Amorphous polymeric polyaxial initiators and compliant crystalline copolymers therefrom
AssigneePoly-Med, Inc.
InventorsShalaby W. Shalaby, Torbjorn Mathisen
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Abstract
An absorbable crystalline, monocentric polyaxial copolymer comprising a central carbon or nitrogen atom and at least three axes, each of which includes an amorphous flexible component adjacent and originating from the central atom and a rigid, crystallizable component extending outwardly from the amorphous, flexible component is disclosed along with the use of such copolymer in medical devices which may contain a bioactive agent. The present invention also relates to a suture, stents, stent mantles and sealing devices made from the polyaxial copolymer.
Claims22
An absorbable, crystalline, monocentric, polyaxial copolymer having improved mechanical characteristics and hydrolytic stability comprising:
- at least three axes originating and extending outwardly from the center of the copolymer, said center being formed from an at least tri-functional initiator molecule, each axis comprising:
- an amorphous, flexible component adjacent to and originating from the center, said flexible component comprising repeat units derived from at least one cyclic monomer selected from the group consisting essentially of carbonates and lactones;
- and
- a rigid, crystallizable component extending outwardly from the amorphous, flexible component, said crystallizable component being formed of repeat units derived from at least one lactone,
- characterized in that lactide is contained in at least one of said two components while glycolide is excluded from said at least one component.
A method of preparing an absorbable, crystalline, monocentric, polyaxial copolymer having improved mechanical properties, comprising the steps of:
- (A) reacting a cyclic monomer or a mixture of cyclic monomers selected from the group consisting of trimethylene carbonate, caprolactone, 1,5-dioxapane-2-one and a small amount of lactide or glycolide in the presence of an organometallic catalyst with one or more polyhydroxy, polyamino, or hydroxyamino compounds having three or more reactive amines and/or hydroxyl groups, to form an amorphous polymeric polyaxial initiator;
- and
- (B) reacting the amorphous, polymeric, polyaxial initiator with glycolide, lactide, caprolactone or 1,4-dioxan-2-one, and in the case of lactide and glycolide, optionally in the presence of a minor amount of one or more of the following monomers:
- 1,4-dioxan-2-one, 1,5-dioxepane-2-one, trimethylene carbonate and caprolactone;
- wherein lactide is used in at least one of the steps.
A polymeric, polyaxial initiator, having at least three axes originating and extending outwardly from the center of the initiator, said center being formed from an at least tri-functional initiator molecule, each axis comprising:
- an amorphous, flexible component adjacent to and originating from the center, said flexible component comprising repeat units derived from at least one cyclic monomer selected from the group consisting essentially of carbonates and lactones, the initiator comprising lactide.
Dependencies are inferred from the claim text.