JP2000217908A - Blood collection device - Google Patents
Blood collection deviceInfo
- Publication number
- JP2000217908A JP2000217908A JP11057496A JP5749699A JP2000217908A JP 2000217908 A JP2000217908 A JP 2000217908A JP 11057496 A JP11057496 A JP 11057496A JP 5749699 A JP5749699 A JP 5749699A JP 2000217908 A JP2000217908 A JP 2000217908A
- Authority
- JP
- Japan
- Prior art keywords
- blood
- filter
- membrane
- anticoagulant
- filtrate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、手術中あるいは術後の
管理期間中に患者の創傷部位から流出した血液を回収
し、浄化し、再輸血する装置に関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for collecting, purifying, and retransfusing blood flowing from a wound site of a patient during or after a surgical operation.
【０００２】[0002]
【従来の技術】従来から行われている同種血輸血、すな
わち血液型が適合する献血者からの輸血には、肝炎やエ
イズ等の感染のリスクや各種免疫反応による副作用など
の問題があることが知られている。これに対し近年、患
者自身の血液を回収して再度患者に返血するいわゆる自
己血輸血が普及してきている。自己血輸血には大きく分
けて、術前に計画的に患者から採血して保存しておき手
術中にこれを輸血する貯血式自己血輸血と、手術中ある
いは術後に患者の術野から血液を吸引回収し返血する術
中術後回収式自己血輸血がある。前者は技術的に同種血
輸血と大きく変わることはないが、手術前に採血期間が
必要であるため計画的に実施される手術にしか適用でき
ない。一方、後者は患者からの出血を回収するので緊急
手術にも対応でき、患者への負担も少なくてすむ。しか
し、回収血には血液凝固物や組織破片、破壊した血球残
骸などの不純物が含まれ、これらの不純物を十分に除去
した上で返血しなければ、さまざまな副作用を発生させ
危険である。そこで、安全に術中術後回収式自己血輸血
が行えるように、回収血から不純物を取り除き再生させ
る装置が実用化されている。それはセルセーバ（商標
名）と呼ばれるものを代表とした遠心式自己血回収装置
であり、術野から吸引された血液をフィルタで濾過し比
較的大きな不純物を除去した後、生理食塩水で細胞洗浄
しながら遠心分離することで浄化された血球成分を回収
するものである。しかしながら、遠心法では遠心の度合
いで血球成分の分離性能が決まるが、術中回収ではでき
るだけ迅速な処理が要求されるため、十分な遠心分離が
できず血球成分の回収率が悪くなる。比重の高い赤血球
の回収率は比較的良いが白血球、血小板などの比重の低
い成分はかなり悪い。従って、結局は同種血輸血を併用
するケースも多く生じているのが現状である。また、遠
心容器の容量単位のバッチ処理となるために回収血が一
定量貯まらなければ処理できず、緊急に返血を必要とす
る場合には大きな問題となる。さらには、遠心分離する
ための機構は複雑で大きなものとなり、コスト面および
操作面での問題も大きい。そこで、遠心分離法に代り多
孔質高分子材料からなる膜型血液濾過器により血液を濾
過し血球成分を分離する膜分離法が考案されている（特
開平５−５０５５４０）。膜分離法では膜の孔径で血球
成分の分離性能が決まり、遠心法のように時間をかけず
に高い血球成分の回収率を実現できる。また、遠心法の
バッチ処理に対し膜分離法では連続に近い処理が可能な
ため、処理速度も高められる。2. Description of the Related Art Conventionally, allogeneic blood transfusion, that is, blood transfusion from a blood donor whose blood type matches, has problems such as the risk of infection such as hepatitis and AIDS and side effects due to various immune reactions. Are known. On the other hand, in recent years, so-called autologous blood transfusion in which a patient's own blood is collected and returned to the patient again has become widespread. Autologous blood transfusions are broadly divided into blood-transfusion-type autologous blood transfusions, which are designed to collect and save blood from patients before surgery, and transfuse them during surgery, and blood from patients' surgical fields during or after surgery. There is an intraoperative postoperative recovery autologous blood transfusion in which blood is collected by suction and returned. Although the former is technically not much different from allogeneic blood transfusion, it can be applied only to planned surgery because a blood sampling period is required before surgery. On the other hand, the latter can collect urgent bleeding from the patient, so that it can cope with emergency surgery, and the burden on the patient can be reduced. However, the collected blood contains impurities such as blood clots, tissue debris, and destroyed blood cell debris. Unless these impurities are sufficiently removed and blood is returned, various side effects are likely to occur. Therefore, an apparatus for removing impurities from the collected blood and regenerating the blood has been put into practical use so that intraoperative and postoperative autologous blood transfusion can be safely performed. It is a centrifugal autologous blood collection device typified by a cell saver (trade name). After filtering blood drawn from the operative field with a filter to remove relatively large impurities, the cell is washed with physiological saline. The blood cell components that have been purified by centrifugation while being collected are collected. However, in the centrifugation method, the separation performance of blood cell components is determined by the degree of centrifugation. However, in intraoperative recovery, processing as quickly as possible is required, so that sufficient centrifugation cannot be performed and the recovery rate of blood cell components deteriorates. The recovery rate of red blood cells with high specific gravity is relatively good, but components with low specific gravity such as white blood cells and platelets are quite bad. Therefore, in the end, there are many cases in which allogeneic blood transfusion is used in combination. In addition, since the batch processing is performed in units of the volume of the centrifugal container, the processing cannot be performed unless a certain amount of collected blood is stored. This is a serious problem when urgently returning blood is required. Furthermore, the mechanism for centrifugation becomes complicated and large, and there are great problems in terms of cost and operation. Therefore, instead of the centrifugal separation method, a membrane separation method has been devised in which blood is filtered by a membrane-type blood filter made of a porous polymer material to separate blood cell components (JP-A-5-505540). In the membrane separation method, the separation performance of blood cell components is determined by the pore diameter of the membrane, and a high blood cell component recovery rate can be realized without taking much time unlike the centrifugation method. In addition, the processing speed can be increased because the membrane separation method can perform a process that is almost continuous as compared with the batch process of the centrifugal method.
