WO2011097604A2

WO2011097604A2 - Adapter for snore detection of patient

Info

Publication number: WO2011097604A2
Application number: PCT/US2011/023977
Authority: WO
Inventors: Kyle L. Adriance; James Chua; James N. Curti
Original assignee: Salter Labs
Priority date: 2010-02-08
Filing date: 2011-02-08
Publication date: 2011-08-11
Also published as: WO2011097604A3

Abstract

An adapter, for detecting breathing information useful in determining patient snore, for use in combination with a pressure sensing device. The adapter is connected to the pressure sensing device via at least one coupling tubing. The adapter comprising a housing having a base surface with an inlet opening being formed in the base surface. An outlet opening is formed in the housing which communicates with the inlet opening via an internal cavity. At least one tubing interface is formed in the housing, adjacent the outlet opening, for coupling a tubing of the pressure sensing device to the outlet opening and facilitate channeling of breathing information, detected by the adapter to the pressure sensing device.

Description

[001] ADAPTER FOR SNORE DETECTION OF PATIENT

[002] FIELD OF THE INVENTION

[003] The present invention relates to an apparatus for sensing sound and/or pressure wave form information and is useful in detecting snore by a patient during for a sleep diagnostic procedure.

[004] BACKGROUND OF THE INVENTION

[005] Sleep apnea (SA) is a common disorder observed in the practice of sleep medicine and is responsible for more mortality and morbidity than any other sleep disorder. Sleep apnea is characterized by recurrent failures to breathe adequately during sleep (termed apneas or hypopneas) as a result of obstructions in the upper airway.

[006] Apnea is typically defined as a complete cessation of airflow. Hypopnea is typically defined as a reduction in airflow disproportionate to the amount of respiratory effort expended and/or insufficient to meet the individual's metabolic needs. During an apnea or a hypopnea-commonly referred to as a respiratory event-oxygen levels in the brain decrease while the carbon dioxide (CO₂) levels rise, thereby causing the person sleeping to awaken. The heart beats rapidly and blood pressure rises (up to levels of 300 mm Hg). The brief arousals to breathe are followed by a return to sleep but, in severe cases, the apneas may recur over 60 times per hour.

[007] Sleep apnea is a serious, yet treatable health problem for individuals. The current standard for the diagnosis of sleep apnea is called polysomnography (PSG), which is administered and analyzed by a trained technician and reviewed by a Board Certified Sleep Specialist. The limited availability of sleep centers coupled with the high capital expense, in order to add additional capacity for diagnosis of sleep disorders, has resulted in a growing number of patients awaiting analysis by PSG.

[008] A conventional full overnight PSG includes recording of the following signals: electroencephalogram (EEG), sub-mental electromyogram (EMG), electroculogram (EOG), respiratory airflow (oronasal flow monitors), respiratory effort (plethysmography), oxygen saturation (oximetry), electrocardiography (ECG), snoring sounds and body position. These signals are considered the "gold standard" for the diagnosis of sleep disorders in that they offer a relatively complete collection of parameters from which respiratory events may be identified and sleep apnea may be reliably diagnosed. The RR interval, commonly referred to as beats per minute, is derived from the ECG. The body position is normally classified as right side, left side, supine, prone, or up (e.g., sitting erect). Typically, a microphone is taped over the pharynx and the body position sensor is attached over the sternum of the patient's chest. Each signal provides some information which assists with the visual observation and recognition of the respiratory events.

[009] A collapse of the upper airway is identified when the amplitude of the respiratory airflow and the effort signals decrease by at least 50%, snoring sounds either crescendo or cease, and oxygen desaturation occurs. A respiratory event is confirmed (i.e., desaturation not a result of artifact) by the recognition of an arousal (i.e., the person awakens to breathe), typically identified by an increase in the frequency of the EEG, an increase in the heart rate or a change in a snoring pattern. The remaining signals assist in determining specific types of respiratory events. For example, the EEG and EOG signals are used to determine if a respiratory event occurred in either non-rapid eye movement (NREM) or rapid eye movement (REM) sleep. The position sensor is used to determine if an airway collapse occurs only, or mostly, in just one body position (e.g., typically the supine position).

[010] A reduction or absence of airflow at the airway opening defines obstructive sleep-disorder breathing. In an adult, the absence of airflow for a duration of 10 seconds is apnea, and airflow reduced below a certain amount is a hypopnea. Ideally one would measure actual flow with a pneumotachygraph of some sort, but in clinical practice this is impractical, and devices that are comfortable and easy to use are generally substituted. The most widely used are thermistors which are placed in front of the nose and the mouth to detect temperature changes of a thermally sensitive resistor, e.g., heating (due to expired gas) and cooling (due to inspired air). They provide recordings of changes in airflow, but as typically employed are not quantitative instruments. In some laboratories, measurement of end tidal CO₂ is used to detect expiration to produce both qualitative and quantitative measures of a patient's breath.

[011] An alternative method is to measure changes in pressure in the nasal airway that occur during breathing. This approach provides an excellent reflection of true nasal flow. A simple nasal cannula, attached to a pressure transducer, can be used to generate a signal that resembles one obtained with a pneumotachograph. It allows detection of the characteristic plateau of pressure due to inspiratory flow limitation that occurs in subtle obstructive hypopneas.

[012] An obstructive apnea or hypopnea is defined as an absence or reduction in airflow, in spite of continued effort to breathe, due to obstruction in the upper airway. Typical polysomnography includes some recording of respiratory effort. The most accurate measure of the effort is a change in pleural pressure as reflected by an esophageal pressure monitor. Progressively more negative pleural pressure swings, leading to an arousal, have been used to define a "Respiratory Effort Related Arousal" (RERA), the event associated with the so-called "Upper Airway Resistance Syndrome". However, the technology of measuring esophageal pressure is uncomfortable and expensive, and rarely used clinically. Most estimates of respiratory effort, during polysomnography, depend on measures of rib cage and/or abdominal motion. The methods include inductance or impedance plethysmography, or simple strain gages. Properly used and calibrated, any of these devices can provide quantitative estimates of lung volume and abdominal-rib cage paradox. However, calibrating during an overnight recording is very difficult and, as a practical matter, is almost never done. The signals provided by respiratory system motion monitors are typically just qualitative estimates of respiratory effort.

