Nerve regeneration-inducing material

Abstract

A non-tubular material for nerve regeneration induction, which can be used for the regeneration of a damaged part in a nerve, and which comprises: (A) a crosslinked form produced by crosslinking a low-endotoxin bioabsorbable polysaccharide having a carboxyl group in the molecule with at least one crosslinkable reagent selected from a compound represented by general formula (I) and a salt thereof via covalent bonds; and (B) a bioabsorbable polymer. R1HN—(CH2)n—NHR2 (I) [wherein R1 and R2 independently represent a hydrogen atom or a group represented by formula: —COCH(NH2)—(CH2)4—NH2, and n represents an integer of 2 to 18]. Thus, a medical material that can induce the regeneration of a damaged part in a nerve is provided.

1 . A nerve regeneration-inducing material, which is a non-tubular material and used to regenerate a damaged site of a nerve, the material comprising: (A) a crosslinked form obtained by covalent bond crosslinking a low endotoxin bioabsorbable polysaccharide having a carboxyl group within a molecule thereof with at least one type of crosslinking reagent selected from a compound represented by the following general formula (I) and a salt thereof; and (B) a bioabsorbable polymer:
   R 1 HN—(CH 2 ) n —NHR 2   (I),
   wherein R 1  and R 2  respectively and independently represent a hydrogen atom or group represented by the formula: —COCH(NH 2 )—(CH 2 ) 4 —NH 2 , and n represents an integer of 2 to 18.   
     
     
         2 . The nerve regeneration-inducing material according to  claim 1 , wherein the bioabsorbable polysaccharide having a carboxyl group in a molecule thereof is at least one type selected from the group consisting of alginic acid, an ester thereof and a salt thereof. 
     
     
         3 . The nerve regeneration-inducing material according to  claim 1 , wherein the crosslinking reagent is an N-hydroxysuccinimide salt of the compound represented by general formula (I). 
     
     
         4 . The nerve regeneration-inducing material according to  claim 3 , wherein the N-hydroxysuccinimide salt of the compound represented by general formula (I) is at least one type selected from the group consisting of a 2N-hydroxysuccinimide salt of diaminoethane, a 2N-hydroxysuccinimide salt of diaminohexane, a 4N-hydroxysuccinimide salt of N,N′-di(lysyl)-diaminoethane and a 3N-hydroxysuccinimide salt of N-(lysyl)-diaminohexane. 
     
     
         5 . The nerve regeneration-inducing material according to  claim 1 , which is in the form of a xerogel. 
     
     
         6 . The nerve regeneration-inducing material according to  claim 1 , wherein the bioabsorbable polymer is at least one type selected from the group consisting of polyglycolic acid, polylactic acid and a copolymer thereof, and polycaprolactone. 
     
     
         7 . The nerve regeneration-inducing material according to  claim 1 , which is irradiated with an electron beam and/or gamma rays at an adsorbed dose of 1 kGy to 100 kGy. 
     
     
         8 . The nerve regeneration-inducing material according to  claim 1 , wherein the material is configured such that, after cutting the material to a size measuring 2 cm long×2 cm wide without specifying thickness, clamping the material at a location 5 mm away from one of cut surfaces with a double clip so as to interpose the same (clamped portion A) and immersing a region up to 10 mm from a cut surface (B) opposing the clamped portion A of the material in physiological saline for 15 minutes, and then a tensile tear test is carried out at a speed of 10 mm/min, with the clamped portion A horizontal to a square surface of the material by passing a needle with a suture through the center of a location 5 mm away from the cut surface (B) of the material and immobilizing both ends of the suture with a clamp, the maximum test force (load) of the material is 0.10 (N) to 10.0 (N). 
     
     
         9 . The nerve regeneration-inducing material according to  claim 2 , wherein the content of at least one type selected from the group consisting of alginic acid, an ester thereof and a salt thereof in the material is 0.2 mg/cm 2  to 12 mg/cm 2  as sodium alginate. 
     
     
         10 . The nerve regeneration-inducing material according to  claim 1 , wherein the content of bioabsorbable polymer in the material is 0.05 mg/cm 2  to 30 mg/cm 2 . 
     
     
         11 - 15 . (canceled) 
     
     
         16 . The nerve regeneration-inducing material according to  claim 1 , wherein the bioabsorbable polysaccharide having a carboxyl group in a molecule thereof is a low endotoxin bioabsorbable polysaccharide. 
     
     
         17 . The nerve regeneration-inducing material according to  claim 2 , wherein the content of at least one type selected from the group consisting of alginic acid, an ester thereof and a salt thereof in the material is 1 mg/cm 2  to 5 mg/cm 2  as sodium alginate. 
     
     
         18 . The nerve regeneration-inducing material according to  claim 1 , wherein the content of bioabsorbable polymer in the material is 1 mg/cm 2  to 5 mg/cm 2 . 
     
     
         19 . The nerve regeneration-inducing material according to  claim 1 , wherein the form of the bioabsorbable polymer is at least one type selected from the group consisting of nonwoven fabric, woven fabric, mesh and needle punch. 
     
     
         20 . The nerve regeneration-inducing material according to  claim 1 , wherein the shape of non-tubular material is at least one type selected from the group consisting of a sheet, a curve, and a sheet with surface irregularities.