Sinusoidal Breast Implant with Smooth Interfaces

Solution Overview

Problem

Current breast implants and tissue expanders face challenges such as higher capsular contracture rates, surface rippling, and regulatory hurdles due to safety concerns and material limitations, leading to suboptimal feel and aesthetic outcomes for patients.

Innovation Solution

A sinusoidal container design with projections, troughs, and smooth interfaces is used for breast implants and tissue expanders, providing a natural feel and aesthetic appearance by mimicking the viscosity and movement of natural breast tissue, while being efficiently manufactured and compliant with FDA regulations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If silicone gel-filled implants are used, then superior feel is achieved, but capsular contracture rate increases and safety concerns arise

Engineering Contradiction:

ImprovefeelVSAvoidcapsular contracture rate

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The implant is divided into an outer container and an inner container, with the inner container containing silicone gel and the outer container containing saline. This segmentation allows the implant to provide the natural feel of silicone gel while using the safer saline outer layer to reduce capsular contracture risk.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implant uses a composite structure combining silicone gel (inner filling) and saline (outer filling) with two separate containers. This composite approach leverages the tactile benefits of silicone while mitigating its safety issues through the saline outer layer.

Inventive Principle:

Principle #40Composite materials

2Reliability

If saline-filled implants are used, then safety is improved, but natural feel and aesthetic appearance deteriorate due to surface rippling

Engineering Contradiction:

ImprovesafetyVSAvoidnatural feel

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The implant is divided into an outer container and an inner container, with the inner container containing silicone gel and the outer container containing saline. This segmentation allows the implant to provide the natural feel of silicone gel while using the safer saline outer layer to reduce capsular contracture risk.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implant uses a composite structure combining silicone gel (inner filling) and saline (outer filling) with two separate containers. This composite approach leverages the tactile benefits of silicone while mitigating its safety issues through the saline outer layer.

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If complex implant designs are used to improve feel and appearance, then aesthetic outcomes are enhanced, but manufacturing complexity and regulatory approval time increase

Engineering Contradiction:

Improveaesthetic appearanceVSAvoidmanufacturing complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The implant is divided into an outer container and an inner container, with the inner container containing silicone gel and the outer container containing saline. This segmentation allows the implant to provide the natural feel of silicone gel while using the safer saline outer layer to reduce capsular contracture risk.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The inner container is placed inside the outer container, creating a nested structure. This nesting approach allows complex functionality (combining two fillings) while maintaining a relatively simple overall structure that may ease manufacturing and regulatory approval.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS11950996B2Hybrid breast implant, method for making and using same

Publication Date: 2024.04.09 BECKER HILTON

AI summary

An implant includes: a sinusoidal container that includes: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs. A process for making an implant includes: forming a sinusoidal container from a polymer, the sinusoidal container including: a plurality of projections; a plurality of troughs; and a plurality of smooth interfaces, wherein a smooth interface is interposed between a projection and an adjacent trough for the plurality of projections, troughs, and interfaces to provide a smooth continuous transition between adjacent projections and troughs; and providing a filling tube attached to the sinusoidal container to make the implant.