阅读说明：本技术 具有用于容纳压力传感器的设备的用于呼吸设备的呼气阀装置 (Expiratory valve device for breathing apparatus with an apparatus for accommodating a pressure sensor ) 是由 卡洛琳·弗兰克 费利克斯·布赖特鲁克 于 2018-05-16 设计创作，主要内容包括：一种用于对患者进行人工呼吸的呼吸设备的呼气阀装置(22)沿着呼气流动方向(E)是可穿流的并且包括：-上游的呼吸气体通道(54),所述上游的呼吸气体通道沿着第一通道路径(K1)延伸并且与所述呼气管路的从所述患者起的部段连接或者能够连接,-下游的呼吸气体通道(58),所述下游的呼吸气体通道沿着第二通道路径(K2)延伸并且与呼吸气体排出部(U)连接或者能够连接,-具有阀体(64)和阀座(66)的阀组件(63),所述阀组件设置在所述上游的呼吸气体通道和所述下游的呼吸气体通道(54,58)之间,使得所述阀组件在所述上游的呼吸气体通道(54)中相对于所述下游的呼吸气体通道(58)存在预定的第一呼吸气体过压时允许从所述上游的呼吸气体通道(54)进入到所述下游的呼吸气体通道(58)中的呼出的呼吸气体流,并且所述阀组件在所述下游的呼吸气体通道(58)中相对于所述上游的呼吸气体通道(54)存在预定的第二呼吸气体过压时阻断从所述下游的呼吸气体通道(58)进入所述上游的呼吸气体通道(54)中的气体流。根据本发明提出,所述呼气阀装置(22)具有旁通室(74),所述旁通室与所述上游的呼吸气体通道(54)流体连通并且从所述上游的呼吸气体通道(54)起延伸到所述下游的呼吸气体通道(58)的区域中并且在该处构成用于耦联气体压力传感器(80)。(An exhalation valve arrangement (22) of a breathing apparatus for artificially breathing a patient is traversable along an exhalation flow direction (E) and comprises: -an upstream breathing gas channel (54) which extends along a first channel path (K1) and is connected or connectable with a section of the breathing gas line from the patient, -a downstream breathing gas channel (58) which extends along a second channel path (K2) and is connected or connectable with a breathing gas outlet (U), -a valve assembly (63) having a valve body (64) and a valve seat (66) which is arranged between the upstream and downstream breathing gas channels (54, 58) in such a way that it allows exhaled breathing gas from the upstream breathing gas channel (54) into the downstream breathing gas channel (58) when a predetermined first breathing gas overpressure exists in the upstream breathing gas channel (54) relative to the downstream breathing gas channel (58) A flow of fluid, and the valve assembly blocks the flow of gas from the downstream breathing gas channel (58) into the upstream breathing gas channel (54) when a predetermined second breathing gas overpressure exists in the downstream breathing gas channel (58) relative to the upstream breathing gas channel (54). According to the invention, the exhalation valve device (22) has a bypass chamber (74) which is in fluid communication with the upstream breathing gas channel (54) and extends from the upstream breathing gas channel (54) into the region of the downstream breathing gas channel (58) and forms a coupling for a gas pressure sensor (80) there.)

1. An exhalation valve arrangement (22; 122) for an exhalation line of a breathing apparatus (10) for artificial respiration of a patient, wherein the exhalation valve arrangement (22; 122) is traversable along an exhalation flow direction (E) and comprises:

an upstream breathing gas channel (54; 154) which extends along a first channel path (K1) and which is connected or connectable to a section (42) of the breathing line from the patient,

a downstream breathing gas channel (58; 158) which extends along a second channel path (K2) and which is connected or connectable with a breathing gas outlet (U), for example the external environment (U),

-a valve assembly (63; 163) having a valve body (64; 164) and a valve seat (66; 166), which is arranged between the upstream and downstream breathing gas channels (54, 58; 154, 158) such that it allows an exhaled breathing gas flow from the upstream breathing gas channel (54; 154) into the downstream breathing gas channel (58; 158) when a predetermined first breathing gas overpressure in the upstream breathing gas channel (54; 154) relative to the downstream breathing gas channel (58; 158) exists and blocks a gas flow from the downstream breathing gas channel (58; 158) into the upstream breathing gas channel (54; 154) when a predetermined second breathing gas overpressure in the downstream breathing gas channel (58; 158) relative to the upstream breathing gas channel (54; 154),

characterized in that the exhalation valve device (22; 122) has a bypass chamber (74; 174) which is in fluid communication with the upstream breathing gas channel (54; 154) and extends from the upstream breathing gas channel (54; 154) into the region of the downstream breathing gas channel (58; 158) and forms a region for coupling a gas pressure sensor (80) thereto.

2. An exhalation valve device (22; 122) according to claim 1,

characterized in that a sensor coupling wall section (56 a; 156a) of a wall bounding the bypass chamber (74; 174) has a sensor coupling opening (82; 182) which passes through the sensor coupling wall section (56 a; 156a) of the bypass chamber (74; 174), wherein the sensor coupling opening (82; 182) is closed by an openable closure (88; 188).

3. An exhalation valve device (22; 122) according to claim 2,

characterized in that the closure (88; 188) comprises a pierceable closure membrane (84; 184) which is formed from a softer material than the material of the surrounding sensor coupling wall section (56 a; 156 a).

4. An exhalation valve device (22; 122) according to claim 3,

characterized in that the closure membrane (84; 184) is formed from an elastomer, in particular from natural rubber or silicone rubber.

5. An exhalation valve device (22; 122) according to claim 3 or 4,

characterized in that the closure membrane (84; 184) has a normal region (84a) and a weakened region (84 b; 184b) of material different from the normal region (84a), in which weakened region the tear strength of the closure membrane (84; 184) is reduced compared to the normal region (84 a).

