JPH029817Y2 - - Google Patents

Description

[Detailed Description of the Invention] Background Technical Field of the Invention The present invention relates to a medical substance transfer device. More specifically, the present invention relates to improvements in medical mass transfer devices such as artificial lungs, artificial kidneys, and artificial livers.

Prior Art Conventionally, medical mass transfer devices such as artificial lungs include a cylindrical housing, a hollow fiber bundle consisting of a large number of hollow fiber membranes for gas exchange inserted into the housing, and an outer surface of the hollow fiber membranes. an oxygen chamber formed by the inner surface of the housing; an oxygen supply port and an oxygen discharge port communicating with the oxygen chamber; a partition wall that supports each end of the hollow fiber membrane and isolates it from the oxygen chamber; A hollow fiber oxygenator is known which includes a blood inlet and an outlet communicating with the internal space of each hollow fiber membrane (Utility Model Publication No. 138947/1983).
Further, the artificial kidney is formed by a cylindrical housing, a hollow fiber bundle consisting of a large number of hollow fiber membranes for dialysis inserted into the housing, an outer surface of the hollow fiber membranes, and an inner surface of the housing. A dialysis room,
A dialysate supply port and a discharge port that communicate with the dialysis chamber, a partition wall that supports each end of the hollow fiber membrane and isolates it from the dialysis chamber, and a blood inlet that communicates with the internal space of each hollow fiber membrane. Hollow fiber artificial kidneys are known, which consist of a
Volume 21 “Chemistry of Medical Materials” pp. 144-146, 1978
Published by Gakkai Publishing Center Co., Ltd. on November 25th).

The blood inlet and outlet in these medical substance transfer devices are formed by headers (blood distribution members) fixed to both ends of the cylindrical housing. In order to prevent blood leakage, the header is usually sealed by pressing it against the partition wall via a soft rubber O-ring that is inserted into a groove formed on the inner peripheral edge of the header. However, in a device sealed in this manner, there is a risk that after a long period of time, the end wall material (potting material) of the device will be compressed by the O-ring and become depressed, resulting in blood leakage.
Further, even if the O-ring is not properly inserted into the groove, blood leakage does not occur immediately after assembly, but leakage occurs when heated by, for example, ethylene oxide gas sterilization. Therefore, it is difficult to test before sterilization.

In order to eliminate such drawbacks, in the medical substance transfer device, the flow path forming member is fixed to the partition wall by filling and sealing the outer periphery of the convex portion of the flow path forming member with a filler. has been proposed (Japanese Patent Application Laid-open No. 58-86172). However, in such devices, the filler is usually made of the same material as the partition wall, so its adhesion is extremely good, whereas the flow path forming member is made of a different material, so its adhesion is poor. Sexuality is not enough,
For example, when the threaded ring rotates, it may peel off and the flow path forming member may rotate together with the threaded ring, causing concerns about liquid tightness.

Purpose of the Invention Accordingly, the purpose of the present invention is to provide a medical substance transfer device with a more reliable and safe sealing structure.

This purpose is to provide a hollow fiber bundle consisting of a cylindrical housing, a plurality of hollow fiber membranes for mass transfer inserted into the housing, and a first tube formed by the outer surface of the hollow fiber membranes and the inner surface of the housing. a mass transfer chamber, a first mass transfer fluid inlet and outlet communicating with the first mass transfer chamber, and each end of the hollow fiber membrane is supported and isolated from the mass transfer chamber. a second mass transfer fluid opening communicating with the internal space of the hollow fiber membrane formed by a partition wall and a flow path forming member having an annular convex portion attached to at least one end of the housing;
In a medical substance transfer device in which the flow path forming member is pressed by a threaded ring provided on the outside thereof, and the threaded ring is screwed onto the housing, the flow path forming member is pressed by a threaded ring provided on the outside thereof, and the threaded ring is screwed onto the housing. , forming annular comb-tooth-shaped protrusions that protrude in the axial direction of the cylindrical housing at certain intervals, and formed by the continuous annular protrusion, the annular comb-tooth-like protrusion, and a partition wall; A medical substance transfer device characterized in that the flow path forming member is fixed to the partition wall by filling and sealing a filler through at least one of at least two holes provided in the screw ring in the space where the thread ring is provided. Ru.

Further, the present invention is a medical substance transfer device in which the height of the continuous annular protrusion protrudes higher than the height of the annular comb-like protrusion. Furthermore, the present invention is a medical substance transfer device in which the annular comb-like convex portion has a flat tip. Further, the present invention provides a medical mass transfer device in which the filler is made of the same material as the potting agent used to form the partition wall.

