DEVICE TO DETECT AND TREAT APNEAS AND HYPOPNEA

Abstract

A method and apparatus for the treatment of Sleep Apnea events and Hypopnea episodes wherein one embodiment comprises a wearable, belt like apparatus containing a microphone and a plethysmograph. The microphone and plethysmograph generate signals that are representative of physiological aspects of respiration, and the signals are transferred to an imbedded computer. The embedded computer extracts the sound of breathing and the sound of the heart beat by Digital Signal Processing techniques. The embedded computer has elements for determining when respiration parameters falls out of defined boundaries for said respiration parameters. This exemplary method provides real-time detection of the onset of a Sleep Apnea event or Hypopnea episode and supplies stimulation signals upon the determination of a Sleep Apnea event or Hypopnea episode to initiate an inhalation. In one embodiment, the stimulus is applied to the patient by a cutaneous rumble effects actuator and/or audio effects broadcasting.

Claims

1. A system for treating a breathing disorder comprising: a sensor capable of detecting physiologic signals; a processor connected to the sensor and configured to process information from the sensor to detect patterns and abnormalities of respiration of a patient and to generate a control signal in response thereto; and a patient stimulator configured to deliver a personalized, tailored stimulus to the patient in response to the control signal; wherein the personalized, tailored stimulus has attributes comprising modifiable attributes including a spectral content and a duration; wherein the personalized, tailored stimulus is delivered via a sense of the human body; and wherein the modifiable attributes and timing of the personalized, tailored stimulus are chosen based on the physiologic state of the patient at the moment the stimulus is needed to elicit a desired physiologic response comprising initiation of inhalation while avoiding or mitigating an undesired physiologic response comprising frank awakening and EEG-determined cortical arousal.

2. The system of claim 1, where the system detects an abnormality of cardiac rhythm and delivers a stimulus.

3. The system of claim 1, wherein the personalized, tailored stimulus is delivered at a time synchronized to the respiratory cycle.

4. The system of claim 1, wherein an alteration of physiologic state is detected or predicted and the personalized, tailored stimulus is delivered before a sleep-disturbed breathing event occurs, thus preventing the event from occurring.

5. The system of claim 1, wherein the modifiable attributes and timing of the personalized, tailored stimulus are chosen to prevent habituation or change the degree of habituation.

6. The system of claim 1, wherein the apparatus is configured to be used in conjunction with a Positive Airway Pressure machine.

7. The system of claim 1, wherein the desired physiologic response includes causing the subject to change body position.

8. The system of claim 1, wherein the undesired physiologic response further includes at least one element selected from a group of undesired events consisting of altered cardiac activity, increased systolic blood pressure, and increased circulating catecholamines

9. The system of claim 1, wherein the sensor is a microphone.

10. The system of claim 1, wherein the sensor is a plethysmograph.

11. A method for treating a breathing disorder comprising: processing information from a sensor capable of detecting physiologic signals to detect patterns and abnormalities of respiration of a patient; and delivering a personalized, tailored stimulus based on a physiologic state of the patient at a particular moment in time to the patient via a patient stimulator; wherein the personalized, tailored stimulus has attributes comprising modifiable attributes including a spectral content and a duration; wherein the personalized, tailored stimulus is delivered via a sense of the human body; and wherein the modifiable attributes and timing of the personalized, tailored stimulus are chosen based on the physiologic state of the patient at the moment the stimulus is needed to elicit a desired physiologic response comprising initiation of inhalation while avoiding or mitigating an undesired physiologic response comprising frank awakening and EEG-determined cortical arousal.

12. The method of claim 11, where the system detects an abnormality of cardiac rhythm and delivers a stimulus.

13. The method of claim 11, wherein the personalized, tailored stimulus is delivered at a time synchronized to the respiratory cycle.

14. The method of claim 11, wherein an alteration of physiologic state is detected or predicted and the personalized, tailored stimulus is delivered before a sleep-disturbed breathing event occurs, thus preventing the event from occurring.

15. The method of claim 11, wherein the attributes, and timing of the personalized, tailored stimulus are chosen to prevent habituation or change the degree of habituation.

16. The method of claim 11, wherein the apparatus is configured to be used in conjunction with a Positive Airway Pressure machine.

17. 1 The method of claim 11, wherein the desired physiologic response includes causing the subject to change body position.

18. The method of claim 11, wherein the undesired physiologic response further includes at least one element selected from a group of undesired events consisting of altered cardiac activity, increased systolic blood pressure, and increased circulating catecholamines.

19. The method of claim 11, wherein the sensor is a microphone.

20. The method of claim 11, wherein the sensor is a plethysmograph.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0043] The invention will be described by reference to the following drawings, in which like numerals refer to like elements, and in which:

[0044] FIG. 1 is a top and Bottom External view of the present invention;

[0045] FIG. 2 is a Cross-section view;

[0046] FIGS. 3A, 3B, and 3C are Block Diagrams of the manner in which Microphone and Plethysmographic sensor data is converted into Signals;

[0047] FIG. 4 is a Block diagram of the Electronic and Electrical elements of the invention;

[0048] FIGS. 5A, and 5B are Block Diagrams of the Training and Monitoring Processes;

[0049] FIG. 6 is a Block Diagram of the Fuzzy Control System; and

[0050] FIG. 7 is a diagram of a Patient wearing the invention.

