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JP2007282928A5 - - Google Patents

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JP2007282928A5
JP2007282928A5 JP2006115073A JP2006115073A JP2007282928A5 JP 2007282928 A5 JP2007282928 A5 JP 2007282928A5 JP 2006115073 A JP2006115073 A JP 2006115073A JP 2006115073 A JP2006115073 A JP 2006115073A JP 2007282928 A5 JP2007282928 A5 JP 2007282928A5
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体外循環回路、圧力測定ラインと圧力測定手段の接続状態の確認方法、及び体外循環装置Extracorporeal circuit, method for confirming connection state between pressure measurement line and pressure measuring device, and extracorporeal circulation device

本発明は、圧力測定ラインを有する体外循環回路、これを用いた圧力測定ラインと圧力測定手段の接続状態の確認方法及びこの方法を実施するための体外循環装置に関するものである。   The present invention relates to an extracorporeal circuit having a pressure measurement line, a method for confirming a connection state between a pressure measurement line and a pressure measurement means using the circuit, and an extracorporeal circulation device for carrying out this method.

体外循環による体液浄化治療では、治療に先立って体液処理器と各回路を体液浄化装置本体に接続し、更に体外循環回路の圧力測定ライン末端と圧力測定手段とを除菌フィルタを介して直接接続する。この作業後、例えば回路内の特定部分の圧力を監視すれば液体流通路の流動状態がわかるため、目詰まり等の有無やその発生部位を察知することが出来る。しかし、もし回路と体液処理器或いは圧力測定ラインと圧力測定部に接続不良があった場合は、回路内の圧力を正しく計測出来なくなり、所定の条件下で運転出来なくなるおそれがある。   In body fluid purification treatment by extracorporeal circulation, prior to treatment, the body fluid treatment device and each circuit are connected to the body fluid purification device body, and the pressure measurement line end of the extracorporeal circulation circuit and the pressure measurement means are directly connected via a sterilization filter. To do. After this work, for example, by monitoring the pressure of a specific part in the circuit, the flow state of the liquid flow path can be known, so it is possible to detect the presence or absence of clogging and the occurrence site. However, if there is a connection failure between the circuit and the body fluid treatment device or the pressure measurement line and the pressure measurement unit, the pressure in the circuit cannot be measured correctly, and there is a possibility that it cannot be operated under a predetermined condition.

そこで、接続不良を検出する方法が幾つか検討されている。例えば特許文献1においては、血液回路のローラーポンプを利用して圧力測定ラインに圧力を負荷し、除菌フィルタの装着不良を検出する方法が開示されている。また特許文献2においては、圧力測定ラインに併設したエアーポンプにより圧力を負荷して接続不良を検出する方法が開示されている。また、特許文献3においては、落差により圧力を負荷して接続不良を検出する方法が開示されている。   Thus, several methods for detecting a connection failure have been studied. For example, Patent Document 1 discloses a method for detecting a mounting failure of a sterilization filter by applying pressure to a pressure measurement line using a roller pump of a blood circuit. Patent Document 2 discloses a method of detecting a connection failure by applying pressure with an air pump provided in the pressure measurement line. Further, Patent Document 3 discloses a method of detecting a connection failure by applying pressure with a drop.

特開平02−289259号公報Japanese Patent Laid-Open No. 02-289259 特開2002−095741号公報JP 2002-095741 A 特開2005−218709号公報JP 2005-218709 A

しかしながら、前述の特許文献1、2、3の何れの方法においても接続不良がおこると圧力測定ラインを含む体外循環回路内は大気圧となるため接続不良箇所の特定が困難であった。また、圧力測定ラインの末端と圧力測定手段とを除菌フィルタを介して接続した場合、接続不良時に除菌フィルタの末端より体外循環回路内部の空気が流失するため、体外循環回路内部の液体で除菌フィルタが濡れてしまうおそれがあった。除菌フィルタは一度濡れてしまうと、再生することは難しく、交換することが必要となるが、その際、圧力測定ラインを切断する必要があり、無菌的な接続が困難となるため、安全上細心の注意と技術を要するという問題があった。   However, in any of the methods disclosed in Patent Documents 1, 2, and 3 described above, if a connection failure occurs, the extracorporeal circuit including the pressure measurement line has an atmospheric pressure, and thus it is difficult to identify a connection failure point. In addition, when the end of the pressure measurement line and the pressure measuring means are connected via a sterilization filter, air inside the extracorporeal circuit is lost from the end of the sterilization filter when the connection is poor. There was a possibility that the sterilization filter might get wet. Once the sterilization filter gets wet, it is difficult to regenerate and it is necessary to replace it. However, it is necessary to cut the pressure measurement line at that time, and aseptic connection becomes difficult. There was a problem that careful attention and skill were required.

本発明は前記課題を解決するものであり、その目的とするところは、圧力測定ラインの接続不良時に除菌フィルタが濡れてしまうことがなく、更には操作及び検知が簡便な圧力測定ラインの接続状態の確認方法及び接続不良箇所の検出方法、この方法を実施するのに適した体外循環回路、更には圧力測定ラインの接続状態の確認方法を実施するのに適した体外循環装置を提供せんとするものである。   The present invention solves the above-mentioned problems, and the object of the present invention is to connect the pressure measurement line so that the sterilization filter does not get wet when the connection of the pressure measurement line is poor, and the operation and detection are simple. To provide a state confirmation method and a connection failure detection method, an extracorporeal circuit suitable for carrying out this method, and an extracorporeal circulation device suitable for carrying out a pressure measurement line connection confirmation method. To do.

本発明者等は、上記課題を解決すべく検討を重ねた結果、通常、接続不良時の体外循環回路内圧は大気圧になることから、接続不良時に体外循環回路内圧を保つことが出来れば、簡便に接続不良を検出出来ると考え、これを実施するための体外循環回路を考案し、これを用いることにより上記推測が正しいことを確認した。つまり、体外循環回路の圧力測定ライン末端と圧力測定手段とを接続時のみに弁が開く弁付きコネクタを介して接続すれば、圧力測定ラインと圧力測定手段との接続不良及び接続不良箇所を簡便に検出出来、しかも接続不良時に除菌フィルタを濡らすことがないことを見出し、本発明を完成したものである。   As a result of repeated investigations to solve the above problems, the present inventors usually have an extracorporeal circuit internal pressure at the time of poor connection, so if the extracorporeal circuit internal pressure at the time of poor connection can be maintained, We thought that a connection failure could be easily detected, and devised an extracorporeal circuit for carrying out this, and confirmed that the above estimation was correct by using this circuit. In other words, if the end of the pressure measurement line of the extracorporeal circuit is connected to the pressure measurement means via a connector with a valve that opens only when the connection is made, the connection between the pressure measurement line and the pressure measurement means can be easily connected. The present invention has been completed by discovering that the sterilization filter is not wetted when the connection is poor.

即ち、前記目的を達成するための本発明に係る体外循環回路の第1の構成は、少なくとも2つ以上の圧力測定ラインを有する体外循環回路であって、前記圧力測定ラインの圧力測定手段との接続側末端に接続時のみに弁が開く弁付きコネクタを有し、前記弁付きコネクタの回路側に除菌フィルタが接続されていることを特徴とすることを特徴とする。   That is, the first configuration of the extracorporeal circuit according to the present invention for achieving the above object is an extracorporeal circuit having at least two or more pressure measurement lines, and the pressure measurement means of the pressure measurement line It has the connector with a valve which opens a valve only at the time of a connection at the connection side terminal, The sterilization filter is connected to the circuit side of the said connector with a valve, It is characterized by the above-mentioned.

また、本発明に係る体外循環回路の第2の構成は、前記第1の構成の体外循環回路に、体液と空気を隔離し、回路内の圧力により変形する変形部を有する圧力測定ラインが接続されていることを特徴とする。 Further, in the second configuration of the extracorporeal circuit according to the present invention, a pressure measurement line having a deforming portion that isolates bodily fluid and air and deforms by the pressure in the circuit is connected to the extracorporeal circuit of the first configuration. It is characterized by being.

