JP5674456B2 - Artificial lung - Google Patents

Description

  The present invention relates to a hollow fiber membrane type artificial lung for removing carbon dioxide in blood and adding oxygen in extracorporeal blood circulation.

Artificial lungs are roughly classified into bubble type and membrane type. Recently, membrane oxygenators with less blood damage such as hemolysis, protein denaturation, blood coagulation, etc. compared to bubble oxygenators, such as hollow fiber membrane oxygenators using porous synthetic resin membranes, are frequently used. ing.
This hollow fiber membrane oxygenator supplies oxygen to one side of the hollow fiber membrane and supplies blood to the other side to perform gas exchange between oxygen and carbon dioxide through the hollow fiber membrane. .
However, in this type of oxygenator, when the room temperature is lower than the blood temperature, the gas flowing in the oxygenator flows out from the end of the hollow fiber membrane (partition wall end surface) while being heated by the blood, and near the end Therefore, a so-called wet rung phenomenon in which water vapor in the gas is condensed may occur. This condensed water partially occludes the hollow fiber membrane and lowers the oxygen capacity. In particular, this phenomenon often occurs during rewarming in hypothermic surgery performed by lowering the blood temperature.

The present applicant has proposed the following artificial lung for the purpose of preventing the above-mentioned wet rung phenomenon.
In the oxygenator disclosed in Japanese Patent Application Laid-Open No. 8-141703 (Patent Document 1), the heating device 1 is mounted so as to cover the gas outlet side port 33 of the hollow fiber membrane oxygenator 2, and the heating member is supplied with the power input from the power supply unit. The heat transfer member 11 is heated by the heating member 12, and the gas outlet 31 and the partition wall 24 of the hollow fiber membrane oxygenator 2 are heated by the heat transfer member 11. On the other hand, the heat of the heating member 12 that has generated heat is insulated by the heat insulating member 13.
Further, in the artificial lung 1 disclosed in Japanese Patent Laid-Open No. 8-141974 (Patent Document 2), an artificial lung housing 2 having a blood inlet 6 and a blood outlet 7 and a number of gas exchange hollows inserted into the artificial lung housing 2. A hollow fiber membrane bundle 3 made of a yarn membrane, partition walls 4a and 4b for fixing both ends of the hollow fiber membrane bundle 3 to both ends of the artificial lung housing 2, and a gas inflow portion formed outside the partition wall 4a 9, a gas outflow portion 10 formed outside the partition wall 4 b, a heat medium introduction portion 11, and a heat medium outlet portion 12, and the gas outflow portion without hindering the outflow of gas from the gas outflow portion 10 10 has a heat medium circulation part 13 that substantially encapsulates 10.

JP-A-8-141073 JP-A-8-141074

The above-mentioned Patent Documents 1 and 2 have a sufficient effect for suppressing the wet rung phenomenon. However, it is necessary to more reliably prevent the wet rung phenomenon, and the present invention and others have intensively studied, and have found that it is necessary to control the temperature of the gas flowing into the oxygenator.
Therefore, the object of the present invention is not only to adjust the temperature at the gas outflow part of the oxygenator, but also to adjust the temperature of the gas flowing into the oxygenator, to reliably prevent the occurrence of the wet rung phenomenon, It is to provide an artificial lung in which the ability is not lowered.

