The present invention relates to a device for respiratory assistance that can be used on patients whose spontaneous respiration is absent or inadequate, whether or not said patients are under artificial respiration.
A device for respiratory assistance is already known from the patent EP-A-0390684 and comprises:
In such a device, the breathable gas supplying the auxiliary channel is in most cases pure oxygen. However, some patients whose bodies are accustomed to a high level of carbon dioxide in the blood cannot tolerate ventilation with pure oxygen, which would pose a risk of heart problems.
Therefore, in order to remedy this drawback, it has already been proposed, in the document EP-A-1441791, to use a respiratory assistance device of this kind that additionally comprises, between the distal orifice of the auxiliary channel and the distal end of the main channel, controllable means of fluid communication which, in the open position, are able to form a passage of variable cross section connecting said main channel to the external environment, in such a way that external air is aspirated through the means of communication by the jet of breathable gas of the main channel. The air thus introduced dilutes the breathable gas, which can then be tolerated by those patients referred to above.
The aspiration of external air arises from the low pressure generated by the jet of breathable gas in the main channel, downstream of the distal orifice of the auxiliary channel. However, the low pressure created proves not only to be insubstantial but also very unstable. This is because it is subject to variations that are unpredictable and difficult to control and that cause irregular aspiration of outside air.
Moreover, the person operating the respiratory assistance device on the patient may be forced to continually adjust the variable cross section of the passage formed by the means of communication (and thus the strength of the aspiration) in order to ensure that the dilution of the respiratory gas by the air remains substantially constant in the main channel.
The object of the present invention is to overcome these drawbacks.
To this end, according to the invention, the device for respiratory assistance is tubular and forms a main channel to be connected via its distal portion to an airway of a patient such that said main channel connects the respiratory system of said patient to the outside, said device comprising:
Thus, by virtue of the present invention, the diverted fraction of breathable gas drives the means of aspiration, which create an aspiration of ambient air, this aspiration being all the more substantial the greater the diverted fraction of breathable gas. In addition, since the diverted fraction of breathable gas is not subject to sudden and unpredictable variations (as the flow of breathable gas from the gas source is continuous and constant), there is no risk of unstable and irregular aspiration of outside air. Moreover, the diverted fraction of breathable gas is mixed with the aspirated ambient air, such that the breathable gas is diluted before arriving in the main channel.
It will thus be noted that, in the present invention, the aspiration of ambient air does not depend on the internal low pressure prevailing within the main channel downstream of the distal orifice of the auxiliary channel; it is created intentionally by the means of aspiration.
Preferably, the device for respiratory assistance comprises means of regulating said fraction of breathable gas diverted by said means of diversion, which regulating means are advantageously arranged between said means of diversion and said means of aspiration. These regulating means can comprise at least one valve.
Thus, it is possible to regulate the diverted fraction of breathable gas so as to adapt the strength of aspiration generated by the means of aspiration (which are driven by the diverted fraction of gas) and, consequently, the volume of ambient air aspirated. In this way it is possible to adjust the dilution of the diverted breathable gas.
It should be noted that the invention provides for the valve of the regulating means to be calibrated so as to be able to precisely control the volume of ambient air aspirated and, consequently, the dilution of the diverted breathable gas.
Preferably, the device for respiratory assistance comprises means of adjusting the flow rate of diluted breathable gas issuing from said means of aspiration and intended to enter said main channel. These means of adjusting the flow rate are advantageously arranged between said means of aspiration and said means of fluid communication. In addition, the means of adjusting the flow rate can comprise at least one valve.
It is thus possible to adjust the flow rate (and therefore the quantity) of diluted breathable gas entering said main channel by way of said means of communication.
In the same way as for the valve of the regulating means, it is also possible to calibrate the valve of the adjusting means in such a way as to know precisely the quantity of diluted breathable gas introduced into the main channel.
Advantageously, said means of fluid communication comprise at least one communication orifice which is formed in the wall of said device.
