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Patentes

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Número de publicaciónWO2002026101 A2
Tipo de publicaciónSolicitud
Número de solicitudPCT/IL2001/000887
Fecha de publicación4 Abr 2002
Fecha de presentación25 Sep 2001
Fecha de prioridad29 Sep 2000
También publicado comoWO2002026101A3
Número de publicaciónPCT/2001/887, PCT/IL/1/000887, PCT/IL/1/00887, PCT/IL/2001/000887, PCT/IL/2001/00887, PCT/IL1/000887, PCT/IL1/00887, PCT/IL1000887, PCT/IL100887, PCT/IL2001/000887, PCT/IL2001/00887, PCT/IL2001000887, PCT/IL200100887, WO 0226101 A2, WO 0226101A2, WO 2002/026101 A2, WO 2002026101 A2, WO 2002026101A2, WO-A2-0226101, WO-A2-2002026101, WO0226101 A2, WO0226101A2, WO2002/026101A2, WO2002026101 A2, WO2002026101A2
InventoresPnina Abramovitz-Shnaider
SolicitanteAbramovitz Shnaider Pnina
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos:  Patentscope, Espacenet
System and method for the control of behavioral disorders
WO 2002026101 A2
Resumen
An arrangement including sensors (12, 14, 16), microprocessor control (18) and a stimulator (22), which can be used for enforcing a corrective regimen on a patient (10) suffering from a dietary or other behavioral disorder.
Reclamaciones  (El texto procesado por OCR puede contener errores)
1. A system for automatically detecting and categorizing behavioral activity, comprising: at least one sensor connected to an animal body to detect activity in tissue associated with said behavioral activity and a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity.
2. A system according to claim 1, where said sensors are implantable into an animal body into tissue associated with said behavioral activity.
3. A system according to claim 1, further comprising a stimulator device for delivering a warning sensation in response to said detected and categorized behavioral activity.
4. A system according to claim 1, comprising a plurality of sensors.
5. A system according to claim 4, where said behavioral activity is dietary activity.
6. A system according to claim 2, where said behavioral activity is dietary activity.
7. A system according to claim 3, where said behavioral activity is dietary activity.
8. A system according to claim 6, operable to categorize said detected signals into at least one of a group comprising mastication events, swallowing events, reverse swallowing events and digestive activity.
9. A system according to claim 8, operable to categorize said events into lone eating events, meal events, binge eating events, and vomiting events.
10. A system according to claim 9, wherein said microprocessor is operable to quantify said events.
11. A system according to claim 9, wherein said microprocessor is programmable to utilize said detected and categorized dietary activity to apply said warning to enforce a dietary regimen on a patient.
12. A system according to claim 11, wherein said dietary regimen is a treatment for a dietary disorder.
13. A system according to claim 12, wherein said dietary disorder is any one of a group comprising anorexia nervosa, bulimia nervosa and obesity.
14. A system according to claim 12, wherein said microprocessor is operable, upon detection of a binge eating event, to operate said stimulator to issue said warning sensation.
15. A system according to claim 12, wherein said dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon passing of any such predetermined time without detection of a meal event, to operate said stimulator to issue said warning sensation.
16. A system according to claim 12, wherein said dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon detection of an eating event at times other than said predetermined times, to operate said stimulator to issue said warning sensation.
17. A system according to claim 3, wherein said sensors and said stimulator device are microdevices directly attachable to muscle tissue and to individual nerve fibers.
18. A system according to claim 17, wherein said microdevices each comprise two electrodes extending from either side of a tubular housing.
19. A system according to claim 3, wherein said sensors and said stimulator comprise antennas for communicating with said microprocessor using r.f. transmission.
20. A system according to claim 3, wherein said sensors and said stimulator are powered inductively from a power source.
21. A system for enforcing a dietary regimen on a patient, said system comprising a plurality of sensors implantable into an animal body into tissue associated with dietary activity to detect activity in said tissue associated with dietary activity, a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said dietary activity, and a stimulator device for delivering a warning sensation to a patient in response to said detected and categorized dietary activity.
22. A system according to claim 21, operable to categorize said detected signals into at least one of a group comprising mastication events, swallowing events, reverse swallowing events and digestive activity.
23. A system according to claim 22, operable to categorize said events into lone eating events, meal events, binge eating events, and vomiting events.
24. A system according to claim 23, wherein said microprocessor is operable to quantify said events.
25. A system according to claim 23, wherein said microprocessor is operable, upon detection of a vomiting event, to operate said stimulator to issue said warning sensation.
26. A system according to claim 25, wherein said dietary regimen is a treatment for a dietary disorder.
27. A system according to claim 26, wherein said dietary disorder is any one of a group comprising anorexia nervosa, bulimia nervosa and obesity.
28. A system according to claim 26, wherein said microprocessor is operable, upon detection of a binge eating event, to operate said stimulator to issue said warning sensation.
29. A system according to claim 26, wherein said dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon passing of any such predetermined time without detection of a meal event, to operate said stimulator to issue said warning sensation.
30. A system according to claim 26, wherein said dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon detection of an eating event at times other than said predetermined times, to operate said stimulator to issue said warning sensation.
31. A system according to claim 21, wherein said sensors and said stimulator device are microdevices directly attachable to muscle tissue and to individual nerve fibers.
32. A system according to claim 31, wherein said microdevices each comprise two electrodes extending from either side of a tubular housing.
33. A system according to claim 21, wherein said sensors and said stimulator comprise antennas for communicating with said microprocessor using r.f. transmission.
34. A system according to claim 21, wherein said sensors and said stimulator are powered inductively from a power source.
35. A system according to claim 2, where said behavioral activity is Bruxism.
36. A system according to claim 3, where said behavioral activity is
Bruxism.
37. A system according to claim 36, operable to categorize said detected signals into grinding events.
38. A system according to claim 37, wherein said microprocessor is operable to quantify said events.
39. A system according to claim 38, wherein said microprocessor is programmable to utilize said detected and categorized grinding activity to apply said warning to interrupt said grinding activity.
40. A system for automatically detecting and categorizing behavioral activity, comprising: a plurality of sensors implantable into an animal body into tissue associated with said behavioral activity to detect activity in said tissue associated with said behavioral activity and a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity.
41. A system for enforcing a behavioral regimen on a patient, said system comprising a plurality of sensors implantable into an animal body into tissue associated with said behavioral activity to detect activity in said tissue associated with said behavioral activity, a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity, and a stimulator device for delivering a warning sensation to a patient in response to said detected and categorized behavioral activity.
42. A method for reinforcing desired behavior and penalizing non-desired behavior in a patient suffering from a behavioral disorder, the method comprising, implanting sensors within the patient in locations enabling the sensors to detect bodily activity associated with said non-desired behavior, implanting at least one stimulator in said patient at a location wherein said stimulator is able to produce an undesirable effect on said patient, detecting outputs of said sensors, processing outputs of said sensors to build up behavior events, matching said behavior events against said non-desired behavior, and in the event of a match therebetween, operating said stimulator to penalize said patient.
Descripción  (El texto procesado por OCR puede contener errores)

