a QRC.
14. 14. A method of processing pathology specimens, the method comprising: receiving and removing a sealed storage container from a shipping container; unsealing the storage container and removing a tissue sample cassette containing a plurality of tissue samples, each tissue sample disposed in a separate compartment of the tissue sample cassette; scanning, by a receiving station of a pathology information system, a cassette identifier embedded on the tissue sample cassette; printing, by a cassette printer, a patient label on the tissue sample cassette based on information from the scanned cassette identifier; removing a lid from the tissue sample cassette and grossly examining the tissue samples within the compartments for intactness; scanning, by a digital imaging system, the tissue sample cassette with the lid removed; uploading, from the digital imaging system, a digital image of the scanned tissue sample cassette to a gross description module of the pathology information system; color coding, for each tissue sample in the tissue sample cassette, one end of the tissue sample a color and a second end of the tissue sample a different color; placing a sponge over the compartments and closing the lid of the tissue sample cassette; placing the closed tissue sample cassette into a tissue processor to dehydrate contents of the tissue sample cassette; removing the tissue sample cassette from the tissue processor; removing the tissue samples from the removed tissue sample cassette and placing the removed tissue samples and an orientation indicator in an embedding mold; covering the tissue samples and the orientation indicator within the embedding mold with liquid paraffin; solidifying the liquid paraffin to create a paraffin block with the tissue samples and the orientation indicator embedded; trimming the paraffin block; mounting the trimmed paraffin block to a slide having a patient identifier; scanning, with a scanning system, the slide to create a digital image of each tissue sample; and saving, by the pathology information system, the digital images as image files based on information from the patient identifier.
15. 15. The method of claim 14, wherein the tissue sample cassette is submerged in formalin within the sealed storage container, the method further comprising wiping out formalin remaining on the tissue sample cassette after removing the tissue sample cassette from the sealed storage container.
16. 16. The method of claim 14, further comprising measuring and recording, by an artificial intelligence program of the gross description module, a length and width of each tissue sample in the digital image.
17. 17. The method of claim 14, prior to placing the closed tissue sample cassette into the tissue processor, further comprising: placing the tissue sample cassette on a cold plate; adding gel to each compartment containing a tissue sample; and solidifying the gel.
18. 18. The method of claim 17, after removing the tissue sample cassette from the tissue processor, further comprising: placing the removed tissue sample cassette on a hot plate; inking a different color dot on the gel of each compartment; softening the gel; trimming and removing a portion of the gel to create individual tissue sample/gel blocks each having a different color dot; and placing the tissue sample/gel blocks into the embedding mold.
19. 19. The method of claim 14, wherein the orientation indicator is used to mount the trimmed paraffin block to the slide so that the tissue samples are intact and in the same orientation as when disposed in the tissue sample cassette.
20. 20. The method of claim 14, wherein the tissue samples are only directly touched by one or more of the sponge, a gel and the paraffin.

Description

SYSTEMS AND METHODS FOR PROCESSING A PATHOLOGY SPECIMEN TECHNICAL FIELD [0001] The present disclosure relates generally to systems and methods for processing pathology specimens, in particular for processing tissue samples in preparation for digital pathology analysis. BACKGROUND [0002] Pathology samples such as tissue samples are typically obtained from a patient and provided to a lab for analysis. For example, a needle biopsy such as an initial transrectal ultrasound (TRUS) guided prostate biopsy may be performed to obtain prostate tissue core samples or laparoscopic collection may be performed to obtain gastrointestinal tissue samples, which then are sent into a lab for processing and analysis. [0003] Typically, such core samples are transferred from the needle biopsy instrument to a glass jar containing formalin by a doctor or medical technician at the site where the biopsy is performed. The glass jar is then labeled, packaged and sent to a lab for processing. However, the tissue samples tend to move around within the jar during transportation and are immersed in formalin, which may damage the tissue, degrade the tissue integrity and/or alter the orientation of the tissue sample. At the lab, the tissue samples are then removed from the jar, such as with tweezers, and affixed to a glass slide for viewing under a microscope or inserted into a board for digital scanning. [0004] In some cases, the core samples are transferred from the needle biopsy instrument to a shipping board having a trench with a sponge soaked in formalin at the bottom of the trench. The shipping board is then labeled, packaged and sent to the lab for processing. However, here again the tissue samples are soaked in formalin and multiple samples in one trench can get mixed up and/or alter their orientation as the sponge is not strong enough to fix the tissue samples in place within the shipping board. At the lab, the tissue samples are then removed from the trench in the shipping board, such as with tweezers, and inserted into a processing board for digital scanning. Here, the tissue samples must be pushed into a single compartment of the processing board with tweezers or forceps. However, such direct handling may break the tissue sample, allow the tissue sample to be dropped and/or contaminate the tissue sample. In addition, sometimes the tissue sample may be longer than the compartment in the processing board. [0005] Providing for taking the entire contents of a needle biopsy and fixing the resulting tissue sample in place in an individual compartment of a collection cassette without using formalin would provide for better tissue integrity and fixed orientation during transportation. Also, providing for transfer of the tissue samples from the collection cassette to a digital scanning slide without directly touching the tissue samples would provide for better tissue integrity and fixed orientation during pathology processing. Accordingly, there is a need for improved systems and methods of preparing, transporting and processing tissue samples for pathology analysis. SUMMARY [0006] In one or more embodiments, a system for processing pathology specimens includes a sample collection module comprising one or more tissue sample cassettes each having a plurality of compartments with each compartment configured to receive a tissue sample, wherein each of the one or more tissue sample cassettes comprises a cassette identifier affixed to the tissue sample cassette, the cassette identifier being one of a barcode and a quick response code (QRC); a sample shipping module comprising a storage container configured to enclose the one or more tissue cassettes and a shipping container configured to receive and protect the shipping container; a sample receiving module comprising a pathology information system receiving station configured to scan a cassette identifier of each of the one or more tissue sample cassettes and a cassette printer configured to print a patient label to be affixed to each of the one or more tissue sample cassettes; a tissue grossing module comprising a digital imaging system configured to take digital images of the tissue samples within the one or more tissue sample cassettes and a pathology information system gross description module configured to measure and record a length and a width of each tissue sample; a tissue processing module comprising a tissue processor configured to receive the one or more tissue sample cassettes and to dehydrate contents of the tissue sample cassettes; a tissue embedding module comprising an embedding mold configured to receive processed tissue samples from one of the one or more tissue sample cassettes and an embedding medium covering the processed tissue samples and an orientation indicator; a tissue cutting module comprising one or more slides configured to receive one or more blocks of hardened embedding medium, each block comprising a set of the processed tissue samples and the orientatio