In addition, in an illustrative embodiment of the device for respiratory assistance of the invention especially for the introduction of the latter, by the mooth, into the carina of a patient respiratory system, said main channel being formed by a flexible tube, said means of fluid communication advantageously comprise a flexible airtight sheath which surrounds said flexible tube, at least on a portion of its length, and which forms a peripheral channel around said flexible tube, wherein said communication orifice opens into and by which aspired ambient air mixed with said diverted fraction of breathable gas is able to flow from the proximal end of said flexible sheath.
In this way, a sweeping of vitiated respiratory gas being in the lumbs may be obtained by expelling it out of the latter with fresh respiratory gas, diluted by ambient air, from the carina through the main channel.
Said means of aspiration may be advantageously directly mounted on said flexible tube near to its proximal end, facilitating the handling of the respiratory assistance device.
Moreover, in one embodiment of the invention, means of deflecting said jet of breathable ventilation gas toward the axis of said main channel are provided opposite said distal orifice of said auxiliary channel, and said means of communication are arranged between said means of deflection and said distal end of said main channel.
The figures in the attached drawing will show clearly how the invention can be implemented. In these figures, identical reference signs designate like elements.
The device 1 comprises a tube 4 which is flexible or pre-shaped (to adapt to the morphology of the patient) and which delimits a main channel 5 with a proximal orifice 6 and a distal orifice 7, respectively, at the ends of said tube 4.
Thus, the main channel 5 is able to ensure a passage between the proximal orifice 6 and distal orifice 7, one of which (the distal orifice 7) is intended to be located within the airways of a patient, while the other (the proximal orifice 6) is intended to be located outside said patient. This proximal orifice 6 can open to the ambient air, and in this case the patient can inhale fresh air and exhale vitiated air through the main channel 5. As is explained below, it is also possible to connect the orifice 6 to a source of breathable gas under pressure and to provide a system of unidirectional valves, such that the patient inhales the breathable gas from said source via said main channel 5 and exhales the vitiated gas to the ambient air, also via this main channel 5.
The diameter of the main channel 5 is of the order of a few millimeters. Satisfactory trials have been carried out with diameters of 3 mm, 7 mm, 8 mm and 12 mm.
Moreover, auxiliary channels 8 are formed within the thickness of the wall of the tube 4, said auxiliary channels 8 extending over almost the entire length of the main channel 5 and being intended to be connected to a source of breathable gas under pressure, as is described below.
The connection to the source of breathable gas can be effected by way of a ring 9, surrounding the tube 4 in a leaktight manner toward the proximal end 2 and delimiting a sealed annular chamber 10 around said tube 4. The auxiliary channels 8 are brought into communication with the annular chamber 10 by way of local cuts 11 made in the wall of the tube 4, and said chamber 10 is connected to said source of breathable gas via a conduit 12. Of course, the proximal ends of the channels 8 are closed off, for example by stoppers 13 introduced from the proximal end face 14 of the tube 4.
The auxiliary channels 8 have a smaller diameter than that of the main channel 5. The diameter of the auxiliary channels 8 is preferably less than 1 mm and is advantageously of the order of 5 to 800 microns. At the distal end, the auxiliary channels 8 open into a recess 15 in the inner wall 16 of the tube 4. The recess 15 is annular and centered on the axis 17 of said tube 4. It comprises a face 15a, which is substantially transverse or slightly inclined in such a way as to constitute a widening of the main channel 5 into which said auxiliary channels 8 open via their orifices 18, and also a face 15b following the face 15a and converging in the direction of the axis 17.
Preferably, between the converging inclined face 15b and the distal orifice 7, the inner wall 16 of the tube 4 has a part slightly widened toward the outside, as is illustrated by the angle A in
Thus, when the auxiliary channels 8 are supplied with breathable gas under pressure by way of the elements 9 to 12, the corresponding jets of gas impact the inclined face 15b, which deflects them in the direction of the axis 17 (arrow F in
At least one supplementary channel 19 is provided within the thickness of the tube 4 and opens out at 19A near the distal end face 20 of the tube 4 and serves as a pressure tap.