SYSTEM AND METHOD FOR THE CONTROL OF BEHAVIORAL

DISORDERS

Technical Field

The present invention relates to a system and method for the control of behavioral disorders such as eating disorders, and more particularly, but not exclusively, to a system and method for control thereof which can be applied directly to a patient and which demands compliance with a dietary regimen.

Background Art

Behavioral disorders, such as eating disorders and Bruxism, are diseases in which a patient develops an undesirable behavior pattern, leading to deterioration in the patient's physical, emotional, or mental condition. In severe cases this may ultimately lead to the patient's death. Treatment of a behavioral disorder requires prevention of the undesirable behavior, and preferably conditioning the patient to avoid the damaging behavior pattern.

Eating disorders, including obesity, anorexia nervosa and bulimia nervosa, are becoming increasingly widespread and are difficult to treat because there is often little alternative but to keep the patient under constant supervision to ensure that they do eat, or do not eat, as the case, may be. These disorders are mainly behavioral disorders, and attempting to change the behavior using conventional techniques is labor-intensive and impractical.

Alternatives to constant supervision include drastic and costly invasive procedures, for example gastric bypass and siiastic vertical ring banding gastroply for treating obesity.

Prolonged hospitalization is often necessary in the cases of Anorexia and

Bulimia nervosa. Prolonged hospitalization is particularly undesirable in that, whilst it may succeed in saving a patient's life, it does not necessarily contribute to the conditioning of a patient to overcome the disorder in the context of a normal life environment. Obesity is a well-documented condition which has both medical and psychological ramifications. Thus, obesity puts a person at risk for other health problems, including, but not limited to, high blood pressure, diabetes, coronary heart disease, and stroke. Conventional weight loss programs are often unsuccessful, with any lost weight being often regained. Weight loss can be maintained only by a long term modification of the person's eating habits.

