RU2601409C2 - Suture filament - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to suture filament, consisting of base in the form of polypropylene monofilament thread with coating made of polyvinylidene difluoride in amount of 5 to 50 % of the base weight.

EFFECT: invention provides increase in strength, decrease of friction properties and reduction of surface roughness of suture filaments.

1 cl, 6 ex, 1 tbl

Description

The invention relates to medicine, in particular to surgical sutures with a polymer coating.

To improve the properties of surgical sutures, a polymer coating / cm is applied to them. Russian Patent No. 2080126, IPC A61L 17/00, publ. 1997; RU Patent No. 2073528, IPC A61L 17/00, publ. 1997 /.

The disadvantage of coating using chitosan is its destruction in the body, which makes it difficult to obtain non-absorbable suture material.

The coating of the copolymer of N-vinylpyrrolidone has low adhesion and strength / Pat. Russia №2065753, A61L 17/00. A method of manufacturing surgical suture materials, publ. 1996 /, and a coating of polyurethane / Titova G.E. Thes. doc. 3 scientific symp "Synthetic polymer materials for medical purposes", Belgorod-Dniester, 1977, p. 12 / not sufficiently inert to biological environments.

In the known method / Pat. Russia No. 1776100, D01F 6/46, D01F 11/04, D06M 16/00, D06M 101: 20, A61L 17/00. A method of obtaining biologically active surgical filaments, publ. 1995 / it is proposed to form a coating from a solution of chitosan in acetic acid, which narrows the scope of application of polyester filaments and a limited number of acid-resistant polymers, excluding the possibility of modifying silk, polyamide and other materials that are not resistant to acids. In addition, the method does not allow penetration of the modifier into the multifilament base and coating of individual fibers. This leads to monolithization of the warp, which significantly increases the stiffness of the thread during bending and complicates knitting. A similar disadvantage is the method / Titova G.E. Thes. doc. 3 scientific symp “Synthetic polymeric materials for medical use”, Belgorod-Dniester, 1977, p.2 /, according to which polyester (dacron) yarns are modified by impregnating the base with polyurethane rubber.

In the patent / Pat. RF №2323689, A61L 17/04. Elastic surgical thread with a sheath, publ. 2008 / a surgical thread is proposed that has an elastic core and an inelastic sheath, however, this design of the thread significantly complicates the technology for its production and increases the cost.

In a known technical solution / Pat. Russia №2065753, A61L 17/00. A method of manufacturing surgical suture materials, publ. 1996 / the original thread is immersed in a hot (40 ... 100 ° C) solution of the polymer composition with an exposure of 1-15 hours and subsequent drying. The disadvantage of this method is the multi-stage and the likelihood of bonding fibers.

The closest in technical essence is a surgical suture thread / Pat. Russia №2275210, А61L 17/04, publ. 2006 - prototype /, consisting of a warp in the form of a monofilament yarn with a coating, it contains polyparaxylene in the amount of 0.25-5% by weight of the warp as a coating.

The disadvantages of the prototype is:

- polyparaxylylene has low adhesion to polypropylene;

- a small coating layer does not significantly increase the frictional properties of the thread.

The technical task is to increase the strength and decrease frictional properties, reduce the surface roughness of surgical suture threads.

The technical problem is solved in that the surgical suture thread, consisting of a warp in the form of a monofilament filament of polypropylene coated, as a coating it contains polyvinylidene fluoride in an amount of from 5 to 50% by weight of the warp.

The solution to the technical problem allows to increase strength, reduce frictional properties and surface roughness of surgical suture threads.

Surgical suture thread consists of a base in the form of a monofilament thread made of polypropylene according to GOST 26996-86 and a coating of polyvinylidene fluoride (TU 6-05-1781-84).

Example 1 of the prototype.

On a surgical suture thread, consisting of a base in the form of a monofilament thread made of polypropylene (conditional number 4/0, metric size 1.5 according to GOST R 53005-2008), with a diameter of 0.17 mm, a polyparoxylene coating is applied. The coating on the threads was 4.4% by weight of the warp.

Example 2

A polypropylene monofilament surgical suture thread (conditional number 4/0 according to GOST R 53005-2008) with a diameter of 0.17 mm, trade name Prolen (manufacturer Ethicon, US) was investigated as a comparison object.

