Biological sample cracking device, gene detection kit and gene detection equipment

Abstract

The utility model discloses a biological sample cracking device, a gene detection kit and gene detection equipment, relates to the field of biological sample treatment, and aims to solve the problem that the application scene of a transverse stirring structure is limited in related technologies. The biological sample cracking device is applied to the gene detection kit which is vertically used, a vertical cracking cavity is formed in the gene detection kit, a sample adding opening communicated with the cracking cavity is formed in the top end of the gene detection kit, and the biological sample cracking device comprises an opening sealing cover, a rotary transmission part and a stirring cutting part. The opening sealing cover is used for being connected with the sample adding opening and sealing the sample adding opening; one end of the rotary transmission part is rotatably connected with the opening sealing cover; the opening sealing cover is provided with a containing hole, and the transmission structure of the rotary transmission part is exposed through the containing hole; the stirring and cutting part is fixedly arranged at the other end of the rotary transmission part and is accommodated in the cracking cavity. The device has the advantages of being wide in application range, simple and compact in structure and capable of improving the cracking effect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of biological sample processing, in particular to a biological sample lysis device, a gene detection kit and a gene detection equipment. BACKGROUND

[0002] Nucleic acid detection has been widely used in various fields such as biology and medicine. The nucleic acid detection process usually includes multiple steps such as sample addition, sample homogenization, cell lysis, nucleic acid extraction, purification and amplification. Among them, biological sample lysis and then release of DNA or RNA and other nucleic acid substances is a key step in the nucleic acid detection process. Biological sample lysis is essentially cell lysis, which can be achieved by chemical, biological enzyme or physical methods.

[0003] The physical method of cell lysis includes ultrasonic treatment, heating, repeated freeze-thawing, rapid large amplitude pressure change and mechanical rupture, and the mechanical rupture includes bead beating. In related technologies, some gene detection equipment adopts a horizontal rotary bead beater. Specifically, a stirring structure is inserted horizontally into a horizontal closed chamber of a reagent kit, and a plurality of grinding beads are placed in the horizontal closed chamber to realize the cell lysis function.

[0004] However, the horizontal insertion installation method of the stirring structure and the function of the stirring structure only stirring have many limitations. On the one hand, the horizontal insertion installation method has a high probability of liquid leakage, and the chamber flow channel structure of the corresponding reagent kit will be more complex, and the reagent kit will occupy more space, which is difficult to apply to the multi-channel nucleic acid detection scene. On the other hand, the stirring structure which can only stir is difficult to meet the solid sample lysis demand or semi-solid sample lysis demand, and its application scene is more limited. UTILITY MODEL CONTENT

[0005] The purpose of the present application is to provide a biological sample lysis device, a gene detection kit and a gene detection equipment, which can alleviate the problem of limited application scene of the horizontal stirring structure in related technologies, have the advantages of more compact overall structure, reduce liquid leakage, wide application range and improve lysis effect.

[0006] Embodiments of the present application are implemented as follows:

[0007] In a first aspect, the embodiments of the present application provide a biological sample lysing device. The biological sample lysing device is applied to a vertical use genetic detection kit. The genetic detection kit has a vertical lysing cavity inside. The top end of the genetic detection kit has a sample adding port in communication with the lysing cavity. The biological sample lysing device comprises an opening sealing cover, a rotary transmission member and a stirring cutting member. The opening sealing cover is used to connect with the sample adding port and to seal the sample adding port. One end of the rotary transmission member is rotatably connected with the opening sealing cover. The opening sealing cover has a receiving hole. The transmission structure of the rotary transmission member is exposed through the receiving hole. The stirring cutting member is fixedly arranged at the other end of the rotary transmission member and is arranged in the lysing cavity.

[0008] In some embodiments, the stirring cutting member comprises a plurality of block-shaped stirring protrusions which are independent of each other and have cutting edges. The plurality of stirring protrusions are arranged around the axis of the rotary transmission member.

[0009] In some embodiments, at least one stirring protrusion has at least one inclined upper rotation surface. The upper rotation surface can lift and throw the grinding medium in the lysing cavity when the rotary transmission member rotates.

[0010] In some embodiments, the upper rotation surface comprises a forward rotation upper rotation surface and a reverse rotation upper rotation surface which have opposite lifting directions. The forward rotation upper rotation surface can lift and throw the grinding medium when the rotary transmission member rotates forward. The reverse rotation upper rotation surface can lift and throw the grinding medium when the rotary transmission member rotates reversely. The forward rotation upper rotation surface and the reverse rotation upper rotation surface are arranged on different stirring protrusions respectively, or the forward rotation upper rotation surface and the reverse rotation upper rotation surface are arranged on the same stirring protrusion simultaneously.

[0011] In some embodiments, at least one stirring protrusion has a contact surface which is perpendicular to the axis of the rotary transmission member.

[0012] In some embodiments, the gap width between the stirring protrusion and the circumferential inner wall of the lysing cavity is less than the particle size of the grinding medium in the lysing cavity.

[0013] In some embodiments, the plurality of stirring protrusions are arranged in a spiral along the axial direction of the rotary transmission member.

[0014] In some embodiments, the plurality of stirring protrusions are aligned in the axial direction of the rotary transmission member, and the plurality of stirring protrusions are aligned in the circumferential direction of the rotary transmission member.

[0015] In some embodiments, the plurality of stirring protrusions are arranged in a staggered manner around the axis of the rotary transmission member.

[0016] In some embodiments, the bottom end of the stirring cutting member and the bottom end of the lysing cavity have a receiving space. The height of the receiving space is not more than half of the height of the lysing cavity.

