JP2006102550A - Hollow fiber membrane oxygenator - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a heat exchange function-equipped hollow fiber membrane oxygenator which has little blood charge as a whole and little pressure loss, and furthermore has enough gas exchange by the condition of containing a heat exchanger placed in an oxygenator section in a housing. <P>SOLUTION: A hollow fiber membrane oxygenator 1 has a cylindrical core 5, a cylindrical hollow fiber membrane sheaf 3 which is twisted around the external surface of the cylindrical core 5, a cylindrical heat exchanger section which is placed in the core 5, and a housing 2. The cylindrical core 5 has a sulcus 51 which forms a blood passage between its external surface and the hollow fiber membrane sheaf 3, and a blood circulation opening 52 which is communicated with a first blood chamber 11 between the core 5 and the cylindrical heat exchanger section and the sulcus 51. The cylindrical heat exchanger section has a cylindrical heat exchanger 31 and cylindrical heat exchanger deformation regulation sections 34, 35. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a hollow fiber membrane type artificial lung with a built-in heat exchange function for adjusting blood temperature, removing carbon dioxide in blood, and adding oxygen to blood in extracorporeal blood circulation.

In recent years, as an artificial cardiopulmonary circuit used for open heart surgery, blood transmission using a centrifugal pump or a pulsating flow pump, and non-transfusion extracorporeal circulation have been widely used. In doing so, it is required to simplify the artificial heart-lung machine circuit, to achieve a low pressure loss and a low filling amount. However, there are current open-heart surgery circuits in which a heat exchanger and an artificial lung are connected and integrated, but they are only connected independently.
As an artificial lung, a membrane oxygenator has become common. A membrane oxygenator mainly uses a hollow fiber membrane, and performs blood gas exchange through the hollow fiber membrane.
As an inflow method of blood into the artificial lung, an internal perfusion method in which blood flows inside the hollow fiber membrane and gas flows outside the hollow fiber membrane, and conversely, blood flows outside the hollow fiber membrane and gas flows into the hollow fiber membrane. There is an external perfusion method to flow inside. It is known that the former has a large pressure loss when circulating blood. On the other hand, the latter is more advantageous than the former in terms of pressure loss.
JP 7-509171 A

  In recent years, centrifugal pumps and pulsatile pumps have become widespread, and in order to perform extracorporeal circulation with these pumps, it is desirable that the pressure loss of the artificial lung is small. Furthermore, as described above, it is desirable that the entire circuit has a low filling amount.

  However, in the conventional one in which the heat exchanger and the artificial lung are connected and integrated, each of the heat exchanger and the artificial lung has a housing and a blood chamber inside thereof, and therefore has a certain filling amount. Become.

  Therefore, the first object of the present invention is to reduce the amount of blood filling and the pressure loss as a whole by placing the heat exchanger part inside the oxygenator part in the housing. Furthermore, the present invention provides a hollow fiber membrane type artificial lung with a built-in heat exchange function having a sufficient gas exchange capability.

  In addition, as a heat exchanger for extracorporeal circulation, a multi-tube type, a bellows (bellows tube) type or the like is used. In particular, the bellows type is effective in the type in which the heat exchanger part is housed inside the artificial lung part as described above. However, in the bellows-type heat exchanger, the shape, that is, the volume changes due to the difference between the internal and external pressures from the bellows-like shape, thereby causing a change in the volume of the blood chamber inside the artificial lung. When the volume changes in the blood chamber inside the oxygenator during use, it is considered that the blood flow is disturbed and the gas exchange capacity is lowered.

  Therefore, the second object of the present invention is to minimize the change in blood chamber volume caused by deformation of the heat exchanger of the heat exchanger, and to allow blood flow due to the change in blood chamber volume of the artificial lung during use. It is intended to provide a hollow fiber membrane type artificial lung with a built-in heat exchange function that hardly causes disturbance.

Recently, an artificial lung using a hollow fiber bundle produced by spirally winding a hollow fiber around a hollow cylindrical core has been proposed (Japanese Patent Publication No. 7-509171). In this type of hollow fiber bundle, an intersecting portion where the wound hollow fibers intersect is formed. In particular, by controlling the rotating body for rotating the hollow cylindrical core and the winder for weaving the hollow fiber membrane according to predetermined conditions, the intersecting portion where the wound hollow fibers intersect and the intersecting portion overlap each other. A hollow fiber crossing annular portion is formed. A blood short-circuit path due to the hollow fiber cross-annular portion may be formed, causing a reduction in gas exchange capacity.
Therefore, a third object of the present invention is an oxygenator using a hollow fiber bundle in which a hollow fiber membrane is spirally wound around the outer surface of such a hollow cylindrical core and a hollow fiber bundle having a hollow fiber cross annular portion is used. The present invention provides a hollow fiber membrane-type oxygenator having a sufficient amount of gas exchanging ability with little formation of a blood short circuit due to the hollow fiber cross-annular portion.

  What achieves said 1st objective is an artificial lung part which consists of a cylindrical core and the cylindrical hollow fiber membrane bundle which consists of many hollow fiber membranes for gas exchange wound around the outer surface of this cylindrical core A hollow fiber membrane type artificial lung with a built-in heat exchange function, comprising: a tubular heat exchanger portion housed in the tubular core; and a housing housing the artificial lung portion and the tubular heat exchanger portion. The cylindrical core includes a groove that forms a blood flow path between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle, and between the cylindrical core and the cylindrical heat exchanger portion. A blood flow opening that communicates with the formed first blood chamber and the groove; and the oxygenator includes a blood inflow port that communicates with the first blood chamber, and an outer surface of the cylindrical hollow fiber membrane And a hollow fiber membrane with a built-in heat exchange function, having a blood outflow port communicating with a second blood chamber formed between the inner surface of the housing It is an artificial lung.

Also, what achieves the third object is a cylindrical core, a cylindrical hollow fiber membrane bundle comprising a plurality of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core, and the cylinder A hollow fiber membrane type artificial lung provided with a housing for storing a hollow fiber membrane bundle, wherein the tubular core has a blood flow path between an outer surface of the tubular core and an inner surface of the tubular hollow fiber membrane bundle. , A first blood chamber formed in the cylindrical core, and a blood circulation opening that communicates with the groove, and the artificial lung communicates with the first blood chamber. A blood inflow port; a blood outflow port communicating with a second blood chamber formed between the outer surface of the cylindrical hollow fiber membrane and the inner surface of the housing; and the cylindrical core is substantially orthogonal to the axial direction. And having an annular flat portion having a predetermined width, the hollow fiber membrane bundle being spiral with respect to the cylindrical core A hollow fiber cross-annular part formed by overlapping the cross-over parts of the hollow fibers, the hollow fiber cross-annular part being located on the annular flat part of the cylindrical core It is a thread membrane oxygenator.
And it is preferable that the width | variety of the said annular flat part is 5-50 mm.

  Further, in the hollow fiber membrane type artificial lung with built-in heat exchange function and the hollow fiber membrane type artificial lung, the groove of the cylindrical core is, for example, a plurality of endless annular grooves or a plurality of start and end annular grooves. And the blood flow opening of the cylindrical core is a plurality of blood flow openings communicating with each of the plurality of annular grooves, or one blood flow opening or a plurality of rings communicating with all of the plurality of annular grooves. A plurality of blood circulation openings communicating with the groove.

