JP4751073B2

JP4751073B2 - Heat exchanger

Info

Publication number: JP4751073B2
Application number: JP2005025234A
Authority: JP
Inventors: 隆徳甲斐; 嘉純松本; 祐治安部
Original assignee: Kawasumi Laboratories Inc
Current assignee: SB Kawasumi Laboratories Inc
Priority date: 2005-02-01
Filing date: 2005-02-01
Publication date: 2011-08-17
Anticipated expiration: 2025-02-01
Also published as: JP2006212075A

Description

本発明は、血液、心筋保護液等の体液あるいは薬液等の液体の温度を調整するための医療用の熱交換器に関する。 The present invention relates to a medical heat exchanger for adjusting the temperature of a body fluid such as blood, myocardial protective fluid, or a liquid such as a chemical solution.

外科手術等の際に患者に代わって血液を循環させたりあるいは追加の血液を患者に送り込んだり薬液を患者に送り込んだりする回路には、血液あるいは薬液の温度を調整するために熱交換器が設けられている。このような熱交換器としては、特許文献１から４（特開平９−２８５５３７、特開平１１−４７２６９、特開平１１−１３７６７１、特開２０００−９３５０９）に記載の熱交換器が記載されている。 Circuits that circulate blood on behalf of the patient during surgery, send additional blood to the patient, or send medicinal solution to the patient are equipped with heat exchangers to adjust the temperature of the blood or medicinal solution It has been. As such heat exchangers, there are described heat exchangers described in Patent Documents 1 to 4 (Japanese Patent Laid-Open Nos. 9-285537, 11-47269, 11-137671, 2000-93509). .

特許文献１には、『筐体（本願のハウジングに相当）１５内に下側から上側に通過される液体の熱交換を導入される熱媒体により行なう熱交換室３６を設けるとともに（筐体１５内を熱交換室３６に形成し）、該熱交換室３６を通過した液体の泡抜きを行なう泡抜き室３９を、該熱交換室３６の上側に設け、該泡抜き室３９で泡抜きされた液体を通過させる通過室４０を筐体１５内における熱交換室３６の内側に設け、血液等の液体が流通する管体３３を複数本、筐体１５内に配置した熱交換器。』が記載されている。（特開平９−２８５５３７（要約、図１、［００１５］））
特許文献１には、「泡抜き室３９を筐体１５内の熱交換室３６の上側に設け、泡抜き室３９で泡抜きされた液体を通過させる通過室４０を筐体１５内の熱交換室３６の内側に設けているので、通過室を流れる体液が見えにくく、体液のプライミング量も多くなるという課題が指摘される。
また「複数本の血液等の液体が流通する管体３３を、筐体１５内に配置し、筐体１５内を熱交換室３６にしている」ので複数本の管体の配置固定が難しく、取付部材３４の経時劣化による血液リークの危惧という課題が指摘される。
特許文献２には、『熱媒体流入口２４、流出口２５、生体循環用液体流入口２６、生体循環用液体流出口２７を備えるハウジング２と、多数の熱交換用細管３１からなる熱交換体３と、熱交換体３の両端部をハウジング２に固定し、ハウジング２内を熱媒体室１１と生体循環用液体室１３とに区分する隔壁４，５とを有し、一方の隔壁５は、他方の隔壁４より上方に位置している。さらに上方の隔壁５の外面の上方に位置し、生体循環用液体室より流出する生体循環用液体が流入する生体循環用液体流通室１３と、この流通室１３の側面を形成する気泡捕捉用フィルター部材１６と、このフィルター部材１６を通過した生体循環用液体が流入する生体循環用液体導出部１４とを有する熱交換器。』が記載されている。（特開平１１−４７２６９（要約、図４、［００１８］））
特許文献２に記載の熱交換器は、熱交換体３を多数の熱交換用細管３１から構成しており、隔壁４、５を高分子ポッティング剤（例えば、ポリウレタン、シリコーンゴム）などにより形成するためポッティング材との接着面積の増大と、それにより経時的な材質劣化による血液リークの可能性が高くなるという課題が指摘され、また複数の熱交換用細管３１の中に血液を通し、ハウジング２内を熱媒体室１１としているため、術者側から血液の流れが確認できないという課題が指摘される。またスペースの大きい生体循環用液体室１３をハウジング２の上部に設けているので体液のプライミング量の増大という課題が指摘される。
また特許文献２、３の記載の発明では、各構成部品（成形品等）を高分子ポッティング剤（例えば、ポリウレタン）で固定し、当該高分子ポッティング剤が体液、熱媒体等と直接接触するように形成されている。（特許文献１に記載の発明も図１の記載からみて同じ。）ところで高分子ポッティング剤（例えば、ポリウレタン）の表面は凹凸になっているので、体液、熱媒体等に含まれる微小な気泡がこれらに接触すると、累積的に付着して気泡溜りの原因となることが指摘されている。 In Patent Document 1, “a heat exchange chamber 36 is provided in a housing (corresponding to the housing of the present application) 15 that performs heat exchange of a liquid that is passed from the lower side to the upper side by a heat medium introduced (housing 15). And a bubble removal chamber 39 for removing bubbles of the liquid that has passed through the heat exchange chamber 36 is provided on the upper side of the heat exchange chamber 36, and the bubbles are removed in the bubble removal chamber 39. A heat exchanger in which a passage chamber 40 through which a liquid passes is provided inside the heat exchange chamber 36 in the housing 15, and a plurality of tube bodies 33 through which a liquid such as blood circulates are arranged in the housing 15. Is described. (Japanese Patent Laid-Open No. 9-285537 (Summary, FIG. 1, [0015]))
Patent Document 1 states that “the bubble removal chamber 39 is provided on the upper side of the heat exchange chamber 36 in the housing 15, and the passage chamber 40 through which the liquid defoamed in the bubble removal chamber 39 passes is exchanged in the housing 15. Since it is provided inside the chamber 36, it is pointed out that the body fluid flowing through the passage chamber is difficult to see and the priming amount of the body fluid increases.
In addition, since the “pipe 33 through which a plurality of liquids such as blood circulate is arranged in the housing 15 and the inside of the housing 15 is used as the heat exchange chamber 36”, it is difficult to arrange and fix the plurality of tubes, The problem of fear of blood leakage due to deterioration of the attachment member 34 with time is pointed out.
Patent Document 2 states that “a heat exchanger composed of a housing 2 including a heat medium inlet 24, an outlet 25, a biological circulation liquid inlet 26, and a biological circulation liquid outlet 27, and a large number of heat exchange capillaries 31. 3 and both ends of the heat exchanger 3 are fixed to the housing 2, and the partition walls 4 and 5 partition the inside of the housing 2 into a heat medium chamber 11 and a biological circulation liquid chamber 13. , Located above the other partition 4. Furthermore, a biological circulation liquid circulation chamber 13 that is located above the outer surface of the upper partition wall 5 and into which the biological circulation liquid flowing out from the biological circulation liquid chamber flows, and a bubble trapping filter that forms the side surface of the circulation chamber 13. A heat exchanger having a member 16 and a biological circulation liquid outlet 14 into which the biological circulation liquid that has passed through the filter member 16 flows. Is described. (Japanese Patent Laid-Open No. 11-47269 (Summary, FIG. 4, [0018]))
In the heat exchanger described in Patent Document 2, the heat exchanger 3 is constituted by a large number of thin tubes 31 for heat exchange, and the partition walls 4 and 5 are formed of a polymer potting agent (for example, polyurethane or silicone rubber). Therefore, it is pointed out that there is a problem that the adhesion area with the potting material is increased and the possibility of blood leakage due to deterioration of the material over time is increased, and the blood is passed through the plurality of thin tubes 31 for heat exchange. Since the inside is the heat medium chamber 11, a problem is pointed out that the blood flow cannot be confirmed from the operator side. In addition, since the living body circulation liquid chamber 13 having a large space is provided in the upper part of the housing 2, a problem of increasing the priming amount of the body fluid is pointed out.
In the inventions described in Patent Documents 2 and 3, each component (molded product or the like) is fixed with a polymer potting agent (for example, polyurethane) so that the polymer potting agent is in direct contact with a body fluid, a heat medium, or the like. Is formed. (The invention described in Patent Document 1 is the same as shown in FIG. 1.) By the way, since the surface of the polymer potting agent (for example, polyurethane) is uneven, minute bubbles contained in body fluid, heat medium, etc. It has been pointed out that, if they come into contact with these, they will accumulate and cause bubbles to accumulate.

