Method of making a polyhydroxyalkanoate filament
View Patent ↗Absorbable polyester fibers, braids, and surgical meshes with improved handling properties 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 have a decreased tendency to curl, in the preferred embodiment, due to the inclusion of relaxation and annealing steps following methods are characterized by the following physical properties: (i) elongation to break from about 17% to about 85% (ii) Young's modulus of less than 350,000 psi, (iii) knot to straight ratio (knot strength/tensile strength) of 55-80% or (iv) load at break from 1100 to 4200 grams.
1. A method of making a polyhydroxyalkanoate filament comprising 4-hydroxybutyrate or copolymers thereof comprising
a) drying the water content of polyhydroxyalkanoate pellets comprising 4-hydroxybutyrate or copolymers thereof to less than 0.01% (w/w);
b) feeding the dried polyhydroxyalkanoate pellets into an extruder barrel under a blanket of nitrogen to melt the polyhydroxyalkanoate;
c) passing the molten polyhydroxyalkanoate through a heated block to a metering pump;
d) extruding the polyhydroxyalkanoate from a die with a single hole spinneret to produce a spun extrudate filament;
e) drawing the spun extrudate filament into a heat zone, maintained at a temperature above the melting temperature of the filament,
f) orienting and relaxing the filament,
g) constraining the filament during orientation and relaxation to shrink the filament, and
h,) annealing the filament,
to produce a polymeric filament comprising 4-hydroxybutyrate or copolymers thereof, wherein the filament has an elongation to break from 17% to 85%, a Young's modulus of less than 350,000 psi, or a load at break between 1100 and 4200 g, and is produced by extrusion, orientation, relaxation and annealing of the extruded filament.
2. The method of claim 1 further comprising an aging step wherein the extruded polyhydroxyalkanoate filament is partially drawn and is stored for a time period ranging from 2 to 72 hours at a temperature between 0 and −80° C.
3. The method of claim 1 further comprising prior to step a) blending into the polyhydroxyalkanoate an additive selected from the group consisting of calcium stearate and calcium phosphate, wherein the additive comprises up to 15% (w/w) of the polyhydroxyalkanoate blend.
4. The method of claim 1 further comprising forming the filament into a suture.
5. The method of claim 1 further comprising forming the filament into a mesh.
6. The method of claim 1 further comprising forming the filament into a medical device.
7. The method of claim 6 comprising forming the filament into a device for repair of tendons or ligaments.