【０００３】しかし、特開平５−５０５５４０に示され
た方法においては以下の問題点がある。血液の洗浄は、
通常、出血の状況によって決められる。例えば心臓およ
び血管系の手術では血液の汚染は少ないため洗浄液量を
少なくし、迅速性を優先するが、骨や消化器系の手術に
おいては血液の汚染が多いため十分な洗浄を必要とす
る。しかし、特開平５−５０５５４０の実施例では洗浄
液を術野から吸引された血液に直接混合しているために
混合比をコントロールすることは困難である。また、該
実施例では洗浄され濃縮された血液のヘマトクリット値
を直接検出して所定のレベル以上になった血液を回収す
るようになっている。ヘマトクリット値を検出する手段
として血液の電導率を測定する方法が例示されているが
光学的方法も含めて血液回路上に電極やセルを設ける必
要があり、使い捨てである血液回路が高価になる。加え
て、該実施例では吸引した血液から血液凝固物や肉片を
除去するために孔径４０μｍのポリエステル性多孔性フ
ィルタを使用することが例示されているが、これは遠心
分離法で使用されているものと何ら変わりがなく膜型血
液濾過器の特性を考慮して選択されたものではない。膜
分離法においては赤血球のみならず白血球の回収率も高
いので、回収された血液を再輸血する際に白血球から出
るサイトカイン等が患者に障害をもたらす可能性があ
る。また、膜型血液濾過器は脂肪による目詰まりで濾過
性能が劣化する。しかし、例示されたフィルタでは白血
球も脂肪球も除去することはできない。さらに、該実施
例では膜型血液濾過器に対して分子量による濾過特性の
み要求しているが、単純に分子量による濾過特性のみ適
合する膜型血液濾過器を使用しても十分な処理速度を得
ることはできず、遠心分離法の問題解決にはならない。However, the method disclosed in Japanese Patent Application Laid-Open No. 5-505540 has the following problems. Blood washing
Usually determined by the bleeding situation. For example, in the operation of the heart and the vascular system, the amount of the washing solution is reduced because the blood is less contaminated and priority is given to quickness. However, in the operation of the bone and the digestive system, the blood is contaminated so that sufficient washing is required. However, in the example of JP-A-5-505540, it is difficult to control the mixing ratio because the washing liquid is directly mixed with the blood sucked from the surgical field. Further, in this embodiment, the hematocrit value of the washed and concentrated blood is directly detected, and the blood having a predetermined level or more is collected. A method of measuring the conductivity of blood is described as an example of a means for detecting a hematocrit value. However, it is necessary to provide electrodes and cells on a blood circuit including an optical method, and a disposable blood circuit becomes expensive. In addition, this example illustrates the use of a 40 μm pore size polyester porous filter to remove blood clots and meat fragments from the aspirated blood, which is used in centrifugation. It was not selected in consideration of the characteristics of the membrane type hemofilter in any way. In the membrane separation method, the recovery rate of not only red blood cells but also white blood cells is high, so that cytokines and the like coming out of white blood cells when the collected blood is retransfused may cause damage to patients. Further, the filtration performance of the membrane-type blood filter deteriorates due to clogging with fat. However, neither the white blood cells nor the fat globules can be removed by the illustrated filter. Furthermore, in this embodiment, only the filtration characteristics based on molecular weight are required for the membrane-type blood filter, but a sufficient processing speed can be obtained by simply using a membrane-type blood filter adapted only for the filtration characteristics based on the molecular weight. It cannot solve the problem of centrifugation.
【０００４】[0004]
【発明が解決しようとする課題】以上の点に鑑み、本発
明は、術中術後の患者からの出血を洗浄回収するにあた
り、従来法に比してより速やかに効率よく処理を行い、
より安全で経済的である血液回収装置を提供することを
目的とする。SUMMARY OF THE INVENTION In view of the above, the present invention provides a method for cleaning and recovering bleeding from a patient during and after an operation, more quickly and efficiently than a conventional method.
It is an object of the present invention to provide a safer and more economical blood collection device.
