WO2017072363A1

WO2017072363A1 - Respiratory mask and ventilator assembly

Info

Publication number: WO2017072363A1
Application number: PCT/EP2016/076247
Authority: WO
Inventors: Henrich Büscher; Valter NASCIMENTO
Original assignee: Henrich Büscher
Priority date: 2015-10-30
Filing date: 2016-10-31
Publication date: 2017-05-04
Also published as: DE202015105799U1

Abstract

The invention relates to a respiratory mask (1) for ventilating a patient, comprising a contact surface (5) which is circumferential in an annular manner and which can be placed on the face (14) of the patient; a curved hood (12), on the edge of which the contact surface (5) runs; and an inlet opening (6) for the respiratory air to be supplied to the patient. According to the invention, the hood (12) is designed to be flat in the vicinity of the face such that the respiratory mask (1) encloses as little volume as possible between the face (14) of the patient and the hood (12), and the respiratory mask (1) has an outlet opening (9) for the respiratory air exhaled by the patient. The invention further relates to a ventilator assembly comprising a ventilator device (11) which has a pump (10) for pumping a respiratory gas mixture, referred to as supply air; a supply air line which conducts the supply air from the ventilator device (11) to the inlet opening (6) of an aforementioned respiratory mask (1); and a discharge air line which conducts the respiratory air exhaled by the patient, referred to as discharge air, to the ventilator device (11).

Description

"Respiratory Mask, and Respiratory System"

Description:

The invention relates to a breathing mask for the ventilation of a patient according to the preamble of claim 1, as well as to a ventilation arrangement using a breathing mask.

Generic breathing masks are known from practice. They have an all-round contact surface, which is usually made of a soft material such. B. consists of a rubber or silicone material. This contact surface can be applied to the patient's face and adapts to the individual face topography of the respective patient due to its soft design. As a result, the closest possible connection of the breathing mask to the patient is effected. Furthermore, a generic breathing mask on a domed hood, for example, spans the mouth and the nose of the patient, and finally, a generic breathing mask has an inlet opening through which the patient to be supplied breathable air can be directed into the interior of the breathing mask. This can be done, for example, with the aid of a ventilator, which has a pump, which conveys a breathing air mixture, the so-called supply air, via an inlet line to this inlet opening of the breathing mask. The ventilator can typically be programmed or adjusted to produce so-called pump strokes to accommodate a desired respiratory rate and lung volume, ie fluctuations in the rate of flow or pressure of the supply air. Often the

Frequency of the pump strokes are set as well as their amplitude, so the pumped at each pump stroke volume of air.

Despite the technically sufficient supply of a patient with oxygen through the supply air, it can not be ruled out that some patients experience a so-called CO ₂ stress, which is perceived as shortness of breath or shortness of breath and can increase to panic. The reason for this is to assume that an individually given CO ₂ threshold in the respiratory air is exceeded for this patient. The CO ₂ content in the breathing air of a person causes the respiratory drive for the autonomous, spontaneous breathing of humans. In the inhaled supply air, the CO ₂ content is typically lower than in the exhaled exhaust air of humans. When a patient is connected to a ventilator assembly having an inlet conduit and a breathing mask, a certain volume of breathing gas is reciprocated as it inhales and exhales, then fresh respiratory gas, ie, fresh supply of air to the lungs the patient can get. If in this oscillating dead space volume CO ₂ back and forth increases to such an extent that the individual respiratory threshold of the patient in question is exceeded, the patient experiences a constant respiratory stimulus despite possibly sufficient oxygen saturation. This can manifest itself for the patient in the aforementioned, subjectively perceived dyspnoea, and since this is not alleviated by the further inhalation and exhalation, the patient's state of health can increase to a panic. The invention has for its object to improve a generic breathing mask to the effect that it supports the avoidance of a subjectively perceived lack of air in the artificial and especially in the assisted ventilation of a patient. Furthermore, the invention has for its object to provide a corresponding respiratory arrangement.

