Disposable pathological sample tissue enrichment centrifugal tube

Abstract

The invention relates to the technical field of medical instruments, in particular to a disposable pathological sample tissue enrichment centrifuge tube which comprises an outer tube, an embedded sleeve, a ring structure and a wedge-shaped guide support. In the invention, the outer tube is matched with the cover body to directly serve as a sample tissue storage container, and is matched with an integral structure jointly formed by the embedded sleeve, the ring structure and the wedge-shaped guide bracket, so that the enrichment of pathological sample tissues can be realized without additionally using absorbent paper, the opportunity that the sample tissues are exposed to the environment is reduced, and the risk of bacterial cross infection is reduced; and the influence of the residue of the absorbent paper scraps on the subsequent detection result can be avoided.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to disposable pathological sample tissue enrichment centrifuge tubes. Background Technology

[0002] During endoscopic examinations, biopsy tissue samples typically originate from tumors in the bronchi, stomach, intestines, etc., which are usually small in size (often on the millimeter scale) and have fragile cellular structures. Furthermore, the current mainstream method for sample transfer and preservation involves using biopsy forceps to grasp the sample tissue, directly adhering it to absorbent paper such as filter paper, and then transferring the tissue-adhered absorbent paper to a standard 15mL centrifuge tube containing cell preservation solutions such as formalin, physiological saline, or other specialized preservation media. However, this method has limitations:

[0003] 1. During the process of detaching the sample tissue from the biopsy forceps and adhering it to the absorbent paper, and during the subsequent placement of the absorbent paper into or removal from the centrifuge tube, a large number of fragile cells are prone to detachment, loss, or mechanical damage. Adhesion is particularly poor when the sample tissue is rich in fluid or mucus, severely impacting the accuracy and sensitivity of subsequent pathological diagnoses (such as the detection of trace amounts of cancer cells or specific infections).

[0004] 2. The procedures for obtaining tissue samples using biopsy forceps, adhering them to absorbent paper, transferring them from the absorbent paper to a centrifuge tube, and then removing the tissue samples from the centrifuge tube are quite cumbersome, time-consuming, and require meticulous operation to avoid sample loss. Especially when adhering the tissue samples, the operator needs to find a suitable position on the absorbent paper and ensure firm adhesion, which is inefficient in the fast-paced environment of clinical procedures.

[0005] 3. During the transfer to absorbent paper or from absorbent paper to centrifuge tubes, the introduction of absorbent paper and the corresponding procedures not only increases the exposure of the sample tissue to the environment, posing a risk of cross-contamination with airborne bacteria, but also means that the sample tissue may detach again during removal, remaining on the tube wall or absorbent paper.

[0006] 4. In the existing processing steps, the sample tissue eventually accumulates at the bottom of the centrifuge tube. However, during the transfer of sample tissue from the absorbent paper to the centrifuge tube, the absorbent paper needs to be removed. After removing the absorbent paper, it is still necessary to locate tiny sample tissues (clumps) at the bottom of the centrifuge tube and carefully aspirate the cell suspension and sample tissue using a pipette for slide preparation or nucleic acid or protein extraction. During this process, the small amount of sample tissue can be difficult to handle and easily leads to loss. Additionally, some debris from the absorbent paper may remain at the bottom of the centrifuge tube, affecting subsequent testing results.

[0007] Therefore, there is an urgent need for a device for the collection and enrichment of pathological tissue samples that reduces the operation by half, minimizes cell loss, lowers the risk of contamination, improves processing efficiency, and facilitates subsequent laboratory operations. Summary of the Invention

[0008] The purpose of this invention is to provide a disposable pathological sample tissue enrichment centrifuge tube to solve the problems existing in the prior art.

