WO2011125758A1 - Composition de dialyse, système d'hémodialyse, et hémodialyseur - Google Patents

Composition de dialyse, système d'hémodialyse, et hémodialyseur Download PDF

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Publication number
WO2011125758A1
WO2011125758A1 PCT/JP2011/058061 JP2011058061W WO2011125758A1 WO 2011125758 A1 WO2011125758 A1 WO 2011125758A1 JP 2011058061 W JP2011058061 W JP 2011058061W WO 2011125758 A1 WO2011125758 A1 WO 2011125758A1
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Prior art keywords
phosphorus
blood
dialysis
casing
dialysate
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PCT/JP2011/058061
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English (en)
Japanese (ja)
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和彦 玉川
恵美 近田
徹 先山
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富田製薬株式会社
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Priority to JP2012509523A priority Critical patent/JP5732676B2/ja
Publication of WO2011125758A1 publication Critical patent/WO2011125758A1/fr

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    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3679—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by absorption

Definitions

  • the present invention relates to a dialysis composition, a hemodialysis system, and a hemodialyzer. Furthermore, the present invention relates to a hemodialysis method using these.
  • hemodialysis patients regularly remove phosphorus accumulated in the body by dialysis therapy such as hemodialysis, hemofiltration dialysis, and hemofiltration (usually 3 times a week for 4 hours once per day). However, it is treated not to lead to hyperphosphatemia. However, since removal of phosphorus is insufficient only by dialysis therapy, hemodialysis patients further correct the amount of phosphorus in the body by taking an oral phosphorus adsorbent.
  • phosphorus 650 mg
  • phosphorus 650 mg
  • phosphorus 650 mg
  • phosphorus 650 mg
  • about 800 to 1000 mg of phosphorus can be removed by one dialysis
  • about 3000 mg of phosphorus can be removed by dialysis three times a week.
  • the removal amount (3000 mg) cannot exceed the phosphorus amount accumulated in one week (4550 mg), and as a result, phosphorus is accumulated in the body.
  • hemodialysis patients who accumulate phosphorus in the body despite dialysis treatment must take oral drugs (phosphorus adsorbents), and side effects (constipation, Abdominal pain, fullness of the abdomen, hypercalcemia, etc.)
  • Patent Document 1 discloses a hemodialysis system in which a phosphorus adsorption part for removing phosphorus accumulated in blood in an extracorporeal blood circuit is provided separately from a hemodialyzer. That is, this hemodialysis system includes an extracorporeal blood circuit through which blood of a hemodialysis patient is circulated, and a blood pump and a hemodialyzer are interposed in the extracorporeal blood circuit.
  • the hemodialyzer includes, for example, a cylindrical casing and a dialysis membrane that is loaded in the casing and through which blood flows.
  • a well-known dialysate is supplied from the dialysate supply device into the casing, contacts the blood via the dialysis membrane, and then discharged outside the casing.
  • the electrolyte substance or the like moves between the blood and the dialysate due to the principle of diffusion in the hemodialyzer, and, for example, a substance such as phosphorus moves from the blood to the dialysate and is removed from the blood.
  • a phosphorus adsorption part is disposed in an extracorporeal blood circuit between a discharge side of a blood pump and a hemodialyzer, and the phosphorus adsorption part includes a container and a phosphorus adsorbent filled in the container. I have.
  • the hemodialysis system disclosed in Patent Document 1 can remove and remove phosphorus in the blood of a hemodialysis patient by using a hemodialyzer and also adsorb and remove phosphorus at a phosphorus adsorption part.
  • the adsorbent since the blood and the phosphorus adsorbent are in direct contact with each other in the phosphorus adsorption part, the adsorbent may adsorb up to the necessary components in the blood, the adsorbent component may be mixed into the blood, and the living body of the adsorbent There is a risk of adverse effects (side effects) due to compatibility.
  • Patent Document 1 discloses that a phosphorus adsorption part is incorporated into an extracorporeal blood circuit in order to increase the amount of phosphorus removed by one dialysis.
  • the adsorbent may adsorb up to the necessary components in the blood, the adsorbent component is mixed into the blood, and the biocompatibility of the adsorbent. Adverse effects (side effects) may occur.
  • the present invention provides a dialysis composition used for efficiently removing phosphorus in blood without directly contacting a phosphorus adsorbent with blood circulating in an extracorporeal blood circuit for dialysis treatment as in Patent Document 1. provide.
  • the present invention provides blood that can efficiently remove phosphorus in blood without directly contacting a phosphorus adsorbent with blood circulating in an extracorporeal blood circuit for dialysis treatment as in Patent Document 1.
  • a dialysis system and hemodialyzer are provided.
  • the present invention provides a hemodialysis method that efficiently removes phosphorus in blood without bringing a phosphorus adsorbent into direct contact with blood circulating in an extracorporeal blood circuit for dialysis treatment as disclosed in Patent Document 1. To do.
  • a dialysis composition supplied to a hemodialyzer comprising a dialysis solution and a phosphorus adsorbent dispersed in the dialysis solution in a solid state.
  • a cylindrical casing comprising a cylindrical casing; A hollow fiber dialysis membrane loaded along the length of the casing; Blood supply means for supplying blood to one of the casing and the hollow fiber dialysis membrane; A dialysis composition is prepared by mixing a dialysis solution and a phosphorus adsorbent dispersed in a solid state in the dialysis solution in either the casing or the hollow fiber dialysis membrane, and the dialysis composition
  • a hemodialysis system comprising supply means for supplying an object.
