JP-2026514379-A - 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. [Selection Diagram] Figure 1

Inventors

• ハリハラン スブラマニアン
• ケイト コスマン
• ソヘイル アブドゥラ
• ニック ムスコス
• サンティアゴ ベルトラン ディアズ
• アレックス ブルーストーン
• タマラ スワンソン
• ブレイク ウォレス
• ジョン ハート
• マルゴー ヘイズ
• マシュー ターナー
• チェスター ヘンダーソン
• マイケル ヘニング

Assignees

• エーエスピー ヘルス インク．
• プラネット イノベーション

Dates

Publication Date

20260511

Application Date

20240329

Priority Date

20230331

Claims (20)

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; and a gripping region having a third 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. An apparatus for sample collection and deposition, which implements the method described in any one or more of claims 16 to 19.

Description

Cross-reference of related applications: This application claims priority to U.S. Provisional Patent Application 6/0, filed on 31 March 2023, the entirety of which is incorporated herein by reference. This specification generally relates to consumables for cytology, and more specifically, to sample vials used for preparing samples for processing. Cytology (also known as cytopathology) involves examining cells from body tissue or fluids to determine a diagnosis. A specific type of physician, called a pathologist, examines cells in tissue samples under a microscope, searching for cellular characteristics or abnormalities. Because cytology examines only very small cells, pathologists require only a very small amount of tissue sample to perform a cytological test. Standard procedures for the collection, preparation, and analysis of biofluidic samples for cytodiagnosis include collecting the biofluidic sample from the patient and transporting it to the cytopathology laboratory. The newly collected sample is prepared through manual steps including multiple centrifugations and cell fixation, washing, and cytochemical staining. These steps are necessary for preparing cell-based assays, including cell smears, cell blocks, and cell solutions. The prepared sample undergoes microscopic examination, flow cytometry, and cytogenetic analysis. The disclosed embodiments of the 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, such as 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. 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 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. 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. 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 base portion having a lower shelf; an upper shelf portion positioned above and parallel to the lower shelf portion; and a panel connecting the distal end of the upper shelf portion to 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. In yet another embodiment, a method for collecting and depositing a sample using the described sample vial includes: affixing a label to the labeling area; loading the buffer solution into the vial body through the 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. The above and other embodiments, as well as their implementations, are described in more detail in the drawings, description, and claims. An example of a sample vial embodiment is shown. This shows an example of a workflow using sample vials. Figure 2 illustrates an example of holding the sample vial shown in Figure 1 between different stages of the workflow shown in Figure 2. An alternative embodiment of the sample vial is shown. Different lid and cap configurations for the sample vial are shown. Different diagrams of sample vial racks used to hold one or more sample vials are shown. An alternative embodiment of the sample vial rack is shown. This diagram hi