WO2008104982A2

WO2008104982A2 - Control of the intake of undesired substances

Info

Publication number: WO2008104982A2
Application number: PCT/IL2008/000257
Authority: WO
Inventors: Michael Arad; Zvi Laster
Original assignee: Stimpulse Ltd.
Priority date: 2007-02-28
Filing date: 2008-02-28
Publication date: 2008-09-04
Also published as: WO2008104982A3

Abstract

A system for controlling the intake of food or drink, incorporating sensors to detect parameters relating to the subject's chewing or swallowing actions. The sensor signals are input to a controller which may activate stimulating electrodes implanted into the deglutition or mastication muscles, thereby controlling the ability of the subject to continue chewing or swallowing. Alternatively, the stimulating electrodes may be implanted in the Gastro-intestinal system to induce a feeling of nausea or satiety. The parameters may be related to the quantity of food, the type of food, the length of time of the intake, the time of day of the intake, the elapsed time since the previous intake, or any other parameter used to characterize the intake's caloric effect on the subject. Adaptations of the system and method may be used to control the intake of harmful or forbidden substances, such as alcohol, drugs or tobacco.

Description

CONTROL OF THE INTAKE OF UNDESIRED SUBSTANCES

FIELD OF THE INVENTION

The present invention relates to the field of the detection and prevention of the intake of undesired materials and substances by a subject, especially in the control of food intake by the use of sensors and stimulation electrodes implanted to detect and control actions related to chewing and swallowing.

BACKGROUND OF THE INVENTION

Obesity represents a major health problem in the western world, with an estimated $100 B or more spent annually for treatment of morbidities associated with obesity. Obesity affects virtually every body system: the heart and circulation, causing hypertension, chronic ischemic heart disease, strokes, sudden death; respiration, causing restrictive pulmonary disease and sleep apnea syndrome; joints, causing osteoarthritis and gout; the gastrointestinal tract, causing gallbladder stones, constipation; the endocrine glands, causing a predisposition to diabetes mellitus and hypogonadism; a person's mood, causing depression, and other undesirable outcomes.

A large number of procedures and devices have been developed for the treatment of obesity. These include surgical procedures performed on the stomach, the most common of which are based on constricting devices that are placed around the proximal part of the stomach in order to restrict the quantity of food ingested during each meal and to achieve a sensation of satiety. Other surgical modalities include various kinds of gastric bypass operations, in which the proximal end of the stomach is sectioned creating a small pouch which is anastomized to the small intestine about 3-5 ft below the stomach. A further procedure is sleeve gastrectomy in which a major part of the stomach is resected by stapling along the small curvature, creating a reduced volume sleeve.

Because of the serious nature of such surgical intervention, other approaches have been adopted by which the ability of the subject to eat solid foods is limited. One such method is a procedure known as jaw wiring or maxillo-mandibular fixation, in which the jaw of the subject is held shut for various periods of time of up to several weeks, during which period, the subject can ingest only fluids. The closure is achieved by attachment of wire staples holding the upper and lower jaws together, such that mouth opening and chewing is impossible. This procedure is often uncomfortable for the subject, and there is a danger of choking from an accumulation of saliva. Additionally, an unwilling subject can readily overcome it by the ingestion of large quantities of high calorific value fluids, such as rich milk shakes, or soft ice cream. Furthermore, the closure generally has to be limited to a period of no longer than a few weeks at a time, to avoid possible complications, such as atrophy of the jaw muscles, loosening of teeth or gingivitis due to poor oral hygiene, and even malfunction of the temporal mandibular joint.

There therefore exists a need for a system for combating obesity, which can control the amount of solid food which the subject can ingest, and which will be readily tolerated and easily controlled.

In addition to the undesirable effects described above of the excess intake of food, there also exist other substances whose intake may be injurious to the health of the subject. Some of these materials are believed to be damaging when taken even at very low levels, such as narcotic drugs or tobacco smoking, while others, such as alcohol, are generally understood to be damaging only when taken in excess of accepted levels. Many methods have been proposed in the prior art for controlling the intake of such materials, generally based either on a self-discipline regime or on externally imposed discipline, applied either to the ingestion of the restricted materials, or to the freedom of access to them. Such methods are important not only for reasons of safeguarding the health of the subject and society around him/her, but also for use by the various law enforcement authorities. However, such methods do not actively address the actual intake of the harmful materials by the subject in real time, but work by means of external psychological means to prevent the subject from using the materials, or by means of physical limitations to prevent the subject from gaining access to the materials.

There therefore also exists a need for a system for combating drug or alcohol abuse, or for preventing smoking, which can control the use of these substances by active means directly related to their intake or use in real time.

The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety. SUMMARY OF THE INVENTION

The present invention seeks to provide according to a first preferred embodiment, a system for the control of food intake, known as an enforced diet system. The system incorporates one or more sensors to detect one or more parameters relating to food or drink being chewed or swallowed by the subject. Since such sensors are located in the general region of the oral cavity, detecting movements associated with chewing or with swallowing, regardless of whether the sensing point is actually within the oral cavity or not, they are termed in this application "orally associated sensors", and are also thuswise claimed, to distinguish them from sensors in other parts of the body. According to preferred embodiments of the invention, the signals from these sensors are input to a controller which, based on the information content of the signals and on the allowed parameters for that subject, generates output signals to activate stimulating electrodes implanted into the deglutition muscles or into the mastication muscles, thereby controlling these muscles and their ability to allow the subject to continue chewing or swallowing actions. Alternatively and preferably, the stimulating electrodes may be implanted to operate on a nerve or nerves controlling these muscles, to the same effect. The parameters may most preferably be related to the quantity of food being taken, but may also relate to the length of time of the intake, the time of day of the intake, the elapsed time since the previous intake, the type of food being taken, and any other parameters which a diet regime may use in order to characterize the caloric intake of the subject.

The signals from the sensor or sensors are preferably fed to a control unit, which is programmed to determine how much food has been ingested, either by the amount of mastication, or by the amount of swallowing, or by a combination thereof. The amount of ingested food permitted to the subject under a food controlled diet regime is also input to the control unit, which is preferably programmed to output a signal to actuate the stimulation electrodes when this amount has been surpassed. The electrodes then transmit excitatory signals to the mastication and/or to the deglutition muscles, which, according to the type of stimulation applied, either undergo sustained contraction or stimulated relaxation, in either case preventing or limiting the ability of further food intake. The controller can be programmed according to the food intake regime predetermined by the subject's physician or dietician, and this regime can comprise either cessation of the ability to chew and swallow for a fixed time after the allowable food intake has been achieved, or prevention of chewing and swallowing for fixed periods during the day, such as during the night or outside of predetermined meal times, or a combination of both, or an enforced reduction in the rate of food intake by the subject while eating.

