JPWO2020085321A1 - インプラント材料及び当該インプラント材料の製造方法 - Google Patents
インプラント材料及び当該インプラント材料の製造方法 Download PDFInfo
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- JPWO2020085321A1 JPWO2020085321A1 JP2020553402A JP2020553402A JPWO2020085321A1 JP WO2020085321 A1 JPWO2020085321 A1 JP WO2020085321A1 JP 2020553402 A JP2020553402 A JP 2020553402A JP 2020553402 A JP2020553402 A JP 2020553402A JP WO2020085321 A1 JPWO2020085321 A1 JP WO2020085321A1
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- implant material
- bone
- cage
- hole
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- Pending
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
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Abstract
Description
実施例1
骨組織は未分化間葉系細胞、骨原生細胞、骨芽細胞、骨細胞(オステオサイト)や破骨細胞などから構成される。新生骨の生成過程では、骨芽細胞がI型コラーゲンなどを分泌し、コラーゲン線維へ添加的にアパタイトを生成して石灰化が進行する。石灰化が進むと、骨細胞となって骨基質中に埋め込まれ、新生骨生成は完了する。
本評価では、多孔体として120度毎の放射状に連結した3枚の有限板を千鳥状に配置した試料を作成した。有限板に設けた溝は幅0.2mm、深さ0.15mmである。板厚は0.5mmとし、溝は板の両面に互いに溝底部が重ならないように配置した。椎骨内埋植用に、ケージ外形は円筒状とした。トラス構造としては、三角形状を採用した。三角形状のトラス構造は放射状に配置した有限板と一致するように連通し、その内接円は500μm(評価試料A)または1000μm(評価試料B)の2種類とした。従来の骨移植による方法や力学的刺激などの外部環境の影響を調査するため、試料はさらにケージ側面に孔を設けた下記の評価試料CからEを準備した(図4)。図4(a)は、従来のインプラント材を示す(評価試料C)。図4(b)は、本発明の一実施態様におけるインプラント材料であって、一方向性の孔が貫通している様子を示す(評価試料D)。図4(c)は、図4(b)のインプラント材料を90度回転させた角度から見た図を示し、ケージ側面の孔を示したものである。(評価試料E)。図4において、10は移植骨、11はケージ側面の孔、12は溝、13は板、14は柱を、それぞれ示す。
試料D:当該多孔体を有するケージで、荷重伝達方向に相当する羊頭尾軸と多孔体の溝が平行に埋め込まれる。
試料E:当該多孔体を有するケージで、羊頭尾軸と多孔体の溝が垂直になるように埋め込まれる。ケージ形状は試料Dと同じであるが、荷重伝達方向は多孔体の溝と90度異なる。
上記の評価試料をCADソフトで設計し、STL形式(Stereolithography)で出力し、そのデータを用いてAM(Additive Manufacturing)にて一体造形した。材質はインプラント材として実績のあるチタン系合金であるTi-6Al-4V合金を採用し、レーザー金属造形機(EOS社製、EOS M290)にて造形した。造形後の溝幅と厚みは設計値(幅0.2mm、深さ0.15mm)に対して、幅は0.1〜0.5mm、深さは0.1〜0.2mmとなっていた。
月齢12ヶ月以上のサフォーク種のヒツジを対象に羊腰椎のL1からL4にそれぞれ1本ずつの試料を埋植した。埋植後8週または16週で屠殺してケージを埋植したL1からL4の椎骨を採取した。
ケージの当該多孔体内部に誘導された骨を評価するため、ビラヌエバ染色を施し、円筒状ケージ中央部に対して、頭尾軸方向に平行な断面で非脱灰薄切片を作成した。ケージ内部の空隙(TV:Total Volume)に占める骨(BV:Bone Volume)の割合を計測した。結果を表1に示す。
従来の骨移植を行うケージを模擬した評価試料Cと、当該多孔体を配した評価試料DとEで引抜試験を実施して、当該多孔体による骨とケージの固着強度を評価した。ケージを埋植した椎骨を解凍後、治具の上部にケージに設けためねじが露出するように椎骨を骨セメントで固定した。治具を引張試験機(INSTRON社製、型番5965)にてケージの引抜試験を実施した。クロスヘッド速度は5mm/minとし、試験中に測定された最大荷重を引抜強度とした。
骨配向化を評価するため、骨組織観察で作成した評価試料Eの薄片化切片を使用して、複屈折法(WPA-micro:Photonic Lattice)にて、骨配向と関係を有するコラーゲン繊維の配向性を解析した。図6に評価試料Eの観察結果を示す。図6(b)は、図6(a)の中央左寄りの長方形で囲んだ部分の拡大図を示す。この結果、評価試料の周囲骨(ヒツジの椎骨)は図に対して水平に配向しているが、当該多孔体内は入口から垂直に配向しているのが分かる。これは、ヒツジの椎骨が本来有する配向性とは異なる配向性を、多孔体自体が誘導していることを示している。
