JP4239220B2 - Component collection device - Google Patents
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- JP4239220B2 JP4239220B2 JP2004265243A JP2004265243A JP4239220B2 JP 4239220 B2 JP4239220 B2 JP 4239220B2 JP 2004265243 A JP2004265243 A JP 2004265243A JP 2004265243 A JP2004265243 A JP 2004265243A JP 4239220 B2 JP4239220 B2 JP 4239220B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/029—Separating blood components present in distinct layers in a container, not otherwise provided for
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5021—Test tubes specially adapted for centrifugation purposes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/02—Adapting objects or devices to another
- B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
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- Animal Behavior & Ethology (AREA)
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Description
本発明は、複数の成分を含む溶液から、目的成分を採取するための成分採取デバイスに関する。 The present invention relates to a component collection device for collecting a target component from a solution containing a plurality of components.
複数成分含有溶液から目的成分を採取する場合に、遠心分離により上清あるいは沈殿物を採取することにより、目的成分を得ることは一般的によく行われる。例えば、遠心管に複数成分含有溶液を加えて遠心処理した後、上清液を別の容器に移し替えるか、又は上清液を廃棄して沈殿物を収集するのが一般的である。
しかし、該目的成分をできる限り無菌の状態で採取したい場合や、複数成分含有溶液を直接手で触れたくない場合は、上記上清や沈殿物を採取する操作は煩雑である。取得したい成分の性質上、少なくとも２回以上の遠心処理を必要とする場合には、さらに煩雑である。
When collecting a target component from a solution containing a plurality of components, it is common to obtain the target component by collecting a supernatant or a precipitate by centrifugation. For example, generally, after adding a multi-component-containing solution to a centrifuge tube and centrifuging, the supernatant is transferred to another container, or the supernatant is discarded and the precipitate is collected.
However, when it is desired to collect the target component in as sterile a state as possible, or when it is not desired to directly touch the multiple component-containing solution by hand, the operation for collecting the supernatant and the precipitate is complicated. In view of the nature of the component to be obtained, it is further complicated when at least two or more centrifugation processes are required.
血小板血漿（Platelet-rich plasma:以下、単に「PRP」という場合もある。）は、医療や口腔外科の領域で広く用いられている。血小板血漿中の血小板の脱顆粒により放出される成長因子、即ち、血小板 由来増殖因子(Platelet-derived growth factor,PDGF)、交換成長因子(transforming growth factor-β,TGF-β）及びインスリン様増殖因子(Insulin-like growth factor-I,IGF-I)などが多く含まれるため、骨再生促進剤等として使用されている（特許文献１）。特許文献１で開示するPRPは、二段の遠心分離法により調製されている。
具体的には、採血した血液を第一の遠心（弱遠心）により、赤血球、白血球を含む層（バフィーコート）及び血小板を含む血漿の三層に分離させ、上層の血小板を含む血漿を採取して別の容器に移し、第二の遠心（強遠心）により、該血小板を含む血漿を血小板と血漿に分離し、上層の余分の血漿を抜き取り、残った血小板を多く含む血漿をPRPとして取得する方法であり、このような方法が広く採用されてきた。
Platelet-rich plasma (hereinafter sometimes simply referred to as “PRP”) is widely used in the fields of medicine and oral surgery. Growth factors released by platelet degranulation in platelet plasma: Platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β) and insulin-like growth factor Since (Insulin-like growth factor-I, IGF-I) and the like are contained in a large amount, it is used as a bone regeneration promoter (Patent Document 1). The PRP disclosed in
Specifically, the collected blood is separated into three layers, a layer containing red blood cells and white blood cells (buffy coat), and plasma containing platelets, by first centrifugation (weak centrifugation), and plasma containing platelets in the upper layer is collected. Transfer the platelet-containing plasma into platelets and plasma by the second centrifugation (strong centrifugation), extract the excess plasma in the upper layer, and obtain the remaining platelet-rich plasma as PRP And such methods have been widely adopted.
PRPを容易に調製する方法は、種々検討されている。
例えば、２つのチャンバーが連通しており、第１チャンバーに全血を入れて第一の遠心を行い、上澄みを第２チャンバーにデカントし、次に第二の遠心を行い、第２チャンバー内の血小板に乏しい血漿の一定量を除去することで、第２チャンバー内にPRPを得る方法が開示されている（特許文献２、３）。この方法では、該チャンバー用の特殊な遠心分離機を必要とする。
Various methods for easily preparing PRP have been studied.
For example, two chambers are connected, whole blood is put into the first chamber, the first centrifugation is performed, the supernatant is decanted into the second chamber, and then the second centrifugation is performed. Methods have been disclosed for obtaining PRP in the second chamber by removing a certain amount of plasma poor in platelets (
他の方法として、遠心管用の２本の吸引用パイプ付キャップを用いる方法が開示されている（特許文献４）。この方法は、異なる長さの２本の吸引用パイプが、遠心管用キャップに固定されており、１方のパイプは、遠心管の底部にほぼ届く長さに設定されており、他のパイプは、やや短い長さに設定されている。遠心管に全血を加え、第一の遠心後に底部の赤血球を長いパイプから吸引除去する。次に第二の遠心を行い、その後上部の血小板に乏しい血漿の一定量を吸引除去することで、血小板を多く含むPRPを得ることができる。この方法では、２本のパイプの長さは固定されており、長さを調節することができないので、遠心管に採取された血液量や血小板量に応じた適切な処理を行うのに不便である。
複数の成分を含む溶液から、目的成分を容易かつ効率よく採取するための成分採取デバイスを提供することである。 An object of the present invention is to provide a component collection device for collecting a target component easily and efficiently from a solution containing a plurality of components.
