CS247619B1 - Process for producing treated non-absorbable surgical fibers - Google Patents

Abstract

The solution relates to the treatment of non-absorbable surgical fibers. A synthetic yarn or synthetic polyfilament fiber prepared, for example, from polypropylene or polyester or from a combination of these polymers is exposed in an unwound, stretched state to heating at a temperature of 140 to 185 ° C. In addition to the main features mentioned, the invention includes other variants. The invention can be used in healthcare for the production of surgical suture materials and in technical fields, especially in instrumentation.

Description

The invention relates to a process for the manufacture of treated non-absorbable surgical fibers.

Presently, absorbable and non-absorbable surgical fibers are produced. They are made monofilament or polyphile. Surgical fibers are used in almost all medical, veterinary and experimental fields and differ considerably in terms of fiber requirements.

In the manufacture of synthetic fibers and in the manufacturing industry, heat treatments are common, in which the yarns or monofilament are subjected to elongation while pulling them behind the nozzle, in the textile industry thermal fixations of yarns or threads on bobbins are common to facilitate further machine processing.

Also known is the drawing of polyamide fibers for the production of cords and the shape heat-fixing of polyester or polypropylene garments. Combinations of polypropylene or polyester core and sheath of natural or other synthetic fibers are also used to achieve higher speeds when using machine sewing threads.

In the manufacture of a surgical suture material, a heat treatment of the polyamide by stretching in a stretched state at a temperature substantially higher than the softening point of the polymer is used, and further thermal fixation is required.

Thermal stretching of polypropylene and polyester monofilaments to reduce their elongation and to obtain suitable surgical monofilaments are described. The improved surface properties of the surgical fibers and their new properties are achieved in particular by applying foreign substances to the fibers and by improving the knitting technique.

Processes based on basic polypropylene and polyester yarns as well as combinations and final heat treatments for surgical use are not described. The current world assortment does not fully cover the needs of newly developed surgical techniques.

AND

The aforementioned drawbacks are partially eliminated by the process for the production of treated non-absorbable surgical fibers according to the invention, which comprises subjecting a synthetic yarn or a synthetic polyfilament fiber prepared, for example, from polypropylene or polyester or a combination of these polymers to heating at 140 DEG. to 185 ° C.

According to the invention, by heat treatment of a single, twisted, synthetic yarn, stabilization of their fibrils is achieved by substantially eliminating axial migration, achieving the properties of monofilaments while maintaining the relative softness of the knots and ends.

The fibers thus treated are suitable for microsurgery. The thermal exposure of two or more twisted yarns is achieved by compacted fibers, sintered together, as monofilaments, while maintaining the relative softness of the knots and ends.

The fibers treated in this way are suitable for semi-microsurgery, they are exceptional because the knitting technique cannot work with only one or two yarns. By lowering the temperature, separate, extremely soft polyphilic fibers with very soft knots and ends are obtained.

The fibers treated in this way are suitable for semi-microsurgery, they are exceptional and are used wherever there is a danger of mechanical irritation, for example, eye bulbs, fallopian tubes, nerves, etc., reminds of this characteristic by the twisted natural silks that surpass strength.

Thermal exposure of knitted or even twisted surgical fibers of lower calibers, made of multiple yarns, results in substantial sintering of their surface, decreases their capillarity and cross-section, and increases their tensile strength while reducing elongation.

The fibers thus treated are suitable for sewing vessels and veins of higher diameters. Thermal exposure of yarns of different types of polymers in combinations processed for the core and sheath of medium or high gauge fibers produces fibers compact with a hard sintered surface, high tensile strength, surgical knot, shear and extraordinary impact, not subject to length changes even with prolonged years load.

The treated fiber is suitable for stitching hard nets, vascular prostheses, fastening artificial heart valves, etc. Optionally, a combination of polymers produces fibers that are compact with a soft sintered surface, high tensile strength, surgical knot, shear, and extraordinary impact, without length changes even under permanent, long-term load.

The fiber treated in this way is suitable for stitching heart chambers, atria and large blood vessels to reduce their volume and for hanging organs subjected to continuous tension. Further, in combinations of polymers, fibers compact with a soft spiral surface with a durable strength, reliable for fiber overlapping or knots are obtained. The treated fiber is suitable for ligatures.

