Device for inducing hypoxic hypercapnia

Abstract

The invention relates to medicine, and more particularly to cardiology, neurology and pulmonology, and can be used for examining the reaction of an organism to metered hypoxic hypercapnia, in particular for evaluating cerebral vessel reactivity and cerebral perfusion reserve, as well as for carrying out hypercapnic training aimed at increasing the resistance of an organism to adverse stress factors and preparing for surgical interventions involving a temporary restriction of the blood flow through the arteries supplying the brain, and for treating diseases, in particular cerebrovascular disorders, coronary perfusion disorders, hypertensive disease, respiratory insufficiency, and the like. Claimed is a device for inducing hypoxic hypercapnia containing cells that are configured in the form of helically twisted channels, wherein each channel forms one cell and is twisted along a helical path at an incline to the plane of the base of a cylinder in such a way that the inlet and the outlet of each channel are vertically diametrically opposed, and wherein a cylindrical housing is provided in the form of a module, the bottom part of which is formed in such a way as to be capable of interfacing with the top part of an identical module.

Description

[0001] DEVICE FOR CREATING HYPOXIC HYPERCAPNIA

[0002] DESCRIPTION

[0003] The invention relates to medicine, namely to cardiology, neurology and pulmonology, and can be used to study the body's response to dosed hypoxic hypercapnia, in particular, to assess the reactivity of cerebral vessels and the perfusion reserve of cerebral circulation, as well as to conduct hypercapnic training aimed at increasing the body's resistance to unfavorable stress factors, preparing for surgical interventions with temporary restriction of blood flow through the arteries supplying the brain, and treating diseases, in particular cerebrovascular accidents, coronary circulation disorders, hypertension, respiratory failure, etc.

[0004] A device is known (USSR patent No. 1123692) that contains a series-connected housing with a "dead" space container, a mixer with a diaphragm for supplying atmospheric air, a valve assembly, a branch pipe with an additional "dead" space container, and a mouthpiece that provides dosing of carbon dioxide in the inhaled air in the range of 1-5% by regulating the supply of air from the surrounding space.

[0005] The disadvantages of the known device are:

[0006] 1) the impossibility of creating a concentration of carbon dioxide in the inhaled air of more than 5%, which is necessary for assessing the perfusion reserve of cerebral circulation and conducting effective hypercapnic training;

[0007] 2) The device has a complex design and does not allow for maximum stratification of exhaled air into portions, which does not allow for the creation of an effective concentration of carbon dioxide.

[0008] The closest in terms of the achieved positive result is a device (RU Patent for Invention No. 2221597), containing a removable mouthpiece and tube, a housing with a "dead" space capacity in the form of parallel labyrinth channels moving relative to each other, with fairings installed in them, allowing dosing hypercapnia in the range of 5-6% CO2 in the alveolar air. The disadvantage of the known device is its insufficient efficiency associated with the need to use a large volume of "dead space" (2000 ml), ensuring the creation of an effective concentration of carbon dioxide, and the associated bulkiness of the device.

[0009] The solutions on the basis of which the “Carbonic” device was created (see https: / / carb onic.ru / produkciya / trenazher / ?) have better efficiency due to the creation of an effective concentration of carbon dioxide in the alveolar air with a smaller volume of “dead space” compared to the prototype, equal to 700-800 ml, and small dimensions of the device.

[0010] Thus, patent RU2383361 describes a device for creating dosed hypercapnic hypoxia, containing a mouthpiece, a central tube, a housing with a capacity of "dead" space, divided into parallel cells connected to each other by means of a connecting space, characterized in that the central tube is equipped with an air mixture intake unit consisting of channels for inhaled and exhaled air, separated by means of a valve mechanism, and is shifted toward the channel for inhaled air, wherein the channel for exhaled air is longer than the channel for inhaled air, and in the channel for exhaled air directly at the valve for exhaled air a sensor for gas analysis is installed.

[0011] This device is bulkier and more complex than the prototype solution (below) due to the presence of a nodal system in which the exhaled air channel is longer than the inhaled air channel, and a gas analysis sensor is installed in the exhaled air channel directly at the exhaled air valve.

[0012] Another known solution is patent RU2303465 for a device for training breathing, comprising a housing with a container having a dead space, as well as a tube and a removable mouthpiece, characterized in that the container is filled with bulk inert granular material in the form of a layer rigidly fixed between nets, through which an elastic tube is passed in such a way that its entrance is located under the said layer, and the exit is equipped with a mouthpiece, while the housing is equipped with movable and fixed covers with openings for the portioned supply of air.