This object is achieved by a respiratory mask having the features of claim 1 and a ventilation arrangement according to claim 7. Advantageous embodiments are described in the subclaims.

In other words, the invention proposes two measures: On the one hand, an outlet opening in the breathing mask is provided in addition to the inlet opening so that the breathing air exhaled by the patient can be removed directly from the breathing mask and can not mix with the incoming air to be inhaled in the near future. The aforementioned accumulation in the respiratory air of the patient with CO ₂ can be significantly reduced in this way, as the back and forth breathed breathing air volume is significantly reduced. Presumably, the subjectively perceived shortness of breath can be avoided in most cases already, because even in spontaneous breathing there is a back-and-forth oscillating dead space volume in the respiratory tract of the human being, without this causing the sensation of a shortness of breath.

As a second measure, according to the proposal, the dead space volume can also be minimized by virtue of the fact that the hood is arched as little as possible, but rather is configured flat close to the face. The hood thus runs as close as possible to the patient's face. In this way, a volume within the breathing mask, namely between the breathing mask and the patient's face, is kept as low as possible. Also in this regard, therefore, according to the proposal can be kept as low as possible while breathing back and forth oscillating dead space. This will support that fresh air can be inhaled as soon as possible after the initial inhalation of this small dead space volume and accordingly the CO ₂ threshold value perceived as critical is not exceeded in the respiratory air of the patient and thus the emergence of respiratory distress or even panic can be avoided.

The present proposal assumes in this context that according to a first embodiment, the proposed breathing mask can be provided in different sizes, similar to clothing sizes, shoes u. Like. Is known, so that in each case the smallest or flatter respiratory mask for the patient in question can be used to keep the dead space within the breathing mask as low as possible.

According to a second embodiment, the breathing mask of the facial geometry can be adapted to also achieve this result of the smallest possible dead space volume. For example, adjustment straps may be provided on the outside of the breathing mask, as are known similarly to luggage such as backpacks, travel bags, and the like. Such adjustment straps can be adjusted to different effective lengths and keep this z. B. with the help of buckles or hook closures. In the case of this second embodiment, the respiratory mask has deformable surfaces, so that a respiratory mask, which initially has a certain basic shape, can be brought into a fit adapted to the respective patient by the deformation of these surfaces. For example, an adjustment belt can run over such a deformable surface, so that during tensioning of the adjustment belt, this surface is wrinkled and as a result the volume arched from the breathing mask is reduced.

Thus, the hood is designed according to the proposal flat close to the face, it can not be advantageous simply a convex, convex Contour, but rather a shape that has a face-like topography according to the covered section of a face. In this way, it can run as close as possible to the face surface of the patient, so that a minimal dead space within the breathing mask is made possible.

Should the respiratory mask for this reason lie comparatively over a large area with areas of the hood and not only with an outer edge forming an all-round contact area, then this airtight coverage of parts of the facial skin is acceptable in the interest of dead space reduction: the proposed respiratory mask is not intended for a longer ventilation time, but only for the so-called assisted ventilation, which may, for example, connect to a prolonged artificial respiration. During assisted ventilation, the previously sedated patient is slowly getting used to his own spontaneous ventilation.

On the one hand, the aforementioned outlet opening in the breathing mask can simply lead into the open, so that the exhaled exhaust air is released into the environment in a manner similar to natural spontaneous breathing. Alternatively, however, it may also be provided that the outlet opening adjoins an own outlet line or exhaust air line, similar to how the inlet opening is connected to an inlet line or air supply line of a respirator. By means of this so-called two-hose ventilation arrangement, the exhaled exhaust air can be supplied to the ventilator, so that, for example, sensors and an evaluation circuit within the ventilator allow conclusions to be drawn about the patient's condition based on the values measured in the exhaust air and, for example, enable a fully automatic adaptation of the ventilator in that the composition of the supply air supplied to the patient or the frequency or the amplitude of the mentioned pump strokes of the ventilator can be adjusted.