6. An exhalation valve device (22; 122) according to claim 5,

characterized in that the closing membrane (84; 184) has a smaller material thickness in the weakened material region (84 b; 184b) than in the normal region (84 a).

7. An exhalation valve device (22; 122) according to claim 5 or 6,

characterized in that the material-weakening regions (84 b; 184b) are formed in a pattern in the closure membrane (84; 184).

8. An exhalation valve device (22; 122) according to any one of the preceding claims,

characterized in that a section of the wall (56; 156) enclosing the downstream breathing gas channel forms the sensor-coupled wall section (56 a; 156a) of the bypass chamber (74; 174).

9. An exhalation valve device (22; 122) according to any one of the preceding claims,

characterized in that the bypass chamber (74; 174) extends in the downstream breathing gas channel (58; 158).

10. An exhalation valve device (22; 122) according to claim 9,

characterized in that a separating wall (76; 176) separating the bypass chamber (74; 174) from the downstream breathing gas channel (58; 158) is formed in one piece with a wall (56; 156) which encloses the downstream breathing gas channel (58; 158).

11. An exhalation valve device (22; 122) according to claim 10,

characterized in that a first exhalation tube (52; 152) which encloses the upstream breathing gas channel (54; 154), a second exhalation tube (56; 156) which encloses the downstream breathing gas channel (58; 158) and a separating wall (76; 176) which separates the bypass chamber (74; 174) from the downstream breathing gas channel (58; 158) are formed in one piece as a channel component (50; 150).

12. An exhalation valve device (22; 122) according to any one of the preceding claims,

characterized in that the valve body (64; 164) is a membrane valve body (64; 164) covering a longitudinal end of the upstream breathing gas channel (54; 154), and the valve seat (66; 166) is formed on the longitudinal end of the upstream breathing gas channel (54; 154).

13. An exhalation valve device (22; 122) according to claim 12 when dependent on claim 3,

characterized in that the diaphragm valve body (64; 164) and the closing diaphragm (84; 184) are arranged with diaphragm faces parallel to each other at the exhalation valve assembly (22; 122).

14. An exhalation valve device (22; 122) according to claim 13,

characterized in that the closing diaphragm (84; 184) is arranged orthogonally to the direction of action of gravity (g) in the ready-to-set exhalation valve device (22; 122), wherein the outer side of the closing diaphragm pointing away from the bypass chamber (74; 174) points opposite to the direction of action of gravity (g).

15. Breathing apparatus (10) for the artificial respiration of a patient with a breathing gas supply device (15), from which an inspiration line leads to a patient breathing interface (31), from which expiration line in turn leads to a breathing gas outlet (U), for example the ambient atmosphere (U),

characterized in that an exhalation valve arrangement (22; 122) according to one of the preceding claims is provided in the exhalation line, wherein an upstream breathing gas channel (54; 154) is connected to the patient breathing interface (31) via a section (42) of the exhalation line for the transmission of exhaled breathing gas from the patient breathing interface (31).

Technical Field

The invention relates to an exhalation valve device for an exhalation line of a breathing apparatus for artificially breathing a patient, wherein the exhalation valve device is traversable in an exhalation flow direction and comprises:

an upstream breathing gas channel which extends along the first channel path and is connected or connectable with a section of the exhalation line which emanates from the patient,

a downstream breathing gas channel extending along a second channel path and connected or connectable with a breathing gas discharge, such as the external environment,

a valve assembly having a valve body and a valve seat, which valve assembly is arranged between the upstream breathing gas channel and the downstream breathing gas channel such that the valve assembly allows a flow of breathing gas of the expired breath from the upstream breathing gas channel into the downstream breathing gas channel when a predetermined first breathing gas overpressure in the upstream breathing gas channel with respect to the downstream breathing gas channel exists, and blocks a flow of gas from the downstream breathing gas channel into the upstream breathing gas channel when a predetermined second breathing gas overpressure in the downstream breathing gas channel with respect to the upstream breathing gas channel exists.

Background

The exhalation valve device, as described hereinabove, is used in a breathing apparatus for at least assisted artificial respiration of a patient in order to generate a flow of breathing gas corresponding in direction to the natural breathing cycle. Breathing apparatuses generally have an inhalation line and an exhalation line with an inhalation valve arrangement arranged in the inhalation line and an exhalation valve arrangement arranged in the exhalation line. The inhalation valve means allows substantially only inspiratory respiratory airflow to the patient when macroscopically observing the process. The exhalation valve device, when viewed macroscopically as such, permits substantially only a flow of exhaled breath in a direction away from the patient's exhalation flow.

When viewing the exhalation valve device in more detail, other processes important to the breathing process can take place there via a pure opening and closing, for example maintaining a residual flow port at the valve assembly towards the end of the exhalation process, in order to ensure that a Positive End Expiratory Pressure (PEEP) is maintained in the exhalation line and thus also in the lungs of the patient in fluid communication therewith "positive end expiratory pressure”)。

The predetermined overpressure of breathing gas, i.e. the overpressure of the first and second breathing gas, mentioned at the outset, need not be identical in magnitude nor lie at the same breathing gas pressure level.

Since the downstream breathing gas channel is open in most known exhalation valve devices towards the external environment as the breathing gas outlet of the breathing apparatus carrying the exhalation valve device, the breathing gas in the downstream breathing gas channel is usually forced by an ambient pressure from its longitudinal end which is open towards the external environment. The first breathing gas overpressure is therefore generally an overpressure in the upstream breathing gas channel with respect to the pressure of the external environment, as is characteristic of an exhalation process, while the second breathing gas overpressure is an overpressure in the ambient pressure with respect to the lower pressure present in the upstream breathing gas channel, as is characteristic of an inhalation process, for example.