[0017] In some embodiments, the biological sample lysing device further comprises at least one V-shaped sealing ring, the V-shaped sealing ring is sleeved on the rotary transmission member, and a sealing lip of the V-shaped sealing ring abuts against the opening sealing cover to seal a gap between the opening sealing cover and the rotary transmission member.

[0018] In some embodiments, an end of the rotary transmission member close to the opening sealing cover has a coupling through hole, the transmission structure comprises at least one coupling boss arranged on a circumferential inner wall of the coupling through hole, and the coupling boss is used for being mutually engaged with a coupling groove on the output end of the rotary actuator.

[0019] In some embodiments, the opening sealing cover is detachably connected with the sample adding port through a screwing structure.

[0020] In the second aspect, the embodiments of the present application provide a gene detection kit, the gene detection kit comprising a kit shell and the biological sample lysing device provided by any one of the embodiments of the first aspect of the present application. The kit shell comprises a lysing cavity and a sample adding port which are in communication with each other, the sample adding port is arranged at a top end of the kit shell, and the lysing cavity is vertically arranged in the kit shell; the biological sample lysing device is connected with the sample adding port through the opening sealing cover, and the stirring cutting member extends into the lysing cavity.

[0021] In the third aspect, the embodiments of the present application provide a gene detection device, the gene detection device comprising a rotary actuator, a heating device and the gene detection kit provided by any one of the embodiments of the second aspect of the present application; the rotary actuator is arranged at a top of the biological sample lysing device, and is used for being coupled and connected with the transmission structure of the biological sample lysing device; the heating device is arranged at one side of the kit shell having the lysing cavity.

[0022] Compared with the prior art, the present application has the following beneficial effects:

[0023] In the embodiments of the present application, the opening sealing cover is used to connect with the sample adding port and can close the sample adding port, so that the sample adding operation is more simple and convenient, and the probability of sample being polluted by the outside during the lysis process is also reduced; the opening sealing cover has a containing hole, and the transmission structure of the rotary transmission member is exposed through the containing hole, so that the rotary transmission member can be normally connected with the external power source and then smoothly rotate, and the power can also be smoothly transmitted to the stirring and cutting member, so that the stirring and cutting member can smoothly perform the stirring and cutting operation in the lysis cavity; under the driving of the rotary transmission member, the stirring and cutting member can fully stir and cut the biological sample in the lysis cavity, so that the biological sample fully contacts with the lysis reagent and the lysis reaction is accelerated, thereby improving the lysis efficiency and enabling the nucleic acid and other components in the sample to be released more quickly; the stirring and cutting member with the cutting function can also adapt to more sample conditions, such as solid samples and semi-solid samples; the sample lysis device is vertically arranged in the lysis cavity and is applied to the gene detection kit used vertically, which is beneficial to the compactness and simplicity of the overall structure of the kit and is beneficial to further application in the multi-channel sample analysis scene, and the application range is wider. BRIEF DESCRIPTION OF DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0025] Figure 1 The overall structure schematic diagram of the gene detection device shown in some embodiments of the present application;

[0026] Figure 2 The partial structure schematic diagram of the gene detection device shown in some embodiments of the present application;

[0027] Figure 3 The overall structure schematic diagram of the gene detection kit shown in some embodiments of the present application;

[0028] Figure 4 The explosion schematic diagram of the gene detection kit shown in some embodiments of the present application;

[0029] Figure 5 The schematic diagram of the gene detection kit shown in some embodiments of the present application using the rotary cover to close the sample adding port;

[0030] Figure 6 The internal schematic diagram of the lysis cavity of the gene detection kit shown in some embodiments of the present application;

[0031] Figure 7Overall structure diagram of biological sample lysing device shown in some embodiments of the present application;

[0032] Figure 8 Overall structure diagram of biological sample lysing device shown in some embodiments of the present application;

[0033] Figure 9 Overall structure diagram of biological sample lysing device shown in some embodiments of the present application;

[0034] Figure 10 Diagram of staggered distribution of stirring protrusions shown in some embodiments of the present application;

[0035] Figure 11 Diagram of staggered distribution of stirring protrusions shown in some embodiments of the present application;

[0036] Figure 12 Diagram of stirring protrusions with relatively gentle upturning angle shown in some embodiments of the present application;

[0037] Figure 13 Diagram of stirring protrusions with relatively steep upturning angle shown in some embodiments of the present application;

[0038] Figure 14 Diagram of stirring cutting member with both forward upturning surface and reverse upturning surface shown in some embodiments of the present application.

[0039] Icon: 1-gene detection device; 11-rotary actuator; 111-coupling groove; 12-heating device; 2-gene detection kit; 21-kit shell; 210-sample adding port; 211-lysing cavity; 213-grinding medium; 214-receiving space; 22-nucleic acid detection chip; 23-rotary cover;

[0040] 3-biological sample lysing device; 31-opening sealing cover; 310-receiving hole; 311-rotation structure; 312-sealing cover shell; 313-sealing cover inner shell; 314-sealing member; 32-rotation transmission member; 320-transmission structure; 321-coupling part; 3210-coupling through hole; 3211-coupling boss; 322-mounting part; 33-stirring cutting member; 330-stirring protrusion; 331-connection part; 3300-upturning surface; 3301-forward upturning surface; 3302-reverse upturning surface; 3303-contact surface; 3304-cutting edge; 34-V-shaped sealing ring; 340-sealing lip; 35-bearing. DETAILED DESCRIPTION

[0041] The terms "first", "second", "third", etc. are only used for differentiation and description, and do not represent the arrangement sequence number, and cannot be understood as indicating or implying relative importance.

