Abstract: Apparatus and methods of monitoring gastric restriction devices are described. Internally mounted sensors detect at least one of a quantity of a test substance, a flow through the stomal opening produced by a restriction device, slippage of the device, and erosion of the gastric wall. In some embodiments flow versus no flow can be determined, or a flow rate can be calculated. Monitoring of internally mounted sensors permits optimization of the performance of a gastric restriction device, using noninvasive techniques.

Abstract: A system for securing an implantable apparatus to a mammal includes a mount including a base portion having a plurality of holes dimensioned to receive rotationally-driven fasteners, each fastener comprising a helical portion having a tip configured for tissue penetration, the mount configured to secure the implantable apparatus relative to tissue of the mammal upon driving the fasteners into the tissue. The system further includes a fastening tool configured to rotationally drive the helical portion of the fasteners into the tissue. The mount may be secured to the fascia covering the sternum via a subcutaneous securement method, or it may be attached to the intra-abdominal wall, behind the sternum, or it may be attached to the sternum directly via bone screws or the like.

Abstract: Methods and apparatus useful for monitoring fluid flow past a gastric restriction device using noninvasive means are described. Some methods involve the use of acoustic energy, e.g., Doppler ultrasound, to monitor the passage of fluid past the restriction device, and apparatus to detect the acoustic energy. In some embodiments the method detects a sound-producing fluid using a microphone, stethoscope, or ultrasound probe and detector combination. In some embodiments, there are described methods of using Doppler ultrasound to monitor the flow of a fluid through a stomal opening, allowing a flow condition, e.g., a flow rate, to be determined, so that a physician can accurately adjust the gastric restriction device.

Abstract: A gastrointestinal implant system includes an adjustable restriction device having a contact surface configured for at least partially engaging a surface of a gastrointestinal tract of a mammal. The implant system further includes an implantable interface including a first driving element, the first driving element being moveable and operatively coupled to the adjustable restriction device by an actuator configured to change the dimension or configuration of the contact surface in response to movement of the first driving element. The system also includes an external adjustment device having a second driving element configured to non-invasively engage the first driving element of the implantable interface from a location external to the mammal. In the system, actuation of the second driving element of the external adjustment device produces movement in the first driving element of the implantable interface and results in a change in the dimension or configuration of the contact surface.

Abstract: Methods and apparatus for quantifying the amount or rate of magnetically susceptible fluid within a gastric lumen are described. In one aspect, a magnetic sensor located external to the patient is configured to detect a quantity of fluid disposed within the gastric lumen. The quantity of fluid may include fluid that is contained upstream with respect to a restriction formed in the gastric lumen (e.g., by a gastric restriction device). The quantity of fluid disposed within the gastric lumen is determined by the magnetic sensor. This quantity may be evaluated over time to then calculate a real time flow rate which can then be displayed to the physician. The methods and devices allow a physician or other trained person to dynamically view real time development of fluid flow within a restricted gastric lumen and may be used in conjunction with adjustments to the gastric restriction device to achieve target or desired flow rates.