WO2016006041A1 - 血液浄化器 - Google Patents
血液浄化器 Download PDFInfo
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- WO2016006041A1 WO2016006041A1 PCT/JP2014/068213 JP2014068213W WO2016006041A1 WO 2016006041 A1 WO2016006041 A1 WO 2016006041A1 JP 2014068213 W JP2014068213 W JP 2014068213W WO 2016006041 A1 WO2016006041 A1 WO 2016006041A1
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- blood
- hollow fiber
- fiber membrane
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- 239000008280 blood Substances 0.000 title claims abstract description 224
- 210000004369 blood Anatomy 0.000 title claims abstract description 224
- 239000012528 membrane Substances 0.000 claims abstract description 161
- 239000012510 hollow fiber Substances 0.000 claims abstract description 138
- 230000008859 change Effects 0.000 claims abstract description 65
- 230000017531 blood circulation Effects 0.000 claims abstract description 57
- 230000004907 flux Effects 0.000 claims abstract description 17
- 239000012466 permeate Substances 0.000 claims abstract description 7
- 239000000706 filtrate Substances 0.000 claims abstract description 5
- 239000007788 liquid Substances 0.000 claims abstract description 5
- 239000012530 fluid Substances 0.000 claims description 4
- 238000001914 filtration Methods 0.000 description 58
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- 238000010586 diagram Methods 0.000 description 8
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- NNLVGZFZQQXQNW-ADJNRHBOSA-N [(2r,3r,4s,5r,6s)-4,5-diacetyloxy-3-[(2s,3r,4s,5r,6r)-3,4,5-triacetyloxy-6-(acetyloxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6s)-4,5,6-triacetyloxy-2-(acetyloxymethyl)oxan-3-yl]oxyoxan-2-yl]methyl acetate Chemical compound O([C@@H]1O[C@@H]([C@H]([C@H](OC(C)=O)[C@H]1OC(C)=O)O[C@H]1[C@@H]([C@@H](OC(C)=O)[C@H](OC(C)=O)[C@@H](COC(C)=O)O1)OC(C)=O)COC(=O)C)[C@@H]1[C@@H](COC(C)=O)O[C@@H](OC(C)=O)[C@H](OC(C)=O)[C@H]1OC(C)=O NNLVGZFZQQXQNW-ADJNRHBOSA-N 0.000 description 4
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Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/08—Hollow fibre membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/1623—Disposition or location of membranes relative to fluids
- A61M1/1627—Dialyser of the inside perfusion type, i.e. blood flow inside hollow membrane fibres or tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3606—Arrangements for blood-volume reduction of extra-corporeal circuits
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
- B01D63/02—Hollow fibre modules
- B01D63/028—Microfluidic devices comprising semi-permeable hollow fibre membranes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
Definitions
- the present invention relates to a blood purifier used for dialysis treatment.
- Patent Document 1 discloses an invention relating to a blood processing module.
- This blood processing module includes a hollow fiber membrane.
- the hollow fiber membrane is made of a hydrophilic polymer and has an average inner diameter of 50 ⁇ m or more and less than 180 ⁇ m.
- the publication discloses that such a blood processing module can be used as a high-performance and / or small-sized blood processing module for hemodialysis, hemofiltration, hemodiafiltration, plasma separation, home dialysis, portable artificial It is also useful as a module for kidneys and implantable artificial kidneys.
- Patent Document 2 discloses an invention related to a hollow fiber membrane.
- This hollow fiber membrane consists of an ionic polymer selected from a cationic polymer or an anionic polymer.
- the ionic polymer comprises a polyvinyl alcohol containing an ionic group selected from a cationic group or an anionic group, or a mixture of a polymer containing the ionic group and a polyvinyl alcohol not containing the ionic group.
- the publication states that according to such a hollow fiber membrane, dialysis can be efficiently performed because of a large ion permeation flux, a large selection coefficient, and excellent mechanical strength. Yes.
- An object of the present invention is to provide a blood purifier that can be used for a long time even if it is downsized.
- the blood purifier according to the present invention includes a plurality of hollow fiber membranes having an effective length of 10 mm or more and 150 mm or less, blood flows inside the hollow fiber membrane, and dialysate and filtrate are outside the hollow fiber membrane.
