JP7389531B2 - 開頭術用非固定型インプラント及びその製造方法 - Google Patents
開頭術用非固定型インプラント及びその製造方法 Download PDFInfo
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- JP7389531B2 JP7389531B2 JP2023506179A JP2023506179A JP7389531B2 JP 7389531 B2 JP7389531 B2 JP 7389531B2 JP 2023506179 A JP2023506179 A JP 2023506179A JP 2023506179 A JP2023506179 A JP 2023506179A JP 7389531 B2 JP7389531 B2 JP 7389531B2
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- styrene
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- craniotomy
- growth factor
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- 239000004745 nonwoven fabric Substances 0.000 description 1
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- 229920001485 poly(butyl acrylate) polymer Polymers 0.000 description 1
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- 238000002278 reconstructive surgery Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
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Landscapes
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Description
部処名:産業通商資源部
研究管理専門機関:韓国産業技術振興院
研究事業名:3Dプリンティング医療機器産業技術実証事業
研究課題名:高分子ベースの生分解性素材を活用した手術用カスタマイズ3Dプリンティングインプラントの実証
寄与率:1/1
主管機関:(株)ティーアンドアール バイオファブ
研究期間:2019年4月1日~2022年12月31日
前記可撓性楔部100の最上端と最下端の幅は、互いに同一であり、可撓性楔部100の中間部の幅よりは大きく形成することがさらに好ましい。
2 頭蓋骨皮弁(flap)
10 開頭術用非固定型インプラント
100 可撓性楔部
200 翼部
201 一側の翼部
202 他側の翼部
Claims (15)
- 開頭術によって生じた頭蓋骨(1)と骨皮弁(2)との間隙を補完するためのインプラントであって、
骨皮弁(2)の外周形状に従うように成形できる可撓性楔部(100)と、
前記可撓性楔部(100)の上部又は下部に結合され、可撓性楔部(100)の両側面に延びる複数の翼部(200)と、を含み、
前記複数の翼部(200)は、多孔質構造を有し、一側の翼部(201)は骨皮弁(2)に隣接してその上に配置され、他側の翼部(202)は頭蓋骨(1)に隣接してその上に配置され、
前記可撓性楔部(100)は、複数の翼部(200)の上方又は下方に複数のラインが積層されて構成され、
前記複数のラインは、突出部(┏┓)と溝部(┗┛)とが交互に繰り返されて連結された構造を有し、底面に対して鋭角を有するように傾斜したAパターンラインと鈍角を有するように傾斜したBパターンラインを含む、開頭術用非固定型インプラント。 - 前記可撓性楔部(100)と複数の翼部(200)は、高分子とリン酸カルシウム化合物が10:0~5:5の重量比で混合された材料を用いてFDM方式の3Dプリンタによって印刷されることを特徴とする、請求項1に記載の開頭術用非固定型インプラント。
- 前記翼部(200)は、第1方向に延びる複数のラインが、300~500μmの幅及び300~500μmの間隔を有するように配置される第1層と、前記第1方向に対して60~120度の角度を有する第2方向に延びる複数のラインが、300~500μmの幅及び300~500μmの間隔を有するように配置される第2層と、を含む格子状多孔質構造であることを特徴とする、請求項1に記載の開頭術用非固定型インプラント。
- 前記可撓性楔部(100)の最上端と最下端の幅は、互いに同一であり、可撓性楔部(100)の中間部の幅よりは大きいことを特徴とする、請求項1に記載の開頭術用非固定型インプラント。