Bruxism is a severe form of teeth grinding occurring primarily during sleep. The pressure exerted on the teeth and jaws is extreme, and can lead to severe wear on the teeth, gums, temporomandibular joint (TMJ) and jaws, headaches, and other problems. Bruxism is currently treated by many methods, among them use of night bite appliances, stress reduction techniques, and sleeping aids, however these do not always alleviate the problems caused by Bruxism.

Disclosure of the Invention The present invention provides round the clock supervision of the patient, acting as a biofeedback system preventing the patient from being able to mislead himself or others about his behavior. The present invention utilizes the reward and penalty aspects of behavioral psychology to adapt the patient's behavior to overcome the condition. According to one aspect of the present invention there is provided a system for automatically detecting and categorizing behavioral activity, comprising at least one sensor connected to an animal body to detect activity in tissue associated with said behavioral activity and a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity. According to another aspect of the present invention there is provided a system for enforcing a dietary regimen on a patient, said system comprising a plurality of sensors implantable into an animal body into tissue associated with dietary activity to detect activity in said tissue associated with dietary activity, a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said dietary activity, and a stimulator device for delivering a warning sensation to a patient in response to said detected and categorized dietary activity. According to yet another aspect of the present invention there is provided a system for automatically detecting and categorizing behavioral activity, comprising a plurality of sensors implantable into an animal body into tissue associated with said behavioral activity to detect activity in said tissue associated with said behavioral activity and a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity.

According to still another aspect of the present invention there is provided a system for enforcing a behavioral regimen on a patient, said system comprising a plurality of sensors implantable into an animal body into tissue associated with said behavioral activity to detect activity in said tissue associated with said behavioral activity, a processor operable to receive signals from said sensors and to interpret said signals, thereby to detect and categorize said behavioral activity, and a stimulator device for delivering a warning sensation to a patient in response to said detected and categorized behavioral activity. According to an additional aspect of the present invention there is provided a method for reinforcing desired behavior and penalizing non-desired behavior in a patient suffering from a behavioral disorder, the method comprising implanting sensors within the patient in locations enabling the sensors to detect bodily activity associated with said non-desired behavior, implanting at least one stimulator in said patient at a location wherein said stimulator is able to produce an undesirable effect on said patient, detecting outputs of said sensors, processing outputs of said sensors to build up behavior events, matching said behavior events against said non-desired behavior, and in the event of a match therebetween, operating said stimulator to penalize said patient. According to further features in preferred embodiments of the invention described below, said sensors are implantable into an animal body into tissue associated with said behavioral activity.

According to still further features in the described preferred embodiments the system further comprising a stimulator device for delivering a warning sensation in response to said detected and categorized behavioral activity. According to still further features in the described preferred embodiments the system comprising a plurality of sensors.

According to still further features in the described preferred embodiments the behavioral activity is dietary activity. According to still further features in the described preferred embodiments the system is operable to categorize said detected signals into at least one of a group comprising mastication events, swallowing events, reverse swallowing events and digestive activity.

According to still further features in the described preferred embodiments the system is operable to categorize said events into lone eating events, meal events, binge eating events, and vomiting events.

According to still further features in the described preferred embodiments the microprocessor is operable to quantify said events.

According to still further features in the described preferred embodiments the microprocessor is programmable to utilize said detected and categorized dietary activity to apply said warning to enforce a dietary regimen on a patient.

According to still further features in the described preferred embodiments the dietary regimen is a treatment for a dietary disorder.

According to still further features in the described preferred embodiments the dietary disorder is any one of a group comprising anorexia nervosa, bulimia nervosa and obesity.

According to still further features in the described preferred embodiments the microprocessor is operable, upon detection of a binge eating event, to operate said stimulator to issue said warning sensation. According to still further features in the described preferred embodiments the dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon passing of any such predetermined time without detection of a meal event, to operate said stimulator to issue said warning sensation.

According to still further features in the described preferred embodiments the dietary regimen requires meals to be taken at predetermined times and wherein said microprocessor is operable, upon detection of an eating event at times other than said predetermined times, to operate said stimulator to issue said warning sensation.

According to still further features in the described preferred embodiments the sensors and said stimulator device are microdevices directly attachable to muscle tissue and to individual nerve fibers.

