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JP2005084017A - Bubble amount detection system and medical device equipped with the bubble amount detection system - Google Patents

Bubble amount detection system and medical device equipped with the bubble amount detection system Download PDF

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JP2005084017A
JP2005084017A JP2003319507A JP2003319507A JP2005084017A JP 2005084017 A JP2005084017 A JP 2005084017A JP 2003319507 A JP2003319507 A JP 2003319507A JP 2003319507 A JP2003319507 A JP 2003319507A JP 2005084017 A JP2005084017 A JP 2005084017A
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bubble
amount
bubble amount
conduit
detection system
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JP4352825B2 (en
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Masaaki Ochi
雅彰 大地
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JMS Co Ltd
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Abstract

【課題】正確な気泡量の検出が可能な気泡量検出システムの提供。
【解決手段】液体が送液される導管に装着され、該導管部分に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記導管を通過する液体の流量に関するデータ及び/又は導管に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって気泡量を算出することを特徴とする気泡量検出システム。
【選択図】図1
A bubble amount detection system capable of accurately detecting a bubble amount is provided.
An ultrasonic transducer that is attached to a conduit through which liquid is fed and that oscillates ultrasonic waves and a receiving-side transducer that receives ultrasonic waves generated by the ultrasonic transducer are provided in the conduit portion. Ultrasonic detection means and bubble amount calculation means for calculating the amount of bubbles based on the detection result of the ultrasonic detection means, and data relating to the flow rate of liquid passing through the conduit and / or related to the conduit A bubble amount detection system that calculates a bubble amount by taking data as a correction parameter for calculating a bubble amount.
[Selection] Figure 1

Description

本発明は、導管内を流れる液体の気泡量、特に微小量(微小体積)の気泡を含む気泡量、例えば医療用装置の導管内を流れる血液または輸液に混入した微小気泡を含む気泡量を誤検知せずに、正確に定量することのできる気泡量の検出システム、および該気泡量の検出システムを搭載した医療用装置に関する。   In the present invention, the amount of bubbles of liquid flowing in a conduit, particularly the amount of bubbles containing a minute amount (minute volume) of bubbles, for example, the amount of bubbles containing minute bubbles mixed in blood or infusion fluid flowing in a conduit of a medical device is erroneously determined. The present invention relates to a bubble amount detection system capable of accurately quantifying without detection, and a medical device equipped with the bubble amount detection system.

医療施設において、輸液・輸血を行う際に誤って患者体内に気泡を注入しないように、気泡検出装置が利用されることは少なくない。その場合、透明でない薬液や血液にも適応可能なように、検出手段の1つとして、超音波が利用されてきた。例えば下記特許文献1および2に示すような手段が知られている。しかし、実際に気泡を含む液中に混入した気泡の量を正確に定量するのは困難であった。   In medical facilities, a bubble detection device is often used so that bubbles are not mistakenly injected into a patient when transfusion or blood transfusion is performed. In that case, ultrasonic waves have been used as one of detection means so that it can be applied to non-transparent drug solutions and blood. For example, means as shown in Patent Documents 1 and 2 below are known. However, it is difficult to accurately quantify the amount of bubbles actually mixed in the liquid containing bubbles.

実開昭59−191662号Japanese Utility Model Publication No.59-191662 特公平6−64016号JP 6-64016

従来、前記特許文献1および2に示すように、液に混入した気泡量の検出は、気泡通過時の受信信号が一定電圧(気泡判定値)以下に低下した時間(受信レベル低下時間)を比例的な換算により算出するものは知られている。しかし、この手段によると、実際には気泡量と受信レベル低下時間は比例関係に乏しいため、超音波検出装置による測定値から算定した気泡量と実際の気泡量との誤差が大きく、正確な気泡量の検出ができないという問題があった。   Conventionally, as shown in Patent Documents 1 and 2, the detection of the amount of bubbles mixed in the liquid is proportional to the time (reception level decrease time) when the reception signal when the bubbles pass decreases below a certain voltage (bubble determination value). What is calculated by a general conversion is known. However, according to this measure, since the amount of bubbles and the reception level drop time are actually poorly proportional, there is a large error between the amount of bubbles calculated from the measured value by the ultrasonic detector and the actual amount of bubbles, and accurate bubbles There was a problem that the amount could not be detected.

図7は従来の検出装置によって、受信レベルの低下時間T1から、気泡検出する仕組みを模式的に示したものである。従来の気泡検出は、超音波の受信レベル(電圧)の波形4から、基準となる電圧以下に低下した時間である低下時間T1を計測することのみで行われた。しかし、上記低下時間T1と気泡量との比例関係は乏しく、上述のように前記の気泡量の検出判定方法では正確な気泡量を検出判定することはできなかった。これは、単泡の気泡体積(μl)が大きく、振動子のかなりの面積を占めるものであれば、受信電圧はほとんど0となるので、比較的正確な気泡量を検出判定することができるが、逆に単泡の気泡体積(μl)が小さい場合には気泡量の算出に使用される前記低下時間T1と気泡量との相関性は少なくなる。図6は従来の気泡検出装置による微小気泡の検出が、どのような状態で行われるかを模式的に示すものであるが、従来の気泡センサでは振動子1の流れ方向の幅(L)は通常3mm程度であるのに対して、一般的に微小気泡とされる0.3〜1.0μlの気泡2は、直径が0.83〜1.24mmであるため、チューブ3内を通過する微小気泡の投影面は完全に振動子内に包含されるように、振動子面積に対して単泡の気泡体積(μl)が、相対的に著しく小さいため、従来法による気泡量の検知における大きな誤差の原因となっていた。 FIG. 7 schematically shows a mechanism for detecting bubbles from a reception level decrease time T 1 using a conventional detection device. Conventional bubble detection is performed only by measuring a decrease time T 1 that is a time when the waveform is decreased below a reference voltage from the waveform 4 of the ultrasonic reception level (voltage). However, the proportional relationship between the drop time T 1 and the amount of bubbles is poor, and as described above, the bubble amount detection / determination method cannot accurately detect and determine the amount of bubbles. This is because if the bubble volume (μl) of a single bubble is large and occupies a considerable area of the vibrator, the received voltage is almost 0, so that a relatively accurate bubble amount can be detected and determined. Conversely, when the bubble volume (μl) of a single bubble is small, the correlation between the drop time T 1 used for calculating the bubble amount and the bubble amount decreases. FIG. 6 schematically shows in what state microbubble detection is performed by a conventional bubble detection device. In the conventional bubble sensor, the width (L) of the vibrator 1 in the flow direction is as follows. The diameter of the bubble 2 of 0.3 to 1.0 μl, which is generally a microbubble, is usually about 3 mm, and the diameter of the bubble 2 is 0.83 to 1.24 mm. Since the bubble projection plane is completely contained in the transducer, the bubble volume (μl) of the single bubble is relatively small relative to the transducer area, so a large error in the detection of the amount of bubbles by the conventional method. It was the cause.

