Drug loaded microfiber sutures for ophthalmic application

Patent metadata

Field	Value
Publication number	US-9533068-B2
Application number	US-201313888164-A
Country	US
Kind code	B2
Filing date	May 6, 2013
Priority date	May 4, 2012
Publication date	Jan 3, 2017
Grant date	Jan 3, 2017

Abstract

Ophthalmic suture materials made from biocompatible and biodegradable polymers with high tensile strength for use in drug delivery, methods of making them, and method of using them for ocular surgery and repair have been developed. The suture materials are made from a combination of a biodegradable, biocompatible polymer and a hydrophilic biocompatible polymer. In a preferred embodiment the suture materials are made from a poly(hydroxyl acid) such as poly(l-lactic acid) and a polyalkylene oxide such as poly(ethylene glycol) or a polyalkylene oxide block copolymer. The sutures entrap (e.g., encapsulate) one or more therapeutic, prophylactic or diagnostic agents and provide prolonged release over a period of at least a week, preferably a month.

First claim

We claim:

1. An ophthalmic suture comprising one or more fibers between about 20 microns and about 60 microns in diameter and having a tensile strength between about 1 GPa and about 2.5 GPa, the fibers comprising
a mixture of a biodegradable, biocompatible polymer selected from the group of polymers consisting of polyhydroxyacids, polyhydroxyalkanoates, polycaprolactones, polyanhydrides, polyesters, hydrophobic polyethers, and copolymers thereof and a polyalkylene oxide hydrophilic polymer,
wherein the amount of the hydrophilic polymer is from about 1 to about 10% by weight of the finished fiber, and
one or more therapeutic, diagnostic, or prophylactic agents directly dispersed or incorporated into the polymer mixture, wherein an effective amount of the therapeutic, prophylactic, or diagnostic agent is released from the suture for at least seven days after placement.

2. The suture of claim 1 , wherein the fiber has a diameter between 30 μm and 50 μm.

3. The suture of claim 1 , wherein the fiber has a diameter between 40 μm and 50 μm.

4. The suture of claim 1 , wherein the fiber has a tensile strength between 1.3 GPa and 2.3 GPa.

5. The suture of claim 1 , wherein the therapeutic agents is selected from the group consisting of anti-glaucoma agents, anti-angiogenesis agents, anti-infective agents, anti-inflammatory agents, growth factors, immunosuppressant agents, anti-allergic agents, and combinations thereof.

6. The suture of claim 5 , wherein the anti-infective agent is levofloxacin.

7. The suture of claim 1 , wherein the polymer is a polyhydroxy acid.

8. The suture of claim 7 , wherein the polymer is poly(lactic acid), poly(lactic acid-co-glycolide), or combination thereof and the hydrophilic polymer is a polyalkylene oxide.

9. The suture of claim 1 , wherein the polyalkylene oxide is selected from the group consisting of polyethylene glycol, polyethylene oxide-polypropylene oxide copolymer, or combination thereof.

10. The suture of claim 8 , wherein the amount of the biodegradable, biocompatible polymer is from about 75 wt % to about 85% by weight of the finished fibers.

11. The suture of claim 10 , wherein the amount of the therapeutic, prophylactic, or diagnostic agent is between about 0.1% and about 50% by weight of the finished fibers.

12. The suture of claim 8 wherein the amount of the biodegradable, biocompatible polymer is from about 75 wt % to about 85% by weight of the finished fibers and the amount of the therapeutic, prophylactic, or diagnostic agent is between about 0.1% and about 50% by weight of the finished fibers.

13. The suture of claim 1 providing a burst release of therapeutic, prophylactic or diagnostic agent.

14. The suture of claim 1 , wherein the period of release is at least two weeks.

15. The suture of claim 1 , wherein the period of release is at least one month.

16. The suture of claim 1 , wherein the period of release is at least three months.

17. The suture of claim 1 in the form of a braided or multifiber suture.

18. A method of sealing or closing a surgical incision or wound in the eye, the method comprising closing the incision or wound with an ophthalmic suture comprising one or more fibers between about 20 microns and about 60 microns in diameter and having a tensile strength between about 1 GPa and about 2.5 GPa, the fibers comprising
a mixture of a biodegradable, biocompatible polymer selected from the group consisting of polymers consisting of polyhydroxyacids, polyhydroxyalkanoates, polycaprolactones, polyanhydrides, polyesters, hydrophobic polyethers, and copolymers thereof and a polyalkylene oxide hydrophilic polymer;
wherein the amount of the hydrophilic polymer is from about 1 to about 10% by weight of the finished fiber,
and one or more therapeutic, diagnostic, or prophylactic agents directly dispersed or incorporated into the polymer mixture, wherein an effective amount of the therapeutic, prophylactic, or diagnostic agent is released from the suture for at least seven days.

19. The method of claim 18 wherein the sutures are appropriate for use in trabeculectomy, pterygium removal, cataract surgery, strabismus correction surgery, penetrating keratoplasty, sclerectomy, or conjunctival closure.

20. The method of claim 18 , wherein the amount of the therapeutic, prophylactic, or diagnostic agent is between about 0.1% and about 50% by weight of the finished fibers.

Assignees

• Univ Johns Hopkins

Inventors

• Kashiwabuchi Fabiana Kimie
• Hanes Justin
• Mao Hai-Quan
• Mcdonnell Peter John
• Xu Qingguo
• Zhang Shuming

Classifications

• A61L2300/604

  Biodegradation · CPC title

• D01D5/0007

  Electro-spinning (non-woven fabrics produced by electro-spinning D04H1/728) · CPC title

• B29K2995/006

  Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible · CPC title

• B29C48/142

  using force fields, e.g. gravity or electrical fields (B29C48/9165 takes precedence) · CPC title

• D01D5/0038

  the fibre formed by solvent evaporation, i.e. dry electro-spinning · CPC title