JP2001178818A - Hollow fiber membrane type artificial lung - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an artificial lung in which no blood short circuit path is formed caused by a circulating crossing part of hollow fiber membrane and which has a sufficient gas exchange capability, even if a hollow fiber membrane bundle which is formed by a hollow fiber membrane is spirally wound on the outer surface of a cylindrical core and is provided with the circulating crossing part of hollow fiber membrane are used in the artificial lung. SOLUTION: The hollow fiber membrane type artificial lung 1 is provided with a cylindrical core 5, a cylindrical hollow fiber membrane bundle 3 consisting of a hollow fiber membrane 3a for gas exchange wound on the outer surface of the core 5, a housing for housing the bundle 3, a gas inlet part and outlet part communicating with the inside of the hollow fiber membrane, and a blood inlet part and outlet part communicating with the inside of the housing. The bundle 3 is formed by winding a hollow fiber membrane on the outer peripheral surface of the cylindrical core 5. In this case, a hollow fiber membrane layer spreading over the outer peripheral surface of the cylindrical core by the hollow fiber membrane is in a multilayer state. In the hollow fiber membrane layer, a crossing part in which the hollow fiber membrane crosses and a folded-back part of the hollow fiber membrane in a gas exchange effective part do not exist.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

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

[0002]

2. Description of the Related Art Recently, an artificial lung using a hollow fiber membrane bundle produced by spirally winding a hollow fiber membrane around a hollow cylindrical core has been proposed (Japanese Patent Application Laid-Open No. 7-509).
No. 171). Such types of hollow fiber membrane bundles include:
Intersections where the wound hollow fiber membranes intersect (cross) are formed. In particular, by controlling the rotating means for rotating the hollow cylindrical core and the winder device for knitting the hollow fiber membrane under predetermined conditions, the intersections where the wound hollow fiber membranes intersect and the intersections thereof Are overlapped to form a hollow fiber crossed annular portion. There is a possibility that a short circuit path of blood due to this hollow fiber membrane crossing annular portion may be formed, and there is a possibility that gas exchange ability may be reduced.

[0003]

Therefore, an object of the present invention is to provide an artificial lung using a hollow fiber membrane bundle formed by spirally winding a hollow fiber membrane around the outer surface of a hollow cylindrical core. An object of the present invention is to provide a hollow fiber membrane-type artificial lung having a sufficient gas exchange ability without forming a blood short circuit caused by a hollow fiber membrane intersection.

[0004]

The above object is achieved by a tubular hollow fiber membrane bundle comprising a tubular core and a number of gas exchange hollow fiber membranes wound around the outer surface of the tubular core. A housing for accommodating the tubular hollow fiber membrane bundle; a gas inflow portion and a gas outflow portion communicating with the inside of the hollow fiber membrane; a blood inflow portion communicating with the outside of the hollow fiber membrane and the inside of the housing; A hollow fiber membrane oxygenator having a blood outflow portion, wherein the tubular hollow fiber membrane bundle is formed by spirally winding a hollow fiber membrane around the outer peripheral surface of the tubular core, and The hollow fiber membrane layer spreading on the outer peripheral surface of the cylindrical core by the fiber membrane is in a multilayered state, and further, the hollow fiber membrane layer has an intersection portion where the hollow fiber membrane intersects in the gas exchange effective portion. And hollow fiber membrane without hollow fiber turnover It is an artificial lung.

[0005] The hollow fiber membrane layer has a crossing portion where the hollow fiber membranes cross each other and a folded portion of the hollow fiber membrane also in a partition portion for fixing both ends of the hollow fiber membrane bundle to the housing in a liquid-tight manner. Preferably, it is not present. Further, the hollow fiber membrane bundle has a multilayer structure in which hollow fiber membrane layers extending on the outer peripheral surface of the cylindrical core are overlapped with each other, and the hollow fiber membrane layer has a folded portion of the hollow fiber membrane at both ends. Is preferably formed by cutting both end portions of the hollow fiber membrane bundle formed body on which is formed. Further, it is preferable that the folding angle θ of the hollow fiber membrane forming the hollow fiber membrane bundle is larger than 90 °. Further, when the length S of the hollow fiber membrane forming the hollow fiber membrane bundle is r, the radius of the hollow fiber membrane bundle in the hollow fiber membrane portion to be measured is L, and the length of the hollow fiber membrane bundle is L, L <S <√ (πr) ² + L ²
It is preferred that Further, the hollow fiber membrane oxygenator may include a tubular heat exchanger unit housed in the tubular core. The hollow fiber membrane bundle is formed by helically winding one or more hollow fiber membranes around a cylindrical core such that all adjacent hollow fiber membranes have substantially constant intervals. And, when winding the hollow fiber membrane around the cylindrical core, a cylindrical core rotating means for rotating the cylindrical core and a winder device for knitting the hollow fiber membrane, the following arithmetic formula 1 Traverse [mm / lot] · 1 / n (integer) = traverse swing width · 2 ± (hollow fiber membrane outer diameter + interval) · winding number (operational expression 1) Preferably, it is formed. Further, it is preferable that n in the arithmetic expression 1 is 2.

[0006]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of a hollow fiber membrane oxygenator according to the present invention. FIG. 1 is a front view showing one embodiment of the hollow fiber membrane oxygenator of the present invention, FIG. 2 is a left side view of the hollow fiber membrane oxygenator shown in FIG. 1, and FIG.
FIG. 4 is a right side view of the hollow fiber membrane oxygenator shown in FIG. 4, FIG. 4 is an explanatory view showing a state in which a housing portion of the hollow fiber membrane oxygenator shown in FIG. 1 is broken, and FIG. 5 is a hollow fiber of the present invention. Explanatory diagram for explaining an example of a hollow fiber membrane bundle used for a membrane oxygenator,
FIG. 6 is an explanatory view for explaining an example of a hollow fiber membrane bundle forming apparatus used for the hollow fiber membrane oxygenator of the present invention, and FIG.
2 is a sectional view taken along line AA of FIG. 2, FIG. 8 is a sectional view taken along line BB of FIG. 2, and FIG. 9 is a sectional view taken along line CC of FIG.