特許文献３には『筒状熱交換器部１０と、この筒状熱交換器部１０に直接巻回された多数のガス交換用中空糸膜からなる筒状中空糸膜束２と、筒状中空糸膜束２および筒状熱交換器部１０とを収納するハウジング３とを備える。中空糸膜の両端は開口した状態で、筒状中空糸膜束２の両端部をハウジング３および筒状熱交換器部１０に２つの隔壁５，６により固定されている。ハウジング３の内部は、中空糸膜外面と筒状熱交換器部１０の外側面１０ａと２つの隔壁５、６間により形成された血液室７と、筒状熱交換器部１０の内部と連通する熱媒体室１６に区分されている。筒状熱交換器部１０にベローズを使用する。』熱交換器内蔵型人工肺が記載されている。（特開平１１−１３７６７１（要約、図４、［００１６］、［００３６］））
特許文献４には、『筒状コア５と、筒状コア５の外表面に巻き付けられた筒状中空糸膜束３と、コア５内に収納された筒状熱交換器部と、ハウジング２とを備える。筒状コア５は、その外表面と中空糸膜束３間に血液流路を形成する溝５１と、コア５と筒状熱交換器部間の第１の血液室１１と溝５１とを連通する血液流通用開口５２を有する。筒状熱交換器部は、筒状熱交換体３１と筒状熱交換体変形規制部３４、３５を備えている。筒状熱交換体３１にベローズ管を使用する。』熱交換器内蔵型人工肺が記載されている。（特開２０００−９３５０９（要約、図４、図５、［００２９］、［００５８］））
特許文献３と特許文献４に記載の熱交換器内蔵型人工肺は、ハウジング２の一端部に、熱媒体の導入と排出ポートを配置し、熱媒体がハウジング２の熱媒体室を往復するように形成されているので熱媒体の使用量が非常に多くなり、したがって熱交換器全体のサイズも大きくなるという課題が指摘される。
また熱交換体の外周に中空糸膜束を配置しているので、ハウジング２内に導入された血液が、中空糸膜束を通過して排出されるので、圧力損失とプライミング量の増大という課題が指摘される。 Patent Document 3 states that “a cylindrical heat exchanger section 10, a cylindrical hollow fiber membrane bundle 2 composed of a large number of gas exchange hollow fiber membranes directly wound around the cylindrical heat exchanger section 10, and a cylindrical shape And a housing 3 for housing the hollow fiber membrane bundle 2 and the cylindrical heat exchanger section 10. Both ends of the hollow fiber membrane are opened, and both ends of the cylindrical hollow fiber membrane bundle 2 are fixed to the housing 3 and the cylindrical heat exchanger unit 10 by two partition walls 5 and 6. The interior of the housing 3 communicates with the blood chamber 7 formed between the outer surface of the hollow fiber membrane, the outer surface 10a of the cylindrical heat exchanger section 10 and the two partition walls 5 and 6, and the interior of the cylindrical heat exchanger section 10. The heat medium chamber 16 is divided. A bellows is used for the cylindrical heat exchanger section 10. ] A heat exchanger built-in oxygenator is described. (JP-A-11-137671 (Summary, FIG. 4, [0016], [0036]))
Patent Document 4 discloses that “a cylindrical core 5, a cylindrical hollow fiber membrane bundle 3 wound around the outer surface of the cylindrical core 5, a cylindrical heat exchanger portion housed in the core 5, and a housing 2. With. The cylindrical core 5 communicates the groove 51 that forms a blood flow path between the outer surface thereof and the hollow fiber membrane bundle 3, and the first blood chamber 11 and the groove 51 between the core 5 and the cylindrical heat exchanger section. The blood circulation opening 52 is provided. The tubular heat exchanger section includes a tubular heat exchange body 31 and tubular heat exchange body deformation regulating sections 34 and 35. A bellows tube is used for the cylindrical heat exchanger 31. ] A heat exchanger built-in oxygenator is described. (Japanese Patent Laid-Open No. 2000-93509 (Summary, FIG. 4, FIG. 5, [0029], [0058]))
In the artificial lung with a built-in heat exchanger described in Patent Literature 3 and Patent Literature 4, the introduction and exhaust ports of the heat medium are arranged at one end of the housing 2 so that the heat medium reciprocates in the heat medium chamber of the housing 2. Therefore, it is pointed out that the amount of the heat medium used is extremely large, and therefore the size of the entire heat exchanger is also increased.
Further, since the hollow fiber membrane bundle is disposed on the outer periphery of the heat exchanger, the blood introduced into the housing 2 is discharged through the hollow fiber membrane bundle, so that there is a problem of increased pressure loss and priming amount. Is pointed out.

特開平９−２８５５３７（要約、図１、［００１５］）JP-A-9-285537 (Summary, FIG. 1, [0015]) 特開平１１−４７２６９（要約、図４、［００１８］）JP 11-47269 (Abstract, FIG. 4, [0018]) 特開平１１−１３７６７１（要約、図４、［００１６］、［００３６］）JP-A-11-137671 (Summary, FIG. 4, [0016], [0036]) 特開２０００−９３５０９（要約、図４、図５、［００２９］、［００５８］）JP 2000-93509 (Abstract, FIG. 4, FIG. 5, [0029], [0058])

解決しようとする問題点は、熱交換体（例えばベローズ管等）が従来の熱交換器においては径等のサイズが非常に大きいので、体液側のプライミング量が大きくなり、術中の体外循環量増えてしまうことが上げられる。
また熱媒体の使用量も多いため、使用時の重量もさらに重くなり、術時の取回しが困難となる。
さらに熱交換体（例えばベローズ管等）そのものが比較的大きい割に熱交換性能はそれほど高くない。
また各構成部品（成形品等）を高分子ポッティング剤（例えば、ポリウレタン）で固定しているめ、当該高分子ポッティング剤の凹凸部に、体液、熱媒体等に含まれる微小な気泡がこれらに接触すると、累積的に付着して気泡溜りの原因となりやすい。 The problem to be solved is that the heat exchanger (eg, bellows tube) has a very large size such as the diameter in the conventional heat exchanger, so the priming amount on the body fluid side becomes large and the extracorporeal circulation volume increases. Can be raised.
In addition, since the amount of heat medium used is large, the weight during use becomes heavier, making it difficult to handle during operation.
Furthermore, the heat exchange performance (for example, a bellows tube) itself is relatively high, but the heat exchange performance is not so high.
In addition, since each component (molded product, etc.) is fixed with a polymer potting agent (for example, polyurethane), minute bubbles contained in body fluid, heat medium, etc. are formed on the uneven portions of the polymer potting agent. When contacted, it tends to accumulate and cause bubbles to accumulate.

