WO2006070890A1 - Hollow fibter type apparatus for blood purification - Google Patents

Abstract

An apparatus for blood purification provided with a packet of hollow fiber membranes in a case which achieves a high dialysis efficiency due to a decrease in the sectional area of a dialysis fluid channel and exhibits a favorable production performance without resorting to any additional parts. This apparatus for blood purification is characterized by: a blood channel being formed in the inner cavity of a hollow fiber membrane while a dialysis fluid channel being formed in the space between hollow fiber membranes, the case being composed of a case body and case ends, and the ratio (a/D) of the inner diameter (a) of the external end part of the above-described case end to the inner diameter (D) of the above-described case body being a/D=1.25 to 1.80.

Description

 Specification

 Hollow fiber blood purifier

 Technical field

 TECHNICAL FIELD [0001] The present invention relates to a blood purifier used in dialysis treatment, and more particularly to a hollow fiber blood purifier with an increased amount of internal filtration and internal reverse filtration in the blood purifier.

 Background art

 [0002] In recent years, an internal filtration promoting type that increases dialysis efficiency by increasing filtration (internal filtration) and reverse filtration (internal reverse filtration) that occur between the blood side and the dialysate side through a semipermeable membrane. The development of blood purifiers is progressing.

 [0003] In powerful development, the amount of internal filtration and internal backfiltration in the blood purifier can be increased by increasing the pressure loss in the blood flow path or dialysate flow path, and the efficiency of Can be further increased. Here, Hagen-Posuille equation, which is a pressure loss derivation formula for laminar flow in a circular pipe

AP = 8 / Z: LQZ R ⁴

 (Δ Ρ: Pressure loss of flow path, μ: Viscosity of fluid, L: Flow path length, R: Flow path radius, Q: Volume flow rate

)

 It can be seen that dialysis efficiency can be increased by increasing the volume flow rate (Q), increasing the channel length L, or decreasing the channel cross-sectional area (π ΐ ^).

[0004] As a blood purification apparatus having a reduced flow path cross-sectional area (π R ² ) in order to increase the dialysis efficiency, it is assumed that the cross-sectional area of the dialysate flow path is reduced, for example, a plurality of hollow fibers A hollow fiber bundle made of a membrane, a blood flow path formed by the hollow fiber membrane lumen, and a dialysate flow path formed by a gap between the inner wall of the case and the hollow fiber membrane and a gap between the hollow fiber membranes. There has been proposed a dialyzer having a substantially cylindrical case and having a cylindrical elastic tube inserted in the gap between the inner wall of the case and the hollow fiber bundle (Patent Document 1).

 Patent Document 1: Japanese Patent Application Laid-Open No. 2004-216143

 Disclosure of the invention

Problems to be solved by the invention [0006] However, since the dialyzer is housed in the case with the hollow fiber membrane bundle inserted inside the elastic tube, the operation of putting the hollow fiber membrane bundle inside the elastic tube, The work efficiency is low because the hollow fiber membrane bundle must be placed in the case so that the tube contacts the case. Furthermore, the dialyzer is inferior in practicality because it requires an additional member other than a commonly used member such as a hollow fiber membrane case called an elastic tube. In other words, a blood purification device is required to have improved practicality by reducing the dialysate flow path cross-sectional area, having good manufacturing workability, and having a simple configuration that does not require any additional members. It is done.

 [0007] That is, an object of the present invention is to provide a blood purifier that has good dialysis efficiency by reducing the cross-sectional area of the dialysate flow path and that has good manufacturing workability without the need for additional members. It is to provide.

 Means for solving the problem

 [0008] Therefore, as a result of intensive studies, the inventors of the present invention have provided a blood purifier having a bundle of hollow fiber membranes in a case, wherein the blood flow path is formed by the lumen of the hollow fiber membrane, A liquid flow path is formed by a gap between the hollow fiber membranes, and the case includes a body portion and a case end body portion, and an outer side of the case end body portion with respect to an inner diameter (D) of the end portion of the body portion. The ratio of the inner diameter (a) of the end (aZD) is aZD = l. The present inventors have found that a blood purification apparatus having a good manufacturing workability is obtained, and the present invention has been achieved.

