TWM551624U - Fixed tube of nucleic acid extraction assembly and nucleic acid extraction assembly - Google Patents
Fixed tube of nucleic acid extraction assembly and nucleic acid extraction assembly Download PDFInfo
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本新型創作關於一種固定管，特別關於一種核酸萃取組件的固定管及核酸萃取組件。 The present invention relates to a fixed tube, and more particularly to a fixed tube and nucleic acid extraction assembly for a nucleic acid extraction module.
隨著人類基因組測序技術的革新、生物醫學分析技術的進步以及大數據分析工具的出現，精準醫療(Precision Medicine)的時代已經到來。精準醫療是一種定制醫療模式，它以人體基因組信息為基礎，結合蛋白質組、代謝組等相關內環境信息，為患者量身製定出最佳治療方案，以期達到治療效果最大化和副作用最小化。 With the advancement of human genome sequencing technology, advances in biomedical analysis technology, and the emergence of big data analysis tools, the era of Precision Medicine has arrived. Precision Medicine is a customized medical model based on human genome information, combined with proteomics, metabolomes and other relevant internal environmental information, to develop the best treatment for patients, in order to maximize the treatment effect and minimize side effects.
血液是流動在人體的血管和心臟中的一種紅色不透明的粘稠液體，主要成分為血漿、血細胞、遺傳物質(染色體和基因)。其中，cfDNA(cell free DNA)就是在血漿中發現的游離DNA片段，而ctDNA就是循環腫瘤DNA片段(circulating tumor DNA)，其是指cfDNA中來自腫瘤釋放的DNA片段。 Blood is a red opaque viscous liquid that flows through the blood vessels and heart of the human body. The main components are plasma, blood cells, genetic material (chromosomes and genes). Among them, cfDNA (cell free DNA) is a free DNA fragment found in plasma, and ctDNA is a circulating tumor DNA, which refers to a DNA fragment released from a tumor in cfDNA.
幾乎每個人的血液中都含有游離的DNA片段(cfDNA)，它們可能來源於細胞的凋亡、壞死，也可能是通過主動釋放的方式(劇烈運動)進入血液。然而，血液中的cfDNA含量很低，在1ml的血漿中，cfDNA的含量約為1ng~100ng之間，ctDNA的含量更低，僅佔cfDNA的0.1%~5%之間。 Almost everyone's blood contains free DNA fragments (cfDNA), which may be derived from cell apoptosis, necrosis, or may enter the blood by active release (severe exercise). However, the amount of cfDNA in the blood is very low. In 1 ml of plasma, the content of cfDNA is between 1 ng and 100 ng, and the content of ctDNA is lower, accounting for only 0.1% to 5% of cfDNA.
有研究已經證實，腫瘤患者外周血中的cfDNA總量高於健康人，通過這一點，cfDNA的含量若增多，可以起到一個很好的提示作用，藉此作為腫瘤初篩的手段。因此，由液態生物檢體(Liquid Biopsy)中純化 出極微量的cfDNA(核酸的一種)乃是精準醫療的第一步。 Studies have confirmed that the total amount of cfDNA in peripheral blood of patients with tumors is higher than that of healthy people. By this, if the content of cfDNA is increased, it can play a good role as a means of screening for tumors. Therefore, it is purified from liquid biopsy (Liquid Biopsy) A very small amount of cfDNA (a type of nucleic acid) is the first step in precision medicine.
在液體活檢的微量游離核酸(Nucleic Acid)手動純化程序中，一般是利用膜管系統(Column System)透過硅膠膜由檢體中提取極微量的核酸。為了得到較大量的核酸，習知的作法是利用小容量(例如0.7ml)的柱膜管並透過多次操作來獲取，或是加大柱膜管的尺寸而以較大容量(例如10ml以上)的柱膜管對應較大的硅膠膜一次來獲取較大量的核酸。然而，第一種作法將耗費相當多的操作時間與成本，第二種作法雖然一次可得到較多量的核酸，但因大柱膜管的硅膠膜增大又增厚，需以較多溶液方可從硅膠膜中沖提出該核酸，故所得到的微量游離核酸濃度並不會提高。 In the manual purification procedure for liquid biopsy of Nucleic Acid, a very small amount of nucleic acid is generally extracted from the sample through a silica gel membrane using a membrane system. In order to obtain a larger amount of nucleic acid, it is conventionally possible to obtain a large volume (for example, 0.7 ml) of a cylindrical tube and obtain it through multiple operations, or to increase the size of the cylindrical tube to a larger capacity (for example, 10 ml or more). The cylindrical tube corresponds to a larger silica membrane to obtain a larger amount of nucleic acid. However, the first method will consume a considerable amount of operation time and cost. The second method can obtain a larger amount of nucleic acid at a time, but the silica membrane of the large cylindrical tube is enlarged and thickened, and more solution is required. The nucleic acid can be flushed out from the silica gel membrane, so that the concentration of the obtained small amount of free nucleic acid does not increase.
本新型創作的目的為提供一種核酸萃取組件的固定管及核酸萃取組件。相較於上述習知的作法而言，本新型創作核酸萃取組件的設計可快速與方便由較大體積的檢體中萃取出較高濃度的核酸。 The purpose of the novel creation is to provide a fixed tube and a nucleic acid extraction assembly for a nucleic acid extraction module. Compared with the above-mentioned conventional methods, the novel nucleic acid extraction module is designed to quickly and conveniently extract a higher concentration of nucleic acid from a larger volume of the sample.
本新型創作提出一種核酸萃取組件的固定管，核酸萃取組件更包括一柱膜管，柱膜管與固定管相互套接，固定管的特徵在於，包括一筒身部、一管口部以及一底部。筒身部沿一第一方向延伸。管口部遠離筒身部的一端具有往一第二方向突出的一突出部，第一方向與第二方向垂直。底部與管口部分別連接筒身部的相對兩側，底部具有一肩部，底部的肩部與柱膜管連接。 The novel creation proposes a fixed tube of a nucleic acid extraction assembly. The nucleic acid extraction assembly further comprises a cylindrical tube tube, and the cylindrical tube and the fixed tube are sleeved with each other. The fixed tube is characterized in that it comprises a barrel portion, a tube portion and a tube. bottom. The barrel portion extends in a first direction. One end of the nozzle portion away from the barrel portion has a protrusion protruding in a second direction, and the first direction is perpendicular to the second direction. The bottom and the mouth portion are respectively connected to opposite sides of the barrel portion, and the bottom portion has a shoulder portion, and the bottom portion of the bottom portion is connected with the columnar tube.
