Apparatus for analysis of eating habits

FIELD OF THE INVENTION

0001The present invention relates generally to tracking eating habits, and specifically to an apparatus for detecting and analyzing the swallowing and digesting of food.

BACKGROUND OF THE INVENTION

0002Morbid obesity is a difficult to treat chronic condition defined by a body mass index (BMI = mass/height² [kg/m²]) greater than 40. For obese persons, excessive weight is commonly associated with increased risk of cardiovascular disease, diabetes, degenerative arthritis, endocrine and pulmonary abnormalities, gallbladder disease and hypertension. Additionally, such persons are highly likely to experience psychological difficulties because of lifestyle restrictions such as reduced mobility and physical capacity, due to back pain, joint problems, and shortness of breath. In severe cases, this can contribute to absenteeism and unemployment. Moreover, impairment of body image can lead to significant psychological disturbances. Repeated failures of dieting and exercise to resolve the problem of obesity can result in feelings of despair and the development of clinical depression.

0003Bariatric surgery is often recommended for persons suffering from morbid obesity. Preferably, the invasive treatment is accompanied by changes in lifestyle, such as improved regulation of eating habits and an appropriate exercise regimen. Such lifestyle changes are dependent upon the self-discipline and cooperation of the patient.

0004A book entitled, Textbook of Gastroenterology, 3rd edition, edited by Yamada (Lippincott, Williams & Wilkins), has in Chapter 10 thereof a description of the physiology of gastric motility and gastric emptying.

0005An abstract entitled, "<nplcit id="ncit0001" npl-type="s" url="http:// www.med-online.com / transneuronix / Product / abstract.htm"><text>Gastric myoelectrical pacing as therapy for morbid obesity: Preliminary results," by Cigaina et al., retrieved on December 24, 2000 from the Web-site http:// www.med-online.com / transneuronix / Product / abstract.htm</text></nplcit>, describes a method for applying monopolar and bipolar gastric stimulation to achieve weight loss.

0006An abstract entitled, "<nplcit id="ncit0002" npl-type="s" url="http:// www.medonline.com / transneuronix / Product / abstract.htm"><text>Implantable gastric stimulator (IGS) as therapy for morbid obesity: Equipment, surgical technique and stimulation parameters," by Cigaina et al., retrieved on December 24, 2000 from the Web-site http:// www.medonline.com / transneuronix / Product / abstract.htm</text></nplcit>, describes techniques of electrical signal therapy designed to treat obesity.

0007<patcit id="pcit0001" dnum="US6129685A"><text>US Patent 6,129,685 to Howard</text></patcit> describes apparatus and methods for regulating appetite by electrical stimulation of the hypothalamus and by microinfusion of an appropriate quantity of a suitable drug to a distinct site or region within the hypothalamus.

0008<patcit id="pcit0002" dnum="US4823808A"><text>US Patent 4,823,808 to Clegg et al.</text></patcit> describes a method for treating obesity, including receiving a physiological measurement and generating audio or visual feedback for the patient to hear or see. The feedback is used for purposes of teaching behavior modification.

0009<patcit id="pcit0003" dnum="US5868141A"><text>US Patent 5,868,141 to Ellias</text></patcit> describes an endoscopic stomach insert for reducing a patient's desire to eat.

0010<patcit id="pcit0004" dnum="US6067991A"><text>US Patents 6,067,991 to Forsell</text></patcit>, <patcit id="pcit0005" dnum="US5601604A"><text>5,601,604 to Vincent</text></patcit>, <patcit id="pcit0006" dnum="US5234454A"><text>5,234,454 to Bangs</text></patcit>, <patcit id="pcit0007" dnum="US4133315A"><text>4,133,315 to Berman et al.</text></patcit>, <patcit id="pcit0008" dnum="US4416267A"><text>4,416,267 to Garren et al</text></patcit>., and <patcit id="pcit0009" dnum="US4592339A"><text>US Patents 4,592,339</text></patcit>, <patcit id="pcit0010" dnum="US5449368A"><text>5,449,368</text></patcit>, <patcit id="pcit0011" dnum="US5226429A"><text>5,226,429</text></patcit> and <patcit id="pcit0012" dnum="US5074868A"><text>5,074,868 to Kuzmak</text></patcit> describe mechanical instruments for implantation in or around the stomach of an obese patient.

0011<patcit id="pcit0013" dnum="US5690691A"><text>US Patent 5,690,691 to Chen et al.</text></patcit> describes a gastric pacemaker for treating obesity and other disorders. The pacemaker includes multiple electrodes which are placed at various positions on the gastrointestinal (GI) tract, and deliver phased electrical stimulation to pace peristaltic movement of material through the GI tract.

0012<patcit id="pcit0014" dnum="US5423872A"><text>US Patent 5,423,872 to Cigaina</text></patcit> describes apparatus for applying electrical pulses to the distal gastric antrum of a patient, so as to reduce the motility of the stomach and to thereby treat obesity or another disorder.

