Injectable Alloplastic Implant Composition for Soft Tissue Augmentation

Solution Overview

Problem

Existing injectable dermal fillers face challenges with injectability and storage stability due to the presence of low molecular weight gelatine components, which also contribute to immunological responses and reduced gel strength.

Innovation Solution

An alloplastic implant composition comprising microparticles with a diameter of 5 to 400 μm suspended in an aqueous suspending agent of denatured type I collagen or atelocollagen, where the denatured collagen has less than 10 wt % of weight average molecular weight 100,000 Daltons or lower and greater than 70 wt % of weight average molecular weight 100 kDa to 258 kDa, and a polydispersity of 1.0 to 1.6, improving physical properties and reducing immunological responses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If low molecular weight gelatine components are present in the suspending agent, then the composition is easier to inject, but the gel strength decreases and immunological responses increase

Engineering Contradiction:

ImproveinjectabilityVSAvoidgel strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The patent applies parameter changes by precisely controlling the molecular weight distribution parameters of the collagen protein in the suspending agent. Specifically, it limits low molecular weight components (Mw < 100,000 Daltons) to less than 10 wt% and ensures high molecular weight components (Mw: 100-258 kDa) constitute greater than 70 wt%, with polydispersity controlled at 1.0 to 1.6. This parameter optimization resolves the contradiction by maintaining adequate gel strength while preserving injectability.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If low molecular weight gelatine components are present in the suspending agent, then the composition is easier to inject, but immunological responses increase

Engineering Contradiction:

ImproveinjectabilityVSAvoidimmunological responses

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by precisely controlling the molecular weight distribution parameters of the collagen protein in the suspending agent. Specifically, it limits low molecular weight components (Mw < 100,000 Daltons) to less than 10 wt% and ensures high molecular weight components (Mw: 100-258 kDa) constitute greater than 70 wt%, with polydispersity controlled at 1.0 to 1.6. This parameter optimization resolves the contradiction by maintaining adequate gel strength while preserving injectability.

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If broad molecular weight distribution is used in the collagen, then the composition is more stable during storage, but the injectability decreases

Engineering Contradiction:

Improvestorage stabilityVSAvoidinjectability

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent applies parameter changes by precisely controlling the molecular weight distribution parameters of the collagen protein in the suspending agent. Specifically, it limits low molecular weight components (Mw < 100,000 Daltons) to less than 10 wt% and ensures high molecular weight components (Mw: 100-258 kDa) constitute greater than 70 wt%, with polydispersity controlled at 1.0 to 1.6. This parameter optimization resolves the contradiction by maintaining adequate gel strength while preserving injectability.

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 composition achieves improved injectability, broad temperature stability, and homogeneous microparticle distribution, reducing the risk of adverse reactions and maintaining stability for extended periods, allowing for effective soft tissue augmentation without the need for pre-treatment skin tests.

Implementation Method 1

microparticles having a diameter of about 5 to about 400 μm suspended in an aqueous suspending agent, wherein the aqueous suspending agent comprises denatured type I collagen or atelocollagen

Methodology Applied

Scientific EffectSuspension: Suspension

Data Source

PatentUS9789222B2Injectable alloplastic implants and methods of use thereof

Publication Date: 2017.10.17 SUNEVA MEDICAL INC

AI summary

Described herein are injectable alloplastic implant compositions that are particularly useful for soft tissue defect augmentation. The compositions include microparticles, such as polymethylmethacrylate particles, and collagen as a suspending agent, wherein the collagen contains a reduced amount of low molecular weight gelatine compared to high molecular weight collagen. By controlling the molecular weight of the collagen in the compositions, the injectability, stability, and antigenicity of the alloplastic implant compositions can be improved.