Self-retaining sutures having effective holding strength and tensile strength

• US 8,852,232 B2
• Filed: 08/04/2010
• Issued: 10/07/2014
• 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:
  US12/850,035
• Publication Number:
  US 20100298875A1
• Time in Patent Office: 1,525 Days
• Field of Search: 606228-231, 606215-216, 29 71- 73
• US Class Current: 606/226
• 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 wound-closure device comprising:

a strand of monofilament suture, having a first end, a second end, a longitudinal axis, a surface and a diameter (D), having a minimum knot pull strength requirement (S);

a plurality of angled cuts present in the surface of the strand and spaced along the strand;

each angled cut giving rise to a tissue-retaining element;

the plurality of angled cuts defining a plurality of tissue-retaining elements spaced along the strand;

the plurality of tissue-retaining elements being adapted to permit movement of the strand through tissue in a direction of the first end and resist movement of the strand through tissue in an opposite direction;

each tissue-retaining element having a tip separated from the strand and a base connected to the strand, and further having an underside which attaches the tissue-retaining element to the strand along a concave arcuate line;

each tissue-retaining element having a length no less than about 0.8 diameters (0.8*D), measured tip-to-base along the longitudinal axis;

the tissue-retaining elements being spaced at a distance no larger than two diameters (2*D), measured tip-to-tip along the longitudinal axis; and

the wound-closure device having a tensile strength no less than about 80% of the USP minimum knot pull strength requirement (S) for monofilament suture of the diameter (D).

2. The wound-closure device of claim 1, wherein the plurality of tissue-retaining elements is effective to resist movement of the suture thread in the opposite direction by holding tissue with a straight pull strength no less than about 80% of the USP minimum knot pull strength requirement (S) for monofilament suture of the diameter (D).

3. The wound-closure device of claim 1, wherein the diameter (D) is less than about 0.5 mm.

4. The wound-closure device of claim 1, wherein the plurality of tissue-retaining elements includes at least thirty (30) tissue-retaining elements.

5. The wound-closure device of claim 4, wherein the plurality of tissue-retaining elements includes a first set of at least ten tissue-retaining elements, a second set of at least ten tissue-retaining elements and a third set of at least ten tissue-retaining elements, the first set of at least ten tissue-retaining elements being radially displaced by 120 degrees from the second set of at least ten tissue-retaining elements, the third set of at least ten tissue-retaining elements being radially displaced by 120 degrees from the first set of at least ten tissue-retaining elements and from the second set of at least ten tissue-retaining elements.

6. The wound-closure device of claim 1, wherein each tissue-retaining element has a length no less than about one diameter (1*D).

7. The wound-closure device of claim 1, further comprising a second plurality of tissue-retaining elements longitudinally-displaced from the first plurality of tissue-retaining elements and adapted to permit movement of the strand through tissue in a direction of the second end and resist movement of the strand through tissue in an opposite direction.

8. The wound-closure device of claim 1, wherein each tip is pointed.

9. The wound-closure device of claim 1, wherein the monofilament suture comprises a copolymer of glycolide and caprolactone.

10. The wound-closure device of claim 1, wherein the monofilament suture comprises a copolymer of glycolide and trimethylene carbonate.

11. A self-retaining suture comprising:

a strand of polymer, having a first end, a second end, a longitudinal axis, a surface and a diameter (D), having a minimum knot pull strength requirement (S);

a plurality of angled cuts present in the surface of the strand and spaced along the strand;

each angled cut giving rise to a tissue-retaining element;

the plurality of angled cuts defining a plurality of tissue-retaining elements spaced along the strand, each tissue-retaining element having an apex separated from the strand and a base connected to the strand, and further having an underside which attaches the tissue-retaining element to the strand along a concave arcuate line;

the plurality of tissue-retaining elements being adapted to permit movement of the strand through tissue in a direction of the first end and resist movement of the strand through tissue in an opposite direction;

each tissue-retaining element having a length no less than about 0.8 diameters (0.8*D), measured apex-to-base along the longitudinal axis;

the tissue-retaining elements being spaced at a distance no larger than two diameters (2*D), measured apex-to-apex along the longitudinal axis; and

the wound-closure device having a tensile strength no less than about 80% of the USP minimum knot pull strength requirement (S) for suture of the diameter (D).

12. The self-retaining suture of claim 11, wherein the plurality of tissue-retaining elements is effective to resist movement of the suture thread in the opposite direction by holding tissue with a straight pull strength no less than about 80% of the USP minimum knot pull strength requirement (S) for suture of the diameter (D).

13. The self-retaining suture of claim 11, wherein the diameter (D) is less than about 0.5 mm.

14. The self-retaining suture of claim 11, wherein the plurality of tissue-retaining elements includes more than thirty (30) tissue-retaining elements.

15. The self-retaining suture of claim 11, wherein the plurality of tissue-retaining elements includes a first set of at least ten tissue-retaining elements, a second set of at least ten tissue-retaining elements and a third set of at least ten tissue-retaining elements, the first set of at least ten tissue-retaining elements being radially displaced by 120 degrees from the second set of at least ten tissue-retaining elements, the third set of at least ten tissue-retaining elements being radially displaced by 120 degrees from the first set of at least ten tissue-retaining elements and from the second set of at least ten tissue-retaining elements.

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

17. The self-retaining suture of claim 11, wherein the polymer comprises a copolymer of glycolide and caprolactone.

18. The self-retaining suture of claim 11, wherein each apex is pointed.

19. A wound-closure device comprising:

a strand of bioabsorbable polymer suture, having a first end, a second end, a longitudinal axis, a surface and a diameter (D), having a minimum knot pull strength requirement (S);

a plurality of angled cuts present in the surface of the strand and spaced along the strand;

each angled cut giving rise to a tissue-retaining element;

the plurality of angled cuts defining a plurality of tissue-retaining elements spaced along the strand, each tissue-retaining element having an apex separated from the strand and a base connected to the strand, and further having an underside which attaches the tissue-retaining element to the strand along a concave arcuate line;

the plurality of tissue-retaining elements being adapted to permit movement of the strand through tissue in a direction of the first end and resist movement of the strand through tissue in an opposite direction;

each tissue-retaining element having a length no less than about 0.8 diameters (0.8*D), measured apex-to-base along the longitudinal axis;

the tissue-retaining elements being spaced at a distance a spacing no larger than two diameters (2*D), measured apex-to-apex along the longitudinal axis;

wherein the diameter (D) is less than 1 mm; and

the tensile strength is greater than 7 lbs.

20. The wound-closure device of claim 19, wherein the plurality of tissue-retaining elements includes more than thirty (30) tissue-retaining elements.