在一實施例中，其特徵在於，管口部的相對兩側更分別具有一第一開口，該些第一開口將突出部區分成兩段。 In an embodiment, the opposite sides of the nozzle portion further have a first opening, and the first openings divide the protrusion into two segments.
在一實施例中，其特徵在於，底部更包括一階梯狀構造與一第四開口，階梯狀構造是從第四開口處沿第一方向延伸，階梯狀構造與柱膜管連接，且柱膜管由階梯狀構造突出於固定管。 In an embodiment, the bottom portion further includes a stepped structure and a fourth opening, the stepped structure extends from the fourth opening in the first direction, the stepped structure is connected to the cylindrical tube, and the column membrane The tube protrudes from the fixed tube by a stepped structure.
在一實施例中，其特徵在於，筒身部的管徑大於階梯狀構造的管徑。 In one embodiment, the tubular body has a larger diameter than the stepped configuration.
在一實施例中，其特徵在於，離筒身部越遠之階梯狀構造的管徑越小。 In one embodiment, the smaller the diameter of the stepped configuration from the barrel portion, the smaller the diameter.
在一實施例中，其特徵在於，筒身部具有一第二開口，第二開口由該些第一開口的其中之一沿第一方向延伸至階梯狀構造。 In an embodiment, the barrel portion has a second opening, and the second opening extends from the first opening in a first direction to a stepped configuration.
在一實施例中，固定管具有一第三開口，第三開口由管口部沿第一方向延伸至階梯狀構造。 In an embodiment, the fixed tube has a third opening, and the third opening extends from the nozzle portion in the first direction to the stepped configuration.
在一實施例中，其特徵在於，柱膜管具有一第一頂部，固定管之肩部套設於柱膜管之第一頂部的外側。 In one embodiment, the cylindrical tube has a first top portion, and the shoulder of the fixed tube is sleeved outside the first top of the cylindrical tube.
本新型創作更提出一種核酸萃取組件，其特徵在於，包括柱膜管以及上述的固定管。 The novel creation further proposes a nucleic acid extraction assembly, which comprises a cylindrical tube and the above fixed tube.
在一實施例中，其特徵在於，一離心組件包括上述的核酸萃取組件與一離心管，且固定管的突出部頂抵在離心管的管口上。 In one embodiment, a centrifugation assembly comprises the nucleic acid extraction assembly described above and a centrifuge tube, and the projection of the fixed tube abuts against the nozzle of the centrifuge tube.
承上所述，在本新型創作之核酸萃取組件的固定管與核酸萃取組件中，藉由固定管之管口部遠離筒身部的一端所具有之突出部的設計，讓操作者可由離心管中易於拿取固定管。另外，通過固定管之底部的設計可使離心操作時，柱膜管不會掉至離心管底，檢體不會由柱膜管中灑出，增加操作的成功率。此外，藉由本新型創作核酸萃取組件中的固定管與柱膜管的結構設計，也可快速與方便由較大體積的檢體中萃取出較高濃度的核酸。 According to the above, in the fixed tube and nucleic acid extraction assembly of the nucleic acid extraction assembly of the present invention, the operator can be made of a centrifuge tube by designing a protruding portion of the tube portion of the fixed tube away from the end portion of the barrel portion. It is easy to take the fixed tube. In addition, through the design of the bottom of the fixed tube, the cylindrical tube will not fall to the bottom of the centrifuge tube during the centrifugation operation, and the sample will not be spilled from the tube tube, increasing the success rate of the operation. In addition, by designing the structure of the fixed tube and the cylindrical tube in the novel nucleic acid extraction module, it is also possible to quickly and conveniently extract a higher concentration of nucleic acid from a larger volume of the sample.
在本新型創作的一實施例中，藉由固定管之第一開口的設計，可將突出部區分成兩段，藉此，也可讓操作者於萃取的過程中易於操作。 In an embodiment of the present invention, the protrusion can be divided into two sections by the design of the first opening of the fixed tube, thereby also allowing the operator to easily operate during the extraction process.
1‧‧‧核酸萃取組件 1‧‧‧Nucleic acid extraction module
11‧‧‧固定管 11‧‧‧Fixed tube
111‧‧‧筒身部 111‧‧‧Body
112‧‧‧管口部 112‧‧‧Tube
1121‧‧‧突出部 1121‧‧‧Protruding
113‧‧‧底部 113‧‧‧ bottom
1131‧‧‧肩部 1131‧‧‧ shoulder
1132‧‧‧階梯狀構造 1132‧‧‧step structure
12‧‧‧柱膜管 12‧‧‧column tube
121、131‧‧‧直筒部 121, 131‧‧‧ Straight
122‧‧‧第一頂部 122‧‧‧ first top
1221‧‧‧延伸部 1221‧‧‧Extension
123‧‧‧管帽 123‧‧‧ Caps
124‧‧‧連接部 124‧‧‧Connecting Department
125‧‧‧第一底部 125‧‧‧ first bottom
13‧‧‧套管 13‧‧‧ casing
132‧‧‧第二底部 132‧‧‧ second bottom
133‧‧‧第二頂部 133‧‧‧ second top
2‧‧‧離心組件 2‧‧‧ Centrifugal components
21‧‧‧離心管 21‧‧‧ centrifuge tube
211‧‧‧管口 211‧‧‧ mouth
22‧‧‧管蓋 22‧‧‧ tube cover
3‧‧‧膜片 3‧‧‧ diaphragm
4‧‧‧檢體 4‧‧‧Check
A-A、B-B‧‧‧直線 A-A, B-B‧‧‧ Straight line
D1‧‧‧第一方向 D1‧‧‧ first direction
D2‧‧‧第二方向 D2‧‧‧ second direction
O1‧‧‧第一開口 O1‧‧‧ first opening
O2‧‧‧第二開口 O2‧‧‧ second opening
O3‧‧‧第三開口 O3‧‧‧ third opening
O4‧‧‧第四開口 O4‧‧‧ fourth opening
α‧‧‧(套管的第二底部與直筒部之間的)夾角 ‧‧‧‧ (between the second bottom of the casing and the straight section)
圖1與圖2分別為本新型創作一實施例之核酸萃取組件的分解示意圖。 1 and 2 are respectively exploded schematic views of a nucleic acid extraction assembly according to an embodiment of the present invention.
