WO2015147698A2

WO2015147698A2 - Method for heating washing fluids, and infusion and transfusion drugs (variants), and device for carrying out the method (variants)

Info

Publication number: WO2015147698A2
Application number: PCT/RU2015/000165
Authority: WO
Inventors: Эдуард Фёдорович СЫРОВАТСКИЙ
Original assignee: Эдуард Фёдорович СЫРОВАТСКИЙ
Priority date: 2014-03-24
Filing date: 2015-04-13
Publication date: 2015-10-01
Also published as: RU2014110912A; RU2016141345A; RU2016141345A3; WO2015147698A3; RU2662427C2

Abstract

The device comprises a continuous-flow infusion thermostat and an electric heater, in the form of an autonomous unit. A detachable part (1) of the thermostat comprises a closed cavity filled with a heat transfer agent (8). A fusion of high-molecular-weight substances serves as the heat transfer agent (8). The melting point of the heat transfer agent is equal to the temperature to which the drug is heated. Five minutes before the beginning of the procedure, the heat transfer agent (8) is melted by the electric heater, away from the patient. A heatable section of a tube (6) of the infusion system is then placed into the detachable part (1) of the thermostat. During the infusion process, the drug is heated by heat escaping as the melt solidifies. The temperature of the heated drug at any rate of infusion is equal to the melting point of the heat transfer agent (8) - said temperature is invariable from the beginning to the end of the procedure. It is ensured that the procedures are safe and that the medicinal and economic efficiency thereof is increased.

Description

The method of heating flushing liquids,

infusion and transfusion drugs (options).

Device for implementing the method (options) The technical field to which the invention relates

The invention can be used in medicine for heating washing fluids, infusion and transfusion preparations. State of the art

A known method of heating flushing fluids, infusion and transfusion preparations with electric flowing heating devices. Heat is supplied to the heated preparations through the wall of the tube of the heated section of the infusion system or through the wall of the disposable flexible cassette connected to it.

As a close analogue of the device used in the implementation of the known method, the Astotherm plus flow-through apparatus [1] was selected, which heats the preparations poured into the blood of patients to 36, 39, 41, or 43 ° C. This device contains a built-in electric heater, a microprocessor that performs the functions of a temperature controller, as well as an alphanumeric display. An electric heater is installed in the holder of the heated section of the tube of the infusion system. The holder has the form of a segment of a cylindrical pipe with a spiral groove on the outer surface.

Known flow apparatus Ranger [2], which allows you to heat up to 41 ° C blood and flushing fluids, which are used in surgical practice. This device also contains an integrated microprocessor-controlled electric heater and an alphanumeric display. There is a groove in the housing of the Ranger for installing a flexible disposable cartridge for the infusion system.

The length of the unheated portion of the tube of the infusion system, ending with a venipuncture needle, is 1.3 for Astotherm plus and 2.3 meters for Ranger. With an external diameter of 4.0 mm tubes, the volume of the drug enclosed in them is 10.4 and 18.5, and with a diameter of 6.8 mm it reaches 36.7 and 65.0 milliliters. It follows that at the beginning of each infusion therapy procedure, the indicated volumes of cold preparations are infused to patients.

The intensity of the cooling of the drug in the considered section of the tube of the infusion system depends on several factors. Such factors are: the speed of the drug in the tube of the infusion system, the speed of movement of the surrounding air, as well as its temperature. If the drug is administered intensively, in the area of the infusion system under consideration, it cools slightly. At low infusion rates, its temperature may drop by several degrees. Therefore, the Ranger apparatus is used only at high and medium infusion rates, and the Astotherm plus heating device is equipped with an “active insulating sheath”. The Hotline system [3] heats the tube section located on the patient side. This section is the central channel of a one-way three-way highway, washed by warm water. The middle channel of the line is connected to the pressure pump, and the outer one to the water vessel equipped with a built-in electric heater. Using warm water, infusion and transfusion preparations, as well as flushing liquids, are heated to 38, 40 or 42 ° C. The Hotline system does not have a control microprocessor, and instead of an alphanumeric display, LEDs are used. In the cavities of the Hotline system, the growth of pathogenic bacteria is possible, therefore they are subject to periodic disinfection.

Any procedure for infusion of a drug heated by a method adopted as an analogue is dangerous for the patient. A threatening situation occurs in the event of an accident in the electrical network or in case of failure of the electronics of the heating apparatus. The risk is increased if the drug, initially having a low temperature, is poured at a high speed. Continuation of such a procedure may result in "unintentional" hypothermia.

