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WO2009089807A1 - Interface utilisateur insonorisée comportant une soupape à pression positive en fin d'expiration - Google Patents

Interface utilisateur insonorisée comportant une soupape à pression positive en fin d'expiration Download PDF

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Publication number
WO2009089807A1
WO2009089807A1 PCT/DE2008/001498 DE2008001498W WO2009089807A1 WO 2009089807 A1 WO2009089807 A1 WO 2009089807A1 DE 2008001498 W DE2008001498 W DE 2008001498W WO 2009089807 A1 WO2009089807 A1 WO 2009089807A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
connection
mask
patient
breathing gas
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/DE2008/001498
Other languages
German (de)
English (en)
Inventor
Frank Herrmann
Wolfgang Wedler
Florian Dietz
Henning Wortelen
Erik Hofbauer
Martin Eifler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Loewenstein Medical Technology GmbH and Co KG
Original Assignee
Loewenstein Medical Technology GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102008005020A external-priority patent/DE102008005020A1/de
Priority claimed from DE200810026321 external-priority patent/DE102008026321A1/de
Application filed by Loewenstein Medical Technology GmbH and Co KG filed Critical Loewenstein Medical Technology GmbH and Co KG
Publication of WO2009089807A1 publication Critical patent/WO2009089807A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B9/00—Component parts for respiratory or breathing apparatus
    • A62B9/02—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0825—Joints or connectors with ball-sockets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/206—Capsule valves, e.g. mushroom, membrane valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/42—Reducing noise

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • this constant flow is already used in sleep medicine via fixed openings for leaching CO2 during CPAP therapy.
  • the closed state can also mean that the pressure on the underside is kept at a constant value, the PEEP level.
  • PI patient interface
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an expiratory pressure must be at least about four hPa to ensure a sufficiently safe rinsing of the carbon dioxide.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • At least one controllable valve is arranged in the region of the device for ventilation.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the expiration opening is selected such that a low noise emission is produced. This can be done by a variety of methods:
  • the opening gap can diffuse the expired air.
  • 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.
  • the pressure drop across the PI or via the PEEP valve at a flow rate of 60 l / min is less than 6 mbar.
  • 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.
  • Another advantage of the invention is the directional position of the expiratory openings of the PEEP valve.
  • 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.
  • 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.
  • An improved mask bead form achieves a higher seal with less contact pressure.
  • 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.
  • 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.
  • 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.
  • Fig. 1 Apparatus for ventilation
  • Fig. 2 Representation of a PI with control pressure connection
  • FIG. 4 Improved membrane geometry for reducing the sound in a mask.
  • Fig. 5 Arrangement of the PEEP valve in the connection for a breathing tube
  • 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. 11 section through the PEEP valve
  • Fig. 14 Side view of a PI with PEEP valve
  • Fig. 15 a) membrane cut laterally b) membrane from above
  • Fig. 1 shows the basic structure of a device for ventilation.
  • a respiratory gas pump is arranged in a device interior.
  • a coupling hose (5) is connected via a coupling (4).
  • 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.
  • 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).
  • 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.
  • a mask bead (13), a forehead support (14) and fastening elements can be coupled to connection points (15) provided for this purpose.
  • 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).
  • 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.
  • 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).
  • 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.
  • FIG. 5 shows a partial view of the patient interface, in which the PEEP valve is integrated into the connection (11) for a 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).
  • 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.
  • FIG. 1 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).
  • a mask bead 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • the latching is preferably formed as a projection (nose) (44) of the locking ring (20), which engages in a corresponding recess of the PI.
  • 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.
  • 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 Grundk ⁇ rpers 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.
  • 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.
  • a larger undercut is realized in order to prevent levering of the snap connection by forces on the hose.
  • the design of several snap segments is envisaged.
  • 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.
  • the PEEP valve as an assembly would be separable from the connecting piece and easier to clean and replace.
  • 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.
  • 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 Ventilgrink ⁇ rper (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.
  • the pressure measuring tube runs along the breathing tube.
  • 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.
  • 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).
  • 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.
  • 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.
  • FIG. 13 shows a further embodiment of a PEEP valve with a cover (41) which has a control pressure connection (18).
  • a control pressure connection (18)
  • 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.
  • a flowmeter / flow measurement channel (56) is integrated into the assembly.
  • 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 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.
  • the bead (59) is less than 1 mm.
  • the check valve seal (57) and the mounting gasket (58) are over 1.5 mm thick.
  • the flexible bead is also rounded.
  • 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.
  • the membrane Due to the properties of the selected membrane (24), a high control accuracy with low noise emission of the PEEP valve can be achieved.
  • 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 Basisisk ⁇ rper (42) of the PEEP valve.
  • 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.
  • 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 °.
  • the direction of the exhaled air is deflected again by 40-90 °, and flows in the direction of the tube.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Emergency Medicine (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Business, Economics & Management (AREA)
  • Emergency Management (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

