WO2023272429A1 - 微量吸管及生物样本制备系统 - Google Patents

微量吸管及生物样本制备系统 Download PDF

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Publication number
WO2023272429A1
WO2023272429A1 PCT/CN2021/102730 CN2021102730W WO2023272429A1 WO 2023272429 A1 WO2023272429 A1 WO 2023272429A1 CN 2021102730 W CN2021102730 W CN 2021102730W WO 2023272429 A1 WO2023272429 A1 WO 2023272429A1
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Prior art keywords
micropipette
biological sample
outer sleeve
tube
sample preparation
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PCT/CN2021/102730
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English (en)
French (fr)
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王俊超
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Individual
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Individual
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Priority to PCT/CN2021/102730 priority Critical patent/WO2023272429A1/zh
Publication of WO2023272429A1 publication Critical patent/WO2023272429A1/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/26—Inoculator or sampler

Definitions

  • the invention relates to a micropipette, in particular to a micropipette used in an automatic biological sample preparation system, and belongs to the field of biological sample testing.
  • the micropipette suitable for a biological sample preparation system, which includes a working module coupled with the micropipette.
  • the micropipette structurally includes an outer sleeve and a piercing tube.
  • the outer sleeve has an upper end and a lower end, and an opening is respectively provided at the upper end and the lower end.
  • the puncture tube is installed in the outer sleeve, and the tapered end of the puncture tube protrudes out of the opening at the lower end of the outer sleeve.
  • the working module of the biological sample preparation system is coupled to the puncture tube, which can drive the puncture tube to move along the longitudinal direction of the outer cannula.
  • the outer sleeve of the micropipette further includes a stirring member disposed on the outer surface of the lower end of the outer sleeve.
  • the stirring member includes at least one protrusion disposed along the length direction of the outer casing.
  • a clamping portion is provided near the upper end of the outer sleeve, wherein the clamping portion protrudes from the outer surface of the outer sleeve.
  • the opening of the puncture tube is provided with a first engaging structure for detachably connecting with the working module.
  • the working module includes an operating part, which is used to pass through the puncture tube of the micropipette, and is detachably connected with the puncture tube, and is configured to drive the puncture tube in the outer casing through the operating part. height to draw biological samples into the outer casing or discharge them out of the outer casing.
  • the operating member is a magnetic bar. Furthermore, the operating member can be used to drive the micropipette to rotate to stir the biological sample.
  • the working module further includes a gripper for gripping the outer tube of the micropipette.
  • the outer sleeve can be provided with a clamping portion close to its upper end, which protrudes from the outer surface of the outer sleeve for the gripper to grasp.
  • Fig. 1 is a schematic diagram according to an embodiment of the present invention.
  • FIGS. 2A and 2B are schematic structural views of a micropipette 100 according to an embodiment of the present invention.
  • FIG. 3A is a schematic structural diagram of a micropipette 200 according to another embodiment of the present invention
  • FIG. 3B is a schematic diagram of an explosion of the micropipette 200 shown in FIG. 3A;
  • FIGS. 4A to 4L are schematic diagrams showing the operation of the micropipette 200 according to an embodiment of the present invention.
  • FIG. 5A is a schematic structural diagram of a micropipette 300 according to another embodiment of the present invention
  • FIG. 5B is an exploded schematic diagram of the micropipette 300 shown in FIG. 5A;
  • FIGS. 6A to 6D are schematic diagrams showing the operation of the micropipette 300 according to an embodiment of the present invention.
  • the present invention proposes a novel micropipette suitable for use in automatic biological sample processing equipment, especially in automatic nucleic acid extraction or testing equipment.
  • the micropipette disclosed in the present invention is configured to be used with automatic biological sample processing equipment, and a single micropipette can complete various operational steps in the biological sample processing process, such as piercing, sampling, mixing, moving and releasing.
  • the micropipette proposed by the present invention can simplify the execution steps of the mechanism of the automatic biological sample processing equipment, and can simultaneously complete the hole breaking and sampling steps through a single execution step.
  • the first aspect of the present invention relates to a biological sample preparation system, which mainly includes a working module and a micropipette.
  • the biological sample preparation system of the present invention is a fully automated nucleic acid extraction (for example, ribose nucleic acid (ribose nucleic acid; RNA) or deoxyribonucleic acid (deoxyribose nucleic acid; DNA)) system, which can effectively prepare High-purity nucleic acid products.
  • ribose nucleic acid ribose nucleic acid
  • DNA deoxyribonucleic acid
  • FIG. 1 is a schematic diagram of a biological sample preparation system 1000 according to an embodiment of the present invention, the system includes a working module 160 , a power supply module 180 and a micropipette 100 .
  • the power supply module 180 is electrically coupled with the working module 160 to provide the electrical energy required to run the biological sample preparation system 1000 .
  • the working module 160 includes a driver 162 , a magnetic attraction module 164 and an operating element 166 coupled to each other.
  • the operating element 166 is driven by the driver 162 to be used with the micropipette 100 to complete the steps of automatic biological sample processing.
  • the working module 160 is an automated robot arm, which can drive the micropipette 100 of the present invention to move horizontally and/or vertically in three-dimensional space.
  • the driver 162 includes, but is not limited to, a motor or an actuator.
  • it can be accomplished by setting up components such as conveyor belts and screws, and the configuration of each component can be adjusted according to actual needs, and according to common knowledge Configure related components.
  • FIGS. 2A and 2B are schematic structural views of a micropipette 100 according to an embodiment of the present invention.
  • the micropipette 100 structurally includes an outer sleeve 110 and a piercing tube 120 , wherein the piercing tube 120 is passed through the outer sleeve 110 .