0013<patcit id="pcit0015" dnum="US5188104A"><text>US Patents 5,188,104</text></patcit> and <patcit id="pcit0016" dnum="US5263480A"><text>5,263,480 to Wernicke et al.</text></patcit> describe a method for stimulating the vagus nerve of a patient so as to alleviate an eating disorder.

0014<patcit id="pcit0017" dnum="US6104955A"><text>US Patents 6,104,955</text></patcit>, <patcit id="pcit0018" dnum="US6091992A"><text>6,091,992</text></patcit>, and <patcit id="pcit0019" dnum="US5836994A"><text>5,836,994 to Bourgeois</text></patcit>, <patcit id="pcit0020" dnum="US6026326A"><text>6,026,326 to Bardy</text></patcit>, and <patcit id="pcit0021" dnum="US3411507A"><text>3,411,507 to Wingrove</text></patcit> describe the application of electrical signals to the GI tract to treat various physiological disorders.

0015<patcit id="pcit0022" dnum="US5979449A"><text>US Patent 5,979,449 to Steer</text></patcit> describes an oral appliance for appetite suppression.

0016<patcit id="pcit0023" dnum="US4975682A"><text>US Patent 4,975,682 to Kerr et al</text></patcit>. describes apparatus for food intake regulation which is external to the body and which is based upon the voluntary cooperation of the subject in order to be effective.

0017<patcit id="pcit0024" dnum="US5861014A"><text>US Patents 5,861,014 to Familoni</text></patcit>, <patcit id="pcit0025" dnum="US5716385A"><text>5,716,385 to Mittal et al.</text></patcit>, and <patcit id="pcit0026" dnum="US5995872A"><text>5,995,872 to Bourgeois</text></patcit> describe methods and apparatus for stimulation of tissue, particularly gastrointestinal tract tissue.

0018<patcit id="pcit0027" dnum="WO9810830A"><text>PCT Patent Publication WO 98/10830 to Ben-Haim et al</text></patcit>., entitled, "Fencing of cardiac muscles," and <patcit id="pcit0028" dnum="US6415178B"><text>US Patent 6,415,178</text></patcit> in the national phase thereof, both of which are assigned to the assignee of the present patent application describe various methods for controlling the behavior of muscle tissue, for example by blocking or altering the transmission of signals therethrough.

0019<patcit id="pcit0029" dnum="WO9903533A"><text>PCT Patent Publication WO 99/03533 to Ben-Haim et al</text></patcit>., entitled, "Smooth muscle controller," and <patcit id="pcit0030" dnum="US6571127B"><text>US Patent 6,571,127</text></patcit> in the national phase thereof, both of which are assigned to the assignee of the present patent application describe apparatus and methods for applying signals to smooth muscle so as to modify the behavior thereof. In particular, apparatus for controlling the stomach is described in which a controller applies an electrical field to electrodes on the stomach wall so as to modify the reaction of muscle tissue therein to an activation signal, while not generating a propagating action potential in the tissue. In the context of the present patent application and in the claims, the use of such a non-excitatory signal to modify the response of one or more cells to electrical activation thereof, without inducing action potentials in the cells, is referred to as Excitable-Tissue Control (ETC). Use of an ETC signal is described in the PCT Patent Publication with respect to treating obesity, by applying the ETC signal to the stomach so as to delay or prevent emptying of the stomach. In addition, a method is described for increasing the motility of the gastrointestinal tract, by applying an ETC signal to a portion of the tract in order to increase the contraction force generated in the portion. <patcit id="pcit0031" dnum="US5188104A"><text>US patent publication 5,188,104</text></patcit> discloses a system and a method of treating patients with compulsive eating disorders, wherein sensors placed in the esophagus and in the stomach are used to determine the amount of food ingested. Vagal stimulation is then delivered to provide a sensation of satiety. <patcit id="pcit0032" dnum="WO02053093A"><text>WO 02/053 093</text></patcit> was published after the filing date of the present application and discloses determining the quality of food by interpreting electrical signals generated in the gastrointestinal tract.

SUMMARY OF THE INVENTION

0020It is an object of the present invention to provide an apparatus for detecting and tracking the swallowing of solids and liquids.

0021It is a further object of the present invention to provide an apparatus for detecting, tracking, quantifying and determining the qualitative character of ingested liquids and solids.

0022It is still a further object of the present invention to provide an improved apparatus for treating obesity.

0023It is yet a further object of the present invention to provide an apparatus that enable the implementation of changes in food ingestion habits in a predictable and controlled manner.

0024It is an additional object of the present invention to provide an apparatus for regulating food ingestion.

0025These objects are achieved by the invention as defined in the claims.