[013] Pressure sensing devices are currently available and used during a sleep diagnostic procedure to detect changes in respiratory air pressure and/or airflow to confirm whether or not a patient is breathing and to gather other breathing information from the patient. Accurate modeling of the patient's breathing cycle is limited by the use of only pressure sensors as the placement of sensors and system failures can cause false readings or pressure offsets that must be adjusted or compensated in order to properly model the breathing cycle.

[014] Such pressure sensing device is typically used during an initial phase of a sleep diagnostic procedure to detect changes in respiratory air pressure and/or airflow and confirm whether or not a patient is breathing as well as gathering other associated breathing information from the patient. One such respiratory air pressure and/or airflow system is offered by Salter Labs of Arvin California under the BINAPS Trademark. This pressure sensing device is typically used during the initial phase of the sleep diagnostic study for gathering air flow information and detecting whether or not the patient is snoring. In addition to gathering associated breathing information from the patient, as noted above, one or more of the following additional information is collected during an initial phase of the sleep diagnostic procedure such as the heart rate of the patient, oxygen (O₂) saturation of the patient, chest excursions of the patient, the abdominal excursions of the patient, an electroencephalogram (EEG) of the patient, and an electrocardiography (ECG) of the patient as well as the position of the patient, namely, whether the patient is resting on his/her back or in some other position.

[015] Once sufficient data is collected from the patient and an airway obstruction(s) is identified, then it becomes necessary to titrate the patient using a conventional Continuous Positive Airway Pressure (CPAP) device to determine the optimum level of pressure needed to "splint" the airway with positive pressure so that the airway remains open while the patent breathes and sleeps.

[016] As is well known in the art, that prior airflow pressure sensing device typically has two output channels which are used to provide waveforms that indicate breathing and snore, which are herein after collectively referred to as "breathing information," via a conventional nasal cannula worn by a patient during the initial phase of the sleep diagnostic procedure. The nasal cannula typically has a pair of spaced apart nares, and possibly one or more mouthpiece prongs, which facilitate detection of the respiratory air pressure wave form and/or the respiratory airflow information in the event that the patient breathes through his/her mouth. The nasal cannula collects or acquires the desired breathing information from the nostrils and/or the mouth of the patient being monitored as the patient breathes during the sleep diagnostic procedure.

[017] The acquired breathing information is channeled or directed along a pair of separate flexible conduits or tubing (one connected to each opposed outlet end of the nasal cannula), and the two separate flexible conduits or tubing which eventually merge or combine with one another, at a Y-shaped coupling device, into a common flexible conduit or tubing. One end of the common flexible conduit or tubing is connected to the Y-shaped coupling device while a second opposed end of the common flexible conduit or tubing is connected to an input port of the pressure sensing device for supplying the acquired breathing information from the patient to the pressure sensing device.

[018] If desired, a filter may be provided somewhere along the common flexible conduit or tubing, or at the interface between the common flexible conduit or tubing and the pressure sensing device, to prevent moisture, or other particulate matter, from flowing or being conveyed from any one of the openings of the nasal cannula into the pressure sensing device.

[019] The acquired breathing information, e.g., the airflow pressure waveform and snore, is received by the input port and is generally conveyed to a piezoelectric crystal or a piezo transducer, for example, which is accommodated within the pressure sensing device. The received signal is initially split into first and second separate signals and the first signal is processed by the respiratory airflow detection circuit while the second signal is separately processed by the snore detection circuit, prior to outputting the processed signals to conventional diagnostic equipment such as polysomnography equipment, for example. As the diagnostic equipment does not form any part of the present invention, per se, a further detail discussion concerning the same will not be provided herein.

[020] The pressure sensing device is typically equipped with a "Hi/Lo" switch for the respiratory airflow detection circuit and a "Hi/Lo" switch for the snore detection circuit and each switch normally has two setting or positions, namely, a Hi (high) position and a Lo (low) position. When either switch is in the Lo (low) position, the amplitude of the output signal is generally one fourth of the amplitude of the output signal for the Hi (high) position. Conversely, when either switch is in its Hi (high) position, the amplitude of the output signal is generally four times the amplitude of the output signal for the Lo (low) position. It is to be appreciated that other relationships or correlations, between the Hi (high) and the Lo (low) positions, are also possible. During a sleep diagnostic procedure, it is to be appreciated that either switch may be in either position.

[021] The acquired respiratory breathing information, received from the patient to be monitored, is collected and inputted to the pressure sensing device via the input port. The input port communicates with the piezo crystal or transducer, via an internal passage, to supply the acquired breathing information thereto and the supplied breathing information at least one of moves, vibrates and/or excites the piezo crystal or the transducer. The piezo crystal or the transducer, in turn, outputs an electrical signal, depending upon the extend or degree that the piezo crystal or the transducer is excited by the supplied breathing information. As noted above, this electrical signal is then divided into two separate signals, and each inputted signal passes through the respective circuits and is suitably processed and outputted to conventional sleep diagnostic equipment, such as a polysomnography equipment, which can then be utilized to collect, monitor, record and/or plot the airflow characteristics and/or the snore characteristics of the patient being monitored, as is necessary or desired. As noted above, the other additional information is collected and supplied to the polysomnography equipment to assist with proper analysis of the patient.

