RU2041718C1 - Method for sterilizing physiologic extracorporeal blood circulation devices - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves assembling a device to be ready for use, introducing ethyl alcohol into the device in the amount determined by a formula V₁/V₂≥ 0,002, where V₁ is the alcohol volume, V₂ is the device volume, sealing the internal cavity of the device by means of plugs and exposing to heat treatment in autoclave or dry heat cabinet. EFFECT: enhanced effectiveness in preparing blood circulation devices for use.

Description

 The invention relates to medicine, namely to a method for thermal sterilization of physiological devices of extracorporeal blood circulation of general and auxiliary cardiopulmonary bypass, hemosorption, hemodialysis, plasmapheresis, ultraviolet irradiation of blood, etc.

 The most reliable method for sterilizing extracorporeal circulation devices is known, a heat treatment method, for example, with water vapor.

 Its disadvantage is that disassembled devices are subjected to autoclaving so that steam can penetrate into the devices, and physiological extracorporeal circulation devices are assembled under sterile conditions immediately before their use (use). This limits the shelf life of sterility to 3 days, increases the risk of reinfection. In addition, when using a defoamer in heart-lung circulation devices, it must be applied immediately before work, because water vapor destroys known defoamers (antifomsilan, propinol, etc.

 The purpose of the invention is the elimination of the destruction of the antifoam (surfactant), increasing the degree of reliability of sterilization, creating the possibility of sterilization of the device in assembled form, which ensures long-term sterility, including during transportation.

 To do this, each physiological device is collected, ethanol is introduced into the device in a certain volume, for example, at the rate of 2-3 ml per 1 liter of the internal volume of the device. After that, its internal cavities are sealed with plugs and subjected to heat treatment with an autoclave in the accepted modes, sterilizing the device from the outside with water vapor or in a dry heat cabinet, and the internal surfaces in contact with blood with saturated vapors of ethyl alcohol.

When the temperature in the autoclave ethyl alcohol, having a boiling point of 78.3 ^{° C,} before water begins to evaporate into the autoclave, creating increased pressure within the sealed physiological extracorporeal circulation apparatus, which will prevent further penetration of water vapor into the device.

 Thus, from the inside, the sealed physiological device of extracorporeal circulation is sterilized with saturated vapors of ethyl alcohol, which, being an antiseptic, increases the degree of sterilization reliability. Outside, sterilization of the device will be carried out, as usual, with water vapor. During heat treatment of the device in a dry oven, each of them is a mini-autoclave operating on ethanol.

 Ethyl alcohol does not destroy antifoaming agents, so they can be applied in advance when assembling physiological cardiopulmonary bypasses. The assembly of devices in sterile conditions disappears. The physiological device is always ready to go. The preservation of the sterility of the physiological device of extracorporeal circulation is determined by the time of preservation of tightness.

The method can be carried out by known devices in accordance with the necessary modes for a specific medical material. For example, a device for extracorporeal circulation, consisting of silicone tubes, metal connecting elements (tees, etc.), a sorption column of glass with a metal slotted nozzle and silicone gaskets, is assembled into a working state, the required volume of ethyl alcohol is introduced into the cavity, free the ends of the tubes are sealed with plugs, for example silicone plugs. Junctions or bandage secured with clamps and subjected to heat treatment in an autoclave at T120 ^{° C,} a pressure of 1.1 atm for 45 min or T 132 ^C, a pressure of 2 atm for 20 minutes in accordance with OST 42-21-2 -85.

The volume of ethyl alcohol V ₁ poured into the device is selected at the rate of 2-3 ml per 1 liter of internal volume V _{2 of the} device.

 The lower limit is due to the fact that below it is not provided full filling of the internal volume with saturated vapors of ethyl alcohol at an autoclaving temperature. When sterilized in a dry oven, the physiological device of extraporal circulation circulates as a mini-autoclave operating on ethanol under autoclaving modes.

Claims (3)

1. METHOD FOR STERILIZING PHYSIOLOGICAL DEVICES OF EXTRACORPORAL BLOOD CIRCULATION, consisting in heat treatment of devices, characterized in that the physiological device of extracorporeal circulation is assembled in a ready-to-use form, ethyl alcohol is introduced into the device in an amount determined by the ratio
V ₁ / V ₂ ≥ 0.002,
where V _{1 is the} volume of alcohol;
V _{2 the} volume of the device,
seal the internal cavity of the device with plugs, and then subjected to heat treatment.  2. The method according to p. 1, characterized in that the heat treatment of the above devices from the outside is carried out with saturated water vapor in autoclaving modes.  3. The method according to p. 1, characterized in that the heat treatment of the said devices from the outside is carried out in a dry heat oven in autoclaving modes.