The system of the present invention has a number of significant advantages over prior art systems. It is a system operating on the subject physiologically, such that circumvention by the subject is very difficult. In spite of its physiological nature, the system is implementable generally by means of minimally invasive surgical procedures, in most cases, by superficial subcutaneous implantation procedures. According to some embodiments, the sensor or sensors can even be mounted non- surgically. Additionally, the system is automatic, and most of its embodiments require no user or supervisor intervention whatsoever. Furthermore, when in place, the system is essentially indiscernible to the subject, so long as the requirements of the diet regime are complied with.

According to further preferred embodiments, the output of the controller may be used to provide signals to other physiological systems for reducing food intake, especially those operative on the gastro-intestinal system. According to such embodiments, the controller can, for instance, actuate an electro-stimulation system which causes relaxation of the small bowel or the large bowel, or which causes relaxation of the stomach and a sensation of satiety, or an electro-stimulation system that causes contraction of the pylorus (gastric outlet), thus delaying gastric emptying, this too causing a feeling of satiety, or an electro-stimulation system that causes contraction of any of the other sphincter muscles of the gastro-intestinal tract, such as the upper esophageal sphincter, or the lower esophageal sphincter, closing off entry of food into the stomach, or an electro-stimulation system which operates on the vagal nerve or a sympathetic nerve of the abdomen, or any of their afferent sensors, to cause a feeling of nausea, which reduces the desire to eat further.

According to further preferred embodiments of the present invention, there is further provided a system for limiting calorific intake, especially of drinks, whereby a sugar level sensor is used in order to provide further input to the controller regarding the sugar content of the food or drink being ingested. This may preferably be performed either by use of a sensor in the mouth to directly detect the glucose content of the food being ingested, or by means of a physiological glucose sensor, such as a glucose blood level detector, which can be located in any part of the subject's body, even remotely from the mouth or G-I tract. The sensor can preferably be in the form of a patch capable of detecting glucose level. Such a patch could preferably even be affixed in the subject's mouth for immediate response.

According to yet further preferred embodiments, a system can be provided whereby the eating habits of the subject are controlled by limiting his ability to eat only within a controlled area, where surveillance of his food intake can be performed. This can preferably be achieved by providing within the controlled area, an enabling signal which releases the stimulatory effects preventing the subject from eating outside of that area. Surveillance and supervision can be either personal, or by means of a video system transmitting the subject's eating pattern to a supervisory center. The supervisor's feedback to the subject can be either in the form of directly given instructions, or in the form of control signals to the stimulatory electrodes to physically limit his eating.

According to further preferred embodiments, the output of the controller may also be used to generate a warning signal to the subject that the food intake permitted under the enforced diet regime is being exceeded, such as some sort of stimulation at a level high enough to be minimally painful. This can be separately from or in addition to the other stimulatory actions mentioned herewithin.

The controller can be programmed to discern between swallowing solid food that is accompanied by mastication and liquids that are not accompanied by mastication, and to stimulate the respective muscles to prevent further eating only when the subject attempts to ingest solid food, but to permit him to drink liquids. This is performed by the use of separate sensors for detecting mastication and deglutition.

According to further preferred embodiments, a diet regime is provided, wherein each portion of food is labeled with the calorific value of the food, and this information is input to the controller which activates the stimulatory electrodes to prevent further eating only when a predefined total calorific input level has been reached.

According to further preferred embodiments, the present invention seeks to provide a system for limiting the level of alcohol intake in a subject such that the subject does not consume an excess of alcohol. In such a system, an alcohol sensor is implanted on the subject's body in such a location that it provides an output signal when a predetermined permitted or advisable dose of alcohol has been exceeded. The sensor can operate either by detecting alcohol vapor in the breath of the subject, much like an alcohol breath test device, or by detecting the alcohol level in the subject's blood. The controller is preferably programmed such that when the alcohol level exceeds the predetermined level, an unpleasant external stimulus is applied to the subject, reminding him forcibly that he has exceeded the safe alcohol intake level. If it is desired to forcibly prevent the subject from continuing to imbibe, the stimulus can preferably be applied at a painful level, or it can be applied, as for the above described food intake limiting system, to the deglutition muscles or nerves to physically prevent the subject from swallowing drink. Other stimulatory signals can preferably be provided, such as audible signals, or signals transmitted to a supervisory authority, depending on the particular operational mode adopted for this embodiment. One advantage of this system is that the signal preventing the subject from continuing to consume alcohol is generated by the effects of the actual realtime consumption of alcohol, such that automatic and speedy response can be provided.

According to further preferred embodiments of the present invention, a system is provided which limits drug abuse by a subject. In this embodiment, the sensor is adapted to detect the ingestion or inhalation of specific drugs which it is tuned to detect. As in the alcohol embodiment, the sensor provides information to the controller which either prevents the subject from continuing to take the drug, preferably by means of an unpleasant stimulus, or it transmits a report to the law enforcement authorities, or similar.

According to further preferred embodiments of the present invention, a system is provided which prevents the subject from smoking tobacco. The sensor is adapted to detect tobacco smoke, and to prevent the subject from continuing to smoke preferably by one of the stimulatory methods mentioned above.

There is therefore provided, in accordance with a further embodiment of the present application, a system for restricting intake of a substance by a subject, the system comprising:

(i) at least one orally associated sensor adapted to detect intake of the substance, (ii) a control unit receiving signals from the at least one sensor and generating an output signal accordingly, and (iii) at least one inhibitor operating on the subject, activated by the output signal.

In the above mentioned system, the inhibitor may be such as to provide a physical stimulus to the subject to discontinue intake of the substance. Additionally, the controller may also be operative to determine whether the detected intake by the subject is to be discontinued according to at least one predetermined criterion. This predetermined criterion may preferably be the elapsed time since the last intake of the substance, or the rate of intake of the substance.

The substance may preferably be any of alcohol, tobacco, a drug, food or drink. In the case that the substance is food or drink, the at least one sensor may preferably be adapted to detect at least one of the subject's mastication and deglutition actions. In such a situation, the sensor may preferably be implanted in at least one of a mastication muscle and a deglutition muscle of the subject, and the inhibitor may preferably be a stimulatory electrode in a location such that, when activated by the output signal, limits at least one of the subject's mastication and deglutition abilities. In the latter case, the stimulatory electrode may preferably be implanted in at least one of a deglutition muscle and a mastication muscle of the subject. Alternatively and preferably, the stimulatory electrode may be implanted in at least one nerve controlling at least one of the subject's mastication and deglutition abilities.

