Disposable Polymer Insert with Variable Thickness for Plantar Ulcer Offloading
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Solution Overview
Problem
Existing treatments for plantar ulcers, such as diabetic foot ulcers, are often complex, invasive, costly, and lack precision, leading to ineffective offloading and potential ulcer worsening.
Innovation Solution
A disposable insert made of a polymer material with a variable thickness and a concavity to offload pressure from plantar skin lesions, ensuring effective pressure distribution and prevention of direct contact with the ulcer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a wool felt insert is used for offloading plantar ulcers, then the treatment is low-cost and simple, but the insert flattens with use reducing offloading effectiveness and requires manual cutting and hole-making which are time-consuming and imprecise
Solution Approach 1:
The insert is pre-manufactured with a pre-formed hole in the ulcer zone and variable thickness distribution before use. This preliminary preparation eliminates the need for manual cutting and hole-making at the point of care, ensuring precise offloading geometry is already optimized before the insert is applied to the patient's foot.
Solution Approach 2:
The insert is designed as a disposable device made from cost-effective foam material. Rather than requiring durable, reusable components with complex adjustment mechanisms, a single-use insert provides precise offloading geometry at low cost, eliminating the need for manual customization while ensuring precision through factory pre-forming.
2Ease of manufacture
If a uniform thickness insert is provided, then the manufacture is simple, but the insert is ineffective at lightening heavy load pressures in zones adjacent to the ulcer
Solution Approach 1:
The insert features variable thickness with different foam density zones: a first zone with greater thickness and density for heavy load areas adjacent to the ulcer, and a second zone with lesser thickness for lighter load areas. This local differentiation of material properties ensures reliable pressure distribution tailored to specific anatomical regions while maintaining manufacturability through modular foam construction.
3Ease of operation
If manual cutting and hole-making of the insert is performed, then the operation is simple, but precision cannot be ensured and the ulcer may still come into direct contact with the ground or felt
Solution Approach 1:
The insert is pre-manufactured with a pre-formed hole in the ulcer zone and variable thickness distribution before use. This preliminary preparation eliminates the need for manual cutting and hole-making at the point of care, ensuring precise offloading geometry is already optimized before the insert is applied to the patient's foot.
Solution Approach 2:
The insert is designed to be self-applying with no manual customization required. The pre-formed hole and variable thickness geometry automatically provide precise ulcer offloading when the insert is placed on the patient's foot, eliminating the need for operator skill in cutting or shaping while maintaining high precision through factory pre-forming.
4Manufacturing precision
If a disposable insert with variable thickness is used, then precise and effective offloading is achieved, but the production complexity increases compared to uniform thickness inserts
Solution Approach 1:
The insert features variable thickness with different foam density zones: a first zone with greater thickness and density for heavy load areas adjacent to the ulcer, and a second zone with lesser thickness for lighter load areas. This local differentiation of material properties ensures reliable pressure distribution tailored to specific anatomical regions while maintaining manufacturability through modular foam construction.
Solution Approach 2:
The insert utilizes variations in foam material parameters (density and thickness) across different zones to achieve precise pressure distribution. By changing material parameters rather than adding mechanical components or complex structures, the patent achieves high manufacturing precision while minimizing structural complexity.
Data Source
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AI summary
The present invention relates to a disposable insert (10) for the treatment of plantar skin lesions (U), comprising a body (12) made of a polymer material and having a variable thickness (t) along its longitudinal axis (T). The body (12) comprises an upper surface (14), configured to support a given portion of the foot (F) of a user, and an opposite lower surface (16). In accordance with the invention, the body (12) comprises a concavity (18) configured to be arranged facing, when the disposable insert (10) is being used, a plantar skin lesion (U) of the user's foot (F), so as to prevent said plantar lesion (U) from coming into contact with the body (12) of the insert (10) or with a support surface. The invention also relates to a kit comprising a plurality of such disposable inserts (10).