  Further, in the hollow fiber membrane type artificial lung with built-in heat exchange function and the hollow fiber membrane type artificial lung, the blood inflow port is provided on one end side of the cylindrical core, and the blood circulation opening Is preferably formed in a region facing a region obtained by extending the center line of the blood inlet port. Furthermore, in the hollow fiber membrane type artificial lung with built-in heat exchange function and the hollow fiber membrane type artificial lung, it is preferable that the apex of the rib formed between the grooves of the cylindrical core is a flat surface. Furthermore, in the hollow fiber membrane type artificial lung with a built-in heat exchange function and the hollow fiber membrane type artificial lung, the cylindrical core extends substantially entirely in the axial direction and has a flat surface-shaped groove non-forming portion. Is preferred. Further, in the hollow fiber membrane type artificial lung with a built-in heat exchange function and the hollow fiber membrane type artificial lung, the groove of the core is formed over almost the entire part of the hollow fiber membrane bundle that contributes to gas exchange. Is preferred. Furthermore, it is preferable that the groove of the core is formed over almost the entire region that contributes to gas exchange of the hollow fiber membrane bundle.

  Further, what achieves the second object described above is an artificial core comprising a cylindrical core and a cylindrical hollow fiber membrane bundle comprising a large number of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core. A heat exchange function including a lung, a cylindrical heat exchanger portion housed in the tubular core, and a housing for housing the artificial lung portion and the tubular heat exchanger portion, and having a blood chamber therein Built-in hollow fiber membrane oxygenator, wherein the cylindrical heat exchanger portion includes a cylindrical and bellows-shaped heat exchanger and regulates the change in the volume of the blood chamber inside the oxygenator during use It is a hollow fiber membrane type artificial lung with a built-in heat exchange function provided with a shape heat exchange element deformation restricting portion.

In all the above-described hollow fiber membrane type artificial lungs and hollow fiber membrane type artificial lungs, it is preferable that the cylindrical heat exchanger is a bellows-like heat exchanger. Furthermore, it is preferable that the cylindrical heat exchange body deformation restricting portion is housed in the bellows-shaped heat exchange body and has a plurality of ribs that come into contact with the inner surface of the bellows or the vicinity of the valley. Further, the cylindrical heat exchange element deformation restricting portion is formed so as to extend in the axial direction with a predetermined width on the inner surface or outer surface or inner surface and outer surface of the bellows-shaped heat exchanger, and at least fill the valley portion of the bellows. It may be a sealed portion. Furthermore, the cylindrical core has an opening for blood circulation, and a groove that forms a blood flow path between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle, A blood inflow port communicating with the first blood chamber formed between the outer surface of the heat exchange section and the inner surface of the cylindrical core; a second blood chamber communicating with the outer surface of the cylindrical hollow fiber membrane and the inner surface of the housing; It may be provided with a blood outflow port communicating with.
And in all the above-mentioned hollow fiber membrane type artificial lung and hollow fiber membrane type artificial lung with built-in heat exchange function, the hollow fiber membrane bundle has one or more hollow fiber membranes at the same time, and all the hollow fiber membranes. Is preferably formed by being wound around the cylindrical core so as to have a substantially constant spacing.

Further, in all of the above-described hollow fiber membrane type artificial lungs and hollow fiber membrane type artificial lungs, the hollow fiber membranes and adjacent hollow fiber membranes substantially parallel to the hollow fiber membranes The distance is preferably 1/10 to 1/1 of the outer diameter of the hollow fiber membrane.
Further, in all of the above-described hollow fiber membrane oxygenator and hollow fiber membrane oxygenator with built-in heat exchange function, the oxygenator includes two partition walls for fixing both ends of the cylindrical hollow fiber membrane bundle to the housing. It is preferable that a gas inflow port and a gas outflow port communicating with the inside of the hollow fiber membrane and a heat medium inflow port and a heat medium outflow port communicating with the inside of the cylindrical heat exchanger portion are provided.
Further, in all the above-described hollow fiber membrane type artificial lung and hollow fiber membrane type artificial lung with built-in heat exchange function, the hollow fiber membrane bundle has one or more hollow fiber membranes simultaneously and all adjacent hollow fibers. The membrane is formed by being spirally wound around a cylindrical core so as to have a substantially constant interval, and when the hollow fiber membrane is wound around the cylindrical core, the cylindrical core The rotating body for rotating the wire and the winder for weaving the hollow fiber membrane may be formed by being wound around the cylindrical core by moving according to the following equation 1.

    Traverse [mm / lot] · n (integer) = traverse swing width · 2 ± (fiber outer diameter + interval) · number of windings (calculation formula 1)

The hollow fiber membrane oxygenator with a built-in heat exchange function of the present invention comprises a cylindrical core and a cylindrical hollow fiber membrane bundle comprising a number of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core. A hollow fiber membrane artificial body with a built-in heat exchange function, comprising an oxygenator, a cylindrical heat exchanger accommodated in the cylindrical core, and a housing for accommodating the oxygenator and the cylindrical heat exchanger A lung, wherein the cylindrical core includes a groove forming a blood flow path between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle, the cylindrical core, and the cylindrical heat exchanger A first blood chamber formed between the portions and a blood circulation opening communicating with the groove; and the oxygenator includes a blood inflow port communicating with the first blood chamber, and the cylindrical hollow A blood outflow port communicating with a second blood chamber formed between the outer surface of the membrane and the inner surface of the housing is provided.
Therefore, by filling the heat exchanger part inside the oxygenator part (tubular hollow fiber membrane bundle) housed in the housing, blood filling caused by the connection between the oxygenator part and the heat exchanger part An increase in the amount can be prevented, and an increase in pressure loss due to the connecting portion can also be prevented. Furthermore, since the oxygenator is an external perfusion type in which blood flows outside the hollow fiber membrane, there is little pressure loss. Furthermore, since the blood passing through the opening for blood circulation from the first blood chamber flows in the groove of the cylindrical core, the blood dispersibility is good and the blood flow into the hollow fiber membrane bundle is also good, and the gas exchange The performance is also high.

The hollow fiber membrane oxygenator with built-in heat exchange function of the present invention comprises a cylindrical core and a cylindrical hollow fiber membrane bundle comprising a number of hollow fiber membranes for gas exchange wound around the outer surface of the cylindrical core. A heat exchanger having a blood chamber therein, and an oxygenator portion, a cylindrical heat exchanger portion housed in the tubular core, and a housing for housing the artificial lung portion and the tubular heat exchanger portion. A hollow fiber membrane type artificial lung with a built-in exchange function, wherein the tubular heat exchanger section includes a tubular and bellows-like heat exchanger and regulates a change in the volume of the blood chamber inside the artificial lung during use. An accordion-like heat exchange element deformation restricting portion is provided.
Therefore, by filling the heat exchanger part inside the oxygenator part (tubular hollow fiber membrane bundle) housed in the housing, blood filling caused by the connection between the oxygenator part and the heat exchanger part An increase in the amount can be prevented, and an increase in pressure loss due to the connecting portion can also be prevented. Furthermore, since the oxygenator is an external perfusion type in which blood flows outside the hollow fiber membrane, there is little pressure loss. Furthermore, by having the cylindrical heat exchange element deformation restricting portion, the capacity change due to the internal pressure fluctuation is very small in the heat exchange element, so that the change in the volume of the blood chamber inside the artificial lung hardly occurs. Therefore, it is extremely unlikely that blood flow is disturbed due to a change in the blood chamber volume of the oxygenator during use.