There are several models of low-cost heating devices for use at low infusion rates on the medical equipment market. These devices are not in demand - medical institutions prefer to purchase expensive universal devices. Such devices significantly increase the cost of infusion therapy procedures.

A decrease in the level of the drug in the container leads to a gradual decrease in the rate of its entry into the patient’s blood. Another factor that reduces the rate of infusion is the reaction of the patient's vascular system. A decrease in the flow rate of the drug leads to an increase in its temperature. The reaction of the patient’s body is obvious - he will spend energy, which he just does not have in this situation.

Any known heating apparatus emits electrical impulses. These devices typically have built-in defibrillation protection. The electrical cord of any known warming device makes it difficult to access a patient’s location. In addition, the power cord complicates sanitization.

Known thermostat [4] - a device that provides a constant temperature in the study of the physical and chemical properties of substances. The thermostat is a vessel, part of the cavity of which, carefully isolated from the surrounding space, is filled with coolant. The test substance, placed in the working area of the thermostat, is in thermal contact with the coolant and has its temperature. The isothermal conditions in the working area of the thermostat are provided by a built-in electric heater with a precision temperature regulator. An electric heater built into another type of thermostat used differently - they melt the coolant. After melting the coolant, the electric heater turns off. Subsequently, the temperature in the working area of the thermostat does not change - it is equal to the melting point of the coolant. The stability of the thermal regime of the thermostat is provided due to the heat released during crystallization of the coolant. Known thermostats, the constant temperature in which provides the process of evaporation of the coolant. In thermostats with a melted or evaporated coolant, the effect that occurs during the implementation of phase transitions of the first kind is used.

The temperature of the system in which the aggregate transformation of the substance occurs does not change until the transition is complete.

In essence, Astotherm plus and Ranger devices, as well as the Hotline system, are the simplest flow-through infusion thermostats with built-in electric heaters and temperature regulators. Thermal insulation of the considered devices is not perfect

- the power of their electric heaters is 450 - 900 watts. This power is an order of magnitude higher than the amount of energy that is needed to heat the preparations to a given temperature.

Disclosure of invention

The claimed group of inventions is aimed at solving two technical problems associated with a single inventive concept.

The first of the tasks is aimed at solving three problems associated with heating flushing fluids, infusion and transfusion preparations. One of these problems is the low therapeutic and economic efficiency of using drugs heated in a known manner. Another problem is that any known heating apparatus is potentially dangerous for patients.

The first technical problem is solved by improving the known method of heating flushing fluids, infusion and transfusion preparations.

A common feature of the known and both variants of the proposed method is that when they are used, a flow infusion thermostat (hereinafter - thermostat) and an electric heater are used.

The following is an example of the use of a new method for intravenous administration of a drug to a patient.

In this case, a new one in the first embodiment of the proposed method consists in the use of an electric heater located far from the patient. In this case, a thermostat is used, in the removable part of which the coolant is contained. The heat carrier is an alloy of macromolecular substances having a melting point in the range of 25 - 45 ° C. In preparation for the procedure, the removable part of the thermostat is pushed onto an electric heater, which melts the coolant, after which the melt is overheated by 3-5 degrees. Continuing preparation for the procedure, the removable part of the thermostat is transferred to the infusion system, then its heated section is placed in the working area of the thermostat.

The drug begins to heat due to the heat released during solidification of the melt. After 1 - 2 minutes, the temperature in the working area of the thermostat drops to the melting point of the coolant. Accordingly, the temperature of the drug rises in the heated area of the infusion system. Set the desired infusion rate. Subsequently, the heat balance in the working area of the thermostat is maintained due to the heat released during solidification of the melt.

In the implementation of the second variant of the proposed method perform similar actions. However, in this case, a substance having a boiling point in the range of 36 to 45 ° C. is used as a heat carrier. The coolant is evaporated with an electric heater, and the resulting steam is overheated by 3-5 degrees. Subsequently, the drug is heated due to the heat released during condensation of the steam.

The second technical problem is aimed at eliminating the shortcomings of the device selected as the closest analogue.

A common feature of the proposed device and its analogue is that both of them contain thermostats and electric heaters.

The proposed device from the analogue differs in that the electric heater is located outside the thermostat. The thermostat contains a removable part with a closed cavity filled with coolant.

The coolant of the thermostat of the device made according to the first embodiment has a melting temperature selected in the range from 25 to 45 ° C.

The coolant of the thermostat of the device made according to the second embodiment has a boiling point selected in the range from 36 to 43 ° C.

Perhaps a different implementation of the proposed device. In this case, the electric heater is located in a closed cavity of the thermostat filled with coolant.

The technical result achieved is: 1) to ensure the safety of the use of heated preparations, and 2) to increase the therapeutic and economic effectiveness of such procedures.