また、本発明に係る圧力測定ラインと圧力測定手段の接続状態の確認方法は、前記第1、第2の構成の体外循環回路における前記圧力測定ラインと前記圧力測定手段の接続状態の確認方法であって、前記圧力測定ラインを前記圧力測定手段に接続し、前記体外循環回路内を加圧若しくは減圧した時に、前記圧力測定手段により圧力の変動を検知した場合は前記圧力測定ラインと前記圧力測定手段の接続は良好と検知し、前記体外循環回路内を加圧若しくは減圧したにもかかわらず前記圧力測定手段により圧力の変動を検知しない場合は前記圧力測定ラインと前記圧力測定手段との接続は不良と検知することを特徴とする。   In addition, the method for confirming the connection state between the pressure measurement line and the pressure measurement unit according to the present invention is a method for confirming the connection state between the pressure measurement line and the pressure measurement unit in the extracorporeal circuit having the first and second configurations. The pressure measurement line is connected to the pressure measurement means, and when pressure fluctuation is detected by the pressure measurement means when the inside of the extracorporeal circuit is pressurized or depressurized, the pressure measurement line and the pressure measurement are detected. The connection between the pressure measurement line and the pressure measurement means is not detected when the pressure measurement means does not detect a change in pressure even though the connection of the means is detected as good and the pressure measurement means does not detect the pressure in the extracorporeal circuit. It is characterized by detecting a failure.

また、本発明に係る体外循環装置は、少なくとも前記第1、第2の構成の体外循環回路と、前記体外循環回路内を加圧若しくは減圧する圧力調整手段と、前記体外循環回路内の圧力を検知する圧力測定手段と、前記体外循環回路内を前記圧力調整手段により加圧若しくは減圧したにもかかわらず前記圧力測定手段により圧力の変動を検知しない場合に圧力の変動が無いことを知らせる警報手段とを有することを特徴とする。   The extracorporeal circulation apparatus according to the present invention includes at least the extracorporeal circulation circuit having the first and second configurations, pressure adjusting means for pressurizing or depressurizing the extracorporeal circulation circuit, and the pressure in the extracorporeal circulation circuit. Pressure measuring means for detecting, and alarm means for notifying that there is no pressure fluctuation when pressure fluctuation is not detected by the pressure measuring means in spite of being pressurized or depressurized in the extracorporeal circuit by the pressure adjusting means It is characterized by having.

本発明によれば、体外循環回路内部を加圧若しくは減圧することにより、体外循環回路に接続された圧力測定ラインと圧力測定手段との接続状態を確認出来、また接続不良箇所を検出出来る。更に、接続時のみに弁が開く弁付きコネクタを前記圧力測定ライン末端に有するため、前記圧力測定ラインと前記圧力測定手段との接続不良時に除菌フィルタが濡れてしまうことも無い。   According to the present invention, by pressurizing or depressurizing the inside of the extracorporeal circuit, the connection state between the pressure measuring line connected to the extracorporeal circuit and the pressure measuring means can be confirmed, and a connection failure point can be detected. Furthermore, since the valve-equipped connector that opens the valve only at the time of connection is provided at the end of the pressure measurement line, the sterilization filter does not get wet when the pressure measurement line and the pressure measurement means are poorly connected.

図により本発明に係る体外循環回路、圧力測定ラインと圧力測定手段の接続状態の確認方法、及び体外循環装置の一実施形態を具体的に説明する。図1は本発明に係る体外循環装置を血液吸着療法に用いる場合の一例を示す模式図、図2は本発明に係る体外循環装置を血液透析装置として構成した場合の一例を示す模式図、図3は本発明に係る体外循環装置を血液透析装置として構成した場合の他の例を示す模式図、図4は本発明に係る体外循環装置を血液透析装置として構成した場合の更に別の例を示す模式図である。   An embodiment of an extracorporeal circuit according to the present invention, a method for confirming a connection state between a pressure measurement line and a pressure measuring means, and an extracorporeal circulation apparatus according to the present invention will be described in detail. FIG. 1 is a schematic diagram showing an example when the extracorporeal circulation apparatus according to the present invention is used for blood adsorption therapy, and FIG. 2 is a schematic diagram showing an example when the extracorporeal circulation apparatus according to the present invention is configured as a hemodialysis apparatus. 3 is a schematic diagram showing another example when the extracorporeal circulation apparatus according to the present invention is configured as a hemodialysis apparatus, and FIG. 4 is still another example when the extracorporeal circulation apparatus according to the present invention is configured as a hemodialysis apparatus. It is a schematic diagram shown.

本発明に係る体外循環装置における体外循環回路の接続不良検出方法の代表的な構成は、体液浄化装置における体外循環回路の接続不良箇所を検出する方法において、少なくとも2つ以上の圧力測定ラインを有する体外循環回路に接続され、圧力測定ラインの圧力測定手段との接続側末端に接続時のみに弁が開く弁付きコネクタを有する複数の圧力測定ラインと、圧力測定ラインの末端側を接続する複数の圧力測定手段と、体外循環回路内部を加圧若しくは減圧する圧力調整手段の機構とを備え、前記体外循環回路内部の圧力を、前記各圧力測定手段で検出することを特徴とする。   A typical configuration of the connection failure detection method for the extracorporeal circulation circuit in the extracorporeal circulation device according to the present invention includes at least two pressure measurement lines in the method for detecting a connection failure portion of the extracorporeal circulation circuit in the body fluid purification device. A plurality of pressure measuring lines connected to the extracorporeal circuit and having a valve-equipped connector that opens only when connected to the end of the pressure measuring line connected to the pressure measuring means, and a plurality of pressure measuring lines connected to the end of the pressure measuring line It has a pressure measuring means and a mechanism of a pressure adjusting means for pressurizing or depressurizing the inside of the extracorporeal circuit, and the pressure inside the extracorporeal circuit is detected by each of the pressure measuring means.

これにより、圧力測定ラインと圧力測定手段との接続不良箇所を検出することが出来る。また、前記圧力測定ラインと前記圧力測定手段との接続不良が発生した場合に除菌フィルタが濡れてしまうことがない。   As a result, it is possible to detect a connection failure location between the pressure measurement line and the pressure measurement means. In addition, when the connection failure between the pressure measurement line and the pressure measurement means occurs, the sterilization filter does not get wet.

本発明でいう体液とは血液、血漿、リンパ液、腹水、尿等のことをいう。   The body fluid referred to in the present invention refers to blood, plasma, lymph, ascites, urine and the like.

本発明でいう体外循環回路とは、体液若しくは透析液等の治療液を循環させるための導管のことを言い、血液濾過療法、血液透析療法、血液濾過透析療法、持続緩徐式血液透析療法、持続緩徐式血液濾過療法、持続緩徐式血液濾過透析療法、血漿交換療法、血漿吸着療法、二重濾過血漿交換療法、血液吸着療法、血球成分除去療法、腹水濾過濃縮再静注療法、経皮的心肺補助等の体外循環療法で用いられる回路のこという。   The extracorporeal circuit as used in the present invention refers to a conduit for circulating a therapeutic fluid such as a body fluid or a dialysis fluid, and includes hemofiltration therapy, hemodialysis therapy, hemofiltration dialysis therapy, sustained slow hemodialysis therapy, continuous Slow hemofiltration therapy, continuous slow hemofiltration dialysis therapy, plasma exchange therapy, plasma adsorption therapy, double filtration plasma exchange therapy, blood adsorption therapy, blood cell component removal therapy, ascites filtration concentrated reinfusion therapy, percutaneous cardiopulmonary A circuit used in extracorporeal circulation therapy such as support.

体外循環回路の素材には塩化ビニル、シリコンゴム、オレフィン系樹脂等が使用出来、中でも軟質塩化ビニルが好んで用いられる。この回路にはチャンバ(「ドリップチャンバ」と呼ばれることもある)、ポンプ用チューブ、コネクタ、三方活栓、圧力測定用分岐チューブ、抗凝固剤注入用接続口、補液接続口、プライミング液接続口、濾液排出用チューブ、一時的体液貯留容器、外付けのクランプ、体液のサンプリングポート、等の部品を必要に応じて付属させることが出来る。   For the material of the extracorporeal circuit, vinyl chloride, silicon rubber, olefin resin, etc. can be used, and among them, soft vinyl chloride is preferred. This circuit has a chamber (sometimes called "drip chamber"), pump tube, connector, three-way stopcock, branch tube for pressure measurement, anticoagulant injection connection port, replacement fluid connection port, priming solution connection port, filtrate Parts such as a discharge tube, a temporary body fluid storage container, an external clamp, a body fluid sampling port, and the like can be attached as necessary.

