Custom Offloading Footwear for Zero-Pressure Diabetic Ulcers
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Solution Overview
Problem
Current diabetic foot ulcer (DFU) management lacks personalized, practical, and lifestyle-compatible offloading solutions that effectively eliminate pressure on the wound site, leading to delayed healing, high recurrence rates, and increased morbidity and mortality.
Innovation Solution
A custom diabetic foot healing system with a diagnostic platform for personalized foot and ankle scanning, generating a hybrid digital model for precise pressure mapping, and fabricating a fully customized device that suspends the ulcer area and provides total contact to the non-ulcerated foot, integrating advanced biologics and sensors for continuous monitoring and adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If custom-made shoes with personalized offloading are used, then wound healing is accelerated and recurrence is prevented, but device complexity and manufacturing cost increase
Solution Approach 1:
The system performs preliminary scanning and digital modeling of the patient's foot before device fabrication. Pressure mapping and 3D scanning are conducted in advance to create a digital twin, allowing the custom shoe to be precisely tailored to the patient's anatomy and pressure distribution patterns before manufacturing begins.
Solution Approach 2:
The system creates a digital copy or digital twin of the patient's foot through 3D scanning and pressure mapping. This digital model serves as a virtual replica that can be manipulated, analyzed, and used to design the custom offloading device without requiring physical prototypes or trial fittings.
2Stress or pressure
If total contact casting is used for offloading, then pressure redistribution is effective, but patient mobility and compliance are reduced
Solution Approach 1:
The custom shoe utilizes flexible yet structurally sound materials that can redistribute pressure effectively while allowing patient movement. The shell is designed to be form-fitting and adaptive, providing the necessary pressure redistribution without the rigidity of traditional total contact casts.
Solution Approach 2:
The device incorporates dynamic elements that adapt to patient movement and weight distribution. The offloading mechanism is designed to move with the patient rather than restricting motion, maintaining effective pressure redistribution during various activities and positions.
3Ease of operation
If removable cast walkers are used, then patient mobility is improved, but offloading effectiveness and compliance are reduced
Solution Approach 1:
The system merges the benefits of mobility with effective offloading by integrating pressure redistribution mechanisms directly into a shoe-like structure that patients can wear continuously. The design combines the comfort and mobility of removable footwear with the therapeutic effectiveness of total contact casting.
Solution Approach 2:
The device incorporates sensors and monitoring systems that provide feedback on pressure distribution, weight-bearing patterns, and compliance. This real-time feedback ensures that effective offloading is maintained while allowing patient mobility, and alerts healthcare providers to any deviations from the prescribed therapy.
4Ease of manufacture
If generic footwear is used, then ease of manufacture and cost are reduced, but pressure distribution and ulcer prevention are inadequate
Solution Approach 1:
The system changes key parameters such as shoe last shape, material density, sole thickness, and cushioning distribution based on the patient's specific pressure map and anatomical measurements. This allows customization of pressure distribution characteristics while maintaining a standardized manufacturing process for the base shoe structure.
Solution Approach 2:
The custom shoe incorporates localized variations in material properties, thickness, and cushioning at specific areas of the foot corresponding to high-pressure zones or ulcer risk areas. This local quality enhancement provides targeted pressure relief where needed while maintaining simplicity in other areas of the shoe design.
Data Source
AI summary
The present invention is a diabetic healing system for the treatment of diabetic foot ulcers. This device promotes the healing process of diabetic foot ulcers by completely offloading the pressures that an ulcer may be subjected to regardless of its size, shape or location on the foot/ankle and/or toes. The device is made of a custom rigid outer shell and a custom inner lattice structure that fully supports, stabilizes and conforms to all aspects of a patient's condition, anomalies and disfigurement. It completely offloads (zero contact) any ulceration regardless of the location on the foot, ankle or toes. The offloading occurs through the use of recessed areas that can be incorporated directly into the lattice structure, or can be included in a “plug” that fits within a small aperture in the lattice structure.