Method and apparatus for elevating retainers on self-retaining sutures

• US 9,125,647 B2
• Filed: 02/20/2009
• Issued: 09/08/2015
• Est. Priority Date: 02/21/2008
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Ethicon, LLC (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Goraltchouk, Alexei, Herrmann, Robert A., Drubetsky, Lev, Gross, Jeffrey Mendel, D'Agostino, William L., Gonzalez Resendiz, Carlos
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/866,027
• Publication Number:
  US 20110046669A1
• Time in Patent Office: 2,391 Days
• Field of Search: 606/228, 83 13- 56, 428357-401, 29 71- 73
• US Class Current: 1/1
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/00995 having a thin film
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: D02J 3/10 by indenting
• CPC Class Codes: Y10T 83/02 Other than completely through work thickness

Abstract

A method and device to elevate retainers on a suture thread to a desired angle such that the retainers can retain the desired elevation. The retainers can be elevated using an apparatus having at least one roller and at least one bending bar, wherein the bending bar contacts the retainers adjacent to the at least one roller to apply a force to the retainers. The retainers can also be elevated using a tube-shaped apparatus. A suture can be made up of an inner core and a coating that upon a stimuli increases the protrusion of the retainers away from the suture core. A coating can be inserted into the cut associated with the retainer and repulsive or expansive forces result in a pushing out of the cut and distending of the retainers away from the suture core.

Claims

1. A method of forming a self-retaining suture comprising the steps of:

forming a plurality of retainers on an elongated suture body by inserting said suture into a retainer-forming machine, wherein said retainer-forming machine forms retainers in said suture; and

performing a step of elevating the retainers away from the suture body, wherein the step of elevating the retainers comprises;

after the retainers have been created by said retainer-forming machine, inserting the suture having retainers into an apparatus having at least one roller and at least one bending bar;

drawing the suture through the apparatus over the at least one roller;

and contacting the retainers with said at least one bending bar, wherein said bending bar physically applies a force to the retainers and bends the retainers back.

2. The method of claim 1 wherein the elevating step further comprises one or more of the following steps in addition to the step of contacting the retainers with at least one bending bar:

applying mechanical energy to the retainers;

applying thermal energy to the retainers;

applying chemical energy to the retainers;

applying electrostatic energy to the retainers;

applying electrical energy to the retainers;

applying elastic energy to the retainers;

forming the retainers in a layer of material that is different that a core of the suture;

coating the suture with a material that causes the retainers to become elevated;

directing a fluid at the retainers; and

applying a stress to one of the suture and the retainer.

3. The self-retaining suture system of claim 1 wherein the retainer is elevated using one or more of:

applying mechanical energy to the retainers;

applying thermal energy to the retainers;

applying chemical energy to the retainers;

applying electrostatic energy to the retainers;

applying electrical energy to the retainers;

applying elastic energy to the retainers;

coating the suture with a material that causes the retainers to become elevated;

directing a fluid at the retainers; and

applying a stress to one of the suture and the retainer.

4. The method of claim 1, wherein the suture body comprises

an inner core and an outer layer, and wherein the step of elevating the retainers further includes providing a transition stimuli to contract the outer layer thereby extending the retainers outwards away from the inner core.

5. The method of claim 4, wherein the outer layer is heat shrink tubing and the transition stimuli includes heating the heat shrink tubing.

6. The method of claim 4, wherein the inner core is a multifilament.

7. The method of claim 1, wherein the suture body further comprises an outer coating, and wherein the step of elevating the retainers further includes

activating the coating to contract, the contraction of the coating causing the retainers to extend outwards away from the suture body.

8. The method of claim 7, wherein the coating is activated by a change in temperature.

9. The method of claim 7, further comprising adding an activator to contract the outer surface.

10. A method of forming a self-retaining suture comprising the steps of:

forming a plurality of retainers on an elongated suture body; and

performing a step of elevating the retainers away from the suture body, wherein the step of elevating the retainers comprises;

inserting the suture having retainers into at least one hollow tube, said hollow tube having an inner surface having a retainer-engaging feature selected from the group consisting of dimples, grooves, bars or projections;

drawing the suture through the at least one hollow tube; and

bending the retainers back within the tube by dragging the retainers along the inner surface of the at least one hollow tube such that the retainers contact said retainer-engaging feature and said retainers are bent back.

11. The method of claim 10, which includes the further steps of:

(a) drawing a first end of the suture through the tube in a first direction, wherein the retainers contact the inner surface of the tube between the first end of the suture and a transition segment of the suture, wherein the tube includes two separable halves, and wherein the suture is being drawn at a first speed;

(b) separating the tube into two halves when the tube reaches the transition segment of the suture;

(c) moving the two halves of the tube in a second direction opposite the first direction until the tube is located proximal to a second end of the suture;

(d) connecting the separated halves of the tube back together proximal to the second end of the suture;

(e) moving the tube in the first direction at a second speed until the tube reaches the transition segment of the suture, wherein the second speed is at least twice as fast as the first speed; and

(f) separating the tube into two halves until the suture passes by the tube.

12. A method of forming a self-retaining suture comprising the steps of:

forming a plurality of retainers on an elongated suture body, said plurality of retainers disposed in a spiral configuration about said elongated suture body; and

performing a step of elevating the plurality of retainers away from the suture body, wherein the step of elevating the retainers comprises lifting the retainers from original elevation angles to increased elevation angles using electrostatic force.

13. The method of claim 12, wherein plastic deformation imposed by the lifting maintains the retainers at elevation angles greater than the original elevation angles.

14. The method of claim 12, wherein the retainers are made from a material that has a corresponding crystallization temperature, and further comprising:

(d) annealing the retainers, while the retainers are lifted using electrostatic force, by increasing the temperature of the retainers to above the crystallization temperature of the material, and thereafter cooling the retainers.

15. The method of claim 14, wherein the step of elevating the retainers includes maintaining the temperature of the retainers above the crystallization temperature for a sufficient time to allow for stress-relaxation at the points where the retainers connect to the suture body.

16. The method of claim 12, wherein the retainers are made from a material that has a corresponding crystallization temperature, and further comprising annealing the retainers, after the retainers were lifted using electrostatic force, by increasing the temperature of the retainers to above the crystallization temperature of the material, and thereafter cooling the retainers.

17. The method of claim 12, further comprising a step of selectively annealing at least part of the retainers while or after the retainers are lifted using electrostatic force.

18. A method of forming a self-retaining suture comprising the steps of:

forming a plurality of retainers on an elongated suture body; and

performing a step of elevating the retainers away from the suture body, wherein the step of elevating the retainers comprises;

contacting the suture body with a solution, wherein the solution expands the suture body extending the retainer out from the suture body; and

applying a contractable film to the expanded suture body and contracting the film to fix the retainer in the extended position.