MEDICAL IMPLANT

• US 20100298952A1
• Filed: 05/19/2010
• Published: 11/25/2010
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: Arsenal Medical, Inc
• Inventors: Palasis, Maria, Ho, Kicherl, You, Chang Cheng, Concagh, Daniel, Sharma, Upma, Core, Lee, Busold, Rany, Zugates, Greg
• Granted Patent: US 8,137,396 B2
• Time in Patent Office: Days
• US Class Current: 623/23.71
• 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 strand comprising a first polymer characterized by a modulus of elasticity greater than about 1 GPa; and

a second polymer at least partially coating said strand, said second polymer characterized by a percent elongation to break that is greater than about 150 percent at 37°

C.;

wherein the second polymer increases the mass of said self-expanding tubular structure by at least about 20 percent.

2. The implantable medical device of claim 1, wherein said first polymer is biodegradable.

3. The implantable medical device of claim 2, wherein said first polymer comprises poly(lactic acid co-glycolic acid).

4. The implantable medical device of claim 3, wherein said poly(lactic acid co-glycolic acid) comprises at least about 75 weight percent of lactic acid.

5. The implantable medical device of claim 4, wherein said poly(lactic acid co-glycolic acid) comprises about 85 weight percent of lactic acid.

6. The implantable medical device of claim 3, wherein said poly(lactic acid co-glycolic acid) comprises up to about 20 weight percent of lactic acid.

7. The implantable medical device of claim 1, wherein said first polymer is characterized by a modulus of elasticity greater than about 6 GPa.

8. The implantable medical device of claim 1, wherein said second polymer is biodegradable.

9. The implantable medical device of claim 8, wherein said second polymer is a random copolymer that is crosslinked.

10. The implantable medical device of claim 8, wherein said second polymer is selected from the group consisting of poly(lactic acid-co-caprolactone), poly(glycolide-co-caprolactone, poly trimethylene carbonate, and poly(lactic acid-co-dioxanone).

11. The implantable medical device of claim 4, wherein said second polymer is poly(lactic acid-co-caprolactone) comprising about 50 to 70 weight percent lactic acid.

12. The implantable medical device of claim 11, wherein said poly(lactic acid-co-caprolactone) is crosslinked with hexamethylene diisocyanate.

13. The implantable medical device of claim 10, wherein the number average molecular weight (Mn) of said second polymer is greater than about 24,000 Da and less than about 100,000 Da.

14. The implantable medical device of claim 1, wherein said second polymer is characterized by an elastic segment having a glass transition temperature less than about 5°

C.

19. The implantable medical device of claim 1, further comprising a therapeutic agent within at least one of said first polymer material and said second polymer material.

20. The implantable medical device of claim 1, wherein the second polymer increases the mass of said self-expanding tubular structure by at least about 30 percent.

21. The implantable medical device of claim 1, wherein said self expanding tubular structure has a first end and a second end,

22. The implantable medical device of claim 1, further comprising a third polymer at least partially coating said second polymer.

23. The implantable medical device of claim 22, further comprising a therapeutic agent within said third polymer.

24. The implantable medical device of claim 1, wherein said second polymer comprises a first segment having a Tg less than about 5°

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

15. The implantable medical device of wherein said self-expanding tubular structure is a braided structure.

16. The implantable medical device of claim 15, wherein said braided structure comprises between 16 and 48 strands.

17. The implantable medical device of claim 16, wherein said strands form an average braid angle of between about 90 degrees and about 135 degrees.

18. The implantable medical device of claim 17, wherein said strands form an average braid angle of between about 110 degrees and about 135 degrees.

25. 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.

26. An implantable medical device, comprising:

a self-expanding tubular structure comprising

at least one strand comprising a first polymer; and

a second polymer at least partially coating said strand, said second polymer comprising a first segment having a Tg less than about 5°

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

wherein the second polymer increases the mass of said self-expanding tubular structure by at least about 20 percent.