PROCESSING CASSETTE

CROSS REFERENCE

[0001 ] This patent application claims the benefit of U.S. Provisional Application No. 62/289,624, filed on February 1 , 2016.

FIELD OF THE INVENTION

[0002] The present invention relates to systems and methods for a dual-purpose biopsy collection container and tissue processing cassette.

BACKGROU N D OF TH E I NVENTION

[0003] When tissue is collected for biopsy, it needs to be identified, preserved, and processed for cutting and staining. Currently different containers are used to collect the tissue, and process the tissue. This requires multiple transfers and manipulation of tissue leading to tissue damage, misidentification of tissue, or even contamination with other tissue samples. These errors may lead a waste of technician's time,

misinterpretation or even misdiagnosis of the biopsied tissue.

[0004] Therefore, there is a need for a device which reduces the potential for these errors and reduces the amount of time and money associated with tissue processing.

SUMMARY

[0005] One aspect of the invention is a container for use with biopsy collection and tissue processing. The container may include four side panels forming a top opening and attached to a bottom panel and a lid for sealing the top opening. At least three of the side panels may include mesh openings covered with a removable adhesive. The container may be filled with formalin. At least one side panel may be attached to the bottom panel by a hinge. The adhesive may be a liquid-proof adhesive film. The adhesive may include a tab for removing the adhesive. The bottom panel may include a QR code or other scan-able code, a bar code, a patient identifier, a unique alphanumeric code, a description of the biopsy, or combinations thereof. The bottom panel may include an adhesive label. [0006] Another aspect may be a container that may include four side panels, a top panel attached to at least three of the four side panels, and a bottom panel attached to at least three of the four side panels. At least one of the side panels may be removable. At least three of the side panels may include mesh openings covered with a removable adhesive. The container may be filled with formalin. The removable side panel may be attached to the bottom panel by a hinge. The adhesive may be a liquid- proof adhesive film. The adhesive may include a tab for removing the adhesive. The bottom panel or removable side panel may include a QR code or other scan-able code, a bar code, a patient identifier, a unique alphanumeric code, a description of the biopsy, or combinations thereof. The bottom panel or removable side panel may include an adhesive label.

[0007] One aspect of the dual tissue collection and processing container may include an internal tissue processing cassette and an external sheath. The internal tissue processing cassette may include four side panels, a top panel composed of a hinged lid or plug style lid, and a bottom panel attached to at least three of the four side panels. One of the four side panels may be detachable with a hinged lid. At least one of the four side walls may be perforated. In an aspect, all four walls of the tissue collection cassette may be perforated. The dual tissue collection and processing container may include an external sheath. The internal tissue processing cassette may be inserted into the external sheath. In one aspect the tissue processing cassette may be inserted into the external sheath and firmly attached to the external sheath. In an aspect, the outer side of the upper portion of the internal tissue processing cassette and the inner side of the upper portion of the external sheath have screw threads. In an aspect the screw threads on the outer side on the upper portion of the internal tissue processing cassette may be attached to the screw threads on the inner side of the upper portion of the external sheath to securely attach the internal tissue processing cassette and the external sheath together. In one aspect, the internal tissue processing cassette may include a lid that may attach over the top opening formed by the four side walls of the panel. In one aspect, the lid that fits over the top opening of the tissue panel may have an extended lip that also fits and covers the top opening of the external sheath after the processing cassette is inserted into the external sheath.

[0008] One aspect may include a method of biopsy collection and tissue processing. The method may include placing a biopsy in a container filled with formalin, labeling the container on a panel without mesh openings, and removing the adhesive from the at least three side panels to release the formalin. The container may include four side panels forming a top opening and be attached to a bottom panel; and a lid for sealing the top opening. At least three of the side panels may include mesh openings covered with a removable adhesive. The method may further include placing the container in a rack of a tissue processing machine. The method may further include embedding the biopsy in paraffin. The label on the container may include a QR code or other scan-able code , a bar code, a patient identifier, a unique alphanumeric code, a description of the biopsy, or combinations thereof. The method may further include generating a requisition sheet from the label on the container.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following figures illustrate various aspects of the disclosure.

