Foldable Superelastic Gastric Residence Article for Extended Drug Delivery
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Solution Overview
Problem
Current oral drug administration methods fail to maintain effective dosage frequency over extended durations due to the limitations of polymers used in self-expanding mechanisms, which restrict size and compatibility, making them unsuitable for patients with swallowing difficulties or young children.
Innovation Solution
A gastric residence article comprising a foldable central superelastic alloy component with elongated limb components connected via linker components, which undergo elastic deformation and recoil to an expanded configuration, facilitated by a degradation or transformation of the linker components, allowing for extended retention in the gastric cavity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If polymers are used in the self-expanding mechanism, then the mechanism can be made biocompatible and melt processable, but the flexural modulus is too low requiring larger mechanism size
Solution Approach 1:
The patent combines superelastic alloy (providing high flexural modulus and shape memory) with polymer materials (providing biocompatibility and processability) to create a composite self-expanding mechanism that achieves both mechanical performance and biological compatibility without requiring excessive size
2Ease of operation
If the self-expanding mechanism size is reduced for suitable administration, then swallowing difficulty is addressed, but the flexural modulus becomes insufficient to resist pyloric sphincter pressure
Solution Approach 1:
By using superelastic alloy as the core structural material, the mechanism achieves high flexural modulus in a compact size, enabling both easy swallowing and sufficient mechanical strength to resist pyloric sphincter pressure
3Ease of manufacture
If a single drug administration is given, then the treatment is simple and cost-effective, but the dosage frequency cannot be maintained over extended duration beyond transit time
Solution Approach 1:
The self-expanding mechanism is pre-configured to expand after oral administration, physically blocking the pyloric sphincter to retain the dosage form in the stomach for extended periods (24-48 hours), thereby maintaining effective dosage frequency without requiring multiple administrations
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 gastric residence article maintains an expanded configuration for at least 24 hours with a folding force of 0.5 N and an opening diameter of at least 2 cm, providing sustained drug delivery and overcoming size limitations for diverse patient populations.
Implementation Method 1
the foldable central superelastic alloy component undergoes elastic deformation when the gastric residence article is in a folded configuration and recoils when the gastric residence article assumes an expanded configuration
Implementation Method 2
said linker component degrades, dissolves, disassociates, or mechanically weakens, thereby resulting in loss of a shape of the gastric residence article in the expanded configuration
Data Source
AI summary
A gastric residence article for oral administration is provided. The article includes a foldable central component, multiple elongated limb components and multiple linker components. The foldable central component includes multiple ribs that include at least one superelastic alloy. The elongated limb components are radially attached to the foldable central component, where the multiple elongated limb components correspond to the multiple ribs. Each of the linker components connects one of the elongated limb components to the foldable central component. The ribs are releasable from a folded first state to an unfolded second state. At least one of the elongated limb components is configured to releasably store drugs. The linker components are configured to transform from a rigid first state to a disengaged second state to allow the elongated limb component to move independently with respect to the foldable central component.