0026In preferred embodiments of the present invention, apparatus for detecting, tracking, quantifying and determining the qualitative character of ingested liquids and solids comprises a sensor coupled to a patient's gastrointestinal tract. Preferably, the sensor generates a signal indicative of the swallowing of food. An analysis module preferably determines a quality of the food, for example, whether it is predominantly solid or liquid, and stores this information in an electronic memory. "Food," as used in the context of the present patent application and in the claims, is to be understood as including both solid and liquid food. "Swallowing," as used in the context of the present patent application and in the claims, is to be understood as being indicative of the onset of eating.

0027In some preferred embodiments of the present invention, swallowing is detected by tracking the electrical activity in muscle tissue in the fundic region of the stomach. Typically, the commencement of enhanced electrical activity is also detected in muscle tissue in the antral region of the stomach. Measurement of the time delay between swallowing and the commencement of electrical activity in the antrum is preferably used to differentiate between solid and liquid matter, which are generally passed at different rates through the stomach.

0028Alternatively or additionally, swallowing is detected by at least one sensor placed at a site on the gastrointestinal tract other than the fundic region of the stomach, and the sensor generates a signal indicative of swallowing. Appropriate sites include, but are not limited to, a site on the esophagus, a site on the stomach, and a site on the throat. Whenever detection of swallowing is described in the present patent application with respect to fundic activity, it is to be understood as being by way of example, and not as excluding detection by a sensor located elsewhere on the gastrointestinal tract.

0029Preferably, measurement of the intensity and/or duration of the electrical activity in the antral region is correlated with aspects of fundic electrical activity denoting swallowing, as described hereinbelow, such that ingested matter of differing chemical and nutritional content can be distinguished. Further preferably, the amount of food accumulated in the fundus or antrum is estimated by measuring a level of electrical activity at various sites in the stomach.

0030Typically, electrical activity response criteria of the stomach of an individual patient are determined and calibrated by measuring the response of the patient's stomach to various types of solid and liquid food. To ensure appropriate compliance, calibration is preferably performed under the supervision of a healthcare worker. For illustration, a table such as the following may be established for a particular patient. Except with respect to the example of sugarless chewing gum, these illustrative values are shown with respect to a constant volume of food or liquid ingested (e.g., 100 ml or steak, water, or tomato juice). <tables id="tabl0001" num="0001"><table frame="all"><title><b>TABLE I</b></title><tgroup cols="4"><colspec colnum="1" colname="col1" colwidth="44mm" /><colspec colnum="2" colname="col2" colwidth="32mm" /><colspec colnum="3" colname="col3" colwidth="30mm" /><colspec colnum="4" colname="col4" colwidth="56mm" /><thead><row><entry valign="top">Substance</entry><entry align="center" valign="top">Fundic activity level</entry><entry align="center" valign="top">Antral activity level</entry><entry align="center" valign="top">Time delay until onset of antral activity</entry></row></thead><tbody><row><entry>Sugarless chewing gum</entry><entry align="center">1</entry><entry align="center">1</entry><entry align="center">-</entry></row><row><entry>Non-caloric liquid - Water</entry><entry align="center">2</entry><entry align="center">1</entry><entry align="center">-</entry></row><row><entry>Caloric liquid - Tomato juice</entry><entry align="center">2</entry><entry align="center">2</entry><entry align="center">&lt;1 Minute</entry></row><row><entry>Caloric liquid - Milk</entry><entry align="center">2</entry><entry align="center">2</entry><entry align="center">&lt;1 Minute</entry></row><row><entry>Solid - Apple</entry><entry align="center">2</entry><entry align="center">2</entry><entry align="center">Minutes</entry></row><row><entry>Solid - Meat</entry><entry align="center">2</entry><entry align="center">3</entry><entry align="center">Minutes</entry></row></tbody></tgroup></table></tables>

0031In this illustration, the measured data are preferably analyzed to determine signal characteristics which correspond to the indicated fundic and antral electrical activity levels. For example, calibration of fundic activity during the chewing of sugarless gum typically yields a low level indication of swallowing, while calibration during the swallowing of liquids and solids yields a greater fundic response. Similarly, there is typically no significant antral response to the patient drinking water, while calibration during the digestion of liquids and solids having higher caloric content yields a greater antral response. Measurements are preferably made of the delay time between swallowing and the commencement of antral activity, because consumption of liquids is typically characterized by a rapid transition from the fundus to the antrum, while solids typically stay in the fundus for at least about 10 minutes prior to being passed to the antrum. Preferably, a large variety of liquids and solids are used to establish a profile of electrical response characteristics for each patient.

0032For some applications, various supplemental sensors are also applied to the gastrointestinal tract or elsewhere on or in the patient's body. These supplemental sensors, which may comprise pH sensors, blood sugar sensors, ultrasound transducers or mechanical sensors, typically convey signals to a control unit of the apparatus indicative of a characteristic of solids or liquids ingested by the patient. For example, an ultrasound transducer may be coupled to indicate whether ingesta are solid or liquid, and a pH sensor may indicate that an acidic drink such as tomato juice was consumed rather than a more basic liquid such as milk.

