WO2009089807A1

WO2009089807A1 - Low-noise application interface with integrated peep valve

Info

Publication number: WO2009089807A1
Application number: PCT/DE2008/001498
Authority: WO
Inventors: Frank Herrmann; Wolfgang Wedler; Florian Dietz; Henning Wortelen; Erik Hofbauer; Martin Eifler
Original assignee: Weinmann Geräte für Medizin GmbH + Co. KG
Priority date: 2008-01-15
Filing date: 2008-09-03
Publication date: 2009-07-23

Abstract

The device is a respiration device and comprises at least one mask body having an inside region and an outside region. It has at least one moulded mask that can be coupled to the mask body for sealing the device with respect to facial regions of a patient. The device is positioned on the head of the patient by way of fastening elements. In addition, a connection for a respiration tube for the supply of respiratory gas is provided. In the region of the respiration device, at least one controllable valve is disposed, which is configured for setting the internal mask pressure and the expiration flow. In order to seal it with respect to the facial regions of the patient, the moulded mask preferably has two sealing lips, which are in contact with the patient's skin.

Description

Low noise application interface with integrated PEEP valve

The invention relates to a device for ventilation, at least consisting of a mask body having an inner region and an outer region and at least one mask bead which can be coupled to the mask body for sealing the device against facial parts of a patient and fastening elements for positioning the device on the head of the patient and a connection for a breathing tube for the supply of respiratory gas.

So-called PEEP or exhalation valves are used, among other things, for the controlled exhalation when using ventilators. Such a valve is usually constructed by an arrangement of base body, membrane and a lid which clamps the membrane between the base body and cover. The main body is usually part of a patient circuit and is connected on one side with the ventilator and on the other side with the patient.

The main body has a valve seat, through which the expiration air can escape during expiration. In inspiration, however, this valve seat is already thought membrane or other sealing element - especially in the area of a bottom - closed. The closing of the valve seat is done by a back pressure, the control pressure, which is applied by the ventilator on the top of the sealing element. For this purpose, a nozzle is preferably attached to the lid, with which the valve can be connected via a pneumatic control line to the ventilator.

The state of the closed or the open valve always adjusts itself according to the forces acting on the sealing element, the balance of forces between the top and bottom of the sealing element. Factors influencing the balance of forces are the pressures on the top and bottom, as well as the respective surfaces of the bottom and top on which the pressure acts. This allows control of inspiration and expiration of mask-ventilated patients at high pressure levels.

The PEEP valves are usually used close to the patient because the dead space is to be kept as low as possible. In addition to the closed and completely open state of the valve, there are many intermediate states depending on the equilibrium of forces, which allow, for example, a constant flow through the valve. Instead of a valve, a defined orifice or exhalation system is used to leach CO2. To avoid massive leaks in the inspiration, however, this is so small that a temporary rebreathing into the tube system is possible.

For example, this constant flow is already used in sleep medicine via fixed openings for leaching CO2 during CPAP therapy.

In many cases it is helpful to maintain this so-called positive end-expiratory pressure, as this gives the alveoli a larger exchange surface for external respiration and subjects the upper respiratory tract to a certain splint, avoiding collapse and possible obstructive apnea phase , The closed state can also mean that the pressure on the underside is kept at a constant value, the PEEP level.

In addition, a so-called patient interface (PI) is necessary for the ventilation of a patient. This establishes the connection between the respirator, the device for supplying breathing gas, and the patient. These PIs are available in a variety of designs. For example, endotracheal tubes and tracheostoma are the invasive variant of a PIs, with a tube placed directly in the upper respiratory tract either via the mouth or via a tracheotomy.

In the non-invasive variants, nasal, oral and full-face masks have prevailed. These usually have a base body which has at least one sealing bead for optimal sealing of the PIS with the nose and / or the mouth. Furthermore, these PIs have holding elements with which the mask is stabilized by a headband or a hood on the head of the patient and the sealing bead is made by slight pressure to seal. For optimal positioning and stabilization of the mask during nocturnal movement is also an adjustable or fixed forehead support coupled with some masks to the basic body.

Basically, different constructive principles are realized for the above-explained principle of leaching of carbon dioxide. In the simplest case, a leakage opening is provided in the area of the respiratory mask or in close proximity to the respiratory mask, via which a leakage flow dependent on the respiratory pressure is constantly generated. To avoid undesirable large leaks, the leakage flow is predetermined so that not all the exhaled air can escape immediately from the hose system. Rather, at the beginning of the expiration, rebreathing into the tubing system is tolerated, but this rebreathed volume is then flushed out via the leak towards the end of the expiration. In time for the beginning of inspiration the system is again free of carbon dioxide-enriched air.