[0051] FIG. 8 is a Block Diagram of Portrait Development

DESCRIPTION OF EMBODIMENTS

[0052] Accordingly, embodiments of the present invention are provided that meet at least one or more of the following objects of the present invention. In one embodiment, a wireless auditory prompter (Bluetooth Earbud) is mounted in the patient's ear and is activated by the stimulation signal to emit an acoustic stimulus which is heard by the patient but is inaudible to others. This embodiment provides a sound to initiate inhalation without requiring other intervention. In another embodiment, a wired auditory prompter is mounted in the patient's ear and is activated by the stimulation signal to emit an acoustic stimulus which is heard by the patient but is inaudible to others. This embodiment provides a sound to initiate inhalation without requiring other intervention.

[0053] In another embodiment, a loud speaker is embedded within the invention and is activated by the stimulation signal to broadcast an acoustic stimulus which is heard by the patient. This embodiment provides a sound to initiate inhalation without requiring other intervention. In another embodiment, the computer detects the absence of a heartbeat and activates an audible alarm by the loud-speaker embedded within the present invention.

[0054] In another embodiment, the computer has means to store the calculated amplitude, periodicity, and duration of respiration for each respiration of the collection of known good respirations from the first self-calibration in imbedded memory. In another embodiment, the computer has means to store the calculated values and parameters in imbedded memory.

[0055] In another embodiment, the computer has means to store the time(s) in which a Sleep Apnea event and Hypopnea episode occurs in imbedded memory. In another embodiment, the computer has means to store the time(s) in which a Sleep Apnea event and Hypopnea episodes are terminated in imbedded memory.

[0056] In another embodiment, the computer has means to export the calculated values and parameters from imbedded memory to other devices.

[0057] In another embodiment, the computer has means to export the time(s) in which a Sleep Apnea event and Hypopnea episode occurs and from imbedded memory to other devices.

[0058] In another embodiment, the computer has means to export the time(s) in which a Sleep Apnea event and Hypopnea episode are terminated from imbedded memory to other devices.

[0059] In another embodiment, the computer has means to import modifications of the computer programs from other devices.

[0060] In another embodiment, the computer has means to import modifications of the computer program that comprises the rules based processing (Fuzzy Logic) from other devices.

[0061] In another embodiment, the plethysmographic sensor can be implemented using a string potentiometer. In another embodiment, the plethysmographic sensor can be implemented using strain gauges.

[0062] In another embodiment, the plethysmographic sensor can be implemented using accelerometers.

[0063] In another embodiment, the plethysmographic sensor can be implemented using Hall Effect components.

[0064] In another embodiment, the plethysmographic sensor can be implemented using LEDS and Photo detectors.

[0065] In another embodiment, the plethysmographic sensor can be implemented using ultrasonic sensors.

[0066] In another embodiment, there might be a plurality of microphones.

[0067] In another embodiment, the mechanical tactile sensory stimulator may be implemented using a Haptic Display.

[0068] In another embodiment, the mechanical tactile sensory stimulator maybe implemented using a Haptic Display comprising shape memory springs.

[0069] In another embodiment, the mechanical tactile sensory stimulator maybe implemented using a Haptic Display using multiple actuators.

[0070] In another embodiment, the mechanical tactile sensory stimulator maybe implemented using a Haptic Display comprising rotating drums.

[0071] In another embodiment, the mechanical tactile sensory stimulator maybe implemented using a Haptic Display comprising electroactive polymers.

[0072] In another embodiment, sensory stimulation may be applied optically by the donning of a device that is worn over the eyes and in which LEDs shine light through the eyelids into the pupils.

[0073] The foregoing has outlined rather broadly the features and technical advantages of the present invention so that those skilled in the art may better understand the detailed description of the invention that follows. Additional features and advantages of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the art should appreciate that they may readily use the conception and the specific embodiment disclosed as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention in its broadest form.

[0074] Before undertaking the Detailed Description, it may be advantageous to set forth definitions of certain words and phrases used throughout this patent document: the terms include and comprise and derivatives thereof mean inclusion without limitation; the term or, is inclusive, meaning and/or; the phrases associated with and associated therewith, as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like; and the term controller means any device, system or part thereof that controls at least one operation, such a device may be implemented in hardware, firmware, or software, or some combination of at least two of the same. Definitions for certain words and phrases are provided throughout this patent document. Those of ordinary skill in the art should understand that in many, if not most, instances, such definitions apply to prior, as well as future uses of such defined words and phrases.

[0075] Measurement by the Computer in this application is defined as an Analog-to-Digital Conversion. The derivative of Analog-to-Digital Conversion is a numeric value that is representative of the Signals Amplitude at the time that the Measurement is made. Those skilled in the art will understand the method of using Analog-to-Digital conversion.

[0076] Processing, Process, Monitoring, and Method are used interchangeably in this document and are collectively defined as the application of software programs that are resident within the Computer as means or manner of procedure to accomplishing something The means and reasons for the Processing will be addressed in detail within this document.

[0077] Other objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. For a general understanding of the present invention, reference is made to the drawings. In the drawings, like reference numerals have been used throughout to designate identical elements. In accordance with this present invention, there is provided an apparatus and method for the diagnosis and treatment of Sleep Apnea and Hypopnea. In one embodiment of the invention, the respirations of the patient are monitored during sleep by the apparatus, which acts as a monitoring system to detect and treat Sleep Apnea events and Hypopnea episodes in the patient. The monitoring system is comprised of a integrated plethysmographic, a integrated microphone, a integrated computer and software program, and methods for applying stimulus to the patient such as a integrated loud speaker, wired and wireless audio, and a integrated rumble effects actuator. The invention is a wearable, belt-like device, the device is fitted around the Thorax or Abdomen of a patient.

