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POROUS BODY AND MATERIAL FOR MEDICAL USE 新技術説明会

外国特許コード F200010141
整理番号 (S2018-0685-N0,180021JP01)
掲載日 2020年6月2日
出願国 世界知的所有権機関(WIPO)
国際出願番号 2019JP022418
国際公開番号 WO 2019235543
国際出願日 令和元年6月5日(2019.6.5)
国際公開日 令和元年12月12日(2019.12.12)
優先権データ
  • 特願2018-108148 (2018.6.5) JP
発明の名称 (英語) POROUS BODY AND MATERIAL FOR MEDICAL USE 新技術説明会
発明の概要(英語) A porous body which has a first surface and a second surface opposite to each other, and which contains a first polymer material and a second polymer material. With respect to this porous body, the Young's modulus of the first polymer material is lower than the Young's modulus of the second polymer material; the in vivo disappearance rate of the first polymer material is higher than the in vivo disappearance rate of the second polymer material; and the composition in a first region of the porous body and the composition in a second region of the porous body are different from each other.
従来技術、競合技術の概要(英語) BACKGROUND ART
Scaffold as the material for the medical device such as, expanded polytetrafluoroethylene (ePTFE) is widely used. EPTFE is flexible, there is no activity to the living organism, many soft tissue-based material have been applied. On the other hand, the body is not absorbed by the ePTFE, thrombus formation in the remote phase, calcification, has a problem such as durability. Therefore, in recent years, with excellent absorption absorbent material can be applied to the medical device has been studied (for example, JP-1-6, see Non-Patent Document 1-9). Prior art document Patent Document 1 JP-2012-519559 Patent Document 2 Japanese Patent Laid-Open No. 2017-080116 Japanese Patent No. 4 6294577 3 patent JP-2013-534978 Patent Document 5 Japanese Patent Publication JP-2014-517070 Patent Document 6 JP-2009-515569 Non-Patent Document Japanese Patent Application Non-Patent Document 1 Sugiura T et al.,"Novel Bioresorbable Vascular Graft With Sponge-Type Scaffold as a Small-Diameter Arterial Graft",Ann Thorac Surg. 102, 720-727 (2016) 3 Wang S et. al.,"Fabrication of small-diameter vascular scaffolds by heparin-bonded P(LLA-CL) composite nanofibers to improve graft patency",International Journal of Nanomedicine,Dove Medical Press, 2013 7 June Non-Patent Document 2 Tara S et al.,"Evaluation of remodeling process in small-diameter cell-free tissue-engineered arterial graft",J. Vasc. Surg.62,734-743 (2015) was non-patent, vol. 8,2131-2139. Non-Patent Document 4 Young Min Shin et.al., 5 Tal Dvir et.al.,"Prevascularization of cardiac patch on the omentum improves its therapeutic outcome",PNAS. 106, 14990-14995 (2009) Non-Patent Document 6 Erik J. Suuronen et.al.,"An acellular matrix-bound ligand enhances the mobilization, recruitment and therapeutic effects of circulating progenitor cells in a hindlimb ischemia model",FASEB J. 23, 1447-1458 (2009) to Non-Patent Document"Mussel-Inspired Immobilization of Vascular Endothelial Growth Factor (VEGF) for Enhanced Endothelialization of Vascular Grafts", Biomacromolecules. 13,2020-2028 (2012) Non-Patent Document 7 K.R.Stevens et.al.,"Physiological function and transplantation of scaffold-free and vascularized human cardiac muscle tissue",PNAS. 106,16568-16573 (2009) the non-patent document 8 N. Engl. J. Med. 344, 532-533 (2001), J. Thorac. Cardiovasc. Surg.139,431-436 (2010) 9 M. Kheradmandi et.al.,"Skeletal muscle regeneration via engineered tissue culture over electrospun nanofibrous chitosan/PVA scaffold",J. Biomed. Mater. Res. Part A(J Biomed Mater Res A). 104,1720-1727 (2016) Non-Patent Document 10 B. M. Learoyd et.al. to Non-Patent Document, "Alterations with age in the viscoelastic properties of human arterial walls", Circ. Res. 18,278-292 (1966)
Problem to be solved
Bioabsorbable excellent absorbent material advantageously applied to a medical device, the rate of absorption of the absorbent material, the intensity of the medical device is difficult to be achieved.