Such exhalation systems provide a very quiet overall system since the exhaled gas escapes from the system at relatively low flow velocities. High-quality pressure control can be realized because both inspiratory and expiratory pressures are controlled only by the blower used or by internal valves. It can also be realized a very simple device structure.

A disadvantage is to be considered that an expiratory pressure must be at least about four hPa to ensure a sufficiently safe rinsing of the carbon dioxide. At high inspiratory pressures, the leakage flow increases and thus an additional inspiratory patient flow must be generated by the blower. The size of the leakage port is a compromise between a desirable large carbon dioxide leaching and undesirable leakage flow.

Another variant for the leaching of carbon dioxide is the use of the patient-near exhalation valve already mentioned. This may be used in combination with a single tube system according to one embodiment. The valve is hereby closed in an inspiratory manner using a control pressure and completely or partially opened expiratory to an environment. Since the valve opening is intentionally specified only during the expiration, the opening cross-section can be dimensioned sufficiently large to prevent rebreathing in the hose system. In addition, a non-return valve can also be used. The required control pressure is generated by the ventilator and directed to the valve using a control tube.

Due to the controlled actuation of the valve, the pressure at the end of the expiration can be reduced to 0 hPa. An undesirable leakage flow in the inspiration phase is avoided. A disadvantage is to be considered that an additional mass is generated by the valve in the region of the patient connection, which hinders the patient. The effective leaching of carbon dioxide results in a high expiratory flow, producing outflow sounds in the immediate vicinity of the patient. End-expiratory pressure is difficult to control and thus varies. Also, whistling sounds are often generated by the valves and an expiratory flow measurement requires a relatively high effort.

An exhalation valve close to the patient can also be used far away from the patient or close to the device in connection with a two-hose system. The mode of operation is similar to the one-hose system already explained, but the use of a shortened control hose is made possible and the exhalation flow can be measured in a simple manner.

Particularly in the ventilation of infants is the dead space or the dead volume, which is exhaled in the expiration of the mask back to PEEP valve to keep as small as possible. This dead volume of the previous systems of mask and PEEP valve is not negligible with respect to CO2 rebreathing and may mean insufficient ventilation and oxygenation of the patient.

In addition, a chain of breathing tube, PEEP valve and mask is built up in the previous systems. This structure is comparatively stiff and heavy and thus represents an inconvenience to the patient as his movements are limited by this chain. In addition, the mask fixation is complicated by this chain and can cause pressure sores, since the harness must be tightened by the increased mass tighter attached to the patient's head.

In particular, at elevated ventilation pressures pressure points occur increasingly; Patients complain of partially bloody and sore nostrils. In these applications, attempts are made to meet the increased sealing requirements and avoidance of the To compensate for the patient unpleasant discharge of respiratory gas in the eye area and the resulting eye irritation by increased Maskenanpressung by additional tightening the Kopfbän- tion.

Also, the location of the expiratory opening, that is, when the sealing element lifts from the valve seat and releases a valve opening and releases the expired air to the expiration of the PEEP valve, important for the comfort of such a system. In many cases, the expired air is blown off directly on the naked skin of the patient, for example in the chest area. This leads to a partial hypothermia of these skin areas, but at least to an unpleasant sensation of the skin.

Even with vorächtlicher positioning of the expiratory opening, the position of this opening is difficult to control for a long time by the nocturnal movement.

In order to prevent patients from being disturbed by noise during their sleep and to minimize the noise level, in some patients a so-called goose gurgle is inserted into the breathing path, which is a tube for extending the distance between the head of the patient and the sound emitting patient valve. This of course increases the dead volume, which in turn affects CO2 rebreathing.

The reason lies in the size of the complete, linked system. The valve openings are usually limited in size (diameter <20mm). This has the consequence that high flows must be dissipated via these valve openings, which keep the noise emissions to an undesirable level; also, the exhalation resistance is increased.

Furthermore, the user of a patient system has to install a usually unmanageable number of different connectors, hoses and valves in the chain, which makes the correct and fast installation of such a chain much more difficult. Object of the present invention is to improve a device of the aforementioned type such that in a low-cost construction of the user comfort is increased.

This object is achieved in that at least one controllable valve is arranged in the region of the device for ventilation. In particular, it is provided that this valve is designed to set the mask internal pressure and / or the exhalation flow.

Inventive valves may be designed, for example, as a switchable PEEP valve or as a switchable exhalation system.

A switchable exhalation system is not used to control the mask pressure or a flow, but is essentially closed in an inspiratory manner and open expiratoryly.