According to still further features in the described preferred embodiments the microdevices each comprise two electrodes extending from either side of a tubular housing.

According to still further features in the described preferred embodiments the said sensors and said stimulator comprise antennas for communicating with said microprocessor using r.f. transmission.

According to still further features in the described preferred embodiments the sensors and said stimulator are powered inductively from a power source.

The present invention successfully addresses the shortcomings of the presently known configurations by providing a round the clock supervision of a patient, acting as a biofeedback system preventing the patient from being able to mislead himself or others about his behavior, while, in preferred embodiments utilizing the reward and penalty aspects of behavioral psychology to adapt the patient's behavior to overcome the condition. Implementation of the method and system of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions. Brief Description of the Drawings

For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings, in which:

Fig. 1 is a generalized diagram showing a patient with a system according to a first embodiment of the present invention implanted therein;

Fig. 2 is a generalized block diagram of the system of Fig. 1;

Fig. 3 is a generalized diagram of a series of templates for use with the embodiment of Fig. 1;

Fig. 4 is a flow diagram showing a simplified procedure for dealing with anorexia nervosa;

Fig. 5 is a flow diagram showing a simplified procedure for dealing with bulimia nervosa; and Fig. 6 is a flow diagram showing a simplified procedure for dealing with obesity.

Description of the Preferred Embodiments

Reference is now made to Fig. 1, which shows a first embodiment of the present invention. A patient 10 has, implanted within him, a series of sensors, 12, 14 and 16. Each sensor is connected to a programmable microprocessor 18, and both the microprocessor and the sensors are connected to a battery 20 mounted on or in association with the patient. Preferably a warning device 22 is implanted or placed on the patient. In the illustrated embodiment, the warning device is place in association with an ear of the patient.

The sensor 12 is placed adjacent or on a tooth, in the oral cavity or in the proximity of the jawbone such that it is able to measure mastication. The sensor 14 is placed in the vicinity of the larynx, trachea, or esophagus so that it can measure swallowing. The sensor 16 is placed in the vicinity of the stomach or the small intestine so that movement of the digestive tract may be measured. The sensors 12-16 may be pressure sensors. Thus the sensor 12 may comprise a piezoelectric pressure pad placed against the jawbone or jaw muscle. Movement of the jaw leads to pressure on the pad, which generates a signal that may be digitized and measured by the microprocessor. Likewise, the sensor 14, a pressure pad, may be placed against the wall of the larynx or trachea. Sensor 16 may comprise a pressure pad to be placed in, on, or against the wall of the stomach.

The sensors 12-16 may alternatively be electromyography electrodes. Thus the sensor 12 may comprise an electromyography electrode placed in association with the mastication muscles. In the case of the sensor 14, an electrode may be placed in association with muscle tissue of the larynx or trachea, and in the case of the sensor 16, an electrode may be placed on the stomach wall in association with muscle tissue of the stomach.

Any or all of the sensors 12-16 may alternatively comprise implantable microminiature sensors, which are microdevices sealed within a housing and which include circuitry for inductively receiving power and control signals to sense biopotential or other biomedical signals. In a preferred embodiment, the microdevices comprise a tubular housing with opposing electrodes extending from each end. The electrodes are preferably self-attaching electrodes that attach to a nerve or muscle without suturing. Such microdevices are attachable to any type of muscle including skeletal, smooth and cardiac.

The microsensor senses biopotentials in the muscle tissue to which it is attached, the biopotential being due to the contraction of the muscle. A sense amplifier preferably amplifies and filters signals, resulting from the biopotentials, which are sensed across the electrodes. The amplified and filtered signals are then sent to a data modulator where they are modulated onto a clock signal. A telemetry circuit transmits the modulated signals through a coil, associated with the sensor, which coil serves as an antenna. Transmission is preferably accomplished using a radio frequency carrier signal having an appropriate carrier frequency. An alternative is to use inductive coupling. An advantage of using inductive coupling is that the same circuitry can be used to power the microsensor and to transmit the signals. Microprocessor 18 comprises a corresponding receiving coil and demodulating circuitry, allowing it to read the data received from the sensors 12 - 16. Microprocessor 18 is an externally programmable device that reads incoming data from the sensors 12 - 16, performs processing of the data, and provides control signals for the warning device 22. The microprocessor 18 is capable of transmitting sensor data by modem, thereby providing remote monitoring capability. Additionally, the microprocessor 18 is remotely programmable by modem.