[0042] In addition, the terms "horizontal", "vertical", "overhanging" and the like do not mean that the components must be absolutely horizontal or overhanging, but can be slightly inclined. For example, "horizontal" only means that it is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0043] In the description of the present application, it should be noted that the terms "inner", "outer", "left", "right", "upper", "lower" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present application is usually placed, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0044] In the description of the present application, unless otherwise explicitly specified and limited, the terms "set", "mounted", "connected", "connected" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be the communication between two elements inside.

[0045] The technical solutions of the present application will be described in detail below with reference to the accompanying drawings.

[0046] Please refer to Figures 1-2 , Figure 1 The overall structure diagram of the gene detection device 1 shown in some embodiments of the present application is shown in the figure. Figure 2 The partial structure diagram of the gene detection device 1 shown in some embodiments of the present application is shown in the figure. Please refer to Figures 1-9 The gene detection device 1 provided by the embodiments of the present application includes a rotary actuator 11, a heating device 12 and a gene detection reagent kit 2.

[0047] The rotary actuator 11 is arranged at the top of the biological sample lysis device 3, the output end of the rotary actuator is provided with a coupler, and the rotary actuator 11 is used to be coupled and connected with the transmission structure 320 of the biological sample lysis device 3 through the coupler; the heating device 12 is arranged on one side of the reagent kit shell 21 having a lysis cavity 211.

[0048] Specifically, the rotating actuator 11 refers to a driving device for driving the biological sample lysis device 3 to rotate, and the heating device 12 refers to a device for heating the lysis cavity 211. The rotating actuator 11 can be a direct-current brushless high-speed motor. The coupling side of the coupling device is provided with a coupling groove 111, which is used for mutual engagement with the coupling boss 3211 of the biological sample lysis device 3. In the embodiment of the present application, the coupling connection of the rotating actuator 11 and the rotating transmission member 32 can transmit the high-speed rotating motion output by the rotating actuator 11 to the rotating transmission member 32 of the biological sample lysis device 3, so as to make the rotating transmission member 32 drive the stirring and cutting member 33 to rotate at high speed, thereby achieving the purpose of homogenously lysing the biological sample.

[0049] Further, the heating device 12 is movably arranged on one side of the genetic detection kit 2 having the lysis cavity 211, and can be close to or away from the lysis cavity 211. When the genetic detection device 1 performs sample lysis work, the heating device 12 is turned on to be heated to about 65℃, and the heating device 12 is controlled to move to be close to the lysis cavity 211, so that the heating block of the heating device 12 tightly abuts against the side wall of the lysis cavity 211. The heating of the lysis cavity 211 can promote the lysis of cells by some enzymes. After lysis is completed, the heating block of the heating device 12 is controlled to stop heating, and the heating device 12 is controlled to move reversely to retreat as a whole and move away from the lysis cavity 211.

[0050] In the above technical solution, the cooperation of the rotating actuator 11 and the heating device 12 can realize the combination of mechanical stirring and thermal lysis of the sample, and further improve the lysis efficiency and uniformity. The cooperation of the rotating actuator 11 and the heating device 12 can make the sample fully mixed and lysed during the lysis process, and improve the accuracy and reliability of genetic detection.

[0051] Please refer to Figures 3-6 , Figure 3 for the overall structure schematic diagram of the genetic detection kit 2 shown in some embodiments of the present application; Figure 4 for the explosion schematic diagram of the genetic detection kit 2 shown in some embodiments of the present application; Figure 5 for the schematic diagram of the genetic detection kit 2 shown in some embodiments of the present application, in which the sample adding port 210 is closed by the rotating cover 23; Figure 6 for the internal schematic diagram of the lysis cavity 211 of the genetic detection kit 2 shown in some embodiments of the present application. Please refer to Figures 1-6 for the genetic detection kit 2 provided by the embodiments of the present application, which includes a kit shell 21 and a biological sample lysis device 3. The biological sample lysis device 3 can be integrated into the kit shell 21, and the biological sample lysis device 3 is connected with the kit shell 21 and the main part of the biological sample lysis device 3 is accommodated in the kit shell 21.

[0052] Specifically, the kit shell 21 includes a lysis cavity 211 and a sample adding port 210 in communication with each other, the sample adding port 210 is arranged at the top end of the kit shell 21, and the lysis cavity 211 is vertically arranged in the interior of the kit shell 21; the biological sample lysis device 3 is connected with the sample adding port 210 through the opening sealing cover 31, and the stirring and cutting piece 33 of the biological sample lysis device 3 extends into the lysis cavity 211; and the nucleic acid detection chip 22 can also be inserted on one side of the kit shell 21.

[0053] In the embodiments of the present application, the kit shell 21 is the main part of the genetic detection kit 2, the lysis cavity 211 is the internal space for lysis of the sample, and the sample adding port 210 is the opening for adding the sample. In some embodiments, when performing lysis work on simple samples (such as viruses) of solution type, it is usually only necessary to add lysis solution into the lysis cavity 211 to achieve lysis without the assistance of the biological sample lysis device 3 to perform stirring and cutting work. Therefore, the sample adding port 210 at the top of the kit shell 21 can be directly closed by a sealed screw cap 23 to reduce experimental cost.

