JP2009297437A - Medical heat exchanger, its method for manufacturing and oxygenator apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To improve a heat exchange efficiency while suppressing the volume of a blood passage by a simple structure for sequentially passing heat medium liquid to a plurality of steps of tubule bundle. <P>SOLUTION: This medical heat exchanger is provided with a tubule bundle module 2 formed of a plurality of heat-transfer tubules 1, sealing members 3a-3c forming a blood passage 5 and sealing the tubule bundle module, wherein both ends of the heat-transfer tubules are exposed, and cold/warm water headers 6 and 7 forming fluid chambers surrounding both ends of the tubule bundle module. The tubule bundle module is divided into a laminated structure of tubule bundles 12a-12c and clearances are formed among the respective tubule bundles by spacers 13. The fluid chamber is partitioned into fluid compartments by partition walls 6b and 7b, the cold/warm water sequentially passes through the plurality of steps of tubule bundle from a fluid compartment 14b and outflows from the fluid compartment 15a. Interposing members 20 having passages communicated with the blood passage 5 are disposed in the clearances of the tubule bundles in the blood passage. The pair of spacers are connected by a pair of connecting crosspieces disposed at both sides of the tubule bundles, and the interposed members are connected to and integrated with the connection crosspieces. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a heat exchanger, particularly a medical heat exchanger suitable for use in a medical device such as a heart-lung machine, a manufacturing method thereof, and an oxygenator equipped with the same.

  In cardiac surgery, a heart-lung machine is used to stop the patient's heart and perform breathing and circulatory functions during that time. Also, during surgery, the patient's oxygen consumption is reduced, so the patient's body temperature needs to be lowered and maintained. For this reason, the oxygenator is provided with a heat exchanger for controlling the temperature of blood taken from the patient.

  As such medical heat exchangers, conventionally, a bellows tube type heat exchanger and a multi-tube type heat exchanger (for example, see Patent Document 1) are known. Of these, the multi-tubular heat exchanger has the same capacity as the bellows tube heat exchanger, so a large heat exchange area can be obtained, so heat exchange compared to the bellows tube heat exchanger There is an advantage of high efficiency.

  A conventional multi-tube heat exchanger will be described with reference to FIGS. 11A to 11C. 11A is a top view of a multi-tube heat exchanger, and FIG. 11B is a side view. FIG. 11C is a perspective view showing the inside of the housing of the heat exchanger, partially shown in cross section.

  This heat exchanger accommodates a thin tube bundle module 102 composed of a plurality of heat transfer thin tubes 101 through which cold / hot water that is a heat medium liquid flows, seal members 103a to 103c that seal the thin tube bundle module 102, and these Housing 104.

  The plurality of heat transfer thin tubes 101 are arranged in parallel and stacked to form a thin tube bundle. As shown in FIGS. 11A and 12C, the central seal member 103c circulates blood, which is a heat exchange liquid, across the surface of each heat transfer thin tube 101 in the central portion in the longitudinal direction of the thin tube bundle module 102. A blood channel 105 having a circular cross section is formed as a heat exchange channel for the purpose. The seal members 103a and 103b at both ends expose both ends of the thin tube bundle module 102, respectively.

  The housing 104 is provided with a blood inlet 106 for guiding blood into the housing and a blood outlet 107 for guiding blood from the housing facing both ends of the blood channel 105. Further, a gap 108 is provided between each of the seal members 103 a to 103 c, and a leakage discharge hole 109 corresponding to the gap 108 is provided in the housing 102.

  In the above configuration, blood is caused to flow from the blood inlet 106 to flow out of the blood outlet 107 through the blood channel 105. At the same time, as shown in FIG. 11A and FIG. 11B, cold / hot water is caused to flow from one exposed end of the thin tube bundle module 102 and to flow out from the other exposed end. Thereby, heat exchange is performed between the blood and the cold / hot water in the blood channel 105.

The gap 108 is provided to detect leakage when blood or cold / hot water leaks due to seal leakage. That is, when there is a seal leak of the third seal member 103c, the leaked blood appears in the gap 108, so that the leak can be detected. In addition, even when cold / warm water leaks due to seal leakage of the first seal member 103a or the second seal member 103b, the leaked cold / warm water appears in the gap 108, and leakage can be detected. The blood or cold / hot water that has flowed into the gap 108 is discharged from the leak discharge hole 109 to the outside of the heat exchanger.
JP-A-2005-224301

  It is required to further improve the heat exchange efficiency for the multi-tube heat exchanger as described above. That is, it is necessary to improve the heat exchange efficiency in order to reduce the blood filling amount in the blood channel 105 as much as possible and to obtain a sufficient heat exchange capability.

In the case of the heat exchanger for artificial lungs examined by the present inventors, it has been found that the heat exchange efficiency is desirably 0.43 or more in practice. The heat exchange area required to clear this target value was 0.014 m ² when the blood flow rate was ² L / min. When this is applied to a structure in which the capacity of the heat exchanger is improved to a blood flow rate of 7 L / min, the heat exchange area simulation results in a heat exchange efficiency of 0.049 m ² in order to obtain a heat exchange efficiency of 0.43 or more. It was found that an exchange area was necessary.

For example, when the heat transfer thin tube 1 having an outer diameter of 1.25 mm is used, it is understood that a heat exchange area of 0.057 m ² can be obtained if the number of laminated heat transfer thin tubes 101 (the number of thin tube layers) is six. . However, when heat exchange efficiency was measured using such a heat exchange module composed of the six-layered thin tube bundle module 102 and the opening diameter of the blood channel 105 being 70 mm, it was much lower than the target value of 0.24. Only the value was obtained.