Detailed Description of the Invention FIG. 1 shows a hollow fiber oxygenator as an example of a mass transfer device according to the invention. That is, the oxygenator includes a housing 1, in which annular male threaded mounting covers 3 and 4 are provided at both ends of a cylindrical main body 2, and the housing 1 is provided with an annular mounting cover 3 and 4, which extend entirely within the housing 1. A large number of, for example, 10,000 to 60,000 hollow fiber membranes for mass transfer (hollow fiber membranes for gas exchange) 5 are arranged in parallel and spaced apart from each other along the longitudinal direction of the housing 1. Both ends of the gas exchange hollow fiber membrane 5 are supported in a liquid-tight manner by partition walls 6 and 7 within the mounting covers 3 and 4, with their respective openings not being closed. The partition walls 6 and 7 together with the outer peripheral surface of the hollow fiber membrane 5 and the inner surface of the housing 1 constitute an oxygen chamber 8, which is a first mass transfer chamber, and close the oxygen chamber 8 and close the oxygen chamber 8, which is a first mass transfer chamber. It isolates the oxygen chamber 8 from a blood circulation space (not shown), which is a second mass transfer fluid space formed inside the thread membrane 5 .

One of the mounting covers 3 is provided with an inlet 9 for supplying oxygen, which is the first mass transfer fluid. The other mounting cover 4 is provided with an outlet 10 for discharging oxygen.

The hollow fiber membrane 5 is made of a porous polyolefin resin such as polypropylene or polyethylene for use in an oxygenator, and polypropylene is particularly suitable. The medical substance transfer device of the present invention will be explained below using an artificial lung as an example. This hollow fiber membrane 5 for an artificial lung has a large number of pores communicating between the inside and outside of the wall. And its inner diameter is about 100 to 1000 μm,
The wall thickness is approximately 10~50μm, the average pore diameter is approximately 200~2000Å,
And the porosity is about 20 to 80%. When a hollow fiber membrane made of such a polyolefin resin is used, gas movement occurs as a volumetric flow, so the membrane resistance during gas movement is small, and the gas exchange performance is significantly improved. However, hollow fiber membranes made of silicone can also be used.

Next, the formation of the partition walls 6 and 7 will be described.
As described above, the partition walls 6 and 7 perform the important function of isolating the inside and outside of the hollow fiber membrane 5. Normally, the partition walls 6 and 7 are made by pouring a highly polar polymeric potting material such as polyurethane, silicone, epoxy resin, etc. onto the inner wall surfaces at both ends of the housing 1 using a centrifugal injection method, and then hardening the material. More specifically, first, a large number of hollow fiber membranes 5 longer than the length of the housing 1 are prepared, and after sealing both open ends with a resin with high viscosity, the cylindrical body 5 of the housing 1 is Place them side by side inside. After that, completely cover both ends of the hollow fiber membrane 5 with a mold cover having a size larger than the diameter of the mounting covers 3 and 4, and rotate the housing 1 around the central axis of the housing 1 to remove both ends. Inject the polymer potting agent from the side. When the resin has hardened after pouring, the mold cover is removed and the outer surface of the resin is cut with a sharp knife to expose both open ends of the hollow fiber membranes 5 to the surface. The partition walls 6 and 7 are thus formed.

The outer surfaces of the partition walls 6 and 7 are formed of flow path forming members 11 and 12 having a continuous convex portion and an annular comb-teeth-like convex portion formed on the outer peripheral edge thereof and protruding in the axial direction of the housing 1. each covered. The flow path forming members 11 and 12 are fluid distribution members 17 and 18 and screw rings 19 and 2, respectively.
As shown in FIG. 1, the end surfaces of continuous protrusions 21 and 22 are brought into contact with the partition walls 6 and 7, respectively, as continuous annular convex portions provided near the peripheral edges of the fluid distribution materials 17 and 18. and screw ring 19,
20 are screwed and fixed to the mounting covers 3 and 4, respectively, thereby forming an inflow chamber 23 and an outflow chamber 24 for blood, which is a second mass transfer fluid, respectively.