A hollow fiber membrane oxygenator 1 of the present invention comprises a tubular hollow fiber membrane bundle 3 comprising a tubular core 5 and a number of hollow fiber membranes 3a for gas exchange wound around the outer surface of the tubular core 5. And a housing for accommodating the tubular hollow fiber membrane bundle 3, a gas inflow portion and a gas outflow portion communicating with the inside of the hollow fiber membrane 3a, and a blood inflow portion and blood communicating with the outside of the hollow fiber membrane 3a and the inside of the housing. And an outflow section. The tubular hollow fiber membrane bundle 3 is formed by spirally winding a hollow fiber membrane around the outer peripheral surface of the cylindrical core 5, and a hollow fiber membrane layer spreading on the outer peripheral surface of the cylindrical core by the hollow fiber membrane is formed. In the hollow fiber membrane layer, there are no crossing points where the hollow fiber membranes intersect with each other or the hollow fiber membrane turning-back parts in the gas exchange effective portion. Specifically, the hollow fiber membrane layer extending on the outer peripheral surface of the cylindrical core 5 is in a state of being multi-layered, and the hollow fiber membrane layer has a hollow fiber folded portion 3b formed at both ends. It is formed by cutting both ends of the formed hollow fiber membrane bundle.

As shown in the drawing, a hollow fiber membrane type oxygenator 1 of this embodiment has a housing 2, an oxygenator accommodated in the housing 2, and a cylindrical member accommodated in the oxygenator. The oxygenator is provided with a heat exchanger, and is a hollow fiber membrane-type oxygenator with a built-in heat exchange function. This hollow fiber membrane oxygenator 1
Is a tubular hollow fiber membrane bundle 3 composed of a tubular core 5 and a number of gas exchange hollow fiber membranes wound around the outer surface of the tubular core 5.
, A tubular heat exchanger section accommodated in the tubular core 5, and a housing 2 accommodating the artificial lung section and the tubular heat exchanger section. The cylindrical core 5 is a cylindrical core 5
And a first blood chamber 11 formed between the cylindrical core 5 and the cylindrical heat exchanger section, and a groove 51 for forming a blood flow path between the outer surface of the cylindrical hollow fiber membrane bundle 3 and the inner surface of the cylindrical hollow fiber membrane bundle 3. And a blood circulation opening 52 that communicates with the blood. The oxygenator 1 is formed between the outer surface of the hollow cylindrical fiber membrane and the inner surface of the housing 2. The blood inflow port 24 communicates with the first blood chamber 11 formed between the cylindrical core 5 and the cylindrical heat exchanger. A blood outflow port 25 communicating with the second blood chamber 12.

In the hollow fiber membrane-type oxygenator 1 of this embodiment, as shown in FIGS. 7 to 9, a cylindrical housing main body 21, a second blood chamber 12, a hollow fiber membrane bundle 3, and a groove 51 are provided from the outside. Core 5, first blood chamber 11, cylindrical heat exchanger 3 provided with
1. 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. As shown in FIGS. 1 to 4 and 7 to 9, the housing 2 includes a cylindrical housing main body 21 having a blood outflow port 25, a gas inflow port 26, a heat medium inflow port 28, and a heat medium outflow port 29. First
Header 22, gas outlet port 27 and cylindrical core 5
Second port provided with an insertion port for blood inflow port 24 provided in
Is provided. On the inner surface of the first header 22, a heat medium chamber forming member connecting portion 22a protruding in a cylindrical shape is provided.
And a partitioning portion 22b for dividing the inside of the cylindrical connecting portion 22a into two parts
Is provided. Further, on the inner surface of the second header 23, a heat medium chamber forming member connecting portion 23a projecting in a cylindrical shape is provided. For this reason, as shown in FIG. 5, a tubular heat medium chamber forming member 32 described later has an open end held by the first header 22 and a closed end held by the second header 23.

First, the oxygenator will be described. FIG.
0 is an explanatory diagram for explaining the internal structure of the oxygenator portion of one embodiment of the hollow fiber membrane oxygenator of the present invention. FIG.
FIG. 12 is a front view of a tubular core used in one embodiment of the hollow fiber membrane oxygenator of the present invention, FIG. 12 is a plan view of the tubular core shown in FIG. 11, and FIG. 13 is a tube shown in FIG. FIG. 4 is a cross-sectional view of the core. FIG. 14 is a left side view of the tubular core shown in FIG. 11, and FIG. 15 is a right side view of the tubular core shown in FIG. The oxygenator comprises a tubular core 5 and a tubular hollow fiber membrane bundle 3 composed of a large number of hollow fiber membranes wound around the outer surface of the tubular core 5. As shown in FIGS. 4 and 7 to 15, the cylindrical core 5 is a cylindrical body, and has a donut plate-like projection 55 extending inward at a predetermined width at one end. Blood inflow port 2 on the outer surface of the flat portion of
4 is formed so as to protrude outward in parallel with the central axis of the cylindrical core 5. On the outer surface of the tubular core 5, a number of grooves 51 are formed between the outer surface of the tubular core 5 and the inner surface of the tubular hollow fiber membrane bundle 3 to form a blood flow path. Further, the tubular core 5 has a blood circulation opening 52 that communicates the groove 51 with the first blood chamber 11 formed between the tubular core 5 and the tubular heat exchanger. The outer diameter of the cylindrical core 5 is 20
The effective length (the length of the entire length not buried in the partition) is preferably about 10 to 730 mm.
The degree is preferred.