  Therefore, a heat exchange module 101 having an outer diameter of 1.25 mm, an opening diameter of the blood channel 105 of 70 mm, and a number of thin tube layers increased in various ways, and the heat exchange efficiency was measured. In order to clear the heat exchange efficiency of 0.43, it was found that the number of thin tube layers must be 18 or more. However, if the number of thin tube layers is 18 under the above-mentioned conditions, the blood filling amount in the blood flow path is 42.3 mL, far exceeding the desired value of 30 mL, which is the blood filling amount. In order to reduce the blood filling amount to 30 mL or less, according to the calculation, the number of tubule layers must be 13 layers or less.

  Thus, it is difficult to obtain a desired heat exchange efficiency by simply increasing the heat exchange area. Therefore, we analyzed the cause that seems to reduce the heat exchange efficiency. As a result, it has been found that the influence of the flow rate of the cold / hot water flowing through the lumen of the heat transfer thin tube is large as a cause of reducing the heat exchange efficiency. This is considered to be due to the fact that the flow rate of cold / hot water affects the change in the film resistance.

  Therefore, the present invention has a configuration of a heat exchanger capable of improving heat exchange efficiency while appropriately controlling the flow of cold / hot water in the lumen of the heat transfer thin tube and suppressing the volume of the blood flow path to be small. Was examined. As a result, the thin tube bundle module is divided in the direction of the blood flow path (longitudinal direction) to form a laminated structure of a plurality of thin tube bundles each including a plurality of heat transfer thin tubes. It has been found that a configuration in which the thin tube bundle is sequentially passed is effective.

  For this purpose, if a spacer is mounted between a plurality of stages of thin tube bundles and a predetermined length interval is formed between each stage, a simple configuration can be realized in which cold and hot water sequentially passes through the thin tube bundles in a desired order. . When such a spacer is used, in the region of the seal member in which the thin tube bundle module is sealed, the portion corresponding to the interval between the stages is filled with the material of the seal member, so that no gap remains.

  However, in the region in the blood flow path, a spacer corresponding to the interval is formed between the stages of the thin tube bundle by mounting the spacer. This gap causes an increase in the filling amount of blood in the blood channel.

  Therefore, the present invention improves the heat exchange efficiency by a simple structure for sequentially passing the heat medium liquid through a bundle of thin tubes of a plurality of stages in the vertical direction, and further increases the volume of the blood flow path due to the gap between the stages. An object of the present invention is to provide a medical heat exchanger having a structure that can be easily manufactured for suppression.

  The medical heat exchanger according to the present invention has a thin tube bundle module formed by arranging and laminating a plurality of heat transfer thin tubes through which a heat medium liquid is circulated in a lumen, and both ends of the heat transfer thin tubes are exposed. Sealing the thin tube bundle module, containing a seal member having a blood flow path through which blood passes so as to contact the outer surface of each of the heat transfer thin tubes, and containing the seal member and the thin tube bundle module, A housing having blood inlets and outlets facing both ends of the blood flow path, and a flow chamber formed so as to surround both ends of the thin tube bundle module, respectively, and the introduction and outlet port of the heat medium liquid And a pair of heat transfer thin tube headers.

  In order to solve the above-mentioned problem, the thin tube bundle module is divided in the direction of the blood flow path to form a stacked structure of a plurality of thin tube bundles each including a plurality of the heat transfer thin tubes. A pair of spacers are attached to regions on both sides of the blood flow path so that a predetermined interval is formed between the stages of the thin tube bundle. At least one of the flow chambers is partitioned into a plurality of flow compartments by partition walls corresponding to the intervals, and the heat medium liquid flowing from the introduction port passes through any of the flow compartments. A flow path is formed so as to sequentially pass through the plurality of stages of thin tube bundles and to flow out of the outlet port via any one of the flow compartments. An insertion member is disposed in the region in the blood flow path so as to fill a part of the volume in the gap formed by the gap of the thin tube bundle, and the insertion member is disposed in the blood flow path. A flow path in communication with the flow path. The pair of spacers are connected to each other by a pair of connecting bars disposed on both sides of the thin tube bundle, and the insertion member is coupled to the connecting bars so that the pair of spacers and the insertion member are integrated. An integrated spacer member is formed.

  According to the heat exchanger having the above configuration, the flow rate of the heat medium liquid flowing through the heat transfer thin tubes can be easily increased by the structure in which the heat medium liquid is sequentially passed through the bundle of thin tubes divided into a plurality of stages. The film resistance on the inner wall of the heat transfer thin tube is reduced, and the heat exchange efficiency can be improved while suppressing the increase in the volume of the blood flow path.

  Further, by dividing the flow chamber at the end of the thin tube bundle module in accordance with the interval formed by attaching a spacer between each step of the thin tube bundle, the heat medium liquid is sequentially passed through the multi-stage thin tube bundle. A simple structure is obtained.

  Furthermore, an increase in the volume of the blood channel due to the mounting of the spacer can be suppressed by disposing the insertion member in the gap between the thin tube bundles in the blood channel. The insertion member is integrated with a pair of spacers via a connecting bar so that the insertion member is accurately held in a region to be a blood flow path when sealing for forming a blood flow path.

  The medical heat exchanger of the present invention can take the following aspects based on the above configuration.

  That is, the insertion member has an outer frame portion on the outermost periphery, and the outer frame portion is made of a material different from the seal member provided along the inner peripheral surface of the seal member surrounding the blood flow channel. The heat transfer thin tube is made of a metal material, the housing and the integrated spacer member are made of a first resin material, and the annular seal portion is made of the first resin material. The second resin material having good adhesion can be used, and the sealing member can be made of a third resin material having good adhesion to the metal material of the heat transfer thin tube.

  Further, the third resin material has better adhesion to the metal material of the heat transfer narrow tube than the second resin material, and the interface between the annular sealing portion and the seal member is the connection of the integrated spacer member. The path from the point intersecting the crosspiece to the inner peripheral surface of the outer frame portion along the interface between the outer frame portion of the insertion member and the annular sealing portion is longer than a predetermined length. It is preferable that a concavo-convex structure is formed on the surface of the outer frame portion.

