Classifications

• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
  • A63B23/18—Exercising apparatus specially adapted for particular parts of the body for improving respiratory function
  • A63B23/185—Rhythm indicators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4857—Indicating the phase of biorhythm
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0016—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the smell sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0022—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the tactile sense, e.g. vibrations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0027—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the hearing sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
  • A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
  • A61M2021/0044—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the sight sense
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
  • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B24/00—Electric or electronic controls for exercising apparatus of preceding groups; Controlling or monitoring of exercises, sportive games, training or athletic performances
  • A63B24/0062—Monitoring athletic performances, e.g. for determining the work of a user on an exercise apparatus, the completed jogging or cycling distance
  • A63B2024/0068—Comparison to target or threshold, previous performance or not real time comparison to other individuals
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
  • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
  • A63B71/0619—Displays, user interfaces and indicating devices, specially adapted for sport equipment, e.g. display mounted on treadmills
  • A63B71/0622—Visual, audio or audio-visual systems for entertaining, instructing or motivating the user
  • A63B2071/0625—Emitting sound, noise or music
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
  • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
  • A63B71/0619—Displays, user interfaces and indicating devices, specially adapted for sport equipment, e.g. display mounted on treadmills
  • A63B2071/0655—Tactile feedback
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
  • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
  • A63B2071/0675—Input for modifying training controls during workout
  • A63B2071/0677—Input by image recognition, e.g. video signals
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
  • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
  • A63B2071/0675—Input for modifying training controls during workout
  • A63B2071/068—Input by voice recognition
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B2220/00—Measuring of physical parameters relating to sporting activity
  • A63B2220/80—Special sensors, transducers or devices therefor
  • A63B2220/808—Microphones
• • A—HUMAN NECESSITIES
  • A63—SPORTS; GAMES; AMUSEMENTS
  • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
  • A63B71/00—Games or sports accessories not covered in groups A63B1/00 - A63B69/00
  • A63B71/06—Indicating or scoring devices for games or players, or for other sports activities
  • A63B71/0686—Timers, rhythm indicators or pacing apparatus using electric or electronic means

Definitions

• the present invention relates to devices for modifying biological rhythms.
• the invention also relates to medical devices that provide direct computer guidance and information to the user to improve health and well-being.
• 4,665,926 issued May 19, 1987 entitled Method and apparatus for measuring the relaxation state of a person
• Such relaxation can be obtained even though, as discussed below, various parameters of respiration have hitherto been thought to be so individual or particularized to a specific subject as to preclude generalizations with respect to respiratory parameters.
• Leuner et al. also discloses that psychophysical relaxation of the subject will give rise to a quantitative change in respiration.
• Gavish et al. (U.S. Pat. No. 6,662,032 issued December 9, 2003, entitled Interventive-diagnostic device), discloses an apparatus for improving health of a user that includes a first sensor, adapted to measure a first physiological variable, which is indicative of a voluntary action of the user.
• a second sensor is adapted to measure a second physiological variable, which is substantially governed by an autonomic nervous system of the user.
• Circuitry is adapted to receive respective first and second sensor signals from the first and second sensors, and, responsive thereto, to generate an output signal which directs the user to modify a parameter of the voluntary action.
• an apparatus for modifying a biorhythm of interest in a user comprising: an apparatus for modifying a biorhythm of interest in a user comprising: an intelligent table and user dynamic store (also referred to herein as an "intelligent table"); a compute unit, wherein the compute unit is operably connected to the intelligent table and wherein the compute unit comprises: means for data processing, memory, wherein the memory comprises non-volatile memory, and means for generating a biorhythm instruction signal; and a biorhythm instruction output device for transmitting a biorhythm instruction signal for a desired biorhythm operably connected to the compute unit, wherein: the biorhythm instruction output device is configured to relay the biorhythm instruction signal to the user, and the biorhythm instruction signal is sensed by the user using sensory perception.
• an intelligent table and user dynamic store also referred to herein as an "intelligent table”
• a compute unit wherein the compute unit is operably connected to the intelligent table and wherein the compute unit comprises: means for data processing, memory, wherein the memory comprises non-volatile
• the apparatus additionally comprises a non-rhythmic user will input device.
• the apparatus additionally comprises a non-rhythmic user will input device.
• the apparatus of claim 1 additionally comprises a biological rhythm detector.
• the apparatus additionally comprises a biological rhythm transform and output device.
• the apparatus additionally comprises a biological rhythm detector operably connected to the biological rhythm transform and output device.
• the user is a human.
• the user is a non-human animal.
• the user produces a modified biorhythm in response to sensing the biorhythm instruction signal, such as an increase or decrease in frequency or modulation of characteristic of the biorhythm
• the sensory perception is selected from the group consisting of vision, audition, olfaction and mechanosensation.
• the output of the biological rhythm output device is selected from the group consisting of visual output, audio output, olfactory output and mechanosensory output.
• the intelligent table comprises a store of knowledge about biorhythm modulation.
• the intelligent table comprises a representation of a desired biorhythm to be produced by the user.
• the apparatus additionally comprises a non-rhythmic user will input device operably connected to the compute unit.
• the apparatus additionally comprises a dynamic variable store operably connected to the compute unit.
• the dynamic variable store is operably connected to the compute unit by a read-write bus.
• the apparatus additionally comprises a code store operably connected to the compute unit.
• the code store is operably connected to the compute unit by a read-only bus.
• the non-volatile memory stores non-rhythmic user will input device state information.
• the non-volatile memory is programmed with desired data and user variables.
• the apparatus additionally comprises means for generating algorithmically a desired biorhythm.
• the apparatus additionally comprises means for sound processing operably connected to the compute unit.
• the apparatus additionally comprises a natural sound data store operably connected to the means for sound processing.
• the biological rhythm transform and output device is a speaker.
• the invention also provides an intelligent table for storing human knowledge of instructions for biological rhythm modulation in a user comprising a representation of a desired biorhythm to be produced by the user for health improvement.
• the intelligent table comprises medical information concerning a therapeutic practice of modulating a biorhythm over time
• the intelligent table is capable of being dynamically modified to customize the intelligent table to the user.
• the intelligent table is capable of being dynamically modified based on input from a non-rhythmic user will input device.
• the intelligent table is capable of being dynamically modified over time with information concerning breathing rate during a user session.
• the intelligent table is capable of being dynamically modified over time with information concerning exhale time: inhale time ratio during a user session.