[0013] A similar solution is a patent for a device for training in hypoxic hypercapnia (RU2308979), containing a tube, a mouthpiece connected to it, and a housing having a volume of “dead” space in the form of labyrinthine channels, characterized in that the labyrinthine channels are formed by an elastic inert porous medium, while the housing is equipped with a spring-loaded piston and a tube passed through the piston and rigidly connected to it.

[0014] The problem with these two solutions is that although the dead space has increased due to the layer of bulk granular material, it is impossible to control the level of air volume that this layer of granular material can absorb. With each inhalation and exhalation, the level of the absorbed volume will be different, as a result of which it is impossible to control the load. These solutions have not found application.

[0015] The closest analogue, which has found embodiment and application in the device "Carbonic", is a device for creating hypoxic hypercapnia (patent RU2301081, published: 20.06.2007), containing a removable mouthpiece, a tube and a cylinder with a "dead space" capacity, characterized in that the "dead space" capacity with a total volume of 700-800 ml is divided into parallel cells, the volume of each of which is related to the volume of the "dead space" 1:500, the cells are connected to each other by means of a connecting space having fairings, while the diaphragm has the ability to regulate the volume of the "dead space" in the range of 100-800 ml by turning off some of the cells from ventilation.

[0016] The technical problem of the prototype is the limited length of the cells of the dead space of the respiratory tract (DSRP), which is linked to the length of the body and in the prototype is about 220 mm. The device according to the prototype works at the maximum load level, which is difficult for weakened people and children to perceive. Also, the device according to the prototype limits the maximum load to the same length of the cells.

[0017] In the Carbonic device, created on the basis of this patent (see https: / / carbonic.ru / produkciya / trenazher / ?), the upper load limit is limited by the presence of rubber gaskets between the device cover and the cellular structure.

[0018] (https: / / carbonic.ru / upload / medialibrary / a88 / dsyxlpeds03afu06y2ff4vlkilny7ohl.pdf), in which the internal diameter gradually decreases (the main rubber seal has a square cross-section with a side of 1 cm, then there is an elastic band with a round hole with a diameter of 7 and 5 mm). The principle of this limitation is described in patent RU2383360 for a device for creating dosed hypercapnic hypoxia, containing a cylinder with a "dead space" capacity divided into parallel cells, and a diaphragm, characterized in that the diaphragm is a valve made in the form of a disk divided into two equal sectors, one of which is hollow and the other solid, and the upper part of the housing with cells is made in the form of a step 5-10 mm high, dividing the plane of contact of the housing with the valve into two equal parts, and the valve has the ability to rotate around the central axis, providing adjustment of the volume of the "dead space".

[0019] But this solution does not actually increase the dead space of the respiratory tract, but only provides an increase in breathing resistance, due to which the load subjectively increases, but the concentration of CO2 inside the device remains the same.

[0020] The objective of the invention is to eliminate the above-described problems inherent in the prototype.

[0021] The technical result of the invention is an increase in the length of the dead space of the respiratory tract (DSRT), the possibility of reducing the level of load, as well as the possibility of increasing the load during training and increasing its effectiveness by changing the concentration of CO2 inside the device.

[0022] The specified technical result is achieved due to the fact that a device for creating hypoxic hypercapnia is claimed, containing a removable breathing tube and a cylindrical body with a "dead space" capacity, where the "dead space" capacity is formed around a hollow through cylindrical channel coming from the breathing tube and is divided into cells, the volume of each of which is related to the volume of the "dead space", and the cells are connected to each other by means of a connecting space having a fairing, also containing a cover with a diaphragm installed on top of the cylindrical body and made with the possibility of regulating the volume of the "dead space" by turning off part of the cells from ventilation, characterized in that the cells are made in the form of spirally twisted channels, where each channel forms one cell and is twisted in a spiral with an inclination to the plane of the base of the cylinder in such a way,that the input and output of each channel are located strictly opposite each other vertically; and the cylindrical body is made in the form of a module in which the lower part is formed in such a way that it can be joined with the upper part of the same module.

[0023] Preferably, the cover is formed by consisting of an upper and lower part, between which there is a diaphragm consisting of at least a shutter supported from below by a spring from the bottom of the lower cover, where through holes are made in the side surface of the lower part of the cover.

