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(12) Patent Application Publication (10) Pub. No.: US 2006/0064037 A1 Shalon Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2006/0064037 A1 Shalon Et Al US 2006OO64037A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0064037 A1 Shalon et al. (43) Pub. Date: Mar. 23, 2006 (54) SYSTEMS AND METHODS FOR Related U.S. Application Data MONITORING AND MODIFYING BEHAVOR (60) Provisional application No. 60/612,292, filed on Sep. 22, 2004. (75) Inventors: Tadmor Shalon, Palo Alto, CA (US); Tidhar Shalon, Tel-Aviv (IL) Publication Classification (51) Int. Cl. Correspondence Address: A6IB 7/00 (2006.01) Martin Moynihan (52) U.S. Cl. ........................... 600/586; 128/903; 128/905 PRTSI, Inc. (57) ABSTRACT P.O. Box 16446 A System for detecting non-verbal acoustic energy generated Arlington, VA 22215 (US) by a Subject is provided. The System includes a Sensor mountable on or in a body region of the Subject, the Sensor being capable of Sensing the non-verbal acoustic energy; and (73) Assignee: Shalon Ventures Research, LLC a processing unit being capable of processing the non-verbal acoustic energy Sensed by the Sensor and deriving an activity (21) Appl. No.: 11/230,645 related Signature therefrom, thereby enabling identification of a specific activity associated with the non-verbal acoustic (22) Filed: Sep. 21, 2005 energy. Patent Application Publication Mar. 23, 2006 Sheet 1 of 12 US 2006/0064037 A1 F.G. 1A 24 Figs. 1a-d Patent Application Publication Mar. 23, 2006 Sheet 2 of 12 US 2006/0064037 A1 DIA -BlueTooth/WiFi : ": D- 36 32 34 Patent Application Publication Mar. 23, 2006 Sheet 3 of 12 US 2006/0064037 A1 punosAEsegelduue)Qe3Que Patent Application Publication Mar. 23, 2006 Sheet 4 of 12 US 2006/0064037 A1 teeth plmly closure was.Microp hone Accelerometer43 . Time?Date44 ( Pulse45 ?V ofi. GSR47 Calorisutput level. Body60. weight input 78 Merchandizing Patent Application Publication Mar. 23, 2006 Sheet 5 of 12 US 2006/0064037 A1 3SuA Fig. 6 Patent Application Publication Mar. 23, 2006 Sheet 6 of 12 US 2006/0064037 A1 Patent Application Publication Mar. 23, 2006 Sheet 7 of 12 US 2006/0064037 A1 Transponder 124 User-Interface Unit 13 CD ey o O Ol was O O. O. O. O. O r 9. 5 C/D Time --> Fig. 9 Patent Application Publication Mar. 23, 2006 Sheet 8 of 12 US 2006/0064037 A1 ========--!> Patent Application Publication Mar. 23, 2006 Sheet 9 of 12 US 2006/0064037 A1 AM LI‘61 euil t R : } i AISueu opSnoow Patent Application Publication Mar. 23, 2006 Sheet 10 of 12 US 2006/0064037 A1 Patent Application Publication Mar. 23, 2006 Sheet 11 of 12 US 2006/0064037 A1 D O O. O. E S g s 3 st o Y op s s s e 9 S. e O S N 2 e S o s OO r s op s se S. Patent Application Publication Mar. 23, 2006 Sheet 12 of 12 US 2006/0064037 A1 s s: i | es e g 3 3 S US 2006/OO64037 A1 Mar. 23, 2006 SYSTEMS AND METHODS FOR MONITORING describes a generic arrangement of implantable Sensors, AND MODIFYING BEHAVOR microprocessors and a negative-feedback Stimulator which can enforce a corrective regimen on a patient Suffering from RELATED APPLICATIONS a dietary or other behavioral disorder. 0001. The present application claims priority from U.S. 0008 Unfortunately none of the approaches described Provisional Patent Application No. 60/612,292, filed on Sep. above have been shown to be effective. The only non-drug 22, 2004. The content of the above Application is incorpo interventions for losing weight that display Some long-term rated herein by reference. efficacy are the various procedures to reduce the Volume of the Stomach or bypass it altogether So that just a Small FIELD AND BACKGROUND OF THE volume of food may satiate the patient. While such INVENTION approaches show Some promise, they require invasive Sur gical procedures with attendant risks and pain, they often 0002 The present invention relates to systems and meth require permanent prosthetic implants and/or irreversible ods for monitoring and modifying behavior of a Subject Such modification of the patient's digestive tract with potentially as a human or an animal. Serious complications and Side effects, they are costly, and 0.003 Successful dieting requires long-term behavior they require long recovery time during which the patient is modification in terms of eating and physical activity. A diet immobile and unproductive. Many of those who are over plan is only part of the Solution. Sticking to the plan requires weight or obese are thus unable or unwilling to undergo Such behavior modification that is generally beyond the ability of interventions. most people to implement without external assistance. There 0009. There is thus a widely recognized need for, and it does not appear to be a diet or proceSS by which people can would be highly advantageous to have, a System and method reliably lose weight and keep it off. Numerous studies have shown 100% weight regain on most diets. Other meta for controlling eating behavior without the invasiveness, Studies show that people regain approximately 75% of the risks, pain, complications, cost, and recovery time associ initial weight loSS after five years. ated with Stomach volume reduction and bypass procedures. 