In accordance with still another preferred embodiment of the present invention, the at least one sensor may be a mechanical sensor detecting relative motion between opposing teeth of the subject. In order to perform this, the mechanical sensor may be connected between opposing teeth of the subject.

For those of the above mentioned embodiments where the substance is food or drink, the inhibitor may preferably be a stimulatory electrode in a location such that, when activated by the output signal, it operates on a gastro-intestinal function of the subject. In this case, the stimulatory electrode may be operative to generate either one of a feeling of satiety or a feeling of nausea. Such a stimulatory electrode may preferably be applied to any one of the stomach, the pyloric sphincter, a sphincter of the esophagus, the peritoneum, the vagal nerve or one of its afferent sensors, and a sympathetic nerve of the abdomen or one of its afferent sensors.

In accordance with further preferred embodiments of the system of the present invention, the inhibitor may be a pain stimulator applied to a part of the subject's anatomy, or an audible stimulator.

In those of the above mentioned embodiments where the substance is food or drink, the at least one sensor may preferably be a glucose level sensor adapted to detect either a physiological glucose level or the glucose level of the food and drink in the subject's mouth. In the former case, the physiological glucose level may preferably be the subject's blood glucose level. In either of the cases, the system may further comprise a sub-system for determining whether the detected physiological glucose level is that of the subject. Such a sub-system may preferably compare the pulse of the person where the glucose level is being measured with that of the subject.

In any of the above-described systems in which the substance is food or drink, the controller may preferably determine the amount of intake of the food or drink by counting the number of at least one of the subject's mastication and deglutition actions. Alternatively and preferably, the controller may determine whether food or drink is being taken in by the subject by counting the ratio of the number of the subject's mastication actions to the number of deglutition actions.

There is further provided in accordance with still another preferred embodiment of the present invention, a system for restricting intake of a substance by a subject, the system comprising:

(i) at least one sensor adapted to detect intake of the substance, (ii) a control unit receiving signals from the at least one sensor and generating an output signal accordingly, and

(iii) a signal transmitter activated by the output signal providing to a third party information regarding the subject's intake of the substance.

In such a system, the substance may be any one of alcohol, tobacco, a drug, food or drink. In the case of food or drink, the third party may preferably be a person supervising diet control of the subject. The at least one sensor may be a glucose level sensor adapted to detect a physiological glucose level of the subject, or the glucose level of any one of the food and drink in the subject's mouth, and the physiological glucose level may be the subject's blood glucose level.

In accordance with a further preferred embodiment of the present invention, there is also provided a system for restricting intake of a substance by a subject, the system comprising:

(i) a controlled area where the subject is permitted to intake the substance, the controlled area having an enabling signal associated with it,

(ii) a control unit receiving at least the enabling signal and generating an output signal accordingly,

(iii) at least one inhibitor operating on the subject, activated by the output signal, the inhibitor preventing the subject from intake of the substance other than in the controlled area.

Such a system may further comprise at least one sensor associated with the subject adapted to detect intake of the substance, and the controller may then also receive signals from the at least one sensor and generate the output signal accordingly.

There is further provided in accordance with yet another preferred embodiment of the present invention a system for restricting intake of a substance by a subject, the system comprising:

(ii) a control unit receiving at least the enabling signal and generating an output signal accordingly, and

Such a system may preferably further comprise at least one sensor associated with the subject adapted to detect intake of the substance, and the controller may then also receive signals from the at least one sensor and generate the output signal accordingly.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:

Figs.1 A and 1 B schematically illustrate systems in accordance with preferred embodiments of the present invention, for reducing food intake in a subject, comprising one or more sensors that detect deglutition (swallowing) or mastication (chewing) and stimulation electrodes activated by a controller to limit these actions when inappropriate;

Figs. 1C and 1 D illustrate schematically a sensor installation that can be performed non-surgically by dental techniques, for detecting chewing motion of the subject's jaws;

Figs. 2A to 2E are block diagrams showing schematically a number of preferable algorithms for the functionality of controllers programmed to stimulate the mastication and/or the deglutition muscles to according to the methods used in the system of the present invention;

Fig. 3 illustrates schematically a system with a controller inputting signals from a remote glucose level sensor; Fig. 4 is a schematic illustration of a further embodiment of the present invention, in which the controller outputs the eating limitation signal for gastrointestinal stimulation; and

Fig. 5 is a schematic illustration of another preferred embodiment of the present invention, in which a controlled location is set up to provide an enabling signal, such as by a wireless or inductive transmission, and only when the subject is within this area can a receiver located. on the subject's person pick-up the signal for use by the controller in setting the stimulating electrodes to allow the subject to eat.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made to Figs. 1A and 1B, which are schematic illustrations of the muscles of the jaw and tongue region respectively, showing a system for controlling food intake in a subject, constructed and operative in accordance with a preferred embodiment of the present invention. The system comprises one or more sensors that detect either deglutition (swallowing) or mastication (chewing), or both. These sensors are preferentially tension sensors but other sensors may equally well be used. Examples of such other sensors are pressure sensors, acoustic sensors, including ultrasound detection modules, accelerometer sensors, electrodes for detecting muscle currents, displacement sensors detecting mutual motion between selected parts of the oral anatomy, temperature sensors (for instance, to detect the ingestion of ice cream), or any other suitable sensor. According to one preferred embodiment, these sensors are implanted in the deglutition (swallowing) muscles, such as the mylohyoid muscles or raphe; genyoglosus; hyohglosus, styloglosus, palatoglosus; pharygoglosus; buccinator; superior, middle, or inferior pharyngeal constrictor muscles; suprahyoid or subhyoid muscles, or intrinsic muscles of the tongue. According to another preferred embodiment, sensors may be implanted in the mastication muscles such as the masseters; internal pterigoid muscles; external pterigoid muscles; temporalis muscle, or any other muscles conveniently accessible for this function. According to further preferred embodiments, sensors may be implanted in both mastication and deglutition muscles.

In Fig. 1A, which shows muscles involved in mastication, a sensor 10 is shown embedded in the superficial part of the masseter muscle 11 , to which there is easy surgical access. In Fig. 1B, which shows muscles in the tongue region, mainly involved in deglutition, a sensor 13 is shown embedded in the styloglossus muscle 14, It is to be understood that these locations are taken as exemplary and non- limiting locations for illustrative purposes of the invention, and that many of the other muscles or nerves in the region, may also be utilized for sensing purposes.