Inventions have a number of advantages over objects adopted as close analogues, namely:

1. The temperature of washing fluids, infusion and transfusion preparations, heated in a new way, is stable from the beginning to the end of the procedures. The change in the flow rate of the drug in the infusion system does not affect its temperature in any way.

2. The electric power of the proposed device is an order of magnitude lower than the power of known heating devices. 3. Personnel safety is ensured by the fact that the electric heater is powered by a step-down transformer.

4. The device has a simple design. In mass production, its price will be 15 - 20 times lower than the cost of the well-known universal heating apparatus.

5. The device does not contain substances hazardous to the health of patients, medical personnel and the environment.

6. All materials of which the device is made are recyclable.

7. The thermostat does not have wires connecting it to an electrical outlet, which facilitates access to the patient, and also simplifies sanitization.

8. The removable part of the thermostat, worn on an electric heater, shields the electromagnetic radiation emitted by it. This ensures the safety of medical personnel. The thermostat cannot cause defibrillation - it does not emit dangerous electrical pulses during the procedure. Brief Description of the Drawings

The proposed device is illustrated by drawings, where in FIG. 1 shows an infusion stand with an infusion system and a thermostat; in FIG. 2 - a fragment of a block of electric heaters; in FIG. 3 - longitudinal section of the thermostat assembly (option 1); in FIG. 4 - longitudinal section of the removable part of the thermostat; in FIG. 5 - attached to the cover of the thermostat shown in FIG. 3, a holder with heated sections of the tube of the infusion system; in FIG. 6 is a longitudinal section of a thermostat assembly (option 2); in FIG. 7 is a section AA of the thermostat shown in FIG. 6. The best option for carrying out the inventions

The proposed device includes a thermostat having a removable and stationary parts. The removable part 1 of the thermostat (Fig. 1 - Fig. 4, Fig. 6, Fig. 7) is made in the form of a thermally insulated vessel, and the stationary part is the cover 2 of this vessel (Fig. 1, Fig. 3, Fig. 5, Fig. 6). In the cover 2 there is a compartment 3 for a board with a circuit for controlling the temperature of the drug, and on its outer surface there is a platform 4 with LEDs. The temperature control circuit board and the LEDs that display it are not shown in the drawings. A through hole 5 is made in the lid 2 (Fig. 3, Fig. 5), intended for the input and output of the tube 6 of the heated section of the infusion system. The cover 2 of the thermostat is mounted on an infusion stand 7 (Fig. 1, Fig. 3, Fig. 5, Fig. 6) installed near the patient's location. The drawings show a thermostat with vacuum thermal insulation. Instead of vacuum, a synthetic material having low thermal conductivity can be used. In the removable part 1 thermostat has a sealed cavity filled with coolant. As the coolant of the thermostat of the device, made according to the first embodiment, an alloy of high molecular substances was used. The composition of the alloy depends on the purpose of the heating device. So, if it is necessary to carry out infusion in a hypothermic mode, a coolant is used that has a melting point below (or equal to) 27 ° C. In other cases, a coolant with a melting point of 36 - 45 ° C is used (such a coolant in the molten state is shown in Fig. 2 - Fig. 4 - position 8). According to another embodiment of the device, the coolant is a substance having a boiling point of 36 - 45 ° C. In FIG. 6, FIG. 7 shows a thermostat made according to the second variant: the closed cavity of its removable part 1 is filled with liquid 9 coolant and its vapor 10. A holder 1 1 of the tube 6 of the heated section of the infusion system is attached to the cover 2 of the thermostat. The holder 1 1 is a segment of a cylindrical pipe with a longitudinal groove 12, through holes 13 and a spiral groove on the outer surface. The outer diameter of the tube 6 of the heated section of the infusion system used in the operation of the device is 6.8 or 4.0 millimeters. In accordance with established practice, the length of the tube 6 is 5.7 or 4.9 meters, and at low rates of infusion, standard infusion systems are used (the length of the tube 6 is 1.5 meters). As a heated section of the infusion system can be a disposable flexible cartridge 14 (Fig. 6, Fig. 7). The composition of the proposed device includes an electric heater unit, remote from the patient. Elements 15 (Fig. 2) of the electric heater block are mounted on the table 16. Elements 15 are connected to a step-down transformer connected to the electric network and disconnected from it by simple automation. In addition to the above device contains a disposable "passive" heat-insulating cover (not shown in the drawings). The cover is used to isolate the portion of the infusion tube located between the thermostat and the patient. Apply a cover at low infusion rates, as well as at low ambient temperatures.

