Barbed Surgical Fastener Assemblies for Secure Implant Attachment
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Solution Overview
Problem
Existing surgical fasteners for repairing anatomical structures like the supraspinatus tendon are inefficient in securely attaching implants due to issues with slipping and damage to tissue, particularly when used with flexible implants.
Innovation Solution
The development of fasteners with barbed shafts, enlarged heads, and outriggers that enhance tissue engagement, along with a delivery system that includes a cartridge and shield, allows for secure attachment of implants to both soft tissue and bone, minimizing tissue damage and ensuring retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical fasteners are used to attach implants to tissue, then the attachment process is simple, but the fasteners slip and cause tissue damage
Solution Approach 1:
The fastener shaft is divided into multiple barbed segments along its length, each with barbs oriented at different angles. This segmentation allows different portions of the shaft to engage tissue at varying orientations, improving grip security while distributing mechanical stress to minimize tissue damage.
Solution Approach 2:
The barbs on the fastener shaft are asymmetrically oriented with leading edges at different angles relative to the shaft axis. This asymmetric configuration provides directional engagement where barbs resist pull-out forces more effectively than push-in forces, securing the implant while controlling the direction and magnitude of tissue interaction forces.
2Reliability
If fasteners with barbed shafts and outriggers are used, then tissue engagement is enhanced, but the device complexity increases
Solution Approach 1:
Multiple functional elements (barbed shaft for tissue engagement, outriggers for implant retention, enlarged head for tool interaction) are merged into a single integrated fastener component. This consolidation achieves enhanced tissue engagement and implant security while avoiding the need for separate delivery components, thereby limiting complexity increases.
Solution Approach 2:
The fastener design incorporates multiple functions within a single structure: the barbed shaft provides tissue anchoring, the outriggers provide implant retention, and the enlarged head provides engagement with delivery tools. This multi-functionality achieves reliable tissue engagement without requiring multiple separate components, thus controlling device complexity.
3Reliability
If a delivery system with cartridge and shield is used, then secure attachment is achieved, but the ease of operation decreases
Solution Approach 1:
The fastener and implant are pre-assembled in a controlled manufacturing environment within the cartridge system, with the shield pre-positioned to protect the implant. This preliminary preparation ensures proper alignment and secure attachment while simplifying the surgical procedure, as the surgeon only needs to deploy the pre-configured assembly rather than assemble components intraoperatively.
Data Source
AI summary
This disclosure includes fasteners for coupling an implant to tissue (e.g., soft-tissue and/or bone), fabric-like implants, and assemblies with fasteners pre-loaded with implants. The present implants generally comprise at least one flexible, fibrous layer that is substantially planar in a flattened state. In some embodiments of the present assemblies for delivery of a fastener, the assembly comprises fastener cartridge, a fibrous implant wrapped around a portion of the cartridge, a fastener extending through the implant, and an elongated shield disposed around the implant and the cartridge such that the implant is retained between the cartridge and the shield. Kits comprise a plurality of fasteners pre-loaded with implants. Some of the present kits also include one or more of the present fastener-delivery apparatuses or tools; for example, a plurality of pre-loaded fasteners with a single, reloadable tool; a plurality of tools each pre-loaded with a fastener that is pre-loaded with an implant; and/or a plurality of cartridges each pre-loaded with a fastener that is pre-loaded with an implant, and a common tool for use with the cartridges.