Cassette Assembly and Processing Method

20220134330 · 2022-05-05

    Inventors

    Cpc classification

    International classification

    Abstract

    A histology processing assembly comprising a frame with an area for application of a unique identifier for a biological sample and a recess for irreversibly receiving a sample carrier which has a compartment for holding the sample which is transmissible to processing fluids. A method is provided in which the sample is placed in the carrier with identifying information at a first location and transported to a second location and loaded into a carrier, marked with the identifying information. The carrier may be used to hold the sample in a pre-determined orientation for processing.

    Claims

    1. A histology processing assembly comprising: i) a cassette frame comprising a recess for irreversibly receiving a sample carrier; and ii) a sample carrier comprising a sample compartment for holding a biological sample and which carrier is transmissible to processing fluids and/or radiation, the sample carrier being adapted for irreversible engagement with the said cassette frame.

    2. An assembly according to claim 1 wherein the sample carrier comprises: i) a rigid frame defining a sample compartment configured for insertion into and engagement with the cassette frame; or ii) a rigid frame and a flexible sample holder comprising a sample compartment and a flexible portion configured for insertion into and engagement with the cassette frame.

    3. An assembly according to claim 2 wherein the said sample carrier comprises a rigid frame comprising four walls, a bottom face having apertures and a top face having apertures and where in the bottom face and top face are transmissible to processing fluids and/or radiation.

    4. An assembly according to claim 3 in which the top face and or bottom face comprises i) a mesh sheet across the bottom face and a mesh sheet across the top face, the mesh sheets defining the said apertures; or ii) a rigid plastics sheet having apertures formed therein

    5. An assembly according to claim 3 wherein the rigid frame comprises a single part defining a rigid wall or comprises an upper part and a lower part adapted to engage together to form the rigid frame.

    6. An assembly according to claim 5 comprising a hingedly mounted or removable lid comprising a mesh screen to define the said top face.

    7. An assembly according to claim 3 wherein the sample carrier and cassette frame are dimensioned such that the top face of the sample carrier is flush with the plane defined by the top edge of the cassette frame when the sample carrier is irreversibly located in the cassette frame.

    8. An assembly according to claim 2 wherein the said sample carrier comprises a rigid frame and a sample compartment and a flexible portion located around at least part the periphery of the sample compartment to act as a bridge between the sample compartment and the rigid frame.

    9. An assembly according to claim 8 wherein the flexible portion is configured so as to allow the sample compartment to be located in two stable positions by displacement in a direction perpendicular to the plane of the rigid frame.

    10. An assembly according to claim 9 wherein the flexible portion comprises an outer part connectable to or connected to the rigid frame and an inner part which connects to the sample compartment to form a bridge between the sample compartment and the rigid frame.

    11. An assembly according to claim 10 wherein the inner part and outer part are hingedly connected such that the inner part is adapted to extend at an inclined angle relative to the plane of the rigid frame of the sample carrier in a first configuration and at an inclined angle on the opposite side of the plane in a second configuration thereby enabling the sample compartment to be locatable in a stable first and second position by application of force to displace the sample compartment perpendicularly relative to the plane of the rigid frame.

    12. An assembly according to claim 8 wherein the sample carrier is adapted to receive or comprises a sample chip having one or more sample bays formed in one face thereof for receipt of the samples.

    13. An assembly according to claim 12 wherein the sample chip comprises a plurality of sample bays extending along the length of the chip as linear, parallel channels.

    14. An assembly according to claim 1 wherein the cassette frame and/or the sample carrier comprise engaging means such that the sample carrier is irreversibly securable in the cassette frame.

    15. An assembly according to claim 1 wherein the cassette frame comprises two side walls, a back wall and a front wall and optionally a bottom face defining a recess for receiving the sample carrier, the front wall comprising an area for receiving a unique identifier such that upon insertion of the sample carrier in the recess, a unique identifier for the sample in the carrier is applied to the area for receiving the identifier.

    16. An assembly according to claim 1 wherein the cassette frame is of the same shape as a standard histology processing cassette and of dimensions: i) 28 to 32 mm×25 to 28 mm×5 to 10 mm; or ii) 50 to 55 by 65 to 80 by 12 to 17 mm.

    17. An assembly according to claim 1 wherein the sample carrier fits in the cassette frame snugly.

    18. An assembly according to claim 17 wherein the sample carrier and/or cassette frame comprises engagement means such that the sample carrier clips into the cassette frame.

