Blood purification device and method for producing same
Provided is a blood purification device including a porous molded body that has a high phosphorus adsorption capacity and that can be used safely. A blood purification device includes a porous molded body containing an inorganic ion-adsorbing material and is characterized by the following: said blood purification device satisfies the relationship B=−0.02 A+2.175±0.185 (74≤A≤94) when the moisture content of the porous molded body is denoted by A and the bulk density is denoted by B; and the number of fine particles having a size of 10 μm or more is 25 or less and the number of fine particles having a size of 25 μm or more is 3 or less in 1 mL of a physiological saline solution for injection both three months and six months after said physiological saline solution for injection is sealed in the blood purification device.
1. A blood purification device comprising a porous molded body comprising a porous molded body-forming polymer and an inorganic ion adsorbent, wherein the relationship B=−0.02 A+2.175±0.185 (74≤A≤94) is satisfied, where A is the water content and B is the bulk density of the porous molded body, while the number of microparticles with sizes of 10 μm or greater is no more than 25 and the number of microparticles with sizes of 25 μm or greater is no more than 3, in 1 mL of the physiological saline for injection at 3 months and 6 months after the physiological saline for injection has been encapsulated in the blood purification device.
2. The blood purification device according to claim 1 , wherein the porous molded body is composed of the porous molded body-forming polymer, a hydrophilic polymer and the inorganic ion adsorbent.
3. The blood purification device according to claim 2 , wherein the porous molded body-forming polymer is an aromatic polysulfone.
4. The blood purification device according to claim 2 or 3 , wherein the hydrophilic polymer is a biocompatible polymer.
5. The blood purification device according to claim 4 , wherein the biocompatible polymer is a polyvinylpyrrolidone (PVP)-based polymer.
6. The blood purification device according to any one of claims 1 to 3 , wherein the porous molded body is coated with a biocompatible polymer.
7. The blood purification device according to claim 6 , wherein the biocompatible polymer is selected from the group consisting of polyvinylpyrrolidone (PVP)-based polymers and polymethoxyethyl acrylate (PMEA).
8. The blood purification device according to any one of claims 1 to 3 , wherein the blood phosphorus adsorption of the porous molded body is 2 mg/ml or greater.
9. The blood purification device according to any one of claims 1 to 3 , wherein the inorganic ion adsorbent contains at least one metal oxide represented by the following formula (1):
MN x O n ·m H 2 O (1)
{where x is 0 to 3, n is 1 to 4, m is 0 to 6, and M and N are metal elements selected from the group consisting of Ti, Zr, Sn, Sc, Y, La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, Lu, Al, Si, Cr, Co, Ga, Fe, Mn, Ni, V, Ge, Nb and Ta, and are different from each other}.
10. The blood purification device according to claim 9 , wherein the metal oxide is selected from among the following groups (a) to (c):
(a) hydrated titanium oxide, hydrated zirconium oxide, hydrated tin oxide, hydrated cerium oxide, hydrated lanthanum oxide and hydrated yttrium oxide;
(b) complex metal oxides comprising at least one metal element selected from the group consisting of titanium, zirconium, tin, cerium, lanthanum, neodymium and yttrium and at least one metal element selected from the group consisting of aluminum, silicon and iron; and
(c) activated alumina.
11. A method for producing the blood purification device according to claim 7 , comprising a step of washing a porous molded body containing the inorganic ion adsorbent with a supercritical fluid or subcritical fluid, and then coating the surface with PMEA.