Pyloric Occlusion Plug With Expandable Anchoring Sections
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Solution Overview
Problem
There is a need for occlusion devices or plugs that are low cost, minimally invasive, easy to deploy, atraumatic, and resist undesired migration, and which can be easily removed from the deployment site if desired, particularly for procedures like gastric bypass where the pylorus needs to be blocked or unblocked.
Innovation Solution
The occlusion devices or plugs are designed with a proximal and distal plug section and an intermediate section, allowing them to shift between expanded and unexpanded configurations, featuring atraumatic surfaces and anti-migration features, and can be deployed and removed using a deployment device with a locking mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the occlusion device is designed to be easily deployable and removable, then the ease of operation is improved, but the device may be more prone to migration or dislodgement
Solution Approach 1:
The occlusion device incorporates expandable sections that can transition between compressed and expanded states. The expandable proximal and distal sections provide anchoring engagement with the body lumen when expanded, preventing migration, while the ability to compress these sections enables easy removal. This dynamic transformation resolves the contradiction between secure positioning and ease of removal.
Solution Approach 2:
The device features a nested structure where the expandable proximal and distal sections can be compressed into the intermediate section during removal. The delivery catheter also nests around the occlusion device during deployment. This nesting mechanism allows the device to be compact for insertion yet expand to provide anchoring engagement, balancing ease of operation with migration resistance.
2Reliability
If the occlusion device uses expandable sections for anchoring engagement, then the resistance to migration is improved, but the device complexity increases
Solution Approach 1:
The occlusion device utilizes flexible expandable sections made from materials like shape memory alloys or nitinol. These flexible structures can be compressed into a small profile for delivery through catheters, then expanded at the target site to provide anchoring engagement. The flexibility and transformability of these thin-walled structures provide migration resistance without requiring complex mechanical assemblies.
Solution Approach 2:
The device employs materials that undergo parameter changes, specifically shape memory alloys that can transition between different structural states in response to temperature or mechanical stimuli. This allows the expandable sections to transform from a compressed delivery state to an expanded deployed state, providing anchoring engagement without complex control mechanisms. The material's inherent properties enable the complexity reduction.
3Object-affected harmful factors
If the occlusion device is made atraumatic with smooth surfaces, then the harm to the body passage is reduced, but the anchoring engagement and resistance to migration may be compromised
Solution Approach 1:
The device employs dynamic expandable sections that transition from a smooth compressed state during insertion to an expanded state that provides anchoring engagement. When expanded, the proximal and distal sections engage with the body lumen through radial expansion rather than through traumatic features. This dynamic transformation allows the device to be both atraumatic during insertion and effective for anchoring when deployed.
Solution Approach 2:
The expandable sections are constructed from flexible materials with smooth surfaces that conform to the body lumen when expanded. These flexible shells provide anchoring through radial engagement and friction rather than through sharp edges or protrusions. The smooth surface reduces trauma during insertion while the expanded configuration provides sufficient anchoring force to prevent migration.
Data Source
AI summary
An occlusion device or plug having a proximal plug section and a distal plug section. The plug sections may each be shifted between an unexpanded configuration and an expanded configuration at the deployment site to occlude the deployment site. A tubular member such as a silicone tube may be used to form an occlusion device or plug shiftable or expandable into a desired configuration. An intermediate section between a proximal plug section and a distal plug section may be configured to be manipulated at least to shift at least one of the plug sections from an expanded configuration to an unexpanded configuration. A pair of stents may be coupled together via an intermediate section in such manner such that manipulation of the intermediate section causes at least one of the stents to shift from an expanded configuration to an unexpanded configuration.