JPH11394A - Hollow yarn film type dialytic filter and dialytic filtration device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a dialytic filter such that pressure loss in one liquid passage of a hollow yarn film type blood-dialzing filter or pressure pressure loss can be regularted during dialytic filtration. SOLUTION: In a dialytic filter 21 which has a cylindrical housing 105 including a bundle of hollow yarn films 106 and in which a flow passage letting flow humor and a flow passage letting flow dialysis liquid are formed with the hollow yarn films 106 between them, the cross-sectional area of the flow passage allowing the flow of dialysis fluid or the like and formed by a gap between the bundle of hollow yarn films 106 and the inner surface of the cylindrical housing 105 after insertion of the bundle of hollow yarn films 106 into the housing 105 is varied and adjusted by a variable-displacement adjustment chamber 107 or deformable adjusting part during the execution of dialytic filtration.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hollow fiber membrane type diafiltration filter used in the treatment of body fluid such as hemodialysis or hemodiafiltration used for the treatment of chronic renal failure or the like, and diafiltration used together with a diafiltration filter. It concerns the device.

[0002]

2. Description of the Related Art On-line hemodiafiltration and push / pull hemodiafiltration are known as large volume fluid replacement therapy using a dialysate as a replacement fluid. However, the on-line hemodiafiltration method requires a special device for extracting a part of the dialysate from the dialysate circuit and supplying it to the extracorporeal blood circulation circuit, and the push / pull hemodiafiltration method requires a special device. In order to periodically change the direction of ultrafiltration between the dialysate and the dialysate, a pump capable of rotating forward / reverse in the dialysate circuit is branched into a dialysate supply / recovery line having a dialysate reservoir. Must be provided. Therefore, in any case, it is necessary to separately add a dedicated device, and there is a disadvantage that the circuit configuration becomes complicated.

[0003] On the other hand, hemodiafiltration therapy in which a large amount of liquid is replaced by using back filtration in a diafiltration filter by increasing the pressure loss of blood or dialysate or both,
Semi-nephron hemodiafiltration filter (Takeshi Shibata et al .: Examination of β2-MG removal using Dialyzer back filtration-Semi-nephron HDF-.
Kidney and dialysis 36 separate volume high performance membrane '94: 17,1994) and pl
ug dialyzer (Noriyuki Hosoya et al .: Development of dialyzer capable of replacing large volumes of liquid.
Kidney and Dialysis 38 Separate Volume High Performance Membrane '95: 94, 1995) is known.

[0004] The present inventors previously inserted a stenosis-forming member having swelling properties between the outer periphery of the bundle of hollow fiber membranes and the inner wall of the housing, thereby forming a middle portion of the dialysate flow path. A diafiltration device has been proposed in which a stenotic portion is provided to increase the pressure loss in the flow path and the diafiltration efficiency is dramatically improved (Japanese Patent Application Laid-Open No. 8-192031). However, the hemodiafiltration device to which the above-mentioned reverse filtration is applied has a drawback that the replacement fluid amount cannot be freely adjusted during the hemodiafiltration therapy.

[0005]

SUMMARY OF THE INVENTION The present invention relates to a hemodiafiltration apparatus in which a large amount of liquid is exchanged by using back filtration in a diafiltration apparatus. It is to provide a hemodiafiltration filter that can be used.

Further, the present invention is directed to a hemodiafiltration apparatus in which a large amount of liquid is exchanged by utilizing back filtration in a hemodiafiltration apparatus, wherein the amount of the substitution liquid can be appropriately adjusted during hemodiafiltration therapy. It is to provide a filter.

[0007]

The present invention solves the above-mentioned problems by adopting the following constitution.

That is, the present invention provides a bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and the first flow path. A second flow path formed by the hollow fiber membrane lumen, between a bodily fluid flowing through one of the two flow paths and a dialysate flowing through the other of the two flow paths; Diafiltration and ultrafiltration by using at least one control chamber formed between the housing and the hollow fiber membrane and capable of changing the volume.

Further, the present invention is characterized in that a plurality of the adjusting chambers are provided.

Further, the present invention is characterized in that at least a part of the adjustment chamber is made of a resin sheet.

Further, the present invention is characterized in that at least a part of the adjustment chamber is made of an elastomer sheet.

Further, the present invention is characterized in that it has a control fluid inlet / outlet for allowing gas and liquid to flow into and out of the control chamber.

