NL1039894C2

NL1039894C2 - Breathing assistance system.

Info

Publication number: NL1039894C2
Application number: NL1039894A
Authority: NL
Inventors: Corne Kruyff; Willem Paul Eduard Eikelenboom; Govert Machiel Bruijn
Original assignee: Cpg Medical B V
Priority date: 2012-11-13
Filing date: 2012-11-13
Publication date: 2014-05-14

Description

BREATHING ASSISTANCE SYSTEM

TECHNICAL FIELD

5 This invention relates generally to the field of breathing assistance systems, more particular to systems and methods for providing failure detection arrangements in a breathing assistance system.

BACKGROUND

10

Currently, Positive Airway Pressure (PAP) is a mode of respiratory ventilation used primarily in the treatment of sleep apnea, for which it was first developed. PAP ventilation is also commonly used for those who are critically ill in hospital with respiratory failure, and in new-born infants (neonates). In these patients, PAP ventilation 15 can prevent the need for tracheal intubation, or allow earlier extubation. Sometimes patients with neuromuscular diseases use this variety of ventilation as well. PAP is realized with a nose or face mask placed on the subject during sleep. Through the mask, positive pressure air is continuously delivered to the subject. The positive pressure air may be delivered to the subject's upper airway to prevent the upper airway 20 tissues from collapsing during sleep, thus reducing the occurrence and/or severity of sleep apnea. The PAP therapy is also useful in case of poor respiratory function. The breathing assistance system is often used to assist breathing when the subject is asleep, but it may also be used during a wake state, or while being involved in daily activities.

25 There are various modes of PAP therapy, of which the following modes are described in short.

- Continuous Positive Airway Pressure (CPAP) - Bilevel Positive Airway Pressure (BPAP) - Inspiratory Positive Airway Pressure (IPAP) 30 - Lower Expiratory Positive Airway Pressure (EPAP)

Continuous positive airway pressure (CPAP) is the use of continuous positive pressure to maintain a continuous level of positive airway pressure. A ventilator is used, which does not cycle during CPAP. No additional pressure above the level of CPAP is 1 0 3 9 8 9 4 2 provided, and patients must initiate all of their breaths. Nasal CPAP is frequently used in neonates.

As a treatment or therapy, CPAP uses mild air pressure to keep an airway open. CPAP typically is used for people who have breathing problems, such as sleep apnea.

5 CPAP also may be used to treat preterm infants whose lungs have not yet fully developed. For example, physicians may use CPAP to treat infants who have respiratory distress syndrome or bronchopulmonary dysplasia. In some preterm infants whose lungs haven't fully developed, CPAP improves survival and decreases the need for steroid treatment for their lungs.

10 CPAP at home utilizes machines specifically designed to deliver a constant flow or pressure. Some CPAP machines have other features as well, such as heated humidifiers. CPAP is the most effective treatment for obstructive sleep apnea, in which the mild pressure from CPAP prevents the airway from collapsing or becoming blocked.

15 Bilevel Positive Airway Pressure (BPAP) is a CPAP mode used during noninvasive positive pressure ventilation. It delivers a preset inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP). BPAP can be described as a CPAP system with a time-cycled or flow-cycled change of the applied CPAP level. CPAP, BPAP and other non-invasive ventilation modes have been shown to be 20 effective management tools for chronic obstructive pulmonary disease and acute respiratory failure. BPAP, is also known as non-invasive positive pressure ventilation (NIPPV) or non-invasive ventilation (NIV), and is sometimes called Variable Positive Airway Pressure (VPAP).

25 Hereinafter all modes based on positive airway pressure modes will be referred to as PAP, unless otherwise stated.

The breathing assistance system comprises a PAP apparatus including a tube for attachment to a PAP mask on the one hand and a PAP mask (hereinafter referred to as 30 “mask”) on the other hand. The PAP apparatus is arranged for delivering air through a tube to the mask. Flawless operation of the breathing assistance system is largely dependent of a flawless delivery of fresh air to be inhaled by the subject and a flawless removal of exhaled air. This flawless operation largely depends on a good Fit Factor (FF) of the mask connected to the PAP apparatus, wherein a higher FF indicates better 3 fit between the face and the mask and less leakage of air. For example, a low Fit Factor of conventional masks may be a result of many mask assemblies being conform to only standard sizes and shapes. Second, conventional masks may not account for differences in the sizes, shapes (irregularities) of the facial features of different subjects, 5 thus causing discomfort, pain or leakage of air. Third, because of the poor seals or fits often associated with conventional masks, the mask may not stay in place, and may shift or move. If the mask does not stay in place, or if the mask does not fit closely to the face, air may leak and the air pressure will drop, thereby nullifying the aimed effect of positive pressure.

