DRUG-ELUTING MEDICAL IMPLANTS

• US 20180085501A1
• Filed: 11/20/2017
• Published: 03/29/2018
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: 480 Biomedical, Inc.
• Inventors: Palasis, Maria, You, Changcheng, Concagh, Danny, Core, Lee, Ho, Kicherl, Sharma, Upma, Zugates, Gregory T.
• Granted Patent: US 10,568,994 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

Abstract

Disclosed are self-expanding medical implants for placement within a lumen of a patient. The implants comprise a woven or non-woven structure having a substantially tubular configuration, and are designed to be low-profile such that they are deliverable with a small diameter catheter. The implants have a high recoverability and desired mechanical properties.

Claims

1-16. -16. (canceled)

17. A medical implant comprising:

a tubular structure comprising struts and open spaces between adjacent said struts, wherein said tubular structure is biostable;

a first conformal coating comprising paclitaxel and a first polymeric material at least partially coating said struts;

wherein said tubular structure is characterized by a surface area of from 11.4 to 53.8 mm2/mm length of the tubular structure, and the amount of paclitaxel is within the range of about 0.002 to about 0.175 micrograms per square millimeter of said surface area; and

wherein the paclitaxel is the sole therapeutic agent in the medical implant.

18. The medical implant of claim 17, wherein the amount of paclitaxel is within the range of about 0.002 to about 0.09 micrograms per square millimeter of said surface area.

19. The medical implant of claim 17, wherein the amount of paclitaxel is within the range of about 0.003 to about 0.12 micrograms per square millimeter of said surface area.

20. The medical implant of claim 17, wherein the amount of paclitaxel is within the range of about 0.004 to about 0.175 micrograms per square millimeter of said surface area.

21. The medical implant of claim 17, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.1 to about 2.0 micrograms per millimeter of length of said tubular structure.

22. The medical implant of claim 21, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.2 to about 2.0 micrograms per millimeter of length of said tubular structure.

23. The medical implant of claim 17, further comprising a second conformal coating at least partially coating said first conformal coating, said second conformal coating comprising a second polymeric material.

24. The medical implant of claim 23, wherein each of the first and second polymeric materials is biodegradable.

25. The medical implant of claim 23, wherein said second conformal coating has a thickness up to 8 microns.

26. A medical implant comprising:

a tubular structure comprising struts and open spaces between adjacent said struts, wherein said tubular structure is biostable;

a first conformal coating comprising a first polymeric material and at least partially coating said struts; and

a second conformal coating at least partially coating said first conformal coating, said second conformal coating comprising a second polymeric material and paclitaxel as a single therapeutic agent in said medical implant;

wherein said tubular structure is characterized by a surface area, and the amount of paclitaxel is within the range of about 0.002 to about 0.175 micrograms per square millimeter of said surface area.

27. The medical implant of claim 26, further comprising a third conformal coating at least partially coating said second conformal coating, said third conformal coating comprising a third polymeric material.

28. The medical implant of claim 27, wherein each of the first, second and third polymeric materials is biodegradable.

29. The medical implant of claim 28 wherein said third conformal coating has a thickness up to 8 microns.

36. The medical implant of claim 26, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.1 to about 2.0 micrograms per millimeter length of said tubular structure.

37. The medical implant of claim 26, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.2 to about 2.0 micrograms per millimeter of length of said tubular structure.

38. The medical implant of claim 36, wherein the amount of paclitaxel is within the range of about 0.002 to about 0.02 micrograms per square millimeter of said surface area.

30. A medical implant comprising:

a tubular structure comprising struts and open spaces between adjacent said struts, wherein said tubular structure is biostable;

a first conformal coating comprising a first polymeric material and at least partially coating said struts; and

a second conformal coating at least partially coating said first conformal coating, said second conformal coating comprising a second polymeric material and an amount of paclitaxel as a single therapeutic agent in said medical implant;

wherein said tubular structure is characterized by a surface area, wherein the amount of paclitaxel is within the range of about 0.002 to about 0.175 micrograms per square millimeter of said surface area, and wherein said tubular structure has a surface area within the range of about 11.4 to about 53.8 square millimeters per millimeter length of said tubular structure.

31. The medical implant of claim 30, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.1 to about 2.0 micrograms per millimeter length of said tubular structure.

32. The medical implant of claim 30, wherein said tubular structure comprises a total amount of paclitaxel within the range of about 0.2 to about 2.0 micrograms per millimeter of length of said tubular structure.

33. The medical implant of claim 30, wherein the amount of paclitaxel is within the range of about 0.002 to about 0.02 micrograms per square millimeter of said surface area.

34. The medical implant of claim 30, further comprising a third conformal coating at least partially coating said second conformal coating, said third conformal coating comprising a third polymeric material.

35. The medical implant of claim 34, wherein each of the first, second and third polymeric materials is biodegradable.