[0054] In some embodiments, the genetic detection kit 2 can also include a plurality of grinding media 213 arranged in the lysis cavity 211. When performing lysis work on complex samples (such as gram-negative bacteria), since the sample can be in the form of solid or semi-solid which is not easy to disperse, or the cell surface of the sample solution to be lysed is protected by a cell wall, it is difficult to fully break and lyse them by relying on high-speed rotation stirring alone. The grinding media 213 (also referred to as grinding beads) in the lysis cavity 211 can move at high speed in disorder when the stirring and cutting piece 33 rotates at high speed, and the high-speed and disordered movement of the plurality of grinding media 213 can hit the cells to cause the cell wall to be damaged, thereby achieving the purpose of lysis.

[0055] The embodiments of the present application integrate the biological sample lysis device 3 and the kit shell 21 together to form a complete modular structure, thereby improving the automation degree and operation convenience of genetic detection; after the sample lysis is completed, the genetic detection kit 2 can make the flow channel of the piston cavity communicate with the flow channel of the lysis cavity 211 by rotating the piston cavity, and then extract the piston so that the homogenously lysed sample solution enters the piston cavity to be further collected for nucleic acid to be tested by the magnetic bead method.

[0056] Please refer to Figures 7-9 , Figure 7 for the overall structure schematic diagram of the biological sample lysis device 3 shown in some embodiments of the present application; Figure 8 for the overall cross-sectional schematic diagram of the biological sample lysis device 3 shown in some embodiments of the present application; Figure 9 for the exploded schematic diagram of the biological sample lysis device 3 shown in some embodiments of the present application. Please refer to Figures 1-9As shown, the embodiment of the present application provides a biological sample lysing device 3, which is applied to a vertical use genetic detection kit 2, the inside of the genetic detection kit 2 has a vertical lysing cavity 211, the top end of the genetic detection kit 2 has a sample adding port 210 which is in communication with the lysing cavity 211, the biological sample lysing device 3 comprises an opening sealing cover 31, a rotary transmission member 32 and a stirring cutting member 33.

[0057] Wherein, the opening sealing cover 31 is used for connecting with the sample adding port 210 and sealing the sample adding port 210; one end of the rotary transmission member 32 can be rotatably connected with the opening sealing cover 31 through a bearing 35; the opening sealing cover 31 has a containing hole 310, and a transmission structure 320 of the rotary transmission member 32 can be exposed through the containing hole 310; the stirring cutting member 33 is fixedly arranged at the other end of the rotary transmission member 32, and the stirring cutting member 33 is contained in the lysing cavity 211.

[0058] In the embodiment of the present application, the opening sealing cover 31 is a component for detachably connecting with the sample adding port 210 at the top end of the genetic detection kit 2 and sealing the sample adding port 210; the rotary transmission member 32 is a component for connecting the opening sealing cover 31 and the stirring cutting member 33, and the rotary transmission member 32 is used for transmitting the power of the external rotary actuator 11 to the stirring cutting member 33, so that the stirring cutting member 33 rotates in the lysing cavity 211, and realizes the stirring and cutting of the biological sample; the stirring cutting member 33 is a component for stirring and cutting the biological sample. In actual use, the sample to be tested and the lysing reagent can be added into the lysing cavity 211 of the genetic detection kit 2, and then the biological sample lysing device 3 is inserted into the lysing cavity 211 and the opening sealing cover 31 is tightened, so that the whole biological sample lysing device 3 is firmly installed on the kit shell 21.

[0059] In the technical solution, the opening sealing cover 31 is used to connect with the sample adding port 210 and can seal the sample adding port 210, so that the sample adding operation is more simple and convenient, and the probability of sample pollution in the lysis process is reduced. The opening sealing cover 31 has a containing hole 310, and the transmission structure 320 of the rotary transmission member 32 is exposed through the containing hole 310, so that the rotary transmission member 32 can be normally connected with an external power source and then smoothly rotate, and the power can be smoothly transmitted to the stirring and cutting member 33, so that the stirring and cutting member 33 can smoothly perform stirring and cutting operation on the biological sample in the lysis cavity 211, and then the biological sample is fully contacted with the lysis reagent, the lysis reaction is accelerated, the lysis efficiency is improved, and the nucleic acid and other components in the sample can be released more quickly. The stirring and cutting member 33 with the cutting function can also adapt to more sample conditions, such as solid samples and semi-solid samples. The biological sample lysis device 3 is vertically arranged in the lysis cavity 211 and applied to the vertical gene detection reagent kit 2, which is beneficial to the compactness and simplicity of the overall structure of the reagent kit, and is beneficial to the further application of the gene detection reagent kit 2 to a multi-channel sample analysis scene, and the application range is wider.

[0060] In the embodiment of the application, the biological sample lysis device 3 realizes rapid and effective segmentation and lysis of biological sample cells through the cooperation of the stirring and cutting member 33 capable of high-speed rotation and the grinding medium 213. The biological sample lysis device 3 is connected with the sample adding port 210 in a screwing manner through the opening sealing cover 31, so that the lysis cavity 211 can maintain a closed state. When performing a sample lysis operation, only the sample and the reagent need to be added to the lysis cavity 211 through the sample adding port 210, and then the opening sealing cover 31 is screwed, and subsequent operations do not need to be opened again, thereby relieving the problem of pollution caused by multiple openings. The biological sample lysis device 3 provided in the embodiment of the application is simple in structure and easy to operate, usually does not need to distinguish sample types, and has a wider application range when used based on a nucleic acid detection and analysis card box (i.e., the gene detection reagent kit 2).