- a hollow fiber membrane bundle through which a liquid containing at least one of them flows, and a main body case containing the hollow fiber membrane bundle, and the volume of the permeate that permeates the hollow fiber membrane is defined as the membrane area of the hollow fiber membrane and Of the permeation flux Jv obtained by dividing by time, the maximum value in the hollow fiber membrane bundle is Jvmax, and the linear velocity of the blood supplied into the hollow fiber membrane and flowing in the hollow fiber membrane is defined as Jvmax.
- the pressure difference between the blood flowing inside the hollow fiber membrane and the liquid flowing outside the hollow fiber membrane is TMP, and TMP, into the hollow fiber membrane per unit membrane area of the hollow fiber membrane.
- Blood filling amount 20 mL / m 2 or more
- the TMP change rate value satisfies the condition of 0.95 or more and 1.05 or less.
- the effective length of the plurality of hollow fiber membranes is 10 mm or more and 40 mm or less.
- the blood filling amount into the hollow fiber membrane per unit membrane area of the hollow fiber membrane is 20 mL / m 2 or more and 30 mL / m 2 or less, and the value of Jvmax / uB is 0.00015 or more and 0.0006.
- the TMP change rate value satisfies the condition of 0.95 to 1.05.
- the pressure loss between the blood inlet side and the blood outlet side of the plurality of hollow fiber membranes is 0 mmHg or more and 60 mmHg or less.
- the blood filling amount in the blood purifier is 5 mL or more and 100 mL or less.
- the present invention it is possible to obtain a blood purifier that can be used for a long time even if it is downsized.
- the experimental result of the experiment example based on Embodiment is shown, It is a figure which shows the relationship between Jvavg [micrometer / s] and a TMP change rate. It is a figure which shows the experimental result of the experiment example based on embodiment, and shows the relationship between Jvavg / uB and TMP change rate. It is a figure which shows the experimental result of the experiment example based on embodiment, and shows the relationship between Jvmax / wall shear rate and TMP change rate. It is a figure which shows the experimental result of the experiment example based on embodiment, and shows the relationship between Jvmax and a TMP change rate.
- FIG. 9 is a first diagram illustrating a relationship between Jvmax / uB and a TMP change rate, showing an experimental result of an experimental example based on the embodiment. It is the 2nd figure which shows the experimental result of the experiment example based on embodiment, and shows the relationship between Jvmax / uB and a TMP change rate.
- FIG. 1 is a diagram schematically showing a blood purification system 100 according to an embodiment.
- the blood purification system 100 purifies blood in a blood purification target (not shown).
- the blood purification system 100 can perform blood purification by an action such as hemodialysis or hemodiafiltration. For example, a patient whose renal function is impaired (such as a function of removing waste in blood due to renal failure or the like). Can be used to treat patients).
- the blood purification system 100 includes a blood purifier 10, blood flow paths 11, 12, dialysate flow paths 13, 14, roller pumps 15, 16, and monitor pumps 17, 18, 19.
- the blood purifier 10 includes a main body case 10C having a cylindrical shape, and a hollow fiber membrane bundle 10H accommodated in the main body case 10C.
- the hollow fiber membrane bundle 10H is configured by bundling a plurality of hollow fiber membranes.
- the main body case 10C is provided with four ports: a blood inlet, a blood outlet, a dialysate inlet, and a dialysate outlet.
- Blood ports 11 and 12 communicating with the inside of a plurality of hollow fiber membranes are connected to the ports of the blood inlet and the blood outlet, respectively.
- Dialysate flow paths 13 and 14 communicating with the outside of the plurality of hollow fiber membranes are connected to the ports of the dialysate inlet and the dialysate outlet, respectively.
- the blood flows to the inside of the hollow fiber membrane through the blood channel 11 connected to the main body case 10C.
- the blood flows from the inside of the hollow fiber membrane to the blood channel 12.
- the dialysate flows to the outside of the hollow fiber membrane through the dialysate flow path 13 connected to the main body case 10C.
- the dialysate flows from the outside of the hollow fiber membrane to the dialysate channel 14.
- the flow path 13 may be closed and the filtrate may be discharged from the flow path 14.
