JP2008173139A5 - - Google Patents
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- JP2008173139A5 JP2008173139A5 JP2007006499A JP2007006499A JP2008173139A5 JP 2008173139 A5 JP2008173139 A5 JP 2008173139A5 JP 2007006499 A JP2007006499 A JP 2007006499A JP 2007006499 A JP2007006499 A JP 2007006499A JP 2008173139 A5 JP2008173139 A5 JP 2008173139A5
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Description
本発明は、液体、特に血液、透析液、補充液、ろ液あるいは血漿を流通させる体外循環回路に関する。さらに詳しくは、加温／冷却効率の非常に優れた、加えて体外循環回路内が陰圧下においても、加温／冷却効率および流量精度を維持でき、体外循環装置への装着も容易な一体型の液体加温／冷却用の体外循環回路および体外循環システムに関する。 The present invention relates to an extracorporeal circuit for circulating a fluid, particularly blood, dialysate, replenisher, filtrate or plasma. More specifically, it has excellent heating / cooling efficiency. In addition, it can maintain heating / cooling efficiency and flow rate accuracy even under negative pressure in the extracorporeal circuit, and can be easily attached to the extracorporeal circulation device. The present invention relates to an extracorporeal circulation circuit and extracorporeal circulation system for liquid heating / cooling.
近年、重篤な循環器系の合併症を有する腎疾患や多臓器不全等の疾患の治療にあたり、特に救急・集中治療領域において持続的血液浄化法と総称される血液浄化法が普及しており、臨床効果を上げている。 In recent years, in the treatment of diseases such as kidney diseases and multiple organ failure that have serious circulatory system complications, blood purification methods, which are collectively called continuous blood purification methods, have become widespread, especially in the field of emergency and intensive care. , Has been clinically effective.
持続的血液浄化法には、具体的には、持続的血液ろ過法（ｃｏｎｔｉｎｕｏｕｓ ｈｅｍｏｆｉｌｔｒａｔｉｏｎ、以下「ＣＨＦ」という）、持続的血液透析法（ｃｏｎｔｉｎｕｏｕｓ ｈｅｍｏｄｉａｌｙｓｉｓ、以下「ＣＨＤ」という）、持続的血液ろ過透析法（ｃｏｎｔｉｎｕｏｕｓ ｈｅｍｏｄｉａｆｉｌｔｒａｔｉｏｎ、以下「ＣＨＤＦ」という）等があり、治療目的に応じて使い分けられている。 Specifically, the continuous blood purification method includes continuous hemofiltration (hereinafter referred to as “CHF”), continuous hemodialysis (hereinafter referred to as “CHD”), and continuous hemofiltration dialysis. There is a method (continuous hemofiltration, hereinafter referred to as “CHDF”), etc., which are used according to the purpose of treatment.
ここで、ＣＨＦとは、半透膜を収容した血液浄化器に血液を流し、ろ過膜を介して血液から老廃物を含むろ液を排出する一方で、補液を体内に補充することを持続的かつ緩徐に施行する方法である。また、ＣＨＤとは、半透膜を介した拡散により、酸塩基平衡の是正等を持続的かつ緩徐に施行する方法である。そして、ＣＨＤＦとは、前記ＣＨＦの小分子量除去能力を改善するために、ろ過液側に透析液を流し、透析効果も得られるように前記ＣＨＦと前記ＣＨＤとを複合させた方法である。 Here, CHF means that blood is passed through a blood purifier containing a semipermeable membrane, and the filtrate containing waste products is discharged from the blood through the filtration membrane, while the replacement fluid is continuously replenished into the body. And it is a method of slowly enforcing. Further, CHD is a method of continuously and slowly performing correction of acid-base balance and the like by diffusion through a semipermeable membrane. The CHDF is a method in which the CHF and the CHD are combined so that a dialysis solution is flowed to the filtrate side in order to improve the small molecular weight removal capability of the CHF, and a dialysis effect is also obtained.
また、肝不全に対する血液浄化法として、血漿交換療法（ｐｌａｓｍａ ｅｘｃｈａｎｇｅ、以下「ＰＥ」という）や、二重ろ過療法（ｄｏｕｂｌｅ ｆｉｌｔｒａｔｉｏｎ ｐｌａｓｍａ ｐｈｅｒｅｓｉｓ、以下「ＤＦＰＰ」という）や、血漿吸着療法（ｐｌａｓｍａ ａｄｓｏｒｐｔｉｏｎ、以下「ＰＡ」という）等のアフェレーシス療法が治療目的に応じて使い分けられ、臨床効果をあげている。 In addition, as a blood purification method for liver failure, plasma exchange therapy (hereinafter referred to as “PE”), double filtration therapy (hereinafter referred to as “DFPP”), plasma adsorption therapy (plasma adsorption), (Hereinafter referred to as “PA”) and other apheresis therapies are used according to the purpose of treatment and have a clinical effect.
ここで、ＰＥとは、肝臓が代謝、解毒する有害物質を除去すると共に肝臓が合成する有用物質を補充する方法である。また、ＤＦＰＰとは、血漿分離器及び血漿成分分離器を用いて前記有用物質の補充液の削減を可能とする方法である。そして、ＰＡとは、分離した血漿を吸着カラムに灌流し、特異的もしくは選択的に病因物質を吸着除去する方法である。 Here, PE is a method of removing harmful substances that are metabolized and detoxified by the liver and supplementing useful substances synthesized by the liver. Further, DFPP is a method that makes it possible to reduce the replenisher of the useful substance using a plasma separator and a plasma component separator. PA is a method in which separated plasma is perfused through an adsorption column to specifically and selectively remove a pathogenic substance.
治療に用いられる透析液、補液、新鮮凍結血漿等の治療液は、治療を行う際に、体液との温度バランスを保つため、加温／冷却することが好ましい。 Treatment fluids such as dialysis fluid, replacement fluid, and fresh frozen plasma used for treatment are preferably heated / cooled in order to maintain a temperature balance with body fluids during treatment.
これらの治療液を効率よく加温する加温器および加温装置の一例として、特許文献１には、枠状のスペーサ部材の表面に樹脂フィルムを接合し、液体を流通させる空間を内部に有する加温器用カートリッジにおいて、樹脂フィルムが当該流路仕切りの間の流路部分で凸形状にカートリッジの外方向に張り出した形状の加温器が記載されている。この加温器は樹脂フィルムが当該流路仕切りの間の流路部分で凸形状にカートリッジの外方向に張り出していることにより、加温プレートとの接触面積を確保することで、加温効率を向上している。 As an example of a warmer and a warming device for efficiently heating these treatment liquids, Patent Document 1 has a space in which a resin film is bonded to the surface of a frame-shaped spacer member to allow the liquid to flow therethrough. In the warmer cartridge, a warmer having a shape in which a resin film protrudes in a convex shape in the flow path portion between the flow path partitions in the outward direction of the cartridge is described. In this heater, the resin film is projected in the outward direction of the cartridge in a convex shape at the flow path portion between the flow path partitions, so that the heating area is secured by ensuring the contact area with the heating plate. It has improved.
しかしながら、この加温器は、表面が樹脂フィルムで構成されているため、回路内が陰圧となった場合、樹脂フィルムが流路の内側に変形してしまい、目的とする加温特性が得られない、即ち加温効率が悪くなるという欠点があった。 However, since the surface of the warmer is made of a resin film, the resin film is deformed to the inside of the flow path when a negative pressure is generated in the circuit, and the desired heating characteristic is obtained. In other words, the heating efficiency is poor.
ここで、図８に、前記した血液浄化療法の一例であるＣＨＤＦの模式図を示す。一般にＣＨＤＦは、血液浄化器５０１、血液回路５０２、ろ液回路５０３、透析液回路５０４、補液回路５０５、血液ポンプ５０６、ろ液ポンプ５０７、透析液ポンプ５０８、補液ポンプ５０９、透析液５１０、補液５１１から構成される血液浄化装置および体外循環回路を用いて治療が行われる。 Here, in FIG. 8, the schematic diagram of CHDF which is an example of the above-mentioned blood purification therapy is shown. In general, CHDF is blood purifier 501, blood circuit 502, filtrate circuit 503, dialysate circuit 504, replacement fluid circuit 505, blood pump 506, filtrate pump 507, dialysate pump 508, replacement fluid pump 509, dialysate 510, replacement fluid. Treatment is performed using the blood purification device 511 and the extracorporeal circuit.
従来、透析液５１０または補液５１１の加温は、透析液ポンプ５０８または補液ポンプ５０９の上流側で行われていた。そのため、加温器よりも高い位置に透析液または補液を設置することで、加温器内の圧力を陽圧としていたため、陰圧に関して考慮する必要がなかった。 Conventionally, heating of the dialysate 510 or the replacement fluid 511 has been performed on the upstream side of the dialysate pump 508 or the replacement fluid pump 509. For this reason, since the dialysate or the replacement fluid is installed at a position higher than the warmer, the pressure in the warmer is set to a positive pressure, so there is no need to consider the negative pressure.
しかしながら、加温器出口から血液回路に到達するまでの間に、温まった治療液は空気との間での熱交換により、再び温度が下がってしまう。従って、透析液ポンプ５０８または補液ポンプ５０９の下流側で治療液を加温することが望ましいが、単に特許文献１の加温器を透析液ポンプ５０８または補液ポンプ５０９の下流側に設置した場合、血液回路内の圧力が陰圧となる可能性があり、ひいては上記したように樹脂フィルムが流路の内側に変形することで、目的とする加温特性が得られず、加温効率が悪くなるという問題があった。さらには、血液回路内が何らかの理由で陰圧状態となり、その後、陽圧状態に復帰した場合、加温器は陰圧状態となることで加温器が収縮し、再度陽圧状態となることで、その容積が元に戻る、つまりは、加温器内の容積が陰圧時に比べて大きくなることで、血液回路から加温器に向かって血液が逆流するという問題があった。 However, before reaching the blood circuit from the outlet of the heater, the temperature of the heated treatment liquid is lowered again due to heat exchange with the air. Therefore, it is desirable to heat the treatment liquid downstream of the dialysate pump 508 or the replacement fluid pump 509, but when the heater of Patent Document 1 is simply installed downstream of the dialysate pump 508 or the replacement fluid pump 509, There is a possibility that the pressure in the blood circuit becomes negative, and as a result, the resin film is deformed inside the flow path as described above, so that the desired heating characteristic cannot be obtained and the heating efficiency is deteriorated. There was a problem. Furthermore, if the inside of the blood circuit is in a negative pressure state for some reason and then returns to the positive pressure state, the warmer contracts due to the negative pressure state, and becomes a positive pressure state again. Therefore, there is a problem that the volume returns to the original, that is, the volume in the warmer becomes larger than that in the negative pressure, so that blood flows backward from the blood circuit toward the warmer.
このような問題を解決するための加温器の一例として、特許文献２には軟質チューブを渦巻シート状に接着加工した液体加温チューブが開示され、特許文献３には、軟質チューブをシート状の部材上に渦巻き状に固定した液体加温バッグが開示されている。 As an example of a warmer for solving such a problem, Patent Document 2 discloses a liquid warming tube obtained by bonding a soft tube into a spiral sheet, and Patent Document 3 discloses a soft tube as a sheet. A liquid heating bag fixed in a spiral shape on the member is disclosed.
しかしながら、こられの例は何れも軟質チューブを曲げ加工しているので、チューブ自体の弾性ゆえに全体を反りや歪みがない平面状に保つことが難しく、加温効率が十分に得られない場合もあった。 However, in all of these examples, since the soft tube is bent, it is difficult to keep the entire surface flat without warping or distortion due to the elasticity of the tube itself, and sufficient heating efficiency may not be obtained. there were.