【０００５】[0005]
【課題を解決するための手段】上記課題を解決するため
に本発明に係る血液回収装置においては、手術中または
術後の管理期間中に患者の創傷部位から流出した血液を
回収し、浄化し、患者へ再輸血する装置であって、創傷
部位から血液を吸引する吸引手段と、前記吸引手段で吸
引された血液に抗凝固剤を混合する抗凝固剤混合手段
と、前記抗凝固剤を混合した血液から、血液凝固物や肉
片、脂肪等を除去するフィルタと、前記フィルタで濾過
された血液を貯留する貯血容器と、前記貯血容器に貯留
された血液と洗浄液とを任意の流量比で混合する血液洗
浄液混合手段と、前記血液洗浄液混合手段で混合された
血液と洗浄液を濾過するための膜型血液濾過器と、前記
膜型血液濾過器の濾過液口から濾過液を定量排出する定
量濾過手段と、前記膜型血液濾過器の血液出口に接続さ
れた血液回収容器と、前記血液回収容器から血液を返送
する返血手段とを具備することを特徴とする。さらに
は、前記膜型血液濾過器の血液入口圧、または前記膜型
血液濾過器の血液入口と血液出口の差圧に応じて前記定
量濾過手段を制御し、前記血液回収容器に回収する血液
の血球濃度を所定の値以上に保つことを特徴としてい
る。そして、前記フィルタは、繊維の外径が３〜６μｍ
嵩密度０．０５〜０．５ｇ／ｃｍ３である繊維塊を少な
くとも１種類含む不織布と、繊維の外径が３μｍ未満で
嵩密度が０．１５〜０．５ｇ／ｃｍ３の不織布とを併存
させてなるものであることが好ましい。また、前記膜型
血液濾過器は、内径１８０〜３５０μｍ、孔径０．２０
〜０．３５μｍで、内径対繊維長比が４００から１１，
０００である、オレフィン系樹脂の微多孔性中空糸から
なることが好ましい。なお、本発明において、吸引手段
とは例えば通常手術室に配備されている真空源に接続し
て術野から血液や骨肉片を吸い取る吸引器を、抗凝固剤
混合手段とは例えばヘパリンやＣＰＤといった抗凝固剤
を生理食塩水のバッグに注入し点滴するものを、貯血容
器とは例えば心臓外科手術に一般的に用いられるリザー
バを、血液洗浄液混合手段とは例えば血液および洗浄液
をそれぞれチュービングポンプで送液し血液ラインと洗
浄液ラインをチャンバ（小容器）で合流させるものを、
定量濾過手段とは例えば膜型血液濾過器の濾過口に接続
されたチュービングポンプを、血液回収容器とは例えば
塩化ビニル製の輸血バッグを、返血手段とは例えば輸血
バッグに設けられた輸血ラインを、それぞれ示してい
る。SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, a blood collecting apparatus according to the present invention collects and purifies blood that has flowed out of a wound site of a patient during an operation or during a postoperative management period. A device for retransfusing blood into a patient, comprising: suction means for sucking blood from a wound site; anticoagulant mixing means for mixing anticoagulant with blood sucked by the suction means; and mixing the anticoagulant A filter that removes blood coagulates, meat pieces, fats, and the like from the collected blood, a blood storage container that stores the blood filtered by the filter, and the blood stored in the blood storage container and the washing liquid mixed at an arbitrary flow ratio. Blood washing liquid mixing means to perform, a membrane blood filter for filtering the blood and the washing liquid mixed by the blood washing liquid mixing means, and quantitative filtration for quantitatively discharging the filtrate from a filtrate port of the membrane blood filter. Means and said A blood collection container connected to the blood outlet of the mold hemofilter, characterized by comprising a blood return means for returning blood from the blood collection container. Further, the quantitative filtration means is controlled in accordance with the blood inlet pressure of the membrane-type blood filter, or the pressure difference between the blood inlet and the blood outlet of the membrane-type blood filter, and the blood to be collected in the blood collection container is controlled. It is characterized in that the blood cell concentration is maintained at or above a predetermined value. The filter has an outer diameter of 3 to 6 μm.
A nonwoven fabric containing at least one fiber mass having a bulk density of 0.05 to 0.5 g / cm3 and a nonwoven fabric having an outer diameter of less than 3 m and a bulk density of 0.15 to 0.5 g / cm3 Is preferable. The membrane type blood filter has an inner diameter of 180 to 350 μm and a pore diameter of 0.20.
０．３0.35 μm and inner diameter to fiber length ratio of 400 to 11,
It is preferably made of a microporous hollow fiber of an olefin resin having a molecular weight of 000. In the present invention, the suction means is, for example, a suction device which is connected to a vacuum source usually provided in an operating room to suck blood or bone and meat fragments from an operation field, and the anticoagulant mixing means is, for example, heparin or CPD. An anticoagulant is infused into a bag of physiological saline to be infused, a blood reservoir is for example a reservoir generally used in cardiac surgery, and a blood washing solution mixing means is for example blood and washing solution sent by a tubing pump. The one that joins the liquid blood line and the washing liquid line in a chamber (small container)
The quantitative filtration means is, for example, a tubing pump connected to a filtration port of a membrane blood filter, the blood collection container is, for example, a blood transfusion bag made of vinyl chloride, and the blood return means is, for example, a blood transfusion line provided in the blood transfusion bag. Are respectively shown.