10 The term mask air leakage will be used hereinafter to refer to a situation wherein air leaks between the mask and the subject’s face.

Air leaks in general may however occur anywhere in the breathing assistance system.

Solutions have been sought to increase safe use and intervene whenever an air 15 leakage is occurring. Current systems exist which provide means to detect general leak in flow of air in breathing assistance systems. For example International patent application W020122013106A1, by Koninklijke Philips Electronics NV (hereinafter referred to as Philips’ patent application) describes a method which enables estimating the leak in flow of air over an extended time in a breathing assistance system. The 20 breathing assistance system collects operation information and data that can be monitored and controlled remotely by using input/output terminals. In order to measure flow of air, an airflow sensor is incorporated in CPAP apparatus.

The Philip’s patent application and other provisions of the current state of the art, 25 require feedback systems coupled to control systems which in turn control the breathing assistance system. These systems lead to enhanced complexity and high error margins, due to multiple input parameters and individual differences per patient. In the end the collection of operation information may only lead to an estimation of the occurrence of a leak in flow of air. Furthermore these systems are not able to detect 30 where in the flow of air the leakage occurs. More specifically, there is no solution for detecting if a leakage of air occurs because of mask air leakage.

DISCLOSURE OF INVENTION

4

It is an object of the invention to provide a system, device and method for controlling a breathing assistance system, more particular to detect changes in characteristics of the air of the flow of air in the system, more specifically to detect mask air leakage and take appropriate action to increase safe operation. It is a further object of the invention to 5 increase comfort in use of the system and its elements.

In order to realize the objects of the invention, the present invention provides for a system, device and method for controlling a breathing assistance system.

The invented breathing assistance system comprises known elements such as a PAP 10 apparatus (e.g. CPAP apparatus), and a tube for transporting air to a mask. The mask comprises a cap and an edge. The edge makes contact to the subject’s face. The mask may be fastened and removed.

The novel aspect of the invention comprises that parameters are registered which determine the characteristics of the air right at the location of the mask. The preferred 15 location to register the parameters is the edge of the cap. To register the parameters, preferably in or near the edge of the cap, sensors are positioned to activate a signal if a registered parameter surpasses a threshold. This threshold may be set in advance, but may also be adjusted during operation.

The aspects of the invention and further embodiments of the present invention, 20 including their advantages will be described hereinafter in detail.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in detail with reference to the following figures.

25 Figure 1 shows in an embodiment of the invented the system and exemplary devices incorporated in or in communication with the system.

DETAILED DESCRIPTION

30 The invention will now be described with reference to the figures.

Figure 1 shows a system 100 in accordance with the present invention. For the sake of showing an overview of various embodiments of the invention in one figure, multiple exemplary devices and sensors are shown at the same time in figure 1. These devices may be exclusively incorporated in the invented system 100, or in combination with 5 other devices. The choice of devices and sensors may depend on individual needs of the subject 500 and may be adjusted and incorporated accordingly.

Devices are connected to other devices via wires represented by lines. Wireless connections are indicated by a lighting symbol.

5 A PAP apparatus 200 (e.g. a CPAP apparatus) is shown which supplies air to a subject 500 through a tube 250 and mask 300. The mask 300 comprises a cap 301 and an edge 302 which is in close contact to the face of the subject 500. The mask comprises one or more sensors of which, by way of an example two sensors 310a and 310b are shown.