Further, the present invention is characterized in that the ultrafiltration speed across the hollow fiber membrane is adjusted by changing the volume of the control chamber.

Further, the present invention is characterized in that dialysate flows through the first flow path and blood flows through the second flow path.

The present invention further provides a bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and A second flow path formed by the hollow fiber membrane lumen, between a bodily fluid flowing through one of the two flow paths and a dialysate flowing through the other of the two flow paths; Diafiltration and ultrafiltration by using at least a part of the housing is a deformable adjusting portion.

Further, the present invention is characterized in that the adjusting section is made of a soft synthetic resin.

Further, the present invention is characterized in that the soft synthetic resin is an elastomer.

Further, the present invention is characterized in that the ultrafiltration speed across the hollow fiber membrane is adjusted by deforming the adjusting section.

Further, the present invention is characterized in that dialysate flows through the first flow path and blood flows through the second flow path.

Further, the present invention is characterized in that the adjusting portion has a portion formed on the entire circumference in a direction perpendicular to the flow direction of the fluid in the housing.

The present invention also provides a bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and A second flow path formed by the hollow fiber membrane lumen, between a bodily fluid flowing through one of the two flow paths and a dialysate flowing through the other of the two flow paths; Diafiltration and ultrafiltration, and a diafiltration apparatus used with a diafiltration device having an adjustable region in which a cross-sectional area of at least a part of the first flow path can be changed, wherein an inlet of the first flow path Detecting means for obtaining at least one of information on the side and the outlet side, and information on the inlet side and the outlet side of the second flow path, and the flow path of the first flow path based on a signal from the detecting means It is characterized by having the adjusting means for adjusting the cross-sectional area.

Further, the present invention is characterized in that the information obtained by the detecting means is the pressure on the inlet side and the outlet side of the first flow path.

Further, the present invention is characterized in that the information acquired by the detecting means is the pressure on the inlet side and the outlet side of the first and second flow paths.

Further, the present invention is characterized in that the information obtained by the detecting means is an indicator substance concentration on the outlet side of the first or second flow path through which a bodily fluid flows.

Further, the present invention is characterized in that the information obtained by the detecting means is an indicator substance concentration on the inlet side of the first or second flow path through which a bodily fluid flows.

Further, the present invention is characterized in that the information obtained by the detecting means is an indicator substance concentration on an outlet side of a flow path of the first or second flow path through which a dialysate flows.

Further, the present invention is characterized in that the information obtained by the detecting means is an indicator substance concentration on the inlet side of the first or second flow path through which the dialysate flows.

Further, the present invention is characterized in that the information acquired by the detecting means is an indicator substance concentration on an inlet side and an outlet side of a flow path of a body fluid in the first or second flow path. I do.

Further, the present invention is characterized in that the information obtained by the detecting means is an indicator substance concentration on an inlet side and an outlet side of a flow path of the first or second flow path through which a dialysate flows. And

Further, the present invention is characterized in that the information obtained by the detection means is the indicator substance concentration on the inlet side and the outlet side of the first and second flow paths.

Further, the indicator substance is any one of urea, creatinine and endotoxin.

The body fluid referred to in the present invention mainly refers to blood, but may be plasma, ascites, or a peritoneal dialysis solution containing a biological component injected into the peritoneal cavity.

The control chamber whose volume can be changed in the present invention refers to a portion whose volume can be changed by external control, and the simplest method is formed by an annular rubber material tubular body such as a tire tube. It is achieved by sending and discharging water from the outside. However, the present invention is not limited to this, and may be formed by an inner surface of a rigid housing and a deformable material fixed to the inner surface. The material of the deformable portion that enables the volume change of the control chamber may be anything as long as it is thin and airtight and liquid tight.
For example, polyester, regenerated cellulose, cellulose acetate, polyamide, vinylidene, acrylic, polyurethane, polyvinyl chloride, polyethylene, polypropylene,
Examples include polyethylene terephthalate and silicone. Elastomers such as polyurethane, polyolefin and silicone may be used.

The volume change of the control chamber is adjusted by injecting and discharging a gas or a liquid from a control fluid outlet port that connects the control chamber to the outside of the housing, thereby forming the hollow fiber bundle on the inner surface of the housing. Adjust the gap in the flow path. As the gas to be injected, any gas may be used as long as it has no danger, such as air, nitrogen, and carbon dioxide. The liquid to be injected may be any liquid such as water, an aqueous solution of an electrolyte such as physiological saline, a high-viscosity polymer solution, or oil, as long as it has no danger and does not corrode the housing and the control chamber member.

