JP2023177553A - artificial lung - Google Patents

Abstract

To suppress an increase in linear velocity.SOLUTION: An artificial lung 130 includes: a hollow fiber bundle 133B with gas exchange functionality wherein a plurality of hollow fiber layers L are laminated, each of the hollow fiber layers comprising a plurality of hollow fibers; and a housing 131 that accommodates the hollow fiber bundle 133B. The hollow fiber bundle 133B includes an outer part OP including large-diameter hollow fibers 3a with a large outer diameter and an inner part IP with small-diameter hollow fibers 3b with a small outer diameter.SELECTED DRAWING: Figure 4

Description

The present invention relates to an oxygenator equipped with a hollow fiber bundle having a gas exchange function.

Patent Document 1 describes a hollow fiber membrane oxygenator that includes a bubble removing section and an oxygen adding section in the same housing. This bubble removal section removes bubbles from the blood. Further, the oxygen adding section performs gas exchange of blood with oxygen or a gas mainly composed of oxygen via the hollow fiber membrane.

Japanese Patent Application Publication No. 2003-111837

In an artificial lung such as that described in Patent Document 1, the oxygen adding section includes a large number of hollow fibers. The large number of hollow fibers are formed to have the same outer diameter. Further, blood flows through the gaps between the hollow fibers in the oxygenated portion. Here, if the number of arranged hollow fibers is increased, the linear velocity (or blood flow velocity) increases because the gap between adjacent hollow fibers narrows.

An oxygenator according to one embodiment is configured by laminating a plurality of hollow fiber layers each including a plurality of hollow fibers, and includes a hollow fiber bundle having a gas exchange function and a housing that accommodates the hollow fiber bundle. The hollow fiber bundle has an outer portion including large diameter hollow fibers having a large outer diameter, and an inner portion including small diameter hollow fibers having a small outer diameter.

Thereby, an increase in linear velocity can be suppressed.

FIG. 2 is a schematic diagram of an extracorporeal circulation system. FIG. 2 is a schematic cross-sectional view of an artificial lung. FIG. 3 is a schematic cross-sectional view of a hollow fiber bundle. It is an explanatory view of an example of arrangement of hollow fibers in a hollow fiber layer. It is an explanatory view of other examples of arrangement of hollow fibers in a hollow fiber layer.

Hereinafter, exemplary embodiments for carrying out the present invention will be described in detail with reference to the drawings. However, the dimensions, materials, shapes, and relative positions of components described in the following embodiments can be set arbitrarily, and can be changed depending on the configuration or various conditions of the apparatus or method to which the present invention is applied. Furthermore, unless otherwise specified, the scope of the present invention is not limited to the embodiments specifically described below.

[Extracorporeal circulation system]
The extracorporeal circulation system 100 shown in FIG. 1 performs a blood circulation operation of a patient P, and adds oxygen and removes carbon dioxide from the blood as gas exchange. As an example, the extracorporeal circulation system 100 includes a blood removal line 112, which is an example of a blood removal circuit, and a blood feeding line 113, which is an example of a blood feeding circuit that transfers blood. Further, the extracorporeal circulation system 100 includes a reservoir 120, which is a blood storage tank that stores drained blood. The blood removal line 112 then transfers the removed blood to the reservoir 120. The extracorporeal circulation system 100 also includes a blood pump 114 that sends blood into the body of the patient P via a blood feeding line 113. Further, the extracorporeal circulation system 100 includes an artificial lung 130 that removes carbon dioxide from the blood and adds oxygen to the blood.

In the blood removal line 112, blood removed from the patient P via a blood removal cannula (not shown) or the like flows toward the reservoir 120. As an example, blood is removed from patient P's superior and inferior vena cava. Then, the reservoir 120 temporarily stores the removed blood. This reservoir 120 is a hard shell type blood storage tank, and is connected to the oxygenator 130 by a blood line 116. Further, the blood in the reservoir 120 is sent to the oxygenator 130 by the blood pump 114 and circulated to the patient P via the blood feeding line 113. That is, blood sent by the blood pump 114 passes through the blood feeding line 113 and flows toward the aorta of the patient P via a blood feeding cannula (not shown) or the like.

