REQUIREMENTS INVESTIGATION ACCORDING THE ELECTRIC WELDING INTESTINAL CONNECTION TOOL FOR FUTURE CLINICAL TRIALS

Abstract

Creation of electro-welded intestinal anastomosis is the expected new technology. The research results introduction in a specialized tool requires preliminary study of changes in the place of electric welding.

The aim of the study – grounding on laboratory research with the prototype of a specialized tool to establish its requirements for creating a weld merging inside intestinal anastomosis for clinical trials.

Materials and Methods. During swine acute experiment and laboratory organs studies, 98 probe series with linear and circular electrodes were provided. The source of electric welding impulses was adapted clinical EK-300M1 and EKVZ-300 "Patonmed" devices. The pressure of tightness loosing was compared with that we had previously defined for stapler anastomosis: (24.2±3.2) mm Hg.

Results and Discussion. The intestinal tissue placing was modeled like a circular anastomosis, and compressed by electrodes in the range from 2.0 to 3.0 N/mm². The voltage was applied up to 140 V, current up to 5 A. In 32.4 % probes, the segments from 1/3 to 1/4 of circle have less dense or cutting with current. The average bursting pressure of the anastomosis in the study was (36.2±12.3) mm Hg, the range of strength of the non-densed areas 12–34 mm Hg. At a pressure of 3.0 N/mm², the distribution of tissue effects made by electric welding current was more even.

Conclusions. The size of the electrodes, volume and limits of tissue compression, functional state of the intestine wall, removal of vapor and fixation from the breakdown are factors of stable tissue density between the electrodes, the flow of electric current and the achievement such intestinal electric welding connection, acceptable for clinical implementation.