The hollow fiber membrane oxygenator with a built-in heat exchange function of the present invention includes a cylindrical core and a cylindrical hollow fiber membrane bundle comprising a number of hollow fiber membranes for gas exchange wound around the outer surface of the cylindrical core, A hollow fiber membrane oxygenator comprising a housing for housing the cylindrical hollow fiber membrane bundle, wherein the cylindrical core is blood between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle. A groove forming a flow path, a first blood chamber formed in the cylindrical core, and a blood circulation opening communicating with the groove; A blood inflow port that communicates; a blood outflow port that communicates with a second blood chamber formed between the outer surface of the tubular hollow fiber membrane and the inner surface of the housing; The hollow fiber membrane bundle has an annular flat portion that is substantially orthogonal and has a predetermined width, and the hollow fiber membrane bundle is screwed into the cylindrical core. And a hollow fiber cross annular portion formed by overlapping the cross portions of the hollow fibers, and the hollow fiber cross annular portion is located on the annular flat portion of the cylindrical core. .
For this reason, since the blood that has passed through the opening for blood circulation from the first blood chamber flows in the groove of the cylindrical core, the blood dispersibility is good and the blood flow into the hollow fiber membrane bundle is also good, and the gas The exchange ability is also high. Furthermore, in this artificial lung, since the hollow fiber cross annular part is located on the annular flat part where the groove of the cylindrical core is not formed, blood flows directly into the hollow fiber cross annular part 3a from the groove. Without flowing into the hollow fiber intersecting annular portion, it flows into the hollow fiber membrane bundle from another groove. For this reason, a short circuit path of blood is rarely formed, and has a sufficient gas exchange ability as an artificial lung.

Accordingly, the hollow fiber membrane oxygenator with built-in heat exchange function of the present invention will be described with reference to the drawings.
1 is a front view showing an embodiment of a hollow fiber membrane oxygenator with a heat exchange function according to the present invention, FIG. 2 is a left side view of the hollow fiber membrane oxygenator with a heat exchange function shown in FIG. 3 is a right side view of the hollow fiber membrane oxygenator with a built-in heat exchange function shown in FIG. 1, FIG. 4 is a cross-sectional view taken along line AA in FIG. 2, and FIG. 5 is a cross-sectional view taken along line BB in FIG. 6 and 6 are cross-sectional views taken along the line CC of FIG.

  A hollow fiber membrane type artificial lung 1 with a built-in heat exchange function of the present invention includes a cylindrical hollow fiber membrane bundle 3 comprising a cylindrical core 5 and a number of hollow fiber membranes for gas exchange wound around the outer surface of the cylindrical core 5. And a tubular heat exchanger portion housed in the tubular core 5 and a housing 2 for housing the artificial lung portion and the tubular heat exchanger portion. The cylindrical core 5 is formed between a groove 51 that forms a blood flow path between the outer surface of the cylindrical core 5 and the inner surface of the cylindrical hollow fiber membrane bundle 3, and between the cylindrical core 5 and the cylindrical heat exchanger section. In addition, a blood circulation opening 52 that communicates between the first blood chamber 11 and the groove 51 is provided. The oxygenator 1 is formed between a blood inflow port 24 communicating with the first blood chamber 11 formed between the cylindrical core 5 and the cylindrical heat exchanger, the outer surface of the cylindrical hollow fiber membrane, and the inner surface of the housing 2. In addition, a blood outflow port 25 communicating with the second blood chamber 12 is provided.

  The hollow fiber membrane type artificial lung 1 with a built-in heat exchange function of the present invention is a cylindrical hollow fiber membrane comprising a cylindrical core 5 and a number of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core 5. An oxygenator comprising a bundle 3, a tubular heat exchanger part housed in a tubular core 5, and a housing 2 housing the artificial lung part and the tubular heat exchanger part. The cylindrical heat exchanger section includes a cylindrical and bellows-shaped heat exchanger 31 and a bellows-shaped heat exchanger that regulates changes in the volume of the blood chamber inside the oxygenator during use. It also includes the deformation restricting portions 34 and 35.

  The hollow fiber membrane oxygenator 1 of the present invention includes a cylindrical core 5 and a cylindrical hollow fiber membrane bundle 3 composed of a number of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core 5; And a housing 2 that houses the tubular hollow fiber membrane bundle 3. The tubular core 5 includes a groove 51 that forms a blood flow path between the outer surface of the tubular core 5 and the inner surface of the tubular hollow fiber membrane bundle 3. The blood flow opening 52 communicates the first blood chamber 11 formed in the cylindrical core 5 and the groove 51. The oxygenator 1 includes a blood inflow port 24 communicating with the first blood chamber 11 and a blood outflow port 25 communicating with the second blood chamber 12 formed between the outer surface of the cylindrical hollow fiber membrane and the inner surface of the housing 2. Furthermore, the cylindrical core 5 has an annular flat portion 55 that is substantially orthogonal to the axial direction and has a predetermined width, and the hollow fiber membrane bundle 3 is spirally wound around the cylindrical core 5. And a hollow fiber intersecting annular portion 3a formed by overlapping hollow fiber intersecting portions (crosswind portions), and the hollow fiber intersecting annular portion 3a is formed on the annular flat portion 55 of the cylindrical core 5. It is also what is located.

  As shown in FIGS. 1 to 6, a hollow fiber membrane type artificial lung 1 with a built-in heat exchange function of this embodiment includes a housing 2, an artificial lung portion housed in the housing 2, and an artificial lung portion. A cylindrical heat exchanger portion is provided.

  In the hollow fiber membrane oxygenator 1 of this embodiment, as shown in FIGS. 5 and 6, a cylinder including a cylindrical housing body 21, a second blood chamber 12, a hollow fiber membrane bundle 3, and a groove 51 from the outside. The core 5, the first blood chamber 11, the cylindrical heat exchanger 31, the cylindrical heat exchanger deformation restricting portions 34 and 35, and the cylindrical heat medium chamber forming member 32 are arranged or formed substantially concentrically in this order. Yes.

  As shown in FIGS. 1 to 5, the housing 2 includes a cylindrical housing body 21 including a blood outflow port 25, a first header 22 including a gas inflow port 26, a heat medium inflow port 28, and a heat medium outflow port 29, A second header 23 having a gas outlet port 27 and a blood inlet port 24 provided in the cylindrical core 5 is provided. The inner surface of the first header 22 is provided with a heat medium chamber forming member connecting portion 22a that protrudes in a cylindrical shape and a partition portion 22b that bisects the inside of the cylindrical connecting portion 22a. In addition, a heat medium chamber forming member connecting portion 23 a protruding in a cylindrical shape is provided on the inner surface of the second header 23. For this reason, as shown in FIG. 5, a cylindrical heat medium chamber forming member 32 to be described later has an opening end side held by the first header 22 and a closed end side held by the second header 23.

  As shown in FIG. 10, which is an explanatory diagram for explaining the internal structure of the heat exchanger unit, the cylindrical heat exchanger unit includes a cylindrical heat exchanger 31 and a cylinder accommodated in the heat exchanger 31. A cylindrical heat exchanger chamber forming member 32, and two cylindrical heat exchanger deformation regulating portions 34 and 35 inserted between the cylindrical heat exchanger member 31 and the cylindrical heat exchanger chamber forming member 32.

  As the cylindrical heat exchanger 31, a so-called bellows heat exchanger is used. As shown in FIG. 10, the bellows type heat exchanger 31 (bellows tube) is formed at a bellows forming portion 31b having a large number of hollow annular protrusions 31a formed substantially parallel to the central side surface, and at both ends thereof. A cylindrical portion 31c substantially equal to the inner diameter of the portion 31b is provided. As shown in FIGS. 4 and 5, one of the cylindrical portions of the heat exchange body 31 is sandwiched between the inner surface of the hollow cylindrical core 5 on the blood inlet port 24 side and the first header 22, and the heat exchange body 31. The other cylindrical portion is inserted between the ring-shaped heat exchanger fixing member 48 inserted into one end of the hollow cylindrical core 5 and between the ring-shaped heat exchanger fixing member 48 and the second header 23. It is sandwiched between the tubular heat exchanger fixing member 49 and the second header 23.

  The bellows type heat exchange element 31 is formed in a so-called fine bellows shape from a metal such as stainless steel or aluminum or a resin material such as polyethylene or polycarbonate. Metals such as stainless steel and aluminum are preferred in terms of strength and heat exchange efficiency. In particular, it is composed of a bellows tube having a wave shape in which irregularities substantially orthogonal to the axial direction (center axis) of the cylindrical heat exchanger 31 are repeated, and the height of the valley and peak is 5.0. About 15.0 mm is the most efficient, and preferably 9.0 to 12.0 mm. Moreover, although the length of the axial direction of a heat exchanger part changes with patients used, the thing of the range of 70.0-150 cm is used.