  • the outer sleeve 110 has an upper end 112 and a lower end 114, wherein the upper end 112 and the lower end 114 are respectively provided with openings 113 and 115.
  • the piercing tube 120 has an upper end 122 and a lower end 124 , wherein the upper end 122 defines an opening 123 , and the lower end 124 tapers into a tapered end 125 .
  • the tapered end 125 of the puncture tube 120 can protrude from the opening 115 of the lower end 114 of the outer cannula 110 for puncturing.
  • the sealed sample or reagent to be tested can be pierced directly through the micropipette 100 to facilitate aspirating the sample or reagent.
  • the micropipette 100 is driven through the working module 160, so that the puncture tube 120 can move up and down in the outer cannula 110 along its longitudinal direction for Suction or discharge of liquid.
  • the puncture tube 120 set in the outer sleeve 110 is driven by the working module 160 and stretched upwards so that the lower end 124 of the puncture tube 120 is away from the lower end 114 of the outer sleeve 110, the liquid can pass through the lower end 114 of the outer sleeve 110.
  • the lower opening 115 is sucked into the outer sleeve 110 to complete sample or reagent suction.
  • the puncture tube 120 arranged in the outer tube 110 is driven by the working module 160 and pushed down so that the lower end 124 of the puncture tube 120 is close to the lower end 114 of the outer tube 110, the liquid can pass through the outer tube 110.
  • the lower end opening 115 is discharged out of the outer sleeve 110 to complete the discharge of samples or reagents.
  • the two components can engage with each other.
  • the micropipette 100 is a disposable component to avoid cross-contamination between biological samples.
  • the micropipette 100 can be made of the following materials, including, but not limited to: silicone, polypropylene (PP), polyethylene (PE), polycarbonate (PC), polyvinylchloride (PVC), polycaprolactone (PCL), acrylonitrile butadiene styrene (ABS), polysulfone (PSU), polycyclohexylene ethylene terephthalate glycol (PCTG), thermoplastic elastomer (TPE), thermo polyurethane (TPU), thermoplastic vulcanizate (TPV), thermoplastic Styrene (TPS), thermoplastic Styrene (TPS), thermoplastic Thermoplastic polyamide elastomer (TPA) or a combination thereof.
  • FIG. 3A is a schematic structural diagram of a micropipette 200 according to another embodiment of the present invention
  • FIG. 3B is a schematic exploded view of the micropipette 200 shown in FIG. 3A
  • the micropipette 200 is substantially the same as the micropipette 100 shown in FIG. 1 , so the same components will not be repeated here.
  • the micropipette 200 is the same as the micropipette 100 shown in FIG. 2A and FIG. 2B , mainly composed of an outer tube 210 and a puncture tube 220 , and the puncture tube 220 can be inserted into the overtube 210 .
  • a clamping portion 218 is provided on the outer surface of the outer sleeve 210 close to the upper end 212 , and the clamping portion 218 protrudes outward along the outer edge of the upper end to form a ring shape.
  • the shape of the clamping portion 218 can also be changed according to actual usage requirements, for example, it is presented as a bump.
  • a stirring member 216 is provided on the outer surface of the outer sleeve 210 close to the lower end 214 for contacting with the sample or reagent and assisting stirring and mixing.
  • the working module (not shown in the figure) is inserted into the puncture tube 220 and engaged with it, and then the micropipette 200 is driven to rotate on the axis, and the stirring member 216 of the outer sleeve 210 assists in stirring the sample or Reagents that produce perturbing efficacy.
  • the stirrer 216 may be a raised strip or a fin disposed on the outside of the outer casing 210 in configuration, and is arranged along the length direction of the outer casing 210, for example, at least One, two, three, four, five ridges or fins, preferably arranged in a symmetrical manner.
  • the upper end 222 of the piercing tube 220 is provided with an engaging structure 228 , so that the working module is detachably connected to the piercing tube 220 through the engaging structure 228 .
  • the engaging structure 228 can select corresponding components according to actual use requirements.
  • the engaging structure 228 is presented in a buckling manner, but it is not limited thereto.
  • FIGS 4A to 4L are schematic diagrams showing the operation of the micropipette 200 according to an embodiment of the present invention.
  • test tube racks for placing test sleeves or micropipettes for sampling
  • test Use reagents and biological samples to be processed, and perform nucleic acid extraction and/or detection through the working module.
  • the multiple accommodation spaces of the sample tank can be filled with required reagents, such as magnetic beads, lysis buffer, and binding buffer. (binding buffer), wash buffer and/or elute buffer.
  • required reagents such as magnetic beads, lysis buffer, and binding buffer. (binding buffer), wash buffer and/or elute buffer.
  • the micropipette 200 is preferably placed on the test tube rack C, so as to facilitate access by the working module.
  • the structure of the working module is similar to that of the working module 160 shown in FIG. 1 , wherein the operating parts are a rod-shaped part 266A and a clamping part 266B.
  • the rod-shaped part 266A can be driven through the driver to pass through the puncture tube 220 from the upper end 222 of the puncture tube 220 , and the rod-shaped part 266A is engaged with the micropipette 200 through the engaging structure 228 of the puncture tube 220 superior.
  • the locking structure 228 may be a corresponding locking block and a locking slot, or other known structures capable of engaging with each other.
  • the rod-shaped part 266A is driven to remove the micropipette 200 from the test tube rack C, and then grabs the clamping part 218 of the outer sleeve 210 with the clamping part 266B, and the clamping part 266B is fixed on the clamping part 218 close together.
  • the clamping member 266B and the rod-shaped member 266A are driven synchronously so that the micropipette 200 directly performs the action of sampling reagent or sample, and the micropipette 200 is driven to make the tapered end 225 of the puncture tube 220 puncture and puncture. Sampling was performed directly after the cap on sample S.