  In addition, the thin tube bundle is held in a state where the heat transfer thin tubes are arranged by thin tube row holding members arranged at both ends, and the pair of spacers holds the thin tube row that is opposed between adjacent stages of the thin tube bundle. It can be set as the structure with which it was mounted | worn between members.

  Moreover, it is preferable that the blood flow path has a cylindrical shape formed by an inner peripheral surface of the annular sealing portion, and the outer frame portion of the insertion member has an annular shape.

  Further, the heat transfer liquid is sequentially passed from the downstream thin tube bundle disposed on the downstream side of the blood flow channel toward the upstream thin tube bundle disposed on the upstream side. A capillary header is preferably constructed.

  An oxygenator of the present invention includes a medical heat exchanger having any one of the above-described configurations, and an oxygenator having a blood channel for performing gas exchange intersecting with the gas channel, and the medical heat exchanger The blood vessel of the medical heat exchanger and the blood channel of the oxygenator can be communicated with each other by stacking the vessel and the oxygenator.

  Hereinafter, a medical heat exchanger and a manufacturing method thereof according to an embodiment of the present invention will be described with reference to the drawings.

(Embodiment 1)
FIG. 1A is a plan view showing a heat exchanger according to Embodiment 1. FIG. 1B is a cross-sectional view taken along the line AA in FIG. 1A. The heat exchanger includes a thin tube bundle module 2 composed of a plurality of heat transfer thin tubes 1 for circulating cold / hot water as a heat medium liquid, seal members 3a to 3c that seal the thin tube bundle module 2, and these And a housing 4 housing the housing.

  The plurality of heat transfer thin tubes 1 are arranged in parallel and stacked to form a thin tube bundle, and cold / hot water flows through the lumen of each heat transfer thin tube 1. The seal member 3c at the center is circular as a heat exchange region for circulating blood, which is a heat exchange liquid, in contact with the outer surface of each heat transfer narrow tube 1 at the center in the longitudinal direction of the thin tube bundle module 2. A blood channel 5 having a cross section is formed. The seal members 3 a and 3 b at both ends expose both ends of the thin tube bundle module 2.

  The housing 4 faces both ends of the thin tube bundle module 2 and has a heat transfer thin tube header, that is, a cold / hot water introduction header 6 and a cold / hot water lead-out header 7 for introducing and deriving cold / hot water. The housing 4 further has blood inlets 8 and blood outlets 9 (see FIG. 1B) facing both ends of the blood flow path 5. The cold / hot water introduction header 6 and the cold / hot water lead-out header 7 are respectively provided with a cold / hot water introduction port 6a and a cold / hot water lead-out port 7a. Further, a gap 10 is provided between each of the seal members 3 a to 3 c, and a liquid discharge hole 11 corresponding to the gap 10 is provided in the housing 4.

  As shown in FIG. 1B, the cold / hot water introduction header 6 and the cold / hot water lead-out header 7 form a fluid chamber that is an empty space surrounding both ends of the thin tube bundle module 2 exposed from the seal members 3a, 3b at both ends. ing. Therefore, all of the cold / hot water introduced and led out flows through the flow chamber formed by the cold / hot water introduction header 6 and the cold / hot water lead-out header 7.

  In the above configuration, blood flows from the blood inlet 8 into the blood channel 5 and flows out from the blood outlet 9. At the same time, cold / hot water is caused to flow from the cold / hot water introduction header 6 into the thin tube bundle module 2 and to flow out from the cold / hot water outlet header 7. Thereby, in the blood flow path 5, heat exchange is performed between blood and cold / hot water. Further, in both cases where blood leaks and cold / warm water leaks, seal leakage can be immediately detected by the gap 10 as in the conventional example, and the occurrence of blood contamination can be prevented.

  As shown in FIG. 1B, the thin tube bundle module 2 is divided into three stages of first to third thin tube bundles 12 a to 12 c each including three layers of heat transfer thin tubes 1. That is, each of the first to third thin tube bundles 12a to 12c is configured by laminating the heat transfer thin tubes 1 in three layers. And the 1st-3rd thin tube bundle 12a-12c is laminated | stacked, and the thin tube bundle module 2 is comprised. Spacers 13 are mounted between the stages of the first to third thin tube bundles 12a to 12c to form a predetermined length interval. By providing an interval with the spacer 13, as described below, the flow chambers inside the cold / hot water introduction header 6 and the cold / hot water lead-out header 7 can be easily divided into a plurality of flow compartments.

  The flow chamber inside the cold / hot water introduction header 6 is divided into an upper flow compartment 14a and a lower flow compartment 14b by a partition wall 6b. End portions of the first and second thin tube bundles 12a and 12b are arranged in the upper flow compartment 14a, and an end portion of the third thin tube bundle 12c is arranged in the lower flow compartment 14b. Further, the flow chamber inside the cold / hot water outlet header 7 is divided into an upper flow compartment 15a and a lower flow compartment 15b by a partition wall 7b. End portions of the first thin tube bundle 12a are arranged in the upper flow compartment 15a, and end portions of the second and third thin tube bundles 12b, 12c are arranged in the lower flow compartment 15b.

  Thus, the flow chamber of the cold / hot water introduction header 6 is divided into the upper flow compartment 14a and the lower flow compartment 14b by the partition 6b, and the flow chamber of the cool / warm water lead-out header 7 is divided by the partition 7b into the upper flow compartment 15a. And the lower flow compartment 15b, it is necessary to form a space between each stage of the first to third thin tube bundles 12a to 12c by the spacer 13. This is because the flow chamber can be easily partitioned into a predetermined state by positioning the end portions of the partition wall 6b and the partition wall 7b facing the first to third thin tube bundles 12a to 12c corresponding to the interval. . However, by arranging the spacer 13, a gap is formed between each stage of the first to third thin tube bundles 12 a to 12 c in the region in the blood flow path 5. An insertion member 20 for filling the gap is arranged. This will be described in detail later.