The statement that the valve assembly permits an expiratory flow in the expiratory flow direction from the upstream breathing gas channel toward the downstream breathing gas channel in the presence of a first breathing gas overpressure and prevents a flow in the opposite direction in the presence of a second predetermined breathing gas overpressure should not exclude the presence of an operating state of the valve assembly in a pressure ratio deviating from the first and second predetermined breathing gas overpressures, which operating state is not mentioned at the beginning of the application. It is only decisive that the mentioned operating state of the valve assembly is present when the mentioned overpressure of breathing gas is present.

The first and second predetermined breathing gas pressures can be a breathing gas overpressure value range, respectively, in order to enable safe breathing for different patients and patient types.

The terms "upstream" and "downstream" at the exhalation valve device relate to structurally unambiguously identifiable exhalation flow directions at the exhalation valve device, respectively, which exhalation flow directions are realized through the exhalation valve device in the presence of a predetermined first breathing gas pressure.

An exhalation valve device of this type is known from WO 02/076544 a 1.

For the most precise possible functional control of the exhalation valve device, in particular in order to be able to set as precisely as possible the PEEP caused by the exhalation valve device at the end of the exhalation process, it is advantageous to identify the breathing gas pressure present upstream of the valve assembly.

In the exhalation line of a breathing apparatus, a flow sensor operating according to the differential pressure principle is usually provided at its proximal end, via which flow sensor information about the pressure of the breathing gas in the exhalation line is also available due to its functional principle. However, structural errors between the measurement site of the breathing gas pressure at the proximal end of the breathing gas line and the measurement site close in the valve assembly, however upstream thereof, affect the feasibility, for example due to the elasticity of the exhalation hose forming the exhalation line up to the exhalation valve arrangement, so that the pressure measurement at the proximal end of the breathing gas line is less efficient for the breathing gas pressure in the distal region of the breathing gas line that is actually present in the breathing gas channel upstream of the valve assembly.

Disclosure of Invention

The object of the present invention is therefore to improve the exhalation valve device initially proposed as follows: the exhalation valve device enables pressure detection in the breathing gas of the exhalation upstream of the valve assembly in a small distance from the valve assembly. This is often structurally difficult, as the breathing gas passage upstream of the exhalation valve assembly is often not directly accessible, depending on the configuration. This is because it is surrounded by an annular chamber, generally radially outwardly, in the direction of expiratory flow, immediately adjacent the valve assembly.

According to the invention, the mentioned object is achieved by an exhalation valve device of the initially mentioned type having a bypass chamber which is in fluid communication with the upstream breathing gas channel and extends from the upstream breathing gas channel into the region of the downstream breathing gas channel and is formed there for coupling with a gas pressure sensor.

Since the downstream breathing gas channel is generally open towards the external environment of the exhalation valve device or breathing apparatus as a whole, the downstream breathing gas channel can in many cases be accessed more simply than the upstream breathing gas channel. The bypass chamber, which extends into the downstream region of the breathing gas channel, is therefore likewise accessible simply, to be precise also in the state already installed in the breathing apparatus. The bypass chamber thus enables a relatively strongly hidden or installed measurement-wise inlet to the upstream breathing gas channel and makes the breathing gas pressure prevailing there detectable for a gas pressure sensor coupled to the bypass chamber. The bypass chamber is formed exclusively for coupling the gas pressure sensor.

Preferably, the bypass chamber is connected at its connection region, for example at one longitudinal end thereof, to the upstream breathing gas channel and opens, for example, into said breathing gas channel, and forms a coupling region, for example at the opposite longitudinal end region thereof, for coupling the gas pressure sensor. The bypass chamber is designed for coupling the pressure sensor in a simple but reliably functioning embodiment, which can be realized by: the sensor coupling wall section of the wall bounding the bypass chamber has a sensor coupling opening which passes through the sensor coupling wall section of the bypass chamber. The sensor coupling opening thus allows access from the outside to the interior of the bypass chamber.

In this case, it is advantageously possible for the respective user, for example a care-giver or responsible doctor, to decide: if it is absolutely necessary or at least desirable to detect the breathing gas pressure in the breathing gas channel upstream in the vicinity of the valve assembly when the sensor coupling opening is closed by a closure which can optionally be opened in order to couple the gas pressure sensor to the bypass chamber in terms of measurement. That is, there are also simpler breathing apparatuses in which the detection of the pressure of the breathing gas upstream is not carried out and which are not equipped to process such a pressure detection signal in terms of signal. In such a breathing apparatus, the exhalation valve device according to the invention can also be used in that the sensor coupling opening is then simply kept closed by a closure element.

In principle, it can be provided that a closure for preventing accidental opening and thus malfunction of the breathing apparatus requires a relatively complex opening movement in order to open the sensor coupling opening and make it accessible for coupling the gas pressure sensor in terms of measurement. The closure part can be screwed off, for example, from the sensor coupling opening, wherein the closure part preferably has to be rotated through several revolutions before it is released from the closed position to such an extent that it can be removed from the sensor coupling opening in order to prevent the sensor coupling opening from being accidentally opened.

However, it is often very critical when using medical life support devices that the time factor is such that the exhalation valve assembly should be insertable onto the breathing apparatus as quickly as possible. In accordance with a preferred further development of the invention, it is therefore proposed that the closure element comprises a pierceable closure membrane which is formed from a material which is softer than the material of the surrounding sensor coupling wall section. Such softer materials can be elastomers, in particular thermoplastic elastomers (TPE). It has proven advantageous here primarily to use natural rubber or silicone rubber. The edge region of the closure part surrounding the closure membrane can then be bonded, for example, to the boundary region of the sensor coupling wall section surrounding the sensor coupling opening, by vulcanization, by two-component injection molding and/or form-fitting connection.