Another easily implementable location for the sensor(s) is shown in Figs. 1C, which are views of the oral cavity of the subject, showing a pair of strain gauge sensor assemblies 18 affixed at the back of the mouth between the upper and lower jaws of the subject. Fig. 1C is a frontal view, while Fig. 1 D is a side view. Such a sensor assembly can be readily fixed to the innermost ends of the last molar teeth 19, between top and bottom jaws, using dental adhesive 6, such as the self-curing polyacrylic ester monomer cements that are used for attaching orthodontic brackets to teeth. The subject's mastication motions can be readily followed using such a sensor. In order to protect the sensitive force sensor 9 itself from excess wear, or from being simply torn by oral forces, the sensor assembly may be constructed of a thin metallic foil 7, attached between the teeth, such that it is the metallic foil that is subject to any wear and tear within the mouth. The strain gauge is affixed to the foil, such that it measures the strain in the foil, without undergoing undue wear or excessive strain itself. To maintain the clarity of the drawing, the signal leads from the strain gauge towards the control unit, are not shown in Fig. 1D. According to a further embodiment, the strain gauge can be sandwiched between two such metallic foils 7, 8, such that it is also protected from wear or damage from food being chewed in the mouth. Alternatively and preferably, the motion between the top and bottom jaws can be detected by a simple wire arrangement connected between the teeth preferably in the post-molar region, one end being attached to a tooth in one jaw, and the other to an angular sensor attached to a tooth in the opposite jaw. Motion of the jaws causes the wire to change its angle relative to the angular sensor, and this detected change in angle is related to the mutual motion of the jaws. Since the installation method for these embodiments is non-surgical, and the sensor assemblies are not costly and can readily be demounted or replaced, methods such as these and locations such as these may have advantages over previously described locations for the sensors.

In addition, one or more stimulatory electrodes are implanted, preferably in one or more of the deglutition muscles or the mastication muscles, or on their associated nerves. In Fig. 1A, a stimulatory electrode 12 is shown embedded in the masseter muscle, as an exemplary and non-limiting location for illustrative purposes of the invention. In Fig. 1B, a stimulatory electrode 15 is shown implanted in the genioglossus muscle 16 under the tongue, as an example of an electrode operating on the deglutition function. It is to be understood that these locations are taken as exemplary and non-limiting locations for illustrative purposes of the invention, and that many of the other muscles or nerves in the region, may also be utilized for stimulating purposes. The sensor or sensors and the stimulating electrode or electrodes may be implanted through the mouth or through a small incision in the neck or jaw. They may also preferably be implanted in the soft tissue above the muscles, such as the mucous tissue within the oral cavity. Alternatively and preferably, they need not be implanted subcutaneously at all but can be affixed onto the skin externally. Application of this technique for use by the stimulatory electrodes is analogous to the commonly used TENS techniques. However, in general, it is more advisable that the stimulatory electrodes be implanted so that they cannot be removed by the subject in an effort to avoid the stimulatory effects. This is less important for the sensors, since the system can be programmed so that if the controller stops receiving input signals from the sensor, such as would occur if the subject were to remove an externally mounted sensor, the default status of the stimulatory electrodes would be to prevent further intake of food.

The sensor(s) feeds its output signal to a control unit 17, preferably powered by an on-board battery, and the controller output is fed to the stimulating electrode(s). The controller may preferably be implanted into the subcutaneous tissue of the neck or the upper thorax, or it may be externally carried. Electrical connection between the controller and the sensor(s) and stimulating electrode(s) is preferably performed by wire, or by wireless link. If a wireless connection is used, the controller can be located elsewhere other than in the immediate vicinity of the subject's mouth, or even at a location remote from the subject.

The number of successive deglutitions or mastications is preferably detected by the sensor or sensors and counted by the controller. From this number, the quantity of food ingested can be deduced, since the bolus size is generally fairly constant. The force exercised during deglutition and more especially during mastication may also be utilized to indicate the consistency of the food, whether solid, semi-solid or liquid.

The control unit, 17, is preferably programmed so that after a predetermined number of successive deglutition and/or mastication movements, the number corresponding to the amount of food allowed to the subject at that time, the electrodes transmit excitatory signals to the relevant mastication and/or deglutition muscles to prevent further eating. These signals preferably have a frequency of from DC to approximately 60 Hz, causing the sustained contraction of the relevant muscle(s), and thus preventing further food intake. Alternatively and preferably, the stimulation may be performed using a frequency of higher than approximately 80 to 100 Hz. Signals in such a frequency range cause relaxation of these muscles, which is an alternative mechanism to prevent their use. Practically, after ingesting the predetermined quantity of food, the subject finds it very difficult to continue to do so since he will not be readily able to chew the food or not be able to swallow it, or both, depending on the location of the stimulatory electrode(s).

The controller must be able to distinguish between sensor signals coming from jaw or throat movements used when eating, and those coming from jaw or throat movements arising from speaking or other non-food related movements, since they need not be considered when calculating the level of food ingested. One simple method of doing so is by analyzing the periodicity of the movements, since chewing is generally a very periodic movement, while speaking is based on intermittent movements. Another method is to determine the ratio of the number of mastication movements to deglutition movements, since in the course of normal eating action, this ratio is fairly fixed, generally in the region of five chewing motions to each swallowing act, though this ratio can be somewhat different for particularly tough or particularly soft foods. Alternatively, use can be made of multiple sensors to characterize typical eating patterns, as contrasted to other non-food related jaw motion. Thus, for example, during the mastication process, besides its vertical motion, the jaw is moved in a perceptible side-to-side motion, in order to enable the grinding of the food by the pre-molar and molar teeth. Multiple motion or position sensors can be used to detect this motion pattern sequence, which is typical of chewing but not of other jaw movements. Additionally, the deglutition action involves a spatio-temporal sequence whereby the swallowing action begins at the front of the tongue, and then proceeds to the muscles around the base of the tongue. Temporal analysis of the signals from two sensors disposed respectively in these two regions should be able to differentiate normal swallowing action from other voluntary or involuntary movements of the tongue or upper pharynx.

According to further preferred embodiments of the present invention, the stimulation electrode can be positioned so as to generate a feeling of nausea, or of the gagging or retching reflex, by application of a low frequency AC voltage to a region which will cause such a reaction. Such regions include any of the oro- pharyngeal mucosa, such as the base of the tongue, the soft palate, the hard palate, the uvula, or the glossopharyngeal nerve or the vagal nerve.