10 Sensor 310a, for example, may comprise a pressure sensor which measures the pressure of the edge 302 of the mask 300 on the face of the subject 500. If the pressure drops below a threshold level the value of the level of the pressure may be may be sent e.g. through wirelessly connection 350a to a processing receiver 201 of the PAP apparatus 200. The processing receiver 201 may determine if the level value is 15 exclusively or in combination with other measured or received parameters sufficient to trigger an alarm, by sending a signal to an alarm device. If the processing receiver 201 determines that a signal should be sent, the signal may be sent as an audible signal produced by a loudspeaker 211, a visual signal to be produced by a device such as a flashing light 212, a vibration signal sent through the mask and/or the tube, the vibration 20 to be produced by a device such as a vibration motor 213 or a signal 216 to remotely trigger a distant device 400 to perform an alarm procedure, the distant device comprising a device such as the PAP apparatus 200, a personal computer, a Personal Digital Assistant (PDA), a smart phone, or an audible alarm. The signal 216 to remotely trigger a distant device 400 may comprise a wireless signal 216. The wireless signal 25 216 may be produced by transceiver 214 and sent through antenna 215 to antenna 401 of distant device 400, which may comprise state of the art transceiver components.

The invented mask 300 may comprise a microphone sensor 310b, which may detect abnormalities in sound, e.g. breathing sound, or airflow sound and send, at such detection, a signal to the processing receiver 201, which determines if an alarm should 30 be triggered, similar to the procedure described before. Alternatively the microphone sensor 310b may function as a microphone input for a communication device. The communication device may comprise a dedicated communication device incorporated in the PAP apparatus (not shown) or a general available mobile phone such as a smart phone 400. The microphone sensor may communicate directly to a smart phone via a 6

Bluetooth connection or may be wirelessly connected 350b to the PAP apparatus 200 via antenna 215 and transceiver 214. In this way the subject 500 is able to have a mobile telephone conversation, without the need to remove the mask 300.

5 Hereinafter further aspects and embodiments of the invention are disclosed.

In a first aspect of the invention a breathing assistance system is provided for supplying a flow of air to a subject, the breathing system comprising: - a Positive Airway Pressure (PAP) apparatus, such as a Continuous Positive Airway 10 Pressure (CPAP) apparatus; - the PAP apparatus comprising a tube arranged for transport of air; - a mask comprising a cap for covering at least a part of a face of the subject; - the mask comprising an edge for making contact to at least a part of the face; - the mask connected to the PAP apparatus with the tube; 15 - the mask arranged to be removably fastened to the subject’s face, characterized in that: - the mask comprises one or more sensors arranged for registering and transmitting one or more parameters in relation to the flow of air; - The PAP apparatus comprises a processing receiver arranged for receiving the one 20 or more registered parameters transmitted by the one or more sensors; - The processing receiver further arranged to generate a signal upon receiving the one or more registered parameters.

By adding sensors to the mask, the location of measuring of airflow is situated closest to the face of the subject. If, during transport the airflow is influenced by changing 25 circumstances, such as a mask leakage, this will be detected at the place closest to the mask leakage. Especially in combination with other fail safe systems of the breathing assistance system, a better determination of the location of the problem in the airflow is obtained. In this way safe operation is improved.

30 In a first embodiment of the first aspect of the invention, the signal comprises a signal of the group comprising: - An audible signal to be produced by a device such as a loud speaker; - A visual signal to be produced by a device such as a flashing light; 7 - A vibration signal sent through the mask and/or the tube, the vibration to be produced by a device such as a vibration motor; - A signal to trigger a distant device to perform an alarm procedure, the distant device comprising a device such as the PAP apparatus, a personal computer, a Personal 5 Digital Assistant (PDA), a smart phone, or an audible alarm system.

In the case of an audible signal, the subject, especially a visual impaired subject, will be able to hear when a problem occurs in the airflow. Especially when the subject is asleep, this may wake him up, in order to take appropriate measures.

10 In the case of a visual signal, the subject is also alarmed, and especially if the subject is hearing impaired, this will be more effective, than an audio signal, especially when the subject is awake.

In the case of a vibration signal, a hearing impaired or a visual impaired subject may be able to detect a problem in the airflow, even when the subject is asleep. A vibrating 15 motor may be attached in close contact to the mask or the tube, in order to transmit a vibration. In this way safe operation is improved.

In a second embodiment of the first aspect the one or more parameters comprise parameters of the group comprising: 20 - Pressure on the edge of the mask; - Mask air leakage; - Speed of the flow of air; - Changing of pressure of the mask on the face; - Occurrence of apnea or hypopnea; 25 - Changing of sound caused by the flow of air; - Snoring, coughing, sneezing, swallowing; - Speech; - Breathing frequency; - Composition of the air of the flow of air; 30 - Volume of the air of the flow of air; - Humidity of the air of the flow of air; - Temperature of the air of the flow of air.