Alternatively or additionally, the closure can be connected with an additional component which, in the state of readiness of the exhalation valve device, interacts with the sensor coupling wall section. Such an additional component can be a plug, for example, which closes an opening which is inevitably produced during the production of the bypass chamber and which is not a sensor coupling opening. The additional component can have a complementary opening and be provided in or on the exhalation valve assembly in the following manner: the sensor coupling opening and the supplementary opening at least overlap. Preferably, the two openings are aligned with each other to provide sufficient coupling surfaces to couple the gas pressure sensor in terms of measurement. The closure element can also comprise a closure membrane, the edge region of which enclosing the closure membrane can be connected to the enclosing region of the attachment element enclosing the additional opening, in a manner different from the above-described method of operation, again using the principle of action already mentioned above. The additional component can be made, for example, from polybutylene terephthalate or polyethylene terephthalate.

The components forming the downstream breathing gas channel, in particular the channel components which will be mentioned below, can be formed from polyester, in particular copolyester, or polycarbonate. Other materials are not excluded.

Such a soft elastic membrane has the advantage not only that it can be pierced quickly so that the exhalation valve assembly is quickly ready for use. A further advantage is also that the soft elastic membrane formed in this way, like a diaphragm, can sealingly surround the piercing element, so that, after piercing the sealing membrane, a faulty flow of gas between the bypass chamber, and thus the breathing gas duct upstream, and the environment outside the bypass chamber is excluded. Preferably, the closing diaphragm is pierced by a conduit connecting the bypass chamber in terms of measurement with the pressure sensor.

"connected in terms of measurement" or "coupled in terms of measurement" mean for the purposes of the present application: the gas pressure sensor thus coupled can detect the pressure in the bypass chamber by connection or coupling. Since the bypass chamber is in turn in fluid communication with the upstream breathing gas channel, the gas pressure sensor on the coupling is therefore able to detect the pressure of the breathing gas in the upstream breathing gas channel.

Furthermore, it is advantageous for the operational safety of the exhalation valve device that the risk of loosening of components and component sections can be ruled out. Thereby, no component sections from the exhalation valve device can reach the patient and be inhaled unintentionally by the patient. Although this risk is virtually absent in the exhalation line, the risk of tearing or detaching the membrane components when the closure membrane is pierced can be kept small or even completely ruled out in the following manner: the closure membrane has a normal region and a weakened region of material different from the normal region in which the tear strength of the membrane is reduced compared to the normal region.

It can thus be ensured that the closure membrane tears open in a defined manner when it is pierced. The sealing action of the membrane after piercing is ensured not only by tearing in a defined manner or by breaking the closure membrane in a defined manner, since the membrane shape of the closure membrane present after piercing is known and predictable. Furthermore, the use of a coupling tube with a relatively large diameter is thus achieved by means of a sealing diaphragm provided at the desired tear-open point or the desired tear-open region, which has a positive effect on the accuracy of the measurement results of the gas pressure sensor coupled to such a large coupling tube or coupling hose. Without a weakened area of material, the larger the object that pierces the film, the less predictable the tear characteristics of the film.

The weakened material region can be formed in a simple manner as follows: the closing membrane has a smaller material thickness in the weakened material region than in the normal region.

The smaller material thickness can be caused by the cut and/or by a stamp in the closure membrane. The cut-out obviously does not extend completely through the material of the closure membrane in the thickness direction, but is only a partial cut-out over a part of the thickness extension of the closure membrane.

In order to be able to bring about a defined and also regular tear-open behavior of the closure membrane, the weakened material regions are preferably designed in a pattern in the closure membrane, in which the orientation of the object penetrating the closure membrane, for example a coupling hose or a coupling tube, is not critical.

The material-weakened area can, for example, have one ring or a plurality of concentric rings, and/or the material-weakened area can comprise at least two lines which intersect in the center of the diaphragm and divide the closed diaphragm into as identical diaphragm-face sections as possible. In the preferred case of a circular closed membrane, the wires run along a diameter.

Despite the formation of the bypass chamber, the exhalation valve device can be inserted into existing breathing apparatuses, and its simple and space-saving design can be achieved in the following manner: the section of the wall enclosing the downstream breathing gas channel forms the sensor-coupled wall section of the bypass chamber. That is, the bypass chamber can then extend in the downstream breathing gas duct, so that the downstream breathing gas duct can have an outer dimension and an outer shape, as do the same exhalation valve device without the bypass chamber.

The exhalation valve device can thus be manufactured in a known shape and in known dimensions. This is also possible in that no large chamber volume is required for the bypass chamber, and the downstream breathing gas channel generally always has a large flow cross section which enables a reduction of the cross section of the bypass chamber without this significantly interfering with the function of the downstream breathing gas channel and thus of the exhalation valve device.

In the region of the sensor-coupled wall section, the downstream breathing gas channel is formed with a bypass chamber located therein, which, as already mentioned above, is not double-walled but only single-walled for weight saving. Since the bypass chamber has a smaller cross-sectional area when viewed in a sectional plane which is orthogonal to the second channel path, a portion of the partition wall which delimits the bypass chamber towards the radial outside runs spaced apart from the channel wall which delimits the breathing gas channel downstream towards the radial outside.

In order to reduce the risk that component sections in the exhalation valve device that may come loose back into an unpredictable path in the breathing gas circuit come loose or come apart, it is preferred that the exhalation valve device is manufactured as one piece around as much as possible. With regard to the bypass chamber which is important for the invention, this preferably means: the partition wall separating the bypass chamber from the downstream breathing gas channel in the downstream breathing gas channel is formed in one piece with the channel wall enclosing the downstream breathing gas channel.

In order to further ensure as high a combination of components as possible, it is advantageous to reduce as far as possible the possible engagement sites in the exhalation valve assembly. Thus, according to a refinement, it can be provided that the first expiration duct which encloses the upstream breathing gas channel, the second expiration duct which encloses the downstream breathing gas channel and the partition wall which separates the bypass chamber from the downstream breathing gas channel are formed in one piece as a channel component.