The first variant of the proposed method is as follows. The heated section of the tube 6, as well as the unheated section with a venipuncture needle, are passed through the opening 5 of the cover 2 and the longitudinal groove 12. The tube 6 is placed in the spiral groove of the holder 1 1 (Fig. 5), after which the infusion system is filled. At least 5 minutes before the start of the infusion therapy procedure, the removable part 1 of the thermostat is transferred to the table of electric heaters (Fig. 2). The detachable part 1 of the thermostat is put on the elements 15 of one of the electric heaters. Then the coolant 8 is melted, and the melt is overheated by 3-5 degrees. Upon completion of these processes, the removable part 1 of the thermostat is transferred to the infusion system. The detachable part 1 of the thermostat is pushed onto the holder 1 1 - thereby the heated sections of the tube 6 wound thereon are brought into thermal contact with the molten coolant 8. The coolant 8 begins to cool, and the contents of the thermostat working area become hot. After 1 - 2 minutes, the temperature in the working zone of the thermostat drops to the melting point of the coolant, as evidenced by the green LED on. Before starting the infusion procedure, 1.3 meters of the heated tube 6, ending with a venipuncture needle, are wound from the holder 1 1. Venipuncture is performed and the set infusion rate is set. The heated preparation cools the coolant 8, but its temperature does not change. The heat balance in the working area of the thermostat is maintained due to the heat released during solidification of the melt. The thermal regime in the working area of the removable part 1 of the thermostat is leveled with air circulating through the openings 13. During the infusion, the amount of solid coolant 8 in the thermostat gradually increases. The solidification of the coolant 8 is completed at the location of the end of the tube 6 of the heated section of the infusion system. After that, the temperature in the working area of the thermostat drops, as evidenced by the yellow LED and a sound signal. If the procedure must be continued, a removable part 1 of another thermostat with a molten coolant is put on a holder 1 1 with a heated section of the infusion system.

The proposed device equally reliably heats the drugs entering it at any speed. When the flow rate changes, the phase transition process accelerates (or slows down) accordingly. In any case, the amount of heat released always corresponds to the amount that the preparation carries away.

Actions similar to those listed above are performed if the device is operated with an electric heater located in the cavity of the thermostat filled with coolant.

The second variant of the proposed method is carried out in a similar manner. However, in this case, another variant of the heating device is used. Liquid electric coolant 9 is evaporated by its electric heater, and the steam 10 being formed is overheated by 3-5 degrees. The drug is heated due to the heat released during the condensation of the coolant vapor.

Using inventions

In the best way, inventions can be used in resuscitation, surgery, obstetrics, gynecology, in the treatment of infectious diseases, in therapy, as well as in veterinary medicine.

List of cited information sources

1. http://www.altaide.ru/index.php?menu=stihler&pid=3.

2. http://www.delrus.com/index.php?part_name=good&g_id=576.

3.http: // level 1 hotline.com/pdf/TM 194849GL-042014_HOTLINE_white_paper.pdf

4. Physical encyclopedic dictionary. Editor-in-chief A. A. Prokhorov. Moscow,

Soviet Encyclopedia, 1984. The list of reference designations and names of elements to which they belong to the thermostat

ostat

s temperature control

led lights

bob 2

ionic system

tripod

heat carrier of the first embodiment of the device; carrier of the second embodiment of the device

coolant of the second embodiment of the device for cleaning the heated section of the infusion system groove of the tube holder of the infusion system hole of the tube holder of the infusion system flexible cassette

tric heater

heaters

Claims

Claim

1. A method of heating flushing fluids, infusion and transfusion preparations (option 1), the implementation of which uses an electric heater and a flow infusion thermostat, characterized in that the heat carrier of the flow infusion thermostat is melted with an electric heater, and the preparation is heated with a solidifying melt.

2. A method of heating flushing fluids, infusion and transfusion preparations (option 2), the implementation of which uses an electric heater and a flow infusion thermostat, characterized in that the heat carrier of the flow infusion thermostat is evaporated with an electric heater, and the preparation is heated with condensing steam.

3. A device for implementing the method according to claim 1, comprising an electric heater and a flow infusion thermostat, characterized in that the electric heater is a separate unit, and the thermostat has a closed cavity filled with a coolant, the melting temperature of which is in the range 25 - 45 ° C .

4. The device according to paragraph 3, characterized in that the electric heater is located in a closed cavity of a flow infusion thermostat filled with coolant.

5. A device for implementing the method according to claim 2, comprising an electric heater and a flow infusion thermostat, characterized in that the electric heater is a separate unit, and the thermostat has a closed cavity filled with a coolant, the boiling point of which is in the range 25 - 45 ° C .