0004 Assessing energy balance, i.e. the net difference SUMMARY OF THE INVENTION between energy intake and expenditure is central to obesity research, prevention, and treatment. The importance of 0010. According to one aspect of the present invention accurately measuring energy balance is appreciated by con there is provided a system for detecting activity related to sidering the dynamics of average weight gain in middle aged non-verbal acoustic energy generated by a Subject compris adults which is about 10 lbs. per decade. This significant ing: (a) a Sensor mountable on or in a body region of the gain in weight follows from a net intake excess of approxi Subject, the Sensor being capable of Sensing the non-verbal mately 0.3% of the daily calorie consumption, which is acoustic energy; and (b) a processing unit being capable of below the awareness of most individuals. National Insti processing the non-verbal acoustic energy Sensed by the tutes of Health, Bioengineering Approaches To Energy Sensor and deriving an activity related Signature therefrom, Balance And Obesity (SBIR/STTR). http://grants1.nih.gov/ thereby enabling classification of a specific activity associ grants/guide/pa-files/PA-04-156.html). ated with the non-verbal acoustic energy. 0011. According to further features in preferred embodi 0005 Today, energy intake is at best only crudely mea ments of the invention described below, the sensor is a Sured by Self reporting food consumed, an approach that microphone. nutritionists know falls well short of its accuracy goals. Although Standard Self-report questionnaire and recall tech 0012. According to still further features in the described niques can provide valuable data on dietary patterns, these preferred embodiments the Sensor is a bone conduction techniques are time consuming, inconvenient, and infamous microphone. for considerable underreporting of food consumed, with this 0013. According to still further features in the described error more pronounced for over weight than non-over preferred embodiments the Sensor is mountable on a head of weight individuals. the Subject. 0006 Several devices and methods which attempt to 0014. According to still further features in the described overcome the deficiencies of Self reporting approaches have preferred embodiments the sensor is mountable behind the been described in the prior art. C. 0007 U.S. Pat. No. 6,135,950 describes a pager size device to aid in controlling a person's daily food intake. U.S. 0015 According to still further features in the described Pat. No. 5,398,688 describes a timer for calculating and preferred embodiments the Sensor is implantable. alerting a user when their maximum eating time has expired. 0016. According to still further features in the described U.S. Pat. Nos. 5,188,104 and 5,263.480 describe the treat preferred embodiments the Sensor and the processing unit ment of eating disorders by nerve Stimulation by detecting are housed in a single device. preSelected events indicative of imminent need for treatment and applying predetermined Stimulating Signal to patient 0017 According to still further features in the described vagus nerve. PCT Publication WO 02/053093 and U.S. preferred embodiments the Sensor and the processing are application Publication No. 2004/01478.16, describe a simi Separately housed. lar invasive technique except that the Stimulation is driven 0018. According to still further features in the described into the Stomach muscle of the Subject, thereby altering the preferred embodiments the System further comprises at least timing of digestion. PCT Publication No. WO 02/026101, one addition Sensor Selected from the group consisting of a US 2006/OO64037 A1 Mar. 23, 2006 heart rate Sensor, an accelerometer, a skin conductance 0033 According to still further features in the described Sensor, a muscle tone Sensor, a blood Sugar level Sense, a bite preferred embodiments the ingestion related motion or Sensor and a Stomach contraction Sensor. acoustic energy is generated by biting, chewing or Swallow ing. 0.019 According to still further features in the described preferred embodiments the System further comprises at least 0034. According to still further features in the described one feedback device. preferred embodiments the acoustic energy is non-verbal acoustic activity. 0020. According to still further features in the described preferred embodiments the at least one feedback device is a 0035. According to still further features in the described Speaker. preferred embodiments the sensor is mountable within the oral cavity of the Subject. 0021 According to still further features in the described preferred embodiments the at least one feedback device is 0036).
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