- Substances in the blood move through the hollow fiber membrane as a semipermeable membrane as a permeate by the action of diffusion into the dialysate To do. Since the hollow fiber membrane used in the blood purifier 10 is excellent in substance permeability and water permeability, even when forced filtration is not performed by dewatering, blood and dialysate are allowed to pass through the hollow fiber membrane. Between, filtration (internal filtration) and backfiltration (internal backfiltration) can be performed.
- blood purifier 10 applies a negative pressure to the dialysate side, and moves substances in the blood (for example, urea, creatinine, water, etc.) to the dialysate side by filtration (hemodialysis). ), Or a fluid replacement fluid (blood filtration and hemodiafiltration).
- blood and dialysate are circulated in opposite directions.
- a liquid (permeate) moves from the higher pressure to the lower pressure of blood and dialysate through the hollow fiber membrane.
- Internal filtration is likely to occur on the blood inflow side in the blood purifier 10, and internal reverse filtration is likely to occur on the blood outflow side in the blood purifier 10.
- the flow rate Q B per unit time of blood flowing into the blood purifier 10 can be changed by a roller pump 15 provided in the blood flow path 11.
- the pressure (P17) of the blood flowing into the blood purifier 10 is monitored by a monitoring pump 17 provided in the blood channel 11.
- the pressure (P18) of the blood flowing out from the blood purifier 10 is monitored by a monitoring pump 18 provided in the blood channel 12.
- the flow rate per unit time of the dialysate flowing into the blood purifier 10 can be changed by a roller pump 16 provided in the dialysate flow path 14. Filtration with a filtration flow rate Q F (slow water flow rate) is performed through the dialysate flow path 14.
- the pressure on the dialysate side (P 19) is monitored by a monitoring pump 19 provided in the dialysate flow path 14.
- TMP transmembrane pressure
- the plurality of hollow fiber membranes accommodated in the main body case 10C have an effective length of 10 mm or more and 150 mm or less, and can be reduced in size depending on the dimension range.
- the effective length referred to here is the length of a part of the plurality of hollow fiber membranes that is actually used for substance exchange between the blood side and the dialysis side in the longitudinal direction.
- the ends of the plurality of hollow fiber membranes in the longitudinal direction are fixed to the inner wall of the main body case 10C via a sealing resin.
- the effective length of the plurality of hollow fiber membranes indicates, for example, the average length of the portions excluding both ends fixed to the body case 10C (sealing resin) among the plurality of hollow fiber membranes.
- the blood purifier 10 is ideally fixed at a position close to the body using a belt or the like.
- the long blood purifier 10 is not preferable because it restricts the operation of the patient, and it is desirable to wrap the blood purifier 10 as short as possible around the torso of the patient sideways (horizontally).
- the width of the adult torso is about 200 mm, and the width of the child's torso is about 150 mm.
- the effective length of the plurality of hollow fiber membranes is 10 mm or more and 150 mm or less, the blood purifier 10 is closely fixed to the patient's body without almost restricting the operation of the patient. It becomes possible to make it.
- the effective length of the plurality of hollow fiber membranes is preferably 10 mm or more and 100 mm or less, more preferably 10 mm or more and 40 mm or less.
- the material of the member constituting the main body case 10C based on the example was PC (polycarbonate).
- the inner diameter of the body portion of the main body case 10C was 40.0 mm.
- the total length of the main body case 10C was 52.6 mm.
- the effective length (average value) of the hollow fiber membrane was 37.6 mm.
- the material constituting the hollow fiber membrane was CTA (cellulose triacetate).
- the inner diameter (average value) of the hollow fiber membrane was 100 ⁇ m.
- the film thickness (average value) of the hollow fiber was 15 ⁇ m.
- the membrane area (average value) of the hollow fiber was 0.55 m 2 .
- the membrane area referred to here is the area of the hollow fiber membrane that is actually used for material exchange between the blood side and the dialysis side in the longitudinal direction, and is the inner surface of the hollow fiber. Is a value calculated with reference to.
- the membrane area of the hollow fiber membrane referred to here is an average membrane area of a portion excluding both ends fixed to the body case 10C (sealing resin) among the plurality of hollow fiber membranes.
- the number of hollow fiber membranes bundled was 46228.
- the ratio (L / D) between the effective length (L) of the hollow fiber membrane and the average inner diameter (D) of the body portion of the main body case 10C was 0.94 (average value).