The blood removal line 112, the blood supply line 113, and the blood line 116 include, for example, tubes made of polyvinyl chloride. Further, a sensor for detecting the blood flow rate, a sensor for detecting blood concentration, and a sensor for detecting oxygen concentration may be connected to the blood removal line 112. Further, the blood supply line 113 may be provided with a sensor for detecting the blood supply flow rate, a sensor for detecting the blood concentration, and a sensor for detecting the oxygen concentration.

The pre-oxygenated venous blood that has been removed or induced outside the body of the patient P is stored in the reservoir 120 and then sent to the oxygenator 130 . Alternatively, reservoir 120 may store arterial blood instead of venous blood. In this case, the removed blood flows from the blood removal line 112 to the oxygenator 130. The artificial lung 130 then removes carbon dioxide from the blood and adds oxygen to the blood. Arterial blood then flows from the oxygenator 130 to the reservoir 120 where it is temporarily stored.

The blood pump 114 is a centrifugal pump that rotates impeller blades using a motor to send blood to the oxygenator 130 . The blood pump 114 aspirates blood stored in the reservoir 120 through the blood line 116 and transfers it to the oxygenator 130. Further, the rotation speed of the motor of the blood pump 114 is controlled by a control signal output from a control device (not shown). Then, the blood pump 114 sends blood at a flow rate that corresponds to the increased or decreased rotational speed. Alternatively, the blood pump 114 may be a roller pump that suctions and pushes out blood in the tube by rotationally moving a rotating roller while crushing the tube.

[Artificial lung]
The oxygenator 130 will be described with reference to FIG. 2. Note that although FIG. 2 is a schematic cross-sectional view of the oxygenator 130, for convenience of explanation, illustration of some components constituting the oxygenator 130 is omitted.

The oxygenator 130 includes a gas exchange element 133B as an example of a gas exchange section having hollow fibers (hereinafter also referred to as hollow fiber membranes) with excellent gas permeability. Further, the oxygenator 130 is connected to a gas supply unit (not shown), and oxygenated gas is supplied to the oxygenator 130 from the gas supply unit. For example, this gas is oxygen or a mixed gas of oxygen and air, with carbon dioxide further added if necessary. Then, the artificial lung 130 removes carbon dioxide from the venous blood (hereinafter also referred to as blood) sent from the reservoir 120 and adds oxygen to it. That is, the artificial lung 130 converts venous blood into arterial blood via the gas exchange element 133B. The oxygenator 130 also includes a heat exchanger (not shown) for adjusting the temperature of blood.

Further, the oxygenator 130 includes a substantially cylindrical housing 131 having a center core 132. This center core 132 is arranged at the center inside the housing 131. The oxygenator 130 also includes a bubble separation filter 133A, which is an example of a bubble separation section. The bubble separation filter 133A is a gas-liquid separation filter disposed on the outer periphery of a heat exchange section (not shown), and separates bubbles from venous blood. Furthermore, the oxygenator 130 includes a gas exchange element 133B, which is an example of a gas exchange section. The gas exchange element 133B is a bundle of hollow fibers arranged around the center core 132.

The bubble separation filter 133A and the gas exchange element 133B are integrally bundled into a cylindrical shape so that the gas exchange element 133B is disposed on the center core 132 side. The housing 131 houses a hollow fiber bundle as a gas exchange element 133B.

The hollow fiber bundle serving as the gas exchange element 133B is configured by laminating a plurality of hollow fiber layers L (FIG. 4) each consisting of a large number of hollow fibers. The gas exchange element 133B has a gas exchange function of exchanging the gas passing inside the hollow fiber with the gas in the blood. Further, both ends of the hollow fiber bundle are fixed by supports 134, which are potting materials made of urethane resin, for example. Thereby, both ends of the hollow fiber bundle are hermetically sealed to the inner wall surface of the housing 131 by the support member 134.