[0061] In some embodiments, the opening sealing cover 31 can be detachably connected with the sample adding port 210 through the screwing structure 311. The ingenious combination of the biological sample lysis device 3 and the sample adding port 210 can make the biological sample lysis device 3 be vertically installed inside the lysis cavity 211 and have a double-sealing effect, thereby reducing the probability of pollution caused by the escape of aerosol in the lysis process.

[0062] Specifically, in some embodiments, the opening sealing cover 31 comprises a sealing cover inner shell 313 and a sealing cover outer shell 312, the sealing cover outer shell 312 is sleeved outside the sealing cover inner shell 313 and is connected with the sealing cover inner shell 313 through a sealing element 314; at the sample adding port 210 of the genetic detection reagent kit 2, an opening flange is provided which protrudes outward relative to the top end surface of the genetic detection reagent kit 2, the sealing cover outer shell 312 and the sealing cover inner shell 313 form a gap for accommodating and connecting the opening flange, and a screw structure 311, for example, a thread structure, is provided on the outer peripheral side wall of the opening flange and the inner peripheral side wall of the sealing cover outer shell 312, which can be correspondingly matched and connected.

[0063] When the opening sealing cover 31 is connected to the sample adding port 210, the sealing cover inner shell 313 extends into the lysis cavity 211 through the sample adding port 210, the sealing cover outer shell 312 is sleeved outside the opening flange and is tightly connected with the opening flange through the screw structure 311; the sealing element 314 blocks the gap between the sealing cover outer shell 312 and the sealing cover inner shell 313 to reduce the entry of pollutants into the lysis cavity 211 or the diffusion of sample solution aerosol out of the reagent kit.

[0064] Further, the sealing cover inner shell 313 has an accommodation hole 310 penetrating through both ends, one end of the rotary transmission member 32 is arranged in the accommodation hole 310 to expose a transmission structure 320 for transmitting torque through the accommodation hole 310. The rotary transmission member 32 comprises a coupling portion 321 and a mounting portion 322, the coupling portion 321 is sleeved outside the mounting portion 322 and is arranged at one end of the mounting portion 322, and the coupling portion 321 can be integrally formed with the mounting portion 322.

[0065] In some embodiments, one end of the rotary transmission member 32 (coupling portion 321) near the opening sealing cover 31 has a coupling through hole 3210, the transmission structure 320 comprises at least one coupling boss 3211 arranged on the circumferential inner wall of the coupling through hole 3210, and the coupling boss 3211 is used for intermeshing with the coupling groove 111 on the output end of the rotary actuator 11. In the embodiments of the present application, the rotary transmission member 32 of the biological sample lysis device 3 is connected in transmission with the output end of the rotary actuator 11 through the interconnection of the coupling boss 3211 and the coupling groove 111 and the adaptation of the coupling through hole 3210 and the coupler, and only torque is transmitted. The high-speed rotary motion output by the rotary actuator 11 is transmitted to the rotary transmission member 32 of the biological sample lysis device 3 through the transmission structure 320, so that the rotary transmission member 32 rotates at high speed, and in turn drives the stirring and cutting member 33 and the stirring protrusion 330 to rotate at high speed, and in combination with the grinding medium 213 of a suitable size to realize rapid and effective lysis of biological sample cells.

[0066] In some embodiments, the biological sample lysing device 3 further comprises at least one V-shaped sealing ring 34, which is sleeved on the rotating transmission member 32, and the sealing lip 340 of the V-shaped sealing ring 34 abuts against the opening sealing cover 31 to seal the gap between the opening sealing cover 31 and the rotating transmission member 32.

[0067] Specifically, the biological sample lysing device 3 comprises two V-shaped sealing rings 34, which are fixed on the shaft where the mounting portion 322 is located by the elastic tension of the V-shaped sealing rings 34, and the flexible sealing lip 340 is kept in contact with the sealing cover inner shell 313 by a small contact force. One V-shaped sealing ring 34 is arranged between the stirring and cutting member 33 and the sealing cover inner shell 313 (end portion) and is sleeved on the mounting portion 322; the other V-shaped sealing ring 34 is arranged between the coupling portion 321 (end portion) and the sealing cover inner shell 313 (end portion of the accommodating hole 310) and is also sleeved on the mounting portion 322. The shaft where the mounting portion 322 is located is rotatably connected with the sealing cover inner shell 313 through the bearing 35.

[0068] In the embodiments of the present application, the flexible sealing lip 340 can compensate for the eccentricity of the shaft where the mounting portion 322 is located, the different shaft degrees after the assembling of the accommodating hole 310 and the shaft where the mounting portion 322 is located, and the machining errors of the shaft where the mounting portion 322 is located. In the above technical solution, the sealing lip 340 of the V-shaped sealing ring 34 can reduce the leakage of internal solution or aerosol to the outside, and at the same time reduce the invasion of dust, dirt and the like into the lysing cavity 211. The V-shaped sealing ring 34 rotates with the shaft where the mounting portion 322 is located, and due to the centrifugal force, the V-shaped sealing ring 34 can be regarded as a sliding ring.

[0069] In some embodiments, the stirring member can comprise a connecting portion 331 and stirring protrusions 330, the connecting portion 331 is sleeved outside the mounting portion 322 and is fixedly connected with the mounting portion 322; and the stirring protrusions 330 are arranged on the circumferential outer wall of the connecting portion 331 and can be integrally formed with the connecting portion 331. In the embodiments of the present application, the stirring protrusions 330 in the stirring and cutting member 33 can be provided in multiple structural forms, multiple specifications or multiple arrangement modes to meet the application requirements of different biological samples in the lysing process and efficiently and high-quality lyse sample cells.