• the invention also provides a method for modifying a biorhythm of interest in a user comprising: providing an intelligent table, wherein the intelligent table comprises a representation of a desired biorhythm to be produced by the user; providing the representation of the desired biorhythm comprising recovering the representation of the desired biorhythm from the intelligent table; generating a biorhythm instruction signal, wherein the biorhythm instruction signal is based on the representation of the desired biorhythm recovered from the intelligent table; and relaying the biorhythm instruction signal to the user, whereby the biorhythm instruction signal is sensed by the user using sensory perception.
• the method comprises, before the step of providing a representation of the desired biorhythm, the step of: providing an apparatus to the user, wherein the apparatus comprises: i. the intelligent table, ii. a compute unit, wherein the compute unit is operably connected to the intelligent table and wherein the compute unit comprises:
• the apparatus additionally comprises a non-rhythmic user will input device.
• the apparatus additionally comprises a biological rhythm detector.
• the apparatus additionally comprises a biological rhythm transform and output device.
• the apparatus additionally comprises a biological rhythm detector operably connected to the biological rhythm transform and output device.
• the user is a human.
• the user is a non-human animal.
• the user produces a modified biorhythm in response to sensing the biorhythm instruction signal, such as an increase or decrease in frequency or modulation of characteristic of the biorhythm
• the sensory perception is selected from the group consisting of vision, audition, olfaction and mechanosensation.
• the output of the biological rhythm output device is selected from the group consisting of visual output, audio output, olfactory output and mechanosensory output.
• the intelligent table comprises a store of knowledge about biorhythm modulation.
• the intelligent table comprises a representation of a desired biorhythm to be produced by the user.
• the apparatus additionally comprises a non-rhythmic user will input device operably connected to the compute unit.
• the apparatus additionally comprises a dynamic variable store operably connected to the compute unit.
• the dynamic variable store is operably connected to the compute unit by a read-write bus.
• the apparatus additionally comprises a code store operably connected to the compute unit.
• the code store is operably connected to the compute unit by a read-only bus.
• the non-volatile memory stores non-rhythmic user will input device state information.
• the non-volatile memory is programmed with desired data and user variables.
• the apparatus additionally comprises means for generating algorithmically a desired biorhythm.
• the apparatus additionally comprises means for sound processing operably connected to the compute unit.
• the apparatus additionally comprises a natural sound data store operably connected to the means for sound processing.
• the biological rhythm transform and output device is a speaker.
• the apparatus additionally comprises means for displaying algorithmically a desired biorhythm, so that the desired biorhythm can be detected by a human sense (e.g., a rhythmic sound or visual stimulus, or even a rhythmic smell or touch that can be perceived by a sensory perception such as vision, audition, olfaction, or mechanosensation)
• the apparatus additionally comprises means for generating these algorithmically desired biorhythms (e.g., with compute unit code and an electronic sound device, such as a sound synthesis circuit or other method, such as code directly controlling an electric signal output device), such as from the memory store or from some other device.
• the non-volatile memory is programmed with desired data and user variables such as current session number, history of user inputs, value of function F, and internal data such as breathing timers and operational data variables.
• desired data and user variables such as current session number, history of user inputs, value of function F, and internal data such as breathing timers and operational data variables.
• the biological instruction output device is operably connected to the compute unit and operably connected to the user to communicate to the human senses a desired biorhythm.
• the biological rhythm detector is operably connected to a biological rhythm transform and output device for added comfort and compliance of the user.
• the users own biological rhythm is feedback directly to the user.
• the apparatus of the invention comprises an intelligent table and user dynamic store that comprises information concerning the mean, best-therapeutic-case, behaviors of the device and the user, when an unknown patient uses the apparatus of the invention.
• the way the knowledge concerning the unknown user in this table is generated is both by codifying general knowledge about human learning of slower, paced, regular breathing for example as disclosed by Meles et al. 2004 (Nonpharmacologic Treatment of Hypertension by Respiratory Exercise in the Home Setting. Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G, American Journal of Hypertension 2004, 17:370—374), and by an iterative approach where the device itself is used as research tool to generate even more detailed knowledge about how users of the device best slow their breathing.
• the invention provides a method for regulating the function of the apparatus of the invention to the users will of the devices behaviors.
• the user will have a non-rhythmic user will input device, such as a binary button, which will non-biorhythrnically instruct the device to modify its behavior.
• the user might instruct the device to stop, or to start, or to discretely change a breathing rate, or to change the ratio of the in-breath to the out-breath.
• These instructions may also be part of the devices heuristic learning about the user.
• the apparatus of the invention comprises a store of personal user state information from the non-rhythmic user will input device that supplements the intelligent table and user dynamic store.
• personal user state information is stored in a non-volatile memory. That is, the personalization of the device may be integral to, or simply interactive with, the knowledge based table.
• the apparatus outputs instructive sounds based on real, recorded natural sounds, whose nature train the user to breathe differently for the desired therapeutic effect.
• the method and apparatus of the invention employ computer directives.
• these computer directives are artificial computer generated sounds or they are natural recorded sounds,
• the computer-generated directives (such as natural sounds) have embedded in them certain sounds that assist the users in biorhythmic activity, for example, to achieve a therapeutic goal or outcome.
• These sound queues added to the base sound, improve the instructive nature of the output sounds by identifying different portions of the breathing cycle to the listener.
• sounds of the user's own biological rhythms are amplified or otherwise supplied or made available to the user with, for example, a microphone, stethoscope or similar sound, sight, or touch amplifying device.
• the user can consciously, semiconsciously, or unconsciously compare these amplified personal biorhythms with the directives that the user is receiving from the computer.
• the user may use this comparison of their own biological biorhythms with the computer instruction of the desired biorhythm, and adjust their own biorhythmic activity to bring the two closer into synchronicity. They do this with a human mental-only comparison and a follow on act of human will controlling their personal biorhythm.
• This human mental comparison reduces the need for a machine readable sensor which could do a machine comparison.
• the invention thus removes the need for an intrusive sensor to dynamically generate a computer readable signal.
• the apparatus and method of the invention is therefore substantially less intrusive and easier to use than existing devices for modulating a user's biological rhythms. 4. BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. IA is a schematic diagram of one embodiment of the apparatus of the invention.
• FIG. IB is a cartoon schematic diagram illustrating general features and principles of the apparatus.
• FIG. 2 is a schematic diagram of a preferred embodiment of the apparatus of the invention. See Section 6.2 for details.
• FIG. 3 is a schematic diagram of another embodiment of the apparatus of the invention. This specific embodiment of the invention does not comprise a biofeedback loop. See Section 6.2 for details.
