WO2014170802A1

WO2014170802A1 - Respiratory device for treating snoring

Info

Publication number: WO2014170802A1
Application number: PCT/IB2014/060613
Authority: WO
Inventors: Meng SHEN; Sheng Jin; Han Yan GONG; Hua Jin
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2013-04-19
Filing date: 2014-04-10
Publication date: 2014-10-23
Anticipated expiration: 2015-10-19

Abstract

The present invention provides a respiratory device (1) for treating snoring comprising a main body portion (3) configured to enclose at least one external orifice of a patient's upper airway to form an enclosed space communicating with the patient's upper airway; a check valve (7) disposed at the main body portion to allow a flow of inhaled gas to flow into the enclosed space and block a flow of exhaled gas from discharging out of the enclosed space; an adjustable flow resistor (9) disposed at the main body portion to resist variably the flow of exhaled gas depending on an amplitude of the patient's snoring; a sensor unit (11) disposed at the main body portion; and a control unit (13) disposed at the main body portion, the control unit being in electrical communication with the adjustable flow resistor and the sensor unit; wherein the sensor unit is configured to detect a real-time pressure within the enclosed space, the control unit determines if the real-time pressure exceeds a preset pressure threshold and controls the adjustable flow resistor to reduce the flow resistance to the flow of exhaled gas if the real-time pressure exceeds the preset pressure threshold. The respiratory device according to the present invention may prevent an excess pressure from being accumulated in the respiratory device.

Description

RESPIRATORY DEVICE FOR TREATING SNORING

FIELD OF THE INVENTION

The invention relates to a respiratory device, in particular to a respiratory device for treating snoring.

BACKGROUND OF THE INVENTION

A flow of breathing gas flows in a smooth, laminar manner when a person breathes normally. Obstructions that occur along the upper airway of a person will result in air turbulence. The flow of turbulent gas is often accompanied by irregular vibration of structures of the upper airway. Snoring occurs when there is a blockage at a back area of the mouth and the nose through which the flow of breathing gas passes. This back area is collapsible when the structures in this area of the upper airway strike each other and vibrate during breathing so that snoring occurs. The resultant sound, snoring, may range from mild to severe.

Many respiratory devices for treating snoring have been developed in order to eliminate the snoring phenomena that have negative effect on the patient and his/her couple's sleep quality. A mechanism for the respiratory devices is based on the EPAP (Expiratory Positive Airway Pressure) which supplies a positive pressure to the patient when the patient exhales. Different from a traditional EPAP used on the ventilator, the positive pressure during the exhalation is obtained from the patients themselves by increasing the flow resistance to the flow of exhaled gas.

A conventional nasal respiratory device generally comprise a hollow main body portion, a pair of nasal prongs extending from and being in fluid communication with the main body portion, a check valve for allowing the flow of gas to flow into the main body portion and a flow resistor for inhibiting the flow of gas from exhalation. In use, the pair of nasal prongs is inserted into the patient's nostrils. However, this flow resistor keeps a constant and high flow resistance during the whole sleep time even if no flow blockage or snoring occurs. In this case, the patient will suffer from hard exhalation which aggravates discomfort and, furthermore, the excess pressure accumulated in the nasal respiratory device could cause some safety issues.

Thus, there is a need to make improvements on the conventional respiratory device. SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide a respiratory device which may prevent an excess pressure from being accumulated in the respiratory device.

It is another object of the present invention to provide a respiratory device which may change the flow resistance to the flow of exhaled gas depending on the patient's snoring to avoid any discomfort and danger.

