Gold Particles for Capsular Contracture Prevention

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Solution Overview

Problem

Capsular contracture, a condition characterized by the formation of tightly-woven collagen fibers around implants, is a painful and aesthetically disturbing complication that current methods to prevent or reduce are often ineffective, painful, and prone to recurrence.

Innovation Solution

The use of gold particles with a cross-section of 20-100 μm and purity greater than 99.00% w/w, which are implanted in proximity to or embedded on the surface of implants, releasing gold ions to suppress the local immune response and reduce granulation tissue formation, thereby preventing or reducing capsular contracture.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current methods (massage, ultrasound, medication) are used to treat capsular contracture, then some therapeutic effect is achieved, but the treatment is painful, expensive, and prone to recurrence

Engineering Contradiction:

Improveeffectiveness of capsular contracture treatmentVSAvoidpain and recurrence of capsular contracture

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Gold particles are implanted into the implant capsule during the initial implantation surgery, before capsular contracture develops. This preliminary placement of gold particles creates a preventive effect that suppresses the immune response and prevents capsular contracture formation, eliminating the need for subsequent painful treatments and reducing recurrence risk

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

Gold particles serve as an intermediary substance between the silicone implant and the host tissue. The gold particles release gold ions that mediate the interaction by suppressing the immune response and reducing granulation tissue formation, thereby preventing the harmful effects of capsular contracture without requiring direct contact or intervention with the painful treatment methods

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If surgical methods (capsulotomy, removal) are used to correct capsular contracture, then the capsule is disrupted or removed, but the procedure is invasive and capsular contracture may reoccur

Engineering Contradiction:

Improvecorrection of capsular contractureVSAvoidsurgical intervention complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Gold particles are implanted during the initial surgery to prevent capsular contracture before it occurs, eliminating the need for complex corrective surgeries later. This preliminary preventive measure simplifies the overall treatment approach and reduces the need for invasive corrective procedures

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The invention extracts the essential preventive function from complex surgical procedures. Instead of requiring complex capsulotomy or removal surgeries, the gold particles provide a simplified, minimally invasive solution that achieves the same protective effect through a straightforward implantation process

Inventive Principle:

Principle #2Taking out (Extraction)

3Ease of operation

If no preventive measure is taken, then the implantation procedure is simple, but capsular contracture develops causing pain and aesthetic distortion

Engineering Contradiction:

Improvesimplicity of implantation procedureVSAvoidcapsular contracture formation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The prevention of capsular contracture is merged with the implantation procedure itself. Gold particles are implanted simultaneously with the silicone implant in a single surgical session, combining the protective function with the primary procedure. This integration maintains simplicity while adding preventive capability, avoiding the need for separate preventive treatments

Inventive Principle:

Principle #5Merging (Combining)

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 gold particles effectively diminish the local immune response and granulation tissue formation, providing a safe and long-lasting solution to capsular contracture by maintaining a localized release of gold ions, reducing inflammation and preventing tissue growth around the implant.

Implementation Method 1

The inflammatory cells produce an ultra-thin layer, a dissolution membrane, on the metallic surface within which the macrophages may control the chemical milieu at the surface of the gold implant to facilitate dissolucytosis of gold ions

Methodology Applied

Scientific EffectDissolucytosis:

Implementation Method 2

Methodology Applied

Scientific EffectIon release:

Data Source

PatentUS11730858B2Gold particles for use in therapy to prevent or reduce capsular contracture

Publication Date: 2023.08.22 SAFE IMPLANT TECH APS

AI summary

Gold implant having a cross-section in the range of 20-100, preferably in the range of 20-40 μm for use in therapy to prevent or reduce capsular contracture. Further, the invention relates to a method of producing a gold-coated implant.