圖3為本新型創作一實施例之核酸萃取組件的組合示意圖。 Fig. 3 is a schematic view showing the combination of a nucleic acid extraction module according to an embodiment of the present invention.
圖4A為圖3之核酸萃取組件沿直線A-A的剖視示意圖。 4A is a schematic cross-sectional view of the nucleic acid extraction assembly of FIG. 3 taken along line A-A.
圖4B為圖3之核酸萃取組件中另一種實施態樣的套管的剖視示意圖。 4B is a schematic cross-sectional view of another embodiment of the nucleic acid extraction assembly of FIG. 3.
圖5A與圖5B為本新型創作不同實施態樣的固定管的示意圖。 5A and 5B are schematic views of a fixed tube in which different embodiments are created.
圖6為本新型創作不同實施態樣的核酸萃取組件的組合示意圖。 Fig. 6 is a schematic view showing the combination of nucleic acid extraction components of different embodiments of the present invention.
圖7與圖8分別為本新型創作一實施例之離心組件的分解示意圖與組合示意圖。 7 and FIG. 8 are respectively an exploded schematic view and a combined schematic view of a centrifugal assembly according to an embodiment of the present invention.
圖9為圖8的離心組件沿直線B-B的剖視示意圖。 Figure 9 is a cross-sectional view of the centrifugal assembly of Figure 8 taken along line B-B.
以下將參照相關圖式，說明依本新型創作實施例之核酸萃取組件的固定管及核酸萃取組件，其中相同的元件將以相同的參照符號加以說明。 The fixed tube and the nucleic acid extraction module of the nucleic acid extraction module according to the novel creation embodiment will be described below with reference to the related drawings, wherein the same elements will be described with the same reference numerals.
本新型創作在液體活檢的核酸純化過程中，是利用一核酸萃取組件通過離心機由檢體中提取極微量的核酸。其中，檢體可例如但不限於血液、血漿、尿液或組織液。另外，利用本新型創作的核酸萃取組件並不需要多次操作，也不需要加大柱膜管或膜片的尺寸，就可快速與方便由較大體積的檢體中萃取出較高產量及較高濃度的核酸。以下將以實施例來說明核酸萃取組件的結構與特徵。 In the nucleic acid purification process of liquid biopsy, the novel preparation uses a nucleic acid extraction component to extract a very small amount of nucleic acid from a sample by a centrifuge. The sample may be, for example but not limited to, blood, plasma, urine or tissue fluid. In addition, the nucleic acid extraction assembly created by the novel does not require multiple operations, and does not need to increase the size of the cylindrical tube or the membrane, so that the high yield can be quickly and conveniently extracted from a larger volume of the sample. Higher concentrations of nucleic acids. The structure and features of the nucleic acid extraction module will be described below by way of examples.
請參照圖1至圖4A所示，其中，圖1與圖2分別為本新型創作一實施例之核酸萃取組件1的分解示意圖，圖3為核酸萃取組件1的組合示意圖，而圖4A為圖3之核酸萃取組件1沿直線A-A的剖視示意圖。 Please refer to FIG. 1 to FIG. 4A , wherein FIG. 1 and FIG. 2 are respectively exploded schematic views of the nucleic acid extraction assembly 1 according to an embodiment of the present invention, FIG. 3 is a schematic diagram of the combination of the nucleic acid extraction assembly 1 , and FIG. 4A is a diagram. 3 is a schematic cross-sectional view of the nucleic acid extraction module 1 along a line AA.
如圖1至圖4A所示，核酸萃取組件1包括一固定管11以及一柱膜管12。本實施例之柱膜管12內可包括一膜片3。另外，本實施例的核酸萃取組件1更可包括一套管13。 As shown in FIGS. 1 to 4A, the nucleic acid extraction module 1 includes a fixed tube 11 and a cylindrical tube 12. A diaphragm 3 may be included in the cylindrical tube 12 of this embodiment. In addition, the nucleic acid extraction module 1 of the present embodiment may further include a sleeve 13.
柱膜管12與固定管11相互套接。本實施例的柱膜管12連接套管13並套設於固定管11內，且柱膜管12的一部份突出於固定管11。其中，固定管11、柱膜管12與套管13實質上分別為直筒狀。固定管11、柱膜管12與套管13的材料例如但不限於為塑膠。另外，本新型創作並不限制柱膜管12、套管13及固定管11的容量與尺寸，只要三者相互搭配即可。在一些實施例中，柱膜管12的容量例如介於0.5ml與1ml之間，故柱膜管12可容納的檢體體積相當少，相對地，設置於柱膜管12內部的膜片3的尺寸也很小。在一些實施例中，套管13的容量較大，例如但不限於可容納10ml以上的檢體。因此，當柱膜管12內的檢體溶液通過膜片3而流出 時，套管13內的檢體可補充至柱膜管12內。由於套管13內的檢體量較多，因此，離心操作完成後，膜片3上可吸附較多量的核酸，進而可萃取出較高濃度的核酸。此外，本實施例的柱膜管12與套管13為兩個不同的構件，然並不以此為限，在一些實施例中，柱膜管12與套管13可為單一構件而為一體成型結構，本新型創作並不限制。 The cylindrical tube 12 and the fixed tube 11 are sleeved with each other. The cylindrical tube 12 of the present embodiment is connected to the sleeve 13 and sleeved in the fixed tube 11, and a part of the cylindrical tube 12 protrudes from the fixed tube 11. The fixed tube 11, the cylindrical tube 12 and the sleeve 13 are substantially straight cylindrical, respectively. The material of the fixed tube 11, the cylindrical tube 12 and the sleeve 13 is, for example but not limited to, plastic. In addition, the novel creation does not limit the capacity and size of the cylindrical tube 12, the sleeve 13 and the fixed tube 11, as long as the three are matched with each other. In some embodiments, the volume of the cylindrical tube 12 is, for example, between 0.5 ml and 1 ml, so that the volume of the sample that the cylindrical tube 12 can accommodate is relatively small, and the diaphragm 3 disposed inside the cylindrical tube 12 is oppositely disposed. The size is also small. In some embodiments, the volume of the cannula 13 is large, such as, but not limited to, a sample that can accommodate more than 10 ml. Therefore, when the sample solution in the cylindrical tube 12 flows out through the diaphragm 3 The specimen within the cannula 13 can be replenished into the cylindrical tube 12. Since the amount of the sample in the cannula 13 is large, after the centrifugation operation is completed, a large amount of nucleic acid can be adsorbed on the membrane 3, and a relatively high concentration of nucleic acid can be extracted. In addition, the cylindrical tube 12 and the sleeve 13 of the present embodiment are two different members, but not limited thereto. In some embodiments, the cylindrical tube 12 and the sleeve 13 may be a single member and integrated. The molding structure, this new creation is not limited.
