Process of making polyhydroxyalkanoate medical textiles
Absorbable polyester fibers, braids, and surgical meshes with prolonged strength retention have been developed. These devices are preferably derived from biocompatible copolymers or homopolymers of 4-hydroxybutyrate. These devices provide a wider range of in vivo strength retention properties than are currently available, and could offer additional benefits such as anti-adhesion properties, reduced risks of infection or other post-operative problems resulting from absorption and eventual elimination of the device, and competitive cost. The devices may also be particularly suitable for use in pediatric populations where their absorption should not hinder growth, and provide in all patient populations wound healing with long-term mechanical stability. The devices may additionally be combined with autologous, allogenic and/or xenogenic tissues to provide implants with improved mechanical, biological and handling properties.
1. A method of making a medical textile from a fiber comprising P4HB polymer, comprising quenching the fiber following extrusion at a temperature that is greater than the glass transition temperature of the polymer, orienting the fiber at a temperature above the polymer's glass transition temperature, allowing the polymer time to crystallize, and then drawing the polymer to yield a fiber with a tensile strength greater than 126 MPa.
2. The method of claim 1 wherein the medical textile is a mesh.
3. The method of claim 2 wherein the mesh is knitted, woven or braided.
4. The method of claim 3 wherein the mesh is a monofilament mesh.
5. The method of claim 4 wherein the mesh is a warp knit.
6. The method of claim 1 wherein the tensile strength of the fiber in the medical textile decreases less than 80% after implantation for 6 months.
7. The method of claim 1 wherein the weight average molecular weight of the fiber in the medical textile decreases less than 75% after implantation of the medical textile for 2 weeks.
8. The method of claim 1 wherein the fiber has an elongation to break of over 20%.
9. The method of claim 1 wherein the medical textile has a breaking strength of at least 10 psi.
10. The method of claim 1 wherein the medical textile is selected from the group consisting of a tube, general surgical mesh, hernia mesh, pericardial patch, anti-adhesion patch, cardiovascular patch, guided tissue regeneration patch, sling, braid, ligament or tendon repair device, meniscus repair device, cartilage repair device, nerve guide, stent, vascular graft, dural patch, organ salvage device, intracardiac defect closure device, mastopexy/breast reconstruction device, tracheal reconstruction device, and bladder repair device.
11. The method of claim 1 wherein the polymer is a copolymer of 4-hydroxybutyrate and one or more co-monomers.
12. The method of claim 11 wherein the co-monomer is glycolate or 3-hydroxybutyrate.
13. The method of claim 1 wherein the medical textile is combined with harvested autologous, allogeneic and/or xenogeneic tissue.
14. The method of claim 1 wherein the medical textile is used for hernia repair, mastopexy/breast reconstruction, rotator cuff repair, vascular grafting/fistulae, tissue flaps, pericardial patching in intracardiac repair, tissue heart valve implants, bowel interposition, and dura patching.