L'invention concerne un dispositif d'assistance respiratoire comportant au moins un corps de masque présentant une partie intérieure et une partie extérieure. Le dispositif comporte également un bourrelet de masque pouvant être connecté au corps de masque, destiné à étancher le dispositif par rapport à des parties du visage d'un patient. Des éléments de fixation servent à positionner le dispositif sur la tête du patient. Une connexion pour un tuyau respiratoire destiné à l'acheminement de gaz respiratoire est également prévue. Au moins une soupape commandable est disposée à proximité du dispositif d'assistance respiratoire, ladite soupape servant à régler la pression intérieure du masque et le flux expiré. Le bourrelet de masque présente de préférence deux lèvres d'étanchéité se trouvant en contact avec la peau du patient, pour l'étanchage par rapport aux parties du visage du patient.
PCT/DE2008/001498 2008-01-15 2008-09-03 Interface utilisateur insonorisée comportant une soupape à pression positive en fin d'expiration Ceased WO2009089807A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102008005020A DE102008005020A1 (de) 2007-01-16 2008-01-15 Geräuscharmes Anwendungsinterface mit integriertem PEEP-Ventil
DE102008005020.2 2008-01-15
DE200810026321 DE102008026321A1 (de) 2007-06-14 2008-06-02 Patientenventil
DE102008026321.4 2008-06-02

Publications (1)

Publication Number Publication Date
WO2009089807A1 true WO2009089807A1 (fr) 2009-07-23

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PCT/DE2008/001498 Ceased WO2009089807A1 (fr) 2008-01-15 2008-09-03 Interface utilisateur insonorisée comportant une soupape à pression positive en fin d'expiration

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014186584A3 (fr) * 2013-05-15 2015-01-08 Fresca Medical Inc. Valve d'auto-rétroaction pour dispositif contre l'apnée du sommeil
WO2015136407A1 (fr) * 2014-03-11 2015-09-17 Koninklijke Philips N.V. Système de clapet à diaphragme compact à deux membres et procédé en référence croisée avec des applications associées
US9333318B2 (en) 2012-04-13 2016-05-10 Fresca Medical, Inc. Sleep apnea device
USD759230S1 (en) 2014-05-30 2016-06-14 Fresca Medical, Inc. Airflow generator for a sleep apnea system
US9492086B2 (en) 2012-03-21 2016-11-15 Fresca Medical, Inc. Apparatus, systems, and methods for treating obstructive sleep apnea
WO2018196895A1 (fr) * 2017-04-27 2018-11-01 Weinmann Emergency Medical Technology Gmbh + Co. Kg Valve pour patient pour mettre en œuvre une respiration artificielle sur un patient au moyen d'un ventilateur mécanique
US10272226B2 (en) 2012-04-13 2019-04-30 Fresca Medical, Inc. Auto-feedback valve for a sleep apnea device
US10307562B2 (en) 2012-04-13 2019-06-04 Fresca Medical, Inc. Auto-feedback valve for a sleep apnea device
CN110787351A (zh) * 2019-11-07 2020-02-14 重庆医科大学附属第一医院 一种多功能无创正压通气面罩
EP3102271B1 (fr) * 2014-05-07 2020-09-30 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dispositif et procédé pour une valve à faible résistance