What achieves the above object is as follows.
(1) A housing, a hollow fiber membrane bundle comprising a number of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and the hollow fiber membrane bundle A partition wall liquid-tightly fixing both ends to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed inside and a gas An oxygenator comprising a gas inflow portion forming member having an inflow port and a gas outflow portion communicating with the inside of the hollow fiber membrane and formed outside the other partition wall, wherein the oxygenator is a gas outflow A heating part having an inflowing gas heating function for heating a gas flowing into the gas inflow part, and the heating part encapsulates the gas outflow part and the gas inflow It extends to the part forming member The heating section includes a heater, a gas flow path heated by the heater, a gas inflow port communicating with one end of the gas flow path, and the other end of the gas flow path Is in communication with the gas inlet of the gas inflow portion forming member , and the heating portion has the heater and is provided to face the partition wall on the gas outflow portion side. An oxygenator comprising an outflow portion heating section, wherein the gas flow path is provided on the opposite side of the gas outflow portion heating section from the partition facing surface and has a curved shape .
Moreover, what achieves the said objective is as follows.
(2) a housing, a hollow fiber membrane bundle made up of a number of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and the hollow fiber membrane bundle A partition wall liquid-tightly fixing both ends to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed inside and a gas An oxygenator comprising a gas inflow portion forming member having an inflow port, a gas outflow portion communicating with the inside of the hollow fiber membrane and formed outside the other partition wall,
The oxygenator has a heating part having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part, and the heating part covers the gas outflow part. The heating part, a heating part, a gas passage heated by the heating heater, and one end of the gas passage. A gas inflow port in communication with the other end of the gas flow path, and the gas inflow port of the gas inflow portion forming member; and the heating portion of the oxygenator housing. An extended warming portion is provided with a side portion extending from the gas outflow portion side to the gas inflow portion side. The extended warming portion is an extended warming portion heater and an extension heated by the heater. An artificial lung having an outlet / heater gas flow path.

Moreover, what achieves the said objective is as follows.
(3) a housing, a hollow fiber membrane bundle made of a plurality of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and the hollow fiber membrane bundle A partition wall liquid-tightly fixing both ends to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed inside and a gas An oxygenator comprising a gas inflow portion forming member having an inflow port and a gas outflow portion communicating with the inside of the hollow fiber membrane and formed outside the other partition wall, wherein the oxygenator is a gas outflow A heating part having an inflowing gas heating function for heating a gas flowing into the gas inflow part, and the heating part encapsulates the gas outflow part and the gas inflow It extends to the part forming member The heating unit includes a heater, a gas channel heated by the heater, and a gas inflow port communicating with one end of the gas channel, and the other end of the gas channel is The gas inflow portion forming member communicates with the gas inlet, and the heating portion is housed in the heating portion housing, and a heating portion housing fixed to the housing of the oxygenator. And a plate-shaped heating body provided with the heater, a curved gas passage formed between the inner surface of the heating section housing and the plate-shaped heating body, and the heating section A gas inflow port provided in the housing and in communication with the gas flow path, the other end of the gas flow path being the gas inflow port of the gas inflow part forming member in the heating part housing Artificial lung in communication with.

(4) the heating unit housing, artificial lung according to (3) which has a gas outlet communicating with the gas outlet portion of the oxygenator.
( 5 ) The artificial lung includes a heat exchanger therein, and the heat exchanger includes a blood circulation chamber, a heat medium circulation chamber in contact with the blood circulation chamber via a heat exchange tube, and the heat (1) to ( 4 ), comprising a heat medium inflow port and a heat medium outflow port communicating with the medium circulation chamber, wherein the blood inflow port or the blood outflow port is in communication with the blood circulation chamber. The artificial lung according to any one of the above.
( 6 ) The artificial lung has a humidity in the gas temperature detection part for detecting the gas temperature in the gas flow path of the heating part or in the gas inflow part of the artificial lung and / or in the gas outflow part. A humidity detection unit for detecting, and a control unit that controls the temperature of the heater using the gas temperature detected by the gas temperature detection unit and / or the humidity detected by the humidity detection unit. The oxygenator according to any one of (1) to (5) above.

