Sample vial consumables for cell pathology

Abstract

Embodiments of the disclosed technology relate to consumables for cytology, including sample vials. In one example, a consumable sample vial is designed to accept a sample volume of 10–750 μL, to accept a buffer solution, and to allow the user to mix the sample with the buffer solution, and then deposit a certain amount of the mixture into another consumable for subsequent processing, e.g., cell deposition and staining. The remaining mixture can be reliably stored and transported using the sample vial. The sample vial is manufactured from a transparent and flexible material that allows the user to observe the fluid and mixture levels within the vial and squeeze out the mixture.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 6 / 0 filed on March 31, 2023, the entire content of which is incorporated herein by reference.

[0002] This specification generally relates to consumable parts for cytology, and more particularly to sample vials used to prepare samples for processing.

Background Art

[0003] Cytology (also known as cell pathology) involves examining cells from body tissues or fluids to determine a diagnosis. A specific type of physician called a pathologist examines the cells in tissue samples under a microscope to look for cell characteristics or abnormalities. Since cytology examines only very tiny cells, the pathologist requires only a very small amount of tissue sample to perform a cytology test.

[0004] Standard procedures for the collection, preparation, and analysis of biological fluid samples for cytodiagnosis include collecting a biological fluid specimen from a patient and transporting it to a cytopathology laboratory. The newly collected sample is prepared by a series of manual processing steps including multiple centrifugations and cell fixation, washing, and cytochemical staining. These are the steps necessary to prepare cell - based assays including cell smear specimens, cell blocks, and cell solutions. The prepared samples are subjected to microscopy, flow cytometry, and cytogenetic analysis.

Summary of the Invention

[0005] Embodiments of the disclosed technology relate to consumables for cytology, including sample vials. In one example, a consumable sample vial is designed to accept a sample volume of 10–750 μL, to accept a buffer solution, and to allow the sample to be mixed with the buffer solution, after which the user can deposit a certain amount of the mixture into another consumable for subsequent processing, e.g., cell deposition and staining. The remaining mixture can be reliably stored and transported using the sample vial. The sample vial is manufactured from a transparent and flexible material that allows the user to observe the fluid and mixture levels within the vial and squeeze out the mixture.

[0006] In one embodiment, a sample vial for sample collection and deposition includes a vial body, a body opening, a nozzle, a labeling area having a second flat portion joined to a first flat portion and in the same plane as the first flat portion, and a gripping area having a third flat portion joined to the second flat portion and in a plane perpendicular to the second flat portion. In this specification, (a) the vial body comprises a bottom portion, an upper portion, and a side wall extending from the upper portion to the bottom portion, the bottom portion and the side wall forming a flexible chamber, the body opening comprises a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening, and (b) the nozzle comprises a nozzle cap having a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion.

[0007] In another embodiment, a system for collecting and depositing samples includes a sample vial, a sample vial rack comprising: a sample vial rack comprising: a sample vial rack comprising: a sample vial rack comprising: a sample vial rack comprising: a sample vial rack comprising: a sample vial rack comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and (b) a sample vial rack comprising: a sample vial rack comprising: the proximal end of the upper shelf portion comprising: a sample vial rack comprising: a sample vial rack comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and a sample vial rack comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and a sample vial rack comprising:

[0008] In yet another embodiment, a method for collecting and depositing a sample using the described sample vial includes: attaching a label to the labeling area; loading the buffer solution into the vial body through the opening of the body; loading the sample into the vial body; homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample; and dispensing the mixture of the homogenized buffer solution and the sample.

[0009] The above and other embodiments, as well as their implementations, are described in more detail in the drawings, description, and claims. [Brief explanation of the drawing]

[0010] [Figure 1] An example of a sample vial embodiment is shown.

[0011] [Figure 2] This shows an example of a workflow using sample vials.

[0012] [Figure 3A-3G] Figure 2 illustrates an example of holding the sample vial shown in Figure 1 between different stages of the workflow shown in Figure 2.

[0013] [Figure 4A-4C] An alternative embodiment of the sample vial is shown.

[0014] [Figure 5A-5C] Different lid and cap configurations for the sample vial are shown.

[0015] [Figure 6A-6C] Different diagrams of sample vial racks used to hold one or more sample vials are shown.

[0016] [Figure 7A-7C] An alternative embodiment of the sample vial rack is shown.

[0017] [Figure 8A-8B] This diagram highlights specific design features of an example sample vial rack.

[0018] [Figure 9] A flowchart illustrating an example of a method for collecting a sample and depositing it into a sample vial is shown. [Modes for carrying out the invention]

[0019] Biofluids are liquid-based cellular solutions derived from the human body. Examples include urine, blood, pleural fluid, ascites, cerebrospinal fluid, aspirates from tumors in the body, and wound exudate. Sample preparation and analysis of biofluids are emerging as an application area that many microfluidic technologies can address. Microfluidic research has focused particularly on the preparation and analysis of blood. Important diagnostic information about patients can be obtained from blood analysis, but other biofluids can also be rich in diagnostic information. These other biofluids present unique sample preparation and analysis challenges that microfluidic technologies are seeking to address.