[0078] At the onset of a Sleep Apnea event or Hypopnea episode the respiratory induced movement (expansion and contraction) of the Thorax and/or Abdomen are significantly reduced. In addition, the movement of air into the lungs is significantly reduced. These decreases are indicators of an onset of a Sleep Apnea event or Hypopnea episode. During sleep, it is normal for the patients' respiration parameters for amplitude, periodicity, and duration of respiration to vary. Discerning between those normal variations in the parameters (for amplitude, periodicity, and duration of respiration during sleep) and abnormal variations in parameters (for amplitude, periodicity, and duration of respiration levels), is performed using a software program that compares those parameters gathered by monitoring parameters (for amplitude, periodicity, and duration of respiration during sleep) to those parameters (for amplitude, periodicity, and duration of respiration) gathered before the patient fell asleep. This method accurately identifies the onset of a Sleep Apnea event or Hypopnea episode and eliminates false determinations. The embedded computer's software program uses rules based processing (Fuzzy Logic) to determine when Stimulation is to be applied in order to restore airway patency (by inducing inspiration). When the patient's respiration parameters are determined by the rules based processing (Fuzzy Logic) as showing the onset of an Sleep Apnea event or Hypopnea episode Stimulation is provided.

[0079] The present invention may use historical data, software programs, algorithms or subroutines to assist with the determination of the rules based processing (Fuzzy Logic) that are appropriate to the patient. The embedded computer's software program uses rules based processing (Fuzzy Logic) to determine the least amount of Stimulation required to induce inspiration.

[0080] The Stimulation is in the form of audio signals and by a cutaneous rumble effects actuator. Rules based processing (Fuzzy Logic) determine the least amount of Stimulation required to induce inspiration. FIGS. 1 through 8, discussed below, and the various embodiments used to describe the principles of the present invention in this patent document are by way of illustration only and should not be construed in any way to limit the scope of the invention. Those skilled in the art will understand that the principles of the present invention may be implemented in any suitably modified system for detecting and terminating an obstructive sleep apnea event. FIG. 1 illustrates one embodiment of the present invention showing External views, Top and Bottom.

[0081] The embodiment of the present invention that is illustrated in FIG. 1 has Microphone 125 capable of detecting sounds within the airway of patient (not shown). One type of microphone that is suitable for use in the present invention is the electret microphone. Microphone 125 is attached to the Housing 145 and Housing 145 is detachably fastened around the Thorax or Abdomen of the patient (not shown) with a Belt 165 and Velcro clasp (not shown in FIG. 1). Housing 145 is fastened around the Thorax or Abdomen of the patient (not shown) so that Microphone 125 is positioned adjacent to the lungs and in contact with the patient (not shown on FIG. 1). LEDs 115 & 120 are Status indicators. The emitted color that the LEDs display are indicative of operational conditions of the present invention. Buttons 105 & 110 control the operations of the present invention.

[0082] The Microphone 125 is capable of generating signals representative of the sounds of breathing of person 120. When Microphone 125 detects sounds of breathing, it generates a signal. The signal generated by the Microphone 125 is transferred via an individual microphone signal line to signal processing circuitry 200 (shown in FIG. 3) contained within Housing 145.

[0083] FIG. 2 is a cross-section (side view) of the present invention It illustrates that belt 265 has one end attached to Housing 245. The other end of belt 265 enters Housing 245 and is attached to Shuttle 270 and too Spring 290. Shuttle 270 travels within Guide 275. Shuttle 270 is attached to Wiper 280. Wiper 280 is an attachment of Membrane Potentiometer 285. The expansion of the Thorax or Abdomen during inspiration causes Belt 265 to pull on Shuttle 270 moving it from its' rest position. Shuttle 270 moves within Guide 275 and deforms Spring 290. The movement of Shuttle 270 also moves Wiper 280. Wiper 280 is pressed down on the top layer of Membrane Potentiometer 285, which in turn touches the bottom layer of Membrane Potentiometer 285. The touching of the upper and lower layer of Membrane Potentiometer 285 creates a voltage divider circuit. The output is voltage. The voltage is a direct inferential reading of the magnitude of the expansion or contraction of the Thorax/Abdomen at any time. The Computer processes the voltage as a Signal. The Signal output of Membrane Potentiometer 285 varies in direct proportion to the position of Shuttle 270 within Guide 275. When an exhalation occurs the Thorax or Abdomen contracts, releasing tension on Shuttle 270. Spring 290 moves Shuttle 270 back towards its rest position within Guide 275. Those skilled in the art will understand the method of using Membrane Potentiometers to sense position. The cutaneous rumble effects actuator 200 is attached to the Housing 245. The collection of elements of FIG. 2 makeup the Integrated Plethysmographic Sensor.

[0084] FIG. 3 is a Block Diagram of the manner in which Microphone and Plethysmographic sensor data is converted into Signals. Referring now to FIG. 3A the Block Diagram is illustrative of the Signal that is outputted from the Integrated Plethysmographic Sensor 301. Buffer 302 conditions the voltage Signal from Plethysmographic Sensor 301. The voltage Signal from Buffer 302 is the Thorax/Abdomen Movement Signal 303. The Computer (not shown in FIG. 3) Processes the Signal 303.

[0085] Referring to FIG. 3B the Block Diagram is illustrative of the Process that the Signals of Breathing Sounds 313 and Heart Beat Sound 312 that are extracted. The Microphone 304 detects a multiplicity of Audio Signals. The multiplicity of Audio Signals are comprised of the Audio components of biologic processes (Heart Beats, audio component of the turbulence that occurs in the human respiratory system during respiration, bowels, snoring, wheezing, yawning, coughing, etc) and external interference artifacts. The multiplicity of signals forms a spectrum of Audio frequencies. The elements of the Block Diagram as represented in FIG. 3B (Buffer 305, Bandpass Filter 306, Envelope Detection 307, Log 308, Sum 309, Integrator 310, and Output Scaling 311) act in concert to filter out the extraneous signals so as to export only the Signals of Respiration 313 and the Signals of the Beating Heart 312. The Process is further detailed in the technical paper ENDER, Derek et al. Process for the Detection and Analysis of Respiratory Airflow and Snoring Sounds During Sleep Using Laryngeal Sound Discrimination: Engineering in Medicine and Biology Society, 1992. Vol. 14. Proceedings of the Annual International Conference of the IEEE. Volume 6, Issue, 29 October-1 Nov. 1992 Page(s):2636-263. Which is hereby incorporated by reference. The Computer (not shown in FIG. 3) processes the exported Signals. Those skilled in the art will understand this method to extract specific Audio Signals from a multiplicity of Audio Signals.