また、通常、血液浄化のような治療に用いられる加温装置の加温面の温度は、血球、蛋白質等の血液成分に悪影響を与えないように４１℃以上に上昇しないように制御されている。そのため、加温プレートから加温器にいかに効率良く熱伝導を行うかが課題となるが、特許文献２および特許文献３に記載されている液体加温チューブにおいては、チューブを曲げすぎると曲げた部分でチューブ内空間が潰れてしまうため、あまり小さな曲げ半径をとることができない。そのため、特許文献２および特許文献３に記載されている液体加温チューブの中心部および四隅には加温面にチューブが全く接していないために熱交換が行われない無駄な加温面領域が形成され、その領域において、空気中への放熱が生じてしまう。しかも、上記したように加温プレートの表面は４１℃以上に上昇しないことから、加温プレートに与えられる熱量は、限られているため、その有効利用を行えないことは、加温性能の向上および装置の小型化を阻む要因となっていた。更に加温チューブは断面が円状であり、加温プレートとの密着性が悪く、加温効率の非常に悪いものであった。 In addition, the temperature of the heating surface of a heating device usually used for treatment such as blood purification is controlled so as not to rise above 41 ° C. so as not to adversely affect blood components such as blood cells and proteins. . Therefore, how to efficiently conduct heat from the heating plate to the heater becomes a problem. However, in the liquid heating tube described in Patent Document 2 and Patent Document 3, the tube is bent if it is bent too much. Since the inner space of the tube is crushed at the portion, a very small bending radius cannot be taken. Therefore, there is a useless heating surface area where heat exchange is not performed because the tube is not in contact with the heating surface at the center and four corners of the liquid heating tube described in Patent Document 2 and Patent Document 3. In this region, heat is released into the air. In addition, as described above, since the surface of the heating plate does not rise to 41 ° C. or higher, the amount of heat given to the heating plate is limited. And it was a factor that hindered downsizing of the device. Furthermore, the heating tube had a circular cross section, poor adhesion to the heating plate, and very poor heating efficiency.
その結果、より低い温度から加温する際や、透析液のように流量が大きい液体を加温するには大きな加温面積を必要とし、従って、より大型の加温装置を必要としていた。 As a result, when warming from a lower temperature or warming a liquid having a large flow rate such as dialysate, a large warming area is required, and thus a larger heating device is required.
さらには、特許文献１および、特許文献２に記載されている加温装置は、加温器または加温チューブとの接触面積を増大させるために、両面から加温を行っているため、装置が複雑化するという問題があった。 Furthermore, since the heating apparatus described in Patent Document 1 and Patent Document 2 is heated from both sides in order to increase the contact area with the heater or the heating tube, the apparatus is There was a problem of increasing complexity.
一方、液体を冷却する冷却器の例として、特許文献４にはバッグ状の冷却バッグを冷却器に挿入することで冷却する冷却器が記載されている。しかしながら、冷却部はバッグ状であるために、上記したような、冷却バッグ内圧力の変化による冷却バッグの容積の変動の問題を解決することはできなかった。 On the other hand, as an example of a cooler that cools a liquid, Patent Document 4 describes a cooler that cools by inserting a bag-like cooling bag into the cooler. However, since the cooling part has a bag shape, it has not been possible to solve the problem of the change in the volume of the cooling bag due to the change in the pressure in the cooling bag as described above.
血液浄化の治療を行うにあたっては、各治療法に対する血液回路を複数の流体移送ポンプを有する血液浄化装置に装着するが、血液回路は繰り返し使用できないので、治療毎に回路の装着および廃棄を行う必要がある。ところが、血液浄化用の回路は一般に複数の部品から複雑に構成されているため、装着ミスや細菌汚染が起こらないように回路をセッティングする上で、医療スタッフは細心の注意を払いつつ、多くの手間や時間を掛ける必要があった。また、廃棄の場合も同様に煩雑なものであった。 When performing blood purification treatment, the blood circuit for each treatment method is attached to a blood purification apparatus having a plurality of fluid transfer pumps. However, since the blood circuit cannot be used repeatedly, it is necessary to attach and discard the circuit for each treatment. There is. However, since the circuit for blood purification is generally composed of a plurality of parts, the medical staff pays close attention to setting up the circuit so that mounting errors and bacterial contamination do not occur. It was necessary to spend time and effort. Also, the disposal is similarly complicated.
このような装着作業の煩雑さを解消する回路の一例として、特許文献５には、透析液を配送および加温するためのカセット回路が記載されている。このカセット回路は、溶液バックと患者または透析機械に導く管路とを連結するための連結要素と、液体を配送するための配送チャンバーと、配送された液体を運ぶための管路と、加熱装置によって所定の温度まで加温する加温部とを一体とすることにより、操作性を向上している。 As an example of a circuit that eliminates the complexity of such mounting work, Patent Document 5 describes a cassette circuit for delivering and warming dialysate. This cassette circuit comprises a connecting element for connecting a solution bag and a conduit leading to a patient or dialysis machine, a delivery chamber for delivering liquid, a conduit for carrying the delivered liquid, and a heating device The operability is improved by integrating the heating unit that heats up to a predetermined temperature.
しかしながら、このカセット回路は、プラスチックにより形成され、流路を構成するベース構造体を少なくとも部分的に覆うフィルムによって管路および配送チャンバーが形成されているため、管路内圧力が陰圧となった際に、管路を覆っているフィルムが凹状に変形する可能性があった。加温中にこのような変形が起こると、上記特許文献１のように加温装置と管路表面との間に隙間が生じて空気層による断熱空間が生じるので、加温効率が著しく低下する。さらに、陰圧により配送チャンバーの壁面の形状が凹状となることで、配送すべき流量が配送チャンバー内に流入されず、所定の流量が得られないという問題点もあった。 However, this cassette circuit is made of plastic, and the pipeline and the delivery chamber are formed by a film that at least partially covers the base structure constituting the flow channel, so the pressure in the pipeline is negative. At that time, there was a possibility that the film covering the pipe line was deformed into a concave shape. If such deformation occurs during heating, a gap is generated between the heating device and the pipe surface as in Patent Document 1, and a heat insulating space is formed by an air layer, so that the heating efficiency is significantly reduced. . Furthermore, since the shape of the wall surface of the delivery chamber becomes concave due to the negative pressure, the flow rate to be delivered does not flow into the delivery chamber, and a predetermined flow rate cannot be obtained.
一方、加温用回路ではないが、支持部材と回路とを一体化して医療スタッフの使い勝手を改善しようとした例が知られている。特許文献６には、支持部材に回路や血液処理装置を一体化した組込み型血液処理用流体モジュールが記載されている。このモジュールは、支持部材と、該支持部材に装着された血液処理装置と、該支持部材に相互連結された複数の流体回路とを備え、これらの流体回路の少なくとも１つが該支持部材に対しＵ字形状に配設され、このＵ字形状部の各々が蠕動ポンプと協動するように該支持部材から延在し、該流体回路の少なくとも１つが該血液処理装置に流体連結されることにより、操作性を向上している。 On the other hand, although it is not a circuit for heating, the example which tried to improve the usability of a medical staff by integrating a support member and a circuit is known. Patent Document 6 describes a built-in blood processing fluid module in which a circuit and a blood processing apparatus are integrated with a support member. The module includes a support member, a blood treatment device mounted on the support member, and a plurality of fluid circuits interconnected to the support member, at least one of these fluid circuits being U with respect to the support member. Each U-shaped portion extends from the support member so as to cooperate with a peristaltic pump, and at least one of the fluid circuits is fluidly connected to the blood processing device, Operability has been improved.
しかしながら、このモジュールは、特許文献３と同様に支持部材に流体回路を這わせて固定する手法をとっているため、支持部材と流体回路とで別の部品を用意する必要があり、コストアップが避けられなかった。また、加温部が別に存在するため、加温部との接続は別途行なわなければならないという問題点もあった。 However, since this module uses a method of fixing the fluid circuit to the support member in the same manner as in Patent Document 3, it is necessary to prepare separate parts for the support member and the fluid circuit, which increases the cost. It was inevitable. In addition, since there is a separate heating unit, there is a problem that connection to the heating unit must be made separately.
このように、加温／冷却効率や流量精度を何ら損なうことなく、しかも医療スタッフにとっての操作性を格段に向上させるには、従来の一体型回路ユニットやそれらの組み合わせではまだまだ不十分であり、改善が求められていた。 As described above, the conventional integrated circuit unit and the combination thereof are still insufficient to significantly improve the operability for the medical staff without impairing the heating / cooling efficiency and the flow rate accuracy. There was a need for improvement.
本発明は上記従来技術の問題点を解決し、加温／冷却効率の非常に優れた、加えて流体回路内が陰圧下においても加温／冷却効率および流量精度を維持でき、さらには回路の加温装置への装着が簡便な液体加温／冷却用の体外循環回路および体外循環システムを提供することを目的とする。 The present invention solves the above-mentioned problems of the prior art, and has excellent heating / cooling efficiency. In addition, the heating / cooling efficiency and flow rate accuracy can be maintained even when the fluid circuit is under negative pressure. An object of the present invention is to provide an extracorporeal circulation circuit and extracorporeal circulation system for liquid heating / cooling that can be easily attached to a heating device.
本発明者等は、上記課題を解決するために鋭意検討を行った結果、液体加温／冷却用の体外循環回路において、流路部等をプラスチックによりシート状に一体的かつ平面的に形成し、且つ少なくとも下流側の流路部（第二の流路部）の断面を略半円弧形状とし、その平面側を加温／冷却プレートに密着するための面とすることによって、前記課題を解決できることを見出し、本発明を完成するに至った。すなわち、本発明は、以下の発明から構成される。 As a result of intensive studies to solve the above-mentioned problems, the inventors of the present invention have formed a flow path portion and the like integrally and planarly in a sheet shape with plastic in an extracorporeal circulation circuit for liquid heating / cooling. In addition, the cross section of at least the downstream flow path section (second flow path section) has a substantially semicircular arc shape, and the plane side is used as a surface to be in close contact with the heating / cooling plate. The present inventors have found that this can be done and have completed the present invention. That is, this invention is comprised from the following invention.
（１）プラスチックによりシート状に一体的かつ平面的に形成された成型体として構成された第二の流路部を備える液体加温／冷却用の体外循環回路であって、前記第二の流路部の断面は略半円弧形状であり、かつ前記第二の流路部が加温／冷却プレートに密着するための平面を有していることを特徴とする液体加温／冷却用の体外循環回路。 (1) An extracorporeal circulation circuit for liquid heating / cooling comprising a second flow path portion configured as a molded body integrally and planarly formed into a sheet shape with plastic, wherein the second flow An external body for liquid heating / cooling, characterized in that the cross-section of the passage is a substantially semicircular arc shape, and the second flow passage has a flat surface for contacting the heating / cooling plate. Circulation circuit.
（２）前記略半円弧形状の幅Ｗに対する高さＨの比Ｈ／Ｗが０．２５〜１．０の範囲である（１）記載の液体加温／冷却用の体外循環回路。 (2) The extracorporeal circuit for liquid heating / cooling according to (1), wherein the ratio H / W of the height H to the width W of the substantially semicircular arc shape is in the range of 0.25 to 1.0.
（３）前記成型体が硬質プラスチックで形成される（１）または（２）記載の液体加温／冷却用の体外循環回路。 (3) The extracorporeal circuit for liquid heating / cooling according to (1) or (2), wherein the molded body is formed of hard plastic.
（４）前記第二の流路部が蛇行するように配置されている（１）乃至（３）の何れかに記載の液体加温／冷却用の体外循環回路。 (4) The extracorporeal circuit for liquid heating / cooling according to any one of (1) to (3), wherein the second flow path portion is arranged to meander.
（５）前記液体加温／冷却用の体外循環回路が、液体導入チューブ、液体導入チューブ接続部、第一の流路部、第一の送液チューブ接続部、送液チューブ、第二の送液チューブ接続部、第二の流路部、液体導出チューブ接続部、液体導出チューブがこの順に液密に接続され、かつ、前記液体導入チューブ接続部、第一の流路部、第一の送液チューブ接続部、第二の送液チューブ接続部、第二の流路部、および液体導出チューブ接続部は、プラスチックによりシート状に一体的かつ平面的に形成された成型体として構成されている（１）乃至（４）の何れかに記載の液体加温／冷却用の体外循環回路。 (5) The extracorporeal circuit for heating / cooling the liquid includes a liquid introduction tube, a liquid introduction tube connecting portion, a first flow path portion, a first liquid feeding tube connecting portion, a liquid feeding tube, and a second feeding tube. The liquid tube connection part, the second flow path part, the liquid lead-out tube connection part, and the liquid lead-out tube are liquid-tightly connected in this order, and the liquid introduction tube connection part, the first flow path part, and the first feed part are connected in this order. The liquid tube connecting portion, the second liquid feeding tube connecting portion, the second flow path portion, and the liquid outlet tube connecting portion are configured as a molded body that is integrally and planarly formed into a sheet shape from plastic. The extracorporeal circuit for heating / cooling a liquid according to any one of (1) to (4).