固定管11具有一筒身部111、一管口部112與一底部113。其中，筒身部111沿一第一方向D1延伸，且管口部112與底部113分別連接筒身部111的相對兩側。另外，管口部112遠離筒身部111的一端具有往一第二方向D2突出的一突出部1121，其中第一方向D1與第二方向D2垂直。另外，本實施例的底部113具有一肩部1131、一階梯狀構造1132以及一第四開口O4。其中，筒身部111的管徑大於階梯狀構造1132的管徑，且是通過底部113的肩部1131與柱膜管12連接。階梯狀構造1132是從第四開口O4處沿第一方向D1延伸，其中，階梯狀構造1132與柱膜管12連接，且柱膜管12由階梯狀構造1132突出於固定管11。於此，柱膜管12是由底部131的第四開口O4突出於固定管11。 The fixed tube 11 has a barrel portion 111, a nozzle portion 112 and a bottom portion 113. The tubular portion 111 extends along a first direction D1, and the nozzle portion 112 and the bottom portion 113 are respectively connected to opposite sides of the tubular portion 111. In addition, one end of the nozzle portion 112 away from the tubular portion 111 has a protruding portion 1121 protruding toward a second direction D2, wherein the first direction D1 is perpendicular to the second direction D2. In addition, the bottom portion 113 of the embodiment has a shoulder portion 1131, a stepped structure 1132, and a fourth opening O4. The tube diameter of the barrel portion 111 is larger than the tube diameter of the stepped structure 1132, and is connected to the column tube 12 through the shoulder portion 1131 of the bottom portion 113. The stepped configuration 1132 extends from the fourth opening O4 in the first direction D1, wherein the stepped configuration 1132 is coupled to the cylindrical tube 12, and the cylindrical tube 12 protrudes from the fixed tube 11 by the stepped configuration 1132. Here, the cylindrical tube 12 protrudes from the fixed tube 11 by the fourth opening O4 of the bottom portion 131.
本實施例的管口部112的相對兩側更分別具有一第一開口O1，該些第一開口O1可將突出部1121區分成兩段。於此，第一方向D1與第二方向D2之間夾一角度。在本實施例中，第一方向D1與第二方向D2之間的夾角例如但不限於90度。在不同的實施例中，第一方向D1與第二方向D2之間的夾角也可大於90度(例如120度)或小於90度(例如75度)，並不限制。具體來說，由於管口部112的相對兩側形成了兩個第一開口O1，因此，可將管口部112與突出部1121一分為二，方便後續的操作。另外，離筒身部111越遠之階梯狀構造1132的管徑越小，藉此使得柱膜管12連接套管13且套設於固定管11內時可固定柱膜管12與套管13，使柱膜管12與套管13不會分離。 The opposite sides of the nozzle portion 112 of the embodiment further have a first opening O1, and the first openings O1 can divide the protruding portion 1121 into two segments. Here, an angle is formed between the first direction D1 and the second direction D2. In the present embodiment, the angle between the first direction D1 and the second direction D2 is, for example but not limited to, 90 degrees. In different embodiments, the angle between the first direction D1 and the second direction D2 may also be greater than 90 degrees (eg, 120 degrees) or less than 90 degrees (eg, 75 degrees), without limitation. Specifically, since the two first openings O1 are formed on opposite sides of the nozzle portion 112, the nozzle portion 112 and the protruding portion 1121 can be divided into two to facilitate subsequent operations. In addition, the smaller the diameter of the stepped structure 1132 from the tubular body portion 111, the smaller the diameter of the stepped structure 1132 is, so that the cylindrical tube 12 and the sleeve 13 can be fixed when the cylindrical tube 12 is connected to the sleeve 13 and sleeved in the fixed tube 11. The column tube 12 and the sleeve 13 are not separated.
本實施例之筒身部111的一側具有一第二開口O2，第二開口O2由該些第一開口O1的其中之一沿第一方向D1延伸至階梯狀構造1132。在不同的實施例中，筒身部111於上述第二開口O2的相對側亦可具有另一第二開口(未繪示)，該另一第二開口也可由第一開口O1的其中另 一沿第一方向D1延伸；或者，如圖5A所示，除了第一開口O1之外，固定管11不具有第二開口O2，但是具有一第三開口O3，第三開口O3是由管口部112的突出部1121沿第一方向D1延伸至階梯狀構造1132。在一些實施例中，固定管11可不具有第一開口O1、第二開口O2與第三開口O3，以及階梯狀構造1132。如圖5B所示，本實施例的固定管11的底部113具有肩部1131以及第四開口O4，不具有階梯狀構造1132，而且，也沒有第一開口O1、第二開口O2與第三開口O3；或者，在另一些實施例中，固定管11可不具有第一開口O1、第二開口O2及/或與第三開口O3，但具有階梯狀構造1132；或者，又一些實施例中，固定管11也可不具有階梯狀構造1132，但具有第一開口O1、第二開口O2及/或與第三開口O3，本新型創作皆不限制。 One side of the barrel portion 111 of the present embodiment has a second opening O2, and the second opening O2 extends from one of the first openings O1 in the first direction D1 to the stepped configuration 1132. In a different embodiment, the body portion 111 may have another second opening (not shown) on the opposite side of the second opening O2, and the other second opening may also be formed by the first opening O1. One extends in the first direction D1; or, as shown in FIG. 5A, the fixed tube 11 has no second opening O2 except for the first opening O1, but has a third opening O3, and the third opening O3 is made of a nozzle The protrusion 1121 of the portion 112 extends in the first direction D1 to the stepped configuration 1132. In some embodiments, the fixed tube 11 may have no first opening O1, a second opening O2 and a third opening O3, and a stepped configuration 1132. As shown in FIG. 5B, the bottom portion 113 of the fixing tube 11 of the present embodiment has a shoulder portion 1131 and a fourth opening O4, and has no stepped structure 1132. Moreover, there is no first opening O1, second opening O2 and third opening. O3; or, in other embodiments, the fixed tube 11 may have no first opening O1, second opening O2, and/or third opening O3, but has a stepped configuration 1132; or, in other embodiments, fixed The tube 11 may also have no stepped configuration 1132, but has a first opening O1, a second opening O2, and/or a third opening O3, and the novel creation is not limited.