• FIG. 4 is a schematic overview of a specific embodiment of the biofeedback loop component of the apparatus of the invention. See Section 6.2 for details.
• FIG. 5 is a schematic detail of an embodiment of the apparatus of the invention. See Section 6.2 for details.
• FIG. 6 is a schematic detail of an embodiment of the apparatus of the invention. See Section 6.2 for details.
• FIG. 7 is a graph of a recorded biorhythmic breathing practice. Typical changes in breathing rate and the ratio between exhale time (Tex) to inhale time (Tin) during a 15-minute session (#20) calculated from data stored in a patient's device, and uploaded to a Web-based reporting system. Gray dots indicate the ratio of exhale time (Tex) to inhale time (Tin). Black dots indicate the breathing rate (bpm). Both vertical scales have the same numerical value, so the ratio of Tex to Tin varies from about 1.2 to over 4. See Section 6.3 for details.
• FIG. 8 is a graph depicting results of using the apparatus of the invention. The graph plots a user's biorhythmic breathing changes (time versus breathing rate, in bpm) over 15 minutes for a first weekly session (1) and a subsequent weekly session until the end session (N). See Section 6.3 for details.
• FIG. 9 shows an example of an intelligent table and user dynamic store based on data derived from FIG. 8, over a 6 minute period. See Section 6.3 for details.
• FIG. 10 shows the heuristic function F being generated. The graph shows two different types of users and their evolving functions F over four user inputs in one session. They have good or poor initial breathing control. A singer would normally have good breath control.
• FIO. 11 shows the value of the function F corresponding with FIG. 10.
• the present invention provides an apparatus for modifying a biorhythm of interest in a user comprising: an apparatus for modifying a biorhythm of interest in a user comprising: an intelligent table and user dynamic store (also referred to herein as an "intelligent table"); a compute unit, wherein the compute unit is operably connected to the intelligent table and wherein the compute unit comprises: means for data processing, memory, wherein the memory comprises non-volatile memory, and means for generating a biorhythm instruction signal; and a biorhythm instruction output device for transmitting a biorhythm instruction signal for a desired biorhythm operably connected to the compute unit, wherein: the biorhythm instruction output device is configured to relay the biorhythm instruction signal to the user, and the biorhythm instruction signal is sensed by the user using sensory perception.
• an intelligent table and user dynamic store also referred to herein as an "intelligent table”
• a compute unit wherein the compute unit is operably connected to the intelligent table and wherein the compute unit comprises: means for data processing, memory, wherein the memory comprises non
• the invention also provides an intelligent table for storing human knowledge of instructions for biological rhythm modulation in a user comprising a representation of a desired biorhythm to be produced by the user for health improvement.
• the invention also provides a method for modifying a biorhythm of interest in a user comprising: providing an intelligent table, wherein the intelligent table comprises a representation of a desired biorhythm to be produced by the user; providing the representation of the desired biorhythm comprising recovering the representation of the desired biorhythm from the intelligent table; generating a biorhythm instruction signal, wherein the biorhythm instruction signal is based on the representation of the desired biorhythm recovered from the intelligent table; and relaying the biorhythm instruction signal to the user, whereby the biorhythm instruction signal is sensed by the user using sensory perception.
• the invention is based on the discovery that human biological rhythm modification, in some cases, is sufficiently predictable that computer sensor monitoring of the current biological rhythm is not required to know the next desired biological rhythm for the desired health benefits.
• Dr. Andrew Weil, MD as discussed herein.
• Dr. Andrew, 2004. Natural Health , Natural Medicine, The complete guide to wellness and self-care for optimum health, Houghton Mifflin Company, rev 2004 prescribes one breathing practice for several medical conditions, without first monitoring the patient's current biorhythm. This is breathing practice is, hence, a generalization.
• Dr. Weil has health benefits, a chief disadvantage Dr.
• Weil's approach is the practice of forcing oneself to breath this way without device assistance or progressive learning, is in it itself stress producing, and can reduce the practices' effectiveness.
• the present invention removes this limitation and is relatively stress free, non-intrusive, and more proven effective.
• a further disadvantage of the Weil breathing practice is a lack of description of the preferred duration of the practice and total practice time not only for temporary relief of the symptoms, but also for a semi- permanent positive change in the disease condition. Medical studies well known in the art address these issues for hypertension (see, e.g., W. Elliott et aL, Graded Blood Pressure Reduction in Hypertensive Outpatients Associated with Use of a Device to Assist with Slow Breathing. J. Clin. Hypertens., 2004 6(10): 553-559).
• the compute unit employs the intelligent table and user dynamic store to compute the current and next desired biological rhythm output to be transmitted to the user.
• the output from the intelligent table and user dynamic store is transmitted directly to the user (e.g., a patient) using a biological rhythm transform and output device.
• the invention additionally comprises a biological rhythm (biorhythm) detector.
• Feedback from the biological rhythm detector is transmitted directly to the user with no intervention by the compute unit or monitor.
• the biological rhythm detector is a far less intrusive device since its output does not need the property of machine readability.
• the biological rhythm detector is operably connected to a biological rhythm transform device, such as an amplifier, and then goes to a biological rhythm subject feedback device.
• a biological rhythm transform device such as an amplifier
• the biological rhythm transform device and the biological rhythm subject feedback device are termed herein the biological rhythm transform and output device.
• the apparatus comprises a non-rhythmic user will input device, such as a pushbutton or slide switch, or rotating knob or more advanced device such as an eyewink detector.
• the non-rhythmic user will input device is activated by an act of the user's mental will.
• Input from the non-rhythmic user will input device changes the state of the apparatus of the invention (e.g., abruptly, not rhythmically ) should the general case predictive mechanism not prove as predicatively accurate as desired by the individual user, and to better handle individual differences in human physiology.
• a change, by a user, in the state of the apparatus is not indicative of an actual measured physiological variable but is indicative of the user's desire to change the state of the machine, for whatever reason.
• the invention additionally comprises a biological rhythm detector, such as a microphone, which is not connected to the compute device.
• the microphone for example, can be amplified and feed back directly to the patient.
• the patient can co-ordinate the directions coming from the compute device, such as sounds, and those of the sounds of their own breathing to modify their own breathing over time.
• the invention additionally comprises a non- volatile memory for storing non-rhythmic user will input device state information, which lessens the need for dynamic state information about the current physiological variable.
• FIG. IA is a view of the overall system.