The control chamber may be one or more in one diafiltration filter, the control fluid outflow or inlet may be one or more, and the control chamber may be formed between the bundle of hollow fiber membranes and the inner surface of the housing. A plurality of control chambers may be provided so that the width of the region for adjusting the gap to be adjusted can be freely adjusted, or the control chamber is divided into a plurality of sections, and a control fluid outflow port is provided for each of the divided sections. You may.

The adjustment of the volume change of the control chamber is not limited to the above, but a gas or liquid may be sealed in the control chamber in advance, and the volume may be changed by heating and cooling from outside the housing. Alternatively, a mechanism that expands and contracts in response to a magnetic force may be provided in the adjustment chamber in advance, and a magnetic field may be applied from outside the housing.

The adjusting portion provided on the housing may be any one which can be deformed by a physical action from the outside of the housing, and may be polypropylene, polyethylene, polyethylene terephthalate, silicone, polyurethane, polyvinyl chloride, styrene butadiene block copolymer. Resins. Elastomers such as polyurethane, polyolefin and silicone are preferred.

The adjusting section of the housing may be provided at a plurality of positions in the middle of the hollow fiber membrane, or may be provided over substantially the entire length of the hollow fiber membrane. In the housing, it may be provided over the entire circumference in the middle of the hollow fiber membrane, or may be provided partially or plurally around the circumference. Preferably, it is provided over the entire circumference at a length of 10 to 75%, more preferably 15 to 50% of the effective length of the hollow fiber membrane.

As the adjusting means used together with the diafiltration filter having the adjusting chamber, when a liquid or gas is used for adjustment, a fluid pump for injecting into or discharging from the adjusting chamber is used. Inject liquid or gas,
It is not limited to this as long as it can be discharged.
When heat or a magnetic field is used for adjustment, a heat exchange device, a magnet coil, or the like can be used.

As the adjusting means used together with the diafiltration filter having the adjusting section, the mechanism of the adjusting chamber can be used, and other mechanisms for deforming the adjusting section of the housing can be used. In this case, it is preferable to have a deformation mechanism mounting portion for mounting a mechanism for deforming the adjusting portion to a portion other than the adjusting portion of the housing.

The information detected by the detection section includes pressure, indicator substance concentration, and the like. In the case of pressure, the pressure loss in the first flow path obtained by subtracting the outlet pressure from the inlet pressure in the first flow path, the second pressure, and the like. Pressure loss in the second channel obtained by subtracting the outlet pressure from the inlet pressure of the channel,
The inlet pressure or the outlet pressure of the corresponding second flow path is obtained by subtracting the inlet pressure or the outlet pressure of the corresponding second flow path from the inlet pressure of the corresponding flow path or the outlet pressure of the corresponding first flow path. There is a specific value obtained by subtracting the outlet differential pressure or a combination thereof. Substituting the above specific values into the relational expression between the pressure difference across the hollow fiber membrane of the diafiltration filter and the mass transfer amount of the indicator substance calculated in advance, calculating the replacement liquid amount and the indicator substance removal amount, separately The adjusting means may be operated in comparison with a set target value.

When the information detected by the detecting section is the concentration of the indicator substance, the information is compared with a target value of the indicator substance concentration set separately, and the adjusting means is operated to determine the sectional area of the first flow path. It may be changed. Regarding the indicator substance concentration, the first
A value calculated by combining the concentrations at the four locations on the outlet side and the inlet side of the second flow path as needed can be used.

[0043]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a hollow fiber membrane type hemodialyzer according to the present invention will be described with reference to the drawings.

FIG. 1 is a schematic diagram of a hollow fiber membrane type hemodiafiltration device of the present invention and a blood circulation circuit using a diafiltration device.