本発明者は先に(1)気泡によって増減した受信レベルの変動値、あるいは受信レベル変動量と、(2)受信レベル低下時間の少なくとも2つのパラメーターを気泡量算出パラメーターとして利用することによって、導管内の気泡を精度良く検出、また定量することを提案している(特願2003−122616)。
本発明者はさらに検討の結果、表1〜4に示されるように導管内腔を流れる液量(流速)、導管に関するデータが気泡量算出に影響を及ぼすこと、さらには超音波振動子の形状も気泡量算出に影響を及ぼすこと(以下、前記各要件を補正パラメーターという)を見出し、この技術的知見に基づいて前記補正パラメーターを上記特願2003−122616の気泡検出手段や他の気泡量算出パラメーターを用いる他の気泡検出手段に採用することにより前記補正パラメーターの及ぼす気泡量算出に及ぼす影響を修正して従来の気泡量検出システムに比較してより正確な定量を行うことが可能な気泡量検出システムを提供することができた。
The inventor previously used (1) at least two parameters of the reception level fluctuation value or the reception level fluctuation amount increased or decreased by the bubble and (2) the reception level decrease time as the bubble amount calculation parameter. It has been proposed to detect and quantify the bubbles in the inside (Japanese Patent Application No. 2003-122616).
As a result of further investigation, the present inventor has further studied that the amount of liquid (flow velocity) flowing through the lumen of the conduit and the data related to the conduit affect the calculation of the amount of bubbles as shown in Tables 1 to 4, and further, the shape of the ultrasonic transducer (Hereinafter, each requirement is referred to as a correction parameter), and based on this technical knowledge, the correction parameter is calculated based on the bubble detection means of the above Japanese Patent Application No. 2003-122616 and other bubble amount calculation. The amount of bubbles that can be quantified more accurately compared to conventional bubble amount detection systems by correcting the influence of the correction parameters on the bubble amount calculation by adopting other bubble detection means that use parameters A detection system could be provided.

前記導管に関するデータとしては、例えば導管径の大きさ(内径、外径)や肉厚、さらには導管を構成する材料等の導管に関するデータが挙げられる。これは、例えば図8に示すようにバネ17等によって気泡センサーの超音波振動子で導管を挟持した場合、導管径の大きさ(内径、外径)や肉厚、さらには導管を構成する材料等によって、図9に示すように導管の振動子への接触面積が影響を受けるからである。さらに、補正パラメーターとしては、導管に接触する超音波振動子のセンサーの形状あるいは寸法等が挙げられる。
本発明においては液量(流速)あるいは導管に関する補正パラメーターのどちらか一方を用いることで、気泡検出の精度が改善できるが、前記のそれぞれの補正パラメーターを採用すればより正確な気泡量の算出が可能となる。
Examples of the data related to the conduit include data related to the conduit such as the diameter (inner diameter, outer diameter) and thickness of the conduit, and the material constituting the conduit. For example, as shown in FIG. 8, when the conduit is sandwiched by the ultrasonic transducer of the bubble sensor by a spring 17 or the like, the size of the conduit (inner diameter, outer diameter), the wall thickness, and further the conduit are configured. This is because the contact area of the conduit to the vibrator is affected by the material or the like as shown in FIG. Furthermore, examples of the correction parameter include the shape or size of the sensor of the ultrasonic transducer that contacts the conduit.
In the present invention, the accuracy of bubble detection can be improved by using either the liquid volume (flow rate) or the correction parameter related to the conduit, but if each of the correction parameters described above is used, more accurate calculation of the bubble volume can be achieved. It becomes possible.

本発明の第1は、内腔に液体が送液される導管に装着され、該導管部分に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記導管を通過する液体の流量に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって気泡量を算出することを特徴とする気泡量検出システムにある。   A first aspect of the present invention is an ultrasonic vibrator that oscillates an ultrasonic wave in the conduit portion where a liquid is fed into a lumen, and receives an ultrasonic wave oscillated by the ultrasonic vibrator. An ultrasonic detection unit including a side vibrator, and a bubble amount calculation unit that calculates a bubble amount based on a detection result of the ultrasonic detection unit, and relates to a flow rate of liquid passing through the conduit in the bubble amount calculation unit. A bubble amount detection system is characterized in that the amount of bubbles is calculated by taking data as a correction parameter for calculating the amount of bubbles.