  • the rod-shaped member 266A rises upwards, while the clamping member 266B maintains a stationary state, so that the piercing tube 220 rises upwards along the longitudinal direction of the outer cannula 210, so that the tapered end 225 of the piercing tube 220
  • the sample is drawn into the outer cannula 210 away from the lower end 214 of the outer cannula 210 .
  • the working module drives the micropipette 200 to move through the rod-shaped part 266A and the clamping part 266B, and puts the aspirated sample into other test reaction tanks, for example, reagent tanks. As shown in FIG.
  • the working module drives the micropipette 200 to move into the reagent tank W1 through the rod-shaped part 266A and the clamping part 266B, and pushes the sample originally absorbed in the outer sleeve 210 down through the driving rod-shaped part 266A. Press, so that the tapered end 225 of the puncture tube 220 moves toward the lower end 214 of the overtube 210, and the puncture tube 220 and the overtube 210 are pressed against each other until the tapered end 225 of the puncture tube 220 protrudes outside the lower end opening 215 of the overtube 210 , allowing the sample in the outer tube 210 to be discharged into the reagent tank W1.
  • the reagent in the reagent tank W1 may contain a plurality of magnetic beads B. At least a part of the lower end of the lower end extends below the liquid surface of the sample to be processed, and the clamping part 266B is spread out in the horizontal direction, so that the clamping part 266B is not fixed on the clamping part 218 of the outer sleeve 210, and then the rod-shaped part 266A drives the micropipette 200 to rotate on the axis, and stirs and mixes through the stirring member (not shown in the figure) on the outer sleeve 210 .
  • the rod 266A is not magnetic, but exists in the form of a general rod.
  • the rod-shaped member 266A is attracted by the magnetic attraction force to the magnetic beads B in the reagent tank W1, so that it is accumulated and adsorbed on the micropipette 200, usually on the jacket Lower end 214 of tube 210 and lower end 224 of piercing tube 220 (FIG. 4H).
  • the rod-shaped member 266A can also be made non-magnetic by adjusting the magnetic attraction module, or the magnetic bead B can be dropped into the inspection slot W2 by the principle of same-sex repulsion, and then manipulated through the working module 260 Clamp 266B or rod 266A is withdrawn from micropipette 200 .
  • the micropipette 200 is moved to the test tube rack C for recovery by driving the rod-shaped part 266A and the clamping part 266B, and the clamping part 266B and the rod-shaped part 266A are removed from the micropipette 200 Exit and leave the micropipette 200 on the test tube rack C.
  • test tube racks In order to avoid contamination between biological samples, those skilled in the art should be able to use their usual experience to set up a plurality of areas, for example, set up at least two test tube racks, one of which is to place clean and unused micropipettes, and the other test tube rack It is to place used micropipettes to establish contaminated and non-contaminated areas to avoid cross-contamination between samples.
  • the working module shown in the present invention can integrate a plurality of magnetic rods and/or holders to process multiple samples at the same time, and the number of said magnetic rods and/or holders can be at least one, two, three , Four or five or more, but not limited thereto.
  • FIG. 5A is a schematic structural diagram of a micropipette 300 according to another embodiment of the present invention
  • FIG. 5B is a schematic exploded view of the micropipette 300 shown in FIG. 5A
  • the micropipette 300 is substantially the same as the micropipette 100 shown in FIG. 1 , therefore, the same components will not be repeated here.
  • the micropipette 300 structurally includes an outer tube 310 and a puncture tube 320 , wherein the puncture tube 320 is passed through the outer tube 310 .
  • the outer sleeve 310 has an upper end 312 and a lower end 314 respectively defining openings 313 and 315 , and the outer sleeve 310 further has a hook 318 at the upper end.
  • the hook 318 is preferably an elastic hook structure, and the number of the hook 318 can be at least one, two, three, four or five hooks. In a preferred embodiment, at least two hooks 318 are disposed on the upper end 312 of the outer sleeve 310 .
  • the puncture tube 320 has an upper end 322 and a lower end 324 , wherein the upper end 322 defines an opening 323 , and the lower end 324 tapers into a tapered end 325 . Furthermore, the upper end 322 of the puncture tube 320 is provided with an engaging structure 328 for detachably connecting with the operating part of the working module. Those skilled in the art should understand that the engaging structure 328 can select corresponding components according to actual use requirements. In this embodiment, the engaging structure 328 is presented in a buckle manner, but it is not limited thereto.
  • the tapered end 325 of the puncture tube 320 can protrude from the lower opening 315 of the outer cannula 310 .
  • a stirring member (not shown in the figure) may be provided on the outer surface of the outer sleeve 310 close to the lower end 314 to assist stirring and mixing.
  • 6A to 6D are schematic diagrams illustrating the operation of the micropipette 300 according to an embodiment of the present invention.
  • micropipette 300 is also combined with and driven by a working module (not shown in the figure) to perform various steps in the biological sample preparation process.
  • the micropipette 300 is preferably placed on the test tube rack C and used as a working module.
  • the structure of the working module is similar to that of the working module 160 shown in FIG. 1 , so the same components will not be described again.
  • the operating member 366 includes a rod-shaped member 382, a first sleeve 384 and a second sleeve 386, wherein the first sleeve 384 is sleeved on the upper end of the rod-shaped member 382 and coupled with it.
  • the second sleeve 386 is sleeved outside the first sleeve 384 and coupled with the first sleeve 384, and the operating member 366 is driven by a driver (not shown in the figure), so that the rod-shaped member 382 can move along the
  • the first sleeve 384 moves up and down along the lengthwise direction
  • the first sleeve 384 can also move up and down along the lengthwise direction of the second sleeve 386 .