0033In a preferred embodiment, the collected data are stored and intermittently uploaded to an external computer, preferably by a wireless communications link, for review by the patient's physician, to enable monitoring of the patient's adherence to a dietary regimen.

0034For some applications, a specific schedule of allowed food ingestion is pre-programmed by the physician into the memory, and a processor is continuously operative to detect whether food consumption is taking place in accordance with the programmed schedule. For some patients, the schedule may be less strict with respect to drinking certain types of liquids, and more strict with respect to eating certain types of solid food. When an exception from the schedule is detected, the processor preferably actuates a signal generator to convey an ingestion-control signal to the patient, in order to encourage the patient to adhere to the schedule. Preferably, but not necessarily, apparatus and methods described in <patcit id="pcit0033" dnum="US60259925B"><text>US Provisional Patent Application 60/259,925</text></patcit>, entitled, "Regulation of eating habits," filed January 5, 2001, and in PCT patent application <patcit id="pcit0034" dnum="WO02053093A"><text>WO 02/053 093</text></patcit> entitled, "Regulation of eating habits," filed in January, 2002, both of which are assigned to the assignee of the present patent application , are utilized in the administration of the ingestion-control signal. Alternatively or additionally, the signal generator generates a visual, audio, or other cue or causes another reasonable discomfort to encourage the patient to adhere to the schedule.

0035For embodiments in which this form of dietary monitoring is supplemented by dietary regulation, the apparatus preferably compares the indications of actual food and drink consumption with the pre-programmed schedule. In the event of a sufficient level of patient non-compliance, the ingestion-control signal is preferably delivered to the patient's stomach via a set of electrodes placed in a vicinity thereof, so as to induce a sensation of discomfort or minor nausea. For example, an unpleasant sensation such as nausea may be induced by altering the natural electrical activity of the stomach, thereby inducing gastric dysrhythmia, or, alternatively, discomfort may be induced by pacing the rectus abdominus muscle.

0036Alternatively or additionally, the signal is applied to another site on or in the patient's body. For example, the ingestion-control signal may be applied mechanically or electrically in a vicinity of the cochlear nerve, so as to induce vertigo. Alternatively, the signal is applied so as to generate a brief pain sensation anywhere on the patient's body, which only recurs if the patient continues to eat. Further alternatively, the signal is applied to the esophagus or to the lower esophageal sphincter, so as to cause contraction of muscle tissue therein, thereby making any further eating difficult or very uncomfortable.

0037Alternatively or additionally, the ingestion-control signal is configured so as to induce a feeling of satiation, preferably but not necessarily in accordance with methods described in <patcit id="pcit0035" dnum="US2002161414A"><text>US Patent Application 2002/161414</text></patcit>, entitled, "Acute and chronic electrical signal therapy for obesity," filed on December 21, 2000, which is assigned to the assignee of the present patent application. For example, methods described in that application for engendering a feeling of satiation may be applied in conjunction with embodiments of the present invention, such that muscles in the vicinity of stretch receptors in the stomach are caused to contract, thereby resulting in decreased hunger sensations. Alternatively or additionally, the feeling of satiation is induced by applying electrical signals which enhance the mobility of chyme from the fundus to the antrum of the stomach, where stretch-receptor signals are generally generated to a greater extent for a given quantity of food than in the fundus.

0038In a preferred embodiment, when an exception from the schedule of allowed food ingestion is detected, the processor preferably conveys the exception to an external operator control unit, which in turn wirelessly communicates the exception in real time to a remote computer system. The remote computer system can be configured to analyze the exception based on predetermined rules and, if necessary, perform an appropriate action, such as notification of a healthcare worker, care provider, or family member of the patient, in order to encourage the patient to adhere to the schedule.

0039Preferably, the schedule of allowed food ingestion can be modified after implantation of the apparatus, typically by means of a wireless communications link. In this manner, the schedule can be adjusted in response to changes in the patient's eating habits and experience with the apparatus.

0040There is therefore provided, in accordance with the present invention, a gastric apparatus according to claim 1.

0041Preferred embodiments are defined in the dependent claims.

0042The methods disclosed herein are provided for illustration only and do not form part of the invention.

0043The present invention will be more fully understood from the following detailed description of the preferred embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