  • the present invention comprises a cylindrical casing and a hollow fiber dialysis membrane loaded in the casing along its length direction, and the inside of the casing and the hollow fiber dialysis membrane A hemodialyzer in which blood circulates in either one and dialysate in the other, A hemodialyzer is provided in which the phosphorus adsorbent is present in the casing or the hollow dialysis membrane through which the dialysate is circulated.
  • a method for dialyzing blood of a hemodialysis patient using the dialysis composition, hemodialysis system, or hemodialyzer is provided.
  • a dialysis composition suitable for efficient removal of phosphorus in blood without directly contacting a phosphorus adsorbent with blood circulating in an extracorporeal blood circuit for dialysis treatment.
  • a hemodialysis system and blood capable of efficiently removing phosphorus in blood without directly contacting a phosphorus adsorbent with blood circulating in an extracorporeal blood circuit for dialysis treatment A dialyzer can be provided.
  • a phosphorus adsorbent is mixed in blood. Since it is possible to efficiently remove phosphorus in the blood while avoiding this, high safety and efficient reduction of the blood phosphorus concentration can be realized, and the problems of the prior art can be overcome.
  • FIG. 1 It is the schematic which shows another hemodialyzer which concerns on 3rd Embodiment. It is a schematic perspective view which shows the hollow fiber shaped semipermeable membrane integrated in the hemodialyzer of FIG. It is a schematic perspective view which shows another aspect of the hollow fiber shaped semipermeable membrane integrated in the hemodialyzer of FIG. It is a figure which shows the X-ray-diffraction result of the sulfuric acid containing / carbonic acid / titanium oxide-like compound (2) used in the Example. It is a figure which shows the X-ray-diffraction result of the carbon-containing and titanium oxide-like compound used in the Example.
  • the dialysis composition according to the first embodiment is a dialysis composition supplied to a hemodialyzer, and includes a dialysis solution and a phosphorus adsorbent dispersed in the dialysis solution in a solid state.
  • the dialysate includes well-known ones such as sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate (or sodium citrate), acetic acid (or citric acid), glucose A, sodium bicarbonate, and the like.
  • a liquid mixture of the liquid B and water for dilution is used.
  • Phosphorus adsorbent dissolves in water (or dialysate) so that its components dissolve in the dialysate and the hemodialyzer does not affect the human body due to the components entering the blood.
  • a difficult substance is preferable.
  • the phosphorus adsorbent is more preferably a substance that is hardly soluble or insoluble in water (or dialysate).
  • “slightly soluble or insoluble in water (or dialysate)” means “very insoluble” or “almost insoluble” as defined in the 15th revision of the Japanese Pharmacopoeia.
  • it is 1000 mL or more and less than 10,000 mL, it means “extremely insoluble”, and when it is 10,000 mL or more, it means “almost insoluble”.
  • the phosphorus adsorbent is low in viscosity and less swellable so as not to become a resistance substance of the dialysate.
  • Such a phosphorus adsorbent that is hardly soluble or insoluble in water (or dialysate) is, for example, titanium oxide, aluminum oxide, zirconium oxide, boehmite-like aluminum oxide, or an acid-treated product thereof, and a hydroxyl group in the acid-treated product.
  • Carbonate-substituted one, or zinc carbonate sulfuric acid-containing titanium oxide-like compound (sulfuric acid ions incorporated into the crystal structure of TiO 2 as a solid solution), sulfuric acid-containing carbonic acid-titanium oxide-like compound (TiO 2 In which sulfate ions and carbonate ions are incorporated into the structure in a solid solution), carbonate-containing / titanium oxide-like compounds (one in which carbonate ions are incorporated into the structure in the TiO 2 crystal structure), etc. These can be used, and can be used even if mixed.
  • the phosphorus adsorbent is preferably a carbon-containing / titanium oxide-like compound containing a carbonate group (CO 3 ).
  • the sulfuric acid / titanium oxide-like compound, the sulfuric acid / carbonic acid / titanium oxide-like compound and the carbonic acid / titanium oxide-like compound are specifically represented by the following formula (1): Examples are compounds. (TiO 2 ) (CO 3 ) X (SO 4 ) y (OH) Z ⁇ nH 2 O (1)
  • x is 0 ⁇ x ⁇ 1; y is 0 ⁇ y ⁇ 1; z is 0 ⁇ z ⁇ 2; n is 0 ⁇ n ⁇ 6.
  • sulfuric acid / titanium oxide-like compounds sulfuric acid / carbonic acid / titanium oxide-like compounds
  • carbonic acid / titanium oxide-like compounds can be produced by known methods.
  • titanium halides such as titanium tetrachloride
  • sulfates such as ammonium sulfate are mixed in an aqueous solution and heated and hydrolyzed at about 90 to 100 ° C. under strongly acidic conditions. By washing with water and drying, a sulfuric acid-containing and titanium oxide-like compound is obtained.
  • sulfuric acid / carbonic acid / titanium oxide-like compound for example, to the aqueous solution in which the sulfuric acid / titanium oxide-like compound obtained by the above method is suspended, a hydrogen carbonate salt such as sodium hydrogen carbonate is added and treated. By washing with water and drying, a part of the sulfuric acid group (SO 4 ) of the sulfuric acid-containing titanium oxide-like compound is replaced with a carbonic acid group (CO 3 ), and a sulfuric acid-containing carbonic acid-titanium oxide-like compound is obtained.
  • a hydrogen carbonate salt such as sodium hydrogen carbonate
  • a carbonate such as disodium carbonate is added to an aqueous solution in which the sulfuric acid-containing / titanium oxide-like compound obtained by the above method is suspended to adjust the pH to about 6-8.