  As shown in FIGS. 4, 5, 6, and 10, the cylindrical heat medium chamber forming member 32 is a cylindrical body having one end (first header 22 side) opened, and the inside is inflow side heat medium. A partition wall 32a that is divided into a chamber 41 and an outflow side heat medium chamber 42, a first opening 33a that communicates with the inflow side heat medium chamber 41 and extends in the axial direction, and communicates with the inflow side heat medium chamber 42 and extends in the axial direction. Protrusions 36a and 36b extending in the axial direction are formed on the side faces of the second opening 33b and at positions shifted by about 90 degrees from the first opening 33a and the second opening 33b. . The protrusion 36a restricts the movement of the deformation restricting portion 34 by entering the groove 51 extending in the axial direction formed at the center of the inner surface of the heat exchanger deformation restricting portion 34. Similarly, the protrusion 36 b restricts the movement of the deformation restricting portion 35 by entering the groove 51 extending in the axial direction formed at the center of the inner surface of the heat exchanger deformation restricting portion 35.

  When the open end side of the cylindrical heat medium chamber forming member 32 is fitted to the heat medium chamber forming member connecting portion 22a of the first header 22, the cylindrical heat medium chamber forming member 32 is shown in FIG. A partition portion 22b that bisects the inside of the cylindrical connection portion 22a is in close contact with one surface (the lower surface in this embodiment) of the tip of the partition wall 32a. Thereby, the inflow side heat medium chamber 41 in the cylindrical heat medium chamber forming member 32 communicates with the heat medium inflow port 28, and the outflow side heat medium chamber 42 communicates with the heat medium outflow port 29.

  Moreover, the two heat exchange element deformation | transformation control parts 34 and 35 are provided with the notch parts 34b and 35b extended in an axial direction in each edge part which is attached, and the two control parts 34 and 35 are attached. Accordingly, as shown in FIGS. 6 and 7, a medium inflow side passage 37 and a medium outflow side passage 38 are formed. In FIG. 7, the cylindrical heat medium chamber forming member 32 is omitted. In addition, you may form the two heat exchange body deformation | transformation control parts 34 and 35 integrally.

  And as shown in FIG. 7 and FIG. 10 which are explanatory drawings for demonstrating the heat exchanger part of one Example of the hollow fiber membrane type artificial lung with a built-in heat exchange function of this invention, two heat-exchange body deformation | transformation restrictions are shown. The parts 34 and 35 are provided with a large number of ribs 34a and 35a for restricting heat exchanger deformation on the outer surface. The deformation regulating ribs 34 a and 35 a are in contact with the inner surface of the bellows valley portion (bottom portion) of the heat exchange element 31 or the vicinity thereof (near the inner curved portion). The cylindrical heat exchange body deformation regulating members 34 and 35 are in contact with the inner surface of the bellows of the heat exchange body 31, and the deformation regulating ribs 34 a and 35 a enter the valley of the bellows tube to form a valley (small diameter portion). By contacting the vicinity, the deformation of the heat exchanger 31 is regulated. When the pressure inside the heat exchanger changes, the heat exchanger 31 tends to meander or expand or contract the bellows. However, in this artificial lung 1, when the pressure inside the heat exchanger changes, even if the heat exchanger 31 tries to deform, the inner surface of the valley portion of the bellows part abuts against the deformation regulating ribs 34a and 35a. Is inhibited. Thereby, even if the pressure inside the heat exchanger changes, it is safe because the change in the volume of the blood chamber inside the artificial lung can be regulated.

  In this embodiment, the deformation regulating ribs 34a and 35a are formed in a plurality of arcs parallel to the outer surface of the cylindrical heat exchange body deformation regulating members 34 and 35, and the valleys of all the bellows portions of the heat exchange body 31 are formed. It has penetrated inside the department. The ribs 34a and 35a may not be arc-shaped but may be ribs discontinuously arranged on the arc (for example, the cross-section is a dot shape such as a circle, an ellipse, or a polygon, or an arc shape). In addition, the rib is preferably provided so as to penetrate all the bellows of the bellows tube, but not all of the bellows of the bellows tube, but appropriately thinned or one of the bellows of the bellows tube It may be provided every other. The height of the ribs 34a and 35a is preferably about 0.1 to 10.0 mm, and more preferably 0.5 to 2.0 mm, although it depends on the depth of the valley portion of the heat exchanger 31. Further, the height of the ribs 34a and 35a is preferably about 1/20 to 1/1 of the depth of the valley portion of the heat exchanger 31.

  Furthermore, in this embodiment, the deformation regulating ribs 34a and 35a do not extend to the entire outer surface of the cylindrical heat exchanger deformation regulating members 34 and 35, but the outer surfaces of the cylindrical heat exchanger deformation regulating members 34 and 35. Rib non-forming portions 34c and 35c extending in the axial direction are provided at both end portions.

  The heat exchange element deformation restricting portion is not limited to the one using the restricting members 34 and 35 as described above. For example, as shown in FIG. It may be a seal portion 45 that extends in the axial direction with a predetermined width and is formed so as to fill at least the bellows valley. As such a restricting portion 45, a plurality of (for example, 2 to 8, preferably 3 to 6) deformation restricting portions 45a, 45b, and 45c extending in the axial direction may be formed using, for example, a potting agent.

  Furthermore, as the heat exchange element deformation restricting portion, for example, as shown in FIG. 9, a plurality of (for example, 2 to 8, preferably 3 to 6) deformations extending in the axial direction directly on the inner surface of the heat exchange element 31. The regulation linear material part (for example, wire, piano wire) 46a, 46b, 46c may be fixed to the apex of the inner surface of the valley part by a welded part 47 (for example, solder).

  And the flow of the heat medium in the heat exchanger part of the oxygenator 1 of this Example is demonstrated using FIG. 5 and FIG. The heat medium that has flowed into the artificial lung from the heat medium inflow port 28 passes through the first header 22 and flows into the inflow side heat medium chamber 41. Then, it passes through the medium inflow side passage 37 formed by the inflow chamber side opening 33a of the cylindrical heat medium chamber forming member 32 and the contact portion of the heat exchange body deformation regulating portions 34, 35, and the heat exchange body 31 It flows between the heat exchange body deformation restricting portions 34 and 35. At this time, the heat exchanger 31 is heated or cooled by the heat medium. The heat medium passes through the medium outflow side passage 38 formed by the abutting portions of the heat exchanger deformation restricting portions 34 and 35 and the outflow chamber side opening 33b of the cylindrical heat medium chamber forming member 32, thereby forming the cylinder. It flows out into the outflow side heat medium chamber 42 in the cylindrical heat medium chamber forming member 32. Then, it passes through the second header 23 and flows out from the heat medium outflow port 29.

Next, the oxygenator will be described.
FIG. 11 is an explanatory view for explaining the internal structure of the oxygenator part of one embodiment of the hollow fiber membrane oxygenator with a heat exchange function of the present invention. 12 is a front view of a cylindrical core used in an embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention, FIG. 13 is a plan view of the cylindrical core shown in FIG. 12, and FIG. FIG. 13 is a cross-sectional view of the cylindrical core shown in FIG. 12. 15 is a left side view of the cylindrical core shown in FIG. 12, and FIG. 16 is a right side view of the cylindrical core shown in FIG. FIG. 18 is an explanatory view for explaining the structure of an oxygenator part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention, and shows a cylindrical core and an upper half hollow fiber membrane in appearance. Represents. FIG. 19 is an explanatory diagram for explaining the structure of an oxygenator part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function according to the present invention.