The oxygenator of the present invention includes a housing, a hollow fiber membrane bundle made up of a plurality of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and a hollow fiber membrane bundle. Partition walls that are liquid-tightly fixed to both ends of the housing, a gas inflow portion that communicates with the inside of the hollow fiber membrane and that is formed outside the one partition wall, and forms a gas inflow portion and a gas flow A gas inflow portion forming member having an inlet, a gas outflow portion communicating with the inside of the hollow fiber membrane and formed outside the other partition wall, and further flowing into the gas outflow portion heating function and the gas inflow portion A heating part having an inflowing gas heating function for heating the gas to be heated.
The heating part encloses the gas outflow part and extends to the gas inflow part forming member, and the heating part is a heater and a gas flow path heated by the heater And a gas inflow port communicating with one end of the gas flow path, and the other end of the gas flow path communicates with a gas inflow port of the gas inflow portion forming member. For this reason, not only the gas outflow part of the oxygenator is heated, but the gas flowing into the gas inflow part of the oxygenator is also heated by the same heating means. The difference in temperature of the gas between the parts is small, the occurrence of the wet rung phenomenon can be surely prevented, and the oxygen capacity is not lowered even when used for a long time.

FIG. 1 is a front view showing an embodiment of the oxygenator according to the present invention. FIG. 2 is a left side view of the oxygenator shown in FIG. FIG. 3 is a right side view of the 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 the internal structure of the heat exchanger part of one embodiment of the oxygenator of the present invention. FIG. 8 is an explanatory diagram for explaining the internal structure of the oxygenator of one embodiment of the oxygenator of the present invention. FIG. 9 is a front view of a cylindrical core used in one embodiment of the oxygenator of the present invention. FIG. 10 is a view showing a state in which the cylindrical core shown in FIG. 9 is rotated 180 degrees around its central axis. 11 is a cross-sectional view of the cylindrical core shown in FIG. 12 is a left side view of the cylindrical core shown in FIG. FIG. 13 is a right side view of the cylindrical core shown in FIG. FIG. 14 is an explanatory diagram for explaining another embodiment of the oxygenator according to the present invention. FIG. 15 is a left side view showing another embodiment of the oxygenator according to the present invention. 16 is a cross-sectional view of the artificial lung shown in FIG. 15 taken along the line DD.

The oxygenator of the present invention will be described using the heat exchange function-embedded hollow fiber membrane oxygenator shown in the drawings.
The oxygenator 1 of the present invention includes a housing 2, a hollow fiber membrane bundle 3 composed of a number of gas exchange hollow fiber membranes inserted into the housing 2, a blood inlet 24 and a blood outlet that communicate with the inside of the housing 2. 25, partition walls 8 and 9 that fix both ends of the hollow fiber membrane bundle 3 to the housing 2 in a fluid-tight manner, and a gas inflow portion 26 that communicates with the inside of the hollow fiber membrane and is formed outside one partition wall 9. A gas inflow portion forming member 22 having a gas inflow portion 26 formed therein and having a gas inflow port 26a, and a gas outflow portion 27 communicating with the inside of the hollow fiber membrane and formed outside the other partition wall 8. Have. The oxygenator 1 has a heating unit 6 having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part 26. The heating part 6 encloses the gas outflow part 27 and extends to the gas inflow part forming member 22. Furthermore, the heating unit 6 includes a heater 61, a gas flow path 7 heated by the heater 61, and a gas inflow port 71 that communicates with one end 72 of the gas flow path 7. The other end 73 of the gas flow path 7 communicates with the gas inlet 26 a of the gas inflow portion forming member 22.

As shown in FIGS. 1 to 6, an oxygenator 1 of this embodiment includes a housing 2, an oxygenator part accommodated in the housing 2, and a cylindrical heat exchanger accommodated in the oxygenator part. Part and the heating part 6 fixed to the side part of the artificial lung part.
The oxygenator 1 according to this embodiment includes an oxygenator part including a cylindrical core 5 and a cylindrical hollow fiber membrane bundle 3 including a plurality of gas exchange hollow fiber membranes wound around the outer surface of the cylindrical core 5. And a cylindrical heat exchanger portion housed in the tubular core 5 and a housing 2 for housing the oxygenator 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. And a blood outflow port 25 communicating with the second blood chamber 12, and a heating unit 6 having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part 26. .