Both ends of the hollow fiber bundle are fixed inside the housing 131 while keeping the hollow part inside the hollow fibers open. The space outside the hollow fiber is fluid-tightly separated from the space communicating with the inside of the hollow fiber. Further, the center core 132 is made of resin such as polypropylene, and is arranged at the center of the hollow fiber bundle. The ends of the hollow fiber bundle are fixed and held by a support 134.

One end of the gas exchange element 133B opens into a space into which gas flows. Specifically, the upper end of the gas exchange element 133B in FIG. 2 opens into a space that communicates with a gas inlet 135, which is an example of a gas inlet for adding oxygen. Then, the oxygen-added gas flows into the space from the gas inlet 135. Further, the lower end of the gas exchange element 133B in FIG. 2 opens into a space communicating with a gas outlet 136, which is an example of a gas outlet for adding oxygen.

A blood outlet 137 through which arterial blood (hereinafter also referred to as blood) flows out is provided above the center core 132 in FIG. 2, passing through the support body 134. The blood outlet 137 communicates with the space around the center core 132. Further, a blood inlet 138 into which venous blood flows is provided at the lower part of the side wall of the substantially cylindrical housing 131 in FIG. 2 . Furthermore, the outer diameter of the center core 132 continuously increases toward the blood outlet 137.

A plurality of ribs extending along the axial direction of the center core 132 are arranged on the outer peripheral surface of the center core 132 . These ribs are arranged radially at equal intervals, for example, the number of ribs is eight. The height of each rib is gradually increased such that the portion of the center core 132 on the blood outlet 137 side is low and the portion on the opposite side is high. Further, the diameter of the virtual outer circumferential circle connecting the vertices, which are the tips of the ribs, is the same over the entire length of the center core 132. A groove is formed between the ribs, and this groove functions as a blood flow path 139A.

Further, a gas exchange element 133B is wound around the center core 132. A gap is formed between the gas exchange element 133B and the center core 132 by the ribs. Thereby, a flow path 139A is formed between the gas exchange element 133B and the surface of the center core 132. The width of this flow path 139A increases as it approaches the blood outlet 137. Furthermore, a bubble separation filter 133A is wound around the outside of the gas exchange element 133B. A blood flow path 139B is formed between the outer circumference of the bubble separation filter 133A and the inner wall surface of the housing 131. Further, the bubble separation filter 133A has a function of separating and removing bubbles from blood.

The hollow fiber membrane used in the gas exchange element 133B is permeable to gas and impermeable to liquid. Therefore, liquids such as blood cannot pass through the hollow fiber membrane. As an example, the hollow fiber membrane is a porous membrane or a homogeneous membrane, and is formed from polyolefin, polysulfone, fluororesin, silicone resin, or the like. The hollow fiber membrane, which is a porous membrane, may be coated with a hydrophobic coating made of fluororesin, silicone resin, or the like on the side that comes into contact with blood. Thereby, the hollow fiber membrane can be used for a long period of time, and in particular, a silicone-coated porous membrane can be used for a long period of time.

The oxygen-added gas shown by the dashed arrow in FIG. 2 flows from the gas inlet 135, passes through the opening of the gas exchange element 133B, and flows into the interior of the hollow fiber. Blood flows outside the hollow fibers, and oxygenated gas flows inside the hollow fibers. At this time, due to the difference in oxygen partial pressure between the outside and inside of the hollow fiber, the oxygen-adding gas inside the hollow fiber passes through the surface of the hollow fiber and moves to the outside. The oxygenated gas that has moved to the outside then diffuses into the blood. At the same time, due to the difference in partial pressure of carbon dioxide between the outside and inside of the hollow fiber, carbon dioxide in the blood permeates the surface of the hollow fiber and moves into the inside of the hollow fiber. The carbon dioxide that has moved inside is then diffused into the gas flowing inside the hollow fiber. Gas exchange is performed in this manner, and the gas that has passed through the hollow fibers is discharged to the outside of the housing 131 from the gas outlet 136.