[0010] FIG. 1 A is an illustration of the dual-purpose container for biopsy collection and tissue processing with mesh openings on all four side panels.

[001 1 ] FIG. 1 B is an illustration of commercially available lids that may be used to cover the top opening of the dual-purpose container.

[0012] FIG. 2 is another view of the dual-purpose container of FIG. 1 with the detached hinged side panel and lid.

[0013] FIG. 3 is another view of the dual-purpose container of FIG. 1 with the detached hinged side panel and lid.

[0014] FIG. 4 is another view of the dual-purpose container of FIG. 1.

[0015] FIG. 5A is an illustration of the dual-purpose container with mesh opening on three side panels. [0016] FIG. 5B is another illustration of the dual-purpose container with mesh opening on three side panels.

[0017] FIG. 6 is an illustration of the dual-purpose container with mesh opening on three side panels that are covered by an adhesive tape.

[0018] FIG. 7A is an illustration of a dual-purpose container including an external sheath.

[0019] FIG. 7B is an illustration of a internal processing cassette of an aspect of the dual-purpose container.

[0020] FIG. 7C is an illustration of a lid that may fit over an opening in the internal processing cassette and external sheath of an aspect of the dual-purpose container.

[0021 ] FIG. 7D is an illustration of an external sheath of an aspect of the dual- purpose container.

[0022] FIG. 7E is an illustration of dual-purpose container, showing the external sheath attached to the internal tissue processing cassette by screw threads.

[0023] FIG. 8 is flow diagram illustrating the use of the dual-purpose container in the process of biopsy collection and processing.

DETAI LED DESCRI PTION

[0024] The disclosure may be understood by reference to the following detailed description, taken in conjunction with the drawings as described below. It is noted that, for purposes of illustrative clarity, certain elements in various drawings may not be drawn to scale.

I. Dual-Purpose Container

[0025] Provided herein is a dual-purpose biopsy container and tissue processing cassette. In an aspect, a single container may be used for both collecting and

processing biopsied tissue. In an alternative aspect the dual-purpose container may also be used in the collection and processing of post-mortem tissue.

[0026] In an aspect, different perceptive views of the dual-purpose container 100 are illustrated in FIG. 2, FIG. 3, FIG. 4, FIG 5A, and FIG. 5B. In an aspect, the top perspective view is illustrated by FIG. 2. In an aspect, an exploded side view of the side panels 102, 106 and the removable side panel 108, and the top panel 112 is illustrated in FIG. 3. In an aspect, a side perspective view of the container 100 is illustrated in FIG. 4. In an aspect, the top perspective view of the container 100, when the side panels and the bottom panel attached with the lid removed, is illustrated in FIG. 5A. In an aspect, the side perspective view of the container 100, when the side panels and the bottom panel attached with the lid removed, is illustrated in FIG. 5B.

[0027] In an aspect, the container may have a rectangular, tubular, cylindrical, hemi-cylindrical shape or have any shape compatible with a tissue processor machine. In an aspect the container is rectangular in shape, with dimensions of about 3.5 cm in a first, about 1 cm in a second dimension, and about 1 cm in a third dimension. In another aspect, the container may have dimensions of about 2.5 cm by about 1 .6 cm by about 1 .6 cm. In one aspect, the container may be about 2.6 cm x about 1 .7 cm x about 1 .7 cm. In various aspects the first dimension of the rectangular container may range from about 10 cm to about 8 cm, from about 9 cm to about 6 cm, from about 7 cm to about 4 cm, from about 5 cm to about 3 cm, from about 4 cm to about 2 cm, and from about 3 cm to about 1 cm. In other aspects, the second dimension may range from about 5 cm to about 3 cm, from about 4 cm to about 2 cm, from about 3 cm to about 1 cm, and from about 2 cm to about 0.5 cm. In additional aspects, the third dimension may range from about 5 cm to about 3 cm, from about 4 cm to about 2 cm, from about 3 cm to about 1 cm, and from about 2 cm to about 0.5 cm. The container may be made of optically clear plastic, other polymers, glass, opaque plastic, or any material capable of holding the tissue and being used in the tissue processing process.

