NDGA Polymerized Collagen Fibers With Tension-Dried Strength

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Solution Overview

Problem

Current methods for producing biocompatible NDGA polymerized collagen fibers do not achieve the high tensile strength and dynamic flexibility necessary to match or exceed that of natural tendons and ligaments, limiting their effectiveness in medical constructs and implants.

Innovation Solution

A method involving treating collagen with nordihydroguairetic acid (NDGA), drying while maintaining tension, washing to remove unreacted cross-linking intermediates, and repeating this process to produce high-strength NDGA polymerized collagen fibers, which are then used to create bioprosthesis with tensile strengths between 180-300 MPa and matching the stiffness and dynamic flexibility of natural tendons and ligaments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If collagen is treated with NDGA and dried without tension, then the manufacturing process is simpler and faster, but the tensile strength of the resulting fibers is insufficient to match natural tendons

Engineering Contradiction:
Improvetensile strengthVSAvoidprocess complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The collagen is pre-aligned under tension during the drying phase before cross-linking occurs. This preliminary alignment of collagen fibers while under tensile load ensures that the subsequent NDGA cross-linking reinforces the fibers in their oriented state, maximizing tensile strength without requiring complex post-processing equipment

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies controlled tension (a mechanical parameter) during the drying process to induce fiber alignment. By changing the physical state of collagen from random to aligned through applied stress, the resulting cross-linked structure achieves superior tensile properties matching natural tendons

Inventive Principle:
Principle #35Parameter changes

2Strength

If collagen is treated with NDGA and dried while holding in tension, then the tensile strength increases to match natural tendon, but the manufacturing time and process complexity increase

Engineering Contradiction:
Improvetensile strengthVSAvoiddrying time
Core Design Contradiction:
StrengthVSLoss of time

Solution Approach 1:

The tension is applied continuously throughout the entire drying process without interruption. This continuous mechanical alignment during moisture removal ensures that collagen fibers maintain their oriented configuration throughout drying, achieving high tensile strength while using a simple, continuous process rather than multiple intermittent steps

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The alignment under tension is performed as a preliminary step during drying itself, combining two functions (alignment and drying) into one continuous operation. This eliminates the need for separate alignment and drying steps, reducing overall process time despite the extended drying duration

Inventive Principle:
Principle #10Preliminary action

3Reliability

If NDGA cross-linking is performed without washing intermediates, then the process is faster, but the biocompatibility and mechanical properties of the fibers deteriorate

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidmanufacturing speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The unreacted NDGA intermediates and byproducts are extracted from the collagen fiber matrix through washing with alcohol or acetone. This removal of harmful residues ensures biocompatibility for implantation while the washing step itself is simple and quick, minimizing impact on manufacturing speed

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

Alcohol or acetone is used as an intermediary solvent to selectively remove unreacted NDGA cross-linking agents from the collagen matrix. This intermediary substance facilitates the separation of desired cross-linked collagen from unwanted chemical residues, ensuring biocompatibility

Inventive Principle:
Principle #24Intermediary (Mediator)

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 NDGA polymerized collagen fibers exhibit tensile strengths and mechanical properties comparable to or exceeding those of natural tendons and ligaments, making them suitable for high-performance bioprosthesis and medical implants with improved durability and functionality.

Implementation Method 1

treating collagen with a solution comprising NDGA; washing the dried NDGA treated collagen in a solution to remove unreacted soluble NDGA cross-linking intermediates

Methodology Applied
Scientific EffectChemical Bonding: Chemical Bonding

Implementation Method 2

drying the NDGA treated collagen while holding the collagen in tension for a period of time

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentUS9603968B2Methods of making high-strength NDGA polymerized collagen fibers and related collagen-prep methods, medical devices and constructs
Publication Date: 2017.03.28 SHRINERS HOSPITALS FOR CRIPPLED CHILDREN
  • US9603968B2 patent drawing
  • US9603968B2 patent drawing
  • US9603968B2 patent drawing

AI summary

The disclosure describes methods of making high-strength NDGA collagen and associated methods of preparing collagen preparatory material and medical bioprostheses.