Self-retaining variable loop sutures

• US 10,492,780 B2
• Filed: 03/23/2012
• Issued: 12/03/2019
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Gross, Jeffrey M., Drubetsky, Lev, D'Agostino, William L., Hunter, William L.
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US13/429,150
• Publication Number:
  US 20120245629A1
• Time in Patent Office: 2,811 Days
• Field of Search: 606228, 606232, 606139, 606146, 606148, 606213, 606222
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• 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 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs

Abstract

A suture having a first end for penetrating tissue, an elongated suture body having a periphery; a plurality of retainers on the periphery, and a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop slidably engaging the elongated body for slidingly varying the circumference of the variable loop, and wherein the first end may pass through the variable loop to secure tissue as an anchor, the anchor preventing movement of the suture in the direction of deployment of the first end.

Claims

1. A self-retaining suture comprising:

a. a needle having a first diameter;

b. a suture comprising;

i. a first end for penetrating tissue, wherein the first end is attached to the needle;

ii. an elongated suture body having a periphery;

iii. a first plurality of retainers on the periphery of the elongated body and oriented to the first end, the first plurality of retainers yielding toward the suture body during movement of the suture through tissue in a direction of deployment of the first end, and resisting movement of the suture, when in tissue, in a direction substantially opposite the direction of deployment of the first end; and

iv. a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop slidably engaging the elongated body for slidingly varying the circumference of the variable loop, wherein the fixed loop has no retainers on its surface and said fixed loop is formed by passing a non-deployment terminus of the suture body around and back upon itself and attaching said non-deployment terminus to the suture body such that said non-deployment terminus is located outside the interior of the fixed loop, wherein the fixed loop has a second diameter that is less than the first diameter that is configured to prevent the needle from passing through the fixed loop, and wherein the first end is configured to pass through the variable loop to secure tissue as an anchor, the anchor preventing movement of the suture in the direction of deployment of the first end.

2. The suture of claim 1, further comprising a surface feature on at least some of the periphery of the elongated body between the fixed loop and the first plurality of retainers, the surface feature resisting sliding of the fixed loop over the surface feature.

3. The suture of claim 1, wherein the elongated body has a cross section having a transverse length (tl) and the fixed loop has an inner transverse length (TL) and wherein the ratio of TL:

tl is about 1;

1 to about 10;

1.

4. The suture of claim 1, wherein the fixed loop further comprises a grasp engagement element.

5. The suture of claim 1, wherein the fixed loop further comprises a visible marking.

6. The suture of claim 1, wherein the cross section of the elongated suture body is non-circular.

7. The suture of claim 1, further comprising a therapeutic agent.

8. The suture of claim 1, wherein the non-deployment terminus is secured to the suture body at an attachment region, and the attachment region is adjacent to the fixed loop.

9. The suture of claim 1, wherein the non-deployment terminus is secured to the suture body at an attachment region, and the attachment region is a welded site.

10. The suture of claim 1, wherein the non-deployment terminus is secured to the suture body at an attachment region, and the attachment region is a glued site.

11. The suture of claim 1, wherein the second end includes a surface feature disposed proximal to the fixed loop, wherein the surface feature is configured to provide a tactile indication.

12. The suture of claim 11, wherein the surface feature is selected from the group consisting of dimpling, rippling, corrugation, roughening, serrations, ridges, and filaments.

13. The suture of claim 1, wherein the fixed loop is enclosed forming a completely bounded perimeter such that the fixed loop does not open up to a portion of the variable loop.

14. The suture of claim 1, wherein the suture further comprises a second plurality of retainers on the periphery of the elongated body disposed within the variable loop, wherein the second plurality of retainers are oriented opposite the first plurality of retainers.

15. A method of suturing comprising:

a. providing a self-retaining system comprising a suture needle and a self-retaining suture, the self-retaining suture comprising a suture thread having a thread diameter, a plurality of tissue retainers and an eyelet, said eyelet formed by passing a non-deployment terminus of the suture thread around and back upon itself and attaching said non-deployment terminus to the suture thread such that said non-deployment terminus is located outside the interior of the eyelet, where the suture thread passes through the eyelet to form a variable loop having an original diameter, wherein the suture needle is attached to an end of the self-retaining suture after the variable loop is formed, wherein the suture needle has a first diameter and the eyelet has a second diameter, wherein the second diameter is less than the first diameter to prevent the suture needle from passing through the eyelet;

b. inserting the needle into the tissue of a patient at a first tissue location after passing the suture thread through the eyelet to form the variable loop;

c. withdrawing the needle from the tissue of the patient at a second tissue location;

d. passing the needle and at least some of the suture thread through the variable loop; and

e. inserting the needle into the tissue of the patient at a third tissue location.

16. The method of claim 15, wherein the suture thread is passed through the variable loop while simultaneously the diameter of the variable loop is decreased.

17. The method of claim 16, wherein the diameter of the variable loop is decreased until the variable loop fits snugly around the suture thread.

18. The method of claim 15, wherein the suture thread is passed through the variable loop until the eyelet, the variable loop and the suture body together form an anchor, and where further movement of the suture thread in the direction of the suture needle is resisted by the anchor.

19. A method of suturing comprising:

a. providing a self-retaining suture, the self-retaining suture comprising a suture thread having a thread diameter, a plurality of tissue retainers and an eyelet, said eyelet formed by passing a non-deployment terminus of the suture thread around and back upon itself and attaching said non-deployment terminus to the suture thread such that said non-deployment terminus is located outside the interior of the eyelet;

b. passing the suture thread through the eyelet to form a variable loop having an original diameter after providing the self-retaining system;

c. attaching a suture needle to an end of the self-retaining suture, wherein the suture needle has a first diameter and the eyelet has a second diameter, wherein the second diameter is less than the first diameter to prevent the suture needle from passing through the eyelet;

d. inserting the needle into the tissue of a patient at a first tissue location after passing the suture thread through the eyelet to form the variable loop;

e. withdrawing the needle from the tissue of the patient at a second tissue location; and

f. passing the needle and at least some of the suture thread through the variable loop.

20. The method of claim 19, further comprising:

inserting the needle into the tissue of the patient at a third tissue location after passing the needle and at least some of the suture thread through the variable loop.