- 前記高分子は、ポリエチレン(Polyethylene)、メタロセン-PE(m-PE)、ポリプロピレン(polypropylene)、ポリイソブチレン(polyisobutylene)、ポリ-4-メチルペンテン-1(poly-4-methylpentene-1)、ポリブタジエン(polybutadiene)、ポリイソプレン(polyisoprene)、ポリシクロオクテン(polycyclooctene)、ポリスチレン、ポリメチルスチレン、ポリビニルナフタレン、スチレン-ブタジエン(SB)、スチレン-ブタジエン-スチレン(SBS)、スチレン-エチレン-ブチレン-スチレン(SEBS)、スチレン-エチレン-プロピレン-スチレン、スチレン-イソプレン、スチレン-イソプレン-スチレン(SIS)、スチレン-ブタジエン-アクリロニトリル(ABS)、スチレン-アクリロニトリル-アクリレート(ASA)、スチレン-エチレン(Styrene-ethylene)、ポリ塩化ビニル(PVC)、ポリクロロプレン及びポリ塩化ビニリデン(PVDC)、ポリメチルメタクリレート(PMMA)、ポリブチルアクリレート(Poly-Butyl acrylate)、ポリラウリルアクリレート、ポリステアリルアセテート、ポリアクリルニトリル、ポリアクリルアミド、ポリアミド(Polyamide)、ポリイミド(polyimides)、ポリアミドイミド(polyamide imides)、ポリエーテルイミド(polyether imides)、ポリエステルイミド(polyester imides)、ポリ(エーテル)ケトン(poly(ether)ketones)、ポリスルホン(polysulphones)、ポリエーテルスルホン(polyethersulphones)、ポリアリールスルホン(polyarylsulphone)、ポリフェニレンスルフィド(polyphenylene sulphide)、ポリベンズイミダゾール(polybenzimidazoles)、ポリヒダントイン(polyhydantoins)、テレフタレート(PET)、ポリブチレンテレフタレート(PBT)、ポリプロピレン(PP)テレフタレート、ポリエチレンナフチレート、ポリ-1,4-ジメチロールシクロヘキサンテレフタレート、ポリヒドロキシベンゾエート、ポリヒドロキシナフタレート、ポリラクチド(polylactides)、ポリグリコリド(polyglycoides)、ポリカプロラクトン(polycaprolactones)、ポリアンヒドリド(polyanhydrides)、ポリアミド(polyamides)、ポリウレタン(polyurethanes)、ポリエステルアミド(polyesteramides)、ポリオルソエステル(polyorthoesters)、ポリジオキサノン(polydioxanones)、ポリアセタール(polyacetals)、ポリケタール(polyketals)、ポリカーボネート(polycarbonates)、ポリオルソカーボネート(polyorthocarbonates)、ポリホスファゼン(polyphosphazenes)、ポリヒドロキシブチレート(polyhydroxybutyrates)、ポリヒドロキシバレレート(polyhydroxyvalerates)、ポリアルキレンオキサレート(polyalkylene oxalate)、ポリアルキレンサクシネート(polyalkylene succinates)、ポリ(リンゴ酸)(poly(malic acid))、ポリ(アミノ酸)(poly(amino acid))、ポリビニルピロリドン(polyvinylpyrrolidone)、ポリエチレングリコール(polyethylene glycol)、ポリヒドロキシセルロース(polyhydroxycellulose)、キチン(chitine)、キトサン(chitosan)、ポリ(L-乳酸)(poly(L-lactic acid))、ポリ(ラクチド-co-グリコリド)(poly(lactide-co-glycolide))、ポリ(ヒドロキシブチレート-co-バレレート(poly(hydroxybutyrate-co-valerate))、及びこれらのコポリマー(copolymers)とターポリマー(terpolymers)よりなる群から選択される少なくとも1種であることを特徴とする、請求項2に記載の開頭術用非固定型インプラント。
- 前記リン酸カルシウム化合物は、ヒドロキシアパタイト(Hydroxyapatite、HAP)、炭酸アパタイト(Carbonated apatite)、リン酸三カルシウム(Tricalcium Phosphate、TCP)、リン酸水素カルシウム(Calcium Hydrogen Phosphate)、第1リン酸カルシウム(Monocalcium phosphate)、第2リン酸カルシウム(Dicalcium phosphate)、二水素リン酸カルシウム(Calcium dihydrogen phosphate)、第3リン酸カルシウム(Tricalcium phosphate)、第10リン酸カルシウム(Octacalcium phosphate)、及びピロリン酸カルシウム(Calcium pyrophosphate)よりなる群から選択される少なくとも1種であることを特徴とする、請求項2に記載の開頭術用非固定型インプラント。