[0070] Specifically, the stirring cutting member 33 can include a plurality of blocks of stirring protrusions 330 with cutting edges 3304, which are independent of each other and are uniformly arranged around the axis A of the rotating transmission member 32. In the embodiments of the present application, the stirring protrusions 330 are protruding parts on the stirring cutting member 33; the stirring protrusions 330 have cutting edges 3304 for enhancing the cutting effect; the cutting edges 3304 refer to edges or corners on the stirring protrusions 330 that can provide shearing force to the sample in the lysis chamber 211. The block-shaped stirring protrusions 330 with cutting edges 3304 can increase the contact area between the stirring cutting member 33 and the sample, improve the cutting efficiency, and make the sample more uniformly lysed.

[0071] In the embodiments of the present application, the region where the stirring protrusions 330 are arranged on the connecting part 331 is usually located in the middle of the lysis chamber 211; the total amount of sample liquid added in the entire lysis chamber 211 is usually not more than two-thirds of the height of the lysis chamber 211; after the stirring cutting member 33 is assembled into the lysis chamber 211, the region where the stirring protrusions 330 are arranged is usually located in the middle of the sample; when the stirring cutting member 33 rotates at high speed, the stirring protrusions 330 can fully contact and collide with the sample, thereby improving the lysis efficiency.

[0072] In some embodiments, the gap width D between the outer edge of the stirring protrusions 330 and the circumferential inner wall of the lysis chamber 211 is usually smaller than the particle size of the grinding medium 213 in the lysis chamber 211, so as to reduce the probability that the grinding medium 213 enters and is stuck in the gap between the stirring protrusions 330 and the inner wall of the lysis chamber 211 when the stirring cutting member 33 rotates, thereby causing rotation jamming or locked-rotor.

[0073] Further, in some embodiments, the bottom end of the stirring cutting member 33 and the bottom end of the lysis chamber 211 have a receiving space 214, and the height H1 or H2 of the receiving space 214 is not more than half of the height of the lysis chamber 211. The receiving space 214 is provided for accommodating the grinding medium 213 and improving the noise generated by the collision between the bottom of the stirring cutting member 33 and the wall of the lysis chamber 211, and also serves as a mounting allowance. When the added sample is in solid state, the entire stirring cutting member 33 can also be smoothly installed into the lysis chamber 211 due to the existence of the mounting allowance. This is because when the sample in solid state is added, there is already grinding medium 213 at the bottom of the lysis chamber 211, and the sample in solid state will occupy part or all of the space at the bottom of the lysis chamber 211, thereby possibly causing the lowest end of the stirring cutting member 33 to be stopped by the sample and the opening sealing cover 31 to be unable to be tightened. The above situation rarely occurs for liquid or semi-liquid samples, which will be pushed away in all directions as the stirring cutting member 33 is inserted downward, while the solid sample usually cannot be pushed away.

[0074] In some embodiments, the at least one stirring protrusion 330 has a contact surface 3303 perpendicular to the axis of the rotating transmission member 32. Specifically, the stirring protrusions 330 can be arranged in a regular square structure and evenly distributed on the outer circumferential sidewall of the connecting portion 331 around the axis A of the rotating transmission member 32. The stirring protrusions 330 can be evenly arranged in multiple rows (such as two rows or four rows) on the outer circumferential sidewall of the connecting portion 331, and the exposed surfaces of the stirring protrusions 330 are parallel or perpendicular to the axis of the rotating transmission member 32.

[0075] In some embodiments, the multiple stirring protrusions 330 are aligned in the axial direction of the rotating transmission member 32, and the multiple stirring protrusions 330 are aligned in the circumferential direction of the rotating transmission member 32. Further, the gap between each two adjacent stirring protrusions 330 in each row of stirring protrusions 330 and the height of each stirring protrusion 330 can be equal, that is, the stirring protrusions 330 on the stirring cutting member 33 are arranged in a convex-concave equal-interval manner. This structure is convenient for mold manufacturing and has good mechanical properties. Specifically, the axial gap between each two adjacent stirring protrusions 330 can be in the range of 1 mm to 2 mm. Correspondingly, based on the gap height between adjacent stirring protrusions 330, the grinding medium 213 preloaded into the lysis chamber 211 also needs to select a grinding bead with a particle size less than 1.2 mm or greater than 1.7 mm, so as to reduce the probability of the grinding bead being stuck in the gap between the stirring protrusions 330. In addition, the grinding bead with a too large particle size is relatively heavy and is easy to sink to the bottom of the lysis chamber 211 and is not easy to be lifted by the vortex or the upward rotating surface when the stirring cutting member 33 rotates. The grinding bead with a too small particle size has a relatively small force to break the cells, and is easy to block the liquid exchange flow channel at the bottom of the lysis chamber 211.

[0076] Please refer to Figure 10 , Figure 10 The schematic diagram of the staggered and evenly distributed stirring protrusions 330 is shown in some embodiments of the present application. Please refer to Figures 8-10 In some embodiments, the multiple stirring protrusions 330 are arranged in a spiral manner along the axial direction of the rotating transmission member 32. Specifically, the spiral arrangement refers to the stirring protrusions 330 arranged in a spiral shape along the axis A of the rotating transmission member 32. The spiral arrangement can increase the stirring path of the stirring cutting member 33, so that the sample is more uniformly mixed and lysed in the lysis chamber 211, and the lysis efficiency is improved.

