JP2011189058A - Blood purification device and incorrect installation detection method for blood purification device - Google Patents

Blood purification device and incorrect installation detection method for blood purification device Download PDF

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JP2011189058A
JP2011189058A JP2010059374A JP2010059374A JP2011189058A JP 2011189058 A JP2011189058 A JP 2011189058A JP 2010059374 A JP2010059374 A JP 2010059374A JP 2010059374 A JP2010059374 A JP 2010059374A JP 2011189058 A JP2011189058 A JP 2011189058A
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JP5525874B2 (en
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Takashi Umimoto
隆志 海本
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Asahi Kasei Medical Co Ltd
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Asahi Kasei Kuraray Medical Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To easily detect incorrect installation of a tube using a pump and a sensor provided in an existing blood purification device. <P>SOLUTION: A blood purification device includes: a blood collection circuit 4 connected to a blood inlet side of a plasma separator 2; a blood pump 5 disposed in the blood collection circuit 4; a plasma circuit 6 connected to a plasma outlet side of the plasma separator 2; a plasma pump 7 disposed in the plasma circuit 6; a blood returning circuit 8 connected to a hemocyte outlet side of the plasma separator 2; and a sensor 9 to detect pressure change in the blood returning circuit 8. The blood purification device further includes a control means 12 which determines that the blood collection circuit 4 is not configured by a normal tube and outputs that effect when the pressure change detected by the sensor 9 in a state in which the blood collection circuit 4 is configured by a tube to be the determination object, the blood returning circuit 8 is closed and the blood pump 5 and the plasma pump 7 are operated, is different from prescribed normal change. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

本発明は、血液浄化装置及び血液浄化装置の誤設置検知方法に関する。   The present invention relates to a blood purification apparatus and an erroneous installation detection method for the blood purification apparatus.

従来より、患者の体内から血液を取り出しこの血液から病因物質や特定の白血球等を除去して体内に戻す血液浄化治療が実施されている。このような血液浄化治療においては、体内から取り出した血液を循環させて体内に戻すための血液回路と、特定の物質を除去・分離する吸着材や分離材等の処理材を有する血液処理器と、を備える血液浄化装置が使用されている。   Conventionally, blood purification treatment has been performed in which blood is taken out from a patient's body, and pathogenic substances, specific white blood cells and the like are removed from the blood and returned to the body. In such blood purification treatment, a blood circuit for circulating blood taken out from the body and returning it to the body, and a blood treatment device having a treatment material such as an adsorbent or a separation material for removing / separating a specific substance, Are used.

現在においては、小児用の血液浄化治療も実施されている。このような小児用の血液浄化治療においては、体外を循環させる血液量を最小限に抑えるため、また、血液を低い流量範囲で高精度に流通させるため、成人治療で用いるチューブよりも内径が小さい小児用のチューブを用いて血液回路を構成している。このような小児用の血液浄化装置において小児用のチューブを成人用のチューブと取り違えると、正しい流量範囲で血液を流通させることができなくなるため、治療効果が期待できなくなる。   At present, blood purification treatment for children is also being implemented. In such blood purification treatment for children, the inner diameter is smaller than the tube used for adult treatment in order to minimize the amount of blood circulating outside the body and to circulate blood with high accuracy in a low flow rate range. The blood circuit is made up of pediatric tubes. In such a pediatric blood purification apparatus, if a pediatric tube is mistaken for an adult tube, blood cannot be circulated in the correct flow rate range, so that a therapeutic effect cannot be expected.

近年においては、このようなチューブの誤設置を防ぐ目的で、チューブの接続部材であるエルボにサイズ識別手段（複数のタブによるコードパターン）を設け、このサイズ識別手段を用いてチューブの製造上のサイズ変動を識別する技術が提案されている（例えば、特許文献１参照）。   In recent years, in order to prevent such an erroneous installation of the tube, a size identifying means (a code pattern with a plurality of tabs) is provided in an elbow that is a connecting member of the tube, and this size identifying means is used to manufacture the tube. A technique for identifying the size variation has been proposed (see, for example, Patent Document 1).

特表２００１−５１７９６４号公報JP-T-2001-517964

特許文献１に記載されたようにエルボにサイズ識別手段を付加する技術は、新規装置設計の段階であれば有用となり得るが、既存装置に対するオプションとしては、設計の大幅な変更を伴うために経済的な観点からも好ましくない。また、このような従来の技術においては、エルボに設けたサイズ識別手段に製造誤差が生じた場合にチューブの誤設置を検知できないという問題がある。   The technique of adding size identification means to the elbow as described in Patent Document 1 can be useful at the stage of designing a new device, but as an option for an existing device, it is economical because it involves a significant change in the design. From a general viewpoint, it is not preferable. Further, in such a conventional technique, there is a problem that an erroneous installation of the tube cannot be detected when a manufacturing error occurs in the size identification means provided in the elbow.

本発明は、かかる事情に鑑みてなされたものであり、既存の血液浄化装置に設けられているポンプや圧力センサを用いて簡単にチューブの誤設置を検知することを目的とする。   The present invention has been made in view of such circumstances, and an object thereof is to easily detect an erroneous installation of a tube using a pump or a pressure sensor provided in an existing blood purification apparatus.

前記目的を達成するため、本発明に係る血液浄化装置は、血液入口から導入された血液に所定の処理を施して第１の出口及び第２の出口から排出する血液処理器と、血液処理器の血液入口側に接続される第１の回路と、第１の回路内の流体を圧送する第１のポンプと、血液処理器の第１の出口側に接続される第２の回路と、第２の回路内の流体を圧送する第２のポンプと、血液処理器の第２の出口側に接続される第３の回路と、第３の回路内の流体の圧力変化を検出する圧力センサと、圧力センサの下流側で第３の回路を閉塞する閉塞手段と、を備え、第１の回路は所定の内径を有する正規チューブ又は正規チューブと異なる内径を有するチューブで構成可能とされる血液浄化装置であって、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞手段で閉塞し第１及び第２のポンプを各々所定の回転数で作動させた状態において圧力センサで検出した圧力変化が所定の正規変化と異なる場合に、第１の回路が正規チューブで構成されていないものと判定してその旨を出力する制御手段を備えるものである。   In order to achieve the above object, a blood purification apparatus according to the present invention includes a blood processor that performs a predetermined process on blood introduced from a blood inlet and discharges the blood from the first outlet and the second outlet, and a blood processor. A first circuit connected to the blood inlet side, a first pump for pumping fluid in the first circuit, a second circuit connected to the first outlet side of the blood processor, A second pump for pumping fluid in the second circuit, a third circuit connected to the second outlet side of the blood processor, and a pressure sensor for detecting a pressure change of the fluid in the third circuit; And a closing means for closing the third circuit on the downstream side of the pressure sensor, wherein the first circuit can be constituted by a normal tube having a predetermined inner diameter or a tube having an inner diameter different from that of the normal tube. A first circuit configured with a tube to be determined; When the pressure change detected by the pressure sensor is different from the predetermined normal change when the first circuit is closed by the closing means and the first and second pumps are each operated at the predetermined rotation speed, the first circuit is It is provided with the control means which determines that it is not comprised with the tube and outputs that.