  • the resulting solution is treated at about 60 to 80 ° C., washed with water and dried to replace the sulfate group (SO 4 ) with the carbonate group (CO 3 ), thereby obtaining a carbonate-containing / titanium oxide-like compound.
  • the phosphorus adsorbent only needs to be dispersed in a solid state before being supplied to the hemodialyzer, and may be used by being dispersed in the A liquid, the B liquid or the dialysis liquid in a solid state.
  • the phosphorus adsorbent may be mixed with the powder-type dialysate to prepare solution A or solution B, and prepared as a dialysate in which the phosphorus adsorbent is dispersed in a solid state.
  • the phosphorus adsorbent desirably has an average particle diameter of 1 to 30 ⁇ m, more preferably 5 to 20 ⁇ m in consideration of dispersibility in a dialysate and phosphorus adsorption performance when applied to a hemodialyzer.
  • the particle size of the phosphorus adsorbent is a value measured by a laser diffraction scattering method, and the average particle size indicates a cumulative volume of 50%.
  • the amount of the phosphorus adsorbent in the dialysis composition is adjusted depending on conditions such as the type of the adsorbent, that is, the phosphorus adsorption performance of the adsorbent and the supply amount of the dialysis composition to the hemodialyzer.
  • the amount of the phosphorus adsorbent is desirably 0.01 to 5% by weight, more preferably 0.1 to 3% by weight, based on the total amount of the dialysate and the phosphorus adsorbent.
  • Such a dialysis composition according to the first embodiment contributes to efficient removal of phosphorus concentration in blood in application to a hemodialysis system described later.
  • the hemodialyzer 1 includes a cylindrical casing 3 sealed at both ends by flanges 2a and 2b.
  • the flanges 2a and 2b have through holes (not shown) opened near the center.
  • Pipes 4 which are extracorporeal blood circuits communicating with the through holes are respectively connected to the outer surfaces of these flanges 2a and 2b.
  • the pipe 4 is provided with a pump (not shown) for supplying blood of a dialysis patient into a plurality of hollow core-like semipermeable membranes.
  • the preparation device 5 serving as the dialysis composition supply means described in the first embodiment is connected to the casing 3 through a supply pipe 6.
  • the preparation device 5 prepares a dialysis composition by mixing the dialysate and the phosphorus adsorbent in a desired ratio. More specifically, the preparation device 5 desires a dialysis solution storage unit for storing a dialysis solution, a phosphorus adsorbent storage unit for storing a phosphorus adsorbent, and a dialysis solution and a phosphorus adsorbent stored in each storage unit. It is only necessary to include a mixing part for mixing at a ratio of 1 and a supply part for supplying the dialysis composition obtained by mixing the dialysate and the phosphorus adsorbent into the casing.
  • the supply pipe 6 is connected to the side surface of the casing 3 in the vicinity of the right flange 2b.
  • the discharge pipe 7 is connected to the side surface of the casing 3 near the left flange 2a.
  • the plurality of hollow core-like semipermeable membranes 8 are loaded in the center of the casing 3 so as to be parallel to each other along the longitudinal direction thereof.
  • the blood taken out from the body of the dialysis patient is dialyzed by the dialyzer 1 while flowing through the piping 4 which is an extracorporeal blood circuit, and is returned to the body of the dialysis patient again.
  • the blood circulation speed and circulation amount are controlled by a blood pump (not shown) interposed in the pipe 4.
  • the blood of the dialysis patient is loaded into the casing 3 from the pipe 4 through the left flange 2a by driving the blood pump.
  • the dialysate is supplied from the supply pipe 6 on the right end side of the casing 3 and discharged from the discharge pipe 7 on the left end side of the casing 3. That is, while blood flows from the left to the right in the plurality of hollow core-shaped semipermeable membranes 8, the dialysate flows from the right to the left in the casing 3 loaded with the plurality of hollow core-shaped semipermeable membranes 8. Circulates in the opposite direction of blood flow.
  • phosphorus in the blood moves to the dialysate according to the principle of diffusion by the hollow core-like semipermeable membrane 8.
  • the transfer amount of phosphorus in the blood to the dialysate increases as the absolute concentration of phosphorus in the blood increases, but decreases with an increase in the phosphorus concentration of the dialysate, thereby restricting the removal of phosphorus.
  • the dialysis composition 11 including the dialysis fluid 9 and the phosphorus adsorbent 10 dispersed in the dialysis fluid 9 is loaded from the preparation device 5 with a plurality of hollow core-like semipermeable membranes 8. Circulates in the opposite direction to the blood flow in the casing 3, diffuses and moves from the blood to the dialysis composition 11, and adsorbs the moved phosphorus by the phosphorus adsorbent 10 so that the dialysis composition 11 circulates in the casing 3.
  • the phosphorus concentration of dialysate 9 can be made to a value close to zero, so that the amount of phosphorus in the blood transferred to the dialysis composition can be remarkably increased as described below, and phosphorus in the blood is efficiently removed. it can.
  • FIG. 3 is a diagram showing the relationship between the blood flow direction and the dialysis composition flow direction (horizontal axis) and the blood and dialysis composition phosphorus concentrations (left and right vertical axes) in the second embodiment.
  • the absolute concentration of phosphorus is high, and in addition, the phosphorus concentration in the dialysis composition is close to zero, so the amount of phosphorus in the blood that diffuses and moves into the dialysis fluid of the dialysis composition can be increased. , Blood phosphorus concentration can be rapidly reduced.