More specifically, the cylindrical core 5 has a plurality of grooves 51 which are not parallel and are not continuous except for both end portions thereof. An annular rib 53 is provided between the grooves 51. The groove of the tubular core 5 is formed so as to cover almost the entire area of the hollow fiber membrane bundle that contributes to gas exchange (effective length, part not buried in the partition wall). The cylindrical core 5 used here is provided with a flat surface-shaped groove non-forming portion 54 which is substantially on an extension of the blood inflow port 24 and extends substantially the entire groove 51 forming portion of the cylindrical core 5. Therefore, 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 an end. As the cylindrical core 5, the groove 5 of the cylindrical core 5 is used.
1 The flat non-groove non-forming portion 54 extending over substantially the entire forming portion
The shape stability of the tubular hollow fiber membrane bundle 3 formed on the outer surface of the tubular core 5 is improved. However, it is not always necessary to provide the groove non-forming portion 54, and the groove 51 and the rib 53 of the tubular core 5 may be an endless complete annular groove 51 and an endless complete annular rib 53. Further, the depth of the groove 51 is preferably about 0.5 to 10.0 mm, and particularly preferably 2.0 to 4.0 mm. The pitch of the groove 51 is 1.0 to 10.0.
mm is preferable, and especially 3.0 to 5.0 mm is preferable. Further, the width of the groove 51 (the width of the maximum portion) is preferably about 1.0 to 10.0 mm.
2.0 to 4.0 mm is preferred. Since the tubular core 5 has a large number of grooves 51 over almost the entire effective length (portion not buried in the partition wall) of the hollow fiber membrane bundle 3, blood can be dispersed throughout the hollow fiber membrane bundle 3. In addition, the entire hollow fiber membrane can be effectively used, and the gas exchange ability is high.

Furthermore, it is preferable that the vertices of the ridges (ribs 53) formed between the grooves 51 of the cylindrical core 5 are flat surfaces. The width of the flat surface of the rib 53 is 0.1 to
About 5.0 mm is preferable, and in particular, 0.8 to 1.2 m
m is preferred. By making the apex of the rib 53 a flat surface as described above, the shape stability of the tubular hollow fiber membrane bundle 3 formed on the outer surface of the tubular core 5 is improved. Further, the groove 51
Has a cross-sectional shape (for example, a trapezoidal cross-section) that expands toward the apex of the rib 53. For this reason, the groove 5
1 (blood channel) spreads toward the inner surface of the hollow fiber membrane bundle, so that the blood can flow into the hollow fiber membrane bundle well.

The blood inflow port 24 is connected to the cylindrical core 5.
Is provided at one end side of 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 so, the blood circulation form in the first blood chamber 11 formed between the cylindrical core and the cylindrical heat exchanger section is likely to be uniform, and the heat exchange efficiency is also high. Specifically, FIG.
As shown in FIG. 15 and FIG. 15, the cylindrical core 5 is substantially on the extension of the above-described blood inflow port 24, and the cylindrical core 5
And a groove non-forming portion 54 extending over substantially the entire groove forming portion. The groove non-forming portion 54 is a thin portion made possible by not forming a groove, whereby a blood guiding portion 56 located substantially on the extension of the blood inflow port 24 inside the cylindrical core 5 is formed. Is formed. The blood guiding portion has an inner diameter larger than that of the other groove forming portions. By providing such a blood guide section 56, blood can be reliably flowed into the entire axial direction of the first blood chamber 11 formed between the cylindrical core and the cylindrical heat exchanger section.

The blood circulation opening 52 is formed in a region (position) facing the groove non-forming portion 54 (blood guiding portion 56).
Are formed. In the cylindrical core 5, the blood circulation opening 52 includes a plurality of blood circulation openings 52 that communicate with each of the plurality of annular grooves 51. That is, the groove non-forming portion 5
Groove 5 of cylindrical core 5 at a position facing 4 (blood guiding portion)
An opening 52 is formed by deleting one portion. For this reason, the rib 53 exists between the adjacent openings 52. Further, in this cylindrical core 5, the thickness of the rib 53 in the opening forming portion 52a is thin, and the inner diameter of the opening forming portion 52a is the same as that of the non-groove forming portion (blood guiding portion), as shown in FIG. The second blood guiding portion 57 is formed wider than the other portions. As described above, by leaving the ridges of the ribs 53 in the opening forming portions 52a, it is possible to avoid deterioration of the physical properties of the cylindrical core 5 and to stabilize the shape of the hollow fiber membrane bundle 3 by securing a contact portion with the hollow fiber membrane. It becomes possible. In addition, since the inner diameter of the opening 52a is smaller than other portions, the blood flowing in the first blood chamber 11 can be reliably guided to the opening 52a. However, the present invention is not limited to this, and the opening forming portion 52a does not have the peak portion of the rib 53, and has one blood circulation opening or the plurality of annular grooves communicating with all of the plurality of annular grooves 51. It may be provided with a plurality of blood circulation openings communicating with 51.

