EP0961626A1

EP0961626A1 - Spontaneous breathing device with continuous positive air pressure (cpap device)

Info

Publication number: EP0961626A1
Application number: EP98910694A
Authority: EP
Inventors: Liselotte Werner; Gert Kniewasser
Original assignee: Med In Medical Innovations
Current assignee: Med In Medical Innovations
Priority date: 1997-11-07
Filing date: 1998-02-17
Publication date: 1999-12-08
Also published as: WO1999024101A1; DE29719834U1; AU6498498A

Abstract

The invention relates to a continuous positive air pressure device (CPAP device) for spontaneous breathing, especially a nasal CPAP device (nCPAP device). The inventive device includes a hollow body (10) in which it is possible to generate a positive pressure. A first opening (20) provided in a side wall of the hollow body (10) allows for the introduction of an air flow (A) in the hollow body (10) and for the discharge of the exhaled air (B). A fitting (30) attached to the hollow body (10) is provided for connecting the hollow body (10) to a nasal and/or mouth piece (100) and a spacer (40) also attached to the hollow body (10) comprises a flow nozzle (50) for directing the air flow (A) towards the opening (20).

Description

Continuous positive airway pressure generating device (CPAP device)

STATE OF THE ART

The present invention generally relates to a device for producing a continuous positive

Airway pressure or CPAP device for short, and in particular a nasal CPAP device or nCPAP device for short.

The principle of these CPAP or nCPAP devices is that the patient breathes against a pressure that is higher than atmospheric pressure, which facilitates and improves spontaneous breathing in certain cases of impaired pulmonary function.

An extremely important application is in the treatment of newborns. The effect of this is that the not yet fully developed lungs are inflated due to the overpressure and a better gas exchange is possible. Another very important factor is that the dangerous collapse of the alveoli due to the negative breathing pressure can be prevented by this technique. Another aspect is that the alveoli are opened better, and thus the overall functional state of the lungs is improved. DE-C-3 119 814 discloses a CPAP or nCPAP device with a breathing channel which opens to the atmosphere at its free end and which at its other end has a coupling piece for attachment to the nose and / or can be provided in the patient's mouth, and with an inlet duct for fresh gas, which is connected to the respiratory duct at a point between its ends and whose flow rate is adjustable.

EP 0 447 443 B1 discloses a development of this known CPAP or nCPAP device, the breathing channel having a first branch channel that can be connected to the coupling piece and a second branch channel that is open to the atmosphere. The two breathing channels form an angle with one another, so that the inlet channel lies essentially in the extension of the first branch channel and is connected to the second branch channel in such a way that the fresh gas flow is directed mainly coaxially in the first branch channel and thereby causes an ejection process. The cross-sectional area of the respective branch duct is many times larger than the smallest cross-sectional surface of the inlet duct, and the length of each branch duct is relatively short and is preferably five times its inner diameter. The breathing channel is assembled with the inlet channel as a compact unit which can be attached to the patient's nose and / or mouth by means of a strip or corresponding means. The fact that the known CPAP or nCPAP devices have a complicated structure, that is to say have separate inlet and outlet channels, and because of their structure are not easily sterilizable and are therefore expensive disposable items, has proven to be disadvantageous in the above known approaches. A further disadvantage of the known CPAP or nCPAP devices lies in the fact that they are not flexible in handling and in connection with compressed air generation devices and pressure measuring devices.

The problem underlying the present invention therefore generally consists in creating a simply constructed, light, sterilizable and flexibly connectable CPAP or nCPAP device.

ADVANTAGES OF THE INVENTION

The CPAP or nCPAP device according to the invention with the features of claim 1, ie the device for generating a continuous positive airway pressure with a hollow body in which an overpressure can be built up; a first opening provided in a side wall of the hollow body for supplying an air flow directed into the hollow body and for discharging the exhaled air flow; a connector which can be attached to the hollow body for connecting the hollow body to a nose and / or mouthpiece; and a spacer which can be attached to the hollow body and on which a flow nozzle for directing the Air flow can be attached to the opening has the advantage over the known approaches that it is completely autoclavable and sterilizable due to its compact two-part construction.

The idea on which the present invention is based is that a Benveniste valve is provided, the cavity of which can be made accessible over a large cross section by removing the connecting piece from one side, so that an effective sterilization of the cavity is possible. No exhalation hose is necessary during operation.

In particular, in the case of the CPAP or nCPAP device according to the invention, the hollow body and preferably also the spacer, the flow nozzle, the tube can be made of a sterilizable material, such as e.g. Manufacture aluminum or fine aluminum or similar. The connector, which is made of Teflon, for example, can also be sterilized or used as a cheap part of the route. In any case, according to the invention there is no need to throw away the expensive finishing component, which is customary in the prior art.

