Bioabsorbable Cinching Fastener for Tissue Fixation
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Solution Overview
Problem
Existing tissue fixation devices are often technique-dependent and can result in inadequate attachment or undesirable long-term effects such as scarring, highlighting a need for simplified, reliable, and repeatable methods for fixing tissue to structures like implantable mesh.
Innovation Solution
A tissue fixation system comprising a delivery tube with an elongated curved needle and a capture needle that slides through a looped fastener to cinch it in place, utilizing interlock structures for self-locking and bioabsorbable materials, allowing for secure and adjustable tissue attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If technique-dependent fixation methods are used, then attachment can be achieved, but reliability and repeatability deteriorate due to variability in surgical technique
Solution Approach 1:
The fastener is designed to be self-aligning and self-tensioning. The elongated fastener automatically orients itself through the tissue and mesh, and the cinching mechanism self-regulates tension without requiring precise surgical technique, making the device independent of operator skill while maintaining high reliability
Solution Approach 2:
The fastener utilizes material property changes through bioabsorbability, transitioning from a deployable state to a degraded state over time. This parameter change allows the device to maintain reliability throughout the healing process while automatically adjusting its mechanical properties as it absorbs moisture and degrades
2Duration of action of stationary object
If permanent fixation materials are used, then long-term stability is improved, but harmful effects increase due to scarring and long-term foreign body presence
Solution Approach 1:
The fastener is designed with time-dependent parameter changes through bioabsorbability. It provides stable fixation during the critical healing period, then gradually degrades and is completely absorbed by the body, eliminating permanent foreign body presence and associated scarring while maintaining long-term stability when needed
Solution Approach 2:
The fastener is temporarily implanted to provide necessary fixation during tissue healing, then deliberately discarded as it bioabsorbs and degrades. This temporary presence provides the needed stability without the long-term harmful effects of permanent implants, allowing the body to recover without permanent foreign material
3Ease of manufacture
If simple filament structures are used, then ease of manufacture is improved, but functionality deteriorates due to lack of self-locking and cinching capability
Solution Approach 1:
The fastener is segmented into distinct functional zones: a delivery portion for insertion, a cinching portion with interlock structures for self-locking, and a loop portion for tensioning. This segmentation allows each zone to perform its specific function reliably while maintaining overall manufacturing simplicity through extrusion or molding processes
Solution Approach 2:
The interlock structures on the fastener provide self-service by automatically engaging with each other to create a self-locking mechanism during deployment. This eliminates the need for complex external locking mechanisms while ensuring reliable fixation, maintaining ease of manufacture through simple geometric features
Data Source
AI summary
A tissue fixation system including a delivery tube and an elongated fastener with a loop at a proximal end and a distal end. A proximal end of an elongated curved needle is attached to the delivery tube. A distal end of the needle is configured to penetrate tissue. The needle includes an open channel sized to receive the elongated fastener with the loop located near the proximal end of the elongated curved needle and the distal end of the elongated fastener located near the distal end of the elongated curved needle. A capture needle is slidably positioned in the delivery tube to slide through the loop in the proximal end of the elongated fastener. The capture needle is configured to grasp the distal end of the elongated fastener and pull the distal end of the elongated fastener through the loop to cinch the elongated fastener.