[0086] Referring again to FIG. 3C. The Signals that are derived by the Plethysmographic Sensor 301 and the Microphone 304 are Measured by the Computer (not shown in FIG. 3). Each Signal is Measured for three (3) discrete Parameters. The Measurement quantity is assigned a numeric value that represents a direct inferential reading of the specific Signal Parameter. The Parameters that are Measured are the: Amplitude 313 of the Signal. The Amplitude 313 is representative of the expansion of the Thorax or Abdomen during an inspiration. Duration of the Signal 314. The Duration of the Signal 314 is the amount time that it takes for an discrete inspiration and exhalation to be completed. Periodicity of the Signal 315. The Periodicity of the Signal 315 is the time between discrete exhalations.

[0087] FIG. 4 is a Block diagram of the Electronic and Electrical elements of the invention. The operation of the invention is illustrated in FIG. 4. It is made up of a number of electronic component sections:

[0088] PIC Computer 409 is the Computer of the invention. On/Off Switch 401 activates and deactivates the invention. Control Switch 402 activation is the method wherein that patient interacts with the invention. Status LED2 403 is a multicolor LED. The color that it presents to the patient indicates the status of the invention. Status LED1 404 is a multicolor LED. The color that it presents to the patient indicates the status of the invention. Battery Pack 405 provides electrical power to the invention.

[0089] FLASH RAM 406 contains the Force Portraits 601, the Fuzzy Control System Rules, and the Processing program instructions. The Computer 409 and it exchange data over a signal buss. SRAM 407 contains the results of arithmetic computations by the Computer 409. The Computer 409 and it exchange data over a signal buss. Clock Oscillator 408 is the Inventions clock. BlueTooth 410 is the section that receives Audio Portrait Signals, Alarm Signals, and Training Period 1 & 2 spoken commands, converts the signals into Bluetooth formatted Signals and wirelessly transmits the Audio Portrait Signals to a Bluetooth wireless Earbud 715 (not shown if FIG. 4) worn by the patient. Speaker 411 Audio Portrait Signals, Alarm Signals, and Training Period 1 & 2 spoken commands and broadcasts them to the patient. USB I/O Port 413 is the means by which external devices communicate with the Computer 409. Signals 414, 415, and 416 are the busses by which the Signals are received by the Computer 409 for Processing.

[0090] FIG. 5 is a Block Diagram of the Training and Monitoring Processes. It is a primary object of the present invention to provide a apparatus and method for detecting and terminating an Sleep Apnea event and Hypopnea episode, within seconds of aid detection. To perform the process I draw your attention to FIG. 5A. FIG. 5A is a block diagram of the Process of Training. The Signals that are generated during Training Periods #1 and #2 are used by the invention to perform Self-checking. This Self-checking procedure verifies that the invention is operating as intended.

[0091] The Process of Self-Checking commences when the patient dons the invention and presses button On/Off Switch 401 (not shown in FIG. 5). The patient is directed to adjust the Belt 165 (not shown in FIG. 5) and Velcro clasp by plain, spoken commands. These spoken commands are fetched from FLASH RAM 406 (not shown in FIG. 5) by the Computer 409 (not shown in FIG. 5) and broadcast to the patient by Bluetooth wireless 410 (not shown in FIG. 5) to the patients Bluetooth Earbud 715 (not shown in FIG. 5) and/or the Speaker 411 (not shown in FIG. 5). The directions are supplied to the patient to insure that the Integrated Plethysmographics' Shuttle 270 (not shown in FIG. 5) is in its' rest position within Guide 275 (not shown in FIG. 5) that allows for uninterrupted movement of the Shuttle 270 (not shown in FIG. 5) during inspiration and exhalation. Furthermore, the Signals are Measured to become a set of Referential Parameters (the process that is used to create these Referential Parameters is addressed in detail later in this document).

[0092] The Process of Training: During Training Period #1, the patent is directed to breath in specific patterns by plain, spoken commands. These spoken commands are fetched from FLASH RAM 406 (not shown in FIG. 5) by the Computer 409 (not showing FIG. 5) and broadcast to the patient by Bluetooth wireless 410 (not shown in FIG. 5) to the patients Bluetooth Earbud 715 (not shown in FIG. 5) and/or the Speaker 411 (not shown in FIG. 5). This Process of Training commences when the patient dons the invention and presses button On/Off Switch 401 (not shown in FIG. 5) The specific patterns include but not limited to:

[0093] Natural Breathing

[0094] Deep Breathing

[0095] Fast Breathing

[0096] Slow Breathing

[0097] No Breathing

[0098] Shallow Breathing

[0099] Breath while Supine

[0100] Breath on the patients Left Side

[0101] Breath on the patients Right Side

[0102] Breath while Prone

[0103] During Training Period #2 the patent is directed to push the Control Switch 402 (not shown in FIG. 5) as they are preparing to go to sleep. All Signals are Measured by the Computer 409 (not shown in FIG. 5) to derive Values for the Signals intrinsic Parameters. All Signals are Measured and Processed in an identical manner

[0104] To illustrate how Signals are Measured by the Computer 409 (not shown in FIG. 5) to derive Values for the Signals' intrinsic Parameters and then Processed we will use the Measurement of a single Parameter as an example. Review FIG. 5A. For this example, the Signal Parameter that will be Measured and Processed is Amplitude 316 (not shown in FIG. 5): The Amplitude is representative of the expansion of the Thorax or Abdomen that occurs during an inspiration:

[0105] 1. Signal Input Storage 501, collects the stream of Signals 303 (not shown in FIG. 5), 312 (not shown in FIG. 5), and 313 (not shown in FIG. 5) for 60 seconds.

