METHOD AND APPARATUS FOR ELEVATING RETAINERS ON SELF-RETAINING SUTURES

• US 20110046669A1
• Filed: 02/20/2009
• Published: 02/24/2011
• Est. Priority Date: 02/21/2008
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Ethicon, LLC (Johnson & Johnson)
• Original Assignee: Angiotech Pharmaceuticals Incorporated
• Inventors: Gonzalez Resendiz, Carlos, Gross, Jeffrey Mendel, Drubetsky, Lev, Herrmann, Robert A., Goraltchouk, Alexei, D'Agostino, William L.
• Granted Patent: US 9,125,647 B2
• Time in Patent Office: Days
• US Class Current: 606/228
• 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 which allows the retainers on a suture thread to be bent by the inner surface of the tube-shaped apparatus. In various embodiments of the invention, 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 thereby ensuring that the suture is held securely in place, preventing wound separation and dehiscence. In an embodiment of the invention, the application of the coating to the outer face of the retainer and attractive forces between the coating at different points results in the distension of the retainers away from the suture core. In an alternative embodiment of the invention, the coating inserts into the cut associated with the retainer and repulsive or expansive forces result in a pushing out of the cut and thereby the 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; and

performing a step of elevating the retainers away from the suture body.

2. The method of claim 1 wherein the elevating step comprises one or more of the following steps:

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.

4. 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;

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.

31. The method of claim 1, wherein the step of elevating the retainers comprises:

inserting the suture having retainers into an apparatus having at least one roller;

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

bending the retainers back using at least one bending bar to apply a force to the retainers, wherein the retainers are bent back adjacent to the at least one roller.

32. The method of claim 1, wherein the step of elevating the retainers comprises:

inserting the suture having retainers into at least one hollow tube;

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.

33. The method of claim 32, 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.

34. The method of claim 1, wherein the step of elevating the retainers comprises

lifting the retainers from original elevation angles to increased elevation angles using electrostatic force.

36. The method of claim 34, wherein plastic deformation imposed by the lifting maintains the retainers at elevation angles greater than the original elevation angles.

37. The method of claim 34, 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.

38. The method of claim 37, 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.

39. The method of claim 34, 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.

41. The method of claim 34, further comprising a step of

selectively annealing at least part of the retainers while and/or after the retainers are lifted using electrostatic force.

74. 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 includes

providing a transition stimuli to contract the outer layer thereby extending the retainers outwards away from the inner core.

75. The method of claim 74, wherein the outer layer is heat shrink tubing and the transition stimuli includes heating the heat shrink tubing.

76. The method of claim 74, wherein the inner core is a multifilament.

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

an outer coating, and wherein the step of elevating the retainers includes

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

79. The method of claim 78, wherein the coating is activated by a change in temperature.

80. The method of claim 78, further comprising adding an activator to contract the outer surface.

81. The method of claim 1, wherein the step of elevating the retainers comprises:

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

applying a film to the expanded suture body to fix the tissue retainer in the extended position.

3. A self-retaining suture system comprising:

a suture having a plurality of retainers formed therein;

said retainers being elevated from the suture after the retainers are formed.

5-30. -30. (canceled)

35. (canceled)

40. (canceled)

42-73. -73. (canceled)

77. (canceled)

82-95. -95. (canceled)

96. A method of forming a self-retaining monofilament suture comprising:

providing an elongated monofilament body;

coating the elongated monofilament body; and

forming a tissue retainer by deforming one or more of the filaments of the coated monofilament elongated body such that the tissue retainer protrudes outward from the outer circumference of the elongated body.

97. The method of claim 96, further comprising forming a fin between the tissue retainer and the coated monofilament elongated body.

98-99. -99. (canceled)