RU2201259C2 - Surgical suture - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: the present innovation deals with surgical suturing ligatures. As material for suturing ligature one should apply synthetic high-modular one based upon aromatic heterocyclic polyamide - "Rusar - C" at stretch modulus being 7480 kGs/sq. mm. The suggested suturing ligature increases efficiency of therapy, improves the flow of reparative processes in area of suturing ligatures. EFFECT: improved results of therapy. 1 ex

Description

 The invention relates to veterinary medicine, namely to surgical suture materials.

 Surgeons use more than 50 types of threads in their work, but unfortunately, to this day, both in medical and veterinary practice, there is no suture material close to ideal.

 The non-absorbable synthetic suture material widely used by surgeons: silk, kapron, lavsan and other threads for various reasons do not satisfy all the requirements for them.

 Synthetic suture materials lack biodegradability. Despite this, they have, in comparison with absorbable sutures, a number of advantages: cheaper, convenient to manufacture, have greater strength and better handling properties, are indispensable for prosthetics and suture of fabrics that are in a state of tension for a long time.

Modern suture surgical materials must have a complex set of properties:
- mechanical and suture - sufficient tensile strength and slight elongation; elasticity and condition of the surface, eliminating the rupture of tissue at the site of tension of the seams; simplicity of tying knots and their reliability from opening and slipping;
- biological - the absence of a pronounced tissue reaction - allergenicity, inflammatory processes, rejection (harmlessness of both the material itself and its decay products); sterility and the ability to preserve it for a long period; lack of so-called "wickness", i.e. the possibility of infection through suture material.

 Known suture surgical sutures that are used in medical practice (1), where a thread with antimicrobial properties consists of a multicore bundle, the threads of which are impregnated with an antimicrobial agent. The entire surface of the bundle is coated with a continuous layer of sebted-out polyurethane, which is not initially coated with an antimicrobial agent.

 There is a surgical thread with a sheath for suturing the wound (2). The thread is made of composite materials. The suction film is formed by polymers from the group of homo- and copolymers of lectides and glivemed.

 These threads, as can be seen, cannot satisfy the surgeon with their wickiness, which is why the joint strength of the wound edges is disrupted, which is especially vital in abdominal surgery.

 The materials for crosslinking used in surgery are obtained by weaving from a stretched and oriented elastic fiber (3) containing repeating units of a complex and ether.

 However, such suture material causes a significantly pronounced response from body tissues in the form of scars and durable adhesions, which in the end result can lead to impaired gastrointestinal tract (GIT) motility in the operated animal.

 Surgical suture from a segmented copolymer containing polymer blocks of esters and ethers (4) and a surgical suture from ethylene and propylene copolymers (5) are also known. This monofilament yarn contains a small amount of polymerized ethylene, and the remainder contains polymerized propylene.

 A disadvantage of the known filaments is the limited possibility of their use only for suturing skin wounds, since they have a pronounced irritating effect, wickness, fragile knot, contribute to the development of adhesive disease when used in abdominal veterinary surgery.

 The closest in technical essence and the achieved result is synthetic high-modulus material (CBM), which by its chemical nature is a third-generation polymer of the group of aromatic heterocyclic amides, having low capillarity, high strength characteristics, and bioinertness in tissues (6).

 Currently, CBM thread developed by the All-Russian Scientific Research Institute of Artificial Fiber (VNIIIVLON) is not produced.

 The invention solves the problem of increasing the effectiveness of treatment, preventing the development of complications in the postoperative period.

 This is achieved by using the fourth-generation synthetic high-modulus material Rusar-S as a surgical suture thread.

 Based on our studies, we found that the strength of Rusar-S threads is 44% higher than silk, 39% lavsan, and 18% higher than SVM.

 Having high strength for a surgical suture material, Rusar-S threads have a lower tensile elongation compared to silk and especially lavsan: 4.70% versus 5.60% for silk, 4.80% for lavsan, 3.70% for CBM . The breaking load in the node was 7.7, respectively; 4.7; 4.3 and 3.2 kg.