[022] One problem associated with the above discussed system of the prior art is that during conventional titration of the patient, when the patient is being supplied with air pressure by a face mask, it is generally important to detect whether or not the patient is snoring. That is, the air pressure level is gradually increased to a level at which the obstruction of the patient is alleviated and thus the patient no longer snores. Typically, the air pressure generates a sufficient back pressure in the breathing passages of the patient as the patient breathes. However, in the event that a perimeter seal of a mask worn by the patient during titration is breached or broken in order to position a cannula, or some other prior art snore detection device, adjacent to the nose and/or mouth of the patient for detecting snore of the patient, such breach in the mask seal causes a leak which affects the titration analysis. That is, any leakage of the mask seal tends to lead to an incorrect and/or an inaccurate determination of the pressure requirements for the patient in order to alleviate any obstruction and this, in turn, can lead to either patient arousal or continued snoring of the patient due to the failure to adequately treat the obstruction. [023] SUMMARY OF THE INVENTION

[024] Wherefore, it is an object of the present invention to provide a snore detection device which facilitates detection of snore of a patient while not in any way compromising the perimeter seal achieved by a mask which is utilized for supplying air pressure to a patient during a titration procedure.

[025] Another object of the present invention is to provide a relatively inexpensive, flexible and disposable snore detection device which reliably and consistently detects snoring by a patient during a sleep diagnostic procedure. Preferably, due to the inexpensive cost of the snore adapter, the snore adapter is a single use product which can be properly disposed of following use thereof.

[026] A still further object of the present invention is to provide a snore adapter which can be molded as a unitary component, from a relatively soft and flexible material, and be easily connected to existing tubing of a conventional pressure detection device.

[027] Yet another object of the present invention is to provide a snore adapter which is relatively small in size and height and can be easily manipulated by the operator as well as easily secured to a desired detection area of the skin of the patient for detecting sound or pressure wave form information from the patient.

[028] Still another object of the present invention is to provide a snore adapter which has a relatively large inlet opening as well as circumferential surface area, formed in a base surface thereof, so that an adequate perimeter seal can be formed completely around the relatively large inlet opening to improve the quality of the sound or pressure waveform information received and detected by the inlet opening.

[029] Another object of the present invention is to provide the snore adapter with a tubing interface which facilitates quick and easy coupling at least at one free end, and possibly a pair of free ends, of the separate flexible conduits or tubings which are connected to a common flexible conduit or tubing, for supplying sufficient breathing information to the pressure sensing device.

[030] Another object of the invention is to funnel, channel and/or direct substantially all of the detected sound and/or pressure wave form information, received by the relatively large inlet opening, into one or possibly the pair of tubes which facilitate channeling and supplying substantially all of the detected sound and/or pressure wave form information along the tube(s) toward the suitable pressure sensing device for subsequent processing.

[031 ] A still further object of the invention is to ensure that the relatively large inlet opening directly communicates with the throat or larynx of the patient so as to detect sufficient sound and/or pressure wave form information from the patient, during breathing, which can be then used to detect snore of the patient.

[032] The present invention also relates to an adapter for detecting breathing information useful in determining patient snore, the adapter comprising a housing having a base surface; an inlet opening being formed in the base surface; an outlet opening being formed in the housing and communicating with the inlet opening via an internal cavity; and a tubing interface being formed in the housing, adjacent the outlet opening, for coupling a tubing to the outlet opening and facilitating channeling of breathing information, detected by the adapter, to a sensing device.

[033] The present invention also relates to the combination of an adapter, for detecting breathing information useful in determining patient snore, being coupled to a pressure sensing device via at least one coupling tubing, the pressure sensing device having a common tubing with a Y-shaped coupling coupled to a pair of the coupling tubings, and the adapter comprising a housing having a base surface; an inlet opening being formed in the base surface; an outlet opening being formed in the housing and communicating with the inlet opening via an internal cavity; and a tubing interface being formed in the housing, adjacent the outlet opening, for coupling at least one tubing to the outlet opening and facilitate channeling of breathing information, detected by the adapter, to the pressure sensing device.

[034] BRIEF DESCRIPTION OF THE DRAWINGS

[035] The invention will now be described, by way of example, with reference to the accompanying drawings in which: [036] Fig. 1 is a diagrammatic view showing connection of the snore adapter, of the present invention, to suitable pressure detection device;

[037] Fig. 2 is a diagrammatic side elevational view of the snore adapter, of the present invention, shown connected to desired pressure detection tubing;

[038] Fig. 2A is a diagrammatic cross sectional view along section line 2A-2A of

Fig. 2;

[039] Fig. 3 is a bottom plan view of the snore adapter of Fig. 2;

[040] Fig. 4 is a top plan view of the snore adapter of Fig. 2;

[041] Fig. 4A is a diagrammatic cross sectional view along section line 4A-4A of

Fig. 4;

[042] Figs. 5A-5J are cross sectional views along the respective sections lines shown in Fig. 4A;

[043] Fig. 6 is a diagrammatic side elevational view of a second embodiment of the snore adapter, of the present invention, shown connected to desired pressure detection tubing;

[044] Fig. 6A is a diagrammatic top plan view of Fig. 6;

[045] Fig. 6B is a diagrammatic bottom plan view of Fig. 6;

[046] Fig. 6C is a diagrammatic front elevational view of Fig. 6;

[047] Fig. 6D is a diagrammatic rear elevational view of Fig. 6;

[048] Fig. 7A is a diagrammatic cross sectional view along section line 7A-7A of

Fig. 6A;

[049] Fig. 7B is a diagrammatic cross sectional view along section line 7B-7B of

Fig. 6;

[050] Fig. 8A is a diagrammatic cross sectional view along section line 8A-8A of

Fig. 6A;

[051] Fig. 8B is a diagrammatic cross sectional view, similar to Fig. 7B, showing a modification thereof; ₉

[052] Fig. 9 is a drawing depicting, in the top two graphs of that Figure, breathing information collected using the BINAPS pressure sensor device of Salter Labs and, in the bottom graph of that Figure, sound and/or pressure wave form information collected from a patient with the snore adapter, according to the present invention, in combination with the BINAPS pressure sensor device of Salter Labs. This graph illustrates the superior results obtained by the BINAPS pressure sensor device of Salter Labs in comparison to the prior art pressure sensor device of Fig. 10;

[053] Fig. 10 is a drawing depicting, in the top two graphs of the Figure, breathing information collected using a competing pressure sensor device and, in the bottom graph of that Figure, sound and/or pressure wave form information collected from a patient with the snore adapter, according to the present invention, in combination with the competing pressure sensor device;

[054] Fig. 1 1 is a diagrammatic front elevational view of a third embodiment of the snore adapter, of the present invention, showing a plurality of snore adapters affixed to an elongate sheet of release paper; and

[055] Fig. 1 1A is a diagrammatic exploded view of base of the third embodiment of the snore adapter.

