Obesity is a difficult to treat chronic condition defined by a body mass index (BMI=mass/height2 [kg/m2]) greater than 30. For obese persons, excessive weight is commonly associated with increased risk of cardiovascular disease, diabetes, degenerative arthritis, endocrine and pulmonary abnormalities, gallbladder disease and hypertension. Additionally, such persons are highly likely to experience psychological difficulties because of lifestyle restrictions such as reduced mobility and physical capacity, due to back pain, joint problems, and shortness of breath. In severe cases, this can contribute to absenteeism and unemployment. Moreover, impairment of body image can lead to significant psychological disturbances. Repeated failures of dieting and exercise to resolve the problem of obesity can result in feelings of despair and the development of clinical depression.
Bariatric surgery is often recommended for persons suffering from morbid obesity. Preferably, the invasive treatment is accompanied by changes in lifestyle, such as improved regulation of eating habits and an appropriate exercise regimen. Such lifestyle changes are dependent upon the self-discipline and cooperation of the patient.
US Patent Application Publication 2004/008023 to Imran et al., which is incorporated herein by reference, describes a device for diagnosing and treating gastric disorders. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. One device described includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals. An endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall. The endoscopic instruments attach or remove the attachment devices and functional devices from the stomach and may be used to assist in determining the optimal attachment location.
A book entitled, Textbook of Gastroenterology, 3rd edition, edited by Yamada (Lippincott, Williams & Wilkins), which is incorporated herein by reference, has in Chapter 10 thereof a description of the physiology of gastric motility and gastric emptying.
An abstract entitled, “Gastric myoelectrical pacing as therapy for morbid obesity: Preliminary results,” by Cigaina et al., retrieved on Dec. 24, 2000 from the Web-site http://www.med-online.com/transneuronix/Product/abstract.htm, which is incorporated herein by reference, describes a method for applying monopolar and bipolar gastric stimulation to achieve weight loss.
An abstract entitled, “Implantable gastric stimulator (IGS) as therapy for morbid obesity: Equipment, surgical technique and stimulation parameters,” by Cigaina et al., retrieved on Dec. 24, 2000 from the Web-site http://www.med-online.com/transneuronix/Product/abstract.htm, which is incorporated herein by reference, describes techniques of electrical signal therapy designed to treat obesity.
Stein et al. wrote an article related to providing incentives relating to medical care, entitled, “Carrots and sticks: Impact of an incentive/disincentive employee flexible credit benefit plan on health status and medical costs,” American Journal of Health Promotion, May/June 1999, V5, I13, 5, which is incorporated herein by reference.
Giuffrida wrote an article regarding providing incentives for enhanced patient compliance, entitled, “Should we pay the patient? Review of financial incentives to enhance patient compliance,” Biomedical Journal, vol. 315, pp. 703-707, 1997, which is incorporated herein by reference.
U.S. Pat. No. 6,270,455 to Brown, which is incorporated herein by reference, describes a networked system for communicating information to a patient and for remotely monitoring the patient. The system includes a server and a remote interface for entering in the server a set of queries to be answered by the patient. The server may be a web server and the remote interface may be a personal computer or remote terminal connected to the server via the Internet. The system also includes measurement apparatus for providing measurement data related to a patient's condition and treatment, and remotely programmable apparatus connected to the server via a communication network, such as the Internet. The remotely programmable apparatus interacts with the patient in accordance with a script program received from the server. The server includes a script generator for generating the script program from the set of queries entered through the remote interface. The script program is received and executed by the remotely programmable apparatus to communicate the queries to the patient, to receive responses to the queries, and to transmit the responses from the apparatus to the server. The measurement data provided by the measurement apparatus may include physiological condition data and drug delivery measurement data for paperless recordation at a remote location.
With respect to one embodiment, the Brown patent describes each patient to be monitored being provided with a monitoring device, designed to provide measurements of a physiological condition of the patient, to record the physiological condition measurements, and to transmit the measurements to the patient's remotely programmable apparatus, e.g., through a standard connection cable 30. Examples of suitable types of monitoring devices include blood glucose meters, respiratory flow meters, blood pressure cuffs, electronic weight scales, and pulse rate monitors. The specific type of monitoring device provided to each patient is dependent upon the patient's disease. For example, diabetes patients are provided with a blood glucose meter for measuring blood glucose concentrations, asthma patients are provided with respiratory flow meters for measuring peak flow rates, and obesity patients are provided with weight scales.
U.S. Pat. No. 6,129,685 to Howard, which is incorporated herein by reference, describes apparatus and methods for regulating appetite by electrical stimulation of the hypothalamus and by microinfusion of an appropriate quantity of a suitable drug to a distinct site or region within the hypothalamus.
U.S. Pat. No. 4,823,808 to Clegg et al., which is incorporated herein by reference, describes a method for treating obesity, including receiving a physiological measurement and generating audio or visual feedback for the patient to hear or see. The feedback is used for purposes of teaching behavior modification.
U.S. Pat. No. 5,868,141 to Ellias, which is incorporated herein by reference, describes an endoscopic stomach insert for reducing a patient's desire to eat.
U.S. Pat. Nos. 6,067,991 to Forsell, 5,601,604 to Vincent, 5,234,454 to Bangs, 4,133,315 to Berman et al., 4,416,267 to Garren et al., and U.S. Pat. Nos. 4,592,339, 5,449,368, 5,226,429 and 5,074,868 to Kuzmak, which are incorporated herein by reference, describe mechanical instruments for implantation in or around the stomach of an obese patient.
