JP7483782B2 - 骨移植片代用品 - Google Patents
骨移植片代用品 Download PDFInfo
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- JP7483782B2 JP7483782B2 JP2022062671A JP2022062671A JP7483782B2 JP 7483782 B2 JP7483782 B2 JP 7483782B2 JP 2022062671 A JP2022062671 A JP 2022062671A JP 2022062671 A JP2022062671 A JP 2022062671A JP 7483782 B2 JP7483782 B2 JP 7483782B2
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- granules
- implant
- implant mass
- mass composition
- biocompatible
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Images
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- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
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- A—HUMAN NECESSITIES
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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Description
本発明は、骨欠損および抜歯創傷などの生体内の欠損部を処置するための多孔質インプラント塊組成物に関し、さらにその製造にも関する。より具体的には、本発明は、機械的に安定しているが、非常に多孔質の骨移植片代用品を可能にする新規な最適化された形状および細孔構造に関する。
骨補填材は、整形外科、歯科手術、外傷学および矯正などの多くの分野で重要である。このような骨補填材は、例えば、骨腫瘍の除去後に残った穴を埋めるため、骨折後の骨欠損部を埋めるため、抜歯後に残る空隙を埋めるため、歯科用または整形外科用インプラント埋入前に骨を増強するため、または抗生物質もしくは骨形成物質の担体として作用させるために使用される。
本発明によるインプラントは、骨伝導性生体適合性の骨移植片代用品を提供することによって上記の課題を解決する。骨移植片代用品は、減少した粒間空間の制限なく、球形多孔質顆粒の実質的に高い機械的安定性を兼ね備えている。顆粒内部の構造は、高い安定性を維持しながら高い気孔率を有しているので、顆粒の著しい破損を招くことなく顆粒を欠損部に押し込むことができ、同時に、骨細胞は顆粒間の空間に成長することができる。
本発明の上記および他の利点および特徴をさらに明確にするために、添付の図面に示されているその特定の実施形態を参照することによって、本発明のより詳細な説明が行われる。これらの図面は、本発明の典型的な実施形態のみを示すものであり、したがってその範囲を限定すると見なされるべきではないことを理解されたい。
図2a~2cによれば、図1による顆粒は、外側からくぼみを加えることによって修正された。使用したポロゲンは、セルロース球であった。加えた圧力は、100MPaであった。これらの例示的な実施形態を作るために、異なるサイズの球形ポロゲン、すなわち図2aに示すように100~200μm、図2bに示すように200~355μm、および図2cに示すように355~500μmを使用した。
本発明の実施形態は、骨欠損または創傷を修復するための成形可能なインプラント組成物を含む。成形可能なインプラント組成物は、複数の粒子状顆粒から形成されている。生体適合性ポリマーは、顆粒の周りに配置されるか、または顆粒上にコーティングされる。顆粒およびポリマーを充填または凝集させてインプラント塊を形成し、ポリマーを可塑剤で軟化させてインプラント塊を成形可能または流動可能にする。インプラント塊は、特定の骨欠損部または構造上の空隙を埋める骨インプラントを形成するように成形または彫刻される。次に、インプラント組成物を、硬化させるか、または硬化を引き起こさせる。以下でより十分に説明されるように、(i)ポリマーを軟化させること、(ii)インプラント塊を形成すること、および(iii)インプラント塊を成形することの順序およびタイミングは、本発明の様々な実施形態に従って変わり得る。
ここで、本発明によるインプラントの様々な成分について説明する。
- 顆粒を製造し、顆粒をポロゲンと混合すること;
- 顆粒の少なくとも一部の表面にポロゲンを押し込むこと;
- ポロゲンが顆粒と接触した表面にくぼみが残るように、ポロゲンをインプラント塊から除去すること
を含む。
上述のように、インプラント組成物の形成は、(i)成形可能(すなわち、塑性変形可能)であるインプラント塊を形成するようにポリマーを軟化させること;および(ii)成形可能なインプラント塊を(エクスサイチュまたはインサイチュで)所望の形状に成形することを含む。本発明の様々な実施形態では、これらの工程は、異なる順序でおよび/または同時に実施される。特に指定のない限り、「未成形」という用語は、患者の中で最終形状に達するために相当量の成形が必要なインプラント塊を意味する。「成形された」という用語は、患者の中でインプラントとして機能するのに成形がほとんどまたはまったく必要ないように十分に形作られたインプラントを意味する。
Claims (11)
- 複数の生体適合性顆粒を含み、前記顆粒の少なくとも一部は、表面のくぼみを有する、生体内の欠損部の処置に使用される多孔質インプラント塊組成物であって、
個々の前記顆粒は、20m2/g未満の比表面積を有し、かつ相互連結した細孔の網状構造を含み、
前記顆粒内の前記相互連結した細孔は、水銀圧入ポロシメトリーにより測定して、焼結粒子間で細孔の少なくとも75%の直径が約1μm~約10μmの間であることによって定義される、均質な表面気孔率を有し、