[056] DETAILED DESCRIPTION OF THE INVENTION

[057] Turning first to Fig. 1 , a brief description concerning the various components of a snore adapter, for use in sensingsound and/or pressure wave form information which can be used to detect snore of a patient, will now be briefly discussed. As can be seen in that figure, a first end 4 of a conventional coupling tubing 6 is connected to the snore adapter 2 of the present invention, which is described below in further detail, while the opposite end 7 of a conventional common tubing 8 is connected to conventional pressure sensing device 10, e.g., equipment which is typically capable of detecting both the breathing airflow of the patient as well as any snoring of the patient. Generally, a conventional Y-shaped coupling 9 interconnects a pair of the conventional coupling tubings 6 with the common tubing 8. The conventional pressure sensing device 10 receives the collected and inputted breathing information and interprets the sensed pressure and/or other breathing information for detecting both airflow and snoring of a patient in the manner described in United States Patent No. 7,451 ,762, and such teaching is incorporated herein by reference.

[058] Turning now to Figs. 2-4A, a detail description concerning the snore adapter 2, according to the present invention, will now be provided. The snore adapter 2 is typically a unitary single component which is manufactured from a plastisol, for example, or some other rigid or flexible material so that the snore adapter 2 may directly contact the skin of a patient without causing irritation or discomfort. As can be seen in those figures, the snore adapter 2 generally comprises a substantially planar, but generally flexible base 12 which is designed to abut against and closely and intimately contact a desired area of the skin of the patient, e.g., the throat or larynx, while, at the same time, the flexible base 12 closely adapts and conforms to the exterior contour or profile of the skin of the patient during use. To facilitate adhering or securing the flexible base 12 of the snore adapter 2 to the desired area of the skin of the patient, e.g., the throat, the larynx, etc., generally the entire base surface 14 of the planar base 12 is typically coated or covered with an adhesive 16 which adhesively secures the snore adapter 2 to skin of a patient but still facilitates removal from the skin following use thereof. It is important that the adhesive 16 generally affix the planar base 12 to the skin so that a perimeter seal S (see Fig. 3) is formed around the entire perimeter of the inlet opening 20, and this perimeter seal assists with obtaining high quality breathing information and data from the patient and also reduces distortion. One suitable adhesive 16 is, for example, a 1522 adhesive manufactured by 3M of St. Paul, MN.

The outwardly facing, exposed adhesive 16 is typically covered with a removable release paper or liner 8 which can be easily peeled away from the adhesive 16, carried by the outwardly facing surface of the planar base 12 of the snore adapter 2, to expose the adhesive 6 which can then be utilized for directly securing the snore adapter 2 to the skin. That is, once the release paper or liner 18 is removed from the base 12, the adhesive 16 is exposed and can attach the base 12 of the snore adapter 2 to the desired area of a patient, during a diagnostic procedure, and facilitate collection of breathing information, as will be discussed below in further detail. Alternatively, a plurality of snore adapters 2 can all be affixed to a large or elongate sheet of release paper, in spaced relationship from one another (similar to Fig. 1 1 ), and each individual snore adapter 2 can then be removed from the large or elongate sheet of release paper when required. It is also to be appreciated that the snore adapter 2 may be directly affixed to the skin of a patient by, for example, a conventional tape so long as the base 12 remains in intimate contact with the skin and forms a suitable perimeter seal S, as discussed above.

[060] The inlet opening 20, e.g., generally circular in shape, is formed in the substantially planar base 12 so as to allow the desiredsound and/or pressure wave form information to enter into a housing 24 of the snore adapter 2. The inlet opening 20 typically has a maximum dimension or diameter of between about 1/8 of an inch to about 1 inch, more preferably between about 3/16 of an inch to about 3/4 of an inch, and most preferably between about 1/4 of an inch to about ½ of an inch which allows desired sound and/or pressure wave form information to enter into a flexible housing 24 of the snore adapter 2 without any obstruction. In addition, an outlet opening 22, e.g., generally circular in shape, is formed in the housing 24. The outlet opening 22 typically has a maximum dimension or diameter of between about 1/32 of an inch to about 1/4 of an inch, more preferably has a dimension or diameter of between about 1/16 of an inch to about 1/8 of an inch, and most preferably has a dimension or diameter of about 5/64 of an inch. The outlet opening 22 is typically sized so as to have approximately the same size as the inside diameter or dimension of the coupling tubing 6 which is to be connected to the snore adapter 2, as discussed below in further detail.

[061] As shown in Fig. 4A, the flexible housing 24 of the snore adapter 2 has a generally "funnel or horn shaped" internal cavity 26 with a 90 degree bend formed therealong. A first end of the funnel or horn shaped internal cavity 26 is coincide with the inlet opening 20 while a smaller second end of the funnel or horn shaped internal cavity 26 is coincident with the outlet opening 22. Due to the shape of the internal cavity 26, substantially all of the sound, pressure wave form information and/or breathing information detected by the snore adapter 2, as the patient breaths during a sleep diagnostic procedure, is received by and passes through the inlet opening 20 and is directed, by the funnel or horn shaped internal cavity 26, toward and out through the outlet opening 22 of the snore adapter 2 into the coupling tubing 6 for conveyance to the pressure sensing device 10.

