Transpyloric Bypass Device with Radially Collapsible Conducting Element
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Solution Overview
Problem
Current duodenal bypass devices face challenges in achieving optimal tissue-compatible and organ-compatible placement, as they often exert excessive radial forces on the pylorus and adjacent structures, leading to potential damage and complications such as bleeding, perforation, and pressure-related issues, while also being difficult to place endoscopically and requiring costly long-term aftercare.
Innovation Solution
A transpyloric and transduodenal bypass device with a radially collapsible and self-erecting conducting element, anchored by gastric and duodenal balloon segments, is placed using an applicator that allows for minimally invasive insertion and removal, utilizing a tubular coupling element with a cuff or sleeve design for secure fixation and adjustable anchoring to reduce radial forces and adapt to sphincter changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transpyloric bypass device is placed to conduct chyme through the pylorus, then the device can bypass-type conduct gastric content into or through the duodenum, but the device exerts excessive radial forces on the pylorus and adjacent structures, leading to tissue damage and complications
Solution Approach 1:
The conducting element is designed to be radially collapsible and self-erecting, allowing it to dynamically adapt to the pyloric sphincter's motility and pressure changes. This dynamic structure reduces continuous radial force while maintaining functional patency during peristalsis and sphincter contraction.
Solution Approach 2:
The device incorporates adjustable anchoring mechanisms with balloon segments that can be inflated or deflated to modify the anchoring force and radial pressure applied to the pylorus. This allows optimization of the balance between secure fixation and tissue-compatible pressure.
2Stability of the object's composition
If the bypass device is firmly anchored to ensure stable placement, then the device remains securely positioned, but the radial forces increase causing bleeding, perforation, and pressure-related complications
Solution Approach 1:
The anchoring system uses distributed balloon segments at different locations (gastric and duodenal sides) rather than a single strong anchor point. This distributes the anchoring force across multiple locations, providing stable fixation while reducing peak radial pressure at any single site.
Solution Approach 2:
The balloon segments can be dynamically adjusted in inflation level to achieve optimal anchoring stability while maintaining tissue-compatible pressures. The system allows for fine-tuning of anchoring force to balance stability with harm prevention.
3Reliability
If the device structure is made complex to achieve adjustable anchoring and reduced radial forces, then tissue compatibility improves, but the device becomes more difficult to place endoscopically
Solution Approach 1:
The collapsible conducting element is nested within the applicator shaft during delivery, and the balloon segments are compressed within the delivery system. This allows the complex device to be delivered through a standard endoscope in a compact form, then deployed and inflated at the target site.
Solution Approach 2:
The applicator serves as an intermediary delivery system that simplifies the placement of the complex bypass device. The applicator guides the collapsible element through the pylorus and facilitates controlled deployment and inflation of the anchoring balloons, making the complex device manageable during endoscopic placement.
4Reliability
If the device requires costly long-term aftercare and monitoring, then patient outcomes can be maintained, but treatment costs increase substantially
Solution Approach 1:
The self-erecting conducting element with its radial resilience and adaptive anchoring reduces the need for continuous medical intervention and monitoring. The device autonomously adapts to physiological changes and maintains function without requiring costly long-term aftercare, while still ensuring reliable patient outcomes.
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 solution enables a safe, minimally invasive, and cost-effective placement and removal of the bypass device, reducing the risk of complications and allowing for adjustable anchoring to maintain sphincter motility, thereby improving patient outcomes and reducing treatment costs.
Implementation Method 1
having a gastric balloon segment, which regionally encloses a cavity of annular structure fillable with a medium, and an annular duodenal anchor element, which is located on the intestine side or distally to the pylorus in the duodenum, for anchoring the transpyloric conducting element distally to the pylorus, having a duodenal balloon segment, which regionally encloses a cavity of annular structure fillable with a medium
Data Source
AI summary
An applicator (26) for a releasable coupling of a transpyloric and, if applicable, transduodenal bypass device (1) comprising a tubular, preferably radially collapsible and self-erecting transpyloric conducting element (4,7), which is or has to be placed in a patient in such a way that it penetrates the pylorus of the patient and is provided with a central conducting lumen comprising an upstream mouth to be placed antegrade of the pylorus and a downstream mouth to be placed retrograde of the pylorus, for (i) accepting the chyme from the stomach, for (ii) bypass-type conducting of the chyme through the pylorus and, if applicable, through the duodenum or a part of the duodenum, and for (iii) releasing the chyme in or beyond the duodenum of the patient, to an endoscope or a catheter having an elongated shaft (28), on the external surface of which the bypass device (1) can be placed and/or plugged in order to insert the bypass device (1) under direct guidance of the endoscope or catheter from the outside of the patient's body in an antegrade way through the upper digestive tract into the stomach, or to remove it in a retrograde way through the upper digestive tract, characterized in that the applicator (26) comprises a tubular coupling element (27), which is or can be slid onto the external surface of the shaft (28) surrounding it, and which entirely or partially penetrates the central conducting lumen of the bypass device (1), thereby bridging a gap between the external surface of the shaft (28) and an internal surface of the central conducting lumen of the bypass device (1).