  • the rod-shaped member 382 , the first sleeve 384 and the second sleeve 386 can move simultaneously or separately according to usage requirements.
  • the driver can be used to drive the operating part 366 to pass through the puncture tube 320 from the upper end 322 of the puncture tube 320 , and to be locked through the engaging structure 328 of the puncture tube 320 . fit on the micropipette 300 , and wherein the hook 318 of the outer sleeve 310 is engaged with the groove 388 of the second sleeve 386 .
  • the operating member 366 is driven to remove the micropipette 300 from the test tube rack C, and move it to the hole plate where detection or sample processing is to be performed.
  • the well plate may be a well plate with 4, 6, 12, 24, 48, 96, 192 or 384 wells. In other embodiments, the well plate may also be in the form of a reagent cassette.
  • the puncture tube 320 is driven to stretch upwards, and the second sleeve 386 fixes the outer sleeve 310, so that The tapered end 325 of the piercing tube 320 is away from the lower end 314 of the outer cannula 310 to draw a sample or reagent into the outer cannula 310 .
  • the micropipette 300 is moved to another reaction well W4 by driving the operating member 366, at least a part of the micropipette 300 is extended downward into the reaction well W4 by the operating member 366, and then the second reaction well W4 is driven.
  • the sleeve tube 384 and the rod-shaped part 382 push down along the longitudinal direction of the second sleeve tube 386, so that the tapered end 325 of the puncture tube 320 moves toward the lower end 314 of the outer sleeve 310, so that the puncture tube 320 and the The tapered end 325 of the outer sleeve 310 abutting against the puncture tube 320 protrudes out of the outer sleeve 310 , allowing the sample or reagent in the outer sleeve 310 to be discharged into the reaction hole W4 .
  • the micropipette 300 is driven to rotate around the axis through the rotating operating member 366 .
  • the surface of the outer sleeve 320 may be provided with a stirring member (not shown in the figure) to assist in stirring and mixing, and the stirring member is arranged at a position below the outer sleeve that contacts the sample or reagent. better.
  • the outer cannula 300 is moved out of the reaction hole W4 through the operating member 366 .
  • FIG. 6D for the steps of removing the micropipette 300 from the test tube rack C.
  • the micropipette 300 is moved to the test tube rack C for recovery by driving the operating member 366 .
  • the operating member 366 moves the micropipette 300 to the test tube rack C, and the micropipette 300 is inserted into the test tube rack C through the driving rod 382, the first sleeve 384 and the second sleeve 386, and the Push down along the lengthwise direction of the rod-shaped member 382 through the first sleeve 384 and the second sleeve 386 to remove the micropipette 300 from the operating member 366 .
