Crystalline p-dioxanone/glycolide copolymers and surgical devices made therefrom

Claim 2

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

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 glycolide 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 copolymer of p-dioxanone and glycolide.

Claim 4

The process of claim 2 wherein said first mixture contains from 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 glycolide is employed in an amount of from about 3 to about 25 weight percent, based on total weight of p-dioxanone and glycolide charged in steps (a) and (b).

Claim 6

The process of claim 2 wherein step (b) is carried out at a temperature within the range of from about 120° to about 180° C.

Claim 7

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

Claim 8

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

Claim 9

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

Claim 10

A crystalline copolymer of p-dioxanone and glycolide containing from about 3 to about 30 weight percent polymerized glycolide, the remainder being polymerized p-dioxanone, said copolymer being characterized as follows: An inherent viscosity of 1.6 to 2.6 dl/g; A melting temperature of 90° to 125° C. by hot stage microscopy; A crystallinity of 25 to 50%; A single peak in the molecular weight distribution curve; and Single phase in the molten state.

Claim 11

A crystalline copolymer of p-dioxanone and glycolide containing from about 3 to about 30 weight percent polymerized glycolide, the remainder being polymerized p-dioxanone, said copolymer being characterized as follows: An inherent viscosity of 1.6 to 2.6 dl/g; A melting temperature of 90° to 125° C. by hot stage microscopy; A crystallinity of 25 to 50%; A single peak in the molecular weight distribution curve; and Single phase in the molten state.

Claim 12

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

Claim 13

A drawn and oriented filament comprising the segmented 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, KPSI 70-120 Knot Tensile, KPSI 40-80 Elongation, % 25-60 Young's Modulus, KPSI 150-300 In Vivo BSR, % 3 weeks 20-50% 4 weeks 10-30% In Vivo Absorption, to zero less than 4 to 5 months ______________________________________

Claim 17

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

Claim 18

A surgical device comprising the copolymer of claim 9.