（６）（１）乃至（５）の何れかに記載の液体加温／冷却用の体外循環回路の少なくとも前記第二の流路部平面側に、液体の流れの上流側から下流側に向かって発熱量／吸熱量が大から小となるように発熱量／吸熱量に勾配を持った加温／冷却プレートが接触していることを特徴とする流体加温／冷却用の体外循環システム。 (6) The liquid heating / cooling extracorporeal circuit according to any one of (1) to (5) is directed to at least the second flow path portion plane side from the upstream side to the downstream side of the liquid flow. An extracorporeal circulation system for fluid heating / cooling, wherein a heating / cooling plate having a gradient in heat generation / endotherm is in contact with the heat generation / endotherm from large to small.
（７）前記液体加温／冷却用の体外循環回路の、少なくとも第二の流路部平面側と対向する面は、断熱材から成る押圧面で押圧されている（６）に記載の流体加温／冷却用の体外循環システム。 (7) The fluid heating according to (6), wherein at least a surface of the extracorporeal circuit for heating / cooling the liquid that is opposed to the plane surface side of the second flow path is pressed by a pressing surface made of a heat insulating material. Extracorporeal circulation system for temperature / cooling.
本発明に係る液体加温／冷却用の体外循環回路および体外循環システムは、加温／冷却プレートにより熱交換された熱を効率良く利用することができるため、その熱交換効率は飛躍的に向上している。更に、本発明に係る液体加温／冷却用の体外循環回路および体外循環システムの第二の流路部（加温／冷却される流路部分）の断面は、片側が平面的に形成された略半円弧形状なので、加温／冷却プレートと第二の流路部との接触面積の確保が容易である。しかも該流路部の平面状の面からのみの加温／冷却で十分に温度調節ができるので、装置も簡素化できる。 Since the extracorporeal circulation circuit and extracorporeal circulation system for liquid heating / cooling according to the present invention can efficiently use the heat exchanged by the heating / cooling plate, the heat exchange efficiency is dramatically improved. is doing. Further, the liquid heating / cooling extracorporeal circulation circuit and the extracorporeal circulation system according to the present invention have the cross section of the second flow passage portion (flow passage portion to be heated / cooled) formed flat on one side. Since it has a substantially semicircular arc shape, it is easy to secure a contact area between the heating / cooling plate and the second flow path portion. In addition, since the temperature can be adjusted sufficiently by heating / cooling only from the planar surface of the flow path portion, the apparatus can be simplified.
更に、加温／冷却プレートが第二の流路部の流体の流れに沿って発熱量／吸熱量の勾配を有する場合、加温／冷却プレートに接触しない面が断熱材で覆われている場合、または両者を併せ持つ場合には、本発明に係る液体加温／冷却用の体外循環回路および体外循環システムの熱交換効率は更に向上する。 Furthermore, when the heating / cooling plate has a gradient of the calorific value / endothermic amount along the flow of the fluid in the second flow path part, the surface not in contact with the heating / cooling plate is covered with a heat insulating material When both are included, the heat exchange efficiency of the extracorporeal circulation circuit and extracorporeal circulation system for liquid heating / cooling according to the present invention is further improved.
更に、本発明に係る液体加温／冷却用の体外循環回路が硬質プラスチックシートで形成されている場合、回路内の圧力が陰圧であっても、一定の形状を保つ事が可能であることから、加温／冷却プレートとの接触面積が変化することなく、安定した熱交換を行うことができる。また流路の変形による管内摩擦等の変化も生じないため、送液の流量精度が安定する。 Furthermore, when the extracorporeal circuit for liquid heating / cooling according to the present invention is formed of a hard plastic sheet, it is possible to maintain a certain shape even if the pressure in the circuit is negative. Therefore, stable heat exchange can be performed without changing the contact area with the heating / cooling plate. In addition, since there is no change in the friction in the pipe due to deformation of the flow path, the flow rate accuracy of the liquid feeding is stabilized.
さらには、プラスチックによりシート状に形成された液体加温／冷却用の体外循環回路主要部の各接続部と、液体導入チューブ、液体導出チューブおよび送液チューブとが夫々液密に接続されているので、医療スタッフによる装着の手数が大幅に減少し、回路装着の操作性、無菌性に優れている。加えて、液体加温／冷却用の体外循環回路が硬質である場合、装置への装着性が更に向上する。 Furthermore, each connection portion of the main part of the extracorporeal circulation circuit for liquid heating / cooling formed in a sheet shape with plastic, and the liquid introduction tube, the liquid discharge tube, and the liquid supply tube are connected in a liquid-tight manner, respectively. As a result, the number of installations by medical staff is greatly reduced, and the operability and sterility of circuit installation are excellent. In addition, when the extracorporeal circulation circuit for liquid heating / cooling is hard, the mounting property to the apparatus is further improved.
以下、図面を参照しながら、本発明に係る液体加温／冷却用の体外循環回路および体外循環システムの実施態様を説明するが、本発明はこれらの態様のみに限定されるものではない。 Hereinafter, embodiments of the extracorporeal circulation circuit and extracorporeal circulation system for liquid heating / cooling according to the present invention will be described with reference to the drawings, but the present invention is not limited to these embodiments.
（液体加温／冷却用の体外循環回路の第一実施態様）
図１は、本発明液体加温／冷却用の体外循環回路の第一実施態様を示す模式図である。
(First embodiment of extracorporeal circuit for liquid heating / cooling)
FIG. 1 is a schematic view showing a first embodiment of an extracorporeal circuit for liquid heating / cooling according to the present invention.
図１において、液体加温／冷却用の体外循環回路１は、液体導入チューブ接続部１１、第一の流路部２０、第一の送液チューブ接続部３１、第二の送液チューブ接続部３２、第二の流路部４０、液体導出チューブ接続部５１がプラスチックによりシート状に一体的かつ平面的に形成された成型体１００と、これらの接続部に接続される各チューブ１０、３０、５０から構成される。 In FIG. 1, the extracorporeal circuit 1 for liquid heating / cooling includes a liquid introduction tube connecting portion 11, a first flow path portion 20, a first liquid feeding tube connecting portion 31, and a second liquid feeding tube connecting portion. 32, the second flow path portion 40, and the liquid outlet tube connecting portion 51 are integrally and planarly formed in a sheet shape with plastic, and the tubes 10, 30 connected to these connecting portions, 50.
本発明で一体的とは、同一の材質により構成される連続した一つの成型体であるということを示し、平面的とは、少なくとも、液体導入チューブ接続部１１、第一の流路部２０、第一の送液チューブ接続部３１、第二の送液チューブ接続部３２、第二の流路部４０、液体導出チューブ接続部５１を連続させるための支持部５５が同一平面上にあることを示し、シート状とは、平面的な支持部５５と各流路部および各チューブ接続部とが連続して形成されることにより、全体として薄い平板形状を形成することを示す。前記成型体１００の液体導入チューブ接続部１１には、液体導入チューブ１０が液密に接続され、加温／冷却すべき液体がここから本液体加温／冷却用の第一の流路部２０に導入される。また、前記成型体１００の液体導出チューブ接続部５１には液体導出チューブ５０が液密に接続され、加温／冷却された液体がここから導出されて血液浄化器や体内に流れていく。さらに、前記成型体１００の前記第一の送液チューブ接続部３１および前記第二の送液チューブ接続部３２には、これらを連通させ、本液体加温／冷却用の体外循環回路１内への液体の導入と導出を所定の流量で行うための送液チューブ３０が液密に接続されている。従って、使用時には、送液チューブ３０には送液ポンプが取り付けられ、このチューブの一部をポンプの回転部がしごいて送液する（ポンプは図示していない）。 In the present invention, the term “integral” means that it is a single continuous molded body made of the same material, and the term “planar” means at least the liquid introduction tube connecting portion 11, the first flow path portion 20, The support part 55 for continuing the 1st liquid supply tube connection part 31, the 2nd liquid supply tube connection part 32, the 2nd flow path part 40, and the liquid derivation tube connection part 51 exists on the same plane. “Sheet shape” indicates that the flat support portion 55 and each flow path portion and each tube connection portion are continuously formed to form a thin flat plate shape as a whole. A liquid introduction tube 10 is liquid-tightly connected to the liquid introduction tube connecting portion 11 of the molded body 100, and a liquid to be heated / cooled from here is a first flow path portion 20 for heating / cooling the liquid. To be introduced. Further, a liquid outlet tube 50 is liquid-tightly connected to the liquid outlet tube connecting portion 51 of the molded body 100, and the heated / cooled liquid is led out therefrom and flows into the blood purifier and the body. Further, the first liquid supply tube connection part 31 and the second liquid supply tube connection part 32 of the molded body 100 are communicated with each other into the extracorporeal circuit 1 for heating / cooling the liquid. A liquid feeding tube 30 for introducing and discharging the liquid at a predetermined flow rate is liquid-tightly connected. Therefore, at the time of use, a liquid feeding pump is attached to the liquid feeding tube 30, and a part of this tube is fed by a rotating part of the pump (the pump is not shown).
このように、液体加温／冷却用の体外循環回路１は、成型体１００に、液体導入チューブ１０と、送液チューブ３０、および液体導出チューブ５０が夫々液密に接続され、液体の導入・導出、加温／冷却、移送といった各機能部が所定の位置関係に配置されているので、回路装着の手順が大幅に減少して操作性が向上し、接続ミスを誘発することもない。 Thus, the extracorporeal circuit 1 for heating / cooling the liquid has the liquid introduction tube 10, the liquid feeding tube 30, and the liquid outlet tube 50 connected to the molded body 100 in a liquid-tight manner. Since the functional units such as derivation, heating / cooling, and transfer are arranged in a predetermined positional relationship, the circuit mounting procedure is greatly reduced, the operability is improved, and connection errors are not induced.
ここで、少なくとも前記第二の流路部４０の断面形状は略半円弧形状である必要がある。断面形状が四角形形状である場合、図２（ａ）に示すように、流路内の液体の主たる流れ２００に対して管内二次流れ２１０が発生し、しかも第一の流れの層２２０と、第二の流れの層２３０に分割される。これに対し、断面形状が略半円弧形状である場合、図２（ｂ）に示すように、流路内の液体の主たる流れ２００と直角な方向の二次的に発生する流れ２１０は、層を成さないため、前記成型体１００の平面側６０を加温／冷却した際の、熱エネルギーは、前記第二の流路部４０内全体を循環するため、加温／冷却効率の向上に大きく貢献している。 Here, at least the cross-sectional shape of the second flow path portion 40 needs to be a substantially semicircular arc shape. When the cross-sectional shape is a quadrangular shape, as shown in FIG. 2A, a secondary flow 210 in the pipe is generated with respect to the main flow 200 of the liquid in the flow path, and the first flow layer 220, Divided into a second flow layer 230. On the other hand, when the cross-sectional shape is a substantially semicircular arc shape, as shown in FIG. 2 (b), the flow 210 that is secondarily generated in a direction perpendicular to the main flow 200 of the liquid in the flow path is Therefore, when the flat surface 60 of the molded body 100 is heated / cooled, the heat energy circulates in the entire second flow path portion 40, thereby improving the heating / cooling efficiency. It contributes greatly.
図１において、前記少なくとも第二の流路部４０の断面形状は、真円の中心を二分割した形状となっているが、断面形状としては、楕円の中心を二分割した形状、十角形のような円に近い多角形の中心を二分割した形状、真円・楕円・多角形の中心から偏心した点を通る直線で分割した小さい方の断面形状であっても特に問題はない。 In FIG. 1, the cross-sectional shape of the at least second channel portion 40 is a shape obtained by dividing the center of a perfect circle into two, but the cross-sectional shape is a shape obtained by dividing the center of an ellipse into two, a decagonal shape. Such a shape obtained by dividing the center of a polygon close to a circle into two parts, or a smaller sectional shape divided by a straight line passing through a point decentered from the center of a perfect circle, ellipse, or polygon is not particularly problematic.