- the cross-sectional area (average value) of the lumen of the hollow fiber membrane was 363 mm 2 .
- the ratio (filling rate) of the hollow fiber membrane (hollow fiber membrane bundle) to the volume of the main body case 10C was 49%.
- a general blood purifier has a so-called elongated shape.
- the blood purifier 10 used in the present embodiment has a short and thick shape.
- the blood filling amount (average value) in the hollow fiber membrane per unit membrane area of the hollow fiber membrane is 20 mL / m 2 or more and 35 mL / m 2 or less.
- the blood filling amount (average value) in the hollow fiber membrane per unit membrane area of the hollow fiber membrane is preferably 20 mL / m 2 or more and 30 mL / m 2 or less.
- the blood filling amount (average value) in the hollow fiber membrane per unit membrane area of the hollow fiber membrane was 25 mL / m 2 .
- Priming volume (blood filling amount) to the blood purifier 10 is 5 mL or more and 100 mL or less.
- the priming volume (blood filling amount) to the hollow fiber membrane bundle in blood purifier 10 is preferably 5 mL or more and 80 mL or less, more preferably 5 mL or more and 50 mL or less.
- the extracorporeal circulating blood volume in blood purification therapy needs to be set to 10% or less of the circulating blood volume in the body.
- the pressure loss (average value) between the blood inlet side and the blood outlet side of the hollow fiber membrane is preferably 0 mmHg or more and 60 mmHg or less.
- the load on the blood is smaller when the structure has less pressure loss. That is, if the membrane area is the same, it can be said that a module having a short thickness is more advantageous for blood filtration than an elongated one.
- the pressure loss (average value) between the blood inlet side and the blood outlet side of the hollow fiber membrane was 56 mmHg in Example 1, 27 mmHg in Example 2, and 19 mmHg in Example 3.
- 1 L of porcine blood was prepared. This blood has HCT adjusted to 30% and TP adjusted to 6.5 g / dL.
- the material of the member constituting the main body case based on the comparative example was PC (polycarbonate).
- the inner diameter of the body portion of the main body case was 23.7 mm.
- the total length of the main body case was 183 mm.
- the effective length (average value) of the hollow fiber membrane was 165 mm.
- the material constituting the hollow fiber membrane was CTA (cellulose triacetate).
- the inner diameter (average value) of the hollow fiber membrane was 200 ⁇ m.
- the film thickness (average value) of the hollow fiber was 15 ⁇ m.
- the membrane area (average value) of the hollow fiber was 0.52 m 2 .
- the membrane area referred to here is the area of the hollow fiber membrane that is actually used for material exchange with the blood side in the longitudinal direction, and is based on the inner surface of the hollow fiber. The value to be calculated.
- the membrane area of the hollow fiber membrane referred to here is an average membrane area of a portion excluding both ends fixed to the main body case (sealing resin) among the plurality of hollow fiber membranes.
- the number of bundles of hollow fiber membranes was 4992.
- the ratio (L / D) between the effective length (L) of the hollow fiber membrane and the average inner diameter (D) of the body portion of the body case was 6.96 (average value).
- the cross-sectional area (average value) of the lumen of the hollow fiber membrane was 157 mm 2 .
- the ratio (filling rate) of the hollow fiber membrane (hollow fiber membrane bundle) to the volume of the main body case was 47%.
- the blood purifier of this comparative example has a so-called elongated shape.
- the pressure loss (average value) between the blood inlet side and the blood outlet side of the hollow fiber membrane was 105 mmHg in Comparative Example 1, 50 mmHg in Comparative Example 2, and 32 mmHg in Comparative Example 3.
- 1 L of porcine blood was prepared. This blood has HCT adjusted to 30% and TP adjusted to 6.5 g / dL.
- blood filtration was started in blood purification system 100, and blood was circulated in a state where a constant filtration flow rate was set for 60 minutes from the start of filtration to perform blood filtration. Sixty minutes after the start of filtration, the filtration flow rate was increased by a certain amount, and blood was circulated for 60 minutes in that state. Thereafter, the initial filtrate flow rate was restored, and blood was circulated for 20 minutes in that state. Thereafter, the filtration flow rate was increased by a certain amount from the previous value, and blood was circulated for 60 minutes in this state.