The hollow fiber membrane bundle 3 is wound around the outer surface of the cylindrical core 5 described above. As shown in FIG. 4, the hollow fiber membrane 3a forming the hollow fiber membrane bundle 3 is sequentially wound around the cylindrical core 5 so that the hollow fiber membrane layer spreading on the outer peripheral surface of the cylindrical core 5 has a multilayer structure. In other words, they are spirally overlapped or wound in a reel shape with a cylindrical core as a core. Furthermore, the hollow fiber membrane layer
In the gas exchange effective portion, there are no intersections where the hollow fiber membranes intersect and no folded portions of the hollow fiber membranes. In particular, in the oxygenator of this embodiment, the hollow fiber membrane layer is formed by the intersection of the hollow fiber membranes and the folded back of the hollow fiber membrane also in the partition wall portion that fixes both ends of the hollow fiber membrane bundle to the housing in a liquid-tight manner. The part does not exist. And
As shown in FIG. 5, such a hollow fiber membrane bundle 3 is formed by cutting both ends of a hollow fiber membrane bundle formed body having a folded portion of the hollow fiber membrane formed at both ends.

The length S of the hollow fiber membrane whose both ends forming the hollow fiber membrane bundle (including the partition wall portion) open at the end face of the partition wall is determined by the radius of the hollow fiber membrane bundle in the hollow fiber membrane portion to be measured ( In other words, when the radius of the hollow fiber membrane bundle at the end face of the partition wall in the hollow fiber membrane portion to be measured) is r, and the length of the hollow fiber membrane bundle (including the partition portion) is L, L <S <
√ (πr) ² + L ² . With such a length, there are no intersections where the hollow fiber membranes intersect and folded portions of the hollow fiber membranes in the gas exchange effective portion and the partition wall portion of the hollow fiber membrane bundle. Further, it is preferable that the turning angle θ (the turning portion is located in the cut portion) of the hollow fiber membrane forming the hollow fiber membrane bundle is larger than 90 °. The turning angle θ is an angle when the hollow fiber membrane bundle is deployed, as shown in FIG. Specifically, as shown in FIG. 5 illustrating a state in which one hollow fiber membrane layer of the hollow fiber membrane bundle is developed, the hollow fiber membrane 3a
Is folded at both ends of the hollow fiber membrane bundle forming body, and one hollow fiber membrane does not cross in one hollow fiber membrane layer. In this embodiment, when winding the hollow fiber membrane around the cylindrical core, the traverse moves to the opposite side (diagonal direction) to the initial position where the winding of the hollow fiber membrane started winding when the winding core makes a half turn. When the winding core makes one rotation, it returns to the vicinity of the winding start point of the hollow fiber membrane (considering the number of simultaneous windings of the hollow fiber membrane and the gap between the hollow fiber membranes).

In FIG. 5, a portion X is a gas exchange effective portion, a portion Y is a partition portion, and 3c is a cut end of both ends of the hollow fiber membrane bundle. Therefore, the folded portion 3b of the hollow fiber membrane formed at both ends of the hollow fiber membrane bundle forming body shown in FIG.
Is cut off, and does not exist in the gas exchange effective portion and the partition wall portion. The number of hollow fiber membrane layers as shown in FIG. 5 (the number of stacked hollow fiber membranes at the end surface of the hollow fiber membrane) varies depending on the membrane area of the oxygenator, but is 3 to 40.
The degree is common. The hollow fiber membrane bundle is formed by winding one or a plurality of hollow fiber membranes around the cylindrical core so that all the hollow fiber membranes have a substantially constant interval. In addition, the distance between adjacent hollow fiber membranes that are substantially parallel to the hollow fiber membrane,
It is preferably 1/10 to 1/1 of the outer diameter of the hollow fiber membrane.

As described above, the hollow fiber membrane bundle in which no crossing portion is formed and the folded portion is located at both ends has one or a plurality of hollow fiber membranes at the same time and almost all of the adjacent hollow fiber membranes have almost no hollow fiber membranes. It is formed by being spirally wound around a cylindrical core so as to have a constant interval,
Further, when the hollow fiber membrane is wound around the cylindrical core, the cylindrical core rotating means 61 for rotating the cylindrical core and the winder device 62 for knitting the hollow fiber membrane are provided by the following arithmetic expression 1 traverse [mm / lot] 1 / n (integer of 2 or more) = traverse swing width 2 ± (outer diameter of hollow fiber membrane + spacing) number of windings (operation formula 1). It should be noted that n is a relationship between the number of revolutions of the winding rotary body and the number of reciprocating winders.
Should be from 2 to 5, preferably 2. As described above, by selecting an integer as n in the above formula 1, it is possible to prevent the formation of a hollow fiber membrane crossing portion (crosswind portion). In the artificial lung 1 of this embodiment, the operation is performed with n = 2.

Therefore, the hollow fiber membrane bundle forming apparatus 6 shown in FIG.
0 will be described. The hollow fiber membrane bundle forming device 60 includes a cylindrical core rotating means 61 and a winder device 62. The cylindrical core rotating means 61 includes a motor 63 and a motor shaft 6.
4 and a core mounting member 6 fixed to the motor shaft 64
5 is provided. The cylindrical core 5 is mounted on a core mounting member 65 and rotated by a motor. Winder device 62
Has a main body 66 having a hollow fiber membrane storage section therein, and a discharge section 75 which discharges the hollow fiber membrane and moves in the axial direction of the main body (parallel to the axis of the cylindrical core, the direction of the arrow). . According to the hollow fiber membrane bundle forming device 60, the traverse width is fixed by the moving width of the discharge unit 75. Also,
It is preferable that one or a plurality of hollow fiber membranes are simultaneously wound around the cylindrical core 5 so that substantially parallel and adjacent hollow fiber membranes have a substantially constant interval. Thereby, the drift of blood can be further suppressed. Further, the distance between the adjacent hollow fiber membranes of the hollow fiber membrane is one of the outer diameter of the hollow fiber membrane.
It is preferably / 10 to 1/1. further,
The distance between the hollow fiber membrane and the adjacent hollow fiber membrane is 30 μm or more.
200 μm is preferred, and particularly preferably 50 μm to 1 μm.
80 μm.

