Medical implant

• US 8,137,396 B2
• Filed: 05/19/2010
• Issued: 03/20/2012
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: 480 Biomedical, Inc.
• Inventors: Busold, Rany, Concagh, Daniel, Core, Lee, Ho, Kicherl, Palasis, Maria, Sharma, Upma, Zugates, Greg, You, Chang cheng
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US12/783,261
• Publication Number:
  US 20100298952A1
• Time in Patent Office: 671 Days
• Field of Search: 623 111- 123, 623 138- 154, 606191-195
• US Class Current: 623/1.38
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2230/0054 V-shaped
• 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 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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 is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.

Claims

1. An implantable medical device, comprising:

a self-expanding tubular structure comprising

at least one biodegradable strand comprising poly(lactic acid-co-glycolic acid) comprising at least about 75 weight percent of lactic acid; and

poly(lactic acid-co-caprolactone) at least partially coating said strand;

wherein said poly(lactic acid-co-caprolactone) is crosslinked and has a number average molecular weight (Mn) greater than about 30,000 Da;

wherein said poly(lactic acid-co-caprolactone) increases the mass of said self-expanding tubular structure by at least about 24 percent;

wherein said self-expanding tubular structure is a braided structure comprising between 16 and 48 strands forming an average braid angle of between about 110 degrees and about 135 degrees.

2. The implantable medical device of claim 1, wherein said poly(lactic acid co-glycolic acid) comprises at least about 85 weight percent of lactic acid.

3. The implantable medical device of claim 1, wherein said at least one biodegradable strand is characterized by a modulus of elasticity greater than about 6 GPa.

4. The implantable medical device of claim 1, wherein said poly(lactic acid-cocaprolactone) is crosslinked with hexamethylene diisocyanate.

5. The implantable medical device of claim 1, wherein the number average molecular weight (Mn) of said poly(lactic acid-co-caprolactone) is greater than about 24,000 Da and less than about 100,000 Da.

6. The implantable medical device of claim 1, wherein said poly(lactic acid-cocaprolactone) is characterized by an elastic segment having a glass transition temperature less than about 5°

C.

7. The implantable medical device of claim 1, further comprising a therapeutic agent within at least one of said poly(lactic acid-co-glycolic acid) and said poly(lactic acid-cocaprolactone).

8. The implantable medical device of claim 1, further comprising an additional polymer at least partially coating said poly(lactic acid-co-caprolactone).

9. The implantable medical device of claim 8, further comprising a therapeutic agent within said additional polymer.

10. The implantable medical device of claim 1, wherein said poly(lactic acid-co-caprolactone) comprises a first segment having a Tg less than about 5°

C. and a second segment that is harder than the first segment.