- the amount to increase the filtration flow rate is set so that the ratio of the blood flow rate to the filtration flow rate increases in the order of 0.025, 0.05, 0.075, and 0.1 each time the filtration flow rate is increased. did.
- the above-described method is repeated in which the circulation for 20 minutes is performed at a low filtration flow rate as described above and the circulation for 60 minutes is performed at a filtration flow rate increased by a certain amount.
- the TMP value (average value) was measured.
- the values of TMP are the TMP value (P0) when 60 minutes have elapsed from the start of filtration, and the TMP when 20 minutes are circulated at a low filtration flow rate as described above. Values (P1 to P8) were measured.
- FIG. 3 is a graph showing the transition of TMP values (points P0 to P8) when the blood flow rate is set to 200 mL / min. Based on the TMP value (P0) when 60 minutes have elapsed from the start of filtration, the filtration flow rate is returned to the initial value 60 minutes after changing the filtration flow rate, and each TMP (P1 when 20 minutes have passed thereafter) ⁇ P8) was calculated as the TMP increase rate. The calculation was performed for each of when the blood flow rate was set to 50 mL / min, when the blood flow rate was set to 100 mL / min, and when the blood flow rate was set to 200 mL / min.
- the permeation flux Jv is obtained by dividing the volume of the permeate permeating through the hollow fiber membrane 20 by the membrane area and time of the hollow fiber membrane.
- the permeation flux Jv shows different values at arbitrary locations in the longitudinal direction of the hollow fiber membrane 20.
- the maximum value in the hollow fiber membrane bundle is defined as Jvmax.
- the permeation flux Jv shows a high value on the blood inlet 21 side and a low value on the blood outlet 22 side.
- the maximum filtration flux Jvmax becomes a value equal to the value of the permeation flux Jv obtained from the most upstream portion in the longitudinal direction of the hollow fiber membrane 20, for example.
- the blood inlet 21 side is a portion where blood is filtered more than the downstream side (outlet 22 side), and a large load acts on the blood inlet 21 side. Focusing on the maximum filtration flux Jvmax is effective for calculating the service life of the hollow fiber membrane.
- the filtration coefficient of the hollow fiber membrane is Lp [ ⁇ m / (s ⁇ mmHg)]
- the AF differential pressure at 60 minutes after the flow rate change is ⁇ P AF [mmHg]
- the colloid osmotic pressure is ⁇ [mmHg]
- the value of the filtration coefficient Lp [ ⁇ m / (s ⁇ mmHg)] is 0.0381 in the example by correcting the annual amount of plasma and water and 0.0637 in the comparative example.
- the value of the pressure ⁇ [mmHg] was 22.88.
- the average value of the permeation flux Jv is indicated by the average filtration flux Jvavg.
- the value of the filtration flow rate Q F [ ⁇ m 3 / s] is changed from 2.5% to 25% of the blood flow rate. For example, at a blood flow rate of 200 mL / min, 8.3 ⁇ 10 10 to 8. The value of 3 ⁇ 10 11 was set, and the film area S [ ⁇ m 2 ] was set to 5 ⁇ 10 11 .
- FIG. 5 is a diagram showing the relationship between TMP [mmHg] and filtration flow rate [mL / min].
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted in the figure as Comparative Example 1.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Comparative Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted in the figure as Comparative Example 3.
- the leftmost one in the figure corresponds to the point P0 in FIG.
- the one shown on the right next to it corresponds to the point P1 in FIG.
- the one shown on the right side corresponds to points P2 to P8 in FIG. 3 in order. It can be seen from the plots of Examples 1 to 3 and Comparative Examples 1 to 3 that the TMP value increases as the filtration flow rate is increased by a certain amount (going upward).
- FIG. 6 is a diagram illustrating the relationship between Jvavg [ ⁇ m / s] and the TMP change rate.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted in the figure as Comparative Example 1.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Comparative Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted in the figure as Comparative Example 3.
- the leftmost one in the figure corresponds to the TMP change rate calculated from the points P0 and P1 in FIG.
- the one shown to the right of the plot corresponds to the TMP change rate calculated from the points P0 and P2 in FIG.
- the one shown on the right side corresponds to the TMP change rate calculated from the point P0 and the points P3 to P8 in FIG. 3 in order.
