Adjustable Intravascular Flow Restriction Device
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Solution Overview
Problem
Current endovascular devices for pulmonary artery banding are bulky and require a large delivery system, making them unsuitable for children, as they cannot be safely used due to size constraints, and existing solutions necessitate surgical interventions that are more invasive and costly.
Innovation Solution
A medical device comprising a stent, a membrane, and a thread, where the membrane forms an adjustable flow opening by forming a loop around it, allowing for reduction in vessel lumen size by tightening the thread, which is introduced via a catheter and fixed in place using a rigid member, enabling minimally invasive procedures without the need for general anesthesia or artificial lung ventilation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If endovascular devices are made bulky to provide sufficient structural support and flow restriction, then the device can achieve reliable flow control, but the device cannot be safely used in children due to size constraints
Solution Approach 1:
The device is divided into multiple functional segments: a delivery catheter for minimally invasive introduction, a self-expanding stent frame that provides structural support, and a separate flow control mechanism. This segmentation allows each component to be optimized independently, enabling reliable flow control without requiring a bulky overall device structure.
Solution Approach 2:
The flow control mechanism is nested within the delivery catheter in a compact configuration before deployment. The stent and flow restriction elements are collapsed within the catheter during introduction, then self-expand after delivery. This nesting approach minimizes the device profile during delivery while maintaining full functionality after deployment, making it suitable for pediatric patients.
2Reliability
If surgical pulmonary artery banding is performed to reduce pulmonary blood flow, then effective flow restriction is achieved, but the procedure is invasive and requires general anesthesia and artificial lung ventilation
Solution Approach 1:
The invention replaces the mechanical surgical banding system with an endovascular delivery system. Instead of external surgical manipulation and suturing, the device is delivered through a catheter and self-expands within the pulmonary artery. The flow restriction is achieved through internal structural elements rather than external constriction, eliminating the need for surgical incisions, general anesthesia, and artificial ventilation.
Solution Approach 2:
The delivery catheter serves as an intermediary tool that enables minimally invasive access to the pulmonary artery. The catheter navigates to the target location and delivers the self-expanding stent and flow control elements without requiring open surgical exposure. This intermediary approach transforms a highly invasive surgical procedure into a less invasive endovascular intervention.
3Ease of manufacture
If conventional surgical banding is used for pulmonary artery flow reduction, then the procedure can be performed with existing surgical techniques, but the hospital stay and operating room time are increased
Solution Approach 1:
The device incorporates dynamic flow control capabilities that allow adjustment of the restriction level after deployment. The self-expanding stent can be adjusted to optimize flow reduction, and the device can be repositioned or reconfigured if needed. This dynamic adaptability reduces the need for prolonged procedures and extended hospital stays for monitoring and adjustment, compared to fixed surgical banding.
Data Source
Figure 1A~2B
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AI summary
The invention regards a medical device for adjustably reducing a vessel lumen. The device comprises a stent part providing a flow channel for the blood and a flexible membrane part within the stent part that closes the flow channel off except for a flow opening. A thread is arranged within the membrane part with one end exiting the device and thus being accessible. The thread forms a loop around the flow opening and by pulling on the thread the loop can be constricted which leads to a reduction of the size of the flow opening.