0044<ul id="ul0001" list-style="none"><li><figref idref="f0001">Fig. 1</figref> is a schematic illustration of apparatus for treating obesity, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0002">Fig. 2</figref> is a schematic block diagram showing a control unit of the apparatus of <figref idref="f0001">Fig. 1</figref>, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0003">Fig. 3</figref> is a schematic diagram showing experimental apparatus used to measure electrical responses to eating in the stomach of a normal rabbit, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0004">Fig. 4</figref> is a graph showing electrical activity in the fundus of a normal rabbit before and during eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0005">Figs. 5A</figref> is a graph showing electrical activity in the fundus of a normal rabbit during and following eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0006">Fig. 5B</figref> is a graph showing details of electrical and mechanical activity recorded during the taking of the data shown in <figref idref="f0005">Fig. 5A</figref>;</li><li><figref idref="f0007">Fig. 6</figref> is a graph showing detail of electrical fundic activity, measured in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0008">Fig. 7</figref> is a graph showing the rate of electrical events in the antrum of a normal dog before and during eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0009">Fig. 8</figref> is a graph showing the rate of electrical events in the antrum of a normal dog before, during, and after eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0010">Fig. 9</figref> is a graph showing electrical and mechanical activity and the rate of electrical events in the antrum of a normal dog before, during, and after eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention; and</li><li><figref idref="f0011">Fig. 10</figref> is a graph showing fundic electrical activity in a normal dog during several periods of eating and non-eating, and results of analysis thereof, in accordance with a preferred embodiment of the present invention.</li></ul>

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

0045<figref idref="f0001">Fig. 1</figref> is a schematic illustration of diet evaluation apparatus 18, which detects when a patient 10 swallows, and detects the type and amount of matter ingested, in accordance with a preferred embodiment of the present invention. Preferably, but not necessarily, apparatus 18 additionally determines, responsive to the detection, whether to apply electrical energy to modify the activity of tissue of patient 10. Apparatus 18 typically comprises mechanical sensors 70, supplemental sensors 72, local sense electrodes 74, operator controls 71, and one or more current-application electrodes 100.

0046Electrodes 74 and 100 are typically coupled to the serosal layer of a stomach 20 and/or inserted into the muscular layer of the stomach in the fundic and antral regions. Alternatively or additionally, the electrodes are coupled elsewhere on the stomach, gastrointestinal tract, or to other suitable locations in or on the patient's body. The number of electrodes and sensors, as well as the positions thereof, are shown in <figref idref="f0001">Fig. 1</figref> by way of example, and other sites on stomach 20 or in or on the patient's body are appropriate for electrode and sensor placement in other applications of the present invention. Different types of electrodes known in the art are typically selected based on the specific condition of the patient's disorder, and may comprise stitch, coil, screw, patch, basket, needle and/or wire electrodes, or substantially any other electrode known in the art of electrical stimulation or sensing in tissue.

0047Preferably, apparatus 18 is implanted in patient 10 in a manner generally similar to that used to implant gastric pacemakers or other apparatus for stimulating or sensing in the gastrointestinal tract that are known in the art. As appropriate, techniques described in one or more of the references cited in the Background section of the present patent application may be adapted for use with these embodiments of the present invention. Other methods and apparatus useful in carrying out some embodiments of the present invention are described in the above-cited <patcit id="pcit0036" dnum="US60259925B"><text>US Provisional Patent Application 60/259,925</text></patcit>, entitled, "Regulation of eating habits " filed on January 5, 2001, and in the above-cited <patcit id="pcit0037" dnum="WO02053093A"><text>PCT patent application WO 02/053093</text></patcit> and in the above-cited <patcit id="pcit0038" dnum="US2002161414A"><text>US Patent Application 2002/161414</text></patcit>, entitled, "Acute and chronic electrical signal therapy for obesity," filed on December 11, 2000, which are assigned to the assignee of the present patent application.

0048<figref idref="f0002">Fig. 2</figref> is a schematic block diagram illustrating details of operation of a control unit 90 of apparatus 18, in accordance with a preferred embodiment of the present invention. Preferably, control unit 90 is implanted in patient 10, and receives signals from mechanical sensors 70, supplemental sensors 72, and local sense electrodes 74, all of which are typically implanted on the gastrointestinal tract of the patient or elsewhere on or in the body of the patient. These sensors and electrodes are preferably adapted to provide an "ingestion activity analysis" block 80 of the control unit with information about food ingestion and/or the present state of the stomach.

0049Preferably, using techniques described hereinbelow, analysis block 80 determines each time that the patient swallows, and also the character and amount of the ingested matter. For example, local sense electrodes 74 coupled to the fundus of the stomach may send signals indicative of fundic electrical activity to analysis block 80, and analysis block 80 identifies aspects of these signals which are characteristic of swallowing of food by the patient. Additionally, mechanical sensors 70 and local sensor electrodes 74 coupled to the corpus and antral regions of the stomach preferably send signals which analysis block 80 identifies as indicative of the onset, duration, and/or intensity of the digestive process in those regions. Preferably, these data are utilized by analysis block 80 to determine a quality of the ingested matter, for example, whether it is predominantly solid or liquid.

0050In a preferred embodiment, analysis block 80 determines the time delay between swallowing (as measured, preferably, by local sense electrodes 74 on the fundus) and the commencement of electrical and mechanical activity in the antrum. This delay is typically used to differentiate between the ingestion of solid and liquid matter, because solids are generally held in the fundus for at least about 10 minutes before being passed to the antrum, while liquids are generally passed to the antrum essentially immediately.

