Medical implants

• US 8,992,601 B2
• Filed: 02/13/2013
• Issued: 03/31/2015
• 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, Daniel, Core, Lee, Ho, Kicherl, Sharma, Upma, Zugates, Gregory T.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/766,294
• Publication Number:
  US 20130158652A1
• Time in Patent Office: 776 Days
• Field of Search: 623/1.15, 623/1.42, 623/1.46, 424/422
• US Class Current: 623/1.38
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes

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 medical implant comprising:

a tubular structure being characterized, as manufactured and when unconstrained, by a first diameter and comprising a first polymeric material;

a conformal coating comprising a second polymeric material, said coating at least partially coating said tubular structure;

wherein said coating increases the mass of said tubular structure by at least 15%;

wherein said tubular structure is characterized by a radial resistive force that does not decrease by more than 50% after being placed into a configuration that is 55% to 90% of said first diameter in an aqueous environment at 37°

C. for eight weeks.

2. The medical implant of claim 1, wherein said second polymeric material is a thermoset elastomer.

3. The medical implant of claim 2, wherein said thermoset elastomer is a polyester urethane.

4. The medical implant of claim 3, wherein the thermoset elastomer is poly (lactic acid-co-caprolactone).

5. The medical implant of claim 4, wherein said poly (lactic acid-co-caprolactone) comprises about 50weight percent of lactic acid and about 50 weight percent of caprolactone.

6. The medical implant of claim 2, wherein said thermoset elastomer is prepared by a process that comprises the steps of:

at least partially dissolving a polyester polymer in a solvent to form a solution;

adding a diisocyanate crosslinker to said solution;

adding a chain terminator to said solution; and

curing said solution.

7. The medical implant of claim 6, wherein said diisocyanate crosslinker is hexamethylene diisocyanate.

8. The medical implant of claim 6, wherein said chain terminator comprises a monoisocyanate.

9. The medical implant of claim 8, wherein said monoisocyanate is 1-dodecylisocyanate.

10. The medical implant of claim 6, wherein said chain terminator comprises a monoalcohol.

11. The medical implant of claim 10, wherein said monoalcohol is 1-dodecanol.

12. The medical implant of claim 2, wherein said first polymeric material comprises poly(lactic acid co-glycolic acid).

13. The medical implant of claim 6, wherein said thermoset elastomer comprises at least 1.5 wt % of said chain terminator.

14. The medical implant of claim 13, wherein said thermoset elastomer comprises at least 2.0 wt % of said chain terminator.

15. The medical implant of claim 13, wherein said thermoset elastomer comprises at least 4.0 wt % of said chain terminator.

16. The medical implant of claim 1, wherein said tubular structure is characterized by a chronic outward force that does not decrease by more than 50% after being placed into a configuration that is 55% to 90% of said first diameter in an aqueous environment at 37°

C. for twelve weeks.

17. The medical implant of claim 1, wherein said tubular structure is characterized by a radial resistive force that does not decrease by more than 50% after being placed into a configuration that is not greater than 75 % of said first diameter in an aqueous environment at 37°

C. for twelve weeks.

18. The medical implant of claim 17, wherein said tubular structure is characterized by a chronic outward force that does not decrease by more than 50% after being placed into a configuration that is not greater than 75% of said first diameter in an aqueous environment at 37°

C. for twelve weeks.

19. The medical implant of claim 1, wherein said tubular structure is characterized by a chronic outward force that does not decrease by more than 25% after being placed into a configuration that is 55% to 90% of said first diameter in an aqueous environment at 37°

C. for eight weeks.