前記本発明の気泡量検出システムによると、気泡量を正確に検出することが必要な医療用装置、例えば透析装置、輸液装置、人工心肺装置などに利用すれば、気泡量を正確に検出するために、検出装置を複雑化することなく、あるいは複雑な操作を採用することなく、簡単にかつ正確な気泡量の検出を行うという目的が達成できる。
すなわち、透析装置には血液ポンプ、輸液装置や人工心肺装置には送液ポンプが搭載されており、かつこれら医療用装置は血液ポンプや送液ポンプによる流量(流速)検出手段も具備しているので、この流量(流速)検出手段によって得られた設定流量データを前記気泡量検出システムに送信し、前記気泡量検出システムの補正パラメーターとして利用することによって前記目的の達成が可能となる。また、前記医療用装置の導管部分に流量(流速)検出手段を有する場合には、この流量(流速)検出手段によって得られた流量(流速)データを前記補正パラメーターとして利用してもよい。さらに前記透析装置、輸液装置や人工心肺装置においては、該装置中を通過する流量(流速)が状況に応じて変更されることがあるが、このような流量(流速)の変更が行われたとしても、本発明の気泡量検出システムによると常に簡単、かつ正確に気泡量の検出を行うことができる。前記医療用装置が備えた流量(流速)検出手段によって得られた流量(流速)データは、例えば通信用回路等のインターフェースを介して気泡量算出手段に伝達される。特に医療用装置が透析装置である場合、気泡量検出システムが透析操作における気泡検出のみならず、プライミング操作時の気泡量検出に有効である。
According to the bubble amount detection system of the present invention, when used in medical devices that require accurate detection of the bubble amount, such as dialysis devices, infusion devices, and cardiopulmonary devices, the amount of bubbles can be detected accurately. In addition, the object of simply and accurately detecting the amount of bubbles can be achieved without complicating the detection device or adopting complicated operations.
That is, a blood pump is mounted on the dialysis device, a liquid pump is mounted on the infusion device and the heart-lung machine, and these medical devices are also provided with a flow rate (flow rate) detection means using the blood pump or the liquid pump. Therefore, by transmitting the set flow rate data obtained by the flow rate (flow velocity) detection means to the bubble amount detection system and using it as a correction parameter of the bubble amount detection system, the object can be achieved. When the flow rate (flow velocity) detection means is provided in the conduit portion of the medical device, flow rate (flow velocity) data obtained by the flow rate (flow velocity) detection means may be used as the correction parameter. Furthermore, in the dialysis device, the infusion device, and the heart-lung machine, the flow rate (flow velocity) passing through the device may be changed depending on the situation, but such a change in flow rate (flow velocity) has been performed. However, according to the bubble amount detection system of the present invention, the bubble amount can always be detected easily and accurately. The flow rate (flow velocity) data obtained by the flow rate (flow velocity) detection means provided in the medical device is transmitted to the bubble amount calculation means via an interface such as a communication circuit. In particular, when the medical device is a dialysis device, the bubble amount detection system is effective not only for detecting bubbles in a dialysis operation but also for detecting the amount of bubbles during a priming operation.

本発明の第2は、内腔に液体が送液される導管に装着された前記導管に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記導管に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって算出気泡量を修正することを特徴とする気泡量検出システムにある。
すなわち、本発明の気泡量検出システムは、内腔に液体が送液される導管に装着された前記導管に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に気泡量算出手段を有する気泡量検出システムにおいて、前記導管に関するデータを前記気泡量算出手段に気泡量を算出するための補正パラメーターとして取り込むことによって、より正確な気泡量を算出することが可能な気泡量検出システムを提供することができた。
According to a second aspect of the present invention, an ultrasonic transducer that oscillates an ultrasonic wave in the conduit that is attached to a conduit through which liquid is fed into the lumen, and a reception side that receives the ultrasonic wave oscillated by the ultrasonic transducer An ultrasonic detection unit including a vibrator, and a bubble amount calculation unit that calculates a bubble amount based on a detection result of the ultrasonic detection unit; In the bubble amount detection system, the calculated bubble amount is corrected by taking in as a correction parameter.
That is, the bubble amount detection system according to the present invention includes an ultrasonic vibrator that oscillates an ultrasonic wave in the conduit that is attached to a conduit through which liquid is fed into the lumen, and an ultrasonic wave that is oscillated by the ultrasonic vibrator. In a bubble amount detection system having an ultrasonic detection means having a receiving-side transducer for receiving and a bubble amount calculation means in a detection result of the ultrasonic detection means, data relating to the conduit is calculated in the bubble amount calculation means. It was possible to provide a bubble amount detection system capable of calculating a more accurate amount of bubbles by taking it in as a correction parameter.

また、前記補正パラメーターを用いる気泡量の算出は、送液する液体中に所定の気泡量(実気泡量)を予め存在させて前記補正パラメーターに関して種々の条件で気泡量の算出を行い、この気泡量算出値と実気泡量との変換結果を示す表(変換表)を作成し、この変換表を利用するか、あるいは前記気泡量の算出値と実気泡量との比例係数(補正係数α)を導出し、この補正係数αを用いて下式(1)に示すように気泡量の算出値を修正することによって正確な気泡量を簡単に算出することができる。
気泡量=α×気泡量算出値 (1)
前記変換表あるいは補正係数αは、例えば気泡量算出手段の情報記憶部分(メモリー)に記憶させ、利用させることができる。
The calculation of the amount of bubbles using the correction parameter is performed by calculating the amount of bubbles under various conditions with respect to the correction parameter by causing a predetermined amount of bubbles (actual bubble amount) to exist in advance in the liquid to be fed. Create a table (conversion table) showing the conversion result between the calculated amount of bubbles and the actual bubble amount and use this conversion table, or use the conversion table to calculate the proportional coefficient (correction coefficient α) between the calculated value of the bubble amount and the actual bubble amount. , And by correcting the calculated value of the bubble amount using the correction coefficient α as shown in the following equation (1), the accurate bubble amount can be easily calculated.
Bubble amount = α × bubble amount calculation value (1)
The conversion table or the correction coefficient α can be stored and used in, for example, an information storage part (memory) of the bubble amount calculating means.