According to one aspect of the present invention, it is to provide a respiratory device for treating snoring comprising:

a main body portion configured to enclose at least one external orifice of a patient's upper airway to form an enclosed space communicating with the patient's upper airway;

at least one check valve disposed at the main body portion to allow a flow of inhaled gas to flow into the enclosed space and block a flow of exhaled gas from discharging out of the enclosed space,

at least one adjustable flow resistor disposed at the main body portion to resist variably the flow of exhaled gas;

a sensor unit disposed at the main body portion; and a control unit disposed at the main body portion, the control unit being in electrical communication with the adjustable flow resistor and the sensor unit; wherein the sensor unit is configured to detect a real-time pressure within the enclosed space, the control unit determines if the real-time pressure exceeds a preset pressure threshold and controls the adjustable flow resistor to reduce the flow resistance to the flow of exhaled gas if the real-time pressure exceeds the preset pressure threshold. According to this invention, when the real-time pressure within the enclosed space exceeds the preset pressure threshold, the control unit controls the adjustable flow resistor to reduce the flow resistance to the flow of exhaled gas, the potential danger for the patient's respiration caused by the excessive pressure accumulated within the enclosed space may be relieved.

Preferably, the sensor unit is further configured to detect the patient's snoring and convert the patient's snoring into an initial electrical signal, the control unit processes the received initial signal, and the adjustable flow resistor changes the flow resistance to the flow of exhaled gas according to the amplitude of the processed signal. According to this invention, the respiratory device may not only prevent an excess pressure from being accumulated in the enclosed space but also change the flow resistance to the flow of exhaled gas depending on the patient's snoring to avoid any discomfort and danger.

Preferably, the control unit comprises a high-pass filter, processing the received initial signal comprises removing the low frequency signal from the detected initial signal by the high-pass filter to extract the snoring signal from the received initial signal, and the adjustable flow resistor changes the flow resistance to the flow of exhaled gas in response to the extracted snoring signal.

Preferably, the control unit comprises a low-pass filter, processing the received initial signal comprises removing the high frequency signal from the detected initial signal by the low-pass filter to extract the respiratory wave from the received initial signal.

Preferably, the adjustable flow resistor is an electrical valve. Preferably, the degree of opening of the electrical valve reduces when the amplitude of the snoring signal increases.

Preferably, the electrical valve opens fully when no snoring occurs.

Preferably, the respiratory device further comprises a holdfast for keeping the respiratory device around the patient's head in place.

Preferably, the respiratory device is a nasal respiratory device, the main body portion defines a hollow cavity, a pair of nasal prongs extend from and are in fluid communication with the hollow cavity, and the enclosed space is partly formed in the hollow cavity.

These and other objects, features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate

corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a nasal respiratory device according to the present invention. FIGS. 2a and 2b show an initial signal detected by a sensor unit and a snoring signal extracted from the initial signal respectively.

FIGS. 3a and 3b show an initial signal detected by a sensor unit and a respiratory signal extracted from the initial signal respectively.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 is a perspective view of a nasal respiratory device according to the present invention. As shown in Fig 1, a nasal respiratory device 1 according to the present invention comprises a main body portion 3 in a tubular shape, a pair of nasal prongs 5 extending from and being in fluid communication with the main body portion 3, one or more check valves 7 disposed to allow the flow of inhaled gas to flow into the main body portion 3 and block the flow of exhaled gas from discharging out of the main body portion 3, and one or more adjustable flow resistors 9 disposed to resist variably the flow of exhaled gas depending on the amplitude of the patient's snoring and allow the patient's free exhaling in absence of snoring. Although the main body portion 3 in the preferred embodiment is shown to be in a tubular shape, the main body portion 3 may be in any suitable shape defining a hollow cavity. The pair of nasal prongs 5 are made from soft and flexible material such as silicone or silicone-like material. In a preferred embodiment, the adjustable flow resistor 9 is an electrical valve which is mounted respectively to the opposite ends of the main body portion 3 and is controlled electronically to change a flow resistance to the flow of exhaled gas. Of course, the nasal respiratory device 1 according to the present invention may comprise a holdfast 10 for keeping the nasal respiratory device 1 around the patient's head in place.