8

These example parameters are particular useful in registering alone or in combination. Changing or occurrence of these parameters may indicate that a change in the airflow is occurring.

In the case of parameter speech, for example, a sensor, such as a microphone, may 5 pick up meaningful words, or unexpected speech, indicating that a signal has to be sent, or the speech may be transmitted in the signal to be analysed by another device. The microphone could also be connected to a mobile phone using e.g. a Bluetooth connection. The subject could for example call a doctor for assistance.

A decrease of pressure on the edge of the mask in combination may indicate a mask air 10 leakage. In combination with a certain level of decrease in pressure of the air in the flow of air of the mask may indicate how much air is leaking because of the mask air leakage. In this way comfort level for the subject is higher and safe operation is improved.

15 In a second aspect of the present invention a mask is provided for use in a breathing assistance system for supplying a flow of air to a subject, the mask comprising: - a cap for covering at least part of the face of a subject; - an edge for making contact to at a least part of the face, - an arrangement for connecting the mask to a tube of a Positive Airway Pressure 20 (PAP) apparatus comprised in the breathing assistance system, characterized in that the mask comprises one or more sensors for registering and transmitting one or more parameters in relation to the flow of air.

By adding sensors to the mask, the location of measuring of airflow is situated closest to the face of the subject. If, during transport the airflow is influenced by changing 25 circumstances, such as a mask leakage, this will be detected at the place closest to the mask leakage. In this way safe operation is improved.

In a first embodiment of the second aspect of the invention, the one or more sensors are located at the edge.

30 Especially for detecting mask air leakage, sensors in the edge will be most effective, in measuring changes in airflow. Any air leaking between the edge of the mask and the subject’s face, will have specific characteristics. By monitoring the functioning of the mask in this way, safe operation is improved.

9

In a second embodiment of the second aspect, the mask further comprises one or more alarm devices arranged to receive the registered one or more parameters transmitted by the sensors, wherein the one or more alarm devices are arranged to activate a signal upon detecting a surpassing of one or more parameter’s threshold values.

5 By incorporating alarm devices in the mask, for example together with the electronics of the sensor in one electronic circuit, it is possible to combine in one electronic circuit the sensing, transmitting and analysing of parameters together with activating of a signal as soon as the alarm device detects that a threshold of a parameter is surpassed. Such a combined module may be compact and occupy little space in the mask. The sensors, 10 alarm devices or the combination of both can be easily replaced or built-in as an add-on to the mask. For the purpose of cleaning of the mask, a compact module with both a sensor and an alarm device may be taken out before cleaning, in order not to damage the circuitry. Sensor and alarm may also share one power source, such as a battery. In this way comfort level for the subject is higher and safe operation improved.

15

In a third embodiment of the second aspect, the signal comprises a signal of the group comprising: - An audible signal to be produced by a device such as a loud speaker; - A visual signal to be produced by a device such as a flashing light; 20 - A vibration signal sent through the mask and/or the tube, the vibration to be produced by a device such as a vibration motor; - A signal to remotely trigger a distant device to perform an alarm procedure, the distant device comprising a device such as the PAP apparatus, a personal computer, a Personal Digital Assistant (PDA), a smart phone, or an audible alarm.

25 The advantages of these example signals were discussed above already. Providing autonomy in transmitting of parameters by the alarm device positioned in the mask requires no additional transmitting means in the PAP apparatus. In this way comfort level for the subject is higher and safe operation is improved.

30 In a fourth embodiment of the second aspect, the one or more sensors are arranged for transmitting the one or more parameters to a distant device, such as the PAP apparatus, a personal computer, a Personal Digital Assistant (PDA) or a smart phone. The advantage is that the distant device may be configured optimally to process the parameters. Data logging, processing etc. require quite some processor power, energy 10 consumption, storage capacity etc. The PAP apparatus, personal computer, PDA or smart phones are usually already equipped with sufficient capabilities. A smart phone for instance may be configured to call a doctor in case of a problem with the mask, such as a continuous mask air leakage. By only registering and transmitting parameters, the 5 electronics in the mask may be limited to the absolute necessary functionality, thus leading to a minimal extra electronics in the mask. Limiting of electronics in the mask leads to less sensitivity for faults, a lighter mask, and less power consumption by the electronics. Less power consumption leads to less demand for battery power. In this way safe operation is improved.