［１］本発明は、ハウジング（２）は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に大径の第一端部（２Ａ）と小径の第二端部（２Ｂ）とを有し、
前記ハウジング（２）の内部に、円筒状の熱交換体（７）を配置し、
当該熱交換体（７）は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に第一端部と、第二端部とを有し、
前記熱交換体（７）内に、内管（６）を配置し、
当該内管（６）は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に第一端部と、第二端部とを有し、
当該内管（６）の内部空間により熱媒体室（２０）を形成し、
前記ハウジング（２）の内壁面と前記熱交換体（７）の外周面との間の空間により体液室（２１）を形成し、
前記熱交換体（７）の第一端部に熱交換体おさえ（１７）を装着し、
当該熱交換体おさえ（１７）は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に第一端部と、第二端部とを有し、
前記内管（６）の第一端部に、前記熱媒体室（２０）と連通する第一熱媒体ポート（８）の一端部を装着し、前記内管（６）の第二端部に、前記熱媒体室（２０）と連通する第二熱媒体ポート（９）の一端部を装着し、
前記ハウジング（２）の前記側部方向に前記体液室（２１）と連通する体液導入ポート（１０）を装着し、
前記ハウジング（２）の第一端部に、第一のカバー（３）を装着し、第二端部に、第二のカバー（４）を装着し、
前記第一熱媒体ポート（８）の一端部を、前記ハウジング（２）の第一端部（２Ａ）に、前記第二熱媒体ポート（９）の一端部を、前記ハウジング（２）の第二端部（２Ｂ）に、それぞれ固定し、
前記ハウジング（２）の前記第一端部（２Ａ）側は、
前記熱交換体（７）の第一端部外周と前記熱交換体おさえ（１７）の第二端部内周との間に、第二Ｏリング（１５）を配置して、当該第二Ｏリング（１５）で液密に固定し、
前記熱交換体（７）の第一端部内周と前記第一熱媒体ポート（８）の一端部外周との間に第一Ｏリング（１４）を配置して、当該第一Ｏリング（１４）で液密に固定し、
前記ハウジング（２）の第二端部（２Ｂ）側は、前記熱交換体（７）の第二端部内周と前記第二熱媒体ポート（９）の一端部外周との間に、第二Ｏリング（１４）を配置して、当該第二Ｏリング（１５）で液密に固定し、
前記熱交換体（７）の第二端部外周と前記ハウジング（２）の第二端部（２Ｂ）の内周との間に第一Ｏリング（１５）を配置し、当該第一Ｏリング（１５）で液密に固定した熱交換器（１）を提供する。
［２］本発明は、前記熱交換体おさえ（１７）は、略円筒状に形成され、前記第一端部に第一鍔部（１７Ａ）、前記第二端部に第二鍔部（１７Ｂ）を有し、当該第二鍔部（１７Ｂ）の体液ないし熱交換媒体との接液部分を鏡面に形成し、
当該第二鍔部（１７Ｂ）側に突起部（１７Ｃ）を形成した［１］に記載の熱交換器（１）を提供する。
［３］本発明は、前記ハウジング（２）の側部方向であってかつ当該ハウジング（２）の長さ方向に沿って体液を分散ないし集合させることのできる空間（ＳＰ）を形成した［１］または［２］に記載の熱交換器（１）を提供する。
［４］本発明は、前記内管（６）の側部方向の上部と下部にスリット（Ｓ）を形成し、当該内管（６）の内部に、前記第一熱媒体ポート（８）から前記第二熱媒体ポート（９）または前記第二熱媒体ポート（９）から前記第一熱媒体ポート（８）へ熱媒体が直接流通するのを遮断し、旋回させるための隔壁板（１９）を配置し、
前記第一熱媒体ポート（８）または前記第二熱媒体ポート（９）から導入される熱媒体が、前記内管（６）の上部または下部のスリット（Ｓ）を経て、前記熱交換体（７）内部の溝（Ｍ）に流入し、
反対側の前記内管（６）の下部または上部のスリット（Ｓ）を経て、再び内管（６）内に流入し、
反対側の前記第二熱媒体ポート（９）または前記第一熱媒体ポート（８）から排出されるように形成した［１］から［３］のいずれか１項に記載の熱交換器（１）を提供する。
［５］本発明は、前記ハウジング（２）に連通管（２２）を介して気泡トラップ（５）を外付し、当該気泡トラップ（５）に、体液排出ポート（１１）を装着した［１］から［４］のいずれか１項に記載の熱交換器（１）を提供する。
［６］本発明は、前記熱交換体（７）は、外径：２０〜３０ｍｍ、及び長さ：５０〜１００ｍｍを有し、
前記ハウジング（２）は、内径：２０〜３１ｍｍ、及び長さ：５０〜１２０ｍｍを有し、
前記熱交換体（７）の体液側のプライミング量は、５〜１５ｍＬである［１］から［５］のいずれか１項に記載の熱交換器（１）を提供する。
[1] In the present invention, the housing (2) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and the first end portion (2A) having a large diameter in the length direction ; a second end portion of the small diameter and (2B),
In the housing (2), a cylindrical heat exchanger body (7) is arranged,
The heat exchanger (7) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and has a first end portion and a second end portion in the length direction,
To the heat exchanger (7) in the inner tube (6) is arranged,
The inner pipe (6) has a length direction and a side direction that intersects the length direction substantially perpendicularly, and has a first end and a second end in the length direction,
A heat medium chamber (20) is formed by the internal space of the inner pipe (6),
A body fluid chamber (21) is formed by a space between the inner wall surface of the housing (2) and the outer peripheral surface of the heat exchange body (7),
Holding the heat exchanger (17) mounted to the first end of the heat exchanger (7),
The heat exchanging body presser (17) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and has a first end portion and a second end portion in the length direction. ,
One end of the first heat medium port (8) communicating with the heat medium chamber (20) is attached to the first end of the inner pipe (6), and the second end of the inner pipe (6) is attached. Attaching one end of the second heat medium port (9) communicating with the heat medium chamber (20),
A body fluid introduction port (10) communicating with the body fluid chamber (21) is mounted in the side direction of the housing (2),
A first cover (3) is attached to the first end of the housing (2), a second cover (4) is attached to the second end,
One end of the first heat medium port (8) is connected to the first end (2A) of the housing (2), and one end of the second heat medium port (9) is connected to the first end of the housing (2). Secure to the two ends (2B) ,
The first end (2A) side of the housing (2) is
A second O-ring (15) is disposed between the outer periphery of the first end of the heat exchanger (7) and the inner periphery of the second end of the heat exchanger retainer (17), and the second O-ring (15) Fix the liquid tightly,
A first O-ring (14) is arranged between the inner periphery of the first end of the heat exchanger (7) and the outer periphery of the one end of the first heat medium port (8). ) Liquid tightly fixed,
The second end (2B) side of the housing (2) is located between the inner periphery of the second end of the heat exchanger (7) and the outer periphery of one end of the second heat medium port (9). Place the O-ring (14) and fix it liquid-tight with the second O-ring (15),
A first O-ring (15) is disposed between the outer periphery of the second end of the heat exchanger (7) and the inner periphery of the second end (2B) of the housing (2), and the first O-ring A heat exchanger (1) fixed liquid-tightly in (15) is provided.
[2] The present invention is suppressed the heat exchanger (17) is formed in a substantially cylindrical shape, said first flange portion to the first end portion (17A), the second flange portion (17B to the second end ), And a liquid contact part with the body fluid or heat exchange medium of the second collar part (17B) is formed on the mirror surface,
A heat exchanger (1) according to [1], in which a protrusion (17C) is formed on the second flange (17B) side, is provided.
[3] The present invention has a space (SP) that can be dispersed or collective body fluid along the length of the housing a side direction (2) and the housing (2) [1 Or a heat exchanger (1) according to [2].
[4] The present invention forms a slit (S) to the side direction of the top and bottom of the inner tube (6), the interior of the inner tube (6), from the first heat medium port (8) the second heat medium port (9) or the second heat medium heat medium to the port from said (9) the first heat medium port (8) is blocked to flow directly, partition plate for pivoting (19) And place
The first heat medium port (8) or the heat medium introduced from the second heat medium port (9) is, via the top or bottom of the slits in the inner pipe (6) (S), said heat exchanger ( 7) flows into the groove (M) inside,
It flows again into the inner pipe (6) through the lower or upper slit (S) of the inner pipe (6) on the opposite side,
The opposite second heat medium port (9) or heat exchanger according formed from [1] to be discharged from the first heat medium body port (8) in any one of [3] ( 1) is provided.
[ 5 ] In the present invention, a bubble trap (5) is externally attached to the housing (2) via a communication tube (22), and a body fluid discharge port (11) is attached to the bubble trap (5) [1] To a heat exchanger (1) according to any one of [4] .
[ 6 ] In the present invention, the heat exchanger (7) has an outer diameter : 20 to 30 mm, and a length : 50 to 100 mm .
Said housing (2) has an inner diameter: 20～31Mm, and length: has a 50 to 120 mm,
The heat exchanger (1) according to any one of [1] to [5] , wherein a priming amount on the body fluid side of the heat exchanger (7) is 5 to 15 mL.

