調査・翻訳担当

米国在住の医療機器調査コンサルタントが調査、報告書完成後、MDIジャパンにて和文に翻訳

目次

1章　各種材料について

1. a) メタル
2. b) ポリマー
3. c) 生分解性・吸収性ポリマー
4. d) 形状記憶ポリマー

2章　ステント用メタル

3章　腐食に対するバイオ・マテリアル

1. a) 骨、血管等生理的負荷の状態での腐食に関する対応
2. b) タンパク質吸着と細胞生存可能性

4章　インプラント・グレードの比較

1. a) ステンレス・スチール
2. b) コバルト合金
3. c) チタン合金
4. d) 貴金属
5. e) マグネシウム

5章　表面酸化腐食について

6章　要求される管の特性

7章　プラスチックの特性、モールディングについて

8章　アプリケーション（金属及びプラスチック）

9章　市場規模とその拡大促進要因

1. a) 金属
2. b) 薬剤溶融
3. c) その他

10章　材料サプライヤーに関する情報

英文目次

1. Materials (Overview)

-Current Metal Options

• Surface Priming processes
• Radial stiffness and strength considerations
• Test methods (ASTM) for Radial Stiffness and Strength
• Tensile strengths, low yield and high yield processes for stent expansion permitting the use of thinner struts for an overall lower profile, improrving flexibility and deliverability

-Current Polymeric Options

• Functionalized surface configurations
• Polymer coatings discussed including bio-erodibles such as poly-L lactic acid, and biostable polymers such as polyurethane derivates.

-Biogradeable & Bioabsorable polymers

• Biochemical surface preparations
• Covalent Bonding considerations

-Shaped memory polymers

• Antibody attachment mechanisms

2. Metal Stent tubing

• Plasma Treatment and metal surface preparation discussion
• Desired attributes
  • Nonpulsatile loading modes (bending, torsion, compression, tension and crush are discussed
  • Design critera discussed for peripheral, biliary and esophageal applications.

3. Biomaterials resistance to corrosion

-Resistance to corrosion under bone and blood vessel physiological loading conditions.
-Protein Adsorption and Cell Viability

4. Comparison of implant grades (Density, tensile strength, etc)

-316L Stainless Steels

• Black hole artifacts

-Cobalt Alloys

• Chrome-Rich Oxide Layer
• L-605 CoCr

-Titanium alloys

• Surface conditions preparation; electrochemical polishing explored including applied voltage, polishing time, acid pickling.

-Refractory
-Precious metals

• ABI Alloy and nickel-free metal allow (palladium and silver) discussed

-Magnesium

• Bioabsorability discussed

-NiTi Alloy (Nitinol)

• Super-elastic, biocompatibility and MRI (Magnetic Resonance Imaging) suitability characteristics discussed.
• Properties for three possible variations of nitinol that includes commonly utilized superelastic condition, martensitic condition and cold worked version.

5. Surface oxide corrosion

• Surface passivation discussed
• Microstructure characterizations of surface oxide film

6. Desired Tubing Attributes

• Mesh structures, coil, slotted tube, ring designs

7. Plastic properties, molding considerations

8. Applications (metal and plastic)

9. MR Imaging

10. TAM (Total Available Market)

-Metal
-Drug eluding
-Other

11. Suppliers

12. Bibliography & References