[0020] Sample collection is the first step in the preparation of samples for analysis, and the collection technique can often affect the downstream cytodiagnostic assays that can be performed. Samples are obtained by collection techniques that vary in the level of invasiveness and risk to the patient. Sample collection techniques include venipuncture, liquid aspiration via a needle or syringe, or saline lavage of mucosal surfaces with catheter assistance. Depending on the required procedure, sample collection is performed at different locations and can be carried out in the patient's treatment room, at the patient's hospital bedside, in an outpatient clinic, or in a clinical laboratory.

[0021] Embodiments of the disclosed technology serve as a sample vial that enables efficient and consistent collection and initial processing of samples that can be further prepared for cytodiagnostic examination, and as an accessory for holding a plurality of sample vials, providing a sample vial rack that enables easy removal of the sample vial and ensures visibility of the bottom of the vial.

[0022] FIG. 1 shows an example embodiment of a sample vial according to the disclosed technology. As shown in the figure, the sample vial includes the following features and / or components.

[0023] - Nozzle cap (1)

[0024] - Nozzle shaft (2)

[0025] - Nozzle tip (3)

[0026] - Vial body (4)

[0027] - Body opening (5)

[0028] - Labeling area (6)

[0029] - Cap tether (7)

[0030] - Vial cap (8)

[0031] - Gripping area (9)

[0032] In this specification, the rim of the nozzle cap (1) fits snugly onto the opening (5) of the vial body, and the nozzle cap (5) assists in dispensing the homogenized sample / buffer mixture into the sample pod (as described in relation to the sample vial workflow in Figure 2).

[0033] The nozzle shaft (2) fits snugly with the vial cap (8), thereby enabling the vial to be sealed. The nozzle shaft (2) ends with a nozzle tip (3) that allows for squeezing out a small, controlled volume of the homogenized sample / buffer mixture.

[0034] The vial body (4) is a flexible chamber that can be mixed by massaging the sample alone or the sample and buffer together. It is also where the user (or operator) squeezes out the homogenized sample / buffer mixture through the nozzle shaft (2) and nozzle tip (3). The body opening (5) is the mouth of the vial body (4) and allows for the insertion of the sample and buffer for homogenization.

[0035] The labeling area (6) is approximately the size of the labeling area on the slide and is an area on which writing can be done or stickers can be attached. The labeling area (6) is physically connected to the vial lid (8) via a lid tether (7). The lid tether (7) is a small, integrated pull-out feature that holds the lid in place until the operator needs to seal the vial, and the vial lid (8) presses against the nozzle shaft (2) to seal the sample vial and retain the contained sample for storage and subsequent analysis. In some examples, the lid tether (7) is designed to break (or pull off) with a few rotations, for example, 3 to 5 rotations to break the vial tether (7) and release the vial lid (8).

[0036] The labeling area (6) is perpendicular to the gripping area (9), allowing the user to hold the sample vial without disturbing the contents of the vial body (4). In one example, the gripping area (9) and the labeling area are designed to add a gap around the vial lid (8) to facilitate user access (for example, having a concave edge instead of a straight edge). In another example, the gripping area (9) is designed to have a ridge to facilitate gripping.

[0037] In some embodiments, a sample vial can be used to prepare and dispense a mixture of the buffer solution and the sample. In other embodiments, a sample vial can be used to prepare and dispense only the sample, and for example, a liquid sample may not require the addition of a buffer solution.

[0038] In some embodiments, the sample vial shown in Figure 1 is a single, integrated consumable made from a material that is elastic even with very thin wall sections and has a low surface energy to ensure effective removal of the sample after processing. This ensures that none of the collected sample becomes waste; for example, after dispensing a portion of the mixture of homogenized buffer and sample into a sample pod, all of the remaining sample can be transferred to a CytoLyt or formalin bottle or a commonly used sample transfer fluid. In some examples, the material is thermoplastic polyurethane, polyvinyl chloride (plasticized), low-density polyethylene, or polypropylene.

[0039] In some embodiments, the dimensions of the sample vial shown in Figure 1 may be configured as follows:

[0040] - The thickness of the bottom of the vial body (4) is approximately 0.3 mm, which ensures that the sample at the bottom of the vial can be easily massaged.

[0041] - The vial tether (7) has a thickness of approximately 0.15 mm, which allows the vial cap (8) to be easily detached (or broken). In some scenarios, the tooling process used to manufacture the sample vials can accommodate a minimum thickness of 0.15 mm.

[0042] - The thickness of the labeling area (6) and the gripping area (9) is approximately 1.2 mm, providing additional rigidity to those areas of the sample vial.

[0043] Figure 2 shows an example of workflow 200 using a sample vial. As shown in the figure, workflow 200 includes labeling the sample vial in the labeling area (6) in operation 210. Optionally, at least a portion of the information on the sample vial label may also be included on the label on the CytoLyt bottle or formalin bottle, and / or on the sample pod (also referred to as the sample input port (SIP)).