また、本発明に係る誤設置検知方法は、血液入口から導入された血液に所定の処理を施して第１の出口及び第２の出口から排出する血液処理器と、血液処理器の血液入口側に接続される第１の回路と、第１の回路内の流体を圧送する第１のポンプと、血液処理器の第１の出口側に接続される第２の回路と、第２の回路内の流体を圧送する第２のポンプと、血液処理器の第２の出口側に接続される第３の回路と、第３の回路内の流体の圧力変化を検出する圧力センサと、圧力センサの下流側で第３の回路を閉塞する閉塞手段と、を備え、第１の回路は所定の内径を有する正規チューブ又は正規チューブと異なる内径を有するチューブで構成可能とされる血液浄化装置の誤設置検知方法であって、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞手段で閉塞し第１及び第２のポンプを各々所定の回転数で作動させた状態において圧力センサで検出した圧力変化が所定の正規変化と一致するか否かを判定する圧力変化判定工程と、圧力変化判定工程において否定的な判定が得られた場合に第１の回路が正規チューブで構成されていないものとしてその旨を出力する誤検知出力工程と、を備えるものである。   In addition, the erroneous installation detection method according to the present invention includes a blood processor that performs a predetermined process on blood introduced from the blood inlet and discharges the blood from the first outlet and the second outlet, and a blood inlet side of the blood processor. A first circuit connected to the first circuit, a first pump for pumping fluid in the first circuit, a second circuit connected to the first outlet side of the blood treatment device, and a second circuit A second pump for pumping the fluid of the fluid, a third circuit connected to the second outlet side of the blood treatment device, a pressure sensor for detecting a pressure change of the fluid in the third circuit, and a pressure sensor And a blocking means for closing the third circuit on the downstream side, wherein the first circuit is configured as a regular tube having a predetermined inner diameter or a blood purification device that can be configured with a tube having an inner diameter different from the regular tube. A detection method comprising: a first circuit configured with a tube to be determined; Pressure change which determines whether or not the pressure change detected by the pressure sensor coincides with a predetermined normal change in a state where the circuit is closed by the closing means and each of the first and second pumps is operated at a predetermined rotational speed. A determination step, and a negative detection output step for outputting the fact that the first circuit is not constituted by a regular tube when a negative determination is obtained in the pressure change determination step.

かかる構成及び方法を採用すると、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞し第１及び第２の回路に設けられた二つのポンプを各々所定の回転数で作動させた状態における第３の回路の圧力変化を所定の正規変化と比較することにより、第１の回路が正規チューブで構成されているか否かを判定することができる。従って、特殊なチューブサイズ識別手段を採用することなく、既存の構成（ポンプや圧力センサ）を用いた簡単な制御により、チューブの誤設置を検知することが可能となる。   When such a configuration and method are employed, the first circuit is constituted by a tube to be determined, the third circuit is closed, and the two pumps provided in the first and second circuits are each operated at a predetermined rotational speed. It is possible to determine whether or not the first circuit is composed of a normal tube by comparing the pressure change of the third circuit in the state in which the first circuit is made with a predetermined normal change. Therefore, it is possible to detect erroneous installation of the tube by simple control using an existing configuration (pump or pressure sensor) without employing a special tube size identification means.

前記血液浄化装置（誤設置検知方法）において、所定の基準方向への圧力変化を正規変化とすることができる。そして、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞手段で閉塞し第１及び第２のポンプを各々所定の回転数で作動させた状態において圧力センサで検出した圧力変化が前記基準方向と反対方向への圧力変化である場合に正規変化と異なると判定する制御手段（圧力変化判定工程）を採用することができる。   In the blood purification apparatus (incorrect installation detection method), a pressure change in a predetermined reference direction can be a normal change. The pressure detected by the pressure sensor in the state where the first circuit is constituted by the tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are each operated at a predetermined rotation speed. Control means (pressure change determination step) that determines that the change is different from the normal change when the change is a pressure change in a direction opposite to the reference direction can be employed.

また、前記血液浄化装置（誤設置検知方法）において、正規変化が圧力上昇となるように第１及び第２のポンプの回転数比を設定する制御手段（回転数比設定工程）を採用することができる。かかる場合においては、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞手段で閉塞し第１及び第２のポンプを各々設定した回転数で作動させた状態において圧力センサで検出した圧力変化が圧力低下である場合に正規変化と異なると判定する制御手段（圧力変化判定工程）を採用することができる。   Further, in the blood purification apparatus (incorrect installation detection method), a control means (rotational speed ratio setting step) for setting the rotational speed ratio of the first and second pumps so that the normal change becomes a pressure increase is adopted. Can do. In such a case, the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are operated at the set rotation speeds, respectively, with the pressure sensor. Control means (pressure change determination step) that determines that the detected pressure change is different from the normal change when the detected pressure change is a pressure drop can be employed.

また、前記血液浄化装置（誤設置検知方法）において、正規変化が圧力低下となるように第１及び第２のポンプの回転数比を設定する制御手段（回転数比設定工程）を採用することができる。かかる場合においては、第１の回路を判定対象となるチューブで構成し第３の回路を閉塞手段で閉塞し第１及び第２のポンプを各々設定した回転数で作動させた状態において圧力センサで検出した圧力変化が圧力上昇である場合に正規変化と異なると判定する制御手段（圧力変化判定工程）を採用することができる。   Further, in the blood purification apparatus (incorrect installation detection method), a control means (rotational speed ratio setting step) for setting the rotational speed ratio of the first and second pumps so that the normal change is a pressure drop is adopted. Can do. In such a case, the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are operated at the set rotation speeds, respectively, with the pressure sensor. Control means (pressure change determination step) that determines that the detected pressure change is different from the normal change when the detected pressure change is a pressure increase can be employed.

本発明によれば、既存の血液浄化装置に設けられているポンプや圧力センサを用いて簡単にチューブの誤設置を検知することが可能となる。   According to the present invention, it is possible to easily detect erroneous tube installation using a pump or a pressure sensor provided in an existing blood purification apparatus.

本発明の実施形態に係る血液浄化装置の構成を説明するための構成図である。It is a block diagram for demonstrating the structure of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第一の誤設置検知方法におけるポンプの回転方向を説明するための説明図である。It is explanatory drawing for demonstrating the rotation direction of the pump in the 1st mistake installation detection method of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第一の誤設置検知方法により小児治療における誤設置を検知する場合のフローチャートである。It is a flowchart in the case of detecting the incorrect installation in the child treatment by the 1st incorrect installation detection method of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第一の誤設置検知方法により成人治療における誤設置を検知する場合のフローチャートである。It is a flowchart in the case of detecting the incorrect installation in adult treatment by the 1st incorrect installation detection method of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第二の誤設置検知方法におけるポンプの回転方向を説明するための説明図である。It is explanatory drawing for demonstrating the rotation direction of the pump in the 2nd misplacement detection method of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第二の誤設置検知方法により小児治療における誤設置を検知する場合のフローチャートである。It is a flowchart in the case of detecting the incorrect installation in the child treatment by the 2nd incorrect installation detection method of the blood purification apparatus which concerns on embodiment of this invention. 本発明の実施形態に係る血液浄化装置の第二の誤設置検知方法により成人治療における誤設置を検知する場合のフローチャートである。It is a flowchart in the case of detecting the incorrect installation in an adult treatment with the 2nd incorrect installation detection method of the blood purification apparatus which concerns on embodiment of this invention.

以下、図面を参照して、本発明の実施形態に係る血液浄化装置及びその誤設置検知方法について説明する。   Hereinafter, with reference to the drawings, a blood purification apparatus according to an embodiment of the present invention and an erroneous installation detection method thereof will be described.

まず、図１及び図２を用いて、本実施形態に係る血液浄化装置１の全体構成について説明する。   First, the overall configuration of the blood purification apparatus 1 according to the present embodiment will be described with reference to FIGS. 1 and 2.

血液浄化装置１は、図１に示すように、血漿分離器２を備えている。血漿分離器２は、血液入口２ａから導入された血液を血漿分離膜により血漿成分と血球成分とに分離し、血漿出口（第１の出口）２ｂから血漿成分を、血球出口（第２の出口）２ｃから血球成分を、各々排出するものであり、本発明における血液処理器として機能する。なお、血漿分離器２によって分離された血漿成分には、所定の処理（例えば廃棄処理や特定物質の分離除去処理）が施される。   The blood purification apparatus 1 includes a plasma separator 2 as shown in FIG. The plasma separator 2 separates the blood introduced from the blood inlet 2a into a plasma component and a blood cell component by a plasma separation membrane, and removes the plasma component from the plasma outlet (first outlet) 2b to the blood cell outlet (second outlet). ) Each of the blood cell components is discharged from 2c, and functions as a blood processor in the present invention. The plasma component separated by the plasma separator 2 is subjected to a predetermined process (for example, a disposal process or a specific substance separation / removal process).

