Intragastric device
An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient's stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state. In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity. After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient's digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.
1. A swallowable, intragastric balloon system comprising:
a balloon comprising a self-sealing valve system attached to a wall of the balloon in a central lumen of the balloon by an adhesive with a shear force greater than about 40 N, the self-sealing valve system comprising a septum, a retaining structure, and a continuous ring;
an inner container within the central lumen of the balloon, the inner container containing from about 0.28 grams to about 4 grams of an inflation agent; and
an outer container configured to be swallowed by a patient without assistance, the outer container comprising a material and a structure configured to control timing of inflation, and containing the inner container and the balloon in a compacted state.
2. The system of claim 1 , wherein the septum has a durometer that is less than a durometer of the retaining structure.
3. The system of claim 1 , wherein the continuous ring is configured to exert a compressive force on the septum.
4. The system of claim 1 , wherein the balloon has a weight of less than about 15 g.
5. The system of claim 1 , wherein the balloon is configured to have a shape upon full inflation selected from the group consisting of ellipsoid, spheroid, and oblate spheroid, wherein the balloon is configured to have a volume of from about 90 cm 3 to about 350 cm 3 upon full inflation.
6. The system of claim 1 , wherein up to about 80 wt. % of a total amount of the inflation agent is powdered citric acid, with a remainder of the inflation agent comprising powdered sodium bicarbonate.
7. The system of claim 1 , wherein the balloon is configured to self-deflate between 25 to 90 days after inflation.
8. A swallowable, intragastric balloon system comprising:
an ingestible capsule formed of a material having a known rate of degradation;
a balloon comprising one or more deflation subcomponents configured for time-dependent deflation, wherein a forced de-lamination scheme is created for time-dependent deflation, wherein the one or more deflation subcomponents comprise a strong first layer, an erodible middle layer and a weak inner layer which are affected by a gastric environment.
9. The system of claim 8 , wherein erosion or degradation of the erodible middle layer is controlled by a gastric environment external to the balloon.
10. The system of claim 8 , wherein the time-dependent deflation is configured to occur within 25 to 90 days after introduction of the intragastric balloon system into a stomach of a patient.
11. The system of claim 8 , wherein time-dependent deflation can be further controlled by designing balloon seam layers with material dependent on the internal environment of the balloon such pH, humidity, and other factors.
12. A swallowable, intragastric balloon system comprising:
an ingestible capsule formed of a material having a known rate of degradation; and
a balloon comprising one or more deflation subcomponents configured for on-demand deflation, wherein the one or more deflation subcomponents comprise a pneumatic valve in the balloon to change the internal pressure by opening and releasing fluid inside and deflating the balloon.