Bioabsorbable surgical device for treating nerve defects

• US 4,870,966 A
• Filed: 02/01/1988
• Issued: 10/03/1989
• Est. Priority Date: 02/01/1988
• Status: Expired due to Term

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: American Colloid Company (Minerals Technologies Incorporated)
• Inventors: Dellon, Arnold L., Mackinnon, Susan E.
• Primary Examiner(s): Coven, Edward M.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/150,594
• Time in Patent Office: 610 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66 C, 128/334 R
• US Class Current: 606/152
• CPC Class Codes: A61B 17/1128 of nerves
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A bioabsorbable tube device for the repair of nerve defects or gaps comprising a flexible, porous, knitted or woven mesh tube. The tube device is crimped along its exterior to provide a tube which can be bent without pinching or crimping the internal circumference of the tube. The internal tube surface is relatively smooth to provide an optimum environment for longitudinal nerve axon growth within the tube.

Claims

1. A medical device adaptable for use in the treatment of a nerve gap or defect comprising a flexible, porous tube of a bioabsorbable polymer material, said tube having a plurality of corrugations on its exterior surface positioned so as to allow said tube to be bent without crimping the internal surface of said tube and having a plurality of flats provided on its interior surface to provide a relatively smooth interior surface and having a substantially constant internal diameter to promote longitudinal axon growth within the tube device and across the nerve gap, and being capable of enclosing and protecting the ends of a severed or lacerated nerve.

2. The device according to claim 1 adaptable for use when the nerve gap or defect is from about 2 millimeters to about 6 centimeters in length.

3. The device according to claim 2 wherein said device is adaptable for use when the nerve gap is from about 2 millimeters to about 2 centimeters in length.

4. The device according to claim 2 wherein said device is adaptable for use when the nerve gap is at least 2 centimeters in length.

5. The device according to claim 2 adaptable for receiving severed nerve ends wherein a plurality of bioabsorbable microsutures projecting through the tube wall and into the epineural layer of the nerve ends are utilized to affix the nerve ends within a tube.

6. The device according to claim 3 wherein the tube is knitted or woven from a plurality of bioabsorbable polymer fibers.

7. The device according to claim 6 wherein the tube is knitted from a plurality of yarns on a weft knitting machine using a single feed jersey stitch type construction, the bioabsorbable polymer fibers being formed by combining three plies of 50 denier yarn and one ply of 25 denier yarn, all plied at 2.3 turns per inch twist.

8. The device according to claim 6 wherein the tube is woven from a plurality of yarns, the warp yarn being 3 ply 46 denier/21 filament biabsorbable polymer yarn having 5 turns per inch twist, the weft (filling) yarn being 3 ply 46 denier/21 filament biabsorbable polymer yarn having 1.5 turns per inch twist.

9. The device according to claim 6 wherein said polymer fibers are selected from the group consisting of polyglycolic acid, polylactic acid, polydioxanone, polylactide-co-glycolide, poly(glycolide-co-trimethylene carbonate), polyestermides, and copolymers and mixtures thereof.

10. The device according to claim 9 wherein said polymer fibers are polyglycolic acid.

11. The device according to claim 9 wherein said polymer fibers are poly(glycolide-co-trimethylene carbonate).

12. A medical device adaptable for use in the treatment of a nerve gap or defect comprising a flexible, porous tube manufactured from a bioabsorbable polymer fiber which is knitted or woven into tube shape, said knitted or woven mesh tube having a plurality of corrugations on its exterior surface such that said tube may be bent without crimping the internal surface of said tube and having a plurality of flats provided on its interior surface to provide a relatively smooth interior surface and having a substantially constant internal diameter to promote longitudinal axon growth within the tube device and across the nerve gap, and being capable of enclosing and protecting the ends of a severed or lacerated nerve.

13. The device according to claim 12 adaptable for receiving severed nerve ends wherein a plurality of bioabsorbable microsutures projecting through the tube wall and into the epineural layer of the nerve ends affix the nerve ends within the tube.

14. The device according to claim 12 wherein the tube is knitted from a plurality of yarns on a weft knitting machine using a single feed jersey stitch type construction, the bioabsorbable polymer fibers being formed by combining three plies of 50 denier yarn and one ply of 25 denier yarn, all plied at 2.3 turns per inch twist.

15. The device according to claim 12 wherein the tube is woven from a plurality of yarns, the warp yarn being 3 ply 46 denier/21 filament bioabsorbable polymer yarn having 5 turns per inch twist, the weft (filling) yarn being 3 ply 46 denier/21 filament biabsorbable polymer yarn having 1.5 turns per inch twist.

16. The device according to claim 12 wherein said polymer fibers are selected from the group consisting of polyglycolic acid, polyactic acid, polydioxanone, poly-(lactide-co-glycolide) poly (glycolide-co-trimethylene carbonate), polyestermides, and copolymers and mixtures thereof.

17. The device according to claim 16 wherein said polymer fibers are polyglycolic acid, and said device is adaptable for use when the nerve gap or defect is from about 1 cm to 3 cm in length.

18. The device according to claim 16 wherein said polymer fibers are poly(glycolide-co-trimethylene carbonate), and said device is adaptable for use when the nerve gap is from 1 cm to 6 cm in length.