EP1778328A1

EP1778328A1 - Gas reservoir bag, distributor housing, breathing mask, and respiration method

Info

Publication number: EP1778328A1
Application number: EP05774437A
Authority: EP
Inventors: Jürgen Reinstädtler; Eckard Glaser
Original assignee: Viasys Healthcare GmbH
Current assignee: Vyaire Medical GmbH
Priority date: 2004-08-21
Filing date: 2005-08-09
Publication date: 2007-05-02
Also published as: DE112005002715A5; WO2006021182A1; US20070163592A1; DE102004040740A1

Abstract

The invention relates to a gas reservoir bag (6) comprising a flexible bag (9) for separating two different gases by means of a connection. Said gas reservoir bag further comprises an outer bag (8) for generating a difference in pressure between the flexible bag (9) and the surroundings of the outer bag (8), said outer bag (8) enveloping the flexible bag (9) with the exception of the connection thereof. The invention also relates to a distributor housing for a breathing mask comprising such a gas reservoir bag as well as a breathing mask encompassing such a distributor housing. The invention finally relates to corresponding methods.

Description

Gas reservoir bag, distributor housing, respiratory mask as well

ventilation modes

The invention relates to a gas reservoir bag referred to in the preamble of claim 1 species, to a distributor housing referred to in the preamble of claim 6 species, a respiratory mask and a ventilation method referred to in the preamble of claim 9 Art.

The invention relates to devices and accessories for the application of oxygen and other gases. Specifically, the invention relates to respiratory masks and gas reservoir bags therefor.

A respiratory mask for effective ventilation with oxygen or other gases is known from EP 1 402 915 A1. FIG. 2 of this application is shown in FIG. 1 of EP 1 402 915 A1, wherein the reference numbers have been retained. Figure 2 shows a mask assembly 10 having a face piece 20, a hollow manifold housing 30 and a gas reservoir bag 40. The face piece 20 has a clearing 27 to which the manifold housing 30 is connected. The manifold housing 30 is a hollow structure with tubing having an inspiratory flow or arm 50 and an expiratory passage or arm 60. The inspiratory arm directs the oxygen delivered through a gas inlet port 52 to the face piece 20. The expiratory arm 60 drains the exhaled gas from the face piece 20 into the surrounding atmosphere via an outlet port 62. The manifold housing 30 may further include a channel 70 that directs ambient air into the inspiratory arm 50 from the surrounding atmosphere. The reservoir bag 40 may be connected to the end of the tubing of the inspiratory arm 50.

An inspiratory valve 54 is disposed in the inspiratory arm 50 between face piece 20 and gas reservoir bag 40. The gas reservoir bag 40 serves only as a partition between the gas, usually oxygen, in its interior and the surrounding atmosphere. In the gas reservoir bag 40 so there is ambient pressure. Installation valve 54 opens when inhaled, more precisely, when the pressure in the face piece 20 falls below the ambient pressure by 1, 5 mbar. An exhalation valve 64 in the expiratory arm 60 opens upon exhalation so that the exhaled air flows from the facepiece 20 to the outlet port 62 where it is released into the environment.

A dilution valve 72 in the channel 70 opens upon inhalation when the gas reservoir bag 40 is empty and a lower gas flow is provided above the gas inlet port 52 than the gas flow needed by a patient in the instantaneous phase of the inspiration cycle. Thus, the patient may additionally inhale ambient air via outlet port 62, channel 70, inspiratory arm 50, and face piece 20.

Anti-septum valve 56, which is redundant in EP 1 402915 A1, is provided in parallel with the proving valve 72.

Gas reservoir bag 40 has the purpose of temporarily storing gas supplied during expiration via gas inlet port 52 for subsequent inspiration. In EP 1 402 915 A1, the advantage of the non-rebreathing mask (NRM) described in this document over a partial rebreathing mask (PRM) is attached to the fact that in the case of a PRM, the gas delivered via gas inlet connection 52 is already diluted in the gas reservoir bag by exhaled air while in an NRM only supplied gas is stored in the gas reservoir bag.

Closely associated with this is that the anatomical dead space is practically filled with cheap ambient air in place of expensive, oxygen-enriched air and this ambient air is released on exhalation largely without mixing with oxygen-enriched air from the alveoli back to the environment. In fact, the ambient air inhaled at the end of the inspiratory phase and intended for the dead space is also enriched to a small extent with the gas supplied because the flow of the supplied gas is constant.

In a calculation example, it is assumed in EP 1 402 915 A1 that the respiratory volume of a patient is 600 ml and the anatomical dead space, which does not take part in the gas exchange with the blood, is 200 ml. It is therefore sufficient to have slightly more than 400 ml of oxygen per respiratory cycle Supply gas inlet port 52 and fill the anatomical dead space with ambient air, without thereby the effective oxygen concentration in the alveoli is significantly reduced.