0051Alternatively or additionally, the amount of food accumulated in the various regions of stomach 20 is estimated by measuring a level of electrical or mechanical activity in a vicinity of those regions. Further alternatively or additionally, analysis block 80 processes data from supplemental sensors 72 indicative of the blood sugar level of the patient, to enable an evaluation of whether and of what type of food has been ingested.

0052In order to improve the accuracy of the analyses described hereinabove, analysis block 80 is preferably calibrated by measuring the appropriate electrical response criteria of stomach 20 of patient 10 to various types of solid and liquid food. To ensure appropriate compliance, calibration is preferably performed under the supervision of a healthcare worker.

0053For some applications, analysis block 80 stores the results of its analysis in a memory block 88 of control unit 90, and these results are later uploaded to an external computer, preferably by a wireless communications link, for review by the patient's physician. Alternatively or additionally, analysis block 80 conveys results of its analysis of the inputs from mechanical sensors 70, supplemental sensors 72, and local sense electrodes 74, to a "parameter search and tuning" block 84 of control unit 90. Block 84 preferably evaluates the analysis performed by analysis block 80 with respect to a pre-programmed or variable ingestion schedule stored in memory block 88, so as to determine whether the patient is eating in compliance with the schedule. Preferably, the schedule can be modified after implantation of control unit 90, by communication from operator controls 71 using methods described hereinbelow. If it is determined that the patient's eating is not in compliance with the schedule (e.g., the patient has eaten too much at one meal, or has eaten too many meals in a day, or has had too much of a certain type of food or drink), then block 84 preferably actuates a signal generator block 86 to generate electrical signals that are applied by current-application electrodes 100 to tissue of patient 10. Block 86 preferably comprises amplifiers, isolation units, and other standard circuitry known in the art of electrical signal generation.

0054The signals generated by block 86 are preferably configured so as to induce a response appropriate for controlling the patient's eating habits. For example, block 86 may drive current-application electrodes 100 to apply signals to the stomach that induce gastric dysrhythmia and the resultant feeling of discomfort or nausea. Alternatively or additionally, the signals are applied to an aural site of patient 10 (e.g., in a vicinity of the cochlear nerve or the tympanic membrane), and are configured to induce vertigo, or another unpleasant balance-related sensation. Alternatively or additionally, block 86 generates a visual, audio, or other cue to encourage the patient to adhere to the schedule.

0055For some applications, control unit 90 drives electrodes 100 to apply a modulation signal to muscle in one area of stomach 20, so as to induce a contraction of the stimulated muscle that, in turn, induces satiety when food in an adjacent area of the stomach causes additional stretching of stretch-receptors therein. This signal may be applied in addition to or instead of the signals described hereinabove that produce gastric or other discomfort. The form of contraction-mediated stretching utilized in these applications simulates the normal appetite-reduction action of the stomach's stretch-receptors, without the patient having eaten the quantities of food which would normally be required to trigger this appetite-reduction response. In a preferred application, current-application electrodes 100 are placed around the body of the stomach and are driven to induce a generally steady-state contraction of the corpus, which simulates electrically the squeezing of the corpus produced mechanically by implanted gastric bands known in the art.

0056Preferably, the signals applied by current-application electrodes 100 include, as appropriate, an Excitable-Tissue Control (ETC) signal and/or an excitatory signal that induces contraction of muscles of the stomach. Aspects of ETC signal application are typically performed in accordance with techniques described in the above-referenced <patcit id="pcit0039" dnum="WO9903533A"><text>PCT Publications WO 99/03533</text></patcit> and <patcit id="pcit0040" dnum="WO9725098A"><text>WO 97/25098</text></patcit> and their corresponding <patcit id="pcit0041" dnum="US6571127B"><text>US patents 6,571,127</text></patcit> and <patcit id="pcit0042" dnum="US6317631B"><text>6,317,631</text></patcit>, <i>mutatis mutandis.</i>

0057Preferably, evaluation apparatus 18 includes remote operator controls 71, external to the patient's body. This remote unit is typically configured to enable the patient or his physician to change parameters of the ingestion schedule stored in memory block 88. For example, if the patient has lost weight, the physician may change the ingestion schedule to allow a single mid-afternoon snack. Alternatively or additionally, operator controls 71 comprise an override button, so that the patient may eat outside of the designated meal times, or consume a particular food or drink not in accordance with the schedule, if the need arises. Operator controls 71 preferably communicate with control unit 90 using standard methods known in the art, such as magnetic induction or radio frequency signals.

0058<figref idref="f0003">Fig. 3</figref> is a schematic diagram showing experimental apparatus 60 used to measure electrical responses to eating in the stomach 64 of a normal rabbit, in accordance with a preferred embodiment of the present invention. Bipolar sense electrodes 62 were coupled to the fundus of stomach 64, and bipolar sense electrodes 63 were coupled to the antrum of the stomach. Additionally, two stitch electrodes 66 with a strain gauge 68 located therebetween were coupled to the antrum.

