Absorbable iron-based alloy medical instrument implant and manufacturing method

Patent metadata

Field	Value
Publication number	US-10543296-B2
Application number	US-201615767610-A
Country	US
Kind code	B2
Filing date	Jun 7, 2016
Priority date	Oct 14, 2015
Publication date	Jan 28, 2020
Grant date	Jan 28, 2020

Abstract

Absorbable iron-based alloy implanted medical device and manufacturing method thereof. The iron-based alloy implanted medical device comprises an iron-based alloy substrate (11), a degradable polymer layer (13) disposed on a surface of the iron-based alloy substrate (11), and a tannic acid chemical conversion film (12) disposed on a surface of the iron-based alloy substrate (11). After the medical device is implanted into a body, the tannic acid chemical conversion film (12) is configured to protect the iron-based alloy substrate (11) coated thereby from being in contact with a body fluid, thereby ensuring that the device meets a clinical mechanical property requirement in the early stage of implantation. Furthermore, the iron-based alloy implanted medical device has a decreased size, and produces a decreased amount of a corrosive product after being implanted, facilitating faster absorption or elimination of the corrosive product.

First claim

The invention claimed is:

1. An absorbable iron-based alloy implanted medical device, comprising:
an iron-based alloy substrate;
a tannic acid chemical conversion film disposed on the surface of the iron-based alloy substrate, with the tannic acid chemical conversion film having a thickness of 0.4 to 0.5 um and covering 95 percent of the surface of the iron-based substrate; and
a polylactic acid coating with a thickness of 6 um completely covering the tannic acid chemical conversion film.

2. The absorbable iron-based alloy implanted medical device according to claim 1 , wherein the iron-based alloy substrate is an iron-based alloy or pure iron with a carbon content less than or equal to 2.11 weight percent.

3. The absorbable iron-based alloy implanted medical device according to claim 1 , wherein the tannic acid chemical conversion film is a product generated by reaction of tannic acid and the iron-based alloy substrate.

4. The absorbable iron-based alloy implanted medical device according to claim 1 , wherein the polylactic acid coating comprises an active drug which is an anti-intimal hyperplasia drug for treating vascular restenosis, an anticoagulant, an anti-platelet adhesion drug, an anti-infective drug, an antibacterial drug or an anti-tumor drug.

5. The absorbable iron-based alloy implanted medical device according to claim 1 , wherein the implanted medical device is a heart implant, a blood vessel implant, a gynecological implant, an andrological implant, a respiratory implant or an orthopedic implant.

6. An absorbable iron-based alloy implanted medical device, comprising:
an iron-based alloy substrate;
a tannic acid chemical conversion film disposed on the surface of the iron-based alloy substrate, with the tannic acid chemical conversion film having a thickness of 0.8 to 1.0 um and completely covering the surface of the iron-based substrate; and
a polylactic acid coating with a thickness of 8 um partially covering the tannic acid chemical conversion film.

7. The absorbable iron-based alloy implanted medical device according to claim 6 , wherein the iron-based alloy substrate is an iron-based alloy or pure iron with a carbon content less than or equal to 2.11 weight percent.

8. The absorbable iron-based alloy implanted medical device according to claim 6 , wherein the tannic acid chemical conversion film is a product generated by reaction of tannic acid and the iron-based alloy substrate.

9. The absorbable iron-based alloy implanted medical device according to claim 6 , wherein the polylactic acid coating comprises an active drug which is an anti-intimal hyperplasia drug for treating vascular restenosis, an anticoagulant, an anti-platelet adhesion drug, an anti-infective drug, an antibacterial drug or an anti-tumor drug.

10. The absorbable iron-based alloy implanted medical device according to claim 6 , wherein the implanted medical device is a heart implant, a blood vessel implant, a gynecological implant, an andrological implant, a respiratory implant or an orthopedic implant.

11. An absorbable iron-based alloy implanted medical device, comprising:
an iron-based alloy substrate;
a tannic acid chemical conversion film disposed on the surface of the iron-based alloy substrate, with the tannic acid chemical conversion film having a thickness of 1.6 to 1.8 um and completely covering the surface of the iron-based substrate; and
a polylactic acid coating with a thickness of 12 um completely covering the tannic acid chemical conversion film.

12. The absorbable iron-based alloy implanted medical device according to claim 11 , wherein the iron-based alloy substrate is an iron-based alloy or pure iron with a carbon content less than or equal to 2.11 weight percent.

13. The absorbable iron-based alloy implanted medical device according to claim 11 , wherein the tannic acid chemical conversion film is a product generated by reaction of tannic acid and the iron-based alloy substrate.

14. The absorbable iron-based alloy implanted medical device according to claim 11 , wherein the polylactic acid coating comprises an active drug which is an anti-intimal hyperplasia drug for treating vascular restenosis, an anticoagulant, an anti-platelet adhesion drug, an anti-infective drug, an antibacterial drug or an anti-tumor drug.

15. The absorbable iron-based alloy implanted medical device according to claim 11 , wherein the implanted medical device is a heart implant, a blood vessel implant, a gynecological implant, an andrological implant, a respiratory implant or an orthopedic implant.

Assignees

• Lifetech Scient Shenzhen Co

Inventors

• Qi Haiping
• Liu Ziqiang
• Qin Li
• Zhang Deyuan
• Lin Wenjiao

Classifications

• A61L27/18

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61L2300/424

  Anti-adhesion agents · CPC title

• A61L31/148

  Materials at least partially resorbable by the body · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title