[0044] Workflow 200 includes loading the sample vial body (4) with buffer in operation 220. In one example, the sample vial body (4) is pre-filled (or loaded) with 20 μL of buffer (e.g., phosphate-buffered saline (PBS)). In operation 230, workflow 200 includes loading the sample into the vial body (4). In one example, the entire contents of the fine-needle aspiration (FNA) needle are deposited into the vial body (4).

[0045] Workflow 200 includes homogenizing the buffer and sample in operation 240, for example, by massaging the vial body (4). The homogenized sample-buffer mixture is then squeezed into the sample pod in small, controlled volumes via the nozzle shaft (2) and nozzle tip (3). In one example, three drops of the homogenized sample-buffer mixture can be squeezed into the sample pod.

[0046] Next, workflow 200 may include, in operations 260-264, pulling away (or breaking) the vial tether (7) to release the vial cap (8) and seal the vial, recording additional information, and transferring the sample vial to the laboratory for further analysis or disposing of the sample vial.

[0047] Alternatively, workflow 200 may then include, in operations 270 and 272, placing the sample pod in the machine, selecting the desired program for analysis, and then disposing of the sample pod. The remaining homogenized mixture of any sample and buffer in the sample vial can also be transferred to a CytoLyt bottle or formalin bottle and taken to the laboratory for further analysis.

[0048] Figures 3A–3G illustrate examples of holding the sample vial from Figure 1 between different stages of the workflow illustrated in Figure 2. Figure 3A shows a three-finger grip that can be used when loading the sample into the sample body of the sample vial (e.g., from an FNA needle) and massaging the vial body to homogenize the mixture of buffer solution and sample. Figure 3B shows a grip used to hold the sample vial when loading. Figures 3C and 3D show grips used when capping and massaging (or dispensing) the homogenized mixture of buffer solution and sample, respectively. Figure 3E shows various functions that can be performed by holding only the gripping area of ​​the sample vial. Figure 3F shows that the sample vial can be manipulated by holding only the upper part of the labeling area, and Figure 3G shows holding the sample vial around the nozzle handle.

[0049] Figures 4A to 4C show alternative embodiments of the sample vial.

[0050] Figure 4A shows an example of a sample vial with a volume and volume gradient exceeding 500 μL. As illustrated, the base is wide enough for the sample vial to stand upright. In different use cases, it can be left stationary on a workbench, hung on a CytoLyt bottle, or capped and sent to the laboratory for processing. The taper at the bottom of the bottle is designed based on one or more factors such as the viscosity of the buffer solution, the viscosity of the collected sample, or the amount of sample to be collected.

[0051] Figure 4B shows an example of a sample vial having a living hinge to facilitate mixing and a spout that controls the location and person for rapid dispensing of the mixture of homogenized buffer solution and sample, rather than a nozzle. In some embodiments, the sample vial of Figure 4B is made of a material (e.g., an elastomer) that allows the internal volume of the sample vial to be completely crushed to push out a small amount of sample (or residue of the mixture of homogenized buffer solution and sample in the sample vial). In other embodiments, the sample vial of Figure 4B may have a volume scale (or filling line) that clearly indicates how much buffer solution should be added to a given volume of collected sample.

[0052] Figure 4C shows an example of a sample vial specifically designed for transport to a remote laboratory, which includes (a) a simple twisted top with wings that snap onto two ribs on the nozzle when the lid is fully screwed on, ensuring that the contents are securely held in place, and (b) a labeling area on the handle for identifying information. In one example, the labeling area measures approximately 10 mm × 20 mm.

[0053] Figures 5A–5C show different nozzle cap (or lid) configurations (referring to the nozzle shaft and nozzle tip, or collectively to the nozzle) for embodiments of the sample vial. As shown in the figures, the nozzle cap is anchored adjacent to the nozzle, with both the nozzle cap and nozzle anchored from the same side of the labeling area (Figure 5A), the nozzle cap anchored diametrically opposite the nozzle (Figure 5B), the nozzle cap anchored from the vial body (Figure 5C, Option 1), or anchored diametrically opposite the nozzle on a flexible portion of the labeling area (Figure 5C, Option 2). Each of the configurations shown in Figures 5A–5C is designed to improve operator (or user) handling and use. For example, the nozzle cap anchoring should facilitate the user breaking the nozzle cap with an intuitive movement, and the nozzle cap tether should be easy to manufacture, etc. (for example, the embodiment shown in Figure 5A is less preferred for this reason).

[0054] The sample vial embodiments described in relation to Figures 1-5 need to be periodically placed on a workbench for short periods (or set aside) when other procedures that do not involve collected samples are being performed. For this purpose, the embodiments described include a sample vial rack that can hold multiple sample vials vertically, allows them to be easily removed from the sample vial rack, and ensures visibility of the bottom of each vial body.

