Tissue Expander with Integrated Fluidic Access for Infection Control
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Solution Overview
Problem
Current methods for breast reconstruction and tissue expansion are plagued by complications such as seroma formation and infection, which often require additional surgeries, exposing patients to increased risks of anesthesia and infection, especially with the use of allograft materials that are hydrophilic and prone to biofilm formation.
Innovation Solution
A tissue expander with integrated fluidic access systems, including an implant port for inflation/deflation and a pocket port for antibiotic delivery and fluid drainage, coated with dissolvable materials that prevent biofilm formation, allowing for the treatment of infections and seroma without removing the implant, thereby reducing the need for repeated surgeries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional tissue expander is used, then the skin envelope can be maintained, but seroma formation and infection risk increase significantly
Solution Approach 1:
The tissue expander is divided into functional segments: the expander shell for volume maintenance, the delivery canal system for fluid/antibiotic distribution, and the porous coating layer for controlled substance release. This segmentation allows each component to address specific problems independently.
Solution Approach 2:
A porous coating material acts as an intermediary between the tissue expander surface and the surrounding tissue. This coating delivers antibiotics and anti-seroma agents directly to the interface, preventing infection and seroma formation without requiring direct needle access to the expander cavity.
2Ease of operation
If needle aspiration is performed to drain seroma, then fluid can be removed, but the tissue expander may be accidentally punctured requiring additional surgery
Solution Approach 1:
The delivery canal system serves as an intermediary pathway that allows safe fluid access to the periprosthetic space without requiring direct needle puncture of the expander shell. Fluid can be delivered or aspirated through this protected route, eliminating the risk of accidental expander damage.
Solution Approach 2:
The delivery canals are pre-positioned and pre-established during the initial surgery, creating safe access pathways before any seroma formation occurs. This preliminary setup allows for subsequent fluid management without the need for risky percutaneous needle insertion.
3Reliability
If allograft material is used to shield the tissue expander, then the skin envelope is better protected, but the hydrophilic nature of the allograft increases seroma and infection risk
Solution Approach 1:
The tissue expander is coated with a porous material that allows for controlled delivery of antibiotics and anti-seroma agents. This porous structure facilitates the release of therapeutic substances while maintaining the protective function of the expander shell, countering the harmful effects of allograft material.
Solution Approach 2:
The surface properties of the tissue expander are modified through coating with porous material that can deliver anti-biofilm agents. This changes the chemical and physical parameters of the surface, making it resistant to biofilm formation despite the presence of hydrophilic allograft material.
4Reliability
If the tissue expander is removed due to infection, then the infection can be treated, but the patient loses the skin pocket and requires additional surgery
Solution Approach 1:
Antibiotics are delivered through the integrated delivery system in advance to prevent infection establishment. This preliminary antibiotic delivery creates a protective effect that allows the tissue expander to remain in place, avoiding the need for removal and subsequent re-surgery.
Solution Approach 2:
The delivery canal system acts as an intermediary that enables in-situ infection treatment without expander removal. Antibiotics can be delivered directly to the infection site through this intermediary pathway, allowing the expander to remain in place and preserve the skin pocket.
Data Source
AI summary
The invention provides systems and methods for tissue expansion. A tissue expander may have an implant portion which may be used to expand the tissue. A delivery/drainage system may be also be provided, which may be in fluid communication with a pocket surrounding the tissue expander. Various port configurations may be provided that may provide access to the implant portion and/or the delivery/drainage system. The tissue expander may advantageously help prevent or treat infection, or check the state of the pocket surrounding the tissue expander.