The opening cross-section of the leakage is dimensioned such that the expiratory flow does not reach the outside completely, thus allowing a temporary rebreathing into the tube system.

The exhalation system is essentially closed during inspiration.

The opening cross-section is designed so that the expiratory pressure can be lowered to below 4 hPa, preferably to 1-2 hPa.

The idea according to the invention comprises a mask for ventilating a patient, which has an integrated valve, preferably a so-called PEEP valve, and thus represents a compact, low-noise and cost-effective solution for ventilation.

The invention provides a device for respiration at least consisting of a mask body with an inner region and an outer region and at least one attached to the mask body. pelbaren Maskenwulst for sealing the device with parts of the face of a patient and fasteners for positioning the device on the head of the patient and a connection for a breathing tube for supplying respiratory gas. In the area of the device for ventilation at least one controllable valve is arranged, which is used for adjustment the mask internal pressure and the exhalation flow.

Furthermore, the valve has at least one valve seat and a sealing element which is in operative contact with the valve seat, in at least one functional state, the sealing element permitting the flow of respiratory gas from the interior of the ventilating device in a first functional state and the flow in a second functional state of breathing gas from the interior of the device for ventilation substantially prevented.

Alternatively, the device according to the invention may be composed of a mask body having an inner region and an outer region, a mask bead coupled to the mask body for sealing the device with facial parts of a person, fastening elements for positioning the device on the head of the patient, a connection for a breathing tube, at least one Connection for a pneumatic control line, at least one sealing element, at least one valve seat and at least one expiration opening.

In further embodiments of the invention optionally at least one element from the following group can be integrated into the device: forehead support for further stabilization of the device on the patient's head, check valve, pressure drop point for taking off the mask internal pressure, pressure sensor, further sensors for determining ventilation conditions and patient parameters.

In further different embodiments of the invention, the valve seat can be mounted either in the area of the mask body, in the area of the forehead rest or on the breathing tube connection. In a further embodiment of the invention, the expiration opening is selected such that a low noise emission is produced. This can be done by a variety of methods:

For example, the opening gap can diffuse the expired air. In a further embodiment, the exhalation gap is selected so that it forms an elongate opening of less than 5 mm, preferably less than 1 mm, in unwound form.

Furthermore, in another embodiment of the invention, the pressure drop across the PI or via the PEEP valve at a flow rate of 60 l / min is less than 6 mbar.

In a further embodiment of the invention, the breathing hose connection has a standardized coupling - preferably ISO 5356 22 mm, male.

Another advantage of the invention is the minimization of necessary connectors and elements from the chain of a patient system around a separate PEEP valve / patient valve.

In addition, the stiffness, the weight, the overall length and the mass of the head of the patient of such a system is minimized by the reduction of components.

Another advantage of the invention is the directional position of the expiratory openings of the PEEP valve. Through the fixed mask, a targeted direction of discharge can be achieved, preferably away from the face and other areas of the patient's skin. Inadvertent blowing of body parts is to be avoided since the installation position is clearly defined and the expiration opening can not be obstructed so easily by a wrong position of the expiration opening. The directed blowing off of the expired air can take place via at least one channel. Preferably, multiple channels are contemplated to avoid high flows.

In a further embodiment of the invention, the valve opening and the expiration opening are chosen to be large, preferably the diameter of the base area of a cylinder spanning through a circular or oval valve seat and the corresponding sealing element is greater than 15 mm.

Another advantage of the invention is the reduction of the exhalation resistance by the largest possible valve opening.

Furthermore, reducing the distance between the mask and the PEEP valve significantly reduces the dead volume in relation to CO2 rebreathing - the distance between the mask and the separate PEEP valve is no longer present.

An improved mask bead form achieves a higher seal with less contact pressure. For this purpose, the mask bead has further sealing elements, sealing ribs, and a wider support, all of which touch at least a portion of the patient's face and seal the inside / interior of the mask from the outside.

The individual sealing ribs, at least one, preferably three, allow a slight leakage at higher pressures. However, the leakage gap, between the sealing rib and the patient, produces a very high resistance due to vortex formation, so that the leakage in the other sealing ribs, as far as possible, in particular the outflow of respiratory gas in the area of the eyes, is avoided. Another sealing bead ensures a comfortable resting of the mask on the head of the patient.

In order to minimize the noise as far as possible, the valve opening is formed by two Koni in a particularly preferred form of the invention. The first cone of solid na- be, the second cone may be approximated by one with an elastic element in its shape as a cone or formed by a conical sealing element. The valve opening is increased or reduced by moving on the axis of the sealing elements to each other.