Advantageous further developments and improvements of the nCPAP device specified in claim 1 are found in the subclaims. According to a preferred development, the hollow body essentially has the shape of a hollow cylinder, on one end face of which the connecting piece can be attached and on the outer surface of which the opening is provided.

According to a further preferred development, the connector consists of a stopper which can be at least partially inserted into the hollow body on the end face. Such a stopper is easy to attach and remove and, with the appropriate design, has a good seal. In addition, the required bushings can be easily provided.

According to a further preferred development, the connecting piece has one or two bushings which correspond to corresponding breathing air because of the nose and / or mouthpiece.

According to a further preferred development, one or two tube stubs pointing outwards are provided in the leadthroughs of the connecting piece for insertion into the nose and / or mouthpiece.

According to a further preferred development, the connecting piece can be rotated relative to the hollow body about at least one specific axis. This enables the position of the connecting piece to be adjusted relative to the patient, so that an optimal laying of the lines is possible. According to a further preferred development, the specific axis lies essentially perpendicular to the axis of the air flow directed into the hollow body.

According to a further preferred development, the spacer has an essentially ring-shaped or cup-shaped shape.

According to a ^" further preferred development, the flow nozzle is guided through a hole in the side wall of the ring shape or cup shape and is directed essentially perpendicular to the opening.

According to a further preferred development, the flow nozzle protrudes a predetermined length into the inside of the ring shape or the inside of the cup shape. This ensures an excellent setup for the flow containers.

According to a further preferred development, the

Sidewall of the ring shape or cup shape on a safety air passage opening and the ring shape or cup shape can be closed with the fingers in such a way that a pressure limitation is provided through the safety air passage opening (45). It is thus possible to temporarily increase the overpressure, the safety air passage opening having a predetermined minimum size for exhaling being present, so that there is no risk of suffocation for the patient. According to a further preferred development, the spacer is fixedly attached to the hollow body, preferably by crimping.

According to a further preferred development, the flow nozzle is fixedly attached to the spacer, preferably by screwing. This also results in a simple adjustment option for the flow nozzle.

According to a further preferred development, a second opening for connecting a pressure measuring device is provided in a side wall of the hollow body, preferably different from the side wall with the opening.

According to a further preferred development, the hollow body essentially has the shape of a hollow cylinder, on one end face of which the connecting piece can be attached, on the other end face the second opening is provided and on the outer surface of which the first opening is provided.

According to a further preferred development, a tube for connection to a pressure measuring line is connected to the second opening at an essentially right angle, preferably using a reinforcing plate attached in the hollow body in the end face. According to a further preferred development, the tube can be rotated relative to the hollow body about at least one specific axis.

According to a further preferred embodiment, the tube extends substantially by the same length from the hollow body away as the flow nozzle so that a line for supplying compressed air to the flow nozzle in substantially the ^"same level as the pressure measuring line can be attached. This construction provides for a expedient attachability of the supply lines.

According to a further preferred development, the hollow body and preferably also the spacer, the flow nozzle, the tube and the tube stub or tubes are made of aluminum or fine aluminum. Aluminum or fine aluminum is a common working material that is easy to machine and easy to sterilize.

According to a further preferred development, the connector is made of Teflon. Teflon is also a common working material that is easy to work with and easy to sterilize and that also has a good seal on the metal of the hollow body if the connector has the appropriate dimensions. In addition, it can be easily twisted or moved, which is not possible or is only possible with difficulty with a conventional rubber stopper. According to a further preferred development, a nose and / or mouthpiece is provided, which is made of silicone.

DRAWINGS

Embodiments of the invention are shown in the drawings and explained in more detail in the following description.

Show it:

Figure 1 is a schematic representation of an embodiment of the CPAP device according to the invention.

2 shows a first cross-sectional view of an exemplary embodiment of a nose attachment piece for connection to the attachment piece; and

FIG. 3 shows a second cross-sectional view of the exemplary embodiment of a nose attachment piece for connection to the attachment piece along the line A-A ', which is indicated in FIG. 2.

DESCRIPTION OF THE EMBODIMENTS

1 shows a schematic representation of an embodiment of the CPAP device according to the invention. The main components of this embodiment of the device according to the invention for generating a continuous positive airway pressure are a cylindrical hollow body 10 in which an overpressure can be built up, a first opening 20 provided in the lateral surface of the cylindrical hollow body 10 for supplying an air flow A directed into the hollow body 10 and for discharging it the exhaled air flow B, a connector 30 which can be attached to the cylindrical hollow body 10 at its one end face 10a, for connecting the hollow body 10 to a nose and / or mouth attachment piece 100, which is explained in more detail in FIGS. 2 and 3, and one which can be attached to the hollow body 10 Spacer 40, on which a flow nozzle 50 for directing the air flow A onto the opening 20 can be attached.