  • the dialysis composition Since the phosphorus concentration in the dialysis composition is close to zero even after the midpoint between the inflow side and the outflow side of the blood where the absolute amount of phosphorus concentration in the blood decreases, the dialysis composition from the phosphorus in the blood The state of high diffusion and movement into the object is maintained, and the phosphorus concentration in the blood can be continuously reduced. As a result, phosphorus in the blood flowing out from the hollow core semipermeable membrane 8 to the pipe 4 can be removed very efficiently as compared with the case where only the dialysate is supplied to the casing.
  • the hemodialysis system according to the second embodiment has the following actions and effects.
  • -The phosphorus concentration in the blood can be remarkably reduced on the blood outflow side of the hollow fiber-shaped semipermeable membrane, that is, the amount of phosphorus removed in the blood in one dialysis operation can be increased.
  • the dose of the oral phosphorus adsorbent used in combination with dialysis can be zero or reduced.
  • side effects such as gastrointestinal symptoms associated with the oral phosphorus adsorbent medication of dialysis patients can be reduced.
  • medical costs can be reduced by reducing the dose.
  • ⁇ Phosphorus adsorbent is not directly in contact with blood circulating in the extracorporeal blood circuit, but is used in the dialysate flow path as a dialysis composition dispersed in the dialysate in a solid state. Side effects and contamination of the phosphorus adsorbent into the blood can be avoided. As a result, extremely safe hemodialysis treatment can be performed.
  • the dialysis composition supply means is not limited to the dialysis composition preparation apparatus shown in FIG.
  • a dialysate preparation device 12 and a phosphorus adsorbent source 13 for introducing a phosphorus adsorbent (or a phosphorus adsorbent suspension) into the supply pipe 6 may be configured.
  • blood was circulated in the hollow fiber-shaped semipermeable membrane, and the dialysis composition was circulated in the casing loaded with the hollow fiber-shaped semipermeable membrane.
  • the flow path may be reversed, that is, blood may be circulated in a casing loaded with a hollow fiber-shaped semipermeable membrane, and the dialysis composition may be circulated in the hollow fiber-shaped semipermeable membrane.
  • the hemodialyzer according to the third embodiment includes a cylindrical casing and a hollow fiber dialysis membrane loaded along the length of the casing, and either the inside of the casing or the hollow fiber dialysis membrane.
  • the dispersed form of the phosphorus adsorbent is 1) dispersed in a solid state in the dialysis fluid, 2) filled in a casing through which the dialysis fluid is circulated, 3) the inner periphery of the hollow fiber dialysis membrane through which the dialysis fluid is circulated It is carried on the surface or the outer peripheral surface.
  • FIG. 5 is a schematic view showing a hemodialyzer according to a third embodiment in a state in which a phosphorus adsorbent is filled in a casing through which a dialysate is circulated.
  • the same members as those in FIG. 5 are identical to those in FIG. 5.
  • the hemodialyzer 1 includes a cylindrical casing 3 whose both ends are sealed by the flanges 2a and 2b described above.
  • Pipes 4 are connected to the outer surfaces of the flanges 2a and 2b, respectively.
  • the pipe 4 is provided with a pump (not shown) for supplying blood of a dialysis patient into a plurality of hollow core-like semipermeable membranes.
  • the dialysate supply pipe 6 prepared by a preparation device (not shown) is connected to the vicinity of the right flange 2 b of the casing 3.
  • the discharge pipe 7 is connected to the side surface of the casing 3 near the left flange 2a.
  • the plurality of hollow core-like semipermeable membranes 8 described above are loaded in the center of the casing 3 so as to be parallel to each other along the longitudinal direction thereof.
  • the casing 3 in which the hollow core-like semipermeable membrane 8 is loaded is filled with a phosphorus adsorbent (for example, a granular phosphorus adsorbent) 14.
  • a mesh (not shown) having a mesh opening smaller than the diameter of the granular phosphorus adsorbent 14 is provided at the connection portion between the supply pipe 6 and the discharge pipe 7 with the casing 3 in order to prevent the granular phosphorus adsorbent 14 from flowing out. ) Is arranged.
  • the same kind of phosphorus adsorbent as that in the first embodiment can be used.
  • Phosphorous adsorbent in the case of particles, is spherical, such as a sphere or ellipsoid, a polygon such as a square or rectangle, a polygonal pyramid such as a triangular pyramid or a quadrangular pyramid, or a columnar shape such as a cylinder, a triangular prism, or a quadrangular prism Thing etc. are mentioned.
  • the phosphorus adsorbent is not limited to a granular form, and may be a lump.
  • the phosphorus adsorbent When the phosphorus adsorbent is granular, it is desirable that it has an average particle diameter of 50 to 1000 ⁇ m, more preferably 100 to 500 ⁇ m.
  • the average particle diameter indicates a cumulative volume 50% value, and the measurement method is as described in the first embodiment.
  • the blood taken out from the body of the dialysis patient is dialyzed by the dialyzer 1 while flowing through the piping 4 which is an extracorporeal blood circuit, and is returned to the body of the dialysis patient again.
  • a blood pump (not shown)
  • blood from the dialysis patient is supplied from the pipe 4 through the left flange 2a into the plurality of hollow core-shaped semipermeable membranes 8 loaded in the casing 3, and again from the right flange 2b. It is discharged to the pipe 4.
  • the dialysate 9 is supplied to the right end side of the casing 3 and discharged from the discharge pipe 7 on the left end side of the casing 3.
  • the dialysate 9 moves in the casing 3 loaded with the plurality of hollow core-shaped semipermeable membranes 8 from right to left. Circulates in the opposite direction of blood flow.