柱膜管12具有一直筒部121、一第一頂部122及一第一底部125，直筒部121沿一第一方向D1延伸，且第一頂部122與第一底部125分別連接於直筒部121的相對兩側。本實施例之柱膜管12的第一頂部122為環狀，第一底部125呈漏斗狀，且如圖3所示，第一底部125與部份的直筒部121是突出於固定管11的底部113。另外，如圖4A所示，本實施例的固定管11之底部113與柱膜管12之第一頂部122連接，且柱膜管12的第一底部125由底部113的第四開口O4往外側突出於固定管11。不過，在不同的實施例中，柱膜管12也可不突出於固定管11，例如直筒部121與底部113切齊或內縮於底部113之內，並不限制。 The cylindrical tube 12 has a straight cylindrical portion 121, a first top portion 122 and a first bottom portion 125. The straight cylindrical portion 121 extends along a first direction D1, and the first top portion 122 and the first bottom portion 125 are respectively connected to the straight portion 121. Relative sides. The first top portion 122 of the cylindrical tube 12 of the present embodiment has an annular shape, and the first bottom portion 125 has a funnel shape. As shown in FIG. 3, the first bottom portion 125 and a portion of the straight cylindrical portion 121 protrude from the fixed tube 11. Bottom 113. In addition, as shown in FIG. 4A, the bottom 113 of the fixed tube 11 of the present embodiment is connected to the first top portion 122 of the cylindrical tube 12, and the first bottom portion 125 of the cylindrical tube 12 is outwardly of the fourth opening O4 of the bottom portion 113. It protrudes from the fixed tube 11. However, in different embodiments, the cylindrical tube 12 may not protrude from the fixed tube 11, for example, the straight portion 121 is flush with or constricted within the bottom portion 113, and is not limited.
具體來說，為了使固定管11可固定柱膜管12，本實施例的固定管11之底部113的管徑與柱膜管12之第一頂部122的管徑對應設置，使得固定管11之肩部1131可套設於柱膜管12之第一頂部122的外側(圖4A，柱膜管12之第一頂部122的延伸部1221卡在固定管11之肩部1131上)，使柱膜管12之第一頂部122的下緣卡在固定管11之底部113的階梯狀構造1132上，使柱膜管12之第一頂部122與底部113連接。但是，在一些實施例中，固定管11之底部113的管徑與柱膜管12之第一頂部122的管徑也可不需對應設置，或不需緊配，只要例如柱膜管12之第一頂部122的延伸部1221卡在固定管11之肩部1131上，或者柱膜管12之第一頂部 122的下緣卡在固定管11之肩部1131上，即可使柱膜管12與固定管11連接，本新型創作並不限制。此外，本實施例的柱膜管12更具有一管帽123及一連接部124，管帽123是透過連接部124連接於柱膜管12的第一頂部122。於此，管帽123是用以蓋住柱膜管12的第一頂部122，當檢體放置於柱膜管12內時，可避免檢體流出(萃取核酸時，管帽123會打開)。 Specifically, in order to fix the cylindrical tube 12 to the fixed tube 11, the diameter of the bottom 113 of the fixed tube 11 of the present embodiment is corresponding to the diameter of the first top portion 122 of the cylindrical tube 12, so that the fixed tube 11 is The shoulder 1131 can be sleeved on the outer side of the first top portion 122 of the cylindrical tube 12 (Fig. 4A, the extension 1221 of the first top portion 122 of the cylindrical tube 12 is caught on the shoulder 1131 of the fixed tube 11), so that the column membrane The lower edge of the first top portion 122 of the tube 12 is snapped onto the stepped configuration 1132 of the bottom portion 113 of the fixed tube 11 such that the first top portion 122 of the cylindrical tube tube 12 is coupled to the bottom portion 113. However, in some embodiments, the diameter of the bottom 113 of the fixed tube 11 and the diameter of the first top 122 of the cylindrical tube 12 may not be correspondingly arranged, or need not be tightly matched, as long as, for example, the cylindrical tube 12 An extension 1221 of a top portion 122 is caught on the shoulder 1131 of the fixed tube 11, or the first top of the cylindrical tube 12 The lower edge of the 122 is caught on the shoulder 1131 of the fixed tube 11, so that the cylindrical tube 12 can be connected to the fixed tube 11, and the creation of the novel is not limited. In addition, the cylindrical tube 12 of the present embodiment further has a cap 123 and a connecting portion 124. The cap 123 is connected to the first top portion 122 of the cylindrical tube 12 through the connecting portion 124. Here, the cap 123 is a first top portion 122 for covering the cylindrical tube 12. When the specimen is placed in the cylindrical tube 12, the sample can be prevented from flowing out (the cap 123 will open when the nucleic acid is extracted).