[0055] Figures 6A–6C show different diagrams of examples of sample vial racks used to hold sample vials. As shown in Figures 6A–6C, the sample vial rack includes the following features and / or components:

[0056] -Magnetic region (1)

[0057] - Empty space (2)

[0058] - Curved edges and fillets (3)

[0059] - Embedded nozzle shelf section (4)

[0060] - Vial visibility (5)

[0061] - Vial hole (6)

[0062] -Lower shelf (7)

[0063] -Upper shelf (8)

[0064] In this specification, the two protruding magnetic areas (1) have circular holders to which magnets can be attached. This allows for magnetic mounting to the deposition and staining device without the nozzle getting in the way or the magnet being pulled away from the component. The empty space (2) helps to facilitate cleaning, reduces manufacturing costs, and was created by removing unused external and internal parts of the sample vial rack. The sample vial rack features curved edges and fillets (3) to improve appearance, ergonomics, and usability.

[0065] The recessed rear (or nozzle) shelf (4) allows the vial nozzle cap to be held securely in place without pressing against the side of the device on which the vial is mounted or affecting the position of the vial body. The notched area of ​​the hole not only provides more gripping space when holding the vial in place, but also offers a direct front view of the bottom of the vial (5) when loading buffer solution and / or sample during the sample preparation process. The keyhole-shaped vial hole (6) allows for easy holding and removal of sample vials.

[0066] The lower shelf section (7) of the sample vial rack not only provides structural support and stability to the overall structure but also provides a stationary shelf for the bottom of the vials to rest on. The width of the upper shelf section (8) is optimized to allow some support below the labeling surface of the sample vials. At the same time, it allows for sufficient gripping space and finger clearance to easily remove the sample vials when lifting them vertically from the sample vial rack.

[0067] In some embodiments, the sample vial rack is manufactured using a stereolithography (SLA) 3D printer and uses printer inks selected from Accura Xtreme Gray, Accura 25, and Accura SL 7820. In other embodiments, the sample vial rack is manufactured using an injection molding process and uses a material that provides strength and a smooth finish, such as polyoxymethylene (POM) or acrylonitrile butadiene styrene (ABS).

[0068] In some embodiments, the thinnest part of the sample vial rack corresponds to the back portion of the magnetic area (1), which is maintained at approximately 0.1 mm to ensure that the magnets used to temporarily attach the sample vial rack to the metal side of the deposition and staining unit are most effective. The initial thickness of the other parts of the sample vial rack is approximately 2.5 mm. More generally, the ratio of the thickness of the other parts of the rack to the magnetic area is maintained at 10:4.

[0069] In some embodiments, the embedded nozzle shelf (4) of the embodiment illustrated in Figures 6A-6C can be replaced with slots or individual holes. By using either slots for nozzles (Figures 7A and 7B) or individual holes for nozzles (Figure 7C), the nozzles of sample vials can be placed in the sample vial rack without interfering with either the placement or removal of open (or capless) sample vials.

[0070] Figures 8A and 8B highlight specific design features of an example sample vial rack. As shown in Figure 8A, the sample vial rack is designed to ensure that [1] there is support below the labeling area of ​​the sample vial, [2] the gripping area has sufficient clearance to allow the user (or operator) to easily grasp the gripping area of ​​the sample vial during placement or removal, [3] there is support for the legs of the sample vial rack for stability, and [4] there is an extension portion of the sample vial rack to reduce the tipping of the nozzle. In embodiments shown in Figures 6A-6C, the feature labeled [4] is replaced by a recessed rear (or nozzle) shelf (4).

[0071] Figure 8B shows that the sample vial rack is shelled from the bottom for material efficiency, cost, and printing time.

[0072] Figure 9 is a flowchart of an example method 900 for collecting a sample and depositing it into a sample vial. Method 900 includes attaching a label to the labeling area of ​​the sample vial in operation 910.

[0073] Method 900 includes loading a buffer solution into the vial body of the sample vial through the opening of the sample vial body in operation 920, and loading the sample into the vial body in operation 930.

[0074] Method 900 includes, in operation 940, homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample.

[0075] Method 900 includes dispensing a mixture of the homogenized buffer solution and the sample using the nozzle of the sample vial in operation 950.

[0076] The disclosed embodiments of the technology provide, in some embodiments, the following technical solutions:

[0077] P1. Apparatus for collecting and depositing a sample, comprising a sample vial, a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; a labeling area having a second flat portion joined to the first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion, the apparatus comprising a sample vial.

[0078] P2. The apparatus according to solution P1, further comprising a vial cap configured to cover the nozzle tip and seal the nozzle shaft, and a cap tether for connecting the vial cap to either a first flat portion or a second flat portion.

[0079] P3. The lid tether thickness is approximately 0.15 mm, as described in Solution P2 of the device.

[0080] P4. The apparatus described in any of the solutions P1 to P3, wherein the thickness of the bottom portion is approximately 0.3 mm, and the thickness of the labeling area and / or gripping area is approximately 1.2 mm.

[0081] P5. An apparatus as described in any of the preceding solutions, wherein the nozzle tip is self-closing.

[0082] P6. Apparatus described in any of the prior solutions, wherein the size of the labeling area is substantially similar to the size of the label for cytopathology slides.