Such a channel member can be manufactured in one piece, for example in an injection moulding process, for example by using a core and a slide. Preferably, the breathing gas channel not only upstream but also downstream extends along a channel axis which is a straight line of the first or second channel path, respectively. Preferably, the first and second channel axes are at an angle to each other. Also preferably, imaginary elongated channel axes intersect each other. This not only achieves a spatially compact configuration of the channel member but also: the valve body is designed as a diaphragm valve body which covers the longitudinal end of the upstream breathing gas channel and this enables the valve seat to be designed at the longitudinal end of the upstream breathing gas channel.

The upstream breathing gas channel can be surrounded radially outwards by an annular chamber at least in its longitudinal end which approaches the valve assembly in the direction of the expiratory flow, from which the downstream breathing gas channel branches off. The annular chamber is then located in terms of flow between the upstream and downstream breathing gas channels in the direction of the expiratory flow. The diaphragm valve body can be fixed to a wall enclosing the annular chamber.

For a simple, yet reliable visual check of the exhalation valve device, it is furthermore advantageous if the diaphragm valve body and the closure diaphragm are arranged on the exhalation valve device with diaphragm faces parallel to one another.

Typically, a diaphragm valve body is incorporated into a breathing apparatus as follows: the diaphragm valve body is preloaded by gravity towards the valve seat, i.e. towards the closed position, in the position of readiness of the exhalation valve assembly in the breathing apparatus. Furthermore, a device of the breathing apparatus is usually present on the side of the diaphragm valve body facing away from the breathing gas channel, which device is designed to apply a predetermined or settable force to the diaphragm valve body acting in the closing direction. This can be a mechanical device, such as a push rod or the like, or it can be a pneumatic device, such as a pressure-loadable gas container, by means of which the diaphragm valve body forms part of the limiting interface.

The exhalation valve device is therefore usually introduced into the housing of the breathing apparatus against the direction of action of gravity into its ready position.

Advantageously, a coupling tube for coupling a gas pressure sensor is already fixedly arranged in the housing of the breathing apparatus. When the closing diaphragm is arranged orthogonally to the direction of action of gravity in the ready-to-place exhalation valve device, the gas pressure sensor can already be coupled in an advantageously simple manner to the upstream breathing gas channel with the exhalation valve device installed in the breathing apparatus, wherein its outer side facing away from the bypass chamber points counter to the direction of action of gravity. When the exhalation valve device is introduced into the housing of the breathing apparatus, it is therefore possible to pass the closing diaphragm during the introduction movement by a coupling tube fixed to the housing.

The invention also relates to a breathing apparatus for the artificial respiration of a patient, having a breathing gas supply device, from which an inspiration line leads to a patient breathing interface, from which an expiration line leads to a breathing gas outlet, for example the ambient atmosphere. In order to achieve the effects and advantages mentioned above, according to the invention, it is proposed that an exhalation valve device, such as the exhalation valve device described and improved above, is provided in the exhalation line. In this case, the upstream breathing gas channel is connected to the patient breathing interface via a section of the breathing line in order to convey the exhaled breathing gas from the patient breathing interface.

The construction of the breathing apparatus described above in the description of the exhalation valve device according to the invention is a development according to the invention of the breathing apparatus mentioned in the above paragraph.

Drawings

The invention is explained in detail below with reference to the figures. The figures show:

figure 1 shows a breathing apparatus according to an embodiment of the invention with an exhalation valve device,

figure 2 shows a perspective view of a first embodiment according to the invention of the exhalation valve assembly of the present application,

figure 3 shows a top view of a closure in the form of a closing diaphragm of the sensor coupling opening at the first embodiment of the exhalation valve assembly,

figure 4 shows a longitudinal section through the exhalation valve assembly of figure 2 in a section plane containing the first and second channel paths,

figure 5 shows a detail of the longitudinal section of figure 4 with the intact closure diaphragm and with the coupling tube arranged outside the bypass chamber at a distance from the closure diaphragm,

figure 6 shows a view of figure 5 with a coupling tube passing through the sensor coupling opening after piercing the closure membrane,

figure 7 shows a longitudinal section through a second embodiment of the expiratory valve device of the present application, corresponding to the view of figure 2, an

Fig. 8 shows a detail of the longitudinal section of fig. 7 with the closure membrane intact.

Detailed Description

In order to illustrate the exhalation valve device according to the present invention, a breathing apparatus using the exhalation valve device will first be described with reference to fig. 1.

In fig. 1, a breathing apparatus is generally indicated at 10. The breathing apparatus 10 is used in the illustrated example for artificially breathing a human patient 12. The breathing apparatus 10 can be accommodated as a mobile breathing apparatus 10 on a rollable stand 13.

The breathing apparatus 10 has a housing 14 in which, since the opaque housing material is not visible from the outside, a pressure-changing device 16 and a control device 18 can be accommodated.

The pressure changing device 16 is designed in a manner known per se and has a breathing gas supply system 15 in the form of a pump, a compressor or a fan, which can be actuated in a variable-load manner in each case in order to change the pressure of the breathing gas introduced as well as to introduce it into the breathing apparatus. The breathing gas supply device 15 can alternatively also be formed by a pressure vessel, which can be connected to the housing 14 of the breathing device 10. The pressure changing device 16 can have a breathing gas supply system 15 and, if appropriate, additionally, or alternatively in the case of a pressurized gas reservoir as breathing gas supply system, a pressure reducing valve or the like. Furthermore, the breathing apparatus 10 has, in a manner known per se, an inhalation valve arrangement 20 and an exhalation valve arrangement 22, which are covered in fig. 1 by the housing 14 of the breathing apparatus 10. The exhalation valve assembly 22 is an exhalation valve assembly according to the present invention.