[062] As noted above, the outlet opening 22 of the snore adapter 2 communicates with the free end 4 of the coupling tube 6 for channeling substantially all of the inputted sound or pressure wave form information and/or breathing information, received by the inlet opening 20, along the flexible coupling tubing 6 to the desired pressure sensing device 10 for subsequent processing and interpretation into accurate and reliable snore information concerning the patient.

[063] An end of the housing 24, adjacent the outlet opening 22, has a tubing interface 28 formed therein. The tubing interface 28 has a tubing recess 29 with a diameter which is sized to closely receive and accommodate the leading free end 4 of the coupling tubing 6 therein, e.g., the tubing recess 29 typically has an internal diameter of between about 1/32 of an inch to about 3/8 of an inch, more preferably has a diameter of between about 3/32 of an inch to about 5/32 of an inch, and most preferably has a diameter of about 1/8 of an inch and a depth of between about 1/8 of an inch to about ½ an inch or so, and more preferably a depth of about 3/8 of an inch or so. It is to be appreciated that the internal diameter of the tubing recess 29 is generally slightly larger than the outlet opening 22 so as to form a stop surface.

[064] A bottom or end surface 30 of the tubing recess 29 forms a stop surface which abuts against a leading end of the coupling tubing 6 so as to prevent further insertion of the coupling tubing 6 within the tubing recess 29. To assist with retaining the coupling tubing 6 in engagement with the tubing interface 28, the snore adapter 2 includes first and second opposed tabs 32, 34 which are located adjacent the entrance to the tubing interface 28. Each one of the first and the second tabs 32, 34 has a length of between about 3/32 of an inch and 3/8 of an inch and a width of between about 3/16 of an inch and about ½ of an inch so as to facilitate secure attachment of the snore adapter 2 to the coupling tubing 6, as will be described below in further detail.

[065] The entire upwardly facing surface 36 of each one of the tabs 32, 34 is covered with an adhesive 38 which facilitates adhering or securing of the first and second tabs 32, 34, respectively, to the leading end 4 of the coupling tubing 6 once the leading end of the coupling tubing 6 abuts against the bottom or end surface 30 of the tubing recess 28. One suitable adhesive 38 is, for example, a 1522 adhesive manufactured by 3M of St. Paul, MN. The outwardly facing, exposed surface 36 of the adhesive 38 is normally covered by a removable release paper or liner (not shown) which can be easily removed and peeled away from and out of contact with the tabs 32, 34 so as to expose the underlying adhesive 38. That is, once the release paper or liner is removed from the tabs 32, 34 and the leading end of the coupling tubing 6 abuts against the stop surface 30, the adhesive 38 is directly exposed and can then be utilized for securing the tabs 32, 34 to the exterior surface of the coupling tubing 6 and facilitate transmission of the collected sound, pressure wave form information and/or breathing information to the pressure sensing device 10 for detecting snoring by the patient.

[066] In order to facilitate coupling of the snore adapter 2 to the conventional the pressure sensing device 10, typically the cannula (not shown), which is connected to the coupling tubings 6, is cut or snipped off from a remainder of the coupling tubings 6 so as to provide a pair of free, unconnected ends 4 of the coupling tubings 6 (see Fig. 1 ). Thereafter, one of the free unconnected ends 4 of the coupling tubings 6 is inserted into the tubing interface 28 of the snore adapter 2 until a leading end thereof abuts against the bottom surface 30 at the base of the tubing recess 29 while the other end of the coupling tubing 6 is suitably blocked off.

[067] Alternative, both the cannula and the Y-shaped coupling 9 may be cut off, just below the Y-shaped coupling 9, and thereafter the single free end of the common tubing 8 may engage with the tubing interface 28 for detecting sound, pressure waveform information and/or breathing information. Another alternative is when a divided cannula, which has two completely separate flow paths, e.g., one for pressure detection and the other for CO₂ sampling, is employed for detecting sound, pressure wave form information and/or breathing information. In this instance, normally only the cannula (not shown) is cut or snipped off from a remainder of the coupling tubings 6 so as to provide a pair of free, unconnected ends 4 of the coupling tubings 6, as with Fig. 1. Thereafter, one of the free unconnected ends 4 of the coupling tubings 6 (i.e., the pressure detection tubing) is inserted into the tubing interface 28 of the snore adapter 2 while the other coupling tubing 6, since it has a completely separate and distinct flow path, does not have to be blocked off.

[068] After the desired free end of the coupling tubing 6 or 8 is inserted into the tubing interface 28, the removable release paper or liner, overlying and covering the pair of securing tabs 32, 34, is removed from the pair of securing tabs 32, 34 so as to expose the underlying adhesive 38. Next, a first one 32 or 34 of the pair of securing tabs 32, 34 is wrapped partially around the first end 4 of the inserted coupling tubing 6 and then a second one 34 or 32 of securing tabs 32, 34 is wrapped around the first end 4 of the inserted coupling tubing 6 so as to adhesively retain the coupling tubing 6 to the snore adapter 2 with the leading end 4 of the coupling tubing 6 in an abutting relationship with the stop surface 30 of the tubing recess 29. Due to such arrangement, the internal surface of the funnel or horn shaped cavity 26 is substantially precisely aligned with the internal passage of the coupling tubing 6 so as to facilitate transmission of substantially all of the detected sound, pressure wave form information and/or breathing information, from the funnel or horn shaped cavity 26 along the internal passage of the coupling tubing 6 to the pressure sensing device 10 for processing.