The sensors 12-16 may alternatively be magnetic or electromagnetic actuators, in which movement of the relevant muscle, organ, bone or cartilage moves a magnet and thus induces a current. Transmission to the microprocessor 18 is preferably as described above.

The sensors 12-16 may alternatively be acoustic devices, which detect sound waves produced by the action of the body part.

Additional sensors may be used together with or instead of the above. For example a sensor can be positioned to measure bowel movements. A suitably sited second esophageal sensor may be able to measure vomiting events. Generally, both a swallowing and a vomiting event are characterized by movements in the esophageal wall. The swallowing and the vomiting event are distinguished in that the swallowing event involves a downward movement of the esophageal wall and vomiting involves an upward movement. Thus the placing of two movement sensors along the wall of the esophagus is sufficient to identify and distinguish between swallowing and vomiting.

Reference is now made to Fig. 2, which is a block diagram at the system level of the embodiment of Fig. 1. Parts that are identical to those shown above are given the same reference numerals and are not referred to again except as necessary for an understanding of the present embodiment. Inputs from each of the above sensors 12, 14 and 16, and any other sensors that may be present, are fed into the microprocessor 18. The microprocessor preferably determines that an eating event has occurred by measuring chewing, swallowing and/or digestive activity, their profile and their sequence of activity. The magnitude of the eating event is preferably determined from the extent of all three activities. The occurrence of chewing only may be due to chewing gum. The occurrence of swallowing only may be due to the swallowing of saliva or drinking. Stomach movements taken alone may also provide an ambiguous signal.

From the extent of the three types of activity the microprocessor 18 is able to record and build up a picture of current dietary activity. In one embodiment, the information may simply be stored for later use by the physician. In a first preferred embodiment, the information gained may then be used to operate the signal device 22. In a simple case the signal device 22 may be a passive indicator which merely indicates an amount of eating that has taken place, or an amount of eating that has been detected over a given time, or a type and duration of eating event.

In a preferred embodiment the signal device issues a warning signal whenever an infraction is detected of a specified dietary regimen that the patient 10 is supposed to be observing.

In an embodiment in which signal device 22 is placed in association with the ear, the warning signal may be an irritating noise which grows in volume over time or a vocal message which provides instructions to the patient. In a preferred embodiment a bone conduction hearing device is implanted in or over a bone behind the ear. This device requires relatively low power to provide an audible signal, minimizing battery replacement. As an alternative, the signal could be a mechanical movement. Depending on where the device 22 is placed, greater or lesser degrees of irritation can be provided. Again the signal may grow in intensity over time.

In an embodiment, the warning device 22 is a microminiature stimulator. Similar in construction to the microminiature sensors referred to above, it comprises a tubular housing with electrodes extending from either end. The electrodes are self- attaching electrodes that may be attached to nerve or muscle without suturing. If placed around a nerve, then the electrodes are configured to curl helically around the desired nerve, thereby permitting the microdevice to stimulate the nerve using a minimal amount of energy. The electrodes are furthermore sufficiently small to allow attachment to a single nerve, thereby preventing tethering of the nerve. The size also permits implantation through small incisions or puncture holes. The microdevice may thus be placed around a nerve to stimulate the nerve as a warning signal whenever the microdevice receives an instruction so to do from the microprocessor 18.

Alternatively, the microdevice may be placed in association with muscle to stimulate the muscle as a warning signal. In this case the patient experiences twitching or a like unpleasant sensation.

As a further alternative, several such microdevices, attached to any combination of nerves and muscles, may comprise the warning device 22. If it is desired to provide a warning signal which steadily grows in severity then initially only one or a few of the microdevices is switched on. As time passes, more and more of the microdevices are switched on.

Alternatively or additionally it may be desired to provide different levels of warning signal, such as a general warning and a severe warning. The general warning may comprise the switching on of a predetermined few of the microdevices and the severe warning may comprise switching on of most or all of the microdevices.

The signal thus serves to provide behavioral conditioning to the patient in that unacceptable behavior is penalized. As eating disorders are essentially behavioral disorders, such an approach is believed to be particularly effective. The solution is less invasive than conventional surgical techniques, does not require constant supervision of the patient and allows the reconditioning of the patient to occur in his normal surroundings, where it is likely to be most effective for the future.