For safety reasons, a calibrated exhaust valve 21 can be provided near the proximal portion 2 of the tube 4. Thus, in the event of an accidental overpressure in the main channel 5, an escape of gas takes place outside the patient, via the wall of the tube 4, so as to eliminate this overpressure instantaneously.
As is shown in
The tube 4 of the device 1 according to the invention can be made of any material already used in respiratory probes, for example polyvinyl chloride, with an optional coating of silicone or steel permitting high-pressure injections.
Of course, the dimensions of the device 1 according to the invention can vary greatly, depending principally on the way the tube is fitted and on the size of the patient, who can be an adult, a child, an infant or a premature baby.
The device 1 moreover comprises a supply and control device 22 which is connected to the proximal orifice 6 of the tube 4 via a connection 23 and to the supplementary channel 19 via a connection 24.
The supply and control device 22 is supplied with breathable gas under pressure, for example pure oxygen, by a source 25, to which it is connected via a conduit 26 on which an adjustable pressure reducer/flowmeter 27 is mounted.
The output of the pressure reducer/flowmeter 27 is connected to the conduit 12 via a branch conduit 28 on which there are mounted in series a controllable valve 29, an adjustable pressure drop device 30 limiting the flow rate and pressure (for example a tube with calibrated conduit), a humidifier 31, and a calibrated exhaust valve 32 whose calibration can be regulated. The controllable valve 29 is controlled by the supply and control device 22 by way of a connection 33.
By way of nonlimiting example, the pressure reducer/flowmeter 27 can deliver, into the conduit 28, the breathable gas coming from the source 25 at a pressure 9, for example equal to 3.5 bar with a maximum adjustable flow rate of, for example, 32 liters per minute, while the flow rate and pressure limiter 30, receiving this breathable gas from the conduit 28, can lower the pressure thereof to a value p, for example equal to 0.5 bar for an adult and to 0.07 bar for a child, and can lower the flow rate to a value d, for example equal to 0.5 liter per minute. As for the exhaust valve 32, it is calibrated to the pressure p.
Moreover (see
As is shown in
The output of the means of diversion 36 of the conduit 12 is connected to the gas inlet stub 35 via a branch conduit 37 on which means of aspiration 38 of ambient air are mounted between the means of diversion 36 and the inlet stub 35.
These means of aspiration 38, functioning on a principle similar to that of an impeller pump, for example, are driven by the fraction of breathable gas diverted from the conduit 12 and originating from the source 25. They are thus able to pump ambient air (symbolized by the arrow P) through an air inlet orifice 38A. At the outlet of the means of aspiration 38, the diverted breathable gas is diluted by the aspirated ambient air.
As is shown in
Advantageously, the regulating valve 39 can be calibrated so as to be able to precisely control the volume of ambient air aspirated and, consequently, the dilution of the diverted breathable gas.
As is illustrated in
The modes of operation of the device 1 according to the first illustrative embodiment (
In a variant of the first illustrative embodiment, which variant is shown in
By virtue of such a ring 41, the pressure of the source 25 of breathable gas necessary for obtaining the oblong pressure zone D can be lowered while at the same time obtaining a pressure zone D of identical pressure.
As a general rule, the distance 1 between the ring 41 and the inclined deflecting face 15b is close to the diameter of the distal part of the main channel 5.
However, in order to obtain the required optimal reduction of pressure of the source 25, it may be advantageous for this distance 1 to be adjustable. It is also advantageous, for the same reason, for the diameter of the central opening 43 of the ring 41 to be adjustable.
As is shown in
An annular opening 66, formed within the annular connector 64, allows fresh breathable gas diluted by ambient air to communicate with the flexible sheath 63. Thus, diluted fresh breathable gas, coming from means 38, may flow in the peripheral channel 65 and may come into the main channel 5 (arrow f), via the orifice 34.
In this variant, means of aspiration 38, having the form of a Venturi tube, are mounted on the annular connector 64 of flexible tube 4, in order to make the handling of device 1 easier.