ここで、上記流路部の断面積が極端に小さいと、流路摩擦により送液される液体のエネルギーの損失が大きくなり、ひいては液体を送液するために要する動力が大きくなるという問題がある。反対に、断面積が極端に大きいと、液体を送液した際に流路内に残留している空気が抜けにくく、空気層が生じるために、加温／冷却効率が悪くなるという問題を生じてしまう。そのため、液体加温／冷却用の体外回路１の成型体１００に形成される流路部の断面は、下記の式（１）で表される水力等価直径が１ｍｍ〜５ｍｍであることが好ましく、さらに望ましくは１．５ｍｍ〜４ｍｍであることが好ましい。 Here, if the cross-sectional area of the flow path portion is extremely small, there is a problem that the energy loss of the liquid fed due to the flow path friction increases, and consequently the power required to feed the liquid increases. . On the other hand, if the cross-sectional area is extremely large, the air remaining in the flow path is difficult to escape when the liquid is fed, and an air layer is formed, resulting in poor heating / cooling efficiency. End up. Therefore, the cross section of the flow path portion formed in the molded body 100 of the extracorporeal circuit 1 for liquid heating / cooling preferably has a hydraulic equivalent diameter represented by the following formula (1) of 1 mm to 5 mm. More desirably, the thickness is 1.5 mm to 4 mm.
水力等価直径＝４×（流路部の断面積）÷（流路部の全長） ・・・（１） Hydraulic equivalent diameter = 4 x (Cross-sectional area of the channel) / (Total length of the channel) (1)
水力等価直径とは、管内の摩擦を考える際に、非円形管の場合に上記のように定義された直径を持つ円とみなして、摩擦損失に関する情報が多い円管の資料を流用して、管摩擦係数や損失係数を予測するためのものである。 The hydraulic equivalent diameter is considered as a circle with a diameter defined as above in the case of a non-circular pipe when considering the friction in the pipe, and diverts data on a circular pipe with a lot of information on friction loss, This is for predicting the pipe friction coefficient and loss coefficient.
加えて、式（１）および、上記した断面形状を満たす形状は無限に考えられるが、前記略半円弧形状の幅Ｗが大きいと、それに伴い式（１）より高さHが低くなり、垂直加重に対する力の分散が水平方向に偏り、ひいては垂直方向に対する力に弱くなる。そのため、前記略半円弧形状の幅Ｗに対する高さＨの比Ｈ／Ｗが、０．２５〜１．０であることが望ましく、更に望ましくは０．４〜０．６である。流路内の二次流れの循環と、垂直荷重への耐性の観点から、最も好ましくはＨ／Ｗが０．５となる真円を二分割した形状である。 In addition, although the shape satisfying the equation (1) and the above-described cross-sectional shape is considered infinite, if the width W of the substantially semicircular arc shape is large, the height H becomes lower than the equation (1) and the vertical The dispersion of the force with respect to the load is biased in the horizontal direction, and thus becomes weaker in the force in the vertical direction. Therefore, the ratio H / W of the height H to the width W of the substantially semicircular arc shape is desirably 0.25 to 1.0, and more desirably 0.4 to 0.6. From the viewpoint of circulation of the secondary flow in the flow path and resistance to vertical load, the shape is most preferably a shape in which a perfect circle with H / W of 0.5 is divided into two.
さらに、図１において、第二の流路部４０の加温／冷却される面は平板であるが、第二の流路部４０とヒータ／冷却面がより接触しやすい状態を得るために、図３に示すように僅かに凸状に張り出した形状をしていても問題はなく、その張り出しの程度は、管内二次流れに影響を与えないようにするために、１ｍｍ程度以内であれば問題なく、張り出しの形状は、矩形、三角形、ドーム状等が挙げられるが特に限定するものではない。 Further, in FIG. 1, the surface to be heated / cooled of the second flow path portion 40 is a flat plate, but in order to obtain a state in which the second flow path portion 40 and the heater / cooling surface are more easily contacted, As shown in FIG. 3, there is no problem even if it has a slightly protruding shape, and the extent of the extension is within about 1 mm so as not to affect the secondary flow in the pipe. There is no problem, and the shape of the overhang includes, but is not particularly limited to, a rectangle, a triangle, and a dome shape.
次に、第一の流路部２０は、加温／冷却しない場合の断面形状は特に限定するものではないが、前記した第二の流路部４０と同等の理由から、前記水力等価直径が１ｍｍ〜５ｍｍを満たすものであれば問題なく、その断面形状を特に限定する必要はない。加温／冷却する場合は、前記した第二の流路部４０と同等の形状であれば問題はない。 Next, the first channel portion 20 is not particularly limited in cross-sectional shape when not heated / cooled, but for the same reason as the second channel portion 40, the hydraulic equivalent diameter is There is no problem as long as it satisfies 1 mm to 5 mm, and there is no need to particularly limit the cross-sectional shape. When heating / cooling, there is no problem as long as the shape is the same as that of the second flow path portion 40 described above.
本発明に係る液体加温／冷却用の体外循環回路においては、成型体１００はプラスチックを用いた、全体としては薄い平板形状であるが、流路部２０、４０の断面形状が略半円弧形状であるので、いわゆるＨ鋼やコルゲート板のように曲げ強度向上に寄与しているという利点も有する。その観点からは、シート面上で流路部の大部分が平行するような流路配置よりも、各流路部２０、４０が縦方向と横方向に入り組んでいる配置や、渦巻き状の配置になっている方が、あらゆる方向に対する曲げ強度向上の点でより優れており、取り扱い性や装着性の向上にも有利である。 In the extracorporeal circuit for liquid heating / cooling according to the present invention, the molded body 100 is made of plastic and has a thin flat plate shape as a whole, but the cross-sectional shapes of the flow path portions 20 and 40 are substantially semicircular arc shapes. Therefore, it has the advantage that it contributes to bending strength improvement like what is called H steel and a corrugated board. From that point of view, rather than a flow passage arrangement in which most of the flow passage portions are parallel to each other on the sheet surface, the arrangement in which the flow passage portions 20 and 40 are arranged in the vertical direction and the horizontal direction, or a spiral arrangement Is better in terms of improving the bending strength in all directions, and is also advantageous in improving handling and mounting.
なお、各流路部２０、４０の配置については、図１には、第一の流路部２０がストレートで、第二の流路部４０の流路長を長くして加温／冷却効率を高めた配置例を示しているが、これに限定する必要はなく、液体導入側でもより効率よく加温／冷却できる流路配置をとってもよい。また、後述する第二の実施態様のような配置や、それに限らずあらゆる配置をデザインすることができる。さらに前記第二の流路部４０は、後述する流体加温／冷却用の体外循環システムと組み合わせた際に、蛇行配列である場合が最も効率がよい。 In addition, about arrangement | positioning of each flow path part 20 and 40, in FIG. 1, the 1st flow path part 20 is straight, and the flow path length of the 2nd flow path part 40 is lengthened, and heating / cooling efficiency is shown. However, the present invention is not limited to this, and a flow path arrangement that can heat / cool more efficiently on the liquid introduction side may be adopted. In addition, an arrangement as in the second embodiment to be described later, or any arrangement can be designed without being limited thereto. Furthermore, when the second flow path portion 40 is combined with an extracorporeal circulation system for fluid heating / cooling, which will be described later, it is most efficient when the second flow path portion 40 has a meandering arrangement.
成型体１００の厚みについては、薄すぎると強度不足となって液体加温／冷却用の体外循環回路１が破損しやすくなり、取り扱いや加温／冷却装置への装着時に支障が生じることがある。反対に厚すぎると、伝熱量は流路部の部材厚みに反比例するため伝熱量が小さくなり、送液される液体が十分に加温／冷却できないという問題が生じる。そのため、成型体１００のプラスチック部材の厚みは、最も高い流量で流される透析液の流量を考慮すると、少なくとも第二の流路部２０の平面側６０において０.２ｍｍ〜１.０ｍｍであることが好ましく、更に望ましくは、０.３ｍｍ〜０.５ｍｍであることが好ましい。その他の部分においては、第二の流路部４０の平面側６０と同等かそれ以上であればよい。 As for the thickness of the molded body 100, if the thickness is too thin, the extracorporeal circulation circuit 1 for liquid heating / cooling is likely to be damaged, which may cause troubles in handling and mounting to the heating / cooling device. . On the other hand, if the thickness is too thick, the amount of heat transfer is inversely proportional to the thickness of the flow path member, so that the amount of heat transfer becomes small, and there is a problem that the liquid to be fed cannot be sufficiently heated / cooled. Therefore, the thickness of the plastic member of the molded body 100 may be 0.2 mm to 1.0 mm at least on the plane side 60 of the second flow path portion 20 in consideration of the flow rate of the dialysate that is flowed at the highest flow rate. More preferably, the thickness is preferably 0.3 mm to 0.5 mm. In other parts, what is necessary is just to be equal to or more than the plane side 60 of the second flow path part 40.
さらに、伝熱量は流路の厚みに反比例することを利用して、加温／冷却される面は薄くすることで伝熱量を増大させ、加温／冷却されない面は厚くすることで放熱量を低減することにより、さらなる加温／冷却効率の向上が可能となる。そのため、成型体１００のプラスチックの厚みが少なくとも第二の流路部４０において表裏で異なるものが好ましく、使用時に、平面側６０を加温／冷却装置のヒータ／冷却面に接触するようにセットすれば、加温／冷却効率が高まる。材質や硬度、あるいは用途（液量）にもよるが、加温／冷却装置のヒータ／冷却面に接触するプラスチックの厚みをもう一方の面の厚みの半分程度まで薄くすることもできる。 Furthermore, using the fact that the amount of heat transfer is inversely proportional to the thickness of the flow path, the surface to be heated / cooled is made thinner to increase the amount of heat transfer, and the surface that is not heated / cooled is made thicker to increase the heat dissipation amount. By reducing the temperature, the heating / cooling efficiency can be further improved. Therefore, it is preferable that the plastic thickness of the molded body 100 is different at least on the front and back sides of the second flow path portion 40, and the flat side 60 is set so as to be in contact with the heater / cooling surface of the heating / cooling device during use. Thus, the heating / cooling efficiency is increased. Depending on the material, hardness, and application (liquid amount), the thickness of the plastic contacting the heater / cooling surface of the heating / cooling device can be reduced to about half the thickness of the other surface.
成型体１００は、プラスチックによりシート状に形成されていれば問題はなく、また患者の体液が直接または間接的に触れるため、生体適合性や生物学的安全性を有している材質が好ましい。材質としては、製造コスト、加工性および操作性の観点から合成樹脂、特に熱可塑性樹脂が好ましい。熱可塑性樹脂としては、ポリオフィレン系樹脂、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、弗素系樹脂、シリコン系樹脂等、さらにはＡＢＳ（アクリロニトリルーブタジエンースチレン共重合体）樹脂、ポリ塩化ビニル、ポリカーボネート、ポリスチレン、ポリアクリレート、ポリアセタール等を例示することができ、何れにおいても好適に用いることができる。材質が硬質プラスチックである場合、回路内を流れる液体の圧力が陰圧下においても流路形状が変形することがなく、加温／冷却装置のヒータ／冷却面との接触が十分になされるため、加温／冷却能力の低下が生じることがない。また、流路形状の変形が起こらないので、液体の流量が変化することもない。これらの理由から、本発明で用いるプラスチックは硬質であることが好ましい。 The molded body 100 is not a problem as long as it is formed into a sheet from plastic, and a material having biocompatibility and biological safety is preferable because the body fluid of the patient is directly or indirectly touched. The material is preferably a synthetic resin, particularly a thermoplastic resin, from the viewpoint of manufacturing cost, processability, and operability. Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used. If the material is hard plastic, the flow path shape will not be deformed even when the pressure of the liquid flowing in the circuit is under negative pressure, and contact with the heater / cooling surface of the heating / cooling device will be sufficient, There is no reduction in heating / cooling capacity. Further, since the flow path shape does not deform, the liquid flow rate does not change. For these reasons, the plastic used in the present invention is preferably hard.
硬質プラスチックの材質や樹脂組成については特に限定する必要はないが、患者の体液が直接または間接的に触れるため、生体適合性や生物学的安全性を有している材質が好ましく、例えば、硬質塩化ビニル、ポリカーボネート、ポリプロピレン、ポリエチレン、ポリメチルペンテン、ポリスチレン、ポリエチレンテレフタレート、硬質ポリウレタン等を挙げることができ、何れにおいても好適に用いることができる。 The material and resin composition of the hard plastic need not be particularly limited. However, a material having biocompatibility and biological safety is preferable because the body fluid of the patient is directly or indirectly touched. Examples thereof include vinyl chloride, polycarbonate, polypropylene, polyethylene, polymethylpentene, polystyrene, polyethylene terephthalate, and rigid polyurethane, and any of them can be suitably used.