The microprocessor is preferably programmed to monitor sensors 12-16 and any other sensors that may be provided. Measurements from the individual sensors, if registering above a certain threshold are taken as system primary events and may typically be characterized as masticating, swallowing, reverse swallowing and digestive system movement events respectively. The primary events are then preferably considered in combination against templates, as will be described below, to identify secondary and tertiary events.

Reference is now made to Fig. 3 which is a simplified diagram showing a series of templates which may be used with the embodiment of Fig. 1 in order to determine the presence of secondary events from the primary events recorded by the sensors. If a sequence of received signals is found to match one of a series of templates then an event corresponding to the template is said to have occurred.

In Fig. 3, a template 30 defines an eating event as comprising mastication lasting for a given time delay, followed by swallowing followed after a given time delay by movements of the digestive system.

A template 32 defines a vomiting event as comprising a relatively violent movement of the stomach, followed by a reverse swallowing event.

A template 34 defines a binge eating event as an event in which a sum total of eating events over a two-hour period exceeds a predetermined threshold. It will be appreciated that a binge eating event is a tertiary event as its identification depends on a summation of eating events which are secondary events.

A template 36 indicates a meal event, which may be defined as a sum of eating events over a half hour period, when they add up to a given threshold level.

It will be appreciated that Fig. 3 is exemplary only and is in no way exhaustive of the templates that are useful in the present invention. Further templates may for example allow measurements of a bowel movement sensor to identify an excess use of laxative event. Refinements of the eating event template may allow for discrimination between eating of crunchy food and eating of chewy food and eating of soft food, based on the strength of the signal from the sensor 12. Such discrimination is useful in estimating the type of food that is being ingested.

Embodiments of the present invention can be used in cases of anorexia nervosa. Anorexia nervosa is diagnosed by the following criteria:

1. Refusal to maintain body weight at or above a minimally normal weight for age and height (e.g., weight loss leading to maintenance of body weight less than 85% of that expected; or failure to make expected weight gain during period of grow, leading to body weight less than 85% of that expected).

2. Intense fear of gaining weight or becoming fat, even though underweight, and

3. Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or denial of the seriousness of the current low body weight. Anorexia nervosa comes in two types, a first type is referred to as the restricting Type and is characterized in that during the current episode of Anorexia Nervosa, the person has not regularly engaged in binge-eating or purging behavior (i.e., self-induced vomiting or the misuse of laxatives, diuretics, or enemas). A second type is known as the binge eating and purging type (or Anorexia hervosa bullemic type): It is characterized in that, during the current episode of Anorexia Nervosa, the person has regularly engaged in binge-eating or purging behavior (i.e., self-induced vomiting or the misuse of laxatives, diuretics, or enemas). The patient is typically extensively involved in restricting caloric intake of any source, avoids food intake, engaged in fasting and in extensive physical exercises, etc.

There are a number of ways in which the embodiment may be used with a patient suffering from anorexia nervosa. For example the embodiment may be used to ensure that an anorexia patient complies with a requirement to eat more than a certain minimum amount and to eat at regular intervals. That minimum amount is firstly expressed in terms of an amount of chewing, swallowing, and digestive activity and then the microprocessor is set to measure that amount of activity. If it does not measure the appropriate quantity of eating within an appropriate time period, or at an appropriate time, the signal device is set to issue a warning signal. If the deficit is not corrected within a short time the warning signal gets worse until eventually it can no longer be ignored. The signal may continue until compliance is detected.

In anorexia nervosa of the binge eating and purging type, there is a tendency to vomit after a meal or after an eating binge. As mentioned above, vomiting is another activity that can be detected with suitable sensors and can therefore be penalized in the same way. In this case, the warning may continue until the patient eats a further quantity of food.

The embodiment is preferably also able to identify an eating binge and, depending on the advice of the skilled person may be set to penalize binge eating as an undesirable behavior, a breach of good eating habits, or may not penalize it at all since the aim is to get the patient to eat. If the binge itself is not to be penalized then it is preferable that vomiting is penalized. Reference is now made, in this connection, to Fig. 4, which is a generalized diagram of a very simplified program that may be O 02/26101

used in a case of anorexia nervosa of the first type, that is of the type that does not involve bingeing and purging behavior.

In Fig. 4, a meal program is set, the patient being required to eat meals at certain times each day. Each required mealtime may be set as a range in which the meal must be eaten or a latest time by which the meal is eaten. For each meal a minimum threshold is set, below which the system does not recognize that a meal has been eaten.