Further, the hollow fiber membrane is wound around the cylindrical core 5 so that the hollow fiber membrane is not disposed outside the cylindrical core 5 at the portion that becomes the groove 51, in other words, the hollow fiber is connected from the top of the rib 53 to the top. In addition, it is preferably performed by spirally winding along the outer periphery of the top of the rib 53. At this time, it is preferable that the hollow fiber membrane is wound at a certain angle with respect to the groove 51 (rib 53) so as not to fall into the groove 51 of the cylindrical core 5. Specifically, an angle of 10 to 50 ° with respect to the groove 51 (rib 53) of the tubular core 5 is preferable, and 20 to 40 ° is more preferable. Further, it is preferable that the folding angle θ of the hollow fiber membrane exceeds 90 °. In addition, the hollow fiber membrane is wound with a certain angle with respect to the groove 51 (rib 53) of the cylindrical core 5 so that the hollow fiber membrane is caught between the cylindrical core 5 and the hollow fiber membrane during priming. The removal of the bubbles can be improved, and the priming property and the gas performance can be improved, and the performance variation due to the falling off of the hollow fiber membrane can be reduced.

As the hollow fiber membrane, a porous gas exchange membrane is used. As the porous hollow fiber membrane, an inner diameter of 100 to 10
00 μm, wall thickness is 5-200 μm, preferably 10-1
00 μm, porosity 20-80%, preferably 30-6
0% and a pore size of 0.01 to 5 μm, preferably 0.1 to 5 μm.
Those having a size of from 01 to 1 μm can be preferably used. In addition, as a material used for the porous membrane, a hydrophobic polymer material such as polypropylene, polyethylene, polysulfone, polyacrylonitrile, polytetrafluoroethylene, and cellulose acetate is used. Preferably, it is a polyolefin-based resin, particularly preferably polypropylene, and more preferably a resin having fine pores formed in a wall by a stretching method or a solid-liquid phase separation method. The outer diameter of the hollow fiber membrane bundle 3 is
The thickness is preferably 30 to 162 mm, and the thickness of the hollow fiber membrane bundle 3 is preferably 3 to 28 mm. Further, 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 a cylindrical space formed between the outer surface and the inner surface of the cylindrical hollow fiber membrane bundle 3. , 50% to 75%. More preferably, it is 53% to 73%.

The hollow fiber membrane bundle 3 composed of hollow fiber membranes having both ends opened is wound around the hollow fiber membrane around the cylindrical core 5, and both ends are fixed to the cylindrical housing body 21 by partition walls 8 and 9. Then, it is produced by cutting both ends of the hollow fiber membrane bundle forming body. Both ends of the cylindrical core 5 around which the hollow fiber membrane bundle 3 is wound around the outer surface are fixed to both ends of the cylindrical housing body 21 by partition walls 8 and 9 in a liquid-tight manner. The second blood chamber 12, which is an annular space (cylindrical space), is formed between the inner surfaces of the main body 21. Blood outflow port 2 formed on the side of cylindrical housing body 21
5 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. Then, as shown in FIG. 10, a heat exchanger section described later is housed inside the tubular core 5 of the oxygenator formed as described above. An annular first blood chamber 11 is formed between the cylindrical core 5 and the cylindrical heat exchanger section, and the blood inflow port 24 communicates with the blood chamber 11.

As shown in FIGS. 7 to 9, the tubular heat exchanger section includes a tubular heat exchanger 31, a tubular heat medium chamber forming member 32 housed in the heat exchanger 31, and a tubular heat exchanger 31. Heat exchanger 3
1 and two cylindrical heat exchanger deforming portions 34 and 35 inserted between the cylindrical heat medium chamber forming member 32. As the tubular heat exchanger 31, a so-called bellows type heat exchanger is used. The bellows type heat exchanger 31 (bellows tube) is shown in FIG.
As shown in FIG. 0, a bellows forming portion having a large number of hollow annular projections formed substantially parallel to the central side surface, and a cylindrical portion 31c formed at both ends thereof and having substantially the same inner diameter as the bellows forming portion are provided. One of the cylindrical portions of the heat exchanger 31 is sandwiched between the inner surface of the end portion of the hollow cylindrical core 5 on the blood inflow port 24 side and the second header 23, and the other of the cylindrical portion of the heat exchanger 31 is a hollow cylindrical member. A ring-shaped heat exchanger fixing member 48 inserted into one end of the core 5, a tubular heat exchanger fixing member 49 inserted between the ring-shaped heat exchanger fixing member 48 and the first header 22; It is sandwiched between the second headers 23.

The bellows type heat exchanger 31 is made of stainless steel,
It is formed in a so-called fine bellows shape from a metal such as 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 formed of a wavy bellows tube in which a large number of irregularities substantially perpendicular to the axial direction (center axis) of the cylindrical heat exchanger 31 are repeated, and the heights of the valleys and peaks are 5.0. The most efficient is about 1 to 15.0 mm, preferably 9.0 to 12.0 mm. The length of the heat exchanger section in the axial direction varies depending on the patient to be used, but is in the range of 70.0 to 150 cm.