    19. A method of handling a biological sample preparatory to a histology processing procedure comprising: i) placing a biological sample in a sample carrier comprising a compartment for holding a biological sample at a first location; ii) placing the sample carrier in a receptacle and, preferably, recording data comprising a unique identifier associated with the sample on the receptacle; iii) transporting the receptacle to a second location; iv) removing the sample carrier from the receptacle and irreversibly locating the sample carrier containing the biological sample in the cassette frame to provide a histology processing assembly comprising the cassette frame and the sample carrier which contains the sample.

    Description

    BRIEF DESCRIPTION OF THE FIGURES

    [0075] The present invention is further described by way of example only with reference to the accompanying drawings, in which:

    [0076] FIGS. 1A to 1C show a perspective view of the component parts of a histology processing assembly according to the invention having a rigid sample carrier and their initial and final configuration;

    [0077] FIGS. 2A to 2C show a perspective view and FIGS. 2D and 2E show a perspective of a section of a histology processing assembly according to the invention;

    [0078] FIGS. 3A to 3C show a schematic representation of a process according to the invention; and

    [0079] FIGS. 4A and 4B show a cassette frame and a top face covering for the cassette frame or for the sample carrier, for use in the invention.

    DETAILED DESCRIPTION OF THE EMBODIMENTS

    [0080] FIG. 1A shows a histology processing assembly having a cassette frame (1) with a recess (2) for receiving a rigid sample carrier (3). The bottom face of the cassette frame (1) has a bottom face (4), transmissible to processing fluids and radiation. As shown, this bottom face is open. It may however comprise a mesh, a rigid plastics sheet comprising apertures or other sheet which is transmissible to processing fluids. The cassette frame (1) has a sloping front wall (5) adapted to receive information enabling information associated with the sample to be analysed. The sample carrier (3) is made of a rigid plastics frame having an upper part (6) and a lower part (7) and is dimensioned to fit within recess (2) irreversibly as shown in FIG. 1B in a manual, snap-fit manner. The upper part (6) and lower part (7) have a mesh covering (8, 9), transmissible to processing fluids and radiation. Instead of a mesh covering the upper part and/or lower part may have a top face or a bottom face or both made of a plastics sheet having apertures defined therein. The sample carrier (3) has three sample recesses (10a, 10b, 10c) in a lengthways orientation. Fewer or greater sample recesses may be provided and may be lengthways, widthways or there may be multiple recesses along the length and across the width as desired. The upper part (6) and lower part (7) are adapted to fit together in a snap-fit manner. Whilst the sample carrier (3) is adapted to irreversibly fit into the recess (2), the upper part (6) is removal from the lower part (7) by means of lip (11), leaving the lower part (7) irreversibly fixed to the cassette frame (1).

    [0081] FIGS. 2A to 2E show a histology processing cassette according to the invention having a cassette frame (1) with a sloping front wall (5) adapted to receive information (16) relating to the sample to be analysed. The sample carrier (3) comprises a rigid wall a sample compartment (12) and deformable peripheral portion (13), the sample carrier (3) being irreversibly engagable with the cassette frame (1). The sample carrier (3) is engageable in a manual, push-fit or snap-fit manner, with the cassette frame (1). The sample compartment (12) has a rectangular flexible bottom part and side walls (23) defining a depression and a top closure part (17) which is placed on top of the bottom part to form the enclosed sample compartment (12). The sample may be placed directly into the sample compartment (12) or may be placed in a sample pod (18) which is itself placed into the sample compartment (12). The sample pod (18) has multiple recesses (19), shown as longitudinal channels but which may be of any configuration and arrangement, each recess being adapted to receive a sample. The sample pod (18) is deformable or flexible and is placed in the sample compartment (12) of the sample carrier (3) as shown in FIG. 2B and the closure part (17) is placed over the sample compartment (12) as shown in FIG. 2C. The sample compartment (12) and sample pod (18) are dimensioned such that the sample is placed therein and is retained in a fixed orientation, thereby ensuring that the intended orientation for observation as determined by the clinician is retained as the sample carrier (3) is transported and placed in the cassette frame (1).

