Barbed Suture With Central Stop For Knotless Fixation
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Solution Overview
Problem
Conventional surgical sutures face issues with knot slippage, breakage, and wound re-opening due to inadequate tensioning and fixation, particularly when securing prosthetic devices like bioprosthetic heart valves, and there is a need for sutures that minimize slippage and simplify surgical procedures while avoiding tissue and sewing ring damage.
Innovation Solution
A surgical suture design featuring an elongated core with a stop projecting between sets of barbs, which is integrally formed and defines the largest cross-sectional dimension, providing additional strength through a braid and a pledget system that secures the suture in place without knots, using a stop to prevent unwanted movement and enhance holding strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sutures with knots are used to secure prosthetic devices, then the sutures can be tied to hold tissue together, but the knots may slip, break, or cause wound re-opening due to inadequate tensioning and fixation
Solution Approach 1:
The patent removes the knot-tying step entirely by extracting the fixation function from the knot and transferring it to the barbed suture design. The barbs on the suture legs engage with the tissue and prosthetic device, providing secure fixation without requiring knots to be tied and pushed down for tensioning.
Solution Approach 2:
The barbed suture is designed to be self-fixating through its barb structure. As the suture is passed through tissue and the prosthetic device, the barbs automatically engage and lock the suture in place, eliminating the need for external knot-tying actions and providing self-tensioning capability.
2Reliability
If barbed sutures are used to secure prosthetic devices without knots, then knot slippage and breakage are eliminated, but additional measures are needed to prevent suture and pledget movement
Solution Approach 1:
The suture system is segmented into distinct functional components: the barbed suture legs for tissue engagement, the central stop for positioning control, and the pledget for distribution and protection. This segmentation allows each component to perform its specific function optimally while working together as an integrated system.
Solution Approach 2:
The stop acts as an intermediary element between the barbed suture legs and the pledget. It provides a positive stop that prevents the pledget from moving along the suture while allowing the suture to be properly positioned and tensioned, mediating the interaction between these components.
3Reliability
If multiple barbed sutures are used around the perimeter of a valve, then the prosthetic device can be securely attached, but the likelihood of surgical error increases due to procedure complexity
Solution Approach 1:
The barbed suture system is designed to be self-aligning and self-positioning. The barbs automatically engage with the tissue and prosthetic device at appropriate locations, and the stop provides natural positioning references, reducing the surgeon's cognitive load and minimizing surgical errors even when multiple sutures are used.
Solution Approach 2:
While not directly applicable to the mechanical function, the concept of visual differentiation applies to the stop and pledget components which provide visual cues to the surgeon about proper positioning and assembly, helping to prevent surgical errors through enhanced visual feedback.
4Strength
If the stop defines the largest cross-sectional dimension of the core, then additional strength is provided, but the suture may be more difficult to pass through tissue and sewing rings
Solution Approach 1:
The stop is designed with localized enhanced properties (largest cross-sectional dimension) only at the specific location where strength is needed, while the rest of the suture core maintains its original dimensions for easy passage through tissue and sewing rings. This local quality enhancement provides strength where required without compromising overall ease of use.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3B
AI summary
A surgical suture comprising an elongated core including a first leg and a second leg and a stop projecting from said elongated core between said first and second legs.