  The artificial lung section includes a cylindrical core 5 and a cylindrical hollow fiber membrane bundle 3 including a large number of hollow fiber membranes wound around the outer surface of the cylindrical core 5.

  As shown in FIGS. 3, 4, 12, 13, 14, and 15, the cylindrical core 5 is a cylindrical body, and at one end, an annular flat plate-like protrusion 56 that extends inward with a predetermined width. The blood inflow port 24 is formed on the outer surface of the annular flat projection 56 so as to protrude outward in parallel with the central axis of the cylindrical core 5. On the outer surface of the cylindrical core 5, a large number of grooves 51 that form a blood flow path are formed between the outer surface of the cylindrical core 5 and the inner surface of the cylindrical hollow fiber membrane bundle 3. Further, the cylindrical core 5 has a blood circulation opening 52 that communicates the groove 51, the cylindrical core 5, and the first blood chamber 11 formed between the cylindrical heat exchanger portions. As the cylindrical core 5, an outer diameter of about 20 to 100 mm is preferable, and an effective length (the length of a portion of the total length not buried in the partition wall) is preferably about 10 to 730 mm.

  Specifically, the cylindrical core 5 has a plurality of grooves 51 that are not parallel and continuous except for both end portions, and an annular rib 53 is formed between the grooves 51. The groove of the cylindrical core 5 is formed so as to extend over almost the entire portion of the hollow fiber membrane bundle that contributes to gas exchange (effective length, a portion that is not buried in the partition wall). The cylindrical core 5 used here is provided with a flat surface non-grooved portion 54 that is substantially on the extension line of the blood inflow port 24 and extends almost entirely over the groove 51 forming portion of the cylindrical core 5. For this reason, the groove 51 and the rib 53 of the cylindrical core 5 are an annular groove 51 (arc-shaped groove 51) and an annular rib 53 (arc-shaped rib) having a start end and a terminal end. As the cylindrical core 5, a cylindrical hollow fiber formed on the outer surface of the cylindrical core 5 is provided with a flat surface-shaped groove non-forming portion 54 that extends over substantially the entire portion of the cylindrical core 5 where the groove 51 is formed. The shape stability of the film bundle 3 is improved. However, the groove non-forming portion 54 is not necessarily provided, and the groove 51 and the rib 53 of the cylindrical core 5 may be an endless complete annular groove 51 and an endless complete annular rib 53. Moreover, as the depth of the groove | channel 51, about 0.5-10.0 mm is suitable, and 2.0-4.0 mm is especially suitable. Moreover, as a pitch of the groove | channel 51, about 1.0-10.0 mm is suitable, and 3.0-5.0 mm is especially suitable. Moreover, as a width | variety (width | variety of the largest part) of the groove | channel 51, about 1.0-10.0 mm is suitable, and 2.0-4.0 mm is especially suitable. Since the cylindrical core 5 includes a large number of grooves 51 over almost the entire length of the hollow fiber membrane bundle 3 (the portion not buried in the partition wall), blood can be dispersed throughout the hollow fiber membrane bundle 3. The entire hollow fiber membrane can be used effectively, and the gas exchange ability is high.

  Furthermore, it is preferable that the peak of the crest (rib 53) formed between the grooves 51 of the cylindrical core 5 is a flat surface. The width of the flat surface of the rib 53 is preferably about 0.1 to 5.0 mm, and particularly preferably 0.8 to 1.2 mm. Thus, the shape stability of the cylindrical hollow fiber membrane bundle 3 formed in the outer surface of the cylindrical core 5 improves by making the vertex of the rib 53 into a flat surface. Further, the groove 51 has a shape (for example, a trapezoidal cross section) whose cross-sectional shape widens toward the apex of the rib 53. For this reason, since the groove | channel 51 (blood flow path) spreads toward a hollow fiber membrane bundle inner surface, the blood inflow into a hollow fiber membrane bundle is made favorable.

  The blood inflow port 24 is provided on one end side of the cylindrical core 5, and the blood circulation opening 52 is formed in a region facing the region where the center line of the blood inflow port 24 is extended. . By doing in this way, the blood circulation form in the 1st blood chamber 11 formed between the cylindrical core and the cylindrical heat exchanger part becomes easy, and the heat exchange efficiency becomes high. Specifically, as shown in FIGS. 6 and 16, the cylindrical core 5 is substantially on the extension line of the blood inflow port 24 described above, and no groove is formed extending substantially over the entire groove forming portion of the cylindrical core 5. The unit 54 is provided. The non-grooved portion 54 is a thin portion that is made possible by not forming a groove, whereby the blood guiding portion 56 located substantially on the extension line of the blood inflow port 24 is formed inside the cylindrical core 5. Is formed. The blood guide portion has a larger inner diameter than the other groove forming portions. By providing such a blood guiding portion 56, blood can be reliably introduced into the entire axial direction of the first blood chamber 11 formed between the cylindrical core and the cylindrical heat exchanger portion.

  A blood circulation opening 52 is formed in a region (position) facing the non-groove forming portion 54 (blood guiding portion 56). In the cylindrical core 5, the blood circulation opening 52 includes a plurality of blood circulation openings 52 communicating with each of the plurality of annular grooves 51. That is, the opening 52 is formed by deleting the groove 51 portion of the cylindrical core 5 at a position facing the groove non-forming portion 54 (blood guiding portion). For this reason, the rib 53 exists between the adjacent openings 52. Furthermore, in this cylindrical core 5, the thickness of the rib 53 in the opening formation part 52a is thin, and as shown in FIG. 16, the inner diameter of the opening formation part 52a is the same as that of the non-groove formation part (blood guiding part). The second blood guiding portion 57 is formed wider than the other portions. As described above, by leaving the crest portion of the rib 53 in the opening forming portion 52a, the physical property of the cylindrical core 5 is avoided and the shape of the hollow fiber membrane bundle 3 is stabilized by securing the contact portion with the hollow fiber membrane. It becomes possible. In addition, by making the inner diameter of the opening forming portion 52a thinner than the other portions, the blood flowing through the first blood chamber 11 is surely guided to the opening forming portion 52.

  However, the present invention is not limited to this, and there is no crest portion of the rib 53 in the opening forming portion 57, and one blood circulation opening or a plurality of annular grooves communicating with all of the plurality of annular grooves 51. A plurality of blood circulation openings communicating with 51 may be provided. 17 includes two blood circulation openings 52b and 52c divided into two by an annular flat portion 55 described later, and a plurality of grooves on one end side (blood inflow port 24 side) from the annular flat portion 55. 51 communicates with the blood circulation opening 52b, and a plurality of grooves 51 on the other end side from the annular flat portion 55 communicate with the blood circulation opening 52c.

  The cylindrical core 5 includes an annular flat portion 55 that is substantially orthogonal to the axial direction with a predetermined width. The annular flat portion 55 is preferably completely annular without being divided. The width of the annular flat portion 55 is larger than the width of the flat surface at the apex of the rib 53, preferably about 1 to 10 mm, and particularly preferably 2 to 5 mm.

  And the hollow fiber membrane bundle 3 is wound around the outer surface of the cylindrical core 5 mentioned above. As shown in FIGS. 18 and 19, the hollow fiber membrane bundle 3 is wound around the cylindrical core 5 in a spiral shape, and the hollow fiber intersecting portion (crosswind portion) where the hollow fibers are in contact with each other and intersect. ) Have a hollow fiber cross annular portion 3a formed by overlapping. Further, the hollow fiber intersecting annular portion 3 a is located on the annular flat portion 55 of the cylindrical core 5. The hollow fiber intersecting annular portion 3a is a portion where the hollow fiber intersecting portions are stacked, and an unequal gap is formed between the hollow fiber membranes as compared with other portions. For this reason, if there is a groove 51 of the core 5 in this portion, blood may flow directly from the groove 51 into the gap in the hollow fiber cross-annular portion 3a, thereby forming a blood short circuit. However, in this artificial lung 1, since this hollow fiber cross annular part 3a is located on the annular flat part 55 where the groove of the cylindrical core 5 is not formed, it is directly inside the hollow fiber cross annular part 3a from the groove. Blood does not flow in, but flows into the hollow fiber intersecting annular portion 3a after flowing into the hollow fiber membrane bundle from another groove. For this reason, a short circuit path of blood is rarely formed, and has a sufficient gas exchange ability as an artificial lung.