  The form of the spacer 13 for forming an interval between each stage of the thin tube bundle will be described with reference to FIGS. 2A to 4. FIG. 2A is a perspective view showing a configuration of a module in which a spacer is mounted between thin tube bundles. However, for convenience of illustration, only the first and second thin tube bundles 12a and 12b in two stages out of the three thin tube bundles are shown. Moreover, in order to avoid the complexity of illustration, illustration is abbreviate | omitted about the connection structure of a pair of spacer 13, and the insertion member 20. As shown in FIG. FIG. 2B is a front view of the module.

  As shown in FIG. 2A, the thin tube bundles 12 a and 12 b are formed by bundling a plurality of heat transfer thin tubes 1 by thin tube row holding members 16 a to 16 d arranged at four locations along the axial direction of the heat transfer thin tubes 1. It is configured. The spacer 13 is mounted between the thin tube row holding members 16a to 16d between the thin tube bundles 12a and 12b.

  One row (layer) of thin tube rows is bound by one set of thin tube row holding members 16a to 16d. The bound state is shown in the perspective view of FIG. 3A. FIG. 3B is a front view thereof. A plurality of heat transfer thin tubes 1 (16 in the example of FIG. 3A) arranged in a line in parallel with each other are held by the thin tube row holding members 16a to 16d to form a heat transfer thin tube group for one layer. ing. The thin tube row holding members 16a to 16d are each formed in a strip shape that crosses the heat transfer thin tube 1, and the heat transfer thin tube 1 passes therethrough. The heat transfer thin tube group having such a configuration is formed by pouring resin into a mold in which a plurality of heat transfer thin tubes 1 are arranged to form the thin tube row holding members 16a to 16d, that is, by insert molding. be able to. A plurality of thin tube receiving recesses 17 into which the heat transfer thin tubes 1 can be fitted are formed on the upper and lower surfaces of the thin tube row holding members 16a to 16d.

  The thin tube bundles 12a and 12b shown in FIG. 2A are formed by laminating three layers of the heat transfer thin tube group shown in FIG. 3A. When laminating, the heat transfer thin tubes 1 constituting each heat transfer thin tube group are fitted into the thin tube receiving recesses 17 provided in the thin tube row holding members 16a to 16d of other heat transfer thin tube groups adjacent to each other vertically. For this reason, the thin tube row holding members 16a to 16d are alternately displaced for each layer adjacent in the vertical direction. Further, the thin tube row holding members 16 a to 16 d are arranged in pairs in regions at both ends of the heat transfer thin tube 1. That is, the narrow tube row holding members 16a and 16b are arranged close to one end, and the thin tube row holding members 16c and 16d are arranged close to each other. With this arrangement, the gap 10 shown in FIG. 1B or the like is formed between the narrow tube row holding members 16b and 16d at both ends.

  Further, a spacer 13 is mounted so as to be interposed between the thin tube row holding members 16a to 16d between the thin tube bundles 12a and 12b, thereby forming an interval 18 having a predetermined size. The spacer 13 has interpolated portions 13a and 13b and a coupling portion 13c that couples the both. By interposing the insertion portions 13a and 13b between the upper and lower thin tube row holding members 16a to 16d, the interval 18 between the thin tube bundles 12a and 12b is held.

  FIG. 4 shows a connection structure of the spacer 13. However, illustration of the insertion member 20 is omitted, and an integrated structure with the insertion member 20 will be described later. In the connection structure shown in FIG. 4, a pair of spacers 13 each including interpolating portions 13 a and 13 b and a coupling portion 13 c are connected by a connecting bar 19. By integrating the pair of spacers in this way, handling in the manufacturing process becomes easy.

  By the way, in the area | region of the sealing members 3a-3c, since the sealing resin is filled in the part corresponding to the space | interval between each step | level, a gap is not formed. However, by attaching the spacer 13, in the region within the blood flow path 5, a gap corresponding to the interval is formed between the stages of the first to third thin tube bundles 12a to 12c. This gap causes an increase in the amount of blood filled in the blood channel 5. In order to suppress this increase in blood filling amount, an insertion member 20 is arranged in the gap between the stages as shown in FIG. 1B. By disposing the insertion member 20, it is possible to fill a part of the gap between the stages of the thin tube bundles 12a to 12c and reduce the volume thereof.

  An example of the shape of the insertion member 20 is shown in FIG. 5A. The insertion member 20 includes a plurality of annular ribs 21 arranged concentrically, and a connecting rib 22 that extends radially in the radial direction of the annular rib 21 and connects the annular ribs 21. The outermost annular rib 21 is supported by an annular frame 23. A portion of the annular frame 23 is sealed in the seal member 3c. The location of the connecting rib 22 shown in FIG. 1B corresponds to the gap 24 between the annular ribs 21. The blood flow path 5 penetrates the insertion member 20 at the gap 24 to ensure the continuity of the flow path.

  FIG. 5B is a cross-sectional view showing a part of the insertion member 20. The annular rib 21 has an oval cross section whose minor axis is the direction of the blood flow path 5. Thereby, the blood filling amount can be reduced without decreasing the heat exchange efficiency.

  In addition to the effect of reducing the blood filling rate in the blood channel 5 by arranging the insertion member 20 as in the present embodiment, between the stages of the first to third thin tube bundles 12a to 12c. Compared with the case where only the gap exists, there is also an effect that bubbles existing in the gap at the beginning can be easily removed. Heat exchange efficiency is also improved by removing the bubbles.

  By arranging the insertion member 20, it is inevitable that the heat exchange efficiency is reduced to some extent, but in order to suppress the reduction of the heat exchange efficiency, the heat transfer thin tube 1 and the insertion member 20 can overlap. The shape of the insertion member 20 is set so as to be as small as possible. Constructing the concentric annular rib 21 as shown in FIG. 5A is effective for adjusting the balance between the reduction of the blood filling amount and the maintenance of the heat exchange efficiency to a satisfactory range.