General disclosure
1 In the first embodiment of the present invention, the porous body are provided. The above-described porous body, for example, the first and second surface 1 opposite to each other having a first surface 2. The above-described porous body, for example, the first polymer material 2. The above-described porous body, for example, 37°C of purified water in the water is determined based on the tensile strength of the porous body with a Young's modulus, 0.1mpa or more is 10mpa or less. In the above-described porous body, porous body (i) taken from the first region 1, the first 10mm x 10mm of the magnitude of the sample 1, to the biological fluid of 35-39 ° C. between the pseudo 30 is immersed in the case in which the mass loss rate of 1 samples, for example, the first porous body (ii) collected from the region 2, the first 10mm x 10mm of the magnitude of the sample 2, to the biological fluid of 35-39 ° C. between the pseudo 30 is immersed in a case in which the mass of the loss rate greater than 2. In the above-described porous body, the first surface 1 of the first and second distance 1 area, the first and the second region 2 smaller than the distance of the surface 1.
In the above-described porous body, the first polymeric material is 2, for example, the second biodegradable plastic 2, the biopolymer 2 first, and, the first selected from the group consisting of natural polymers 2 1 including at least one material. In the above-described porous body, the second biodegradable plastic is 2, for example, D (i) poly (PDLA) lactic acid, lactic acid (PLLA) poly L, poly lactic acid and DL (PDLLA), poly (ε - caprolactone), polyglactin, carbonate, decomposition of the polyurethane, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) selected from the group consisting of salts and derivatives thereof at least one 1. In the above-described porous body, the first body 2 is polymer, for example, (i) collagen, fibrin, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of one 1. In the above-described porous body, the first 2 natural polymer is, for example, chitin (i), sericin, fibroin, carboxymethyl cellulose, chitosan, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of one 1.
The above-described porous body, the first polymer material 2 is also excellent in a biodegradable or bioresorbable 1 may include a first polymeric material. In the above-described porous body, the mass of the loss rate and the first 1, second sample 2 and the rate of mass loss of the difference in absolute value is, greater than or equal to 0.5%. The absolute value of the difference described above, preferably 0.7% or more, more preferably 1.0% or more, more preferably 1.5% or more, more preferably 2% or more, more preferably 2.5% or more, more preferably 3% or more.
2 In the first embodiment of the present invention, the porous body are provided. The above-described porous body, for example, the first and second surface 1 opposite to each other having a first surface 2. The above-described porous body, for example, the first polymer material 2 and the second polymeric material 1. In the above-described porous body, for example, the first Young's modulus of the polymer material 1, 2 is smaller than the first Young's modulus of the polymeric material. In the above-described porous body, for example, the first polymeric material 1 the loss rate of the in vivo, the first polymeric material 2 is greater than the rate of disappearance of the in-vivo. In the above-described porous body, for example, the first region 1 and the composition of the porous body, porous body in the region 2 and the second composition, are different from each other. In the above-described porous body, for example, the first surface 1 of the first and second distance 1 area, the first and the second region 2 smaller than the distance of the surface 1.