[069] The coupling tubing 6 is typically selected so that the internal diameter of passage of the coupling tubing 6 substantially coincides with the internal diameter of the outlet opening 22 and substantially all of thesound and/or pressure wave form information, which enters the inlet opening 20, is channeled by the funnel or horn shaped internal cavity 26 toward the outlet opening 22 and into the internal passage of the coupling tubing 6 for conveyance of such breathing information along the coupling tubing 6 to the snore detection device 10 while minimizing the amount of the sensedsound and/or pressure wave form information which reflects or bounces off an end face of the leading end 4 of the coupling tubing 6.

[070] The interior shape and contour of the funnel or horn shaped internal cavity

26 is generally important in reflecting, redirecting and/or channeling sufficiently all of the sensedsound and/or pressure wave form information, at substantially a 90 degree angle, so that such sensedsound and/or pressure wave form information is directed along the coupling tubing 6, affixed to the snore apparatus 2, to the snore detection device 10. As shown in Figs. 5A-5J, the internal cavity 26 generally has a shape which gradually reduces in size from the inlet opening 20 toward the outlet opening 22. The surface of the internal cavity 26 is generally smooth and does not contain any protrusions or sharp edges therein which may distort and/or reflect sound and/or pressure wave form information. These various cross-sectional views show the internal contour of the funnel or horn shaped internal cavity 26 which facilitates the channeling of the detected sound and/or pressure wave form information and/or breathing information toward the outlet opening 22.

[071] With reference now to Figs. 6-8B, a detail description concerning a second embodiment of the snore adapter 2, according to the present invention, will now be discussed. As this embodiment is quite similar to the first embodiments in a number of respects, identical elements or features are given identical reference numerals. As such, only the differences between the second embodiment and the first embodiment the will be discussed in detail.

[072] As with the previous embodiment, the snore adapter 2 includes the flexible base 12 which closely adapts and conforms to the exterior contour of the skin of the patient during use. In addition, the inlet opening 20 is coupled to the outlet opening 22 by a funnel or horn shaped internal cavity 26 having a 90 degree bend. The primary differences between the first embodiment and the second embodiment are the use of a tubing interface 28 having a pair of recesses 29, the shape of the internal cavity 26 adjacent the outlet opening 22, the use of a pair of coupling tubings 6 (instead of a single coupling tubing 6) and the elimination of the tabs 32, 34.

[073] According to this embodiment, the tubing interface 28 is again formed in the end of the housing 24 adjacent the outlet opening 22. The outlet opening 22, according to this embodiment, typically has a maximum dimension or diameter of between about 1/32 of an inch to about 1/4 of an inch, more preferably has a dimension or diameter of between about 3/64 of an inch to about 1/8 of an inch, and most preferably has a dimension or diameter of about 3/64 of an inch to about 5/64 of an inch. However, the tubing interface 28 comprises a pair of adjacent substantially identical tubing recesses 29 which are each sized to closely receive and accommodate the leading free end 4 of a coupling tubing 6 therein, e.g., each tubing recess 29 typically has a diameter of between about 1/32 of an inch to about 5/16 of an inch, more preferably has a diameter of between about 1/16 of an inch to about 3/16 of an inch, and most preferably has a diameter of about 5/64 of an inch to about 1/8 of an inch and a depth of between about 1/8 of an inch to about ½ an inch or so, and more preferably a depth of about 3/8 of an inch or so.

[074] A bottom or end surface 30 of each tubing recess 29 forms a stop surface

30 which abuts against the respective coupling tubing 6 to prevent further insertion of the respective coupling tubing 6 into the tubing recess 29. To assist with retaining the coupling tubing 6 in engagement with the tubing recess 29, each tubing recess 29 generally has an interference fit with the exterior surface of the inserted coupling tubing 6 so as to retain the tubing therein solely by friction, e.g., the internal diameter of the tubing recess 29 is slightly smaller in size (possibly a few thousands of any inch) than the external diameter of the coupling tubing 6 and/or may be tapered.

[075] As with the previous embodiment, typically, a cannula (not shown), which is connected to the free ends of the coupling tubings 6, is cut or snipped off from a remainder of the coupling tubings 6 so as to provide a pair of free, unconnected ends 4 of coupling tubings 6. Thereafter, each one of the free unconnected ends 4 of the coupling tubings 6 is inserted into a respective one of the tubing recesses 29 of the snore adapter 2 until a leading end thereof abuts against the stop surface 30 formed at the base of the tubing recess 29. Due to such arrangement, the internal surface of the funnel or horn shaped cavity 26 is aligned with the internal passage of each one of the tubings 6 so as to facilitate transmission of substantially all of the detected sound or pressure wave form information and/or breathing information along the internal passage of the coupling tubings 6 to the pressure sensing device 10 for subsequent processing. The detected and conveyed sounds, being conveyed along the coupling tubings 6, generally combines with one another at the Y-shaped coupling 9 and the combined sound or pressure wave form information and/or breathing information is, thereafter, conveyed by the common tubing 8 to the pressure sensing device 10.

[076] The internal diameter of passage of the coupling tubing 6 generally coincides with the internal diameter of the outlet opening 22 so that substantially all of thesound and/or pressure wave form information, which enters the inlet opening 20, is reflected, redirected and/or channeled by the funnel or horn shaped internal cavity 26 toward the outlet opening 22 and into the inlet end 4 of the coupling tubing 6 for conveyance of such sound or pressure wave form information and/or other breathing information along the coupling tubing 6 to the snore detection device 10 while minimizing the amount of the sensedsound and/or pressure wave form information which reflects off an end face of the leading end 4 of either of the coupling tubings 6.

[077] The interior shape and contour of the funnel or horn shaped internal cavity

26, as generally shown in Figs. 5A-5J, is important in redirecting and/or channeling sufficiently all of the sensedsound and/or pressure wave form information at substantially a 90 degree angle so that such sensedsound and/or pressure wave form information is directed along the coupling tubings 6, affixed to the snore apparatus 2, to the snore detection device 10. As with the previous embodiment, the internal cavity 26 has a smooth surface without any protrusions or sharp edges or surfaces which may reflectsound and/or pressure wave form information.