硬質の程度としては、シート状の形態を自力で保持できる程度であればよく、特に樹脂硬度等で厳密に特定する必要はない。 The degree of hardness is not limited as long as the sheet-like form can be maintained by itself, and it is not particularly necessary to strictly specify the resin hardness.
成型体１００は、ブロー成型、インジェクション成型等により一体成型されたものでもよく、あるいは二枚の成型シートの貼り合わせにより形成されたものであってもよい。後者の場合は、例えば切削、シート成型、プレス成型やインジェクション成型等により、シートの面方向に延びる流路断面を形成した一方の成型シートと、該シートに貼り合せた際に流路断面を完成するように相補的な流路断面を形成した他方の成型シートとを貼り合わせることによって得られる。製造コスト、加工性、操作性の観点から、成型シートを貼り合わせることにより形成されていることが好ましい。 The molded body 100 may be integrally molded by blow molding, injection molding, or the like, or may be formed by bonding two molded sheets. In the latter case, for example, by cutting, sheet molding, press molding, injection molding, etc., one channel sheet that has a channel section extending in the surface direction of the sheet is formed, and the channel section is completed when bonded to the sheet. Thus, it is obtained by pasting together the other molded sheet having a complementary flow path cross section. From the viewpoint of manufacturing cost, workability, and operability, it is preferable that the molded sheet is formed by bonding.
液体導入チューブ１０、送液チューブ３０、液体導出チューブ５０は、各体外循環療法に則して選択されればよく特に限定するものではない。例えば体外循環療法の中の一つである血液浄化療法においては、一般的に１ｍｍ〜１０ｍｍ程度の内径のチューブが選択される。通常各チューブの断面形状は円形であるが、必ずしも円形断面でなくても良く、楕円形や四角形、六角形を含む非円形断面であっても問題はない。材質としては、合成樹脂、金属およびガラス等の何れでも構わないが、製造コスト、加工性および操作性の観点から合成樹脂、特に熱可塑性樹脂が好ましい。熱可塑性樹脂としては、ポリオフィレン系樹脂、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、弗素系樹脂、シリコン系樹脂等、さらにはＡＢＳ（アクリロニトリルーブタジエンースチレン共重合体）樹脂、ポリ塩化ビニル、ポリカーボネート、ポリスチレン、ポリアクリレート、ポリアセタール等を例示することができ、何れにおいても好適に用いることができる。なかでも、軟質素材は折れ曲がりや割れ等に強く、操作時の柔軟性に優れているため好ましく、組み立て性の理由から軟質塩化ビニルが特に好ましい。 The liquid introduction tube 10, the liquid feeding tube 30, and the liquid outlet tube 50 are not particularly limited as long as they are selected according to each extracorporeal circulation therapy. For example, in blood purification therapy which is one of extracorporeal circulation therapy, a tube having an inner diameter of about 1 mm to 10 mm is generally selected. Usually, the cross-sectional shape of each tube is circular, but it does not necessarily have to be a circular cross-section, and there is no problem even if it is a non-circular cross-section including an ellipse, a quadrangle, or a hexagon. The material may be any of synthetic resin, metal, glass and the like, but synthetic resin, particularly thermoplastic resin is preferable from the viewpoint of manufacturing cost, processability and operability. Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used. Among these, a soft material is preferable because it is resistant to bending and cracking and has excellent flexibility during operation, and soft vinyl chloride is particularly preferable for the reason of assembly.
液体導入チューブ接続部１１、第一の送液チューブ接続部３１、第二の送液チューブ接続部３２、液体導出チューブ接続部５１の形状は、特に限定するものではないが、前記した接続される各チューブに則した形状をしていることが好ましい。材質は、成型体１００と同様であれば特に問題はない。 The shapes of the liquid introduction tube connecting portion 11, the first liquid feeding tube connecting portion 31, the second liquid feeding tube connecting portion 32, and the liquid outlet tube connecting portion 51 are not particularly limited, but are connected as described above. It is preferable to have a shape conforming to each tube. There is no particular problem as long as the material is the same as that of the molded body 100.
送液チューブ３０に取り付けて液体を送液する手段は、ポンプであればよく、チューブをしごいて送液するチューブポンプであれば何れでもよい。例えば、回転式のチューブポンプは、複数のローラが取り付けられた回転体を備えており、その回転体の外周に送液チューブ３０をセットすれば、その回転体が回転することにより、複数のローラがチューブをしごきながら送液動作をする構造となっている。チューブは円弧状に規制されており、その円弧の中心が回転体の中心となり、複数のローラは公転しつつ自転することによりチューブをしごいて送液する。 The means for feeding the liquid by attaching it to the liquid feeding tube 30 may be a pump, and any means may be used as long as it is a tube pump that squeezes the liquid and feeds it. For example, a rotary tube pump includes a rotating body to which a plurality of rollers are attached. When the liquid feeding tube 30 is set on the outer periphery of the rotating body, the rotating body rotates to thereby generate a plurality of rollers. Has a structure that feeds liquid while squeezing the tube. The tube is regulated in a circular arc shape, and the center of the circular arc becomes the center of the rotating body, and the plurality of rollers rotate and revolve to rotate the tube and feed liquid.
ここで、送液チューブの送液方向（ポンプの回転体の回転方向）は、液体導入チューブ１０から液体導出チューブ５０に液体が流通する方向であっても、またその逆であっても問題はなく、特に限定するものではない。前者の場合、背景技術で示したように、ポンプ下流側で陰圧となった場合でも液体加温／冷却用の体外循環回路１は変形を起こすことがないため問題なく使用でき、後者の場合、流通させる薬液の設置位置を液体加温／冷却用の体外循環回路１よりも重力方向下側に設置して、回路内が陰圧となった場合でも同様の理由で問題なく使用できるため、装置の設計の自由度が向上する。 Here, there is a problem whether the liquid feeding direction of the liquid feeding tube (the rotational direction of the rotary body of the pump) is the direction in which the liquid flows from the liquid introduction tube 10 to the liquid outlet tube 50 or vice versa. There is no particular limitation. In the former case, as shown in the background art, the extracorporeal circuit 1 for liquid heating / cooling can be used without any problem even when a negative pressure is generated on the downstream side of the pump. Since the installation position of the chemical solution to be circulated is installed below the extracorporeal circulation circuit 1 for liquid heating / cooling in the direction of gravity, even if the inside of the circuit becomes negative pressure, it can be used without problems for the same reason. The degree of freedom in device design is improved.
成型体１００の各接続部１１、３１、３２、５１と液体導入チューブ１０、送液チューブ３０、液体導出チューブ５０との接合方法、さらに、成型体同士の貼り合わせの手段は特に限定する必要はないが、一般に、合成樹脂の接合には熱溶融接合や接着による接合が用いられ、例えば、熱溶融接合においては、高周波溶接、誘導加熱溶接、超音波溶接、摩擦溶接、スピン溶接、熱板溶接、熱線溶接などを用いることができ、接着剤の種類としては、シアノアクリレート系、エポキシ系、ポリウレタン系、合成ゴム系、紫外線硬化型、変性アクリル樹脂系、ホットメルトタイプ等を例示することができる。これらの中から、使用温度や流量等を考慮して適宜選択すればよい。 The joining method of each connection part 11, 31, 32, 51 of the molded body 100 and the liquid introducing tube 10, the liquid feeding tube 30, and the liquid outlet tube 50, and the means for bonding the molded bodies need to be particularly limited. In general, however, hot melt bonding or bonding by bonding is used for bonding synthetic resins. For example, in hot melt bonding, high frequency welding, induction heating welding, ultrasonic welding, friction welding, spin welding, hot plate welding are used. Heat ray welding can be used, and examples of the adhesive include cyanoacrylate, epoxy, polyurethane, synthetic rubber, ultraviolet curable, modified acrylic resin, and hot melt type. . What is necessary is just to select suitably in consideration of operating temperature, flow volume, etc. from these.
また成型体１００の各接続部１１、３１、３２、５１と液体導入チューブ１０、送液チューブ３０、液体導出チューブ５０とを直接接合するのみでなく、それぞれの間に別な材質、例えばポリカーボネート等の継ぎ手を介して接合してもよい。 Further, not only the connecting portions 11, 31, 32, 51 of the molded body 100 and the liquid introduction tube 10, the liquid feeding tube 30, and the liquid outlet tube 50 are directly joined, but another material, for example, polycarbonate or the like is provided between them. You may join via a joint.
なお、図１に示す態様においては、各接続部１１、３１、３２、５１が成型体１００の周縁部から奥まったところに設けられているが、こうすると各チューブ１０、３０、５０との接合強度が高まるので好ましい。但し、これに限定するものではなく、周縁部からノズル状に突出させ、それを各チューブ１０、３０、５０に挿入する構造でもよい。より好ましくは、図１に示す態様であって、かつ、各チューブ１０、３０、５０の内壁と各流路部２０、４０の内壁との間に段差がなく、面一になる構造である。 In addition, in the aspect shown in FIG. 1, although each connection part 11, 31, 32, 51 is provided in the place which became deep from the peripheral part of the molded object 100, it joins with each tube 10, 30, 50 by doing so. It is preferable because the strength is increased. However, the present invention is not limited to this, and a structure in which it protrudes in a nozzle shape from the peripheral edge portion and is inserted into each tube 10, 30, 50 may be used. More preferably, there is no step between the inner wall of each tube 10, 30, 50 and the inner wall of each flow channel part 20, 40, which is the embodiment shown in FIG.
ここで、流通させる液体によっては、液体流通管路を途中で分岐する場合もある。例えば、液体導入チューブ１０の途中から分岐させる場合、液体導入チューブ１０の途中にＴ字管を接続してそこに分岐管路を設ける方法が簡便ではあるが、部品点数の増加は避けられない。そこで、図４に示す液体加温／冷却用の体外循環回路１’のように、成型体１００’の第一の流路部２０に分岐点７１および分岐チューブ接続部７０を設け、そこに分岐チューブ８０を接続することにより、接続点数と、部品点数を減らすことができ、コストダウンに有効である。また図４において、第一の流路部２０の分岐点は１つであるが、用途に応じて２つ以上設置しても問題はなく、特に限定するものではない。さらに、第二の流路部４０から分岐するものであっても問題はなく、特に限定するものではない。 Here, depending on the liquid to be circulated, the liquid circulation pipe may be branched in the middle. For example, when branching from the middle of the liquid introduction tube 10, a method of connecting a T-shaped tube in the middle of the liquid introduction tube 10 and providing a branch pipe there is an inevitable increase in the number of parts. Therefore, as in the extracorporeal circulation circuit 1 ′ for liquid heating / cooling shown in FIG. 4, a branch point 71 and a branch tube connecting portion 70 are provided in the first flow path portion 20 of the molded body 100 ′, and the branch is made there. By connecting the tube 80, the number of connection points and the number of parts can be reduced, which is effective for cost reduction. In FIG. 4, the first flow path section 20 has one branch point, but there is no problem even if two or more branch points are installed depending on the application, and there is no particular limitation. Furthermore, there is no problem even if it is branched from the second flow path section 40, and there is no particular limitation.
液体加温／冷却用の体外循環回路１に送液される液体は、目的に応じて種々異なるため、特に限定する必要はないが、例えば、血液、透析液、補充液、ろ液、または血漿などが挙げられる。補充液は、一般的にはバッグに充填されている市販のろ過型人工腎臓用補液（商品例：扶桑薬品工業株式会社製のサブラッドＢ、味の素ファルマ株式会社製のＨＦソリタなど）を使用する場合が多い。透析液は、慢性腎不全の患者に施行される血液透析で使用される、調製された透析液でもよく、前記ろ過型人工腎臓用補液を使用する場合も多い。血漿は、例えば新鮮凍結血漿等が用いられ、アルブミン溶液等で代用することもある。 The liquid to be sent to the extracorporeal circuit 1 for heating / cooling the liquid varies depending on the purpose, and is not particularly limited. For example, blood, dialysate, replenisher, filtrate, or plasma Etc. In the case of using a commercially available filter-type artificial kidney replacement solution (product example: Subrad B manufactured by Fuso Pharmaceutical Co., Ltd., HF Solita manufactured by Ajinomoto Pharma Co., Ltd., etc.) that is generally filled in a bag. There are many. The dialysis solution may be a prepared dialysis solution used in hemodialysis performed for patients with chronic renal failure, and the filtration type artificial kidney replacement fluid is often used. As the plasma, for example, fresh frozen plasma or the like is used, and an albumin solution or the like may be substituted.