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 6, the housing 2 includes a cylindrical housing body 21 having a blood outflow port 25, a gas inflow port 26 a, a heat medium inflow port 28, and a heat medium outflow port 29. It has. The inner surface of the gas inflow portion forming member 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. Further, as shown in FIG. 5, a cylindrical heat medium chamber forming member 32 to be described later is sealed at the opening end side by a lid member 65.

As shown in FIG. 7 which is an explanatory view for explaining the internal structure of the heat exchanger unit, the cylindrical heat exchanger unit is 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. 7, 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, forming a bellows. 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 exchanger 31 is sandwiched between the inner surface of the hollow cylindrical core 5 on the blood inlet port 24 side and the sealing member 65, and the cylindrical portion of the heat exchanger 31. The other part is a ring-shaped heat exchanger fixing member 48 inserted into one end of the hollow cylindrical core 5 and a tube inserted between the ring-shaped heat exchanger fixing member 48 and the gas inflow portion forming member 22. Between the gas heat exchanger fixing member 49 and the gas inflow portion forming member 22.

  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 7, the cylindrical heat medium chamber forming member 32 is a cylindrical body that is open at one end (the gas inflow portion forming member 22 side). A partition wall 32a that is divided into a medium 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 in the axial direction. Protrusions 36a and 36b extending in the axial direction are formed on the side surfaces of the second opening 33b that extends and face each other and are shifted by about 90 degrees from the first opening 33a and the second opening 33b and project outward. Yes. The protrusion 36 a restricts the movement of the deformation restricting portion 34 by entering a groove extending in the axial direction formed at the center of the inner surface of the heat exchanger deformation restricting portion 34. Similarly, the protrusion 36b restricts the movement of the deformation restricting portion 35 by entering a groove 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 gas inflow portion forming member 22, as 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 distal end portion of the 32 partition walls 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 to which it attaches, and the two control parts 34 and 35 are attached. Thus, 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 which is explanatory drawing for demonstrating the heat exchanger part of one Example of the oxygenator of this invention, the two heat exchange body deformation | transformation control parts 34 and 35 have many heat | fever on an outer surface. Exchanger deformation regulation ribs 34a and 35a are provided. 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 element deformation restricting portions 4 and 35 come into contact with the inner surface of the bellows of the heat exchanger 31 and the deformation restricting ribs 34a and 35a penetrate into the valley of the bellows tube to form a valley portion (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 meanders and tries to 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 34 a and 35 a are formed in a plurality of arcs parallel to the outer surfaces of the cylindrical heat exchange body deformation regulating portions 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.

Further, in this embodiment, the deformation regulating ribs 34a and 35a do not extend to the entire outer surface of the cylindrical heat exchanger deformation restricting portions 34 and 35, but the outer surfaces of the cylindrical heat exchanger deforming restricting portions 34 and 35. Rib non-forming portions 34c and 35c extending in the axial direction are provided at both end portions. In addition, as a heat exchange body deformation | transformation control part, it is not limited to the thing using the control parts 34 and 35 as mentioned above.
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 gas inflow portion forming member 22 and flows into the inflow side heat medium chamber 41. Then, it passes through the inflow chamber side opening 33a of the cylindrical heat medium chamber forming member 32 and the medium inflow side passage 37 formed by the contact portions of the heat exchange body deformation restricting portions 34 and 35, and the heat exchange body 31 and the heat It flows between the 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 gas inflow portion forming member 22 and flows out from the heat medium outflow port 29.