  • the working module can also use the magnetic attraction module to enable the operating part 366 to execute the nucleic acid extraction or detection method developed on the magnetic bead technology platform.
  • the arrangement of the magnetic attraction module and the operating member 366 is in principle the same as that of the above-mentioned embodiments, so it will not be repeated here.

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Abstract

在此公开一种微量吸管和含所述微量吸管的生物样本制备系统。所述微量吸管包括外套管和穿刺管。所述外套管的上端和下端分别设有开口，穿刺管穿设于外套管中，其中穿刺管的上端设有开口，下端渐缩成一锥状末端。所述微量吸管透过与生物样本制备系统的工作模块可操作地连接，以利用微量吸管执行生物样本处理或检测的步骤。

Description

微量吸管及生物样本制备系统 技术领域
本发明是关于一种微量吸管，且特别是关于一种供自动化生物样本制备系统使用的微量吸管，属于生物样本检验领域。
背景技术
在自动化生物样本制备设备的领域中，尤其在核酸萃取或生物技术检验的过程涵盖多种步骤，例如，取样、混合、分离等，为避免样本间交叉污染，过程中需不断地使用或更换取样耗材。另一方面，现有的取样耗材，即，吸管(pipette或pipette tip)，样式有限使得于设计自动化设备上机构体积无法缩小，且执行的实验流程较为繁琐，无法有效率地执行自动化核酸萃取或生物技术检验。
有鉴于此，为了提升生物样本设备的处理效能，本领域亟需一种改良的微量吸管和自动化生物样本制备系统，以改善现有技术的不足。
发明内容
发明内容旨在提供本发明内容的简化摘要，以使阅读者对本发明内容具备基本的理解。此发明内容并非本发明内容的完整概述，且其用意并非在指出本发明实施例的重要/关键组件或界定本发明的范围。
本发明一方面关于一种微量吸管，适用于一生物样本制备系统，其包含一工作模块与所述微量吸管耦接。所述微量吸管在结构上包含一外套管和一穿刺管。具体而言，外套管具有一上端和一下端，且于上端和下端分别设有一开口，所述穿刺管设有一上端和一下端，其中上端设有开口，下端渐缩成一锥状末端，且所述穿刺管穿设于外套管中，且穿刺管的锥状末端凸出于外套管下端的开口外。在实际使用的过程，所述生物样本制备系统的工作模块与该穿刺管耦接，可驱动穿刺管沿着外套管 的纵长方向移动。
依据本发明一实施方式，所述微量吸管的外套管更包含一搅拌件，设于外套管下端的外表面上。在一实施方式中，所述搅拌件包含至少一凸起沿着外套管的长度方向设置。
依据本发明另一实施方式，所述外套管接近上端处设有一夹持部，其中该夹持部凸出于该外套管的外表面。
在一实施方式中，所述穿刺管的开口设有一第一卡合结构，用以与工作模块可拆卸式地连接。
本发明另一方面是关于一种生物样本制备系统，包含上述任一实施方式所示的微量吸管和一工作模块。具体而言，所述工作模块包含一操作件，用以穿设于微量吸管的穿刺管中，并与穿刺管可拆卸式地连接，且经配置可透过操作件驱动穿刺管于外套管内的高度，以吸取生物样本至外套管内或排出于外套管外。
在一具体的实施方式中，所述操作件为一磁棒。再者，所述操作件可用以驱动该微量吸管旋转，以搅拌生物样本。
依据本发明一实施方式，所述工作模块更包含ㄧ夹取件，用以夹取微量吸管的外套管。具体而言，所外套管接近其上端处可设有一夹持部，凸出于外套管的外表面供夹取件抓持。
在参阅下文实施方式后，本领域技术人员当可轻易了解本发明的基本精神及其他发明目的，以及本发明所采用的技术手段与实施方式。
附图说明
为让本发明的上述与其他目的、特征、优点与实施例能更明显易懂，所附附图的说明如下：
图1为依据本发明一实施方式所示的的示意图；
图2A和图2B为依据本发明一实施方式所示的微量吸管100的结构示意图；
图3A为依据本发明另一实施方式所示的微量吸管200的结构示意图，图3B为图3A微量吸管200的爆炸示意图；
图4A至图4L为依据本发明一实施方式所示的微量吸管200的操作示意图；
图5A为依据本发明另一实施方式所示的微量吸管300的结构示意图，图5B为图5A微量吸管300的爆炸示意图；以及
图6A至图6D为依据本发明一实施方式所示的微量吸管300的操作示意图；
根据惯常的作业方式，图中各种特征与组件并未依比例绘制，其绘制方式是为了以最佳的方式呈现与本发明相关的具体特征与组件。此外，在不同附图间，以相同或相似的组件符号来指称相似的组件/部件；
附图标记：
生物样本制备系统1000；
工作模块160；
电源供应模块180；
微量吸管100、200、300；
工作模块160、260；
驱动器162；
磁吸模块164；
操作件166、366；
外套管110、210、310；
外套管的上端112、212、312；
外套管的下端114、214、314；
开口113、114、115、123、313、315、323；
穿刺管120、220、320；
穿刺管的上端122、222、322；
穿刺管的下端124、224、324；
锥状末端125、225、325；
搅拌件216；
夹持部218；
卡合结构228、328；
杆状件266A、382；
夹持件266B；
卡勾318；
第一套管384；
第二套管386；
沟槽388；
试管架C；
磁珠B；
试剂槽W1；
检视槽W2；
孔盘W3；
反应孔W4。
具体实施方式
为了使本发明内容的叙述更加详尽与完备，下文针对了本发明的实施方式与具体实施例提出了说明性的描述；但这并非实施或运用本发明具体实施例的唯一形式。实施方式中涵盖了多个具体实施例的特征以及用以建构与操作这些具体实施例的方法步骤与其顺序。然而，也可利用其他具体实施例来达成相同或均等的功能与步骤顺序。