The connector 30 consists of a stopper made of Teflon, which can be at least partially inserted into the hollow body 10 on the end face 10a. This stopper is expediently a graduated turned part. It has two bushings (dashed lines) which correspond to the respiratory airways of the nose attachment 100. In the feedthroughs of the connector 30, two outwardly pointing tube stubs 35 are provided for insertion into the nose and / or mouthpiece 100.

Due to its construction as a plug, the connecting piece 30 can be rotated about the cylinder axis relative to the hollow body 10, which is essentially perpendicular to the axis of the air flow A directed into the hollow body 10.

On the other end face 10b of the cylindrical hollow body 10 there is a second opening for connecting one

Pressure gauge provided. For this purpose, a tube 60 for connection to a pressure measuring line is connected to the second opening at a substantially right angle using a reinforcement plate (not shown) attached in the hollow body 10 in the end face 10b.

The tube 60 extends essentially the same length away from the hollow body 10 as the flow nozzle 50, so that a line for supplying compressed air to the flow nozzle can be attached to the flow nozzle 50 at substantially the same height as the pressure measurement line.

In the exemplary embodiment shown, the hollow body 10, the spacer 40, the flow nozzle 50, the tube 60, the reinforcing plate and the tube stub 35 are made of aluminum or fine aluminum.

The spacer 40 is fixedly attached to the hollow body 10 by crimping with an inserted ring. In addition, the flow nozzle 50 is fixedly attached to the spacer 40 by screwing. Finally, the tube 60 is firmly and tightly attached to the hollow body 10 by crimping or screwing. As an alternative to this, the tube 60 could be attached to the hollow body 10 such that it can be rotated about at least a certain axis, wherein a corresponding tightness as with the connection piece 30 must be ensured.

The spacer 40 has a substantially annular shape. The flow nozzle 50 is passed through a hole in the side wall of the ring shape and directed substantially perpendicular to the opening 20. The flow nozzle

50 protrudes into the ring shape interior by a predetermined length.

The side wall of the ring shape has a safety air passage opening 45. The ring shape of this construction can be closed with the fingers in such a way that the exhaled air flow B runs through the safety air passage opening 45.

2 shows a first cross-sectional view of an exemplary embodiment of a nose attachment piece for connection to the attachment piece.

The nose piece 100 shown is made of very soft silicone. It has a central part 150 in

The shape of a cuboid with two holes 151, 152 and two starting therefrom, protruding from the plane of the drawing, thin-walled nose insertion tubes 153, 154. On both sides of the cuboid, tabs 160, 170 are attached, which can be attached to the patient's head by means of a band or corresponding means which can be guided through corresponding holes 165, 175.

Otherwise, the nose attachment 100 is expediently a disposable part, since silicone hardens during autoclaving and could thus damage the patient's nasal entrances.

The function and structural details of this embodiment of the CPAP device according to the invention are explained in more detail below.

The dimensions are typically:

Length of hollow cylinder 15 mm diameter of hollow cylinder 15 mm diameter of ring spacer 10 mm Width of ring spacer 10 mm Length of flow nozzle 15 mm, of which 5 mm in the ring spacer

First opening diameter 5 mm Diameter safety

Air passage opening 3 mm

Tube stub length 5 mm

Diameter tube stub 2 mm width nosepiece cuboid 15 mm

Height of nosepiece cuboid 5 mm

Deep nosepiece cuboid 10 mm

Length of tabs 17 mm

The air flow supplied through the flow nozzle 50 is typically 10 to 15 liters per minute. As a result, an overpressure proportional to this is built up in the cylindrical cavity 10. The larger the first opening 20, the lower the pressure build-up. The aim is to achieve an exact balance between the amount of gas supplied, the cylinder volume and the diameter of the first opening, so that as far as possible no ambient air is supplied during ventilation that could shift the 0 ₂ concentration. Furthermore, the outputs to the nose attachment are also optimized so that there is as little dead space as possible when breathing.

In the simplest case, a water column measuring device with a water lock can serve as the pressure measuring device, otherwise more complex electronic measuring devices can of course also be used.

All conventional gas driving devices can be used as the compressed air generating device. It should be noted that the choice made of two tube interfaces, one for pressure measurement and one for gas supply, means that the choice of these two corresponding devices is largely free.