上記課題を解決するために、本発明者らは鋭意研究を進めた結果、目的成分を採取するための遠心分離操作に関連して、目的成分又は目的でない成分を吸引するための筒状体の長さを変えることができれば、容易に目的成分を採取できることに着目し、本発明の成分採取デバイスを完成した。 In order to solve the above-mentioned problems, the present inventors have conducted intensive research. As a result, in connection with the centrifugation operation for collecting the target component, the cylindrical body for sucking the target component or the non-target component is used. Focusing on the fact that the target component can be easily collected if the length can be changed, the component collecting device of the present invention has been completed.
すなわち、本発明は、以下よりなる。
１． 容器にキャップとして装着可能なホルダーと、該ホルダーの縦軸方向に貫通された吸引用筒状体を含み、該ホルダーから容器内に突出する該吸引用筒状体の長さが調節可能な構造を含み、当該構造が前記ホルダーの内側と前記吸引用筒状体の一部にねじ部を設け、該両ねじ部を嵌合させることによって、ホルダーの縦軸方向に吸引用筒状体を貫通させて結合し、該ねじ部によって容器内に突出する吸引用筒状体の長さを調節可能とする構造からなり、前記容器がゴム栓をした容器であり、前記吸引用筒状体の容器内に突出する端部が吸引針の構造からなり、前記吸引針が前記ゴム栓を刺通可能な金属針である、複数成分含有溶液から、目的の成分を採取するための成分採取デバイス。
２． 前記吸引用筒状体の容器の外方向に突出する端部が、容器内の成分を吸引可能な装置、容器又はデバイスと連結可能な構造からなる前項１に記載の成分採取デバイス。
３． 前記ホルダー及び／又は吸引用筒状体に容器内部と外部とを連通するエアー取り込み手段を設けた前項１または２に記載の成分採取デバイス。
４． 前記容器がゴム栓をした容器であり、前記エアー取り込み手段が前記ゴム栓を刺通可能な金属筒である前項３に記載の成分採取デバイス。
５． 前項１〜４のいずれか一に記載の成分採取デバイスを用いた目的成分の採取方法。
６． 以下の１）〜４）の工程を含む前項５に記載の目的成分の採取方法：
１）複数成分含有溶液を含む容器を遠心分離機にかける工程；
２）成分採取デバイスを容器に装着する工程；
３）遠心分離により形成された分離層であって、複数成分含有溶液のうち吸引する特定成分の分離層に、吸引用筒状体の先端がくるように吸引用筒状体の長さを調節する工程；
４）上記３）の特定成分を吸引する工程。
７． 上記４）の工程において特定成分を採取する別途容器を使用し、上記１）の工程における容器及び該別途容器がゴム栓をした真空採血管であることを特徴とする前項６に記載の目的成分の採取方法。
８． 複数成分含有溶液が血液である前項６又は７に記載の目的成分の採取方法。
９． 前項７又は８の方法において、少なくとも１）、３）及び４）の工程を、異なる条件において２回以上繰り返すことを特徴とする目的成分濃縮液の調製方法。
１０． 目的成分が血小板血漿である前項９に記載の目的成分濃縮液の調製方法。
１１． 以下の工程を含む前項１０に記載の目的成分濃縮液の調製方法：
１）全血を含む容器を遠心分離機にかけ、下から赤血球層、バフィーコート層、血漿・血小板層に分離する工程；
２）成分採取デバイスを１）の容器に装着する工程；
３）吸引用筒状体の先端が血漿・血小板層に位置するように吸引用筒状体の長さを調節する工程；
４）血漿及び血小板を採取する工程；
５）血漿及び血小板を別途容器に移す工程；
６）血漿及び血小板を含む容器を遠心分離機にかけ、下から血小板層、血漿層に分離する工程；
７）成分採取デバイスを６）の容器に装着する工程；
８）吸引用筒状体の先端が血漿層に位置するように吸引用筒状体の長さを調節する工程；
９）一定量の血漿を採取する工程；
１０）容器内に残った血漿及び血小板を懸濁する工程。
１２． 前項１〜４のいずれか一に記載の成分採取デバイスを含む成分採取キット。
That is, this invention consists of the following.
1. A structure that includes a holder that can be attached to the container as a cap, and a suction cylinder that penetrates in the longitudinal direction of the holder, and the length of the suction cylinder that protrudes from the holder into the container can be adjusted. The structure is provided with a threaded portion on the inside of the holder and a part of the suction cylindrical body, and by fitting both the threaded portions, the suction cylindrical body penetrates in the longitudinal direction of the holder. And the length of the suction cylinder protruding into the container by the threaded portion is adjustable, and the container is a container with a rubber stopper, and the container of the suction cylinder A component collection device for collecting a target component from a solution containing a plurality of components, wherein an end projecting inward has a structure of a suction needle, and the suction needle is a metal needle that can pierce the rubber stopper.
2. 2. The component collection device according to
3. 3. The component collection device according to
4). 4. The component collection device according to
5). 5. A method for collecting a target component using the component collection device according to any one of 1 to 4 above.
6). The method for collecting the target component according to
1) A step of centrifuging a container containing a solution containing multiple components;
2) A step of attaching the component collection device to the container;
3) A separation layer formed by centrifugation, and the length of the suction cylinder is adjusted so that the tip of the suction cylinder comes to the separation layer of the specific component to be sucked out of the solution containing multiple components The step of:
4) A step of sucking the specific component of 3) above.
7). 7. The target component according to item 6 above, wherein a separate container for collecting the specific component is used in the step 4), and the container in the step 1) and the separate container are vacuum blood collection tubes with rubber stoppers. Collection method.
8). 8. The method for collecting a target component according to item 6 or 7 above, wherein the multiple component-containing solution is blood.
9. 9. A method for preparing a target component concentrate, which comprises repeating at least the steps 1), 3) and 4) two or more times under different conditions in the method of the preceding item 7 or 8 .