[0028] In an aspect the container 100 as illustrated in FIG. 1A, may include four side panels 102, 104, 106, 108, a top opening 111 , and a bottom panel 110. The side panels may come together to form the top opening 111 and be attached to the bottom panel 110 to form the container 100. The contents of the container 100 may be accessed from at least two areas of the container 100. In an aspect, the top opening 111 may be used for accessing the interior of the container 100. A lid 112 may be placed on the top opening 111 of the container 100 to seal the top opening 111. In an aspect, the lid 112 may be a press-in cuvette-style lid. In an aspect the lid used may be a commercially available press-in cuvette style lids as illustrated in FIG. 1 B. In various aspects, the lid may also be a hinged lid, snap lid, slide lid or a screw-on type lid. In various aspects lid may be made of rubber, silicone, glass, or plastic.

[0029] In one aspect, the contents of the container 100 may also be accessed by a hinged side panel of the container 100. In an aspect, the hinge may be at the bottom of the container so that if there is lid failure, the specimen may not be as likely to fall out during tissue processing. In an alternate aspect, as illustrated in FIG. 6, the hinge 116 may be between the bottom panel and the hinged side panel, on the bottom of the detachable side panel. In an aspect, the hinged side panel may make it easier for histology personnel to access the specimen in the container. The large hinged side panel may be removable, so histology personnel may easily access the entire contents of the container. In various aspects, the removable side panel may or may not contain mesh openings.

[0030] The detachable hinged side panel may have thin plastic side lips or projections on the interior edges in order to seal the container. In an aspect, the side projections may be less than about 0.1 cm by about 0.1 cm. In various aspects the first side projection may range from about 1 cm to about 0.5 cm, from about 0.75 cm to about 0.25 cm, from about 0.5 cm to about 0.2 cm, and from about 0.25 cm to about 0.08 cm. In various aspects the second side projection may range from about 1 cm to about 0.5 cm, from about 0.75 cm to about 0.25 cm, from about 0.5 cm to about 0.2 cm, and from about 0.25 cm to about 0.08 cm. The detachable hinged side panel may also have a latch on the upper most ends, which may latch into an opening on the container or one of the other side panels. In an aspect, the latch may measure about 0.5 cm by about 0.1 cm by about 0.1 cm. In various aspects the first dimension of the latch may measure from about 2 cm to about 1 cm, from about 1 .5 cm to about 0.8 cm, from about 0.5 cm to about 0.25 cm, and about 0.2 cm to about 0.1 cm. In various aspects, the second and third dimension of the latch may measure from about 1 cm to about 0.5 cm, from about 0.75 cm to about 0.25 cm, from about 0.2 cm to about 0.1 cm, and about 0.15 cm to about 0.05 cm.

[0031 ] In an aspect a removable adhesive cover 114 may cover the meshed side panels, as illustrated in FIG. 6. The removable adhesive cover 114 may be water proof and cover all the side panels that are meshed. In an aspect, covering the meshed side panels with the adhesive cover 114 may make the container 100 leak-proof when filled with a liquid preservative.

[0032] In an aspect as seen in FIG. 5A and FIG. 5B, the container 100 may include four side panels, a top panel, and a bottom panel. In an aspect, one side panel may be removable. The removable side panel may be hinged or plug-style to seal when in place. In various aspects, the removable side panel may or may not contain mesh openings. In an aspect, an opening may not be formed at the top, and the top panel may be connected to at least three side panels. The removable side panel may be made of rubber or plastic.