本発明の気泡量検出システムにおける気泡量算出パラメーターとしては、例えば受信側振動子の受信した受信レベル値(電圧変化値)が所定値以下に低下する時間(受信レベル低下時間)、受信レベル値の変化量(電圧変化値)あるいは受信レベル値の変化率が挙げられる。
前記受信レベル低下時間は定常電圧値Vcから一定電圧(気泡判定値)以下に低下した時間(受信レベル低下時間)であり、また、前記定常電圧Vcは気泡非検出時の電圧値の平均値である。また、前記の気泡量算出パラメーターの受信レベル値(電圧変化値)の変化量あるいは受信レベル値(電圧変化値)の変化率は定常電圧値Vcと気泡検出時に低下する電圧との差に基づいて算出されたものである。
As the bubble amount calculation parameter in the bubble amount detection system of the present invention, for example, the time during which the reception level value (voltage change value) received by the receiving-side transducer decreases below a predetermined value (reception level decrease time), the reception level value The change rate (voltage change value) or the rate of change of the reception level value can be mentioned.
The reception level decrease time is a time (reception level decrease time) when the steady voltage value Vc drops below a certain voltage (bubble determination value), and the steady voltage Vc is an average value of voltage values when no bubble is detected. is there. In addition, the amount of change in the reception level value (voltage change value) or the rate of change in the reception level value (voltage change value) of the bubble amount calculation parameter is based on the difference between the steady voltage value Vc and the voltage that decreases when the bubble is detected. It is calculated.

以下、本発明に係る気泡検出装置を図により詳細に説明する。
1.装置全体
図2は、本発明の1つの実施例である気泡検出装置全体の構成概略を示すブロック図である。図2において、発振回路5は導管3の両側に挟着された超音波振動子1aに連絡されている。なお、発振回路の連絡する超音波振動子1aは超音波を発振する側であり、対向して導管に装着された超音波振動子1bは、超音波を受信する側である。導管内に気泡2が存在すると、発振側振動子1aから発振された超音波は、減衰した状態で受信側振動子1bに受信される。
さらに、受信側振動子1bに連絡しているのは、それぞれ順番に増幅回路6、整流回路7である。増幅回路6は受信側振動子1bの受信した電圧を増幅する機能を有し、整流回路7は振幅変化を取り出す機能を有する。整流回路7は受信レベル値が所定値以下に低下した時間(受信レベル低下時間T)を測定する波形形状測定回路8に連絡される。波形形状測定回路8は、通常、A−D変換器(Analog−Digital Convertor)が使用される。このA−D変換器で測定された受信レベル低下時間Tは、気泡量の値を算出する気泡量算出手段10に送信される。この気泡量算出手段10では、送信された前記受信レベル低下時間T、あるいは受信レベル値の変化量(電圧変化値)あるいは受信レベル値の変化率と設定流量(実流量)または流速、導管に関するデータ、超音波振動子(センサ)1の形状等の補正パラメーターを用いて気泡量が算出される。
Hereinafter, the bubble detection apparatus according to the present invention will be described in detail with reference to the drawings.
1. Entire Device FIG. 2 is a block diagram showing a schematic configuration of the entire bubble detection device according to one embodiment of the present invention. In FIG. 2, the oscillation circuit 5 is connected to an ultrasonic transducer 1 a sandwiched on both sides of the conduit 3. In addition, the ultrasonic transducer | vibrator 1a which an oscillation circuit communicates is a side which oscillates an ultrasonic wave, and the ultrasonic transducer | vibrator 1b with which it was attached to the conduit | pipe oppositely is a side which receives an ultrasonic wave. When the bubble 2 is present in the conduit, the ultrasonic wave oscillated from the oscillation-side transducer 1a is received by the reception-side transducer 1b in an attenuated state.
Further, the amplifier circuit 6 and the rectifier circuit 7 are in turn connected to the receiving-side vibrator 1b. The amplifier circuit 6 has a function of amplifying the voltage received by the receiving-side vibrator 1b, and the rectifier circuit 7 has a function of extracting the amplitude change. The rectifier circuit 7 is in communication with a waveform shape measuring circuit 8 that measures the time (reception level decrease time T) when the reception level value has decreased below a predetermined value. As the waveform shape measuring circuit 8, an A-D converter (Analog-Digital Converter) is usually used. The reception level decrease time T measured by the AD converter is transmitted to the bubble amount calculation means 10 that calculates the bubble amount value. In the bubble amount calculation means 10, the received reception level decrease time T, the amount of change in the reception level value (voltage change value), the rate of change in the reception level value, the set flow rate (actual flow rate) or flow velocity, and the data relating to the conduit The amount of bubbles is calculated using correction parameters such as the shape of the ultrasonic transducer (sensor) 1.

2.波形形状測定回路
波形形状測定回路8には、図3に示すようにA−D変換器14が組み込まれ、A−D変換器14によって受信レベル低下時間Tの算出が以下のようにして行われる。
先ず、気泡の存在の判定基準となる気泡判定電圧Vsを設定する。気泡判定電圧Vsは、検知したいと考える最小径(体積)の気泡が通過した場合の電圧低下量から決定されるが、通常は定常電圧Vcの−2%〜−10%に設定する。電圧測定値が、上記の気泡判定電圧Vs以下になったときの時間(図4におけるt2−t1)が、受信レベル低下時間Tである。受信レベル低下時間Tは、導管内を通過するのにかかる時間(通過時間)を示す指標となる。ここで、定常電圧VCは導管とセンサ(振動子)の接触状態などで変動することがあるため、マイクロコンピュータでA−D変換器の電圧値を気泡通過の検知に影響しない時間の平均値とする。
この定常電圧の変化を電気回路で補正するため、増幅回路6に自動振幅制御機能付き(AGC)増幅器を採用しても良い。そのような構成にすることにより、センサの接触状態に起因する受信電圧の変動があっても、増幅器の出力振幅が一定に維持されるので、定常電圧を常時平均化処理する必要が無くなる。その結果、気泡判定電圧Vsは固定電圧値にすることができ、マイクロコンピュータの負担を軽減できる。
2. Waveform Shape Measurement Circuit The waveform shape measurement circuit 8 incorporates an A / D converter 14 as shown in FIG. 3, and the A / D converter 14 calculates the reception level decrease time T as follows. .
First, a bubble determination voltage Vs that is a determination criterion for the presence of bubbles is set. The bubble determination voltage Vs is determined from a voltage drop amount when a bubble having the minimum diameter (volume) that is desired to be detected passes, but is normally set to −2% to −10% of the steady voltage Vc. The time when the voltage measurement value becomes equal to or lower than the bubble determination voltage Vs (t2-t1 in FIG. 4) is the reception level decrease time T. The reception level decrease time T is an index indicating the time taken to pass through the conduit (passage time). Here, since the steady voltage VC may fluctuate depending on the contact state between the conduit and the sensor (vibrator) or the like, the voltage value of the A-D converter by the microcomputer is an average value of time that does not affect the detection of bubble passage. To do.
In order to correct the change in the steady voltage with an electric circuit, the amplifier circuit 6 may be provided with an automatic amplitude control function (AGC) amplifier. With such a configuration, the output amplitude of the amplifier is kept constant even when the received voltage varies due to the contact state of the sensor, so that it is not necessary to always average the steady voltage. As a result, the bubble determination voltage Vs can be set to a fixed voltage value, and the burden on the microcomputer can be reduced.