このような液体加温／冷却用の体外循環回路１は、成型、接合後そのままの状態で使用してもよいが、特に血液浄化等の医療用途においては、滅菌して利用する。滅菌方法は通常の医療用具の滅菌方法に準じるとよく、薬液、ガス、放射線、高圧蒸気、加熱、等によって処理すればよい。 Such an extracorporeal circuit 1 for heating / cooling the liquid may be used as it is after being molded and joined, but is sterilized and used particularly in medical applications such as blood purification. The sterilization method may be in accordance with a normal sterilization method for medical devices, and may be treated with a chemical solution, gas, radiation, high-pressure steam, heating, or the like.
（液体加温／冷却用の体外循環回路の第二実施態様）
治療法によっては、使用される液体は１種類のみでなく、複数の液体が同時に使用される場合がある。その際に、図１または図４に示すような、１つの液体流通管路しか有さない液体加温／冷却用の体外循環回路の場合、必要とする液体の種類だけ液体加温／冷却用の体外循環回路を用意する必要があるが、一つの液体加温／冷却用の体外循環回路に複数の液体流通管路を設けることにより、この問題を解決することができる。
(Second embodiment of extracorporeal circuit for liquid heating / cooling)
Depending on the treatment method, not only one kind of liquid but also a plurality of liquids may be used at the same time. At that time, in the case of an extracorporeal circulation circuit for liquid heating / cooling having only one liquid circulation pipe as shown in FIG. 1 or FIG. 4, only the necessary liquid types are used for liquid heating / cooling. However, this problem can be solved by providing a plurality of liquid circulation lines in one extracorporeal circulation circuit for liquid heating / cooling.
図５は、本発明に係る液体加温／冷却用の体外循環回路の第二実施態様を示す模式図である。前記第一実施態様と同等の機能を有する部分については、同一の符号にダッシュ記号或いはアルファベットの添え字を付して説明を省略する。 FIG. 5 is a schematic diagram showing a second embodiment of the extracorporeal circuit for liquid heating / cooling according to the present invention. About the part which has a function equivalent to said 1st embodiment, a dash or an alphabetic suffix is attached | subjected to the same code | symbol, and description is abbreviate | omitted.
図５に示す液体加温用の体外循環回路１''において、液体導入チューブ１０ａ、液体導出チューブ５０ａ、および送液チューブ３０ａが、第一の流路部２０ａ、第二の流路部４０ａの各接続部に液密に接続されて第一の液体流通管路を形成している。同様に、液体導入チューブ１０ｂ、液体導出チューブ５０ｂおよび送液チューブ３０ｂが第一の流路部２０ｂ、第二の流路部４０ｂの各接続部に液密に接続されて第二の液体流通管路を形成し、液体導入チューブ１０ｃ、液体導出チューブ５０ｃおよび送液チューブ３０ｃが第一の流路部２０ｃ、第二の流路部４０ｃの各接続部にそれぞれ液密に接続されて第三の液体流通管路を形成している。そして、第一、第二、及び第三の液体流通管路のチューブ以外の部分は、成型体１００''として一体的に形成されている。 In the extracorporeal circuit 1 ″ for liquid heating shown in FIG. 5, the liquid introduction tube 10a, the liquid outlet tube 50a, and the liquid feeding tube 30a are formed of the first flow path portion 20a and the second flow path portion 40a. A first liquid circulation conduit is formed by being liquid-tightly connected to each connection portion. Similarly, the liquid introduction tube 10b, the liquid outlet tube 50b, and the liquid feeding tube 30b are liquid-tightly connected to the respective connection portions of the first flow path portion 20b and the second flow path portion 40b, so that the second liquid circulation pipe The liquid introduction tube 10c, the liquid lead-out tube 50c, and the liquid feeding tube 30c are liquid-tightly connected to the connection portions of the first flow path portion 20c and the second flow path portion 40c, respectively. A liquid flow conduit is formed. The portions other than the tubes of the first, second, and third liquid flow conduits are integrally formed as a molded body 100 ″.
例えば、ＣＨＤＦを施行する際には、第一の液体導入チューブ１０ａにはろ液を、第二の液体導入チューブ１０ｂには透析液を、第三の液体の導入チューブ１０ｃには補充液を流通させればよく、補充液の流通量を０とするとＣＨＤが、透析液の流通量を０とすると前記ＣＨＦが施行可能となる。 For example, when performing CHDF, a filtrate is circulated in the first liquid introduction tube 10a, a dialysate is circulated in the second liquid introduction tube 10b, and a replenisher is circulated in the third liquid introduction tube 10c. If the flow rate of the replenisher is 0, CHD can be performed. If the flow rate of the dialysate is 0, the CHF can be performed.
第一の液体流通管路にろ液を流通させる場合、加温／冷却する必要はないため、第二の流路部２０ａは蛇行する必要はない。このように、複数の液体流通管路を設ける場合、全ての液体流通管路に加温／冷却用の流路を設ける必要はなく、必要に応じて適宜設定すれば問題はない。 When the filtrate is circulated through the first liquid circulation conduit, it is not necessary to heat / cool, and therefore the second flow path portion 20a does not need to meander. As described above, when a plurality of liquid circulation pipes are provided, it is not necessary to provide heating / cooling flow paths in all the liquid circulation pipes, and there is no problem if they are appropriately set as necessary.
さらに、このように、成型体１００''に、複数の流路部が同時に設けられており、液体の導入・導出、加温／冷却、移送といった各機能部が所定の位置関係に配置されているので、回路装着の手順が大幅に減少して操作性が向上し、接続ミスを誘発することもない。 Further, in this way, the molded body 100 ″ is provided with a plurality of flow paths at the same time, and the respective functional parts such as liquid introduction / derivation, heating / cooling, and transfer are arranged in a predetermined positional relationship. As a result, circuit installation procedures are greatly reduced, operability is improved, and connection errors are not induced.
以上、本発明に係る液体加温／冷却用の体外循環回路について実施態様の例を示したが、本発明はこれらの例に限定されるものではなく、液体流通管路の配置や数は目的に応じて適宜設定すればよい。 As mentioned above, although the example of the embodiment was shown about the extracorporeal circuit for the liquid heating / cooling which concerns on this invention, this invention is not limited to these examples, The arrangement | positioning and number of liquid circulation pipe lines are the purpose. What is necessary is just to set suitably according to.
（流体加温／冷却用の体外循環システムの実施態様）
次に、本発明にかかる流体加温／冷却用の体外循環システムの実施態様について説明する。
(Embodiment of extracorporeal circulation system for fluid heating / cooling)
Next, an embodiment of the extracorporeal circulation system for fluid heating / cooling according to the present invention will be described.
本発明の流体加温用の体外循環システムは、前述した液体加温／冷却用の体外循環回路の少なくとも加温／冷却する部分（以下第二の流路部）を挟み込んで加温／冷却するタイプの加温／冷却装置を組み込んだシステムであり、第二の流路部の平面側にあたる面に接触して加温／冷却する加温／冷却プレートと、第二の流路部４０の平面側に対向する面を押圧して、第二の流路部４０の平面側を前記ヒータ／冷却面に密着させる押圧面とから主として構成される加温／冷却装置を組み込んだシステムである。 The extracorporeal circulation system for fluid warming according to the present invention warms / cools by sandwiching at least the portion for heating / cooling (hereinafter referred to as second flow path portion) of the extracorporeal circulation circuit for liquid warming / cooling described above. This is a system incorporating a heating / cooling device of the type, a heating / cooling plate for heating / cooling in contact with a surface corresponding to the flat surface side of the second flow path section, and a plane of the second flow path section 40 This is a system that incorporates a heating / cooling device mainly composed of a pressing surface that presses the surface facing the side and makes the flat surface side of the second flow path portion 40 closely contact the heater / cooling surface.
図６は、その流体加温／冷却用の体外循環システムの加温部３００を示している。ヒータ／冷却面３１０は、第二の流路部４０の平面側６０に接触することにより流れる液体を加温／冷却し、それと同時に、押圧面３２０が第二の流路部４０の平面側に対向する面を押圧することにより、第二の流路部４０を前記ヒータ／冷却面３１０に密着させている。 FIG. 6 shows the heating unit 300 of the extracorporeal circulation system for fluid heating / cooling. The heater / cooling surface 310 heats / cools the flowing liquid by contacting the flat side 60 of the second flow path unit 40, and at the same time, the pressing surface 320 is on the flat side of the second flow path unit 40. The second flow path portion 40 is brought into close contact with the heater / cooling surface 310 by pressing the opposing surfaces.
ヒータ／冷却面の発熱量／吸熱量の分布は、第二の流路部４０の、液体の流れの上流側から下流側に向かって発熱量／吸熱量が大から小となるように発熱量／吸熱量に勾配を持たせると、さらに加温／冷却効率の向上に有効である。流れの上流側においては、液体の温度とヒータ／冷却面の、温度の差が大きいため、高い熱交換効率が期待できるため、積極的に熱を与え／奪い、液体の温度とヒータ／冷却面の温度の差が小さい流れの下流側においては、上流側に比べて熱交換効率が落ちるため、積極的に熱を加えて／奪っても高い加温／冷却能力は期待できないため、上流側に比べて与える／奪う熱は小さくすることで、ヒータ／冷却面全体のワット数が同一であっても、ヒータ／冷却面全体に均一な熱を与える場合に比べ、前記構成とすることで、高い加温／冷却効率を得ることができる。ヒータ／冷却面に発熱量／吸熱量の分布をもたせる手段としては、発熱量／吸熱量の異なるヒータ／冷却器を、複数個ヒータ／冷却面に取り付ける方法、ヒータ／冷却器のワット密度／吸熱量に勾配を持たせる方法等が挙げられるが、その手段は特に限定するものではない。 The distribution of the heat generation amount / heat absorption amount of the heater / cooling surface is such that the heat generation amount / heat absorption amount of the second flow path portion 40 increases from large to small from the upstream side to the downstream side of the liquid flow. / Giving a gradient to the endothermic amount is effective for further improving the heating / cooling efficiency. Since the temperature difference between the liquid temperature and the heater / cooling surface is large at the upstream side of the flow, high heat exchange efficiency can be expected. On the downstream side of the flow where the temperature difference is small, the heat exchange efficiency is lower than that on the upstream side, so high heating / cooling capacity cannot be expected even if heat is actively added / taken away. Compared with the case where uniform heat is applied to the entire heater / cooling surface, even if the wattage of the entire heater / cooling surface is the same, it is high by adopting the above-described configuration. Heating / cooling efficiency can be obtained. The heater / cooling surface has a distribution of heat generation / absorption amounts by attaching multiple heaters / coolers with different heat generation / absorption amounts to the heater / cooling surface, watt density / absorption of the heater / cooler. A method of giving a gradient to the amount of heat can be mentioned, but the means is not particularly limited.
さらに、液体加温／冷却用の体外循環回路の、液体の流れの上流側から下流側に追従して発熱量／吸熱量の勾配を持たせるとき、第二の流路部４０の形状が渦巻き状であるとヒータ／冷却面にそれに沿って発熱量／吸熱量の勾配を持たせることは難しい。そのため、前記したように、体外循環回路の第二の流路部は蛇行配列していることが最も好ましい。 Further, when the extracorporeal circulation circuit for liquid heating / cooling has a gradient of the calorific value / absorbed amount following the upstream side to the downstream side of the liquid flow, the shape of the second flow path portion 40 is a spiral. If it is in the shape, it is difficult to give a gradient of the amount of heat generation / endotherm along the heater / cooling surface. Therefore, as described above, the second flow path portion of the extracorporeal circuit is most preferably arranged in a meandering manner.
