Knotless Tissue Fixation Strap for Ventral Hernia Closure
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Solution Overview
Problem
Conventional sutures used in hernia repairs, particularly for ventral hernias, face challenges such as high failure rates, excessive postoperative complications, and tedious procedural steps due to their circular or single-point cross-sectional profile, which concentrates force and requires multiple clamps and knots, leading to potential tearing and increased surgical complexity.
Innovation Solution
A medical device comprising a strap with a one-way locking mechanism, allowing for knotless and clampless approximation of tissue, featuring a lock-head and a strap that can be tightened sequentially without the need for knots or clamps, providing a larger tissue contact area and reducing the risk of tearing through tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional sutures are used for hernia repair, then the repair can be performed with simple materials, but the force is concentrated at a single point causing tissue tearing and high failure rates
Solution Approach 1:
The patent transitions from a one-dimensional suture (line) to a two-dimensional strap (surface) that distributes force across a broader area. The strap's width allows force distribution across multiple tissue fibers simultaneously, preventing the concentrated stress that causes suture-induced tissue tearing while maintaining repair strength.
Solution Approach 2:
The strap is designed with non-uniform cross-sectional properties, being wider at the tissue contact region to maximize force distribution and narrower at the insertion point for easier passage. This local variation in geometry optimizes both the force distribution capability and the ease of deployment.
2Strength
If multiple interrupted sutures are used to close large defects, then the closure strength increases, but the procedural complexity and time required increase significantly
Solution Approach 1:
The patent combines multiple suture functions into a single continuous strap structure. Instead of placing and securing multiple separate sutures individually, the strap spans across the entire defect and can be tensioned as one continuous element, achieving equivalent or superior closure strength while dramatically reducing the number of discrete steps required.
Solution Approach 2:
The strap is pre-configured with engagement features (teeth, ratchets, or locking mechanisms) that allow it to be deployed and secured in a single sequence of actions. This preliminary design of the strap structure enables the surgeon to achieve the cumulative effect of multiple sutures through a streamlined, pre-planned insertion process.
3Strength
If prosthetic mesh is used to cover large defects, then the structural support is improved, but postoperative complications such as seroma formation and infection increase
Solution Approach 1:
The strap appears to be designed as a temporary or short-term implant that provides structural support during the critical healing period but can be removed once tissue regeneration is complete. This contrasts with permanent mesh implants that remain in the body indefinitely, reducing the long-term risk of complications like seroma formation and infection associated with foreign body presence.
4Reliability
If conventional sutures with knots are used, then the tissue can be secured, but the knotting process increases surgical time and introduces additional points of failure
Solution Approach 1:
The strap incorporates self-securing mechanisms such as self-locking engagement features, ratchets, or friction-based retention systems that automatically secure the tissue without requiring manual knot tying. The strap's design allows it to maintain tension and secure the defect through its inherent mechanical properties, eliminating the time-consuming knotting process and removing knots as potential failure points.
Data Source
Figure 1
Figure 2A~2G
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AI summary
A medical device for approximating and securing tissue without requiring knots includes a lock-head, a strap section, distal protuberance, and a leader section. The device also includes a transition section between the leader and the strap section and a stiffening section proximal to the protuberance. The leader section is used to draw the strap section into the body through small apertures in tissue and the transition section provides a gradual transition in stiffness and size between the leader and the strap section.