另外，請再參照圖3所示，在本實施例中，由於筒身部111具有第二開口O2，因此當柱膜管12放置於固定管11內時，其管帽123可由第一開口O1沿著筒身部111的第二開口O2往下，一直到肩部1131為止，使得柱膜管12可設置於固定管11內而使柱膜管12的第一底部125與部份的直筒部121可從底部113的第四開口O4突出於固定管11，進而使柱膜管12的第一頂部122可與階梯狀構造1132連接。在不同的實施例中，如圖6所示，若柱膜管12沒有設置管帽123與連接部124的話，則筒身部111可不需具有第二開口O2。 In addition, referring to FIG. 3, in the embodiment, since the barrel portion 111 has the second opening O2, when the cylindrical tube 12 is placed in the fixed tube 11, the cap 123 can be the first opening O1. Down the second opening O2 of the barrel portion 111 until the shoulder portion 1131, so that the cylindrical tube 12 can be disposed in the fixed tube 11 to make the first bottom portion 125 of the cylindrical tube tube 12 and a portion of the straight tube portion The 121 may protrude from the fixed opening 11 from the fourth opening O4 of the bottom portion 113, thereby allowing the first top portion 122 of the cylindrical tube 12 to be coupled to the stepped configuration 1132. In a different embodiment, as shown in FIG. 6, if the tubular tube 12 is not provided with the cap 123 and the connecting portion 124, the tubular portion 111 need not have the second opening O2.
本實施例的套管13具有一直筒部131、一第二底部132與一第二頂部133。直筒部131亦沿第一方向D1延伸，且第二底部132與第二頂部133分別連接於直筒部131的相對兩側。其中，第二頂部133為環狀，第二底部132亦呈漏斗狀，且其管徑與柱膜管12之第一頂部122的管徑對應設置，使得套管13與柱膜管12連接時，套管13的第二底部132可插設於柱膜管12的第一頂部122內，使檢體可由套管13流向柱膜管12。此外，在本實施例中，當柱膜管12連接套管13並套設於固定管11內時，套管13的第二底部132的一部分由第一頂部122插設於柱膜管12，使柱膜管12之第一頂部122可套設於套管13之第二底部132的外側後，再將其放置於固定管11內。而如圖4A及圖4B所示，第二底部132與直筒部131之間的夾角α的角度可以是大於157度(如圖4A)至小於或等於180度(如圖4B)。如此一來，可避免樣本殘留在夾角α處，進一步可提升核酸萃取組件1的萃取效率。此外，本實施例之套管13並不具有管帽，但是在一些實施例中，套管13也可具有一管帽(未繪示)，以蓋合於第二頂部133，並不限制。 The sleeve 13 of the present embodiment has a straight cylindrical portion 131, a second bottom portion 132 and a second top portion 133. The straight portion 131 also extends in the first direction D1, and the second bottom portion 132 and the second top portion 133 are respectively connected to opposite sides of the straight portion 131. The second top portion 133 is annular, and the second bottom portion 132 is also funnel-shaped, and the diameter of the second bottom portion 132 is corresponding to the diameter of the first top portion 122 of the cylindrical tube tube 12, so that the sleeve 13 is connected to the cylindrical tube tube 12. The second bottom portion 132 of the cannula 13 can be inserted into the first top portion 122 of the cylindrical tube 12 such that the sample can flow from the cannula 13 to the cylindrical tube 12. In addition, in the present embodiment, when the cylindrical tube 12 is connected to the sleeve 13 and sleeved in the fixed tube 11, a portion of the second bottom portion 132 of the sleeve 13 is inserted into the cylindrical tube 12 by the first top portion 122, The first top portion 122 of the cylindrical tube 12 can be sleeved on the outside of the second bottom portion 132 of the sleeve 13, and then placed in the fixed tube 11. 4A and 4B, the angle α between the second bottom portion 132 and the straight portion 131 may be greater than 157 degrees (as shown in FIG. 4A) to less than or equal to 180 degrees (FIG. 4B). In this way, the sample can be prevented from remaining at the angle α, which further improves the extraction efficiency of the nucleic acid extraction module 1. In addition, the sleeve 13 of the present embodiment does not have a cap, but in some embodiments, the sleeve 13 may also have a cap (not shown) to cover the second top 133, and is not limited.
膜片3設置於柱膜管12內部，並鄰近第一底部125。在一 些實施例中，膜片3例如但不限於為硅膠膜片(Silica Membrane)，並帶有正電，而檢體經前一處理程序後，其內含有的核酸可帶有負電，利用正負電相吸的特性可於離心時使核酸附著於膜片3上，再透過後續的程序將附著於膜片3上的核酸萃取出來。 The diaphragm 3 is disposed inside the cylindrical tube 12 and adjacent to the first bottom portion 125. In a In some embodiments, the membrane 3 is, for example but not limited to, a silica gel membrane (Silica Membrane) and is positively charged, and the nucleic acid contained in the specimen may be negatively charged after the previous treatment procedure, using positive and negative The electrical phase absorption property allows the nucleic acid to adhere to the membrane 3 during centrifugation, and the nucleic acid attached to the membrane 3 is extracted through a subsequent procedure.
承上，在本實施例之核酸萃取組件1中，藉由管口部112遠離筒身部111的一端具有往第二方向D2突出的突出部1121之設計，可使操作者容易拿取固定管11。另外，通過固定管11之底部113的肩部1131可卡住柱膜管12，使離心操作時檢體不會由柱膜管12或套管13中灑出，增加操作時的成功率(若沒有卡住，離心時柱膜管則有可能會脫落，檢體會灑出而不會通過膜片3，離心操作將失敗)。另外，藉由固定管11之該些第一開口O1的設計，可將突出部1121區分成兩段，藉此，可讓操作者於萃取時易於操作。例如方便將柱膜管12與套管13置放於固定管11內，也方便將柱膜管12與套管13由固定管11內取出。此外，由於套管13的容量較大，可容納的檢體量較大、但是膜片3的尺寸不放大，故通過核酸萃取組件1的結構設計，也可快速與方便由檢體中萃取出較高產量及較高濃度的核酸。 In the nucleic acid extraction module 1 of the present embodiment, the end portion of the nozzle portion 112 away from the tubular portion 111 has a projection portion 1121 protruding in the second direction D2, so that the operator can easily take the fixed tube. 11. In addition, the shoulder portion 1131 of the bottom portion 113 of the fixed tube 11 can catch the cylindrical tube 12, so that the sample is not sprinkled by the cylindrical tube 12 or the cannula 13 during the centrifugation operation, thereby increasing the success rate during operation (if If there is no jam, the cylindrical tube may fall off during centrifugation, the sample will spill out without passing through the diaphragm 3, and the centrifugation operation will fail). In addition, by designing the first openings O1 of the fixed tube 11, the protrusions 1121 can be divided into two sections, thereby allowing the operator to easily operate during extraction. For example, it is convenient to place the cylindrical tube 12 and the sleeve 13 in the fixed tube 11, and it is also convenient to take out the cylindrical tube 12 and the sleeve 13 from the fixed tube 11. In addition, since the capacity of the sleeve 13 is large, the amount of the sample that can be accommodated is large, but the size of the diaphragm 3 is not enlarged, so the structure design of the nucleic acid extraction assembly 1 can be quickly and conveniently extracted from the sample. Higher yields and higher concentrations of nucleic acids.