図１に示すように、血漿分離器２の血液入口２ａには採血回路（第１の回路）４が接続され、採血回路４には、採血回路４内の流体を圧送する血液ポンプ（第１のポンプ）５が配置される。採血回路４は、図２に示すように、内径の異なる２種類のチューブ（内径ΦAの成人用チューブ及び内径ΦCの小児用チューブ；ΦA＞ΦC）で構成可能となっている。小児用血液浄化治療を実施する場合には、小径の小児用チューブで採血回路４を構成する。一方、成人用血液浄化治療を実施する場合には、大径の成人用チューブで採血回路４を構成する。 As shown in FIG. 1, a blood collection circuit (first circuit) 4 is connected to the blood inlet 2 a of the plasma separator 2, and a blood pump (first circuit) that pumps fluid in the blood collection circuit 4 to the blood collection circuit 4. 5) is arranged. As shown in FIG. 2, the blood collection circuit 4 can be composed of two types of tubes having different inner diameters (adult tube having an inner diameter Φ A and pediatric tube having an inner diameter Φ C ; Φ A > Φ C ). When the blood purification treatment for children is performed, the blood collection circuit 4 is constituted by a small diameter tube for children. On the other hand, when blood purification treatment for adults is performed, the blood collection circuit 4 is composed of a large diameter adult tube.

血漿分離器２の血漿出口２ｂには血漿回路（第２の回路）６が接続され、血漿回路６には、血漿回路６内の流体を圧送する血漿ポンプ（第２のポンプ）７が配置される。血漿分離器２の血球出口２ｃには返血回路（第３の回路）８が接続され、返血回路８には、返血回路８内の流体の圧力変化を検出する圧力センサ９と、圧力センサ９の下流側で返血回路８を閉塞するクランプ（閉塞手段）１０と、が配置される。   A plasma circuit (second circuit) 6 is connected to the plasma outlet 2 b of the plasma separator 2, and a plasma pump (second pump) 7 that pumps fluid in the plasma circuit 6 is disposed in the plasma circuit 6. The A blood return circuit (third circuit) 8 is connected to the blood cell outlet 2 c of the plasma separator 2, and the blood return circuit 8 includes a pressure sensor 9 that detects a pressure change of the fluid in the blood return circuit 8, and a pressure. A clamp (closing means) 10 for closing the blood return circuit 8 on the downstream side of the sensor 9 is disposed.

血液浄化装置１は、さらに制御手段１２を備える。制御手段１２は、例えばメモリやＣＰＵ（Central Processing Unit）等を備えたコンピュータにより構成され、メモリに記録された各種プログラムをＣＰＵが実行することにより、血液浄化装置１の各種機器を制御する。具体的には、制御手段１２は、圧力センサ９等の各種センサで取得した圧力情報等に基づいて、血液ポンプ５及び血漿ポンプ７を含む各種ポンプや図示されていない各種バルブ等の機器を制御する。   Blood purification apparatus 1 further includes control means 12. The control means 12 is comprised by the computer provided with memory, CPU (Central Processing Unit), etc., for example, and controls the various apparatuses of the blood purification apparatus 1 when CPU runs the various programs recorded on memory. Specifically, the control unit 12 controls devices such as various pumps including the blood pump 5 and the plasma pump 7 and various valves (not shown) based on pressure information acquired by various sensors such as the pressure sensor 9. To do.

また、制御手段１２は、採血回路４に配置された血液ポンプ５及び血漿回路６に配置された血漿ポンプ７を各々所定の回転数で作動させた状態で、返血回路８に配置された圧力センサ９で圧力変化を検出し、この圧力変化を予め設定した正規変化と比較することにより、採血回路４が正規のチューブで構成されているか否かを判定する。そして、制御手段１２は、この判定結果を図示されていない出力装置に出力する。出力装置としては、判定結果を画像で表示する表示装置や判定結果を音声で出力する音声出力装置を採用することができる。   In addition, the control means 12 is configured so that the blood pump 5 disposed in the blood collection circuit 4 and the plasma pump 7 disposed in the plasma circuit 6 are each operated at a predetermined rotation speed, and the pressure disposed in the blood return circuit 8. The sensor 9 detects a pressure change, and compares the pressure change with a preset normal change to determine whether or not the blood collection circuit 4 is formed of a normal tube. And the control means 12 outputs this determination result to the output device which is not illustrated. As the output device, a display device that displays the determination result as an image or an audio output device that outputs the determination result by voice can be employed.

次に、図２〜図７を用いて、本実施形態に係る血液浄化装置１の採血回路４を構成するチューブの誤設置を検知する方法（誤設置検知方法）について説明する。   Next, a method for detecting erroneous installation of the tubes constituting the blood collection circuit 4 of the blood purification apparatus 1 according to this embodiment (an erroneous installation detection method) will be described with reference to FIGS.

最初に、本誤設置検知方法において前提とされる物理現象について説明する。   First, the physical phenomenon assumed in this erroneous installation detection method will be described.

採血回路４を構成するチューブ内を流通する流体（気体や液体）の流量Ｑは、チューブの内径Φと、採血回路４に配置された血液ポンプ５の回転数Ｎと、によって決定される。具体的には、流量Ｑは「Ｑ＝ｋ×Φ2×Ｎ」（ｋは比例係数）なる算出式によって算出される。ここで、血液ポンプ５の回転数Ｎ1と血漿ポンプ７の回転数Ｎ2との比（回転数比＝Ｎ1／Ｎ2）をαとすると、採血回路４を内径Φ1のチューブで構成した場合における血液ポンプ５の流量Ｑ1と、血漿回路６を内径Φ2のチューブで構成した場合における血漿ポンプ７の流量Ｑ2との比（流量比＝Ｑ1／Ｑ2）βは、以下の式で表される。
β＝（ｋ×Φ1 2×Ｎ1）／（ｋ×Φ2 2×Ｎ2）＝α×（Φ1／Φ2）2 The flow rate Q of the fluid (gas or liquid) flowing through the tube constituting the blood collection circuit 4 is determined by the inner diameter Φ of the tube and the rotation speed N of the blood pump 5 disposed in the blood collection circuit 4. Specifically, the flow rate Q is calculated by a calculation formula “Q = k × Φ 2 × N” (k is a proportional coefficient). Configuration Here, if the ratio between the rotation speed N 2 of the rotational speed N 1 and plasma pump 7 of the blood pump 5 (rotational speed ratio = N 1 / N 2) and alpha, the blood circuit 4 in the inner diameter [Phi 1 tube The ratio (flow ratio = Q 1 / Q 2 ) β between the flow rate Q 1 of the blood pump 5 and the flow rate Q 2 of the plasma pump 7 when the plasma circuit 6 is formed of a tube having an inner diameter Φ 2 is as follows: It is expressed by the following formula.
β = (k × Φ 1 2 × N 1 ) / (k × Φ 2 2 × N 2 ) = α × (Φ 1 / Φ 2 ) 2

