Ultra-thin, high strength, drug-loaded sutures and coatings thereof

Patent metadata

Field	Value
Publication number	US-2019142993-A1
Application number	US-201716083787-A
Country	US
Kind code	A1
Filing date	Mar 13, 2017
Priority date	Mar 11, 2016
Publication date	May 16, 2019
Grant date	—

Abstract

Small-diameter suture materials and suture coating materials made from the twisting or braiding of biocompatible polymeric fibers have been developed, which support drug delivery and maintain a high tensile strength. The fibers 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. While monofilament fibers lose tensile strength with the inclusion of active agents, twisting the drug-loaded, multifilament fibers allows for an increase in the tensile strength for the overall composites, while still retaining a small diameter. The methods of making these materials and using them for ocular surgery and vasculature repair have also been developed.

First claim

1 . A suture comprising a plurality of fibers, the fibers comprising a biocompatible polymer and one or more therapeutic, diagnostic, or prophylactic agents, wherein the plurality of fibers are twisted or braided in a bundle to form multifilament suture, wherein the suture has a size and a tensile strength necessary to meet the United States Pharmacopeia (U.S.P.) criteria.

2 . The suture of claim 1 , wherein the suture has a diameter between 20 μm and less than 30 μm and a tensile strength greater than 0.24 N.

3 . The suture of claim 1 , wherein the suture has a diameter between 30 μm and less than 40 μm, and a tensile strength greater than 0.49 N.

4 . The suture of claim 1 , wherein the suture has a diameter between 40 μm and less than 50 μm, and a tensile strength greater than 0.69 N.

5 . The suture of claim 1 , wherein the suture has a diameter between 50 μm and less than 70 μm, and a tensile strength greater than 1.37 N.

6 . The suture of claim 1 , wherein the therapeutic or prophylactic comprises an analgesic agent, an anti-glaucoma agent, an anti-angiogenesis agent, an anti-infective agent, an anti-proliferative agent, an anti-inflammatory agent, an anti-scarring agent, a growth factor, an immunosuppressant agent, an anti-allergic agent, or a combination thereof.

7 . The suture of claim 1 , wherein the biocompatible polymer is selected from the group consisting of polyhydroxyacids, polyhydroxyalkanoates, polycaprolactones, poly(orthoesters), polyanhydrides, poly(phosphazenes), polycarbonates, polyamides, polyesteramides, polyesters, poly(dioxanones), poly(alkylene alkylates), hydrophobic polyethers, polyurethanes, polyetheresters, polyacetals, polycyanoacrylates, polyacrylates, polymethylmethacrylates, polysiloxanes, poly(oxyethylene)/poly(oxypropylene) copolymers, polyketals, polyphosphates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, poly(maleic acids), and copolymers thereof.

8 . The suture of claim 1 , wherein the biocompatible fibers further comprise a hydrophilic polymer.

9 . The suture of claim 8 , wherein the hydrophilic polymer is a polyalkylene oxide selected from the group consisting of polyethylene glycol, polyethylene oxide-polypropylene oxide copolymer, or combination thereof.

10 . The suture of claim 1 wherein the biocompatible polymer comprises polycaprolactone, polydioxanone, polylactide, polyglycolide, polylactide-co-glycolide, polyethylene glycol, or a copolymer thereof.

11 . The suture of claim 1 , wherein the biocompatible polymer comprises polycaprolactone, polylactide-co-glycolide, polydioxanone, polyglycolide, polyethylene glycol, or a copolymer thereof, and the therapeutic, diagnostic, or prognostic agent comprises moxifloxacin, levofloxacin, bacitracin, tobramycin, or a combination thereof.

12 . The suture of claim 1 , wherein the polymer comprises polycaprolactone, polylactic acid, polylactide-co-glycolide, polydioxanone, polyglycolide, polyalkylene glycol, or a copolymer or combination thereof and the therapeutic, diagnostic, or prognostic agent comprises rapamycin, tacrolimus, everolimus, paclitaxel, or a combination thereof.

13 . The suture of claim 1 , wherein the suture releases an effective amount of the therapeutic, prophylactic, or diagnostic agent for at least 7 days.

14 . The suture of claim 1 comprising a coating.

15 . The suture of claim 1 , wherein the fibers coat around another suture, thread or device.

16 . The coating of claim 15 , wherein the coating releases an effective amount of the therapeutic, prophylactic, or diagnostic agent for at least seven days.

17 . A method of sealing or closing a surgical incision or a wound, comprising closing the incision or the wound with a suture of any claim 1 .

18 . A method of making the suture of claim 1 comprising twisting or braiding a plurality of polymeric nanofibers.

19 . The method of claim 18 wherein the fibers are twisted or braided around a suture, thread or device.

20 . The method of claim 18 wherein the polymeric nanofibers are spun from one or more jets into one or more collectors.

21 . The method of claim 18 producing twisted or braided fibers having the sizes and strength requirements necessary for the United States Pharmacopeia #2-0-#7-0 sutures.

22 . The method of claim 18 producing twisted or braided fibers having the sizes and strength requirements necessary for the United States Pharmacopeia #8-0, #9-0, and #10-0 sutures.

Assignees

• Univ Johns Hopkins

Inventors

• Parikh Kunal S
• Hanes Justin
• Ensign Laura

Classifications

• A61L2300/402

  Anaestetics, analgesics, e.g. lidocaine · CPC title

• D04C1/06

  Braid or lace serving particular purposes · CPC title

• D01H7/02

  for imparting permanent twist · CPC title

• A61L17/12

  Homopolymers or copolymers of glycolic acid or lactic acid · CPC title

• A61L2300/41

  Anti-inflammatory agents, e.g. NSAIDs · CPC title