The system then follows the time of day. If the end of a mealtime is reached and the meal has not been eaten then the patient is penalized. The penalty is repeated intermittently until a meal event is detected. If a meal is detected but followed by any form of purging behavior, such as vomiting or use of laxative, then that too is penalized, although that is not usually seen in this type of condition.

A further condition for which the present embodiment may be useful for is bulimia nervosa. Bulimia nervosa is characterized by the following features 1. Recurrent episodes of binge eating. An episode of binge eating is characterized, as before, by both of the following: a. eating, within a discrete period of time (e.g. within any 2-hour period), an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances b. a sense of lack of control over eating during the episode (e.g. a feeling that one cannot stop eating or control what or how much one is eating)

2. Recurrent inappropriate compensatory behavior in order to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications; fasting; or excessive exercise. 3. The binge eating and inappropriate compensatory behaviors both occur, on average, at least twice a week for 3 months.

4. Self-evaluation is unduly influenced by body shape and weight. Bulimia nervosa is again categorized into two types, a purging type in which, during the current episode of Bulimia Nervosa, the person has regularly engaged in self-induced vomiting or the misuse of laxatives, diuretics, or enemas, and a non-purging type as follows: during the current episode of Bulimia Nervosa, the person has used other inappropriate compensatory behaviors, such as fasting or excessive exercise, but has not regularly engaged in self-induced vomiting, or misuse of laxatives, diuretics, or enemas. The present embodiment may advantageously be used by a sufferer from

Bulimia Nervosa. The microprocessor 18 may be programmed to ensure that a regular and constant eating program is adhered to, including fixed meal times and minimum and maximum quantities of food, and it may be programmed to identify the ingestion of a large quantity of food within a short space of time, which is indicative of binge eating. In both cases, the microprocessor may be programmed to operate the warning device 22 upon detection of an infringement.

Reference is now made to Fig. 5, which is a simplified flow diagram showing a very general way in which the embodiment could be used in the treatment of bulimia nervosa. The embodiment of Fig. 5 essentially gives the same regimen of compulsory meals and penalizing of purging events that has been described above in respect of Fig. 4, but in addition it penalizes binge eating events.

The above-described embodiment may additionally be used to treat obesity. For example, in the case of obesity, the microprocessor 18 is preferably programmed to expect the patient not to exceed a maximum eating level. Often a diet will be set specifying that the patient eat relatively small quantities at regular, and possibly frequent intervals. Mealtimes may be specified, as well as maximum quantities to be eaten per meal. Exceeding the limit at a specified mealtime, missing a meal by a specified margin or eating at all in between meals are activities that may be penalized by operation of the signal device 22. By contrast with anorexia, excess eating is not an activity which can be remedied by a further activity and thus the penalty signal preferably continues for a predetermined time selected by a person skilled in the field. Certain forms of obesity may be characterized by recurrent episodes of binge eating. Such episodes have the following two characteristics:

1. They involve eating a larger amount of food than normal during a short period of time (less than two hours), and

2. they involve lack of control over eating during the binge episode. Binge eating episodes are associated with three or more of the following

1. Eating much more rapidly than normal

2. Eating until feeling uncomfortably full

3. Eating large amounts of food when not physically hungry 4. Eating alone because you are embarrassed by how much you're eating

5. Feeling disgusted, depressed, or guilty after overeating

6. Marked distress regarding over eating is present

7. Binge eating occurs at least 2 days a week for six months

Binge eating is not followed by inappropriate compensatory (purging) behavior (as described for bulimia and anorexia nervosa)

As will be seen from the above, a tendency to binge eating is difficult to treat conventionally because the patient has to be watched around the clock. However, an embodiment of the present invention can easily be programmed to identify a binge eating episode and to begin the issuance of the warning signal. Reference is now made to Fig. 6, which is a generalized flow diagram showing a simplified program for the treatment of obesity, including the treatment of forms of obesity which include binge eating events.

As before fixed mealtimes are set. For each meal a maximum amount of eating is also set. The system monitors the time of day to decide whether it is a mealtime or not. If it is not a mealtime then any eating event is penalized. If it is a mealtime then an eating event is permitted. Optionally, as shown in the figure, the meal may be mandatory and failure to eat the meal can be penalized. The inclusion of such a feature is at the discretion of the healthcare professional concerned with the patient. If the meal is found to exceed the preset maximum then the patient is penalized. Additionally, if the excess is found to reach a preset threshold for a binge eating event, then the patient is given an additional penalty. If it is not desired to give a special penalty for a binge eating event then it is not necessary in this flow chart to identify a binge eating event. This is because in any case the system will penalize the patient for eating between meals or for excessive eating at a meal. Another embodiment of the invention may be used to treat mild obesity or other behavioral disorders. In this embodiment the sensors, warning device, and microprocessor are all external. This embodiment is useful when the patient's condition is not critical, and the healthcare professional judges that the patient will voluntarily use the system regularly and correctly, and comply with the warning signals produced by the warning device.