[0106] 2. Within Block 502 the Signals from within Signal Input Storage 501 are Measured. Values are Processed so that only the largest Value for any Inspiration is kept. [0107] a. The method of this specific Processing follows this format: [0108] i. IF Value(Now) is GREATER than or EQUAL to Value(Previous) THEN assign Value(Now) to Value(Previous). [0109] ii. IF Value(Now) is Less than or Equal to Value(Previous) THEN store Value(Previous) within Value Storage 503 as it is the largest value for this Inspiration.

[0110] 3. The stored largest Values within Value Storage 503 form a set named VS.

[0111] 4. The Values set VS is arithmetically Processed in the following manner within Block 504 [0112] a. Calculate the arithmetic average of the Values in the set VS. [0113] b. Subtract each Value in the set from the arithmetic average. [0114] c. Square the deviation of each Value in the set from the arithmetic average. [0115] d. Calculate the arithmetic average of the Squared deviations. [0116] e. Calculate the square root of the arithmetic average of the Squared deviations. [0117] f. The result is the root-mean-square deviation.

[0118] 5. The arithmetic average of the Values in the set VS is stored as a Referential Parameter in the Training Period 1 and 2 Referential Parameter Storage 505.

[0119] 6. The root-mean-square deviation of the Values in the set VS is stored as a Referential Parameter in the Training Period 1 and 2 Referential Parameter Storage 505.

[0120] The Process of Monitoring: It is a primary object of the present invention to provide an apparatus and method for detecting and terminating a Sleep Apnea event and Hypopnea episode, within seconds of the detection. FIG. 5B is a block diagram of the Process of Monitoring. The Signals Input Flow 506 comprises Signals 303 (not shown in FIG. 5), 312 (not shown in FIG. 5), and 313 (not shown in FIG. 5). Signals Input Flow 506 is Measured and Processed by the Computer by Value Assignment 507. The Processing steps are

[0121] 1. Upon the Measurement by the Computer 409 (not shown in FIG. 5) a Numeric Value is assigned for each Parameter that is Measured.

[0122] 2. The Numeric Value is stored in Numeric Value Storage 508.

[0123] 3. Subtraction arithmetic operation 509. Parametric Numeric Value(Now) minus it's arithmetic average Referential Parameter equals Result1.

[0124] The Numeric value for a Parameter is further Processed by the Computer (not shown in FIG. 5) by recalling the Referential Parameters specific to the Parameter that is being Processed at this time.

[0125] The Processing consists of a series logic operation by the Computer (not shown in FIG. 5). The format of these series of logic operation Performed within Evaluation 510:

[0126] 1. If Result1 is equal or Greater than 0 then Do Nothing

[0127] 2. If Result1 is Less than 0 then [0128] a. Subtract Parametric Numeric Value(Now) from each Value contained within the Value Set of VS. [0129] b. If any result of the previous operation (step 2a) is a positive integer then: [0130] I. Divide Result1 by the root-meansquare deviation Referential Parameters parameter equals Result2. [0131] II. If Results2 is Less than 0 then Do Nothing [0132] III. If Results2 is Greater than 0 then present Results2 to the Fuzzy Control System for determination as to whether Stimulation should be applied.

[0133] FIG. 6 is a Block Diagram of the Fuzzy Control System The Detecting and Terminating Process utilizes Fuzzy logic processes. The Fuzzy Control System controls two Processes.

[0134] 1. Monitoring

[0135] 2. Stimulation

[0136] Fuzzy logic processing is described, for example, in U.S. Pat. No. 7,426,435, issued to GAUTHIER, et al. Sep. 16, 2008, The disclosures of these United States patents are incorporated herein by reference. Another example is NAZERAN, HOMER et al. A Fuzzy Inference System for Detection of Obstructive Sleep Apnea: Proceedings23rd Annual ConferenceIEEE/EMBS October 25-28, 2001, Istanbul, TURKEY, which is hereby incorporated by reference.

[0137] Referring to FIG. 6, the Fuzzy Control System Process for Monitoring is as follows: Result2 values are the input variables to the Fuzzy Control System. The Result2 values are mapped into by sets of membership functions known as fuzzy sets. The process of converting a Result2 values (in the nomenclature of Fuzzy Logic these Result2 values are referred to as Crisp Input Values) to a fuzzy value is called fuzzifi-cation. The fuzzification occurs in the Input stage 601 of the Fuzzy Control System. The fuzzified Result2 values are evaluated in the next stage of the Fuzzy Control System, the Processing stage 602. The Processing stage 602 uses a collection of logic rules. The Computer then makes decisions for what action to take based on that collection of logic rules. The Rules are in the form of IF statements:

[0138] An example of a logic rule would be: [0139] IF amplitude IS very low AND periodicity IS very long apply stimulation.

[0140] In this example, the two input variables are very low and very long that have values defined as fuzzy sets. The output variable, stimulation, is also defined by a fuzzy set that can have values like long, louder, less loud, and so on. The results of the Processing Stage are combined to give a specific (Crisp) answer; this Crisp answer translates results into values. This takes place in the Crisp Control Stage 604. If the Crisp answer is to initiate Stimulation then the Process steps are as described or shown herein.