The safety air passage opening on the ring spacer has an important function. If the ring spacer is closed with the fingers on both sides, the pressure increases immediately. This is used to inflate the lungs. However, the safety air passage opening limits the pressure to a predetermined value, which depends in particular on its diameter. If the CPAP device is operated with the above dimensions and the pressure during normal operation is 5 cm water column, then an increase to 12 cm water column is achieved by closing the ring spacer at the side.

Although the present invention has been described above on the basis of a preferred exemplary embodiment, it is not restricted thereto, but rather can be modified in many ways.

In particular, the dimensions can be chosen according to the respective requirements. Furthermore, the spacer can also be cup-shaped instead of ring-shaped. The cavity can also have a shape other than the cylindrical shape.

Claims

PATENT CLAIMS

1. Device for generating a continuous positive airway pressure (CPAP device), in particular nasal CPAP device (nCPAP device), with:

a hollow body (10) in which an overpressure can be built up;

a first opening (20) provided in a side wall of the hollow body (10) for supplying an air flow (A) directed into the hollow body (10) and for discharging the exhaled air flow (B);

a connecting piece (30) which can be attached to the hollow body (10) for connecting the hollow body (10) to a nose and / or mouthpiece (100); and

a spacer (40) which can be attached to the hollow body (10) and to which a flow nozzle (50) for directing the air flow (A) onto the opening (20) can be attached.

2. Device according to claim 1, characterized in that the hollow body (10) substantially the shape of a The hollow cylinder has, on one end face (10a) of the connecting piece (30) is fitted and on which the casing ^¬ the opening (20) surface is provided.

3. Device according to claim 1 or 2, characterized in that the connecting piece (30) consists of a plug which is at least partially insertable on the end face (10a) in the hollow body (10).

4. Device according to one of the preceding claims, characterized in that the connecting piece (30) has one or two bushings which correspond to corresponding respiratory airways of the nose and / or mouthpiece (100).

5. The device according to claim 4, characterized in that in the bushings of the connecting piece (30) one or two outwardly pointing tube stubs (35) for insertion into the nose and / or mouthpiece (100) are provided.

6. Device according to one of the preceding claims, characterized in that the connecting piece (30) can be rotated relative to the hollow body (10) about at least one specific axis.

7. The device according to claim 6, characterized in that the specific axis substantially perpendicular to the axis the air flow (A) directed into the hollow body (10).

8. Device according to one of the preceding claims, characterized in that the spacer (40) has a substantially annular or cup-shaped shape.

9. The device according to claim 8, characterized in that the flow nozzle (50) is guided through a hole in the side wall of the ring shape or cup shape and is directed substantially perpendicular to the opening (20).

10. The device according to claim 9, characterized in that the flow nozzle (50) protrudes by a predetermined length into the ring shape interior or cup shape interior.

11. The device according to .Anspruch 8, 9 or 10, characterized in that the side wall of the ring shape or cup shape has a safety air passage opening (45) and the ring shape or cup shape can be closed with the fingers so that the security -Air passage opening (45) a pressure limitation is provided.

12. Device according to one of the preceding claims, characterized in that the spacer (40) is fixed to the hollow body (10), preferably by crimping.

13. Device according to one of the preceding claims, characterized in that the flow nozzle (50) is fixedly attached to the spacer (40), preferably by screwing.

14. Device according to one of the preceding claims, characterized in that in a, preferably from the side wall ^" with the opening (20) different side wall of the hollow body (10), a second opening is provided for connecting a pressure measuring device.

15. The apparatus according to claim 14, characterized in that the hollow body (10) has essentially the shape of a hollow cylinder, on one end face (10 a). The connector (30) can be attached, on the other end face (10 b), the second opening is provided and on the outer surface of which the first opening (20) is provided.

16. The apparatus according to claim 14, characterized in that with the second opening at a substantially right angle, a tube (60) for connection to a pressure measuring line, preferably using a in the hollow body (10) in the end face (10b) attached reinforcement kungsplatte, is connected.

17. The apparatus according to claim 16, characterized in that the tube (60) is rotatable relative to the hollow body (10) about at least a certain axis.

18. The apparatus according to claim 16 or 17, characterized in that the tube (60) extends substantially the same length from the hollow body (10) away as the flow nozzle (50), so that a line for supplying compressed air to the flow nozzle can be attached essentially at the same height as the pressure measuring line.

19. Device according to one of the preceding claims, characterized in that the hollow body (10) and preferably also the spacer (40), the flow nozzle (50), the tube (60) and the or the tube stub (35) made of aluminum or fine aluminum are manufactured.

20. Device according to one of the preceding claims, characterized in that the connecting piece (30) is made of Teflon.

21. Device according to one of the preceding claims, characterized in that a nose and / or mouthpiece (100) is provided, which is made of silicone.