〈１〉前記［１］に記載の発明によれば、
〈１−１〉ハウジング２の第一端部２Ａ側は、熱交換体７の第一端部外周と熱交換体おさえ１７の第二端部内周との間に、第二Ｏリング１５を配置して、当該第二Ｏリング１５で液密に固定し、かつ熱交換体７の第一端部内周と前記第一熱媒体ポート８の一端部外周との間に第一Ｏリング１４を配置して、当該第一Ｏリング１４で液密に固定し、
ハウジング２の第二端部２Ｂ側は、熱交換体７の第二端部内周と第二熱媒体ポート９の一端部外周との間に、第二Ｏリング１４を配置して、当該第二Ｏリング１５で液密に固定し、かつ熱交換体７の第二端部外周とハウジング２の第二端部２Ｂの内周との間に第一Ｏリング１５を配置し、当該第一Ｏリング１５で液密に固定しているので、
従来の熱交換器で使用されていた固定剤（ウレタン等のポッテイング剤）の経時劣化に起因する液漏れを確実に防止することができる。
さらにいえば、特許文献２（特開平１１−４７２６９号）のようにウレタン等のポッテイング剤（固定剤）を使用しないので、経時劣化がほとんどなく、液漏れが生じにくい。
〈１−２〉また各構成部品（成形品等）を高分子ポッテイング剤（例えば、ポリウレタン）ではなく、接着剤で固定できるので、気泡溜りが生じにくい。また各構成部品（成形品等）を間接的に高分子ポッテイング剤（例えば、ポリウレタン）で固定しても、構造上、高分子ポッテイング剤は、体液、熱媒体等と直接接触しないように形成されているので、気泡溜りが生じにくい。
〈１−３〉ハウジング２の両端部（第一端部２Ａと第二端部２Ｂ）に第一カバー３と第二カバー４を装着して、第一熱媒体ポート８と第二熱媒体ポート９をハウジング２を固定することにより、各部品の固定が安定化し、製造工程も簡素化することができる。特許文献２のようにウレタン等のポッテイング剤（固定剤）注入用の装置が不要であるから、手動で組み立て可能となる。
〈２〉前記［２］に記載の発明によれば、熱交換体おさえ１７の第二鍔部１７Ｂの体液ないし熱交換媒体との接液部分を鏡面に形成することにより、この部分に気泡が付着することがなく、また当該第二鍔部１７Ｂ側に突起部１７Ｃを形成することにより、プライミング時にハウジングの上下の隅に生じやすい気泡溜まりを防ぐことができる。
〈３〉前記［３］に記載の発明によれば、ハウジング２の長さ方向に沿って体液を分散ないし集合させることのできる空間ＳＰを形成しているので、熱交換性能が向上させることができる。
〈４〉前記［４］に記載の発明によれば、ハウジング２に連通管２２を介して気泡トラップ５を外付すること、及び／又は、内管６の上下にスリットＳを形成し、内管６の内部に、第一熱媒体ポート８から第二熱媒体ポート９または第二熱媒体ポート９から第一熱媒体ポート８へ熱媒体が直接流通するのを遮断し、旋回流として旋回させるための隔壁板１９を配置することにより、熱交換体（例えばベローズ管等）のサイズを従来のものよりも、はるかに小さくすることにより熱交換器全体のサイズをコンパクト化、軽量化することができる。
〈５〉熱交換体（例えばベローズ管等）のサイズを従来のものよりも、はるかに小さくすることにより、体液側のプライミング量を低減することにより、術中の体外循環血液（体液）量が最小限に抑えられる。
〈６〉熱交換器全体のサイズをコンパクト化したにもかかわらず、従来の熱交換器よりも熱交換性能が向上させることができる。
<1> According to the invention described in [1] above,
<1-1> On the first end 2 </ b > A side of the housing 2, the second O-ring 15 is disposed between the outer periphery of the first end of the heat exchanger 7 and the inner periphery of the second end of the heat exchanger retainer 17. Then, the first O-ring 14 is disposed between the inner periphery of the first end of the heat exchanger 7 and the outer periphery of the one end of the first heat medium port 8. Then, the first O-ring 14 is fixed in a liquid-tight manner,
On the second end 2B side of the housing 2, a second O-ring 14 is disposed between the inner periphery of the second end of the heat exchanger 7 and the outer periphery of one end of the second heat medium port 9. The first O-ring 15 is disposed between the outer periphery of the second end portion of the heat exchanger 7 and the inner periphery of the second end portion 2B of the housing 2. Since it is fixed liquid-tight with the ring 15,
It is possible to reliably prevent liquid leakage due to deterioration over time of a fixing agent (potting agent such as urethane) used in a conventional heat exchanger .
Furthermore, since no potting agent (fixing agent ) such as urethane is used as in Patent Document 2 (Japanese Patent Application Laid-Open No. 11-47269), there is almost no deterioration over time and liquid leakage hardly occurs.
<1-2> The respective components (molded articles) polymer Potte Lee ing agent (e.g., polyurethane) but since it adhesively secured, the bubble reservoir unlikely to occur. The indirectly polymer Potte Lee ing agent each component (molded product) (e.g., polyurethane) be fixed in, the structure, the polymer Potte Lee ing agent does not contact body fluids, direct the heat medium, and the like Therefore, it is difficult for bubble accumulation to occur.
<1-3> First cover 3 and second cover 4 are attached to both ends (first end 2A and second end 2B) of housing 2, and first heat medium port 8 and second heat medium port By fixing the housing 2 to 9, the fixing of each component is stabilized, and the manufacturing process can be simplified. Since a device for injecting a potting agent (fixing agent ) such as urethane is not required as in Patent Document 2, it can be assembled manually.
<2> According to the invention described in [2] above, by forming a liquid contact portion with the body fluid or the heat exchange medium of the second flange portion 17B of the heat exchange body retainer 17 on the mirror surface, bubbles are formed in this portion. By forming the projecting portion 17C on the second flange portion 17B side without adhering, it is possible to prevent bubble accumulation that tends to occur at the upper and lower corners of the housing during priming.
<3> According to the invention described in [3], since the space SP in which body fluid can be dispersed or gathered along the length direction of the housing 2 is formed, heat exchange performance can be improved. it can.
<4> According to the invention described in [4] above, the bubble trap 5 is externally attached to the housing 2 through the communication pipe 22 and / or the slits S are formed above and below the inner pipe 6, In the pipe 6, the direct flow of the heat medium from the first heat medium port 8 to the second heat medium port 9 or from the second heat medium port 9 to the first heat medium port 8 is blocked and swirled as a swirl flow. By arranging the partition plate 19 for the purpose, the size of the entire heat exchanger can be reduced and reduced in weight by making the size of the heat exchanger (for example, a bellows tube) much smaller than that of the conventional one. it can.
<5> Minimizing the amount of extracorporeal blood (body fluid) during surgery by reducing the priming amount on the body fluid side by making the size of the heat exchanger (eg, bellows tube) much smaller than the conventional one. It can be suppressed to the limit.
<6> Despite downsizing the overall size of the heat exchanger, the heat exchange performance can be improved compared to the conventional heat exchanger.

図１は、本発明の熱交換器の一例を示す外観図[（Ａ）正面図（Ｂ）平面図（Ｃ）底面図（Ｄ）左側面図（Ｅ）右側面図]、図２は本発明の熱交換器の拡大断面図、図３は図１のＡ―Ａ´断面図（Ｂ方向矢視図）である。
本発明の熱交換器１は、図１から図３に例示するように、筒状の細長いハウジング２と、当該ハウジング２の内部に配置される熱交換体７と、当該ハウジング２の端部に装着される気泡トラップ５とから構成される。
本発明の熱交換器１の構造の特徴は、ハウジング２の（大径の）第一端部２Ａ側は、熱交換体７の第一端部外周と熱交換体おさえ１７の第二端部内周との間に、第二Ｏリング１５を配置して、当該第二Ｏリング１５で液密に固定し、かつ熱交換体７の第一端部内周と前記第一熱媒体ポート８の一端部外周との間に第一Ｏリング１４を配置して、当該第一Ｏリング１４で液密に固定している点である。
またハウジング２の（小径の）第二端部２Ｂ側は、熱交換体７の第二端部内周と第二熱媒体ポート９の一端部外周との間に、第二Ｏリング１４を配置して、当該第二Ｏリング１５で液密に固定し、かつ熱交換体７の第二端部外周とハウジング２の第二端部２Ｂの内周との間に第一Ｏリング１５を配置し、当該第一Ｏリング１５で液密に固定している点である。
以下各構成部品ついて詳述する。
FIG. 1 is an external view showing an example of the heat exchanger of the present invention [(A) front view (B) plan view (C) bottom view (D) left side view (E) right side view], FIG. The expanded sectional view of the heat exchanger of the invention, FIG. 3 is a sectional view taken along the line AA ′ of FIG.
As illustrated in FIGS. 1 to 3, the heat exchanger 1 of the present invention includes a cylindrical elongated housing 2, a heat exchanger 7 disposed inside the housing 2, and an end of the housing 2. It is comprised from the bubble trap 5 with which it mounts | wears.
The feature of the structure of the heat exchanger 1 of the present invention is that the (large-diameter) first end 2A side of the housing 2 is located in the outer periphery of the first end of the heat exchanger 7 and the second end of the heat exchanger retainer 17. A second O-ring 15 is arranged between the circumference and fixed with the second O-ring 15 in a liquid-tight manner, and the inner circumference of the first end of the heat exchanger 7 and one end of the first heat medium port 8 The first O-ring 14 is disposed between the outer periphery and the first O-ring 14 is fixed in a liquid-tight manner.
Further, on the (small diameter) second end 2B side of the housing 2, a second O-ring 14 is disposed between the inner periphery of the second end of the heat exchanger 7 and the outer periphery of one end of the second heat medium port 9. The first O-ring 15 is disposed between the outer periphery of the second end of the heat exchanger 7 and the inner periphery of the second end 2B of the housing 2. The first O-ring 15 is fixed in a liquid-tight manner.
Each component will be described in detail below.