[0009] To address the problems existing in the prior art, the present invention adopts the following technical solution:

[0010] A disposable pathological sample enrichment centrifuge tube, comprising:

[0011] The outer tube forms an internal accommodating space and is equipped with a cover;

[0012] The inner nest is coaxially arranged inside the outer tube and near the entrance of the outer tube, and the inner nest is clearance-fitted with the outer tube;

[0013] A ring structure comprising a ring body and an extension integrally connected, wherein the ring body is disposed at the upper position of the inner nest, and the extension extends from the ring body to the outside of the outer tube;

[0014] A wedge-shaped guide bracket is fixedly installed at the bottom of the inner nest and is coaxially arranged with the inner nest. The wedge-shaped guide bracket forms an inclination angle with the bottom of the inner nest.

[0015] The inner nest, the ring structure, and the wedge-shaped guide bracket together form a whole that can be detachably connected to the outer tube. When the extension is pulled, the ring body and the inner nest separate.

[0016] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the ring body is a ring structure, which is coaxially and tightly fitted on the outer periphery of the upper part of the inner nest to form a sealing ring band.

[0017] The inner side of the ring body abuts against the outer wall of the inner nest, the outer side of the ring body abuts against the inner wall of the outer tube, and the contact surface between the sealing ring and the inner wall of the outer tube is a continuous annular sealing surface.

[0018] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the inner sidewall of the ring body is connected to the inner nested top outer sidewall with an interference fit.

[0019] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the wedge-shaped transverse support is a wedge-shaped structure arranged along the inner nested central axis, and the cross-section of the wedge-shaped transverse support is a V-shaped groove.

[0020] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the extension is a pull ring formed by the ring body extending upward and toward the opening of the outer tube. The inner edge of the pull ring is integrally formed with the ring body, and the outer edge of the pull ring is disposed at the edge of the opening of the outer tube.

[0021] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the tilt angle is a tilt angle of 10°-20°.

[0022] As an improvement to the technical solution of the disposable pathological sample enrichment centrifuge tube of the present invention, the outer edge of the extension is provided with a thickened lip, and the thickened lip forms a locking position with the edge of the outer tube opening so that the extension and the outer tube are interference fit.

[0023] The beneficial effects of this invention are:

[0024] In this invention, the outer tube and the cap are used directly as a sample tissue preservation container. The overall structure, which is composed of the inner nest, the ring structure and the wedge-shaped guide support, can achieve the enrichment of pathological sample tissue without the need for additional absorbent paper. This reduces the chance of sample tissue being exposed to the environment, lowers the risk of bacterial cross-infection, and also avoids the impact of absorbent paper debris on subsequent test results. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the disposable pathological sample enrichment centrifuge tube of the present invention.

[0026] Figure 2 for Figure 1 A schematic diagram of the nested three-dimensional structure, highlighting the wedge-shaped guide bracket, the ring body, and the extension.

[0027] Explanation of reference numerals in the attached drawings: 1 - outer tube; 2 - inner nest; 3 - ring body; 301 - extension; 4 - wedge-shaped guide bracket; 401 - bracket width; 402 - bracket depth; 403 - tilt angle. Detailed Implementation

[0028] To make the objectives, technical solutions, and beneficial effects of this invention clearer, the technical solutions in the embodiments of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments.

[0029] like Figure 1 and Figure 2 As shown, the present invention provides a disposable pathological sample enrichment centrifuge tube, comprising:

[0030] The outer tube 1 forms an accommodating space and is equipped with a cover;

[0031] The inner nest 2 is coaxially arranged inside the outer tube 1 and close to the entrance of the outer tube 1. The inner nest 2 and the outer tube 1 are fitted with a clearance.

[0032] The ring structure includes a ring body 3 and an extension 301 connected as one piece. The ring body 3 is located at the upper part of the inner nest 2, and the extension 301 extends from the ring body 3 to the outside of the outer tube 1.

[0033] The wedge-shaped guide bracket 4 is fixedly installed at the bottom of the inner nest 2 and is coaxially arranged with the inner nest 2. The wedge-shaped guide bracket 4 and the bottom of the inner nest 2 form an inclination angle of 403.