【０００６】本発明で言うフィルタとは、抗凝固剤を混
合した血液から血液凝固物や肉片、脂肪等を除去するた
めの濾過フィルターを言うが、本フィルタは、不織布よ
り成ることが好ましく、また、血液の流れに従って上流
側が外径の大きい繊維から成る不織布、下流側が外径の
小さい繊維から成る不織布で構成されている事が更に好
ましい。外径の大きい繊維から成る不織布で血液に混入
する肉片や骨片、血液の凝集成分、脂肪塊等が除去さ
れ、外径の小さい繊維から成る不織布で血液中の白血球
が除去される。好ましい不織布の組み合わせは、繊維の
外径が３〜６μｍ、嵩密度０．０５〜０．５ｇ／ｃｍ３
である繊維塊を少なくとも１種類含む不織布と、繊維の
外径が３μｍ未満で嵩密度が０．１５〜０．５ｇ／ｃｍ
３の不織布とを併存させたものである。この組み合わせ
は、フィルタの目詰まりが少なく、除去対象の物質を効
率良く除去出来る組み合わせである。また、本発明で言
う膜型血液濾過器とは、血液中の有形成分即ち血球は透
過せず、液性成分を透過する濾過器であり、血球と液性
成分を分離する手段が多孔質膜より成る濾過器を言う。
膜の形状は平膜、中空糸膜等があるが、中空糸膜が好ま
しい。膜の材質はポリオレフィン、セルロースアセテー
ト、ポリスルホン、エチレンビニルアルコール等各種用
いることができるが、ポリオレフィン系樹脂が好まし
い。膜が中空糸膜である場合のディメンジョン等は、内
径１８０〜３５０μｍ、孔径０．２〜０．３５μｍで、
内径対繊維長比（中空繊維有効長／中空糸内径）が４０
０から１１，０００である場合に好ましい結果を与え
る。この仕様においては、実際的な血液流量（１００〜
５００ｍＬ／ｍｉｎ）で１回の濾過にてヘマトクリット
値が４０％〜６５％の実用的な回収血液が得られる。即
ち、再循環を必要とすることがないため高速の処理が可
能となる。また、ポリエチレンを延伸開口法にて製作し
た微多孔性中空糸はディープフィルタでありサーフェイ
スフィルタとは異なり異物で目詰まりを起し難い。従っ
て濾過面積が急激に減少することはなく濾過性能が持続
する。The term "filter" as used in the present invention refers to a filter for removing blood coagulates, meat chips, fats, etc. from blood mixed with an anticoagulant. The filter is preferably made of a nonwoven fabric. It is more preferable that the upstream side is constituted by a non-woven fabric composed of fibers having a large outer diameter and the downstream side is constituted by a non-woven fabric composed of fibers having a small outer diameter according to the flow of blood. Meat pieces and bone fragments, blood coagulation components, fat clumps, and the like mixed into the blood are removed by the nonwoven fabric having a large outer diameter, and leukocytes in the blood are removed by the nonwoven fabric made of the small outer diameter fiber. A preferred combination of nonwoven fabrics has a fiber outer diameter of 3 to 6 μm and a bulk density of 0.05 to 0.5 g / cm 3.
A non-woven fabric containing at least one kind of fiber lump, having an outer diameter of less than 3 μm and a bulk density of 0.15 to 0.5 g / cm
No. 3 coexists. This combination is a combination in which the clogging of the filter is small and the substance to be removed can be efficiently removed. Further, the membrane type blood filter referred to in the present invention is a filter that does not transmit formed components in blood, that is, blood cells, but transmits liquid components, and means for separating blood cells and liquid components is porous. Refers to a filter made of a membrane.
The shape of the membrane includes a flat membrane and a hollow fiber membrane, and a hollow fiber membrane is preferred. Various materials such as polyolefin, cellulose acetate, polysulfone, and ethylene vinyl alcohol can be used as the material of the membrane, but polyolefin resins are preferable. When the membrane is a hollow fiber membrane, the dimensions are 180 to 350 μm in inner diameter and 0.2 to 0.35 μm in pore size.
Inner diameter to fiber length ratio (effective length of hollow fiber / inner diameter of hollow fiber) is 40
A value between 0 and 11,000 gives favorable results. In this specification, the actual blood flow (100-
One filtration at 500 mL / min can provide a practically collected blood having a hematocrit value of 40% to 65%. That is, high-speed processing is possible because no recirculation is required. Further, the microporous hollow fiber made of polyethylene by a stretch opening method is a deep filter and unlike a surface filter, is unlikely to be clogged with foreign matter. Therefore, the filtration performance is maintained without a sudden decrease in the filtration area.
【０００７】[0007]
【作用】前記構成によれば、術野からの吸引された血液
は、抗凝固剤添加の後、フィルタで血液凝固物等の大き
な不純物のみならず白血球や脂肪球が除去され、貯血容
器に貯められ、洗浄液と任意の比率で混合された後、血
液濾過器に送られる。そして、濾過液ポンプにより濾過
された洗浄液および洗浄液に浮遊する不純物が廃棄さ
れ、清浄された血球成分が適切な濃度で効率良く、すな
わち少ないロスで、血液回収容器に回収される。この工
程は速やかに進行され、出血が多い場合でも短い時間で
回収、輸血が行える。According to the above construction, after the anti-coagulant is added, the blood aspirated from the operative field is filtered to remove not only large impurities such as blood coagulates but also white blood cells and fat globules, and stored in the blood storage container. After being mixed with the washing solution at an arbitrary ratio, it is sent to the hemofilter. Then, the washing solution filtered by the filtrate pump and impurities floating in the washing solution are discarded, and the purified blood cell component is efficiently collected at an appropriate concentration, that is, with low loss, in the blood collection container. This process proceeds promptly, and collection and transfusion can be performed in a short time even if there is much bleeding.