Example 3-6 on the claimed object.

Example 3

A surgical suture thread consisting of a warp in the form of a monofilament filament of polypropylene with a diameter of 0.17 mm (conditional number 4/0, metric size 1.5 according to GOST R 53005-2008) is coated with a nonequilibrium low-temperature plasma in a plasma-forming gas - argon , at a working pressure in the discharge chamber of 26 Pa with a plasma-forming gas flow rate of 0.05 g / s, at a voltage of 3 kV at the anode and a current strength of 0.5 A. The processing time is 5 min. The coating is applied in an amount of 5% by weight of the base.

Example 4

A surgical suture thread, consisting of a warp in the form of a monofilament thread made of polypropylene (conditional number 4/0, metric size 1.5 according to GOST R 53005-2008) with a diameter of 0.17 mm coated with polyvinylidene fluoride, is obtained analogously to example 3. The processing time is nonequilibrium low temperature plasma is 9 min. The coating is applied in an amount of 8.6% by weight of the base.

Example 5

A surgical suture thread, consisting of a warp in the form of a monofilament thread made of polypropylene (conditional number 4/0, metric size 1.5 according to GOST R 53005-2008) with a diameter of 0.17 mm coated with polyvinylidene fluoride, is obtained analogously to example 3. The processing time is nonequilibrium low temperature plasma is 10 min. The coating is applied in an amount of 25% by weight of the base.

Example 6

Surgical suture thread, consisting of a warp in the form of a monofilament thread made of polypropylene (conditional number 4/0, metric size 1.5 according to GOST R 53005-2008), 0.17 mm in diameter, coated with polyvinylidene fluoride, is obtained analogously to example 3. Processing time nonequilibrium low-temperature plasma is 15 minutes The coating is applied in an amount of 50 by weight of the base.

The determination of the tensile strength of the yarn in tension in the dry state is determined by the breaking load in a simple node and the elongation at break of the thread in a simple node. The determination of these characteristics is carried out on a tensile testing machine 2038P-0.05. When testing the tensile strength at break, the samples are fixed in the upper and lower grippers with elastic gaskets to prevent slipping and breakage of the thread near the edges of the grippers. The initial distance between the grippers is 100 mm and the loading speed is 100 mm / min. To obtain the experimental values of the strength of the thread, the strength in the node of the thread and elongation, 10 samples of the thread are torn.

When conducting frictional tests, the force required to draw the thread along the dry suede surface of a sample of dressed leather as an imitator of living biological tissue is recorded. The tests are carried out as follows: between the grips in a horizontal position, a cylindrical frame with a diameter of 40 mm is attached, wrapped with a piece of suede leather 18 cm long. After fixing the end of the thread in the movable grip of the testing machine, one revolution is made around the mandrel, and a weight of 50 g is suspended by the end of the thread. The loading speed is 100 mm / min. Using this method, the force of straining (the force that must be applied to the thread in order to begin the advancement of the thread through the fabric) and the friction force (the force that must be applied to the thread after it is strained and necessary to continue moving through the fabric) are determined.

The arithmetic average roughness parameter is determined according to GOST 2789-73 “Surface roughness. Parameters and characteristics ”by confocal laser scanning microscopy (LSM) using an Olympus model OLS 4000 LEXT microscope.

The strength, frictional properties and roughness of the surgical suture are shown in the table.

As can be seen from the examples of specific performance and table data, a surgical suture thread made of polypropylene with a polyvinylidene fluoride coating has high tensile strength in a simple knot and elongation when the thread is torn in a simple knot, low frictional properties (shearing force and friction force) and low roughness.

The claimed object can be widely used in surgery for implantation of heart valves, prosthetics of vessels and other organs and tissues, for suturing aponeurosis, skin, tendons, bile ducts, pancreas, gastrointestinal tract, in plastic and cosmetic surgery and in cases requiring long-term fixation of the edges of the surgical wound.

Claims (1)

Surgical suture thread, consisting of a base in the form of a monofilament filament of polypropylene with a coating, characterized in that it contains polyvinylidene fluoride in an amount of 5 to 50% by weight of the base as a coating.