  Further, the hollow fiber membrane bundle 3 has one or more (preferably 2 to 16) hollow fiber membranes at the same time, and all the adjacent hollow fiber membranes have a substantially constant interval. And a winder for weaving the hollow fiber membrane and a rotating body for rotating the cylindrical core 5 when the hollow fiber membrane is wound on the cylindrical core. Are preferably formed by being wound around the cylindrical core 5 by moving according to the following formula 1.

    Traverse [mm / lot] · n (integer) = traverse swing width · 2 ± (fiber outer diameter + interval) · number of windings (Formula 1)

  By doing so, it is possible to reduce the formation of blood drift. At this time, n, which is the relationship between the number of rotations of the winding rotary body and the number of rewinds of the winder, should be 1 to 5, and preferably 1. Thus, by selecting an integer as n in the above formula 1, the hollow fiber intersecting annular portion 3a in which the hollow fiber intersecting portions (crosswind portions) overlap is formed. The number of hollow fiber intersecting annular portions 3a formed is the same as the value of n. In the artificial lung 1 of this embodiment, n = 1 is performed. In this case, the hollow fiber is bundled at the center of the hollow fiber membrane bundle 3 (before cutting both ends) wound around the outer surface of the cylindrical core 5. An intersecting annular portion 3a is formed. For this reason, the hollow fiber is wound on the annular flat part 55 of the cylindrical core 5 by winding the hollow fiber around the cylindrical core 5 so that the annular flat part 55 of the cylindrical core 5 is positioned at the center of the traverse swing width. The hollow fiber membrane bundle 3 in which the hollow fiber intersecting annular portion 3a where the intersecting portions (crosswind portions) overlap can be obtained.

  In particular, one or more hollow fiber membranes are preferably wound around the cylindrical core 5 at the same time so that the hollow fiber membranes that are substantially parallel and adjacent to each other have a substantially constant spacing. Thereby, the drift of blood can be suppressed more. Moreover, it is preferable that the distance between adjacent hollow fiber membranes is 1/10 to 1/1 of the outer diameter of the hollow fiber membrane. Furthermore, the distance between adjacent hollow fiber membranes is preferably 30 μm to 200 μm, and particularly preferably 50 μm to 180 μm.

  Further, the hollow fiber is wound around the cylindrical core 5 so that the hollow fiber is not disposed outside the cylindrical core 5 in a portion that becomes the groove 51, in other words, the rib 53 is connected to the apex from the apex of the rib 53. It is preferably performed by winding spirally around the outer periphery of the apex. At this time, it is preferable to wind the hollow fiber at a certain angle with respect to the groove 51 (rib 53) so that the hollow fiber does not fall into the groove 51 of the cylindrical core 5. Specifically, an angle of 10 to 50 degrees is preferable with respect to the groove 51 (rib 53) of the cylindrical core 5, and 20 to 40 degrees is more preferable. In addition, the hollow fiber is wound while having a certain angle with respect to the groove 51 (rib 53) of the cylindrical core 5, so that bubbles that are trapped between the cylindrical core 5 and the hollow fiber during priming can be obtained. The disconnection is improved, the priming property and the gas performance are improved, and the variation in performance due to the fiber dropping can be reduced.

  A porous gas exchange membrane is used as the hollow fiber membrane. The porous hollow fiber membrane has an inner diameter of 100 to 1000 μm, a wall thickness of 5 to 200 μm, preferably 10 to 100 μm, a porosity of 20 to 80%, preferably 30 to 60%, and a pore diameter of 0.01 to The thing of 5 micrometers, Preferably 0.01-1 micrometer can be used preferably. Moreover, as a material used for the porous membrane, a hydrophobic polymer material such as polypropylene, polyethylene, polysulfone, polyacrylonitrile, polytetrafluoroethylene, and cellulose acetate is used. Polyolefin resins are preferable, and polypropylene is particularly preferable, and a resin in which micropores are formed on the wall by a stretching method or a solid-liquid phase separation method is more preferable. The outer diameter of the hollow fiber membrane bundle 3 is preferably 30 to 162 mm, and the thickness of the hollow fiber membrane bundle 3 is preferably 10 mm to 28 mm. Furthermore, the cylindrical hollow fiber membrane bundle 3 formed on the outer surface of the cylindrical core 5 has a filling rate of the hollow fiber membrane with respect to the cylindrical space formed between the outer side surface and the inner side surface of the cylindrical hollow fiber membrane bundle 3. 50% to 75% is preferable. More preferably, it is 53% to 73%.

  The hollow fiber membrane bundle 3 is wound around the cylindrical core 5 and then fixed at both ends to the cylindrical housing body 21 by the partition walls 8 and 9, and both ends of the hollow fiber membrane bundle 3 are cut. The Thereby, both ends of the hollow fiber membrane are opened at the end face of the partition wall.

  Both ends of the cylindrical core 5 around which the hollow fiber membrane bundle 3 is wound on the outer surface are liquid-tightly fixed to both end portions of the cylindrical housing body 21 by the partition walls 8 and 9, and the cylindrical hollow fiber membrane outer surface and the cylindrical housing are fixed. A second blood chamber 12 that is an annular space (cylindrical space) is formed between the inner surfaces of the main body 21. A blood outflow port 25 formed on the side surface of the cylindrical housing body 21 communicates with the second blood chamber 12. The partition walls 8 and 9 are formed of a potting agent such as polyurethane or silicone rubber.

  And as shown in FIG. 11, the heat exchanger part mentioned above is accommodated in the cylindrical core 5 of the artificial lung part formed as mentioned above. An annular first blood chamber 11 is formed between the cylindrical core 5 and the cylindrical heat exchanger portion, and the blood inflow port 24 communicates with the blood chamber 11.

  In the oxygenator 1, blood flowing from the blood inflow port 24 flows into the blood guiding part 57 constituting a part of the blood chamber 11 between the cylindrical core 5 and the cylindrical heat exchanger unit, and is cylindrical. After flowing between the core 5 and the tubular heat exchanger, it flows out of the tubular core 5 through an opening 52 formed at a position facing the first blood guiding portion 57. The blood flowing out from the core 5 flows into the plurality of grooves 51 formed on the outer surface of the cylindrical core 5 located between the inner surface of the hollow fiber membrane bundle 3 and the cylindrical core 5, and then flows into the hollow fiber membrane bundle 3. To do. In the oxygenator of this embodiment, a number of grooves 51 are formed so as to extend over almost the entire portion of the hollow fiber membrane bundle 3 that contributes to gas exchange (effective length, the portion that is not buried in the partition wall). The entire hollow fiber membrane bundle 3 can be dispersed, the entire hollow fiber membrane can be used effectively, and the gas exchange ability is high. Then, after contacting the hollow fiber membrane and performing gas exchange, it flows into the second blood chamber 12 formed between the cylindrical housing body 21 and the outer surface of the hollow fiber membrane (the outer surface of the hollow fiber membrane bundle 3), and blood It flows out from the outflow port 25. Further, the oxygen-containing gas flowing in from the gas inflow port 26 passes through the first header 22, flows into the hollow fiber membrane from the partition wall end face, passes through the second header 23, and flows out from the gas outflow port 27. . Note that hot water or cold water flows into the heat exchanger section from the heat medium inflow port 28 as necessary, and the hot water or cold water that has flowed through the heat exchanger section flows out of the heat medium outflow port 29.