[0034] The inner nest 2, the ring structure, and the wedge-shaped guide bracket 4 together form a whole that can be detachably connected to the outer tube 1. When the extension 301 is pulled, the ring body 3 and the inner nest 2 separate.

[0035] In detail, firstly, in this invention, the outer tube 1, together with the cap, directly serves as a sample tissue preservation container. Combined with the inner nest 2, the ring structure, and the wedge-shaped guide support 4, the overall structure can achieve the enrichment of pathological sample tissue without the need for additional absorbent paper. This reduces the chance of sample tissue being exposed to the environment, lowers the risk of bacterial cross-infection, and also avoids the impact of absorbent paper debris on subsequent test results.

[0036] Secondly, the inner nest 2 is located near the inlet of the outer tube 1. During use, the sample tissue can be directly placed into the inner nest 2 using biopsy forceps, eliminating the cumbersome steps of sample adhesion and transfer to absorbent paper in the prior art.

[0037] Furthermore, since the wedge-shaped guide scaffold 4 and the bottom of the inner nest 2 form an inclined angle 403, the sample tissue can be guided to slide down the inclined surface of the wedge-shaped guide scaffold 4 to the bottom of the outer tube 1, realizing the automatic enrichment of the sample tissue. There is no need for manual searching and transfer of small sample tissues as in the existing technology, which reduces cell shedding, loss or mechanical damage. It is especially suitable for sample tissues rich in fluid or mucus, ensuring the accuracy and sensitivity of subsequent pathological diagnosis.

[0038] Furthermore, the extension 301 of the pull ring structure allows the ring body 3 to separate from the inner nest 2, facilitating the disassembly of the inner nest 2 and subsequent sample tissue processing. Moreover, this invention is a single-use product, requiring no cleaning or reuse, further reducing the risk of contamination. The enriched sample tissue is concentrated at the bottom of the outer tube 1, making it convenient for subsequent pipetting of cell suspensions, slide preparation, or nucleic acid protein extraction, improving laboratory operational convenience and maximizing the preservation of sample tissue integrity, thus meeting the core requirements of pathological sample collection and enrichment.

[0039] This invention utilizes a wedge-shaped guide support 4 at the bottom of the inner nest 2 to directly receive micro-pathological samples gripped by endoscopic biopsy forceps, eliminating the need for traditional absorbent paper and achieving direct sample collection. Furthermore, a medical-grade silicone ring structure ensures stable fixation and easy separation of the inner nest 2 from the outer tube 1. Combined with the flushing action of the preservation solution, the sample detaches from the wedge-shaped guide support 4 and settles to the bottom of the outer tube 1. After removing the inner nest 2, the sample is directly concentrated at the bottom of the standard outer tube 1, facilitating subsequent laboratory operations. Ultimately, this improves sample recovery rate, increases operational efficiency, and reduces the risk of contamination.

[0040] In some embodiments of the present invention, the ring body 3 is a ring structure, which is coaxially and tightly fitted on the outer periphery of the upper part of the inner nest 2 to form a sealing ring band.

[0041] The inner side of the ring body 3 abuts against the outer wall of the inner nest 2, and the outer side of the ring body 3 abuts against the inner wall of the outer tube 1. The contact surface between the sealing ring and the inner wall of the outer tube 1 is a continuous annular sealing surface.

[0042] In detail, the ring body 3 is coaxially and tightly fitted around the upper periphery of the inner nest 2 to form a sealing ring band. Its inner and outer sides abut against the inner nest 2 and the inner wall of the outer tube 1, respectively. Combined with the continuous annular sealing surface, this achieves a reliable seal between the inner nest 2 and the outer tube 1, preventing leakage of the preservation solution and the entry of external contaminants. It also provides a stable fixing force for the inner nest 2, preventing it from shifting or falling off during operation and centrifugation. Simultaneously, it ensures uniform contact between the ring body 3 and the inner wall of the outer tube 1, guaranteeing smooth separation of the inner nest 2 without jamming. As a specific embodiment of this method, the width of the friction sealing surface between the ring body 3 and the inner wall of the outer tube 1 is 2-4 mm, and the wall thickness of the inner nest is 0.5-1.0 mm, to ensure the stability of the inner nest 2 and the smoothness of its separation.