- 前記高分子とリン酸カルシウム化合物とが混合された材料には、カルボキシルメチルセルロース(carboxyl methyl cellulose)、ヘパラン硫酸(heparan sulfate)、ヒアルロン酸(hyaluronic acid)、コラーゲン(collagen)、デキストラン(dextran)及びアルジネート(alginate)よりなる群から選択される天然高分子物質が少なくとも1種さらに含まれることを特徴とする、請求項2に記載の開頭術用非固定型インプラント。
- 前記高分子とリン酸カルシウム化合物とが混合された材料には、骨形成タンパク質(BMP)、上皮細胞成長因子(EGF)、線維芽細胞成長因子(FGF)、転換成長因子(TGFbeta)、血小板由来増殖因子(PDGF)、血管内皮細胞増殖因子(VEGE)、インスリン様成長因子(IGF-1)、チオレドキシン(TRX)、幹細胞因子(SCF)、肝細胞増殖因子(HGF)、ヒト成長ホルモン(Human Growth Hormone)及びアンジオゲニン(Angiogenin)のうちの少なくとも1種がさらに含まれることを特徴とする、請求項2に記載の開頭術用非固定型インプラント。
- 開頭術により生じた頭蓋骨(1)と骨皮弁(2)との間隙を補完するためのインプラント(10)の製造方法であって、
高分子とリン酸カルシウム化合物とを10:0~5:5の重量比で混合して材料を準備するステップと、
前記材料を用いてFDM方式の3Dプリンタによって複数の翼部(200)を印刷するステップと、
前記複数の翼部(200)の上方に前記材料を用いてFDM方式の3Dプリンタによって複数のラインを積層させて可撓性楔部(100)を形成するステップと、を含み、
前記複数の翼部(200)は、多孔質構造を有し、一側の翼部(201)は骨皮弁(2)に隣接してその上に配置され、他側の翼部(202)は頭蓋骨(1)に隣接してその上に配置され、
前記可撓性楔部(100)を形成するステップは、
前記可撓性楔部(100)は、複数の翼部(200)の上方又は下方に複数のラインが積層されて構成され、
前記複数のラインは、突出部(┏┓)と溝部(┗┛)が交互に繰り返されて連結された構造を有し、底面に対して鋭角を有するように傾斜したAパターンラインと鈍角を有するように傾斜したBパターンラインを含むように形成される、開頭術用非固定型インプラントの製造方法。 - 前記複数の翼部(200)を印刷するステップは、
第1方向に延びる複数のラインが、300~500μmの幅及び300~500μmの間隔を有するように配置される第1層を形成するステップと、前記第1方向に対して60~120度の角度を有する第2方向に延びる複数のラインが、300~500μmの幅及び300~500μmの間隔を有するように配置される第2層を形成するステップと、を含み、
第1層を形成するステップと、第2層を形成するステップとが順次行われるが、少なくとも2回繰り返し行われることを特徴とする、請求項9に記載の開頭術用非固定型インプラントの製造方法。 - 前記可撓性楔部(100)の最上端と最下端の幅は、互いに同一であり、可撓性楔部(100)の中間部の幅よりは大きく形成する、請求項9に記載の開頭術用非固定型インプラントの製造方法。
- 前記高分子は、ポリエチレン(Polyethylene)、メタロセン-PE(m-PE)、ポリプロピレン(polypropylene)、ポリイソブチレン(polyisobutylene)、ポリ-4-メチルペンテン-1(poly-4-methylpentene-1)、ポリブタジエン(polybutadiene)、ポリイソプレン(polyisoprene)、ポリシクロオクテン(polycyclooctene)、ポリスチレン、ポリメチルスチレン、ポリビニルナフタレン、スチレン-ブタジエン(SB)、スチレン-ブタジエン-スチレン(SBS)、スチレン-エチレン-ブチレン-スチレン(SEBS)、スチレン-エチレン-プロピレン-スチレン、スチレン-イソプレン、スチレン-イソプレン-スチレン(SIS)、スチレン-ブタジエン-アクリロニトリル(ABS)、スチレン-アクリロニトリル-アクリレート(ASA)、スチレン-エチレン(Styrene-ethylene)、ポリ塩化ビニル(PVC)、ポリクロロプレン及びポリ塩化ビニリデン(PVDC)、ポリメチルメタクリレート(PMMA)、ポリブチルアクリレート(Poly-Butyl acrylate)、ポリラウリルアクリレート、ポリステアリルアセテート、ポリアクリルニトリル、ポリアクリルアミド、ポリアミド(Polyamide)、ポリイミド(polyimides)、ポリアミドイミド(polyamide imides)、ポリエーテルイミド(polyether imides)、ポリエステルイミド(polyester