Knotless Tissue Approximation Strap With One-Way Locking
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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 tension, and complications from large prosthetic mesh patches, leading to tedious and cumbersome surgical procedures with multiple clamps and knots.
Innovation Solution
A medical device comprising a lock-head, strap section, and leader section with a transition section, allowing for knotless and clampless approximation of tissue using a one-way locking mechanism, which can be sequentially tightened to close defects like ventral hernias.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sutures are used to close hernia defects, then tissue approximation is achieved, but the repair has high failure rates due to excessive tension and concentration of force at single points
Solution Approach 1:
The suture is divided into multiple segments or strands (e.g., 3-5 strands) that are distributed across the tissue defect. Each strand carries a portion of the total load, preventing excessive tension concentration at any single point and reducing the risk of suture failure or tissue damage.
Solution Approach 2:
The suture configuration transitions from a single-point or linear approximation to a distributed multi-strand system that spans the tissue defect in multiple dimensions. This distributes the tensile forces across a broader area and multiple load paths, enhancing repair reliability.
2Reliability
If multiple interrupted sutures with knots are used to close large defects, then tissue approximation is improved, but the surgical procedure becomes tedious and time-consuming
Solution Approach 1:
Multiple suture strands are combined into a single continuous or pre-assembled multi-strand suture system that can be deployed as one unit. This eliminates the need to individually tie multiple separate knots, significantly reducing surgical time while maintaining closure strength through the distributed multi-strand configuration.
Solution Approach 2:
The multi-strand suture system is pre-assembled or pre-configured before surgery, with strands arranged and secured in a manner that provides immediate tensile strength upon deployment. This preliminary preparation eliminates time-consuming intraoperative knot-tying steps while ensuring reliable closure.
3Reliability
If a large prosthetic mesh patch is used to cover the defect, then closure is achieved, but postoperative complications such as seroma formation and infection increase
Solution Approach 1:
The large prosthetic mesh patch is removed or replaced with a biological alternative such as an acellular dermal matrix (ADM). This extraction of the synthetic mesh eliminates the source of seroma formation and infection risks associated with large foreign body implants, while ADM provides a biocompatible scaffold for tissue regeneration.
4Ease of operation
If conventional sutures with circular cross-section are used, then tissue approximation is achieved, but force distribution is poor leading to tissue cutting or tearing
Solution Approach 1:
The suture system uses a composite construction with multiple strands of different materials or configurations (e.g., monofilament and multifilament combinations, or strands with varying diameters and stiffness). This composite structure optimizes both the ease of tissue approximation and the distribution of mechanical forces across the tissue defect.
Data Source
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.