  • phosphorus in the blood moves to the dialysate according to the principle of diffusion by the hollow core-like semipermeable membrane 8.
  • the amount of transfer of phosphorus in the blood to the dialysate increases as the absolute concentration of phosphorus in the blood increases as described above, but tends to decrease as the phosphorus concentration of the dialysate increases.
  • a granular phosphorus adsorbent 14 is filled in the casing 3, and the phosphorus that has diffused and moved from the blood flowing through the hollow semipermeable membrane 8 to the dialysate is transferred with the phosphorus adsorbent 14. While the dialysis fluid is adsorbed and circulates in the casing 3, the phosphorus concentration of the dialysis fluid 9 can be approximated to zero, so that the amount of phosphorus in the blood that moves to the dialysis fluid is significantly increased as described below. And phosphorus in the blood can be removed efficiently.
  • the absolute concentration of phosphorus is high on the blood inflow side and the phosphorus concentration of the dialysate is a value close to zero, the amount of phosphorus in the blood that diffuses and moves into the dialysate as in FIG. And phosphorus concentration in the blood can be rapidly decreased. Since the absolute value of phosphorus concentration in the blood is reduced, the concentration of phosphorus in the dialysate is close to zero even after the midpoint between the inflow side and outflow side of the blood. High diffusion and movement are maintained, and the phosphorus concentration in the blood can be continuously reduced. As a result, phosphorus in blood flowing out from the hollow core-like semipermeable membrane 8 to the pipe 4 can be removed very efficiently.
  • the hemodialyzer according to the third embodiment shown in FIG. 5 can increase the amount of phosphorus removal in the blood in one dialysis operation as in the second embodiment described above.
  • the dose of medication can be zero or reduced.
  • side effects such as gastrointestinal symptoms associated with the oral phosphorus adsorbent medication of dialysis patients can be reduced.
  • the phosphorus adsorbent is used by being filled in the casing 3 which is a flow path for dialysate without directly contacting the blood circulating in the extracorporeal blood circuit, side effects due to the phosphorus adsorbent on the blood and phosphorus adsorption on the blood are used. Mixing of the agent can be avoided. As a result, extremely safe hemodialysis treatment can be performed.
  • FIG. 6 is a schematic view showing a hemodialyzer according to a third embodiment in which a phosphorus adsorbent is supported on the outer peripheral surface of a hollow fiber dialysis membrane through which a dialysate is circulated
  • FIG. 7 is a blood diagram of FIG. It is a perspective view which shows the hollow fiber shaped semipermeable membrane integrated in a dialyzer.
  • FIG. 6 the same members as those shown in FIG.
  • the plurality of hollow core-like semipermeable membranes 8 are loaded in the center of the casing 3 so as to be parallel to each other along the longitudinal direction thereof. As shown in FIG. 7, the hollow core-like semipermeable membrane 8 has a phosphorus adsorbent (for example, a plurality of powdered phosphorus adsorbents) 15 supported on its outer peripheral surface.
  • a phosphorus adsorbent for example, a plurality of powdered phosphorus adsorbents
  • the same kind of phosphorus adsorbent as that in the first embodiment can be used.
  • the phosphorus adsorbent When the phosphorus adsorbent is in a powder form, it is desirable that it has an average particle size of 0.1 to 30 ⁇ m, more preferably 1 to 20 ⁇ m.
  • the average particle diameter indicates a cumulative volume 50% value, and the measurement method is as described in the first embodiment.
  • the phosphorus adsorbent is preferably supported on the outer peripheral surface of the hollow core-shaped semipermeable membrane at an area ratio of 10 to 90%.
  • the phosphorus adsorbent may be immobilized on the outer peripheral surface of the hollow core-shaped semipermeable membrane by a known method.
  • a powdered phosphorus adsorbent 15 is supported on the outer peripheral surface (surface through which dialysate flows) of the hollow core-like semipermeable membrane 8 as shown in FIG.
  • the phosphorus that has diffused and moved from the blood flowing through the hollow semi-permeable semipermeable membrane 8 to the dialysate 9 is quickly adsorbed by the phosphorus adsorbent 15 and the dialysate 9 flows through the casing 3, Since the phosphorus concentration of the dialysate 9 can be made a value close to zero, as described below, the amount of phosphorus in the blood that moves to the dialysate can be significantly increased, and phosphorus in the blood can be efficiently removed.
  • the absolute concentration of phosphorus is high on the blood inflow side and the phosphorus concentration of the dialysate is a value close to zero, the amount of phosphorus in the blood that diffuses and moves into the dialysate as in FIG. And phosphorus concentration in the blood can be rapidly decreased. Since the absolute value of phosphorus concentration in the blood is reduced, the concentration of phosphorus in the dialysate is close to zero even after the midpoint between the inflow side and outflow side of the blood. High diffusion and movement are maintained, and the phosphorus concentration in the blood can be continuously reduced. As a result, phosphorus in blood flowing out from the hollow core-like semipermeable membrane 8 to the pipe 4 can be removed very efficiently.
  • the hemodialyzer of this aspect according to the third embodiment shown in FIG. 6 can be used in combination with dialysis because the amount of phosphorus removal in blood in one dialysis operation can be increased as in the first embodiment described above.
  • the dose of oral phosphorus adsorbent can be reduced to zero or reduced.
  • Phosphorus adsorbent is not directly contacted with blood circulating in the extracorporeal blood circuit, and is used by being supported on the outer peripheral surface of the hollow core-like semipermeable membrane 8 which is a flow path for dialysate. Side effects and contamination of the phosphorus adsorbent into the blood can be avoided. As a result, extremely safe hemodialysis treatment can be performed.