[0083] P7. Apparatus according to any of the preceding solutions, wherein the rim of the nozzle cap includes a first set of grooves configured to interlock with a second set of grooves on the circular opening of the sample vial.

[0084] P8. Apparatus described in any of the preceding solutions, wherein the volume of the flexible chamber is less than 800 μL.

[0085] P9. Apparatus according to any of the preceding solutions, wherein the sample vial is made from thermoplastic polyurethane, plasticized polyvinyl chloride, low-density polyethylene, or polypropylene.

[0086] P10. A system for collecting and depositing samples, comprising: a sample vial as described in any of solutions P1 to P9; a sample vial holding structure comprising: a sample vial rack comprising: a base having a lower shelf; (a) an upper shelf positioned above and parallel to the lower shelf; and (b) a panel connecting the distal end of the upper shelf and the distal end of the lower shelf, wherein the proximal end of the upper shelf comprises a plurality of keyhole-shaped openings, each keyhole-shaped opening comprising a hole having a diameter larger than the diameter of the sample vial and a notch wider than the thickness of the gripping area; and a sample vial rack comprising: one or more magnet holders on the back of the panel.

[0087] P11. The system according to solution P10, wherein one or more magnetic holders are configured to detachably attach a sample vial rack to a sample deposition and staining system.

[0088] P12. The system described in any of the preceding solutions, wherein the thickness of the upper shelf and / or lower shelf is approximately 2.5 mm, and the thickness of each of the one or more magnet holders is approximately 1.0 mm.

[0089] P13. A system according to any of the preceding solutions, wherein one or more magnet holders have an upper surface configured to support the nozzle cap of a sample vial when the sample vial is placed in one of a plurality of keyhole-shaped openings.

[0090] P14. The sample vial rack is made from a plastic printing material compatible with stereolithography three-dimensional (3D) printing, as described in any of the solutions on pages P10 to P13.

[0091] P15. The system described in any of the solutions P10-P13, wherein the sample vial rack is made from polyoxymethylene or acrylonitrile butadiene styrene (ABS).

[0092] P16. A method for preparing a sample for deposition and staining, using a sample vial described in any of the solutions P1 to P9 in combination with a sample vial rack described in any of the solutions P10 to P15.

[0093] P17. A method for collecting and depositing a sample using a sample vial described in any of the solutions on P1 to P9, the method comprising: attaching a label to the labeling area; loading the buffer solution into the vial body through the body opening; loading the sample into the vial body; homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample; and dispensing the mixture of the homogenized buffer solution and the sample.

[0094] P18. The method according to solution P17, further comprising dispensing a mixture of the homogenized buffer solution and the sample into a sample pod.

[0095] P19. The method of solution P17, further comprising detaching the nozzle cap by breaking the nozzle tether and sealing the sample vial by fitting the nozzle cap tightly into the opening of the main body.

[0096] P20. The sample is collected using fine-needle aspiration (FNA), according to any of the methods described on pages P17-P19.

[0097] The embodiments of the disclosed technology provide, in some embodiments, the following additional technical solutions:

[0098] N1. Apparatus for collecting and depositing a sample, comprising: a sample vial, a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; a labeling area having a second flat portion joined to the first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion, the sample vial.

[0099] N2. Apparatus for collecting and depositing a sample, comprising: a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; a labeling area having a second flat portion joined to the first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion.

[0100] N3. The apparatus according to solution N1 or N2, further comprising a vial lid configured to cover the nozzle tip and seal the nozzle shaft, and a lid tether connecting the vial lid to either a first flat portion or a second flat portion.

[0101] N4. The device described in Solution N3, where the thickness of the lid tether is approximately 0.15 mm.

[0102] N5. The apparatus according to any of solutions N1 to N4, wherein the thickness of the bottom portion is approximately 0.3 mm, and the thickness of the labeling area and / or gripping area is approximately 1.2 mm.

[0103] N6. The apparatus described in any of solutions N1 to N5, wherein the nozzle tip is self-closing.

[0104] N7. The apparatus described in any of solutions N1 to N6, wherein the size of the labeling area is substantially similar to the size of the label for cell pathology slides.

[0105] N8. The apparatus according to any of solutions N1 to N7, wherein the rim of the nozzle cap includes a first set of grooves configured to interlock with a second set of grooves on the circular opening of the sample vial.

[0106] N9. The apparatus described in any of solutions N1 to N8, wherein the volume of the flexible chamber is less than 800 μL.

[0107] N10. The apparatus according to any of solutions N1 to N9, wherein the sample vial is made from thermoplastic polyurethane, plasticized polyvinyl chloride, low-density polyethylene, or polypropylene.

[0108] N11. A system for collecting samples for deposition and staining, comprising: a sample vial; a sample vial rack comprising: a sample vial holding structure comprising: a base portion having a lower shelf portion; (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and (b) a panel connecting the distal end of the upper shelf portion and the distal end of the lower shelf portion, wherein the proximal end of the upper shelf portion comprises a plurality of keyhole-shaped openings, each keyhole-shaped opening comprising a hole having a diameter larger than the diameter of the sample vial and a notch wider than the thickness of the gripping area; and a sample vial rack comprising: one or more magnet holders on the back of the panel.