- FIG. 7 is a diagram showing the relationship between Jvavg / uB and the TMP change rate.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted in the figure as Comparative Example 1.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Comparative Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted in the figure as Comparative Example 3.
- the leftmost one in the figure corresponds to the TMP change rate calculated from the points P0 and P1 in FIG.
- the one shown to the right of the plot corresponds to the TMP change rate calculated from the points P0 and P2 in FIG.
- the one shown on the right side corresponds to the TMP change rate calculated from the point P0 and the points P3 to P8 in FIG. 3 in order.
- Jvavg / uB is 0.005 to 0.00.
- the transition of Examples 2 and 3 and the transition of Comparative Examples 1 and 2 show the same tendency, or in the range of Jvavg / uB from 0.01 to 0.015, compared with the transition of Example 3. Since the transition of Example 2 shows a similar tendency, it can be said that the viewpoint of “relation between Jvmax / uB and TMP change rate” described later is easier to compare (details will be described later).
- FIG. 8 is a diagram showing the relationship between Jvmax / wall shear rate and TMP change rate.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted in the figure as Comparative Example 1.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Comparative Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted in the figure as Comparative Example 3.
- the leftmost one in the figure corresponds to the TMP change rate calculated from the points P0 and P1 in FIG.
- the one shown to the right of the plot corresponds to the TMP change rate calculated from the points P1 and P2 in FIG.
- point P2 and point P3, point P3 and point P4 point P4 and point P5, point P5 and point P6, point P6 and point in FIG. This corresponds to the TMP change rate per hour calculated from P7, point P7, and point P8.
- FIG. 9 is a diagram illustrating the relationship between Jvmax and the TMP change rate.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the result when the blood flow rate to the blood purifier is set to 200 mL / min is plotted in the figure as Comparative Example 1.
- the leftmost one in the figure corresponds to the TMP change rate calculated from the points P0 and P1 in FIG.
- the one shown to the right of the plot corresponds to the TMP change rate calculated from the points P1 and P2 in FIG.
- point P2 and point P3, point P3 and point P4 point P4 and point P5, point P5 and point P6, point P6 and point in FIG. This corresponds to the TMP change rate per hour calculated from P7, point P7, and point P8.
- FIG. 10 and 11 are diagrams showing the relationship between Jvmax / uB and the TMP change rate.
- FIG. 11 corresponds to an enlarged view of a part of FIG. 10 (the range where Jvmax / uB is 0 to 0.0005).
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted as Example 1 in the drawing.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in the figure as Example 2.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Example 3 in the figure.
- the results when the blood flow rate to the blood purifier is set to 200 mL / min are plotted in the figure as Comparative Example 1.
- the results when the blood flow rate to the blood purifier is set to 100 mL / min are plotted in FIG.
- the results when the blood flow rate to the blood purifier is set to 50 mL / min are plotted as Comparative Example 3.
- the leftmost one in the figure corresponds to the TMP change rate calculated from the points P0 and P1 in FIG.
- the one shown to the right of the plot corresponds to the TMP change rate calculated from the points P0 and P2 in FIG.
- the one shown on the right side corresponds to the TMP change rate calculated from the point P0 and the points P3 to P8 in FIG. 3 in order.
- blood purifier 10 can be used for a long time if designed so that Jvmax is about 0.015% or more and 0.06% or less with respect to linear velocity uB. Even so, the rate of change in TMP is 0.95 or more and 1.05 or less, and it is considered that stable use is possible with little fouling.
- Comparative Examples 1 to 3 even when Jvmax is designed to be about 0.015% or more and 0.06% or less with respect to the linear velocity uB, the TMP when the blood purifier is used for a long period of time. Since the rate of change exceeds 1.05, more fouling occurs than in Examples 1 to 3, and it can be said that the range of filtration flow rate and blood flow rate that can be used stably is narrow.
- the blood filling amount into the hollow fiber membrane per unit membrane area of the hollow fiber membrane is set to 20 mL / m 2 or more and 35 mL / m 2 or less. Therefore, the blood filling amount in the hollow fiber membrane per unit membrane area of the hollow fiber membrane is 20 mL / m 2 or more and 35 mL / m 2 or less, and the value of Jvmax / uB is 0.00015 or more and 0.0006 or less. Under the circumstances, when the value of the TMP change rate satisfies the condition of 0.95 or more and 1.05 or less, the TMP change rate is 0.95 or more and 1.05 even if the blood purifier 10 is used for a long time. The following values are taken, and it can be said that stable use is possible with less fouling.