  In addition, as a material for forming the members excluding the heat exchanger 31 such as the cylindrical housing body 21, the cylindrical core 5, the first and second headers 22 and 23, polyolefin (for example, polyethylene, polypropylene), ester resin (For example, polyethylene terephthalate), styrene resin (for example, polystyrene, MS resin, MBS resin), polycarbonate, and the like can be used.

  Further, the blood contact surface of the artificial lung 1 is preferably an antithrombotic surface. An antithrombotic surface can be formed by coating an antithrombotic material on the surface and further fixing. As the antithrombotic material, heparin, urokinase, HEMA-St-HEMA copolymer, poly-HEMA and the like can be used.

  Next, specific examples and comparative examples of the heat exchange function-embedded hollow fiber membrane oxygenator of the present invention will be described.

(Example)
A cylindrical housing body having an outer diameter of 84.0 mm, an inner diameter of 75.0 mm, and a length of 110.0 mm was used. In addition, as the first header and the second header, those having shapes as shown in FIGS. 1 to 4 were used.

  The bellows type heat exchanger has an outer diameter of 75 mm, an inner diameter of 50 mm, a length of 110.0 mm, a bellows forming portion length of 90.0 mm, a number of peaks of 40, and a bellows (mountain) pitch of 2.25 mm. Was used. Then, in the bellows type heat exchange body, a cylinder with one end closed in a shape as shown in FIG. 10 having an outer diameter of the cylindrical portion of 39.0 mm, an outer diameter of the rib portion of 47.0 mm, and a length of 116.0 mm. A combination of two heat exchange body deformation regulating members having a shape as shown in FIG. 10 was inserted on the outer side of the heat medium chamber forming member. The heat exchanger deformation restricting member is a member having a length of 92.0 mm, a maximum diameter portion of 52.0 mm, and 40 ribs (height: 1.0 mm, width: 0.5 mm) formed in parallel on the outer surface. The rib of the member was inserted so as to enter the inner space of the valley of the bellows type heat exchanger.

  The cylindrical core has a shape as shown in FIGS. 12 to 16, and has a length of 152.0 mm, an inner diameter of 75.0 mm, a groove forming portion length of 90.0 mm, and a groove depth of height 2. 5 mm, groove | interval 3.0 mm, the width | variety of the flat surface of a rib vertex 1.0mm, the number of grooves 40, and the thing which has an annular | circular flat surface of width 3.0mm in the outer periphery on the outer periphery were used. And said bellows type heat exchanger was inserted in this cylindrical core.

  Four porous polypropylene hollow fiber membranes having an inner diameter of 195 μm, an outer diameter of 295 μm, and a porosity of about 35% are rewound on the outer surface of the cylindrical core while keeping the distance between the hollow fiber membranes constant. The hollow fiber membrane interval is also the same as the previously wound hollow fiber membrane interval, and the hollow fiber membranes are wound so that the interval between adjacent hollow fiber membranes is constant. A hollow fiber membrane bobbin with built-in exchanger was produced. When the hollow fiber membrane is wound around the cylindrical core, a rotating body for rotating the cylindrical core 5 and a winder for weaving the hollow fiber membrane are moved according to the following formula, thereby forming a hollow fiber membrane bundle The hollow fiber crossing annular portion was located on the annular flat surface of the core.

    Traverse [mm / lot] · 1 (integer) = traverse swing width · 2 ± (fiber outer diameter + interval) · number of wraps

Then, both ends of the hollow fiber membrane bundle are fixed to both ends of the cylindrical housing body together with the core by a potting agent, and the hollow is fixed without cutting the heat exchanger portion while rotating around the heat exchanger portion. Both ends of the thread membrane bobbin were cut. Then, the first header and the second header described above are attached to both ends of the cylindrical housing main body, the membrane area is 2.5 m ² , and the heat exchange function built-in hollow fiber having a structure as shown in FIGS. A membrane oxygenator was prepared.

(Comparative example)
The membrane area is the same as in the example except that a cylindrical core having no groove is used, and a cylindrical member having the same shape as the above-described heat exchange body deformation regulating member and having no rib is used. A hollow fiber membrane oxygenator with a built-in heat exchange function of 5 m ² was produced.

(Experiment)
For the artificial lungs of Examples and Comparative Examples produced as described above, the following experiment was performed using bovine blood. For bovine blood, standard venous blood as defined by Association for the Advancement of Medical Instrumentation (AMMI) was used, and an anticoagulant added thereto was perfused into each oxygenator at a flow rate of 7 L / min. For each oxygenator, blood is collected in the vicinity of the blood inflow port and in the vicinity of the blood outflow port, and the oxygen gas partial pressure, carbon dioxide partial pressure, pH, etc. are obtained with a blood gas analyzer, and the oxygen transfer amount, carbon dioxide transfer The amount was determined. Moreover, the pressure loss and blood filling amount at a blood flow rate of 7 L / min were measured. The results were as shown in Table 1 below.

[Table 1]
┌────┬──────┬──────────┬┬────────┐
│ │ Oxygen transfer │ Carbon dioxide transfer │ Pressure loss │
│ │ (L / min) │ (L / min) │ (mmHg) │
├────┼──────┼──────────┼┼────────┤
│ Examples │ 490 │ 350 │ 100 │
├────┼──────┼──────────┼┼────────┤
│Comparison example │ 400 │ 300 │ 200 │
└────┴──────┴──────────┴┴────────┘

FIG. 1 is a front view showing an embodiment of a hollow fiber membrane oxygenator with a built-in heat exchange function according to the present invention. FIG. 2 is a left side view of the heat exchange function-embedded hollow fiber membrane oxygenator shown in FIG. FIG. 3 is a right side view of the heat exchange function-embedded hollow fiber membrane oxygenator shown in FIG. 4 is a cross-sectional view taken along line AA in FIG. 5 is a cross-sectional view taken along line BB in FIG. FIG. 6 is a cross-sectional view taken along the line CC of FIG. FIG. 7 is an explanatory view for explaining a heat exchanger part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. FIG. 8 is an explanatory view for explaining a heat exchanger part of another embodiment of the hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. FIG. 9 is an explanatory view for explaining a heat exchanger part of another embodiment of the hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. FIG. 10 is an explanatory view for explaining the internal structure of the heat exchanger part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. FIG. 11 is an explanatory view for explaining the internal structure of the oxygenator part of one embodiment of the hollow fiber membrane oxygenator with a heat exchange function of the present invention. FIG. 12 is a front view of a cylindrical core used in one embodiment of the hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. 13 is a plan view of the cylindrical core shown in FIG. 14 is a cross-sectional view of the cylindrical core shown in FIG. 15 is a left side view of the cylindrical core shown in FIG. FIG. 16 is a right side view of the cylindrical core shown in FIG. FIG. 17 is a plan view of a cylindrical core used in another embodiment of the heat exchange function-embedded hollow fiber membrane type artificial lung. FIG. 18 is an explanatory view for explaining the structure of the oxygenator part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function of the present invention. FIG. 19 is an explanatory diagram for explaining the structure of an oxygenator part of one embodiment of a hollow fiber membrane type artificial lung with a built-in heat exchange function according to the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Hollow fiber membrane type artificial lung 2 Housing 3 Tubular hollow fiber membrane bundle 3a Hollow fiber cross | intersection annular part 5 Tubular core 11 First blood chamber 12 Second blood chamber 21 Tubular housing main body 22 First header 23 First 2 header 24 blood inflow port 25 blood outflow port 26 gas inflow port 27 gas outflow port 28 heat medium inflow port 29 heat medium outflow port 31 cylindrical heat exchange bodies 34, 35 cylindrical heat exchange body deformation regulating portion 51 groove 52 blood Distribution opening 55 annular flat part