  Since the insertion member 20 is disposed between the steps, if it is integrated with the spacer 13, the operation when assembling integrally with the first to third thin tube bundles 12 a to 12 c becomes easy. On the other hand, when the insertion member 20 is separated from the spacer 13, when the insertion member 20 is sealed with the seal members 3 a to 3 c in combination with the first to third thin tube bundles 12 a to 12 c, the blood flow of the insertion member 20 is reduced. A structure for positioning with respect to the path 5 is required. On the other hand, if the insertion member 20 is integrated with the spacer 13, the insertion member 20 is positioned via the spacer 13, so that sealing with the seal members 3a to 3c can be performed with high accuracy.

  FIG. 6A shows an example of a structure in which the insertion member 20 is integrated with the spacer 13. In this integrated structure, a pair of spacers 13 are integrated by a connecting bar 19, and the insertion member 20 is coupled to the connecting bar 19. In such a structure, the spacer 13 is interposed between the upper and lower thin tube row holding members 16a to 16d (see FIG. 2A) with respect to the first to third thin tube bundles 12a to 12c, thereby providing an integrated structure. The whole is positioned between the first to third thin tube bundles 12a to 12c. Therefore, the insertion member 20 is accurately held in the region to be the blood flow path 5 when the portion of the annular frame 23 is sealed by the seal member 3c.

  In the present embodiment, the material constituting the heat transfer thin tube 1 is preferably a metal material such as stainless steel. As the material of the housing 4, for example, a resin material such as a polycarbonate resin that is transparent and excellent in breakage resistance can be used. As a resin material for forming the seal members 3a to 3c, for example, a thermosetting resin such as a silicon resin, a polyurethane resin, or an epoxy resin can be used. Among these, an epoxy resin is preferable from the viewpoint of excellent adhesiveness with a material (for example, a metal material) constituting the heat transfer thin tube 1. As a material of the spacer 13, for example, a polycarbonate resin can be used. The insertion member 20 is integrally formed of the same material as the spacer 13.

  In the integrated structure of the present embodiment, the concavo-convex structure 25 is formed in the portion of the annular frame 23 of the insertion member 20. The cross-sectional shape of the uneven structure 25 is shown in FIG. 6B. This cross section is a cross section along the radial direction of the insertion member 20. An uneven structure 25 is provided between the outer peripheral portion 23 a and the inner peripheral portion 23 b of the annular frame 23, and the unevenness is repeated along the radial direction of the annular frame 23. The reason why such an uneven structure 25 is provided will be described with reference to FIG.

  FIG. 7 is a plan view showing a state in which the first to third thin tube bundles 12a to 12c are stacked via the integral structure of the spacer 13 and the insertion member 20 and sealed by the seal members 3a to 3c. Typically, epoxy resin is used as the sealing members 3a to 3c. This is because the adhesiveness with the material (for example, metal material) constituting the heat transfer thin tube 1 is excellent. Since the polycarbonate resin is used as the material of the spacer 13, the insertion member 20 is also formed of the polycarbonate resin. Therefore, polyurethane resin is used for the annular sealing portion 26 that seals the annular frame 23 of the insertion member 20 in the seal member 3c. This is because the adhesiveness of the housing 4 and the insertion member 20 to the polycarbonate resin is good.

  However, the adhesion between the polycarbonate resin and the epoxy resin and the adhesion between the polyurethane resin and the metal heat transfer thin tube are not sufficiently good. Therefore, when the structure in which the spacer and the interposer member integrated as shown in FIG. 6 are sandwiched by the thin tube bundle is sealed with only the polyurethane resin, the liquid is transmitted through the joint portion between the polyurethane resin and the heat transfer thin tube. There is a risk of exudation. In order to prevent the liquid from leaching out (entering) through such a path, the connecting member 19 made of polycarbonate resin is sealed by a sealing member 3c made of epoxy resin.

  On the other hand, when the polyurethane resin is not used, that is, when the heat transfer thin tube is sealed only with the epoxy resin, the adhesive property between the polycarbonate resin and the epoxy resin forming the insertion member 20 or the connecting bar 19 is not good. The liquid may ooze out from the joint. Therefore, as shown in FIG. 7, liquid leakage is prevented by forming an annular sealing portion 26 in which the boundary between the epoxy resin sealing member 3 c and the annular frame 23 is sealed with polyurethane resin.

  Even when the structure as described above is employed, in the portion where the sealing member 3c seals the connecting bar 19, the area between the connecting bar 19 and the sealing member 3c through the interface between the connecting bar 19 and the sealing member 3c is reached. A communication path is easily formed. Therefore, if the blood flow path 5 communicates through the interface between the annular sealing portion 26 made of polyurethane resin and the annular frame 23 made of polycarbonate resin to the interface between the connecting bar 19 and the seal member 3c, the blood flow path 5 becomes The capillary tube holding members 16a to 16d communicate with the region, and therefore the outside. As a result, there is a risk of blood leaking.

  The interface between the polyurethane resin of the annular sealing portion 26 and the polycarbonate resin of the annular frame 23 communicates with the interface between the connecting bar 19 and the seal member 3c through a path indicated by an arrow B or an arrow C in FIG. The path of arrow B is the longest and the path of arrow C is the shortest. According to experiments, when the interface between the polyurethane resin and the polycarbonate resin is, for example, a bonding distance of a predetermined value, for example, 10 mm or more, it is possible to set the state in which leakage can be avoided. The uneven structure 25 of the annular frame 23 is formed as a means for increasing the adhesion distance in the annular sealing portion 26 and avoiding such leakage.

  That is, the concavo-convex structure 25 forms a concavo-convex pattern on the surface between the outer peripheral portion 23a and the inner peripheral portion 23b of the annular frame 23 as shown in FIG. 6B. By repeating this unevenness, the distance between the interface between the annular sealing portion 26 and the annular frame 23 in the radial direction of the annular frame 23 is increased. Thereby, the adhesion distance of a polyurethane resin and a polycarbonate resin can be made into predetermined value, for example, 10 mm or more.