[0024] Preferably, the diaphragm is formed by three flaps:

[0025] - the upper valve is made in the form of a flat circle with a central hole, two cutouts in the form of sectors and a thrust protrusion;

[0026] - the middle damper is made up of a low-height cylinder, the upper part of which is formed by a flat circle with a central opening, two cutouts in the form of sectors and a thrust protrusion located on the side surface of the cylinder, which is cut off by half of the base in the part that does not cover the cutouts of the sectors;

[0027] - the lower valve is made consisting of a rim formed around a central hollow cylinder and connected to it by plate stiffeners, and part of the rim has a cut in the side surface along the height by half the diameter.

[0028] Preferably, each channel of the cell is twisted in a spiral around the central axis at an angle equal to 360° • X, where X is the number of turns of the channel in a spiral.

[0029] Preferably, the channels of the cells located closer to the through cylindrical channel have a larger angle of inclination than the channels located on the periphery of the cylindrical body.

[0030] Preferably, the outer surface of the cylindrical body in the upper part has an external thread corresponding to the diameter of the internal thread that the lower inner surface of the cylindrical body has.

[0031] Brief description of the drawings

[0032] Fig. 1 shows the structure of a cylindrical body consisting of two modules with a separated connecting space.

[0033] Fig. 2 shows the device of a cylindrical body consisting of two modules assembled without a breathing tube.

[0034] Fig. 3 shows the structure of a cylindrical body consisting of two modules and the principle of fixing a breathing tube to it.

[0035] Fig. 4 shows a sectional view of the device consisting of two modules, where the arrows indicate the movement of air flows (A - with a fully open diaphragm, B - with a fully closed diaphragm).

[0036] Fig. 5 shows a longitudinal and transverse section of a part of the body.

[0037] Fig. 6 shows a part of the housing without the outer casing enclosing the outer channels of the cells.

[0038] Fig. 7 shows an example of the diaphragm design (assembly principle).

[0039] Fig. 8 shows an example of the diaphragm design (disassembled view of the components).

[0040] Fig.9 shows the operating principle of the diaphragm for opening / closing flows.

[0041] Fig. 10 shows an example of the implementation of a cover in the simplest version of the diaphragm.

[0042] Fig.11-Fig.12 show tests of prototypes.

[0043] In the drawings: 1 - cylindrical body, 2 - cover, 3 - branch pipe, 4 - connecting space, 5 - fairing, 6 - docking groove, 7 - docking protrusion, 8 - cylindrical channel, 9 - cells, 9.1 - peripheral cells, 9.2 - cells adjacent closer to the cylindrical channel, 10 - breathing tube, 11 - connecting connector, 12 - lower flap, 13 - middle flap, 14 - upper flap, 15 - stiffener, 16 - hollow cylinder, 17 - rim, 18 - truncated circle of the middle flap, 19 - central hole of the middle flap, 20 - side surface of the cylinder of the middle flap, 21 - cutouts of the middle flap, 22 - truncated circle of the upper flap, 23 - cutouts of the upper flap, 24 - central hole of the upper flap, 25 - thrust projection, 26 - open air passage, 27 - blocked air flow, 28 - spring, 29 - lower part of the cover, 30 - upper part of the cover, 31 - through holes in the lower part of the cover.

[0044] Implementation of the invention

[0045] The device (see Fig. 1 - Fig. 3) for creating hypoxic hypercapnia, as in the prototype, contains a removable breathing tube 10 and a cylindrical body 1 with a "dead space" capacity, where the "dead space" capacity is formed around a hollow through cylindrical channel 8, going from the breathing tube 10 through a branch pipe 3 on the cover 2, and is divided into cells, the volume of each of which is related to the volume of the "dead space". The cells are connected to each other by means of a connecting space 4, having a fairing 5.

[0046] The device also contains a cover 2 with a diaphragm, installed on top of the cylindrical body and designed with the ability to regulate the volume of "dead space" by turning off some of the cells from ventilation.

[0047] What is new in the claimed invention is that the cells 9 are made in the form of spirally twisted channels (see the section of the housing part in Fig. 6), where each channel forms one cell and is twisted in a spiral with an inclination to the plane of the base of the cylinder in such a way that the input and output of each channel are located strictly opposite each other vertically.

[0048] In this case, the cylindrical body 1 is made in the form of a module, in which the lower part is formed in such a way that it can be joined with the upper part of the same module.

[0049] This design of the device ensures the modularity of the cylindrical body 1, which allows increasing the height by adding identical modules. Also, this design of the device increases the length of the cell channels 9. All these conditions allow obtaining a larger volume of "dead space" than in the prototype.