本発明でいう体外循環装置とは、血液濾過装置、血液透析装置、血液濾過透析装置、持続緩徐式血液透析装置、持続緩徐式血液濾過装置、持続緩徐式血液濾過透析装置、血漿交換装置、血漿吸着装置、二重濾過血漿交換装置、血液吸着装置、血球成分除去装置、腹水濾過濃縮再静注装置、経皮的心肺補助等の体外循環装置のこという。   The extracorporeal circulation device referred to in the present invention is a blood filtration device, hemodialysis device, hemofiltration dialysis device, continuous slow hemodialysis device, continuous slow hemofiltration device, continuous slow hemofiltration dialysis device, plasma exchange device, plasma It refers to extracorporeal circulation devices such as adsorption devices, double filtration plasma exchange devices, blood adsorption devices, blood cell component removal devices, ascites filtration concentration reinfusion devices, and percutaneous cardiopulmonary assistance.

本発明でいう圧力測定ラインは、体液の流通を担うメインチューブ若しくは体液に接する透析液等の治療液の流通を担う非体液チューブから分岐するが、その分岐の仕方は、直接、或いは、例えばT字管、十字管、三方活栓、ドリップチャンバのような部品を通じて枝分かれすることが出来、体外循環回路から枝分かれしてさえいれば、その手段は問わない。体液の体外循環回路における圧力測定ラインには、動脈圧測定ライン、静脈圧測定ライン、採血圧測定ライン濾過圧測定ライン、血漿圧測定ライン、血漿入り口圧測定ライン等がある。 The pressure measurement line referred to in the present invention branches from a main tube responsible for the circulation of body fluid or a non-body fluid tube responsible for the treatment fluid such as dialysate in contact with the body fluid. Any means can be used as long as it can branch through parts such as a character tube, a cross tube, a three-way stopcock, and a drip chamber, and can branch from an extracorporeal circuit. Examples of pressure measurement lines in the extracorporeal circuit for body fluid include an arterial pressure measurement line, a venous pressure measurement line, a blood pressure collection measurement line , a filtration pressure measurement line, a plasma pressure measurement line, and a plasma inlet pressure measurement line.

本発明に用いられる接続時のみに弁が開く弁付きコネクタとは、圧力測定手段の接続部分が正しく接続されているときには弁が開き、圧力測定ラインと圧力測定手段が不完全にしか連通しておらず正しく接続されていない、或いは圧力測定ラインと圧力測定手段が接続されていないときには弁が閉じており、圧力測定ラインの末端は流体の流通が出来ない状態になる弁のことをいう。例示すると、テルモ社製シュアプラグ(SP-1S)のようなコネクタが挙げられる。   The valve-equipped connector used only in the connection of the present invention is such that the valve opens when the connecting part of the pressure measuring means is correctly connected, and the pressure measuring line and the pressure measuring means communicate incompletely. When the pressure measurement line and the pressure measurement means are not connected, the valve is closed and the end of the pressure measurement line is a valve in which fluid cannot flow. Illustrative examples include connectors such as Terumo's Sure Plug (SP-1S).

本発明でいう圧力測定手段とは、体外循環回路内の圧力を検知するもので、−500mmHg〜500mmHg程度の圧力を測定する手段のことを言い、ブルドンカン式圧力計、マノメータ、半導体圧力センサ等が例示出来る。中でも半導体圧力センサが電気出力として圧力データを得ることが出来、警報手段を制御し易いので用い易い。体外循環回路における圧力測定手段には、動脈圧測定部、静脈圧測定部、非血液側圧力測定部等がある。   The pressure measuring means in the present invention is a means for detecting the pressure in the extracorporeal circuit and means a pressure of about −500 mmHg to 500 mmHg, such as a bourdoncan pressure gauge, manometer, semiconductor pressure sensor, etc. It can be illustrated. Among them, the semiconductor pressure sensor can obtain pressure data as an electrical output and is easy to use because it can easily control the alarm means. The pressure measuring means in the extracorporeal circuit includes an arterial pressure measuring unit, a venous pressure measuring unit, a non-blood side pressure measuring unit, and the like.

本発明でいう圧力調整手段とは、体外循環回路内を加圧若しくは減圧する手段のことを言い、エアーポンプ、回転式のチューブポンプ(ローラーポンプ)、落差等が例示出来るが、これらに限定されるものではない。中でも、治療に不必要な機器の取り付けがないため、一般的に体液浄化装置に使用されている回転式のチューブポンプを用いると良い。体液の体外循環回路における圧力調整手段は、血液ポンプ等である。   The pressure adjusting means in the present invention means means for pressurizing or depressurizing the extracorporeal circuit, and examples thereof include an air pump, a rotary tube pump (roller pump), and a head, but are not limited thereto. It is not something. Especially, since there is no attachment of equipment unnecessary for treatment, it is preferable to use a rotary tube pump generally used in a body fluid purification device. The pressure adjusting means in the extracorporeal circuit for body fluid is a blood pump or the like.

本発明でいう除菌フィルタとは、体外循環回路内に雑菌が混入するのを防ぐために用いられるフィルタであり、孔径は0.45μm以下、好ましくは0.3μm以下、より好ましくは0.22μm以下のメンブレンフィルタを用いる。また、体外循環回路内の液体により圧力測定手段が濡らされて破損することを防止するために、ガス透過性が高く且つ疎水性のメンブレンフィルタを用いることが好ましい。疎水性膜は水性液体が通過するのを阻止する性質があるので、圧力測定手段が濡れて破損することを防止出来る。このような除菌フィルタが弁付きコネクタの回路側に接続される。   The sterilization filter referred to in the present invention is a filter used to prevent contamination of germs in the extracorporeal circuit, and has a pore size of 0.45 μm or less, preferably 0.3 μm or less, more preferably 0.22 μm or less. Use a membrane filter. In order to prevent the pressure measuring means from being wetted and damaged by the liquid in the extracorporeal circuit, it is preferable to use a hydrophobic membrane filter having high gas permeability. Since the hydrophobic membrane has the property of preventing the aqueous liquid from passing through, the pressure measuring means can be prevented from getting wet and broken. Such a sterilization filter is connected to the circuit side of the connector with valve.

本発明でいう体液と空気を隔離する隔膜を内蔵した圧力センサ(以下、「隔膜式圧力センサ」という)とは、体液と空気との接触を防止するために、隔膜(体外循環回路内の圧力により変形する変形部)で体液と空気とを分離して圧力測定を行うことが出来るものである。   In the present invention, a pressure sensor (hereinafter referred to as “diaphragm pressure sensor”) that separates a body fluid from air is used to prevent contact between the body fluid and air. Pressure can be measured by separating the body fluid and the air by the deformable portion).

この隔膜式圧力センサは、密閉された容器内部を隔膜により体液室と空気室とに分割し、前記体液室を体液が流通するように体外循環回路を接続するとともに、前記空気室の空気の圧力を計測出来る構造を有している。隔膜式圧力センサの容器形状は、球形、円筒形等と多種あり、その材質は生体適合性を有し、かつ硬質であることが好ましく、塩化ビニル、硬質塩化ビニル、ポリカーボネート、シリコン系樹脂、ポリプロピレン、ポリエチレン、ポリウレタン等が挙げられる。   This diaphragm type pressure sensor divides the inside of a sealed container into a body fluid chamber and an air chamber by a diaphragm, and connects an extracorporeal circuit so that the body fluid flows through the body fluid chamber, and the air pressure in the air chamber It has a structure that can measure. The container type of the diaphragm type pressure sensor has various shapes such as a spherical shape, a cylindrical shape, etc., and the material is preferably biocompatible and rigid. Vinyl chloride, hard vinyl chloride, polycarbonate, silicone resin, polypropylene , Polyethylene, polyurethane and the like.