10

In a fifth embodiment of the second aspect, the mask comprises a control arranged for adjusting the one or more threshold values of the one or more parameters.

By adding a control to the mask, the subject or a processing unit may adjust a threshold of a parameter. If for example the alarm device is set to only activate a signal if the 15 parameter “temperature of the air of the flow of air” changes by one degrees, and the subject does not experience this temperature change as uncomfortable, the subject may adjust the threshold value to a higher level, e.g. two degrees Celsius, to prevent that too often a signal is activated by the alarm device.

The parameter’s threshold values may also comprise absolute values, such as 20 temperature, humidity and speed and pressure of the air of the flow of air, which threshold values may be adjusted. In this way comfort level for the subject is higher and safe operation is improved.

In a sixth embodiment of the second aspect, the one or more sensors are arranged for 25 transmitting the one or more parameters wirelessly, using a wireless system such as Wi-Fi, Bluetooth, ZigBee or Wireless USB.

These wireless technologies are generally known. The use of these technologies in communicating the signals from the mask to an external/distant device is especially valuable, because a breathing system contains already a lot of equipment, tubes, etc.. 30 Any extra wiring will lead to an extra chance of failure, because of entanglement of wires. Especially when the subject is asleep, this is a serious risk, when the subject tosses and turns a lot in bed.

Not being hindered by wires, the comfort level for the subject is higher and safe operation is improved.

11

In a seventh embodiment of the second aspect, the one or more parameters comprise parameters of the group comprising: - pressure on the edge of the mask; 5 - mask air leakage; - changing of speed of the flow of air; - changing of pressure of the mask on the face; - occurrence of apnea or hypopnea; - changing of sound caused by the flow of air; 10 - snoring, coughing, sneezing, swallowing; - speech; - breathing frequency; - composition of the air of the flow of air; - volume of the air of the flow of air; 15 - humidity of the air of the flow of air; - temperature of the air of the flow of air.

In an eighth embodiment of the second aspect, the one or more sensors comprise any one of the group comprising: 20 - a carbon dioxide sensor arranged for measuring the amount of carbon dioxide in the air of the flow of air; - a temperature sensor arranged for measuring temperature of the air of the flow of air; - an airflow meter arranged for measuring the speed of flow of air through the 25 mask; - a pressure sensor or a force sensing resistor arranged for measuring pressure of the mask on the face; - a humidity sensor arranged for measuring humidity of the air of the flow of air; - an audio sensor or microphone arranged for measuring sound.

30 These example sensors are able to register the characteristics of the air of the flow of air. By registering these parameters and transmitting them to an alarm device detection of dangerous changes in the characteristic of the air is possible and therefore safe operation is improved.

12

In a third aspect of the present invention, a method is provided for controlling a breathing assistance system, the breathing assistance system comprising: - a Positive Airway Pressure (PAP) apparatus, such as a Continuous Positive Airway Pressure (CPAP) apparatus; 5 - the PAP apparatus comprising a tube arranged for transport of air; - a mask comprising a cap for covering at least part of a face of the subject; - the cap comprising an edge for making contact to at least part of the face; - the mask connected to the PAP apparatus with the tube; - the mask arranged to be removably fastened to the subject’s face, 10 characterized in that the method comprises the steps of: A. delivering air from the PAP apparatus through the tube to the mask; B. registering one or more parameters in relation to the flow of air, using one or more sensors positioned at the location of the mask, such as at the edge of the mask; C. activating a signal if the one or more registered parameters surpass a threshold.

15 The method has as starting principle that the registration of the parameters that determine the characteristics of the air of the air flow takes place at the location of the mask. By signalling surpassing of thresholds, it is possible to use the method for monitoring the status and working of the breathing assistance system and especially monitoring if air delivery to the subject is guaranteed. More particular, the occurrence of 20 a mask air leakage may be detected with greater accuracy in this way. In this way safe operation is improved.