[0141] FIG. 7 is a diagram of a typical Patient wearing the invention. Patient 700, has the positioned the Housing 705 on his Thorax and has fastened Belt 710 to hold it in place. The patient 700 is wearing the Bluetooth Earbud 715.

[0142] FIG. 8 is a Block Diagram of Portrait Development. Before continuing it may be advantageous to set forth definitions of certain words and phrases. Stored Portrait Stimulation Parameters are [0143] Effective Portraits [0144] Irritation Index [0145] Audio Portrait [0146] Force Portrait [0147] Effectivity Index

[0148] Effective Portraits:

[0149] Is that combination of an Audio Portrait and a Force Portrait that have been found through a Process (described below) to generate an inspiration in a Patient who is having an Sleep Apnea event or Hypopnea episode.

[0150] Irritation Index:

[0151] The Irritation Index is an arbitrary value assigned to Portraits Audio and Force) at the time that the Portrait is created and inputted into the FLASH RAM 406. It is indicative of how reactive a patient would be to that Portrait, As an example, the playing of an Audio file of a woman screaming would be assigned a higher Irritation Index value than that of Audio file of a birds singing.

[0152] Force Portrait:

[0153] The mechanical tactile sensory stimulator 200 (not shown in FIG. 6) differ from a simple vibrator in that it is capable of simulating a wide range of tactile effects. The Haptic effects are assembled by using software instructions to control the force amplitude, wave shape, and pulse duration to the stimulation effectors. These instructions are combined to form Force Portraits. The Force Portraits are stored in the Haptic effects library area of the Portrait Storage 801 (not shown in FIG. 6). Different Force Portraits are felt as different tactile sensations by the patients. These Force Portraits are assigned an Irritation Index value. The choice of which Force Portrait to use for the mechanical tactile sensory stimulator is determined by the Fuzzy Logic System.

[0154] Audio Portrait

[0155] A method of Stimulation is the playing of prerecorded Audio files. These Audio files are stored in the Portrait Storage 801 (not shown in FIG. 6) as Audio Portraits. The Audio Portrait is made up the Audio File Name, a Volume value, the File length, and the Audio File Irritation Index value. There are multiplicities of stored Audio Portrait. The Audio files are sent to the patient by a Bluetooth wireless transmitter 410 (not shown in FIG. 6) to a Bluetooth wireless Earbud 715 (not shown in FIG. 6). Bluetooth is a wireless protocol utilizing short-range communications technology facilitating data transmission over short distances from fixed and/or mobile device. Bluetooth wireless communication is described, for example, in U.S. Pat. No. 7,225,064, issued to FUDALI, et al. May 29, 2007. The disclosures of these United States patents are incorporated herein by reference. The choice of which Audio Portrait to use for the Audio Stimulus is determined by the Fuzzy Logic System.

[0156] Effectivity Index:

[0157] The Effectivity Index is the sum of the Irritation Indexes of an Audio and Force Portraits couple. The larger the numerical value of the Effectivity Index than the more vigorous the Stimulus delivered to the patient. The present invention relates to an apparatus to detect and end an occurrence of a Sleep Apnea event or Hypopnea episode, in a manner that will decrease or eliminate hypoxia, hypercapnia and the disturbance of pulmonary hemodynamics

[0158] To apply Stimulus in a manner that will decrease or eliminate hypoxia, hypercapnia and the disturbance of pulmonary hemodynamics it is necessary to determine what stimuli is both effective in initiating Inspiration within 2 seconds of the stimulus application while simultaneously decreasing or eliminating the disturbance of pulmonary hemodynamics

[0159] The Method to develop a set of stimuli that is both effective in initiating Inspiration within 2 seconds of the Stimulus application while simultaneously decreasing or eliminating the disturbance of pulmonary hemodynamics is as follows. The sets of stimuli are called Effective Portraits. When the Fuzzy Control System Process of FIG. 6 (not shown in FIG. 8) detects the onset of a Sleep Apnea event or Hypopnea episode, it attempts to select the of Effective Portrait from within Portrait Storage 801.

[0160] If there is no Effective Portrait (as would happen when the patient initially dons the invention then the Process of developing an Effective Portrait commences:

[0161] 1. The Fuzzy Control System of FIG. 6 (not shown in FIG. 8) inputs a random selection of a Force and Audio Portrait from the Portrait Library 802 forming a Temporary Couple.

[0162] 2. The Temporary Couple is sent to the Stimulus Effectors 806.

[0163] 3. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the patient to determine if there is aninspiration.

[0164] 4. If Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines that further Stimulation is required then another random selection of a Force and Audio Portrait is made from the Portrait Library 802 forming another Temporary Couple.

[0165] 5. This Temporary Couple will have a larger Effectivity Index than the previous Temporary Couple Effectivity Index.

[0166] 6. This Temporary Couple is sent to the Stimulus Effectors 806.

[0167] 7. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the patient to determine if there is an inspiration.

[0168] 8. Steps 5-7 cycle until the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines that Stimulus is no longer required. The Temporary Couple is stored in Portrait Storage 801 as an Effective Portrait.

[0169] Effectivity of the Effective Portrait changes in a cyclic pattern during sleep as the amount of Stimulus required to initiate an inhalation waxes and wanes. This is the Method for adapting to that cyclic processWhen the Fuzzy Control System Process of FIG. 6 (not shown in FIG. 8) detects the onset of a Sleep Apnea event or Hypopnea episode, it attempts to use the Effective Portrait that has been stored in Portrait Storage 801. If there is an Effective Portrait in Portrait Storage 801 then the Fuzzy Control System of FIG. 6 (not shown in FIG. 8) will:

[0170] 1. Send that Effective Portrait to the Stimulus Effectors 806.