U.S. Pat. No. 5,690,691 to Chen et al., which is incorporated herein by reference, describes a gastric pacemaker for treating obesity and other disorders. The pacemaker includes multiple electrodes which are placed at various positions on the gastrointestinal (GI) tract, and deliver phased electrical stimulation to pace peristaltic movement of material through the GI tract.
U.S. Pat. No. 5,423,872 to Cigaina, which is incorporated herein by reference, describes apparatus for applying electrical pulses to the distal gastric antrum of a patient, so as to reduce the motility of the stomach and to thereby treat obesity or another disorder.
U.S. Pat. Nos. 5,188,104 and 5,263,480 to Wernicke et al., which are incorporated herein by reference, describe a method for stimulating the vagus nerve of a patient so as to alleviate an eating disorder.
U.S. Pat. Nos. 6,104,955, 6,091,992, and 5,836,994 to Bourgeois, 6,026,326 to Bardy, and 3,411,507 to Wingrove, which are incorporated herein by reference, describe the application of electrical signals to the GI tract to treat various physiological disorders.
U.S. Pat. No. 5,979,449 to Steer, which is incorporated herein by reference, describes an oral appliance for appetite suppression.
U.S. Pat. No. 4,975,682 to Kerr et al., which is incorporated herein by reference, describes apparatus for food intake regulation which is external to the body and which is based upon the voluntary cooperation of the subject in order to be effective.
U.S. Pat. Nos. 5,861,014 to Familoni, 5,716,385 to Mittal et al., and 5,995,872 to Bourgeois, are incorporated herein by reference, and describe methods and apparatus for stimulation of tissue, particularly gastrointestinal tract tissue.
PCT Patent Publication WO 98/10830 to Ben-Haim et al., entitled, “Fencing of cardiac muscles,” and U.S. patent application Ser. No. 09/254,903 in the national phase thereof, which issued as U.S. Pat. No. 6,415,178, both of which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe various methods for controlling the behavior of muscle tissue, for example by blocking or altering the transmission of signals therethrough.
PCT Patent Publication WO 99/03533 to Ben-Haim et al., entitled, “Smooth muscle controller,” and U.S. patent application Ser. No. 09/481,253 in the national phase thereof, which issued as U.S. Pat. No. 6,571,127, both of which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe apparatus and methods for applying signals to smooth muscle so as to modify the behavior thereof. In particular, apparatus for controlling the stomach is described in which a controller applies an electrical field to electrodes on the stomach wall so as to modify the reaction of muscle tissue therein to an activation signal, while not generating a propagating action potential in the tissue. In the context of the present patent application and in the claims, the use of such a non-excitatory signal to modify the response of one or more cells to electrical activation thereof, without inducing action potentials in the cells, is referred to as Excitable-Tissue Control (ETC). Use of an ETC signal is described in the PCT Patent Publication with respect to treating obesity, by applying the ETC signal to the stomach so as to delay or prevent emptying of the stomach. In addition, a method is described for increasing the motility of the gastrointestinal tract, by applying an ETC signal to a portion of the tract in order to increase the contraction force generated in the portion.
PCT Patent Publication WO 02/082968 to Policker et al., entitled, “Analysis of eating habits,” which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes apparatus and methods for detecting the occurrence of an eating event by a subject and analyzing the quantity and characteristics of the food ingested.
US Patent Application Publication 2004/0098068 to Carbunaru et al., which is incorporated herein by reference, describes techniques for both recharging and communicating with a stimulator having a rechargeable battery, which stimulator is implanted deeply in the body, in particular where the stimulator is a microstimulator. The system includes a base station and an external device, e.g., a chair pad. The chair pad may contain an antenna/charging coil and a booster coil. The antenna/charging coil can be used for charging the rechargeable battery and also for communicating with the stimulator using frequency shift keying and on-off keying. The booster coil can be used to recharge a battery depleted to zero volts. The base station connected to the chair pad may be used to power the antenna/charging coil and the booster coil.
U.S. Pat. No. 6,516,227 to Meadows et al., which is incorporated herein by reference, describes a spinal cord stimulation (SCS) system including a replenishable power source, e.g., a rechargeable battery, that requires only an occasional recharge. The SCS system monitors the state of charge of the internal power source and controls the charging process by monitoring the amount of energy used by the SCS system, and hence the state of charge of the power source. A suitable bidirectional telemetry link allows the SCS system to inform the patient or clinician regarding the status of the system, including the state of charge, and makes requests to initiate an external charge process.
US Patent Application Publication 2003/0114899 to Woods et al., which is incorporated herein by reference, describes techniques for detecting the status of a rechargeable battery included within an implantable medical device. The medical device can incorporate a status indicator which signals the user concerning the battery status, e.g., low battery level. The signal may be audible or it may arise from an electrical stimulation that is perceptually distinguished from the operative, therapeutic stimulation. The external programmer may also incorporate a second battery status indicator that is visual, audible, or physically felt. Battery status data may be conveyed on visual displays on the external programmer by uploading this information from the medical device using a bi-directional telemetry link.
U.S. Pat. No. 6,185,452 to Schulman et al., which is incorporated herein by reference, describes a device configured for implanting beneath a patient's skin for the purpose of tissue stimulation (e.g., nerve or muscle stimulation) and/or parameter monitoring and/or data communication. Alternatively, the device is configurable to monitor a biological parameter or to operate as a transponder to retransmit received command messages.
US Patent Application Publication 2004/0106963 to Tsukamoto et al., which is incorporated herein by reference, describes an implantable integrated power module incorporating a power source (e.g., a battery), a power management circuit, a magnetically inductive coupling system for remote communication and/or inductive charging, and a homing device for locating the implanted inductive charging coil. Communication (one- or two-way) may be carried out using the inductive charging link, a separate inductive pathway, or another pathway such as RF or light waves.
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