In a first embodiment of the third aspect of the invention, the signal comprises a signal of the group comprising: 25 - an audible signal to be produced by a device such as a loud speaker; - a visual signal to be produced by a device such as a flashing light; - a vibration signal sent through the mask and/or the tube, the vibration to be produced by a device such as a vibration motor; - a signal to remotely trigger a distant device to perform an alarm procedure, the 30 distant device comprising a device such as the PAP apparatus, a personal computer, a Personal Digital Assistant (PDA), a smart phone, or an audible alarm.

In a second embodiment of the third aspect, the method comprises the step of manually adjusting the one or more threshold values of the one or more parameters.

13

In this way the subject is able to adjust the parameter’s threshold values himself according to his own preferences. In this way comfort level for the subject is higher and safe operation is improved.

5 In a third embodiment of the third aspect, the method comprises the step of adjusting the one or more threshold values of the one or more parameters automatically by a selflearning mechanism.

To assist the subject in controlling the parameter’s threshold values, a self-learning mechanism is provided. There are many forms of self-learning mechanisms. Most are 10 based on comparing input parameters with output parameters and determining significant relations between them. A self-learning mechanism will improve adjustments, when the amount of significant relations and/or historical data increases. In this way comfort level for the subject is higher and safe operation is improved.

15 In a fourth embodiment of the third aspect, the self-learning mechanism comprises the steps of: a) logging sensor data which comprise the registered parameters of the one or more sensors; b) logging control data which comprise historical data in relation to the manually 20 adjusting of the one or more threshold values of the one or more parameters; c) identifying significant relations between the logged sensor data and the logged control data; d) adjusting the one or more threshold values of the one or more parameters based on the identified significant relations.

25 These steps are to be taken to obtain an optimal self-learning mechanism. In this way comfort level for the subject is higher and safe operation improved.

In a fifth embodiment of the third aspect, the one or more parameters comprise parameters of the group comprising: 30 - Pressure on the edge of the mask; - Mask air leakage; - Speed of the flow of air; - Pressure of the mask on the face; - Occurrence of apnea or hypopnea; 14 - Sound caused by the flow of air; - Snoring, coughing, sneezing, swallowing; - Speech; - Breathing frequency; 5 - Composition of the air of the flow of air; - Volume of the air of the flow of air; - Humidity of the air of the flow of air; - Temperature of the air of the flow of air.

10 In a sixth embodiment of the third aspect, the method further comprises the steps of: D. The PAP apparatus receiving the signal; E. The PAP apparatus adjusting, based on the received signal, one or more settings in relation to the flow of air.

In this way a direct feedback loop is created, wherein the PAP apparatus may adjust 15 settings autonomously based on a received signal in relation to a parameter. For example if a temperature drop is measured in air in the mask, the PAP apparatus may increase the temperature of the supplied air until, the threshold values cease to be surpassed. In this way comfort level for the subject is higher and safe operation improved.

20

In a seventh embodiment of the third aspect, the settings comprise settings of the group comprising: - Pressure of the air of the flow of air; - Humidity of the air of the flow of air; 25 - Temperature of the air of the flow of air.

These example settings may be adjusted, which provides to a large extent a selfregulating system, which does not need manual adjustments by the subject. In this way comfort level for the subject is higher and safe operation is improved.

30 The term "substantially" herein, such as in "substantially at a location" etc., will be understood by the person skilled in the art. In embodiments the adjective substantially may be removed. Where applicable, the term "substantially" may also include embodiments with "entirely", "completely", "all", etc. Where applicable, the term "substantially" may also relate to 90% or higher, such as 95% or higher, especially 99% 15 or higher, including 100%. The term "comprise" includes also embodiments wherein the term "comprises" means "consists of.

It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative 5 embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. Use of the verb "to comprise" and its conjugations does not exclude the presence of elements or steps other than those stated in a claim. The term "and/or" includes any and all combinations of one or more of the associated listed items. The article "a" or 10 "an" preceding an element does not exclude the presence of a plurality of such elements. The article "the" preceding an element does not exclude the presence of a plurality of such elements. In the device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not 15 indicate that a combination of these measures cannot be used to advantage.

BEST MODE FOR CARRYING OUT THE INVENTION

The best mode for carrying out the invention is to provide a breathing assistance system 20 comprising a PAP apparatus with a tube for transporting air to a mask covering a part of a subject’s face, wherein the mask comprises a sensor arranged for registering and wirelessly transmitting parameters in relation to a mask air leakage occurring at the edge of the mask, and wherein the PAP apparatus is arranged to generate an alarm upon receiving the one or more registered parameters.

