Drug eluting medical implant

• US 10,617,796 B2
• Filed: 04/20/2018
• Issued: 04/14/2020
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: Lyra Therapeutics, Inc.
• Inventors: Palasis, Maria, You, Changcheng, Concagh, Danny, Core, Lee, Ho, Kicherl, Sharma, Upma, Zugates, Gregory T.
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/958,279
• Publication Number:
  US 20180296736A1
• Time in Patent Office: 725 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. A method of making a self-expanding implant, comprising:

a) manufacturing a tubular structure to a first diameter, said structure comprising at least one strand comprising a first polymer; and

b) coating said tubular structure with a second polymer so that it at least partially coats said strand, said second polymer comprising an elastomeric polymer that when compressed or elongated, applies a force to the tubular structure that acts in favor of radial expansion, thereby making a self-expanding implant.

2. The method of claim 1, further comprising the step c) collapsing said self-expanding implant to a second, reduced diameter so as to create a crimped implant.

3. The method of claim 2, further comprising the step d) placing said crimped implant in a catheter.

4. The method of claim 3, further comprising the step e) extruding said crimped implant from said catheter such that said implant self-expands towards the first diameter.

5. The method of claim 4, wherein said implant self-expands to at least 80% of said first diameter.

6. The method of claim 4, wherein said implant self-expands to at least 90% of said first diameter.

7. The method of claim 4, wherein said implant self-expands to at least 95% of said first diameter.

8. The method of claim 1, wherein said first polymer is biodegradable.

9. The method of claim 1, wherein said first polymer comprises poly(lactic acid co-glycolic acid).

10. The method of claim 1, wherein said second polymer comprises an elastic segment having a glass transition temperature less than about 5°

C.

11. The method of claim 1, wherein said second polymer is poly(lactic acid-co-caprolactone).

12. The method of claim 1, wherein said poly(lactic acid-co-caprolactone) is crosslinked with hexamethylene diisocyanate.

13. The method of claim 1, wherein the crosslinked density of the elastomeric polymer is optimized with hexamethylene diisocyante, or other crosslinkers or in combination with chain terminators.

14. The method of claim 1, wherein said tubular structure of step a) is a braided structure comprising a plurality of strands.

15. The method of claim 14, wherein said braided structure comprises between 16 and 48 strands.

16. The method of claim 14, wherein said strands form an average braid angle of between about 90 degrees and about 135 degrees.

17. The method of claim 1, wherein the second polymer increases the mass of said self-expanding implant by at least 15 percent.

18. The method of claim 1, further comprising the step of at least partially coating said second polymer with a third polymer.

19. The method of claim 18, wherein said third polymer comprises a therapeutic agent.

20. The method of claim 19, further comprising the step of at least partially coating said third polymer with a topcoat, said topcoat regulating the delivery of the therapeutic agent.