Osmotic Tissue Expander with Solute Granules
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Solution Overview
Problem
Current tissue expanders require frequent external inflation, leading to discomfort, risk of infection, and potential tissue damage, and typically need to be replaced with a permanent implant, while also posing safety concerns due to potential solute release upon rupture.
Innovation Solution
An implantable device with an expandable elastomeric matrix and embedded solute granules that creates an osmotic gradient for slow and continuous tissue expansion, eliminating the need for external inflation and allowing the device to function as both a tissue expander and permanent implant, with a design that prevents high solute concentrations from being released upon breach.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional tissue expanders are used requiring frequent external inflation, then tissue expansion can be achieved, but patient discomfort increases and infection risk rises
Solution Approach 1:
The tissue expander is designed to inflate automatically through a biodegradable balloon capsule that releases controlled amounts of saline solution over time. The device serves itself by utilizing the degradation of the balloon capsule material to trigger incremental expansion without requiring external intervention, thereby eliminating infection risks associated with repeated needle punctures and patient discomfort.
Solution Approach 2:
The expansion mechanism is pre-programmed into the device during manufacturing. The biodegradable balloon capsule is pre-filled with controlled volumes of saline solution at specific locations, and the degradation schedule is predetermined based on the material composition. This allows the tissue expansion to follow a pre-planned timeline optimized for tissue adaptation, removing the need for real-time external control.
2Reliability
If traditional tissue expanders are used requiring replacement with permanent implant, then tissue expansion function is achieved, but additional surgery and device complexity increase
Solution Approach 1:
The device is designed to perform multiple functions: it serves as both a temporary tissue expander during the expansion phase and as a permanent breast implant afterward. The expandable shell maintains tissue expansion capability while also providing the structural basis for the final implant. The biodegradable balloon capsule serves as both an expansion mechanism and a placeholder that is gradually replaced by ingrown tissue, eliminating the need for a separate permanent implant device.
Solution Approach 2:
The patent combines the tissue expander function and the permanent implant structure into a single integrated device. The expandable shell becomes the permanent implant capsule, and the biodegradable balloon capsule merges with the surrounding tissue during degradation. This consolidation eliminates the need for a second surgical procedure to implant a separate permanent device.
3Productivity
If tissue expanders use high concentration solute for rapid expansion, then expansion speed increases, but tissue damage and necrosis risk increase upon rupture
Solution Approach 1:
Instead of using a single large-volume high-concentration solute release, the device employs multiple small-volume releases of saline solution distributed over time through the biodegradable balloon capsule degradation. Each incremental release provides partial expansion action, allowing tissue to adapt gradually. The total expansion volume is distributed across many small steps, preventing excessive local concentration that would cause tissue damage while maintaining overall productivity.
Solution Approach 2:
The device changes the parameter of solute concentration over time through controlled degradation of the balloon capsule. Initially, the capsule contains concentrated saline solution for efficient space utilization, but as it degrades, the concentration is gradually diluted through controlled leakage and mixing with surrounding tissues. This dynamic parameter change allows rapid initial expansion followed by gentle continued expansion, avoiding the tissue damage associated with sustained high concentrations.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device provides gradual and controlled tissue expansion without external intervention, reducing discomfort and infection risks, and can remain in place as a permanent implant, addressing safety concerns by limiting solute exposure in case of rupture.
Implementation Method 1
the device, when implanted within the body of the patient, can be exposed to fluid within the patient to create an osmotic gradient across a boundary of the device
Implementation Method 2
the boundaries are permeable to water at a temperature of between 35° C. and 41° C.
Data Source
AI summary
A method of manufacturing a tissue expander for implanting into a body of a living subject can include mixing granules of a solute with an elastomer. The method can further include forming a matrix with the elastomer. The granules can be embedded within the elastomer. The elastomer can define boundaries of a plurality of chambers within the matrix. The method can further include curing the elastomer, such that the boundaries of the matrix are permeable to water at a temperature between a desired temperature range.