Next, the oxygenator will be described.
FIG. 8 is an explanatory diagram for explaining the internal structure of the oxygenator of one embodiment of the oxygenator of 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. 4 to 6 and FIGS. 8 to 13, the cylindrical core 5 is a cylindrical body, and at one end, an annular flat plate-like protrusion 55 extending inward with a predetermined width is formed. The blood inflow port 24 is formed on the outer surface of the annular flat plate-like projecting portion 55 so as to project 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 effective 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 13, 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 guiding part has an inner diameter larger than that of the other groove forming part. 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. 13, 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 in the first blood chamber 11 is surely guided to the opening forming portion 52a. However, the present invention is not limited to this, and there is no crest portion of the rib 53 in the opening forming portion 52a, and one blood circulation opening or a plurality of annular grooves communicating with all of the plurality of annular grooves 51 is provided. A plurality of blood circulation openings communicating with 51 may be provided.
The cylindrical core 5 includes an annular flat plate-like projecting portion 55 that is substantially orthogonal to the axial direction with a predetermined width. It is preferable that the annular flat projection 55 is completely annular without being divided. The width of the annular flat projection 55 is wider than the flat surface at the apex of the rib 53, and is 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.
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 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. The oxygen-containing gas flowing in from the gas inlet 26a passes through the gas inflow portion forming member 22 and flows into the hollow fiber membrane from the end face of the partition wall, passes through the gas outflow portion 27 in the heating portion housing 23, and passes through the gas. It flows out from the discharge port 27a. 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.

Further, as a material for forming the members excluding the heat exchanger 31 such as the cylindrical housing main body 21, the cylindrical core 5, the gas inflow portion forming member 22, and the heating portion housing 23, polyolefin (for example, polyethylene, polypropylene), ester Resin (for example, polyethylene terephthalate), styrene resin (for example, polystyrene, MS resin, MBS resin), polycarbonate, etc. 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, the heating unit 6 will be described.
The oxygenator 1 of the present invention includes a heating part 6 that encapsulates the gas outflow part 27 and extends to the gas inflow part forming member 22. The heating unit 6 has a heating function of the gas outflow part 27 and an inflowing gas heating function for heating the gas flowing into the gas inflow part 26. In the oxygenator 1 of this embodiment, as shown in FIGS. 1 to 6, the heating unit 6 includes a heater 61, a gas channel 7 heated by the heater 61, and a gas channel 7. A gas inflow port 71 communicating with one end 72 of the gas is provided. The other end 73 of the gas flow path 7 communicates with the gas inlet 26 a of the gas inflow portion forming member 22.
In particular, in this embodiment, the heating unit 6 includes a heater 61 and includes a gas outflow portion heating unit 60 provided so as to face the partition wall 8 on the gas outflow portion 27 side. Specifically, the gas outflow portion heating unit 60 faces the artificial lung partition wall 8 at a predetermined distance, and forms a gas outflow portion 27 between the partition wall 8 and the formed gas outflow portion 27. Heating is possible. In this embodiment, the gas flow path 7 is provided on the opposite side of the surface facing the partition wall 8 (gas outflow part 27) of the gas outflow part heating part 60, and has a curved path shape. Yes.

  Specifically, the heating unit 6 includes a heating unit housing 23 fixed to an end portion of the artificial lung housing 2 on the partition wall 8 side, and a heater 61 that is accommodated in the heating unit housing 23. A gas outflow portion heating section 60 formed by the plate-shaped heating body 63 and a curved gas flow path 7 formed between the inner surface of the heating section housing 23 and the plate-shaped heating body 63 are provided. . Furthermore, the heating unit 6 includes a gas inflow port 71 that is provided in the heating unit housing 23 and communicates with one end 72 of the gas flow path 7. The other end 73 of the gas flow path 7 In the housing, it communicates with the gas inlet 26 a of the gas inflow portion forming member 22. The plate-shaped heating body 63 is formed of a hard material formed of a certain amount of heat conductive material, and a heater 61 (specifically, a heater wire) is embedded therein. The heater 61 is heated by heater heating means (not shown, specifically, energization means) connected to the heater terminal 62. As shown in FIG. 2, the heater 61 meanders in a zigzag shape and has a sufficient length.