受信レベル低下時間Tは、図5に示すコンパレータ15によって、比較信号(整流回路7からの受信レベル値)と基準値VS(気泡判定電圧)を比較することによって測定される。図4の下方に示す気泡検出判定出力16の時間Tを読み取ることによっても可能である。図4は気泡検出における経時的な受信レベル変化の波形と、コンパレータから算出された気泡検出判定出力16との関係を示す模式図である。   The reception level decrease time T is measured by comparing the comparison signal (reception level value from the rectifier circuit 7) with the reference value VS (bubble determination voltage) by the comparator 15 shown in FIG. It is also possible by reading the time T of the bubble detection determination output 16 shown in the lower part of FIG. FIG. 4 is a schematic diagram showing the relationship between the waveform of the reception level change with time in bubble detection and the bubble detection determination output 16 calculated from the comparator.

3.気泡量算出手段
上記の波形形状測定回路で得られた受信レベル低下時間Tから気泡量を算出するために、以下に説明する気泡量算出手段10を使用する。この気泡量算出手段10には前記受信レベル低下時間Tに加えて前記補正パラメーターに関するデータが入力され、前記気泡量検出パラメーターと補正パラメーターを利用して気泡量が算出されるので正確な気泡量の算出が可能となる。
前記補正パラメーターを利用する気泡量の算出は、例えば前記変換表11あるいは補正係数αを用いて簡単に行うことができる。例えば、補正係数αを用いる場合、気泡量をX、受信レベル低下時間をTとすると、X ∝ αTの式を用いて、簡単、かつ正確に気泡量を算出することができる。また、前記変換表11を採用する場合、各補正パラメーターはデータ間に一定の比率が成立するので、各補正パラメーターは使用される頻度が高いパラメーター値のみについて変換表を準備して例えばメモリーに記憶させ、この変換表に記載が無い場合には、この変換表を利用して補間計算を採用することでより少ないデータで気泡量の算出が可能となる
さらに前記補正パラメーターを用いる気泡量の検出手段としては、基準となる液流量V1と使用時の液流量V2を設定し、この流量比(V2/V1)と受信レベル低下時間Tとの積によっても、単純かつ容易に気泡量Xを算出することができる。
3. Bubble amount calculation means In order to calculate the bubble amount from the reception level decrease time T obtained by the waveform shape measurement circuit, the bubble amount calculation means 10 described below is used. In addition to the reception level decrease time T, data related to the correction parameter is input to the bubble amount calculation means 10 and the bubble amount is calculated using the bubble amount detection parameter and the correction parameter. Calculation is possible.
The calculation of the bubble amount using the correction parameter can be easily performed using, for example, the conversion table 11 or the correction coefficient α. For example, when the correction coefficient α is used, if the bubble amount is X and the reception level reduction time is T, the bubble amount can be calculated easily and accurately using the equation X ∝ αT. Further, when the conversion table 11 is adopted, each correction parameter has a certain ratio between the data, so that each correction parameter prepares a conversion table only for parameter values that are frequently used and stores them in a memory, for example. If there is no description in this conversion table, it is possible to calculate the bubble amount with less data by adopting interpolation calculation using this conversion table. Further, the bubble amount detection means using the correction parameter As a reference, a reference liquid flow rate V1 and a liquid flow rate V2 at the time of use are set, and the bubble amount X is simply and easily calculated by the product of the flow rate ratio (V2 / V1) and the reception level decrease time T. be able to.

4.気泡量積算手段および警報発生装置
微小気泡は一定量以上、人体に流入すると、障害を与える危険性があるため、流入した微小気泡を気泡量積算手段13により積算できるようにしておき、その積算値が設定量以上に達したときに、警報装置や送液装置に対し、何らかの指令・制御を行うものが望ましい。例えば、単位時間当りに、気泡の積算量が0.1ml以上になった場合、自動的に警報等を発し、さらに送液ポンプの停止、あるいは導管を閉止するなどの措置を行うものであり、それによって、医療従事者の負担が軽減される。
4). Bubble amount integrating means and alarm generating device Since there is a risk of causing damage if microbubbles flow into the human body over a certain amount, the bubble amount integrating means 13 is allowed to integrate the inflowing microbubbles, and the integrated value It is desirable to perform some kind of instruction / control on the alarm device or the liquid delivery device when the value reaches the set amount or more. For example, when the accumulated amount of bubbles per unit time is 0.1 ml or more, an alarm is automatically issued, and further measures such as stopping the liquid feed pump or closing the conduit are performed. As a result, the burden on health care workers is reduced.

次に気泡量の算出を行う場合において、流量(流速)や導管の影響について、以下に説明する。
1.流量(流速)の影響
表4に示すチューブを使用し、そのチューブ内に既知の気泡量(0.3〜20μl)を混入して、送液ポンプの流量(速)を100ml/minおよび250ml/minと変化させ送液したとき、気泡量が電圧低下量、または低下率にどのように影響するか実験した。この実験結果を表1および2に示す。実験結果から電圧低下率(表中では、変化率)は気泡量と良好な相関性を示し、通過時間は流量によって大きく影響を受けるが、電圧低下率は通過時間ほど流量に影響されないことが判った。
Next, the influence of the flow rate (flow velocity) and the conduit when the bubble amount is calculated will be described below.
1. Effect of flow rate (flow rate) Using a tube shown in Table 4, a known bubble volume (0.3 to 20 μl) was mixed in the tube, and the flow rate (speed) of the liquid feed pump was set to 100 ml / min and 250 ml / An experiment was conducted to determine how the amount of bubbles affects the voltage drop amount or the drop rate when the liquid is fed while changing to min. The results of this experiment are shown in Tables 1 and 2. The experimental results show that the voltage drop rate (change rate in the table) shows a good correlation with the amount of bubbles and the passage time is greatly influenced by the flow rate, but the voltage drop rate is not affected by the flow rate as much as the passage time. It was.