【０００８】[0008]
【実施例】以下に本発明の実施例を図面に基づき説明す
る。図１は本発明の一実施例の構成を示すものである。
真空源２１は貯血容器４の内部を負圧に保ち、その結果
術野の血液は吸引ハンドル１から吸引される。抗凝固剤
バッグ２には生理食塩水で希釈されたヘパリンやＣＰＤ
等の抗凝固剤が供給されており、点滴により血液と混合
される。抗凝固剤が添加された血液は貯血容器４の入口
に設けられたフィルタ３で濾過され、術野で混入した組
織破片や血栓などの比較的大きな不純物が取り除かれた
後に貯血容器に貯められる。貯血容器４にはレベル計
５，６が設置されておりそれぞれの位置まで血液が貯ま
ったことを検出できるようになっている。そこで、レベ
ル計５が血液を検知すれば血液ポンプ９が初期設定流量
で運転を始める。また、同時に洗浄液ポンプ１０および
濾過液ポンプ１６も運転を始める。洗浄液ポンプは予め
設定された血液洗浄液比で洗浄液バッグ８に供給されて
いる生理食塩水を送液する。例えば、心臓手術の場合は
血液の汚染が少ないために血液洗浄液比は１：１に設定
され、洗浄液ポンプ１０は血液ポンプ９と同じ流量で運
転される。また、整形分野の手術では血液洗浄液比は
１：３に設定され、洗浄液ポンプ１０は血液ポンプ９の
３倍の流量で運転される。血液と洗浄液は混合槽７で合
流し混ざり合って血液濾過器１２へ送られる。血液濾過
器１２は複数の中空糸膜から構成され、血液入口１３か
ら流入した血液が中空糸膜の内側を通り血液出口１４か
ら流出する間に、中空糸膜壁の細孔の径より小さな物質
が濾過され濾過液口２２から排出される。濾過液ポンプ
１６は最初は洗浄液ポンプ１０と同じ流量で運転され
る。すなわち、一旦洗浄液で希釈された血液が希釈前の
濃度となる条件である。しかし、貯血容器４の血液は、
抗凝固剤や術野で散布された生理食塩水で希釈されてい
るため、患者への返血にはさらに濃縮を必要とされるの
でさらに次のように制御される。血液濾過器１２は血液
の流れに対して抵抗体として働くのでこの前後で発生し
た差圧は流れる血液の流量と粘性に依存する。血液の粘
性は血球濃度を反映しているため差圧と流量から血球濃
度を求めることができる。従って、本実施例では、圧力
センサ１１で測定された入口圧Ｐｉと圧力センサ１５に
より測定された出口圧Ｐｏの差（ΔＰ＝Ｐｉ−Ｐｏ）
が、所定の限界値以上になるように濾過液ポンプ１６の
流量を制御している。ΔＰの限界値は血液濾過器１２の
仕様に依存するため実験的に求めた、回収血に必要な濃
度の血液における流量とΔＰの関係から決定される。例
えば、回収値に必要な血液濃度（ヘマトクリット値）を
５０％とし実験的にもとめた血液濾過器１２の流量Ｑと
差圧ΔＰの特性を、 ΔＰ Ｈｃｔ５０＝ｆ（Ｑ） とする。血液ポンプをＱｂ、洗浄液ポンプをＱｗの流量
で運転しているとすると血液濾過器１２に発生する差圧
がｆ（Ｑｂ＋Ｑｗ）以上になるように濾過液ポンプ１６
で濾過すれば血液濾過器１２の血液出口１４から出てく
る血液はヘマトクリット値が５０％以上となる。ただ
し、一般的に膜型の血液濾過器で血液を濾過する場合、
血液側の圧やＴＭＰ（血液側の圧と濾過側の圧の差）が
高くなりすぎると赤血球が破壊する現象、いわゆる溶血
が起こることが知られている。従って、本実施例では血
液濾過器１２の血液側の圧の最大値であるＰｉおよびＴ
ＭＰの最大値（ＴＭＰｍａｘ＝Ｐｉ−Ｐｆ：Ｐｆは濾過
側の圧力センサ２３にて測定された圧）に対して上限値
を定め、この上限値を超さないように血液ポンプ９およ
び濾過液ポンプ１６の流量を制限している。流路切替器
１８は当初貯血容器４側に流通するようになっている
が、以上の制御の結果ΔＰが所定の圧以上すなわち所定
の血球濃度以上で安定した場合血液回収バッグ１９側に
切換り、洗浄濃縮された血液が回収される。すなわち、
十分な血球濃度に濃縮されていない血液は貯血容器４へ
戻され、再度血液濾過器１２で濾過され最終的には目的
とする濃度に濃縮される。血液濾過器１２は、血液の性
状や処理量に応じて脂肪や蛋白質などが中空糸膜の細孔
にトラップされ、その結果十分な流量特性や濾過性能が
得られなくなる場合がある。従って上記の制御過程にお
いて血液流量や濾過液流量を所定の流量以下に下げても
ＰｉやＴＭＰが上限値を下回らない場合、一旦血液ポン
プ９と濾過液ポンプ１６を停止し洗浄液のみを流して血
液濾過器１２そのものを洗浄し、性能を回復させてい
る。貯血容器４内の血液が処理され回収されれば、レベ
ル計６がこれを検知する。このとき血液ポンプ９、濾過
液ポンプ１６は停止し、洗浄液ポンプ１０は血液濾過器
１２内の血液が洗浄液で置換される量だけ送液して停止
する。そして、再度吸引された血液が貯血容器４に溜り
レベル計５が液面を検知すれば以上の動作を繰り返す。
回収された血液は輸血ライン２０から患者に輸血され
る。本実施例における制御のフロー図を図２に示す。Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 shows the configuration of one embodiment of the present invention.
The vacuum source 21 keeps the inside of the blood reservoir 4 at a negative pressure, so that blood in the operation field is sucked from the suction handle 1. The anticoagulant bag 2 contains heparin or CPD diluted with physiological saline.