Advantageously, the Atennnnaske be designed so large that the hood covers both the mouth and the nostrils of the patient. In this way, the supply air supplied to the patient can not inadvertently escape through the respective other body opening in the face of the patient, but can reliably reach the lungs of the patient.

Advantageously, both the inlet opening and the outlet opening of the breathing mask can each have connection means, so that these two openings can be connected to a corresponding breathing air hose of a ventilator, for example to the aforementioned supply air line, with which the fresh air or supply air to the inlet opening of Breathing mask can reach, and so that a second hose as exhaust line can lead the exhaust air exhaled by the patient back through the outlet opening of the breathing mask to the ventilator.

Connecting means of the inlet opening can advantageously differ in color from the connection means of the outlet opening. In this way, the handling of the breathing mask and its integration into a ventilation arrangement, namely in particular with regard to the correct connection of the supply air line and the exhaust air line, facilitated. This is especially true if the connection means present on the respective lines are likewise configured differently in terms of color, so that connection means of the same coloration on the different lines on the one hand and on the respiratory mask on the other hand are always to be connected to one another.

In order to enable the desired air guidance during the ventilation of the patient, a switching valve can be arranged or can be arranged between the inlet opening and the outlet opening The inlet opening and the outlet opening of the breathing mask must each be provided with an automatic valve, which may for example be designed as check valves, so that they automatically open or close in adaptation to the respective pressure conditions. Alternatively, a deliberate control of the valves may be provided, for example by means of servomotors or similar actuators, these servomotors can also be controlled by the mentioned ventilator, if in the ventilator for this purpose the required electronic control and the corresponding electrical connections are provided ,

The proposed designed according respiratory mask or a two-hose ventilation arrangement, which can be implemented with a proposed breathing mask, allows the reduction or complete prevention of infection, since in the respiratory system virtually no mixing of supply and exhaust air occurs. In the two-hose system, additional units can be attached as desired, for example nebulizing units for moistening the respiratory air or for adding medicaments. The two-hose system allows optimal control of the supply air and exhaust air. All factory respiratory programs of a ventilator can be used. In all respiratory programs, the dead space is minimized by the proposed design respiratory mask and the mixture of expiration and inhaled supply air excluded. If, after prolonged, possibly medically induced unconsciousness, the patient subsequently has to learn to breathe properly, this learning process can be carried out without the CO2 stress mentioned above. In addition, it is not necessary to literally overstretch the lungs and to promote a particularly large supply air volume by means of particularly large amplitudes of the pump strokes, only to be able to supply sufficient fresh supply air in view of an undesirably large dead space volume. Particularly advantageously, a separate supply of CO _{2 can be} provided so that deliberately CO ₂ can be mixed into the supply air supplied to the patient in order to trigger a respiratory stimulus, namely to effect the so-called breath trigger. While in conventional ventilation arrangements with a comparatively large dead space volume, the CO ₂ value may increase undesirably high and may exceed a subjective threshold value of the respective patient, so that the patient then experiences a lack of air, in the case of a proposed breathing mask and the mentioned additional CO ₂ admixture Supply air, the CO ₂ value in the supply air to be lowered quickly when the patient due to the breath trigger sufficient spontaneous breathing begins, so that as a respiratory trigger required CO ₂ value may initially be provided, but also reduces the CO ₂ dosage just as quickly can be used to avoid the otherwise occurring CO ₂ stress in the patient.

Even if the proposed embodiment of a breathing mask in itself should be known from other fields of application, for example for sports or protection purposes, a respiratory system containing such a breathing mask and serving for the assisted ventilation of a patient constitutes a particularly advantageous embodiment of such a ventilation arrangement ,

The present proposal is explained below with reference to the purely schematic and not to scale drawings. It shows

1 shows a breathing mask on a head of a patient, and FIG. 2 shows a ventilation arrangement using a

Respiratory mask according to FIG. 1. 1 shows a respiratory mask 1 which is fastened to a head 2 of a patient which is indicated only in regions and serves to ventilate the patient. The breathing mask 1 extends like a hood over a nose 3 and a mouth 4 of the patient and abuts the face of the patient with a contact surface 5 which runs along the edge of the breathing mask 1.