Embodiments of the invention are also useful in conjunction with atypical eating disorders. Atypical eating disorders, which are generally diagnosed on a per patient basis, may include: 1. disordered eating that is atypical (e.g., chewing and spitting) or

2. subsyndromal eating disorder (e.g. bingeing and purging weekly) In the event of an atypical eating disorder, the microprocessor 18 is preferably programmed on a per patient basis, by a person skilled in the field, to provide an effective treatment for the symptoms noted in the particular case. Part of the treatment for eating disorders involves a full Nutritional evaluation of the patient. This should include an assessment of caloric intake and caloric/other nutrient needs. Although the embodiment described does not specify a way of directly measuring a caloric intake it does provide data which may allow an estimate to be made. Thus the embodiment is advantageous in assisting in preparing such an evaluation.

In order to assist in assessing calorific intake, an additional microsensor is preferably implanted under the skin to provide continuous glucose monitoring. The additional microsensor is preferably an implantable continuous glucose monitoring system utilizing fluorescence detection and utilizing a microporous sensor material incorporating pH-sensitive fluorescent probe molecules. The material of the microsensor preferably has metal complexes embedded therein and is treated such that the local environment of the metal complexes embedded in the material is alkaline. Variations in the local glucose concentrations in the tissue will result in the release or uptake of protons in the immediate vicinity of the microsensor. The material can be made so that it provides an electrical signal that varies with pH. The signal may be provided to an amplifier and then modulated as described with the previous microdevices for transmission to the microprocessor 18. Thus, continued monitoring of blood sugar levels may be provided, which can be used simply to provide data for later study. Alternatively, the patient could be given an additional warning signal if the blood sugar level drops below a certain threshold. In general, as well as providing a warning signal to the user, the system may be programmed to keep detailed records of measurements made. The measurements may be read by suitable programs to give the physician responsible for treatment a clear idea of progress.

There is thus provided, in accordance with embodiments of the present invention, an arrangement including sensors, a stimulator and microprocessor control, which can be used for enforcing a dietary regimen on a patient suffering from a dietary disorder. By providing reliable feedback to the patient, behavioral psychology is used to reinforce good eating habits and thereby enable the patient to overcome the disorder. Another embodiment of the invention can be used to treat Bruxism. In this embodiment sensors are placed in the jaw. These sensors measure jaw movement, pressure, and position. Teeth grinding is characterized by periods of small, high- pressure motions of the jaw or of the mastication muscles, during which periods the jaw is closed. The microprocessor monitors the jaw sensors and the time of day, and uses a template to translate these primary events into a grinding event. The microprocessor then determines and applies the correct penalty until the grinding behavior is stopped. For example, during the daytime only a brief warning signal may be required to end the teeth grinding, whereas during sleep a more prolonged or intense signal may be required. In a further embodiment for the treatment of Bruxism, sensors are implanted in or on the skull. These sensors detect brain activity in order to determine whether the patient is awake or asleep.

Whilst the foregoing description has described the invention in respect of eating disorders and Bruxism, it will be appreciated that the invention is applicable to any behavioral disorder that can be detected and quantified automatically. Furthermore, whilst the foregoing description has described a human patient, it will be appreciated that non-human animals are also liable to behavioral disorders and may be treated in the same way.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

It should be noted that the sensors referred to hereinabove comprise piezoelectric, electromagnetic, acceleration, enzymatic, chemical, acoustic and thermal sensors, separately or in suitable combination.

It should be understood that Biofeedback techniques could utilize the system and method described herein.

It 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. Rather the scope of the present invention is defined by the appended claims and includes both combinations and subcombinations of the various features described hereinabove as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description.

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Clasificaciones
Clasificación internacionalA61B5/11, A61B7/00, A61B5/0488, A61B5/00
Clasificación cooperativaA61B7/008, A61B5/4528, A61B5/11, A61B5/4547, A61B5/0031, A61B5/4519, A61B5/0488
Clasificación europeaA61B5/00B9
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