［ハウジング２］
ハウジング２は筒状に形成され、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に大径の第一端部２Ａと小径の第二端部２Ｂを有する。
大径の第一端部２Ａの開口部は、熱交換体７が挿入できる大きさに形成され、小径の第二端部２Ｂ側には、（環状の）段部２Ｄが形成され、当該段部２Ｄに熱交換体７の端部（注：図２の例示によれば蛇腹部分の端部）が突き当たって止まるようにしている。
また図１から図２に例示するように、ハウジング２の側部方向の底部には、体液室２１と連通する体液（心筋保護液）導入ポート１０が装着（一体成形）されている。
配置位置は、左右中央どの位置でも良い。
またハウジング２の側部方向であってかつ当該ハウジング２の長さ方向に沿って体液を分散ないし集合させることのできる空間ＳＰを形成している。
またハウジング２の内部には、円筒状の熱交換体７が配置される。
ハウジング２の内壁面と前記熱交換体７の外周面との間の空間により体液室２１を形成している。
また図１から図２に例示するように、ハウジング２には、体液室２１と連通する気泡トラップ５が外付けされている。
[Housing 2]
The housing 2 is formed in a cylindrical shape, and a side direction intersecting the longitudinal direction and the length direction substantially perpendicular, the second end of the first end portion 2A and the small diameter of the large diameter the lengthwise 2B.
The opening portion of the first end portion 2A having a large diameter is formed in a size that allows the heat exchanger 7 to be inserted, and a (annular) step portion 2D is formed on the second end portion 2B having a small diameter. The end of the heat exchanger 7 (note: the end of the bellows portion according to the illustration of FIG. 2) abuts against the portion 2D and stops.
Further, as illustrated in FIGS. 1 to 2, a body fluid (myocardial protective fluid) introduction port 10 communicating with the body fluid chamber 21 is attached (integrated molding) to the bottom of the housing 2 in the lateral direction .
The arrangement position may be any position in the center of the left and right.
Further, a space SP is formed in which the body fluid can be dispersed or gathered along the side direction of the housing 2 and along the length direction of the housing 2.
A cylindrical heat exchange body 7 is disposed inside the housing 2.
A body fluid chamber 21 is formed by a space between the inner wall surface of the housing 2 and the outer peripheral surface of the heat exchange body 7.
As illustrated in FIGS. 1 to 2, a bubble trap 5 communicating with the body fluid chamber 21 is externally attached to the housing 2.

［熱交換体７］
円筒状の熱交換体７は、ステンレス、アルミ等の金属もしくはポリエチレン、ポリカーボネート等の樹脂材料によりいわゆる細かな状に形成されている。
熱交換体７は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、長さ方向に第一端部と、第二端部とを有する。
なお熱交換体７の両端部（第一端部と第二端部）は（蛇腹を形成することなく）細径に形成され、その内外面は、第一Ｏリング１４と第二Ｏリング１５が密着できるようにフラット（平滑）に形成されている。
強度、熱交換効率の面からステンレス、アルミ等の金属が好ましい。特に、筒状熱交換体７の軸方向（中心軸）に対してほぼ直交する凹凸が多数繰り返された波状となっているベローズ管からなり、その外径はφ２０〜３０ｍｍ、谷部と山部の高さは２．０〜５．０ｍｍ程度が最も効率が良く、また熱交換器７の軸方向の長さは、使用される患者によって異なるが、５０〜１００ｍｍの範囲のものが好ましい。熱交換体７の体液側のプライミング量（ハウジング２の内壁面と熱交換体７の外周面との間の空間により形成される体液室２１のプライミング量を意味し、熱交換体７の蛇腹部分の空間も含む。気泡トラップ５の部分は含まない。）は５〜１５ｍＬと少ない方が効率は良い。
熱交換体７は熱交換体おさえ１７により、ハウジング２に固定される。
熱交換体７とハウジング２の隙間は０〜１ｍｍである。
[Heat Exchanger 7]
The cylindrical heat exchanger 7 is formed in a so-called fine shape from a metal such as stainless steel or aluminum or a resin material such as polyethylene or polycarbonate.
The heat exchange element 7 has a length direction and a side direction that intersects the length direction substantially perpendicularly, and has a first end and a second end in the length direction.
Both end portions (first end portion and second end portion) of the heat exchange element 7 are formed with a small diameter (without forming a bellows), and the inner and outer surfaces thereof are the first O-ring 14 and the second O-ring 15. It is formed flat (smooth) so that can adhere.
Metals such as stainless steel and aluminum are preferred in terms of strength and heat exchange efficiency. In particular, it consists of a bellows tube that has a wave shape in which irregularities substantially orthogonal to the axial direction (center axis) of the cylindrical heat exchanger 7 are repeated, and its outer diameter is φ20 to 30 mm, valley and peak The height of the heat exchanger 7 is most efficient when it is about 2.0 to 5.0 mm, and the axial length of the heat exchanger 7 varies depending on the patient to be used, but is preferably in the range of 50 to 100 mm. Priming amount of body fluid side of the heat exchanger 7 (refer priming amount of body fluid chamber 21 formed by the space between the inner wall and the outer circumferential surface of the heat exchanger 7 of the housing 2, the bellows portion of the heat exchanger 7 (The portion of the bubble trap 5 is not included.) Is as low as 5 to 15 mL.
The heat exchanger 7 is fixed to the housing 2 by a heat exchanger holder 17.
The clearance between the heat exchanger 7 and the housing 2 is 0 to 1 mm.

［熱交換体おさえ１７］
熱交換体おさえ１７は熱交換体７を押さえながらハウジング２に固定する部品である。熱交換体おさえ１７は、略円筒状（略環状も含む）に形成され、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に第一端部と、第二端部とを有する。
両端部に、すなわち第一端部に第一鍔部１７Ａ、第二端部側に第二鍔部１７Ｂを有し、第二鍔部１７Ｂ側に突起部１７Ｃを形成している。
図２の例示によれば本体（中央の略円筒状部）と第一鍔部１７Ａの形状は、ハウジング２の小径の第二端部２Ｂと段部２Ｄの形状と実質的に同じ形状に形成されている。
熱交換体おさえ１７の内周と熱交換体７の端部外周との間に後述する第一Ｏリングおさえ１６を配置して、これらの液密性を維持している。
熱交換体おさえ１７とハウジング２は、接着剤で固定するか、相互の接触部に係合ないし係止用の突起ないし溝を形成して固定するか、或いはテーパー嵌合等により固定しても良い。また熱交換体おさえ１７とハウジング２の隙間があまり多い場合は、ウレタンなどの高分子ポッテイング剤Ｐで塞ぐことができる。なお当該高分子ポッテイング剤は、図２に例示するように第二鍔部１７Ｂとハウジング２との隙間を少なくすること（ほとんど密着に近い）により、体液、熱媒体等と直接接触しないように形成されているので、気泡溜りが生じにくい。
また熱交換体７の端部（蛇腹の端部）を押さえる面（第二鍔部１７Ｂ側の前方壁面、第二鍔部１７Ｂの体液ないし熱交換媒体との接液部分）を鏡面に形成することにより、この部分に気泡が付着することがなく、当該第二鍔部１７Ｂ側に爪状の突起部１７Ｃをハウジングの側部方向の上方かつまたは下方（底部）に配置されるように、形成することにより、プライミング時にハウジングの上下の隅に生じやすい気泡溜まりを防ぐことができる。
[Heat exchange body presser 17]
The heat exchanger holder 17 is a component that is fixed to the housing 2 while holding the heat exchanger 7. The heat exchanging body presser 17 is formed in a substantially cylindrical shape (including a substantially annular shape), has a length direction and a side direction that intersects the length direction substantially perpendicularly, and has a first end portion in the length direction. And a second end.
At both ends , that is, the first end portion has a first flange portion 17A , the second end portion side has a second flange portion 17B, and a projection portion 17C is formed on the second flange portion 17B side.
According to the illustration of FIG. 2, the main body (substantially cylindrical portion in the center) and the first flange portion 17 </ b> A are formed in substantially the same shape as the second end portion 2 </ b> B and the step portion 2 </ b> D of the small diameter of the housing 2. Has been.
A first O-ring retainer 16 described later is disposed between the inner periphery of the heat exchanger element 17 and the outer periphery of the end of the heat exchanger element 7 to maintain these liquid tightnesses.
The heat exchanger holder 17 and the housing 2 may be fixed with an adhesive, fixed by forming protrusions or grooves for engagement or locking at mutual contact portions, or fixed by taper fitting or the like. good. In addition, when the gap between the heat exchanger holder 17 and the housing 2 is too large, it can be closed with a polymer potting agent P such as urethane. The polymer potting agent is formed so as not to come into direct contact with body fluids, heat medium, etc. by reducing the gap between the second flange 17B and the housing 2 (almost close to adhesion) as illustrated in FIG. Therefore, it is difficult for bubble accumulation to occur.
Further, a surface for pressing the end (the bellows end) of the heat exchange element 7 (a front wall surface on the second flange part 17B side, a part in contact with the body fluid or the heat exchange medium of the second flange part 17B) is formed on the mirror surface. In this way, there is no air bubble adhering to this part, and the claw-like projection 17C is formed on the second flange part 17B side so as to be arranged above and below (bottom part) in the side part direction of the housing. By doing so, it is possible to prevent bubble accumulation that tends to occur at the upper and lower corners of the housing during priming.