• a compute unit 4 relies on an intelligent table 1 (in memory) (also referred to herein as “intelligent table and user dynamic store”) to compute the current and next desired biological rhythm output to give the patient.
• the output goes directly to the user/ patient by a biorhythm instruction output device 25.
• a non-rhythmic user will input device 5 changes the state of the device and intelligent table and user dynamic store.. Since an intelligent table and user dynamic store is employed in the apparatus, no biological rhythm sensor needs to send input to the compute unit 4 in order to facilitate amelioration of the user's health or condition.
• This particular embodiment of the invention also comprises a biological rhythm detector 27 that is operably connected to the biological rhythm transform and output device 29 and to the user.
• a biorhythm transform device 26 amplifies the signal before it is transmitted to the user.
• the user receives this "feedback" signal without the signal first going to the compute unit 4. That is, this biofeedback loop is independent of the intelligent table 1 , compute unit 4, and biological rhythm output device 25 circuitry.
• the user has the option of comparing the rhythms generated by the compute unit 4 with their own transformed biological rhythm, and they can choose to co-ordinate the two rhythms.
• FIG. IB uses cartoon or iconic figures of the identical logical connections and devices as in FIG. IA to illustrate the concepts involved.
• the apparatus of the invention comprises an intelligent table and user dynamic store (also referred to herein as an "intelligent table") operably connected to the compute unit (by any connection known in the art that has a bandwidth greater than 10k bits per second).
• the intelligent table and user dynamic store stores human knowledge about the medical practice of modulating biological rhythm over time, both for short times such as one user session, and long times such as many multiple sessions or over months or years of elapsed time.
• the intelligent table and user dynamic store can be modified to customize it the individual user or class of user based on a non-rhythmic user will input device. Section 6.2, FIG. 11 describes how the heuristic function F modifies the contents of the intelligent table and user dynamic store.
• the intelligent table and user dynamic store stores information about how to modify the biorhythm of interest in an average user.
• the contents of the intelligent table and user dynamic store can be dynamically modified heuristically to customize the device to the individual user, or to the appropriate class of the individual user.
• the present invention is based in part on the knowledge by the inventor and others that although breathing rates and breathing rate changes are somewhat individualized, as a first-order approximation, breathing rate change generalizations can be successfully used to promote relaxation for medical treatments.
• Dr. Andrew Weil, MD asserts many medical benefits of the following breathing generalization on page 128 in "Natural Health, Natural Medicine” (Weil, Andrew, 2004. Natural Health , Natural Medicine, The complete guide to wellness and self-care for optimum health, Houghton Miffiin Company, rev 2004):
• the intelligent table and user dynamic store comprises a store of knowledge about biorhythm modulation.
• FIG. 7, 8, and 9 illustrate, at a general level, the contents of this store, which comprises medical information or data concerning the medical or therapeutic practice of modulating biorhythms over time, both for short times such as one user session (FIG. 7), and long times such as many multiple sessions or over months or years of elapsed time (FIG. 8).
• the intelligent table comprises representations of encoded desired, medically beneficial biorhythms to be produced by a user.
• the step of providing a representation of a desired biorhythm comprises recovering the representation of encoded biorhythm from the intelligent table and later algorithmically decoding it at a time it should be produced by the user for desired medical benefits.
• the step of providing a representation of a desired biorhythm comprises recovering the representation of encoded biorhythm from the intelligent table and later algorithmically decoding it at a time it should be produced by the user for desired medical benefits.
• the read of the biorhythm comes from a breathing device that records statistics of a user's breathing behavior as the user slows their breathing during each session of use.
• the information encoded in FIG. 8 could be acquired in this manner.
• Elements in the intelligent table can be further be customized to the individual user.
• Information included in the table can be, for example, how different people comfortably slow their breathing over multiple sessions, while bringing about a desired health benefit, such as reducing high blood pressure.
• a phenomenological approach can be used to generate elements in the intelligent table.
• the apparatus of the invention instructs a user to breathe at a breathing rate estimated to be optimal over one or more 15-minute sessions.
• the temporary blood pressure reduction is measured for each of the instructed sessions. Since attempting to slow breathing too quickly can produce stress in a user, the temporary blood pressure reductions are good indications of the state of the user's relaxation and whether the estimated optimal breathing rate is indeed optimal or not.
• the intelligent table portion of the intelligent table and user dynamic store specifies the directive that the apparatus outputs during each session. In a specific embodiment, the directive is based on medical knowledge known to be most effective at that point in the training or therapy.
• FIG. 7 shows a measured breathing cycle during the twentieth session of breathing biorhythm modification.
• the breathing slows down from over 15 breaths-per-minute (BPM) to 10 BPM in about 4 minutes, to just over 6 BPM in 15 minutes.
• BPM breaths-per-minute
• the exact shape of this breathing slowdown will vary somewhat during each session, as should the compute output instructions; however this general shape is known to be medically effective for hypertension reduction.
• the ratio of exhale time to inhale time varies from 1 to 1 to about 1 to 3. This is also known to be medically effective for reducing hypertension.
• An example of a sample computer table data structure that implements changes like those of FIG. 7 and 8 is shown in FIG. 9.
• FIG. 8 indicates for each minute what the breathing rate should be, given certain initial starting conditions.
• the intelligent table is modified at each non-rhythmic user will input device act or at the end of a session of such an act.
• Each session is based on the session number or other variables as well as the current contents of this table.
• the code takes whatever contents were active in the data structure and the behavior of the apparatus changes even as the executing code stays the same.
• the table intelligent codifies human intelligence and wisdom about how to breathe for human health.
• the table itself can be a relatively straightforward data structure, e.g., any data structure commonly known in the art, such as x by y table , which is accessed by the value of x and y. See FIG. 9 for an example of such a table.
• the intelligent table and user dynamic store is a heuristic data structure.
• the compute unit pattern recognizes the history of the user will inputs. At each new user will input, the device learns more about that user and how that user may vary from the norm represented in the initial table. This learning process about the individual user (heuristic) can, in certain embodiments, further modify the controlling table contents (or other data construct). In a relatively short time (for example, two to five fifteen minute sessions), the device's behavior in the future needs no more user will inputs, since the device has learned enough about the user to know how to change its behaviors indefinitely into the future, without further user will input.
• the apparatus of the invention may learn that the user wants the device to go slower three times in a row, and has the intelligence to know what that likely means for the indefinite future.
• the heuristic aspect of learning about the user is only slightly dependent on the other parameters that control the device's behavior, such as the session number and the general breathing reduction knowledge. Therefore, in one embodiment, the apparatus of the invention classifies the user from his user will inputs and then uses that classification as part of the rules-based knowledge used to construct the'biorhythm table for, or during, each new session.