10. 10. The method for preparing a target component concentrate according to item 9 above, wherein the target component is platelet plasma.
11. The method for preparing the target component concentrate according to the above item 10 comprising the following steps:
1) A step of separating a container containing whole blood from a bottom into a red blood cell layer, a buffy coat layer, a plasma / platelet layer;
2) A step of attaching the component collection device to the container of 1);
3) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma / platelet layer;
4) collecting plasma and platelets;
5) Step of transferring plasma and platelets to a separate container;
6) Centrifuge the container containing plasma and platelets to separate the platelet layer and plasma layer from below;
7) A step of attaching the component collection device to the container of 6);
8) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma layer;
9) collecting a certain amount of plasma;
10) A step of suspending plasma and platelets remaining in the container.
12 The component collection kit containing the component collection device as described in any one of the preceding clauses 1-4 .
本発明の成分採取デバイスを使用すると、容器内の複数成分含有溶液から効率的に目的成分を採取ことができる。また、本発明の成分採取デバイスは、遠心分離可能な既存の容器に装着させることができ、特殊な容器や遠心分離機を準備する必要なく、容易に目的成分を採取ことができる。例えば、採血管に採取した血液から、容易に効率的にPRPを調製することができる。 When the component collection device of the present invention is used, the target component can be efficiently collected from the multiple component-containing solution in the container. In addition, the component collection device of the present invention can be attached to an existing container that can be centrifuged, and the target component can be easily collected without the need to prepare a special container or centrifuge. For example, PRP can be easily and efficiently prepared from blood collected in a blood collection tube.
本発明の複数成分含有溶液とは、異なる比重を有する複数の成分を含有する溶液を意味し、具体的には血液、尿等の生体成分、細胞培養液、細胞培養液、リンパ液、組織液、タンパク含有液、DNA含有液、高分子溶液、有機溶媒／水溶液混合液（水と油）等を例示することができ、より好適には、血液を例示することができる。例えば、血液には赤血球、白血球、血小板等の比重の異なる複数の成分が含まれている。採血した血液から、目的成分を取得するために、回転数の異なる複数の遠心分離処理を行い、必要に応じて上清を取得したり、上清を廃棄したりする必要がある。
例えば血液は、病院等の検査機関等において採血され、採血管に保存される。保存された採血管等の容器をそのまま利用して血液中の目的成分を採取することができれば、便利であるばかりではなく、血液等が人の手に直接触れることなく、安全かつ衛生的である。
The multi-component-containing solution of the present invention means a solution containing a plurality of components having different specific gravities, specifically, biological components such as blood and urine, cell culture fluid, cell culture fluid, lymph fluid, tissue fluid, protein Examples include a containing solution, a DNA-containing solution, a polymer solution, an organic solvent / aqueous solution mixture (water and oil), and more preferably, blood. For example, blood contains a plurality of components having different specific gravities such as red blood cells, white blood cells, and platelets. In order to acquire the target component from the collected blood, it is necessary to perform a plurality of centrifugal separation processes with different rotation speeds, to acquire a supernatant as needed, or to discard the supernatant.
For example, blood is collected in a laboratory such as a hospital and stored in a blood collection tube. If the target component in blood can be collected using a stored blood collection tube or the like as it is, it is not only convenient, but it is safe and hygienic without the blood directly touching human hands. .
本発明の成分採取デバイスの説明にあたり、「容器」とは、複数成分含有溶液用の容器であって、例えば血液、尿などの検体の収集容器であり、遠心分離可能なものをいう。具体的には、採血管や、遠心管などがあげられる。 In the description of the component collection device of the present invention, the “container” is a container for a solution containing a plurality of components, for example, a collection container for specimens such as blood and urine, which can be centrifuged. Specific examples include a blood collection tube and a centrifuge tube.
本発明の「容器にキャップとして装着可能なホルダー」とは、上述の容器の蓋をしたまま、又は容器の蓋をはずした状態で、容器の開口部にキャップとして装着可能であり、該ホルダーの縦軸方向に貫通された吸引用筒状体を容器内に挿入し、固定することができる吸引用筒状体を支えるホルダーを意味する。該ホルダーの容器に装着可能な部位は、容器側の装着部位、例えば採血管の蓋部又は開口部を覆って固定され、キャップとして装着しうる大きさの形状であれば良い。該ホルダーが容器に装着されることによって、本発明の成分採取デバイスそのものが容器に装着されることとなる。ホルダーの素材は、特に限定されないが、例えばポリエチレン、ポリプロピレン、ポリカーボネート等が好適である。 The “holder that can be attached to a container as a cap” of the present invention can be attached as a cap to the opening of a container with the container lid being removed or with the container lid removed. It means a holder that supports the suction cylinder that can be inserted and fixed in the container with the suction cylinder penetrated in the longitudinal direction. The part of the holder that can be attached to the container may be any shape as long as it is fixed so as to cover the attachment part on the container side, for example, the lid or opening of the blood collection tube and can be attached as a cap. By mounting the holder on the container, the component collection device of the present invention itself is mounted on the container. The material of the holder is not particularly limited, but for example, polyethylene, polypropylene, polycarbonate, and the like are suitable.
本発明の「ホルダーの縦軸方向に貫通された吸引用筒状体」とは、上述のホルダーの縦軸方向に貫通されており、容器内に挿入され、遠心処理によって多層に分離された複数の成分うち特定成分の層に吸引用筒状体の先端がくるように調節し、該特定成分を吸引するための筒状体をいう。ここで、「特定成分」とは、目的成分であっても良いし、目的成分を容器内に残しておきたい場合は目的外の成分であっても良い。 The “cylinder for suction penetrating in the longitudinal direction of the holder” of the present invention refers to a plurality of pieces that are penetrated in the longitudinal direction of the above-mentioned holder, inserted into a container, and separated into multiple layers by centrifugation. The cylindrical body for sucking the specific component by adjusting so that the tip of the suction cylindrical body comes to the layer of the specific component. Here, the “specific component” may be a target component, or may be a component other than the target when it is desired to leave the target component in the container.