請參照圖7至圖9所示，其中，圖7與圖8分別為本新型創作一實施例之離心組件2的分解示意圖與組合示意圖，而圖9為圖8之離心組件2沿直線B-B的剖視示意圖。 Please refer to FIG. 7 to FIG. 9 , wherein FIG. 7 and FIG. 8 are respectively an exploded schematic view and a combined schematic view of the centrifugal assembly 2 according to an embodiment of the present invention, and FIG. 9 is a schematic diagram of the centrifugal assembly 2 of FIG. 8 along a straight line BB. A schematic cross-sectional view.
本實施例的離心組件2包括一核酸萃取組件1、一離心管21與一管蓋22。核酸萃取組件1的具體技術特徵及其變化態樣已於上述中詳述，不再贅述。 The centrifugation assembly 2 of the present embodiment includes a nucleic acid extraction assembly 1, a centrifuge tube 21 and a tube cover 22. Specific technical features of the nucleic acid extraction module 1 and variations thereof have been described in detail above and will not be described again.
在一些實施例中，離心管21的容量例如但不限於為50ml。在實施上，柱膜管12連接套管13並套設於固定管11以組成核酸萃取組件1後，可先將檢體4加入套管13與柱膜管12，由於套管13的容量較大(例如10ml以上)，故可容納較多的檢體4，再將核酸萃取組件1放置於離心管21內，使固定管11的突出部1121頂抵在離心管21的管口211上，使得固定管11可架設於離心管21，再以管蓋22蓋合離心管21後(例如但不限於鎖合)，將離心組件2放置於離心機中，以通過離心作用使檢體4通過膜片 3，使檢體4內含的核酸可被膜片3所吸附，進而由檢體4中萃取出核酸。 In some embodiments, the capacity of the centrifuge tube 21 is, for example but not limited to, 50 ml. In practice, after the cylindrical tube 12 is connected to the sleeve 13 and sleeved on the fixed tube 11 to constitute the nucleic acid extraction assembly 1, the sample 4 can be first added to the sleeve 13 and the cylindrical tube 12, because the capacity of the sleeve 13 is relatively Large (for example, 10 ml or more), so that a large number of specimens 4 can be accommodated, and the nucleic acid extraction module 1 is placed in the centrifuge tube 21, so that the protruding portion 1121 of the fixed tube 11 abuts against the nozzle 211 of the centrifuge tube 21, The fixed tube 11 can be placed on the centrifuge tube 21, and after the tube cover 22 is closed with the tube cover 22 (such as but not limited to the lock), the centrifugation assembly 2 is placed in the centrifuge to pass the sample 4 by centrifugation. Diaphragm 3. The nucleic acid contained in the sample 4 can be adsorbed by the membrane 3, and the nucleic acid can be extracted from the sample 4.
在習知萃取核酸的技術中，並不使用套管13與固定管11。另外，柱膜管12的容量相當小，要萃取出一定含量的核酸時，則需透過多次操作才可，如此，將花費很多工時與操作成本。若操作一次就要得到一定含量核酸的話，則必須加大柱膜管的尺寸(例如10ml以上)，以容置較大量的檢體，同時也要因應柱膜管的容量加大而使用較大尺寸的膜片。 In the conventional technique of extracting nucleic acid, the sleeve 13 and the fixed tube 11 are not used. In addition, the capacity of the cylindrical tube 12 is relatively small, and when a certain amount of nucleic acid is extracted, it is necessary to perform a plurality of operations, and thus, it takes a lot of man-hours and operating costs. If a certain amount of nucleic acid is obtained after one operation, the size of the cylindrical tube (for example, 10 ml or more) must be increased to accommodate a larger amount of the sample, and the larger the capacity of the cylindrical tube is used. Dimensional diaphragm.
然而，上述的這種方式有以下三種缺點：(1)、用較大尺寸的膜片回收相同量的核酸時，由於膜片較大，故核酸會較為分散結合於膜片上，使用溶液(例如純水)沖提膜片時，較易未浸潤完全而導致該部分核酸回收率降低。(2)、用較多的溶液沖提膜片時，也會稀釋核酸的濃度，導致濃度太低則無法進行後續的偵測反應，如次世代定序(NGS)反應。(3)、為了使核酸帶有呈負電，必需對檢體進行前處理程序，由於前處理程序所使用的裂解溶液中帶有高濃度的鹽，因此，即使經洗滌液洗滌後，仍然會有小部分的鹽留在膜片上，當膜片太大時會增加這些鹽類的殘留量，這些鹽將會干擾後面的PCR(聚合連鎖反應)的結果。 However, the above-mentioned method has the following three disadvantages: (1) When the same amount of nucleic acid is recovered by using a larger-sized membrane, since the membrane is larger, the nucleic acid is more dispersed and bonded to the membrane, and the solution is used ( For example, when pure water is used to extract the membrane, it is easier to completely infiltrate, resulting in a decrease in the recovery rate of the nucleic acid. (2) When the membrane is washed with more solution, the concentration of the nucleic acid is also diluted, so that the concentration is too low to perform subsequent detection reactions, such as the next generation sequencing (NGS) reaction. (3) In order to make the nucleic acid negatively charged, it is necessary to carry out a pretreatment procedure on the sample. Since the lysis solution used in the pretreatment procedure has a high concentration of salt, even after washing with the washing solution, there will still be A small portion of the salt remains on the membrane, and when the membrane is too large, the residual amount of these salts is increased, and these salts will interfere with the results of subsequent PCR (polymerization chain reaction).
