Cross-linked Collagen Gel Volume Stability
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Solution Overview
Problem
Cross-linked collagen implants used for soft tissue augmentation often shrink in volume post-implantation due to fluid absorption, requiring additional injections to maintain volume stability.
Innovation Solution
Collagen is cross-linked in a micro to non-fibrillar form at a high concentration, using specific pH ranges and cross-linking agents like glutaraldehyde to create a stable gel state that resists biological degradation and maintains shape, with optional addition of a local anesthetic like lidocaine for pain reduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If collagen is cross-linked to improve mechanical properties and resistance to resorption, then persistence is improved, but volume stability deteriorates due to shrinkage from fluid absorption
Solution Approach 1:
The patent applies parameter changes by modifying the pH parameter during cross-linking (using pH 2-5 or pH 9-12 instead of neutral pH) and collagen concentration (3-150 mg/mL), which fundamentally alters the collagen structure from fibrillar to micro-to-nonfibrillar form. This structural transformation enables the collagen to resist syneresis while maintaining volume stability, resolving the contradiction between persistence and volume stability.
2Volume of moving object
If additional injections are administered to maintain volume, then volume stability is improved, but loss of time and increased complexity worsen
Solution Approach 1:
The patent applies preliminary action by pre-modifying the collagen structure through cross-linking at non-neutral pH and high concentration before implantation. This preliminary structural modification ensures that the collagen implant inherently resists fluid absorption and maintains volume stability throughout its persistence period, eliminating the need for additional corrective injections and the time they would require.
3Ease of manufacture
If collagen is cross-linked at neutral pH, then ease of manufacture is improved, but volume stability deteriorates due to syneresis
Solution Approach 1:
The patent applies parameter changes by deliberately using non-neutral pH values (2-5 or 9-12) during cross-linking instead of neutral pH. This parameter modification induces a fundamental structural change in collagen from fibrillar to micro-to-nonfibrillar form, which prevents syneresis and maintains volume stability. The process remains manufacturable with appropriate equipment for pH control.
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 cross-linked collagen maintains improved volume stability and shape retention, resisting cellular infiltration and breakdown, making it suitable for deep dermal corrections and providing mechanical strength to the body.
Implementation Method 1
the cross-linking agent is capable of forming covalent bonds between amino acid residues in the micro to non-fibrillar collagen
Implementation Method 2
The cross-linked collagen of the present invention is in a gel but not fibrous state. It locks water in the gel and does not disperse like a fibrous collagen suspension
Implementation Method 3
increase its resistance to resorption
Data Source
AI summary
The present invention discloses collagen cross-linked in a micro to non-fibrillar form and at a high concentration. The cross-linked collagen gel has improved volume stability or persistence than collagen cross-linked at a neutral pH. Also disclosed are methods for preparing the inventive cross-linked collagen and using such for augmenting soft tissues in mammals.