3 In the first embodiment of the present invention, the porous body are provided. The above-described porous body, for example, the first and second surface 1 opposite to each other having a first surface 2. The above-described porous body, for example, the first polymer material 2 and the second polymeric material 1. In the above-described porous body, for example, the first Young's modulus of the polymer material 1, 2 is smaller than the first Young's modulus of the polymeric material. In the above-described porous body, for example, the first polymeric material 1 of the phosphate-buffered saline with respect to the absorption is, for example, the first polymeric material 2 with respect to the phosphate-buffered saline is larger than the absorbent. In the above-described porous body, for example, the first region 1 and the composition of the porous body, porous body in the region 2 and the second composition, are different from each other. In the above-described porous body, for example, the first surface 1 of the first and second distance 1 area, the first and the second region 2 smaller than the distance of the surface 1.
1 In the above, according to embodiments of the first and second 2 3 in the porous body, porous body 1 (a) in the region of the first, the second density of the polymeric material 1 with respect to the ratio of the density of the polymeric material 2, (b) in the region of the first porous body 2, density of the polymeric material 1 with respect to the first 2 and the ratio of the density of the polymeric material, may be different from one another. The above-described porous body, porous body 1 disposed on the surface of the surface side of the first, the second surface 1 may comprise a porous. The above-described porous body, the first surface 1 2 disposed on the surface side of the first, the second support surface 1, may comprise a porous support layer. In the above-described porous body, the first region 1, at least a portion of the first surface 1 may be disposed. In the above-described porous body, the first region 2, at least a portion of the support layer may be disposed.
In the above-described porous body, the first support surface and each of the layers 1, 1 and the second polymeric material comprises a polymeric material 2 may have a composite fiber web. In the above-described porous body, the first area 1 (i) in the composite fiber, the first polymeric material 1 to the mass of the mass ratio of the first polymeric material 2, the composite fiber (ii) in the first region 2, the first polymeric material 1 to the mass of the mass fraction of the first polymeric material 2 may be smaller than that.
In the above-described porous body, the first support surface and each of the layers 1, 1 and the second polymeric material comprises a polymeric material 2 may have a composite fiber web. In the above-described porous body, the composite fiber is, the first polymeric material 2 of the shell 1 of the core and the second polymeric material comprising a core-shell structure may have. In the above-described porous body, the first area 1 (i) in the composite fiber, the diameter or equivalent diameter of the shell with respect to the ratio of the diameter or equivalent diameter of the core, (ii) the second region 2 in the composite fiber, the diameter or equivalent diameter of the shell of the core may be smaller than the ratio of the diameter or equivalent diameter.
In the above-described porous body, porous body (c) in the region 3 of the first, the second density of the polymeric material 1 with respect to the ratio of the density of the polymeric material 2, (b) in the region of the first porous body 2, the first density of the polymeric material 1 with respect to the percentage of density of the polymeric material 2, may be different from one another. In the above-described porous body, the second distance 3 area and the second surface 1, the first and the second region 2 may be smaller than the distance of the surface 1. In the above-described porous body, the first region 3, at least a portion of the support layer may be disposed.
The above-described porous body, porous body 2 disposed on the surface of the surface side of the first, the second surface 2 may comprise a porous. In the above-described porous body, the support layer, the first surface and second surface 1 may be disposed between the 2. In the above-described porous body, porous body (d) in the first region 4, the first density of the polymeric material 1 with respect to the ratio of the density of the polymeric material 2, (b) in the region of the first porous body 2, the first density of the polymeric material 1 with respect to the percentage of density of the polymeric material 2, may be different from one another. In the above-described porous body, the first surface 1 of the first and second distance 4 area, the first and the second region 2 may be larger than the distance of the surface 1. In the above-described porous body, the first region 4, at least a portion of the first surface 2 may be disposed. The above-described porous body, a sheet or film shape (i), (ii) in a roll shape or tubular, or, (iii) a block-shaped, columnar or may be in the form of a pad.
In the above-described porous body, the first polymeric material is 1, (i) (PMA) methyl polyacrylate, polymethyl methacrylate (PMMA), polyvinyl alcohol (PVA), hyaluronic acid, alginic acid, polyglycolic acid (PGA), polyethylene carbonate (PEC), collagen, fibrin, polyglactin, chitosan, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) at least one selected from the salts and derivatives of these substances may include 1.