The control device 18 is typically implemented as a computer or microprocessor. The control device comprises a data memory device, not shown in fig. 1, in order to store data required for the operation of the breathing apparatus 10 and to be able to be called up when required. The storage device can also be located outside the housing 14 during network operation and be connected to the control device 18 via a data transmission connection. The data transmission connection can be formed by a cable line or a radio line. However, in order to prevent disturbances of the data transmission connection from possibly having an effect on the operation of the breathing apparatus 10, the memory device is preferably integrated into the control device 18 or at least accommodated in the same housing 14 as the control device.

For the purpose of inputting data into the breathing apparatus 10 or, more precisely, into the control device 18, the breathing apparatus 10 has a data input 24, which is represented in the example shown in fig. 1 by a keyboard. Alternatively or in addition to the keyboard shown, the control device 18 can also receive data via various data inputs, for example via a network line, a radio line or via a sensor interface 26, which will be discussed in more detail below.

For outputting the data to the therapist performing the treatment, the breathing apparatus 10 can have an output device, in the example shown a screen.

For the purpose of artificial respiration, the patient 12 is connected to the breathing apparatus 10, more precisely to the pressure changing device 16 in the housing 14, via a breathing line arrangement 30. The patient 12 is for this purpose inserted with an endotracheal tube 31.

Outside the housing 14, the breathing line arrangement 30 has an intake hose 32, via which fresh breathing gas can be conducted from the breathing gas source 15 and the pressure changing device 16 into the lungs of the patient 12. The inspiratory hose 32 can be interrupted and has a first inspiratory hose 34 and a second inspiratory hose 36, between which a control device 38 can be provided for the targeted humidification and optionally also temperature regulation of the fresh breathing gas delivered to the patient 12. The regulating device 38 can be connected to an external liquid reservoir 40, via which water for humidification or a drug for, for example, anti-inflammation or widening the breathing path can be supplied to the breathing gas. When using the present breathing apparatus 10 as an anesthetic breathing apparatus, it is possible in this way to controllably deliver volatile anesthetic agents to the patient 12 via the breathing apparatus 10. The regulating device 38 ensures that the fresh breathing gas is delivered to the patient 12 with a predetermined moisture content, if necessary with the addition of a pharmaceutical aerosol, and at a predetermined temperature.

The breathing circuit arrangement 30 has, in addition to the inhalation valve arrangement 20 already mentioned, an exhalation valve arrangement 22 and, in addition, an exhalation hose 42, via which the metabolized breathing gas is blown out of the lungs of the patient 12 into the atmosphere.

Inhalation hose 32 is coupled to inhalation valve assembly 20 and exhalation hose 42 is coupled to exhalation valve assembly 22. Possible operating controls for the valve devices 20 and 22 are also carried out by the control device 18, in addition to the self-control by breathing.

During a breathing cycle, the exhalation valve arrangement 22 is first closed and the inhalation valve arrangement 20 is opened for the duration of the inhalation phase, so that fresh breathing gas can be conducted from the housing 14 to the patient 12 only via the inhalation hose 32. The flow of fresh breathing gas is brought about by a targeted increase in the pressure of the breathing gas by means of the pressure changing device 16. Due to the pressure increase, fresh breathing gas flows into the lungs of the patient 12 and there inflates the body region in the vicinity of the lungs, i.e. in particular the chest, against the elasticity of the individual of the body part in the vicinity of the lungs. Thereby, the gas pressure in the interior of the lungs of the patient 12 is also increased.

At the end of the inspiration phase, the inspiration valve means 20 is closed and the expiration valve means 22 is opened. The exhalation phase is initiated. Due to the increased gas pressure of the breathing gas located in the lungs of the patient 12 up to the end of the inspiration phase, this breathing gas flows through the expiration valve arrangement 22 into the atmosphere after opening, wherein the gas pressure in the lungs of the patient 12 drops with the continued flow duration. If the gas pressure in the lungs 12 reaches the Positive End Expiratory Pressure (PEEP) set at the breathing apparatus 10, i.e. a pressure slightly above atmospheric pressure, the expiratory phase is ended and immediately followed by another breathing cycle.

During the inspiration phase, a so-called tidal volume of breathing, i.e. the volume of breathing gas per breath, is delivered to the patient 12. The tidal volume of breaths is multiplied by the number of breath cycles per minute, i.e. by the breathing frequency, resulting in the minute volume of the artificial breath currently performed.

Preferably, the breathing apparatus 10, in particular the control device 18, is designed to determine breathing operating parameters which characterize the breathing operation of the breathing apparatus 10 in order to ensure that the breathing operation is matched as optimally as possible to the respective patient 12 to be breathed at each point in time. It is particularly advantageous for the determination of one or more breathing operating parameters to be carried out with the aid of the breathing frequency, so that for each breathing cycle current breathing operating parameters can be provided which are thus optimally adapted to the patient 12.

To this end, the breathing apparatus 10 is connected in a data-transmitting manner to one or more sensors which monitor the state of the patient and/or the operation of the breathing apparatus.

One of these sensors is a proximal flow sensor 44 which is arranged on the side of the Y-connector 45 which is close to the patient 12 and detects there the breathing gas flow which is present in the breathing line arrangement 30. The flow sensor 44 can be coupled to the data input 26 of the control device 18 by means of a sensor line arrangement 46. The sensor line arrangement 46 can, but need not, include an electrical signal transmission line. The sensor line arrangement can likewise have hose lines which transmit the gas pressure prevailing in the flow direction on both sides of the flow sensor 44 to the data input 26, where it is quantified by the pressure sensor 27. The flow sensor 44 is preferably a flow sensor operating on the differential pressure principle, but can also be a flow sensor operating on other physical principles of action.

A further flow sensor 48 is provided in the housing 14, which is referred to as a distal flow sensor 48 because of its greater distance from the patient 12 compared to the proximal flow sensor 44.