このようにポンプの流量比βは、ポンプの回転数比αと、回路の内径比の自乗と、によって決まることがわかる。そして、血液回路４、血漿回路６及び返血回路８を所定の検査流体（例えば気体）で満たした状態においてクランプ１０で返血回路８を閉塞し、図２に示すような方向で血液ポンプ５及び血漿ポンプ７を回転させると、βが１より大きい場合（血液ポンプ５の流量Ｑ1が血漿ポンプ７の流量Ｑ2よりも大きい場合）には、返血回路８に配置した圧力センサ９で検出される圧力が低下する一方、βが１より小さい場合（血液ポンプ５の流量Ｑ1が血漿ポンプ７の流量Ｑ2よりも小さい場合）には、圧力センサ９で検出される圧力が上昇する。換言すれば、圧力センサ９で圧力低下が検出された場合には、βが１より大きくなりβの式より「α＞（Φ2／Φ1）2」なる関係が成立する一方、圧力センサ９で圧力上昇が検出された場合には、βが１より小さくなり「α＜（Φ2／Φ1）2」なる関係が成立する。 Thus, it can be seen that the flow rate ratio β of the pump is determined by the rotational speed ratio α of the pump and the square of the inner diameter ratio of the circuit. Then, the blood return circuit 8 is closed with the clamp 10 in a state where the blood circuit 4, the plasma circuit 6 and the blood return circuit 8 are filled with a predetermined test fluid (for example, gas), and the blood pump 5 is oriented in the direction shown in FIG. When the plasma pump 7 is rotated, when β is larger than 1 (when the flow rate Q 1 of the blood pump 5 is larger than the flow rate Q 2 of the plasma pump 7), the pressure sensor 9 disposed in the blood return circuit 8 is used. On the other hand, when the detected pressure decreases, when β is smaller than 1 (when the flow rate Q 1 of the blood pump 5 is smaller than the flow rate Q 2 of the plasma pump 7), the pressure detected by the pressure sensor 9 increases. . In other words, when a pressure drop is detected by the pressure sensor 9, β is greater than 1 and the relationship of “α> (Φ 2 / Φ 1 ) 2 ” is established from the expression of β, while the pressure sensor 9 When a pressure increase is detected at [beta], [beta] is smaller than 1 and the relation [[alpha] <([Phi] 2 / [Phi] 1 ) 2 ] is established.

逆に、図５に示すような方向で血液ポンプ５及び血漿ポンプ７を回転させると、βが１より大きい場合（血液ポンプ５の流量Ｑ1が血漿ポンプ７の流量Ｑ2よりも大きい場合）には、返血回路８に配置した圧力センサ９で検出される圧力が上昇する一方、βが１より小さい場合（血液ポンプ５の流量Ｑ1が血漿ポンプ７の流量Ｑ2よりも小さい場合）には、圧力センサ９で検出される圧力が低下する。換言すれば、圧力センサ９で圧力上昇が検出された場合には、βが１より大きくなり「α＞（Φ2／Φ1）2」なる関係が成立する一方、圧力センサ９で圧力低下が検出された場合には、βが１より小さくなり「α＜（Φ2／Φ1）2」なる関係が成立する。 Conversely, when the blood pump 5 and the plasma pump 7 are rotated in the direction as shown in FIG. 5, β is greater than 1 (when the flow rate Q 1 of the blood pump 5 is greater than the flow rate Q 2 of the plasma pump 7). In the case where the pressure detected by the pressure sensor 9 disposed in the blood return circuit 8 increases, β is smaller than 1 (when the flow rate Q 1 of the blood pump 5 is smaller than the flow rate Q 2 of the plasma pump 7). The pressure detected by the pressure sensor 9 decreases. In other words, when a pressure increase is detected by the pressure sensor 9, β is greater than 1 and the relationship “α> (Φ 2 / Φ 1 ) 2 ” is established, while the pressure sensor 9 causes a pressure drop. If it is detected, β is smaller than 1 and the relationship “α <(Φ 2 / Φ 1 ) 2 ” is established.

本誤設置検知方法においては、以上の物理現象を前提として、採血回路４を構成するチューブの内径に応じて圧力センサ９で検出される圧力変化が切り替わるように血液ポンプ５及び血漿ポンプ７の回転数比α（＝Ｎ1／Ｎ2）を設定して同一方向に回転させ、この場合に圧力センサ９で検出される圧力変化を予め設定した正規変化と比較することにより、採血回路４が正規チューブで構成されているか否かを判定する。 In this erroneous installation detection method, on the premise of the above physical phenomenon, the rotation of the blood pump 5 and the plasma pump 7 so that the pressure change detected by the pressure sensor 9 is switched according to the inner diameter of the tube constituting the blood collection circuit 4. By setting the number ratio α (= N 1 / N 2 ) and rotating in the same direction, the pressure change detected by the pressure sensor 9 in this case is compared with a preset normal change, whereby the blood collection circuit 4 is normalized. It is determined whether or not it is composed of a tube.

＜１＞第１の誤設置検知方法
まず、本実施形態に係る血液浄化装置１の血液ポンプ５及び血漿ポンプ７を図２に示すような方向で回転させる場合の誤設置検知方法（第１の誤設置検知方法）について説明する。第１の誤設置検知方法においては、以下に説明する小児用血液浄化治療及び成人用血液浄化治療の双方において、血漿回路６を成人用チューブ（内径ΦA）で構成することとする。 <1> First Misinstallation Detection Method First, the misinstallation detection method (the first misalignment detection method when the blood pump 5 and the plasma pump 7 of the blood purification apparatus 1 according to the present embodiment are rotated in the direction shown in FIG. An erroneous installation detection method) will be described. In the first erroneous installation detection method, the plasma circuit 6 is composed of an adult tube (inner diameter Φ A ) in both the blood purification treatment for children and the blood purification treatment for adults described below.

＜１−１＞小児用血液浄化治療における誤設置検知
図３のフローチャートを用いて、第１の誤設置検知方法により小児用血液浄化治療におけるチューブの誤設置を検知する場合の手順について説明する。 <1-1> Detection of Misinstallation in Pediatric Blood Purification Treatment Using the flowchart of FIG. 3, a procedure for detecting an erroneous tube installation in pediatric blood purification treatment using the first misplacement detection method will be described.

小児用血液浄化治療においては、採血回路４を小児用チューブ（内径ΦC）（正規チューブ）で構成した場合に圧力センサ９で圧力上昇（増加方向への圧力変化）が検出される一方、採血回路４を成人用チューブ（内径ΦA）（ΦA＞ΦC）で構成した場合に圧力センサ９で圧力低下（減少方向への圧力変化）が検出されるようにポンプの回転数比αを設定する。すなわち、採血回路４を内径ΦCの小児用チューブで構成した場合にβが１より小さくなり「α＜（ΦA／ΦC）2」なる関係が成立する一方、採血回路４を内径ΦAの成人用チューブで構成した場合にβが１より大きくなり「α＞（ΦA／ΦA）2＝１」なる関係が成立するように、以下の範囲でαを設定する（回転数比設定工程：Ｓ１）。
１＜α＜（ΦA／ΦC）2 In blood purification treatment for children, when the blood collection circuit 4 is constituted by a child tube (inner diameter Φ C ) (regular tube), a pressure increase (pressure change in an increasing direction) is detected by the pressure sensor 9 while blood collection. When the circuit 4 is composed of an adult tube (inner diameter Φ A ) (Φ A > Φ C ), the pump rotational speed ratio α is set so that the pressure sensor 9 detects a pressure drop (pressure change in the decreasing direction). Set. That is, when the blood collection circuit 4 is constituted by a pediatric tube having an inner diameter Φ C , β becomes smaller than 1 and the relationship of “α <(Φ A / Φ C ) 2 ” is established, while the blood collection circuit 4 has an inner diameter Φ A Α is set in the following range so that β is greater than 1 and the relationship of “α> (Φ A / Φ A ) 2 = 1” is established (rotational speed ratio setting). Step: S1).
1 <α <(Φ A / Φ C ) 2

そして、血液浄化装置１の制御手段１２は、採血回路４を小児用チューブで構成した場合に圧力センサ９で検出される圧力変化（圧力上昇）を「正規変化」として保存しておく（正規変化保存工程：Ｓ２）。   And the control means 12 of the blood purification apparatus 1 preserve | saves the pressure change (pressure rise) detected by the pressure sensor 9 as the "normal change" when the blood collection circuit 4 is comprised with the tube for children (normal change). Storage step: S2).