In the above-described porous body, the first polymeric material is 2, (i) collagen, fibrin, polyglactin, chitosan, chitin, fibroin, sericin, D (PDLA) poly lactic acid, lactic acid (PLLA) poly L, poly lactic acid and DL (PDLLA), poly (ε - caprolactone) (PCL), polyethylene carbonate, a polyurethane, carboxymethyl cellulose, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) at least one selected from the salts and derivatives of these substances may include 1.
In the above-described porous body, the first polymeric material is 2, carboxymethyl cellulose (CMC) (i), and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) at least one selected from the salts and derivatives of these substances may include 1.
In the above-described porous body, the first polymeric material is 1, the second biodegradable plastic 1, the biopolymer 1 first, and, the first selected from the group consisting of natural polymers 1 1 may include at least one material. In the above-described porous body, the second biodegradable plastic is 1, (i) polyglycolic acid, polyvinyl alcohol, polyglactin, carbonate, decomposition of the polyurethane, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1. In the above-described porous body, the second biopolymer is 1, (i) collagen, fibrin, alginic acid, hyaluronic acid, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1. In the above-described porous body, the first natural polymer is 1, the chitosan (i), and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1.
In the above-described porous body, the first polymeric material is 2, the second biodegradable plastic 2, the biopolymer 2 first, and, the first selected from the group consisting of natural polymers 2 1 may include at least one material. In the above-described porous body, the second biodegradable plastic is 2, (i) poly (PDLA) D-lactic acid, lactic acid (PLLA) poly L, poly lactic acid and DL (PDLLA), poly (ε - caprolactone), polyglactin, carbonate, decomposition of the polyurethane, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1. In the above-described porous body, the second biopolymer is 2, (i) collagen, fibrin, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1. In the above-described porous body, the first 2 natural polymer, chitin (i), sericin, fibroin, carboxymethyl cellulose, chitosan, and, (ii) at least one of the monomers constituting these copolymer of 2, or, at least one of these 1 monomers constituting the copolymer with other monomers, and, (iii) and salts and derivatives of these at least one selected from the group consisting of may be 1.
In the above-described porous body, the first polymeric material 1, and the second polymeric material 2. As the first polymeric material 1, for example, the first (i) Young's modulus than the polymeric material 2 is small, and, also (ii) the first polymer material 2, the rate of disappearance of in vivo, or, for the biological fluid absorbent material of a high pseudo is selected.
In the above-described porous body, the first Young's modulus of the polymer material 1, 0.001mpa or more preferably 100mpa or less, more preferably 0.01mpa or more 50mpa or less, 0.03mpa or more and still more preferably 20mpa or less. Young's modulus of the first polymeric material 2, 0.01mpa or more preferably 2000mpa or less, more preferably 0.1mpa or more 1000mpa or less, 1mpa or more and still more preferably 500mpa or less.
In the above-described porous body, for example, the first polymeric material is 2, 0.01mpa or more than 2000mpa Young's modulus is selected from a polymeric material. On the other hand, the second polymeric material is 1, a Young's modulus, 0.001mpa or more and 100mpa or less, and, 2 a small Young's modulus than the first polymeric material is selected from a polymeric material.
In the above-described porous body, the first polymeric material 1 in the body of the day the rate of disappearance of the mass/50%, more preferably 1 1 00 or less, more preferably less than 50 1 or more, more preferably 30 1 or less. 2 The first day the rate of disappearance of the in-vivo polymeric material has a mass/50%, more preferably 10 7 30 or less, more preferably less than 3 65 10 or more, more preferably 3 65 20 or less.