また、体液と空気を分離する隔膜の形状は、平板形、三角波形、サイン波のような形状等あるが圧力を正しく測定出来るものであれば問題は無い。そして、その隔膜の材質は生体適合性を有し、かつ圧力に対して柔軟に変形することが好ましく、塩化ビニル、ポリ塩化ビニル、シリコン系樹脂、スチレン系熱可塑性エラストマー、スチレン系熱可塑性エラストマーコンパウンド等が挙げられる。また、平板形状を成しているが、断面から見て三角波形状や、サイン波のような形状をしていても問題はなく、また、変形部に占める変形する部分の面積や形状は、圧力を正しく測定出来るものであれば問題はなく、特に限定するものではない。   Further, the shape of the diaphragm for separating the body fluid from the air has a shape such as a flat plate shape, a triangular waveform, and a sine wave, but there is no problem as long as the pressure can be measured correctly. The material of the diaphragm is biocompatible and preferably deforms flexibly with respect to pressure. Vinyl chloride, polyvinyl chloride, silicone resin, styrene thermoplastic elastomer, styrene thermoplastic elastomer compound Etc. Although it has a flat plate shape, there is no problem even if it has a triangular wave shape or a sine wave shape when viewed from the cross section, and the area and shape of the deformed portion in the deformed portion is the pressure There is no problem as long as it can be measured correctly, and there is no particular limitation.

このような体液と空気を隔離する隔膜を内蔵した圧力センサを有する圧力測定ラインが体外循環回路に接続される。   A pressure measurement line having a pressure sensor with a built-in diaphragm for separating body fluid and air is connected to the extracorporeal circuit.

本発明でいう体液処理器とは、血液を含む体液から除去対象物質を除去する、或いは血液を含む体液中の成分を賦活する、等の機能を持つ医療用具をいう。血液を処理する体液処理器は血液処理器と呼ぶ。例えば病因物質を吸着により除去する吸着器(全血を処理するタイプと血漿或いは血漿成分を処理するタイプがある)、血球に富む成分と血漿とに分離する血漿分離器(膜方式と遠心分離方式がある)、血漿中の高分子量物質と低分子量物質とを分離する血漿成分分離器、血液透析器、血液濾過透析器、血液濾過器、特定のリガンドを固定した刺激材による血球の刺激を行なう免疫賦活器、血液中の特定の血球を除去する血球選択除去器、膜を通して酸素と二酸化炭素を移動させる人口肺等が例示出来る。   The body fluid treatment device as used in the present invention refers to a medical device having functions such as removing a substance to be removed from a body fluid containing blood or activating components in a body fluid containing blood. A body fluid treatment device for treating blood is called a blood treatment device. For example, an adsorber that removes pathogenic substances by adsorption (there is a type that processes whole blood and a type that processes plasma or plasma components), a plasma separator that separates blood cell-rich components and plasma (membrane type and centrifuge type) Stimulate blood cells with a plasma component separator, hemodialyzer, hemofiltration dialyzer, hemofilter, and a stimulator with a specific ligand fixed to separate high and low molecular weight substances in plasma Examples include an immunostimulator, a blood cell selective remover that removes specific blood cells in the blood, and a artificial lung that moves oxygen and carbon dioxide through the membrane.

本発明でいう警報手段とは、警報発生を視覚的に伝えるLED(Light Emitting Diode;発光ダイオード)、ランプ等の発光素子やモニタ表示、または警報発生を聴覚的に伝えるブザー等のことをいうが、使用者に警報を知らせることが出来る手段であれば良い。   The alarm means in the present invention refers to a light emitting diode (LED) that visually transmits an alarm occurrence, a light emitting element such as a lamp, a monitor display, or a buzzer that audibly transmits an alarm occurrence. Any means that can notify the user of an alarm may be used.

本発明に係る警報手段は、体外循環回路内を圧力調整手段により加圧もしくは減圧したにもかかわらず圧力測定手段により圧力の変動を検知しない場合に圧力の変動が無いことを知らせるものである。   The alarm means according to the present invention informs that there is no pressure fluctuation when the pressure measuring means does not detect the pressure fluctuation even though the extracorporeal circuit is pressurized or depressurized by the pressure adjusting means.

以下、本発明に係る体外循環回路、圧力測定ラインと圧力測定手段との接続状態の確認方法、及び体外循環装置について例を示しながら説明する。以下に示す具体的な部材の配置等は、理解を容易にするための例示であって、本発明はこれに限定されるものではない。   Hereinafter, the extracorporeal circuit, the method for confirming the connection state between the pressure measurement line and the pressure measuring means, and the extracorporeal circulation apparatus according to the present invention will be described with examples. The arrangement of the specific members shown below is an example for facilitating understanding, and the present invention is not limited to this.

図1は、本発明の実施態様の一つとして血液吸着装置の例を示すものである。図1において、体外循環装置となる血液吸着装置20は、制御手段となる制御部11aと、体液処理器となる血液処理器2と、該血液処理器2の血液入口側に接続された動脈側血液回路3と、血液出口側に接続された静脈側血液回路4とを有している。   FIG. 1 shows an example of a blood adsorption device as one embodiment of the present invention. In FIG. 1, a blood adsorption device 20 serving as an extracorporeal circulation device includes a control unit 11a serving as a control means, a blood processing device 2 serving as a body fluid treatment device, and an artery side connected to the blood inlet side of the blood treatment device 2. It has a blood circuit 3 and a venous blood circuit 4 connected to the blood outlet side.

この動脈側血液回路3と静脈側血液回路4の血液流路となるチューブをメインチューブと呼ぶ。尚、本実施形態の血液処理器2は、血液吸着器であるが、内部空間に充填液を満たしたウェットタイプでも充填液を充填しないドライタイプでもかまわない。尚、本実施態様での血液処理器2はウェットタイプとして説明する。   The tube that serves as the blood flow path for the arterial blood circuit 3 and the venous blood circuit 4 is called a main tube. The blood treatment device 2 of the present embodiment is a blood adsorber, but may be a wet type in which the internal space is filled with a filling liquid or a dry type in which no filling liquid is filled. In addition, the blood processor 2 in this embodiment is demonstrated as a wet type.

動脈側血液回路3には、圧力測定ラインとなる動脈圧測定ライン7aよりも末端側に体外循環回路内を加圧若しくは減圧する圧力調整手段となる血液ポンプ1が配置され、該血液ポンプ1と血液処理器2との間には動脈側チャンバ6aを介して、動脈圧測定ライン7aが配置さている。   The arterial blood circuit 3 is provided with a blood pump 1 serving as a pressure adjusting means for pressurizing or depressurizing the extracorporeal circuit closer to the distal side than the arterial pressure measuring line 7a serving as a pressure measuring line. An arterial pressure measurement line 7a is arranged between the blood processor 2 and the arterial chamber 6a.

この動脈圧測定ライン7aの末端側から順に接続時のみに弁が開く弁付きコネクタ9a、疎水性膜を濾過部とした除菌フィルタ8aが配置されており、接続時のみに弁が開く弁付きコネクタ9aにより制御部11aにある体外循環回路内の圧力を検知する圧力測定手段となる動脈圧測定部10aに接続されている。   A connector 9a with a valve that opens only when connected from the end side of the arterial pressure measurement line 7a, and a sterilization filter 8a that uses a hydrophobic membrane as a filtration part are arranged, and a valve that opens only when connected The connector 9a is connected to an arterial pressure measurement unit 10a serving as a pressure measurement means for detecting the pressure in the extracorporeal circuit in the control unit 11a.