  As shown in FIG. 7, the concavo-convex structure 25 is formed at four locations, and when the concavo-convex structure 25 is not formed at these locations, the above-described adhesion distance is less than a predetermined value. By providing the concavo-convex structure 25 at such a location, an effect of avoiding leakage can be obtained. Note that the value of the adhesion distance necessary for avoiding leakage such as 10 mm or more varies depending on various conditions. Accordingly, it is necessary to select the locations where there is a possibility of leakage at the distance between the interface between the annular sealing portion 26 and the annular frame 23 according to the specifications and provide the concavo-convex structure 25.

  Operations and effects obtained by the heat exchanger configured as described above will be described below. The cool / warm water introduced from the cool / warm water introduction port 6a into the lower flow compartment 14b of the cool / warm water introduction header 6 flows through the lumen of the heat transfer thin tube 1 of the third thin tube bundle 12c and flows under the cool / warm water outlet header 7. It flows into the compartment 15b. Then, it further enters the heat transfer thin tube 1 of the second thin tube bundle 12b and reaches the upper flow compartment 14a of the cold / hot water introduction header 6. Then, next, it enters the heat transfer thin tube 1 of the first thin tube bundle 12a, reaches the upper flow compartment 15a of the cold / hot water outlet header 7, and flows out from the cold / hot water outlet port 7a.

  In this way, the cold / hot water introduction header 6 and the cold / hot water lead-out header 7 are configured such that the introduced cold / warm water sequentially passes through the three stages of the first to third thin tube bundles 12c to 12a. In this way, the configuration in which the cold / hot water to be introduced sequentially passes through the plurality of divided thin tube bundles is referred to as divided flow in the following description. On the other hand, as in the conventional example, a configuration in which the cold / hot water to be introduced flows into all the heat transfer thin tubes 1 in the cold / hot water introduction header 6 all at once is referred to as simultaneous flow.

  By adopting the divided flow, the flow rate of the cold / hot water flowing through the heat transfer thin tubes 1 of the thin tube bundles 12c to 12a can be increased if the flow rate of the cold / hot water is the same as compared with the case of the simultaneous flow. it can. Thereby, the film resistance on the inner wall of the heat transfer thin tube 1 is reduced, and the heat exchange efficiency can be improved. In the conventional simultaneous flow, the heat exchange efficiency can be improved by increasing the supply flow rate (flow velocity) from the cold / hot water supply source, but the flow rate of the cold / hot water supply source is increased on the medical facility side. That is actually difficult. Therefore, it is practically very effective to improve the heat exchange efficiency as in the present embodiment.

  In the embodiment shown in FIG. 1B, a vertically folded structure, that is, a structure in which the thin tube bundle module 2 is divided in the blood flow direction, ie, the vertical direction, to form a plurality of thin tube bundles. Yes. Moreover, the cold / hot water flows through the thin tube bundle 12b and the thin tube bundle 12a sequentially from the downstream thin tube bundle 12c arranged on the downstream side of the blood channel 5 toward the upstream stage. Thereby, the flow of cold / hot water is countercurrent to the blood flow, which is effective for obtaining higher heat exchange efficiency.

  As described above, FIG. 8 shows the result of an experiment on the effect of improving the heat exchange efficiency by the divided flow. However, it is an experimental result in the state without an insertion member. The “divided parallel flow” and “divided counterflow” in FIG. 8 show the divided flow according to the present embodiment for the simultaneous flow. The “divided counterflow” is a case where the thin tube bundle module is divided in the flow direction of the heat medium liquid as shown in FIG. 1B and set so that the heat medium liquid becomes a countercurrent. “Divided parallel flow” indicates a case where the division mode is the same, but the heat medium liquid is set to have a parallel flow in the same direction as the circulation of blood. In any case, the opening diameter of the blood channel 5 was 70 mm, and the number of layers of the heat transfer thin tube 1 was 12.

  From FIG. 8, it can be seen that the heat exchange efficiency is higher in the case of divided parallel flow and divided counter flow, which are divided flow, compared to the case of simultaneous flow. This is because, as described above, the flow resistance of the cool / warm water flowing through the heat transfer thin tube 1 is larger in the divided flow, so that the film resistance is reduced. Moreover, since the temperature difference between the heat medium liquid and the blood can be kept high also on the downstream side of the blood, a result of higher heat exchange efficiency is obtained in the divided counter flow than in the divided parallel flow. In contrast to the simultaneous flow, the heat exchange efficiency is improved by 36% in the case of divided parallel flow, and the heat exchange efficiency is improved by 54% in the case of divided counter flow.

  Next, as shown in FIG. 1B, when the thin tube bundle module 2 is divided in the flow direction of the heat medium liquid to form a multi-layer thin tube bundle, the appropriate number of thin tube bundles and each thin tube bundle are The result of having examined about the suitable number of layers of the heat-transfer thin tube 1 to comprise is shown in FIG.

  (A) of FIG. 9 is a case where the number of stages of the thin tube bundle is two, that is, the number of stages where the flow of the cold / hot water is folded is two, and the heat transfer thin tubes constituting the thin tube bundle of each stage are three layers (the number of laminated layers). The measurement result of the heat exchange efficiency in the case of 4 layers, 5 layers, and 6 layers is shown. FIG. 9B shows the case where the number of stages of the folded thin tube bundle is three, and the measurement of the heat exchange efficiency in the case where the heat transfer thin tubes constituting the thin tube bundle of each step are two layers, three layers, and four layers. Results are shown. ESA shown at the bottom of the horizontal axis is an effective surface area, and U is a flow rate of the heat medium. From FIG. 9, it can be seen that the number of folded thin tube bundles is higher in the case of three stages in (b) than in the case of two stages in (a).