In fig. 2, a perspective view of the exhalation valve assembly 22 is shown removed from the housing 14 of the breathing apparatus 10. A longitudinal section of the exhalation valve assembly 22 is shown roughly in fig. 4.

The exhalation valve assembly 22 will be explained in detail below with reference to fig. 2 and 4.

The exhalation valve assembly 22 comprises a channel component which is produced essentially in one piece by injection molding and which has an upstream exhalation tube 52 which delimits the upstream breathing gas channel 54 radially to the outside and a downstream exhalation tube 56 which encloses a downstream breathing gas channel 58. The upstream breathing gas channel 54 extends along a first channel path K1, which is designed as a straight channel axis, and the downstream breathing gas channel 58 extends along a second channel path, which is likewise designed as a straight channel path K2.

The exhalation valve assembly 22 is traversed by the exhaled breathing gas in the exhalation flow direction E.

The downstream end section of the upstream expiration duct 52 is surrounded radially outwardly by an annular chamber duct 60, which delimits an annular chamber 62 radially outwardly. The annular chamber 62 is delimited radially inwardly by the upstream breathing gas pipe 52.

The exhalation valve assembly 22 has, in the region of the end downstream of the upstream exhalation tube 52, a valve assembly 63 (see fig. 4) which has a diaphragm valve body 64 and also a valve seat 66.

The diaphragm valve body 64 is held at the longitudinal end of the annular chamber tube 60 close to the downstream longitudinal end of the upstream expiration duct 52 and has, on its side 64b facing the upstream expiration duct 52, a valve seat surface by means of which the diaphragm valve body 64 can be seated on a valve seat 66 formed at the downstream longitudinal end of the upstream expiration duct 52.

In the ready-to-install position of the exhalation valve arrangement 22, the first channel path K1 runs parallel to the direction of action of gravity g, so that the diaphragm valve body 64 is preloaded by gravity into the closed position shown in fig. 4, in which the diaphragm valve body 64 rests on the valve seat 66 and fluidically separates the upstream breathing gas channel 54 from the downstream breathing gas channel 58.

The downstream breathing gas channel 58 opens into the external environment U. The external environment forms the breathing gas outlet of the breathing apparatus 10 and the exhalation valve assembly 22. The exhaled breathing gas thus has an ambient pressure from the downstream longitudinal end of the downstream exhalation tube 56.

If, as is typical for exhalation processes, an overpressure with respect to the ambient pressure prevails in the upstream breathing gas duct 54, wherein the ambient pressure also acts on the side 64a of the diaphragm valve body 64 facing away from the valve seat 66, the diaphragm valve body 64 is lifted from the valve seat 66 essentially along the first duct path K1, so that an annular gap 68 is produced between the side 64b of the diaphragm valve body 64 facing the valve seat 66 and the valve seat 66, the gap height of which gap is still 0 in fig. 4.

Thus, when the valve assembly 63 is open, the exhaled breathing gas flows in a manner driven by the relative overpressure in the upstream breathing gas channel 54 through the valve gap 68 into the annular chamber 62 and from there into the downstream breathing gas channel 58 and finally into the external environment U.

For better orientation it should be noted that the upstream expiration duct 52 has in its upstream longitudinal end region opposite the valve seat 66 a connection structure 53 by means of which the upstream expiration duct 52 and thus the expiration valve arrangement 22 can be connected with the expiration hose 42 in fig. 1.

The relative overpressure present in the upstream breathing gas channel 54 with respect to the gas pressure in the downstream breathing gas channel 58 decreases as the duration of the exhalation process increases. It is important here to maintain a Positive End Expiratory Pressure (PEEP) in order to provide a positive counter pressure to the patient's lungs until the end of the expiration process in order to prevent atrophy of the patient's lungs in artificial respiration.

The PEEP setting is achieved by setting the gap height of the valve gap 68. To this end, the exhalation valve system 22 comprises an actuator 70 (shown only in fig. 4), for example an electromagnetic actuator 70, from which a push rod 72 can be moved out of the control device 18 of the breathing apparatus 10 and can be moved in again.

The push rod 72 can engage with its longitudinal end remote from the remaining actuator 70 and driving forward in the removal movement against the rigid plate 65 in the diaphragm valve body 64, so that the diaphragm valve body 64 can be moved in a defined manner by the actuator 70 toward the valve seat 66. The lifting of the diaphragm valve body 64 from the valve seat 66 is not performed by the push rod 72 or the actuator 70, since only a pressure force, but not a tensile force, can be transmitted as a result of the abutting engagement between the push rod 72 and the rigid plate 65.

In order to set the positive end expiratory pressure accurately by means of the actuator 70, it is advantageous to know the expiratory gas pressure that is present in the upstream breathing gas channel 54 as close as possible to the valve seat 66.

To this end, the exhalation valve assembly 22 according to the invention has a bypass chamber 74 (see fig. 4) within the downstream exhalation tube 56. The bypass chamber 74 is in fluid flow communication at its longitudinal end 74a with the upstream breathing gas passage 54. Thus, the same gas pressure is also present in the bypass chamber 74 as at the downstream end of the upstream breathing gas channel 54.

A dividing wall 76 separating the bypass chamber from the downstream breathing gas passage 58 is preferably formed integrally with the exhalation tubes 52 and 56 and the annular chamber tube 60. A compact device is thereby obtained, from which no component or component section can be detached.

Due to the integral formation of the partition wall 76 with the channel member 50, the opening of the bypass chamber 74, which is occupied by the slider during the manufacture in terms of injection molding, must be closed off by the plug 78 at the finished exhalation valve assembly 22. The plug 78 can be connected to the remaining channel member 50 with a friction fit, either by bonding or by welding.