一方、静脈側血液回路4はその途中部に静脈側チャンバ6bを介して圧力測定ラインとなる静脈圧測定ライン7bが配置されている。この静脈圧測定ライン7bの末端側から順に接続時のみに弁が開く弁付きコネクタ9b、疎水性膜を濾過部とした除菌フィルタ8bが配置されており、接続時のみに弁が開く弁付きコネクタ9bにより制御部11aにある圧力測定手段となる静脈圧測定部10bに接続されている。   On the other hand, the venous blood circuit 4 is provided with a venous pressure measuring line 7b serving as a pressure measuring line through the venous chamber 6b in the middle thereof. A connector 9b with a valve that opens only at the time of connection from the end side of the venous pressure measurement line 7b, and a sterilization filter 8b that uses a hydrophobic membrane as a filtration part are arranged, and a valve that opens only at the time of connection is provided. The connector 9b is connected to a venous pressure measuring unit 10b serving as a pressure measuring unit in the control unit 11a.

尚、静脈側血液回路4の末端側にはプライミング液貯留部12が接続されているが、プライミング液貯留部12は動脈側血液回路3の末端側に接続されていても良い。   Although the priming fluid reservoir 12 is connected to the distal side of the venous blood circuit 4, the priming fluid reservoir 12 may be connected to the distal side of the arterial blood circuit 3.

静脈側血液回路4の静脈圧測定ライン7bよりも末端側には、本回路の遮断と解除を行なうためのバルブ5が配置されている。バルブ5は特に限定しないが、鉗子の他にクランプ類、例えばローラークランプ、ロバートクランプ及びピンチバルブ等が軟質の血液回路の一時的な遮断、解除に特に優れており好ましい。   A valve 5 for blocking and releasing the circuit is disposed on the terminal side of the venous blood circuit 4 from the venous pressure measurement line 7b. The valve 5 is not particularly limited, but clamps other than forceps, for example, a roller clamp, a Robert clamp, a pinch valve, and the like are particularly excellent in temporarily blocking and releasing a soft blood circuit, and are preferable.

血液処理器2は、動脈側血液回路3及び静脈側血液回路4を接続するための二つの接続部を有している。   The blood processor 2 has two connection parts for connecting the arterial blood circuit 3 and the venous blood circuit 4.

圧力測定ラインである動静脈圧測定ライン7a,7bは、それぞれ疎水性の除菌フィルタ8a,8bを介して、接続時のみに弁が開く弁付きコネクタ9a,9bによって圧力測定手段となる動静脈圧測定部10a,10bにそれぞれ接続されるラインである。   The arteriovenous pressure measuring lines 7a and 7b, which are pressure measuring lines, are arteriovenous serving as pressure measuring means by means of connectors 9a and 9b with valves that open only when connected via hydrophobic sterilizing filters 8a and 8b, respectively. These lines are connected to the pressure measuring units 10a and 10b, respectively.

圧力測定ラインである動静脈圧測定ライン7a,7bの仕様は特に限定する必要は無く、体外循環回路に一般的に用いられる圧力測定ラインを用いれば良い。例示すれば、内径0.5mm〜5mm、肉厚0.5mm〜2mm程度の軟質塩化ビニルチューブまたはシリコンチューブ等であれば、体外循環レベルの圧変形には耐えて正確な圧力測定が出来る。   The specifications of the arteriovenous pressure measurement lines 7a and 7b, which are pressure measurement lines, are not particularly limited, and a pressure measurement line generally used for an extracorporeal circuit may be used. For example, a soft vinyl chloride tube or silicon tube having an inner diameter of 0.5 mm to 5 mm and a wall thickness of 0.5 mm to 2 mm can withstand pressure deformation at the extracorporeal circulation level and perform accurate pressure measurement.

前記圧力測定ラインに配置する除菌フィルタ8a,8bは、過度の圧力上昇や何らかの誤操作によって、体外循環装置となる血液吸着装置20の圧力測定部内に血液等の液体が浸入したり、或いは血液吸着装置20から体外循環回路内へ雑菌が侵入するのを防止したりするために取り付けられている。   The sterilization filters 8a and 8b arranged in the pressure measurement line may infiltrate a liquid such as blood into the pressure measurement unit of the blood adsorption device 20 serving as an extracorporeal circulation device or blood adsorption due to excessive pressure increase or some misoperation. It is attached to prevent germs from entering the extracorporeal circuit from the device 20.

また、圧力測定ラインである動静脈圧測定ライン7a,7bの末端に配置され、該動静脈圧測定ライン7a,7bと圧力測定手段となる動静脈圧測定部10a,10bとの接続に使用する接続時のみに弁が開く弁付きコネクタ9a,9bは、圧力測定ラインである動静脈圧測定ライン7a,7bと、圧力測定手段となる動静脈圧測定部10a,10bとの接続が正常な場合は弁が開くことで通気可能となり、圧力測定ラインである動静脈圧測定ライン7a,7bと、圧力測定手段となる動静脈圧測定部10a,10bとの接続が接続不良時には弁が閉まることで通気不可能となる機能を有する。従って、弁が閉まっている状態で密閉性を保つことが出来る弁付きコネクタである必要がある。   The arteriovenous pressure measuring lines 7a and 7b, which are pressure measuring lines, are disposed at the ends of the arteriovenous pressure measuring lines 7a and 7b and used to connect the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means. When the connectors 9a and 9b with valves that open the valve only at the time of connection are normally connected to the arteriovenous pressure measuring lines 7a and 7b as pressure measuring lines and the arteriovenous pressure measuring units 10a and 10b as pressure measuring means When the valve is opened, ventilation becomes possible, and when the connection between the arteriovenous pressure measuring lines 7a and 7b as pressure measuring lines and the arteriovenous pressure measuring units 10a and 10b as pressure measuring means is poorly connected, the valve is closed. It has a function that prevents ventilation. Therefore, it is necessary to provide a connector with a valve that can maintain hermeticity when the valve is closed.

尚、図示しないが、動静脈圧測定部10a,10bは、体外循環装置となる血液吸着装置20の本体内部で圧力計に接続しており、その実測値は本体の表示部に表示される。圧力計の仕様や表示機構は特に限定しない。また、一般的な計装機器と同様に、実測値が所定の設定圧に到達する、或いは所定の範囲を外れると信号音や警報を吹鳴させても良い。   Although not shown, the arteriovenous pressure measuring units 10a and 10b are connected to a pressure gauge inside the main body of the blood adsorbing device 20 serving as an extracorporeal circulation device, and the measured values are displayed on the display unit of the main body. The specifications and display mechanism of the pressure gauge are not particularly limited. Further, similarly to general instrumentation equipment, a signal sound or an alarm may be sounded when the actually measured value reaches a predetermined set pressure or is out of a predetermined range.

以上が本発明の体外循環装置となる血液吸着装置20の全体構成であるが、本血液回路に付随するポンプ類やチャンバ等の仕様については特に限定する必要はなく、体外循環療法において一般的に用いられるものであれば何れでも良い。また、抗凝固剤の注入回路やサンプリングポート等、体外循環回路で当然に用いられる付随品については図示しないが、それぞれ適宜配置すれば良い。   The above is the overall configuration of the blood adsorption device 20 serving as the extracorporeal circulation device of the present invention. However, the specifications of pumps and chambers associated with the blood circuit are not particularly limited, and are generally used in extracorporeal circulation therapy. Any may be used as long as it is used. In addition, incidental products such as anticoagulant injection circuits and sampling ports, which are naturally used in the extracorporeal circuit, are not shown, but may be appropriately arranged.

続いて、上記構成を有する血液吸着装置20により圧力測定ラインと圧力測定手段との接続状態の確認方法及び接続不良箇所を検出する方法について説明する。   Next, a method for confirming the connection state between the pressure measurement line and the pressure measurement means and a method for detecting a connection failure location using the blood adsorption device 20 having the above-described configuration will be described.

初期状態としては、圧力調整手段となる血液ポンプ1が配置されている動脈側血液回路3は、血液ポンプ1を停止状態にすることによって血液回路の一部が遮断されており、また、静脈側血液回路4はバルブ5を閉じることにより遮断されている。即ち、バルブ5のみではなく、血液ポンプ1も回路を一時的に遮断する開閉手段として作用している。   As an initial state, the arterial blood circuit 3 in which the blood pump 1 serving as the pressure adjusting means is disposed is partially blocked by bringing the blood pump 1 to a stop state, and the vein side Blood circuit 4 is shut off by closing valve 5. That is, not only the valve 5 but also the blood pump 1 acts as an opening / closing means for temporarily shutting off the circuit.