本発明のホルダーが容器に装着されて固定されている状態で、容器内に挿入されている吸引用筒状体の長さを自在に調節できることが必要である。吸引用筒状体の長さの調節方法は、例えば、吸引用筒状体をホルダー内でスライドさせてもよいが、好ましくは、前記ホルダーの内側と、吸引用筒状体の外側の一部にねじ部を設け、両ねじ部を嵌合させることで達成される。両ねじ部の嵌合により、安定した状態でホルダーと吸引用筒状体が結合される。
容器内に突出した吸引用筒状体は、容器の底面部にほぼ届く程度の長さから容器内の複数成分含有溶液の液面よりやや下に届く長さの間で調節可能であればよい。
本発明の吸引用筒状体の容器内に突出する部分の筒状体の形状は、複数成分含有溶液を遠心分離し、特定成分を吸引しうる形状であれば良く特に限定されないが、例えば注射針のような形状とすることができる。
In the state where the holder of the present invention is mounted and fixed to the container, it is necessary to be able to freely adjust the length of the suction cylinder inserted into the container. The method of adjusting the length of the suction cylinder may be, for example, sliding the suction cylinder within the holder, but preferably the inside of the holder and a part of the outside of the suction cylinder This is achieved by providing a threaded portion and fitting both threaded portions. By fitting the both screw portions, the holder and the suction cylinder are coupled in a stable state.
The suction cylindrical body protruding into the container is only required to be adjustable between a length that can reach the bottom surface of the container and a length that reaches a little below the liquid surface of the multiple component-containing solution in the container. .
The shape of the cylindrical body of the portion protruding into the container of the suction tubular body of the present invention is not particularly limited as long as it is a shape that can centrifuge a multi-component-containing solution and suck a specific component. It can be shaped like a needle.
例えば、血液からPRPを取得するために、本発明の成分採取デバイスを使用する場合は、採血管に収集した血液を採血管に入れたまま遠心分離し、そのまま該デバイスを採血管に装着し、利用できれば、特別の容器や特別の遠心分離器を準備する必要なく、便利である。
特に、例えば採血管の蓋をしたまま、本発明のデバイスを装着できれば安全性、衛生面からも、特に好適である。このような観点から、本発明の容器内に突出する吸引用筒状体の端部の形状は、採血管のゴム蓋等を貫通しうる形状をしていることが好ましい。具体的には、吸引針のような形状とすることができる。また、該吸引用筒状体の素材は、上記目的を達成可能なものであれば特に限定されず、プラスチック又は金属製のものを使用することができる。例えばゴム蓋を刺通させる場合には、ゴム片が容器内に脱落しないことが必要であるため、具体的には注射針等に適用される金属針が好適である。
For example, when using the component collection device of the present invention to obtain PRP from blood, the blood collected in the blood collection tube is centrifuged while placed in the blood collection tube, and the device is directly attached to the blood collection tube. If available, it is convenient without the need for special containers or special centrifuges.
In particular, it is particularly preferable from the viewpoint of safety and hygiene if the device of the present invention can be mounted with the lid of the blood collection tube, for example. From such a viewpoint, it is preferable that the shape of the end portion of the suction cylindrical body protruding into the container of the present invention is a shape that can penetrate the rubber lid of the blood collection tube. Specifically, it can be shaped like a suction needle. Moreover, the raw material of the cylindrical body for suction is not particularly limited as long as the object can be achieved, and a plastic or metal material can be used. For example, when a rubber lid is pierced, it is necessary that the rubber piece does not fall into the container. Specifically, a metal needle applied to an injection needle or the like is preferable.
本発明の吸引用筒状体の容器外に突出する端部は、例えばアスピレーター、真空採血管又はシリンジのような容器内の成分を吸引可能な装置、容器、デバイス等と結合可能であれば良い。例えば真空採血管と結合させる場合には、吸引用筒状体の容器外に突出する端部は、採血管のゴム蓋を刺通可能な形状、例えば金属針のような形状とすることができる。一方、シリンジと結合させる場合には、吸引用筒状体の容器外に突出する端部は、市販のルアー式、ロック式の両方のシリンジと結合可能な構造であることが好適である。 The end of the suction cylindrical body of the present invention that protrudes outside the container only needs to be able to be coupled to an apparatus, container, device, or the like that can suck components in the container, such as an aspirator, a vacuum blood collection tube, or a syringe. . For example, when combined with a vacuum blood collection tube, the end of the suction tube that protrudes outside the container can have a shape that allows the rubber lid of the blood collection tube to be pierced, such as a metal needle. . On the other hand, in the case of coupling with a syringe, it is preferable that the end of the suction tubular body protruding outside the container has a structure that can be coupled with both commercially available luer type and lock type syringes.
