Covered Corkscrew Tissue Anchor for Anti-Entanglement Implantation
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Solution Overview
Problem
Existing tissue anchors and piercing devices face issues of entanglement with sutures and biological anatomy, such as chordae tendineae, during medical procedures, and lack visibility during implantation, leading to potential damage and procedural complications.
Innovation Solution
The development of tissue anchors with a cover feature, such as cloth or polymer film, that prevents entanglement and includes radiopaque markers for improved visibility, along with a swivel feature to prevent suture twisting and unscrewing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If tissue anchors have exposed helical structures for tissue engagement, then anchoring capability is improved, but entanglement with sutures and biological anatomy increases
Solution Approach 1:
The tissue anchor is segmented into distinct functional zones: a covered distal portion for smooth passage through tissue and chordae tendineae, and an exposed helical anchoring portion for secure engagement. This segmentation allows each zone to perform its specific function without interfering with the other, reducing entanglement while maintaining anchoring strength.
Solution Approach 2:
A biocompatible cover acts as an intermediary between the helical anchoring structure and the biological tissue. The cover allows the anchor to pass through delicate structures like chordae tendineae without entanglement, while still enabling the exposed helical portion to engage securely with the tissue for anchoring.
2Device complexity
If tissue anchors lack visibility features, then device complexity is reduced, but visibility during implantation deteriorates
Solution Approach 1:
Radiopaque markers are incorporated into the cover material, causing it to appear distinct under fluoroscopic imaging. These markers create visible contrast against surrounding tissues, allowing real-time visualization of the anchor's position and orientation during implantation without adding significant structural complexity.
3Ease of manufacture
If tissue anchors lack protective covers, then ease of manufacture is improved, but entanglement with biological anatomy increases
Solution Approach 1:
A thin, flexible biocompatible cover is applied to the distal portion of the tissue anchor. This cover is simple to manufacture using conventional coating or wrapping techniques, and it provides protection against entanglement with delicate biological structures like chordae tendineae during the implantation process.
4Strength
If tissue anchors have exposed helical structures, then tissue engagement capability is improved, but visibility and protection during insertion deteriorates
Solution Approach 1:
The anchor structure is divided into a covered distal portion for safe passage through tissue and an exposed helical portion for reliable tissue engagement. This segmentation ensures that the aggressive helical structure only contacts tissue after safe passage is achieved, while the covered portion provides protection during insertion.
Solution Approach 2:
The distal portion of the anchor is pre-covered with a protective biocompatible material before insertion. This preliminary protective action prevents entanglement and damage during the critical insertion phase, while the exposed helical portion remains ready for immediate tissue engagement upon deployment.
Data Source
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AI summary
A tissue anchor includes a driver head associated with a proximal portion of the tissue anchor, a pointed tip portion associated with a distal portion of the tissue anchor, a tissue-engagement portion disposed between the driver head and the pointed tip portion, and a cover configured to cover at least a portion of the tissue-engagement portion.