Glue medical Sulfacrylate

PURPOSE
Glue medical "Sulfacrylate" (hereinafter referred to as glue) is intended for
bonding of soft tissues of a living organism:
- in surgery of the gastrointestinal tract for sealing sutures and anastomoses;
- when performing surgical interventions for traumatic injuries
parenchymal organs: liver, kidneys, spleen, pancreas;
- when performing reconstructive surgical interventions on the biliary tract;
- when performing reconstructive operations on the urinary tract:
kidney system, ureter, bladder, urethra;
- in thoracic surgery during surgical interventions on the lung, bronchi, pleura,
mediastinal organs, diaphragm plastics; closure of bronchopleural and thoracopleural
fistulas;
- in cardiovascular surgery for sealing vascular anastomoses;
- in obstetrics and gynecology when performing surgical interventions on the uterus, its
appendages, vagina;
- in neurosurgery when removing brain tumors and vascular anomalies in the form of arterio-
venous malformations for vascular embolization;
- when performing surgical interventions on the organs of the pancreato-duodenal zone,
for occlusion of the pancreatic ducts;
- when closing the internal hernial orifice using synthetic material,
which is fixed with glue;
- for fixing mesh skin flaps when performing plastic surgery on
body surface;
- for gluing polymeric materials or hemostatic sponge along the line of seams with
purpose of hemostasis;
- for occlusion of fistulous passages;
- for fixation of bone grafts;
- in plastic surgery and cosmetology to create seamless skin
anastomoses;
- in dentistry;
- in otorhinolaryngology;
- in ophthalmology;
- in endoscopic surgery;
- in oncology;
MAIN CHARACTERISTICS
The adhesive consists of ethyl-α-cyanoacrylate (binder), butyl acrylate
(plasticizer)
and
sulfolane methacrylate
(anti-inflammatory,
antimicrobial
component), is a colorless transparent liquid with a specific odor,
specific gravity 1.05-1.07 g/cm³, viscosity 8-85 cst.
The glue is soluble in acetone, dimethylformamide, dimethyl sulfoxide.
The adhesive is subjected to sterilization by the method of electron beam sterilization.
Upon contact with living tissue and aqueous solutions, the adhesive quickly polymerizes; time
polymerization depends on the nature of the bonded tissue and ranges from 10 to 120 s. Glue
has high adhesive properties. When applied to bonded tissues, reliably
sticks them together to form a strong elastic film. During polymerization, the adhesive gives
slight shrinkage, bringing together fragments of glued fabrics more tightly.
In the body, the glue undergoes gradual resorption. Germination
connective tissue through the adhesive film occurs as a result of rapid resorption
low molecular weight part and pore formation; complete resorption of the adhesive occurs after 30-45
days after application, depending on the thickness of the adhesive film, the method of its application and
the nature of the bonded fabrics.
The glue has a bactericidal effect against pathogens of surgical
infections: Escherichia coli, Staphylococcus aureus, Proteus, bacillus blue-green pus.
Adhesive in consumer packaging is not explosive, does not ignite, does not
toxic effect on the human body. Does not emit harmful substances during application
substances exceeding the maximum permissible levels for polymeric materials.
PACKAGE
The glue is packed in sterile syringes and tubes.
Syringe tips are closed with PTFE gaskets and sealed
polypropylene cannulas. A label is placed on the body of each syringe and tube with
indicating the short name of the adhesive, the volume in ml and the trademark of the enterprise -
manufacturer. A label is placed on each individual package with a syringe and a tube.
indicating the batch number, date of issue and expiration date. Syringes and tubes with glue in
individual packages
staffed
blunt curved single-use needles, packed in cardboard packs. Each pack contains instructions for
application.
GENERAL PRINCIPLES FOR USE OF GLUE IN SURGICAL PRACTICE
The adhesive is ready to use without additional preparation.
Before use, open individual packaging. From the syringe tip
the cannula and gasket are removed, the attached needle is put on the tip of the syringe. tuba
open by turning the lid. For ease of use, put on the tip of the tube
the supplied needle.
The glue is fluid and does not polymerize in a dry needle.
Before applying the adhesive, the wound surface is dried with a gauze napkin, if available.
large bleeding vessels perform their ligation.
Glue is applied to the wound surface, while achieving its uniform
spreading over the treated area. With this application, the adhesive covers a thin layer
wound surface and quickly polymerizes, forming a thin elastic film. Specified
The method allows precise dosing and application of the adhesive. Polymerization proceeds within 10-120
seconds, resulting in the formation of an elastic film that ensures tightness
connections of glued surfaces or hemostasis of the wound surface.
The consumption of glue is about 0.03 ml (1 drop) per 1 cm2 of the treated surface.
BE CAREFUL!
When applying more glue
polymerization proceeds for a longer time, while on the wound surface
a "hard scab" of polymerized adhesive is formed. Excess applied adhesive reduces
the effectiveness of its application.
To accelerate polymerization, the surface of the adhesive film can be moistened
saline solution or furacillin solution.
Depending on the purpose of the surgical operation, glue can achieve
various effects: perform hemostasis with moderate parenchymal bleeding,
strengthen the suture line of the created anastomosis, seal the damaged area, carry out
fixation of the organ, create an organ anastomosis, seal the fistula, etc.
PRECAUTIONS FOR USE
Keep out of the reach of children!
Avoid contact with eyes!
Do not use after the expiration date!
POSSIBLE SIDE EFFECTS
Allergic reactions to adhesive components are possible.
When applying an excess amount of glue, the formation of a "hard scab" is possible
polymerized adhesive, which reduces the effectiveness of its application and increases the time
biodegradation. The resulting "hard scab" of polymerized adhesive can injure
nearby tissues, as well as cause embolism if it enters the bloodstream.
CONTRAINDICATIONS
Individual intolerance to the components of the adhesive.
Glue should not be applied to nervous tissue (unless it is intended to be intentionally
destruction), on the cornea of ​​the eye, on the elements of the middle and inner ear, olfactory
epithelium, vocal cords.
STORAGE AND USE CONDITIONS
Glue is stored in a place protected from light at a temperature not exceeding 15 ° C
(from 2 to 15 °C).
Shelf life 1 year. Do not use after the expiration date!
INFORMATION ON DISPOSAL OR DISPOSAL
Products used in surgical practice must be destroyed as
class B medical waste according to SanPiN 2.1.7.2790.