Figurenbesehreibung

Fig. 1: Apparatus for ventilation

Fig. 2: Representation of a PI with control pressure connection

Fig. 3: Principle valve arrangement

FIG. 4: Improved membrane geometry for reducing the sound in a mask. FIG

Fig. 5: Arrangement of the PEEP valve in the connection for a breathing tube

Fig. 6: Maskenwulstanordnung

Fig. 7: Representation of a PI with PEEP valve

Fig. 8: section through PI and PEEP valve

Fig. 9: three views of the locking ring

Fig. 10: PEEP valve

Fig. 11: section through the PEEP valve

Fig. 12: Cover of the PEEP valve

13 shows another embodiment of a PEEP valve

Fig. 14: Side view of a PI with PEEP valve Fig. 15: a) membrane cut laterally b) membrane from above

16: a) side view of the base body of the PEEP valve b) top view of the base body of the PEEP valve

Fig. 1 shows the basic structure of a device for ventilation. In the area of a device housing (1) with control panel (2) and display (3) a respiratory gas pump is arranged in a device interior. A coupling hose (5) is connected via a coupling (4). To enable data transmission, the device housing (1) has an interface (8). A patient / PEEP valve (6) is arranged in the region of an extension of the connecting tube (5) facing away from the device housing (1). This can be connected to the connection for a breathing tube (11) or other elements such as a HME filter.

In addition, FIG. 1 shows a patient interface (7), which is designed as a nasal mask. A fixation in the region of a user's head can take place via a hood (10). On both sides of the device-side (1) and PI-side (7), fittings (not shown) are mounted to connect both sides to a pilot pressure line (12). This arrangement can be significantly improved by eliminating the patient valve in their handling with other benefits.

Fig. 2 shows a structure of a patient interface. On the mask body (7), a mask bead (13), a forehead support (14) and fastening elements can be coupled to connection points (15) provided for this purpose. In addition, this PI has a control pressure port (18) to which a connection hose to the ventilator can be attached. This arrangement passes the control pressure to the sealing element and puts them in motion and ensures a tight valve arrangement. An advantage of this arrangement is the ball joint (19) to call. This can be separated by twisting the locking ring (20) from the mask body (7). The closing ring also contains the valve Order with sealing element and the mask body (7) the valve seat. Both together form the valve opening and the exspiration opening, which can be chosen to be large in order to avoid the noises and a high expiratory resistance due to high flows.

Fig. 3 shows the principle of a valve assembly, as it can be used in a patient interface. The mask body (7) forms with a conical opening (25), the valve seat. The mask body (7) is limited by its two outer surfaces, the mask inner surface (21) and the mask outer surface (22). The direction of the cone can also be reversed, i. the larger opening can also be embedded in the mask inner surface (21).

In Fig. 3a, the control pressure on the top (26) of the sealing element (24) is brought. Depending on how large the balance of power, opens, raises or lowers the sealing element (24), which can be gummed for a better sealing property or otherwise coated.

In Fig. 3b, the sealing element (24) consists of a membrane or other flexible and stretchable material and seals by applying a control pressure via the control pressure connection (18) with the conical opening (25) of the mask body (7) the mask interior to the mask outer space from.

4 shows a valve arrangement with an improved membrane geometry. The valve seat (26) is formed by a round opening to the mask interior (27). The mask interior (27) is closed by lowering the membrane (28) onto the valve seat (26). By applying a control pressure via the control pressure connection (18), the force from the mask internal pressure can be counteracted as a result. The advantage of the novel membrane shape, which does not have a flat surface at its center, but rather a surface which conically tapers counter to the direction of flow (30), is the avoidance of dead water regions in the expiratory flow. Dead water areas are sources of turbulence and noise developments. The expiratory flow is directed out of the mask interior (27) to the outside into the atmosphere (29). The opening (29) is shown here by way of example; However, it can take many forms: annular gap, many small channels, etc.

The shape of the membrane can be held in shape by hard mold elements (31) which are applied to the membrane surface, for example by gluing, welding. Even at high flow rates, the membrane retains its shape and, thanks to a very light material of the molded element, its dynamic reactivity. This improved application is preferably accomplished in a mask, but may be applied to other applications, such as in a standard PEEP or exhalation valve.

5 shows a partial view of the patient interface, in which the PEEP valve is integrated into the connection (11) for a breathing tube. In order not to breathe back the exhaled air into the breathing tube, a check valve (32) is integrated. The valve seat may have either a concave (34), convex (33) or straight shape (shown mirrored for simplicity of illustration). In all three forms, the sealing element (24) is pressed by means of the control pressure via the control pressure connection (18) against the valve seat (26), thus achieving a seal. The advantage of this arrangement is the long expiratory gap or the long gap (35, 36) between the sealing element (24) and the valve seat (26), through which the expiration flow (30) reaches the atmosphere. The openings (37) make the connection from the mask interior (27) to the valve arrangement.