[078] With reference to Fig. 8B, a slight modification of the funnel or horn shaped internal cavity 26, adjacent the outlet opening 22, is shown and will be briefly discussed. As shown in that Figure, the funnel or horn shaped internal cavity 26, adjacent the outlet opening 22, divides into two separate flow paths 26' and 26", i.e., one for each one of the tubing recesses 29. Each one of these separate flow paths then further tapers toward the respective tubing recess 29 so as to better assist with channeling and directing all of the detected sound or pressure wave form information and/or other breathing information toward the respective tubing recess 29. According to this modification, preferably the coupling tubing 6 is selected so that the internal diameter of passage (not labeled) of the coupling tubing 6 substantially coincides with the internal diameter of the respective outlet opening 22 so that substantially all of thesound and/or pressure wave form information, which enters the inlet opening 20, is reflected, redirected and channeled by the funnel or horn shaped internal cavity 26 toward one of the two separate flow paths 26' and 26" and into one of the outlet openings 22 and finally into one of the coupling tubings 6 for conveyance of such sound or pressure wave form information and/or other breathing information along the coupling tubings 6 to the pressure sensing device 10 while minimizing the amount of the sensedsound and/or pressure wave form information which reflects off the end face of the leading end 4 of either of the coupling tubings 6. If desired, as discussed above, the snore adapter 2 may possibly include one or a pair of tabs (not shown) which is/are supported adjacent the entrance to the tubing interface 28 to assist with retaining the coupling tubing 6 or 8 in engagement with the tubing interface 28.

[079] With reference to Fig. 9, this figure depicts, in the top two graphs of that

Figure, breathing information collected using the BINAPS pressure sensor device of Salter Labs and, in the bottom graph of that Figure, thesound and/or pressure wave form information of the patient detected with the snore adapter, according to the present invention, connected to the BINAPS pressure sensor device of Salter Labs. The bottom graph of Fig. 9 shows patient snoring, as detected by the snore adapter according to the present invention, and, as shown in that bottom graph, generates precisesound and/or pressure wave form information relating to when the patient is snoring during the diagnostic procedure. In addition, as is apparent from this Figure, the quality of the data collected by the snore adapter 2 and the BINAPS pressure sensor device of Salter Labs is generally superior of that obtained by the combination of Fig. 10 and discussed below. In addition, the signal line between each indicated snore is very straight and clean thereby indicating that the signal generally has high quality and such high quality signal, in turn, leads to more accurate and reliable detection of patient snoring.

[080] With reference to Fig. 10, this Figure depicts three graphs similar to those shown in Fig. 9, discussed above, but the results were obtained utilizing the snore adapter of the present invention and a competing pressure sensor device of another company. As can be seen in the left hand portion of the bottom graph of that Figure, although some patient snore is able to be detected which coincides with the snore obtained by the pressure sensing device, the amplitude as well as the quality of the signal are inferior to the breathing information obtained by the arrangement of Fig. 9. Moreover, when the prior art pressure sensor device was switched from the "low" setting (see the left half of the bottom graph of that Figure) to the "high" setting (see the right half of the bottom graph of that Figure), the the detected signal, although somewhat improved over the "low" setting, is not as clear and clean as the results achieved by Fig. 9, e.g., the snore amplitude is not as high and it is generally somewhat difficult to determine precisely when the patient is snoring.

[081] It is to be appreciated that the snore adapter 2 may be affixed to a respective tubing 6 by a variety of other types of conventional interfaces, e.g., glue, threaded connections, mating couplings, etc., and/or may be provided with the pressure sensing device 10 as a combined unit.

[082] With reference now to Figs. 1 1 and 1 1 A, a detail description concerning a third embodiment of the snore adapter 2, according to the present invention, will now be discussed. As this embodiment is quite similar to both of the first and second embodiments in many respects, identical elements or features are given identical reference numerals. As such, only the differences between the third embodiment and the first and the second embodiments will be discussed in detail, namely, the manner in which the adhesive is affixed to the base 12 of the snore adapter 2.

[083] According to this embodiment, in order to facilitate adhering or securing the base 12 of the snore adapter 2 to the desired area of the skin of the patient, e.g., the throat, the larynx, etc., an intermediate backing member 40, as shown in Fig. 1 1A, carries a suitable first and second adhesive 16', 16 on both opposed surfaces 42, 44 thereof. The intermediate backing member 40 is affixed to and generally covers the entire base surface 14 of the base 12. An important aspect of this embodiment is that the first adhesive 16', located between the flexible base 12 and the first opposed surface 42 of the intermediate backing member 40, has greater adhesion therebetween than the second adhesive 16, located between the release paper46 and the second opposed surface 44 of the intermediate backing member 40, so that an end user can readily peel or remove a desired one of the snore adapters 2 from the release paper (see Fig. 1 1 ) for use, as discussed above. Further, the attachment of the first adhesive 16', located between the flexible base 12 and the first opposed surface 42 of the intermediate backing member 40, also has a greater adhesion than the second adhesive 16, located between the skin of a patient and the second opposed surface 44 of the intermediate backing member 40, so that, following use, the end user can readily peel or remove the snore adapter 2 from the patient. As with the previous embodiments, a suitable first adhesive for the backing member 40 is, for example, a 1522 adhesive manufactured by 3M of St. Paul, MN, although other conventional adhesives can also be employed. The intermediate backing member 40 is a typically a woven cloth, manufactured by bore example, Flexcon Industrial Park, which has a skin contact adhesive, e.g., a H-566 adhesive, on the second surface thereof which is manufactured by Flexcon Industrial Park of Spencer, MA. Typically, the first and the second adhesives 16', 16, supported on opposed surfaces 42, 44 of the intermediate backing member 40, are different adhesives but may possibly be the same adhesive.