Figure 2005084017
Figure 2005084017

Figure 2005084017
Figure 2005084017

2.導管に関するデータの影響
表4に示す細径肉薄、太径肉厚および太径肉薄の各チューブに、既知の0.3μl、0.6μl、1.0μlおよび2.0μlの気泡を注入し、送液流量250ml/minで固定して気泡の無いときの受信電圧である約1.4Vから10%低下の通過時間(mS)を測定した結果を下記表3に示す。
2. Effect of data on conduits Introduce known 0.3 μl, 0.6 μl, 1.0 μl and 2.0 μl bubbles into each of the small, thin, thick and thin tubes shown in Table 4 Table 3 below shows the results of measuring the passage time (mS) of 10% reduction from about 1.4 V which is the reception voltage when the liquid flow rate is fixed at 250 ml / min and there are no bubbles.

Figure 2005084017
前表の結果より、同じ気泡量が通過した場合であっても、所定の電圧低下率に要する通過時間(mS)は導管に関するデータの影響を大きく受けることが判る。
なお、前表3および4に記載の細径と太径および肉厚および肉薄という導管径および導管肉厚に関する記載は、導管径および導管肉厚に関して特定基準に基づいて表現したものではなく、前記3種類のチューブの導管径および導管肉厚を相対的に表現したものである。
Figure 2005084017
From the results in the previous table, it can be seen that even when the same amount of bubbles passes, the passage time (mS) required for a predetermined voltage drop rate is greatly affected by the data on the conduit.
In addition, the description regarding the conduit diameter and the conduit thickness of the small diameter, the large diameter, the wall thickness, and the wall thickness described in Tables 3 and 4 above is not expressed based on the specific criteria regarding the conduit diameter and the conduit wall thickness. FIG. 4 is a relative representation of the conduit diameter and the conduit wall thickness of the three types of tubes.

Figure 2005084017
Figure 2005084017

本発明によれば、気泡量を前記気泡量検出パラメーターと補正パラメーターの両者を考慮して、気泡量を算出するため、導管の寸法、超音波の減衰を測定するセンサの形状・寸法、導管内を流れる液の流速などの各因子による気泡量の検出誤差が低く抑えられる。また、本発明の構成は特別な装置を必要とするものではないため、簡単に実施可能である。そのため、様々な状況の下で、微小量(微小体積)の気泡を正確に且つ容易に定量することが可能となる。
ただし、本発明の気泡量検出システムは、例えば体積が0.3〜1.0μl程度の単泡のみならず、これら微小量(微小体積)の気泡よりも体積の大きい気泡であっても、これら気泡を含む液体が導管を通過する液体の流量に関するデータおよび/または導管に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって正確に気泡量を算出することが可能である。
According to the present invention, in order to calculate the bubble amount in consideration of both the bubble amount detection parameter and the correction parameter, the size of the conduit, the shape and size of the sensor for measuring the attenuation of the ultrasonic wave, The detection error of the amount of bubbles due to various factors such as the flow velocity of the liquid flowing through is kept low. Further, the configuration of the present invention does not require a special device and can be easily implemented. Therefore, it is possible to accurately and easily quantify a small amount (small volume) of bubbles under various circumstances.
However, the bubble amount detection system of the present invention is not limited to a single bubble having a volume of about 0.3 to 1.0 μl, for example, even if it is a bubble having a volume larger than those of a minute amount (minute volume). It is possible to accurately calculate the amount of bubbles by incorporating data relating to the flow rate of the liquid through which the liquid containing bubbles passes and / or data relating to the conduit as correction parameters for calculating the amount of bubbles.

補正パラメーターとして流量(実流量)を使用した本発明の気泡量検出システムを透析装置に使用し、微小量(微小体積)の気泡を含む前記透析装置の気泡量を簡単かつ正確に測定することができた。   The bubble amount detection system of the present invention using the flow rate (actual flow rate) as a correction parameter can be used in a dialysis machine to easily and accurately measure the bubble volume of the dialysis machine containing a small amount (small volume) of bubbles. did it.

図1に基づいて説明する。
半透膜を介して血液と透析液とを接触させ浄化する血液透析器(図示せず)、血液を循環させる血液循環系(図示せず)、透析液を送液ならびに排液する透析液給排液系(図示せず)、前記血液循環系に設けた血液ポンプ、該血液ポンプの回転速度や回転方向を制御するモーター制御回路、該モーター制御回路に血液ポンプの流量(実流量)あるいは流速を設定するための回転速度や回転方向の情報を送信し該モーター制御回路を制御する制御回路(CPU)、および透析装置の気泡量を測定する導管部分に装着された該導管部分に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段と該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記血液ポンプの回転数によって設定された血液流の設定流量データを気泡量算出のための補正パラメーターとして送信し、この算出手段において前記補正パラメーターと受信レベル低下時間をリンクさせることによって正確な気泡量を算出することが可能な透析装置。
本実施例の透析装置においては、補正パラメーターとして前記の血液量の設定流量データに加えて、内径と肉厚、内径と外径あるいは外径と肉厚の導管に関する寸法のデータを使用しても良い。
This will be described with reference to FIG.
A hemodialyzer (not shown) that contacts and purifies blood and dialysate through a semipermeable membrane, a blood circulation system (not shown) that circulates blood, and dialysate supply that delivers and drains dialysate A drainage system (not shown), a blood pump provided in the blood circulation system, a motor control circuit for controlling the rotation speed and direction of the blood pump, and a flow rate (actual flow rate) or flow rate of the blood pump in the motor control circuit A control circuit (CPU) that controls the motor control circuit by transmitting information on the rotation speed and rotation direction for setting the ultrasonic wave and ultrasonic waves are applied to the conduit part mounted on the conduit part that measures the amount of bubbles in the dialyzer Ultrasonic wave detecting means including an ultrasonic transducer that oscillates and a receiving-side vibrator that receives ultrasonic waves oscillated by the ultrasonic vibrator, and a bubble that calculates the amount of bubbles based on the detection result of the ultrasonic wave detecting means Has quantity calculation means In both cases, the flow rate setting data of the blood flow set by the rotation speed of the blood pump is transmitted to the bubble amount calculation means as a correction parameter for calculating the bubble amount. A dialysis machine capable of calculating the accurate amount of bubbles by linking.
In the dialysis apparatus of the present embodiment, in addition to the blood volume setting flow rate data described above, the data on the inner diameter and the wall thickness, the inner diameter and the outer diameter, or the outer diameter and the wall thickness can be used as the correction parameter. good.