[0109] N12. A system for collecting a sample for deposition and staining, comprising: a sample vial, a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; and a second flat portion joined to the first flat portion and located in the same plane as the first flat portion. A sample vial comprising: a sample vial comprising: a labeling area and a gripping area comprising: a gripping area comprising: a sample vial rack comprising: a base comprising: a lower shelf portion comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and (b) a panel connecting the distal end of the upper shelf portion and the distal end of the lower shelf portion, wherein the proximal end of the upper shelf portion comprises: a plurality of keyhole-shaped openings, each keyhole-shaped opening comprising: a hole having a diameter larger than the diameter of the sample vial; and a notch wider than the thickness of the gripping area; and a sample vial rack comprising: one or more magnet holders on the back of the panel.

[0110] N13. The system according to solution N11 or N12, wherein one or more magnet holders are configured to detachably attach a sample vial rack to a sample deposition and staining system.

[0111] N14. The system according to any of solutions N11 to N13, wherein the thickness of the upper shelf and / or lower shelf is approximately 2.5 mm, and the thickness of each of the one or more magnet holders is approximately 1.0 mm.

[0112] N15. The system according to any of solutions N11 to N14, wherein one or more magnet holders have an upper surface configured to support the nozzle cap of a sample vial when the sample vial is placed in one of a plurality of keyhole-shaped openings.

[0113] N16. The system according to any of solutions N11 to N15, wherein the sample vial rack is made from a plastic printing material compatible with stereolithography three-dimensional (3D) printing.

[0114] N17. The system according to any of solutions N11 to N15, wherein the sample vial rack is made from polyoxymethylene or acrylonitrile butadiene styrene (ABS).

[0115] N18. A method for collecting a sample and depositing it in a sample vial, wherein the sample vial comprises a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle cap having a rim configured to fit into the circular opening; a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip; and a nozzle tether connecting the nozzle cap to the first flat portion. A method comprising: a nozzle; a labeling area having a second flat portion joined to a first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion, the method comprising: attaching a label to the labeling area; loading a buffer solution into the vial body through the body opening; loading a sample into the vial body; homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample; and dispensing the mixture of the homogenized buffer solution and the sample.

[0116] N19. A method for collecting a sample and depositing it in a sample vial, comprising: attaching a label to the labeling area of ​​the sample vial; loading a buffer solution into the vial body of the sample vial through the opening of the sample vial body; loading the sample into the vial body; homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample; and dispensing the mixture of the homogenized buffer solution and the sample using the nozzle of the sample vial.

[0117] N20. The method according to solution N18 or N19, further comprising dispensing a mixture of the homogenized buffer solution and the sample into a sample pod.

[0118] N21. The method according to solution N18 or N19, further comprising detaching the nozzle cap by breaking the nozzle tether and sealing the sample vial by fitting the nozzle cap tightly into the opening of the main body.

[0119] N22. The method according to any of solutions N18-N21, wherein the sample is collected using fine-needle aspiration (FNA).

[0120] The embodiments of the disclosed technology provide, in some embodiments, the following additional technical solutions:

[0121] C1. A sample vial for collecting and depositing a sample, comprising: a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, wherein the bottom portion and side walls form a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; a labeling area having a second flat portion joined to the first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion.

[0122] C2. The sample vial according to solution C1, further comprising a vial lid configured to cover the nozzle tip and seal the nozzle shaft, and a lid tether connecting the vial lid to either a first flat portion or a second flat portion.

[0123] C3. The sample vial described in Solution C2 has a lid tether thickness of approximately 0.15 mm.

[0124] C4. A sample vial according to any of solutions C1 to C3, wherein the thickness of the bottom portion is approximately 0.3 mm and the thickness of the labeling area and / or gripping area is approximately 1.2 mm.

[0125] C5. A sample vial described in any of solutions C1 to C3, wherein the nozzle tip is self-closing.

[0126] C6. A sample vial described in any of solutions C1-C3, wherein the size of the labeling area is substantially similar to the size of the label for cell pathology slides.

[0127] C7. A sample vial according to any of solutions C1 to C3, wherein the rim of the nozzle cap includes a first set of grooves configured to interlock with a second set of grooves on the circular opening of the sample vial.

[0128] C8. A sample vial according to any of solutions C1 to C3, wherein the volume of the flexible chamber is less than 800 μL.

[0129] C9. A sample vial according to any of solutions C1 to C3, wherein the sample vial is made from thermoplastic polyurethane, plasticized polyvinyl chloride, low-density polyethylene, or polypropylene.