In addition, as is shown in
Moreover, as known, flexible tube 4 may comprise an inflatable fixing balloon 68, arranged downstream of flexible sheath 63. The inflatable balloon 68, simple or double, may be inflated by an inflatable gas (arrow F1) coming from a source 69 and transported by a supplementary channel 70, formed within the thickness of tube 4. This channel 70 opens into the fixing balloon 68 at 71. In addition, the membrane of balloon 68 may be at least partially strengthened in order to avoid any rip caused by a patient bite, during introduction of flexible tube 4 by the patient month.
Thus, in this variant of the first illustrative embodiment, the flexible tube 4 may be easily inserted into a patient respiratory system, as far as its distal end 7 is located near to the carina (not shown). Then, dead space between distal end 7 of flexible tube 4 and patient lumbs is reduced to a minimum.
In this way, a sweeping of vitiated respiratory gas in the lumbs may be obtained by expelling it out of the latter with fresh respiratory gas, diluted by ambient air, from the carina through the main channel 5.
As is shown in
The inner passage 44 is delimited by a proximal orifice 46 and by a distal orifice 47 at the proximal end 48 and distal end 49, respectively, of said tubular connector 1.1.
The purpose of the conical wall 45 is to deflect, in the direction of the longitudinal axis 50 of the inner passage 44, the jets of breathable gas that are injected through auxiliary channels 51 and supplied from an orifice 52 continued by a lateral intake stub 53, by way of a peripheral annular chamber 54. The jets of breathable gas, originating from a source 25 of breathable gas, open out of the auxiliary channels 51 via the orifices 51A thereof.
The intake stub 53 is connected to means of diversion (similar to those described above in relation to
Moreover, near its distal portion 48, the wall of the tubular connector 1.1 is provided with a communication orifice 34 which is continued radially outward by a lateral gas inlet stub 35, and the orifice 34 and stub form means of fluid communication with the device 1.1.
These means of fluid communication can be supplied with diluted breathable gas via a diversion conduit 37, by way of the means of diversion 36, a regulating valve 39, means of aspiration 38, and an adjusting valve 40 (described above in relation to
Moreover, the tubular connector 1.1 comprises a tubular central portion 55 which is interposed between the proximal portion 48 and the distal portion 49 and of which the distal longitudinal end 55A projects slightly into the inner passage 44 in such a way as to form a downstream ring with a function similar to that of the aforementioned downstream ring 41.
Exhaust orifices 56 are formed in the lateral wall of the middle portion 55 in such a way as to connect the inner passage 44 to the ambient air. These exhaust orifices 56 are preferably distributed uniformly about the axis 50, on the same section of the middle portion 55. They make it easier for the patient to exhale by allowing vitiated gas to escape from the respiratory system of said patient.
The exhaust orifices 56 can also be covered by a ring 56A which is able to turn gently around the middle portion 55 and is itself provided with holes 56B whose diameter is at least equal to that of the orifices 56 and which can be disposed opposite the orifices 56 by rotating the ring 56A.
Moreover, at the distal portion 49, the tubular connector 1.1 comprises an annular peripheral chamber arranged coaxially with respect to said connector 1.1. The annular peripheral chamber 60 opens out at the distal end 47 of the connector 1.1 and is provided, at its proximal end, with an outlet stub 61, which can be connected to a gas analyzer and to a pressure measurement device (neither of which is shown).
A fibrous or porous filter 62 is arranged in the annular peripheral chamber 60 in order to attenuate the gas turbulence and, consequently, excessive pressure variations.
Although they have not been shown in
Of course, it will be readily appreciated that the device 1, 1.1 according to the present invention, can have numerous other uses, for example as a nasal probe, oral probe, tracheal probe, laryngeal mask, King system, Combitube (registered trademark), etc. It is obvious that the dimensions of said device are then adapted to each particular use.
Number | Date | Country | Kind |
---|---|---|---|
09 01122 | Mar 2009 | FR | national |
09 04364 | Sep 2009 | FR | national |