本発明の気泡量検出システムを採用した透析装置における気泡量算出方法を示す概念図。The conceptual diagram which shows the bubble amount calculation method in the dialysis apparatus which employ | adopted the bubble amount detection system of this invention. 本発明の換算表を使用する気泡量検出システムの概略を示すブロック図。The block diagram which shows the outline of the bubble quantity detection system which uses the conversion table of this invention. A−D変換器14が組み込まれた波形形状測定回路8の構成概略を示す模式図。The schematic diagram which shows the structure outline of the waveform shape measuring circuit 8 in which the AD converter 14 was incorporated. 気泡検出における経時的な受信レベル変化の波形と、コンパレータから算出された気泡検出判定出力16との関係を示す模式図。The schematic diagram which shows the relationship between the waveform of the reception level change with time in bubble detection, and the bubble detection determination output 16 calculated from the comparator. 気泡検出の際、受信レベル低下時間を読み取るためのコンパレータの模式図。The schematic diagram of the comparator for reading the reception level fall time at the time of bubble detection. 従来の気泡検出装置での問題点を示すための概念図。The conceptual diagram for showing the problem in the conventional bubble detection apparatus. 従来の気泡検出装置によって、気泡検出を行う原理を示す概念図。The conceptual diagram which shows the principle which performs a bubble detection with the conventional bubble detection apparatus. 発振側振動子および受信側振動子とチューブの接触状態を示す図である。It is a figure which shows the contact state of an oscillation side vibrator | oscillator and a receiving side vibrator | oscillator, and a tube. 導管に関するデータによって発振側振動子および受信側振動子とチューブの接触状態が変化することを説明した図である。It is the figure explaining that the contact state of an oscillation side vibrator | oscillator, a receiving side vibrator | oscillator, and a tube changes with the data regarding a conduit | pipe.

符号の説明Explanation of symbols

1.超音波振動子
1a.発振側振動子
1b.受信側振動子
2.気泡
3.導管(チューブ)
4.受信レベル波形
5.発振回路
6.増幅回路
7.整流回路
8.波形形状測定回路
10.気泡量算出手段
11.変換表
12.警報発生装置
13.気泡量積算手段
14.A−D変換器
15.コンパレータ
16.気泡検出判定出力
17.バネ
18.発振側振動子
19.受信側振動子
20.チューブ
21.チューブ
22.チューブ
Vc.定常電圧
Vs.気泡判定電圧
VB.電圧最低点
T1.受信レベル(電圧)低下時間
T.受信レベル低下時間
L.超音波振動子の流路方向の幅
t1.電圧測定値が気泡判定電圧Vs以下となる点
t2.電圧測定値が気泡判定電圧Vs以下の終点
1. Ultrasonic vibrator 1a. Oscillator 1b. 1. Receiving-side vibrator Bubble 3 Conduit (tube)
4). 4. Reception level waveform 5. Oscillator circuit Amplifier circuit 7. Rectifier circuit8. 9. Waveform shape measuring circuit 10. Bubble amount calculation means Conversion table 12. Alarm generator 13. Bubble amount integrating means 14. A-D converter 15. Comparator 16. Bubble detection determination output 17. Spring 18. Oscillation side vibrator 19. Receiving-side vibrator 20. Tube 21. Tube 22. Tube Vc. Steady voltage Vs. Bubble determination voltage VB. Voltage minimum point T1. Reception level (voltage) drop time Reception level reduction time The width t1 of the flow direction of the ultrasonic transducer. Point t2 where the measured voltage value is equal to or lower than the bubble determination voltage Vs The end point of the measured voltage is less than the bubble determination voltage Vs

Claims (14)