The pre-oxygenated venous blood that has been removed or induced outside the body of the patient P is sent from the reservoir 120 to the oxygenator 130 . Blood indicated by solid arrows in FIG. 2 flows in from the blood inlet 138 and passes through the flow path 139B. Further, blood flows from the flow path 139B toward the inside of the housing 131 through the bubble separation filter 133A. The air bubbles in the blood are then discharged to the outside of the housing 131 from a purge port (not shown) provided at the top of the housing 131. Thereafter, the temperature of the venous blood is adjusted by a heat exchanger (not shown).

Furthermore, the blood from which air bubbles have been removed flows toward the inside of the housing 131 through the gaps between the hollow fibers of the gas exchange element 133B. The blood comes into contact with the surface of the hollow fiber while passing through this gap, and gas exchange occurs between the blood and the oxygenated gas. Further, the hollow fibers of the gas exchange element 133B are wound in a crisscross manner. Therefore, the blood reliably contacts the surface of the hollow fibers and gas exchange is performed efficiently.

A clot is separated from the arterial blood that has passed through the gas exchange element 133B for gas exchange by a clot separation filter (not shown), which is an example of a clot separation section disposed inside the gas exchange element 133B. Thereafter, the arterial blood flows out of the oxygenator 130 from the blood outlet 137 through the flow path 139A. The arterial blood is then sent to the patient P through the blood supply line 113 and returned to the patient P's body. Note that the extracorporeal circulation system 100 may be provided with a line filter for removing air bubbles, foreign substances, and white blood cells from blood that is circulated extracorporeally.

[Method for manufacturing hollow fiber bundle]
The hollow fiber bundle can be manufactured by winding a large number of hollow fibers around the outer periphery of the center core 132. As an example, the hollow fiber is wound around the outer periphery of the center core 132 by attaching the center core 132 to a mounting shaft of a hollow fiber winding device and rotating the mounting shaft a predetermined number of times at a constant rotational speed. At this time, the thread guide provided outside the mounting shaft is moved along the axial direction of the mounting shaft in synchronization with the rotation of the mounting shaft. As a result, the hollow fibers let out from the holes in the thread guide are wound around the outer periphery of the center core 132. Further, the hollow fibers are wound as a set of a plurality of hollow fibers, for example, six hollow fibers are wound as a set. Note that instead of winding the hollow fibers in a crosswise manner, the hollow fibers may be wound in another manner.

The thread guide moves, for example, from one end of the center core 132 to the other end at a constant speed. Then, the thread guide that has moved to the other end changes its moving direction in the opposite direction and moves again from the other end to the one end at a constant speed. After a predetermined number of reciprocations, the thread guide moves according to different movement cycles. In this way, it is possible to obtain a hollow fiber bundle in which a large number of hollow fibers are wound around the center core 132 in a crosswise manner. Thereafter, the hollow fiber bundle is inserted into the housing 131, and the housing 131 is rotated about an axis perpendicular to the longitudinal direction of the housing 131 while supplying the potting material to the end of the housing 131. After the potting material has hardened, the ends of the hollow fiber bundle are cut together with the potting material. Note that the length of the interval between the hollow fibers in the hollow fiber bundle is adjusted, for example, by the interval between a plurality of holes formed in the fiber guide and through which the hollow fibers pass.

[Hollow fiber bundle]
The hollow fiber bundle will be described with reference to FIGS. 2 to 4. Note that FIG. 3 is an explanatory diagram of blood flowing through the hollow fiber bundle, and FIG. 4 shows a schematic cross section of a part of the hollow fiber bundle.

