Suture methods and devices

• US 10,548,592 B2
• Filed: 05/16/2005
• Issued: 02/04/2020
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Ruff, Gregory L., Leung, Jeffrey C., Kaplan, Andrew, Megaro, Matthew A., Batchelor, Stanton D.
• Primary Examiner(s): Anderson, Gregory A
• Application Number:
  US10/908,539
• Publication Number:
  US 20050267531A1
• Time in Patent Office: 5,377 Days
• Field of Search: 606228
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1146 of tendons
• CPC Class Codes: A61B 2017/00761 Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs

Abstract

A barbed suture including a body with barbs on the periphery, a pointed end, and an anchor at one end to resist movement of the suture in the direction of the pointed end is provided. One or more limbs on the anchor may be provided, which may be arcuate, of varying lengths, and of varying distribution about the periphery of the suture body. Other anchor designs are provided. Methods of placing single-directional and bi-directional barbed sutures to approximate the tissue on each side of a wound and to position and support tissue in the absence of a wound, as in cosmetic surgery, are provided, and may include terminal J-stitches or S-stitches. Methods of placement may be made with sharp, pointed ends, which may be needles, or insertion devices. Sinusoidal patterns of sutures that have amplitudes generally perpendicular to the resultant holding force of the suture are provided.

Claims

1. A barbed suture comprising:

(a) an elongated body with a cross section, where the cross section has a transverse length;

(b) one pointed end, wherein the pointed end includes a needle;

(c) a proximal end; and

(d) a plurality of staggered cuts in the elongated body providing for a plurality of staggered barbs extending from the periphery of the elongated body, the barbs yielding toward the elongated body during movement of the barbed suture through tissue in the direction of movement of the pointed end and the barbs resisting movement of the barbed suture through the tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue;

the proximal end having a loop through which the elongated body may pass to secure tissue as an anchor, wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern such that two or more barbs are not laterally adjacent one another along the periphery of the elongated body.

2. The barbed suture of claim 1, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the pointed end passing through the inner perimeter of the loop.

3. The barbed suture of claim 1, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.

4. The barbed suture of claim 1, wherein the needle is integral with the elongated body.

5. The barbed suture of claim 1, wherein the number of barbs in the helical pattern that occupy one revolution is not an integer.

6. The barbed suture of claim 1, wherein the barbs are arranged in three rows along the elongated body, wherein the rows are spaced 120 degrees from one another around the circumference of the elongated body.

7. The barbed suture of claim 1, wherein the transverse length is about 100 to 500 microns.

8. The barbed suture of claim 1, wherein the loop has a diameter such that the barbed suture can pass through the loop without the barbs on the elongated body engaging the loop.

9. A barbed suture comprising:

(a) a pointed end including a needle;

(b) an elongated body, the needle being secured to the elongated body, the elongated body having a periphery and a generally circular cross-section with a diameter, wherein a plurality of staggered cuts in the elongated body provide a plurality of staggered barbs extending from the periphery, an entirety of a barb adapted to yield toward the elongated body during movement of the barbed suture through tissue in a direction of movement of the pointed end and resist movement of the barbed suture through the tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue; and

(c) one end opposite the pointed end having a loop through which the elongated body may pass to secure tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about .1 to 6,

wherein the barbs are arranged in a helical pattern such that two or more barbs are not laterally adjacent one another along the periphery of the elongated body.

10. The barbed suture of claim 9, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the pointed end passing through the inner perimeter of the loop.

11. The barbed suture of claim 9, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.

12. The barbed suture of claim 9, wherein the needle is integrally secured to the elongated body.

13. The barbed suture of claim 9, wherein the number of barbs in the helical pattern that occupy one revolution is not an integer.

14. The barbed suture of claim 9, wherein the barbs are arranged in three rows along the elongated body, where the rows are spaced 120 degrees from one another around the circumference of the elongated body.

15. A barbed suture comprising:

(a) a needle;

(b) an elongated body, the needle being attached to the elongated body, the elongated body being generally circular in cross-section and having a periphery, the elongated body being flexible and substantially nonresilient, the elongated body having a plurality of staggered cuts that give rise to a plurality of barbs staggered along the periphery of the elongated body and being adapted to yield toward the elongated body during movement of the barbed suture through tissue in a direction of movement of the needle and resist movement of the barbed suture through the tissue in a direction opposite the direction of movement of the needle by engagement of the barbs with tissue surrounding the elongated body; and

(c) one end opposite the needle having a loop through which the needle and elongated body may pass to secure tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the elongated body in the direction of movement of the needle,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern such that two or more barbs are not laterally adjacent one another along the periphery of the elongated body.

16. The barbed suture of claim 15, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the needle passing through the inner perimeter of the loop.

