Implantable Flow Connector with Self-Retaining Flange
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Solution Overview
Problem
Current methods for forming anastomoses in vascular surgery are prone to complications due to technical and biomechanical issues such as poor patency, leakage, and thrombosis, requiring precise and time-consuming suturing techniques, especially in small or diseased vessels.
Innovation Solution
An implantable flow connector with a conduit and circumferential flange designed for implantation in tissue-enclosed body spaces, featuring a lumen with adjustable diameters and a self-retaining flange to minimize leakage and enhance stability, reducing the need for additional securing elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing techniques are used to form anastomoses, then connection between vessels can be achieved, but the procedure becomes time-consuming and prone to complications such as leakage and poor patency
Solution Approach 1:
The patent replaces the mechanical suturing system with a mechanical expansion system. A balloon catheter is inserted through the flow connector and inflated to expand the mandrel, which in turn expands the flow connector into its final configuration. This substitution eliminates the need for time-consuming sutures while achieving reliable anastomosis through controlled mechanical expansion that creates precise openings and secure connections in the vessel wall.
Solution Approach 2:
The patent utilizes parameter changes in the form of controlled expansion. The flow connector is delivered in a compressed state and then expanded to its full size using balloon inflation. This parameter change from compressed to expanded state allows the device to be easily inserted through small openings and then achieve secure anchoring and vessel engagement, significantly reducing surgical time while improving reliability.
2Reliability
If precise suturing is performed to prevent leakage, then connection stability can be improved, but the complexity and difficulty of the procedure increases
Solution Approach 1:
The patent replaces complex suturing mechanics with a simplified balloon expansion mechanism. The balloon catheter system provides controlled radial expansion that creates uniform openings in the vessel wall and secures the flow connector without requiring multiple sutures. This substitution reduces procedure complexity while maintaining connection stability through the mechanical anchoring effect of the expanded flow connector against the vessel wall.
Solution Approach 2:
The flow connector is designed to be self-securing through its expansion mechanism. Once the balloon is inflated and the flow connector expands to its final size, it automatically anchors itself to the vessel wall through friction and mechanical interlocking, eliminating the need for additional securing elements like sutures. This self-service capability simplifies the surgical procedure while ensuring stable connection.
3Reliability
If conventional anastomosis methods are used, then vessel connection can be established, but complications such as thrombosis and poor patency occur frequently
Solution Approach 1:
The patent replaces suturing with controlled balloon expansion to create clean, precise openings in the vessel wall. The balloon inflation process allows for controlled tissue separation and flow connector insertion, creating a more uniform and less traumatic connection that reduces thrombus formation. The mechanical expansion ensures proper positioning and secure anchoring, minimizing leakage pathways that would otherwise occur with suturing.
Solution Approach 2:
The controlled parameter change of balloon inflation allows for precise control over the creation of vessel openings and the expansion of the flow connector. This controlled expansion creates uniform, clean cuts in the vessel wall rather than the irregular tears caused by suturing, thereby reducing thrombus formation. The gradual inflation process also allows for controlled tissue response, minimizing damage and promoting better long-term patency.
Data Source
AI summary
An implantable flow connector for fluidically coupling a source tissue-enclosed body space with a destination element, comprising: a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and a circumferential flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising one or more circumferentially adjacent sections at least one of which has a rigidity that decreases in a radially-increasing direction.