Crystalline copolymers of p-dioxanone and lactide and surgical devices made therefrom

Claim 2

Process for producing a crystalline copolymer of p-dioxanone and lactide which comprises subjecting a mixture of p-dioxanone homopolymer, p-dioxanone monomer, and lactide to an elevated temperature for a period of time sufficient to produce a crystalline copolymer of p-dioxanone and lactide.

Claim 3

Process of claim 1 which comprises the steps of: (a) polymerizing p-dioxanone monomer in the presence of a catalytically effective amount of a polymerization catalyst and an initiator to produce a first mixture of p-dioxanone homopolymer and p-dioxanone monomer; and (b) adding lactide to said first mixture to produce a second mixture, and subjecting said second mixture to an elevated temperature for a period of time sufficient to produce a crystalline copolymer of p-dioxanone and lactide.

Claim 4

The process of claim 2 wherein said first mixture contains from about 15 to 30 weight percent p-dioxanone monomer, based on total weight of said first mixture.

Claim 5

The process of claim 2 wherein the lactide is employed in an amount of from about 2 to about 30 weight percent, based on total weight of p-dioxanone and lactide charged in steps (a) and (b).

Claim 6

The process of claim 2 wherein step (b) is carried out at a temperature of from about 110° C. to about 160° C.

Claim 7

A crystalline copolymer of p-dioxanone and lactide produced by the process of claim 1.

Claim 8

A crystalline copolymer of p-dioxanone and lactide produced by the process of claim 2.

Claim 9

A crystalline copolymer of p-dioxanone and lactide produced by the process of claim 3.

Claim 10

A copolymer of p-dioxanone and lactide containing from about 70 to about 98 weight percent polymerized p-dioxanone, the remainder being co-polymerized lactide, said copolymer being characterized as follows: an inherent viscosity of from about 1.6 to 2.7; a melting point of about 90° to about 110° C.; a crystallinity of about 20 to about 45 percent; a single peak in the molecular weight distribution curve; and, single phase in the molten state, by optical microscopy

Claim 11

A copolymer of p-dioxanone and lactide containing from about 70 to about 98 weight percent polymerized p-dioxanone, the remainder being co-polymerized lactide, said copolymer being characterized as follows: an inherent viscosity of from about 1.6 to 2.7; a melting point of about 90° to about 110° C.; a crystallinity of about 20 to about 45 percent; a single peak in the molecular weight distribution curve; and, single phase in the molten state, by optical microscopy

Claim 12

The copolymer of claim 9 containing from about 90 to 97 mol percent polymerized p-dioxanone, the remainder being co-polymerized lactide.

Claim 13

A drawn and oriented filament comprising the copolymer of claim 10.

Claim 14

The filament of claim 11 in the form of a monofilament.

Claim 15

The filament of claim 12 in the form of a sterile surgical suture.

Claim 16

The monofilament of claim 12 having the following properties: ______________________________________ straight tensile strength 70-110 kpsi knot tensile strength 40-70 kpsi elongation 30-65% Young's modulus 100-250 kpsi In vivo BSR, 3 weeks 50-70% 4 weeks 40-50% 8 weeks 5-15% In vivo absorption, to zero less than 5 to 6 months ______________________________________

Claim 17

The sterile surgical suture of claim 13 attached to a needle.

Claim 18

A surgical device comprising the crystalline copolymer of claim 9.