  • blood was circulated in the hollow fiber-shaped semipermeable membrane, and the dialysate was circulated in the casing loaded with the hollow fiber-shaped semipermeable membrane.
  • the flow path of the dialysate may be reversed, that is, the blood may be circulated through the casing loaded with the hollow fiber-shaped semipermeable membrane, and the dialysate may be circulated through the hollow fiber-shaped semipermeable membrane.
  • a phosphorus adsorbent for example, a plurality of powdered phosphorus adsorbents 15 is supported on the inner peripheral surface of a hollow fiber-shaped semipermeable membrane through which the dialysate is circulated as shown in FIG.
  • the type, average particle size, loading, loading method, and the like of the phosphorus adsorbent to be supported on the inner peripheral surface of the hollow fiber-shaped semipermeable membrane are the same as in the case of supporting on the outer peripheral surface of the hollow core-shaped semipermeable membrane.
  • the hemodialysis method of the fourth embodiment is characterized in that hemodialysis is performed on a dialysis patient using the dialysis composition, hemodialysis system, or hemodialyzer.
  • the method for performing hemodialysis on a dialysis patient is not particularly limited as long as the dialysis composition, hemodialysis system, or hemodialyzer is used.
  • Dialysis time, blood flow rate and flow rate As for the flow rate and flow rate of the dialysate, the same conditions as in normal hemodialysis can be employed.
  • the patient to which the above first to fourth embodiments are applied is not particularly limited as long as it is a patient requiring hemodialysis such as a renal failure patient.
  • patients with renal failure associated with hyperphosphatemia are preferable because the phosphorus in the medium can be efficiently removed.
  • compositional analysis of sulfuric acid / carbonic acid / titanium oxide-like compounds and carbonic acid / titanium oxide-like compounds The composition of the obtained sulfuric acid / carbonic acid / titanium oxide-like compound and carbonic acid / titanium oxide-like compound was measured by the following method.
  • Titanium oxide content (%) (BT) ⁇ f ⁇ 0.79888 / sampled amount (g) / 1000 ⁇ 250/5 ⁇ 100 here
  • B Consumption amount (mL) of 0.01 mol / L bismuth nitrate solution in the blank test
  • T consumption (mL) of 0.01 mol / L bismuth nitrate solution
  • f 0.01 mol / L factor of bismuth nitrate solution
  • TiO 2 amount required for consumption of 0.01 mol / L disodium dihydrogen ethylenediamine tetraacetate solution 1mL is 0.7988Mg.
  • Measurement method of carbonic acid content The following test methods are as follows: JIS R9011: 2006 lime test method 18. Carbon dioxide quantification method 18.1 Barium carbonate back titration method as a reference, and using the apparatus of FIG. 1 described in JIS R9011: 2006 went. In order to avoid confusion with FIG. 1 described in the hemodialysis system of the present text, FIG. 1 described in JIS R9011: 2006 is replaced with FIG. About 2 g of sample was accurately weighed and placed in a sample decomposition flask (B in FIG. A). In addition, in order to boil smoothly, several boiling stones were added.
  • the absorption part was vigorously shaken up and down for about 5 minutes, the pinch cock and the glass cock were opened, and the absorption liquid remaining in the spherical part was allowed to flow down into the Erlenmeyer flask.
  • the spherical part is removed from the Erlenmeyer flask, a rubber stopper (J in FIG. A) is fitted, the tip of the burette (K in FIG. A) is inserted deeply, and titrated with a 0.2 mol / L hydrochloric acid standard solution. The end point was when it disappeared.
  • a blank test was performed by the same operation. The measurement result was substituted into the following equation to determine the carbonic acid (CO 3 ) content.
  • Carbonic acid content (%) ⁇ (BT) ⁇ f ⁇ 0.0044 / sampled amount (g) ⁇ 60/44 ⁇ 100 ⁇ / ⁇ 1- (loss on drying / 100) ⁇
  • T consumption of 0.2 mol / L hydrochloric acid standard solution (mL)
  • B Consumption (mL) of 0.2 mol / L hydrochloric acid standard solution in the blank test
  • f Factor of 0.2 mol / L hydrochloric acid standard solution Loss on drying: Loss on drying (%) determined by the following “4. Measuring method of drying loss” It is.
  • Method for measuring loss on drying 1 g of a sample was dried at 105 ° C. for 3 hours, and the change in weight before and after the treatment was measured. The weight of the sample before the drying treatment was taken as 100%, and the ratio of the weight reduced in the sample after the drying treatment was determined as the loss on drying.
  • FIG. 9 shows the results of the sulfuric acid / carbonic acid / titanium oxide-like compound (2)
  • FIG. 10 shows the results of the carbonic acid / titanium oxide-like compound.
  • Dialysis Test [Phosphorus removal test (dialysis test)] 1. Dialysis Test Method The following test was performed using AM-BC-08F manufactured by Asahi Kasei Medical Co., Ltd. or KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. as a dialyzer. A dialysate supply line was connected to the dialysate supply port of the dialyzer, and a dialysate discharge line was connected to the dialysate discharge port. On the other hand, a blood inflow line is connected to the blood inflow port of the dialyzer, a blood outflow line is connected to the blood outflow port, and the pseudo blood flowing out of the blood outflow line is not circulated again to the dialyzer. The device was assembled.
