Customized Insoles with Elastomeric Networks for Diabetic Ulcer Pressure Management
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Solution Overview
Problem
Current treatments for diabetic foot ulcers, such as total contact casts and offloading boots, restrict mobility, require frequent wound dressing, and lead to slow healing due to constant encapsulation, with no effective solution for patients to resume normal life activities, and existing products focus more on prevention rather than management and cure.
Innovation Solution
Customized insoles with support layers simulating biomechanical properties of human skin, featuring elastomeric networks with specific elasticity moduli and Shore Hardness ratios, and recessed portions for ulcer isolation, manufactured using 3D modeling and additive manufacturing to redistribute pressure and promote healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If total contact casts or offloading boots are used to treat foot ulcers, then pressure redistribution is achieved, but patient mobility is reduced and wound healing is slowed due to constant encapsulation
Solution Approach 1:
The insole is divided into multiple regions with different support characteristics - high support regions, low support regions, and offloading regions - allowing pressure redistribution while maintaining mobility. Each region independently addresses specific pressure management needs without requiring complete encapsulation of the foot.
Solution Approach 2:
Different portions of the insole provide different levels of support and pressure relief tailored to specific anatomical locations and ulcer needs. The high support regions provide structural stability, while low support regions allow flexibility, creating localized pressure management zones that preserve overall foot mobility.
2Stress or pressure
If total contact casts are used to enclose ulcers, then pressure relief is provided, but wound healing is delayed due to lack of atmospheric exposure
Solution Approach 1:
The insole uses a flexible support layer that can adapt to the foot's contours and ulcer locations, providing pressure relief through controlled support zones rather than rigid encapsulation. This flexible structure allows the wound to breathe and exchange gases with the atmosphere while maintaining pressure management.
3Ease of operation
If customized insoles with skin-like elastomeric networks are used, then pressure redistribution and mobility are improved, but manufacturing complexity increases
Solution Approach 1:
The elastomeric network's elasticity modulus is specifically tuned to match human skin's biomechanical properties, enabling the insole to naturally conform to foot movements and pressure distributions. This parameter optimization allows complex functionality to emerge from material properties rather than intricate structural design, simplifying manufacturing.
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 customized insoles provide improved mobility, reduce pressure on ulcers, enhance healing by allowing atmospheric exposure, and offer a practical, low-cost solution for managing and preventing diabetic foot ulcers, enabling patients to maintain their daily activities.
Implementation Method 1
The support material comprises an elastomeric network having an elasticity modulus low stretch ratio from 2-8 MPa and an elasticity modulus high stretch ratio from 6-90 MPa
Implementation Method 2
The elastomeric network comprises a crosslinked siloxane network comprising a first siloxane having a Shore Hardness of from 00-0 to 00-15 and a second siloxane having a Shore Hardness of from 10 A to 60 A
Data Source
AI summary
Disclosed herein are insoles useful for treating skin injuries on a foot, for instance ulcers. The insoles are customizable for each patient's foot and can include various portions of differing softness, depending on the needs of the patient. For instance, it can be beneficial for certain sections of the foot to contact a firmer material, whereas other sections contact a softer material. Some, or all, of the materials can include one or more biofidelic skin simulant materials. Thus, various implementations include one or more regions that can include the same or different materials. For example, a custom insole can include a heel support region, a midfoot support region, and a forefoot support region, and the support regions can be subdivided into medial and lateral support regions or toe regions. One or more regions may have a custom isolation segment to prevent the progression of ulcers and/or expedite wound healing.