According to a further preferred embodiment, the sensor signals provide information to the control unit about the number of chewing movements, and/or the number of swallowing movements. A combination of these parameters provides information about the overall eating speed of the subject. If information is provided about the strength of the mastication movements, then informatioη can be obtained about the consistency of the food ingested, since more solid foods generally require stronger chewing motion.

The controller may be programmed to stimulate the mastication and or the deglutition muscles to prevent further attempts to masticate or swallow food for a predetermined time after a given number of successive chewing or swallowing actions sensed by the sensors. Additionally the control unit may be programmed to prevent eating during particular hours of the day and or night.

By processing inputs from separate mastication and deglutition sensors, the controller can be programmed to discern between swallowing solid food (accompanied by mastication), and liquids (not accompanied by mastication), and to stimulate the respective muscles or nerves to prevent further eating only when the subject attempts to ingest solid food, but to permit him to drink liquids. According to further preferred embodiments of the present invention, the consumption of liquids may be permissible to the subject only on condition that they are liquids having a low caloric value, such as water or diet drinks. In order to ascertain this, there is further provided, according to another preferred embodiment of the present invention, a system in which a sugar level sensor is used in order to provide further input to the controller regarding the sugar content of the actual food or drink being ingested. This may preferably be performed by use of a sensor in the mouth, either attached externally to the mucosa, or superficially implanted, to directly detect the glucose content of the food being ingested. Alternatively and preferably, use can be made of a physiological glucose sensor, such as a glucose blood level detector, as further described hereinbelow.

According to even further preferred embodiments of the present invention, a sensor may be used which is capable of determining the level of fat in the food being eaten, such that the eating habits of a subject with a restricted fat diet can be controlled. Sensors capable of determining other food components may also be used for specific dietary control. Reference is now made to Figs. 2A to 2E, which are block diagrams of some preferred operational algorithms by which the controller may be programmed, in order to implement the use of the system of the present invention according to some of the various embodiments described herewithin.

Fig. 2A is a block diagram illustrating one preferred method for the overall control of the operation of the present invention. At step 20, the controller receives an input from one of the sensors indicating that chewing or swallowing has been detected in the subject. A check is made in step 22 whether the chewing action, if present, has a regular period, indicating chewing related to eating 30, as opposed to other random jaw movements unrelated to chewing and therefore not requiring any action 24. At the same time, a check is also made in step 26, whether the chewing action, if present, has a distinct lateral component, as detected by sensors at both sides of the subject's jaw, this too being indicative of an eating action 30, as opposed to a random jaw movement 28 requiring no further action. If as a result of either of the checks in steps 22 and 26, eating is detected 30, the controller uses the deglutition sensor output to sum the number of swallowing actions performed, this being indicative of the amount of food eaten. At step 34, if the number of deglutitions is found to be less than the number N allowed by the diet regime for this subject, the subject is allowed to continue to eat, and control passes to step 36 where a predetermined delay time T2 is waited before returning to step 32 to recount the number of deglutitions performed. If on the other hand, at step 34, the number of deglutitions is found to be greater than the number N allowed by the diet regime for this subject, the control passes to step 38, actuating the stimulatory electrodes fitted to the subject, and stopping him from continuing to eat. This eating block is applied for a predetermined time Tl ₁ chosen to be sufficient to provide motivation to the subject to stop eating on his own accord without the need for continued physical constraint. Once that period T1 has passed, the particular meal is assumed to be completed, and the control system passes to macro-options for control of the subject's habits between meals. Examples of algorithms for such macro-options are shown below in Figs. 2C and 2D.

Reference is now made to Fig. 2B, which is a block diagram illustrating an alternative preferred method for determining and controlling the eating habits of the subject. The algorithm of Fig. 2B is used to prevent the subject from eating too rapidly, rapid eating being known to reduce the feeling of satiety in the subject, and therefore operating against the aims of the diet regime. Once eating has been positively identified in step 30, the control system measures, in step 40, the elapsed time between deglutitions. If a particular swallowing action is found in step 42 to follow the previously action by time t less than a predetermined time T3, determined to be the minimum desired time between deglutitions, then control passes to step 44, actuating the stimulatory electrodes fitted to the subject, and stopping him from continuing to eat temporarily. After a delay time T4, generally of the order of anything from several seconds to several tens of seconds, and executed in step 46, the control again allows the subject to eat, and returns to step 40 to continue monitoring the rate of eating by timing swallowing actions. If the subject at step 42 is not found to be eating too quickly, the control continues according to Fig. 2A, counting the total number of deglutitions to determine when to stop the present meal according to the amount of food eaten.

Reference is now made to Figs. 2C and 2D, which are block diagrams of two alternative preferred operational algorithms for limiting the subject's eating actions between meals, according to two different macro-options. In the method of Fig. 2C, if the system detects a bona-fide eating action in step 50, it first determines in step 52 the elapsed time, t, since the last meal. If this time exceeds the inter-meal waiting time T5, as shown in step 54, the subject is allowed to eat the next meal, and control is taken over, preferably by the algorithm of Fig. 2A. If, on the other hand, the time t does not exceed the inter-meal waiting time T5, in step 56, the stimulatory electrode(s) are activated, and the subject is prevented from eating. After a predetermined delay time in step 58, the control system returns to 50 to monitor the subject for new mastication or deglutition action.