As shown in FIG. 3, the hollow fiber bundle has an outer part OP including large diameter hollow fibers 3a with a large outer diameter, and an inner part IP including small diameter hollow fibers 3b with a small outer diameter. Moreover, the inner part IP is located in a region close to the center core 132, which is an example of a core around which a plurality of hollow fibers are wound. That is, the inner part IP is located in an inner region closer to the center core 132 than the outer part OP. In other words, the outer part OP made of the large diameter hollow fibers 3a is wound around the outside of the inner part IP made of the small diameter hollow fibers 3b. Interfiber flow paths through which blood passes, as indicated by solid arrows in FIG. 3, are formed around the large-diameter hollow fibers 3a and around the small-diameter hollow fibers 3b. In addition, in FIG. 3, only one arrow indicates the inter-yarn flow path. However, in reality, interfiber flow paths are also formed around the other large-diameter hollow fibers 3a and around the other small-diameter hollow fibers 3b.

Further, as shown in FIG. 2, the gas exchange element 133B includes an inner part IP and an outer part OP. Furthermore, at least a portion of the outer portion OP may include small diameter hollow fibers 3b, and at least a portion of the inner portion IP may include large diameter hollow fibers 3a. In this case, in the hollow fiber layer L, the large-diameter hollow fibers 3a and the small-diameter hollow fibers 3b may be arranged alternately. However, since the inner portion IP is composed only of the small-diameter hollow fibers 3b, the increase in linear velocity can be further suppressed.

Further, in the radial direction (or stacking direction LD) perpendicular to the center line CL of the center core 132, the length of the radius of the inner portion IP is shorter than the length of the radius of the center core 132. As an example, in the radial direction of the oxygenator 130, the radius of the center core 132 is 15 mm. The length of the inner portion IP in the radial direction is 10 mm. That is, the inner portion IP is provided around the center core 132 from a position 15 mm away from the center line CL to a position 25 mm away from the center line CL. Note that the length of the inner portion IP in the radial direction may be in a range of 2.5 mm or more and 10 mm or less.

Further, as an example, the length of the outer portion OP in the radial direction is 10 mm. That is, the outer portion OP is provided around the inner portion IP from a position 25 mm away from the center line CL to a position 35 mm away from the center line CL. Note that the length of the outer portion OP in the radial direction may range from 17.5 mm or less to 10 mm or more. Further, the length of the inner portion IP in the radial direction is a length measured on a straight line passing through the center line CL and the apex of the rib of the center core 132. As an example, the inner part IP is set in a range from one-half or less to one-third or more of the gas exchange element 133B in the radial direction. For example, if the radius of the gas exchange element 133B is 30 mm, the radius of the inner portion IP is set in a range from 15 mm or less to 10 mm or more.

In the oxygenator 130, if the gap between adjacent hollow fibers is narrow, the linear velocity, which is the speed at which blood passes through the cross section of the oxygenator 130, will increase. If the linear velocity increases, activation of blood components may occur, leading to coagulation of the blood components. Here, the inner part IP has a shorter circumference than the outer part OP. Therefore, in the inner part IP, the total value of the gaps between the hollow fibers, that is, the total width of the gaps becomes narrower than in the outer part OP. Therefore, as shown in FIG. 3, in the oxygenator 130 of this embodiment, the inner part IP includes a plurality of small diameter hollow fibers 3b. Specifically, as shown in FIG. 4, in the circumferential direction CD (FIG. 3) of the hollow fiber layer L of the inner part IP, a plurality of small diameter hollow fibers 3b are arranged adjacent to each other at equal intervals. It is located. In the circumferential direction CD of the hollow fiber layer L of the outer portion OP, a plurality of large diameter hollow fibers 3a are arranged adjacent to each other at equal intervals.

