Patient-Specific Dermal Regeneration Sheet for Diabetic Foot Ulcers

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Solution Overview

Problem

Existing methods fail to effectively restore skin tissue in diabetic foot ulcers, leading to a significant quality of life degradation and increased amputation risk for diabetic patients.

Innovation Solution

A method involving the extraction and processing of autologous adipose tissue to create a patient-specific skin regeneration sheet using 3D printing and bioprinting techniques, incorporating adipose-derived stromal vascular fraction and extracellular matrix with fibrin glue for rapid skin restoration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional skin restoration methods are used for diabetic foot ulcers, then the treatment process is simple, but the skin restoration effectiveness is insufficient and the treatment time is prolonged

Engineering Contradiction:

Improveskin restoration effectivenessVSAvoidmanufacturing process complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the skin restoration process into multiple functional layers: a base layer containing adipose tissue extract and growth factors, a middle layer with fibrin glue for structural support, and an outer layer with protective and regenerative properties. Each layer is prepared separately and then assembled into a composite sheet, allowing optimization of each layer's function while achieving overall restoration effectiveness.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent creates a composite skin regeneration sheet combining multiple materials: adipose tissue extract, fibrin glue, growth factors, and other bioactive components. This composite structure integrates the regenerative properties of adipose tissue with the structural and adhesive properties of fibrin glue, achieving both effectiveness and controlled complexity through material composition rather than procedural complexity.

Inventive Principle:

Principle #40Composite materials

2Manufacturing precision

If patient-specific 3D printing is used to manufacture skin regeneration sheets, then the shape matching and restoration effectiveness are improved, but the manufacturing time and complexity increase

Engineering Contradiction:

Improveshape matching precisionVSAvoidmanufacturing time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by creating a 3D mold of the patient's affected area before manufacturing the skin sheet. This mold captures the precise geometry and contours of the ulcer site, allowing the subsequent skin regeneration sheet to be custom-formed to match the exact shape and depth of the defect. This preliminary modeling step enables precise fitting without requiring complex real-time adjustments during application.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent utilizes parameter changes in the 3D printing process, specifically controlling the pore size, layer thickness, and material composition parameters to optimize both the manufacturing speed and the final product precision. By adjusting these parameters, the system achieves high shape matching precision while maintaining reasonable manufacturing time through efficient material deposition and curing cycles.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If adipose tissue is extensively processed through multiple filters, then the cell activity and growth factor content are improved, but the processing time and complexity increase

Engineering Contradiction:

Improvecell activityVSAvoidprocessing speed

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent segments the filtration process into distinct stages with specific pore sizes: a first filtration stage to remove large debris, a second stage with medium pore size to retain cells while allowing smaller particles to pass, and a final stage to concentrate the adipose tissue extract. This segmented approach ensures high cell activity and growth factor content at each stage while maintaining overall processing efficiency through optimized flow rates and filter configurations.

Inventive Principle:

Principle #1Segmentation

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 method enables rapid production of a skin regeneration sheet that matches the affected area, promoting high cell activity and effective restoration of diabetic foot ulcers.

Implementation Method 1

obtaining 3D data of the skin defect area of a patient using a 3D scanner

Methodology Applied

Scientific EffectLight reflection: Reflection

Implementation Method 2

curing the proto-layer into a skin regeneration layer by applying a second solution containing thrombin onto the proto-layer

Methodology Applied

Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

removing fibers in the autologous adipose tissue using a first filter having a pore diameter of 2 to 3 mm

Methodology Applied

Scientific EffectPhysical filtration: Filter (physical)

Data Source

PatentUS12465622B2Method of manufacturing diabetic foot patient-specific dermal regeneration sheet and diabetic foot patient-specific dermal regeneration sheet manufactured using the same

Publication Date: 2025.11.11 ROKIT HEALTHCARE INC

AI summary

The specification relates to a method of manufacturing a diabetic foot patient-specific skin regeneration sheet, and a diabetic foot patient-specific skin regeneration sheet.