[0171] 2. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the patient. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines that further Stimulation is required. [0172] a Force and Audio Portrait is chosen from the Portrait Library 802 forming a Temporary Couple whose Effectivity Index is incrementally greater than the Effectivity Index of the Effective Portrait stored in Portrait Storage 801. [0173] b. Sends that Effective Portrait to the Stimulus Effectors 806. [0174] i. Step 2 cycles until the Fuzzy Logic System of FIG. 6 (not shown if FIG. 8) determines that there exists' no need further for Stimulation (an inhalation is detected). [0175] ii. This Temporary Couple replaces the Effective Portrait stored within Portrait Storage 801.

[0176] 3. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines that no further Stimulation is required then when the next Sleep Apnea event or Hypopnea episode is detected. [0177] a Force and Audio Portrait is chosen from the Portrait Library 802 forming a Temporary Couple whose Effectivity Index is incrementally less than the Effectivity Index of the Effective Portrait stored in Portrait Storage 801. [0178] b. Sends that Temporary Couple to the Stimulus Effectors 806. [0179] c. After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the patient. [0180] i. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines that no further Stimulation is required then this Temporary Couple replaces the Effective Portrait stored within Portrait Storage 801. [0181] ii. If the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) determines further Stimulation is required then 1) a Force and Audio Portrait is chosen from the Portrait Library 802 forming a Temporary Couple whose Effectivity Index is incrementally greater than the Effectivity Index of the Effective Portrait stored in Portrait Storage 801.

[0182] 2) Sends that Effective Portrait to the Stimulus Effectors 806.

[0183] 3) After a 2 Second Delay 805 the Fuzzy Logic System of FIG. 6 (not shown in FIG. 8) Monitors the patient.

[0184] 4) Step 3) cycles until the Fuzzy Logic System of FIG. 6 (not shown if FIG. 8) determines that there exists' no need further for Stimulation (an inhalation is detected.

[0185] 5) This Temporary Couple replaces the Effective Portrait stored within Portrait Storage 801.

CITATION LIST

Patent Literature

[0186] U.S. Pat. No. 7,387,608 Apparatus and method for the treatment of sleep related disorders Jun. 1, 2008 Dunlop; David A, Gunderman, Jr.; Robert Dale [0187] U.S. Pat. No. 7,371,220 System and method for real-time apnea/hypopnea detection using an implantable medical system May 1, 2008 Koh; Steve, Park; Euljoon, Benser [0188] 2005/0085865 Breathing disorder detection and therapy delivery device and method Apr. 1, 2005 Tehrani, Amir J [0189] 2006/0097879 SIDS and apnea monitoring system May 1, 2006 Lippincott; Kathy J [0190] 2005/0101833 Apparatus for the treatment of sleep apnea May 1, 2005 Hsu, William [0191] U.S. Pat. No. 6,935,335 System and method for treating obstructive sleep apnea Aug. 1, 2005 Lehrman; Michael L., Halleck; Michael E [0192] U.S. Pat. No. 6,666,830 System and method for detecting theonset of an obstructive sleep apnea event Dec. 1, 2003 Lehrman; Michael L., Halleck; Michael E. Ferguson; Pete, Kumar; Harpal, Lay; Graham, Llewellyn; Mike, Place; John D. [0193] U.S. Pat. No. 6,241,683 Phonospirometry for non-invasive monitoring of respiration Jun. 1, 2001 Macklem; Peter T., Que; Cheng-Li, Kelly; Suzanne M., Kolmaga; Krzystof, Durand; Louis-Gilles [0194] U.S. Pat. No. 6,290,654 Obstructive sleep apnea detection apparatus and method using pattern recognition Sep. 1, 2001 Karakasoglu; Ahmet
U.S. Pat. No. 6,011,477 Respiration and movement monitoring system Jan. 4, 2000 Teodorescu; Horia-Nicolai, Mlynek; Daniel J.

[0195] U.S. Pat. No. 5,853,005 Acoustic monitoring system Dec. 1, 1998 Scanlon; Michael V

[0196] U.S. Pat. No. 5,769,084 Method and apparatus for diagnosing sleep breathing disorders Jun. 1, 1998 Katz; Richard A., Lawee; Michael S., Newman; A. Kief

U.S. Pat. No. 5,555,891 Vibrotactile stimulator system for detecting and interrupting apnea in infants Sep. 1, 1996 Eisenfeld; Leonard I.

[0197] U.S. Pat. No. 5,540,733 Method and apparatus for detecting and treating obstructive sleep apnea Jul. 1, 1996 Testerman; Roy L., Erickson; Donald J., Bierbaum; Ralph W.

[0198] U.S. Pat. No. 5,522,862 Method and apparatus for treating obstructive sleep apnea Jun. 4, 1996, Testerman; Roy L., Erickson; Donald J. [0199] U.S. Pat. No. 5,277,194 Breathing monitor and stimulator, Jan. 11, 1994. Hosterman; Craig, Smith; Alvin W.

[0200] U.S. Pat. No. 5,107,855 Apena monitor for detection of aperiodic sinusoidal movement May 1, 1992 Harrington; Reginald, Crossley; Ralph

[0201] U.S. Pat. No. 5,050,614 Apparatus and method for inspiration detection Sep. 1, 1991 Logan; Charles H.