次いで、血液浄化装置１の制御手段１２は、チューブの誤設置の判定を行う。すなわち、制御手段１２は、採血回路４を判定対象となるチューブで構成し返血回路８をクランプ１０で閉塞した状態で、回転数比設定工程Ｓ１で設定した回転数比αで血液ポンプ５及び血漿ポンプ７を同一方向に回転させ、そのときに圧力センサ９で検出した圧力変化が正規変化保存工程Ｓ２で保存した正規変化（圧力上昇）と一致するか否かを判定する（圧力変化判定工程：Ｓ３）。   Next, the control means 12 of the blood purification apparatus 1 determines whether the tube is incorrectly installed. That is, the control means 12 comprises the blood pump 5 and the blood pump 5 at the rotational speed ratio α set in the rotational speed ratio setting step S1 in a state where the blood collection circuit 4 is constituted by a tube to be determined and the blood return circuit 8 is closed by the clamp 10. The plasma pump 7 is rotated in the same direction, and it is determined whether or not the pressure change detected by the pressure sensor 9 at that time coincides with the normal change (pressure increase) stored in the normal change storage step S2 (pressure change determination step) : S3).

制御手段１２は、圧力変化判定工程Ｓ３において、検出した圧力変化が正規変化と一致すると判定した場合には、採血回路４が正規チューブ（小児用チューブ）で構成されているものとしてその旨を出力する（正規出力工程：Ｓ４）。一方、制御手段１２は、圧力変化判定工程Ｓ３において、検出した圧力変化が正規変化と異なると判定した場合には、採血回路４が正規チューブで構成されていないものとしてその旨を出力する（誤検知出力工程：Ｓ５）。以上の工程群により、小児用血液浄化治療において、採血回路４が小児用チューブで構成されているか否かを検知することができる。   When it is determined in the pressure change determination step S3 that the detected pressure change coincides with the normal change, the control means 12 outputs the fact that the blood collection circuit 4 is constituted by a normal tube (pediatric tube). (Normal output process: S4). On the other hand, if it is determined in the pressure change determination step S3 that the detected pressure change is different from the normal change, the control means 12 outputs that fact as an assumption that the blood collection circuit 4 is not composed of a normal tube (error) Detection output step: S5). With the above process group, it is possible to detect whether or not the blood collection circuit 4 is composed of a child tube in the blood purification treatment for children.

＜１−２＞成人用血液浄化治療における誤設置検知
図４のフローチャートを用いて、第１の誤設置検知方法により成人用血液浄化治療におけるチューブの誤設置を検知する場合の手順について説明する。 <1-2> Detection of Misinstallation in Adult Blood Purification Treatment Using the flowchart of FIG. 4, a procedure for detecting an erroneous tube installation in adult blood purification treatment using the first misinstallation detection method will be described.

成人用血液浄化治療においては、採血回路４を成人用チューブ（内径ΦA）（正規チューブ）で構成した場合に圧力センサ９で圧力低下（減少方向への圧力変化）が検出される一方、採血回路４を小児用チューブ（内径ΦC）で構成した場合に圧力センサ９で圧力上昇（増加方向への圧力変化）が検出されるようにポンプの回転数比αを設定する。すなわち、採血回路４を内径ΦAの成人用チューブで構成した場合にβが１より大きくなり「α＞（ΦA／ΦA）2＝１」なる関係が成立する一方、採血回路４を内径ΦCの小児用チューブで構成した場合にβが１より小さくなり「α＜（ΦA／ΦC）2」なる関係が成立するようにαを設定する（回転数比設定工程：Ｓ１１）。回転数比設定工程Ｓ１１で設定されるαの範囲は、＜１−１＞の回転数比設定工程Ｓ１で設定される範囲と同様に「１＜α＜（ΦA／ΦC）2」となる。 In blood purification treatment for adults, when the blood collection circuit 4 is composed of an adult tube (inner diameter Φ A ) (regular tube), a pressure drop (pressure change in a decreasing direction) is detected by the pressure sensor 9 while blood collection. When the circuit 4 is constituted by a child tube (inner diameter Φ C ), the rotational speed ratio α of the pump is set so that the pressure sensor 9 detects a pressure increase (pressure change in the increasing direction). That is, when the blood collection circuit 4 is composed of an adult tube having an inner diameter Φ A , β is larger than 1 and the relationship “α> (Φ A / Φ A ) 2 = 1” is established, while the blood collection circuit 4 is Α is set so that β is smaller than 1 and a relationship of “α <(Φ A / Φ C ) 2 ” is established when the Φ C pediatric tube is configured (rotational speed ratio setting step: S11). The range of α set in the rotation speed ratio setting step S11 is “1 <α <(Φ A / Φ C ) 2 ”, similar to the range set in the rotation speed ratio setting process S1 of <1-1>. Become.

そして、血液浄化装置１の制御手段１２は、採血回路４を成人用チューブで構成した場合に圧力センサ９で検出される圧力変化（圧力低下）を「正規変化」として保存しておく（正規変化保存工程：Ｓ１２）。   And the control means 12 of the blood purification apparatus 1 preserve | saves the pressure change (pressure drop) detected by the pressure sensor 9 as a "normal change" when the blood collection circuit 4 is comprised with an adult tube (normal change). Storage step: S12).

次いで、血液浄化装置１の制御手段１２は、チューブの誤設置の判定を行う。すなわち、制御手段１２は、採血回路４を判定対象となるチューブで構成し返血回路８をクランプ１０で閉塞した状態で、回転数比設定工程Ｓ１１で設定した回転数比αで血液ポンプ５及び血漿ポンプ７を同一方向に回転させ、そのときに圧力センサ９で検出した圧力変化が正規変化保存工程Ｓ１２で保存した正規変化（圧力低下）と一致するか否かを判定する（圧力変化判定工程：Ｓ１３）。   Next, the control means 12 of the blood purification apparatus 1 determines whether the tube is incorrectly installed. That is, the control means 12 comprises the blood pump 5 and the blood pump 5 at the rotational speed ratio α set in the rotational speed ratio setting step S11 in a state where the blood collection circuit 4 is constituted by a tube to be determined and the blood return circuit 8 is closed by the clamp 10. The plasma pump 7 is rotated in the same direction, and it is determined whether or not the pressure change detected by the pressure sensor 9 coincides with the normal change (pressure drop) stored in the normal change storage step S12 (pressure change determination step). : S13).

制御手段１２は、圧力変化判定工程Ｓ１３において、検出した圧力変化が正規変化と一致すると判定した場合には、採血回路４が正規チューブ（成人用チューブ）で構成されているものとしてその旨を出力する（正規出力工程：Ｓ１４）。一方、制御手段１２は、圧力変化判定工程Ｓ１３において、検出した圧力変化が正規変化と異なると判定した場合には、採血回路４が正規チューブで構成されていないものとしてその旨を出力する（誤検知出力工程：Ｓ１５）。以上の工程群により、成人用血液浄化治療において、採血回路４が成人用チューブで構成されているか否かを検知することができる。   When it is determined in the pressure change determination step S13 that the detected pressure change matches with the normal change, the control means 12 outputs that fact on the assumption that the blood collection circuit 4 is composed of a normal tube (adult tube). (Normal output process: S14). On the other hand, if it is determined in the pressure change determination step S13 that the detected pressure change is different from the normal change, the control means 12 outputs that fact as an assumption that the blood collection circuit 4 is not configured with a normal tube (error) Detection output step: S15). With the above process group, it is possible to detect whether or not the blood collection circuit 4 is composed of an adult tube in adult blood purification treatment.

＜２＞第２の誤設置検知方法
続いて、本実施形態に係る血液浄化装置１の血液ポンプ５及び血漿ポンプ７を図５に示すような方向で回転させる場合の誤設置検知方法（第２の誤設置検知方法）について説明する。第２の誤設置検知方法においても、以下に説明する小児用血液浄化治療及び成人用血液浄化治療の双方において、血漿回路６を成人用チューブ（内径ΦA）で構成することとする。 <2> Second Misinstallation Detection Method Subsequently, the misinstallation detection method when the blood pump 5 and the plasma pump 7 of the blood purification apparatus 1 according to this embodiment are rotated in the direction shown in FIG. Will be described. Also in the second erroneous installation detection method, the plasma circuit 6 is constituted by an adult tube (inner diameter Φ A ) in both the blood purification treatment for children and the blood purification treatment for adults described below.