Claims (21)

An artificial lung part composed of a cylindrical core, a cylindrical hollow fiber membrane bundle made up of a number of hollow fiber membranes for gas exchange wound around the outer surface of the cylindrical core, and a cylinder housed in the cylindrical core A hollow fiber membrane type artificial lung with a built-in heat exchange function, comprising a tubular heat exchanger part and a housing for housing the artificial lung part and the tubular heat exchanger part, wherein the tubular core is the tubular core A groove for forming a blood flow path between the outer surface of the tubular hollow fiber membrane bundle and the inner surface of the tubular hollow fiber membrane bundle, a first blood chamber formed between the tubular core and the tubular heat exchanger section, and the groove A blood flow opening that communicates with the first blood chamber, and a blood inflow port that communicates with the first blood chamber, and a second hollow formed between the outer surface of the cylindrical hollow fiber membrane and the inner surface of the housing. A hollow fiber membrane oxygenator with a built-in heat exchange function, characterized by comprising a blood outflow port communicating with a blood chamber. The groove of the cylindrical core is a plurality of endless annular grooves or a plurality of annular grooves having a plurality of start ends and terminal ends, and the blood circulation opening of the cylindrical core has a plurality of communication with each of the plurality of annular grooves. 2. The hollow fiber membrane with a built-in heat exchange function according to claim 1, which is a blood circulation opening or a plurality of blood circulation openings communicating with all of the plurality of annular grooves. Type artificial lung. The blood inflow port is provided on one end side of the cylindrical core, and the blood circulation opening is formed in a region facing a region extending a center line of the blood inflow port. A hollow fiber membrane type artificial lung having a heat exchange function according to 1 or 2. The hollow fiber membrane oxygenator with a built-in heat exchange function according to any one of claims 1 to 3, wherein the apex of the rib formed between the grooves of the cylindrical core is a flat surface. The hollow fiber membrane type artificial lung with a built-in heat exchange function according to any one of claims 1 to 4, wherein the cylindrical core extends substantially in the axial direction and includes a flat surface-shaped groove-unformed portion. The hollow fiber membrane oxygenator with a heat exchange function according to any one of claims 1 to 5, wherein the groove of the core is formed over almost the entire region of the portion contributing to gas exchange of the hollow fiber membrane bundle. An artificial lung part composed of a cylindrical core, a cylindrical hollow fiber membrane bundle made up of a number of hollow fiber membranes for gas exchange wound around the outer surface of the cylindrical core, and a cylinder housed in the cylindrical core A hollow fiber membrane type artificial lung with a built-in heat exchange function, having a blood chamber therein, and a housing for housing the oxygenator and the cylindrical heat exchanger. The heat exchanger part includes a cylindrical and bellows-like heat exchanger, and also includes a bellows-like heat exchanger deformation restricting part that restricts a change in the volume of the blood chamber inside the oxygenator during use. A hollow fiber membrane oxygenator with built-in heat exchange function. The said cylindrical heat exchange body deformation | transformation control part is accommodated in the said bellows-shaped heat exchange body, and has a some rib which contacts the inner surface of the valley part of the said bellows, or a valley part vicinity. Hollow fiber membrane oxygenator with built-in heat exchange function. The cylindrical heat exchange element deformation restricting portion is formed to extend in the axial direction with a predetermined width on the inner surface or outer surface or the inner surface and outer surface of the bellows-shaped heat exchanger, and at least fill the valley portion of the bellows. The hollow fiber membrane type artificial lung with a built-in heat exchange function according to claim 7, which is a seal portion. The cylindrical core has a blood circulation opening, and a groove that forms a blood flow path between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle, A blood inflow port communicating with the first blood chamber formed between the outer surface of the exchange part and the inner surface of the cylindrical core, and a second blood chamber communicating with the outer surface of the cylindrical hollow fiber membrane and the inner surface of the housing The hollow fiber membrane type artificial lung with a built-in heat exchange function according to any one of claims 7 to 9, further comprising a blood outflow port. The hollow fiber membrane bundle is formed by winding one or a plurality of hollow fiber membranes around the cylindrical core so that all the hollow fiber membranes have a substantially constant interval. The hollow fiber membrane oxygenator with a built-in heat exchange function according to any one of claims 1 to 10. The distance between the hollow fiber membrane and an adjacent hollow fiber membrane that is substantially parallel to the hollow fiber membrane is 1/10 to 1/1 of the outer diameter of the hollow fiber membrane. 11. A hollow fiber membrane oxygenator with a built-in heat exchange function according to any one of 11 above. The artificial lung includes two partition walls for fixing both ends of the cylindrical hollow fiber membrane bundle to the housing, a gas inflow port and a gas outflow port communicating with the inside of the hollow fiber membrane, and the cylindrical heat exchanger portion. The hollow fiber membrane oxygenator according to any one of claims 1 to 12, further comprising a heat medium inflow port and a heat medium outflow port communicating with the inside of the heat medium. A hollow fiber comprising a cylindrical core, a cylindrical hollow fiber membrane bundle made of a large number of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core, and a housing that houses the cylindrical hollow fiber membrane bundle In the membrane oxygenator, the cylindrical core is formed in the cylindrical core, and a groove that forms a blood flow path between an outer surface of the cylindrical core and an inner surface of the cylindrical hollow fiber membrane bundle. A blood flow opening that communicates with the first blood chamber and the groove, and the artificial lung includes a blood inflow port that communicates with the first blood chamber, the outer surface of the cylindrical hollow fiber membrane, and the A blood outflow port that communicates with a second blood chamber formed between the inner surfaces of the housing; and the cylindrical core has an annular flat portion that is substantially orthogonal to the axial direction and has a predetermined width. The hollow fiber membrane bundle is spirally wound around the cylindrical core, and the hollow fiber crossing A hollow fiber cross annulus is formed overlap, the hollow fiber cross-annular portion, the hollow fiber membrane oxygenator, characterized in that located on the annular flat portion of the tubular core. The hollow fiber membrane bundle is formed by spirally winding one or more hollow fiber membranes around a cylindrical core so that all the adjacent hollow fiber membranes have a substantially constant interval. When the hollow fiber membrane is wound around the cylindrical core, a rotating body for rotating the cylindrical core and a winder for weaving the hollow fiber membrane are expressed by the following formula 1.
Traverse [mm / lot] · n (integer) = traverse swing width · 2 ± (fiber outer diameter + interval) · number of windings (calculation formula 1)
The hollow fiber membrane oxygenator according to claim 14, wherein the lung is formed by being wound around a cylindrical core by moving at the same time. The distance between the hollow fiber membrane and an adjacent hollow fiber membrane that is substantially parallel to the hollow fiber membrane is 1/10 to 1/1 of the outer diameter of the hollow fiber membrane. 15. A hollow fiber membrane oxygenator according to 15. The hollow fiber membrane oxygenator according to any one of claims 14 to 16, wherein the hollow fiber membrane oxygenator includes a cylindrical heat exchanger part housed in the cylindrical core. 18. The hollow fiber membrane oxygenator according to claim 14, wherein the annular flat portion has a width of 5 to 50 mm. The hollow fiber membrane oxygenator according to any one of claims 14 to 18, wherein apexes of ribs formed between the grooves of the cylindrical core are flat surfaces. The hollow fiber membrane oxygenator according to any one of claims 14 to 19, wherein the cylindrical core extends substantially in the axial direction and includes a flat surface-shaped groove-unformed portion. 21. The hollow fiber membrane type artificial lung with built-in heat exchange function according to claim 14, wherein the groove of the core is formed over substantially the entire area of the portion contributing to gas exchange of the hollow fiber membrane bundle.

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