Intragastric expandable devices

Inventors

Cohen, Gil • Artamonov, Valery • Hashimshony, Dan

Assignees

Epitomee Medical Ltd

Abstract

The disclosure provides a biodegradable device, administered to a patient in a compact ingestible encapsulated form. The device is self-expandable in the stomach upon contact with liquid, to assume an expanded, voluminous configuration within the stomach. The devices have a folded configuration in which intake is facilitated by the patient, and are designed to unfold and self-expand in the stomach after intake due to expansion of a plurality of expandable zones that comprise one or more gel-forming materials. The disclosure provides such devices, methods of their manufacture, as well as base units thereof.

Core Innovation

The invention concerns a biodegradable self-expandable device having a primary folded state and an expanded state. The device comprises a thin annular base unit divided into a plurality of consecutive segments along a circumference, where each segment is defined between successive first fold axes and comprises one second fold axis, with the first and second fold axes alternatingly arranged along the circumference.

In the primary folded state, the segments are folded such that the first fold axes extend along a common axis, and each folded segment assumes a loop-like conformation with the second fold axis defining an apex of the loop-like conformation. The folded segments are substantially stacked one over the other.

At least one or more segments include zones comprising at least one gel-forming material, with the gel-forming material in each zone encapsulated between at least two layers of liquid-permeable material. The gel-forming material is configured for swelling upon contact with liquid, and this swelling irreversibly switches the device from the primary folded state to the expanded state in which the first fold axes are distanced one from the other.

The annular base unit is formed out of a thin strip having a longitudinal axis, with the first and second fold axes alternatingly arranged along and perpendicular to the longitudinal axis. The strip extends between matching end portions configured for attachment one to the other to form the annular base unit, and in some configurations a gastric degradable shell encapsulates the secondary folded device until shell degradation exposes the gel zones.

Claims Coverage

The provided content includes one independent claim centered on an annular biodegradable self-expandable device with alternating first and second fold axes and an irreversible gel-swelling switching mechanism, with multiple dependent claim refinements addressing folded states, expanded-state geometry, attachment-region structure, gel formulation architecture, and degradation behavior.

Claim coverage centers on the interaction between an annular segmented fold architecture and encapsulated gel-forming material that swells upon liquid contact to irreversibly switch the device to an expanded state with distanced first fold axes.

Stated Advantages

Documented Applications