さらに、本発明の成分採取デバイスとともに、エアー取り込み手段を設けることができる。例えば、本発明の吸引用筒状体を複数成分含有溶液を含む容器のゴム栓に刺通させたとき、容器が密封状態になり、特定成分を吸引することが困難な場合がある。そのような場合に、エアー取り込み手段を設けることによって、スムーズに特定成分を吸引することができる。エアー取り込み手段は、成分採取デバイスのホルダー及び／又は吸引用筒状体に設けることができる。例えば、吸引用筒状体とホルダーの連結部付近に、吸引用筒状体を貫通させた別の筒状体を設置することで、エアーを取り込むことができる。例えば、別の筒状体と吸引用筒状体を共に容器のゴム栓に刺通させたとき、吸引用筒状体と、別の筒状体の間に隙間ができ、該隙間と上記ねじ部の隙間から容器内にエアーを取り込むことができる。 Furthermore, an air intake means can be provided together with the component collection device of the present invention. For example, when the suction cylindrical body of the present invention is pierced through a rubber stopper of a container containing a multi-component-containing solution, the container may be sealed and it may be difficult to suck a specific component. In such a case, the specific component can be sucked smoothly by providing the air intake means. The air intake means can be provided in the holder of the component collection device and / or the suction cylinder. For example, air can be taken in by installing another cylindrical body that penetrates the suction cylindrical body in the vicinity of the connecting portion between the suction cylindrical body and the holder. For example, when another tubular body and a suction tubular body are both pierced through the rubber stopper of the container, a gap is formed between the suction tubular body and another tubular body, and the gap and the screw Air can be taken into the container from the gap between the portions.
本発明の目的成分は、成分採取デバイスにより少なくとも以下の１）〜４）の工程を含む方法により採取することができる。
１）複数成分含有溶液を含む容器を遠心分離機にかける工程；
２）成分採取デバイスを容器に装着する工程；
３）遠心分離により形成された分離層であって、複数成分含有溶液のうち吸引する特定成分の分離層に、吸引用筒状体の先端がくるように吸引用筒状体の長さを調節する工程；
４）上記３）の特定成分を吸引する工程。
The target component of the present invention can be collected by a method including at least the following steps 1) to 4) with a component collection device.
1) A step of centrifuging a container containing a solution containing multiple components;
2) A step of attaching the component collection device to the container;
3) A separation layer formed by centrifugation, and the length of the suction cylinder is adjusted so that the tip of the suction cylinder comes to the separation layer of the specific component to be sucked out of the solution containing multiple components The step of:
4) A step of sucking the specific component of 3) above.
さらに、上記４）の工程において目的成分を採取する別途容器を使用し、上記１）の工程における容器および該別途容器がゴム栓をした真空採血管である場合、密封した容器から別途密封した容器へ特定の成分のみを採取することができ、コンタミネーションを防止することができて好ましい。 Further, when a separate container for collecting the target component is used in the step 4) and the container in the step 1) and the separate container are vacuum blood collection tubes with rubber stoppers, the sealed container is a separately sealed container. It is preferable that only specific components can be collected, and contamination can be prevented.
また、上記の工程のうち、容器の形状、遠心分離器の形状により、まず２）の成分採取デバイスを容器に装着する工程を１）複数成分含有溶液を含む容器を遠心分離機にかける工程の前に行うこともできる。 In addition, among the above steps, depending on the shape of the container and the shape of the centrifuge, first, the step of mounting the component collecting device of 2) on the container is 1) the step of applying the container containing the multi-component containing solution to the centrifuge It can also be done before.
さらに、上記の工程のうち、少なくとも１）、３）及び４）の工程を、異なる条件において２回以上繰り返すことで目的成分を採取することを利用して目的成分濃縮液を調製することができる。ここで、２）の成分採取デバイスを容器に装着する工程を複数回繰り返すことを必須の要件としないのは、成分採取デバイスを容器に装着したまま、遠心分離器にかけることができれば、再度の装着は必要としないからである。また、異なる条件で繰り返すとは、例えば遠心分離処理の回転数、処理時間や、筒状体の長さ、吸引する特定成分の具体的な物質等が異なることをいう。 Furthermore, a target component concentrate can be prepared by collecting the target component by repeating at least the steps 1), 3) and 4) two or more times under different conditions. . Here, it is not an essential requirement to repeat the step of attaching the component collection device of 2) to the container a plurality of times, if the component collection device can be applied to the centrifuge while being attached to the container. This is because wearing is not necessary. Moreover, repeating under different conditions means that, for example, the number of rotations of the centrifugal separation process, the processing time, the length of the cylindrical body, the specific substance of the specific component to be sucked, and the like are different.
本発明の目的成分採取方法は、複数成分含有溶液が血液の場合にも適用することができる。そして、該血液から多血小板血漿を調製することができる。例えば、次の工程を含む方法により、血小板血漿を調製することができる。
１）全血を含む容器を遠心分離機にかけ、下から赤血球層、バフィーコート層、血漿・血小板層に分離する工程；
２）成分採取デバイスを１）の容器に装着する工程；
３）吸引用筒状体の先端が血漿・血小板層に位置するように吸引用筒状体の長さを調節する工程；
４）血漿および血小板を採取する工程；
５）血漿および血小板を別途容器に移す工程；
６）血漿および血小板を含む容器を遠心分離機にかけ、下から血小板層、血漿層に分離する工程；
７）成分採取デバイスを６）の容器に装着する工程；
８）吸引用筒状体の先端が血漿層に位置するように吸引用筒状体の長さを調節する工程；
９）一定量の血漿を採取する工程；
１０）容器内に残った血漿および血小板を懸濁する工程。
The target component collecting method of the present invention can also be applied when the multi-component-containing solution is blood. Then, platelet-rich plasma can be prepared from the blood. For example, platelet plasma can be prepared by a method including the following steps.
1) A step of separating a container containing whole blood from a bottom into a red blood cell layer, a buffy coat layer, a plasma / platelet layer;
2) A step of attaching the component collection device to the container of 1);
3) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma / platelet layer;
4) collecting plasma and platelets;
5) Step of transferring plasma and platelets to a separate container;
6) A step of centrifuging a container containing plasma and platelets to separate the platelet layer and plasma layer from below;
7) A step of attaching the component collection device to the container of 6);
8) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma layer;
9) collecting a certain amount of plasma;
10) A step of suspending plasma and platelets remaining in the container.
