Bioabsorbable biomedical implants

• US 10,272,606 B2
• Filed: 05/15/2014
• Issued: 04/30/2019
• Est. Priority Date: 05/15/2013
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/278,367
• Publication Number:
  US 20140343667A1
• Time in Patent Office: 1,811 Days
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/126 containing carbon fillers
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• 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: B29C 48/0022 combined with cutting
• CPC Class Codes: B29K 2067/04 Polyesters derived from hydroxycarboxylic acids
• CPC Class Codes: B29K 2307/04 Carbon
• CPC Class Codes: B29K 2309/08 Glass
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29K 2995/006 Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A bioabsorbable biomedical implant is disclosed. The implant includes a tubular scaffold comprising a plurality of interconnected polymer struts. The interconnected polymer struts defines a plurality of deformable cells. The polymer struts have an average thickness of no more than 150 μm. Methods for making the bioabsorbable biomedical implant, including the methods for making the fiber-reinforced polymer composite materials for the tubular scaffold, are also disclosed.

Claims

1. A biomedical implant, comprising:

an expandable tubular scaffold comprising a plurality of polymer struts, wherein the polymer struts are interconnected, define a plurality of deformable cells and have an average thickness of no more than 150 μ

m, and

a coating disposed on the polymer struts, the coating including at least one polymer and a crystalline macrolide immunosuppressive drug,

wherein the polymer struts comprise a fiber-reinforced polymer composite material, the fiber-reinforced polymer composite material comprising a bioabsorbable polymer material and a bioabsorbable reinforcement fiber material, wherein the fiber-reinforced polymer composite material is not located in the coating and wherein the fiber material includes reinforcement fibers that are longitudinally aligned along a center axis of the polymer struts.

2. The biomedical implant of claim 1, wherein the reinforcement fiber material is bioabsorbable glass.

3. The biomedical implant of claim 1, wherein the reinforcement fiber material is distributed throughout the polymer struts.

4. The biomedical implant of claim 1, wherein the fiber-reinforced polymer composite material has a tensile modulus that is at least five times, at least three times, or at least two times of a tensile modulus of the bioabsorbable polymer.

5. The biomedical implant of claim 1, wherein the fiber-reinforced polymer composite material has a tensile strength that is at least five times, at least three times, or at least two times of a tensile strength of the bioabsorbable polymer.

6. The biomedical implant of claim 1, wherein the fiber-reinforced polymer composite material comprises from 0.1 wt % to 15 wt % of the reinforcement fiber material.

7. The biomedical implant of claim 1, wherein the bioabsorbable polymer material is selected from the group consisting of polylactides (PLA);

poly(lactide-co-glycolide) (PLGA);

polyanhydrides;

polyorthoesters;

poly(N-(2-hydroxypropyl) methacrylamide);

poly(dl-lactide) (DLPLA);

poly(l-lactide) (LPLA);

poly(d-lactide) (DPLA);

polyglycolide (PGA);

poly(dioxanone) (PDO);

poly(glycolide-co-trimethylene carbonate) (PGA-TMC);

poly(l-lactide-co-glycolide) (PGA-LPLA);

poly(dl-lactide-co-glycolide) (PGA-DLPLA);

poly(l-lactide-co-dl-lactide) (LPLA-DLPLA);

poly(glycolide-co-trimethylene carbonate-co-dioxanone) (PDO-PGA-TMC), poly(lactic acid-co-caprolactone) (PLACL), and mixtures or co-polymers thereof.

8. The biomedical implant of claim 7, wherein the bioabsorbable polymer material is PLGA.

9. The biomedical implant of claim 1, wherein the polymer struts have anisotropic elastic modulus.

10. The biomedical implant of claim 9, wherein the polymer struts have an average longitudinal elastic modulus and an average lateral elastic modulus, the average longitudinal elastic modulus being greater than the average lateral elastic modulus.

11. The biomedical implant of claim 9, wherein the average longitudinal elastic modulus is at least three times, at least five times, or at least ten times the average lateral elastic modulus.

12. The biomedical implant of claim 1, wherein more than 50%, more than 70%, or more than 90% of the reinforcement fiber material in the polymer struts are longitudinally aligned.

13. The biomedical implant of claim 1, wherein the polymer struts are not structurally reinforced with a metal material.

14. The biomedical implant of claim 1, further comprising a pharmaceutical agent incorporated to the tubular scaffold.

15. The biomedical implant of claim 14, wherein the pharmaceutical agent is rapamycin.

16. The biomedical implant of claim 14, wherein the pharmaceutical agent is impregnated in the polymer struts.

17. The biomedical implant of claim 14, wherein at least a portion of the tubular scaffold is covered with a coating comprising the pharmaceutical agent.