An improved mask bead geometry (41) is shown in FIG. There is located between the mask interior (27) and atmosphere (38) at least one sealing rib (39). The number of sealing ribs can be increased depending on the application. This has a positive effect on the sealing between the spaces (27, 38) via the pressing of the mask bead (41) on the upper skin surface. surface (40). Another advantage is the lower contact force between the bead (41) and the skin surface (40), so that bruises are largely avoided, even if the user sets a higher ventilation pressure.

Fig. 7 shows a patient interface (7), which is designed as a mask. A fixation in the region of a user's head can take place via a headband (10).

On the mask body (7) is a mask bead (13), an adjustable forehead support (14) and via fastening elements at designated connection points (15) a headband (10) coupled. The connecting piece of a control pressure line (18) is integrated in the cover.

In addition, this PI has a control pressure port (18) to which a connection hose to the ventilator can be attached. This arrangement relays the control pressure to the sealing element of the PEEP valve (6) and sets it in motion and ensures a tight valve arrangement. An advantage of this arrangement is the integration of the PEEP valve (6) into the patient interface (7). The PEEP valve takes in this embodiment, the place of the ball joint (19) of Figure 2 a. The PEEP valve can be separated as a unit from the mask body (7) by twisting off the closing element (20), which is designed here as a closing ring. The locking ring (20) is located on the PEEP valve and is rotatably connected to the PEEP valve. Also, the hose connection (11) is part of the PEEP valve.

Fig. 8 shows a section through the mask body (7) attached to the PEEP valve. It can be seen that the control pressure port (18) is constructed as an integral part of the lid (41). The lid is formed on its inside so that it partially receives the membrane (24) and fixed in the assembled state. According to the invention, a PEEP valve integrated into the mask comprises at least one main body, a membrane (24) and a lid, so that the lid is removed from the main body can be to clean the membrane (24), for example.

The interface according to the invention for PI is neutral, the PEEP valve is then plugged in and holds by friction / terminals, or designed individually and is then designed as a catch or bayonet.

Fig. 9 shows three views of the locking ring (20). It can be seen in the region of the outer circumference of the locking ring arranged operating projections (43) which are formed symmetrically on opposite sides of the locking ring. The locking ring is used for releasably fixing the PEEP valve to the mask body. For this purpose, the locking ring devices for fixing * (45), here three bayonet teeth, which are arranged symmetrically along the circumference.

Fig. 9 c shows the lower portion of the locking ring (20), which forms the point of contact with the Pi and has a circumferential insertion bevel (46) and bayonet teeth (45).

A circumferential slot (47), between the bayonet teeth (45) and the insertion bevel (46), ensures easy installation. In addition, the interface is sealed in the assembled state, in that a, serving as a recording, web-shaped counter-structure (centering ring) (48) of the PI engages in the slot (47).

The bayonet teeth engage in corresponding counter-structures (not shown) implemented in the PI. By rotating the locking ring (20) engage the bayonet teeth (45) in the counter-structure.

To install the PEEP valve on the Pi, the locking ring (20) is positioned in the area of the centering ring (48) of the PI. Due to the arrangement of the mountings for the bayonet teeth in the PI and a corresponding arrangement of the bayonet teeth, the bayonet teeth can only be inserted in a single predetermined position. tion into the recesses in the PI. This provides an encoding.

After insertion of the bayonet teeth in the recesses, a rotation of the locking ring (20) relative to the PI takes place such that the latching is effective. The latching is preferably formed as a projection (nose) (44) of the locking ring (20), which engages in a corresponding recess of the PI.

In principle, however, a reverse training is conceivable. An elastic locking of the latching is supported by the fact that the locking ring (20) is formed of a relatively soft material, so that the soft projection of the locking ring (20) is inserted into the recess of the PI and also out of this again herausdrehbar.

After a final assembly process rotation of the locking ring (20) relative to the PI assembly process is completed. The end position of the closing ring (20) is predetermined by a lateral stop of the bayonet teeth (45) on the recesses in the PI. The bayonet teeth (45) engage behind the recesses, so that the overall arrangement withstands tensile loads. Dismantle the PEEP valve in reverse order as described above for installation.

The construction of the locking ring (20) causes the locking ring (20) without play and possibly can be placed under pretension on the PI. This has the consequence that the outflow of the respiratory gas does not take place via the interface between the PEEP valve (closing ring) and PI, but .only via the PEEP valve.