0059Reference is now made to <figref idref="f0004">Figs. 4</figref>, <figref idref="f0005">5A</figref> and <figref idref="f0006">5B</figref>, which are graphs showing the results of experiments performed using apparatus 60 in a rabbit, in accordance with a preferred embodiment of the present invention. <figref idref="f0004">Fig. 4</figref> shows electrical activity in the fundus, measured during a five minute period before the rabbit was fed solid food, and during a more than six minute period while the rabbit was eating solid food. It can be seen that the second period is distinguished by markedly increased electrical activity. Spikes, typified by those marked "A," "B," and "C" in this graph, are preferably identified by a control unit operating in accordance with these embodiments of the present invention, and are interpreted as indications of eating. It is noted that in the case of the rabbit experiment shown in <figref idref="f0004">Fig. 4</figref>, electrical activity as measured by spikes per unit time increased by a factor of about 8, and is therefore considered to be a good indication of the initiation and continuation of eating.

0060<figref idref="f0005">Fig. 5A</figref> is a graph showing the electrical response of the fundus of the rabbit stomach, and the results of analysis thereof, in accordance with a preferred embodiment of the present invention. In this experiment, the measurements were first taken for five minutes while the rabbit was eating solid food, and were continued for almost 10 minutes after the rabbit ceased eating. It is clearly seen that the period after the rabbit ate is characterized by significantly less electrical activity than that which occurred during eating. Spikes, such as those marked "A," "B," and "C" in this graph, occur at a rate at least 15 times higher during eating than thereafter, and are therefore preferably used by a control unit to determine both the onset and the termination of eating.

0061<figref idref="f0006">Fig. 5B</figref> is an expanded view of some of the data shown in <figref idref="f0005">Fig. 5A</figref>, additionally showing simultaneous mechanical and electrical activity in the antrum of the rabbit. The top graph shows mechanical activity in the antrum as measured by strain gauge 68 (<figref idref="f0003">Fig. 3</figref>), and the middle graph shows electrical activity in the antrum, measured by electrodes 63 during the same time period. The repeated co-occurrence of antral mechanical and electrical activity, as seen in <figref idref="f0006">Fig. 5B</figref>, is indicative of the expected antral mechanical response to antral electrical activity.

0062The bottom graph of <figref idref="f0006">Fig. 5B</figref> shows the measured electrical activity in the fundus during the same period, i.e., while the rabbit was eating. It can be seen that, while there is close correlation between mechanical and electrical activity in the antrum, there is no correlation seen between fundic electrical activity and either measure of antral activity. Control unit 90 (<figref idref="f0002">Fig. 2</figref>) is therefore generally enabled to measure and differentiate between fundic and antral response, and to utilize this information to facilitate the evaluations and determinations described herein.

0063<figref idref="f0007">Fig. 6</figref> is a graph showing electrical impedance measurements made between two stitch electrodes placed in the stomach of a pig, in accordance with a preferred embodiment of the present invention. In this experiment, fundic volume was measured at the same time as the impedance was measured, and the data show a clear dependence of the impedance on the volume. It is hypothesized that as the fundus distends, the fundic wall thickness decreases, producing a corresponding increase in electrical impedance. Alternatively or additionally, the increased distance between the two electrodes produced as a result of the distension causes the electrical impedance to increase. Similar experimental results (not shown) were obtained when impedance and volume measurements were made in the antrum. Moreover, changes in impedance were found to correlate with waves of antral activity.

0064Reference is now made to <figref idref="f0008">Figs. 7</figref>, <figref idref="f0009">8</figref>, <figref idref="f0010">9</figref>, and <figref idref="f0011">10</figref>, which are graphs showing the results of experiments performed using apparatus (not shown) similar to apparatus 60 in several normal dogs, in accordance with a preferred embodiment of the present invention. All of the dogs fasted for approximately 24 hours prior to eating during the experiments.

0065<figref idref="f0008">Fig. 7</figref> shows the rate of electrical events in the antrum in a dog, measured during a six minute period before the dog was fed solid food and during a more than seven minute period while the dog was eating solid food. Electrical events that were recorded were spikes in the signal of amplitude at least a threshold amount greater than the signal noise. It will be appreciated that detecting changes in other events may be useful for some applications. It will also be appreciated that whereas data shown in the figures reflects measurements of antral electrical events, for some applications the analysis techniques described herein may also be implemented with respect to the rate of fundic electrical events.

0066It can be seen that the second period is distinguished by a markedly decreased rate of antral electrical events. Such a decrease is preferably identified by a control unit operating in accordance with these embodiments of the present invention, and is interpreted as an indication of eating. It is noted that the rate of antral electrical events, as measured by events per unit time, decreased on average by about 20% beginning about one minute after the initiation of eating, and is therefore considered to be a good indication of the initiation and continuation of eating. (Decreases of up to about 50% were seen in other experiments.) Similar results were obtained in experiments on two other dogs (not shown).