• the apparatus learns that the user is a slow neurological learner from his non-rhythmic user will input device inputs.
• Compute unit comprises memory and means for data processing.
• the compute unit can be, for example, a modest performance MCU, which provides means for data processing. Many such devices are commercially available for under $10 ($US). A modest performance MPU might also be used with the appropriate peripherals to control the system.
• the compute unit computes the directive output signals based on a number of variables. One variable would be the session number, such that the output biorhythrnic signals vary each therapeutic session (usually tens of minutes), and knowing the past history of all prior output signals each therapeutic session. In this way the output signals vary as the biorhythmic modification progresses over time.
• the compute unit accesses the intelligent table and user dynamic store, such that knowledge based rules modify the output signals. These knowledge based rules are discussed in the description of the intelligent table and user dynamic store.
• the compute unit stores and pattern interprets the history of non-rhythmic user will input device inputs over time. User will inputs are interpreted in the context of the state of the device at the time of the input, such as the current session number, and the current directive output signals, such as the current breathing rate. Another compute unit variable could be the number of minutes into the current session. The user will input pattern recognition over time efficiently customizes the devices behavior to the individual user for maximum health benefit.
• the compute unit has access to variables stored from session to session in nonvolatile memory. [000128] 5.2.1 Memory
• the intelligent table and user dynamic store is stored in a memory storage device in an MCU.
• Any type of memory storage device known in the art may be employed that is non-volatile from session-to-session.
• an Atmel Corporation MCU such as the model ATtiny2313, would furnish a suitable nonvolatile memory store.
• an MPU any type of external flash known in the art may be used.
• the code instruction store is also in flash or EPROM.
• the apparatus comprises a personal user state information store that stores the processed inputs from the non-rhythmic user will input device.
• these inputs are a detailed historical store of the inputs or an algorithm interpretation of the non-rhythmic user will input device inputs, which is then stored.
• this detailed historical store is used to create the heuristic function, F, which varies with each non-rhythmic user will input device input that customizes the intelligent table and user dynamic store to the individual, At some point this function normally stabilizes.
• the personal user state information store can have two or more components, for example, one component that derives from control inputs during the use of the device and the other component that derives from initial personalization of the device before use, such as inputs in response to questions.
• the apparatus can request that the user breather at a rate faster than 10 BPM and the user can answer this request by employing the non- rhythmic user will input device that it does or does not desire this breathing rate.
• This component may come from additional initial personalization of the device before use, such as inputs in response to audio questions.
• Personal user state store may or may not be in the same memory as the intelligent table and user dynamic store .
• the personal user state information store is in a different memory or different memory segment than the intelligent table and user dynamic store.
• the heuristic function (F) value itself which is derived from the personal user state store, would be in the intelligent table and user dynamic store.
• the sound element components, which the compute unit uses to generate the signals to Biorhythm instruction output device in one embodiment is in a separate dedicated EPROM. However, in practice these sound elements can be in any non-volatile store and do not have to in a separate device.
• 5.2.1.3 Code variable store [000136] Executing code normally entails fast temporary variable store. In one embodiment this is in static RAM inside the MCU. However due to relatively light need for a means for data processing, it is possible writeable flash memory could serve this purpose. [000137] 5.2.2 Means for generating a biorhythm instruction signal
• the compute unit uses its components to calculate the biorhythm instruction signal appropriate for each device use for each user.
• the compute unit accesses the intelligent table and, from the desired BPM in the table, instructs a sound-synthesis integrated circuit or similar device known in the art to play that sound, which generates the appropriate signal to the biorhythm instruction output device.
• the audio synthesis component might play sounds in its accessible memory by a numbered command.
• the number in its command could be a number that corresponds to the desired BPM.
• the biorhythm instruction output device outputs directive information to the user about the desired biorhythm.
• Information generated by the compute unit is transformed into a human sensory form and output to the user such as headset or speaker.
• the output device must be detectable by the user by one or more of their five senses, and therefore audio, visual, tactile, taste, or smell producing device could be used that could reliably be understood as the b ⁇ orhythms of interest.
• Such devices could be light emitting screens (LED OR LCD, etc), vibrating touch devices such as a touch pad with tactile feedback (see, e.g., U.S. Patent No. 5,977,867 ), and additional audio producing devices such as speakers or electronic instruments.
• Non-rhythmic user will input device
• the apparatus comprises a non-rhythmic user will input device.
• Any non-rhythmic user will input device known in the art, e.g., a limb-activated device, a voice- activated device, an image detector (such as a camera with processing), etc. by which a mental control decision, as opposed to a measurable physiological variable, can be communicated to the compute unit.
• the non-rhythmic user will input device is a push button.
• the non-rhythmic user will input device changes the state of the apparatus to conform to an outcome desired by the user, for example, to slow down or speed up the training breathing rate or to increase of decrease the amount of audio cuing embedded in the training sounds.
• the non-rhythmic user will input device does not sense a physiological biorhythm variable of interest (such as breathing rate, or heart rate). Rather, a non- rhythmic user will input using the non-rhythmic user will input device indicates a mental act of will (i.e., a mental decision on the part of the user) to control the biorhythm of interest.
• a mental act of i.e., a mental decision on the part of the user
• the thought (or decision) on the part of the user to execute a non- rhythmic user will input using the non-rhythmic user will input device is not a sensing or detection of the biorhythm; rather, it is a conscious decision on the part of the user.
• the user may decide to change the computer output biorhythm by activating the non-rhythmic user will input device, e.g., pushing a pushbutton.
• the appropriate synchronization is that the user can mimic, with good inter rhythm accuracy, the biorhythms of biorhythm instruction output device with minimal stress and a calming feeling.
• the inter-rhythm accuracy, for breathing for example would be that the users breathes in , breathes out, and pauses for roughly the same amount of time as instructed by the biorhythm instruction output device.
• the apparatus of the invention comprises no machine-readable hardware biorhythmic sensor, such as a motion sensor attached to the human chest or stomach, which measures the rhythmic movement of the chest during breathing.
• a biorhythmic sensor such as a motion sensor attached to the human chest or stomach, which measures the rhythmic movement of the chest during breathing.
• Such a sensor can produce an analog signal related chest position over time and this analog signal can be converted to a digital input readable by an MCU.
• an act of thought or will to change a physiological biorhythm of interest is distinct from the physiological biorhythm itself.