- the blood filling amount in the hollow fiber membrane per unit membrane area of the hollow fiber membrane is 20 mL / m 2 or more and 30 mL / m 2 or less, and the value of Jvmax / uB is 0.00015 or more and 0.0006 or less. In such a situation, it is preferable that the value of the TMP change rate satisfies the condition of 0.95 or more and 1.05 or less.
- a smaller blood filling amount in the hollow fiber membrane is more advantageous for blood filtration.
- the blood purifier 10 having a small blood filling amount per membrane area and having the above-described short and thick shape can not only be reduced in size and improved in portability, but also in a predetermined range. It can be seen that high performance can be achieved by setting the conditions to be used.
- 10 blood purifier 10C body case, 10H hollow fiber membrane bundle, 11, 12 blood flow path, 13, 14 dialysate flow path, 15, 16 roller pump, 17, 18, 19 monitor pump, 20 hollow fiber membrane, 21 entrance, 22 exit, 100 blood purification system.
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Abstract
Description
血液が中空糸膜に接触すると、中空糸膜の表面が変性したり、中空糸膜の表面に血中成分や蛋白質が堆積しゲル層が形成されたり、吸着によって膜孔の狭窄または閉塞が起きたり(ファウリング)、血液の凝固によって中空糸膜の内腔自体にも血栓が形成されたりする。上述の血液浄化システム100(図1参照)を用いて長時間にわたって血液濾過(C:Continuous)HFを施行した場合に、血液浄化器10の中空糸膜にファウリング(fouling)や凝固などが発生しにくく血液浄化器10の性能が適切に発揮されるような、血液流量、濾過流量、ならびに血液流量と濾過流量との比などの各種の設定条件ついて検討した。本実験例においては、上述の実施の形態に基づく実施例の構成を有する血液浄化器10と、それとは異なる比較例の構成を有する血液浄化器とを準備した。
実施例に基づく本体ケース10Cを構成している部材の材質は、PC(ポリカーボネート)とした。本体ケース10Cの胴部の内径は、40.0mmとした。本体ケース10Cの全長は、52.6mmとした。本実施例においては、中空糸膜の有効長(平均値)は、37.6mmとした。中空糸膜を構成している部材の材質は、CTA(セルローストリアセテート)とした。
比較例に基づく本体ケースを構成している部材の材質は、PC(ポリカーボネート)とした。本体ケースの胴部の内径は、23.7mmとした。本体ケースの全長は、183mmとした。本比較例においては、中空糸膜の有効長(平均値)は、165mmとした。中空糸膜を構成している部材の材質は、CTA(セルローストリアセテート)とした。
図5は、TMP[mmHg]と、濾過流量[mL/min]との関係を示す図である。上述の実施例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、実施例1として図中にプロットされている。血液浄化器への血液流量を100mL/minに設定したときの結果は、実施例2として図中にプロットされている。血液浄化器への血液流量を50mL/minに設定したときの結果は、実施例3として図中にプロットされている。
図6は、Jvavg[μm/s]と、TMP変化率との関係を示す図である。上述の実施例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、実施例1として図中にプロットされている。血液浄化器への血液流量を100mL/minに設定したときの結果は、実施例2として図中にプロットされている。血液浄化器への血液流量を50mL/minに設定したときの結果は、実施例3として図中にプロットされている。
中空糸膜内に供給され中空糸膜内で流れる血液の線速度は、uB[μm/s]によって示される(図4参照)。血液浄化器内に流入する血液の単位時間あたりの血液流量をQB[μm3/s]とし、中空糸膜の断面積の和をA[μm2]とすると、線速度uBは、uB=QB/Aの式で表すことができる。