As shown in FIGS. 7 to 9, the cylindrical heat medium chamber forming member 32 is a cylindrical body having an open end (on the side of the second header 23). A partition wall 32a that divides into the 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;
A second opening 33b communicating with the outflow side heat medium chamber 42 and extending in the axial direction is formed on a side face facing the first opening 33a and the second opening 33b at a position shifted from the first opening 33a and the second opening 33b by about 90 °, and protrudes outward. Projections 36a and 36b extending in the axial direction. The protrusion 36a regulates the movement of the deformation restricting portion 34 by entering into an axially extending groove 51 formed at the center of the inner surface of the heat exchange member deformation restricting portion 34. Similarly,
The protrusion 36b restricts the movement of the deformation restricting portion 35 by entering into the axially extending groove 51 formed at the center of the inner surface of the heat exchanger deforming restricting portion 35.

When the opening end side of the cylindrical heat medium chamber forming member 32 is fitted to the heat medium chamber forming member connecting portion 22a of the first header 22, as shown in FIG. A partitioning portion 22b that divides the inside of the tubular connecting portion 22a into two parts is in close contact with one surface (lower surface in this embodiment) of the distal end portion of the partition wall 32a of the forming member 32. Thereby, the inflow side heat medium chamber 41 in the tubular 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. In addition, the two heat exchanger deformation restricting portions 3
4 and 35 are provided with notches extending in the axial direction at respective end portions to be joined, and the two regulating portions 3 are provided.
As shown in FIG. 9, a medium inflow side passage 37 and a medium outflow side passage 38 are formed by the mating of the members 4 and 35. Two heat exchanger deformation restricting portions 34, 35
May be formed integrally.

The flow of the heat medium in the heat exchanger section of the oxygenator 1 according to this embodiment will be described with reference to FIGS. The heat medium that has flowed into the oxygenator from the heat medium inflow port 28 flows into the heat medium chamber 41 on the inflow side through the first header 22. Then, the tubular heat medium chamber forming member 3
2 inflow chamber side opening 33a and heat exchange body deformation regulating portion 3
The medium inflow side passage 37 formed by the abutting portions 4 and 35
Through the heat exchanger 31 and the heat exchanger deformation restricting portion 34,
It flows between 35. At this time, the heat exchanger 31
Is heated or cooled. The heat medium passes through the medium outflow side passage 38 formed by the contact portions of the heat exchange body deformation restricting portions 34 and 35 and the outflow chamber side opening 33b of the tubular heat medium chamber forming member 32, thereby forming a tube. It flows out into the outflow side heat medium chamber 42 in the heat medium chamber forming member 32. Then, it passes through the inside of the first header 22 and flows out of the heat medium outflow port 29.

In the oxygenator 1, the blood flowing from the blood inflow port 24 flows into the blood guiding portion 56 which forms a part of the blood chamber 11 between the cylindrical core 5 and the cylindrical heat exchanger. Then, after flowing between the tubular core 5 and the tubular heat exchanger, it flows out of the tubular core 5 through the opening 52 formed at a position facing the first blood guide portion 56. The blood flowing out of the cylindrical core 5 flows into a plurality of grooves 51 formed on the inner surface of the hollow fiber membrane bundle 3 and the outer surface of the cylindrical core 5 located between the cylindrical core 5, and then flows into the hollow fiber membrane bundle 3. Flows in between. In the oxygenator of this embodiment, the portion (effective length,
Since a large number of grooves 51 are formed so as to cover almost the entire area (parts not buried in the partition walls), blood can be dispersed throughout the hollow fiber membrane bundle 3, and the entire hollow fiber membrane can be used effectively. Gas exchange capacity is also high. Then, after the gas comes into contact with the hollow fiber membrane and gas is exchanged, the gas 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 the blood flows therethrough. Outflow port 25
More outflow. Further, the oxygen-containing gas flowing from the gas inlet port 26 flows into the hollow fiber membrane from the partition end face through the first header 22, passes through the second header 23, and flows out from the gas outlet port 27. .

As materials for forming members other than the heat exchanger 31 such as the cylindrical housing body 21, the cylindrical core 5, the first and second headers 22 and 23, polyolefin (for example, polyethylene and polypropylene), Ester resin (eg, polyethylene terephthalate), styrene resin (eg, polystyrene, MS resin, MBS)
Resin), polycarbonate and the like. further,
The blood contact surface of the oxygenator 1 is preferably an antithrombotic surface. The antithrombotic surface can be formed by coating and further fixing the antithrombotic material on the surface. Heparin, urokinase, HEMA-
St-HEMA copolymer, poly-HEMA and the like can be used.

[0030]

