Laminated Collagen Nerve Guide with NDGA Crosslinking

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Solution Overview

Problem

Current biomedical materials for medical constructs, such as nerve guides and implants, lack sufficient mechanical strength and flexibility to effectively support nerve repair and tissue reinforcement while maintaining biocompatibility and ease of use.

Innovation Solution

The development of collagen constructs with multiple laminated layers, including a repeating pattern of collagen fibers sandwiched between collagen film layers, cross-linked with nordihydroguaiaretic acid (NDGA), which are wound onto a support member with specific pitches and angles to create a strong yet flexible medical device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If collagen fibers are wound with multiple laminated layers to enhance mechanical strength, then the construct achieves sufficient tensile strength and structural integrity, but the manufacturing process becomes more complex and time-consuming

Engineering Contradiction:
Improvetensile strengthVSAvoidmanufacturing process complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The collagen construct is divided into multiple laminated layers with different fiber orientations (0°, 45°, 90°) to distribute mechanical loads effectively. Each layer contributes specific strength properties, achieving high overall tensile strength while maintaining manageable layer-by-layer manufacturing

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The winding process uses periodic pitch variations and repeating fiber angle patterns (0°, 45°, 90° sequence) to create consistent laminated structures. This periodic approach standardizes the manufacturing process, reducing complexity through repetition while building cumulative strength across layers

Inventive Principle:
Principle #19Periodic action

2Strength

If collagen fibers are wound with specific pitches and angles to optimize mechanical properties, then the construct achieves enhanced strength and flexibility, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvemechanical strengthVSAvoidwinding pitch and angle precision
Core Design Contradiction:
StrengthVSManufacturing precision

Solution Approach 1:

Different fiber angles (0°, 45°, 90°) are assigned to different layers to optimize local mechanical properties for specific load directions. This local differentiation achieves comprehensive strength while using simple, repeatable winding patterns for each layer

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The winding pitch and fiber angles are systematically varied across layers (0° for circumferential strength, 45° for diagonal reinforcement, 90° for longitudinal strength) to achieve optimal mechanical properties through parameter optimization rather than extreme precision in single parameters

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If multiple collagen film layers are applied to sandwich the collagen fibers, then the construct achieves improved structural integrity and surface smoothness, but the manufacturing time and process complexity increase

Engineering Contradiction:
Improvestructural integrityVSAvoidmanufacturing time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

Multiple collagen film layers are merged to sandwich and bind the collagen fiber layers together, creating a unified laminated structure. This merging approach improves structural integrity by integrating films and fibers into a single composite construct

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

Collagen films are applied in advance to wrap and secure the wound collagen fibers before final crosslinking. This preliminary action stabilizes the fiber architecture early in the process, preventing structural collapse and reducing the need for time-consuming adjustments later

Inventive Principle:
Principle #10Preliminary action

4Strength

If collagen constructs are cross-linked with NDGA to enhance mechanical strength, then the construct achieves improved tensile strength and stability, but the biocompatibility concerns may increase due to chemical crosslinking

Engineering Contradiction:
Improvetensile strengthVSAvoidbiocompatibility
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The crosslinking process uses controlled parameters (NDGA concentration, treatment time, temperature) to achieve sufficient tensile strength while minimizing residual chemicals. By optimizing these parameters, the construct attains mechanical strength close to natural tendon (91 MPa) while maintaining biocompatibility for nerve repair applications

Inventive Principle:
Principle #35Parameter changes

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 resulting collagen constructs exhibit enhanced mechanical strength and elasticity, suitable for nerve guides and implants, providing effective support for nerve repair and tissue reinforcement while maintaining biocompatibility and ease of use.

Implementation Method 1

The collagen film can be applied as a collagen gel to and the tube can be cross-linked with nordihydroguaiaretic acid (NDGA) to create a polymerized collagen tube.

Methodology Applied
Scientific EffectChemical cross-linking: Chemical Bonding

Implementation Method 2

placing a liquid or gel comprising soluble collagen onto the at least one wound collagen fiber during or after the winding step so that the elongate construct is wetted and/or so that the outer surface is covered in a collagen film, when the soluble collagen is dry.

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS10238773B2Methods of making collagen fiber medical constructs and related medical constructs, including nerve guides and patches
Publication Date: 2019.03.26 MIMEDX GROUP INC
  • US10238773B2 patent drawing
  • US10238773B2 patent drawing
  • US10238773B2 patent drawing

AI summary

The disclosure describes methods of winding collagen fiber to make medical constructs and related collagen fiber tube and patch devices.