Since certain changes may be made in the above described snore adapter and associated method, without departing from the spirit and scope of the invention herein involved, it is intended that all of the subject matter of the above description or shown in the accompanying drawings shall be interpreted merely as examples illustrating the inventive concept herein and shall not be construed as limiting the invention.

Claims

Wherefore, we claim:

1. An adapter for detecting breathing information useful in determining patient snore, the adapter comprising:

a housing having a base surface;

an inlet opening being formed in the base surface;

at least one outlet opening being formed in the housing and communicating with the inlet opening via an internal cavity; and

a tubing interface being formed in the housing, adjacent the outlet opening, for coupling a coupling tubing to the at least one outlet opening and facilitating channeling of breathing information, detected by the adapter, to a sensing device.

2. The adapter according to claim 1 , wherein an adhesive is applied to the base surface for securing the base surface of the adapter to skin of the patient and forming a perimeter seal about the inlet opening of the adapter, and a base release liner covers the adhesive applied to the base surface.

3. The adapter according to claim 1 , wherein the tubing interface comprises at least one tubing recess, and a bottom surface of the recess forms a stop surface which prevents further insertion of the coupling tubing into the recess.

4. The adapter according to claim 1 , wherein the housing supports at least one tab adjacent the tubing interface, and the at least one tab facilitates securing the coupling tubing to the adapter once the coupling tubing engages within the tubing interface.

5. The adapter according to claim 1 , wherein the housing supports a pair of tabs adjacent the tubing interface, and each one of the pair of tabs facilitates securing the coupling tubing to the adapter once the coupling tubing engages within the tubing interface.

6. The adapter according to claim 4, wherein an adhesive is applied to the at least one tab for securing the adapter to the coupling tubing, and a tab release liner covers the adhesive applied to the at least one tab.

7. The adapter according to claim 1 , wherein the tubing interface comprises a pair of adjacent tubing recesses, and a bottom surface of each one of the tubing recesses forms a stop surface which prevents further insertion of a respective coupling tubing into the recess.

8. The adapter according to claim 7, wherein an adhesive is applied to the base surface for securing the base surface of the adapter to skin of the patient and forming a perimeter seal about the inlet opening of the adapter, and a base release liner covers the adhesive applied to the base surface.

9. The adapter according to claim 1 , wherein the internal cavity is generally funnel or horn shaped and has a substantially 90 degree bend formed along the cavity, and a larger first end of the internal cavity is coincide with the inlet opening while a smaller second end of the internal cavity is generally coincide with the outlet opening so that breathing information, detected from a patient, passes through the inlet opening and is directed, by the internal cavity, toward and out through the outlet opening of the snore adapter.

10. A combination of an adapter, for detecting breathing information useful in determining patient snore, being coupled to a pressure sensing device via at least one coupling tubing and the adapter comprising:

a housing having a base surface;

an inlet opening being formed in the base surface;

an outlet opening being formed in the housing and communicating with the inlet opening via an internal cavity; and

a tubing interface being formed in the housing, adjacent the outlet opening, for coupling the coupling tubing to the outlet opening and facilitating channeling of breathing information, detected by the adapter, to the pressure sensing device.

11. The combination according to claim 10, wherein the tubing interface comprises a pair of adjacent tubing recesses, and a bottom surface of each one of the tubing recesses forms a stop surface which prevents further insertion of a respective coupling tubing into the recess.

12. The combination according to claim 10, wherein an adhesive is applied to the base surface for securing the base surface of the adapterto skin of the patient and forming a perimeter seal about the inlet opening of the adapter, and a base release liner covers the adhesive applied to the base surface.

13. The combination according to claim 10, wherein the internal cavity is generally funnel or horn shaped and generally has a 90 degree bend formed along the cavity, and a larger first end of the internal cavity is coincide with the inlet opening while a smaller second end of the internal cavity is generally coincide with the outlet opening so that breathing information, detected from a patient, passes through the inlet opening and is directed, by the internal cavity, toward and out through the outlet opening of the snore adapter into the coupling tubing for conveyance to the pressure sensing device.

14. A method of detecting breathing information, useful in determining patient snore, by use of an adapter, the adapter comprising a housing having a base surface, an inlet opening being formed in the base surface, an outlet opening being formed in the housing and communicating with the inlet opening via an internal cavity, and a tubing interface being formed in the housing, adjacent the outlet opening, for coupling a coupling tubing to the outlet opening and facilitating channeling of breathing information, detected by the adapter, to a sensing device, the method comprising the steps of:

placing the adapter adjacent a throat of a patient;

detecting breathing information from the patient via the adapter; and channeling the detected breathing information from the patient through the inlet opening, the internal cavity, the outlet opening and the coupling tubing to the sensing device for processing.

15. The adapter according to claim 1 , wherein an intermed iate backing member carries an adhesive on both opposed surfaces thereof, and the intermediate backing member is affixed to and generally covers a base surface of the base for securing a base surface of the adapter to skin of the patient and forming a perimeter seal about the inlet opening of the adapter, and a release liner covers the adhesive applied to an outer surface of the intermediate backing member.

16. The adapter according to claim 1 , wherein an adhesive, located between the base and a first opposed surface of the intermediate backing member, has a greater adhesion than the adhesive, located between the release liner and a second opposed surface of the intermediate backing member, so that the snore adapter can be removed from the release liner.

17. The adapter according to claim 16, wherein the adhesive, located between the base and the first opposed surface of the intermediate backing member, has a greater adhesion than the adhesive, located between the skin of a patient and the second opposed surface of the intermediate backing member, so that, following use, the snore adapter can be peeled or removed from the skin of the patient.

18. The adapter according to claim 15, wherein the release liner is elongate and a plurality of the snore adapter are adhesively affixed to the elongate release liner.

19. The adapter according to claim 2, wherein the release liner is elongate and a plurality of the snore adapter are adhesively affixed to the elongate release liner.