The method of Fig. 2D, on the other hand, limits the subject's ability to eat to specific times of day, predetermined by the program as allowed meal times. In Fig. 2D, if the system detects a bona-fide eating action in step 50, it first determines in step 60 whether the time of day is within the allowed meal time range. If so, then the subject is allowed to continue to eat, within the constraints of the overall system control, such as that illustrated in Fig.2A. If on the other hand, the time is outside of the permitted meal time range, in step 56, the stimulatory electrode(s) are activated, and the subject is prevented from eating. After a predetermined delay time in step 58, the control system returns to 50 to monitor the subject for new mastication or deglutition action. Reference is now made to Fig. 2E, which is a preferred embodiment of a method whereby the controller discerns between eating and drinking, and if drinking is detected, limits the subject to dietetic drinks as determined by sugar content measurements performed on the subject. Such a routine is preferably performed as part of the overall eating control algorithm shown in Fig. 2A. In step 70, the system has received sensor signals indicating swallowing action. As a result, a check is made at step 72, based on the record of mastication and deglutition events stored in the controller's memory, whether a mastication event was detected during a predetermined time interval of T7 immediately before the swallowing action was detected. If such chewing was detected, it is assumed that the swallowing is part of the normal action of eating, and control continues preferably with the steps of the method of Fig. 2A.. If, on the other hand, no chewing is detected, it is assumed that the subject has swallowed a liquid, and in step 74, after a suitable delay time T8, which is typically some tens of seconds, a glucose level is measured on the subject, preferably by a blood glucose measurement. If, in step 76, no elevated glucose level is detected, it is assumed that the subject has partaken of a dietetic drink, and control returns to step 74, to again measure the glucose level after a further delay of time T8. If, on the other hand, the glucose level is found to be above the allowed threshold, it is assumed that the subject has partaken of a forbidden high caloric value drink, and in step 78, stimulatory electrodes, preferably operable on the subject's deglutition muscles, are actuated to stop the subject temporarily from continuing to drink. After a predetermined delay time T9, the control system returns to the start of the overall eating monitor algorithm of Fig. 2A, to monitor the subject for new mastication and deglutition action. It is understood that within this algorithm is included the possibility of returning to step 70 of the algorithm of Fig. 2E, to continue monitoring for sweet drinks. The steps 70 and 72, whereby it is determined whether the subject is eating solid food or is only drinking, are only needed when control is to be exercised over the intake of non-diet drinks by the subject. It is to be understood that the glucose measurement routine, as described in the preferred routine covered by steps 74 to 78, can also be applied without steps 70 and 72, to determine whenever the subject is consuming foodstuffs with a sugar content over the level permitted to him.

It is to be understood that the methods shown in the block diagrams of Figs. 2A to 2E are only examples of preferred methods by which the present invention can be implemented, and that the methods shown are not intended to limit the invention to these particular routines. Alternative algorithms can be proposed and used to implement the present invention.

Reference is now made to Fig. 3, which illustrates schematically a system, showing the controller 31 preferably equipped with an antenna 33 that can pick up signals from a remote glucose level sensor 35, such as transcutaneous, percutaneous or implanted glucose level sensors. The sensor can be located intra- orally for direct glucose measurement on the substance ingested, or anywhere on the body 35 for physiological glucose level measurement. The controller is programmed preferably to inhibit swallowing, such as by applying a signal to a deglutition stimulation electrode 37 if the subject attempts to drink sweet beverages, as indicated by a high glucose level output from the glucose sensor 35. Alternatively and preferably, any of the other inhibiting methods described herein may be used to prevent the subject form continuing to imbibe the sweet beverage. The antennae are shown in an exaggerated form in Fig. 3 outside of the subject's body, in order to illustrate their functionality in transmitting data from the sensor to the controller. In practice, the antennae may be built into the transmitting and receiving units themselves.

This embodiment is feasible because of the fast appearance of glucose in the blood stream following sugar ingestion, such that an almost immediate control signal can be generated if a raised glucose level is detected. Although a blood glucose sensor is shown in the embodiment of Fig. 3, it is to be understood that other glucose level measurements can equally well be used in this embodiment of the present invention, such as interstitial glucose levels, or as measured by electro- permeation, by ultrasound permeation, by the use of micro-pumps, by IR spectroscopy, by enzymatic measurements, or by the use of osmotic sensors. In particular, since the accuracy required of the glucose level measurement is significantly lower than that required by, for instance, diabetic monitoring, it is possible to use a low cost glucose monitor, which conforms to the aims of simplicity of the solution offered by the system of the present invention.

Since the glucose level input may be derived from a sensor generally located remotely from the food intake sensors, the system can preferably be equipped with a security feature which ensures that the glucose level sensor is indeed fitted on the subject undergoing the diet regime, and whose food intake is being monitored. One preferred method of so doing is for the controller to check for the synchronizing of the food intake with the rise in glucose level. Lack of such synchronization may be indicative that the glucose sensor providing the input to the system is installed on another person. Alternatively and preferably, if the glucose level is measured using a blood glucose sensor, the sensor unit can be equipped to transmit the pulse of the wearer, which can be compared with the pulse of the subject, detected for instance, by means of a piezo-electric sensor preferably implanted in the controller, or by a separate sensor. Lack of synchronization between the two detected pulses may be indicative that the glucose sensor providing the input to the system is installed on a person other than the subject, in which case the default setting of the system is actuated, and continued intake is prevented. Alternative security checks could be measurement of the blood pressure or the perspiration of the subject, both of which can be correlated to the intake of food.

Reference is now made to Fig. 4, which is a schematic illustration of a further embodiment of the present invention, in which the analysis of the deglutition and mastication by the controller for determining the quantity and quality of food ingested, serves as the input to a gastro-intestinal stimulation scheme, adapted to ensure reduced food intake. The stimulation effect can be adapted either to generate a feeling of satiety, or to generate a feeling of nausea, either case discouraging the subject from continuing to eat. The stimulation can preferably be applied to a number of possible targets. Application to the digestive track region, such as to the colon, results in a colono-gastric reflex, preventing the stomach from emptying, and thus providing a feeling of fullness. Alternatively, the stimulus can be applied to the vagus nerve, or one of its sensors, or to the peritoneum. A strong nausea generating effect can be achieved by applying the stimulus to any of the sympathetic nerves of the abdomen or their afferents, such as the greater, the lesser or the least thoracic splanchic nerves, to the celia plexus nerve, or to nerves within the peritoneum. However, these nerves are less accessible than the vagal nerve for the implantation procedure. Alternatively, the pyloric sphincter muscles can be stimulated to delay gastric emptying, or the upper or lower esophageal sphincters, to close off entry of food into the stomach. According to other preferred embodiments, vagal or sympathetic stimulation, each with its optimal frequency and intensity range, can be applied in order to reduce the gastro-intestinal transit time, thus leading to reduced absorption or to mal-absorption of the traversing food, such that less calorific value is extracted therefrom.

In Fig. 4, there is shown the mastication or deglutition sensor 90 inputting its signal to the control unit 92, which outputs a signal to a stimulation electrode 94 causing relaxation of the stomach and a sensation of satiety. Also shown in Fig. 4 is an electrode applied in an alternative position causing contraction of the pylorus 96 (gastric outlet) after eating a predetermined quantity of food, thereby delaying gastric emptying. Alternative sphincter electrode positions at the upper esophageal sphincter 97 and lower esophageal sphincter 98 are also shown.