 [0009] Further, the present invention is preferably the blood purifier, wherein the hollow fiber membrane filling rate at the outer end portion of the case end portion is 35% or less. In the present invention, the blood purifier may be a blood purifier package packaged with the hollow fiber membrane in a dry state.

 The invention's effect

[0010] By using the blood purifier of the present invention, dialysis efficiency is good, and it is necessary to use additional members, and the manufacturing efficiency is good. Furthermore, the blood purifier of the present invention has a sufficient gap between the hollow fiber membranes in the case end portion, so that it is easy to fill the adhesive forming the partition wall, and air is supplied to each individual hollow fiber membrane. Can be exposed to conventional hollow It is easier than a thread type blood purifier. Therefore, the blood purifier can easily dry a liquid such as water and can be suitably used as a dry type blood purifier. Brief Description of Drawings

 FIG. 1 is a schematic perspective view of an embodiment of a blood purifier according to the present invention.

 FIG. 2 is a cross-sectional view taken along the line XX of the main body 2 of the blood purifier shown in FIG.

 Explanation of symbols

 1 Blood purifier

 2 Body

 3, 3 'header

 4, 4 'Connector, Kuta

 31, 31 'Blood outflow inlet

 4, 4 'Connector, Kuta

 41, 41 'Dialysate outlet

 5 cases

 6 Hollow fiber membrane

 7, 7 'Case end

 8 Torso

 9, 9 'wall

 10, 10 'trunk end

 BEST MODE FOR CARRYING OUT THE INVENTION

 Hereinafter, the present invention will be described with reference to the drawings, but the present invention is not limited to these.

 FIG. 1 is a schematic perspective view of an embodiment of the blood purifier of the present invention. The blood purifier 1 includes headers 3 and 3 ′ at both ends of the main body 2 and connectors 4 and 4 ′ near the both ends. The headers 3 and 3 'are provided with blood outlets 31 and 31', respectively. Further, the main body 2 is provided with dialysate outflow ports 41, 41 ′ as openings of the connectors 4, 4 ′.

FIG. 2 is an XX cross-sectional view of the blood purifier body 2 of FIG. Blood purifier 1 The main body 2 includes a bundle of hollow fiber membranes in which a plurality of hollow fiber membranes 6 are bundled inside the case 5. As shown in FIG. 2, the case 5 has a body portion 8 formed between the case end portions 7 and 7 ′ via a wall-like portion 9 and is a substantially cylindrical body. A hollow fiber membrane bundle including a plurality of hollow fiber membranes 6 is densely filled in the body portion 8, and the filling is rough toward the outer end portion A of the case end portion. At the outer end A, the lumen of each hollow fiber membrane is open and forms a blood flow path. In FIG. 1, an inclined portion may be provided between the case end 10 and the case end 7 which is the end of the case 8 located at the center of the case 5. Therefore, the trunk end 10 is a part that can be recognized as a substantial end of the substantially cylindrical trunk.

 [0016] The hollow fiber membrane bundle is fixed to the inside of the case 5 by a potting portion formed by curing the potting agent at the end portions of the case end portions 7 and 7 'having a diameter larger than that of the body portion 8. It is. In addition, a potting agent is injected into the gap between the inner wall of the case 5 and the hollow fiber membrane by a known method and cured, whereby the hollow fiber membrane bundle that does not block the hollow fiber membrane lumen is placed in the case 5. Can be fixed to. As the potting agent, polyurethane, silicone, epoxy resin or the like can be used, and polyurethane resin is preferably used from the viewpoint of biocompatibility. The potting part 11 also serves to prevent the dialysate flowing in the dialysate flow path from flowing to both ends of the hollow fiber membrane.