[0043] In some embodiments of the present invention, the inner sidewall of the ring body 3 and the top outer sidewall of the inner nest 2 are connected by an interference fit, which can achieve tight fixation between the two, avoid relative sliding or loosening between the ring body 3 and the inner nest 2, ensure the structural stability of the sealing ring, and further improve the overall fixing effect of the inner nest 2, prevent it from shifting during operation and centrifugation, and also ensure the sealing effect, avoiding leakage of the preservation liquid and intrusion of external contamination.

[0044] In some embodiments of the present invention, the wedge-shaped transverse support is a wedge-shaped structure arranged along the central axis of the inner nest 2. The cross-section of the wedge-shaped transverse support has a V-shaped groove, which can accurately fit the tip of mainstream endoscopic biopsy forceps, providing a dedicated support point for the release of the sample from the biopsy forceps. It can guide the sample to be quickly detached from the forceps tip and deposited in the groove, avoiding sample scattering. At the same time, the V-shaped groove structure can cooperate with the flushing of the preservation solution, guiding the liquid flow to concentrate on the sample attachment site, accelerating sample detachment and settling to the bottom of the tube, reducing sample residue and cell loss, and improving sample recovery rate. As a specific embodiment of this invention, the width 401 of the wedge-shaped transverse support is 2-3 mm, and the depth 402 is 0.5 cm. It should be noted that these dimensions are determined by comparing the opening angle of the sampling forceps to facilitate the transfer of the sample to the wedge-shaped guide support after sampling.

[0045] In some embodiments of the present invention, the extension 301 is a pull ring formed by the ring body 3 extending upward and toward the opening of the outer tube 1. The inner edge of the pull ring is integrally formed with the ring body 3, and the outer edge of the pull ring is disposed at the edge of the opening of the outer tube 1.

[0046] In detail, the pull ring is formed by the ring body 3 extending upwards and toward the opening of the outer tube 1. The inner edge is integrally formed with the ring body 3, and the outer edge is located at the edge of the opening of the outer tube 1. The integral forming design ensures the firmness of the structural connection and avoids breakage when pulled. The pull ring is conspicuous and easy to operate at the edge of the tube opening. It can be lifted upwards with one hand to separate the inner nest 2 from the outer tube 1. The operation is convenient and ergonomic, which greatly improves the efficiency of laboratory sample processing. At the same time, this structure can ensure that the force is even when lifting, so that the inner nest 2 can be smoothly pulled out of the outer tube 1 without jamming. In addition, under normal conditions, the pull ring can limit the ring body 3, further stabilizing the installation position of the inner nest 2.

[0047] Preferably, the tilt angle 403 is 10°-20°. This angle range of 10°-20° is compatible with the operating angle of the mainstream endoscopic biopsy forceps head, allowing the biopsy forceps to easily fit against the stent's bevel to complete the sample removal action. This facilitates rapid clinical operation and reduces mechanical damage during sample removal. At the same time, this angle optimizes the flushing and guiding effect of the preservation solution, guiding the fluid flow to concentrate and flush the sample attachment site, accelerating the sample's detachment from the stent and settling to the bottom of the tube, reducing sample residue and improving cell recovery rate.

[0048] In some embodiments of the present invention, the outer edge of the extension 301 is provided with a thickened lip, which forms a locking position with the edge of the outer tube 1 opening, so that the extension 301 and the outer tube 1 are in an interference fit. This allows the pull ring to be firmly fixed to the edge of the tube opening, effectively preventing the inner nest 2 from shifting or loosening under normal conditions, and ensuring structural stability during centrifugation, shaking, and other operations. At the same time, this locking design can precisely define the installation position of the inner nest 2, ensuring that it is in the optimal sample collection position 1-2 cm below the tube opening. Moreover, the interference fit structure can be easily disengaged when a pulling force is applied, without affecting the convenient lifting and separation of the inner nest 2, thus balancing the fixing effect and the ease of operation. Specifically, the pull ring and the outer tube 1 opening are in a slight interference fit, and the inner nest is installed 1-2 cm below the outer tube opening.