なお、本発明は成分採取デバイス、該成分採取デバイスを用いた目的成分採取方法及び目的成分採取キットにも及ぶ。例えば、吸引用筒状体の容器外に突出する端部にアスピレーターまたはゴム栓をした真空採血管などに結合可能な別途結合部材が挙げられる。該別途結合部材とは金属針を備えたホルダーなどがであり、該金属針を備えたホルダーは吸引用筒状体の容器外に突出する端部に直接またはチューブを介して接続することができる。特に、金属針を備えたホルダーをチューブを介して接続する場合は、真空採血管を逆さにすることがなく操作性が向上するために好ましい。
さらに、本発明の目的成分採取キットにおける好ましい例として、筒状体が金属針の構造である場合、誤穿刺による医療事故を防止するために、該金属針周辺を覆うカバー又は容器を安定に固定させるスタンドなどが挙げられる。
The present invention extends to a component collection device, a target component collection method and a target component collection kit using the component collection device. For example, a separate coupling member that can be coupled to an aspirator or a vacuum blood collection tube with a rubber stopper at the end protruding outside the container of the suction cylinder is mentioned. The separate coupling member is a holder equipped with a metal needle, etc., and the holder equipped with the metal needle can be connected directly or through a tube to the end of the suction cylinder that protrudes outside the container. . In particular, when a holder equipped with a metal needle is connected via a tube, it is preferable because the operability is improved without inverting the vacuum blood collection tube.
Furthermore, as a preferable example in the target component collection kit of the present invention, when the cylindrical body has a structure of a metal needle, a cover or container covering the periphery of the metal needle is stably fixed in order to prevent a medical accident due to erroneous puncture. A stand to make it.
本発明の理解を助けるために、以下に実施例として添付図面を参照しながら説明する。なお、図中同一符号は同一又は対応する部分を示すものとする。本発明はこれら実施例に限定されるものではない。 In order to help the understanding of the present invention, the following description will be given by way of example with reference to the accompanying drawings. In the drawings, the same reference numerals indicate the same or corresponding parts. The present invention is not limited to these examples.
（実施例１）成分採取デバイス
以下に、添付図面の図１及び２について説明する。図１は本発明の成分採取デバイスの一例であり、図２は、図１のデバイスの断面図である。
装着可能なホルダー(1)は、ホルダー上部の内側の一部にねじ部(12)を有する。上該ホルダー(1)の縦軸方向に吸引用筒状体(2)が貫通されている。該吸引用筒状体(2)にはホルダー内部のねじ部(12)と勘合するようにねじ部(22)が設けられている。採血管等の容器内に挿入される側の吸引用筒状体の先端部(23)は、採血管のゴム蓋を貫通可能なように刺通可能な形状となっている。採血管等の容器の外側の吸引用筒状体の端部(24)は、シリンジ、真空採血管等と結合可能な形状である。真空採血管等と結合させるために、注射針を介することもできる。
(Example 1) Component collection device Hereinafter, FIGS. 1 and 2 of the accompanying drawings will be described. FIG. 1 is an example of a component collection device of the present invention, and FIG. 2 is a cross-sectional view of the device of FIG.
The mountable holder (1) has a threaded portion (12) in a part of the inside of the upper part of the holder. The suction cylinder (2) is penetrated in the vertical direction of the holder (1). The suction cylindrical body (2) is provided with a screw portion (22) so as to be fitted with the screw portion (12) inside the holder. The distal end portion (23) of the suction cylinder on the side inserted into a container such as a blood collection tube has a shape that can be pierced so as to be able to penetrate the rubber lid of the blood collection tube. The end (24) of the suction tubular body outside the container such as a blood collection tube has a shape that can be coupled to a syringe, a vacuum blood collection tube, or the like. An injection needle may be used for coupling with a vacuum blood collection tube or the like.
（実施例２）成分採取デバイスの使用態様
実施例１の成分採取デバイスを、容器の一例である真空採血管に装着した図を図３に示す。真空採血管に吸引用筒状体を挿入し、ホルダーの端部(13)を、真空採血管の蓋部にキャップのように装着し、固定する。ホルダー内部のねじ部(12)と吸引用筒状体のねじ部(22)を回転させて、容器内に突出した吸引用筒状体の長さを調節することができる。
(Example 2) Usage mode of component collection device Fig. 3 shows a view of mounting the component collection device of Example 1 on a vacuum blood collection tube which is an example of a container. The suction tube is inserted into the vacuum blood collection tube, and the end (13) of the holder is attached to the lid of the vacuum blood collection tube like a cap and fixed. The length of the suction cylindrical body protruding into the container can be adjusted by rotating the screw section (12) inside the holder and the screw section (22) of the suction cylindrical body.
（実施例３）エアー取り込み手段
実施例１の成分採取デバイスに設けたエアー取り込み手段を図４に示す。吸引用筒状体とホルダーの連結部付近に、吸引用筒状体を貫通させた別の筒状体であるエアー取り込み用筒状体を設置することによる。該エアー取り込み用筒状体及び吸引用筒状体を共に容器のゴム栓に刺通させると、吸引用筒状体と該エアー取り込み用筒状体の間に隙間ができ、該隙間と上記ねじ部の隙間から容器内にエアーを取り込むことができる。
(Example 3) Air intake means The air intake means provided in the component collection device of Example 1 is shown in FIG. By installing a cylindrical body for air intake, which is another cylindrical body penetrating the cylindrical body for suction, in the vicinity of the connecting portion between the cylindrical body for suction and the holder. When both the air intake cylindrical body and the suction cylindrical body are pierced through the rubber stopper of the container, a gap is formed between the suction cylindrical body and the air intake cylindrical body, and the gap and the screw Air can be taken into the container from the gap between the portions.
