Self-retaining sutures having effective holding strength and tensile strength

• US 8,821,540 B2
• Filed: 08/04/2010
• Issued: 09/02/2014
• Est. Priority Date: 09/30/2002
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Ethicon, LLC (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Leung, Jeffrey C., Ruff, Gregory L., Megaro, Matthew A.
• Primary Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US12/850,063
• Publication Number:
  US 20100298876A1
• Time in Patent Office: 1,490 Days
• Field of Search: 606228-231, 606215-216
• US Class Current: 606/228
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: Y10T 83/852 Responsive to force

Abstract

A barbed suture with a first end and a second end and a body with a plurality of barbs extending from the body. Each barb causes the suture to resist movement in an opposite direction from which the barb faces. Projections extend from said suture. The projections can also engage tissue. The barbs cover the projections when the first end of the suture is moved in tissue and exposes the projections in order to engage tissue when the suture is moved in the direction of the second end through tissue.

Claims

1. A self-retaining suture formed from stock monofilament of a bioabsorbable polymer, the stock monofilament having a filament diameter (SD) and a tensile strength, wherein the self-retaining suture comprises:

a strand of said stock monofilament, the strand having a first end, a second end, a longitudinal axis, and a surface;

a plurality of cuts made into the surface of the strand;

the cuts extending from a beginning at the surface to an end within the strand, the plurality of cuts defining a plurality of barbs adapted to permit movement of the strand through tissue towards the first end and resist movement in an opposite direction;

each barb having a tip separated from the strand and a base connected to the strand at the end of the cut, and further having an underside which attaches the barb to the strand along a concave arcuate line;

each barb having a length no less than about 0.8 filament diameters (0.8*SD), measured tip-to-base along the longitudinal axis;

adjacent barbs being distributed at a spacing no larger than two filament diameters (2*SD), measured tip-to-tip along the longitudinal axis;

each barb having a ratio of cut depth to SD from about 0.05 to about 0.5;

each barb having a cut angle formed between the barb and the strand from about 140 degrees to about 175 degrees; and

the self-retaining suture having a tensile strength no less than about one third of the tensile strength of the stock monofilament from which the self-retaining suture is made.

2. The self-retaining suture of claim 1, wherein the spacing between adjacent barbs is less than about one-and-a-half filament diameters (1.5*SD).

3. The self-retaining suture of claim 2, wherein the filament diameter (SD) is less than about 1 mm.

4. The self-retaining suture of claim 3, wherein the spacing between adjacent barbs is less than about 1 mm.

5. The self-retaining suture of claim 4, wherein the filament diameter (SD) is less than about 0.5 mm.

6. The self-retaining suture of claim 1, wherein each barb has a length no less than about one filament diameter (1*SD).

7. The self-retaining suture of claim 1, wherein the plurality of barbs includes a first set of barbs, a second set of barbs and a third set of barbs, the first set of barbs being radially displaced by 120 degrees from the second set of barbs, the third set of barbs being radially displaced by 120 degrees from first set of barbs and from the second set of barbs.

8. The self-retaining suture of claim 1, wherein the self-retaining suture has a tensile strength at least substantially equivalent to a USP minimum knot pull strength requirement for an unbarbed suture made from the same stock monofilament.

9. The self-retaining suture of claim 1, wherein the self-retaining suture has a tensile strength greater than 7 pounds.

10. The self-retaining suture of claim 1, wherein the bio-absorbable polymer is a polymer of at least one monomer selected from the group consisting of:

dioxanone;

lactide;

glycolide; and

caprolactone.

11. The self-retaining suture of claim 1, wherein the bio-absorbable polymer comprises a copolymer of glycolide and trimethylene carbonate.

12. The self-retaining suture of claim 1, wherein the tip of each barb is pointed.

13. A wound-closure device formed from stock monofilament of a bioabsorbable polymer, the stock monofilament being elongate and flexible and having a filament diameter (SD) and a tensile strength, wherein the wound-closure device comprises:

a strand of said stock monofilament, the strand having a first end, a second end, a longitudinal axis, and a surface;

a plurality of cuts made into the surface of the strand;

the cuts extending from a beginning at the surface to an end within the strand, the plurality of cuts defining a plurality of projections adapted to permit movement of the strand through tissue towards the first end and resist movement in an opposite direction;

each projection having an apex separated from the strand and a base connected to the strand at the end of the cut that defines the projection, and further having an underside which attaches the projection to the strand along a concave arcuate line;

each projection having a length no less than about 0.8 filament diameters (0.8*SD), measured apex-to-base along the longitudinal axis;

adjacent projections being distributed at a spacing no larger than two filament diameters (2*SD), measured apex-to-apex along the longitudinal axis;

each projection having a ratio of cut depth to SD from about 0.05 to about 0.5; and

each projection having a cut angle formed between the projection and the strand from about 140 degrees to about 175 degrees.

14. The wound-closure device of claim 13, wherein the plurality of projections includes a first set of at least thirty projections, a second set of at least thirty projections and a third set of at least thirty projections, the first set of at least thirty projections being radially displaced by 120 degrees from the second set of at least thirty projections, the third set of at least thirty projections being radially displaced by 120 degrees from the first set of at least thirty projections and from the second set of at least thirty projections.

15. The wound-closure device of claim 13, wherein each projection has a length no less than about one filament diameter (1*SD).

16. The wound-closure device of claim 13, wherein the wound-closure device has a tensile strength at least substantially equivalent to a USP minimum knot pull strength requirement for a suture made, without such projections, from the same stock monofilament.

17. The wound-closure device of claim 13, wherein the wound-closure device has a tensile strength greater than seven pounds.

18. The wound-closure device of claim 13, wherein each apex is pointed.

19. The wound-closure device of claim 13, wherein each projection comprises a barb.

20. A wound-closure device formed from stock monofilament of a bioabsorbable polymer, the stock monofilament being elongate and flexible and having a filament diameter (SD) less than 1 mm, wherein the wound-closure device comprises:

a strand of said stock monofilament, the strand having a first end, a second end, a longitudinal axis, and a surface;

a plurality of cuts made into the surface of the strand;

the cuts extending from a beginning at the surface to an end within the strand, the plurality of cuts defining a plurality of projections adapted to permit movement of the strand through tissue towards the first end and resist movement in an opposite direction;

each projection having an apex separated from the strand and a base connected to the strand at the end of the cut that defines the projection, and further having an underside which attaches the projection to the strand along a concave arcuate line;

each projection having a length no less than about 0.8 filament diameters (0.8*SD), measured apex-to-base along the longitudinal axis;

adjacent projections being distributed at a spacing no larger than two filament diameters (2*SD), measured apex-to-apex along the longitudinal axis;

each projection having a ratio of cut depth to SD from about 0.05 to about 0.5;

each projection having a cut angle formed between the projection and the strand from about 140 degrees to about 175 degrees; and

the wound-closure device having a tensile strength greater than 7 lbs.