As shown in FIGS. 2 and 4, the gas flow path 7 has a width extending in the peripheral direction of the heating unit housing 23 and has a curved shape meandering in the thickness direction of the housing 23. The gas is heated by passing through the flow path.
In this embodiment, one surface of the gas flow path 7 is formed by one surface of the plate-like heating body 63, and the other surface of the gas flow path 7 is formed by the gas flow path forming member 74. ing. The gas flow path forming member 74 is preferably formed of a heat insulating material. The gas flow path forming member 74 may be formed integrally with the housing 23. Moreover, the housing 23 is provided with the opening for making the blood inflow port 24 protrude, as shown in FIG.1, FIG2 and FIG.4.
Further, in the oxygenator 1 of this embodiment, the warming part 6 includes an extended warming part 6a that extends from the gas outflow part 27 side to the gas inflow part 26 side of the oxygenator housing 2 side. The extension heating unit 6a includes an extension heating unit heater 61a and an extension heating unit gas flow path 7a that is heated by the heater 61a. The housing 23 includes a lower lid portion 23 a, and an extension portion heating portion housing is formed by the inside of the lower lid portion 23 a and the lower portion of the housing 23.
In this embodiment, the extension part heating part 6a has a structure substantially similar to the heating part 6 described above. Specifically, as shown in FIG. 4, the extension heating unit 6 a includes a plate-like heating body 63 a in which an extension part heater 61 a (heater wire) continuous with the heater 61 is embedded. Further, an extended heating portion gas flow path 7a is provided which is located outside or inside (in the illustrated embodiment, outside) of the plate-shaped heating body 63a and communicates with the gas flow path 7 described above. In the example shown in FIG. 4, the heater of the extension heating unit is the extension of the heater 61 described above, and its end is near the end of the artificial lung housing 2 on the partition wall 9 side. It is supposed to be located.

The extended heating part gas flow path 7a has a width extending a predetermined length in the peripheral direction of the oxygenator housing 2 and has a curved shape meandering in the thickness direction of the lower lid part 23a. As the gas passes through, it is heated. And the gas inflow port 26a has approached into the edge part 73 of the gas flow path 7a of the extension heating part 6a, and both are connected in the airtight state. In addition, one surface of the gas channel 71 is formed by one surface of the plate-like heating body 63a, and the other surface of the gas channel 71 is formed by a gas channel forming member 74a. The gas flow path forming member 74a is preferably formed of a heat insulating material. The gas flow path forming member 74a may be formed at one end of the lower lid portion 23a.
In the oxygenator 1 of the present invention, the gas outflow part 27 of the artificial lung is directly heated by the heating part 6, so that the gas outflow part 27, in other words, the partition wall 8 portion that restrains the hollow fiber membrane bundle is provided. Heated to suppress the occurrence of the wet rung phenomenon. Furthermore, while using the heating part 6 which heats the gas outflow part 27 of the above-mentioned oxygenator, the heated gas is not cooled until reaching the gas inlet of the oxygenator. The difference in gas temperature between the gas outflow part and the gas inflow part is small, more reliably preventing the occurrence of the wet rung phenomenon, and the oxygen capacity can be increased even after long use. It will not decline.

In addition, the structure of the extension heating part is not limited to what was mentioned above.
For example, it may be of a type like the artificial lung 10 shown in FIG.
In the oxygenator 10 of this embodiment, as in the above-described oxygenator 1, the heating unit 6 has a heater 61, and the side of the oxygenator housing 2 is connected to the gas inflow part 26 from the gas outflow part 27 side. An extended heating part 6b extending to the side is provided. The housing 23 includes a lower lid portion 23a, and an extension portion of the housing is configured by the inside of the lower lid portion 23a and the lower portion of the housing 23.
The extension part heating part 6b of this embodiment includes a straight tubular extension heating part gas flow path 7b communicating with the gas flow path 7 described above, and an end 73 thereof is connected to the gas inlet 26a. Airtight communication. In addition, the heater 61b (specifically, heater wire) is disposed in a spiral shape so as to surround the extended heating portion gas flow path 7b. By doing so, it becomes possible to warm the gas flowing into the gas inlet 26a of the artificial lung more reliably.