As shown in FIG. 2, the fluid distribution materials 17 and 18 forming the flow path forming members 11 and 12 are integrally formed with a continuous annular protrusion 21 as a continuous annular convex portion near the periphery. Annular comb-like protrusions 14 are integrally formed as annular comb-like protrusions at regular intervals on the outer peripheral edge of the annular protrusions 21 . The protrusion height of this continuous annular protrusion 21 is usually higher than the protrusion height of the annular comb tooth-like protrusion 14,
The protruding ends thereof come into contact with the partition walls 6 and 7.
In this case, the tip of the continuous annular protrusion 21 is curved so that it comes into close contact with the partition wall when the screw rings 19, 20 are tightened, or the tip is tapered toward the tip. It is desirable that the The annular comb tooth-like protrusion 14 consists of a protruding part and a slit part, which are usually formed at regular intervals, and the interval between the slit parts 27 and 28 is usually 3 to 9 mm, preferably 5 to 7 mm. . Further, the interval between the protrusions 35 and 36 is usually 1 to 5
mm, preferably 2 to 4 mm, and the tip of the protrusion is usually flat. Also, an annular comb tooth-like protrusion 14
It is desirable that the width of the continuous annular protrusion 21 be larger than the width of the continuous annular protrusion 21 in order to increase the contact area with the filler described later and to increase the resistance to the rotational torque of the screw ring.

Note that the flow path forming members 11 and 12 have inlets 25 and 2 for blood, which is a second mass transfer fluid, respectively.
6 is provided.

At least two holes 2 are provided in the gaps at the peripheral edges of the partitions 6, 7 formed by the partitions 6, 7 and the flow path forming members 11, 12, which communicate with the gaps.
Sealing is achieved by filling the fillers 31 and 32 from one of the fillers 9 and 30.

As shown in FIG. 3, the fillers 31 and 32 are formed by bringing the distal end of the continuous annular protrusion 21 into contact with the partition wall 6, so that the continuous annular protrusion 21, the annular comb tooth-like protrusion 14, and the partition wall 6 are brought into contact with each other. The space formed by the In addition, as shown in FIG. 4, continuous annular protrusion 2
1 and the annular comb tooth-like protrusion 14.
After the O-ring 16 is inserted, the space formed by the annular comb-teeth-like projection 14 of the O-ring 16 and the partition wall 6 may be filled with fillers 31 and 32. In this case, the tip of the continuous annular protrusion 21 does not normally come into contact with the partition wall, so the shape of the tip is not particularly limited.

The filler used in the present invention is in a liquid state or has sufficient fluidity when injected into the void through the hole, and is suitable for at least one part of the flow path forming member.
It is a curable resin that has good adhesion to the partition walls 1 and 12 and the partition walls 6 and 7, respectively. As such a filler, there are usually potting agents with high polarity similar to those used to form the partition walls 6 and 7, such as polyurethane, silicone, epoxy resin, etc., and polyurethane gives particularly preferable results.
Moreover, polycarbonate is preferable as the material for the flow path forming members 11 and 12.

As the polyurethane, any of prepolymer adhesives, polyisocyanate adhesives, and isocyanate-modified polymers can be used, but polypolymer adhesives are usually preferably used. Examples of prepolymer adhesives include prepolymers (NCO/OH=1:1 to 1.5) of 4,4'-diphenylmethane diisocyanate and bifunctional castor oil derivatives (e.g. polypropylene glycol ester of ricinoleic acid, molecular weight 540). and a curing agent consisting of a mixture of a bifunctional castor oil derivative, a polyfunctional polypropylene glycol (molecular weight 2000 to 3000), and an amino alcohol (weight ratio 50 to 70:15 to 25:15 to 25), in which the number of functional groups is almost the same. For example,
Some are mixed at a weight ratio of 65:35 to 59:41,
It can be cured at room temperature, has appropriate elasticity, and has excellent adhesive properties.

In addition, in Figure 1, each opening has a cap 3.
3 and 34 are attached.

The above is an example of an oxygenator, and as shown in Japanese Patent Application No. 55-115868, when a heat exchanger is coaxially connected to one end of the oxygenator, other Of course, the flow path forming member used at the end (the end opposite to the oxygenator) can also be firmly sealed in the same manner.

In addition, hollow fiber membranes used in medical mass transfer devices similar in structure to the artificial lungs include cuprammonium regenerated cellulose membranes, cellulose acetate regenerated cellulose membranes, polymethyl methacrylate stereocomplex membranes, polyacrylonitrile membranes, and ethylene membranes. - An artificial kidney can be obtained by using a hollow fiber membrane such as a vinyl alcohol copolymer membrane.

Specific Effects of the Invention The medical mass transfer device of the present invention having the above configuration is used by being incorporated into an extracorporeal circulation circuit for a second mass transfer fluid, such as blood. For example, in the case of an artificial lung, blood is introduced from a blood inlet 25 by a blood pump (not shown), passes through each hollow fiber membrane 5 through a blood inflow chamber 23, and is introduced between Oxygen introduced into the first mass transfer chamber 16 through the port 9 is applied, carbon dioxide gas is discharged, and then the blood passes through the blood outlet chamber 24 to the blood outlet 26.
is discharged from. Oxygen in the first mass transfer chamber 16 is discharged from the outlet 10 together with carbon dioxide gas. In the case of an artificial kidney, the principle is almost the same, and dialysate is used instead of oxygen. Also,
The same applies to artificial kidneys.