As an alternative to gastric stimulation of various types, or to stimuli related to the eating functions, according to further preferred embodiments of the present invention, the electrodes can be activated to apply a stimulus unrelated to the gastric or the eating functions at all, such as to apply a pain stimulus to a predetermined part of the subject's anatomy, or an auditory stimulus at a level which the subject finds annoying, in order to encourage the subject to cease eating.

There are a number of preferred application regimes by which the system of the present invention can be utilized to fulfill its function of limiting food intake by the subject.

According to a first embodiment, the controller can be programmed to simply limit the amount of food that the subject eats within an allotted meal. In order to accomplish this, input data regarding the allowable amount of food, the length of time defining the meal duration and even preferably, the type of food consumed is entered into the controller, and the stimulation outputs adjusted by the controller to react when the food intake, as measured by the various sensors, exceeds any of the programmed parameters. Additionally, the controller can be programmed to limit the speed at which the subject eats, by ensuring adequate rest periods between each act of deglutition. According to these embodiments, the system can thus provide correct training to the subject to eat more slowly, in addition to training him to eat less and to eat selectively. This particular mode is important since it is known in the art that the level of satiation from a meal is dependent on the speed with which the meal is eaten; the faster the meal is eaten, the less the satiation effect.

According to another embodiment, the controller can be programmed to limit the subject to eating only at specific times. This is an extension of the above described embodiment, in that the meal duration is preferably delineated also by means of a minimal fixed interval between the so-called meals. The controller is programmed to block the eating ability of the subject between such defined meal times, thus thwarting attempts by the subject to partake of snacks between his or her allowed set meals. Additionally, the controller can preferably be programmed to allow different types of meals at different times of the day, with the subject limited to eating the allowed meal at each predetermined period of the day. Since each meal will generally have a different constitution and size, and the manner in which the subject consumes it varies from person to person, before use of the system for enforced diet control on a subject, one or more characterization test runs should be performed with the subject for different types of foods, in order to "teach" the system how the subject chews and/or swallows each type of food. The characteristic sensing patterns for different types of food for a particular subject can then be stored in the controller memory, and used thereafter for recognizing what type of food is being ingested by the subject at any subsequent meal. This information can subsequently be used to ensure that the subject is eating the predetermined meal, and at the allotted time.

Different meal types can preferably be characterized by the use a code, such as a bar-code, or a coded, manually-entered identity number, applied to each pre- prepared meal, or to each pre-prepared portion or serving of such a meal. According to one preferred embodiment, the code simply defines the type of meal chosen, i.e. whether it is intended as a breakfast, lunch or dinner meal, and will be used by the controller to prevent the subject from attempting to amend his dietary regime by swapping meal types. According to a further preferred embodiment, the code defines the meal content in terms of the types of specific portions therein. The stored characteristic sensing pattern can be used to confirm that the subject is eating the predetermined meal intended for him/her according to the planned dietary regime, since the meal type and content, as determined by the code attached thereto, will need to match the meal type and content as determined by the subject's real-time chewing or swallowing pattern, as monitored by the subject's sensors. This embodiment is useful for preventing the subject from attempting to circumvent the system by entering or scanning in the code on the predetermined meal, and then eating something completely different. Lack of correlation will cause the system to actuate the stimulatory sensors to prevent the subject from eating the bogus meal. According to a further preferred embodiment, the code shows the calorific value of the complete meal, or each portion or serving thereof, and this information is input to the controller which activates the stimulatory electrodes to prevent further eating only when a predefined total calorific input level has been reached. According to a further preferred embodiment of the present invention, the meals for use with the system can be prepared to include specific markers having a predefined concentration and type, which can be detected by a suitable sensor implanted on the subject. The sensor uses the detected marker characteristic and total amount, to determine whether or not the subject is allowed to consume the meal, or part thereof. The sensor preferably ascertains the type of meal being eaten, and the quantity of food therein. If the type of meal is not that allowed at that time according to the diet regime, or if the permitted quantity of food is exceeded, or if the speed of eating is exceeded, the controller can be programmed to send an activating signal to the stimulatory electrodes, thus preventing the subject from continuing to eat. One possible type of marker for use with this embodiment is a suspension of ferromagnetic particles in the form of microcapsules coated with a biologically inert coating, dispersed through the meal content. The sensor can then preferably be any type of electromagnetic detector which will detect the particles. Another possible type of marker could be a material having a specific IR transmission or reflection spectrum, and the use of a sensor for detecting this spectrum. However, any other type of acceptable marker and detector can equally well be used for implementing this embodiment of the present invention.

According to further preferred embodiments of the present invention, the controller can be programmed to allow the subject to eat meals only within a certain location, where it is known that there is control and inspection of what the subject eats, and preferably also only at predetermined times, in cases where it is known that only then is such supervision present. Reference is now made to Fig. 5 which is a schematic illustration of one preferred embodiment of this application of the present invention. The controlled location 80 is set up to provide an enabling signal, such as by a wireless or inductive transmission 82, and only when the subject is within this area can a receiver antenna 84 located on the subject's person pick-up the signal for use by the controller 86 in setting the stimulating electrodes to allow the subject to eat. Such an embodiment is particularly suitable for limiting the subject to eating only in supervised locations, such as in the home, or in the dining room at work, thus preventing him/her from eating snacks between meals when away from home or outside of the dining room at work. It is also applicable for use in diet retreats or obesity treatment courses, in which the subject is limiting to eating only in supervised areas, such as the dining room. In the example shown in Fig. 5, the inhibiting electrode or electrodes 89 are shown applied to limit the subject's deglutition action, though it is to be understood that any of the above mentioned inhibition methods, such as on the gastro-intestinal tract 87 or nerves, are equally applicable. Additionally, the preferred embodiment of Fig. 5 also shows the controller receiving signals from a sensor 88 mounted where it will detect the intake of the food or drink by the subject, though it is to be understood that in such a controlled area 80, visual monitoring and supervision, either local or remote, may take the place of such food or drink intake detection.

According to further preferred embodiments of the present invention, there is also provided a system using mastication or deglutition sensors as described hereinabove, whereby the subject's food intake is measured by these sensors, and the results monitored at an active control point. According to the results of the monitoring, the monitoring point may send commands to the subject to stop eating. The monitor can be a live supervisor, which could be either a professional dietician or associated personnel, or even a family member, such as the subject's spouse. The monitoring could be either at the same location as the subject, or it could be at a remote location, where many subjects could be monitored by one person. The monitor could also preferably accumulate data about the total food intake of the subject, in order to integrate the subject's daily caloric intake. The system can also preferably use a video monitor to view remotely what the subject is eating, instead of using sensors implanted on the subject. The video monitor can be programmed to turn on only when the subject associated with that monitor enters the controlled surveillance area, by using a proximity detection system or a radio location system, of the type known in the art. According to another alternative preferred method of this arrangement, the eating actions of the subject can be monitored by personnel at the control point, who then can send commands to stimulating electrodes implanted on the subject, thus preventing him from continuing to eat without the need for personal instructions, Alternatively and preferably, by the use of both sensors and stimulatory electrodes on the subject, the monitoring can be made to be fully automatic, as per one of the embodiments described hereinabove.