Thereby, in the inner portion IP, the gap between the hollow fibers can be widened by an amount corresponding to the difference in outer diameter between the large diameter hollow fibers 3a and the small diameter hollow fibers 3b. For example, in the example shown in FIG. 4, the outer diameter of the large diameter hollow fibers 3a is 0.3 mm, and the outer diameter of the small diameter hollow fibers 3b is 0.2 mm. In the inner part IP, the gap between adjacent hollow fibers can be made wider than in the outer part OP. Specifically, the length of the gap between the large-diameter hollow fibers 3a in the outer part OP, that is, the shortest part between the outer surfaces of adjacent large-diameter hollow fibers 3a, is 0.15 mm, and the length of the shortest part between the outer surfaces of adjacent large-diameter hollow fibers 3a is 0.15 mm, The total gap in the range is 0.3 mm. On the other hand, the length of the shortest part between the outer surfaces of the small-diameter hollow fibers 3b in the inner part IP is 0.13 mm, and the total value of the gaps in the range of the circumference of 1.2 mm is 0.39 mm. Thus, in the inner part IP, the total value of the gaps between adjacent hollow fibers is wider than in the outer part OP. In the example of FIG. 4, the gap in the inner part IP can be set to 1.3 times the gap in the outer part OP.

Note that the length of the shortest portion can be translated as the average interval between hollow fibers. This average interval is the average length of the gaps between the hollow fibers, and is the length along the straight line orthogonal to the central axis of the hollow fibers. When the hollow fibers are wound diagonally with respect to the central axis of the center core 132, the average interval is the length along the straight line perpendicular to the central axis along the extending direction of the diagonally extending hollow fibers. be. In other words, the length is the distance between hollow fibers that are wound diagonally and in parallel. As an example, the outer diameter of the small diameter hollow fiber 3b is included in the range of 0.15 mm or more and 0.25 mm or less. Further, except for tolerances, the outer diameters of the plurality of small diameter hollow fibers 3b are set to be the same. Similarly, except for tolerances, the outer diameters of the plurality of large diameter hollow fibers 3a are set to be the same.

Since the inner part IP includes the small-diameter hollow fibers 3b, even if the number of hollow fibers arranged in the inner part IP is increased, an increase in the linear velocity in the oxygenator 130 can be suppressed. Furthermore, the total value of the gaps between the hollow fibers in the inner portion IP can be increased. That is, the difference between the total value of gaps in the inner part IP and the total value of gaps in the outer part OP can be reduced. Note that the number of hollow fibers can be increased by adjusting the length between the central axes of adjacent hollow fibers in the direction of the central axes of adjacent hollow fibers. The length between the central axes can be translated as the average pitch of the hollow fibers. In the example of FIG. 4, the average pitch in the outer part OP is 0.4 mm, and the average pitch in the inner part IP is 0.33 mm. In this way, by narrowing the average pitch, the number of yarns can be increased.

As an example, the average pitch and spacing can be measured and calculated at the end of the hollow fiber bundle that is sealed by the support 134. Note that the hollow fiber bundle is configured by laminating a large number of hollow fiber layers L each consisting of a plurality of hollow fibers. This hollow fiber layer L is composed of a plurality of hollow fibers arranged in an array direction intersecting the lamination direction LD. In the lamination direction LD, the hollow fibers are in contact with each other. Therefore, the average pitch and average interval are measured and calculated in the direction orthogonal to the lamination direction LD. This lamination direction LD is a direction from the outer surface of the hollow fiber bundle toward the center core 132.

Furthermore, since the inner part IP includes the small diameter hollow fibers 3b, the contact area between the blood and the hollow fibers in the inner part IP can be increased. To explain using the example of FIG. 4, in the outer portion OP, the large diameter hollow fibers 3a are also lined up in the plane of the drawing (that is, in the depth direction). Therefore, the outer part is formed by a rectangular parallelepiped whose length in the vertical direction in the figure is 0.6 mm, length in the horizontal direction in the figure is 1.2 mm, and length in the paper plane direction in the figure is 1.2 mm. When the virtual space of the OP is defined, the space includes six large diameter hollow fibers 3a.

Similarly, in the inner portion IP, the small diameter hollow fibers 3b are also lined up in the paper surface direction in the figure. Therefore, the inner part is formed by a rectangular parallelepiped whose length in the vertical direction in the figure is 0.6 mm, length in the horizontal direction in the figure is 1.2 mm, and length in the paper plane direction in the figure is 1.2 mm. When the virtual IP space is defined, the space includes twelve small diameter hollow fibers 3b.