虽然用以界定本发明较广范围的数值范围与参数皆是约略的数值，此处已尽可能精确地呈现具体实施例中的相关数值。然而，任何数值本质上不可避免地含有因个别测试方法所致的标准偏差。在此处，“约”通常系指实际数值在一特定数值或范围的正负10％、5％、1％或0.5％之内。或者是，“约”一词代表实际数值落在平均值的可接受标准误差之内，视本领域技术人员的考虑而定。除了实验例之外，或除非另有明确的说明，当可理解此处所用的所有范围、数量、数值与百分比(例如用以描述材料用量、时间长短、温度、操作条件、数量比例及其他相似者)均经过“约”的修饰。因此，除非另有相反的说明，本说明书与附随申请专利范围所公开的数值参数皆为约略的数值，且可视需求而更动。至 少应将这些数值参数理解为所指出的有效位数与套用一般进位法所得到的数值。
除非本说明书另有定义，此处所用的科学与技术词汇的含义与本领域技术人员所理解与惯用的意义相同。此外，在不和上下文冲突的情形下，本说明书所用的单数名词涵盖该名词的复数型；而所用的复数名词时也涵盖该名词的单数型。
为解决现有技术所存在的问题，本发明提出一种新颖的微量吸管，适合应用在自动化生物样本处理设备，特别是应用在自动化核酸萃取或检验的设备上。本发明所揭露的微量吸管经配置搭配自动化生物样本处理设备使用，以单一微量吸管即能够完成生物样本处理过程的多种操作步骤，例如，破孔、取样、混合、移动和释放。再者，依照本发明所提出的微量吸管能够简化自动化生物样本处理设备的机构的执行步骤，透过单一执行步骤即可同时完成破孔及取样步骤。
1.生物样本制备系统
本发明第一方面是关于一种生物样本制备系统，其主包括一工作模块和一微量吸管。在较佳的实施方式中，本发明的生物样本制备系统为一全自动化核酸萃取(例如，核醣核酸(ribose nucleic acid；RNA)或脱氧核醣核酸(deoxyribose nucleic acid；DNA))系统，能够有效制备高纯度的核酸产物。
图1为依据本发明一实施方式所示的生物样本制备系统1000的示意图，所述系统包括工作模块160、电源供应模块180和微量吸管100。所述电源供应模块180与工作模块160电性耦接，用以提供运行生物样本制备系统1000所需的电能。工作模块160包括彼此耦接的驱动器162、磁吸模块164和操作件166，利用驱动器162驱动操作件166搭配微量吸管100使用，用以完成自动化生物样本处理的步骤。
在一实施方式中，所述工作模块160为自动化机械手臂，能带动本发明微量吸管100于三维空间中横向和/或纵向移动。在可任选的实施方式中，所述驱动器162包括但不限于，马达或致动器。再者，为达到驱动本发明微量吸管100于三维空间中横向和/或纵向移动，可透过设置传 输带、螺杆等构件完成，且各构件配置的方式可依据实际需求调整，并依据通常知识加以配置相关构件。
2.微量吸管
图2A和图2B为依据本发明一实施方式所示的微量吸管100的结构示意图。所述微量吸管100在结构上包含外套管110和穿刺管120，其中穿刺管120穿设于外套管110中。所述外套管110具有一上端112和一下端114，其中该上端112和该下端114分别设有开口113和115。所述穿刺管120具有一上端122和一下端124，其中上端122设有一开口123，下端124渐缩成一锥状末端125。在一较佳的实施方式中，当穿刺管120穿设于外套管110时，穿刺管120的锥状末端125可凸出于外套管110下端114的开口115外，用以进行穿刺。举例来说，可透过所述微量吸管100直接穿刺密封的待检测样本或试剂，以利吸取样本或试剂。
请同时参见图1和图2A、2B，在实际使用的过程中，所述微量吸管100透过工作模块160驱动，可使穿刺管120于外套管内110沿着其纵长方向上下移动，用以吸取或排放液体。具体而言，当设于外套管110内的穿刺管120经工作模块160驱动，向上拉伸使穿刺管120的下端124远离外套管110的下端114时，所述液体可透过外套管110的下端开口115被吸入至外套管110内，完成样本或试剂吸取。相对地，当设于外套管110内的穿刺管120经工作模块160驱动，向下推压使穿刺管120的下端124接近外套管110的下端114时，所述液体可透过外套管110的下端开口115被排出至外套管110外，完成样本或试剂排放。在一实施方式中，当外套管110经工作模块160驱动，向下推压使穿刺管120抵住外套管110时，二构件可相互卡合。
在较佳的实施方式中，所述微量吸管100是一次性使用的构件，避免生物样本间交叉污染的状况发生。举例而言，所述微量吸管100可利用以下材料所制成，包含，但不限于：silicone,polypropylene(PP),polyethylene(PE),polycarbonate(PC),polyvinylchloride(PVC),polycaprolactone(PCL),acrylonitrile butadiene styrene(ABS),polysulfone(PSU),polycyclohexylenedimethylene terephthalate glycol(PCTG), thermoplastic elastomer(TPE),thermo polyurethane(TPU),thermoplastic vulcanizate(TPV),thermoplastic Styrene(TPS),thermoplastic polyester elastomer(TPEE),thermoplastic polyamide elastomer(TPA)或其组合。
图3A为依据本发明另一实施方式所示的微量吸管200的结构示意图，图3B为图3A微量吸管200的爆炸示意图。原则上所述微量吸管200与图1所示的微量吸管100大致相同，因此，相同组件在此不另赘述。
所述微量吸管200同图2A和图2B所示微量吸管100，主要由外套管210和穿刺管220所组成，且其中所述穿刺管220可穿设于外套管210中。在本实施方式中，所述外套管210的外表面接近上端212处设有夹持部218，所述夹持部218沿着上端的外缘向外凸出形成一环型。本领域技术人员应当可以理解所述夹持部218的形状也可依据实际使用需求改变，例如，以凸块呈现。
再者，外套管210的外表面接近下端214处设有搅拌件216，用以与样本或试剂接触，协助搅拌混合。于实际使用上，将工作模块(图中未绘示)穿设于穿刺管220中并与其卡合，接着带动微量吸管200呈轴心旋转，透过外套管210的搅拌件216协助搅拌样本或试剂，产生扰动的功效。