前記顆粒の少なくとも一部は、生体適合性ポリマーで被覆されており、かつ、前記生体適合性ポリマーの少なくとも一部を調整するのに十分な量の可塑剤が前記インプラント塊組成物中に含まれており、これにより、前記インプラント塊組成物は所望の形状に塑性変形可能であり、その後、前記インプラント塊組成物から可塑剤の少なくとも一部を除去することで硬化可能である、多孔質インプラント塊組成物。 - 前記インプラント塊が合成物である、請求項1記載のインプラント塊組成物。
- 前記生体適合性顆粒が、生体適合性セラミック、生体適合性ガラス、およびそれらの組み合わせからなる群から選択される材料を含む、請求項1または2記載のインプラント塊組成物。
- 前記生体適合性顆粒が、酸化ケイ素、硫酸カルシウム、リン酸カルシウム、およびそれらの組み合わせからなる群から選択される材料を含む、請求項1から3までのいずれか1項記載のインプラント塊組成物。
- 前記生体適合性顆粒が、リン酸一カルシウム一水和物、無水リン酸一カルシウム、リン酸二カルシウム無水物、無水リン酸二カルシウム、リン酸四カルシウム、オルトリン酸カルシウム、ピロリン酸カルシウム、α-リン酸三カルシウム、β-リン酸三カルシウム、ヒドロキシアパタイト、炭酸ヒドロキシアパタイト、アパタイト、バイオガラス、およびそれらの組み合わせからなる群から選択される材料を含む、請求項4記載のインプラント塊組成物。
- 前記相互連結した細孔の網状構造が、細胞の組み込みを可能にする、請求項1から5までのいずれか1項記載のインプラント塊組成物。
- 前記顆粒が、表面のくぼみを有する、請求項1から6までのいずれか1項記載のインプラント塊組成物。
- 前記顆粒が、不規則な形状である、請求項1から7までのいずれか1項記載のインプラント塊組成物。
- 前記顆粒が、不規則な表面を有する、請求項1から8までのいずれか1項記載のインプラント塊組成物。
- 前記顆粒が、100μm~約4000μmのフェレット径を有する、請求項1から9までのいずれか1項記載のインプラント塊組成物。
- 前記顆粒が、500μm~約1500μmのフェレット径を有する、請求項1から10までのいずれか1項記載のインプラント塊組成物。
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EP16206784.7 | 2016-12-23 | ||
EP16206784.7A EP3338815A1 (en) | 2016-12-23 | 2016-12-23 | Bone graft substitute |
JP2019534244A JP7197483B2 (ja) | 2016-12-23 | 2017-12-20 | 骨移植片代用品 |
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IT201900003947A1 (it) * | 2019-03-19 | 2020-09-19 | Mt Ortho S R L | Granulo in materiale metallico biocompatibile per vertebroplastica. |
JP2022537061A (ja) * | 2019-06-19 | 2022-08-23 | スミリオ インコーポレイテッド | 応力緩和耐性歯列矯正器具 |
CN110812687A (zh) * | 2019-11-18 | 2020-02-21 | 山东君合春医药科技有限公司 | 一种多孔聚合物微针的制备方法 |
US20210154015A1 (en) * | 2019-11-27 | 2021-05-27 | Igor Roshkovan | Surgical Technique for alveolar ridge augmentation with maxillary sinus elevation (lateral approach) using a pre-portioned and ready pre-packaged graft composition in gelatin bag and method of producing it |
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US20050013973A1 (en) | 2001-01-19 | 2005-01-20 | Richter Paul Wilhelm | Implant |
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JP2009084147A (ja) | 2007-09-10 | 2009-04-23 | National Institute Of Advanced Industrial & Technology | リン酸カルシウム系成形体の多孔体及びその製造方法 |
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JP2020503109A (ja) | 2020-01-30 |
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EP3558404C0 (en) | 2023-06-07 |
EP4144386B1 (en) | 2024-04-03 |
EP3338815A1 (en) | 2018-06-27 |
US20210283301A1 (en) | 2021-09-16 |
US20210236689A1 (en) | 2021-08-05 |
EP4144386C0 (en) | 2024-04-03 |
EP3558404A1 (en) | 2019-10-30 |
ES2954288T3 (es) | 2023-11-21 |
CN110087699B (zh) | 2022-06-07 |
CN110087699A (zh) | 2019-08-02 |
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