One end 10 of the arterial circuit 8 a is connected to a blood vessel of a patient, and the other end is connected to the inlet of one flow path of the diafiltration filter 2. One end 11 of the vein-side circuit 8b is connected to a blood vessel of a patient, and the other end is connected to an outlet of a flow path connected to the arterial circuit 8a of the diafiltration filter 2. A blood pump 7 is disposed in the arterial circuit 8a, and blood is sent to the diafiltration filter 2 through the arterial circuit by the blood pump 7, and the blood purified by the blood purification action of the diafiltration device is supplied to the venous side. It is returned to the patient through the circuit. Inside the diafiltration filter 2, there is a hollow fiber membrane, another flow path separated by the hollow fiber membrane is formed, and the dialysis fluid circuits 9a and 9b are connected and connected. A dialysate control device 5 is arranged in the dialysate circuits 9a and 9b. The dialysate control device 5 includes a dialysate circuit 9a,
The flow rate of the dialysate flowing through the dialysis filter 9b can be controlled to set the amount of liquid to be sent to the diafiltration filter 2 and the amount of discharge. Arterial circuit 8
a, sensors 6a, 6b, 6c for obtaining information on the fluid in the circuits are provided in the vein side circuit 8b and the dialysate circuits 9a, 9b.
6d is installed, and the signal of each sensor is transmitted to the detecting means 4. The result collected by the detecting means 4 and compared with other set values is transmitted to the adjusting means 3, which adjusts the first formed by the inner wall of the housing of the diafiltration filter 2 and the outer surface of the hollow fiber membrane. The cross-sectional area of the flow path can be changed.

FIGS. 2 and 3 are a longitudinal section (FIG. 2) showing one embodiment of the diafiltration filter of the present invention and a transverse section (FIG. 3) of a control chamber portion. In the diafiltration filter 2, a hollow fiber membrane 106 is filled in a housing 105, and both ends of the hollow fiber membrane 106 are separated by partition walls 104a and 104b.
5 is fixed. Since the partition wall 104 is filled in a liquid-tight manner between the outer surface at the end of the hollow fiber membrane 106 and the inner wall at the end of the housing 105, the inner wall of the housing 105 and the inner wall of the hollow fiber membrane 106 sandwich the hollow fiber membrane 106. It is partitioned into a first channel 109 formed on the outside and a second channel 110 formed by the lumen of the hollow fiber membrane 106.

A control chamber 107 is formed in the first flow path 109 by a control chamber wall 111. The control chamber 107 communicates with the outside through a control fluid outlet 108. The control fluid outflow / inlet port 108 communicates with the control means 3, and the control means 3 controls a change in the volume of the control chamber 107.

The first flow path 109 has a liquid outlet 103
a and 103b are provided near the ends of the bundle of hollow fiber membranes. The second flow path 110 formed by the lumen of the hollow fiber membrane 106 opens outside the partition walls 104a and 104b, and the openings are provided with headers 102a and 102b, respectively.
The header is provided with liquid outlets 101a and 101b.

FIGS. 4 and 5 correspond to FIGS. 2 and 3, respectively. In order to increase the pressure loss in the first flow path, a liquid or gas is introduced into the control chamber 207 and the volume of the control chamber 207 is increased. And the flow path cross-sectional area at the center of the housing is reduced. By increasing or decreasing the amount of liquid or gas in the control chamber 207, the pressure loss in the first flow path increases.

By setting the pressure loss to an appropriate value, the pressure on the inlet side of the first flow path becomes higher than the pressure on the corresponding second flow path, and the pressure from the first flow path to the second flow path is increased. The liquid moves, and the pressure at the outlet side of the first flow path becomes lower than the pressure of the corresponding second flow path, and the liquid moves from the second flow path to the first flow path. .

The diafiltration device of the present invention moves a liquid between a body fluid and a dialysate in this manner, so that a large amount of fluid can be replaced by a simple mechanism, and thus unnecessary substances contained in the body fluid can be replaced. Can be efficiently removed. Further, the diafiltration device of the present invention can easily adjust the pressure loss of the first flow path, so that the amount of the replacement liquid can be appropriately adjusted.

FIG. 6 shows another embodiment of the present invention. The control chamber 307 is provided with the liquid outlets 103a, 103 of the first flow path.
It is provided in almost the entire area between b. Thereby, the first
Since the entire pressure loss can be increased in a wide area of the flow path 309, no external force is applied to only some of the hollow fiber membranes. Therefore, the load on the hollow fiber membrane can be reduced.