And the like, and is mixed with blood by infusion. The blood to which the anticoagulant has been added is filtered by a filter 3 provided at the inlet of the blood storage container 4 and stored in the blood storage container after relatively large impurities such as tissue debris and thrombus mixed in the operation field are removed. The blood reservoir 4 is provided with level meters 5 and 6 so that it is possible to detect that blood has accumulated at each position. Therefore, if the level meter 5 detects blood, the blood pump 9 starts operating at the initially set flow rate. At the same time, the washing liquid pump 10 and the filtrate pump 16 also start operating. The washing liquid pump sends the physiological saline supplied to the washing liquid bag 8 at a preset blood washing liquid ratio. For example, in the case of cardiac surgery, the blood washing liquid ratio is set to 1: 1 because blood contamination is small, and the washing liquid pump 10 is operated at the same flow rate as the blood pump 9. Further, in the surgery in the field of orthopedics, the blood washing liquid ratio is set to 1: 3, and the washing liquid pump 10 is operated at a flow rate three times that of the blood pump 9. The blood and the washing liquid are combined in the mixing tank 7, mixed and sent to the blood filter 12. The blood filter 12 is composed of a plurality of hollow fiber membranes, and while the blood flowing from the blood inlet 13 passes through the inside of the hollow fiber membrane and flows out of the blood outlet 14, a substance smaller than the diameter of the pores of the hollow fiber membrane wall is formed. Is filtered and discharged from the filtrate port 22. The filtrate pump 16 is initially operated at the same flow rate as the washing liquid pump 10. That is, the condition is such that the blood once diluted with the washing liquid has the concentration before the dilution. However, the blood in the blood reservoir 4
Since it is diluted with an anticoagulant or a physiological saline sprayed in the operation field, further concentration is required for returning blood to the patient. Therefore, it is further controlled as follows. Since the blood filter 12 acts as a resistor against the blood flow, the differential pressure generated before and after the blood filter 12 depends on the flow rate and viscosity of the flowing blood. Since the viscosity of blood reflects the blood cell concentration, the blood cell concentration can be determined from the differential pressure and the flow rate. Therefore, in this embodiment, the difference between the inlet pressure Pi measured by the pressure sensor 11 and the outlet pressure Po measured by the pressure sensor 15 (ΔP = Pi−Po).
However, the flow rate of the filtrate pump 16 is controlled so as to be equal to or more than a predetermined limit value. Since the limit value of ΔP depends on the specifications of the hemofilter 12, the limit value is determined from the relationship between ΔP and the flow rate of blood having a concentration required for the collected blood, which is experimentally obtained. For example, let the blood concentration (hematocrit value) required for the recovery value be 50%, and the characteristics of the flow rate Q and the differential pressure ΔP of the blood filter 12 experimentally determined are ΔP Hct50 = f (Q). Assuming that the blood pump is operated at the flow rate of Qb and the washing liquid pump is operated at the flow rate of Qw, the filtrate pump 16 is adjusted so that the differential pressure generated in the blood filter 12 becomes f (Qb + Qw) or more.
, The blood coming out of the blood outlet 14 of the blood filter 12 has a hematocrit value of 50% or more. However, in general, when filtering blood with a membrane-type blood filter,
It is known that when the blood side pressure or TMP (difference between the blood side pressure and the filtration side pressure) is too high, the phenomenon that red blood cells are destroyed, so-called hemolysis, occurs. Therefore, in the present embodiment, Pi and T, which are the maximum values of the blood pressure of the blood filter 12 on the blood side, are used.
An upper limit is set for the maximum value of MP (TMPmax = Pi-Pf: Pf is a pressure measured by the pressure sensor 23 on the filtration side), and the blood pump 9 and the filtrate pump are set so as not to exceed the upper limit. 16 are limited. The flow path switch 18 is initially circulated to the blood storage container 4 side. However, when ΔP is stabilized at a predetermined pressure or more, that is, at a predetermined blood cell concentration or more as a result of the above control, the flow is switched to the blood collection bag 19 side. The blood that has been washed and concentrated is collected. That is,
The blood that has not been concentrated to a sufficient blood cell concentration is returned to the blood storage container 4, filtered again by the blood filter 12, and finally concentrated to a target concentration. In the blood filter 12, fats, proteins, and the like are trapped in the pores of the hollow fiber membrane depending on the properties and processing amount of blood, and as a result, sufficient flow characteristics and filtration performance may not be obtained. Therefore, if Pi or TMP does not fall below the upper limit even if the blood flow rate or the filtrate flow rate is reduced to a predetermined flow rate or less in the above control process, the blood pump 9 and the filtrate pump 16 are temporarily stopped, and only the washing liquid is flowed. The filter 12 itself is washed to restore the performance. If the blood in the blood storage container 4 is processed and collected, the level meter 6 detects this. At this time, the blood pump 9 and the filtrate pump 16 are stopped, and the washing liquid pump 10 is stopped by sending the amount of blood in the blood filter 12 that is replaced with the washing liquid. Then, when the aspirated blood is collected in the blood reservoir 4 and the level meter 5 detects the liquid level, the above operation is repeated.
The collected blood is transfused from the transfusion line 20 to the patient. FIG. 2 shows a flowchart of the control in this embodiment.