（実施例４）デバイスにシリンジを連結する場合
血液から血小板血漿(PRP)を調製する場合の方法を例示して説明する（図５）。
１）採血した血液（全血）を含む採血管を、回転数160gで10分間遠心分離機にかけ、下から赤血球層、バフィーコート層、血漿・血小板層に分離する工程；
２）実施例１の成分採取デバイスを容器に装着する工程；
３）上記１）の工程で得た分離層のうち、吸引用筒状体の先端(23)が血漿・血小板層に位置するように吸引用筒状体の長さを調節する工程；
４）吸引用筒状体(24)にシリンジを連結し、該シリンジ内に血漿および血小板を採取する工程；
５）シリンジ内に吸引した血漿および血小板をを別の採血管に採取する工程；
６）血小板を含む血漿を含む採血管を、回転数400gで10分間遠心分離機にかけ、下から血小板層、血漿層に分離する工程；
７）成分採取デバイスを６）の容器に装着する工程；
８）上記６）の工程で得た分離層のうち、吸引用筒状体の先端(23)が血漿層に位置するように吸引用筒状体の長さを調節する工程；
９）吸引用筒状体にシリンジを連結し、該シリンジ内に血漿を適当量吸引する工程；
１０）容器内に残った血漿および血小板を懸濁することで、PRPを採取する。
(Example 4) When a syringe is connected to a device A method for preparing platelet plasma (PRP) from blood will be exemplified and described (FIG. 5).
1) A step of separating a blood collection tube containing collected blood (whole blood) into a red blood cell layer, a buffy coat layer, and a plasma / platelet layer from the bottom by centrifuging at 160 g for 10 minutes;
2) A step of attaching the component collection device of Example 1 to a container;
3) A step of adjusting the length of the suction cylinder so that the tip (23) of the suction cylinder is located in the plasma / platelet layer among the separation layers obtained in the step 1);
4) A step of connecting a syringe to the suction cylinder (24) and collecting plasma and platelets in the syringe;
5) A step of collecting plasma and platelets sucked into a syringe into another blood collection tube;
6) A step of separating a blood collection tube containing plasma containing platelets into a platelet layer and a plasma layer from below by centrifuging at 400 g for 10 minutes;
7) A step of attaching the component collection device to the container of 6);
8) A step of adjusting the length of the suction cylinder so that the tip (23) of the suction cylinder is located in the plasma layer among the separation layers obtained in the step 6);
9) A step of connecting a syringe to the cylindrical body for suction, and sucking an appropriate amount of plasma into the syringe;
10) Collect PRP by suspending plasma and platelets remaining in the container.
（実施例５）デバイスに真空採血管を連結する場合
血液からPRPを調製する場合の方法を例示して説明する（図６）。
１）〜３）については実施例４と同様に行う。
４）吸引用筒状体(24)に、真空採血管を連結し、該真空採血管内に血漿および血小板を採取する工程；
５）４）で血漿および血小板を採取した真空採血管からデバイスを取り外し、該真空採血管を回転数400gで10分間遠心分離機にかけ、下から血小板層、血漿層に分離する工程；
６）上記５）の工程で得た分離層のうち、吸引用筒状体の先端(23)を血漿の層に届く長さに調節する工程；
７）吸引用筒状体(24)に別の真空採血管を連結し、該シリンジ内に血漿を適当量吸引する工程；
８）容器内に残った血漿および血小板を懸濁することで、PRPを採取する。
(Example 5) When a vacuum blood collection tube is connected to a device A method for preparing PRP from blood will be exemplified and described (FIG. 6).
About 1) -3), it carries out similarly to Example 4. FIG.
4) A step of connecting a vacuum blood collection tube to the suction cylinder (24) and collecting plasma and platelets in the vacuum blood collection tube;
5) A step of removing the device from the vacuum blood collection tube from which plasma and platelets were collected in 4), centrifuging the vacuum blood collection tube for 10 minutes at a rotational speed of 400 g, and separating the platelet layer and the plasma layer from the bottom;
6) A step of adjusting the tip (23) of the suction cylinder among the separated layers obtained in the step 5) to a length that reaches the plasma layer;
7) A step of connecting another vacuum blood collection tube to the suction cylinder (24) and sucking an appropriate amount of plasma into the syringe;
8) Collect PRP by suspending plasma and platelets remaining in the container.
本発明の成分採取デバイスを使用すると、例えば、採血管に採取した血液から、容易にPRPを調製することができる。この場合、既に市販されている採血管及び既存の遠心分離器を用いて調製することができるので、既存の容器、機器を有効活用しながら目的成分の濃縮液を得ることができる。
例えば、PRPは口腔外科領域でも使用されるが、本発明の成分採取デバイスを使用すると、病院又は検査機関等で採血管に採血した血液を用いて開業歯科医等が医院内に別の遠心分離器を設置する必要なく容易に効率よくPRPを調製することができる。
When the component collection device of the present invention is used, for example, PRP can be easily prepared from blood collected in a blood collection tube. In this case, since it can be prepared using a commercially available blood collection tube and an existing centrifuge, a concentrated solution of the target component can be obtained while effectively utilizing existing containers and equipment.
For example, although PRP is also used in the field of oral surgery, when the component collection device of the present invention is used, a practitioner or the like using a blood sample collected in a blood collection tube at a hospital or a laboratory or the like is separated into a separate clinic in the clinic. PRP can be prepared easily and efficiently without the need to install a vessel.