[0077] Please refer to Figure 11 , Figure 11 The schematic diagram of the staggered and evenly distributed stirring protrusions 330 is shown in some embodiments of the present application. Please refer to Figures 8-11As shown, in some embodiments, the plurality of stirring protrusions 330 are staggered and evenly distributed around the axis A of the rotary transmission 32. Specifically, around the axis A of the rotary transmission 32, the stirring protrusions 330 in two adjacent rows are staggered, i.e. the stirring protrusions 330 in the first row are aligned with the gaps between the stirring protrusions 330 in the second row, and the stirring protrusions 330 in the second row are aligned with the gaps between the stirring protrusions 330 in the third row. Thus, when the grinding beads with a height less than the gap between the adjacent stirring protrusions 330 pass through the stirring protrusions 330 in the first row, they are more likely to collide with the stirring protrusions 330 in the second row instead of sliding through, which can increase the collision probability of the grinding medium 213 and the sample cells.

[0078] Please refer to Figures 12-13 , Figure 12 a schematic diagram of the stirring protrusions 330 with a relatively gentle up-spin angle shown in some embodiments of the present application; Figure 13 a schematic diagram of the stirring protrusions 330 with a relatively steep up-spin angle shown in some embodiments of the present application. Please refer to Figures 8-13 As shown, in some embodiments, at least one stirring protrusion 330 has at least one inclined up-spin surface 3300. In the case of rotation of the rotary transmission 32, the up-spin surface 3300 can lift and throw the grinding medium 213 in the lysis chamber 211. Figures 12-13 The rotation direction corresponding to the up-spin surface 3300 shown is the first rotation direction P. Figure 12 The up-spin angle of the up-spin surface 3300 shown is relatively gentle; Figure 13 The up-spin angle of the up-spin surface 3300 shown is relatively steep. The two up-spin surfaces 3300 with different inclination angles relative to the horizontal direction have different effects on the disturbance and lifting of the liquid, i.e. whether the sample type is a body fluid, a secretion or a tissue, it can be directly added to the lysis chamber 211 for lysis without pretreatment; in addition, the arrangement of the up-spin surface 3300 is conducive to lifting and throwing the grinding medium 213, increasing the movement of the grinding medium 213 and making it more fully contact with the sample, to further improve the lysis efficiency.

[0079] Further, the up-spin surface 3300 can be a plane or a curved surface; a plurality of up-spin surfaces 3300 arranged in sequence along the same spiral line can coincide with the same spiral rising surface, or can be inclined in the same direction but with different inclination angles.

[0080] Please refer to Figure 14 , Figure 14 a schematic diagram of the stirring cutter 33 with both the forward rotation up-spin surface 3301 and the reverse rotation up-spin surface 3302 shown in some embodiments of the present application. Please refer to Figures 8-14As shown, in some embodiments, the upper rotating surface 3300 can include a forward rotating upper rotating surface 3301 and a reverse rotating upper rotating surface 3302, the forward rotating upper rotating surface 3301 is capable of lifting and throwing the grinding medium 213 when the rotating actuator 32 rotates in the first rotation direction P, and the reverse rotating upper rotating surface 3302 is capable of lifting and throwing the grinding medium 213 when the rotating actuator 32 rotates in the second rotation direction Q; the forward rotating upper rotating surface 3301 and the reverse rotating upper rotating surface 3302 can be respectively arranged on different stirring protrusions 330, or the forward rotating upper rotating surface 3301 and the reverse rotating upper rotating surface 3302 can be arranged on the same stirring protrusion 330 at the same time.

[0081] Further, the forward rotating upper rotating surface 3301 and the reverse rotating upper rotating surface 3302 can be staggered on the outer peripheral side wall of the connecting portion 331. The plurality of reverse rotating upper rotating surfaces 3302 can be arranged in sequence based on at least one first spiral ascending line (i.e., a spiral line ascending in the first rotation direction P), and the plurality of forward rotating upper rotating surfaces 3301 can be arranged in sequence based on at least one second spiral ascending line in the opposite direction (i.e., a spiral line ascending in the second rotation direction Q).

[0082] In the above technical solution, the simultaneous arrangement of the forward rotating upper rotating surface 3301 and the reverse rotating upper rotating surface 3302 can adapt to the torque output mode of the rotating actuator 11 performing forward and reverse rotation alternately. No matter the rotating actuator 11 rotates forward, reverses, or alternately rotates forward and reverses, the stirring and cutting member 33 can disturb the liquid and lift the grinding medium 213 to the greatest extent, further improving the uniformity and efficiency of the lysis.

[0083] In an operation process, for the genetic detection kit 2 provided with the biological sample lysis device 3, all reagents for nucleic acid extraction are preloaded in the kit, including the grinding medium 213 for lysis of cells, and the specific operation process is as follows.

[0084] First, the opening sealing cover 31 on the genetic detection kit 2 is unscrewed, the biological sample to be tested is added to the lysis cavity 211 of the kit, and the stirring and cutting member 33 is inserted into the lysis cavity 211 through the sample adding port 210, and the opening sealing cover 31 is screwed again.

[0085] Secondly, the gene detection kit 2 with the sample is put into the suitable gene detection equipment 1, and the subsequent steps can be automatically completed by the gene detection equipment 1. The gene detection kit 2 enters the inside of the gene detection equipment 1, the rotary brake moves downward, the coupler on the output end thereof is inserted into the coupling through hole 3210 of the biological sample lysis device 3, and the coupling convex 3211 is engaged with the coupling groove 111. At the same time, the heating device 12 also moves to the vicinity of the lysis cavity 211 of the gene detection kit 2 and closely adheres to the side wall of the lysis cavity 211, and the heating block in the heating device 12 starts to heat, so that the temperature in the lysis cavity 211 is increased to 65℃ (the temperature can be set according to the actual experiment). The rotary brake is started, and the rotating speed can be set to 8000 rpm.