The above described preferred embodiments of the system of the present invention have all been related to the question of the restriction of food or drink intake, which to a person subject to restrictions on such intake, could be regarded as "harmful substances". However, it is to be understood that the same basic techniques described above, and the same preferred embodiments described above, are also applicable to the control of the intake of more conventional "harmful substances" such as drugs, tobacco and alcohol. The claimed invention and its various applicable embodiments are thus meant to cover the control of the intake of these substances too, using appropriate sensors for the detection of the intake of each substance, or of the presence of the substance itself. The feedback or response when the restricted substance is detected can preferably be by means of an unpleasant stimulus, or by transmission of a signal or report to law enforcement authorities.

It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.

Claims

CLAIMS We claim:

1. A system for restricting intake of a substance by a subject, said system comprising: at least one orally associated sensor adapted to detect intake of said substance; a control unit receiving signals from said at least one sensor and generating an output signal accordingly; and at least one inhibitor operating on said subject, activated by said output signal.

2. A system according to claim 1 and wherein said inhibitor provides a physical stimulus to said subject to discontinue intake of said substance.

3. A system according to either of claims 1 and 2 and wherein said controller further determines whether said detected intake by said subject is to be discontinued according to at least one predetermined criterion.

4. A system according to any of the previous claims and wherein said substance is any one of alcohol, tobacco and a drug.

5. A system according to any of claims 1 to 3, and wherein said substance is either one of food and drink.

6. A system according to claim 5 and wherein said at least one sensor is adapted to detect at least one of the subject's mastication and deglutition actions.

7. A system according to claim 6 and wherein said sensor is implanted in at least one of a mastication muscle and a deglutition muscle of said subject.

8. A system according to claim 5 and wherein said inhibitor is a stimulatory electrode in a location such that, when activated by said output signal, limits at least one of said subject's mastication and deglutition abilities.

9. A system according to claim 8 and wherein said stimulatory electrode is implanted in at least one of a deglutition muscle and a mastication muscle of said subject.

10. A system according to claim 8 and wherein said stimulatory electrode is implanted in at least one nerve controlling at least one of the subject's mastication and deglutition abilities.

11. A system according to claim 5 and wherein said inhibitor is a stimulatory electrode in a location such that, when activated by said output signal, operates on a gastro-intestinal function of the subject.

12. A system according to claim 11 and wherein said stimulatory electrode is operative to generate either one of a feeling of satiety or a feeling of nausea.

13. A system according to claim 12 and wherein said stimulatory electrode is applied to any one of the stomach, the pyloric sphincter, a sphincter of the esophagus, the peritoneum, the vagal nerve or one of its afferent sensors, and a sympathetic nerve of the abdomen or one of its afferent sensors.

14. A system according to any of claims 1 to 5, wherein said inhibitor is a pain stimulator applied to a part of the subject's anatomy.

15. A system according to any of claims 1 to 5, wherein said inhibitor is an audible stimulator.

16. A system according to claim 5 and wherein said at least one sensor is a glucose level sensor adapted to detect at least one of a physiological glucose level and the glucose level of any one of said food and drink in the subject's mouth.

17. A system according to claim 16 and wherein said physiological glucose level is the subject's blood glucose level.

18. A system according to either of claim 16 and 17, further comprising a subsystem for determining whether said detected physiological glucose level is that of said subject.

19. A system according to claim 18 and wherein said subsystem compares the pulse of the person where said glucose level is being measured with that of said subject.

20. A system according to claim 3, wherein said predetermined criterion is the elapsed time since the last intake of said substance.

21. A system according to claim 3, wherein said predetermined criterion is the rate of intake of said substance.

22. A system according to either of claims 6 and 7, wherein said controller determines the amount of intake of either one of said food and drink by counting the number of at least one of the subject's mastication and deglutition actions.

23. A system according to either of claims 6 and 7, wherein said controller determines whether food or drink is being taken in by the subject by counting the ratio of the number of the subject's mastication actions to the number of deglutition actions.

24. A system according to claim 5 and wherein said at least one sensor is a mechanical sensor detecting relative motion between opposing teeth of said subject.

25. A system according to claim 24 and wherein said mechanical sensor is connected between opposing teeth of said subject.

26. A system for restricting intake of a substance by a subject, said system comprising: at least one sensor adapted to detect intake of said substance; a control unit receiving signals from said at least one sensor and generating an output signal accordingly; and a signal transmitter activated by said output signal providing to a third party information regarding the subject's intake of said substance.

27. A system according to claim 26 and wherein said substance is any one of alcohol, tobacco and a drug.

28. A system according to claim 26 and wherein said substance is any one of food and drink.

29. A system according to claim 28 and wherein said third party is person supervising diet control of the subject.

30. A system according to claim 28 and wherein said at least one sensor is a glucose level sensor adapted to detect at least one of a physiological glucose level and the glucose level of any one of said food and drink in the subject's mouth.

31. A system according to claim 30 and wherein said physiological glucose level is the subject's blood glucose level.

32. A system for restricting intake of a substance by a subject, said system comprising: a controlled area where the subject is permitted to intake said substance, said controlled area having an enabling signal associated with it; a control unit receiving at least said enabling signal and generating an output signal accordingly; at least one inhibitor operating on said subject, activated by said output signal, said inhibitor preventing said subject from intake of said substance other than in said controlled area.

33. A system according to claim 32, further comprising at least one sensor associated with the subject adapted to detect intake of said substance, and wherein said controller further receives signals from said at least one sensor and generates said output signal accordingly.

34. A system for restricting intake of a substance by a subject, said system comprising: a controlled area where the subject is permitted to intake said substance, said controlled area having an enabling signal associated with it; a control unit receiving at least said enabling signal and generating an output signal accordingly; and a signal transmitter activated by said output signal providing to a third party information regarding the subject's intake of said substance.

35. A system according to claim 34, further comprising at least one sensor associated with the subject adapted to detect intake of said substance, and wherein said controller further receives signals from said at least one sensor and generates said output signal accordingly.