［内管６］
熱交換体７の内部に、細長い内管６が配置される。内管６は、長さ方向と当該長さ方向と略垂直に交わる側部方向とを有し、前記長さ方向に第一端部と、第二端部とを有する。
内管６の第一端部に、熱媒体室２０と連通する第一熱媒体ポート８の一端部を装着し、内管６の第二端部に、熱媒体室２０と連通する第二熱媒体ポート９の一端部を装着している。
内管６の内部空間により熱媒体室２０を形成し、内管６の側部方向の上下には、図１、３に例示するように熱媒体を熱交換体７（ベローズ）内部へ連通させるための複数のスリットＳが形成されている。（図２では、例示的にスリットＳの一部を中央部に記載しているが、実際には内管６の長さ方向のほぼ全域に亘って形成される。）
スリットＳは０．５ｍｍ〜５ｍｍの溝あるいは開放面積が４０ｍｍ²〜４００ｍｍ²の隙間（狭いと圧力損失の増大、広いと流速低下）が望ましい。
さらに内管６内には、隔壁板１９を斜めに傾斜して配置し、第一熱媒体ポート８から第二熱媒体ポート９または第二熱媒体ポート９から第一熱媒体ポート８へ熱媒体が直接流通するのを遮断し旋回流として旋回させる。
すなわち第一熱媒体ポート８または第二熱媒体９から導入される熱媒体は、上または下のスリットＳを経て、熱交換体７（ベローズ）内部の溝Ｍに流入し、反対側の下または上のスリットＳを経て、再び内管６内に流入し、反対側の第二の熱媒体ポート９または第一の熱媒体ポート８から排出される。
[Inner pipe 6]
An elongated inner tube 6 is disposed inside the heat exchanger 7. The inner tube 6 has a length direction and a side direction that intersects the length direction substantially perpendicularly, and has a first end portion and a second end portion in the length direction.
One end of the first heat medium port 8 communicating with the heat medium chamber 20 is attached to the first end of the inner tube 6, and the second heat communicating with the heat medium chamber 20 is connected to the second end of the inner tube 6. One end of the medium port 9 is attached.
A heat medium chamber 20 is formed by the inner space of the inner pipe 6, and the heat medium is communicated with the heat exchanger 7 (bellows) inside the upper and lower sides of the inner pipe 6 as illustrated in FIGS. For this purpose, a plurality of slits S are formed. (In FIG. 2, a part of the slit S is exemplarily shown in the central portion, but in actuality, it is formed over almost the entire area of the inner tube 6 in the length direction.)
Slit S is (increased narrow pressure loss, wide flow velocity decreases) grooves or open area is 40mm ^² ~400mm ² of the gap 0.5mm~5mm is desirable.
Further, a partition plate 19 is disposed obliquely in the inner pipe 6, and the heat medium is transferred from the first heat medium port 8 to the second heat medium port 9 or from the second heat medium port 9 to the first heat medium port 8. Is blocked from direct circulation and swirled as a swirling flow.
That is, the heat medium introduced from the first heat medium port 8 or the second heat medium 9 flows into the groove M inside the heat exchanger 7 (bellows) through the upper or lower slit S, and the lower or It flows into the inner pipe 6 again through the upper slit S and is discharged from the second heat medium port 9 or the first heat medium port 8 on the opposite side.

［第一熱媒体ポート８、第二熱媒体ポート９］
図２に例示するように、ハウジング２の両端部には、熱媒体室２０と連通する第一熱媒体ポート８と第二熱媒体ポート９が装着されている。
すなわち第一熱媒体ポート８と第二熱媒体ポート９は内管６と連通するように接続されている。
第一熱媒体ポート８と第二熱媒体ポート９と内管６とは、相互の接触部に係合ないし係止用の突起ないし溝を形成して固定するか、或いはテーパー嵌合等により固定しても良い。また接着剤を用いて固定しても良い。
第一熱媒体ポート８と第二熱媒体ポート９のハウジング２側の一端部外周は、凹凸の少ない曲面（管状体）になっており、熱交換体７の端部内面と第一熱媒体ポート８と第二熱媒体ポート９の端部外周との間に第一Ｏリング１４を配置して、これらの液密性を維持している。
第一熱媒体ポート８と第二熱媒体ポート９は図１、２の例示では、エルボ状（Ｌ字で下向き）に形成されているが、ストレート状に（まっすぐ横に伸びるように）形成しても良い。要するに市販のカプラ栓に接続できる形状であれば良い。
[ First heat medium port 8 , second heat medium port 9]
As illustrated in FIG. 2, a first heat medium port 8 and a second heat medium port 9 communicating with the heat medium chamber 20 are attached to both ends of the housing 2.
That is, the first heat medium port 8 and the second heat medium port 9 are connected so as to communicate with the inner pipe 6.
A first heat medium port 8 and the second heat medium port 9 and the inner tube 6 fixed, or fixed to form a projection or groove for engaging or locking the contact portion of one another, or by taper fitting, etc. You may do it. Moreover, you may fix using an adhesive agent.
A first heat medium ports 8 one end periphery of the housing 2 side of the second heat medium port 9 is a curved surface (tubular body) less uneven, end inner surface and the first heat medium of the heat exchanger 7 port 8 and by the first O-ring 14 is disposed between the outer circumference of the end portion of the second heat medium port 9, it maintains these liquid tightness.
In the example of FIGS. 1 and 2, the first heat medium port 8 and the second heat medium port 9 are formed in an elbow shape (L-shaped downward), but are formed in a straight shape (straightly extending sideways). May be. In short, any shape that can be connected to a commercially available coupler plug may be used.

［第一のカバー３と第二のカバー４］
ハウジング２は両端部に、第一のカバー３と第二のカバー４を装着し、第一熱媒体ポート８と第二熱媒体ポート９をハウジング２に固定している。
第一のカバー３と第二のカバー４は、ハウジング２と第一熱媒体ポート８と第二熱媒体ポート９の固定を強固にする部品である。
また第二のカバー４に、連通管２２の装着溝（図示せず）を形成することにより、気泡トラップ５も合わせて固定できる。
また第一のカバー３と第二のカバー４は、第一熱媒体ポート８と第二熱媒体ポート９がストレートであれば一部品で良いがＬ字の場合は二部品（例えば半円筒状の二ピースに分割したもの）なる。二部品の場合の接続は、相互の接触部に係合ないし係止用の突起ないし溝を形成して固定するか、或いはテーパー嵌合等により固定しても良い。また接着剤を用いて固定しても良い。
[ First cover 3 and second cover 4]
The housing 2 is provided with a first cover 3 and a second cover 4 at both ends, and the first heat medium port 8 and the second heat medium port 9 are fixed to the housing 2.
The first cover 3 and the second cover 4 are components that firmly fix the housing 2, the first heat medium port 8, and the second heat medium port 9.
Further, by forming a mounting groove (not shown) for the communication pipe 22 in the second cover 4, the bubble trap 5 can be fixed together.
The first cover 3 and the second cover 4 may be one part if the first heat medium port 8 and the second heat medium port 9 are straight, but two parts (for example, a semi-cylindrical shape) Divided into two pieces). The connection in the case of two parts may be fixed by forming protrusions or grooves for engagement or locking at mutual contact portions, or may be fixed by taper fitting or the like. Moreover, you may fix using an adhesive agent.