25

INDUSTRIAL APPLICABILITY

The invention is applicable in various fields of technology where a reliable and safe to use positive airway pressure is required. Possible areas are CPAP therapy supporting 30 equipment for sleep apnea patients, breathing assistance systems for fire fighters, pilots and passengers of airplanes and divers.

1039894

Claims

A ventilation system (100) for providing an air flow to a person (500), the ventilation system (100) comprising: 5. a positive pressure ventilation (PAP) device (200), such as a continuous positive pressure ventilation ( CPAP) device; - the PAP device (200) comprising a hose (250) adapted for transporting air; - a mask (300) comprising a cap (301) for covering at least a part of the face of the person (500); - The mask (300) comprising an edge (302) for contacting at least a portion of the face; - the mask (300) connected to the PAP device (200) with the hose (250); - the mask (300) adapted to be removably attached to the face of the person (500), characterized in that - the mask (300) comprises one or more sensors (310a, b) adapted for registration and dispatch of one or more parameters in relation to the air flow; - the PAP device (200) comprises a processing receiver (201) adapted to receive the one or more registered parameters sent by the one or more sensors (310a, b); 25. The processing receiver (201) is further adapted to generate a signal upon receipt of the one or more registered parameters.

A respiratory system according to claim 2, characterized in that the signal is included in the group comprising: 30. a sound signal to be delivered by an apparatus such as a loudspeaker (211); - a visual signal to be given by a device such as a flash lamp (212); - a vibrating signal controlled by the mask (300) and / or the hose (250) to give the vibrating signal by an apparatus such as a vibrating motor (213); 1 03 9894 - a signal to control a device remotely to perform an alarm procedure, the device remotely comprising a device such as the PAP device (200), a personal computer, a Personal Digital Assistant (PDA) (400 ), a smart phone, or a sound alarm system. 5

A respiratory system (100) according to any one of the preceding claims, characterized in that the one or more parameters are included in the group comprising: - air leakage from the mask (300); 10. speed of the air flow; - pressure of the mask (300) on the face; - occurrence of apnea or hypopnea; - noise caused by the air flow; - snoring, coughing, sneezing, swallowing; 15. speech; - breathing frequency; - composition of the air from the air stream; - volume of air from the air stream; - humidity of the air from the air stream; 20. air temperature of the air stream.

A mask (300) for use in a respiratory system (100) for providing an air flow to a person (500), the mask (300) comprising: 25. a hood (301) for covering at least a portion of the face of the person (500); - an edge (302) for contacting at least a portion of the face; - a device for connecting the mask (300) to a hose (250) of a positive pressure ventilation (PAP) device (200) comprising in the ventilation system (100), characterized in that, the mask (300) is one or a plurality of sensors (310a, b) for recording and transmitting one or more parameters in relation to the air flow.

A mask (300) according to claim 4, characterized in that the one or more sensors (310a, b) are placed at the edge.

A mask (300) according to claim 4 or 5, characterized in that the mask (300) further comprises one or more alarm devices arranged to control the registered one or more parameters sent by the one or more sensors (310a, b) to receive, wherein the one or more alarm devices are arranged to activate a signal upon detection of an exceedance of one or more limit values of the one or more parameters.

A mask (300) according to claim 6, characterized in that the signal is included in the group comprising: - a sound signal to be given by an apparatus such as a loudspeaker (211); - a visual signal to be given by a device such as a flash lamp (212); - a vibration signal controlled by the mask and / or the stroke, to give the vibration signal through a device such as a vibration motor (213); - a signal to control a remote device to perform an alarm procedure, the remote device comprising a device such as the PAP device (200), a personal computer, a Personal Digital Assistant (PDA) (400), a smart phone, or a sound alarm system. 25

A mask (300) as claimed in any one of claims 4-7, characterized in that the one or more sensors (310a, b) are adapted to transmit (216) the one or more parameters to a remote device, such as the PAP device (200), a personal computer, a Personal Digital Assistant (PDA) (400) or a smart phone.