[0033] There may be mesh openings on at least three of the side panels of the container 100. In one aspect, all four side panels may include mesh openings. The mesh openings in the side panels may allow for the flow of chemicals through the container during tissue processing. In an aspect, the mesh openings may cover at least 30%, at least 50%, or at least 90% of the surface area of each side panel of the container. In various aspects, the mesh openings may cover from about 10% to about 40%, from about 30% to about 60%, from about 40% to about 70%, and from about 60% to about 95% of each side panel of the container. In an aspect, the mesh openings may range in diameter from about 0.025 cm to about 0.15 cm. In various aspects, the mesh opening may range from about 0.01 cm to about 0.02 cm, from about 0.015 cm to about 0.025 cm, from about 0.02 cm to about 0.05 cm, from about 0.04 cm to about 0.08 cm, from about 0.1 cm to about 0.2 cm, from about 0.2 cm to about 0.5 cm, and from about 0.5 cm to about 2 cm. In an aspect, the mesh openings may further be covered with a fabric mesh, synthetic mesh, or filter paper.

[0034] The container may be pre-filled with a preservative. In one aspect, the preservative may be formalin. In other aspects, the preservative may be glutaraldehyde, Bouin's fluid, or Carnoy's fluid. A removable plastic adhesive may cover at least three side panels with mesh openings in order to keep the preservative in the container. In one aspect, the adhesive may cover all four of the side panels. The adhesive may be a liquid-proof adhesive film. In an aspect, the container may have a tab for removing the plastic adhesive. In an aspect, the tab may be on a side panel without mesh openings. A side panel without mesh openings, the top, the lid, or the bottom panel may come preprinted with a QR code or other scan-able code, a bar code, and/or a corresponding unique alphanumeric code, which can be copied onto a requisition sheet. This QR code may be used to enter information about the unique specimen into a computer system. There may also be space available on a side panel without mesh openings, the top, the lid, or the bottom panel for a printed adhesive label to be applied, for printing directly on the container, or a hand written label. The label may include a patient identifier or information about the biopsy specimen.

[0035] The use of the dual-purpose container may necessitate the modification or adaptation of other equipment or devices used in the tissue processing process. In an aspect, modified cassette racks for the tissue processer may be used to fit the dual- purpose containers. The modified cassette racks may be made of plastic or metal. In an aspect, a modified printer may be capable of printing directly on the dual-purpose container. The printer or a computer may be capable of scanning a QR code or bar code on the container and assign the container a case number. The QR code or bar code may be programmed with the patient name, MRN, biopsy type, or any other information relevant to the patient or biopsy. Modified tissue molds sized to the dual- purpose container may be used for embedding the specimen in paraffin. In various aspects, the embedding material may be paraffin, plastic, or resin. In an aspect, the modified tissue molds may be made of metal or plastic. A modified storage solution for paraffin-embedded tissue from the dual-purpose container may be used. In an aspect, the modified storage may be made of plastic or metal. In an aspect the storage may be cryo-preservation storage.

[0036] In an aspect, as illustrated in FIG. 7A, the dual-purpose container 101 may include an external sheath 140. Unlike the container 100 of FIGS. 1 -6, the container 101 of FIG. 7A does not include a removable adhesive around the side walls. In an aspect the dual-purpose container 101 includes an inner processing cassette 103 and an external sheath 140. In an aspect the external sheath 140 may contain tissue preserving fluids like formalin. The internal tissue processing cassette 103 may include four side panels, a top opening, and a bottom panel. The side panels may come together to form the top opening and be attached to the bottom panel to form the container 101. The internal tissue processing cassette 103 may extend into a cylindrically shaped top component 118. The length of the internal processing cassette 103 including the top cylindrical component may measure from about 2 cm to about 12 cm. In various aspects the length of the internal processing cassettes may measure from about 1 .5 cm to about 3 cm, from 2 cm to about 5 cm from about 4 cm to about 8 cm, from about 7 cm to about 12 cm, from about 10 cm to about 15 cm. The internal tissue processing cassette 103 may be insertable into the external sheath 140.