  • the simulated blood was 66.62 g of sodium chloride, 3.73 g of potassium chloride, 1.84 g of calcium chloride dihydrate, 3.05 g of magnesium chloride hexahydrate, 2.84 g of disodium hydrogen phosphate (anhydrous), 6 mol. / L hydrochloric acid (3.3 mL) and glucose (20.00 g) were accurately weighed and dissolved by adding water to make exactly 1 L to obtain simulated blood A solution.
  • 16.8 g of sodium hydrogen carbonate was accurately weighed and dissolved by adding water to make exactly 1 L to obtain simulated blood B solution.
  • 1 L of pseudo blood B liquid was added to make the total liquid volume 10 L, and pseudo blood was obtained.
  • the phosphorus concentration of this simulated blood was 62.0 ppm.
  • the solution was discharged through the dialysate discharge line.
  • a phosphorus removal test was performed in which simulated blood was collected from the blood outflow line connected to the blood outlet of the dialyzer 15 minutes after the start of dialysate supply. The phosphorus concentration in the simulated blood after the phosphorus removal test was measured under the conditions described later.
  • Comparative Example 2 A phosphorus removal test was performed under the same conditions as in Comparative Example 1 except that KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. was used as the dialyzer.
  • Example 1 AM-BC-08F manufactured by Asahi Kasei Medical Co., Ltd. was used as the dialyzer. Dialysate (Kindaly Dialyzer 2E; manufactured by Fuso Pharmaceutical Co., Ltd.) 0.1 g of sulfuric acid / carbonic acid / titanium oxide-like compound (1) (phosphorus adsorbent) per 100 mL is dispersed and suspended in a solid state. Inventive dialysis compositions were prepared. Using this dialysis composition, a phosphorus removal test was performed in the same manner as in Comparative Example 1.
  • Example 2 As a dialyzer, KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. was used. 1 g of sulfuric acid / carbonic acid / titanium oxide-like compound (2) (phosphorus adsorbent) per 100 mL of dialysate (Kindaly dialyzer 2E; manufactured by Fuso Pharmaceutical Co., Ltd.) was dispersed and suspended in a solid state. A dialysis composition was prepared. Using this dialysis composition, a phosphorus removal test was performed in the same manner as in Comparative Example 1.
  • Example 3 As a dialyzer, KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. was used. Dialysate (Kindaly dialyzer 2E; manufactured by Fuso Pharmaceutical Co., Ltd.) 3 g of sulfuric acid / carbonic acid / titanium oxide-like compound (2) (phosphorus adsorbent) per 100 mL was dispersed and suspended in a solid state. A dialysis composition was prepared. Using this dialysis composition, a phosphorus removal test was performed in the same manner as in Comparative Example 1.
  • Example 4 As a dialyzer, KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. was used. Dialysate (Kindaly dialyzer 2E; manufactured by Fuso Pharmaceutical Co., Ltd.) 1 g of carbon-containing / titanium oxide-like compound (phosphorus adsorbent) per 100 mL is dispersed and suspended in a solid state to prepare the dialysis composition of the present invention. did. Using this dialysis composition, a phosphorus removal test was performed in the same manner as in Comparative Example 1.
  • Example 5 As a dialyzer, KF-08C manufactured by Asahi Kasei Kuraray Medical Co., Ltd. was used. Dialysate (Kindaly dialyzer 2E; manufactured by Fuso Yakuhin Kogyo Co., Ltd.) 3 g of carbon dioxide-containing titanium oxide-like compound (phosphorus adsorbent) per 100 mL is dispersed and suspended in a solid state to prepare the dialysis composition of the invention did. Using this dialysis composition, a phosphorus removal test was performed in the same manner as in Comparative Example 1.
  • Method for Measuring Phosphorus Concentration Phosphorus concentration in simulated blood collected in each Comparative Example and Example was measured by the following method.
  • Method for Measuring Phosphorus Concentration in Simulated Blood For simulated blood after flowing for 15 minutes, 0.48 mL of 6 mol / L hydrochloric acid aqueous solution was added per 100 mL to prepare a sample solution. 20 mL of this solution and 1 mL of a 1000 ppm nitrate ion solution (internal standard solution) were accurately weighed and water was added to make exactly 100 mL to obtain a sample solution.
  • FIGS. 11 shows the results of the phosphorus removal test according to Comparative Example 1 and Example 1
  • FIG. 12 shows the results of the phosphorus removal test according to Comparative Example 2 and Examples 2 to 3
  • FIG. 13 shows the results of Comparative Example 2 and Example. 4 shows the results of the phosphorus removal test according to 4-5.
  • phosphorus removal ability depends not only on the type of dialysis composition but also on the performance of the dialyzer.
  • the performance of AM-BC-08 and KF-08C used in this dialysis test is shown in Table 5. Since KF-08C has a lower phosphorus clearance than AM-BC-08F, even in the same conditions except for the type of dialyzer, Comparative Example 2 has a lower phosphorus removal efficiency than Comparative Example 1 ( (See Table 4).
  • the test results include the phosphorus adsorbent by including the phosphorus adsorbent in the dialysate, regardless of the dialyzer used. It has been demonstrated that the phosphorus removal efficiency is significantly improved as compared to the case where it is not.

Abstract

La présente invention concerne un hémodialyseur capable d'éliminer efficacement le phosphore dans le sang sans qu'un adsorbant au phosphore soit mis en contact direct avec le sang circulant dans un circuit sanguin extracorporel à des fins de traitement de dialyse. La présente invention concerne spécifiquement un hémodialyseur qui est pourvu d'un boîtier cylindrique et d'une membrane de dialyse à fibre creuse chargée le long de la direction longitudinale du boîtier dans le boîtier et dans lequel le sang est amené à passer à travers le boîtier ou la membrane de dialyse à fibre creuse, et une solution de dialyse est passée à travers l'autre. Ledit hémodialyseur est caractérisé en ce que l'adsorbant au phosphore est présent dans le boîtier ou la membrane de dialyse à fibre creuse, à travers laquelle la solution de dialyse est passée.