The sensor coupling wall section 56a of the downstream exhalation tube 56, which in the installed state of the exhalation valve device 22 preferably points counter to the direction of action of gravity g, is designed for the measured coupling of a gas pressure sensor 80 (see fig. 4), which surrounds both the downstream breathing gas duct 58 and the bypass chamber 74 at the location where the sensor coupling wall section 56a is designed.

In fig. 4 and 6, the gas pressure sensor 80 is shown coupled measurably to the bypass chamber and thus to the upstream breathing gas duct 54, and in fig. 2, 3 and 5 the exhalation valve device 22 is only designed for coupling to the gas pressure sensor, but is shown without such a coupling being realized.

It follows that the exhalation valve arrangement 22 can be operated not only by means of the gas pressure sensor 80 which is coupled in terms of measurement via the bypass chamber 74 to the upstream breathing gas channel 54, but also without such a coupling.

For simplicity of production, a sensor coupling opening 82 is formed in the sensor coupling wall section 56a, which for simplicity of production is preferably formed with a flat outer surface on its side pointing radially away from the downstream breathing gas duct 58 and away from the bypass chamber 74, said sensor coupling opening passing completely through the sensor coupling wall section 56a in the thickness direction of the downstream exhalation tube 56. The sensor coupling opening 82 is first closed by a closure diaphragm 84 (see fig. 2, 3 and 5). However, the closing membrane 84 can be pierced in a simple manner so that the bypass chamber 74 is accessible from the outside environment U. Fig. 4 and 6, for example, show how a closing diaphragm 84, which originally covers a sensor coupling opening 82, is pierced by a coupling tube 81, which connects the inner region of the bypass chamber 74 to the gas pressure sensor 80 in terms of measurement.

As can be seen in fig. 3, the closure membrane 84 can be enclosed by an edge region 86 which is connected integrally to the closure membrane 84 and is connected to the sensor coupling wall section 56a in a non-releasable manner, for example by adhesive bonding. The closure diaphragm 84 and the edge section 86 then form a closure 88 which closes the sensor coupling opening 82.

As can be seen in particular in fig. 5, the edge section 86 of the closure element 88 is bonded to a boundary region 90 of the sensor coupling wall section 56a which surrounds the sensor coupling opening 82.

In the unopened state, the membrane 84 has normal regions 84a and weakened regions of material 84b having a smaller membrane wall thickness than the normal regions 84 a.

The weakened material region 84b, as exemplarily shown in fig. 3, comprises two diametrical lines intersecting each other at right angles, along which the film 84 has a smaller wall thickness than in the regions on both sides of the line. Thus, the normal region 84a is divided into four equally sized sub-regions, wherein each sub-region occupies one quadrant of the, for example, circular membrane 84. Each diametrical line of weakened material area 84b here divides the membrane 84 into approximately two equally sized face areas.

By forming the weakened area 84b of material, the film 84 tears along the line of the weakened area 84b of material forming the desired tear location when pierced by the coupling tube 81, as shown in fig. 4 to 6, such that the film 84 opens in a predetermined manner when pierced by means of the coupling tube 81.

As is shown in fig. 6, both the edge region 86 of the closure element 88 and the membrane rest can seal the coupling tube 81 radially outward at the location of the passed-through sensor coupling opening 82 in order to prevent a gas flow error between the interior of the bypass chamber 74 and the external environment U and thus to prevent a distortion of the gas pressure in the upstream breathing gas channel 54 determined by the gas pressure sensor 80.

Figure 7 shows a second embodiment of the expiratory valve device according to the invention, in the same perspective and position of the section plane as figure 2. The components and component sections that are identical to those of the first embodiment and have the same function are provided in the second embodiment with the same reference numerals as in the first embodiment of fig. 2 to 6, but increased by the number 100.

The second embodiment is described next only with respect to its differences from the first embodiment, and reference is otherwise made to the description of the first embodiment with respect to the explanation of the second embodiment of fig. 7 and 8.

In the second embodiment shown in fig. 7 and 8, a closure 188 (see fig. 8) is provided on the plug 178 as an additional component that cooperates with the sensor coupling wall section 156 a. The plug 178 here has a complementary opening 192 at a fastening leg projecting from the plug head 178a, for example a fastening bushing 178b which is enclosed in a closed manner, which overlaps the sensor coupling opening 182, preferably a coaxial opening axis which passes centrally through the respective opening 182 and 192. The edge region 186 enclosing the closure membrane 184 is connected in the present second exemplary embodiment to a peripheral edge region 194 enclosing the supplementary opening 192, for example by two-component injection molding.

In the ready state of the exhalation valve assembly 122, the fastening leg, in particular in the form of the fastening bushing 178b which surrounds in a closed manner, encloses a portion of the interior volume of the bypass chamber 174.

The section of the plug 178 having the supplemental opening 192 can be accommodated in a receiving structure 196 in the sensor coupling section 156a, which delimits the plug section on both sides along the through-axis D of the supplemental opening 192. However, the plug section with the supplementary opening 192 can also be accommodated only radially outside by the material of the downstream exhalation tube 156, as in the first embodiment, or between the separating wall 176 and the sensor coupling section 156 a.

The sensor coupling opening 182 is preferably no smaller than the complementary opening 192 and also preferably has the same shape. The sensor coupling opening 182 can be slightly larger than or as large as the complementary opening 192, in particular if the material of the sensor coupling wall section 156a is still laid behind the plug section with the complementary opening 192 in the through direction R along the through axis D. At least the part of the sensor coupling opening 182 lying behind the supplementary opening 192 in the through direction R can be larger than the supplementary opening 192 in order to provide an accommodation space for the film remnants projecting from the edge region 186 after piercing the closure membrane 184 in the through direction R, which accommodation space is located between the sensor coupling wall section 156a and the coupling tube passing through the sensor coupling opening 182 and the supplementary opening 192.