A mask according to any one of claims 6-8, characterized in that the mask (300) comprises an operating button adapted to adjust the one or more limit values of the one or more parameters.

D. reception of the signal by the PAP device (200); E. adjustment by the PAP device (200), based on the received signal, of one or more settings related to the air flow.

A mask according to any one of claims 4-9, characterized in that the one or more sensors (310a, b) are adapted for wireless transmission (350a, b) of the one or more parameters, using a wireless system 5 such as Wi-Fi, Bluetooth, ZigBee or Wireless USB.

A mask according to any one of claims 4-10, characterized in that the one or more parameters are included in the group comprising: - air leakage from the mask (300); 10. speed of the air flow; - pressure of the mask (300) on the face; - occurrence of apnea or hypopnea; - noise caused by the air flow; - snoring, coughing, sneezing, swallowing; 15. speech; - breathing frequency; - composition of the air from the air stream; - volume of air from the air stream; - humidity of the air from the air stream; 20. air temperature of the air stream.

12. A mask (300) according to any one of claims 4-11, characterized in that the one or more sensors (310a, b) are included in the group comprising: A carbon dioxide sensor adapted to measure the amount of carbon dioxide in the air from the air stream; A temperature sensor adapted to measure the temperature of the air from the air stream; An air flow meter adapted to measure the velocity of the air flow through the mask (300);

A pressure sensor or a pressure sensitive resistor adapted to measure the pressure of the mask (300) on the face; A humidity sensor adapted to measure the air humidity of the air stream; A sound sensor or microphone that is designed for measuring sound.

A method of monitoring a respiratory system (100) for providing an air flow to a person (500), the respiratory system (100) comprising: 5. a positive pressure (PAP) device (200), such as a continuous positive pressure (CPAP) device; - the PAP device (200) comprising a hose adapted for transporting air; - a mask (300) comprising a cap (301) for covering at least a part of the face of the person (500); - the mask (300) comprising an edge (302) for contacting at least a portion of the face; - the mask (300) connected to the PAP device (200) with a hose (250); The mask (300) adapted to be removably attached to the face of the person (500), characterized in that, the method comprises the following steps: A. delivery of air from the PAP device (200) by the tube (250) to the mask (300); B. recording one or more parameters in relation to the air flow, using one or more sensors (310a, b) positioned at the location of the mask (300), such as the edge (302) of the mask; C. activation of a signal if the one or more registered parameters exceed one or more limit values.

A method according to claim 13, characterized in that the signal is included in the group comprising: - a sound signal to be given by an apparatus such as a loudspeaker (211); - a visual signal to be given by a device such as a flash lamp (212); - a vibration signal controlled by the mask and / or the stroke, to give the vibration signal by a device such as a vibration motor (213); - a signal to control a remote device to perform an alarm procedure, the remote device comprising a device such as the PAP device (200), a personal computer, a Personal Digital Assistant (PDA) (400), a smart phone, or a sound alarm system. 5

A method according to claim 13 or 14, characterized in that the method comprises the step of manually adjusting the one multiple limit values of the one or more parameters.

A method according to any one of claims 13-15, characterized in that the method comprises the step of automatically adjusting the one or more limit values of the one or more automatically by a self-learning mechanism.

A method according to claim 16, characterized in that the self-learning mechanism comprises the following steps: a) recording sensor data comprising the registered parameters of the one or more sensors (310a, b); b) recording control data which includes historical data in relation to the manual adjustment of the one or more limit values of the one or more parameters; c) identify meaningful relationships between recorded sensor data and the recorded control data; d) adaptation of the one or more limit values of the one or more parameters based on the identified meaningful relationships.

A method according to any one of claims 13-17, characterized in that the one or more parameters are included in the group comprising: - air leakage from the mask (300); 30. speed of the air flow; - pressure of the mask (300) on the face; - occurrence of apnea or hypopnea; - noise caused by the air flow; - snoring, coughing, sneezing, swallowing; - speech; - breathing frequency; - composition of the air from the air stream; - volume of air from the air stream; 5. humidity of the air from the air stream; - temperature of the air from the air stream.

A method according to any one of claims 13-18, characterized in that the method further comprises the following steps:

A method according to claim 19, characterized in that the settings are included in the group: - air pressure of the air flow; - humidity of the air from the air stream; - temperature of the air from the air stream. 20 1039894