Braided polyester suture and implantable medical device

Surgery – Instruments – Suture or ligature

Reexamination Certificate

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Details

C606S230000

Reexamination Certificate

active

06203564

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a braided polyester suture made from high-tenacity polyester yarn filaments.
2. Related Background Art
Braided sutures are well known in the art as disclosed, for example in U.S. Pat. No. 5,019,093. Various natural and artificial polymeric materials have been used in manufacture of braided sutures, including surgical gut, silk, cotton, polyolefins, polyamides, polyglycolic acid and polyesters. Braided polyester sutures are useful in applications where a strong, nonabsorbable suture is needed to permanently repair tissue. They are frequently used in cardiovascular surgery, as well as in ophthalmic and neurological procedures. Examples of commercial braided polyester sutures are ETHIBOND EXCEL®, manufactured by Ethicon, Inc., TICRON® manufactured by Sherwood-Davis & Geck and TEVDEK® manufactured by Deknatel.
The surface roughness of braided sutures is of great importance to surgeons. Excessive roughness affects the knot-tying and knot-holding properties of the suture, causing an uneven movement known as “chattering.” This characteristic increases the difficulty of accurately placing knots. In addition, the uneven force exerted on the suture during tying may lead to increased suture breakage. Typically, sutures are coated with a lubricating material, e.g., polybutilate, to improve the handling characteristics of the sutures.
In addition, conventional polyethylene terephthalate (PET) sutures can exhibit reduced tensile strength and have a tendency to fray. This also leads to increased suture breakage during tying of surgeon's knots.
U.S. Pat. No. 5,318,575 discloses use of high-tenacity, low-elongation fibers to produce a reinforced band for attaching tissue or bone. However, the high-tenacity, low-elongation fibers are made from polyethylene of extremely high molecular weight, with other materials being used only as filler yarns. No suggestion is made that high-tenacity polyester fibers would be suitable for use in surgical repair products.
SUMMARY OF THE INVENTION
It is an object of this invention to provide a braided polyester suture exhibiting reduced surface roughness, high tensile strength and a reduced tendency to fray.
These and other objects and advantages are achieved by a braided polyester suture produced from a polymer having an intrinsic viscosity greater than about 0.95 and formed from yarn filaments having a tenacity of from about 7 to about 11 g/denier and a percent elongation to break of less than 30 percent.
The invention is further directed to an implantable medical device produced from a polymer having an intrinsic viscosity greater than about 0.95 and formed from yarn filaments having a tenacity of from about 7 to about 11 g/denier and a percent elongation to break of less than about 30 percent.


REFERENCES:
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Product Brochure for Ethicon Excel™ Polyester suture, copyright by Ethicon, Inc. 1995.

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