在一实施方式中，搅拌件216在构形上可以是设于外套管210外面的凸条或翼片，沿着外套管210的长度方向设置，例如，于外套管210的外表面上增设至少一、二、三、四、五个凸条或翼片，且较佳以对称的方式排列设置。
此外，所述穿刺管220的上端222设有卡合结构228，使得所述工作模块透过卡合结构228与穿刺管220可拆卸式的连接。本领域技术人员应当可以理解，所述卡合结构228可依据实际使用需求选用相对应的构件，在本实施方式中所属卡合结构228是以卡扣方式呈现，但不限于此。
图4A至图4L为依据本发明一实施方式所示的微量吸管200使用的操作示意图。
本领域技术人员应当可以理解自动化生物样本制备系统，例如，核酸萃取或检验系统，于工作台面上通常设有试管架、试剂槽、样本槽，供放置取样用的试验套管或微量吸管、试验用试剂及待处理生物样本，并透过所述工作模块执行核酸萃取和/或检测。
再者，在非限制的实施方式中，可依据生物样本制备的目的，于样本槽复数个容置空间中填充所需的试剂，例如，磁珠、裂解缓冲液(lysis buffer)、结合缓冲液(binding buffer)、冲洗缓冲液(wash buffer)和/或冲提缓冲液(elute buffer)。
请参见图4A至4C，于样本实际处理的过程，所述微量吸管200较佳是置于试管架C上，以利工作模块取用。在本实施方式中，所述工作模块架构与图1所示工作模块160类似，其中所述操作件为杆状件266A和夹持件266B。在实际使用过程，可透过驱动器驱动杆状件266A从穿刺管220的上端222穿设于穿刺管220中，且杆状件266A透过穿刺管220的卡合结构228卡合于微量吸管200上。举例而言，所述卡合结构228可以是相对应的卡块及卡槽，或者是其他公知能够相互卡合的结构。杆状件266A经驱动将微量吸管200从试管架C取下，再以夹持件266B抓取所述外套管210的夹持部218，并且夹持件266B靠拢固定于夹持部218上。接着，参见图4D，所述夹持件266B和杆状件266A经同步驱动使微量吸管200直接进行试剂或样本取样的动作，驱动微量吸管200使穿刺管220的锥状末端225穿刺并划破样本S的上盖后直接进行取样。
在图4E中，杆状件266A向上升起，而夹持件266B维持定点不动状态，使得穿刺管220沿着外套管210的纵长方向向上升起，使穿刺管220的锥状末端225远离外套管210的下端214，将样本吸入至外套管210内。接着，所述工作模块透过所述杆状件266A和夹持件266B驱动微量吸管200移动，并将吸取的样本置入至其他试验反应槽内，例如，试剂槽。参见图4F所示，工作模块透过杆状件266A和夹持件266B驱动微量吸管200移动至试剂槽W1内，将原吸取于外套管210内的样本透过驱动杆状件266A向下推压，使穿刺管220的锥状末端225往外套管210的下端214移动，并使穿刺管220和外套管210相抵至穿刺管220 的锥状末端225凸出于外套管210的下端开口215外，让外套管210内的样本排出于试剂槽W1中。
请参见图4G，需要注意的是若以磁珠技术平台进行核酸萃取试验为例，所述试剂槽W1中的试剂可含有复数磁珠B，将微量吸管200中的穿刺管220连同外套管210的下端至少一部分伸入至欲处理样本的液面下，夹持件266B以水平方向向外展开，使夹持件266B非固定于外套管210的夹持部218上，再藉由杆状件266A带动微量吸管200呈轴心旋转，透过外套管210上搅拌件(图中未绘示)进行搅拌混合。需要注意的是于此阶段所述杆状件266A并无磁性，而是以一般棒状件的形式存在。接着，待搅拌完成，透过工作模块中磁吸模块的驱动，使杆状件266A藉由磁吸力吸附试剂槽W1内的磁珠B，使其聚积吸附于微量吸管200上，通常吸附于外套管210的下端214和穿刺管220的下端224(图4H)。透过杆状件266A和夹持件266B将附有磁珠B的微量吸管200移动至检视槽W2上，透过抽离杆状件266A带动穿刺管220向上抽离外套管210，使磁珠B落入至检视槽W2中，再将夹持件266B向上带动外套管210离开检视槽W2(图4I和图4J)。另外，在其他实施方式中，也可透过调控磁吸模块使杆状件266A无磁性或以同性相斥的原理，使磁珠B掉落至检视槽W2中，再透过工作模块260操控夹持件266B或杆状件266A抽离微量吸管200。完成生物样本处理或检测步骤任务后，透过驱动杆状件266A和夹持件266B将微量吸管200移至试管架C上进行回收，将夹持件266B和杆状件266A从微量吸管200上退出，将微量吸管200留置于试管架C上。
为避免生物样本间污染的产生，本领域技术人员应当可利用其通常经验设置复数个区域，例如，设立至少二试管架，其中一试管架是置放干净尚未使用的微量吸管，另一试管架则是置放已使用过的微量吸管，建立污染和无污染的区域，避免样本间交叉污染的情况发生。
再者，本发明所示的工作模块可整合复数个磁棒和/或夹持件，以同时处理多个样本，所述磁棒和/或夹持件的数量可以是至少一、二、三、四或五以上，并不限于此。
图5A为依据本发明另一实施方式所示的微量吸管300的结构示意图，图5B为图5A微量吸管300的爆炸示意图。原则上所述微量吸管300与图1所示的微量吸管100大致相同，因此，相同组件在此不另赘述。
请同时参见图5A和图5B，所述微量吸管300在结构上包含外套管310和穿刺管320，其中穿刺管320穿设于外套管310中。所述外套管310具有一上端312和一下端314，分别设有开口313和315，且所述外套管310于上端处更设有卡勾318。具体而言，所述卡勾318较佳是具有弹性的卡勾结构，且所述卡勾318配置的数量可以是至少一、二、三、四或五个卡勾。在较佳的实施方式中，于外套管310的上端312处设有至少二卡勾318。
所述穿刺管320具有一上端322和一下端324，其中上端322设有一开口323，下端324渐缩成一锥状末端325。再者，所述穿刺管320的上端322设有卡合结构328，用以与工作模块的操作件可拆卸式的连接。本领域技术人员应当可以理解，所述卡合结构328可依据实际使用需求选用相对应的构件，在本实施方式中所属卡合结构328是以卡扣方式呈现，但不限于此。
在一较佳的实施方式中，当穿刺管320穿设于外套管310时，穿刺管320的锥状末端325可凸出于外套管310下端开口315外。再者，外套管310的外表面接近下端314处可设有搅拌件(图中未绘示)，用以协助搅拌混合。
图6A至图6D为依据本发明一实施方式所示的微量吸管300的操作示意图。