[0049] More specifically, in this invention, the outer tube 1 serves as the fundamental support and final sample enrichment component of the entire invention, providing space for the inner nest 2 and the ring structure. In this invention, the outer tube 1 is preferably a standard 15mL conical-bottom centrifuge tube made of medical-grade polypropylene. Its capacity, height, and nozzle diameter conform to general laboratory specifications, ensuring compatibility with all standard laboratory centrifuges. Typical dimensions of the outer tube 1 are as follows: capacity 15ml ± 5% (approximately 14.25ml - 15.75ml), height 115mm ± 5mm (approximately 109.25mm - 120.75mm), and nozzle diameter 18mm ± 1mm ​​(approximately 17mm - 19mm). Furthermore, the outer tube 1 is equipped with a standard screw cap for opening and closing.

[0050] The inner nest 2 is injection molded from medical-grade polypropylene, and its material is the same as or compatible with that of the outer tube 1, exhibiting good biocompatibility and chemical stability. The wall thickness of the inner nest 2 is designed between 0.5mm and 1.0mm to ensure sufficient strength while reducing weight. The overall shape of the inner nest 2 is adapted to the inner cavity of the outer tube 1, allowing for smooth insertion and removal.

[0051] The ring structure is mainly used to facilitate the inner nest 2 being fixed in the accommodating space of the outer tube 1. The ring structure is made of silicone.

[0052] The working principle of this invention is that the wedge-shaped guide bracket 4 in the center of the inner nest 2 directly receives the sample gripped by the biopsy forceps, and through the optimized silicone ring connection structure and pull ring design, the sample is efficiently transferred in situ in the preservation solution and conveniently separated from the inner nest 2, ultimately achieving the purpose of enriching the sample at the bottom of the tube.

[0053] The steps for using this invention are as follows:

[0054] S1, Clinical sample collection

[0055] The doctor uses endoscopic biopsy forceps to grasp the target tissue sample. While holding the sample with the biopsy forceps, the forceps tip is inserted into the centrifuge tube with the cap already opened until the forceps tip contacts the wedge-shaped guide support 4 in the center of the innermost 2.

[0056] Gently push the forceps head forward along the inclined surface of the wedge-shaped guide bracket 4 and release the clamp, or make a slight downward scraping motion. The sample is efficiently peeled off from the forceps head and deposited directly on the surface of the wedge-shaped guide bracket or falls to the bottom of the inner nest. Remove the biopsy forceps. This process does not require the use of absorbent paper.

[0057] This process requires no absorbent paper, and then the biopsy forceps are removed.

[0058] S2. Sample Transfer and Preservation

[0059] Inject an appropriate amount of cell preservation solution (such as formalin, physiological saline, or a special preservation solution) into the outer tube 1 of the centrifuge tube. The liquid level should at least completely cover the bottom of the inner tube 2 and the sample, usually between 5-10 ml. Then tighten the centrifuge tube cap.

[0060] Hold the centrifuge tube and invert it or shake it horizontally several times (approximately 5-10 seconds). During this process, the preservation solution forms a flow inside the centrifuge tube, and the flushing action of the preservation solution will cause the sample to detach from the wedge-shaped guide support and settle to the bottom of the outer tube 1. The wedge-shaped guide support helps to guide the liquid flow to concentrate and flush the sample attachment point, causing the sample to completely detach from the wedge-shaped guide support 4 and settle to the conical bottom of the outer tube 1.

[0061] S3. Laboratory Sample Enrichment and Removal

[0062] Send the centrifuge tubes containing the samples to the laboratory. A centrifugation step may be selectively performed to further enrich cells and tissue fragments at the bottom of the outer tube 1. Open the cap.