• the user's decision to change the biorhythm of interest is a cognitive or emotional reaction, rather than a voluntary motor behavioral reaction. For example, it may take the user a period of time after receiving feedback from the biological rhythm detector and biological rhythm transform and output device, or even in the absence of that feedback, to decide whether or not to change a given instructed biorhythm.
• the user's act of activating the non-rhythmic user will input device does not constitute a true sensing of a physiological biorhythmic variable, but instead of the users will to change the devices behavior.
• the apparatus of the invention comprises a biological rhythm detector. Any detector known in the art can be employed as a biological rhythm detector, provided that the compute unit does not have an operable connection to the biological ihythm detector.
• the biological rhythm detector is a microphone.
• the biological rhythm detector is a stethoscope, a motion detector, a blood pressure sensor, an electrocardiographic sensor, a heart rate detector, an ultrasonic sensor, a visual pattern sensor, or other biorhythmic sensors.
• Biological rhythms that can be detected include, but are not limited to: respiration, heartbeat, blood or other fluid movement, sleeping patterns. EKG, brain waves, etc. Any device known in the art for detecting such a rhythm can be used in the methods and apparatus of the invention.
• the apparatus of the invention comprises a biological rhythm output device that may, in certain embodiments, also comprise a transform device (referred to herein as a "biological rhythm transform and output device") (FIG. 1).
• the biological rhythm transform and output device is similar to the biorhythm instruction output device, except that its input derives from the biorhythmic sensor and not from the compute unit.
• the transform portion simply means that before the output of biological rhythm sensor is input to biological rhythm output, it may be changed (transformed) for technological or for functional reasons. In certain embodiments, no change (null or identity transform) is performed and the biological rhythm transform and output device functions simply as an output device.
• An example of a technological reason may be, for example, that the output of a typical microphone breathing sensor must be amplified before it is sent to a speaker, the output device.
• a functional change may be, for example, that the biological rhythm sensor is time-modified, such as delayed , for a health improvement reason, before it is send to the output device. Any transform known in the art is possible.
• various components of the apparatus of the invention have an operable connection to the user, so that the user senses the information transmitted.
• Information can be transmitted to the user, for example, by the biorhythm instruction output device, by, e.g., a status LED on the apparatus, and by the biological rhythm transform and output device.
• LEDs indicate a state of the apparatus such as power on.
• information can be received from the user by the biological rhythm detector and/or by the non-rhythmic user will input device.
• FIGS. 1-2 indicate connections between these two devices.
• the apparatus and method of the invention can be used to treat, reverse, and/or ameliorate numerous diseases, disorders and conditions, including, but not limited to hypertension, stress related disorders such as post-traumatic stress disorders, anxiety disorders, depression, asthma, insomnia, lupus, mood swings, pain, PMS, and gastrointestinal disorders.
• the invention provides an apparatus and method for facilitating amelioration of the health of a user or of a disease, disorder or health condition of the user certain other lung conditions, recovery from lung illnesses which used a lung machine, by changing (or perhaps even establishing) a rhythmic physiological variable of the user, such as breathing or other biorhythmic activity, into a therapeutically desired range.
• Other health conditions which may be improved are congestive heart failure, cystic fibrosis, low oxygenation in the blood, and to reduce post-surgery recovery time.
• the following examples demonstrate how the apparatus of the invention guides breathing in a user.
• the user receives the soothing sounds of their own breathing, the learning of slower, regular breathing with a desired ration of in-breath to out-breath and pause periods.
• No intrusive components e.g., breath sensor belts, are used.
• Users hear soothing directive sounds in their ears that instruct them how to breathe and that vary over the practice, both during one session and over multiple sessions.
• Example 1 Use of the intelligent table and user dynamic store
• an intelligent table rather than a biorhythm sensor, is used, thus avoiding the drawbacks of a machine readable biorhythm sensor such as a motion sensor in a belt around the waist measure the chest or stomach motion during breathing. Discomfort is caused for a number of reasons.
• a machine readable biorhythm sensor such as a motion sensor in a belt around the waist measure the chest or stomach motion during breathing. Discomfort is caused for a number of reasons.
• a certain level of accurate function is required, which in a belt motion sensor, for example, often means frequent adjusting of the belt's position or tightness. Without this adjustment, functioning of the device can stop, since it is dependent on this machine readable sensor for basic operation.
• the apparatus of the invention comprises an intelligent table, a compute unit, and a biorhythm instruction output device. More detail on each of these components is disclosed below in section 6.2, example 2. However, a brief description of this "minimal system" embodiment is as follows. This embodiment system is shown in FIG. 1.
• This "minimal system" embodiment is achieved by removing the biological rhythm detector, biological rhythm transform and output device, and the non-rhythmic user will input device.
• the compute unit receives the current sound file instructive file, the correct BPM, etc., to play from the intelligent table.
• the compute unit instructs the biorhythm instruction output device to play a sound. Since there is no non-rhythmic user will input device, the intelligent table will not be heuristic. However, the instructions will be adequate for many users.
• There is also no biological rhythm detector or biological rhythm transform and output device This can, in certain instances make more difficult for the user to breathe as instructed, but again, many users will be able to do this.
• a non-rhythmic user will input device can be added to the "minimal system” device.
• the table is heuristic and will customize to an individual user.
• a biological rhythm detector and a biological rhythm transform and output device can be added to the "minimal system” device. This will greatly assist users in complying with the device's instructed breathing with minimal stress.
• FIGS. 2 - 6 shows embodiments of the apparatus of the invention.
• FIG. 2 shows a schematic diagram of this specific embodiment of the invention.
• the intelligent table also referred to herein as "intelligent table and user dynamic store”
• the code store 2 the dynamic variable store 3
• the compute unit 4 the natural sound data store 6
• the means for sound processing in this embodiment, a sound processing unit 7 are comprised in a single unit.
• the compute element determines instructive sounds to play .for the user from initial settings, the non-rhythmic user will input device 5, and from stored memory in the compute element shown, and from any other initial conditions.
• speaker 2 8 is adjacent to the user's left ear and speaker 1 12 is adjacent to the user's right ea). 9, microphone. 19, speaker 1 wire. 20, speaker 2 wire. 21, microphone wire. 24, body of living (e.g., human) user. 28, user's mind and will.
• the intelligent table and user dynamic store 1 in the embodiment in FIG. 3 comprises medical information on the manner in which most users slow or change their biorhythms to most effectively reduce their hypertension and / or stress or other medical condition.