于此实施方式中，所述微量吸管300同样是以工作模块(图中未绘示)加以与其结合并驱动，以执行生物样本制备过程各种步骤。
于样本实际处理的过程，所述微量吸管300较佳是置于试管架C上，以工作模块取用。在本实施方式中，所述工作模块架构与图1所示工作模块160类似，因此，相同的组件不另赘述。在本实施方式中，所述操作件366包含一杆状件382、一第一套管384和一第二套管386，其中 第一套管384套设于杆状件382的上端并与其耦接，第二套管386套设于第一套管384外并与第一套管384耦接，所述操作件366经驱动器(图中未绘示)驱动，使得杆状件382可沿着第一套管384纵长方向上下移动，且第一套管384也可沿着该第二套管386的纵长方向上下移动。再者，所述杆状件382、第一套管384和第二套管386可依据使用需求同时或分别移动。
请同时参见图5A和图6A，在实际使用过程中，可透过驱动器驱动操作件366从穿刺管320的上端322穿设于穿刺管320中，并透过穿刺管320的卡合结构328卡合于微量吸管300上，且其中外套管310的卡勾318卡合于第二套管386的沟槽388上。操作件366经驱动将微量吸管300从试管架C取下，移至欲进行检测或样本处理的孔盘上。在可任选的实施方式中，所述孔盘可以是4、6、12、24、48、96、192或384孔的孔盘。在其他实施方式中，所述孔盘也可以是以试剂卡匣的形式存在。
请参见图6B，利用操作件366驱动微量吸管300移至孔盘W3上方，驱动微量吸管300向下并以穿刺管320的锥状末端325穿刺孔盘W3的上盖或封膜后直接插入至样本或试剂的液面下进行取样。透过驱动第一套管384和杆状件382沿着所述第二套管386的纵长方向向上伸起，带动穿刺管320向上拉伸，而第二套管386固定外套管310，使穿刺管320的锥状末端325远离外套管310的下端314，将样本或试剂吸入至外套管310内。
接着，请参见图6C，透过驱动操作件366移动微量吸管300移动至另一反应孔W4上，藉由操作件366将微量吸管300至少一部分向下伸入至反应孔W4内，再驱动第一套管384和杆状件382沿着所述第二套管386的纵长方向向下推压，使穿刺管320的锥状末端325往外套管310的下端314移动，使穿刺管320和外套管310相抵至穿刺管320的锥状末端325凸出于外套管310外，让外套管310内的样本或试剂排出于反应孔W4中。
接着，若需进行搅拌混合的动作，透过旋转操作件366带动微量吸管300呈轴心旋转。在非限制的实施方式中，所述外套管320的表面可 设有搅拌件(图中未绘示)，以协助进行搅拌混合，且所述搅拌件设于外套管下方接触样本或试剂的部位较佳。待完成处理后，透过操作件366带动外套管300移出于反应孔W4外。
除此之外，于卸除微量吸管300于试管架C上的步骤请参见图6D。透过驱动操作件366将微量吸管300移至试管架C上进行回收。具体而言，操作件366将微量吸管300移至试管架C上，透过驱动杆状件382、第一套管384和第二套管386将微量吸管300伸入至试管架C上，透过第一套管384和第二套管386沿着杆状件382的纵长方向向下推压，从将微量吸管300从操作件366上退除。
需要注意的在此实施方式中，所述工作模块也可藉由磁吸模块，使操作件366执行以磁珠技术平台所开发的核酸萃取或检验法。所述磁吸模块与操作件366的配置方式原则上与前述各实施方式相同，因此，在此不另赘述。
虽然上文实施方式中揭露了本发明的具体实施例，然其并非用以限定本发明，本领域技术人员在不悖离本发明的原理与精神的情形下，当可对其进行各种变动与修饰，因此本发明的保护范围当以附随权利要求所界定者为准。

Claims (10)

  1. 一种微量吸管，适用于一生物样本制备系统，其包含一工作模块，其中所述微量吸管包含：
    一外套管，具有一上端和一下端，其中所述上端和所述下端分别设有一开口；以及
    一穿刺管，设有一上端和一下端，其中所述上端设有一开口，所述下端渐缩成一锥状末端，且其中所述穿刺管穿设于所述外套管中，且所述穿刺管的所述锥状末端凸出于所述外套管下端的开口外，且其中所述工作模块与所述穿刺管耦接，驱动所述穿刺管沿着所述外套管的纵长方向移动。
  2. 如权利要求1所述的微量吸管，其中，所述外套管更包含一搅拌件，设于所述外套管下端的外表面上。
  3. 如权利要求2所述的微量吸管，其中，所述搅拌件包含至少一凸起沿着所述外套管的长度方向设置。
  4. 如权利要求3所述的微量吸管，其中，所述外套管接近所述上端处设有一夹持部，其中所述夹持部凸出于所述外套管的外表面。
  5. 如权利要求1所述的微量吸管，其中，所述穿刺管的所述开口更包含一第一卡合结构，用以与所述工作模块可拆卸式地连接。
  6. 一种生物样本制备系统，包含：
    一如权利要求1所述的微量吸管；以及
    一工作模块，包含一操作件，用以与所述微量吸管的所述穿刺管可拆卸式地连接，其中经配置可透过所述操作件驱动所述穿刺管于所述外套管内的高度，以吸取所述生物样本至所述外套管内或排出于所述外套管外。
  7. 如权利要求6所述的生物样本制备系统，其中，所述操作件为一磁棒。
  8. 如权利要求6所述的生物样本制备系统，其中，所述操作件用 以驱动所述微量吸管旋转，以搅拌所述生物样本。
  9. 如权利要求6所述的生物样本制备系统，其中，所述工作模块更包含ㄧ夹取件，经配置用以夹取所述微量吸管的所述外套管。
  10. 如权利要求9所述的生物样本制备系统，其中，所述外套管接近所述上端处设有一夹持部，凸出于所述外套管的外表面，且其中所述夹取件透过所述夹持部夹取所述外套管。
PCT/CN2021/102730 2021-06-28 2021-06-28 微量吸管及生物样本制备系统 Ceased WO2023272429A1 (zh)

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CN2574601Y (zh) * 2002-07-27 2003-09-24 盛茂地 多功能采血器
CN1550226A (zh) * 2003-04-16 2004-12-01 贝克顿迪肯森公司 带有被动罩的安全罩针组件
JP2008259686A (ja) * 2007-04-12 2008-10-30 National Institute Of Advanced Industrial & Technology 試料採取器
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