  When the number of folded thin tube bundles is 3, the number of layers of the heat transfer thin tubes constituting the thin tube bundle is 2, that is, the case of the 2-2-2 layer at the left end of FIG. The heat exchange efficiency is slightly inferior to the case of four layers. However, it is possible to obtain high heat exchange efficiency compared to the case of two stages. In addition, the total number of heat transfer thin tubes in the three stages is six, and the heat exchange efficiency is sufficiently high as compared with the two-stage structure having two or more heat transfer thin tube layers corresponding to this. can get. The same number of heat transfer thin tube layers means that the blood filling amount is about the same. Therefore, according to the structure of 2-2-2 layer, it turns out that heat exchange efficiency can be improved, suppressing the blood filling amount.

  In the case of three stages, it can be seen that there is no significant difference in heat exchange efficiency when the number of heat transfer thin tubes constituting the thin tube bundle is between 3 and 4 layers. However, four or more stages are over-spec, and the flow rate does not increase due to increased pressure loss. Considering this result, it can be seen that the best practical structure can be obtained when thin tube bundles composed of three layers of heat transfer thin tubes are laminated in three stages.

  In addition, in the case of an odd number of turn-back structures such as a three-stage folded structure, the cold / hot water introduction port 6a and the cold / hot water outlet port 7a can be distributed to both ends of the thin tube bundle module 2, and the port layout has a good balance. is there.

  Although not shown in the above-mentioned drawings, the housing 4 is divided and formed, for example, at the bottom of the housing and the top of the housing, and has a structure in which the thin tube bundle module 2 and the like are accommodated and joined together.

  In the above description, the structure of the cold / hot water introduction header and the cold / hot water lead-out header in the case where the thin tube bundle has three stages is shown, but it is easy to configure similarly in the case of other stages. That is, a flow compartment corresponding to the one-stage thin tube bundle located at the upstream end or the downstream end is necessarily provided. Accordingly, a flow compartment is formed at least in the cold / hot water introduction header and the cold / hot water lead-out header. In addition, the flow compartment is partitioned in correspondence with the other two-stage thin tube bundles. The introduction port and the discharge port are provided for the flow compartment corresponding to the one-stage thin tube bundle. Thereby, the flow path is formed so that the heat medium liquid flowing in from the introduction port sequentially passes through the plurality of stages of thin tube bundles and flows out from the outlet port.

  About the fall of the heat exchange efficiency by arrange | positioning an insertion member between the steps of a thin tube bundle, in the case of a structure where there is much overlap of an insertion member and a heat-transfer thin tube, a fall is large. This is probably because the insertion member blocks the blood flow and restricts the blood flow along the outer surface of the heat transfer tubule. Accordingly, by appropriately setting the shape of the insertion member 20 so that the overlap with the heat transfer thin tube 1 is minimized, the decrease in heat exchange efficiency is suppressed to a range that does not cause a problem in practice, and the blood flow is reduced. The blood filling rate in the road can be reduced.

(Embodiment 2)
FIG. 10 is a cross-sectional view showing the oxygenator according to the second embodiment. This heart-lung machine is configured by combining the heat exchanger 30 in the first embodiment with the oxygenator 40.

  The heat exchanger 30 is stacked on the oxygenator 40, and the housing 4 of the heat exchanger 30 is coupled to the housing 31 of the oxygenator 40. However, the housing 4 of the heat exchanger 30 and the housing 31 of the oxygenator 40 may be formed integrally. In the region of the artificial lung 40, a gas introduction path 32 for introducing oxygen gas and a gas lead-out path 33 for deriving carbon dioxide and the like in the blood are provided.

  The artificial lung 40 includes a plurality of hollow fiber membranes 34 and a seal member 35. The sealing member 35 seals the hollow fiber membrane 34 so that blood does not enter the gas introduction path 32 and the gas outlet path 33. Sealing by the sealing member 35 is performed so that both ends of the hollow fiber constituting the hollow fiber membrane 34 are exposed. The gas introduction path 32 and the gas outlet path 33 are communicated with each other by a hollow fiber constituting the hollow fiber membrane 34.

  Further, the space where the sealing member 35 does not exist in the oxygenator 40 constitutes a cylindrical blood channel 36, and the hollow fiber membrane 34 is exposed in the blood channel 36. Further, the blood inlet side of the blood channel 36 communicates with the outlet side of the blood channel 5 of the heat exchanger 30.

  With the above configuration, the blood heat-exchanged through the blood channel 5 flows into the blood channel 36, where it contacts the hollow fiber membrane 34. At this time, oxygen gas flowing through the hollow fiber membrane 34 is taken into the blood. Further, the blood into which oxygen gas has been taken in is led out to the outside from a blood outlet 37 provided in the housing 31 and returned to the patient. On the other hand, carbon dioxide in the blood is taken into the hollow fiber membrane 34 and then led out by the gas lead-out path 33.

  Thus, in the oxygenator shown in FIG. 10, the blood temperature is adjusted by the heat exchanger 30, and the blood whose temperature has been adjusted is gas-exchanged by the oxygenator 40. At this time, even if a seal leak occurs in the heat exchanger 30 and cold / warm water flowing through the heat transfer thin tubes 1 flows out, the cold / warm water is accumulated in the gap 10 and then discharged to the outside. For this reason, according to the heart-lung machine shown in FIG. 10, a seal | sticker leak can be detected and the contamination of the blood by cold / hot water can be suppressed.

  According to the present invention, since the flow rate of cold / hot water flowing through the heat transfer thin tube can be increased, the film resistance on the inner wall of the heat transfer thin tube is reduced, and the increase in the volume of the blood flow path is suppressed, and the heat exchange efficiency is increased. It can be improved and is useful as a heat exchanger for use in an oxygenator or the like.