[0130] C10. A system for collecting a sample for deposition and staining, comprising: a sample vial, a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle having a nozzle cap with a rim configured to fit into the circular opening, a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, and a nozzle tether connecting the nozzle cap to the first flat portion; and a second flat portion joined to the first flat portion and located in the same plane as the first flat portion. A sample vial comprising: a sample vial comprising: a labeling area and a gripping area comprising: a gripping area comprising: a sample vial rack comprising: a base comprising: a lower shelf portion comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and (b) a panel connecting the distal end of the upper shelf portion and the distal end of the lower shelf portion, wherein the proximal end of the upper shelf portion comprises: a plurality of keyhole-shaped openings, each keyhole-shaped opening comprising: a hole having a diameter larger than the diameter of the sample vial; and a notch wider than the thickness of the gripping area; and a sample vial rack comprising: one or more magnet holders on the back of the panel.

[0131] C11. The system according to solution C10, wherein one or more magnetic holders are configured to detachably attach a sample vial rack to a sample deposition and staining system.

[0132] C12. The system described in Solution C10, wherein the thickness of the upper shelf and / or lower shelf is approximately 2.5 mm, and the thickness of each of the one or more magnet holders is approximately 1.0 mm.

[0133] C13. The system according to solution C10, wherein one or more magnet holders have an upper surface configured to support the nozzle cap of a sample vial when the sample vial is placed in one of a plurality of keyhole-shaped openings.

[0134] C14. The system described in any of solutions C10-C13, wherein the sample vial rack is made from a plastic printing material compatible with stereolithography three-dimensional (3D) printing.

[0135] C15. The system according to any of solutions C10 to C13, wherein the sample vial rack is made from polyoxymethylene or acrylonitrile butadiene styrene (ABS).

[0136] C16. A method for collecting a sample and depositing it in a sample vial, wherein the sample vial comprises a vial body having a bottom portion, an upper portion, and side walls extending from the upper portion to the bottom portion, the bottom portion and side walls forming a flexible chamber; a body opening having a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening; a nozzle cap having a rim configured to fit into the circular opening; a nozzle shaft extending from the nozzle cap and terminating at the nozzle tip; and a nozzle tether connecting the nozzle cap to the first flat portion. A method comprising: a nozzle; a labeling area having a second flat portion joined to a first flat portion and located in the same plane as the first flat portion; and a gripping area having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion, the method comprising: attaching a label to the labeling area; loading a buffer solution into the vial body through the body opening; loading a sample into the vial body; homogenizing the buffer solution and the sample using the vial body to create a mixture of the homogenized buffer solution and the sample; and dispensing the mixture of the homogenized buffer solution and the sample.

[0137] C17. The method according to solution C16, further comprising dispensing a mixture of the homogenized buffer solution and the sample into a sample pod.

[0138] C18. The method of solution C16, further comprising detaching the nozzle cap by breaking the nozzle tether and sealing the sample vial by fitting the nozzle cap tightly into the opening of the body.

[0139] C19. The method described in any of solutions C16-C18, wherein the sample is collected using fine-needle aspiration (FNA).

[0140] C20. Apparatus for sample collection and deposition that implements one or more of the methods described in Solution C16-C19.

[0141] In this specification, the term “cell sample” refers to any biological sample containing cells. A cell sample may be a tissue sample or a sample taken from an object (e.g., any collection of cells). A tissue sample may be a collection of interconnected cells that perform similar functions within an organism. A cell sample may also be any solid or fluid sample obtained, excreted, or secreted from any living organism, including, but not limited to, single-celled or multicellular organisms such as bacteria, yeasts, protozoa, and amoebas (e.g., samples from healthy or seemingly healthy human subjects, or samples from human patients suffering from a condition or disease being diagnosed or investigated, such as cancer, plants, or animals). In some embodiments, a cell sample may be placed on a microscope slide and may include, but not limited to, tissue sections, organs, tumor sections, smears, frozen sections, cytological preps, or cell lines. Samples may be obtained using incisional biopsy, core biopsy, excision biopsy, fine-needle aspiration (e.g., fine-needle aspiration (FNA)), core needle biopsy, stereotactic biopsy, open biopsy, or surgical biopsy.

[0142] The detailed description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Specific embodiments and examples of the technology are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the technology, as will be recognized by those skilled in the art. The various embodiments described herein may also be combined to provide further embodiments.

[0143] From the above, specific embodiments of the present technology are described herein for illustrative purposes only. However, to avoid unnecessarily obscuring the description of embodiments of the present technology, well-known structures and functions are not shown or described in detail.

[0144] Furthermore, while specific embodiments are described herein for illustrative purposes, it should be understood that various modifications can be made without departing from the Art. Moreover, while advantages related to specific embodiments of the Art are described in relation to those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are necessarily required to exhibit such advantages to fall within the scope of the Art. Therefore, this disclosure and related art may encompass other embodiments not expressly shown or described herein.

Claims

1. A sample vial for collecting and depositing samples, A vial body comprising a bottom portion, an upper portion, and a side wall extending from the upper portion to the bottom portion, wherein the bottom portion and the side wall form a flexible chamber, The body opening comprises a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening, It is a nozzle, A nozzle cap having a rim configured to fit into the circular opening, A nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, A nozzle comprising a nozzle tether connecting the nozzle cap to the first flat portion, A labeling region comprising a second flat portion joined to the first flat portion and located in the same plane as the first flat portion, A sample vial comprising a gripping region having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion.