１ ホルダー
１２ ねじ部
１３ 容器との装着部位
２ 吸引用筒状体
２２ ねじ部
２３ 容器内の吸引用筒状体端部
２４ 容器外の吸引用筒状体端部
３ エアー取り込み用筒状体
４ 真空採血管
４１ ゴム栓
５ シリンジ
ａ 血液
ｂ 赤血球層
ｃ バフィーコート層
ｄ 血漿・血小板層
ｅ 血小板層
ｆ 血漿層
DESCRIPTION OF
Claims (12)
１）複数成分含有溶液を含む容器を遠心分離機にかける工程；
２）成分採取デバイスを容器に装着する工程；
３）遠心分離により形成された分離層であって、複数成分含有溶液のうち吸引する特定成分の分離層に、吸引用筒状体の先端がくるように吸引用筒状体の長さを調節する工程；
４）上記３）の特定成分を吸引する工程。 The method for collecting a target component according to claim 5 , comprising the following steps 1) to 4):
1) A step of centrifuging a container containing a solution containing multiple components;
2) A step of attaching the component collection device to the container;
3) A separation layer formed by centrifugation, and the length of the suction cylinder is adjusted so that the tip of the suction cylinder comes to the separation layer of the specific component to be sucked out of the solution containing multiple components The step of:
4) A step of sucking the specific component of 3) above.
１）全血を含む容器を遠心分離機にかけ、下から赤血球層、バフィーコート層、血漿・血小板層に分離する工程；
２）成分採取デバイスを１）の容器に装着する工程；
３）吸引用筒状体の先端が血漿・血小板層に位置するように吸引用筒状体の長さを調節する工程；
４）血漿及び血小板を採取する工程；
５）血漿及び血小板を別途容器に移す工程；
６）血漿及び血小板を含む容器を遠心分離機にかけ、下から血小板層、血漿層に分離する工程；
７）成分採取デバイスを６）の容器に装着する工程；
８）吸引用筒状体の先端が血漿層に位置するように吸引用筒状体の長さを調節する工程；
９）一定量の血漿を採取する工程；
１０）容器内に残った血漿及び血小板を懸濁する工程。 The preparation method of the target component concentrate of Claim 10 including the following processes:
1) A step of separating a container containing whole blood from a bottom into a red blood cell layer, a buffy coat layer, a plasma / platelet layer;
2) A step of attaching the component collection device to the container of 1);
3) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma / platelet layer;
4) collecting plasma and platelets;
5) Step of transferring plasma and platelets to a separate container;
6) Centrifuge the container containing plasma and platelets to separate the platelet layer and plasma layer from below;
7) A step of attaching the component collection device to the container of 6);
8) adjusting the length of the suction cylinder so that the tip of the suction cylinder is positioned in the plasma layer;
9) collecting a certain amount of plasma;
10) A step of suspending plasma and platelets remaining in the container.
Priority Applications (2)
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| JP2004265243A JP4239220B2 (en) | 2004-09-13 | 2004-09-13 | Component collection device |
| PCT/JP2005/016782 WO2006030749A1 (en) | 2004-09-13 | 2005-09-12 | Component-collecting device |
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| JP2004265243A JP4239220B2 (en) | 2004-09-13 | 2004-09-13 | Component collection device |
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| JP4239220B2 true JP4239220B2 (en) | 2009-03-18 |
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| JP4983204B2 (en) * | 2006-10-27 | 2012-07-25 | ニプロ株式会社 | Centrifuge container and centrifuge method |
| US9050403B2 (en) | 2006-10-27 | 2015-06-09 | Nipro Corporation | Platelet-rich plasma separator and platelet-rich plasma separation method |
| JP4894566B2 (en) * | 2007-03-08 | 2012-03-14 | ニプロ株式会社 | Blood sample dispensing kit and blood sample dispensing method |
| JP5105925B2 (en) | 2007-03-26 | 2012-12-26 | 京セラメディカル株式会社 | Centrifugal device |
| JP5022854B2 (en) * | 2007-10-04 | 2012-09-12 | 日立アロカメディカル株式会社 | Blood collection method and blood collection coupler |
| PE20150961A1 (en) * | 2009-05-14 | 2015-07-04 | Biotechnology Inst I Mas D Sl | EXTRACTION DEVICE FOR THE EXECUTION OF A METHOD OF PREPARATION OF AT LEAST ONE COMPOUND FROM BLOOD |
| US7927563B1 (en) * | 2009-10-13 | 2011-04-19 | Cytomedix, Inc. | Kit for separation of biological fluids |
| KR101069877B1 (en) * | 2009-10-28 | 2011-10-05 | 임기표 | Kit of centrifuge separation and methods for centrifuging using the same |
| KR101008583B1 (en) | 2010-10-27 | 2011-01-17 | 주식회사 메디사랑 | Filtration device for the separation of platelet rich fibrin |
| WO2014092115A1 (en) * | 2012-12-13 | 2014-06-19 | 株式会社ジェイ・エム・エス | Device for separating/housing blood components and method for preparing platelet-rich plasma |
| WO2015178023A1 (en) * | 2014-05-21 | 2015-11-26 | ニプロ株式会社 | Dispensing holder |
| WO2016094451A1 (en) * | 2014-12-08 | 2016-06-16 | Saint-Gobain Performance Plastics Corporation | Closed system for extracting isolated medium |
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| JPH08304387A (en) * | 1995-04-28 | 1996-11-22 | Aloka Co Ltd | Blood specimen sampling device |
| US6280400B1 (en) * | 1998-12-05 | 2001-08-28 | Becton Dickinson And Company | Device and method for separating component of a liquid sample |
| CN1310980A (en) * | 2000-02-29 | 2001-09-05 | 迪亚西斯公司 | Method and equipment for treating various kinds of liquid |
| DE10053974A1 (en) * | 2000-10-31 | 2002-05-29 | Roche Diagnostics Gmbh | Blood collection system |
| US6835353B2 (en) * | 2001-06-06 | 2004-12-28 | Perfusion Partners And Associates, Inc. | Centrifuge tube assembly |
| JP2003055237A (en) * | 2001-08-15 | 2003-02-26 | Japan Science & Technology Corp | Osteoanagenesis promoting agent |
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| JP2006078428A (en) | 2006-03-23 |
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