Micro Sling with Autofixing Tails for Minimally Invasive Implantation
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Solution Overview
Problem
Current treatments for urinary and faecal incontinence, such as transobturator and transvaginal retropubic approaches, face complications like vascular injuries, pain from abdominal wounds, and long-term foreign body reactions due to large needles and tape masses, which require complex modifications and have high morbidity and complication rates.
Innovation Solution
A micro sling with self-anchoring tails and a flat elongated part that allows for simultaneous implantation through a single incision, using a mini trocar or needle, which reduces trauma and the need for post-implantation modifications, and features autofixing tails with thorn-like projections for efficient anchoring without pulling, minimizing tissue damage and foreign body reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If large needles (3-6 mm diameter, 200 mm length) are used for inserting the tape in transobturator or transvaginal retropubic approaches, then the tape can be effectively implanted, but vascular injuries occur and abdominal wounds cause pain
Solution Approach 1:
The sling is divided into a mid-part and two separate fixing tails, each with self-anchoring means. This segmentation allows the sling to be implanted through smaller punctures rather than requiring large needles, thereby reducing vascular injuries and abdominal wound pain while maintaining implantation effectiveness
Solution Approach 2:
The fixing tails are equipped with self-anchoring means that automatically secure the sling to the surrounding tissue without requiring large needles or complex implantation tools. The self-anchoring mechanism performs the fixation function independently, eliminating the need for harmful large needle insertions
2Reliability
If large needles are used for implantation, then the tape can be effectively positioned, but the needles cause trauma and require removal through abdominal punctures causing additional pain
Solution Approach 1:
By segmenting the sling into a mid-part and separate fixing tails with integrated self-anchoring means, the design eliminates the need for long needles to be removed through abdominal punctures. The self-anchoring tails secure the sling in place without requiring needle removal, thereby reducing trauma and abdominal wound pain while maintaining positioning accuracy
Solution Approach 2:
The self-anchoring means on the fixing tails performs the positioning and fixation functions without requiring large needles to be inserted and removed through the abdomen. The self-service anchoring mechanism achieves accurate positioning while avoiding the harmful effects of needle removal trauma
3Reliability
If a large tape mass is retained inside the body, then incontinence treatment is achieved, but inflammation, infection translocation, erosion, and fistula occur
Solution Approach 1:
The sling is segmented into a mid-part and two fixing tails, with the fixing tails containing the self-anchoring means. This segmentation allows for a more compact and biocompatible design that reduces the foreign body reaction, thereby maintaining incontinence treatment efficacy while minimizing inflammation, infection, erosion, and fistula
Solution Approach 2:
The fixing tails with self-anchoring means are designed to be minimally invasive and biocompatible, creating local quality differences that reduce foreign body reactions. The self-anchoring mechanism provides effective treatment with reduced harm by using localized, tissue-compatible anchoring structures rather than large foreign tape masses
4Reliability
If complex modifications are required after implantation, then the procedure can be completed, but the device complexity and surgical time increase
Solution Approach 1:
The self-anchoring means is pre-integrated into the fixing tails during manufacturing, performing the anchoring action before the surgical procedure. This preliminary action eliminates the need for complex post-implantation modifications, thereby completing the procedure reliably while reducing device complexity and surgical time
Data Source
AI summary
Sling for urinary and fecal incontinence treatment comprises a mid-part 2, at least two fixing tails 3 provided with a anchoring means and comprising an elongated part 7, fixed to the mid-part 2, and an end part 4 fixed to the elongated part 7. The end part 4 includes a connection means 6 connectable to a tool. At least one fixing tail 3 is a autofixing tail including self-anchoring means 30, 31, 32, 33. The two elongated parts are flat and the end parts are axially disconnectable from the tool. The flat elongated part of the autofixing tail comprises flat self-anchoring means.