［第一Ｏリングおさえ１６、第二Ｏリングおさえ１８］
本発明では、第一Ｏリング１４と第二Ｏリング１５を前記のように各部品（熱交換体７、熱交換体おさえ１７、第一熱媒体ポート８と第二熱媒体ポート９）との間に配置して、各部品を液密に固定しているが、隙間ができるので各部品の間に第一Ｏリング１４と第二Ｏリング１５が振動などで動かないように隙間を減らす部品である。一部品でも二部品（例えば半円（筒）状の二ピースに分割したもの）でも良い。また成形品である必要もなく要するに第一Ｏリング１４と第二Ｏリング１５を動きにくくすることができれば良いのでウレタンのように固化する充填剤で代替しても良い。
第一Ｏリングおさえ１６、第二Ｏリングおさえ１８は、製品上なくてはならないものではなく、安全性の向上のためできればあったほうが良い部品である。
［気泡トラップ５］
気泡トラップ５は連通管２２を介してハウジング２上側部に装着され、側部に体液排出ポート１１、天面に気泡抜きポート１２、側部に温度センサー装着ポート１３、内部に１００〜２００メッシュのフィルター２３が装着されている。異物や凝固血が存在した場合にフィルター２３上に捕捉することができる。フィルターの材質はポリエステル系やポリウレタン等が用いられる。
[ First O-ring presser 16, second O-ring presser 18]
In the present invention, the first O-ring 14 and the second O-ring 15 are connected to the respective components (the heat exchanger 7, the heat exchanger 17 and the first heat medium port 8 and the second heat medium port 9) as described above . The components are arranged in between, and each component is fixed in a liquid-tight manner. However, since there is a gap, a component that reduces the gap so that the first O-ring 14 and the second O-ring 15 do not move due to vibration or the like between the components. It is. One part or two parts (for example, one divided into two pieces of semicircle (cylinder) shape) may be used. In addition, the first O-ring 14 and the second O-ring 15 need only be made difficult to move without being a molded product, and may be replaced with a filler that solidifies like urethane.
The first O-ring retainer 16 and the second O-ring retainer 18 are not indispensable on the product, but are better parts if possible to improve safety.
[Bubble trap 5]
The bubble trap 5 is attached to the upper part of the housing 2 through the communication pipe 22, the body fluid discharge port 11 on the side, the bubble removal port 12 on the top, the temperature sensor attachment port 13 on the side, and 100 to 200 mesh inside. A filter 23 is attached. When foreign matter or coagulated blood is present, it can be captured on the filter 23. The filter material is polyester or polyurethane.

本発明の熱交換器１は、例えば以下のように使用される。
（１）温水等の熱媒体は、第一熱媒体ポート８または第二熱媒体ポート９のいずれかから熱媒体室２０内に導入され、他方の第一熱媒体ポート８または第二熱媒体ポート９のいずれかから排出される。すなわちシングルパスで、熱媒体室２０内を通過する。
熱媒体室２０には隔壁板１９（一体成型で内管６内に配置された）が配置されているので、例えば第一熱媒体ポート８より流入した熱媒体は、図４に例示するように内管６の上側のスリットＳを介して熱交換体７（ベローズ）内側の溝Ｍに沿って流れ、内管６の下側のスリットＳより再び内管６内に入り第二熱媒体ポート９より流出する。また例えば第二ポート９より流入した熱媒体は、内管６の下側のスリットＳを介して熱交換体７（ベローズ）内側の溝Ｍに沿って流れ、内管６の上側のスリットＳより再び内管６内に入り第一熱媒体ポート８より流出する。
（２）体液導入ポート１０から血液を導入すると、血液は、体液室２１の底部から熱交換体７の外周を旋回しながら天井部へ向けて、移動し、連通管２２、気泡トラップ５を経て、体液排出ポート１１から排出される。
（３）血液中に含まれる気泡は、気泡トラップ５内で捕捉され、気泡抜きポート１２より排出される。
The heat exchanger 1 of the present invention is used as follows, for example.
(1) A heat medium such as hot water is introduced into the heat medium chamber 20 from either the first heat medium port 8 or the second heat medium port 9, and the other first heat medium port 8 or second heat medium port. 9 is discharged. That is, it passes through the heat medium chamber 20 in a single pass.
Since the partition plate 19 (arranged in the inner tube 6 by integral molding) is disposed in the heat medium chamber 20, for example, the heat medium flowing in from the first heat medium port 8 is as illustrated in FIG. It flows along the groove M inside the heat exchanger 7 (bellows) through the slit S on the upper side of the inner tube 6, enters the inner tube 6 again from the slit S on the lower side of the inner tube 6, and enters the second heat medium port 9. More outflow. Further, for example, the heat medium flowing in from the second port 9 flows along the groove M inside the heat exchanger 7 (bellows) through the slit S on the lower side of the inner tube 6, and from the slit S on the upper side of the inner tube 6. It enters the inner pipe 6 again and flows out from the first heat medium port 8.
(2) When blood is introduced from the bodily fluid introduction port 10, the blood moves from the bottom of the bodily fluid chamber 21 toward the ceiling while turning the outer periphery of the heat exchange body 7, and passes through the communication pipe 22 and the bubble trap 5. The fluid is discharged from the body fluid discharge port 11.
(3) Bubbles contained in the blood are captured in the bubble trap 5 and discharged from the bubble removal port 12.

次に本発明の熱交換器（実施例）と従来の熱交換器（比較例１、２）について、プライミング量、圧力損失、熱交換率等について示す。
（実施例）本発明の熱交換器（実施例）は、図１ないし図２に例示したものを使用した。
（比較例）比較例１は、AVECOR製 MYOtherm、比較例２は川澄化学工業製 Plegiorを使用した。実施例と比較例１、２の熱交換体の寸法（外径×長さ）と山の高さは、表１に記載のものを使用した。実施例と比較例１は熱交換体としてステンレス製ベローズを使用し、比較例２の熱交換体はアルミネジ状パイプを使用した。
なお実施例のハウジングは長さが９５ｍｍ、外径が３０ｍｍ、内径２６ｍｍ、内管６は長さが８４ｍｍ、外径が１７ｍｍ、内径１３ｍｍのものを使用した。
（実験）上記の実施例および比較例１、２の熱交換器について、体液流速５００ｍＬ／ｍｉｎ（２２℃）、熱媒体流速４Ｌ／ｍｉｎ（０℃）における圧力損失、熱媒体のプライミング量、熱交換率を測定した。
圧力損失は体液側の導入口側圧力と排出口側圧力をハンディマノメータ（COPAL ELECTRONICS）で測定し、次式により求めた。
圧力損失＝導入口側圧力−排出口側圧力
熱交換率は体液側に２２℃の水を５００ｍＬ／ｍｉｎの速度で、熱媒体（冷却水）側に０℃の水を４Ｌ／ｍｉｎの速度で流し、体液排出口側の温度と熱媒体（冷却水）導入口側の温度をサーモメータ（日機装YSI4000）にて測定し、次式により求めた。なお、体液側の水はクラレKM-30D、熱媒体（冷却水）側の水はトラベノールCOMPU-FLOの血液ポンプを用いた。
熱交換率＝（体液側排出口温度−２２）÷（冷却水導入口温度−２２）
結果は、以下に示す表１の通りであった。
表１の結果により、本実施例の熱交換器は、比較例１、２のものよりも、熱交換体７の寸法を大幅に小型化でき、熱交換体の体液側のプライミング量を省力化できる。このように小型化しても圧力損失が小さく、熱交換率も向上させることができることが確認できた。