液体を加温するヒータ／冷却面３１０は第二の流路部４０の平面側６０に均一に接触し、加温／冷却できるものであれば何れでもよい。例えば、合成樹脂、金属、ガラス等の材質からなる平板の表面に、面状ヒータ（例えば、一対の面状絶縁シート間に発熱抵抗体などを挟持するヒータ等）を接合したものや熱交換器が挙げられるが、製造コストと小型化の観点から面状ヒータが好ましい。面状ヒータの例としては、シリコンラバーヒータ、ポリエステルヒータ、ポリイミドヒータ等が挙げられる。一方、冷却の例としては、ペルチェ素子を用いた冷却、冷蔵庫に代表される冷凍機を利用した冷却、レーザー冷却などが挙げられ、製造コスト、小型化の観点からペルチェ素子を用いた冷却が好ましい。平板の材質は、熱伝導性と製造コスト、耐久性の観点から、金属、特にアルミニウムが好ましく、さらに第二の流路部４０との接触面積を向上するために、軟質な熱良導性の素材、例えば、シリコン系ゲル、シリコン系ゴム、アクリル系ゴム、エチレンプロピレン系ゴム、グラファイト、シリコンペースト等を用いてもよく、いずれにおいても好適に用いることができる。 The heater / cooling surface 310 for heating the liquid may be any as long as it is in uniform contact with the plane side 60 of the second flow path section 40 and can be heated / cooled. For example, a flat plate made of a material such as synthetic resin, metal, glass, etc., with a planar heater (for example, a heater that sandwiches a heating resistor between a pair of planar insulating sheets) or a heat exchanger However, a planar heater is preferable from the viewpoint of manufacturing cost and miniaturization. Examples of the planar heater include a silicon rubber heater, a polyester heater, and a polyimide heater. On the other hand, examples of cooling include cooling using a Peltier element, cooling using a refrigerator represented by a refrigerator, laser cooling, etc. Cooling using a Peltier element is preferable from the viewpoint of manufacturing cost and miniaturization. . The material of the flat plate is preferably a metal, particularly aluminum, from the viewpoints of thermal conductivity, manufacturing cost, and durability. Further, in order to improve the contact area with the second flow path portion 40, a soft thermal conductive material is used. A raw material, for example, silicon-based gel, silicon-based rubber, acrylic rubber, ethylene-propylene-based rubber, graphite, silicon paste, or the like may be used, and any of them can be suitably used.
ヒータ／冷却面３１０は、ヒータ／冷却面の表面温度を検知し、それをフィードバックすることで所定の温度に保つタイプが好ましい。表面温度を検知する方法は特に限定しないが、例えばサーミスタや白金測温抵抗体等が挙げられる。このような測定器は、ヒータ／冷却面の表面温度を適宜測定できる位置に配置されていればよく、その場所、数は限定されるものではない。 The heater / cooling surface 310 is preferably a type that detects the surface temperature of the heater / cooling surface and feeds it back to a predetermined temperature. The method for detecting the surface temperature is not particularly limited, and examples include a thermistor and a platinum resistance temperature detector. Such a measuring device should just be arrange | positioned in the position which can measure the surface temperature of a heater / cooling surface suitably, The place and number are not limited.
加えて、上記したように、一般に血液浄化療法においては、血球、蛋白質等の血液成分に悪影響を与えないように４１℃を超えないように、加温／冷却される液体の温度を制御することが望ましい。そのためヒータ／冷却面の最大表面温度は４１℃を超えないように制御されることが望ましく、それ以下の温度で所定の温度まで上昇／下降するよう制御されることが好ましい。 In addition, as described above, generally in blood purification therapy, the temperature of the heated / cooled liquid is controlled so as not to exceed 41 ° C. so as not to adversely affect blood components such as blood cells and proteins. Is desirable. For this reason, the maximum surface temperature of the heater / cooling surface is desirably controlled so as not to exceed 41 ° C., and preferably controlled so as to rise / fall to a predetermined temperature below that temperature.
さらに、ヒータ／冷却面３１０の形状・面積は、第二の流路部４０の形状・面積とほぼ同等の形状・面積を持つことが好ましい。ヒータ／冷却面の形状・面積が第二の流路部４０の形状・面積よりも大き過ぎる場合、上記した４１℃までしか表面温度が上昇しないといった限られた条件の中で、発生／吸収した熱を空気中に放熱してしまう空間ができることで、加温／冷却能力の向上への障害となる。そのため、ヒータ／冷却面の形状・面積は、第二の流路部４０の形状・面積に対して、１００〜１３０％程度の面積であることが好ましく、さらに望ましくは、１００〜１２０％程度の面積であることが好ましい。 Furthermore, it is preferable that the shape / area of the heater / cooling surface 310 is substantially the same as the shape / area of the second flow path portion 40. When the shape / area of the heater / cooling surface is too larger than the shape / area of the second flow path section 40, it was generated / absorbed under the limited condition that the surface temperature only increased to 41 ° C. The creation of a space that dissipates heat into the air is an obstacle to improving the heating / cooling capacity. Therefore, the shape / area of the heater / cooling surface is preferably about 100 to 130%, more preferably about 100 to 120%, with respect to the shape / area of the second flow path portion 40. An area is preferred.
押圧面３２０は、第二の流路部４０の平面側６０に接触する面とは反対の面を押圧することにより、第二の流路部４０の平面側をヒータ／冷却面３１０に密着させるものであれば何れでもよいが、さらに、第二の流路部４０を破壊から保護するため、軟質素材で構成されていることが好ましい。 The pressing surface 320 presses the surface opposite to the surface that contacts the flat surface side 60 of the second flow path portion 40, thereby bringing the flat surface side of the second flow path portion 40 into close contact with the heater / cooling surface 310. Any material can be used, but it is preferable that the second flow path portion 40 is made of a soft material in order to protect the second flow path portion 40 from destruction.
加えて、押圧面３２０が、熱伝導性の低い素材、つまり断熱材で構成されている場合、第二の流路部４０からの放熱を遮断することができるため、さらなる加温／冷却能力の向上に有効である。 In addition, when the pressing surface 320 is made of a material having low thermal conductivity, that is, a heat insulating material, since heat radiation from the second flow path portion 40 can be blocked, further heating / cooling capability can be achieved. It is effective for improvement.
そのような材質としては、例えば、合成ゴムやシリコンゴム等が挙げられるが、上記した効果を発揮するものであれば何でもよく、特に限定するものではない。 Examples of such a material include synthetic rubber and silicon rubber, but any material can be used as long as it exhibits the above-described effects, and the material is not particularly limited.
また図６において、押圧面３２０は、液体加温用の第二の流路部４０の一部を覆うように記載されているが、全体を覆う場合でも同等の効果は得られ、その形状を特に限定するものではない。 Further, in FIG. 6, the pressing surface 320 is described so as to cover a part of the second flow path portion 40 for liquid heating, but the same effect can be obtained even when the entire surface is covered. There is no particular limitation.
流体加温／冷却用の体外循環システムの加温／冷却部３００において、押圧面３２０が、第二の流路部４０の平面側をヒータ／冷却面３１０に密着させるための手段は特に限定しない。例えば、押圧面３２０とヒータ／冷却面３１０が平行に設置されており、その間に第二の流路部４０を挿入し、ヒータ／冷却面３１０を押圧面３２０に向かって平行に移動させ、または／および押圧面３２０をヒータ／冷却面３１０に向かって平行に移動させることで第二の流路部４０を密着させる手段や、またはヒータ／冷却面３１０と押圧面３２０のいずれか一辺が蝶番等で繋がっており、どちらかの面を閉めることで密着させる手段等が挙げられる。 In the warming / cooling unit 300 of the extracorporeal circulation system for fluid warming / cooling, means for the pressing surface 320 to closely contact the flat side of the second flow path unit 40 to the heater / cooling surface 310 is not particularly limited. . For example, the pressing surface 320 and the heater / cooling surface 310 are installed in parallel, the second flow path section 40 is inserted between them, and the heater / cooling surface 310 is moved in parallel toward the pressing surface 320, or / And means for moving the pressing surface 320 in parallel toward the heater / cooling surface 310 to bring the second flow path portion 40 into close contact, or one side of the heater / cooling surface 310 and the pressing surface 320 is a hinge or the like It is connected by, and means etc. which adheres by closing either side is mentioned.
このように、本発明に係る流体加温／冷却用の体外循環システムの加温／冷却部３００は、ヒータ／冷却面３１０の発熱量／吸熱量の分布を、第二の流路部４０の、液体の流れの上流側から下流側に向かって発熱量／吸熱量が大から小となるように勾配を持たせることに加えて押圧面３２０に断熱効果をもたせることで、加温／冷却能力の向上が図られる。 As described above, the heating / cooling unit 300 of the extracorporeal circulation system for fluid heating / cooling according to the present invention distributes the calorific value / heat absorption amount distribution of the heater / cooling surface 310 of the second flow path unit 40. In addition to providing a gradient so that the amount of heat generated / absorbed from large to small from the upstream side to the downstream side of the liquid flow, the pressure surface 320 has a heat insulating effect, thereby heating / cooling capability. Is improved.
以下実施例により本発明の効果を確認したので説明する。 Hereinafter, the effects of the present invention have been confirmed by examples, which will be described.
図１に示す、本発明の液体加温用の体外循環回路および体外循環システムと、従来技術との比較を行った。体外循環回路に、液体導入口の温度を２０℃として、流量を２０、４０、６０、８０、１００ｍＬ／ｍｉｎとして水道水を流通させ、液体導出口の温度の測定を行った。 The extracorporeal circulation circuit and extracorporeal circulation system for liquid heating of the present invention shown in FIG. 1 were compared with the prior art. In the extracorporeal circuit, tap water was circulated at a liquid inlet temperature of 20 ° C. and flow rates of 20, 40, 60, 80, and 100 mL / min, and the temperature of the liquid outlet was measured.
[実施例１]
図１に示す構成の液体加温用の体外循環回路を用いて液体の加熱テストを行なった。第二の流路部断面半円形状の幅を３ｍｍ、高さを１．５ｍｍ、流路長を２０００ｍｍ、加温面・押圧面の各シート厚みを０．３ｍｍ、蛇行部の幅を１００ｍｍ、蛇行部の流路の間隔を３ｍｍ、加温面の形状は平板状、材質をポリカーボネートとし、各チューブの材質は軟質塩ビ、液体導入チューブ・液体導出チューブの内径を３．４ｍｍ、送液チューブの内径を４．５ｍｍ、流体加温用の体外循環システムの発熱量を７５Ｗ、材質をアルミニウムとし、ヒータ面と、前記第二の流路が配置されている部分の面積は、１５０００ｍｍ2 でほぼ同等であった。ワット密度に勾配を持たせることによりヒータ面に発熱量の勾配を持ち、加温面のみ加温を行う。押圧面は０．００６ｋｇ／ｍｍ2 の荷重を一様に加え、断熱材として緩衝材の一種である旭化成ライフ＆リビング株式会社製サンテックフォーム（登録商標）を用いた。結果を図７に記載する。
[Example 1]
A liquid heating test was performed using an extracorporeal circuit for heating a liquid having the configuration shown in FIG. Second channel cross-sectional semicircular width of 3 mm, height of 1.5 mm, channel length of 2000 mm, each sheet thickness of the heating surface and pressing surface is 0.3 mm, the width of the meandering portion is 100 mm, The flow path of the meandering portion is 3 mm, the heating surface is flat, the material is polycarbonate, the material of each tube is soft PVC, the inner diameter of the liquid introduction tube / liquid outlet tube is 3.4 mm, the liquid feeding tube The inner diameter is 4.5 mm, the heat generation amount of the extracorporeal circulation system for fluid heating is 75 W, the material is aluminum, and the area of the heater surface and the portion where the second flow path is arranged is approximately 15000 mm 2. there were. By providing a gradient in the watt density, the heater surface has a gradient of heat generation, and only the heating surface is heated. As the pressing surface, a load of 0.006 kg / mm @ 2 was uniformly applied, and Suntech Foam (registered trademark) manufactured by Asahi Kasei Life & Living Co., Ltd., which is a kind of cushioning material, was used as a heat insulating material. The results are shown in FIG.