図8は、Jvmax/壁ずり速度と、TMP変化率との関係を示す図である。壁ずり速度とは、流体の移動量が時間とともに増す割合のことであり、たとえば円管内層流の流れにおいては、壁面からの距離をR、流体の平均速度をuBとしたときに、(壁ずり速度)=4uB/Rの式によって得ることができるものである。上述の実施例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、実施例1として図中にプロットされている。血液浄化器への血液流量を100mL/minに設定したときの結果は、実施例2として図中にプロットされている。血液浄化器への血液流量を50mL/minに設定したときの結果は、実施例3として図中にプロットされている。
図9は、Jvmaxと、TMP変化率との関係を示す図である。上述の実施例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、実施例1として図中にプロットされている。血液浄化器への血液流量を100mL/minに設定したときの結果は、実施例2として図中にプロットされている。血液浄化器への血液流量を50mL/minに設定したときの結果は、実施例3として図中にプロットされている。上述の比較例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、比較例1として図中にプロットされている。
図10および図11は、Jvmax/uBと、TMP変化率との関係を示す図である。図11は、図10の一部(Jvmax/uBが0~0.0005の範囲)を拡大したものに相当している。上述の実施例の構成を有する血液浄化器について、血液浄化器への血液流量を200mL/minに設定したときの結果は、実施例1として図中にプロットされている。血液浄化器への血液流量を100mL/minに設定したときの結果は、実施例2として図中にプロットされている。血液浄化器への血液流量を50mL/minに設定したときの結果は、実施例3として図中にプロットされている。
Claims (5)
- 10mm以上150mm以下の有効長を有する複数本の中空糸膜を含み、前記中空糸膜の内側に血液が流れ、前記中空糸膜の外側に透析液および濾液のうちの少なくとも一方を含む液が流れる中空糸膜束と、
前記中空糸膜束を収容する本体ケースと、を備え、
前記中空糸膜を透過する透過液の体積を前記中空糸膜の膜面積および時間で除算することによって得られる透過流束Jvのうち、前記中空糸膜束の中での最大値をJvmaxとし、
前記中空糸膜内に供給され前記中空糸膜内で流れる血液の線速度をuBとし、
前記中空糸膜の内側を流れる血液と前記中空糸膜の外側を流れる前記液との間の圧力差をTMPとすると、
前記中空糸膜の単位膜面積あたりの前記中空糸膜内への血液充填量が20mL/m2以上35mL/m2以下となり、且つJvmax/uBの値が0.00015以上0.0006以下となる状況下において、TMP変化率の値が0.95以上1.05以下となる条件を満足している、
血液浄化器。 - 複数本の前記中空糸膜の前記有効長は、10mm以上40mm以下である、
請求項1に記載の血液浄化器。 - 前記中空糸膜の単位膜面積あたりの前記中空糸膜内への血液充填量が20mL/m2以上30mL/m2以下となり、且つJvmax/uBの値が0.00015以上0.0006以下となる状況下において、TMP変化率の値が0.95以上1.05以下の条件を満足している、
請求項1または2に記載の血液浄化器。 - 複数本の前記中空糸膜の血液入口側と血液出口側との圧力損失は、0mmHg以上60mmHg以下である、
請求項1から3のいずれかに記載の血液浄化器。 - 当該血液浄化器内への血液充填量は、5mL以上100mL以下である、
請求項1から4のいずれかに記載の血液浄化器。
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JPH06228887A (ja) * | 1993-02-01 | 1994-08-16 | Asahi Medical Co Ltd | 改質中空糸およびその製造方法 |
JPH1080477A (ja) * | 1996-09-09 | 1998-03-31 | Toray Ind Inc | 血液処理用モジュール |
JP2006340977A (ja) * | 2005-06-10 | 2006-12-21 | Toyobo Co Ltd | 中空糸膜および血液浄化器 |
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US4650457A (en) * | 1985-08-16 | 1987-03-17 | Kuraray Co., Ltd. | Apparatus for extracorporeal lung assist |
CA2202969C (en) * | 1996-04-19 | 2001-07-24 | Shingo Emi | Selectively permeable hollow fiber membrane and process for producing same |
JP3642065B1 (ja) * | 2004-03-22 | 2005-04-27 | 東洋紡績株式会社 | 選択透過性分離膜および選択透過性分離膜の製造方法 |
JP5418739B1 (ja) * | 2012-02-09 | 2014-02-19 | 東洋紡株式会社 | 中空糸型半透膜及びその製造方法及びモジュール及び水処理方法 |
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JPH1080477A (ja) * | 1996-09-09 | 1998-03-31 | Toray Ind Inc | 血液処理用モジュール |
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