 We have not found any reports of the use of Rusar-S threads in medical and veterinary surgery in the available domestic and foreign literature. By its chemical nature, the Rusar-S thread is a fourth-generation polymer of the group of aromatic amides (polyamides), which are distinguished by high chemical resistance and physical and mechanical properties. Light brown with a golden hue Rusar-S thread consists of several fibers, which are spun into one monofilament thread.

Physico-mechanical properties of the thread "Rusar-S" based on aromatic heterocyclic polyamide:
Metric number - - 14.5
(or linear density) - - 129 tex.

Spin - - 162 cr / m
Breaking load - - 23 kgf
Specific breaking load - - 294 kgf / mm ²
Elongation at break - - 4.7%
Tensile modulus - - 7480 kgf / mm ²
Preservation of strength in the loop - - 51.8%
in the node - - 42.0%
Based on laboratory studies conducted in the Department of Pharmacology, Toxicology and Ecology of the All-Russian Scientific Research Veterinary Institute of Pathology, Pharmacology and Therapy (VNIVIPPiT, Voronezh), there is an official conclusion that the Rusar-S thread has low toxicity and does not have allergenic, embryotoxic and cumulative properties. When fed to white rats for 3 months, it does not cause negative changes in functional systems and organs (examination 02/33 of January 19, 2000).

 Deep clinical trials on different types of domestic and laboratory animals revealed a significant superiority of the Rusar-S thread over silk and lavsan. This was confirmed by morphological, histochemical, electron microscopic studies (transmission and scanning electron microscopy).

 The use of Rusar-S thread as a suture material increases the effectiveness of treatment, the course of reparative processes in the suture ligature zone. The use of the inventive filament was characterized by minor damage and mild aseptic inflammation of the surrounding tissues. Postoperative complications were absent in all observation periods.

 An example of a specific implementation 1.

 In order to test the feasibility of using the Rusar-S thread in veterinary surgery, an experimental study was conducted in one of the farms of the Voronezh region on 12 bulls of Holstein-Friesian breed aged 5-6 months, selected on the basis of analogues. The animals were divided into three groups of 4 heads each. After conduction anesthesia of the celiac nerves according to Magda, all of them underwent rumenotomy in conjunction with local infiltration anesthesia at the incision site.

 The control in our studies was domestic synthetic threads - lavsan and silk of comparable sizes, because they are also made by the synthetic method and, moreover, are widely used in veterinary practice as the most affordable material.

 As the suture material in the first group, the experimental Rusar-S 3 thread was used, in the second - silk, 6, and in the third - lavsan, 6. The wounds were sutured with a Sadowsky-Plahotin double-row suture.

 The skin wounds in calves after rumenotomy, sutured with the Rusar-S thread, always healed by primary intention.

 Similarly, in most cases, calf skin wounds healed after intermittent knotted situational sutures with lavsan and silk were applied, with the only difference being that in the latter case the scars were massive, rough and significantly exceeded the size of the suture with Rusar-S thread.

 In about 25% (lavsan) and 50% (silk) of the operated calves, the sutures healed by secondary intention. Ligature fistulas were formed at the site of the puncture canals, the lumen of which was filled with pus. Regenerative processes in these cases flowed sluggishly.

 This allows us to conclude that suture material from Rusar-S thread is biologically inert compared to standard silk and lavsan.

Sources of information
1. Kudryavtsev G.I. Reinforcing chemical fibers for composite materials. - M.: Chemistry, 1992, p. 89.

 2. US 4649921 MKI A 61 L 17/00.

 3. US 4,520,822 A, June 4, 85.

 4. WO 88/00062 A, 01/14/08.

 5. SU 1402349 A, 06/15/88.

 6. RF patent 2141343, A 61 17/00, BI 32, 11.20.99.

Claims (1)

Monofilament surgical suture material based on high-modulus polyamide, characterized in that, as the polyamide, the suture material contains an aromatic heterocyclic polyamide with a tensile modulus of 7480 kgf / mm ² .