In order to realize a simple separability of PEEP valve and PI, further embodiments of the interface are conceivable. Thus, this can be designed as a snap connection, as a ring snap connection or snap hook segments, wherein the Entrie- Gelung by lateral pressure on the body or simple Abhebein the Grundkδrpers done. An easy-to-disconnect interface for connecting PI and PEEP valves offers many advantages. For example, the patient may disconnect the PEEP valve (with attached tubing) from the PI to go to the toilet. The PEEP valve can also be cleaned or rebuilt separately.

In another embodiment, there are two interfaces for separating the PEEP valve from the PI in the region of the PEEP valve; one between the base body and the base body of the PEEP valve and another between the base body of the PEEP valve and PI. A rotation of 360 ° between the base body and PI or between the base body and a base ring, allows the patient a large range of motion, characterized in that the hose connection is thus rotatable.

The rotatability between the base body and base body of the PEEP valve is realized by a ring snap connection. In the direction of the hose connection, a larger undercut is realized in order to prevent levering of the snap connection by forces on the hose. As an alternative to the ring snap connection, the design of several snap segments is envisaged. In a further embodiment, two lateral snap hooks are realized. By lateral pressure on the housing, the release of the snap hook is achieved.

An interface between the main body of the PEEP valve and the, the PEEP valve-carrying, connecting piece provides manufacturing technology has the advantage that two geometrically relatively simple components are to be produced, which are connected via a common interface. In addition, the PEEP valve as an assembly would be separable from the connecting piece and easier to clean and replace.

According to the invention, the modular construction of a PI takes place via uniform interfaces, so that by replacing a component or an assembly the PI can be replaced by a CPAP mask with integrated Exhalation system can be converted into a respiratory mask with integrated PEEP valve. Depending on the required ventilation situation, the basic body of the PI can be equipped with various exhalation systems or PEEP valves.

Fig. 10 shows the PEEP valve (6) without connected hoses. This consists externally of a Ventilgrundkδrper (42) and a cover (41) with the connection piece for the control tube (18). Between both a sealing element (24), for example a membrane, supported (not shown). The hose connection (11) connects the PEEP valve via an interface with the breathing tube and with the PI. About the connecting piece (19) pressure and / or flow are measured.

The valve body (42) of the integrated PEEP valve contains a pressure measuring connection (19), a hose connection (11), a receptacle for the membrane (24) and interfaces to the cover and patient interface. The pressure measuring connection in the base body of the valve is preferably arranged such that the pressure measuring connection (19) is positioned laterally from the hose connection (11). Particularly preferred pressure measuring connection and hose connection are arranged so that both are substantially parallel to each other.

This offers the advantage of a common hose laying parallel to each other. For example, the pressure measuring tube runs along the breathing tube. Preferably, the control tube runs along the breathing tube.

The angle between the axes of hose connection and PEEP control connection is preferably such that the connections are parallel to one another. The axes of hose connection and PEEP control connection form a plane.

The diameter of the hose connection (11) is in the range 22 mm, the diameter of the pressure measuring connection (19) and control connection (18) are in the range 4 - 7 mm. The PEEP pressure can be lowered to 0 and can be individually regulated. In Fig. 11 a section through the PEEP valve (6) is shown. This has a valve main body (42), a return diaphragm (49), a control diaphragm (24) and two conical surfaces (50), which can form a connection between the valve main body (42) and the second body (9).

Furthermore, cones (50) are attached to the two ends of the connection (11), which connect the patient interface and the ventilator via a breathing tube to the valve on the one hand. Further, a bayonet lock (51) is shown. The pins for the bayonet lock, in an array around the cylinder, 3x120 ° or 4x90 °, to ensure a uniform surface pressure between the two bodies of the valve and the elastic membrane.

The inspiratory flow (52) passes via the non-return membrane (49) through the valve in the direction of the patient interface. The control valve or the control diaphragm (24) closes with the basic body and prevents outflow of the inspiratory air. The control pressure in the control line is directed to the control pressure port (18) and can spread over the face of the control diaphragm. Due to the balance of forces, applied by the internal and control pressure, and due to the area ratio between the upper and lower control diaphragm surface closes the control diaphragm. The control pressure is adjusted so that the membrane releases the exhalation gap when the mask internal pressure is about twice greater than the control pressure.

In expiration (53), the air from the check valve diaphragm (49) is prevented from entering the breathing tube (not shown) so that at a given control pressure the control diaphragm opens and the air can escape via the expiratory port (36).