【０００９】図３は本実施例の貯血容器４の詳細図であ
る。血液採取口２４から入ってきた術野の血液は全てフ
ィルタ３を通る構造となっている。フィルタ３は図４に
示すように円筒状の不織布３０，３１の同心二重構造と
なっている。不織布３１は外径が３〜６μｍの繊維から
なり不織布３０は外径が３μｍ未満の繊維からなる。こ
れらの不織布はメッシュ状の支持筒２８，２９で挟まれ
ており、不織布３１が０．０５〜０．５ｇ／ｃｍ３、不
織布３０が０．１５〜０．５ｇ／ｃｍ３の嵩密度に保た
れている。術野の血液がこのような構造のフィルタ３を
通るとき次のような濾過特性がある。先ず血液は不織布
３１で濾過されるが、このとき術野で混入した肉片や骨
片、手術中に変成した凝集成分、脂肪等の粘着物質が除
去される。不織布３１を通過した血液は次に不織布３０
で濾過されるがこのとき白血球が除去される。なおこの
フィルタの構造および効果は特公平２−１３５８８に詳
しく示されている。図５は本実施例における血液濾過器
１２の構造を示すものである。血液は血液入口１３から
流入し中空糸３２の内側を通り血液出口１４から流出す
る。このとき、中空糸３２に無数に開けられた細孔から
細孔径より小さい物質が濾過され濾過液口２２から排出
される。本実施例ではポリエチレンを延伸開口法にて製
作した微多孔性中空糸を使用しており、その仕様は下表
の通りである。 この仕様においては、実際的な血液流量（１００〜５０
０ｍＬ／ｍｉｎ）で一回の濾過にてヘマトクリット値が
４０％〜６５％の実用的な回収血液が得られる。すなわ
ち、再循環を必要とすることがないため高速の処理が可
能となる。また、ポリエチレンを延伸開口法にて製作し
た微多孔性中空糸はディープフィルタでありサーフェイ
スフィルタとは異なり異物で目詰まりを起し難い。従っ
て濾過面積が急激に減少することはなく濾過性能が持続
する。FIG. 3 is a detailed view of the blood storage container 4 of the present embodiment. All the blood in the operative field that has entered through the blood sampling port 24 passes through the filter 3. The filter 3 has a concentric double structure of cylindrical nonwoven fabrics 30 and 31 as shown in FIG. The nonwoven fabric 31 is made of fibers having an outer diameter of 3 to 6 μm, and the nonwoven fabric 30 is made of fibers having an outer diameter of less than 3 μm. These non-woven fabrics are sandwiched between mesh-like support cylinders 28 and 29, and the non-woven fabric 31 has a bulk density of 0.05 to 0.5 g / cm 3 and the non-woven fabric 30 has a bulk density of 0.15 to 0.5 g / cm 3. I'm dripping. When blood in the surgical field passes through the filter 3 having such a structure, the following filtering characteristics are obtained. First, the blood is filtered by the nonwoven fabric 31. At this time, meat and bone fragments mixed in the operation field, cohesive components denatured during the operation, and adhesive substances such as fat are removed. The blood that has passed through the nonwoven fabric 31 is then passed through the nonwoven fabric 30
At which time the white blood cells are removed. The structure and effect of this filter are described in detail in Japanese Patent Publication No. 2-13588. FIG. 5 shows the structure of the blood filter 12 in the present embodiment. The blood flows in from the blood inlet 13, passes through the inside of the hollow fiber 32, and flows out from the blood outlet 14. At this time, substances smaller than the pore diameter are filtered from the countless pores formed in the hollow fiber 32 and discharged from the filtrate port 22. In this embodiment, a microporous hollow fiber made of polyethylene by a stretch opening method is used, and the specifications are as shown in the table below. In this specification, the actual blood flow (100-50
(0 mL / min), a practical filtration with a hematocrit value of 40% to 65% can be obtained by one filtration. That is, high-speed processing can be performed because recirculation is not required. Further, the microporous hollow fiber made of polyethylene by a stretch opening method is a deep filter and unlike a surface filter, is unlikely to be clogged with foreign matter. Therefore, the filtration performance is maintained without a sudden decrease in the filtration area.
【００１０】[0010]
【発明の効果】本発明の装置を使用することにより、術
中術後の患者からの出血から必要とする血球を高い効率
で迅速に回収することができ、患者に安全な自己血を輸
血することが可能となった。EFFECTS OF THE INVENTION By using the device of the present invention, necessary blood cells can be rapidly and efficiently collected from bleeding from a patient during and after an operation, and a safe autologous blood can be transfused to a patient. Became possible.
【図１】本発明による自己血回収装置の実施例の構成を
示した説明図である。FIG. 1 is an explanatory diagram showing a configuration of an embodiment of an autologous blood collecting apparatus according to the present invention.
【図２】本発明の実施例における制御例を示したフロー
図である。FIG. 2 is a flowchart illustrating a control example according to the embodiment of the present invention.
【図３】本発明の実施例における貯血容器の構造を示し
た説明図である。FIG. 3 is an explanatory view showing a structure of a blood storage container in the embodiment of the present invention.
【図４】本発明の実施例におけるフィルタの構造を示し
た説明図である。FIG. 4 is an explanatory diagram showing a structure of a filter according to the embodiment of the present invention.
【図５】本発明の実施例における血液濾過器の構造を示
した説明図である。FIG. 5 is an explanatory view showing the structure of the blood filter according to the embodiment of the present invention.