The nasal respiratory device 1 according to the present invention further comprises a sensor unit 11 disposed at the main body portion 3 and a control unit 13 disposed at the main body portion 3. Although the sensor unit 11 in the illustrated embodiment is disposed outside of the main body portion 3, the sensor unit 11 may be disposed inside of the main body portion 3. When the sensor unit 11 is disposed outside of the main body portion 3, the sensor unit 11 is in communication with the inner space of the main body portion 3. The sensor unit 11 is configured to detect the patient's snoring and convert the patient's snoring into an initial electrical signal. The control unit 13 is in electrical communication with the adjustable flow resistor 9 and the sensor unit 11. The control unit 13 receives the initial signal from the sensor unit 11 and processes the received initial signal. And the adjustable flow resistor 9 is controlled by the control unit to change the flow resistance to the flow of exhaled gas according to the processed signal.

The control unit 13 comprises a high-pass filter and/or a low-pass filter. Processing the received initial signal comprises removing the low frequency signal from the received initial signal through the high-pass filter. The most significant criterion for detecting the initial signal is its sampling rate. The appropriate sampling rate should be around 200 Hz. According to the settings of Polysomnogram (PSG) and the known knowledge in the art, the snoring features can be extracted and analyzed when the signal below 70 Hz is removed by the high-pass filter of the control unit 13. FIG. 2a shows the initial signal detected by the sensor unit 11. FIG 2b shows a snoring signal extracted from the initial signal. Therefore, the snoring signals are easily detectable in absence of audio sensor. The control unit 13 sends the extracted snoring signal to the adjustable flow resistor 9. The adjustable flow resistor 9 changes the flow resistance to the flow of exhaled gas according to the amplitude of the snoring signal. The larger the amplitude of the snoring signal is, the higher the flow resistance to the flow of exhaled gas is, thereby establishing a positive air pressure in the upper airway of the patient which effectively prevents the airway from collapsing. In the case that the adjustable flow resistor 9 is an electrical valve, the degree of opening of the electrical valve reduces when the amplitude of the snoring signal increases. When no snoring occurs, the electrical valve opens fully without establishing any significant flow resistance to the flow of exhaled gas. Hereby, the amplitude of the snoring signal might means the maximum value of the snoring signal within a certain period, or the amplitude of the snoring signal could means the average value of the snoring signal within a certain period, preferably said certain period is a respiratory circle.

The respiratory wave during the inhalation and exhalation is an important parameter for monitoring the medical effectiveness of a nasal respiratory device. For example, the respiratory wave can distinguish whether the AHI (Apnea Hypopnea Index) is reduced by the nasal respiratory device. The conventional nasal respiratory device that utilizes the expiratory positive pressure is unable to trace the whole night respiratory status and clinical effectiveness. According to the present invention, processing the received initial signal may further comprise removing the high frequency (i.e. more than 5 Hz) signal from the received initial signal by the low-pass filter of the control unit 13. FIG. 3 a shows an initial signal detected by a sensor unit. FIG 3b shows a respiratory signal extracted from the initial signal. According to the present invention, not only the snoring signal can be detectable but also the respiratory wave may be in-timely recorded.

The pressure within the main body portion 3 increases gradually when the adjustable flow resistors 9 resists the flow of exhaled gas. If the pressure accumulated within the main body portion 3 rises too high, the patient may feel breathless and uncomfortable, thereby imposing potential danger for the patient's respiration. According to the invention, the sensor unit 11 is further configured to detect the real-time pressure within the main body portion 3 and send the detected real-time pressure to the control unit 13. The control unit 13 determines if the real-time pressure exceeds a preset pressure threshold. If the real-time pressure exceeds the preset pressure threshold, the control unit 13 controls the adjustable flow resistor 9 to reduce the flow resistance to the flow of exhaled gas, resulting in a larger passage for the flow of exhaled gas. Here, the real-time pressure used to compared with the preset pressure could be an instant value. Hereby, it also should be clear that as control signals the real-time pressure will take priority over the amplitude of the patient's snoring. This means if the below two situation are detected by the sensor unit 11 during the same period: (a) the real-time pressure exceeds the preset pressure threshold and (b) the amplitude of the patient's snoring increases, then the (a) situation will prevail, and the control unit 13 will control the adjustable flow resistor 9 to reduce the flow resistance to the flow of exhaled gas. Although the above-mentioned reduction of the flow resistance of the adjustable flow resistor 9 could be a gradual change, preferably the reduction is a skipping change, for example, when said (a) situation is detected then the adjustable flow resistor 9 will be set to ¼ open, ½ open, ¾ open or even fully open. As a result, the detected real-time pressure within the main body portion 3 is decreased accordingly to be below the preset pressure threshold, and the breath safety issue will be relieved. In an extreme case, if the adjustable flow resistor 9 has malfunction and closes fully by accident, the sensor unit 11 can detect this situation since the pressure level within the main body portion 3 exceeds the preset pressure threshold. The nasal respiratory device then will start a safety protection function such as trying to open the adjustable flow resistor 9 compulsively or give out an alarm to wake the patient.