2. A vial lid configured to cover the nozzle tip and seal the nozzle shaft, The sample vial according to claim 1, further comprising a lid tether for connecting the vial lid to either the first flat portion or the second flat portion.

3. The sample vial according to claim 2, wherein the thickness of the lid tether is approximately 0.15 mm.

4. The sample vial according to any one of claims 1 to 3, wherein the thickness of the bottom portion is approximately 0.3 mm, and the thickness of the labeling area and / or the gripping area is approximately 1.2 mm.

5. The sample vial according to any one of claims 1 to 3, wherein the nozzle tip is of the self-closing type.

6. The sample vial according to any one of claims 1 to 3, wherein the size of the labeling area is substantially similar to the size of a label for a cell pathology slide.

7. The sample vial according to any one of claims 1 to 3, wherein the rim of the nozzle cap includes a first set of grooves configured to interlock with a second set of grooves on the circular opening of the sample vial.

8. The sample vial according to any one of claims 1 to 3, wherein the volume of the flexible chamber is less than 800 μL.

9. The sample vial according to any one of claims 1 to 3, wherein the sample vial is made from thermoplastic polyurethane, plasticized polyvinyl chloride, low-density polyethylene, or polypropylene.

10. A system for collecting samples for deposition and staining, It is a sample vial, A vial body comprising a bottom portion, an upper portion, and a side wall extending from the upper portion to the bottom portion, wherein the bottom portion and the side wall form a flexible chamber, The body opening comprises a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening, It is a nozzle, A nozzle cap having a rim configured to fit into the circular opening, A nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, A nozzle comprising a nozzle tether connecting the nozzle cap to the first flat portion, A labeling region comprising a second flat portion joined to the first flat portion and located in the same plane as the first flat portion, A sample vial comprising: a gripping region having a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion; A sample vial rack, A base with a lower shelf, A sample vial holding structure comprising: (a) an upper shelf portion positioned above and parallel to the lower shelf portion; and (b) a panel connecting the distal end of the upper shelf portion and the distal end of the lower shelf portion, wherein the proximal end of the upper shelf portion comprises a plurality of keyhole-shaped openings, each keyhole-shaped opening comprising a hole having a diameter larger than the diameter of the sample vial and a notch wider than the thickness of the gripping area, A system comprising a sample vial rack, which includes one or more magnetic holders on the back of the panel.

11. The system according to claim 10, wherein one or more magnet holders are configured to detachably attach the sample vial rack to the sample deposition and staining system.

12. The system according to claim 10, wherein the thickness of the upper shelf and / or the lower shelf is approximately 2.5 mm, and the thickness of each of the one or more magnet holders is approximately 1.0 mm.

13. The system according to claim 10, wherein one or more magnet holders have an upper surface configured to support the nozzle cap of the sample vial when the sample vial is placed in one of the plurality of keyhole-shaped openings.

14. The system according to any one of claims 10 to 13, wherein the sample vial rack is made from a plastic printing material compatible with stereolithography three-dimensional (3D) printing.

15. The system according to any one of claims 10 to 13, wherein the sample vial rack is made from polyoxymethylene or acrylonitrile butadiene styrene (ABS).

16. A method for collecting a sample and depositing it into a sample vial, The aforementioned sample vial A vial body comprising a bottom portion, an upper portion, and a side wall extending from the upper portion to the bottom portion, wherein the bottom portion and the side wall form a flexible chamber, The body opening comprises a circular opening joined to the upper portion of the vial body and a first flat portion extending outward from the circumference of the circular opening, It is a nozzle, A nozzle cap having a rim configured to fit into the circular opening, A nozzle shaft extending from the nozzle cap and terminating at the nozzle tip, A nozzle comprising a nozzle tether connecting the nozzle cap to the first flat portion, A labeling region comprising a second flat portion joined to the first flat portion and located in the same plane as the first flat portion, A gripping region comprising a third flat portion joined to the second flat portion and located in a plane perpendicular to the second flat portion, The method described above is A label is affixed to the labeling area, The buffer solution is loaded into the vial body through the opening of the main body, Loading the aforementioned sample into the vial body, Using the vial body, the buffer solution and the sample are homogenized to create a mixture of the homogenized buffer solution and the sample. A method comprising dispensing a mixture of the homogenized buffer solution and the sample.

17. The method according to claim 16, further comprising dispensing the mixture of the homogenized buffer solution and the sample into a sample pod.

18. By breaking the nozzle tether, the nozzle cap is detached. The method according to claim 16, further comprising sealing the sample vial by fitting the nozzle cap snugly into the opening of the main body.

19. The method according to any one of claims 16 to 18, wherein the sample is collected using fine-needle aspiration (FNA).

20. Apparatus for sample collection and deposition, which implements the method described in any one or more of claims 16 to 19.

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