The top view which shows the structure of the medical heat exchanger in Embodiment 1. FIG. AA sectional view of the medical heat exchanger The perspective view of the module which installed the spacer between the thin tube bundles of the medical heat exchanger Front view of the module shown in FIG. 2A of the medical heat exchanger Perspective view of a unit capillary row that constitutes a bundle of thin tubes of the medical heat exchanger Front view of unit capillary row shown in FIG. 3A of the medical heat exchanger The perspective view which shows the form of a spacer The top view which shows the insertion member of the medical heat exchanger in Embodiment 1 A sectional view of a part of the insertion member The perspective view which shows the integral structure of the same insertion member and a spacer Sectional drawing which shows the principal part in the integral structure of the insertion member and spacer Plan view for explaining the problem of the same body structure The figure which shows the relationship between the division | segmentation aspect of a thin tube bundle module, and a heat exchange coefficient The figure which shows the relationship between the folding structure of the heat exchanger in Embodiment 1, and a heat exchange coefficient Sectional drawing which shows the heart-lung machine in Embodiment 2 Top view showing the configuration of a conventional heat exchanger Side view showing the configuration of the heat exchanger The perspective view which shows the inside of the housing in the heat exchanger in a partial cross section

Explanation of symbols

DESCRIPTION OF SYMBOLS 1,101 Heat transfer thin tube 2,102 Thin tube bundle module 3a-3c, 103a-103c Seal member 4,104 Housing 5,105 Blood flow path 6 Cold / hot water introduction header 6a Cold / hot water introduction port 6b, 7b Bulkhead 7 Cold / hot water extraction header 7a Cold / warm water outlet port 8, 106 Blood inlet 9, 107 Blood outlet 10, 108 Gap 11, 109 Leakage outlet 12a-12c First to third tubule bundles 13 Spacers 13a, 13b Interposer 13c Joint 14a 15a Upper flow compartments 14b, 15b Lower flow compartments 16a to 16d Thin tube row holding member 17 Thin tube receiving recess 18 Space 20 Insertion member 21 Annular rib 22 Connection rib 23 Annular frame 23a Outer peripheral portion 23b Inner peripheral portion 24 Clearance 25 Unevenness Structure 26 Annular sealing part 30 Heat exchanger 31 Housing 32 Gas introduction path 33 Gas extraction path 34 Hollow fiber Membrane 35 Seal member 36 Blood flow path 37 Blood outlet 40 Artificial lung

Claims (7)

A thin tube bundle module formed by laminating and stacking a plurality of heat transfer thin tubes through which the heat medium liquid flows in the lumen;
A seal member that seals the thin tube bundle module so that both ends of the heat transfer thin tube are exposed, and forms a blood flow path through which blood passes so as to be in contact with the outer surface of each of the heat transfer thin tubes;
A housing that houses the seal member and the thin tube bundle module, and that has both blood inlets and outlets facing both ends of the blood channel;
In a medical heat exchanger comprising a pair of heat transfer narrow tube headers, each having a flow chamber so as to surround both ends of the thin tube bundle module, and having a heat transfer medium liquid introduction and discharge port
The thin tube bundle module is divided in the direction of the blood flow path to form a laminated structure of a plurality of thin tube bundles each including a plurality of the heat transfer thin tubes,
A pair of spacers are respectively attached to regions on both sides sandwiching the blood flow path so that a predetermined interval is formed between the stages of the plurality of thin tube bundles,
At least one of the flow chambers is partitioned into a plurality of flow compartments by partition walls corresponding to the intervals, and the heat medium liquid flowing from the introduction port passes through any of the flow compartments. A flow path is formed so as to sequentially pass through the plurality of thin tube bundles and flow out from the outlet port via any one of the flow compartments,
In the region within the blood flow path, an insertion member is disposed so as to fill a part of the volume in the gap formed by the interval of the thin tube bundle, and the insertion member communicates with the blood flow path. A flow path that
The pair of spacers are connected to each other by a pair of connecting bars disposed on both sides of the thin tube bundle, and the insertion member is coupled to the connecting bars so that the pair of spacers and the insertion member are integrated. A heat exchanger characterized in that an integrated spacer member is formed. The insertion member has an outer frame portion on the outermost periphery,
The outer frame portion is sealed by an annular sealing portion made of a material different from the seal member provided along the inner peripheral surface of the seal member surrounding the blood flow path,
The heat transfer thin tube is made of a metal material,
The housing and the integrated spacer member are made of a first resin material,
The annular sealing portion is made of a second resin material having good adhesiveness with the first resin material,
2. The heat exchanger according to claim 1, wherein the seal member is made of a third resin material having good adhesion to the metal material of the heat transfer thin tube. The third resin material has better adhesion to the metal material of the heat transfer capillary than the second resin material,
From the point where the interface between the annular sealing portion and the sealing member intersects with the connecting bar of the integrated spacer member, the outer frame portion of the insertion member is disposed along the interface between the outer sealing portion and the annular sealing portion. The heat exchanger according to claim 2, wherein a concavo-convex structure is formed on a surface of the outer frame portion so that a path reaching the inner peripheral surface is longer than a predetermined length. In the thin tube bundle, the arrangement state of the heat transfer thin tubes is held by the thin tube row holding members arranged at both ends,
The medical heat exchanger according to any one of claims 1 to 3, wherein the pair of spacers are mounted between the thin tube row holding members facing each other between adjacent steps of the thin tube bundle. The blood flow path has a cylindrical shape formed by an inner peripheral surface of the annular sealing portion,
The heat exchanger according to any one of claims 1 to 4, wherein the outer frame portion of the insertion member has an annular shape.   The heat transfer thin tube header so that the heat medium liquid sequentially passes from the downstream thin tube bundle disposed downstream of the blood flow channel toward the upstream thin tube bundle disposed upstream. The heat exchanger according to any one of claims 1 to 5, wherein the heat exchanger is configured. The heat exchanger according to any one of claims 1 to 6,
An artificial lung having a blood flow path for performing gas exchange crossing the gas flow path,
The oxygenator device in which the heat exchanger and the oxygenator are stacked so that the blood channel of the heat exchanger and the blood channel of the oxygenator are in communication.

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