＜２−１＞小児用血液浄化治療における誤設置検知
図６のフローチャートを用いて、第２の誤設置検知方法により小児用血液浄化治療におけるチューブの誤設置を検知する場合の手順について説明する。 <2-1> Detection of Misinstallation in Pediatric Blood Purification Treatment Using the flowchart of FIG. 6, a procedure for detecting an erroneous tube installation in pediatric blood purification treatment using the second misplacement detection method will be described.

小児用血液浄化治療においては、採血回路４を小児用チューブ（内径ΦC）（正規チューブ）で構成した場合に圧力センサ９で圧力低下（減少方向への圧力変化）が検出される一方、採血回路４を成人用チューブ（内径ΦA）で構成した場合に圧力センサ９で圧力上昇（増加方向への圧力変化）が検出されるようにポンプの回転数比αを設定する。すなわち、採血回路４を内径ΦCの小児用チューブで構成した場合にβが１より大きくなり「α＞（ΦA／ΦA）2＝１」なる関係が成立する一方、採血回路４を内径ΦAの成人用チューブで構成した場合にβが１より小さくなり「α＜（ΦA／ΦC）2」なる関係が成立するように、以下の範囲でαを設定する（回転数比設定工程：Ｓ２１）。
１＜α＜（ΦA／ΦC）2 In blood purification treatment for children, when the blood collection circuit 4 is constituted by a child tube (inner diameter Φ C ) (regular tube), a pressure drop (pressure change in a decreasing direction) is detected by the pressure sensor 9, while blood collection When the circuit 4 is composed of an adult tube (inner diameter Φ A ), the pump speed ratio α is set so that the pressure sensor 9 detects a pressure increase (pressure change in the increasing direction). That is, when the blood collection circuit 4 is constituted by a tube for children with an inner diameter Φ C , β is greater than 1 and the relationship “α> (Φ A / Φ A ) 2 = 1” is established, while the blood collection circuit 4 is as [Phi when configured in adult tube a beta is smaller than 1 "α <(Φ a / Φ C ) 2 " the relationship is satisfied, sets the alpha within the following range (rotational speed ratio setting Step: S21).
1 <α <(Φ A / Φ C ) 2

そして、血液浄化装置１の制御手段１２は、採血回路４を小児用チューブで構成した場合に圧力センサ９で検出される圧力変化（圧力低下）を「正規変化」として保存しておく（正規変化保存工程：Ｓ２２）。   And the control means 12 of the blood purification apparatus 1 preserve | saves the pressure change (pressure drop) detected by the pressure sensor 9 when the blood collection circuit 4 is comprised by the tube for children as a "normal change" (normal change). Storage step: S22).

次いで、血液浄化装置１の制御手段１２は、チューブの誤設置の判定を行う。すなわち、制御手段１２は、採血回路４を判定対象となるチューブで構成し返血回路８をクランプ１０で閉塞した状態で、回転数比設定工程Ｓ２１で設定した回転数比αで血液ポンプ５及び血漿ポンプ７を同一方向に回転させ、そのときに圧力センサ９で検出した圧力変化が正規変化保存工程Ｓ２２で保存した正規変化（圧力低下）と一致するか否かを判定する（圧力変化判定工程：Ｓ２３）。   Next, the control means 12 of the blood purification apparatus 1 determines whether the tube is incorrectly installed. That is, the control means 12 comprises the blood pump 5 and the blood pump 5 at the rotational speed ratio α set in the rotational speed ratio setting step S21 in a state where the blood collection circuit 4 is configured by a tube to be determined and the blood return circuit 8 is closed by the clamp 10. The plasma pump 7 is rotated in the same direction, and it is determined whether or not the pressure change detected by the pressure sensor 9 at that time coincides with the normal change (pressure drop) stored in the normal change storage step S22 (pressure change determination step) : S23).

制御手段１２は、圧力変化判定工程Ｓ２３において、検出した圧力変化が正規変化と一致すると判定した場合には、採血回路４が正規チューブ（小児用チューブ）で構成されているものとしてその旨を出力する（正規出力工程：Ｓ２４）。一方、制御手段１２は、圧力変化判定工程Ｓ２３において、検出した圧力変化が正規変化と異なると判定した場合には、採血回路４が正規チューブで構成されていないものとしてその旨を出力する（誤検知出力工程：Ｓ２５）。以上の工程群により、小児用血液浄化治療において、採血回路４が小児用チューブで構成されているか否かを検知することができる。   When it is determined in the pressure change determination step S23 that the detected pressure change matches the normal change, the control means 12 outputs that effect as the blood collection circuit 4 is constituted by a normal tube (pediatric tube). (Normal output process: S24). On the other hand, if the control means 12 determines in the pressure change determination step S23 that the detected pressure change is different from the normal change, the control means 12 outputs that fact assuming that the blood collection circuit 4 is not composed of a normal tube (error). Detection output step: S25). With the above process group, it is possible to detect whether or not the blood collection circuit 4 is composed of a child tube in the blood purification treatment for children.

＜２−２＞成人用血液浄化治療における誤設置検知
続いて、図７のフローチャートを用いて、第２の誤設置検知方法により成人用血液浄化治療におけるチューブの誤設置を検知する場合の手順について説明する。 <2-2> Detection of erroneous installation in adult blood purification treatment Next, with reference to the flowchart of FIG. 7, a procedure for detecting erroneous installation of a tube in adult blood purification treatment using the second erroneous installation detection method will be described. explain.

成人用血液浄化治療においては、採血回路４を成人用チューブ（内径ΦA）（正規チューブ）で構成した場合に圧力センサ９で圧力上昇（増加方向への圧力変化）が検出される一方、採血回路４を小児用チューブ（内径ΦC）で構成した場合に圧力センサ９で圧力低下（減少方向への圧力変化）が検出されるようにポンプの回転数比αを設定する。すなわち、採血回路４を内径ΦAの成人用チューブで構成した場合にβが１より小さくなり「α＜（ΦA／ΦC）2」なる関係が成立する一方、採血回路４を内径ΦCの小児用チューブで構成した場合にβが１より大きくなり「α＞（ΦA／ΦA）2＝１」なる関係が成立するようにαを設定する（回転数比設定工程：Ｓ３１）。回転数比設定工程Ｓ３１で設定されるαの範囲は、＜２−１＞の回転数比設定工程Ｓ２１で設定される範囲と同様に「１＜α＜（ΦA／ΦC）2」となる。 In blood purification treatment for adults, when the blood collection circuit 4 is composed of an adult tube (inner diameter Φ A ) (regular tube), a pressure increase (pressure change in the increasing direction) is detected by the pressure sensor 9, while blood collection When the circuit 4 is constituted by a child tube (inner diameter Φ C ), the rotational speed ratio α of the pump is set so that a pressure drop (pressure change in the decreasing direction) is detected by the pressure sensor 9. That is, when the blood collection circuit 4 is composed of an adult tube having an inner diameter Φ A , β is smaller than 1 and the relationship “α <(Φ A / Φ C ) 2 ” is established, while the blood collection circuit 4 is formed with an inner diameter Φ C. Is set so that β is greater than 1 and the relationship “α> (Φ A / Φ A ) 2 = 1” is established (rotational speed ratio setting step: S31). The range of α set in the rotation speed ratio setting step S31 is “1 <α <(Φ A / Φ C ) 2 ”, similar to the range set in the rotation speed ratio setting process S21 of <2-1>. Become.

そして、血液浄化装置１の制御手段１２は、採血回路４を成人用チューブで構成した場合に圧力センサ９で検出される圧力変化（圧力上昇）を「正規変化」として保存しておく（正規変化保存工程：Ｓ３２）。   Then, the control means 12 of the blood purification apparatus 1 stores the pressure change (pressure increase) detected by the pressure sensor 9 when the blood collection circuit 4 is composed of an adult tube as a “normal change” (normal change). Storage step: S32).