EXAMPLES Next, specific examples and comparative examples of the hollow fiber membrane oxygenator of the present invention will be described. (Example) An outer diameter of 110.
Those having a diameter of 0 mm, an inner diameter of 106.0 mm and a length of 114.0 mm were used. Further, as the first header and the second header, those having shapes as shown in FIGS. 1 to 4 were used. The outer diameter of the bellows type heat exchanger is 75.0 m.
m, the inner diameter was 50.0 mm, the length was 114.0 mm, the length of the bellows forming portion was 90.0 mm, the number of peaks was 40, and the pitch of the bellows (peaks) was 2.25 mm. In the bellows type heat exchanger, a tube having a shape as shown in FIG. 8 having an outer diameter of a cylindrical portion of 39.0 mm, an outer diameter of a rib portion of 47.0 mm, and a length of 114.0 mm is closed at one end. A heat-medium chamber forming member and a combination of two heat-exchanger-deformation restricting members on the outside thereof were inserted. The heat exchanger deformation restricting member has a length of 9
2.0 mm, a maximum diameter portion of 52.0 mm, 40 ribs (height: 1.0 mm, width: 0.5 mm) formed in parallel on the outer surface, and the rib of the regulating member is a bellows type heat exchanger. It was inserted so as to penetrate into the inner space of the valley. The cylindrical core has a shape as shown in FIGS. 11 to 15, a length of 152.0 mm, an outer diameter of 84.0 mm, and an inner diameter of 7
5.0 mm, groove forming portion length 90.0 mm, groove depth 2.5 mm, groove interval 3.0 mm, flat surface width of rib apex 1.0 mm, number of grooves 40 on the outer periphery Was used. Then, the bellows type heat exchanger was inserted into the cylindrical core. On the outer surface of the cylindrical core, an inner diameter of 195 μm,
A porous polypropylene hollow fiber membrane having an outer diameter of 295 μm and a porosity of about 35% is rewound while maintaining the interval between the four hollow fiber membranes at 100 μm, and then the interval between the adjacent hollow fiber membranes is also previously wound. The hollow fiber membrane was wound so that the distance between the adjacent hollow fiber membranes was constant, and the hollow fiber membrane bobbin with a built-in heat exchanger also serving as a flow path regulating plate was produced. . When the hollow fiber membrane is wound on the cylindrical core, a rotating body for rotating the cylindrical core and a winder for knitting the hollow fiber membrane move according to the following formula, and the hollow fiber membrane layer as shown in FIG. The hollow fiber membrane bundle forming body of the spirally-shaped laminate was manufactured. Traverse [mm / lot] · 1/2 = traverse swing width · 2 ± (hollow fiber membrane outer diameter + interval) · number of windings More specifically, four hollow fiber membranes arranged in substantially parallel When the take-up core makes a 回 転 turn when the take-up core rotates, the traverse moves to the opposite side (diagonal direction) to the initial position where the hollow fiber membrane has started to be taken up, and the take-up core makes one turn. To the vicinity of the winding start point of the hollow fiber membrane (at a position about 1600 μm away from the winding start point in consideration of the number of simultaneous windings of the hollow fiber membranes and the gap between the hollow fiber membranes). In consideration of the gradual enlargement of the above, a hollow fiber membrane bundle forming body (filling rate in the hollow fiber membrane bundle: 68%) was produced by repeating the above procedure. Then, both ends of the hollow fiber membrane bundle forming body are fixed to both ends of the cylindrical housing main body together with the cylindrical core with a potting agent, and while rotating around the heat exchanger portion, without cutting the heat exchanger portion, Both ends of the fixed hollow fiber bobbin were cut.
Then, the first header and the second header described above are attached to both ends of the cylindrical housing main body, and the membrane area 2.
5 m ² , blood filling volume 250 ml, and FIGS.
A hollow fiber membrane type artificial lung having a structure as shown in FIGS. 7 to 9 was produced.

(Comparative Example) When winding four hollow fiber membranes arranged substantially in parallel on a cylindrical core, one rotation of the winding core causes the hollow fiber membrane to start winding on the opposite side. When the traverse moves in the diagonal direction and the winding core makes two rotations, the winding starts near the winding start point of the hollow fiber membrane (considering the number of simultaneous winding of the hollow fiber membrane and the gap between the hollow fiber membranes). (At a position about 1600 μm away from the point), and this is repeated in consideration of the gradual expansion of the hollow fiber membrane bundle, whereby the hollow fiber membrane bundle forming body (filling rate in the hollow fiber membrane bundle of 68%) is obtained. Except for the preparation, a hollow fiber membrane-type artificial lung having a membrane area of 2.5 m ² and a blood filling amount of 250 ml was prepared in the same manner as in Example. In the formed hollow fiber membrane formed body, a hollow fiber membrane crossing portion annular laminated portion was formed in which the crossing portions of the hollow fiber membranes were laminated in the axial center of the core.

(Experiment) The following experiments were performed using bovine blood for the artificial lungs of Examples and Comparative Examples produced as described above. Bovine blood was collected from AAMI (Associa).
Tion for the Advance of M
Using standard venous blood as determined by the Electronic Instrumentation, an anticoagulant added thereto was perfused into each artificial lung at a flow rate of 7 L / min. Then, for each oxygenator, blood is collected near the blood inflow port and near the blood outflow port, and the oxygen gas partial pressure, carbon dioxide partial pressure, pH, etc. are determined by a blood gas analyzer, and the oxygen transfer amount and the carbon dioxide transfer The amount was determined. The pressure loss at a blood flow rate of 7 L / min was measured. The results were as shown in Table 1 below.

[0033]

[Table 1]

[0034]

As described above, the hollow fiber membrane-type artificial lung of the present invention comprises a tubular core, and a tubular hollow fiber membrane bundle composed of a large number of gas exchange hollow fiber membranes wound around the outer surface of the tubular core. A housing for accommodating the tubular hollow fiber membrane bundle; a gas inflow portion and a gas outflow portion communicating with the inside of the hollow fiber membrane; and a blood inflow portion and blood outflow communicating with the outside of the hollow fiber membrane and the inside of the housing. And a hollow fiber membrane-type artificial lung comprising: a tubular hollow fiber membrane bundle formed by spirally winding a hollow fiber membrane around the outer peripheral surface of the tubular core;
The hollow fiber membrane layer, which spreads on the outer peripheral surface of the tubular core by the hollow fiber membrane, is in a multilayered state, and furthermore, the hollow fiber membrane layer has an intersection where the hollow fiber membrane intersects the gas exchange effective portion. Since there is no portion and no folded portion of the hollow fiber membrane, a short circuit path of blood due to the intersection is not formed in the hollow fiber membrane bundle, and the artificial lung has high gas exchange ability.

[Brief description of the drawings]

FIG. 1 is a front view showing one embodiment of a hollow fiber membrane-type artificial lung of the present invention.