Moreover, the artificial lungs of all the embodiments described above may have a control unit 80 as shown in FIGS. 15 and 16.
FIG. 15 is a left side view showing an embodiment of the oxygenator of the present invention. 16 is a cross-sectional view of the artificial lung shown in FIG. 15 taken along the line DD.
The oxygenator 20 of this embodiment has a gas temperature for detecting the gas temperature in the gas flow path 7 (7a) of the heating unit 6 or in the gas inlet 26 (including the gas inlet 26a) of the oxygenator. A detection unit 77 is provided. In particular, in this embodiment, the gas temperature detector 77 is provided at or near the end 73 of the gas flow path 7 communicating with the gas inlet 26a. When the gas temperature detector 77 is provided in the gas flow path, it is preferably provided on the downstream side thereof. The gas temperature detection unit 77 may detect the temperature in the gas inflow part 26 of the artificial lung (including the gas inflow port 26a), in other words, may be provided in the gas inflow part forming member 22. As the temperature detector 77, a known temperature sensor such as a thermistor or a thermoelectric lamp can be used.
In addition, the oxygenator 20 of this embodiment includes a humidity detector 78 for detecting humidity in the gas outflow portion 27 (including the gas outlet 27a). In particular, in this embodiment, as shown in FIG. 15 and FIG. 16, the humidity detector 78 is provided at a position separated from the gas outlet 27a in order to make it less susceptible to the outside air humidity. Humidity sensors that use two thermistors to measure humidity using the difference in thermal conductivity between moisture and dry air, ceramic humidity sensors, polymer film humidity sensors, and other known sensors are used. it can.

The oxygenator 20 of this embodiment controls the temperature of the heater 61 using the gas temperature detected by the gas temperature detector 77 and the humidity detected by the humidity detector 78 described above. A control unit 80 is provided. In the control unit 80, for example, when the humidity detected by the humidity detection unit 78 is a predetermined value or more or a time when the humidity is more than a predetermined value becomes a predetermined time or more, the heating temperature by the heater 61 is increased. In addition, when the humidity detected by the humidity detector 78 is equal to or less than a predetermined value or less than a predetermined value is equal to or longer than a predetermined time, the heating by the heater 61 is stopped or the heating level is lowered. It is preferable. Further, the control unit 80 stops the heating by the heater 61 or sets the heating level when the temperature detected by the temperature detection unit 77 is equal to or higher than a predetermined value or a predetermined time or longer and exceeds a predetermined time. Further, the heating temperature of the heater 61 is increased when the humidity detected by the temperature detection unit 77 is equal to or less than a predetermined value or when the humidity is equal to or less than a predetermined time. Is preferred.
As described above, the oxygenator 20 of this embodiment includes both the gas temperature detector 77 and the humidity detector 78. Thus, although it is preferable to provide both, only one of the gas temperature detection part 77 and the humidity detection part 78 may be sufficient. In the case of only one, the control unit 80 controls the heater 61 using the gas temperature detection unit 77 or the humidity detection unit 78.

DESCRIPTION OF SYMBOLS 1 Artificial lung 2 Housing 3 Hollow fiber membrane bundle 5 Tubular core 6 Heating part 7 Gas flow path 11 1st blood chamber 12 2nd blood chamber 21 Tubular housing main body 22 Gas inflow part formation member 23 Heating part housing 24 Blood inflow port 25 Blood outflow port 26 Gas inflow portion 26a Gas inflow port 27 Gas outflow portion 27a Gas outflow port 28 Heat medium inflow port 29 Heat medium outflow port 61 Heating heater

Claims (6)