0067<figref idref="f0009">Fig. 8</figref> is a graph showing the rate of electrical events in the antrum in a second dog, measured during a more than 40 minute period before the dog was fed solid food, during an approximately 13 minute period while the dog was eating solid food (interrupted by an approximately 6 minute period of non-eating), and during an almost 60 minute period after the dog ceased eating. It is clearly seen that the period beginning approximately four minutes after the dog ceased eating is characterized by return to a rate of antral electrical events almost equal to the rate prior to eating, and significantly higher than the reduced rate during eating. The rate of antral electrical events is therefore preferably used by a control unit to determine both the onset and the termination of antral activity.

0068<figref idref="f0010">Fig. 9</figref> is a graph showing simultaneous mechanical activity, electrical activity, and rate of electrical events in the antrum of a third dog, measured during a more than 16 minute period before the dog was fed solid food, during an approximately 3.5 minute period while the dog was eating solid food, and during a more than four minute period after the dog ceased eating. The top graph shows mechanical activity in the antrum as measured by a strain gauge, and the middle graph shows electrical activity in the antrum, measured by electrodes during the same time period. It can be seen that co-occurring mechanical and electrical activity began approximately 1.5 minutes prior to the beginning of eating, corresponding with the onset of cephalic phase activity (brain activity reflecting the mental anticipation of eating).

0069The bottom graph of <figref idref="f0010">Fig. 9</figref> shows the rate of electrical events in the antrum of the dog. It can be seen that the second period is distinguished by a markedly decreased rate of antral electrical events, consistent with the results of the first dog experiment described hereinabove. An increase in mechanical and/or electrical antral activity prior to eating as occurred in this experiment is preferably identified by a control unit operating in accordance with these embodiments of the present invention, and provides additional information that can be interpreted together with information such as the decreased rate of antral electrical events observed in this experiment to provide indications of anticipation of eating, eating and/or gastric digestion.

0070<figref idref="f0011">Fig. 10</figref> is a graph showing electrical impedance measurements made between two stitch electrodes in the fundus of a fourth dog, measured during five sequential periods: (1) an approximately 22 minute period before the dog was fed solid food (portion of period not shown), (2) an approximately three minute period while the dog was eating solid food, (3) an approximately 7.5 minute period during which the dog did not eat, (4) an approximately one minute period while the dog was eating solid food, and (5) a greater than 10 minute period after the dog ceased eating.

0071It can be seen that the eating periods (second and fourth periods) are distinguished by markedly increased fundic electrical impedance. Such increases are preferably identified by a control unit operating in accordance with these embodiments of the present invention, and are interpreted as indications of eating. This interpretation is supported by the correlation between impedance and volume measurements in the fundus obtained in the pig experiments described hereinabove. It is noted that in the case of the dog experiment shown in <figref idref="f0011">Fig. 10</figref>, the fundic electrical impedance, as measured in ohms, increased by more than about 12%, beginning less than about one minute after the initiation of eating during the second period, and by about 5% beginning less than about one minute after the initiation of eating during the fourth period. The fundic electrical impedance is therefore considered to be a good indication of the initiation and continuation of eating. Similar results were obtained in two other experiments on different days on the same dog (not shown).

0072It is clearly seen in <figref idref="f0011">Fig. 10</figref> that the period beginning almost immediately after the dog ceased eating (the fifth period) is characterized by a return of fundic electrical impedance to a value almost equal to that prior to eating, and significantly lower than the increased value observed during eating. Fundic electrical impedance is therefore preferably used by a control unit to determine both the onset and the termination of eating.

0073The inventors have observed that fundic electrical impedance (e.g., as measured in the case of the dog experiment shown in <figref idref="f0011">Fig. 10</figref>), as an indicator of eating, typically exhibits lower variability than antral electrical impedance, and is less affected by movement and/or change in posture of the subject. Fundic electrical impedance also typically provides more reliable detection of eating than antral activity.

0074In preferred embodiments of the present invention, measurements of antral and/or fundic electrical impedance are used in conjunction with or separately from other indicators of swallowing or digestion, described hereinabove, in order to track a patient's eating habits. Advantageously, impedance measurements made between two electrodes located even at mutually remote sites on a portion of the stomach can be accurate indicators of global strain of that portion, while a mechanical strain gauge placed at a particular site on the stomach generally only yields an indication of strain at that site.

0075It will be recognized by persons skilled in the art that more complex combinations of variations in levels of electrical or mechanical activity in different regions of the stomach may occur than those demonstrated in the experiments described hereinabove. For example, certain electrical or mechanical activity may lag the eating of certain amounts and types of food. Examples of more complex combinations (not shown) were obtained in additional experiments in other dogs. Analysis block 80, with proper calibration as described hereinabove, can readily be enabled to evaluate such complex combinations.

0076It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove, but is limited only by the scope of the claims.