• FIG. 3 illustrates that the intelligent table and user dynamic store 1 knows accurately, for beneficial results, the mean desired behavior of the device's target user population when performing this therapy over an extended periods of time, particularly the first 8 weeks or so.
• 2 represent the code store. 3, dynamic variable store. 4, compute unit. 5, non-rhythmic user will input device. 6, natural sound data store. 7, sound processing unit, which may be implemented by a commercial sound chip with internal code. 8, speaker 2.
• encoded information about the actions of all previous uses of the non- rhythmic user will input device 5 is stored in the intelligent table and user dynamic store current state store. A series of discrete user's input, caught in time with the device's activity, can lead to efficient user type identification, so that many users can be distinguished from each other. This customizes the device to the user.
• a heuristic application of the intelligent table and user dynamic store is possible based on an interaction of the unique non-rhythmic user will input device and the current state table contents.
• the intelligent table and user dynamic store 1 has rhythmic sound indices, from roughly 14 breaths-per-minute (BPM) to 5 BPM, at one BPM or so changes.
• the absolute time of the critical non-active pause period change.
• the ratios of the in-breath to out-breath and ratio of the pause to the total breathing cycle change.
• the instructional sounds encourage a very precise cycle of total in-breath time (inhale), transition-to-out-breath time, out- breath time (exhale), and non-active time (pause) before the next inhale.
• This precise cycle can be tailored for a desired effect, such as hypertension reduction, stress reduction, increased oxygen in the blood, or many more.
• the contents of the intelligent table and user dynamic store is based on research into the nature of the normal or most common way the users in a population of interest most easily change their biorhythmic activity into a therapeutic range, and how their bodies, including their neurological systems, learn this new desired behavior. This repeated, temporary change in their biological rhythm over larger periods of time is what produces the semi-permanent improvement in the user's health.
• this table has, based on the initial non-rhythmic user will input device 5, a linked list of biorhythmic activity sounds, which it will play for a 15 minute therapy session.
• a preferred operation of the device shown in FIG. 2 is the user's attempt to breathe as the compute unit 4 sounds instruct, in one or both ear speakers (12, 8). As a user breathes, the user hears their own breath or biological rhythm amplified from a microphone 9, or stethoscope, or other amplification device known in the art.
• biorhythm input devices can be output to a sensory system, e.g., visual, auditory, olfactory or mechanosensory output.
• a sensory system e.g., visual, auditory, olfactory or mechanosensory output.
• the compute unit 4 based on all initial conditions (such as the state variables of the device, such as the session number, the function F, and initial user input,) the intelligent table and user dynamic store 1, automatically slows down its instructive breathing sounds, with no further non-rhythmic user will input device 5 or sensors required. The user therapeutically modifies their sounds to match those output from the compute unit 4.
• the user does not touch the non-rhythmic user will input device 5 and will power the device up. The device will know if the user has ever given non-rhythmic user will input device 5 and, if not, will start a sequence known to be effective for most new users to the therapy provided by the apparatus of the invention.
• the user may hear soothing ocean waves, which gently guide the user to breathe in as the waves roll in and to breathe out as the waves roll out.
• there are additional audio cues provided to augment the sound to the ocean waves (for example, to assist new users), which may further structure the wave according to the desired breathing cycle.
• the device gently changes the breathing cycle, for example, both in the ratio of the various times and in the total length of the cycle.
• the total length increases from, e.g., 14 breaths-per-minute (BPM) (4.3 seconds) to a lower number of breaths per minute (e.g., one or two BPM lower).
• BPM breaths-per-minute
• These changes can be, in certain embodiments, discontinuous changes, normally one or two BPM changes.
• the non-active pause period can also change
• Leuner U.S. Patent No. 4,665,926) discusses in detail this pause period and its indication of the relaxation of the general user. The process continues for the 15 minute therapy session.
• the user has the willful option of adjusting the device's behavior (output sounds) with the non-rhythmic user will input device 5 controls to assist in their biorhythmic activity.
• the use may wish to change the device's sounds rather than to change their own breathing sounds. Further experience with the device will reveal if this improves to the device's effectiveness with an individual user.
• the device stores information about the current state, including, for example, the fact the first 15 minute session is completed, and information about the use of a non-rhythmic user will input device 5, such as if and under what conditions (session number, current BPM, minute into the session, etc.) user inputs were received.
• this process continues indefinitely (e.g., days or weeks) or until the user determines a change in some aspect of the device's behavior is desired.
• a desired device change may be, for example, that the user has been using the device for some time and has changed or influenced the user's autonomic neurology.
• the user may now wish, for example that someone who has not gone through those same neurological changes uses the same device. That new person may wish to restore the device to its initial conditions.
• This user also might also want to change the breathing cycle in some way such as the rate of breathing or the amount or type of audio cues embedded in the natural sounds.
• FIG. 3 shows the details of a preferred embodiment of the compute unit 4, the intelligent table and user dynamic store 1, the code store 2 and the non-rhythmic user will input device 5.
• a microphone, 9, is employed as the biorhythm detector; an audio amplifier, 11, is employed as the biorhythm transform device; and a speaker (“speaker #1 ,”), 12, is employed as the biorhythm output device.
• the embodiment of the apparatus shown in FIG. 3 also comprises a sound processing unit 7.
• the sound processing unit is controlled by the compute unit 4, to control access to natural sounds data store 6 or other data store to play the desire natural sound.
• a MC27801CO1 by STMicroelectronics 39, Chemin du Champ des Filles, C. P. 21, CH 1228 Plan-Les-Ouates, GENEVA, Switzerland, Tel: +41 22 929 29
• the sound processing unit subsystem is disclosed in the discussion of FIG. 5.
• FIG. 3 also shows the details of the compute unit 4.
• the compute unit 4 comprises four main components.
• the first is the intelligent table and user dynamic store 5.
• the second is a microprocessor and its firmware.
• the third is a dynamic variable store to store dynamic program variables.
• the fourth is a code store 2 to store the code to accomplish the above.
• the compute unit is an Atmel MCU. With the Atmel processor, ATtiny2313, the code store 2 is flash memory, the dynamic variable store 3 is static memory, and the intelligent table and user dynamic store 1 store is EEPROM or FLASH inside the MCU itself.
• the dynamic variable store may or may not be in separate memory from the intelligent table and user dynamic store 1 and in one embodiment, is in the same memory. They are functionally distinct only from the code point of view, and the performance aspects of their technology.
