Intraluminal Device Fixation via Tissue Bridging Connector
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Solution Overview
Problem
Intraluminal devices, such as bariatric and metabolic devices, face challenges with distal migration due to peristalsis, requiring effective fixation methods that balance short-term and long-term anchoring without damaging the gastroesophageal junction.
Innovation Solution
An intraluminal device with a connector system that includes a separable filament coated with a bio-compatible material, facilitating tissue ingrowth for long-term fixation and temporary resistance to distal migration using a tissue penetrating fastener, allowing for easy explantation without tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tissue ingrowth is used for fixation, then long-term fixation stability is improved, but device removeability deteriorates
Solution Approach 1:
The fixation system is divided into two distinct components: a permanent fixation element that remains in the tissue to provide long-term stability through tissue ingrowth, and a temporary retention element that can be easily removed for device explantation. This segmentation allows the permanent and removable functions to coexist without interfering with each other.
Solution Approach 2:
The temporary retention element is designed to provide initial fixation stability during the early healing period while tissue ingrowth is developing. Once the tissue has adequately grown around the permanent fixation element (typically after several weeks), the temporary element is removed, transitioning from short-term to long-term fixation.
2Reliability
If strong fixation is applied to resist distal migration, then device stability is improved, but tissue damage risk increases
Solution Approach 1:
The fixation elements are designed with differentiated local properties: the permanent fixation element has a surface geometry and material composition optimized for promoting tissue ingrowth and integration, while the temporary retention element has properties optimized for easy removal with minimal tissue trauma. This local quality differentiation allows each element to perform its specific function optimally.
Solution Approach 2:
The fixation system transitions dynamically over time: initially providing strong mechanical retention to prevent distal migration, then gradually transitioning to biological fixation through tissue ingrowth, and finally allowing easy removal of the temporary element once integration is complete. This dynamic adaptation optimizes both stability and tissue safety throughout the device lifecycle.
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 provides stable short-term and long-term fixation, resisting distal migration while allowing for safe removal by tissue bridging and bioabsorbable components, ensuring minimal tissue damage and effective anchoring in the gastroesophageal region.
Implementation Method 1
facilitating tissue ingrowth for long-term fixation
Implementation Method 2
bioabsorbable components, ensuring minimal tissue damage
Data Source
AI summary
An intraluminal device and method of fixation of an intraluminal device to resist distal migration in a mammalian lumen or hollow organ that is subject to peristalsis, according to an aspect of the invention, includes spaced apart wall portions connected with a connector. The wall portions are configured to the size and shape of a portion of the lumen or hollow organ and the connector is configured to be positioned against a wall of the lumen or hollow organ. The intraluminal device is positioned in a mammalian lumen or hollow organ that is subject to peristalsis. The device is fixed in the lumen or hollow organ against distal migration, wherein tissue lining the lumen or hollow organ bridges over the connector. The device is explanted after tissue bridges over the connector including separating the connector from one or both of the wall portions and withdrawing the connector axially from the tissue bridging over the connector.