[0037] In an aspect, the outer side of the cylindrical component 118 of the internal tissue processing cassette 103 may have a plurality of screw threads 119, and the inner side of the external sheath 140 may have a plurality of screw threads 143. The plurality of screw threads 119 may be on an upper portion of the outer side of the internal tissue processing cassette 103 or the cylindrical component 118, and the plurality of screw threads 143 may be on an upper portion of the inner side of the external sheath 140. In an aspect, the screw threads of the outer side of the internal tissue processing cassette 119 and the thread screws of inner side of external sheath 143 may be combined, to hold the internal processing cassette and the external sheath securely together, as illustrated in FIG. 7E.

[0038] In various aspects, the external sheath 140 may be made of glass, silicone, plastic or other polymers. In an aspect, the external sheath 140 may be cylindrical in shape and may have a radius measuring from about 1 cm to about 10 cm. In several aspects, the radius of the external sheath may be from about 0.5 cm to about 2 cm, from about 1 cm to about 4 cm, from about 3 cm to about 6 cm, from about 5 cm to about 8 cm, from about 7 cm to about 10 cm, from about 9 cm to about 12 cm. In an aspect, the length of the external sheath 140 maybe the same as the length of the internal tissue processing cassette 103, and the lid 130 may be used to seal both the internal tissue processing cassette 103 and external sheath 140 to form the dual- purpose container 101. In an aspect, as illustrated in FIG. 7A, an extension 132 of the lid 130 may fit over the cylindrical component 118 of the internal tissue processing cassette 101, and the extension 134 of the lid 130 may fit over the lip 142 of the external sheath 140. In an aspect the internal tissue processing cassette 103 used in the dual-purpose container 101 may be illustrated by FIG. 7B. In an aspect, the cap 130, as illustrated by FIG. 7C, may fit over and seal both the internal tissue processing cassette 103 and the external sheath 140. In an aspect, the external sheath 140 is illustrated by FIG. 7D.

II. Methods of Using the Dual-Purpose Container

[0039] In an aspect, FIG. 8 generally illustrates the method 800 a clinician and/or technician may use to collect a biopsy specimen and process the specimen. In an aspect, using the dual-purpose container may reduce the number of steps in processing a biopsy specimen compared to the current standard. In step 800, the clinician or technician may biopsy and excise tissue from the patient. In step 804, the excised tissue may be placed in a dual-purpose labeled biopsy container and sent to the pathology department. In an aspect, the label may include a QR code and the container may include an adhesive around any side panels of the container with mesh openings. In step 806, the QR code may be scanned and the adhesive removed, the container may be placed in a rack, and the container may be processed in a tissue processing machine. In step 808, the tissue may be embedded in paraffin. In step 810, the tissue may be sliced on a microtome. In step 812, the tissue may be embedded and stained on a slide. In step 814, the tissue in paraffin blocks may be stored for future processing.

[0040] In an aspect, the clinician may take a biopsy, remove the lid of the dual- purpose container, place the biopsy in the container, and then replace the lid. The container may be pre-filled with a tissue preservative, such as formalin. In an aspect, the preservative used may be glutaraldehyde, Bouin's fluid, or Carnoy's fluid. An adhesive label may be printed with a commercially available label printer and applied to one of the long sides of the biopsy container. In an aspect, patient identification and specimen description may be hand-written on the adhesive label. In an aspect, there may be multiple biopsies from one patient, each placed in different dual-purpose containers. A requisition sheet may be generated by computer or by hand and may include patient identification and a description for each specimen that is part of a case.

