Intragastric device

Inventors

Brister, Mark C. • Quintana, Nelson • Patel, Kaushik A. • Drake, Neil R. • Llevares, Antonio C. • Markovic, Dubravka • Rasdal, Andrew P. • VandenBerg, Amy D. L.

Assignees

Vyome Holdings Inc

Abstract

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.

Core Innovation

The invention provides an orally ingestible, free-floating intragastric volume-occupying implant for obesity treatment that transitions from a compact swallowable delivery state to an expanded deployed state in the stomach. The balloon-based device includes an inflation subcomponent and a deflation subcomponent, where inflation occurs after esophageal transit and deflation is initiated without invasive procedures. The volume-occupying subcomponent is configured to provide satiety in the stomach through deployment of a no external orifice sealed balloon.

A self-sealing valve system is provided as part of the volume-occupying subcomponent and is attached to a wall of the balloon in a central lumen by an adhesive with a shear force greater than about 40 N. The self-sealing valve system comprises a septum, a retaining structure, and a continuous ring configured to exert a compressive force on the septum, where the septum has a durometer that is less than a durometer of the retaining structure. The balloon-based volume-occupying subcomponent has a weight of less than about 15 g, and on full inflation is configured in one of ellipsoid, spheroid, or oblate spheroid shapes with a volume of about 90 cm3 to about 350 cm3.

The device further includes a drug delivery subcomponent that supports delivery of a pharmaceutical substance using degradable and/or dissolvable structures and/or externally directed release. Examples described include pharmaceutical substances placed in degradable pockets, reservoirs, microcapsules, coatings, or a biodegradable plug that releases in the stomach after degradation, as well as release upon expansion using creases or gradual release mechanisms associated with pumps, valves, breakage, disintegration, or diffusion of silver ions.

The invention also includes optional tracking and visualization features using radioopaque or barium markers, microchips, and fluorescent and/or infrared and/or ultraviolet features, as well as antimicrobial functionality via antimicrobial outer layers and/or silver ions. Timing control during deployment is described as preventing inflation during esophageal transit and enabling inflation after a predetermined period, and the system can include erodible seams configured to assist deflated passage through the pyloric sphincter.

Claims Coverage

The content explicitly provides one independent claim covering a balloon-based drug delivery system with four inventive features.

The claim coverage centers on a balloon volume-occupying subcomponent with a self-sealing valve system defined by adhesive shear attachment, septum/retaining structure durometer difference, and a compressive continuous ring, together with specified mass, shape, and inflation volume constraints, and a drug delivery subcomponent.

Stated Advantages

Documented Applications