A housing, a hollow fiber membrane bundle made of a plurality of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and both ends of the hollow fiber membrane bundle A partition wall liquid-tightly fixed to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed therein and a gas inflow port An oxygenator comprising a gas inflow portion forming member, a gas outflow portion communicating with the inside of the hollow fiber membrane and formed on the outside of the other partition wall,
The oxygenator has a heating part having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part, and the heating part covers the gas outflow part. The heating part, a heating part, a gas passage heated by the heating heater, and one end of the gas passage. A gas inflow port that communicates with the other end of the gas flow path communicates with the gas inlet of the gas inflow portion forming member ; and the heating portion includes the heater. And a gas outflow portion heating portion provided to face the partition wall on the gas outflow portion side, and the gas flow path is provided on the opposite side of the gas outflow portion heating portion to the partition facing surface, An artificial lung characterized by a curved shape . A housing, a hollow fiber membrane bundle made of a plurality of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and both ends of the hollow fiber membrane bundle A partition wall liquid-tightly fixed to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed therein and a gas inflow port An oxygenator comprising a gas inflow portion forming member, a gas outflow portion communicating with the inside of the hollow fiber membrane and formed on the outside of the other partition wall,
  The oxygenator has a heating part having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part, and the heating part covers the gas outflow part. The heating part, a heating part, a gas passage heated by the heating heater, and one end of the gas passage. A gas inflow port in communication with the other end of the gas flow path, and the gas inflow port of the gas inflow portion forming member; and the heating portion of the oxygenator housing. An extended warming portion is provided with a side portion extending from the gas outflow portion side to the gas inflow portion side. The extended warming portion is an extended warming portion heater and an extension heated by the heater. An oxygenator characterized by having a heating / heating part gas flow path. A housing, a hollow fiber membrane bundle made of a plurality of gas exchange hollow fiber membranes inserted into the housing, a blood inlet and a blood outlet communicating with the inside of the housing, and both ends of the hollow fiber membrane bundle A partition wall liquid-tightly fixed to the housing, a gas inflow portion communicating with the inside of the hollow fiber membrane and formed outside one of the partition walls, a gas inflow portion formed therein and a gas inflow port An oxygenator comprising a gas inflow portion forming member, a gas outflow portion communicating with the inside of the hollow fiber membrane and formed on the outside of the other partition wall,
  The oxygenator has a heating part having a gas outflow part heating function and an inflow gas heating function for heating the gas flowing into the gas inflow part, and the heating part covers the gas outflow part. The heating part, a heating part, a gas passage heated by the heating heater, and one end of the gas passage. A gas inflow port in communication with the other end of the gas flow path communicating with the gas inflow port of the gas inflow portion forming member; and the heating portion includes the housing of the oxygenator A heating part housing fixed to the heating part housing, a plate-like heating body housed in the heating part housing and provided with the heater, and a space between the inner surface of the heating part housing and the plate-like heating body Curved gas flow formed in And a gas inflow port that is provided in the heating unit housing and communicates with the gas channel, and the other end of the gas channel is formed in the heating unit housing. An oxygenator in communication with the gas inlet of a member. The artificial lung according to claim 3 , wherein the heating unit housing includes a gas exhaust port communicating with the gas outflow portion of the artificial lung. The artificial lung includes a heat exchanger therein, and the heat exchanger includes a blood circulation chamber, a heat medium circulation chamber in contact with the blood circulation chamber via a heat exchange tube, and the heat medium circulation chamber. and a heat medium inlet port and the heat medium outlet port communicating said blood inlet or the blood outlet port, according to any one of claims 1 to 4 in which communicates with said blood circulation chamber Artificial lung. The oxygenator detects humidity in a gas temperature detection unit for detecting a gas temperature in the gas flow path of the heating unit or in the gas inflow unit of the oxygenator and / or in the gas outflow unit. And a controller that controls the temperature of the heater using the gas temperature detected by the gas temperature detector and / or the humidity detected by the humidity detector. The artificial lung according to any one of 5 to 5.

Images