Adjustable Fringed Matrix Cover for Implant Stabilization
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Solution Overview
Problem
Current methods for covering implantable devices like breast implants and tissue expanders using acellular dermal matrices result in significant wastage, palpable suture lines, nerve entrapment, increased surgical time, and risk of needle puncture, which can lead to implant malposition and additional surgeries.
Innovation Solution
A size-adjustable cover made from a single piece of two-dimensional implantable matrix material with radiating fringes that fold inward to form an overlapping pocket, featuring integral stabilization tabs and punched openings for suture threading to prevent puncture and nerve entrapment, allowing for adjustable dimensions and reduced suture lines.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple strips of dermal matrix are used to cover and stabilize the implantable device, then the device is stabilized at the site of implantation, but significant wastage of expensive matrix material occurs and preparation time increases
Solution Approach 1:
The dermal matrix is divided into multiple strips that can be arranged in a patchwork configuration to cover the implantable device. This segmentation allows the matrix to be tailored to the specific shape and size of the device while minimizing wastage by using only the necessary portions of the matrix material.
Solution Approach 2:
The dermal matrix strips serve multiple functions: they provide coverage over the implantable device and simultaneously act as stabilization elements when sutured to the chest wall. This multi-functionality eliminates the need for separate stabilization components, reducing overall material usage and preparation time.
2Reliability
If multiple strips of dermal matrix are joined together, then the implantable device is covered and stabilized, but palpable suture lines are created which may trigger false alarms
Solution Approach 1:
Multiple dermal matrix strips are joined together through suturing to create a continuous cover over the implantable device. The suture lines are placed in the subcutaneous tissue rather than on the skin surface, merging the stabilization function with the coverage function while hiding the suture lines from external view and detection.
3Reliability
If a suture line is placed on the lateral aspect of the implant enclosure, then implant migration into the axillary area is prevented, but nerve entrapment can occur leading to acute and chronic pain
Solution Approach 1:
The dermal matrix is sutured to the chest wall at multiple locations, including the lateral aspect to prevent implant migration. However, the suture placement is carefully controlled to avoid the lateral chest wall area where nerves are superficial and abundant, thereby preventing nerve entrapment while still achieving the desired stabilization.
4Reliability
If dermal matrix sheets are sutured to the chest wall for stabilization, then the implantable device is secured, but needle puncture of the implantable device can occur leading to rupture
Solution Approach 1:
The dermal matrix acts as an intermediary layer between the chest wall and the implantable device. By suturing the dermal matrix to the chest wall rather than directly suturing to the implantable device, the risk of needle puncture and subsequent rupture is eliminated while still achieving stable fixation.
5Adaptability or versatility
If a patchwork of multiple pieces of dermal matrix is used, then implantable devices with varying dimensions can be covered, but cost increases due to material wastage
Solution Approach 1:
The dermal matrix is segmented into multiple strips of varying lengths and widths that can be configured to match the specific dimensions of different implantable devices. This segmentation allows for precise fitting and minimizes material wastage by using only the necessary portions of the matrix for each device size.
Solution Approach 2:
The dermal matrix strips can be dynamically adjusted and arranged in different configurations depending on the size and shape of the implantable device. This flexibility allows the same basic matrix material to be adapted to various device dimensions without requiring separate pre-cut pieces for each device type.
Data Source
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.