次に、本発明のインプラント材料として、ボックス型ケージを設計して、骨配向の誘導効果を調べた。具体的に、大型動物試験(ヒツジ)として、具体的に、ヒツジの椎間に設置したボックス型ケージの押出試験を行った。すなわち、ヒツジを用いた大型動物試験によって、ヒトの臨床と同様に椎間へボックス型ケージを埋植し、埋植8週後にボックス型ケージの押出試験を実施した。ボックス型ケージの高さ8mmおよび11mmの2種類について、図4(a)の評価試料Cと等価のボックス型ケージの移植骨群(移植骨をケージにあらかじめ充填)と、図4(b)の評価試料Dと等価の骨配向化誘導群の比較押出し試験を実施した。
2 板と板の間の内接円
3 溝幅
4 溝深さ
5 周囲骨
6 周囲骨とインプラント材料内部とを連通する孔(第二の孔)
7 インプラント材料の内部(多孔体内部)
8 インプラント材料内部の孔間を連通する孔
10 移植骨
11 ケージ側面の孔
12 溝
13 板
14 柱
15 孔
30 厚み方向
31 本発明の別の態様におけるケージ
32 ケージの挿入方向
41、51 椎体・終板との接触面を形成するボックス型ケージの天井構造
42、52 配向多孔質を形成する柱構造
43 椎体
44 椎体終板形状にボックス型ケージ(本発明の一例におけるインプラント材料)の接触面がフィットする様子
45 ボックス型ケージ
46 終板
Claims (16)
- 少なくとも一方向へ孔を有するインプラント材料であって、前記孔を構成する部材は、溝を有することを特徴とするインプラント材料。
- 前記孔を構成する部材は、柱及び/又は板によって構成されている請求項1記載のインプラント材料。
- 前記溝は、前記柱及び/又は板に設けられている請求項1又は2に記載のインプラント材料。
- 前記孔は、前記柱及び/又は板によって、複数構成されている請求項1〜3のいずれか1項に記載のインプラント材料。
- 前記溝は、前記柱及び/又は板の表裏面において、交互に配置されていることを特徴とする請求項1〜4のいずれか1項に記載のインプラント材料。
- 前記柱及び/又は板は、単体及び/又はブロックで構成されている請求項2記載のインプラント材料。
- 前記柱及び/又は板は、たわむように設計されている請求項2記載のインプラント材料。
- 前記孔は、前記インプラント材料を貫通しないか、又は前記インプラント材料を貫通する構成である請求項1〜7のいずれか1項に記載のインプラント材料。
- 前記インプラント材料が、高分子材料、セラミックス材料、金属材料、非晶質材料、又はそれらの混合材料から選択される少なくとも1種である請求項1〜8のいずれか1項に記載のインプラント材料。
- 前記溝の幅は、0.25〜500μmであることを特徴とする請求項1〜9のいずれか1項に記載のインプラント材料。
- 前記孔は、複数ある場合に、互いに連通している請求項1〜10のいずれか1項に記載のインプラント材料。
- 前記柱及び/又は板はそれら自体が伸縮構造を有することによって、又は前記柱もしくは前記板の厚さ、幅、又は高さを変化させることによって、前記柱及び/又は板がたわむように設計されている請求項7記載のインプラント材料。
- 前記インプラント材料と生体とが接触する少なくとも一部の接触面において、前記インプラント材料は、たわむように設計されている請求項1〜12のいずれか1項に記載のインプラント材料。
- 前記孔はトラス構造体により形成され、当該孔の内接円は、500μm〜2000μmである請求項1〜13のいずれか1項に記載のインプラント材料。
- 前記インプラント材料は、ケージ状構造を有し、前記ケージ状構造の側面において第二の孔を有する請求項1〜14のいずれか1項に記載のインプラント材料。
- 請求項1〜15のいずれか1項に記載のインプラント材料を製造するための方法であって、3D造形法によって製造するインプラント材料の製造方法。
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JP3181826U (ja) * | 2012-12-12 | 2013-02-21 | 優一郎 河原 | 歯科用インプラント |
JP2015529150A (ja) * | 2012-09-25 | 2015-10-05 | フォー−ウェブ・インコーポレイテッド | プログラム可能な移植片、および骨構造を修復するためにプログラム可能な移植片を用いる方法 |
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CN2852990Y (zh) * | 2005-09-29 | 2007-01-03 | 四川国纳科技有限公司 | 仿生骨修复体 |
DE102007056993A1 (de) * | 2007-11-27 | 2009-06-04 | Kilian Kraus | Knochenkontaktierende Implantate |
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CN108601662B (zh) * | 2015-12-16 | 2021-01-12 | 纽文思公司 | 多孔脊柱融合植入物 |
CN205359713U (zh) * | 2016-01-08 | 2016-07-06 | 四川大学 | 自稳定节段人工骨 |
CN206612975U (zh) * | 2016-12-19 | 2017-11-07 | 深圳德智达科技有限公司 | 一种人工骨材 |
CN106667626B (zh) * | 2017-01-01 | 2019-02-01 | 常州华森医疗器械有限公司 | 多孔钛椎间融合器及其制备方法 |
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