 The blood purifier of the present invention has a ratio (aZD) of the inner diameter (a) of the outer end A of the case end to the inner diameter (D) of the end (trunk end 10) of the trunk 8. The force ZD = 1.25 to 1.80, preferably 1.30 to L70, and more preferably 1.28 to L58. Since the blood purifier of the present invention has a strong ratio, the flow passage cross-sectional area is reduced in the body, and the dialysis fluid linear velocity is increased to improve the diffusion efficiency, thereby realizing excellent dialysis efficiency. can do. Further, the blood purifier of the present invention has the above ratio, so that a space is provided between the body end portions 10 and 10 ′ inside the case end body portions 7 and 7 ′ and the potting portions 11 and 11 ′. Therefore, the dialysate flowing in from one of the dialysate outlets 41 and 41 ′ can easily enter between the hollow fiber membranes, so that the dialysate easily flows into all dialysate channels. Can do.

[0018] Further, compared to the filling rate of the hollow fiber membrane bundle inside the body part, Since the filling rate of the hollow fiber membrane bundle on the side is low, the gap between the hollow fiber membrane bundles increases below the dialysate outflow inlet compared to the body part, so that the dialysate is evenly spaced between the hollow fiber membranes. Easy to flow into. The filling rate of the hollow fiber membrane bundle on the inside of the case end is not particularly limited, but the filling rate at the outer end A of the case end is not more than 35%. This is preferable because poor filling of the potting agent at the time of forming the part hardly occurs. Also, the lower limit of the filling rate at the outer end A of the case end is lower, and the lower the filling rate, the easier it is for the dialysate to flow into all dialysate channels. Therefore, the filling rate at the outer end portion of the case end portion can be 35 to 10%. Here, the filling rate means the ratio of the cross-sectional area of the hollow fiber membrane to the cross-sectional area of the case, and can be calculated by the following formula.

 Filling rate (%) = (hollow fiber membrane outer diameter Z2 X π X number of hollow fiber membranes)

 / (Case inner diameter Ζ2 X π) X 100

[0019] In the blood purifier of the present invention, the case 5 contains a hollow fiber bundle 3 made of a plurality of hollow fiber membranes. As the hollow fiber membrane, for example, polysulfone, polyether sulfone, polyacrylonitrinole, polyamide, polyethylene, polypropylene, senorelose acetate, regenerated cellulose, etc. are preferably used. The hollow fiber membrane desirably has an ultrafiltration rate (UFR) of 20 mLZhr'm ² 'mmHg or more so that unnecessary components in blood can be surely removed. The hollow fiber membrane is accommodated in the case 5 in the form of a hollow fiber bundle obtained by bundling about 100 to 18,000. The effective membrane area of the hollow fiber membrane in the dialyzer is preferably 0.1 to ^3. Om ² , more preferably 0.1 to ^2.5 m ² . Further, the filling rate of the hollow fiber membrane in the case 5 is 20 to 80%, more preferably 40 to 60%. In addition, in order to obtain the effective membrane area of the hollow fiber membrane in the target dialyzer, the length of the hollow fiber membrane and the number of hollow fiber membranes are appropriately changed, and the length of the case is also changed to match it. Say it with a word.

[0020] In the blood purifier of the present invention, the case and the header are made of, for example, an acrylic resin such as polyethylene, polypropylene, polycarbonate, and polymethyl methacrylate, hard polychlorinated butyl, styrene butadiene copolymer, polystyrene. Made of hard resin. To ensure blood visibility inside the blood purifier, the case and header are shaped. The material to be formed is preferably transparent or translucent. Further, in order to distinguish between the blood outflow inlet and the two headers, the two headers may be formed of materials colored in different colors.

 Example

 [0021] Examples and comparative examples of the present invention are shown below, but the present invention is not limited thereto.

 [0022] (Example 1)

A hollow fiber bundle obtained by bundling approximately 8,500 polyethersulfone hollow fiber membranes with an inner diameter of 200 μm and an outer diameter of 260 μm was 295 mm in length, and the inner diameter of the case end (outer end of the case end) 47 It was inserted into the central part of a polycarbonate blood purifier case with 5mm, barrel inner diameter 32.5mm, and trunk length 220mm. Thereafter, a potting agent was injected into both ends of the case body by a known method, and the hollow fiber bundle was fixed in the case body. The effective membrane area of the hollow fiber bundle was 1.5 m ² , the filling rate at the trunk end of the hollow fiber bundle was 54.4%, and the filling rate at the case end was 25.7%. Next, headers were attached to both ends of the case to obtain the blood purifier of Example 1.