FIG. 7 shows another embodiment of the present invention. First
Three control chambers 407a, 407b, 4
07c and the corresponding regulating fluid outlet 408
a, 408b and 408c are provided. Thereby, in the first flow path 409, the pressure gradient in the middle of the hollow fiber membrane can be partially adjusted. Therefore, it is possible to adjust the portion where the liquid moves between the first flow path and the second flow path, or to change the width of changing the cross-sectional area of the first flow path. Further, when a certain portion of the hollow fiber membrane is deteriorated due to clogging or the like, it is possible to take measures such as using another portion.

FIG. 8 shows another embodiment of the diafiltration filter according to the present invention. The housings 505a and 505b are made of hard plastic, and the middle part is a deformable adjusting part 51.
2. The adjustment part 512 of the diafiltration filter 25 is provided over the entire circumference in the middle of the hollow fiber membrane. Housing 50
Both ends of 5a, 505b and the adjusting part 512 are joined in a liquid-tight manner. The control chamber 512 is provided with the liquid outlet 103
It may be provided in almost the entire area between the points a and 103b.

FIG. 9 shows a state in which the diafiltration device 25 is adjusted to the jig fixture 6.
16 shows a state in which the cross-sectional area of a part of the first flow path 609 is reduced by the adjusting part deforming means 613 provided on the mounting jig fixture 616 when the mounting member 16 is mounted. The adjusting part deforming means 613 has a fluid chamber 614 and further has a connection port 61.
5 are provided. By injecting or discharging gas or liquid from the connection port 615, the volume of the fluid chamber 614 changes. Therefore, the adjusting section deforming means exhibits the same operation as the adjusting chamber when combined with the adjusting section and the adjusting jig fixture, so that the same control method as that of the adjusting chamber can be adopted. Further, as a material of the adjusting portion deforming means 613, a material that can be used as a material of the adjusting chamber 107 can be used.

FIG. 10 shows another method of deforming the adjusting section. The adjustment jig fixture 720 is fixed to the housing at a portion not shown. Adjusting jig fixture 7
Reference numeral 20 denotes a deforming pusher 721 as an adjusting unit deforming means.
a, 721b, 721c, and 721d, which move back and forth, press the adjustment unit 712, and adjust the cross-sectional area of the first flow path 709.

The adjusting means of the diafiltration apparatus used together with the diafiltration apparatus having the adjusting section of the present invention includes a modified jig fixture,
An adjusting part deforming means is included. The deformed jig fixture and the adjusting unit deforming means are not limited to those described above. Further, the adjusting means is not limited to the above-described example.

In the case of hemodiafiltration, a dialysate is usually passed through the first channel and blood is passed through the second channel. However, blood is allowed to flow through the first flow path,
This does not exclude the flow of the dialysate through the flow path. In addition, high liquid replacement can be achieved even if plasma after plasma separation or peritoneal dialysis solution is treated.

[0059]

EXAMPLE 1 A bundle of about 10,000 polysulfone hollow fiber membranes (effective membrane area 1.5 m ² ) having an outer diameter of 280 μm and an inner diameter of 200 μm was placed in a polycarbonate housing (effective length 23.5 cm, inner diameter 3.45 cm). ). A cylindrical bag-shaped control chamber made of polyethylene as shown in FIGS. 2 and 3 is fixed to the inner surface of the housing, and a control fluid outlet, a dialysate inlet, and a dialysate outlet are provided outside the housing.

Next, a polyurethane potting agent was injected into both ends of each hollow fiber membrane inserted into the cylindrical housing,
After curing, the partition walls were formed, the hollow fiber membranes were fixed, and both ends were sliced to open the lumen of each hollow fiber membrane. Headers were fixed to both ends of the cylindrical housing in a liquid-tight manner by fusion to obtain a diafiltration filter.

99.9995 purity from the control fluid outlet
% Or more of nitrogen was injected, the gap between the inner surface of the housing and the hollow fiber membrane bundle was narrowed, and the cross-sectional area of the flow path was reduced.

[0062]

Example 2 A bundle of the same polysulfone hollow fiber membrane as in Example 1 was placed in a polypropylene housing (diameter: 23.5 cm, inner diameter: 3.35 cm) with a dialysate inlet and dialysate outlet.
45 cm).

Next, a polyurethane potting agent is injected into both ends of each hollow fiber membrane inserted into the cylindrical housing, and cured to form a partition wall to fix each hollow fiber membrane. The fibrous membrane was opened. Headers were fixed to both ends of the cylindrical housing in a liquid-tight manner by fusion to obtain a diafiltration filter.