PCT/JP2011/058061 2010-03-31 2011-03-30 Composition de dialyse, système d'hémodialyse, et hémodialyseur WO2011125758A1 (fr)

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WO2017094478A1 (fr) * 2015-11-30 2017-06-08 東レ株式会社 Adsorbant de phosphore, fibre poreuse et colonnes d'adsorption de phosphore
WO2018212269A1 (fr) 2017-05-17 2018-11-22 旭化成メディカル株式会社 Agent adsorbant le phosphore destiné au traitement du sang, système de traitement du sang et méthode de traitement du sang
JP2019510560A (ja) * 2016-03-18 2019-04-18 ヘモ プラス エスエーアールエル 血液透析用の少なくとも１つの濃縮物溶液を調製するためのユニット及びそのような溶液を調製するための方法
WO2019189884A1 (fr) 2018-03-30 2019-10-03 旭化成メディカル株式会社 Dispositif de purification de sang et son procédé de production
WO2019189881A1 (fr) 2018-03-30 2019-10-03 旭化成メディカル株式会社 Dispositif de purification de sang et son procédé de production
WO2020203927A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Purificateur de sang
WO2020203923A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Purificateur de sang
WO2020203926A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Dispositif de purification du sang et son procédé de fabrication
US11090421B2 (en) 2018-11-28 2021-08-17 Baxter International Inc. Systems and methods for batch sorbent material reuse
FR3109734A1 (fr) * 2020-05-04 2021-11-05 Mexbrain Système de dialyse pour le traitement du sepsis
US11253849B2 (en) 2018-11-28 2022-02-22 Baxter International Inc. Systems and methods for onsite sorbent material reuse
US11925916B2 (en) 2018-11-28 2024-03-12 Baxter International Inc. Method and composition for removing uremic toxins

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US11964084B2 (en) 2015-11-11 2024-04-23 Asahi Kasei Medical Co., Ltd. Phosphate adsorbing agent for blood processing, blood processing system and blood processing method
JPWO2017082423A1 (ja) * 2015-11-11 2018-08-30 旭化成メディカル株式会社 血液処理用リン吸着剤、血液処理システム及び血液処理方法
WO2017082423A1 (fr) * 2015-11-11 2017-05-18 旭化成メディカル株式会社 Agent adsorbant le phosphore pour le traitement du sang, système de traitement du sang et méthode de traitement du sang
WO2017094478A1 (fr) * 2015-11-30 2017-06-08 東レ株式会社 Adsorbant de phosphore, fibre poreuse et colonnes d'adsorption de phosphore
CN108289991A (zh) * 2015-11-30 2018-07-17 东丽株式会社 磷吸附剂、多孔质纤维和磷吸附柱
JP2019510560A (ja) * 2016-03-18 2019-04-18 ヘモ プラス エスエーアールエル 血液透析用の少なくとも１つの濃縮物溶液を調製するためのユニット及びそのような溶液を調製するための方法
WO2018212269A1 (fr) 2017-05-17 2018-11-22 旭化成メディカル株式会社 Agent adsorbant le phosphore destiné au traitement du sang, système de traitement du sang et méthode de traitement du sang
TWI667027B (zh) * 2017-05-17 2019-08-01 日商旭化成醫療股份有限公司 血液處理用磷吸附劑、血液處理系統及血液處理方法
US11224871B2 (en) 2017-05-17 2022-01-18 Asahi Kasei Medical Co., Ltd. Phosphate adsorbing agent for blood processing, blood processing system and blood processing method
WO2019189881A1 (fr) 2018-03-30 2019-10-03 旭化成メディカル株式会社 Dispositif de purification de sang et son procédé de production
US11806461B2 (en) 2018-03-30 2023-11-07 Asahi Kasei Medical Co., Ltd. Blood purification device and method for producing same
JPWO2019189884A1 (ja) * 2018-03-30 2020-12-17 旭化成メディカル株式会社 血液浄化器及びその製法
US11878101B2 (en) 2018-03-30 2024-01-23 Asahi Kasei Medical Co., Ltd. Blood purification device and method for producing same
WO2019189884A1 (fr) 2018-03-30 2019-10-03 旭化成メディカル株式会社 Dispositif de purification de sang et son procédé de production
US11925916B2 (en) 2018-11-28 2024-03-12 Baxter International Inc. Method and composition for removing uremic toxins
US11090421B2 (en) 2018-11-28 2021-08-17 Baxter International Inc. Systems and methods for batch sorbent material reuse
US11833284B2 (en) 2018-11-28 2023-12-05 Baxter International Inc. Systems and methods for batch sorbent material reuse
US11253849B2 (en) 2018-11-28 2022-02-22 Baxter International Inc. Systems and methods for onsite sorbent material reuse
WO2020203923A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Purificateur de sang
WO2020203926A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Dispositif de purification du sang et son procédé de fabrication
WO2020203927A1 (fr) 2019-03-29 2020-10-08 旭化成メディカル株式会社 Purificateur de sang
WO2021224569A1 (fr) * 2020-05-04 2021-11-11 Mexbrain Système de dialyse pour le traitement du sepsis.
FR3109734A1 (fr) * 2020-05-04 2021-11-05 Mexbrain Système de dialyse pour le traitement du sepsis

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