[実施例２]
実施例１の液体加温用の体外循環回路と同等のものを用い、流体加温用の体外循環システムの発熱量を７５Ｗ、材質をアルミニウムとし、ヒータ面と、前記第二の流路が配置されている部分の面積は、１５０００ｍｍ2 でほぼ同等として液体の加温テストを行った。ヒータ面に発熱量の勾配を持たず、加温面のみ加温が行われ、ヒータ面の発熱は均一に行われた。押圧面は０．００６ｋｇ／ｍｍ2 の荷重を一様に加え、断熱材として緩衝材の一種である旭化成ライフ＆リビング株式会社製サンテックフォーム（登録商標）を用いた。結果を図７に示す。
[Example 2]
Using an equivalent to the extracorporeal circulation circuit for liquid heating in Example 1, the exothermic amount of the extracorporeal circulation system for fluid warming is 75 W, the material is aluminum, the heater surface, and the second flow path are arranged. The liquid heating test was conducted with the area of the portion being 15,000 mm @ 2 being almost equal. The heater surface did not have a gradient of heat generation, and only the heating surface was heated, and the heating of the heater surface was performed uniformly. As the pressing surface, a load of 0.006 kg / mm @ 2 was uniformly applied, and Suntech Foam (registered trademark) manufactured by Asahi Kasei Life & Living Co., Ltd., which is a kind of cushioning material, was used as a heat insulating material. The results are shown in FIG.
[比較例１]
図１に示す構成の液体加温用の体外循環回路の断面形状が矩形の場合を用いて液体の加熱テストを行なった。
[Comparative Example 1]
The liquid heating test was performed using the case where the cross-sectional shape of the extracorporeal circulation circuit for liquid heating having the configuration shown in FIG. 1 is rectangular.
第二の流路部断面矩形形状の幅を３ｍｍ、高さを１．５ｍｍ、流路長を２０００ｍｍ、加温面・押圧面の各シート厚みを０．３ｍｍ、蛇行部の幅を１００ｍｍ、蛇行部の流路の間隔を３ｍｍ、加温面の形状は平板状、材質をポリカーボネートとし、各チューブの材質は軟質塩ビ、液体導入チューブ・液体導出チューブの内径を３．４ｍｍ、送液チューブの内径を４．５ｍｍ、流体加温用の体外循環システムの発熱量を７５Ｗ、材質をアルミニウムとし、ヒータ面と、前記第二の流路が配置されている部分の面積は、１５０００ｍｍ2 でほぼ同等であった。ヒータ面に発熱量の勾配を持たず、加温面のみ加温が行われ、ヒータ面の発熱は均一に行われる。押圧面は０．００６ｋｇ／ｍｍ2 の荷重を一様に加え、断熱材として緩衝材の一種である旭化成ライフ＆リビング株式会社製サンテックフォーム（登録商標）を用いた。結果を図７に示す。 The width of the second channel section rectangular shape is 3 mm, the height is 1.5 mm, the channel length is 2000 mm, the thickness of each sheet of the heating surface and the pressing surface is 0.3 mm, the width of the meandering portion is 100 mm, and the meandering The distance between the flow paths is 3 mm, the shape of the heating surface is flat, the material is polycarbonate, the material of each tube is soft PVC, the inner diameter of the liquid introduction tube / liquid outlet tube is 3.4 mm, and the inner diameter of the liquid feeding tube Is 4.5 mm, the heat generation amount of the extracorporeal circulation system for fluid heating is 75 W, the material is aluminum, and the area of the heater surface and the portion where the second flow path is arranged is approximately 15000 mm 2. there were. The heater surface does not have a gradient of heat generation, and only the heating surface is heated, and the heating of the heater surface is performed uniformly. As the pressing surface, a load of 0.006 kg / mm @ 2 was uniformly applied, and Suntech Foam (registered trademark) manufactured by Asahi Kasei Life & Living Co., Ltd., which is a kind of cushioning material, was used as a heat insulating material. The results are shown in FIG.
[比較例２]
特許文献２に記載されているような、軟質チューブを渦巻シート状に接着加工した液体加温チューブを用いて液体の加熱テストを行なった。
[Comparative Example 2]
A liquid heating test was performed using a liquid heating tube obtained by bonding a soft tube into a spiral sheet shape as described in Patent Document 2.
チューブ内径３．４ｍｍ、チューブ外形４．９ｍｍ、流路長３０００ｍｍ、ヒータ面の形状渦巻シート状であるためその外周の形状は円であり、その円の外径は１５０ｍｍ、面積は、１７６６ｍｍ2 、ヒータ面は、１５０×１５０ｍｍの矩形形状で、その面積は２２５００ｍｍ2 である。流体加温用の体外循環システムの発熱量を１００Ｗ、材質をアルミニウムとし、ヒータ面に発熱量の勾配を持たず、両面から加温が行われ、ヒータ面の発熱は均一に行われる。チューブは、ヒータ面とヒータ面との隙間が、４．４ｍｍとなるまで押しつぶした。結果を図７に示す。 The inner diameter of the tube is 3.4 mm, the outer shape of the tube is 4.9 mm, the flow path length is 3000 mm, and the shape of the heater surface is a spiral sheet, so the outer shape is a circle, the outer diameter of the circle is 150 mm, the area is 1766 mm 2 , The heater surface has a rectangular shape of 150 × 150 mm, and its area is 22,500 mm 2 . The extracorporeal circulation system for heating the fluid has a heat generation amount of 100 W, the material is aluminum, the heater surface has no gradient of the heat generation amount, and heating is performed from both sides, and the heater surface generates heat uniformly. The tube was crushed until the gap between the heater surface and the heater surface was 4.4 mm. The results are shown in FIG.
[比較方法]
下記の方法で加温能力の比較テストを行った。
[Comparison method]
The comparative test of the heating ability was performed by the following method.
１．液体加温用の体外循環回路に、液体導入チューブ接続部から、上流に５０ｍｍの位置での液体導入チューブ内の入口温度が２０℃となるように調整した水道水を送液ポンプを用い、２０、４０、６０、８０、１００ｍＬ／ｍｉｎの流量で送液する。 1. Using a liquid feed pump, tap water adjusted so that the inlet temperature in the liquid introduction tube at a position of 50 mm upstream from the liquid introduction tube connection portion is 20 ° C. is supplied to the extracorporeal circuit for liquid heating. , 40, 60, 80, and 100 mL / min.
２．ヒータ面の最高温度を４０℃とする。 2. The maximum temperature of the heater surface is 40 ° C.
３．液体導出チューブ接続部から、下流に５０ｍｍの位置での液体導出チューブ内の温度の温度を測定する。 3. From the liquid outlet tube connecting portion, the temperature of the temperature in the liquid outlet tube at a position of 50 mm downstream is measured.
[比較結果]
縦軸を出口温度、横軸を送液ポンプの流量として、図７に比較結果をしめす。図７に示すように、本発明の一つの実施例である実施例２において、著しい効果が示され、加えて実施例１において、さらなる効果があることが示された。
[Comparison result]
The comparison results are shown in FIG. 7, where the vertical axis represents the outlet temperature and the horizontal axis represents the flow rate of the liquid feed pump. As shown in FIG. 7, in Example 2, which is one embodiment of the present invention, a remarkable effect was shown. In addition, in Example 1, it was shown that there was a further effect.
本発明は、持続的血液浄化法、血漿交換療法、二重ろ過療法、血漿吸着療法等の各種血液浄化法を実施する際に、血液浄化器へ各種液体を供給し、運転制御する血液浄化装置に取り付けて好適に利用することができる。 The present invention provides a blood purification apparatus that supplies various liquids to a blood purifier and controls operation when performing various blood purification methods such as continuous blood purification, plasma exchange therapy, double filtration therapy, and plasma adsorption therapy. It can be suitably used by being attached to.
１、１'、１'' …液体加温／冷却用の体外循環回路
１０、１０ａ、１０ｂ、１０ｃ …液体導入チューブ
１１、１１ａ、１１ｂ、１１ｃ …液体導入チューブ接続部
２０、２０ａ、２０ｂ、２０ｃ …第一の流路部
３０、３０ａ、３０ｂ、３０ｃ …送液チューブ
３１、３１ａ、３１ｂ、３１ｃ …第一の送液チューブ接続部
３２、３２ａ、３２ｂ、３２ｃ …第二の送液チューブ接続部
４０、４０ａ、４０ｂ、４０ｃ …第二の流路部
５０、５０ａ、５０ｂ、５０ｃ …液体導出チューブ
５１、５１ａ、５１ｂ、５１ｃ …液体導出チューブ接続部
５５ …支持部
６０ …平面側
７０ …分岐チューブ接続部
７１ …分岐点
８０ …分岐チュ−ブ
１００、１００'、１００'' …成型体
２００ …管内の主たる流れ
２１０ …管内二次流れ
２２０ …管内二次流れ第一の流れの層
２３０ …管内二次流れ第二の流れの層
３００ …流体加温用の体外循環システムの加温部
３１０ …加温／冷却面
３２０ …押圧面
５０１ …血液浄化器
５０２ …血液回路
５０３ …ろ過回路
５０４ …透析液回路
５０５ …補液回路
５０６ …血液ポンプ
５０７ …ろ過ポンプ
５０８ …透析液ポンプ
５０９ …補液ポンプ
５１０ …透析液
５１１ …補液
DESCRIPTION OF SYMBOLS 1, 1 ', 1''... Extracorporeal circulation circuit for liquid heating / cooling 10, 10a, 10b, 10c ... Liquid introduction tube 11, 11a, 11b, 11c ... Liquid introduction tube connection part 20, 20a, 20b, 20c ... 1st flow path part 30, 30a, 30b, 30c ... Liquid feeding tube 31, 31a, 31b, 31c ... 1st liquid feeding tube connection part 32, 32a, 32b, 32c ... 2nd liquid feeding tube connection part 40, 40a, 40b, 40c ... 2nd flow-path part 50, 50a, 50b, 50c ... Liquid outlet tube 51, 51a, 51b, 51c ... Liquid outlet tube connection part 55 ... Support part 60 ... Plane side 70 ... Branch tube Connection portion 71 ... Branch point 80 ... Branch tube 100, 100 ', 100''... Molded body 200 ... Main flow in pipe 210 ... Secondary flow in pipe 220 ... Two in pipe Secondary flow First flow layer 230 ... Secondary flow in pipe Second flow layer 300 ... Heating part of extracorporeal circulation system for fluid heating 310 ... Heating / cooling surface 320 ... Pressing surface 501 ... Blood purifier DESCRIPTION OF SYMBOLS 502 ... Blood circuit 503 ... Filtration circuit 504 ... Dialysate circuit 505 ... Replacement fluid circuit 506 ... Blood pump 507 ... Filtration pump 508 ... Dialysate pump 509 ... Replacement fluid pump 510 ... Dialysate 511 ... Replacement fluid
Claims (7)
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| JP2007006499A JP2008173139A (en) | 2007-01-16 | 2007-01-16 | Extracorporeal circulation circuit and extracorporeal circulation system for warming/cooling liquid |
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| JP5031073B2 (en) * | 2010-07-21 | 2012-09-19 | 株式会社ソディック | Power supply device for wire cut electrical discharge machine |
| GB2491623A (en) * | 2011-06-09 | 2012-12-12 | Alberto Martinez Albalat | Multilayer fluid heat exchanger comprising plastic and metal layers |
| JP2015157041A (en) * | 2014-02-25 | 2015-09-03 | 株式会社メテク | Transfusion warmer |
| DE102016107110B4 (en) | 2016-04-18 | 2023-06-15 | Adceris Gmbh & Co. Kg | Device and system for intravascular and/or extracorporeal cooling and/or heating of a human or animal body |
| JP7265911B2 (en) * | 2018-07-10 | 2023-04-27 | 旭化成メディカル株式会社 | Manufacturing method of weighing chamber |
| JP7236912B2 (en) * | 2018-07-10 | 2023-03-10 | 旭化成メディカル株式会社 | Heating panel manufacturing method, heating panel and channel holding device |
| JP7165528B2 (en) * | 2018-07-26 | 2022-11-04 | 旭化成メディカル株式会社 | Heating panel, panel circuit and blood purification device |
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| NL8701233A (en) * | 1987-05-22 | 1988-12-16 | Medistad Holland | BLOOD HEATER. |
| JP2574042Y2 (en) * | 1993-11-18 | 1998-06-11 | 株式会社メテク | Fluid warming device |
| JP4156571B2 (en) * | 2004-07-26 | 2008-09-24 | 株式会社 谷田部 | Medical heat exchange bag and manufacturing method thereof |
| KR20070048212A (en) * | 2004-07-28 | 2007-05-08 | 쓰리엠 이노베이티브 프로퍼티즈 컴파니 | Heat exchanger and fluid reservoir |
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