[0086] In the process of rotating the rotary brake, the grinding medium 213 is also disturbed and collided by the high-speed rotating stirring protrusions 330 of the stirring cutter 33, the grinding medium 213 bombards the cells, so that the cell wall is damaged, and the effect of cell lysis is achieved. The rotary brake can rotate clockwise, counterclockwise or alternately clockwise / counterclockwise, and the alternately clockwise / counterclockwise mode is usually adopted. The alternately clockwise / counterclockwise rotation combined with the wall heating of the heating device 12 can improve the collision probability and lysis speed of the grinding medium 213.

[0087] After lysis, the rotary brake stops rotating and moves upward, so that the coupler is separated from the coupling through hole 3210 of the biological sample lysis device 3, and the heating block of the heating device 12 ends heating and moves away from the side wall of the lysis cavity 211. The nucleic acid detection kit is taken out or transferred, and subsequent operations can be performed.

[0088] The above only describes the preferred embodiments of the present application and is not used to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A biological sample lysing device, characterized by, The biological sample lysing device is applied to a vertical gene detection kit, the inside of the gene detection kit has a vertical lysing cavity, the top end of the gene detection kit has a sample adding port, the sample adding port is communicated with the lysing cavity, and the biological sample lysing device comprises: An opening sealing cover is used for being connected with the sample adding port and for sealing the sample adding port; A rotating transmission member is rotatably connected to one end of the opening sealing cover; the opening sealing cover has a containing hole, and a transmission structure of the rotating transmission member is exposed through the containing hole; A stirring cutting member is fixed to the other end of the rotating transmission member, and the stirring cutting member is contained in the lysing cavity.

2. The biological sample lysing device of claim 1, wherein, The stirring cutting member comprises a plurality of block-shaped stirring protrusions which are independent from each other and have cutting edges, and the plurality of stirring protrusions are arranged around the axis of the rotating transmission member.

3. The biological sample lysing device of claim 2, wherein, At least one of the stirring protrusions has at least one inclined upper rotation surface; under the rotation of the rotating transmission member, the upper rotation surface can lift and throw the grinding medium in the lysing cavity.

4. The biological sample lysing device of claim 3, wherein, The upper rotation surface comprises a forward rotation upper rotation surface and a reverse rotation upper rotation surface which have opposite lifting directions; the forward rotation upper rotation surface can lift and throw the grinding medium under the forward rotation of the rotating transmission member, and the reverse rotation upper rotation surface can lift and throw the grinding medium under the reverse rotation of the rotating transmission member; The forward rotation upper rotation surface and the reverse rotation upper rotation surface are respectively arranged on different stirring protrusions, or the forward rotation upper rotation surface and the reverse rotation upper rotation surface are arranged on the same stirring protrusion.

5. The biological sample lysing device of claim 2, wherein, At least one of the stirring protrusions has a contact surface which is perpendicular to the axis of the rotating transmission member.

6. The biological sample lysing device of claim 2, wherein, The gap width between the stirring protrusion and the circumferential inner wall of the lysing cavity is smaller than the particle size of the grinding medium in the lysing cavity.

7. The biological sample lysing device of any one of claims 2-6, wherein, The plurality of stirring protrusions are helically arranged in the axial direction of the rotating transmission member.

8. The biological sample lysing device of any one of claims 2-6, wherein, The plurality of stirring protrusions are aligned in the axial direction of the rotating transmission member, and the plurality of stirring protrusions are aligned in the circumferential direction of the rotating transmission member.

9. The biological sample lysing device of any one of claims 2-6, wherein, The plurality of stirring protrusions are staggered and uniformly distributed around the axis of the rotating transmission member.

10. The biological sample lysing device of any one of claims 1-6, wherein, The bottom end of the stirring cutting member and the bottom end of the lysing cavity have a containing space, and the height of the containing space is not more than half of the height of the lysing cavity.

11. The biological sample lysing device of any one of claims 1-6, wherein, The biological sample lysing device further comprises at least one V-shaped sealing ring, the V-shaped sealing ring is sleeved on the rotating transmission member, and the sealing lip of the V-shaped sealing ring abuts against the opening sealing cover to seal the gap between the opening sealing cover and the rotating transmission member.

12. The biological sample lysing device of any one of claims 1-6, wherein, The end of the rotating transmission member close to the opening sealing cover has a coupling through hole, the transmission structure comprises at least one coupling boss, the coupling boss is arranged on the circumferential inner wall of the coupling through hole, and the coupling boss is used for being engaged with the coupling groove on the output end of the rotary actuator.

13. The biological sample lysing device of any one of claims 1-6, wherein, The opening sealing cover is detachably connected with the sample adding port through a screwing structure.

14. A genetic detection kit, characterized by, The gene detection kit comprises: A kit shell comprises a lysis cavity and a sample adding port in communication with each other, the sample adding port is arranged at the top end of the kit shell, and the lysis cavity is vertically arranged in the interior of the kit shell; The biological sample lysis device of any one of claims 1 to 13 is connected with the sample adding port through the opening sealing cover, and the stirring cutting member extends into the lysis cavity.

15. A gene detection apparatus, characterized by comprising: The gene detection device comprises: The gene detection kit of claim 14; A rotary actuator is arranged at the top of the biological sample lysis device, and the rotary actuator is used for coupling connection with the transmission structure of the biological sample lysis device; A heating device is arranged on one side of the kit shell having the lysis cavity.

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