静脈側血液回路4の末端には生理食塩水を充填したプライミング液貯留部12が接続されている。更に動脈側、静脈側の圧力測定ラインとなる動静脈圧測定ライン7a,7bは、それぞれ圧力測定手段となる動静脈圧測定部10a,10bに接続され、既に圧力測定と表示が可能な状態になっている。   A priming solution reservoir 12 filled with physiological saline is connected to the end of the venous blood circuit 4. Further, the arteriovenous pressure measuring lines 7a and 7b serving as the arterial and venous pressure measuring lines are respectively connected to the arteriovenous pressure measuring units 10a and 10b serving as the pressure measuring means so that the pressure measurement and display can be performed. It has become.

このように、初期状態では圧力測定ラインとなる動静脈圧測定ライン7a,7b以外の全ての流体流通路がその一部で遮断されており、液体の流通は出来ない。尚、体液処理器となる血液処理器2がウェットタイプの場合も、上記の通り血液処理器2に接続する全ての液体流通路が遮断されているため、充填液が回路内を移動することはない。   Thus, in the initial state, all fluid flow passages other than the arteriovenous pressure measurement lines 7a and 7b, which are pressure measurement lines, are blocked at a part thereof, and the liquid cannot be circulated. Even when the blood treatment device 2 serving as a body fluid treatment device is of a wet type, all the liquid flow paths connected to the blood treatment device 2 are blocked as described above, so that the filling liquid does not move in the circuit. .

尚、もし圧力測定ラインとなる動静脈圧測定ライン7a,7bと圧力測定手段となる動静脈圧測定部10a,10bとの接続が外れていても、動静脈圧測定ライン7a,7b末端に配置されている弁付きコネクタ9a,9bが閉じているため、プライミング液貯留部12の液、血液処理器2内部の充填液は実質的に移動せず、除菌フィルタ8a,8bが濡れてしまうということは無い。   Even if the connection between the arteriovenous pressure measuring lines 7a and 7b serving as pressure measuring lines and the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means is disconnected, the arteriovenous pressure measuring lines 7a and 7b are arranged at the ends. Since the valved connectors 9a and 9b are closed, the liquid in the priming liquid reservoir 12 and the filling liquid in the blood treatment device 2 do not substantially move, and the sterilization filters 8a and 8b are wetted. There is nothing.

次に、初期状態を維持しつつ、圧力調整手段となる血液ポンプ1を血液処理器2、圧力測定ラインとなる動静脈圧測定ライン7a,7bで構成されている回路内部を加圧若しくは減圧させる方向に駆動させ、圧力測定手段となる動静脈圧測定部10a,10bによってそれぞれの圧力を監視することで、圧力測定ラインとなる動静脈圧測定ライン7a,7bと圧力測定手段となる動静脈圧測定部10a,10bとの接続不良箇所を検出する。   Next, while maintaining the initial state, the blood pump 1 serving as the pressure adjusting means is pressurized or depressurized inside the circuit constituted by the blood processor 2 and the arteriovenous pressure measuring lines 7a and 7b serving as pressure measuring lines. By driving in the direction and monitoring the respective pressures by the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means, the arteriovenous pressure measuring lines 7a and 7b serving as pressure measuring lines and the arteriovenous pressure serving as pressure measuring means Detects a connection failure location with the measurement units 10a and 10b.

つまり、接続不良のある圧力測定手段となる動静脈圧測定部10a,10bの圧力は、前記回路内部を加圧若しくは減圧しているにもかかわらず圧力が上昇若しくは下降しないため、接続不良箇所を特定出来る。   That is, the pressure of the arteriovenous pressure measuring units 10a and 10b serving as a pressure measuring means having a poor connection does not increase or decrease even though the inside of the circuit is pressurized or depressurized. It can be specified.

また、正常に接続されている圧力測定手段となる動静脈圧測定部10a,10bの圧力は上昇若しくは下降するので、任意の設定圧に達したことを検知することで、圧力測定ラインとなる動静脈圧測定ライン7a,7bと、圧力測定手段となる動静脈圧測定部10a,10bとが接続されていることを確認出来る。   In addition, since the pressure of the arteriovenous pressure measuring units 10a and 10b, which are normally connected pressure measuring means, rises or falls, detecting that the pressure has reached an arbitrary set pressure enables the movement of the pressure measurement line. It can be confirmed that the venous pressure measuring lines 7a and 7b are connected to the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means.

尚、圧力測定ラインとなる動静脈圧測定ライン7a,7bと、圧力測定手段となる動静脈圧測定部10a,10bとが接続されていることを確認するための設定圧は、血液回路、血液ポンプ1等に負担をかけない程度であれば、特に限定はしない。   The set pressure for confirming that the arteriovenous pressure measuring lines 7a and 7b serving as pressure measuring lines and the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means are connected is a blood circuit, blood There is no particular limitation as long as it does not place a burden on the pump 1 or the like.

また、上記接続不良の検出は、各圧力測定手段となる動静脈圧測定部10a,10bの圧力値を使用者が読み取り、設定範囲内にあることを判断する単純な方法でも良い。しかし、体外循環装置となる血液吸着装置20に備えられた制御手段となる制御11aを用いて判断させるように構成し、接続不良箇所を自動的に検知する血液浄化装置として構成することも出来る。その場合、図示しない記憶手段に設定圧若しくは設定圧範囲を記憶させておき、制御部11aが所定のタイミング(例えば使用者による操作等)において記憶した設定範囲と検出した各圧力を比較し、判断した結果をモニタ表示、または信号音にて警報を発するように構成する。   The connection failure may be detected by a simple method in which the user reads the pressure values of the arteriovenous pressure measuring units 10a and 10b serving as the respective pressure measuring means and determines that they are within the set range. However, it may be configured to make a determination using the control 11a serving as a control means provided in the blood adsorption device 20 serving as an extracorporeal circulation device, and may be configured as a blood purification device that automatically detects a connection failure point. In that case, the set pressure or set pressure range is stored in a storage means (not shown), and the control unit 11a compares the detected pressure with the set range stored at a predetermined timing (for example, operation by the user), and makes a determination. The result is displayed on a monitor or an alarm is generated by a signal sound.

即ち、圧力測定ラインとなる動静脈圧測定ライン7a,7bを圧力測定手段となる動静脈圧測定部10a,10bにそれぞれ接続し、体外循環回路内を加圧もしくは減圧した時に、圧力測定手段となる動静脈圧測定部10a,10bにより圧力の変動を検知した場合は圧力測定ラインとなる動静脈圧測定ライン7a,7bと圧力測定手段となる動静脈圧測定部10a,10bとの接続は良好と検知し、体外循環回路内を加圧もしくは減圧したにもかかわらず圧力測定手段となる動静脈圧測定部10a,10bにより圧力の変動を検知しない場合は圧力測定ラインとなる動静脈圧測定ライン7a,7bと圧力測定手段となる動静脈圧測定部10a,10bとの接続は不良と検知することが出来る。   That is, when the arteriovenous pressure measuring lines 7a and 7b serving as pressure measuring lines are connected to the arteriovenous pressure measuring units 10a and 10b serving as pressure measuring means, respectively, When the fluctuation of pressure is detected by the arteriovenous pressure measuring units 10a and 10b, the connection between the arteriovenous pressure measuring lines 7a and 7b serving as the pressure measuring line and the arteriovenous pressure measuring units 10a and 10b serving as the pressure measuring means is good. If the fluctuation of pressure is not detected by the arteriovenous pressure measuring units 10a and 10b, which are pressure measuring means, even though the inside of the extracorporeal circuit is pressurized or depressurized, the arteriovenous pressure measuring line which is a pressure measuring line The connection between 7a, 7b and the arteriovenous pressure measuring units 10a, 10b serving as pressure measuring means can be detected as defective.