[0064]

Embodiment 3 A polyurethane housing inlet side member (effective length 10 cm, inner diameter 3.45 cm) and a polyurethane housing outlet side member (effective length 10 cm, inner diameter 3.45 c)
m) at one end of each polyurethane elastomer tube (inner diameter 3.45 cm, thickness 0.3 mm, housing spacing 3.5 cm, overlap with housing member 6 m)
m) was placed over the housing at both ends of the tube, and the overlapping portion was adhesively fixed. Furthermore, the whole was fixed with a cylindrical fixing tool having an internal shape substantially similar to the outer shape of the housing after the adhesive fixation.

The same bundle of polysulfone hollow fiber membranes as in Example 1 was inserted into the housing with the cylindrical fixture prepared above.

Next, a polyurethane potting agent is injected into both ends of each hollow fiber membrane inserted into the housing with the cylindrical fixing tool, and cured to form a partition wall to fix each hollow fiber membrane.
Both ends were sliced to open each hollow fiber membrane. Headers are fused to both ends of the housing, respectively.
It was fixed in a liquid-tight manner to obtain a diafiltration filter.

[0067]

Embodiment 4 A polyurethane housing inlet side member (effective length 10 cm, inner diameter 3.45 cm) and a polyurethane housing outlet side member (effective length 10 cm, inner diameter 3.45 c)
m) was fixed as a whole with a cylindrical fixture at an interval of 3.5 cm.

The same bundle of polysulfone hollow fiber membranes as in Example 1 was inserted into the housing with the cylindrical fixture prepared above.

Next, a polyurethane potting agent was injected into both ends of each hollow fiber membrane inserted into the housing with the cylindrical fixture, and was cured to form a partition, thereby fixing each hollow fiber membrane.
Both ends were sliced to open each hollow fiber membrane. The cylindrical fixed shaft was removed from the housing, and a polyurethane potting agent was injected into a gap of 3.5 cm between the housings and cured. Headers were fixed to both ends of the cylindrical housing in a liquid-tight manner by fusion to obtain a diafiltration filter.

[0070]

Comparative Example 1 A stenosis forming material 4 made of sodium acrylate fiber was added to a bundle of polysulfone hollow fiber membranes as in Example 1.
g was wound with a width (4 cm). This bundle of hollow fiber membranes is placed in a polycarbonate housing with a dialysate inlet and a dialysate outlet (effective length 23.5 cm, inner diameter 3.45 c).
m).

Next, a polyurethane potting agent is injected into both ends of each hollow fiber membrane inserted into the cylindrical housing, and cured to form a partition wall to fix each hollow fiber membrane. The fibrous membrane was opened. Headers were fixed to both ends of the cylindrical housing in a liquid-tight manner by fusion to obtain a diafiltration filter.

[0072]

Test Example 1 Each of the diafiltration filters of Examples 1 to 3 and Comparative Example 1 was supplied with a blood-side flow rate, a dialysate-side flow rate, and a filtration flow rate of 2 respectively.
The dialysate was flowed at 00, 500, and 15 ml / min. The dialysate pressure loss at that time was measured. Further, in Example 1, the dialysate-side flow path was narrowed, and in Examples 2 to 4, the variable range of the dialysate-side pressure loss was measured by deforming using the adjusting unit deforming means shown in FIG.

Table 1 shows the results. In comparison with Test Example 1, Examples 1-4 can vary the pressure loss on the dialysate side over a wide range,
During the diafiltration, the replacement liquid volume could be changed freely.

[0074]

[Table 1]

[0075]

As described above, the diafiltration filter of the present invention has a bundle of hollow fiber membranes in a housing and a space between the inner wall of the housing and the outer surface of the hollow fiber membranes separated by the hollow fiber membranes. A body fluid that has a first channel formed and a second channel formed by the hollow fiber membrane lumen, and a body fluid flowing through one of the two channels, and the other of the two channels; A dialysis filter for performing dialysis and ultrafiltration with a dialysate flowing through the flow path of (a), and having at least one control chamber formed between the housing and the hollow fiber membrane and capable of changing the volume. Thus, a pressure difference is generated between the upstream side and the downstream side of the first flow path, so that the amount of the replacement liquid can be freely adjusted during the diafiltration. Further, in the present invention, since a plurality of the control chambers are provided,
The width of changing the cross-sectional area of the first flow path can be changed.