17. The barbed suture of claim 15, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.

18. The barbed suture of claim 15, wherein the number of barbs in the helical pattern that occupy one revolution is not an integer.

19. The barbed suture of claim 15, wherein the barbs are arranged in three rows along the elongated body, where the rows are spaced 120 degrees from one another around the circumference of the elongated body.

20. A barbed suture comprising:

(a) an elongated body with a cross section, where the cross section has a transverse length;

(b) one pointed end;

(c) a proximal end; and

(d) a plurality of staggered cuts in the elongated body providing for a plurality of staggered barbs extending from a periphery of the elongated body, the barbs yielding toward the elongated body during movement of the barbed suture through tissue in the direction of movement of the pointed end and the barbs resisting movement of the barbed suture through the tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue;

the proximal end having a loop through which the elongated body may pass to secure one end but not both ends of the barbed suture to tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern such that two or more barbs are not laterally adjacent one another in the cross-section.

21. The barbed suture of claim 20, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the pointed end passing through the inner perimeter of the loop.

22. The barbed suture of claim 20, wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.

23. The barbed suture of claim 20, wherein the number of barbs in the helical pattern that occupy one revolution is not an integer.

24. The barbed suture of claim 20, wherein the barbs are arranged in three rows along the elongated body, where the rows are spaced 120 degrees from one another around the circumference of the elongated body.

25. A barbed suture comprising:

(a) a pointed end including a needle;

(b) an elongated body, the needle being secured to the elongated body, the elongated body having a periphery and a generally circular cross-section with a diameter, wherein a plurality of staggered cuts in the elongated body provide a plurality of staggered barbs extending from the periphery, an entirety of a barb adapted to yield toward the elongated body during movement of the barbed suture through the tissue in a direction of movement of the pointed end and resist movement of the barbed suture through tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue; and

(c) one end opposite the pointed end having a loop through which the elongated body may pass to secure tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern,

wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the pointed end passing through the inner perimeter of the loop.

26. A barbed suture comprising:

(a) a pointed end including a needle;

(b) an elongated body, the needle being secured to the elongated body, the elongated body having a periphery and a generally circular cross-section with a diameter, wherein a plurality of staggered cuts in the elongated body provide a plurality of staggered barbs extending from the periphery, an entirety of a barb adapted to yield toward the elongated body during movement of the barbed suture through tissue in a direction of movement of the pointed end and resist movement of the barbed suture through the tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue; and

(c) one end opposite the pointed end having a loop through which the elongated body may pass to secure tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern,

wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.

27. A barbed suture comprising:

(a) an elongated body with a cross section, where the cross section has a transverse length;

(b) one pointed end;

(c) a proximal end; and

(d) a plurality of staggered cuts in the elongated body providing for a plurality of staggered barbs extending from a periphery of the elongated body, the barbs yielding toward the elongated body during movement of the barbed suture through the tissue in the direction of movement of the pointed end and the barbs resisting movement of the barbed suture through tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue;

the proximal end having a loop through which the elongated body may pass to secure one end but not both ends of the barbed suture to tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees, wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern,

wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter of the loop is uninterrupted by any surface features that are configured to affect the pointed end passing through the inner perimeter of the loop.

28. A barbed suture comprising:

(a) an elongated body with a cross section, where the cross section has a transverse length;

(b) one pointed end;

(c) a proximal end; and

(d) a plurality of staggered cuts in the elongated body providing for a plurality of staggered barbs extending from a periphery of the elongated body, the barbs yielding toward the elongated body during movement of the barbed suture through tissue in the direction of movement of the pointed end and the barbs resisting movement of the barbed suture through the tissue in a direction opposite the direction of movement of the pointed end by engagement of the barbs within the tissue;

the proximal end having a loop through which the elongated body may pass to secure one end but not both ends of the barbed suture to tissue as an anchor wherein the anchor does not include barbs on the loop, the anchor preventing movement of the barbed suture in the direction of movement of the pointed end,

wherein the barbs are characterized by a barb cut depth (Dc), wherein the ratio of the barb cut depth to the transverse length is about 0.05 to about 0.6,

wherein the barbs are characterized by a barb cut angle (Ø

), wherein the barb cut angle ranges from 140 to 175 degrees,

wherein the barbs are characterized by a barb cut length (Lc), wherein the ratio of the barb cut length to transverse length is about 0.2 to about 2,

wherein the barbs are characterized by a longitudinal distance between barbs cut into the elongated body, wherein the ratio of the longitudinal distance between barbs to the transverse length is about 0.1 to 6,

wherein the barbs are arranged in a helical pattern,

wherein the loop has an inner perimeter and an outer perimeter, wherein the inner perimeter has a curved proximal end and a pointed distal end, with continuously curved lateral edges extending from the curved proximal end to the pointed distal end.