Foldable Intragastric Expander With Controlled Hydrogel Swelling
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Solution Overview
Problem
Existing ingestible devices for stomach volume reduction and satiety enhancement are temporary and invasive, lacking a controlled expansion mechanism and effective degradation process.
Innovation Solution
A biodegradable, self-expandable device with alternating fold axes and gel-forming material zones, designed to expand upon contact with stomach fluids, providing controlled volume reduction and satiety through a compact, foldable configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the device is administered in a compact ingestible form, then it can be easily swallowed by the patient, but it occupies minimal volume in the stomach
Solution Approach 1:
The device employs a nested structure where the gel-forming material is encapsulated within liquid-permeable layers, which are in turn contained within the foldable device structure. This nested arrangement allows the device to be administered in a compact form while containing the expansion mechanism that will later occupy stomach volume
Solution Approach 2:
The device utilizes parameter changes through the gel-forming material that transitions from a compact state during administration to an expanded state upon contact with gastric fluids. This parameter change enables the device to overcome the contradiction between compact administration and volume occupation in the stomach
2Productivity
If the device expands rapidly in the stomach, then it quickly reduces stomach volume and increases satiety, but it may cause discomfort or damage to the stomach walls
Solution Approach 1:
The device employs liquid-permeable (porous) material layers that control the ingress of gastric fluids to the gel-forming material. This porous structure enables controlled expansion by regulating the rate at which the gel absorbs fluid, thus preventing rapid expansion that could harm stomach walls while still achieving effective volume reduction
Solution Approach 2:
The device structure includes folded segments and encapsulated gel material that act as a cushioning mechanism. The gradual expansion of the gel within the constrained folded structure provides a buffering effect, preventing sudden pressure spikes against the stomach walls while maintaining effective satiety induction
3Duration of action of moving object
If the device remains in the stomach for an extended period, then it provides prolonged satiety effect, but it increases the risk of degradation issues and complications
Solution Approach 1:
The device is designed as a temporary, disposable implant that provides satiety effect for a limited duration before intentional degradation. This approach prioritizes reliability by ensuring the device degrades after serving its purpose, eliminating long-term retention risks while maintaining effective satiety induction during the operational period
Solution Approach 2:
The device incorporates mechanisms for periodic degradation through intentional design features that allow controlled breakdown after a predetermined period. This periodic action ensures the device maintains structural integrity during the satiety induction period while reliably degrading afterward to prevent complications
4Reliability
If the device uses a complex expansion mechanism, then it achieves controlled and reliable expansion, but it increases device complexity and manufacturing difficulty
Solution Approach 1:
The device employs self-service expansion mechanisms where the gel-forming material automatically expands upon contact with gastric fluids without requiring external control systems. The folded structure itself serves as the expansion mechanism, utilizing the natural swelling properties of the gel to drive the unfolding and expansion process, thereby achieving reliable controlled expansion while minimizing device complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively reduces stomach volume and increases satiety by expanding to apply pressure on stomach walls, promoting weight loss and satiety through controlled expansion and degradation.
Implementation Method 1
The gel-forming material is configured for swelling upon contact with liquid (e.g. liquid in the stomach that permeates through the liquid-permeable layers after ingestion of the device) to irreversibly switch the device from the first folded state to the expanded state
Implementation Method 2
liquid in the stomach that permeates through the liquid-permeable layers after ingestion of the device
Data Source
AI summary
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.