12 a and b show the lid (41) from above (a) and from below (b) with its recess for the bayonet closure (54) and the control pressure port (18) through which the control pressure can be applied to the control valve. The spring (55), together with the opposing surface on the base body (not shown), clamps the membrane between these two bodies so that it is firmly positioned.

FIG. 13 shows a further embodiment of a PEEP valve with a cover (41) which has a control pressure connection (18). Between the base body (42) and cover (41) is the control diaphragm (24), which is held by a bayonet lock and the two bodies (41, 42). The elasticity of the membrane makes the bayonet closure possible. The lid is turned on the base body. This is done by a spring-surface connection on the outer edge of the arrangement.

In this embodiment, a flowmeter / flow measurement channel (56) is integrated into the assembly. Likewise, there is a membrane receptacle for a check valve membrane (49) within the arrangement.

FIG. 14 shows a side view of a PI designed as a ventilation mask with integrated PEEP valve. Due to the functional integration according to the invention, the PEEP valve is part of the mask. In the side view of the quite large-dimensioned exhalation gap (36) of the PEEP valve (6) and the course of the exhaled air (53) can be clearly seen. The cross section of the air outlet openings of the exhalation gap (36) is greater than 50 mm ² , preferably the cross section is greater than 100 mm ² , more preferably in the range 150 mm ² or larger. A large cross section causes a low flow, which is associated with a low noise.

The discharge of the exhaled air (53) takes place due to the geometry of the exhalation gap (36) to the side and along the tube down. The height of the PEEP valve above the PI (mask body) is less than about 70 mm, preferably less than 60 mm, and more preferably less than 55 mm. The mask body is a maximum of 70 mm high, preferably a maximum of 55 mm high. The total construction height of PEEP valve and PI, in order to be comfortable for the patient still in use, preferably less than 140 mm, more preferably less than 100 mm.

Fig. 15 a) shows a section through the membrane, wherein the underside of the membrane facing upward, b) shows the membrane from above.

The membrane is constructed of an elastomer and substantially round. The membrane (24) has two functions: a check valve seal (57) which is exposed to the control pressure, and a mounting gasket (58) which sealingly connects the lid and base body of the valve. Both functional parts of the membrane are connected to each other via the bead (59). These two functions are united by the elasticity and geometry of the membrane. In addition, the necessary force in a bayonet closure contact pressure of the lid is absorbed by the elasticity of the membrane. In the absence of these elastic elements, the lid is loose and can be easily solved by shaking. The bead (59) is at least twice thinner than the non-return valve seal (57) and the mounting gasket (58) because of the material thickness. Preferably, the bead (59) is less than 1 mm. Preferably, the check valve seal (57) and the mounting gasket (58) are over 1.5 mm thick. The flexible bead is also rounded. Preferably, the side of the bead is rounded, which is in contact with the exhaled air. The flexibility allows the bead (59) of the check valve seal (57) between the two positions open - closed to change.

Due to the properties of the selected membrane (24), a high control accuracy with low noise emission of the PEEP valve can be achieved. For this purpose, the membrane has a Shore hardness in the range of small Shore 30 on the A scale. Prefers The Shore hardness of the membrane is in the range Shore 5 to Shore 30 on the A scale.

The noise emission of the integrated PEPP valve according to the invention is in the region 32 dBa at a ventilation pressure of 35 hPa.

Fig. 16 a) shows a side view of the base body (42) of the PEEP valve with the exhalation gap (36). The exhalation flow (30) comes laterally from the PEEP valve and is directed away from the patient's face.

Fig. 16 b) shows a plan view of the Basisiskδrper (42) of the PEEP valve. Here, the substantially round valve seat (26) can be seen. This has a material thickness of at least 1 mm in thickness. The upper edge of the valve seat (26) is flat, in other embodiments, the upper edge of the valve seat (26) may also be rounded. The opening cross-section, which is limited by the valve seat, is preferably greater than 10 mm, particularly preferably 15 mm or larger. When the pressure of the exhalation gas (30) is about twice the control pressure, the check valve seal (57) of the diaphragm lifts off the valve seat. The exhaled air flows along the bead (59) into the exhaled gas space (60) of the PEEP valve and from there via the outlet opening (36) into the ambient air. The exhaled air, which comes from the mask interior, flows approximately perpendicular to the membrane (24) and is deflected along the bead by about 180 °. In the region of the exhalation gas space (60) and / or the exhalation opening (36), the direction of the exhaled air is deflected again by 40-90 °, and flows in the direction of the tube.

As is apparent from Fig. 16 a), the axes of the diaphragm (24) and the valve seat are tilted with respect to the axis of the mask body. Preferably around 25 °.