在本實施例的離心組件2中不需進行多次的操作，而且透過核酸萃取組件1之固定管11、柱膜管12與套管13的結構設計，不需加大柱膜管12的尺寸就可容量較大量的檢體。另外，在液體活檢中，核酸量都很少，且遠低於膜片3的最大吸附量，故也不需加大膜片3，因此，只要一次操作就可得到較高產量的核酸，除了不會有上述的三種缺點外，而且也可用較少的溶液就可將核酸由膜片中沖提下來，相較於習知技術而言，只要一次的萃取操作就可萃取出較高產量與較高濃度的核酸。 In the centrifugal assembly 2 of the present embodiment, it is not necessary to perform multiple operations, and the structural design of the fixed tube 11, the cylindrical tube 12 and the sleeve 13 of the nucleic acid extraction assembly 1 is not required to increase the size of the cylindrical tube 12. It is possible to have a larger capacity of the sample. In addition, in the liquid biopsy, the amount of nucleic acid is small, and is much lower than the maximum adsorption amount of the membrane 3, so there is no need to increase the membrane 3, so that a high yield of nucleic acid can be obtained in one operation, except There are no three disadvantages mentioned above, and the nucleic acid can be extracted from the membrane with less solution. Compared with the prior art, a single extraction operation can extract a higher yield and Higher concentrations of nucleic acids.
特別說明的是，由於上述實施例是利用固定管11支撐柱膜管12，為了使後續的提取核酸過程更容易進行，可將柱膜管12由固定管11中取出，柱膜管12即可放在一般的(例如2ml)收集管(collection tube)中，再進行後續沖洗、乾燥與沖提(Elution)等步驟。因此，使柱膜管12與固定管11可分離的設計讓後續這三個步驟更為簡便，也讓檢體4可以用較小體積的溶液沖提在例如1.5ml的離心管中，不僅可提高核酸的濃度，柱膜管12也更方便儲存與日後取用。 In particular, since the above embodiment uses the fixed tube 11 to support the cylindrical tube 12, in order to facilitate the subsequent process of extracting nucleic acid, the cylindrical tube 12 can be taken out from the fixed tube 11, and the cylindrical tube 12 can be It is placed in a general (for example, 2 ml) collection tube, followed by subsequent washing, drying, and elution. Therefore, the design that separates the cylindrical tube 12 from the fixed tube 11 makes the subsequent three steps simpler, and allows the sample 4 to be flushed with a smaller volume of solution in, for example, a 1.5 ml centrifuge tube, not only By increasing the concentration of nucleic acids, the cylindrical tube 12 is also more convenient to store and later accessible.
綜上所述，在本新型創作之核酸萃取組件的固定管與核酸萃取組件中，藉由固定管之管口部遠離筒身部的一端所具有之突出部的設計，讓操作者可由離心管中易於拿取固定管。另外，通過固定管之底部的設計可使離心操作時，柱膜管不會與套管分離，檢體不會由柱膜管中灑出，增加操作的成功率。此外，藉由本新型創作核酸萃取組件中的固定管與柱膜管的結構設計，也可快速與方便由較大體積的檢體中萃取出較高產量及較高濃度的核酸。 In summary, in the fixed tube and nucleic acid extraction assembly of the nucleic acid extraction module of the present invention, the operator can be made of a centrifuge tube by the design of the protruding portion of the tube mouth of the fixed tube away from the end of the barrel portion. It is easy to take the fixed tube. In addition, the design of the bottom of the fixed tube allows the cylindrical tube to be separated from the cannula during centrifugation, and the sample is not spilled from the cylindrical tube, increasing the success rate of the operation. In addition, by the structural design of the fixed tube and the cylindrical tube in the novel nucleic acid extraction module, the higher yield and higher concentration of nucleic acid can be extracted quickly and conveniently from a larger volume of the sample.
在本新型創作的一實施例中，藉由固定管之第一開口的設計，可將突出部區分成兩段，藉此，也可讓操作者於萃取的過程中易於操作。 In an embodiment of the present invention, the protrusion can be divided into two sections by the design of the first opening of the fixed tube, thereby also allowing the operator to easily operate during the extraction process.
以上所述僅為舉例性，而非為限制性者。任何未脫離本創作之精神與範疇，而對其進行之等效修改或變更，均應包含於後附之申請專利範圍中。 The above is intended to be illustrative only and not limiting. Any equivalent modifications or alterations to the spirit and scope of this creation shall be included in the scope of the appended patent application.
1‧‧‧核酸萃取組件 1‧‧‧Nucleic acid extraction module
11‧‧‧固定管 11‧‧‧Fixed tube
111‧‧‧筒身部 111‧‧‧Body
112‧‧‧管口部 112‧‧‧Tube
1121‧‧‧突出部 1121‧‧‧Protruding
113‧‧‧底部 113‧‧‧ bottom
1131‧‧‧肩部 1131‧‧‧ shoulder
1132‧‧‧階梯狀構造 1132‧‧‧step structure
12‧‧‧柱膜管 12‧‧‧column tube
121、131‧‧‧直筒部 121, 131‧‧‧ Straight
122‧‧‧第一頂部 122‧‧‧ first top
1221‧‧‧延伸部 1221‧‧‧Extension
123‧‧‧管帽 123‧‧‧ Caps
124‧‧‧連接部 124‧‧‧Connecting Department
125‧‧‧第一底部 125‧‧‧ first bottom
13‧‧‧套管 13‧‧‧ casing
132‧‧‧第二底部 132‧‧‧ second bottom
133‧‧‧第二頂部 133‧‧‧ second top
3‧‧‧膜片 3‧‧‧ diaphragm
D1‧‧‧第一方向 D1‧‧‧ first direction
D2‧‧‧第二方向 D2‧‧‧ second direction
O1‧‧‧第一開口 O1‧‧‧ first opening
O2‧‧‧第二開口 O2‧‧‧ second opening
O4‧‧‧第四開口 O4‧‧‧ fourth opening
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2019001228A1 (en) * | 2017-06-30 | 2019-01-03 | 开启基因股份有限公司 | Fixed tube of nucleic acid extraction component, and nucleic acid extraction component |
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| WO2019001228A1 (en) * | 2017-06-30 | 2019-01-03 | 开启基因股份有限公司 | Fixed tube of nucleic acid extraction component, and nucleic acid extraction component |
| US11365406B2 (en) | 2017-06-30 | 2022-06-21 | Catchgene Co., Ltd. | Fixed tube of nucleic acid extraction component, and nucleic acid extraction component |
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