[0202] U.S. Pat. No. 4,781,201 Cardiovascular artifact filter Nov. 1, 1988 Wright; John C., Triebel

[0203] U.S. Pat. No. 4,694,839 Auxiliary stimulation apparatus for apnea distress Sep. 1, 1987 Timme; William F

[0204] U.S. Pat. No. 4,686,999 Multi-channel ventilation monitor and method Aug. 1, 1987 Snyder; Leon T., Scarfone; Frank A., Reuss; James L., Campen; George V., Yates; George H.

[0205] U.S. Pat. No. 4,365,636 Method of monitoring patient respiration and predicting apnea there from Dec. 1, 1982 Barker; Kent R.

[0206] U.S. Pat. No. 4,296,757 Respiratory monitor and excessive intrathoracic or abdominal pressure indicator Oct. 1, 1981 Taylor; Thomas

[0207] CONTINUATION APPLICATION 2505240 OSA HYPDXIA ONSET DETECTOR AND INTERRUPTOR Nov. 26, 2007

Non-Patent Literature

[0208] H. SCHNEIDER et al, Effects of arousal and sleep state on systemic and pulmonary hemodynamics in obstructive apnea, J. Appl. Physiol. 88: 1084-1092, 2000.

[0209] D. M. Carlson et al, Acoustically induced cortical arousal increases phasic pharyngeal muscle and diaphragmatic EMG in NREM sleep, Journal of Applied Physiology, Vol 76, Issue 4 1553-1559.

[0210] W. T. McNicholas, Arousal in the sleep apnea syndrome: a mixed blessing?, Eur Respir J 1998; 12: 1239-1241.

[0211] Robert C. Basner M D et al, Respiratory and Arousal Responses to Acoustic Stimulation, Chest. 1997; 112:1567-1571.

[0212] Gang Bao et al., Acute and chronic blood pressure response to recurrent acoustic arousal in rats, Am J Hypertens (1999) 12, 504-510.

[0213] R. C. Basner et al, Effect of induced transient arousal on obstructive apnea duration, J. App Physiol. 78(4): 1469-1476, 1995.

[0214] Dina Brooks et al, Obstructive Sleep Apnea as a Cause of Systemic Hypertension Evidence from a Canine Model, J. Clin. Invest. Volume 99, Number 1, January 1997, 106-109.

[0215] MARY J. MORRELL et al, Sleep Fragmentation, Awake Blood Pressure, and Sleep-Disordered Breathing in a Population-based Study, Am. J. Respir. Crit. Care Med., Volume 162, Number 6, December 2000, 2091-2096.

[0216] Robert C. Basner et al, Respiratory and Arousal Responses to Acoustic Stimulation, Chest 1997; 112; 1567-1571.

[0217] RICHARD S. T. LEUNG et al, Sleep Apnea and Cardiovascular Disease, Am. J. Respir. Crit. Care Med., Volume 164, Number 12, December 2001, 2147-2165.

[0218] Denise M. ODriscoll et al, Cardiovascular response to arousal from sleep under controlled conditions of central and peripheral chemoreceptor stimulation in humans, J Appl Physiol 96:865-870, 2004.

[0219] Denise M. ODriscoll et al, Occlusion of the upper airway does not augment the cardiovascular response to arousal from sleep in humans, J Appl Physiol 98:1349-1355, 2005.

[0220] U. Leuenberger et al, Surges of muscle sympathetic nerve activity during obstructive apnea are linked to hypoxemia, Am. J. Respir. Crit. Care Med., Volume 164, Number 12, December 2001, 2147-2165.

[0221] RICHARD S. T. LEUNG et al, Sleep Apnea and Cardiovascular Disease, Journal of Applied Physiology, Vol 79, Issue 2 581-588.

[0222] Richard B. Berry M D, Sleep Apnea Impairs the Arousal Response to Airway Occlusion, Chest. 1996; 109:1490-1496.

[0223] T. KATO et al, Experimentally induced arousals during sleep: a cross-modality matching paradigm, J. Sleep Res. (2004) 13, 229-23.

[0224] Christian Guilleminault et al, The effect of CNS activation versus EEG arousal during sleep on heart rate response and daytime tests, Clinical Neurophysiology 117 (2006) 731-739.

[0225] Emilia Sforza, M D et al, Effects of Sleep Deprivation on Spontaneous Arousals in Humans, SLEEP, Vol. 27, No. 6, 2004.

[0226] J. F. Masa et al, Assessment of thoracoabdominal bands to detect respiratory effort-related arousal, Eur Respir J 2003; 22: 661-667.

[0227] R. C. Basner et al, Effect of induced transient arousal on obstructive apnea duration, J Appl Physiol 78: 1469-1476, 1995.

[0228] HIROSHI MIKI et al, New Treatment for Obstructive Apnea Syndrome by Electrical Stimulation of Submental Region, Tohoku J. exp. Med., 1988, 154, 91-92.

[0229] C. Guilleminault et al, The effect of CNS activation versus EEG arousal during sleep on heart rate response and daytime tests, Clinical Neurophysiology, Volume 117, Issue 4, Pages 731-739.

[0230] Immersion Corporation, Next-generation TouchSense Vibration for Video Game Console Systems, 31 Aug. 2006.

[0231] Sheroz Khan, I Adam et al, Rule-Based Fuzzy Logic Controller with Adaptable Reference, International Journal of Intelligent Technology Volume 3 Number 1.

[0232] E. Sforza et al, Nocturnal evolution of respiratory effort in obstructive sleep apnoea syndrome: influence on arousal threshold, Eur Respir J 1998; 121257-126 DOI: 10.1183/09031936.98.12061257.

[0233] Homer Nazeran et al, A Fuzzy Inference System for Detection of Obstructive Sleep Apnea. Proceedings23rd Annual ConferenceIEEE/EMBS Oct. 25-28, 2001, Istanbul, TURKEY.