    [0082] The sample carrier (3) is marked with information relating to the sample to be analysed. The sample is taken from the patient or subject or recovered from a stored location and placed in the sample carrier (3) which is marked with the sample information before, during or soon after the sample is placed therein. The sample carrier (3) containing the sample may then be placed in the cassette frame (1) which is also marked with the sample information or identifier. Thus, placing of the sample in the sample carrier (3) may be carried out at the same location or at a remote location to the cassette frame (1), and applying the sample information or identifier to both the cassette frame and to the sample carrier (3) enables sample tracing, control and pharmacovigilance between different locations for taking the same and analysing it.

    [0083] The flexible portion (13) acts as a bridge between the sample compartment (12) and the rigid wall of sample carrier (3). The flexible portion (13) is configured so as to allow the sample compartment to be displaced between two stable positions, the first wholly within the recess of the cassette frame (1) such that it does not extend below or above the cassette frame (1) as shown in FIGS. 2B to 2D, and the second extending below the cassette frame as shown in FIG. 2E and being adapted to be displaced in a direction perpendicular to the plane defined by the rigid wall of the sample carrier.

    [0084] FIGS. 2D and 2E show perspective views of a longitudinal section of the processing cassette in the first position shown in FIG. 2D and the second position, shown in FIG. 2E. The peripherally extending flexible portion (13) comprises an inner portion (20) and an outer portion (21) connected via a hinge or crease (22), the inner and outer portions and hinge extending peripherally around the sample compartment (12) and, together, constituting flexible portion (13). In the first position, the inner portion slopes upwardly towards the sample compartment (12) as shown in FIG. 3D and in the second position the inner portion slopes downwardly towards the sample compartment (12) as shown in FIG. 2E.

    [0085] The sample compartment (12) may be displaced between the first position and the second position, manually or by automated means. In the second position, the sample compartment (12) and, if present, sample pod (18) are proud of the bottom face of the cassette frame and may be subjected to histology or pathology procedures, for example sectioning. The sample compartment (12) and pod (18) are suitably constructed of sectionable material.

    [0086] FIGS. 3A to 3C illustrate the method of the invention in that the sample, biopsy or specimen is obtained from the patient or retrieved from a stored location and placed in the sample compartment (12) of the sample carrier (3) as shown in FIG. 3A-I. The sample compartment is securely closed as shown in FIG. 3A-II. The upper part (6) is placed over the lower part to provide a closed sample carrier (3. The closed sample carrier is then placed in a sample pot (23) in FIG. 3A-III marked with information (24) relating to the patient. This process may be carried out in a clinic.

    [0087] The pot (23) and optionally the sample carrier (3) are marked with information or an identifier for the sample(s). The pot (3) may then be transported to a remote location where the sample carrier (3), with the samples retained in a fixed orientation therein, may then be processed in a laboratory process.

    [0088] As shown in FIG. 3B, in a laboratory process, the pot (23) is received from a remote location, for example a clinic or hospital, (FIG. 3B-I) the sample carrier (3) is removed from pot (23) (FIG. 3B-II) and irreversibly placed in a cassette frame (1) as shown in FIG. 3B-III, marked with the sample information or identifier, for example by printing, such that the sample(s) is in the desired orientation for subsequent processing and sectioning. The sample carrier is located within the height of the wall of the cassette frame such that it does not protrude above or below the wall of the cassette frame. The information may be obtained directly from the pot (23) or by an automated system. After sample processing, for example subjecting to contact with histological processing fluids, the upper part (6) of the sample carrier (3) is discarded and the sample may then be embedded in wax in a known manner in a known histological sample preparation and analysis process and subjected to further processing.

    [0089] The sample may then be processed as shown in FIG. 3C-I by removing the top (6) of the sample carrier (3) to expose the samples in each of the channels in the sample compartment. The samples are then suitably embedded in a standard histological process or processed in another desired manner. The sample is thereby embedded in the desired orientation determined by the clinician on taking the sample in the clinic. The orientation and handling of the sample has been carried out remotely from the analysis process with no physical handling of the sample since the initial placing of the sample in the sample carrier, thereby reducing the risk of sample damage or otherwise being compromised.

    [0090] FIG. 4A shows a cassette frame for use in the invention which has a bottom face (4) defined by a rigid plastics sheet having apertures (25) therein in a regular array. FIG. 4B shows a planar detachable top part of a sample carrier. This may be employed instead of a top part having a mesh and is removable from the lower part of the sample carrier to enable sample processing as shown in FIG. 3C.

    [0091] If desired, the cassette frame may comprise a lid s shown in FIG. 4B for detachable or pivotal engagement with the cassette frame.