１ 吸引ハンドル ２ 抗凝固剤バッグ ３ フィルタ ４ 貯血容器 ５，６ レベル計 ７ 混合槽 ８ 洗浄液バッグ ９ 血液ポンプ １０ 洗浄液ポンプ １１，１５，２３ 圧力センサ １２ 血液濾過器 １３ 血液入口 １４ 血液出口 １６ 濾過液ポンプ １７ 濾過液バッグ １８ 流路切替器 １９ 血液回収バッグ ２０ 輸血ライン ２１ 真空源 ２２ 濾過液口 ２４ 血液採取口 ２５ 真空源接続口 ２６ 血液戻り口 ２７ ドレイン口 ２８，２９ 支持筒 ３０，３１ 不織布 ３２ 中空糸 DESCRIPTION OF SYMBOLS 1 Suction handle 2 Anticoagulant bag 3 Filter 4 Blood storage container 5,6 Level meter 7 Mixing tank 8 Cleaning liquid bag 9 Blood pump 10 Cleaning liquid pump 11,15,23 Pressure sensor 12 Blood filter 13 Blood inlet 14 Blood outlet 16 Filtrate Pump 17 Filtrate bag 18 Flow path switch 19 Blood collection bag 20 Blood transfusion line 21 Vacuum source 22 Filtrate port 24 Blood sampling port 25 Vacuum source connection port 26 Blood return port 27 Drain port 28,29 Support cylinder 30,31 Non-woven fabric 32 Hollow fiber
フロントページの続き Ｆターム(参考） 4C038 TA10 4C077 AA09 AA11 BB02 CC03 DD01 DD12 DD13 DD17 DD19 EE01 EE02 KK01 KK04 KK09 KK30 LL05 LL11 LL21 NN07 PP02 PP15 4D006 GA13 HA02 HA18 KA02 KA63 KB14 KC02 KE02P KE03P KE06Q KE07P KE09P KE14R KE21P KE22Q KE23Q KE24Q MA01 MA22 MA31 MA33 MA40 MB20 MC18 MC22X MC34 MC62 NA34 PA01 PB09 PB43 PC41 4D064 AA05 AA29 BC06 BC11 BQ01Continued on the front page F term (reference) 4C038 TA10 4C077 AA09 AA11 BB02 CC03 DD01 DD12 DD13 DD17 DD19 EE01 EE02 KK01 KK04 KK09 KK30 LL05 LL11 LL21 NN07 PP02 PP15 4D006 GA13 HA02 HA18 KA02 KE63 KE63 KE63 KE63 KE63 KE24Q MA01 MA22 MA31 MA33 MA40 MB20 MC18 MC22X MC34 MC62 NA34 PA01 PB09 PB43 PC41 4D064 AA05 AA29 BC06 BC11 BQ01
Claims (4)
段で吸引された血液に抗凝固剤を混合する抗凝固剤混合
手段と、前記抗凝固剤を混合した血液から、血液凝固物
や肉片、脂肪等を除去するフィルタと、前記フィルタで
濾過された血液を貯留する貯血容器と、前記貯血容器に
貯留された血液と洗浄液とを任意の流量比で混合する血
液洗浄液混合手段と、前記血液洗浄液混合手段で混合さ
れた血液と洗浄液を濾過するための膜型血液濾過器と、
前記膜型血液濾過器の濾過液口から濾過液を定量排出す
る定量濾過手段と、前記膜型血液濾過器の血液出口に接
続された血液回収容器と、前記血液回収容器から血液を
返送する返血手段と、を具備する血液回収装置。1. A suction means for sucking blood, an anticoagulant mixing means for mixing an anticoagulant with the blood sucked by the suction means, and a blood coagulated product or meat piece from the blood mixed with the anticoagulant. A filter for removing fat and the like, a blood reservoir for storing the blood filtered by the filter, a blood cleaning liquid mixing means for mixing the blood stored in the blood reservoir and the cleaning liquid at an arbitrary flow ratio, and the blood A membrane blood filter for filtering the blood and the washing liquid mixed by the washing liquid mixing means,
A quantitative filtration means for quantitatively discharging the filtrate from a filtrate port of the membrane-type blood filter, a blood collection container connected to a blood outlet of the membrane-type blood filter, and a return for returning blood from the blood collection container. And a blood collecting device.
は前記膜型血液濾過器の血液入口と血液出口の差圧に応
じて前記定量濾過手段を制御し、前記血液回収容器に回
収する血液の血球濃度を所定の値以上に保つことを特徴
とする請求項１に記載の血液回収装置。2. The quantitative filtration means is controlled in accordance with the blood inlet pressure of the membrane-type blood filter or the pressure difference between the blood inlet and the blood outlet of the membrane-type blood filter, and is collected in the blood collection container. The blood collection device according to claim 1, wherein the blood cell concentration of the blood is maintained at a predetermined value or more.
ｍ嵩密度０．０５〜０．５ｇ／ｃｍ３である繊維塊を少
なくとも１種類含む不織布と、繊維の外径が３μｍ未満
で嵩密度が０．１５〜０．５ｇ／ｃｍ３の不織布とを併
存させてなることを特徴とする請求項１に記載の血液回
収装置。3. The filter according to claim 1, wherein the outer diameter of the fiber is 3 to 6 μm.
m A nonwoven fabric containing at least one kind of fiber mass having a bulk density of 0.05 to 0.5 g / cm3 and a nonwoven fabric having a fiber outer diameter of less than 3 µm and a bulk density of 0.15 to 0.5 g / cm3 coexist. The blood collection device according to claim 1, wherein
０μｍ、孔径０．２０〜０．３５μｍで、内径対繊維長
比が４００から１１，０００である、オレフィン系樹脂
の微多孔性中空糸からなることを特徴とする請求項１に
記載の血液回収装置。4. The membrane type blood filter according to claim 1, wherein the inner diameter is 180 to 35.
The blood collection according to claim 1, comprising an olefin-based resin microporous hollow fiber having a pore diameter of 0.20 to 0.35 [mu] m and an inner diameter to fiber length ratio of 400 to 11,000. apparatus.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11057496A JP2000217908A (en) | 1999-01-29 | 1999-01-29 | Blood collection device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11057496A JP2000217908A (en) | 1999-01-29 | 1999-01-29 | Blood collection device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000217908A true JP2000217908A (en) | 2000-08-08 |
Family
ID=13057347
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11057496A Pending JP2000217908A (en) | 1999-01-29 | 1999-01-29 | Blood collection device |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000217908A (en) |
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