In the preferred embodiment as stated above, the respiratory device for treating snoring according to the invention is a nasal respiratory device. However, the respiratory device for treating snoring according to the invention may be a nasal/oral mask which covers the patient's nose and mouth. In the latter case, the main body portion of the respiratory device forms the body of the nasal/oral mask so that the external orifices (nostrils and mouth) of the patient's upper airway are enclosed separately from the ambient atmosphere. Of course, the respiratory device for treating snoring according to the invention may be an oral mask which covers only the patient's mouth.

Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims.

Claims

1. A respiratory device for treating snoring comprising:

a main body portion (3) configured to enclose at least one external orifice of a patient's upper airway to form an enclosed space communicating with the patient's upper airway; at least one check valve (7) disposed at the main body portion (3) to allow a flow of inhaled gas to flow into the enclosed space and block a flow of exhaled gas from discharging out of the enclosed space;

at least one adjustable flow resistor (9) disposed on the main body portion (3) to resist variably the flow of exhaled gas;

a sensor unit (11) disposed at the main body portion (3); and

a control unit (13) disposed at the main body portion (3), the control unit (13) being in electrical communication with the adjustable flow resistor (9) and the sensor unit (11); wherein the sensor unit (11) is configured to detect a real-time pressure within the enclosed space, the control unit (13) determines if the real-time pressure exceeds a preset pressure threshold and controls the adjustable flow resistor (9) to reduce the flow resistance to the flow of exhaled gas if the real-time pressure exceeds the preset pressure threshold.

2. The respiratory device according to claim 1, wherein the sensor unit (11) is further configured to detect the patient's snoring and convert the patient's snoring into an initial electrical signal, the control unit (13) processes the received initial electrical signal, and the adjustable flow resistor (9) changes the flow resistance to the flow of exhaled gas according to the processed signal.

3. The respiratory device according to claim 2, wherein the control unit (13) comprises a high-pass filter, processing the received initial electrical signal comprises removing the low frequency signal from the received initial electrical signal by the high-pass filter to extract the snoring signal from the received initial electrical signal, and the adjustable flow resistor (9) changes the flow resistance to the flow of exhaled gas in response to the amplitude of the extracted snoring signal.

4. The respiratory device according to claim 2 or 3, wherein the control unit (13) comprises a low-pass filter, processing the received initial electrical signal comprises removing the high frequency signal from the received initial electrical signal by the low-pass filter to extract the respiratory wave from the received initial electrical signal.

5. The respiratory device according to any one of claims 1-3, wherein the adjustable flow resistor (9) is an electrical valve.

6. The respiratory device according to claim 5, wherein the degree of opening of the electrical valve reduces when the amplitude of the snoring signal increases.

7. The respiratory device according to claim 5, wherein the electrical valve opens fully when no snoring occurs.

8. The respiratory device according to any one of claims 1-3, wherein the respiratory device further comprises a holdfast (10) for keeping the respiratory device around the patient's head in place.

9. The respiratory device according to any one of claims 1-3, wherein the respiratory device is a nasal respiratory device, the main body portion (3) defines a hollow cavity, a pair of nasal prongs (5) extend from and are in fluid communication with the hollow cavity , and the enclosed space is partly formed in the hollow cavity.