Annulus Repair Plug with Flowable Seal for Disc Tears
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Solution Overview
Problem
Current methods for repairing tears or closing openings in the annulus of intervertebral discs are inadequate, as they often fail over time or require difficult plug insertion and may not securely cover the external side of the annulus, leading to potential reherniation.
Innovation Solution
A soft tissue repair system utilizing a combination of first and second plugs, where the first plug is configured to conform to the annulus and secure itself with a clamping mechanism, and the second plug is a flowable material that sets to form a flexible plug to fill gaps and secure the opening from the interior or exterior surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sutures are used to close the annulus tear, then the tear can be closed, but the repair can fail over time
Solution Approach 1:
The repair system divides the closure function into two separate components: a first plug that provides structural closure and a second flowable plug material that seals gaps and conforms to the tear geometry. This segmentation allows each component to specialize in one function, improving overall repair durability compared to a single suture or plug approach.
Solution Approach 2:
The system combines two different material types: a structured first plug material (which can be rigid or flexible) and a flowable second plug material (adhesive or gel-like). This composite approach leverages the strengths of each material type - the structural integrity of the first plug and the gap-filling sealing capability of the second plug - to create a more reliable and long-lasting repair.
2Ease of operation
If plugs are inserted from the exterior of the annulus, then the opening can be closed, but difficult positioning or enlarging of the tear is required
Solution Approach 1:
The insertion procedure is segmented into two independent steps: first inserting the structured first plug to provide closure, then injecting the flowable second plug material to seal gaps. This segmentation allows each component to be inserted using optimized techniques - the first plug can be positioned structurally, while the second material flows into place - reducing overall procedural complexity.
Solution Approach 2:
The second plug material is delivered in a flowable state through injection (hydraulic principle), allowing it to be easily introduced into the tear without requiring complex mechanical insertion tools or significant enlargement of the tear opening. The material flows into the defect and then sets in place.
3Ease of operation
If only external side coverage is provided, then insertion is simpler, but secure coverage of the annulus opening is compromised
Solution Approach 1:
The repair system applies different material properties to different locations within the tear: the first plug provides structured closure at the primary defect site, while the flowable second plug material fills gaps and conforms to the local geometry of the tear. This local customization of material properties ensures secure coverage throughout the entire opening while maintaining insertion simplicity.
Solution Approach 2:
By combining a structured first plug material with a flowable second plug material, the system achieves both insertion simplicity and secure coverage. The first plug can be inserted relatively simply to provide closure, while the second material flows into all gaps and irregularities to ensure complete and secure coverage of the entire opening.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively and securely closes annulus openings, withstanding internal disc pressures and accommodating disc movement, using minimally invasive techniques and materials like collagen, polymers, and metals, thereby preventing reherniation and ensuring long-term repair.
Implementation Method 1
the flowable plug material can set or harden to form a flexible plug material
Data Source
AI summary
A soft tissue repair system is provided for covering or filling openings in the annulus of an intervertebral disc. The soft tissue repair system uses a single plug or a combination of a first plug and a second plug. The second plug is a flowable plug such as an adhesive material or a material that hardens to a flexible plug material. Each plug is configured to close the opening in the annulus and can be positioned within the opening, over the opening at the exterior surface or over the opening at the interior surface. The plug can also be combined with a clamping mechanism that engages the annulus to secure the plug in the opening.