 [0023] (Example 2)

 A blood purifier of Example 2 was obtained in the same manner as Example 1 except that the inner diameter of the trunk end was 28.5 mm. The filling ratio at the trunk end was 70.7%.

[0024] (Example 3)

 A blood purifier of Example 3 was obtained in the same manner as in Example 1 except that the inner diameter of the trunk end was 34. Omm. The torso filling factor was 49.7%.

[0025] (Comparative example)

 A comparative blood purifier was obtained in the same manner as in Example 1 except that a polycarbonate blood purifier case having an overall length of 263 mm and an inner diameter of 36.9 mm was used.

[0026] (A PD measurement)

Flow the dialysate at a flow rate of 50 OmLZmin through the dialysate flow paths of the dialyzers obtained in Examples 1 to 3 and the comparative example, and measure the pressure at the dialysate inlet and the dialysate outlet. Was used to measure the pressure loss of the dialysate. The results are shown in Table 1. [0027] (Clearance measurement)

 Using each of the blood purifiers obtained in Examples 1 to 3 and the comparative example, the blood clarifier performance evaluation method and functional classification determined by the Japan Dialysis Medical Association (Japan Dialysis Medical Society Journal 29 卷 8, 1231 -1245, 1996), the clearance of j82 microglobulin (molecular weight 11,800) was measured. The measurement was performed after 60 min dialysis (blood flow rate 200 mLZmin, dialysate flow rate 500 mLZmin, water removal rate 15 mLZmin) using bovine blood (Ht = 30%, total protein concentration 6.5 gZdL, 37 ° C). The measurement is performed using bovine blood (Ht = 30%, total protein concentration 6.5 gZdL, | 8 2 microglobulin concentration lmgZL, 37 ° C), and the measurement conditions are blood flow rate 200 mLZmin, dialysate flow rate 500 mLZmin, The water removal rate was 15 mLZmin. Table 1 shows the measurement results.

 [0028] [Table 1]

 [0029] From the above embodiment, the blood purifier of the present invention has a large pressure loss, and thus has an excellent clearance.

 Industrial applicability

[0030] By using the blood purifier of the present invention, the dialysis efficiency is good, and it is necessary to use additional members, and the manufacturing workability is good. Therefore, renal function due to renal failure, etc. It is suitable as a blood purifier for use in the treatment of patients with impaired blood pressure.

 Furthermore, the blood purifier of the present invention can store the hollow fiber membrane bundle directly in the case, and since there is a sufficient gap between the hollow fiber membranes in the case end portion, air is supplied to the hollow fiber membrane. Since exposure to each individual is easier than conventional hollow fiber blood purifiers, it is easy to dry liquids such as water. For example, a method described in Japanese Patent Publication No. 05-50946 is used. It can be suitably used as a type of blood purifier. That is, the blood purifier is suitable as a blood purifier package packaged with the hollow fiber membrane in a dry state.

Claims

The scope of the claims  [1] A blood purifier comprising a bundle of hollow fiber membranes in a case,  A blood channel is formed by the lumen of the hollow fiber membrane and the header;  A dialysate channel is formed by the gap between the hollow fiber membranes,  The case includes a body part and a case end part,  The ratio (aZD) of the inner diameter (a) of the outer end portion of the case end portion to the inner diameter (D) of the end portion of the body portion is:  a / D = l. 25 ~ 1.80  A blood purifier characterized by that. [2] The blood purifier according to [1], wherein a filling rate of the hollow fiber membrane in an outer end portion of the case end portion is 35% or less. [3] A blood purifier package according to claim 1 or claim 2, wherein the hollow fiber membrane is packaged in a dry state.