[0050] This allows some of the cells to be switched off from ventilation and the volume of “dead space” to be changed in the range from 100 ml to 1500 ml or more (depending on the number of connected cellular modules), which changes the concentration of carbon dioxide in the alveolar air in the range of 3-8% or more and the oxygen deficiency in the range of 0-11% or more.

[0051] Each channel of cell 9 can be twisted in a spiral around the central axis at an angle equal to 360° • X, where X is the number of turns of the channel in a spiral and can be an integer from 1 or more.

[0052] The cover 2 can be formed by consisting of an upper 30 and lower 29 parts, between which there is a diaphragm consisting of at least a shutter 14, supported from below by a spring 28 from the bottom of the lower cover 29, where through holes 31 are made in the side surface of the lower part of the cover 29. This shutter can regulate the load level from 50% to 100% (see the example in Fig. 10).

[0053] More effective is a diaphragm (see Fig. 7, Fig. 8), which is formed by three valves, where:

[0054] - the upper flap 14 is made in the form of a flat circle 22 with a central opening 24, two cutouts 23 in the form of sectors and a thrust projection 25; - the middle flap 13 is made consisting of a cylinder 20 of small height, the upper part of which is formed by a flat circle 18 with a central opening 19, two cutouts 21 in the form of sectors and a thrust projection 25, located on the side surface of the cylinder 20, which is cut off by half of the base in the part that does not cover the cutouts of the sectors 21;

[0055] - the lower valve 12 is made consisting of a rim 17 formed around a central hollow cylinder 16 and connected to it by plate stiffeners 15, wherein part of the rim has a cut in the side surface along the height by half the diameter.

[0056] As can be seen from Fig. 9, this diaphragm design allows changing the load level with complete blocking 27 of the air flow from 0% (Fig. 4(B), Fig. 9(G)) to complete air passage 26 by 100% (Fig. 4(A), Fig. 9(B)). In this case, smooth regulation is possible (see Fig. 9(A, B)), when there is both air passage 26 and its blocking 27. Protrusions 25 fix the position of each of the flaps 13 and 14 in the closed or open position.

[0057] In order to ensure that the input and output of each channel are located strictly opposite each other vertically (especially with a large number of twisted turns), it is desirable to form the channels of cells 9.2 located closer to the through cylindrical channel 8 with a larger angle of inclination than the channels 9.1 located on the periphery of the cylindrical body (see the example in Fig. 5).

[0058] As shown in Fig.1 - Fig.3, the cylindrical body is a module. When making modules of the same type, such modules can be screwed on as additional ones to increase the volume of "dead space".

[0059] The joining of modules to each other may be different. For example, the outer surface of the cylindrical body 1 in the upper part may have an external thread corresponding to the diameter of the internal thread, which the lower inner surface of the cylindrical body has. The connecting space 4 with the fairing 5 must also be formed in this case with an external thread on the outer surface in order to screw into the internal thread, which the lower inner surface of the cylindrical body has, or must have docking grooves 6 for docking projections 7, which are located in the lower part of each module of the cylindrical body 1.

[0060] The device is assembled from at least one module. Regardless of how many modules are screwed together, the connecting space 4 with the fairing 5 is fixed to the lower module, and the cover 2 with the diaphragm and the branch pipe 3 (see Fig. 2) is fixed to the upper module for subsequent fixation to the branch pipe 3 using the connecting connector 11 of the breathing tube 10 (see Fig. 3). After which the device will be ready for operation.

[0061] Breathing is performed through a mouthpiece in tube 10 or through a mask. Exhaled air fills the central tube, then the connecting space and is directed into the cells filling the body, and is released into the atmosphere through openings in the cellular structure of the body. At the end of exhalation, alveolar air enriched with carbon dioxide and poor in oxygen remains in the cells. Air movement during inhalation is performed in the opposite direction to exhalation. In this case, alveolar air from the cells and the central tube, enriched with carbon dioxide and poor in oxygen, enters the lungs.

[0062] The air flow passing through the tube 10 then descends along the cylindrical channel 8 and enters the connecting space 4 with the fairing 5, where it is distributed evenly across all the channels of the cells 9. When the diaphragm is fully opened by 100%, the air flows exit from the side openings 31 of the lower part 29 of the cover 2 and through the openings in the diaphragm itself (see Fig. 4(A)). And when the flow through the diaphragm is completely blocked (see Fig. 9(G)) the air flow does not exit the cover (see Fig. 4(B)).

[0063] Unlike the prototype, the declared device allows, due to modularity, to increase the volume of “dead space” by (K - 1) * 100%, where K is the number of joined modules of 2 or more pieces.