液体が送液される導管に装着され、該導管部分に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記導管を通過する液体の流量に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって気泡量を算出することを特徴とする気泡量検出システム。 Ultrasonic detecting means equipped with an ultrasonic transducer that is attached to a conduit through which liquid is fed and that oscillates ultrasonic waves in the conduit portion, and a receiving-side transducer that receives ultrasonic waves oscillated by the ultrasonic transducer And a bubble amount calculation means for calculating the amount of bubbles based on the detection result of the ultrasonic detection means, and data relating to the flow rate of the liquid passing through the conduit is calculated in the bubble amount calculation means. A bubble amount detection system, wherein the bubble amount is calculated by taking in as. 液体が送液される導管に装着され、該導管部分に超音波を発振する超音波振動子と該超音波振動子によって発振された超音波を受信する受信側振動子を備えた超音波検出手段および該超音波検出手段の検出結果に基づいて気泡量を算出する気泡量算出手段を有するとともに、前記気泡量算出手段に前記導管に関するデータを気泡量算出のための補正パラメーターとして取り込むことによって気泡量を算出することを特徴とする気泡量検出システム。 Ultrasonic detecting means equipped with an ultrasonic transducer that is attached to a conduit through which liquid is fed and that oscillates ultrasonic waves in the conduit portion, and a receiving-side transducer that receives ultrasonic waves oscillated by the ultrasonic transducer And a bubble amount calculating means for calculating a bubble amount based on the detection result of the ultrasonic detecting means, and taking in the data related to the conduit as a correction parameter for calculating the bubble amount into the bubble amount calculating means. A bubble quantity detection system characterized by calculating 流量に関するデータが、医療用装置の導管部分における流量のデータであることを特徴とする請求項1に記載の気泡量検出システム。 The bubble amount detection system according to claim 1, wherein the flow rate data is flow rate data in a conduit portion of a medical device. 導管に関するデータが、医療用装置の導管部分に関するデータであることを特徴とする請求項2に記載の気泡量検出システム。 The bubble amount detection system according to claim 2, wherein the data regarding the conduit is data regarding the conduit portion of the medical device. 気泡量算出手段における気泡量を算出するパラメーターが、受信側振動子の受信した受信レベル値(電圧変化値)が所定値以下に低下する時間(受信レベル低下時間)、受信レベル値の変化量(電圧変化値)あるいは受信レベル値の変化率であることを特徴とする請求項1〜4のいずれかに記載の気泡検出システム。 The parameter for calculating the bubble amount in the bubble amount calculation means is the time when the reception level value (voltage change value) received by the receiving-side transducer decreases below a predetermined value (reception level decrease time), the amount of change in the reception level value ( The bubble detection system according to any one of claims 1 to 4, which is a rate of change in voltage change value) or reception level value. 気泡量算出手段における補正パラメーターを用いる気泡量の算出が、送液する液体中に所定の気泡量(実気泡量)を予め存在させて設定流量あるいは導管に関して種々の条件で気泡量の算出を行い、この気泡量算出値と実気泡量との変換結果を示す表(以下、変換表ともいう)を作成し、この変換表を利用して行われることを特徴とする請求項1〜5のいずれかに記載の気泡検出システム。 The calculation of the amount of bubbles using the correction parameter in the bubble amount calculation means is to calculate the amount of bubbles under various conditions with respect to the set flow rate or the conduit with a predetermined amount of bubbles (actual bubble amount) pre-existing in the liquid to be fed. 6. A table (hereinafter also referred to as a conversion table) indicating a conversion result between the bubble amount calculation value and the actual bubble amount is created, and the conversion table is used to perform the conversion. The bubble detection system according to Crab. 気泡量算出手段における補正パラメーターを用いる気泡量の算出が、送液する液体中に所定の気泡量(実気泡量)を予め存在させて設定流量あるいは導管に関して種々の条件で気泡量の算出を行い、この気泡量算出値と実気泡量との比例係数(以下、補正係数αともいう)を導出し、下式(1)に示すようにこの補正係数αを用いて行われることを特徴とする請求項1〜6のいずれかに記載の気泡検出システム。
気泡量=α×気泡量算出値 (1)
The calculation of the amount of bubbles using the correction parameter in the bubble amount calculation means is performed by calculating the amount of bubbles under various conditions with respect to the set flow rate or the conduit in the presence of a predetermined amount of bubbles (actual bubble amount) in the liquid to be fed. A proportional coefficient (hereinafter also referred to as a correction coefficient α) between the calculated value of the bubble amount and the actual bubble amount is derived, and the correction coefficient α is used as shown in the following equation (1). The bubble detection system in any one of Claims 1-6.
Bubble amount = α × bubble amount calculation value (1)
気泡量算出手段が情報記憶部分(メモリー)を有し、該メモリーに前記変換表あるいは補正係数αを記憶させたものであることを特徴とする請求項6または7に記載の気泡検出システム。 The bubble detection system according to claim 6 or 7, wherein the bubble amount calculation means has an information storage part (memory), and the conversion table or the correction coefficient α is stored in the memory. 気泡量算出パラメーターの受信レベル低下時間が、定常電圧値Vcから一定電圧(気泡判定値)以下に低下するに要する時間(受信レベル低下時間)であって、前記定常電圧Vcが気泡非検出時の電圧値の平均値であることを特徴とする請求項5〜8のいずれかに記載の気泡検出装置。 The reception level decrease time of the bubble amount calculation parameter is the time (reception level decrease time) required for the reception voltage decrease time to decrease below a certain voltage (bubble determination value) from the steady voltage value Vc. The bubble detection device according to claim 5, wherein the bubble detection device is an average value of voltage values. 気泡量算出パラメーターの受信レベル値(電圧変化値)の変化量あるいは受信レベル値(電圧変化値)の変化率が、定常電圧値Vcと気泡検出時に低下する電圧との差に基づいて算出されたものであることを特徴とする請求項5〜8のいずれかに記載の気泡検出装置。 The amount of change in the reception level value (voltage change value) or the rate of change in the reception level value (voltage change value) of the bubble amount calculation parameter was calculated based on the difference between the steady voltage value Vc and the voltage that decreases when the bubble is detected. The bubble detection device according to claim 5, wherein the bubble detection device is a device. 請求項1〜10のいずれかに記載の気泡量検出システムを搭載した医療用装置。 A medical device equipped with the bubble amount detection system according to claim 1. 医療用装置が透析装置、輸液装置あるいは人工心肺装置であることを特徴とする請求項11に記載の医療用装置。 The medical device according to claim 11, wherein the medical device is a dialysis device, an infusion device, or a heart-lung machine. 医療用装置の流量検出装置あるいは送液手段によって得られた流量データを前記気泡量検出システムに送信し、前記気泡量検出システムの補正パラメーターとして利用することを特徴とする請求項11または12に記載の医療用装置。 13. The flow rate data obtained by a flow rate detection device or a liquid feeding means of a medical device is transmitted to the bubble amount detection system and used as a correction parameter of the bubble amount detection system. Medical equipment. 医療用装置が透析装置であって、気泡量検出システムが透析操作における気泡検出および/またはプライミング操作時の気泡量検出に使用可能なことを特徴とする請求項11〜13のいずれかに記載の医療用装置。 The medical device is a dialysis device, and the air bubble amount detection system can be used for air bubble detection in dialysis operation and / or air bubble amount detection during priming operation. Medical device.
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