Fringed Matrix Cover for Size-Adjustable Implant Stabilization
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Solution Overview
Problem
Existing implantable devices face issues such as wastage of matrix material, increased preparation time, palpable suture lines, nerve entrapment, needle punctures, and implant malposition due to current stabilization methods, which are costly and inefficient.
Innovation Solution
A single-piece, two-dimensional implantable matrix cover with concentric circles and radiating fringes that can be adjusted to fit various device sizes, featuring integral stabilization tabs and suture loops to secure the device without puncturing it, eliminating palpable suture lines and nerve entrapment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple strips of dermal matrix are used to cover implantable devices, then coverage and stabilization are achieved, but material waste increases and preparation time increases
Solution Approach 1:
The single piece of dermal matrix is divided into multiple fringes that radiate from the inner circle, allowing the material to be configured to match the circular shape of implantable devices while minimizing waste. The fringes can be folded and sutured to create coverage without requiring multiple separate strips of matrix material.
Solution Approach 2:
The dermal matrix is transformed from a two-dimensional flat sheet into a three-dimensional conformal cover by folding the fringes inward and suturing them to create an envelope around the implantable device. This dimensional transformation allows a single piece of material to provide complete coverage that would otherwise require multiple strips.
2Reliability
If multiple strips of dermal matrix are sutured together, then coverage is achieved, but palpable suture lines are created causing nerve entrapment and false alarms
Solution Approach 1:
The single piece of dermal matrix is divided into multiple fringes that radiate from the inner circle, allowing the material to be configured to match the circular shape of implantable devices while minimizing waste. The fringes can be folded and sutured to create coverage without requiring multiple separate strips of matrix material.
Solution Approach 2:
Multiple fringes are joined together through suturing at their edges to form a continuous envelope around the implantable device. By combining the fringes into a unified structure, the design eliminates the need for multiple separate suture lines that would create palpable edges and potential nerve entrapment sites.
3Reliability
If dermal matrix is sewn directly to host tissue, then stabilization is achieved, but the shell of the implantable device is damaged
Solution Approach 1:
The dermal matrix cover serves as an intermediary layer between the implantable device and the host tissue. Instead of sewing directly to the device shell, the matrix is sutured to surrounding host tissue, distributing mechanical forces and preventing direct contact between sutures and the device shell, thereby avoiding damage.
4Reliability
If host muscle and fascia are elevated for stabilization, then implantable device stability is improved, but patient pain and disability increase
Solution Approach 1:
The stabilization function is extracted from the host muscle and fascia elevation and transferred to the dermal matrix cover itself. The matrix is designed with stabilization features that provide device stability without requiring the trauma of muscle and fascia elevation, thereby eliminating patient pain and disability associated with this approach.
5Loss of substance
If a single-piece matrix cover is used, then material waste is reduced and preparation time is minimized, but adaptability to various device sizes is challenged
Solution Approach 1:
The fringes of the dermal matrix are designed to be flexible and adjustable in length, allowing the single-piece cover to adapt to implantable devices of varying sizes. The fringes can be trimmed or configured during surgery to match the specific dimensions of the device being covered, providing versatility without requiring multiple pre-cut sizes.
Solution Approach 2:
The dimensions and configuration of the fringes can be modified to accommodate different device sizes and shapes. By changing the parameters of the fringe length, width, and spacing, a single basic design can be adapted to cover various implantable devices, from small to large dimensions, without material waste.
Data Source
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AI summary
A size adjustable cover used for soft tissue reinforcement which is adapted to envelop an implantable device, such as a breast implant, in a surgical application. The cover is formed using a circular two-dimensional implantable matrix material having an inner circle and a plurality of fringes which radiate circumferentially from the inner circle. The implantable device is positioned upon the inner circle, and the plurality of fringes are folded inwardly to form an overlapping implant pocket which envelops the implantable device. Each fringe further has a punched opening, allowing a loop of suture thread to link each fringe together. Certain fringes are excluded from the loop to create stabilization tabs which radiate from the inner circle and are attached to a site of host implantation to stabilize the cover and the implantable device within.