次いで、血液浄化装置１の制御手段１２は、チューブの誤設置の判定を行う。すなわち、制御手段１２は、採血回路４を判定対象となるチューブで構成し返血回路８をクランプ１０で閉塞した状態で、回転数比設定工程Ｓ３１で設定した回転数比αで血液ポンプ５及び血漿ポンプ７を同一方向に回転させ、そのときに圧力センサ９で検出した圧力変化が正規変化保存工程Ｓ３２で保存した正規変化（圧力上昇）と一致するか否かを判定する（圧力変化判定工程：Ｓ３３）。   Next, the control means 12 of the blood purification apparatus 1 determines whether the tube is incorrectly installed. That is, the control means 12 comprises the blood pump 5 and the blood pump 5 at the rotational speed ratio α set in the rotational speed ratio setting step S31 in a state where the blood collection circuit 4 is constituted by a tube to be determined and the blood return circuit 8 is closed by the clamp 10. The plasma pump 7 is rotated in the same direction, and it is determined whether the pressure change detected by the pressure sensor 9 at that time coincides with the normal change (pressure increase) stored in the normal change storage step S32 (pressure change determination step) : S33).

制御手段１２は、圧力変化判定工程Ｓ３３において、検出した圧力変化が正規変化と一致すると判定した場合には、採血回路４が正規チューブ（成人用チューブ）で構成されているものとしてその旨を出力する（正規出力工程：Ｓ３４）。一方、制御手段１２は、圧力変化判定工程Ｓ３３において、検出した圧力変化が正規変化と異なると判定した場合には、採血回路４が正規チューブで構成されていないものとしてその旨を出力する（誤検知出力工程：Ｓ３５）。以上の工程群により、成人用血液浄化治療において、採血回路４が成人用チューブで構成されているか否かを検知することができる。   When the control means 12 determines in the pressure change determination step S33 that the detected pressure change matches the normal change, the control means 12 outputs the fact that the blood collection circuit 4 is constituted by a normal tube (adult tube). (Normal output process: S34). On the other hand, if the control means 12 determines in the pressure change determination step S33 that the detected pressure change is different from the normal change, the control means 12 outputs that fact assuming that the blood collection circuit 4 is not composed of a normal tube (error). Detection output step: S35). With the above process group, it is possible to detect whether or not the blood collection circuit 4 is composed of an adult tube in adult blood purification treatment.

以上説明した実施形態に係る血液浄化装置１においては、採血回路４を判定対象となるチューブで構成し返血回路８を閉塞し採血回路４及び血漿回路６に設けられた二つのポンプを各々所定の回転数で作動させた状態における返血回路８の圧力変化を正規変化（所定の基準方向への圧力変化）と比較することにより、採血回路４が正規チューブで構成されているか否かを判定することができる。従って、特殊なチューブサイズ識別手段を採用することなく、既存の構成（ポンプや圧力センサ）を用いた簡単な制御により、チューブの誤設置を検知することが可能となる。   In the blood purification apparatus 1 according to the embodiment described above, the blood collection circuit 4 is configured by a tube to be determined, the blood return circuit 8 is closed, and two pumps provided in the blood collection circuit 4 and the plasma circuit 6 are respectively specified. It is determined whether or not the blood collection circuit 4 is constituted by a normal tube by comparing the pressure change of the blood return circuit 8 in a state where the blood collection circuit 4 is operated at a rotational speed of 2 with a normal change (pressure change in a predetermined reference direction). can do. Therefore, it is possible to detect erroneous installation of the tube by simple control using an existing configuration (pump or pressure sensor) without employing a special tube size identification means.

なお、以上の実施形態においては、血漿分離器を備えた血液浄化装置（具体的には、単純血漿交換療法（Plasma Exchange：ＰＥ）や二重濾過血漿交換療法（Double Filtration Plasmapheresis：ＤＦＰＰ）に使用される血液浄化装置）に本発明を適用した例を示したが、同様の構成（血液処理器の血液入口側に接続される第１の回路、第１の回路に配置される第１のポンプ、血液処理器の第１の出口側に接続される第２の回路、第２の回路に配置される第２のポンプ、血液処理器の第２の出口側に接続される第３の回路、第３の回路の圧力変化を検出する圧力センサ、第３の回路を閉塞する閉塞手段等）を備える他の血液浄化装置に本発明を適用することもできる。例えば、持続的血液濾過療法（Continuous Hemofiltration：ＣＨＦ）、持続的血液透析療法（Continuous Hemodialysis：ＣＨＤ）、持続的血液濾過透析療法（Continuous Hemodiafiltration：ＣＨＤＦ）等に使用される濾過・拡散用の血液浄化器を備えた血液浄化装置に本発明を適用することもできる。   In the above embodiment, a blood purification apparatus equipped with a plasma separator (specifically, used for simple plasma exchange (PE) or double filtration plasmapheresis (DFPP)). An example in which the present invention is applied to a blood purification device to be used has been shown, but the same configuration (first circuit connected to the blood inlet side of the blood treatment device, first pump arranged in the first circuit) A second circuit connected to the first outlet side of the blood processor, a second pump arranged in the second circuit, a third circuit connected to the second outlet side of the blood processor, The present invention can also be applied to other blood purification apparatuses including a pressure sensor for detecting a pressure change in the third circuit, a closing means for closing the third circuit, and the like. For example, blood purification for filtration and diffusion used in continuous hemofiltration (CHF), continuous hemodialysis (CHD), continuous hemodiafiltration (CHDF), etc. The present invention can also be applied to a blood purification apparatus provided with a vessel.

１…血液浄化装置
２…血漿分離器（血液処理器）
２ａ…血液入口
２ｂ…血漿出口（第１の出口）
２ｃ…血球出口（第２の出口）
４…採血回路（第１の回路）
５…血液ポンプ（第１のポンプ）
６…血漿回路（第２の回路）
７…血漿ポンプ（第２のポンプ）
８…返血回路（第３の回路）
９…圧力センサ
１０…クランプ（閉塞手段）
１２…制御手段
Ｓ１・Ｓ１１・Ｓ２１・Ｓ３１…回転数比設定工程
Ｓ３・Ｓ１３・Ｓ２３・Ｓ３３…圧力変化判定工程
Ｓ５・Ｓ１５・Ｓ２５・Ｓ３５…誤検知出力工程 DESCRIPTION OF SYMBOLS 1 ... Blood purification apparatus 2 ... Plasma separator (blood processing device)
2a ... Blood inlet 2b ... Plasma outlet (first outlet)
2c ... Blood cell outlet (second outlet)
4 ... Blood collection circuit (first circuit)
5 ... Blood pump (first pump)
6 ... Plasma circuit (second circuit)
7 ... Plasma pump (second pump)
8 ... Blood return circuit (third circuit)
9 ... Pressure sensor 10 ... Clamp (blocking means)
12. Control means S1, S11, S21, S31 ... Rotational speed ratio setting step S3, S13, S23, S33 ... Pressure change determination step S5, S15, S25, S35 ... False detection output step

Claims (8)

