Single-Wire Implantable Clip for Heart Implant Gap Sealing
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Solution Overview
Problem
Therapeutic implants such as replacement valves and occlusion devices often experience leakage due to gaps between their circumference and the heart anatomy, which are non-circular and vary in shape, leading to inefficient blood flow and compromised device performance.
Innovation Solution
A catheter-based deployment system using a clip with a single length of wire shaped into a first and second arm, equipped with barbed ends, is used to close gaps by inserting one arm into the therapeutic implant and the other into native tissue, with an actuator to crimp the clip and bring the arms together, effectively sealing non-circular gaps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If circular plugs are used to seal gaps, then the sealing process is simple, but the plugs cannot sufficiently close non-circular gaps to prevent blood flow
Solution Approach 1:
The patent applies asymmetry by transitioning from circular plugs to non-circular clips that match the anatomical geometry. The clips are specifically designed with asymmetric shapes (rectangular, D-shaped, crescent-shaped) to conform to non-circular gaps between therapeutic implants and heart tissue, enabling effective sealing where circular plugs fail.
Solution Approach 2:
The patent implements local quality by customizing the clip shape to match the specific local geometry of each gap. Different clip configurations (rectangular for square gaps, D-shaped for crescent gaps) are applied locally to match the specific anatomical configuration, ensuring optimal sealing effectiveness for each unique gap shape.
2Ease of manufacture
If discrete sized implants are used, then manufacturing and packaging is simplified, but gaps form when implants do not fully oppose the heart wall
Solution Approach 1:
The patent applies segmentation by dividing the sealing function into multiple discrete clips that can be deployed at different locations around the implant. Each clip addresses a specific gap segment, allowing the system to compensate for size mismatches between discrete implants and continuous anatomical structures.
Solution Approach 2:
The patent uses clips as intermediary elements between the therapeutic implant and the heart tissue. These clips act as mediators that bridge the gap caused by size mismatches, providing a flexible connection that adapts to anatomical variations without requiring custom-sized implants.
3Adaptability or versatility
If multiple separate deployment systems are used for different gap shapes, then each gap type can be optimized, but device complexity increases
Solution Approach 1:
The patent implements universality by designing a single catheter-based delivery system capable of deploying multiple clip types. The system can deliver rectangular clips, D-shaped clips, and other configurations through the same catheter, eliminating the need for separate deployment systems for each gap shape while maintaining adaptability to different anatomical configurations.
Data Source
AI summary
Devices, systems, and methods for preventing leakage through a therapeutic implant are provided. The apparatus includes an implantable clip having a single length of wire. The single length of wire is shaped into a first arm, a second arm, and a loop positioned laterally between the first arm and the second arm and longitudinally proximal of the first arm and the second arm. The first arm is configured to be inserted into a therapeutic implant within a heart of a patient and the second arm is configured to be inserted into a native tissue of the heart. The first arm and the second arm are configured to urge a border of the therapeutic implant and a border of the native tissue toward one another and close a gap between the therapeutic implant and the native tissue.