Example 1

A single polypropylene 24 dtex yarn was rewound from spool to spool using a set of rollers, passing 2 m in a tunnel heated to 160 ° C. This thermal exposure resulted in the sintering of their surface. The obtained fiber was pressed into microsurgical and traumatic needles RB 6/1, sterilized and sterile filled. At the exit control, the OA decadicating fiber exhibited an average straight tensile strength of 0.90 N and 0.65 N in the surgical node at an average elongation of 19 i.

Example 2

A combination of polymers achieved by circumscribing a single polyester yarn of 84 dtex with a single polypropylene yarn of 40 dtex, winding from a spool to a spool using a set of rollers, by passing a tunnel of 2 m length at 140 ° C. A slight surface sintering was achieved. The obtained fiber was pressed into semichlurgical atraumatic needles RC 10/1, sterilized and sterile filled. At the outcome inspection, the OB decimal marking fiber had an average straight tensile strength of 6.0 N and 4.1 N at the surgical node and an average elongation at break of 12%.

Example3

The double polyester yarn was jumped together, rewound from reel to reel using a roll and breaker system, passing 2 m in a tunnel heated to 165 ° C. This yarn assembly and thermal exposure made the fiber very soft. After being pressed into the semi-microsurgical atraumatic needles, the TRC 10/1 was sterilized and sterile filled. At the outcome inspection, the decimal marking OB fiber exhibited an average tensile strength of 3.6 N and 2.4 N in the surgical node at an average ductility of 12 ³ .

Example 4

Polypropylene yarn 44 dtex 3x3, twisted, was treated by secondary drawing on the basis of the elongation calculation at the difference of the revolutions of the rollers 44 and the temperature of 164 ° C, it was stabilized at the same temperature under synchronized revolutions of the unwinder and the winder. This system of yarns and thermal exposure resulted in sintering of the fiber surface, reducing capillarity and fiber cross-section. After being pressed into RC 14/1 atraumatic needles, it was sterilized and sterile filled.

At the outcome inspection, the 1C decadicating fiber exhibited an average straight tensile strength of 16.8 N and 10.1 N in the surgical node at an average elongation of 16%.

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Example 5

Polymer combination achieved using polyester dye 84 dtex 1x5, twisted, resulting in a titer of 420 dtex as the core for a knitted fabric of polypropylene yarn 56 dtex, followed by elongation based on the elongation calculation at 33 rpm and 162 ° C and equilibration at the same temperature. A sintered surface of the fiber has been achieved, the capillarity and cross-section of the fiber have been reduced.

After being pressed into the atraumatic needles, the RB 35 was sterilized and sterile filled.

At the final inspection, the 3A decimal marking fiber had an average straight tensile strength of 42.0 N and 25.5 N in the surgical node at an average elongation of 20%.

The Orsilon sterile polyamide standard of the same decadic marking requires an average straight tensile strength of 23.6 N and 18.6 N in the surgical node 1 ductility of 20 to 40%, which illustrates improved fiber properties of the invention.

The fibers of the invention are intended for surgical and microsurgical use in human and veterinary medicine as a suture and ligation material. However, their properties are likely to be used for other purposes, such as auxiliary fibers for permanent fixation, insertion, etc.

It is probable that some fibers will also be used in technical fields outside of health care for high strength, low elongation, stability, etc., especially in instrumentation.

Claims (8)

Process for the manufacture of treated, non-absorbable surgical fibers, characterized in that the synthetic yarn or synthetic polyfilament fiber, prepared for example from polypropylene or polyester or a combination of these polymers, is subjected to heating at a temperature of 140 to 185 ° C. 2. The method according to claim 1, wherein the single synthetic yarn is separately folded prior to thermal exposure. 3. The method of claim 1 wherein the synthetic polyfilament fiber is pre-heat treated from at least two yarns or monofilaments prior to thermal exposure. 4. The method of claim 1 wherein the synthetic polyphilic fiber is braided from at least three yarns or monofilaments prior to thermal exposure. 5. The method of claim 1, wherein the synthetic polyfilament fiber is braided, obese, or encased prior to thermal exposure in the form of a fibril core. 6. Method according to claim 5, characterized in that the individual turns are juxtaposed when the core is bypassed. 7. A method according to any one of claims 1 to 6, wherein the heating temperature is reduced by up to 20 [deg.] C. by treatment, for example by connecting the synthetic yarn or synthetic polyphilic fiber with a liquid in which the thermal exposure is carried out. 8. A method according to any one of claims 1 to 7, characterized in that the permanently tensioned state is achieved, for example, by winding the fibers on the frames or by continuously unwinding the individual fibers and fiber groups from the unwinder rolls and winding onto the winder rolls.