FIG. 2 is a left side view of the hollow fiber membrane-type oxygenator shown in FIG.

FIG. 3 is a right side view of the hollow fiber membrane-type oxygenator shown in FIG.

FIG. 4 is an explanatory view showing a state where the housing of the hollow fiber membrane-type artificial lung shown in FIG. 1 is partially peeled off.

FIG. 5 is an explanatory diagram for explaining an intersection of an example of a hollow fiber membrane bundle used for the hollow fiber membrane-type oxygenator of the present invention.

FIG. 6 is an explanatory diagram for explaining an example of a hollow fiber membrane bundle forming device used in the hollow fiber membrane-type artificial lung of the present invention.

FIG. 7 is a sectional view taken along the line AA of FIG. 2;

FIG. 8 is a sectional view taken along the line BB of FIG. 2;

FIG. 9 is a sectional view taken along line CC of FIG. 1;

FIG. 10 is an explanatory diagram for explaining an internal structure of an artificial lung portion of one embodiment of the hollow fiber membrane-type artificial lung of the present invention.

FIG. 11 is a front view of a tubular core used in one embodiment of the hollow fiber membrane-type oxygenator of the present invention.

FIG. 12 is a plan view of the tubular core shown in FIG. 11;

FIG. 13 is a sectional view of the cylindrical core shown in FIG. 11;

FIG. 14 is a left side view of the cylindrical core shown in FIG. 11;

FIG. 15 is a right side view of the cylindrical core shown in FIG. 11;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Hollow fiber membrane oxygenator 2 Housing 3 Cylindrical hollow fiber membrane bundle 3a Hollow fiber membrane 3b Folded part 3c Cutting end 5 Cylindrical core 11 First blood chamber 12 Second blood chamber 21 Cylindrical housing main body 22 First Header 23 second header 24 blood inflow port 25 blood outflow port 26 gas inflow port 27 gas outflow port 28 heat medium inflow port 29 heat medium outflow port 31 cylindrical heat exchanger 34, 35 cylindrical heat exchanger deformation restrictor 51 groove 52 opening for blood circulation

Continued on front page F term (reference) 4C077 AA03 BB06 CC05 KK15 LL05 PP04 PP08 PP15 PP18 4D006 GA35 HA08 JA16Z JA25Z JB02 JB05 KE16Q MA01 MA22 MA24 MA31 MA33 MB03 MC18 MC22 MC23 MC30 MC39 MC62 PA01 PB09 PB64 PC48

Claims (8)

[Claims] 1. A tubular hollow fiber membrane bundle comprising a tubular core, a plurality of gas exchange hollow fiber membranes wound around the outer surface of the tubular core, and a housing for accommodating the tubular hollow fiber membrane bundle. When,
A hollow fiber membrane oxygenator comprising: a gas inflow portion and a gas outflow portion communicating with the inside of the hollow fiber membrane; and a blood inflow portion and a blood outflow portion communicating with the outside of the hollow fiber membrane and the inside of the housing. The tubular hollow fiber membrane bundle is formed by spirally winding a hollow fiber membrane around the outer peripheral surface of the tubular core, and the hollow fiber membrane layer is spread on the outer peripheral surface of the tubular core by the hollow fiber membrane. However, the hollow fiber membrane layer is characterized in that the hollow fiber membrane layer does not have a crossing portion where the hollow fiber membranes intersect in the gas exchange effective portion and a folded portion of the hollow fiber membrane. Hollow fiber membrane oxygenator. 2. The hollow fiber membrane layer has a crossing portion where the hollow fiber membranes cross each other and a folded portion of the hollow fiber membrane in a partition portion for fixing both ends of the hollow fiber membrane bundle to the housing in a liquid-tight manner. The hollow fiber membrane-type artificial lung according to claim 1, which does not exist. 3. The hollow fiber membrane bundle has a multilayer structure in which hollow fiber membrane layers extending on an outer peripheral surface of a cylindrical core are overlapped with each other, and the hollow fiber membrane layers have hollow fiber membranes at both ends. 3 is formed by cutting both ends of a hollow fiber membrane bundle formed body formed with a folded portion.
2. The hollow fiber membrane-type artificial lung according to item 1. 4. The folding angle θ of the hollow fiber membrane forming the hollow fiber membrane bundle is larger than 90 °.
4. The hollow fiber membrane-type oxygenator according to any one of items 3 to 3. 5. The length S of the hollow fiber membrane forming the hollow fiber membrane bundle is represented by r as the radius of the hollow fiber membrane bundle in the hollow fiber membrane portion to be measured, and L as the length of the hollow fiber membrane bundle. When L <
The hollow fiber membrane-type artificial lung according to claim 1, wherein S <√ (πr) ² + L ² . 6. The hollow fiber membrane oxygenator according to claim 1, wherein the hollow fiber membrane oxygenator has a tubular heat exchanger section housed in the tubular core. . 7. The hollow fiber membrane bundle, wherein one or more hollow fiber membranes are wound at the same time and all adjacent hollow fiber membranes are spirally wound around a cylindrical core so as to be at a substantially constant interval. And, when winding the hollow fiber membrane around the cylindrical core, a cylindrical core rotating means for rotating the cylindrical core and a winder device for knitting the hollow fiber membrane, Calculation formula 1 below Traverse [mm / lot] · 1 / n (integer) = traverse swing width · 2 ± (hollow fiber membrane outer diameter + interval) · Number of windings (calculation formula 1) The hollow fiber membrane-type oxygenator according to any one of claims 1 to 6, wherein the oxygenator is formed by performing the following steps. 8. The hollow fiber membrane oxygenator according to claim 7, wherein n in the arithmetic expression 1 is 2.