• the Atmel MCU ATtiny2313
• SPI Serial Processor Interface
• the Atmel MCU has parallel port interrupts used for the non-rhythmic user will input device 5. For example, the user could push a pushbutton or turn a knob to indicate that they will the waves to slow down or speed up or change their audio cuing properties. This user control input then goes to the MCU and the program implements the user instructed change.
• FIG.4 shows the microphone-9 to-amplifier 11, to speaker 2, 12 subsystem.
• the apparatus of the invention comprises the subsystem, which may, in certain embodiments, dramatically improve obtaining the invention's therapeutic goals.
• the microphone- 9 to-speaker 12 circuit is a soothing help to breathing as desired by the user, as well as with assisting the general relaxation response desired, then that circuit is deemed desired for the operation of the apparatus and method of the invention.
• the microphone 9 output never inputs to the compute unit 4 and only goes into the user's ear.
• FIG. 5 shows an implementation detail, hi one embodiment, the code store 2 is accessed with a read-only bus. In another embodiment, the intelligent table and user dynamic store interface bus is read / writeable. In another embodiment, the non-rhythmic user will input device 5 can be written to memory to be available to the program. In another embodiment, heuristic code might modify the rhythm sound indices in the table.
• FIG. 5 also shows a schematic detail of an embodiment of the apparatus of the invention showing the sound instruction unit and its operable connections after receiving the compute unit 4 commands.
• FIG. 6 a schematic diagram of sound processing in one embodiment of the apparatus of the invention. 6, natural sound data store. 7, means for sound processing (in this embodiment, a sound processing unit). 8, speaker 2. 9, microphone. 15, MCU command interface. 16, audio out. 17, biorhythm output device (e.g., an audio amplifier). 18, read bus of data store (e.g., direct memory access, DMA).
• DMA direct memory access
• the biorhythm instruction output device is speaker 2 8.
• FIG. 7 Shows a clinically measured way to breath during a 15 minutes session as shown by Elliott et al. (MedGenMed Pulmonary Medicine, "Device-Guided Breathing to Lower Blood Pressure: Case Report and Clinical Overview" Posted 08/01/2006 by William J. Elliott, MD, PhD; Joseph L. Izzo, Jr, MD). This was measured during the 20th device guided breathing session; however, the shape of the curve has been shown effective for a variety of sessions. Note that the black dots, which represent breaths-per-minutes, or BPMs, slow from about 15 BPM at the start to 10 BPM in a few miniates. This user settles at around 6 BPM, deep within the therapeutic zone, in about 9 minutes.
• BPMs breaths-per-minutes
• FIG. 7 also shows the ratios of the exhalation to the inhalation time changes from about 1.2 to over 4. This increased ratio, as well as increased total time, has been shown to be effective to reduce blood pressure.
• the apparatus of the invention uses this knowledge of medically effective BPM slowdowns that occur each 15 minute session, such as shown in FIG.
• such medical knowledge resides in the intelligent table.
• FIG. 8 illustrates additional knowledge beyond one 15-minute session, as in FIG. 7.
• the middle curve of FIG. 8 is the same curve as in FIG. 7, however the top curve is for the first week and the bottom curve is for a week significantly greater than 20.
• the shape of the curves are similar, in the sense, they all decrease BPMs faster at first, and eventually slow the decrease rate. They also show the effect of neurologically adapting to and learning slower breathing, so by the final week, the initial BPM decrease is quite rapid.
• the table as shown in FIG. 9, could have 36 rows, as discussed below.
• the intelligent table could have, for example, a row that correlates, either as an identity or algorithmically, with the device use session number. For example, different session numbers could use the same row. That is, each time the device is used for 15 minutes, this increments the session number, which algorithmically affects which row in the intelligent table is employed.
• Another effect of which row is employed in the intelligent table is a non-rhythmic user will input. For example, starting at 1 could be thought of as the initial starting row for an unused apparatus of the invention, which means that for the first minute a user would breathe at 15 BPM.
• the function F starts at a value of 1.
• FIGS. 7-8 There are other algorithmic ways to encapsulate the knowledge in FIGS. 7-8, and to customize them to the individual user.
• the curves in FIGS. 7-8 could be represented by parameterized mathematical functions, where the parameters are algorithmically controlled by the session number, the immediate button pushes, and the function F.
• Different curves can be generated by different constant values.
• FIG. 10 show the function F evolving over four button pushes for two different types of users, one user who is a calm, experienced singer and another user who is habitually nervous and has asthma.
• the graph shows both the initial curve the device would recommend generally, and the curves each of these people would actually desire.
• the new value F is displayed in slide 11.
• the curve the device now recommends for each user is also displayed.
• the first button pushes for both users occur quickly and adjust he devices initial BPMs.
• the next button push is not for another three minutes and the last button push is at 12 minutes.
• the numbers represent BPM, so that "12” represents 12 BPM.
• F represents a function generated by pattern recognition of the history of user inputs. F multiplies the table's numbers and dynamically changes with each input.
• Minutes represents the number of minutes into the user session, so “6” is the sixth minute into a 15-minute session.
• the follow-on button pushes are later because the deviation from the new standard curve is less, since the curve is not changing as fast.
• the first two button pushes are caused more by the initial desired breathing rate, and the second two are caused more by how fast the user wants to change each session after the start of the session. That is, the initial rate may more closely represent the normal daily breathing rate and the second rate may represent more their breath control.
• the fourth button push in this example, the value F has stabilized and in the future, the device recommended BPMs will be much closer to the users desired breathing rates. In practice, most people are able to breathe at different BPMs without too much difficulty and may choose to not push the button to obtain a preferred breathing cycle.
• FIG. 11 depicts the function F.
• the function F is a pattern recognition algorithm of the history of non-rhythmic user will input device inputs that classifies users into useful classes for the purpose of predicting effective biorhythmic changes for them as individuals.
• FIG. 11 shows four button pushes, based on FIG. 10. This pattern, predicts the changes from the norm of this data structure as shown in figure 8, as an shown by the function F.
• Function F is a heuristic time evolving function, which changes as the number of non-rhythmic user will input device inputs increase.
• a simple example of a function F is a slow-down button push multiplies the values in the table by (K ⁇ l>0) and a speed-up button push multiplies the total function by (K>1). For example in the first minute of the practice at the starting line "starting 1", one will see an entry F 12. This means at this point the device will instruct the user to breathe 12 BPM times the function F, which is initially I 5 or 12 BPM. Now assuming no buttons have ever been pushed but a slow-down button is pushed now. This means 12 is multiplied by (k ⁇ l>0). Suppose that this is in this practice a multiplication by .8.

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