The contact area between the large-diameter hollow fiber 3a and blood in the virtual space, that is, the area of the outer surface of the substantially cylindrical large-diameter hollow fiber 3a, is determined by the circumferential length of the large-diameter hollow fiber 3a ( 0.942 mm). That is, the total contact area of the large diameter hollow fibers 3a arranged in the rectangular parallelepiped is 6.78 mm ² =6×(0.942 mm×1.2). Further, the contact area between the small diameter hollow fiber 3b and blood in the virtual space, that is, the area of the outer surface of the substantially cylindrical small diameter hollow fiber 3b is determined by the circumferential length of the small diameter hollow fiber 3b ( 0.628 mm). That is, the total contact area of the small diameter hollow fibers 3b arranged in the rectangular parallelepiped is 9.04 mm ² =12×(0.628 mm×1.2). In this way, in the example of FIG. 4, the contact area at the inner part IP can be set to about 1.3 times that of the outer part OP. Thereby, the contact area and contact time between the blood and the hollow fibers can be ensured.

Furthermore, the filling rate of the small-diameter hollow fibers 3b in the inner part IP is equal to or lower than the filling rate of the large-diameter hollow fibers 3a in the outer part OP. Here, the filling rate is the ratio of the area occupied by the hollow fibers per unit area. Further, the filling rate can be measured and calculated at the end portion of the hollow fiber bundle that is sealed by the support body 134. In the example of FIG. 4, since the cross-sectional area of the large-diameter hollow fibers 3a in the outer part OP is 0.07 ^mm2 , the filling rate is 0.51=0.07÷(0.3×(0.3+0.15 )) becomes. The filling rate per unit area of 1 mm ² of ^the small diameter hollow fibers 3b of the inner part IP is 0.45=0.03÷(0.2×(0.2+0 .13)), which is lower than the outer part OP. Thereby, even if the inter-yarn flow path becomes narrow, the filling rate can be lowered to suppress an increase in resistance.

According to the artificial lung 130 according to the present embodiment described above, even if the number of yarns is increased, an increase in linear velocity can be suppressed, and the contact area and contact time with blood can be ensured. Furthermore, the average spacing in the hollow fiber layer L of the inner portion IP can be increased. As a result of this, the inter-yarn flow path is expanded, and pressure loss can be reduced. That is, when blood is sent by the blood pump 114, resistance increases if the inter-thread flow path is narrow. As a result, it becomes necessary to pump blood at a higher pressure. In order to send blood at high pressure, it becomes necessary to improve the pressure resistance of the blood line 116. Furthermore, if the inter-thread flow path is narrow, it becomes difficult for blood to flow, resulting in stagnation of the blood, which causes the blood to coagulate, narrowing the inter-thread flow path, and making it even more difficult for blood to flow. Furthermore, flowing blood at high pressure may cause red blood cells to be destroyed by shear stress. On the other hand, according to the present embodiment, since the inter-yarn flow path is wide, the resistance is small and pressure loss can be reduced. As a result, blood can be sent at a lower pressure and the blood can flow more easily.

Although the present invention has been described above with reference to each embodiment, the present invention is not limited to the above embodiments. The present invention includes inventions modified within the scope of the present invention and inventions equivalent to the present invention. Further, each embodiment, each modification, and the technical means included in each embodiment or each modification can be combined as appropriate within the scope of the present invention.

For example, as shown in FIG. 5, the average interval in the hollow fiber layer L of the inner part IP may be the same as the average interval in the hollow fiber layer L of the outer part OP. Specifically, in the example of FIG. 5, the average interval in the hollow fiber layer L between the inner part IP and the outer part OP is 0.14 mm. The outer diameter of the large diameter hollow fibers 3a is 0.3 mm, and the outer diameter of the small diameter hollow fibers 3b is 0.2 mm. Therefore, the average pitch in the hollow fiber layer L of the outer portion OP is 0.44 mm. Moreover, the average pitch in the hollow fiber layer L of the inner part IP is 0.34 mm.

