RU-2026100699-A - A drug-eluting stent comprising a biocompatible thermoplastic polymer shell and a drug-containing coating

Inventors

• Марра Морейра Александер
• Кордейро Эдуардо Жозе
• Нунес Де Соуза Жордана
• Алмейда Флеури Курадо Лусиано
• Да Кунья Нето Мелкиадес

Assignees

• СКИТЕК МЕДИКАЛ ИНК.

Dates

Publication Date

20260508

Application Date

20240614

Priority Date

20230615

Claims (20)

1. 1. A drug-eluting stent (10) containing:
2. - an expandable structural frame (20) designed to resist radial compression when placed in the lumen of a patient's body, wherein the structural frame comprises a central portion (21) located between a proximal end (22) and a distal end (23);
3. - a shell (30) located only in the central part in such a way that the central part is covered with the shell and the ends are not covered with the shell; wherein the shell contains a biocompatible thermoplastic polymer and, optionally, a fiber-forming substance;
4. - in which the proximal and distal ends have a coating containing a drug (40), wherein the coating contains a biodegradable polymer and the drug Limus; and
5. - in which the central part of the structural framework and the shell do not contain the medicinal product Limus.
6. 2. A drug-eluting stent according to claim 1, wherein the sheath does not contain a drug.
7. 3. A drug-eluting stent according to claim 1 or 2, wherein the structural framework (20) comprises a luminal surface (24) and an abluminal surface (25), and wherein the sheath (30) comprises an inner layer (31) covering the luminal surface of the central portion of the structural framework and/or an outer layer (32) covering the abluminal surface of the central portion of the structural framework.
8. 4. A drug-eluting stent according to any one of claims 1 to 3, wherein the biocompatible thermoplastic polymer is selected from the group consisting of polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), polyurethane, and mixtures thereof.
9. 5. The drug-eluting stent of claim 4, wherein the biocompatible thermoplastic polymer is electrospun PTFE or expanded polytetrafluoroethylene (ePTFE).
10. 6. A drug-eluting stent according to any one of claims 1 to 5, wherein the biodegradable polymer is poly-α-hydroxy acid; optionally, wherein the poly-α-hydroxy acid is selected from the group consisting of poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), polylactic acid, polyglycolic acid (PGA), poly lactide-co-glycolic acid (PLGA) and mixtures thereof.
11. 7. A drug-eluting stent according to any one of claims 1 to 6, wherein the drug-containing coating (40) is located on the luminal surface, on the abluminal surface, or on both surfaces, at both the proximal (22) and distal (23) ends.
12. 8. A drug-eluting stent according to any one of claims 1-7, wherein the drug Limus is selected from the group consisting of sirolimus (rapamycin), pimecrolimus, tacrolimus, everolimus, zotarolimus, novolimus, myolimus, temsirolimus, deforolimus, biolimus, or combinations thereof.
13. 9. A drug-eluting stent according to any one of claims 1 to 8, wherein the Limus drug has a concentration of 1 to 10 μg/ mm2 of coated surface, in particular 2 to 5 μg/ mm2 of coated surface.
14. 10. A stent according to any one of claims 1 to 9, wherein the biodegradable polymer and the Limus drug are in a weight ratio of 1.7:1 to 3.5:1 and, optionally, the drug-containing coating has a thickness of 20 μm.
15. 11. A drug-eluting stent according to any one of claims 1 to 10, wherein the drug-containing coating (40) optionally further comprises a second active substance, wherein the second active substance is an anticoagulant.
16. 12. A drug-eluting stent according to claim 11, wherein the second active substance is heparin or low molecular weight heparin (LMWH).
17. 13. A drug-eluting stent according to any one of claims 1 to 12, wherein the structural frame (20) has a length of 40 to 100 mm, and the proximal (22) and distal (23) ends coated with a drug, independently of each other, have a length of 0.5 to 30 mm.
18. 14. A method for manufacturing a drug-eluting stent (10), which comprises:
19. (a) providing an expandable structural frame (20) configured to resist radial compression when placed within a lumen of a patient's body, the structural frame comprising a central portion (21) located between a proximal end (22) and a distal end (23);
20. (b) coating only the central portion of the structural framework with a shell (30) made of a biocompatible thermoplastic polymer such that the ends are not coated, optionally, wherein the structural framework has a length of 40 mm to 100 mm, and the proximal and distal ends coated with the drug, independently of each other, have a length of 0.5 to 30 mm; and