[0064] Even when using one module, unlike the prototype, it has a larger volume of "dead space" due to the longer length of the channels. The longer length of the channels is provided by the spiral twisting of each channel, which gives a longer channel length at the same height of the device.

[0065] According to the invention, a prototype was manufactured, which successfully passed the test on volunteers (see Fig. 11, Fig. 12). According to the subjects, in comparison with the Carbonic device (see https: / / carbonic.ru / produkciya / trenazher / ?), the device according to the invention allowed to reduce the load level both with the help of the diaphragm and by reducing the number of modules used, and also allowed to increase the load during training and improve its effectiveness by changing the concentration of CO2 inside the device by increasing the number of modules.

[0066] The subjects noted that as a result of regular training using the device according to the invention, the following occurs:

[0067] 1) Moderate stress on the body, which increases overall stress resistance in relation to various stress factors in the external environment.

[0068] 2) A gradual increase in the level of CO2 in the blood, which leads to normalization of the lumen of the vessels (primarily muscular arterioles), that is, vasodilation and relief of vascular spasm (reduction or complete elimination of vasoconstriction), resulting in normalization of blood pressure.

[0069] 3) Increasing the body's resistance to ischemia (tissues and organs are trained to tolerate moderate hypoxia), preventing strokes and heart attacks, and reducing the degree of damage to organs and tissues during vascular accidents.

[0070] 4) Increased endurance during physical activity.

[0071] 6) Reduced anxiety, increased psychological stability.

[0072] The efficiency of changing the CO2 concentration inside the device is significantly higher than in the prototype and other known analogues.

[0073] A comparison of the characteristics of known devices and the claimed invention is shown in Table 1.

[0074] Table 1

[0075] From a comparison of the characteristics of the devices, it is clear that, unlike the prototype (the device according to patent RU2301081) and other devices available on the Russian market, the declared device:

[0076] 1) Significantly increases the length of the dead space of the airways (DSA) due to the spiral structure of the air ducts in the cellular blocks.

[0077] 2) Allows to reduce the initial level of load for weakened people and children.

[0078] 3) Allows you to virtually unlimitedly increase the load during training due to the modular design.

[0079] 4) Allows you to increase the level of CO2 in the air inhaled from the simulator to 8% or more, which ensures high training efficiency.

[0080] 5) The problem of load regulation inherent in the "Carbonic" device is solved. Instead of increasing breathing resistance, the declared device smoothly increases the load and changes the CO2 concentration inside the device, while in the prototype device this concentration remains the same.

Claims

FORMULA 1. A device for creating hypoxic hypercapnia, comprising a removable breathing tube, a cylindrical body, with a capacity of the connecting space, having a fairing and a cover with a diaphragm, installed on top of the cylindrical body and made with the possibility of regulating the volume of the connecting space by turning off part of the cells from ventilation; made with the possibility of releasing exhaled air into the atmosphere through a hollow through cylindrical channel and cells and inhaling air enriched with carbon dioxide and poor in oxygen from the cells and the hollow through cylindrical channel;in which the capacity of the connecting space is formed around a hollow through cylindrical channel coming from a removable breathing tube and is divided into cells, the volume of each of which is related to the volume of the connecting space, characterized in that the cells are made in the form of spirally twisted channels, where each spirally twisted channel forms one cell and is twisted in a spiral with an inclination to the plane of the base of the cylinder in such a way that the input and output of each channel are opposite each other vertically; the cylindrical body is made in the form of a module, in which the lower part is formed in such a way that it can be joined with the upper part of the same module;the diaphragm consists of an upper flap made in the form of a flat circle with a central opening, two cutouts in the form of sectors and a thrust projection, a middle flap consisting of a cylinder, the upper part of which is formed by a flat circle with a central opening, two cutouts in the form of sectors and a thrust projection located on the side surface of the cylinder, which is cut off by half the base in the part that does not cover the cutouts of the sectors, a lower flap consisting of a rim formed around the central hollow cylinder and connected to it by plate stiffeners, where part of the rim has a cut in the side surface along the height by half the diameter.

2. The device according to item 1, characterized in that the spirally twisted channels located closer to the hollow through cylindrical channel have a larger angle of inclination than the channels located on the periphery of the cylindrical body. 12 SUBSTITUTE SHEET (RULE 26) 3. The device according to item 1, characterized in that the outer surface of the cylindrical body in the upper part has an external thread corresponding to the diameter of the internal thread on the lower inner surface of the cylindrical body. 13 SUBSTITUTE SHEET (RULE 26)

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