Absorbable iron-based instrument

Patent metadata

Field	Value
Publication number	US-11684692-B2
Application number	US-201716473896-A
Country	US
Kind code	B2
Filing date	Dec 19, 2017
Priority date	Dec 30, 2016
Publication date	Jun 27, 2023
Grant date	Jun 27, 2023

Abstract

An absorbable iron-based instrument is provided having an iron-based substrate, a zinc-containing protector in contact with the iron-based substrate, and a degradable polyester in contact with the iron-based substrate and/or the zinc-containing protector. The range of the ratio of the mass of the zinc-containing protector to the mass of the iron-based substrate is 1:200 to 1:2. In the degradable polyester, the mass fraction of a low-molecular-weight part with a molecular weight of less than 10,000 is less than or equal to 5%; alternatively, in the degradable polyester, the mass fraction of a residual monomer is less than or equal to 2%.

First claim

The invention claimed is:

1. An absorbable iron-based device, comprising an iron-based substrate, a zinc-containing protector that completely covers the iron-based substrate, and a degradable polyester in contact with the iron-based substrate and/or the zinc-containing protector, wherein the ratio of the mass of the zinc-containing protector to the mass of the iron-based substrate ranges between 1:200 and 1:2; and wherein the degradable polyester is poly-D,L-lactic acid having a molecular weight less than 10,000, a mass fraction of 2 percent and a residual monomer having a mass fraction of 1.6 percent.

2. The absorbable iron-based device according to claim 1 , wherein the degradable polyester is obtained by separating and/or purifying raw materials of the degradable polyester by a precipitation method, gel permeation chromatography, an ultrafiltration film filtration method or an extraction method.

3. The absorbable iron-based device according to claim 1 , wherein the ratio of the mass of the degradable polyester to the mass of the iron-based substrate ranges between 1:1 and 1:200.

4. The absorbable iron-based device according to claim 1 , wherein the ratio of the mass of the degradable polyester to the mass of the iron-based substrate ranges between 1:6 and 1:100.

5. The absorbable iron-based device according to claim 1 , wherein the zinc-containing protector is zinc elementary substance or zinc alloy.

6. The absorbable iron-based device according to claim 1 , wherein the degradable polyester is in contact with the iron-based substrate in at least one of the following manners: the degradable polyester at least partially covers the surface of the iron-based substrate; or the iron-based substrate is provided with gaps, grooves or holes, and the degradable polyester is arranged in the gaps, grooves or holes, or the iron-based substrate has an inner cavity, and the inner cavity is filled with the degradable polyester.

7. The absorbable iron-based alloy implanted medical device according to claim 1 , wherein the iron-based substrate is made of pure iron or iron-based alloy, and the carbon content of the iron-based alloy is less than or equal to 2.11 percent.

8. The absorbable iron-based device according to claim 1 , wherein the absorbable iron-based device further comprises an active drug, and the active drug is mixed with the degradable polyester at a mass ratio of 1:(0.2-20).

9. The absorbable iron-based device according to claim 8 , wherein the active drug is selected from the group consisting of a drug for inhibiting vascular proliferation, an antiplatelet drug, an antithrombotic drug, an anti-inflammatory reaction drug or an antisensitization drug; the drug for inhibiting the vascular proliferation is selected from the group consisting of taxol, a taxol derivative, sirolimus or a sirolimus derivative; the antiplatelet drug is cilostazol; the antithrombotic drug is heparin; the anti-inflammatory reaction drug is dexamethasone; and the antisensitization drug is selected from the group consisting of diphenhydramine, chlorpheniramine, promethazine, hydrocortisone, triamcinolone, methylprednisolone, clarityne, fexofenadine, levocetirizine, mizolastine or ebastine.

10. The absorbable iron-based device according to claim 1 , wherein the absorbable iron-based device comprises a vascular stent, a non-endovascular stent, an occluder, an orthopaedic implant, a dental implant, a respiratory implant, a gynecological implant, an andrological implant, a suture or a bolt; the non-endovascular stent comprises a tracheal stent, an esophageal stent, a urethral stent, an intestinal stent or a biliary stent; and the orthopaedic implant comprises a fixing screw, a fixing rivet or a bone plate.

Assignees

• Biotyx Medical Shenzhen Co Ltd
• Lifetech Scient Shenzhen Co

Inventors

• Sun Hongtao
• Zhang Deyuan
• Hu Jun
• Chen Liping

Classifications

• A61L2300/41

  Anti-inflammatory agents, e.g. NSAIDs · CPC title

• A61L27/04 Primary

  Metals or alloys · CPC title

• A61L27/54

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

• A61L31/022

  Metals or alloys · CPC title

• A61L27/34

  Macromolecular materials · CPC title