[0041 ] The specimen may then be sent with the requisition sheet to the pathology laboratory. In an aspect the specimen may be send to a gross room of a laboratory. In the laboratory, the laboratory personnel may accession the specimen. In an aspect the identification of the specimen may be scanned or entered into the pathology computer system. The dual-purpose container may then be labeled with a printed adhesive label with the case number along a side panel not covered by adhesive film, the top, the lid, or the bottom panel. In various aspects, the dual-purpose container may be labeled by a printed adhesive label, a hand written adhesive label, hand written directly on the container, or printed directly on the container. In one aspect, the label may be printed by scanning a QR code or bar code (which has been entered into the computer system already) or by using information on the requisition sheet and on the label on the container. The label can be printed on an adhesive with a commercially available label printer, or special printers may scan and print directly on the containers (similar systems exist currently for existing tissue processing cassettes).

[0042] In an aspect, the adhesive film may include a tab accessible from a side panel for easy removal from the three covered sides. The adhesive film may be removed from the dual-purpose container by pulling the tab by hand or with forceps. In an aspect, when the dual-purpose container includes an external sheath in place of the adhesive, the external sheath may be removed by removing the lid. The lid may then be replaced over the internal tissue processing cassette before processing. In an aspect, the other hand or thumb may press the exposed portion of the hinged cassette lid for stability. The mesh-like holes are exposed and the container is placed on a negative- pressure surface or a paper towel to remove formalin from the container. The very small mesh-like holes may allow a variety of chemicals to flow through the container when the specimen is placed in the tissue processor machine before being imbedded in paraffin. If necessary, the specimen may be measured and described and a "gross description" report may be generated. In an aspect, this may be done by a human through an optically clear container, or a computer program may be created to do this with the use of a scanner. The dual purpose container may then be placed in a rack in formalin, which may be transferred to the tissue processor machine.

[0043] In an aspect, by using the dual-purpose container, the step of

manipulating the specimen may be removed. This may mean a decreased risk of complete or partial specimen loss. Using the dual-use container may decrease the risk of specimen contamination. In an aspect, using the dual-purpose container may decrease the risk of crushing/harming specimen during manipulation. There may be a decreased risk of labeling errors compared to the existing method when the biopsy specimen is moved into the tissue processing cassette. There may be a decreased processing time for personnel responsible for printing biopsy cassettes, accessioning cases and dictating and grossing biopsy cases. This may mean cheaper case

processing due to multiple hours of labor per day saved. In an aspect, there may be a decreased number of containers from the traditional biopsy container and separate cassette to a single dual-purpose container, which may allow for a lower cost of materials. In an aspect, turn-around time may decrease because the specimen can go directly to the tissue processor without delays.

[0044] In various aspects, the container may be used with prostate core needle biopsies, breast core needle biopsies, other core needle biopsies or specimens generated by Interventional Radiology, endometrial curettages (may need more than one container for large biopsies), gastro-intestinal biopsies (large polyps are the exception), and bone marrow biopsies (for large bone marrow aspirates, may put some in dual-purpose container and remainder in large traditional biopsy container).

[0045] In an alternate aspect the dual collection and processing container may be used to collect and process postmortem tissues of humans. In another aspect the containers may be used to collect biopsy or postmortem tissue of animals in a veterinary practice. In an aspect the dual-purpose containers may be used to collect insect specimens that may need to be collected and processed. In an aspect the dual- purpose containers may be used to collect plant specimens that may need to be collected, preserved and processed.

[0046] Having described several embodiments, it will be recognized by those skilled in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Additionally, a number of well-known processes and elements have not been described in order to avoid unnecessarily obscuring the present invention. Accordingly, the above description should not be taken as limiting the scope of the invention. [0047] Those skilled in the art will appreciate that the presently disclosed embodiments teach by way of example and not by limitation. Therefore, the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. The following claims are intended to cover all generic and specific features described herein, as well as all statements of the scope of the present method and system, which, as a matter of language, might be said to fall there between.