Further, in the present invention, since at least a part of the control chamber is formed of a resin sheet, it can be controlled by the pressure of gas, liquid or the like.

Further, in the present invention, since at least a part of the adjustment chamber is made of an elastomer sheet, a simple adjustment mechanism can be used.

In the present invention, since the dialysate flows through the first flow path and the blood flows through the second flow path, damage to blood cell components can be reduced.

The present invention further provides a bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and the first flow path. A second flow path formed by the hollow fiber membrane lumen, between a bodily fluid flowing through one of the two flow paths and a dialysate flowing through the other of the two flow paths; Diafiltration and ultrafiltration in a diafiltration device, wherein at least a part of the housing is a deformable adjusting portion, so that the structure of the diafiltration device is simple and the amount of the replacement liquid during the diafiltration is increased. Can be adjusted freely. Further, in the present invention, since the adjusting section is made of a soft synthetic resin, it can be controlled by the pressure of gas, liquid, or the like.

In the present invention, since the soft synthetic resin is an elastomer, a simple adjusting mechanism can be used.

Further, the present invention is characterized in that the ultrafiltration speed across the hollow fiber membrane is adjusted by deforming the adjusting section.

In the present invention, since the dialysate flows through the first flow path and the blood flows through the second flow path, damage to blood cell components can be reduced.

Further, according to the present invention, since the adjusting portion has a portion formed on the entire periphery in the middle of the housing in the flow direction of the fluid, uniform constriction from the entire periphery can be achieved.

The present invention also relates to a bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and the first flow path. A second flow path formed by the hollow fiber membrane lumen, between a bodily fluid flowing through one of the two flow paths and a dialysate flowing through the other of the two flow paths; Diafiltration and ultrafiltration, and a diafiltration apparatus used with a diafiltration device having an adjustable region in which a cross-sectional area of at least a part of the first flow path can be changed, wherein an inlet of the first flow path Detecting means for obtaining at least one of information on the side and the outlet side, and information on the inlet side and the outlet side of the second flow path, and the flow path of the first flow path based on a signal from the detecting means Since it has the adjusting means for adjusting the cross-sectional area, a pressure difference is generated between the upstream side and the downstream side of the first flow path, and the dialysis filter is formed. It is possible to freely adjust the substitution fluid amount in force. Further, according to the present invention, since the information acquired by the detecting means is the pressure on the inlet side and the outlet side of the first flow path, the adjusting means can be controlled by the pressure loss of the first flow path.

Further, according to the present invention, since the information obtained by the detecting means is the pressures on the inlet and outlet sides of the first and second flow paths, the pressure loss in the first flow path, The adjusting means can be controlled by any of the pressure loss of the flow path and the differential pressure between the first flow path and the second flow path.

Further, according to the present invention, since the information acquired by the detecting means is the concentration of the indicator substance at the outlet side of the flow path of the first or second flow path through which the bodily fluid flows, The adjusting means can be controlled by the indicator substance concentration state.

Further, according to the present invention, since the information obtained by the detecting means is the indicator substance concentration on the inlet side of the first or second flow path through which the bodily fluid flows, the information can be obtained in the patient's body. The adjusting means can be controlled by the indicator substance concentration state.

Further, according to the present invention, since the information obtained by the detection means is the indicator substance concentration at the outlet side of the flow path of the dialysate in the first or second flow path, The adjusting means can be controlled by the indicator substance concentration state of the dialysate.

Further, according to the present invention, since the information acquired by the detecting means is the indicator substance concentration on the inlet side and the outlet side of the first or second flow path through which the bodily fluid flows.
The adjusting means can be controlled by the liquid replacement performance of the diafiltration device.

Further, according to the present invention, since the information acquired by the detecting means is the indicator substance concentration on the inlet side and the outlet side of the flow path through which the dialysate flows in the first or second flow path, The adjusting means can be controlled by the liquid replacement performance of the filter.

Further, according to the present invention, since the information obtained by the detecting means is the indicator substance concentration on the inlet side and the outlet side of the first and second flow paths, the information is adjusted by the liquid replacement performance of the diafiltration filter. The means can be controlled.

Further, since the indicator substance is any one of urea, creatinine and endotoxin, the progress of the diafiltration can be grasped from the concentrations of urea and creatinine. Further, when the concentration of endotoxin in the dialysate increases, the cross-sectional area of the first flow path can be increased, the pressure loss in the first flow path can be reduced, and liquid replacement can be suppressed.

