Readily Absorbable Copolymer Compositions for High Strength Sutures Having Enhanced Strength Retention Post-Implantation

Patent metadata

Field	Value
Publication number	US-2020000958-A1
Application number	US-201816021322-A
Country	US
Kind code	A1
Filing date	Jun 28, 2018
Priority date	Jun 28, 2018
Publication date	Jan 2, 2020
Grant date	—

Abstract

Novel surgical sutures and novel medical devices made from novel semi-crystalline, glycolide-rich A-B-A triblock copolymers of glycolide and lactide, wherein said B-segment is a fully amorphous random copolymer of glycolide and lactide, for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, meshes and other medical devices, especially for patients with compromised healing. The novel sutures have improved properties and improved breaking strength retention, while still substantially absorbing within about a 120-day period post-implantation.

First claim

We claim:

1 . An absorbable medical device made from an absorbable copolymer of the structure A-B-A comprising end segments A and middle segment B, wherein said end-segments A comprise polymerized glycolide and the middle segment B comprises polymerized glycolide and polymerized lactide, and wherein said middle segment B is fully amorphous and contains about 30 mole percent to about 80 mole percent of polymerized lactide, and about 20 mole percent to about 70 mole percent of polymerized glycolide, and wherein the total amount of polymerized glycolide in the absorbable copolymer is about 88 mole percent to about 92 mole percent of said absorbable copolymer and the total amount of polymerized lactide is about 8 mole percent to about 12 mole percent of said absorbable copolymer.

2 . The absorbable medical device of claim 1 , wherein said device is selected from the group consisting of monofilament sutures, multifilament sutures, barbed sutures, surgical meshes, surgical fabrics, films, surgical tapes, and injection molded articles.

3 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 13 mils, a minimum pre-implantation straight tensile strength of about 17 pounds, and a minimum average straight tensile strength of about 14 pounds at 21 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

4 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 13 mils, a minimum pre-implantation average straight tensile strength of about 17 pounds, and a minimum average straight tensile strength of about 7 pounds at 35 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

5 . The multifilament absorbable suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 13 mils, a minimum pre-implantation average straight tensile strength of about 17 pounds, and a minimum average straight tensile strength of about 2.3 pounds at 42 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

6 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 13 mils, a minimum pre-implantation average straight tensile strength of about 17 pounds, and a minimum average straight tensile strength of about 1.0 pounds at 49 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

7 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 23 mils, a minimum pre-implantation straight tensile strength of about 38 pounds, and a minimum average straight tensile strength of about 30 pounds at 21 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

8 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 23 mils, a minimum pre-implantation straight tensile strength of about 38 pounds, and a minimum average straight tensile strength of about 20 pounds at 35 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

9 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the suture has a diameter of about 23 mils, a minimum pre-implantation straight tensile strength of about 38 pounds, and a minimum average straight tensile strength of about 5.5 pounds at 42 days post-implantation, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

10 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the minimum straight tensile strength remaining at 21 days post-implantation is about 80 percent of the initial straight tensile strength value, and wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

11 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the minimum straight tensile strength remaining at 35 days post-implantation is about 50 percent from the initial straight tensile strength value, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

12 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising about 88 mole percent to about 92 mole percent of polymerized glycolide and about 8 mole percent to about 12 mole percent of polymerized lactide, wherein the minimum straight tensile strength remaining at 42 days post-implantation is about 10 percent of the initial straight tensile strength value, and, wherein the suture is substantially absorbed in about 120 days or less, post-implantation.

13 . The absorbable multifilament suture of claim 2 , wherein said suture comprises a plurality of filaments, the filaments comprising a poly(lactide-co-glycolide) copolymer, said copolymer comprising

Assignees

• Ethicon Inc

Inventors

• Jamiolkowski Dennis D
• Defelice Christopher
• Andjelic Sasa
• Kelly Brian M
• Wisnudel Marc
• Steiger Daniel
• Chen Gaoyuan Gavin

Classifications

• C08G63/08

  Lactones or lactides · CPC title

• A61B17/06166 Primary

  Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M) · CPC title

• A61B2017/00004

  (bio)absorbable, (bio)resorbable or resorptive · CPC title

• A61L17/12 Primary

  Homopolymers or copolymers of glycolic acid or lactic acid · CPC title

• A61L2300/404

  Biocides, antimicrobial agents, antiseptic agents · CPC title