血液入口から導入された血液に所定の処理を施して第１の出口及び第２の出口から排出する血液処理器と、前記血液処理器の血液入口側に接続される第１の回路と、前記第１の回路内の流体を圧送する第１のポンプと、前記血液処理器の第１の出口側に接続される第２の回路と、前記第２の回路内の流体を圧送する第２のポンプと、前記血液処理器の第２の出口側に接続される第３の回路と、前記第３の回路内の流体の圧力変化を検出する圧力センサと、前記圧力センサの下流側で第３の回路を閉塞する閉塞手段と、を備え、前記第１の回路は所定の内径を有する正規チューブ又は正規チューブと異なる内径を有するチューブで構成可能とされる血液浄化装置であって、
前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々所定の回転数で作動させた状態において前記圧力センサで検出した圧力変化が所定の正規変化と異なる場合に、前記第１の回路が前記正規チューブで構成されていないものと判定してその旨を出力する制御手段を備える、
血液浄化装置。 A blood treatment device that performs a predetermined treatment on the blood introduced from the blood inlet and discharges the blood from the first outlet and the second outlet; a first circuit connected to the blood inlet side of the blood treatment device; A first pump for pumping fluid in the first circuit; a second circuit connected to the first outlet side of the blood processor; and a second pump for pumping fluid in the second circuit A pump, a third circuit connected to the second outlet side of the blood processor, a pressure sensor for detecting a pressure change of the fluid in the third circuit, and a third downstream of the pressure sensor. And the first circuit is a regular tube having a predetermined inner diameter or a blood purification device that can be configured by a tube having an inner diameter different from the regular tube,
In the state where the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are each operated at a predetermined rotational speed, the pressure sensor When the detected pressure change is different from a predetermined normal change, the first circuit is provided with a control unit that determines that the first circuit is not configured by the normal tube and outputs the fact.
Blood purification device. 前記正規変化は、所定の基準方向への圧力変化であり、
前記制御手段は、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々所定の回転数で作動させた状態において前記圧力センサで検出した圧力変化が前記基準方向と反対方向への圧力変化である場合に前記正規変化と異なると判定する、
請求項１に記載の血液浄化装置。 The normal change is a pressure change in a predetermined reference direction,
The control means is a state in which the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are each operated at a predetermined rotational speed. The pressure change detected by the pressure sensor is determined to be different from the normal change when the pressure change is in a direction opposite to the reference direction,
The blood purification apparatus according to claim 1. 前記制御手段は、
前記正規変化が圧力上昇となるように前記第１及び第２のポンプの回転数比を設定し、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々設定した回転数で作動させた状態において前記圧力センサで検出した圧力変化が圧力低下である場合に前記正規変化と異なると判定する、
請求項２に記載の血液浄化装置。 The control means includes
The rotation speed ratio of the first and second pumps is set so that the normal change is a pressure increase, the first circuit is configured by a tube to be determined, and the third circuit is configured by the blocking means. When the pressure change detected by the pressure sensor is a pressure drop in a state where the first and second pumps are closed and operated at a set number of revolutions, it is determined that the pressure change is different from the normal change.
The blood purification apparatus according to claim 2. 前記制御手段は、
前記正規変化が圧力低下となるように前記第１及び第２のポンプの回転数比を設定し、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々設定した回転数で作動させた状態において前記圧力センサで検出した圧力変化が圧力上昇である場合に前記正規変化と異なると判定する、
請求項２に記載の血液浄化装置。 The control means includes
The rotational speed ratio of the first and second pumps is set so that the normal change is a pressure drop, the first circuit is configured by a tube to be determined, and the third circuit is configured by the blocking means. When the pressure change detected by the pressure sensor is a pressure increase in a state where the first pump and the second pump are operated at the set rotation speed, the pressure change is determined to be different from the normal change.
The blood purification apparatus according to claim 2. 血液入口から導入された血液に所定の処理を施して第１の出口及び第２の出口から排出する血液処理器と、前記血液処理器の血液入口側に接続される第１の回路と、前記第１の回路内の流体を圧送する第１のポンプと、前記血液処理器の第１の出口側に接続される第２の回路と、前記第２の回路内の流体を圧送する第２のポンプと、前記血液処理器の第２の出口側に接続される第３の回路と、前記第３の回路内の流体の圧力変化を検出する圧力センサと、前記圧力センサの下流側で第３の回路を閉塞する閉塞手段と、を備え、前記第１の回路は所定の内径を有する正規チューブ又は正規チューブと異なる内径を有するチューブで構成可能とされる血液浄化装置の誤設置検知方法であって、
前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々所定の回転数で作動させた状態において前記圧力センサで検出した圧力変化が所定の正規変化と一致するか否かを判定する圧力変化判定工程と、
前記圧力変化判定工程において否定的な判定が得られた場合に前記第１の回路が前記正規チューブで構成されていないものとしてその旨を出力する誤検知出力工程と、
を備える、
血液浄化装置の誤設置検知方法。 A blood treatment device that performs a predetermined treatment on the blood introduced from the blood inlet and discharges the blood from the first outlet and the second outlet; a first circuit connected to the blood inlet side of the blood treatment device; A first pump for pumping fluid in the first circuit; a second circuit connected to the first outlet side of the blood processor; and a second pump for pumping fluid in the second circuit A pump, a third circuit connected to the second outlet side of the blood processor, a pressure sensor for detecting a pressure change of the fluid in the third circuit, and a third downstream of the pressure sensor. The first circuit is a normal tube having a predetermined inner diameter, or a blood purification device misinstallation detection method that can be configured by a tube having an inner diameter different from that of the normal tube. And
In the state where the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are each operated at a predetermined rotational speed, the pressure sensor A pressure change determination step of determining whether or not the detected pressure change matches a predetermined normal change;
When a negative determination is obtained in the pressure change determination step, a false detection output step for outputting the fact that the first circuit is not constituted by the regular tube;
Comprising
Detection method of incorrect installation of blood purification device. 前記正規変化は、所定の基準方向への圧力変化であり、
前記圧力変化判定工程では、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々所定の回転数で作動させた状態において前記圧力センサで検出した圧力変化が前記基準方向と反対方向への圧力変化である場合に前記正規変化と一致しないと判定する、
請求項５に記載の血液浄化装置の誤設置検知方法。 The normal change is a pressure change in a predetermined reference direction,
In the pressure change determination step, the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are operated at a predetermined number of revolutions, respectively. When the pressure change detected by the pressure sensor in the state is a pressure change in a direction opposite to the reference direction, it is determined that it does not coincide with the normal change.
The method for detecting erroneous installation of the blood purification apparatus according to claim 5. 前記正規変化が圧力上昇となるように前記第１及び第２のポンプの回転数比を設定する回転数比設定工程を備え、
前記圧力変化判定工程では、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々設定した回転数で作動させた状態において前記圧力センサで検出した圧力変化が圧力低下である場合に前記正規変化と一致しないと判定する、
請求項６に記載の血液浄化装置の誤設置検知方法。 A rotation speed ratio setting step of setting a rotation speed ratio of the first and second pumps so that the normal change is a pressure increase;
In the pressure change determining step, the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are operated at respective set rotation speeds. In the state where the pressure change detected by the pressure sensor is a pressure drop, it is determined not to match the normal change,
The method for detecting erroneous installation of the blood purification apparatus according to claim 6. 前記正規変化が圧力低下となるように前記第１及び第２のポンプの回転数比を設定する回転数比設定工程を備え、
前記圧力変化判定工程では、前記第１の回路を判定対象となるチューブで構成し前記第３の回路を前記閉塞手段で閉塞し前記第１及び第２のポンプを各々設定した回転数で作動させた状態において前記圧力センサで検出した圧力変化が圧力上昇である場合に前記正規変化と一致しないと判定する、
請求項６に記載の血液浄化装置の誤設置検知方法。 A rotation speed ratio setting step of setting a rotation speed ratio of the first and second pumps so that the normal change is a pressure drop;
In the pressure change determining step, the first circuit is constituted by a tube to be determined, the third circuit is closed by the closing means, and the first and second pumps are operated at respective set rotation speeds. When the pressure change detected by the pressure sensor in the state is a pressure increase, it is determined that it does not coincide with the normal change.
The method for detecting erroneous installation of the blood purification apparatus according to claim 6.
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006043315A (en) * 2004-08-09 2006-02-16 Asahi Kasei Medical Co Ltd Hemofiltration apparatus
WO2010133319A1 (en) * 2009-05-19 2010-11-25 Fresenius Medical Care Deutschland Gmbh Apparatus and method for identifying a tubing system for an extracorporeal blood treatment device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006043315A (en) * 2004-08-09 2006-02-16 Asahi Kasei Medical Co Ltd Hemofiltration apparatus
WO2010133319A1 (en) * 2009-05-19 2010-11-25 Fresenius Medical Care Deutschland Gmbh Apparatus and method for identifying a tubing system for an extracorporeal blood treatment device
JP2012527261A (en) * 2009-05-19 2012-11-08 フレセニウス・メディカル・ケア・ドイチュラント・ゲーエムベーハー Apparatus and method for identifying a tube line system for an extracorporeal blood treatment apparatus

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