The arrangement of the membrane (24) laterally on the main body of the valve is chosen so that the axis of the mask body, the axis the diaphragm (24) and the axis of the hose connection (11) each form angles between 60 and 120 ° to each other.

In another embodiment, the arrangement of the membrane (24) on the base body of the valve is such that the axis of the mask body, the axis of the membrane (24) and the axis of the hose connection lie approximately in one plane.

Claims

Patent claims

1. A device for ventilation, at least consisting of a patient interface and fasteners for positioning the device on the head of the patient and a connection for a breathing tube for the supply of breathing gas, characterized in that in the region of the device for ventilation at least one controllable valve is arranged ,

2. Device according to claim 1, characterized in that the valve is integrally formed at least partially integrally with the mask body.

3. A device according to claim 1, characterized in that the valve is integrally formed at least partially integral with the connection for the supply of breathing gas.

4. The device according to claim 1, characterized in that the valve or parts thereof is detachably connected to the patient interface or the connection for the supply of breathing gas.

5. Device according to one of the preceding claims, characterized in that the valve is designed as a PEEP valve.

6. Device according to one of the preceding claims, characterized in that the valve has at least one valve seat and with the valve seat, in at least one functional state, standing in operative contact sealing element, wherein the sealing element in a first functional state, the flow of breathing gas from the interior of the Device for outdoor allows and in a second functional state substantially prevents the flow of breathing gas from the interior of the device to the outside.

7. Device according to one of the preceding claims, characterized in that the opening cross-section of the leakage is dimensioned such that the expiratory flow is not completely in the outdoor area, but a temporary rebreathing is made possible in the hose system.

8. Device according to one of the preceding claims, characterized in that the axis of the Steuerleitungs- connection of the lid, the axis of the pressure measuring connection of the base body and / or the axis of the connection for the supply of breathing gas are arranged substantially parallel to each other.

9. Device according to one of the preceding claims, characterized in that the axis of the Steuerleitungs- connection of the lid and the axis of the connection for the supply of breathing gas are arranged substantially in one plane.

10. Device according to one of the preceding claims, characterized in that the base body is detachably attached to the patient interface or to a closing element.

11. The device according to claim 10, characterized in that the compound is designed as a friction / clamping connection.

12. The device according to claim 10, characterized in that the connection is designed as a bayonet connection or as a latching.

13. The apparatus according to claim 10 to 12, characterized in that the connection is a latching connection with at least one snap element and that the connection by an at least partially attached release bevel or by the deformation or dislocation of at least partial areas of the base body and / or the closing element again can be separated.

14. The device according to at least one of claims 17 to 20, characterized in that the undercut of the snap connection is larger, at least in one sub-segment than in at least one other sub-segment.

15. Device according to one of the preceding claims, characterized in that the base body is rotatably mounted relative to the mask body.

16. Device according to one of the preceding claims, characterized in that the cross section of the at least one expiration opening of the main body of the valve in sum is at least 50 mm ² .

17. Device according to one of the preceding claims, characterized in that the cross section of the at least one expiration opening of the main body of the valve in sum is at least 150 mm ² .

18. Device according to one of the preceding claims, characterized in that the at least one Exspirationsöff- tion of the body at least partially substantially in the direction of the axis of the terminal for supplying breathing gas or at least partially in an angular range of up to 100 ° to the axis of the terminal is arranged for the supply of breathing gas.

19. Device according to one of the preceding claims, characterized in that the expiratory resistance is less than 6 mbar at a flow rate of 60 l / min.

20. Device according to one of the preceding claims, characterized in that the device for ventilation is modular so constructed that the device for ventilation by replacing a component or assembly of a standard ventilation mask with integrated exhalation system and / or by a standard Respiratory mask without integrated exhalation system can be converted into a mask with controllable valve.

21. The device according to claim 1 to 20, characterized in that the valve consists of at least a lid, a sealing element and a base body.

22. Device according to one of the preceding claims, characterized in that the valve for adjusting the internal mask pressure and / or for setting the exhalation flow is formed.

23. Device according to one of the preceding claims, characterized in that the valve includes a sealing element, which allows a flow of breathing gas from the interior of the device to the outside in response to a control signal of a ventilator.

24. Device according to one of the preceding claims, characterized in that the switchable exhalation system during inspiration is substantially closed and exspiratorisch at least temporarily open.

25. Device according to one of the preceding claims, characterized in that the lid of the valve has a connection for a control line.

26. Device according to one of the preceding claims, characterized in that the base body of the valve has a pressure measuring connection.

27. The device according to claim 26, characterized in that the pressure measuring port is recessed relative to the base body.