図2は体外循環装置が血液透析装置である場合の装置構成を例に示す図である。図2に示すように、体外循環装置となる血液透析装置21は、制御手段となる制御部11bを備えている。体液処理器となる血液処理器2の非血液側には、廃液回路15と透析液供給回路16が接続されている。   FIG. 2 is a diagram showing an example of a device configuration when the extracorporeal circulation device is a hemodialysis device. As shown in FIG. 2, a hemodialysis apparatus 21 serving as an extracorporeal circulation apparatus includes a control unit 11b serving as control means. A waste fluid circuit 15 and a dialysate supply circuit 16 are connected to the non-blood side of the blood treatment device 2 serving as a body fluid treatment device.

透析液供給回路16には、透析液供給ポンプ14を解して透析液貯留部17が接続されている。このように血液処理器2の非血液側回路に2本の非血液側チューブを接続する場合、圧力測定ラインとなる非血液側圧力測定ライン7cを血液処理器2に直接接続出来ないので、廃液回路15の一部に接続している。   The dialysate supply circuit 16 is connected to a dialysate reservoir 17 through the dialysate supply pump 14. Thus, when two non-blood side tubes are connected to the non-blood side circuit of the blood treatment device 2, the non-blood side pressure measurement line 7c, which is a pressure measurement line, cannot be directly connected to the blood treatment device 2, so that the waste liquid It is connected to a part of the circuit 15.

ここで、排出ポンプ13は、廃液回路15において非血液側測定ライン7cよりも末端側に接続されている。排出ポンプ13を開閉手段として回路を遮断し、非血液側圧力測定ライン7cにより圧力を検出し、該圧力測定ラインとなる非血液側圧力測定ライン7cと、圧力測定手段となる非血液側圧力測定部10cとの接続状態を判別するためである。   Here, the discharge pump 13 is connected to the end side of the waste liquid circuit 15 with respect to the non-blood side measurement line 7c. The circuit is cut off using the drain pump 13 as an opening / closing means, the pressure is detected by the non-blood side pressure measurement line 7c, the non-blood side pressure measurement line 7c serving as the pressure measurement line, and the non-blood side pressure measurement serving as the pressure measurement means This is to determine the connection state with the unit 10c.

尚、排出ポンプ13を圧力調整手段として、血液ポンプ1と透析液供給ポンプ14を開閉手段とする、若しくは透析液供給ポンプ14を圧力調整手段として、血液ポンプ1と排出ポンプ13を開閉手段として用いることも可能である。   The discharge pump 13 is used as pressure adjusting means, and the blood pump 1 and dialysate supply pump 14 are used as opening / closing means, or the dialysate supply pump 14 is used as pressure adjusting means, and the blood pump 1 and discharge pump 13 are used as opening / closing means. It is also possible.

尚、図2において、圧力測定ラインである非血液側圧力測定ライン7cの末端に配置され、該非血液側圧力測定ライン7cと、圧力測定手段となる非血液側圧力測定部10cとの接続に使用する接続時のみに弁が開く弁付きコネクタ9cは、前述と同様に、圧力測定ラインである非血液側圧力測定ライン7cと、圧力測定手段となる非血液側圧力測定部10cとの接続が正常な場合は弁が開くことで通気可能となり、圧力測定ラインである非血液側圧力測定ライン7cと、圧力測定手段となる非血液側圧力測定部10cとの接続が接続不良時には弁が閉まることで通気不可能となる機能を有する。   In FIG. 2, it is arranged at the end of the non-blood side pressure measurement line 7c, which is a pressure measurement line, and is used for connection between the non-blood side pressure measurement line 7c and the non-blood side pressure measurement unit 10c serving as a pressure measurement means. In the connector 9c with a valve that opens only at the time of connection, the connection between the non-blood side pressure measurement line 7c, which is a pressure measurement line, and the non-blood side pressure measurement unit 10c, which is a pressure measurement means, is normal as described above. In this case, the valve can be opened to allow ventilation, and when the connection between the non-blood side pressure measurement line 7c, which is a pressure measurement line, and the non-blood side pressure measurement unit 10c, which is a pressure measurement means, is poorly connected, the valve is closed. It has a function that prevents ventilation.

圧力測定ラインである非血液側圧力測定ライン7cは、疎水性の除菌フィルタ8cを介して、接続時のみに弁が開く弁付きコネクタ9cによって圧力測定手段となる非血液側圧力測定部10cに接続されるラインである。他の構成は前述した図1と同様に構成され、同様の効果を得ることが出来る。   The non-blood side pressure measurement line 7c, which is a pressure measurement line, is connected to the non-blood side pressure measurement unit 10c serving as a pressure measurement means by a connector 9c with a valve that opens only when connected via a hydrophobic sterilization filter 8c. It is a line to be connected. Other configurations are the same as those in FIG. 1 described above, and the same effects can be obtained.

図3は、図2に示して前述した体外循環装置となる血液透析装置21において、動脈側チャンバ6a、動脈圧測定ライン7a、除菌フィルタ8a、弁付きコネクタ9aが無い場合を示す図である。この場合も、上記と同様に回路内部を血液ポンプ1、排出ポンプ13、若しくは透析液供給ポンプ14のいずれかの圧力調整手段により加減圧し、圧力測定ラインとなる静脈圧測定ライン7b,非血液側圧力測定ライン7cを通じて各圧力測定ラインの接続状態を確認出来、かつ接続不良箇所がある場合はその箇所を検出し、前述した警報手段により警報を発することが可能である。他の構成は前述した図1、図2と同様に構成され、同様の効果を得ることが出来る。   FIG. 3 is a view showing a case where the arterial chamber 6a, the arterial pressure measurement line 7a, the sterilization filter 8a, and the connector 9a with a valve are not provided in the hemodialysis apparatus 21 which is the extracorporeal circulation apparatus shown in FIG. . In this case as well, the inside of the circuit is pressurized and depressurized by any of the pressure adjusting means of the blood pump 1, the discharge pump 13 or the dialysate supply pump 14 in the same manner as described above, and the venous pressure measuring line 7b serving as the pressure measuring line The connection state of each pressure measurement line can be confirmed through the side pressure measurement line 7c, and if there is a connection failure location, that location can be detected and an alarm can be issued by the alarm means described above. Other configurations are the same as those in FIGS. 1 and 2 described above, and the same effects can be obtained.

図4は、図2に示して前述した体外循環装置となる血液透析装置21において、動脈側チャンバ6aの替わりに隔膜を介して回路内部の圧力を測定する隔膜式圧力センサ18を設置し、除菌フィルタ8aと弁付きコネクタ9aが無い場合を示す図である。   FIG. 4 shows a hemodialysis apparatus 21 which is the extracorporeal circulation apparatus shown in FIG. 2 and is provided with a diaphragm type pressure sensor 18 for measuring the pressure inside the circuit through the diaphragm instead of the arterial chamber 6a. It is a figure which shows the case where there is no bacteria filter 8a and the connector 9a with a valve.

本実施形態では、隔膜式圧力センサ18を設置すると隔膜を介して回路内部の圧力を測定出来るため、隔膜式圧力センサ18から分岐している圧力測定ラインとなる動脈圧測定ライン7aと、圧力測定手段となる動脈圧測定部10aとの接続不良時に回路内部の圧力は保たれる。よって、この場合も圧力測定ラインとなる動脈圧測定ライン7aと、圧力測定手段となる動脈圧測定部10aとの接続状態を上記と同様に、回路内部の圧力を加減することで確認出来る。   In the present embodiment, when the diaphragm type pressure sensor 18 is installed, the pressure inside the circuit can be measured through the diaphragm. Therefore, the arterial pressure measurement line 7a which is a pressure measurement line branched from the diaphragm type pressure sensor 18 and the pressure measurement The pressure inside the circuit is maintained when the connection with the arterial pressure measuring unit 10a as a means is poor. Therefore, also in this case, the connection state between the arterial pressure measurement line 7a serving as the pressure measurement line and the arterial pressure measurement unit 10a serving as the pressure measurement means can be confirmed by adjusting the pressure inside the circuit in the same manner as described above.