Next, the priming amount, pressure loss, heat exchange rate, etc. will be described for the heat exchanger of the present invention (Example) and conventional heat exchangers (Comparative Examples 1 and 2).
(Example) As the heat exchanger (example) of the present invention, the heat exchanger illustrated in FIGS. 1 and 2 was used.
(Comparative Example) Comparative Example 1 used MYOtherm manufactured by AVECOR, and Comparative Example 2 used Plegior manufactured by Kawasumi Chemical Industry. The dimensions shown in Table 1 were used for the dimensions (outer diameter x length) and the height of the peaks of the heat exchangers of Examples and Comparative Examples 1 and 2. In Example and Comparative Example 1, a stainless steel bellows was used as a heat exchanger, and an aluminum threaded pipe was used as the heat exchanger in Comparative Example 2.
The housing of the example was 95 mm in length, the outer diameter was 30 mm, the inner diameter was 26 mm, and the inner tube 6 was 84 mm in length, the outer diameter was 17 mm, and the inner diameter was 13 mm.
(Experiment) About the heat exchanger of said Example and Comparative Examples 1 and 2, the pressure loss at the body fluid flow rate of 500 mL / min (22 degreeC), the heat medium flow rate of 4 L / min (0 degreeC), the priming amount of a heat medium, heat The exchange rate was measured.
The pressure loss was determined by the following equation by measuring the inlet side pressure and the outlet side pressure on the body fluid side with a handy manometer (COPAL ELECTRONICS).
Pressure loss = inlet side pressure-outlet side pressure The heat exchange rate is 22 mL water at the body fluid side at a rate of 500 mL / min and 0 ° C water at the heat medium (cooling water) side at a rate of 4 L / min. The temperature at the body fluid discharge port side and the temperature at the heat medium (cooling water) inlet port side were measured with a thermometer (Nikkiso YSI4000) and calculated by the following equation. The body fluid side water used was a Kuraray KM-30D and the heat medium (cooling water) side water used was a Trabenol COMPU-FLO blood pump.
Heat exchange rate = (body fluid side outlet temperature−22) ÷ (cooling water inlet temperature−22)
The results were as shown in Table 1 below.
From the results shown in Table 1, the heat exchanger of the present example can greatly reduce the size of the heat exchanger 7 compared to those of Comparative Examples 1 and 2, and the priming amount on the body fluid side of the heat exchanger can be saved. it can. It was confirmed that the pressure loss is small and the heat exchange rate can be improved even if the size is reduced.

本発明の熱交換器の外観図［（Ａ）正面図（Ｂ）平面図（Ｃ）底面図（Ｄ）左側面図（Ｅ）右側面図］External view of heat exchanger of the present invention [(A) front view (B) plan view (C) bottom view (D) left side view (E) right side view] 本発明の熱交換器の拡大断面図Enlarged sectional view of the heat exchanger of the present invention 図１のＡ−Ａ´断面図（Ｂ方向矢視図）AA 'sectional view of FIG. 1 (B direction arrow view)

Explanation of symbols

１熱交換器
２ハウジング
２Ａ第一端部（大径部）
２Ｂ第二端部（小径部）
２Ｄ（第二端部２Ｂの段部）
３第一のカバー
４第二のカバー
５気泡トラップ
６内管
Ｓスリット
７熱交換体（ベローズ）
Ｍ溝
８第一熱媒体ポート
９第二熱媒体ポート
１０体液導入ポート
１１体液排出ポート
１２気泡抜きポート
１３温度センサー装着ポート
１４第一Ｏリング
１５第二Ｏリング
１６第一Ｏリングおさえ（おさえ部材）
１８第二Ｏリングおさえ（おさえ部材）
１７熱交換体おさえ（おさえ部材）
１７Ａ第一鍔部
１７Ｂ第二鍔部
１７Ｃ突起部
１９隔壁板
２０熱媒体室
２１体液室
２２連通管
２３フィルター
Ｐポッテイング剤 1 Heat Exchanger 2 Housing 2A First End (Large Diameter)
2B Second end (small diameter part)
2D (Stepped portion of the second end 2B)
3 First cover 4 Second cover 5 Bubble trap 6 Inner tube S Slit 7 Heat exchanger (bellows)
M Groove 8 First heat medium port 9 Second heat medium port 10 Body fluid introduction port 11 Body fluid discharge port 12 Air bubble removal port 13 Temperature sensor mounting port 14 First O ring 15 Second O ring 16 First O ring presser (holding member )
18 2nd O-ring presser (presser member)
17 Heat exchanger presser (presser member)
17A 1st collar part 17B 2nd collar part 17C Projection part 19 Partition plate 20 Heat medium chamber 21 Body fluid chamber 22 Communication pipe 23 Filter P Potting agent

Claims

The housing (2) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and has a large diameter first end (2A) and a small diameter second end ( 2B) and has,
In the housing (2), a cylindrical heat exchanger body (7) is arranged,
The heat exchanger (7) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and has a first end portion and a second end portion in the length direction,
To the heat exchanger (7) in the inner tube (6) is arranged,
The inner pipe (6) has a length direction and a side direction that intersects the length direction substantially perpendicularly, and has a first end and a second end in the length direction,
A heat medium chamber (20) is formed by the internal space of the inner pipe (6),
A body fluid chamber (21) is formed by a space between the inner wall surface of the housing (2) and the outer peripheral surface of the heat exchange body (7),
Holding the heat exchanger (17) mounted to the first end of the heat exchanger (7),
The heat exchanging body presser (17) has a length direction and a side portion direction that intersects the length direction substantially perpendicularly, and has a first end portion and a second end portion in the length direction. ,
One end of the first heat medium port (8) communicating with the heat medium chamber (20) is attached to the first end of the inner pipe (6), and the second end of the inner pipe (6) is attached. Attaching one end of the second heat medium port (9) communicating with the heat medium chamber (20),
A body fluid introduction port (10) communicating with the body fluid chamber (21) is mounted in the side direction of the housing (2),
A first cover (3) is attached to the first end of the housing (2), a second cover (4) is attached to the second end,
One end of the first heat medium port (8) is connected to the first end (2A) of the housing (2), and one end of the second heat medium port (9) is connected to the first end of the housing (2). Secure to the two ends (2B) ,
The first end (2A) side of the housing (2) is
A second O-ring (15) is disposed between the outer periphery of the first end of the heat exchanger (7) and the inner periphery of the second end of the heat exchanger retainer (17), and the second O-ring (15) Fix the liquid tightly,
A first O-ring (14) is arranged between the inner periphery of the first end of the heat exchanger (7) and the outer periphery of the one end of the first heat medium port (8). ) Liquid tightly fixed,
The second end (2B) side of the housing (2) is located between the inner periphery of the second end of the heat exchanger (7) and the outer periphery of one end of the second heat medium port (9). Place the O-ring (14) and fix it liquid-tight with the second O-ring (15),
A first O-ring (15) is disposed between the outer periphery of the second end of the heat exchanger (7) and the inner periphery of the second end (2B) of the housing (2), and the first O-ring A heat exchanger (1) characterized by being liquid-tightly fixed in (15 ).

Holding said heat exchanger (17) is formed in a substantially cylindrical shape, the first flange portion to said first end portion (17A), a second flange portion (17B) to said second end, said first Form the liquid contact part with the body fluid or heat exchange medium of the second collar part (17B) on the mirror surface,
The heat exchanger (1) according to claim 1, wherein a protrusion (17C) is formed on the second flange (17B) side.

The space (SP) in which bodily fluids can be dispersed or gathered is formed in a side part direction of the housing (2) and along a length direction of the housing (2). The heat exchanger (1) according to claim 2.

A slit (S) to the side direction of the top and bottom of the inner tube (6), inside, the second heat medium port from said first heat medium port (8) of the inner tube (6) ( 9) or heating medium to block the flowing directly from the second heat medium port (9) to the first heat medium port (8), arranged partition plate (19) for pivoting,
The first heat medium port (8) or the heat medium introduced from the second heat medium port (9) is, via the top or bottom of the slits in the inner pipe (6) (S), said heat exchanger ( 7) flows into the groove (M) inside,
It flows again into the inner pipe (6) through the lower or upper slit (S) of the inner pipe (6) on the opposite side,
According to claims 1, characterized in that formed so as to be discharged from the second heat medium port (9) or the first heat medium body opposite port (8) in any one of claims 3 Heat exchanger (1).

Subjected outside the bubble trap (5) through the communicating tubes (22) in the housing (2), to the bubble trap (5), claim 1, characterized in that wearing the body fluid discharge port (11) The heat exchanger (1) according to any one of claims 4 .

The heat exchanger (7) has an outer diameter : 20-30 mm, and a length : 50-100 mm ,
Said housing (2) has an inner diameter: 20～31Mm, and length: has a 50 to 120 mm,
Priming amount of body fluid side of the heat exchanger (7), the heat exchanger as claimed in any one of claims 5, characterized in that the 5-15 mL (1).