In the above-described porous body, for example, the first polymeric material is 2, the rate of disappearance of in vivo mass equal to or less than 7 30 10 or the date/50% selected from the polymeric material. On the other hand, the second polymeric material is 1, the date the loss rate of in vivo 1 1 00 or less and the mass/50% or more, and, the second polymeric material 2 of the in vivo than the rate of disappearance of high polymer materials selected from metals.
In the above-described porous body, the first polymeric material 1 with respect to the phosphate-buffered saline is absorbent, the second immersion in the 7, 1% or more preferably 90% or less, more preferably 70% or less 1% or more, more preferably 50% or less 1% or more. 2 A first polymeric material of phosphate buffered saline with respect to the absorption is, immersed in the first 7, less than or equal to 10% 0% or more. The second polymeric material 2 of the phosphoric acid absorbent is a buffered saline solution, immersed in the first 30, 0% or more preferably 60% or less, more preferably 50% or less 0% or more, more preferably 40% or less 0% or more. The second polymeric material 2 of the phosphoric acid absorbent is a buffered saline solution, is immersed in the second (i) 7, 0% or more and 10% or less, and, in the first dip (ii) 30, 60% may be less than or equal to 0% or more, 0% or more may be less than or equal to 50%, 40% may be less than or equal to 0% or more.
In the above-described porous body, for example, the first polymeric material is 2, phosphate buffered saline solution absorption, the first immersion in the 7, 0% or more and 10% or less, and, more or less than 30 0% in the second dip 60% is selected from a polymer material. On the other hand, the second polymeric material is 1, phosphate buffered saline to the absorption of water, immersed in a 7 1% or more and less than or equal to 90% first, and, the second polymeric material 2 in phosphate buffered saline for more than a large absorbent is selected from a polymeric material.
In the above-described porous body, the first polymeric material comprises a polyvinyl alcohol is 1, the first polymeric material 2 may comprise primarily fibroin. In the above-described porous body, the first polymeric material comprises a polycaprolactone is mainly 1, the first polymeric material 2 may comprise silk fibroin is mainly. In the above-described porous body, the first polymeric material comprises a polyvinyl alcohol is 1, the first polymeric material is mainly 2 may include a polycaprolactone. In the above-described porous body, the first and second 1 polymeric material 2 as a combination of a polymer material, polyvinyl alcohol (i), silk fibroin, (ii) and collagen, fibroin, (iii) hyaluronic acid, silk fibroin, and (iv) alginate, silk fibroin, and biodegradable polyurethanes (v), silk fibroin, and polypropyl (vi), silk fibroin, and (vii) polyvinyl alcohol, polylactic acid, collagen (viii), poly (ε - caprolactone), and polypropyl (iX), polylactic acid, polyvinyl alcohol (Xi), polylactic acid, polyglycolic acid (Xii), polylactic acid, and hyaluronic acid (Xiii), polylactic acid, alginic acid and (Xiv), polylactic acid and the like are exemplified.
4 In the first embodiment of the present invention, there is provided a medical material. Is the type of material, the first of the 1, 2 or 3 according to an embodiment of the first containing a porous body.
In addition, the above summary of the invention, all of the necessary features of the present invention are not listed. In addition, sub-combinations of groups of these features, can be the invention.
  • 出願人(英語)
  • ※2012年7月以前掲載分については米国以外のすべての指定国
  • TOKYO UNIVERSITY OF AGRICULTURE AND TECHNOLOGY
  • NIPPON MEDICAL SCHOOL FOUNDATION
  • 発明者(英語)
  • NAKAZAWA YASUMOTO
  • SAKATA CHIEMI
  • TARA SHUHEI
  • KOYANAGI ERI
国際特許分類(IPC)
指定国 National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN BR BW BY BZ CA CH CL CN CO CR CU CZ DE DJ DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IR IS JO JP KE KG KH KN KP KR KW KZ LA LC LK LR LS LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PA PE PG PH PL PT QA RO RS RU RW SA SC SD SE SG SK SL SM ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA RW SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW KM ML MR NE SN ST TD TG
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