つまり、図4のような構成でも回路内部を血液ポンプ1、排出ポンプ13、若しくは透析液供給ポンプ14の何れかの圧力調整手段により体外循環回路内を加減圧し、圧力測定ラインとなる動脈圧測定ライン7a,静脈圧測定ライン7b,非血液側圧力測定ライン7cをそれぞれ通じて各圧力測定ラインの接続状態を確認出来、かつ接続不良箇所がある場合はその箇所を検出し、前述した警報手段により警報を発することが可能である。   In other words, even in the configuration as shown in FIG. 4, the inside of the circuit is pressurized and depressurized in the extracorporeal circuit by any of the pressure adjusting means of the blood pump 1, the discharge pump 13, or the dialysate supply pump 14, and the arterial pressure serving as a pressure measurement line The connection state of each pressure measurement line can be confirmed through the measurement line 7a, the venous pressure measurement line 7b, and the non-blood side pressure measurement line 7c, respectively. Can issue an alarm.

尚、図4では、隔膜式圧力センサ18と該隔膜式圧力センサ18から分岐した圧力測定ラインは動脈側血液回路部にあるが、隔膜式圧力センサ18と該隔膜式圧力センサ18から分岐した圧力測定ラインの位置は限定されない。他の構成は前述した図1、図2と同様に構成され、同様の効果を得ることが出来る。   In FIG. 4, the diaphragm pressure sensor 18 and the pressure measurement line branched from the diaphragm pressure sensor 18 are in the arterial blood circuit section, but the pressure branched from the diaphragm pressure sensor 18 and the diaphragm pressure sensor 18. The position of the measurement line is not limited. Other configurations are the same as those in FIGS. 1 and 2 described above, and the same effects can be obtained.

本発明の活用例として、圧力測定ラインを有する体外循環回路、これを用いた圧力測定ラインと圧力測定手段の接続状態の確認方法及びこの方法を実施するための体外循環装置に適用することが出来る。   As an application example of the present invention, it can be applied to an extracorporeal circuit having a pressure measurement line, a method for confirming the connection state between the pressure measurement line and the pressure measuring means using the circuit, and an extracorporeal circulation device for carrying out this method. .

本発明に係る体外循環装置を血液吸着療法に用いる場合の一例を示す模式図である。It is a schematic diagram which shows an example in the case of using the extracorporeal circulation apparatus which concerns on this invention for blood adsorption therapy. 本発明に係る体外循環装置を血液透析装置として構成した場合の一例を示す模式図である。It is a schematic diagram which shows an example at the time of comprising the extracorporeal circulation apparatus which concerns on this invention as a hemodialysis apparatus. 本発明に係る体外循環装置を血液透析装置として構成した場合の他の例を示す模式図である。It is a schematic diagram which shows the other example at the time of comprising the extracorporeal circulation apparatus which concerns on this invention as a hemodialysis apparatus. 本発明に係る体外循環装置を血液透析装置として構成した場合の更に別の例を示す模式図である。It is a schematic diagram which shows another example at the time of comprising the extracorporeal circulation apparatus which concerns on this invention as a hemodialysis apparatus.

1…血液ポンプ(圧力調整手段)
2…血液処理器(体液処理器)
3…動脈側血液回路
4…静脈側血液回路
5…バルブ
6a…動脈側チャンバ
6b…静脈側チャンバ
7a…動脈圧測定ライン(圧力測定ライン)
7b…静脈圧測定ライン(圧力測定ライン)
7c…非血液側圧力測定ライン(圧力測定ライン)
8a〜8c…除菌フィルタ
9a〜9c…接続時のみに弁が開く弁付きコネクタ
10a…動脈圧測定部(圧力測定手段)
10b…静脈圧測定部(圧力測定手段)
10c…非血液側圧力測定部(圧力測定手段)
11a,11b…制御部
12…プライミング液貯留部
13…排出ポンプ
14…透析液供給ポンプ
15…廃液回路
16…透析液供給回路
17…透析液貯留部
18…隔膜式圧力センサ
20…血液吸着装置(体外循環装置)
21…血液透析装置(体外循環装置)
1 ... Blood pump (pressure adjusting means)
2 ... Blood processor (Body fluid processor)
3 ... Arterial blood circuit 4 ... Venous blood circuit 5 ... Valve 6a ... Arterial chamber 6b ... Venous chamber 7a ... Arterial pressure measurement line (pressure measurement line)
7b ... Venous pressure measurement line (pressure measurement line)
7c ... Non-blood pressure measurement line (pressure measurement line)
8a to 8c ... sanitizing filter 9a to 9c ... connector with valve that opens only when connected
10a ... Arterial pressure measuring part (pressure measuring means)
10b ... Venous pressure measuring unit (pressure measuring means)
10c ... Non-blood side pressure measuring part (pressure measuring means)
11a, 11b ... control unit
12 ... Priming fluid reservoir
13 ... Drain pump
14 Dialysate supply pump
15 ... Waste liquid circuit
16 ... Dialysate supply circuit
17 ... Dialysate reservoir
18 ... diaphragm pressure sensor
20 ... Blood adsorption device (extracorporeal circulation device)
21 ... Hemodialysis device (extracorporeal circulation device)

Claims (4)

少なくとも2つ以上の圧力測定ラインを有する体外循環回路であって、
前記圧力測定ラインの圧力測定手段との接続側末端に接続時のみに弁が開く弁付きコネクタを有し、
前記弁付きコネクタの回路側に除菌フィルタが接続されていることを特徴とする、体外循環回路。
An extracorporeal circuit having at least two pressure measurement lines,
A valve-equipped connector that opens only when connected to the end of the pressure measuring line connected to the pressure measuring means;
An extracorporeal circulation circuit, wherein a sterilization filter is connected to the circuit side of the connector with valve.
請求項1記載の体外循環回路に、体液と空気を隔離し、回路内の圧力により変形する変形部を有する圧力測定ラインが接続されていることを特徴とする、体外循環回路。 The extracorporeal circuit according to claim 1 , wherein a pressure measuring line is connected to the extracorporeal circuit to isolate a body fluid and air and to have a deforming part that deforms by the pressure in the circuit. 請求項1または請求項2のいずれかに記載の体外循環回路における前記圧力測定ラインと前記圧力測定手段の接続状態の確認方法であって、
前記圧力測定ラインを前記圧力測定手段に接続し、
前記体外循環回路内を加圧もしくは減圧した時に、前記圧力測定手段により圧力の変動を検知した場合は前記圧力測定ラインと前記圧力測定手段の接続は良好と検知し、
前記体外循環回路内を加圧もしくは減圧したにもかかわらず前記圧力測定手段により圧力の変動を検知しない場合は前記圧力測定ラインと前記圧力測定手段との接続は不良と検知することを特徴とする、圧力測定ラインと圧力測定手段の接続状態の確認方法。
A method for confirming a connection state between the pressure measurement line and the pressure measurement means in the extracorporeal circuit according to claim 1,
Connecting the pressure measuring line to the pressure measuring means;
When pressure fluctuation is detected by the pressure measuring means when pressurizing or depressurizing the extracorporeal circuit, the connection between the pressure measuring line and the pressure measuring means is detected as good,
A connection between the pressure measurement line and the pressure measuring means is detected as defective when the pressure measuring means does not detect a pressure fluctuation even though the inside of the extracorporeal circuit is pressurized or depressurized. The confirmation method of the connection state of the pressure measurement line and the pressure measurement means.
少なくとも請求項1または請求項2のいずれかに記載の体外循環回路と、
前記体外循環回路内を加圧もしくは減圧する圧力調整手段と、
前記体外循環回路内の圧力を検知する圧力測定手段と、
前記体外循環回路内を前記圧力調整手段により加圧もしくは減圧したにもかかわらず前記圧力測定手段により圧力の変動を検知しない場合に圧力の変動が無いことを知らせる警報手段と、
を有することを特徴とする、体外循環装置。
At least the extracorporeal circuit according to claim 1 or 2,
Pressure adjusting means for pressurizing or depressurizing the extracorporeal circuit;
Pressure measuring means for detecting the pressure in the extracorporeal circuit,
An alarm means for notifying that there is no pressure fluctuation when pressure fluctuation is not detected by the pressure measuring means even though the extracorporeal circuit is pressurized or depressurized by the pressure adjusting means;
An extracorporeal circulation device comprising:
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