The breathing mask 1 has an inlet opening 6 through which breathing air can be supplied to the patient. By connecting means 7, a breathing air hose 8 can be connected to the inlet opening 6 or removed from the inlet opening 6. Furthermore, the breathing mask 1 has an outlet opening 9, which likewise has connection means 7, wherein a second breathing air hose 8 is detachably connected to the outlet opening 9 by means of these connection means 7. The inputs and

Outlet openings 6 and 9 may differ in terms of their design and position of the embodiment shown purely by way of example. For example, they may be juxtaposed instead of stacked, or higher than shown in FIG.

The inlet opening 6 and the outlet opening 9 are designed differently in color, so that a veritable color code can be used: the colored air ducts 8 of different color can be correctly connected to the same-colored connection means 7 of the breathing mask 1 on the one hand, and on the other hand just as correctly to the same the same color connections of a pump 10 shown in Fig. 2 of a ventilator 1 1 are connected. The breathing air hose 8, which runs from the air outlet of the pump 10 to the inlet opening 6 of the breathing mask 1, thereby forms a supply air line of the respiratory arrangement shown in FIG. 2, wherein the other breathing air hose 8 as exhaust air line exhausts the air exhaled by the patient from the outlet opening 9 the breathing mask 1 to the pump 10 of the ventilator 1 1 leads. Notwithstanding the illustrated embodiment, the correct connection of the two Atemluftschlauche 8 to the pump 10 on the one hand and to the breathing mask 1 on the other hand also be ensured that the Atemluftschlauche 8 and the respective connection means 7 are not colored, but geometrically designed differently. In the simplest case, this different geometry can be due to different

Diameter of Atemluftschlauche 8 and the connection means

7 are effected. Because of this different geometry, for example, a breathing air hose 8, which serves as a supply air line and is to be connected to the inlet opening 6 of the breathing mask 1, are not connected to the outlet opening 9 of the breathing mask 1. At the pump 10 of the ventilator 1 1, the connections for the Atemluftschlauche 8 are also geometrically different, so that even in the area of the pump 10 a confusion when connecting the Atemluftschlauche

8 is excluded. In addition to this different geometry, which prevents misconnections, also the mentioned color code can be used, so that a particularly quick and easy handling of the breathing air hoses 8 is supported.

In Fig. 1 it can be seen that the breathing mask 1 comprises a hood 12 which is bounded by the contact surface 5 and bulges on the head 2 of the patient on the face 14. In a dashed line is indicated that the hood 12 has a basic shape in which the hood 12 includes a first, relatively large volume or bulges over a first, relatively large volume. In a solid line with respect to this basic shape, the fit of the hood 12 is shown. In this fit, the hood 12 extends closer to the face 14 of the patient and overarching a comparatively smaller, second volume compared to its basic shape. In this fit, the distance between the hood 12 and the face 14 of the patient compared to Reduced basic shape, so that the hood 12 of the breathing mask 1 includes an advantageously low volume.

The adjustment of the hood 12 between its basic shape and its fit is done with the aid of Verstellgurten 15, ie straps whose effective length can be changed by means of a known adjustment fitting. In the illustrated embodiment, it is provided that the adjustment straps 15 extend around the head 2 of the patient, so that the two ends of an adjustment belt 15 connect to the breathing mask 1 on different sides. In the case of the above adjustment belt 15, for example, its two ends connect to the hood 12 to the right and left of the nose 3. In the lower adjustment belt 15, the two ends of both sides of the inlet and outlet ports 6 and 9 close to the hood 12 at.