In practice, the oxygen flow is set much lower, so that the patient inhales partially pure oxygen and partially ambient air. As is known, the oxygen content of exhaled air is about 16 percent. This is still sufficient, for example, to ventilate accident victims word-of-mouth.

From what has been said so far, during normal operation, the gas reservoir bag is completely emptied during each inspiration and should never be filled to the point, because otherwise the gas supplied via gas inlet port 52 escapes into the environment via valves 54 and 64. The minimum volume of gas reservoir bag 40 depends on the needs of the patient, with 500 ml being a sufficient size for most intensive care patients.

EP 1 402 915 A1 has the goal of applying oxygen as effectively as possible and thus, for example, to extend the limited range of gas cylinders in ambulances. Another problem is that the exhaled air of a

Patients may be dangerous to other patients or the clinic staff. Depending on the disease, the exhaled air may contain viruses or bacteria. Also, the gas supplied via gas inlet port 52 may contain medicine that may be hazardous to other patients. Therefore, at outlet port 62 a

Filters are connected.

Breathing apparatus or respirators for mechanical, artificial respiration in all forms of an oxygen deficiency state are also known. Among other things, they are used for long-term ventilation, with three basic types being distinguished, depending on the switchover mechanism from inhalation to expiration. With the pressure-controlled respirator, the inspiration phase is completed when the device has reached a specified ventilation pressure. With the volume-controlled respirator, inspiration stops when a previously set volume of gas leaves the respirator. In the exhalation limb of these devices, a spirometer is installed, which measures the tidal volume of the patient. In addition, these devices usually have audible or visual alarm signals. Finally, there are time-controlled ventilators, where the gas mixture within a previously entered time. The expiration is usually passive, but can also be supported by a generation of negative pressure. The newer type ventilators have technical, mostly electronically controlled, facilities that allow a patient-friendly type of ventilation. For example, the inspiratory time may be extended to three times the expiration time, pressurized breathing may be performed, and the respirator may be "triggered" by the patient, with even weak breaths providing the mechanical support (Roche Lexicon Medicine, 4th Edition, edited by the Hoffmann-La Roche AG and Urban & Fischer, Urban & Fischer, Munich, Stuttgart, Jena, Lübeck, Ulm).

It is the object of the invention to expand the field of application of a mask arrangement, as is known from EP 1 402915 A1.

This object is achieved by the teaching of the independent claims.

Preferred embodiments of the invention are subject of the dependent claims.

An advantage of a double-walled gas reservoir bag is that the inner bag can buffer an additional gas used during ventilation during expiration, while the outer bag absorbs the overpressure generated by a ventilator during inspiration.

An advantage of the introduction of the promoted by a ventilator air in the space between the inner and the outer bag is that the overpressure generated by the ventilator can be compensated in a simple manner. It is also surprisingly advantageous here that not even the inspiratory volume measured by the respirator is falsified by this procedure. The volume of air that flows into the space between the two bags and thus is not available for inspiration is replaced by gas from the inner bag. The measurement result is distorted only by the largely constant gas flow through the gas inlet connection 52.

If the outer bag has two ports, namely one for connecting a breathing tube and one for connection to a distributor housing, the double-walled gas reservoir bag fits optimally into a modular system. If the outer bag is rigid, the outer bag can also compensate for negative pressure that arises when a ventilator also aids the patient in expiration.

The gas reservoir bag can also be advantageously integrated into a distributor housing or both articles can be packed together as disposable articles.

The same applies to the additional integration of a facepiece or its addition to a packaging unit.

In the following, a preferred embodiment of the invention will be explained in more detail with reference to the accompanying drawings. Showing:

1 shows a mask arrangement according to the invention; and

Fig. 2 shows a mask arrangement according to the prior art.

Fig. 1 shows a mask arrangement according to the invention. This differs from a mask arrangement shown in FIG. 2 essentially by the double-walled gas reservoir bag 6, which makes it possible to connect a ventilator 2 via a breathing tube 5.

Similar to gas reservoir bag 40, the inner, flexible bag 9 serves only as a partition between the gas, usually oxygen, in its interior and the ambient air between the inner and outer bag 8. The inner bag 9 is flexible so as to avoid any pressure difference between its interior and exterior to create.

The outer bag 8 serves to compensate for the overpressure generated by the respirator 2 during inspiration. The outer bag 8 is filled tight at least during inspiration and should change its volume as little as possible under normal ventilation pressures.

In order to make handling easy, a ventilation hose-like Y-piece 7 is provided. Y-piece 7 is shaped at the top so as to fit on outlet port 62. The lower part of Y-piece 7 is modeled outlet port 62, so that here a breathing tube 5 can be connected. So can Distribution box 30 are equipped with a simple gas reservoir bag 40 or with a double-walled gas reservoir bag 6 as required.