[0063] The operator holds the outer tube 1 firmly with one hand, and pinches the silicone pull ring fixed to the edge of the tube opening with the thumb and forefinger of the other hand. A moderate and stable pulling force is applied upward along the centrifuge tube axis. Under the action of the pulling force, the outer surface of the silicone ring structure slides relative to the inner wall of the outer tube 1. Since the outer edge of the pull ring is fixed, this pulling force will smoothly pull the entire inner cavity sleeve out of the outer tube 1 as a whole.

[0064] After removing the two inner nested components, the sample (cell suspension and precipitated tissue block) is directly exposed and enriched at the bottom of the smooth standard outer tube 1.

[0065] Researchers can immediately use a standard pipette with the tip to directly insert into the bottom of the outer tube 1 to accurately aspirate the required volume of cell suspension for smear preparation, cell block preparation, or liquid biopsy, or aspirate tissue blocks for subsequent testing such as paraffin embedding and nucleic acid extraction.

[0066] Compared with existing technologies, the operation steps of this invention are simplified to taking the sample with biopsy forceps, and then releasing the sample directly to the bottom of the outer tube 1 under the action of the wedge-shaped guide support 4. After closing the cap, it can be shaken, eliminating the steps of absorbent paper adhesion and transfer in existing technologies. Combined with the silicone ring structure, it achieves rapid one-handed separation of the inner nest 2, requiring no additional tools, shortening operation time and improving laboratory efficiency. Furthermore, by eliminating the steps of absorbent paper adhesion and transfer in existing technologies, the exposure time of the sample to air is reduced, eliminating the potential contaminant of absorbent paper, and preventing absorbent paper debris from remaining at the bottom of the tube and affecting subsequent testing. Moreover, in this invention, all components are aseptically injection molded and assembled, and are directly discarded after use without the need for cleaning and reuse, further reducing the risk of cross-infection in clinical practice and meeting the aseptic operation standards for pathological sample handling.

[0067] Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

Claims

1. A disposable pathological sample enrichment centrifuge tube, characterized in that, include: The outer tube forms an internal accommodating space and is equipped with a cover; The inner nest is coaxially arranged inside the outer tube and near the entrance of the outer tube, and the inner nest is clearance-fitted with the outer tube; A ring structure comprising a ring body and an extension integrally connected, wherein the ring body is disposed at the upper position of the inner nest, and the extension extends from the ring body to the outside of the outer tube; A wedge-shaped guide bracket is fixedly installed at the bottom of the inner nest and is coaxially arranged with the inner nest. The wedge-shaped guide bracket forms an inclination angle with the bottom of the inner nest. The inner nest, the ring structure, and the wedge-shaped guide bracket together form a whole that can be detachably connected to the outer tube. When the extension is pulled, the ring body and the inner nest separate.

2. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The ring body is a ring structure, which is coaxially and tightly fitted around the outer periphery of the upper part of the inner nest to form a sealing ring band; The inner side of the ring body abuts against the outer wall of the inner nest, the outer side of the ring body abuts against the inner wall of the outer tube, and the contact surface between the sealing ring and the inner wall of the outer tube is a continuous annular sealing surface.

3. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The inner wall of the ring body is interference-fitted with the inner nested top outer wall.

4. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The wedge-shaped transverse support is a wedge-shaped structure arranged along the central axis of the inner nest, and the cross-section of the wedge-shaped transverse support is a V-shaped groove.

5. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The extension is a pull ring formed by extending the ring body upward and toward the opening of the outer tube. The inner edge of the pull ring is integrally formed with the ring body, and the outer edge of the pull ring is located at the edge of the opening of the outer tube.

6. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The tilt angle is a tilt angle of 10°-20°.

7. The disposable pathological sample enrichment centrifuge tube according to claim 1, characterized in that, The outer edge of the extension is provided with a thickened lip, which forms a locking position with the edge of the outer tube opening so that the extension and the outer tube are interference-fitted.

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