In FIG. 5, counting the hollow fibers arranged over a circumference with a length of 7.48 mm, the number of large diameter hollow fibers 3a in the hollow fiber layer L of the outer portion OP is seventeen. The number of small diameter hollow fibers 3b in the hollow fiber layer L of the inner part IP is twenty-two. In this manner, by including the small-diameter hollow fibers 3b in the inner portion IP, the number of yarns can be increased while ensuring the average spacing.

As another example, the average spacing in the hollow fiber layers L of the inner portion IP may be narrower than the average spacing in the hollow fiber layers L of the outer portion OP. Further, the average spacing in a portion of the hollow fiber layer L of the inner portion IP may be different from the average spacing in another portion of the hollow fiber layer L of the inner portion IP. In this case, there will be a portion in the inner portion IP where the small diameter hollow fibers 3b are not lined up at equal intervals. Furthermore, the average spacing in a portion of the hollow fiber layer L of the outer portion OP may be different from the average spacing in another portion of the hollow fiber layer L of the outer portion OP. In this case, in the outer portion OP, there is a portion where the large diameter hollow fibers 3a are not lined up at equal intervals.

Part or all of the above embodiments may be described as in the following additional notes, but are not limited to the following.

(Additional note 1)
A hollow fiber bundle that is configured by laminating a plurality of hollow fiber layers each consisting of a plurality of hollow fibers and has a gas exchange function;
a housing for accommodating the hollow fiber bundle;
The hollow fiber bundle has an outer portion including large diameter hollow fibers having a large outer diameter, and an inner portion including small diameter hollow fibers having a small outer diameter.

(Additional note 2)
further comprising a core around which a plurality of the hollow fibers are wound,
The oxygenator according to supplementary note 1, wherein the inner part is located in a region closer to the core than the outer part.

(Additional note 3)
In the circumferential direction of the hollow fiber layer in the inner side, a plurality of the small diameter hollow fibers are arranged side by side,
The oxygenator according to appendix 1 or 2, wherein a plurality of the large-diameter hollow fibers are arranged side by side in the circumferential direction of the hollow fiber layer of the outer portion.

(Additional note 4)
Any one of Supplementary Notes 1 to 3, wherein in the radial direction of the oxygenator, the radius of the inner part is set in a range from one-half or less to one-third or more of the radius of the hollow fiber bundle. The artificial lung described in .

(Appendix 5)
5. The oxygenator according to any one of Supplementary Notes 1 to 4, wherein the filling rate of the small diameter hollow fibers in the inner part is equal to or lower than the filling rate of the large diameter hollow fibers in the outer part.

3a: Large diameter hollow fiber 3b: Small diameter hollow fiber 131: Housing 133B: Gas exchange element (hollow fiber bundle)
L: Hollow fiber layer IP: Inner part OP: Outer part

Claims (5)

A hollow fiber bundle that is configured by laminating a plurality of hollow fiber layers each consisting of a plurality of hollow fibers and has a gas exchange function;
a housing for accommodating the hollow fiber bundle;
The hollow fiber bundle has an outer portion including large diameter hollow fibers having a large outer diameter, and an inner portion including small diameter hollow fibers having a small outer diameter. further comprising a core around which a plurality of the hollow fibers are wound,
The oxygenator according to claim 1, wherein the inner part is located in a region closer to the core than the outer part. In the circumferential direction of the hollow fiber layer in the inner side, a plurality of the small diameter hollow fibers are arranged side by side,
The artificial lung according to claim 1 or 2, wherein a plurality of the large-diameter hollow fibers are arranged side by side in the circumferential direction of the hollow fiber layer of the outer portion. The artificial lung according to claim 1 or 2, wherein in the radial direction of the artificial lung, the radius of the inner part is set in a range from one-half or less to one-third or more of the radius of the hollow fiber bundle. lung. The artificial lung according to claim 1 or 2, wherein the filling rate of the small diameter hollow fibers in the inner part is equal to or lower than the filling rate of the large diameter hollow fibers in the outer part.

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