Y-piece 7 serves to introduce ambient air supplied under positive pressure from the ventilator 2 partially into the space between inner bag 9 and outer bag 8 in order to compress the gas in inner bag 9 to this overpressure. The remaining ambient air delivered by ventilator 2 is routed via channel 70, dilution valve 72, inspiratory arm 50, and inspiratory valve 54 to facepiece 20.

In ventilator 2, two turbines 3 and 4 are shown to indicate that this ventilator can generate both positive and negative pressure to assist in inspiration or expiration by turbine 3 and 4, respectively. If the ventilator 2 generates a negative pressure, the outer bag 8 must be rigid, so that the term "housing" would be more appropriate instead of "bag".

Finally, it should be noted that in the structure shown in Figure 1 Antierstickungsventil 56 and dilution valve 72 are not redundant, since dilution valve 72 leads to respirator 2 and not directly to the ambient air. If respirator 2 generate a negative pressure by means of turbine 4, this is also transmitted via inner bag 9 into inspiratory arm 50. The opening pressure of anti-seize valve 56 must be greater in magnitude than this negative pressure, otherwise the gas supplied via gas inlet port 52 is diluted with ambient air.

Unless otherwise stated, "connected" should be understood to mean that gas can flow between the two connected parts.

Under gas mixture should in this application, a pure gas z. B. for medical purposes, in particular oxygen are understood.

The invention has been explained in detail above with reference to preferred embodiments. However, it will be apparent to those skilled in the art that various modifications and changes can be made without departing from the spirit of the invention. Therefore, the scope of protection is defined by the following claims and their equivalents. LIST OF REFERENCE NUMBERS

1 mask arrangement

2 respirator

3 turbine

5 4 turbine

5 breathing tube

6 gas reservoir bags

7 Y-piece

8 outer bag

10 9 inner bag

10 mask arrangement

20 face piece

27 glade

30 distributor housing

15 40 gas reservoir bags

50 inspiration arm

52 gas inlet connection

56 anti-seepage valve

60 expiratory arm

20 62 outlet connection

64 expiratory valve

70 channel

72 dilution valve

Claims

Claims 1. Gas Reservoir Bag with:

a flexible bag (9) for separating two different gases with a port;

marked by:

an outer bag (8) for creating a pressure differential between the flexible bag (9) and the periphery of the outer bag (8), the outer bag (8) surrounding the flexible bag (9) except for its connection.

2. Gas reservoir bag according to claim 1, characterized in that also the outer bag (8) has a connection with which the outer bag to a ventilator (2) can be connected.

3. Gas reservoir bag according to claim 2, characterized in that the outer bag (8) has two ports, one of which is provided for connecting a breathing tube (5) and the other for connection to a distributor housing (30).

4. Gas reservoir bag according to claim 3, characterized in that the outer bag (8) between the two terminals reinforced and ventilator hose-shaped, one of the two ports on an outlet port (62) of a distributor housing (30) fits and the other and the outlet port (62) is self-formed.

5. Gas reservoir bag according to one of the above claims, characterized in that the outer bag (8) is rigid.

6. Distribution housing for a respiratory mask with:

a port for a face piece (20);

an inspiratory arm (50) connected to the port for the face piece (20); an expiratory arm (60) connected to the port for the face piece (20);

a gas inlet port (52) connected to the inspiratory arm (50); and

a gas reservoir bag (6) connected to the inspiratory arm (50) for allowing gas to flow from the gas inlet port (52) and gas reservoir bag (6) via the inspiratory arm (50) to the port for the facepiece (20) during an inspiratory phase and that during an expiratory phase, gas may flow from the gas inlet port (52) into the gas reservoir bag (6) and from the port for a facepiece (20) through the expiratory arm;

characterized in that the gas reservoir bag (6) is a gas reservoir bag according to any one of claims 1 to 5 and that the connection of the flexible bag (9) is connected to the inspiratory arm (50).

7. Distribution box according to claim 6, characterized in that also the outer bag (8) has a connection with which the outer bag (8) is connected to an outlet port (62) of the expiratory arm (60).

8. Ventilation mask with:

a face piece (20); and

a manifold housing (30) according to claim 6 or 7, whose port for a facepiece is connected to the face piece (20).

9. A ventilation method for ventilating a patient with a gas mixture whose composition deviates from the composition of the ambient air, comprising:

Supplying (52) a gas mixture whose composition deviates from the composition of the ambient air, both during inspiration and during expiration; Introducing the gas mixture into a flexible bag (9) during expiration;

Inhaling the supplied gas mixture and the gas mixture in the bag (9) during inspiration; and

marked by:

Supplying (5, 7, 62) ambient air under pressure versus ambient air pressure during inspiration; and

Compressing the gas mixture in the bag (9) at the same pressure under which the ambient air is supplied.

Ventilation method according to claim 9, characterized in that the supplied ambient air is at least partially introduced into a space between an outer bag (8) and the flexible bag (9), the outer bag (8) surrounding the flexible bag (9).