imides)、ポリ(エーテル)ケトン(poly(ether)ketones)、ポリスルホン(polysulphones)、ポリエーテルスルホン(polyethersulphones)、ポリアリールスルホン(polyarylsulphone)、ポリフェニレンスルフィド(polyphenylene sulphide)、ポリベンズイミダゾール(polybenzimidazoles)、ポリヒダントイン(polyhydantoins)、テレフタレート(PET)、ポリブチレンテレフタレート(PBT)、ポリプロピレン(PP)テレフタレート、ポリエチレンナフチレート、ポリ-1,4-ジメチロールシクロヘキサンテレフタレート、ポリヒドロキシベンゾエート、ポリヒドロキシナフタレート、ポリラクチド(polylactides)、ポリグリコリド(polyglycoides)、ポリカプロラクトン(polycaprolactones)、ポリアンヒドリド(polyanhydrides)、ポリアミド(polyamides)、ポリウレタン(polyurethanes)、ポリエステルアミド(polyesteramides)、ポリオルソエステル(polyorthoesters)、ポリジオキサノン(polydioxanones)、ポリアセタール(polyacetals)、ポリケタール(polyketals)、ポリカーボネート(polycarbonates)、ポリオルソカーボネート(polyorthocarbonates)、ポリホスファゼン(polyphosphazenes)、ポリヒドロキシブチレート(polyhydroxybutyrates)、ポリヒドロキシバレレート(polyhydroxyvalerates)、ポリアルキレンオキサレート(polyalkylene oxalate)、ポリアルキレンサクシネート(polyalkylene succinates)、ポリ(リンゴ酸)(poly(malic acid))、ポリ(アミノ酸)(poly(amino acid))、ポリビニルピロリドン(polyvinylpyrrolidone)、ポリエチレングリコール(polyethylene glycol)、ポリヒドロキシセルロース(polyhydroxycellulose)、キチン(chitine)、キトサン(chitosan)、ポリ(L-乳酸)(poly(L-lactic acid))、ポリ(ラクチド-co-グリコリド)(poly(lactide-co-glycolide))、ポリ(ヒドロキシブチレート-co-バレレート(poly(hydroxybutyrate-co-valerate))、及びこれらのコポリマー(copolymers)とターポリマー(terpolymers)よりなる群から選択される少なくとも1種であることを特徴とする、請求項9に記載の開頭術用非固定型インプラントの製造方法。
- 前記リン酸カルシウム化合物は、ヒドロキシアパタイト(Hydroxyapatite、HAP)、炭酸アパタイト(Carbonated apatite)、リン酸三カルシウム(Tricalcium Phosphate、TCP)、リン酸水素カルシウム(Calcium Hydrogen Phosphate)、第1リン酸カルシウム(Monocalcium phosphate)、第2リン酸カルシウム(Dicalcium phosphate)、二水素リン酸カルシウム(Calcium dihydrogen phosphate)、第3リン酸カルシウム(Tricalcium phosphate)、第10リン酸カルシウム(Octacalcium phosphate)、及びピロリン酸カルシウム(Calcium pyrophosphate)よりなる群から選択される少なくとも1種であることを特徴とする、請求項9に記載の開頭術用非固定型インプラントの製造方法。
- 前記高分子とリン酸カルシウム化合物とが混合された材料には、カルボキシルメチルセルロース(carboxyl methyl cellulose)、ヘパラン硫酸(heparan sulfate)、ヒアルロン酸(hyaluronic acid)、コラーゲン(collagen)、デキストラン(dextran)及びアルジネート(alginate)よりなる群から選択される天然高分子物質が少なくとも1種さらに含まれることを特徴とする、請求項9に記載の開頭術用非固定型インプラントの製造方法。
- 前記高分子とリン酸カルシウム化合物とが混合された材料には、骨形成タンパク質(BMP)、上皮細胞成長因子(EGF)、線維芽細胞成長因子(FGF)、転換成長因子(TGFbeta)、血小板由来増殖因子(PDGF)、血管内皮細胞増殖因子(VEGE)、インスリン様成長因子(IGF-1)、チオレドキシン(TRX)、幹細胞因子(SCF)、肝細胞増殖因子(HGF)、ヒト成長ホルモン(Human Growth Hormone)及びアンジオゲニン(Angiogenin)のうちの少なくとも1種がさらに含まれることを特徴とする、請求項9に記載の開頭術用非固定型インプラントの製造方法。
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