Citations (5)

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Publication number Priority date Publication date Assignee Title
US3097642A (en) * 1956-08-21 1963-07-16 Allan M Russell Face mask
US4989596A (en) * 1989-02-14 1991-02-05 Macris Allen G Face chamber
US5109840A (en) * 1991-02-14 1992-05-05 Specialty Packaging Licensing Company Resuscitator having directional control valve with internal "PEEP" adjustment valve
US20080115787A1 (en) * 2006-06-30 2008-05-22 Aeris Therapeutics Respiratory assistance apparatus and method
WO2008070989A1 (fr) * 2006-12-13 2008-06-19 Ludwik Fedorko Procédé et appareil d'assistance ventilatoire

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3097642A (en) * 1956-08-21 1963-07-16 Allan M Russell Face mask
US4989596A (en) * 1989-02-14 1991-02-05 Macris Allen G Face chamber
US5109840A (en) * 1991-02-14 1992-05-05 Specialty Packaging Licensing Company Resuscitator having directional control valve with internal "PEEP" adjustment valve
US20080115787A1 (en) * 2006-06-30 2008-05-22 Aeris Therapeutics Respiratory assistance apparatus and method
WO2008070989A1 (fr) * 2006-12-13 2008-06-19 Ludwik Fedorko Procédé et appareil d'assistance ventilatoire

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9492086B2 (en) 2012-03-21 2016-11-15 Fresca Medical, Inc. Apparatus, systems, and methods for treating obstructive sleep apnea
US10307562B2 (en) 2012-04-13 2019-06-04 Fresca Medical, Inc. Auto-feedback valve for a sleep apnea device
US9333318B2 (en) 2012-04-13 2016-05-10 Fresca Medical, Inc. Sleep apnea device
US10272226B2 (en) 2012-04-13 2019-04-30 Fresca Medical, Inc. Auto-feedback valve for a sleep apnea device
WO2014186584A3 (fr) * 2013-05-15 2015-01-08 Fresca Medical Inc. Valve d'auto-rétroaction pour dispositif contre l'apnée du sommeil
CN106102813B (zh) * 2014-03-11 2019-03-12 皇家飞利浦有限公司 紧凑的双肢隔膜阀系统和方法
US20170014594A1 (en) * 2014-03-11 2017-01-19 Koninklijke Philips N.V. Compact dual limb diaphragm valve system and method
CN106102813A (zh) * 2014-03-11 2016-11-09 皇家飞利浦有限公司 紧凑的双肢隔膜阀系统和方法
WO2015136407A1 (fr) * 2014-03-11 2015-09-17 Koninklijke Philips N.V. Système de clapet à diaphragme compact à deux membres et procédé en référence croisée avec des applications associées
US11147939B2 (en) 2014-03-11 2021-10-19 Koninklijke Philips N.V. Compact dual limb diaphragm valve system and method
EP3102271B1 (fr) * 2014-05-07 2020-09-30 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dispositif et procédé pour une valve à faible résistance
USD759230S1 (en) 2014-05-30 2016-06-14 Fresca Medical, Inc. Airflow generator for a sleep apnea system
WO2018196895A1 (fr) * 2017-04-27 2018-11-01 Weinmann Emergency Medical Technology Gmbh + Co. Kg Valve pour patient pour mettre en œuvre une respiration artificielle sur un patient au moyen d'un ventilateur mécanique
RU2734464C1 (ru) * 2017-04-27 2020-10-16 Вайнманн Эмёрдженси Медикал Текнолоджи Гмбх + Ко. Кг Клапан пациента для искусственной вентиляции легких пациента с помощью аппарата искусственной вентиляции легких
US11484683B2 (en) 2017-04-27 2022-11-01 Weinmann Emergency Medical Technology Gmbh + Co. Kg Patient valve for ventilating a patient with a ventilator
CN110787351A (zh) * 2019-11-07 2020-02-14 重庆医科大学附属第一医院 一种多功能无创正压通气面罩

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