The adjusting straps 15 in each case close to the hood 12 from the outside, so that, firstly, the hood 12 with its contact surface 5 can lie as close as possible to the face 14 of the patient. Second, thus the Verstellgurte 15 and their respective adjustment fitting are accessible from the outside, so that corrections are possible while the hood 12 is applied to the face 14, and so that the changes in shape resulting from the changes of the hood 12 are immediately visible. As a result, a rapid adjustment of the shape of the breathing mask 1, in particular of the hood 12, in adaptation to the contour of the face 12 of the respective patient is made possible.

Thus, the adjustment of the hood 12 may cause a change - namely a reduction - of the hood 12 vaulted volume, the hood 12 has deformable surfaces 16. In the embodiment of Fig. 1, these deformable surfaces 16 form a fold which is parallel to the peripheral contour of the hood 12 and thus adjacent to the contact surface 5. In the illustrated embodiment, the deformation of the hood 12 is effected by the Verstellgurte 15, so that the force required for the deformation on the head 2 of the patient acts. Notwithstanding the illustrated embodiment can be provided that the clamping force is absorbed exclusively within the hood 12 itself, so that additional tethers the head 2 of the patient need only be applied under such a tension, which ensures the secure fit of the hood 12 on the face 14.

Therefore, deviating from the illustrated embodiment, the breathing mask 1 Verstellgurte 15 have that connect with its two ends on the same side of the hood 12, for example, each one near the outer edge, and on the other hand near the center line of the hood 12. So, for example, such Adjustment belt 15 on the one hand near the contact surface 5 to be attached to the hood 12, and with its other end, for example, where the hood 12 is located in front of the mouth 4 or the nose 3 or where in the illustrated embodiment, the two inlet and Auslassöffnun- gen 6 and 9 are located. In such an embodiment of the hood 12, the deformable surfaces 16 are typically located at a greater distance from the contact surface 5 and from the outer peripheral contour of the hood 12 than the deformable surfaces 16 shown in FIG.

Claims

Claims:

1 . Respiratory mask (1) for ventilating a patient,

with a contact surface (5) which can run round the patient's face (14)

and a domed hood (12), at the edge of which the contact surface (5) runs,

and with an inlet opening (6) for the respiratory air to be supplied to the patient,

characterized,

in that the hood (12) is configured flat close to the face, such that the breathing mask (1) encloses as small a volume as possible between the face (14) of the patient and the hood (12),

and in that the breathing mask (1) has an outlet opening (9) for the breathing air exhaled by the patient.

2. Respiratory mask according to claim 1,

characterized,

in that the hood (12) is designed to cover the mouth (4) and the nostrils of the patient.

3. Respiratory mask according to claim 1 or 2,

characterized,

in that both the inlet opening (6) and the outlet opening (9) are each provided with connection means (7) for connection to a respiratory air hose (8) of a ventilator (11).

4. Respiratory mask according to claim 3,

characterized,

in that the connection means (7) of the inlet opening (6) and the connection means (7) of the outlet opening (9) have a different color. Respiratory mask according to one of the preceding claims, characterized

in that the breathing mask (1) has deformable surfaces (16) in such a way that breathing mask (1) can be deformed from a basic shape by the deformation of these surfaces (16) into a fit adapted to the respective patient in the manner in which

that the breathing mask (1) in its fit has a vaulted volume of the breathing mask (1), which is less than the vaulted volume of the breathing mask (1) in its basic form.

Respiratory mask according to claim 5,

characterized,

that adjusting straps (15) are arranged on the outside of the breathing mask (1).

Ventilation arrangement

with a ventilator (1 1), which has a pump (10) for conveying a respiratory gas mixture called supply air,

an air supply line, which leads the supply air from the ventilator (1 1) to the inlet opening (6) of a breathing mask (1), which is designed according to one of the preceding claims,

and with an exhaust duct, which leads the exhaled by the patient, referred to as exhaust air breathing air to the ventilator (1 1).