Coatings for the manufacture and application of polyhydroxyalkanoate medical devices

Abstract

Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.

1 - 5 . (canceled) 
     
     
         6 . A knitted or woven surgical mesh comprising poly-4-hydroxybutyrate monofilament fibers comprising a residual level of-polyethylene glycol sorbitan monolaurate, wherein the mesh is knit or woven using monofilament fibers coated with polyethylene glycol sorbitan monolaurate, and the polyethylene glycol sorbitan monolaurate coating is removed using a scouring process and leaving residual level of polyethylene glycol sorbitan monolaurate on the mesh that is less than 0.5 weight percent and greater than zero weight percent of the mesh. 
     
     
         7 . The mesh of  claim 6  wherein the mesh has been scoured by water and wherein the temperature of the water is above 4° C. 
     
     
         8 . The mesh of  claim 6  wherein ultrasound or a water soluble detergent is used to enhance the scouring of the mesh. 
     
     
         9 . The mesh of  claim 6  wherein the scoured mesh is heat set in hot water. 
     
     
         10 . The mesh of  claim 6  wherein the scoured mesh is washed with alcohol or aqueous alcohol. 
     
     
         11 . The mesh of  claim 6 , wherein the mesh further comprises one or more of the following: collagen, plasticizer, nucleant, dye, therapeutic agent, calcium carbonate, hydroxyapatite, tricalcium phosphate, diagnostic agent, prophylactic agent, contrast agent, radiopaque marker, and radioactive substance. 
     
     
         12 . The mesh of  claim 11 , comprising collagen and a therapeutic agent and optionally, wherein the therapeutic agent is an antibiotic. 
     
     
         13 . The mesh of  claim 6 , wherein the mesh further comprises polypropylene fibers. 
     
     
         14 . The mesh of  claim 6 , wherein the mesh is non-cytotoxic as determined by the in vitro ISO Elution Method (1×MEM Extract). 
     
     
         15 . A knitted or woven surgical mesh comprising poly-4-hydroxybutyrate monofilament fibers and a residual coating comprising polymers, copolymers or oligomers of ethylene oxide or propylene oxide, wherein the mesh is knit or woven using monofilament fibers coated with polymers, copolymers or oligomers of ethylene oxide or propylene oxide, and the coating is removed using a scouring process that leaves a residual level of the coating which is less than 2 weight percent and greater than zero weight percent of the mesh. 
     
     
         16 . A medical device comprising the mesh of claim  1 , where the device is selected from the group consisting of devices for temporary wound or tissue support, devices for soft tissue repair, devices for replacement or regeneration, repair patches, tissue engineering scaffolds, hernia repair devices, slings, rotator cuff repair devices, guided tissue repair/regeneration devices, tendon repair devices, ligament repair devices, wound dressings, devices for cosmetic, breast, facial, neck and plastic surgery, breast reconstruction devices selected from the group consisting of breast augmentation, devices for mastopexy, devices for breast reduction, devices for breast positioning and shaping, and devices for breast reconstruction following mastectomy, devices for blepharoplasty, devices for facial scar revisions, devices for forehead lifts, devices for mentoplasty, devices for malar augmentation, devices for otoplasty, devices for rhinoplasty, devices for neck lift surgery, devices for rhytidectomy, and devices to lift and support sagging areas of the face, brow, and neck. 
     
     
         17 . A method of manufacturing the knitted or woven surgical mesh of claim  1  comprising: coating monofilament fibers of poly-4-hydroxybutyrate with polyethylene glycol sorbitan monolaurate, knitting or weaving the fibers into a mesh, ultrasonically scouring the mesh with water to remove the polyethylene glycol sorbitan monolaurate, while retaining a residual level polyethylene glycol sorbitan monolaurate, wherein the residual level is less than 0.5 weight percent and greater than zero weight percent of the mesh, heat setting the mesh in hot water, and washing the mesh with aqueous alcohol. 
     
     
         18 . A method of manufacturing a knitted or woven surgical mesh comprising poly-4-hydroxybutyrate monofilament fibers and a residual coating comprising polymers, copolymers or oligomers of ethylene oxide or propylene oxide, the method comprising coating the monofilament fibers of poly-4-hydroxybutyrate with polymers, copolymers or oligomers of ethylene oxide or propylene oxide, and substantially but not completely removing the coating using an ultrasonic scouring process such that the residual level of the coating is less than 2 weight percent and greater than zero weight percent of the mesh. 
     
     
         19 . The method of  claim 17 , comprising dipping the mesh into a solution comprising a therapeutic agent. 
     
     
         20 . The method of  claim 19 , wherein the solution comprises collagen.