Specific Effects of the Invention As described above, the present invention provides a medical substance transfer device in which a continuous annular convex portion and an outer circumferential portion of the continuous annular convex portion are arranged at a certain interval on the peripheral edge of the flow path forming member at the end. Annular comb-tooth-like protrusions protruding in the axial direction of the cylindrical housing are integrally formed, and a filler is filled in the space formed by these continuous annular protrusions, the annular comb-tooth-like protrusions, and the partition wall. Since the channel-forming member is fixed to the partition wall by filling, the contact area between the filler and the channel-forming member is large, and the slit portion formed by the comb teeth is formed by the filler. Due to the resistance, the resistance to the rotational torque of the screw ring or the like becomes extremely large, so that there is no fear that the flow path forming member will peel off, and a highly reliable seal can be obtained. In addition, since the outer projection is comb-shaped, it is extremely easy to enter the filler into the space between the continuous annular projection and the comb-shaped projection inside the slit, and to remove air from this space. becomes.

Further, if the height of the continuous annular projection is made to protrude higher than the height of the annular comb-like projection, an excellent sealing effect can be obtained without using an O-ring or the like. This is particularly effective in the case of members that are easily bonded and easily deformed and are therefore unsuitable for use with O-rings, or members that are difficult to fuse together. Further, by flattening the tip of the annular comb-like convex portion, the area of resistance to rotational torque can be increased, so that an excellent sealing effect can be obtained. Furthermore, by making the filler the same material as the potting agent used to form the partition walls, the adhesion to the partition walls is improved and an excellent sealing effect can be obtained. Furthermore, if the surface of the partition wall is smooth and does not deform, or if the surface is a member with poor adhesion, O
The use of rings provides a reliable seal.

[Brief explanation of the drawing]

FIG. 1 is a partial cross-sectional view showing an embodiment of a medical substance transfer device according to the present invention, FIG. 2 is a partial cross-sectional view showing an example of a fluid distribution member constituting a flow path forming member used in the device of the present invention, FIG. 3 is an enlarged sectional view showing an example of the sealed state, and FIG. 4 is an enlarged partial sectional view showing another example of the sealed state. 1... Housing, 2... Cylindrical body, 3, 4...
... Mounting cover, 5 ... Hollow fiber membrane, 6, 7 ... Partition wall, 8 ... First mass transfer chamber, 9 ... First mass transfer fluid inlet, 10 ... First mass transfer fluid Outlet, 11, 12...Liquid flow path forming member, 14...
...Annular comb tooth-like protrusion, 16...O ring, 1
7, 18... Fluid distribution member, 19, 20... Screw ring, 21, 22... Continuous annular protrusion, 23...
Inflow chamber, 24...Outflow chamber, 25...Liquid inlet, 2
6...Liquid outlet, 27, 28...Slit part, 2
9, 30, 39... hole, 31, 32... filler,
35, 36... protrusion.

Claims (1)

[Claims for Utility Model Registration] (1) A cylindrical housing, a hollow fiber bundle consisting of a large number of hollow fiber membranes for mass transfer inserted into the housing, an outer surface of the hollow fiber membranes, and an inner surface of the housing. a first mass transfer chamber formed by;
a first mass transfer fluid inlet and outlet communicating with the first mass transfer chamber; a partition wall that respectively supports each end of the hollow fiber membrane and isolates it from the mass transfer chamber; a second mass transfer fluid opening communicating with the internal space of the hollow fiber membrane formed by a flow path forming member having an annular convex portion attached to at least one end; In a medical substance transfer device that is pressed by a threaded ring provided on the outside and the threaded ring is screwed onto the housing, a certain interval is set on the outer peripheral edge of the continuous annular convex part of the flow path forming member. annularly arranged comb-like protrusions protruding in the axial direction of the cylindrical housing; A medical substance transfer device, wherein the flow path forming member is fixed to the partition wall by filling and sealing at least one of the at least two holes with a filler. (2) The medical substance transfer device according to claim 1, wherein the height of the continuous annular protrusion protrudes higher than the height of the annular comb-like protrusion. (3) The medical substance transfer device according to claim 1 or 2, wherein the tip of the annular comb-like convex portion is flat. (4) The medical substance transfer device according to any one of claims 1 to 3, wherein the filler is made of the same material as the potting agent used to form the partition wall.