[Brief description of the drawings]

FIG. 1 is a schematic diagram of an example of a blood circulation circuit using a diafiltration filter and a diafiltration device according to the present invention.

FIG. 2 is a schematic view of a longitudinal section of an example of a diafiltration filter having a control chamber according to the present invention.

FIG. 3 is a schematic cross-sectional view of a control chamber portion of an example of a diafiltration filter having a control chamber according to the present invention.

4 is a schematic view of a longitudinal section when the volume of the control chamber of the diafiltration filter of FIG. 2 according to the present invention is increased.

FIG. 5 is a schematic cross-sectional view of a control chamber portion of the dialysis filter of FIG. 2 according to the present invention when the control chamber volume is increased.

FIG. 6 is a schematic longitudinal sectional view of an example of another diafiltration filter having a control chamber according to the present invention.

FIG. 7 is a schematic view of a vertical section of an example of another diafiltration filter having a control chamber according to the present invention.

FIG. 8 is a schematic view of a vertical section of an example of a diafiltration filter having a control unit according to the present invention.

FIG. 9 is a schematic view of a longitudinal section when the flow path cross-sectional area of the dialysis filter of FIG. 6 according to the present invention is reduced.

FIG. 10 is a schematic cross-sectional view showing an example of a means for reducing a flow path cross-sectional area of a diafiltration filter having a control unit according to the present invention.

[Explanation of symbols]

2 ... hollow fiber membrane type hemodiafiltration filter 3 ... adjusting means 4 ... detecting means 5 ... dialysate control device 6a, 6b, 6c, 6d ... sensor 7 ··· Blood pump 8a ··· Artery side circuit 8b ··· Vein side circuit 9a, 9b ··· Dialysate circuit 21, 22, 23, 24, 25, 26 ··· Diafiltration filter 101a .., 101b... Liquid outlets 102a, 102b... Header 103a, 103b... Liquid outlets 104a, 104b... Partition walls 105, 405, 505a, 505b. , 706... Hollow fiber membranes 107, 207, 307, 407a, 407b, 407
c ··· Control chamber 108, 408a, 408b, 408c ··· Control fluid outflow / inlet 109, 209, 309, 409, 509, 609, 7
09 first passage 110, 410, 510 second passage 111, 211, 311, 411a, 411b, 411
c adjustment chamber member 512, 612, 712 adjustment section 613 adjustment section deforming means 614 fluid chamber 615 connection port 616, 720 adjustment Jig fixing tool 720a, 720b, 720c720d ... Deformer presser

Claims (3)

[Claims] 1. A bundle of hollow fiber membranes in a housing, a first flow path separated by the hollow fiber membranes and formed between an inner wall of the housing and an outer surface of the hollow fiber membranes, and inside the hollow fiber membranes. Having a second flow path formed by a cavity, dialysing and limiting between body fluid flowing through one of the two flow paths and dialysate flowing through the other of the two flow paths; A diafiltration filter for performing external filtration, characterized by having at least one volume-changeable control chamber formed between the inner wall of the housing and the bundle of the hollow fiber membranes. 2. A bundle of hollow fiber membranes in a housing, a first flow path formed between the inner wall of the housing and the outer surface of the hollow fiber membrane, separated by the hollow fiber membranes, and the inside of the hollow fiber membranes. Having a second flow path formed by a cavity, dialysing and limiting between body fluid flowing through one of the two flow paths and dialysate flowing through the other of the two flow paths; A hollow fiber membrane type diafiltration filter for performing external filtration, wherein at least a part of the housing is a deformable adjusting portion. 3. A bundle of hollow fiber membranes in a housing, a first flow path separated by the hollow fiber membranes and formed between the inner wall of the housing and the outer surface of the hollow fiber membranes, and the inside of the hollow fiber membranes. Having a second flow path formed by a cavity, dialysing and limiting between body fluid flowing through one of the two flow paths and dialysate flowing through the other of the two flow paths; A diafiltration device for performing external filtration, which is used together with a diafiltration device having a control region in which a cross-sectional area of at least a part of the first flow path can be changed,
The detecting means for acquiring at least one of the information on the inlet side and the outlet side of the first flow path, and the information on the inlet side and the outlet side of the second flow path; A diafiltration apparatus comprising the adjusting means for adjusting the cross-sectional area of the first flow path.