Breast implant removal device

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Solution Overview

Problem

The removal of breast implants, especially those with ruptured or leaking silicone fill material, is challenging due to the fragility of the outer elastomeric shell and the tendency of silicone polymer fill material to adhere to tissues and instruments, leading to increased operating time and risk of further damage during removal.

Innovation Solution

A device comprising a housing with a proximal and distal portion, a suction port, and a ring with a rounded inner edge, which applies suction to draw the implant through an orifice, minimizing contact and friction, and allowing for efficient containment and removal of the implant and any leaked material.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If digital grasping or clamp instruments are used to remove the implant, then the implant can be grasped and removed, but the outer elastomeric shell may be further damaged or torn due to fragility

Engineering Contradiction:
Improveimplant graspingVSAvoidshell integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device uses suction (negative pressure) to grasp and remove the implant without mechanical contact with the fragile shell. The suction force pulls the implant through the orifice while the sealed chamber prevents direct mechanical grasping that could tear the deteriorated elastomeric shell.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The device employs a flexible sealed chamber that conforms to the implant shape, allowing the chamber walls to gently engage the implant surface without concentrated stress points. This flexible enclosure protects the fragile outer shell from mechanical damage while maintaining secure grasping through distributed suction forces.

Inventive Principle:
Principle #30Flexible shells and thin films

2Length of moving object

If the implant is removed through a small opening in the scar pocket and skin, then the incision size is minimized, but the removal process becomes time-consuming and difficult

Engineering Contradiction:
Improveincision sizeVSAvoidremoval speed
Core Design Contradiction:
Length of moving objectVSProductivity

Solution Approach 1:

The device separates the removal function into distinct components: a sealed chamber for containment, an orifice for minimal incision, and a suction mechanism for active extraction. This segmentation allows the implant to be pulled through the small orifice using suction force, eliminating the need for large incisions while maintaining efficient removal speed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device replaces manual mechanical grasping and pulling through the incision with a suction-based system. The suction force acts remotely through the sealed chamber to draw the implant through the small orifice, eliminating the need for direct mechanical manipulation that would require larger openings or more time.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If the implant is removed intact, then further damage is prevented, but the silicone polymer fill material adheres to tissues and instruments making cleanup difficult

Engineering Contradiction:
Improveimplant integrityVSAvoidsilicone adhesion
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device extracts the implant as a complete unit from the body through the sealed chamber, keeping the silicone fill material contained within the intact implant shell throughout removal. The silicone adheres only to the internal surfaces of the sealed chamber, which can be easily detached and disposed of as a single unit, eliminating widespread adhesion to tissues and instruments.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The sealed chamber serves multiple functions: it contains the implant during removal, prevents silicone leakage, provides a collection container for the entire implant, and acts as a disposal receptacle. This multi-functionality addresses the adhesion problem by consolidating all silicone contact surfaces into a single removable component.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Productivity

If suction is applied to draw the implant through the orifice, then removal efficiency is improved, but the force may damage the fragile outer shell

Engineering Contradiction:
Improveremoval efficiencyVSAvoidshell strength
Core Design Contradiction:
ProductivityVSStrength

Solution Approach 1:

The sealed chamber acts as a cushioning enclosure that distributes the suction force uniformly across the entire implant surface before it reaches the fragile outer shell. This pre-distribution of forces prevents concentrated stress on weak areas of the shell, allowing efficient suction-based removal without causing additional damage to the deteriorated elastomeric material.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 device enables efficient and intact removal of breast implants, reducing operating time and minimizing the risk of further damage or leakage, while effectively containing the silicone polymer fill material to prevent granuloma formation.

Implementation Method 1

applying suction to the housing sufficient to draw the breast implant through the orifice

Methodology Applied
Scientific EffectSuction: Suction

Data Source

PatentEP3810035B1Breast implant removal device
Publication Date: 2024.12.18 KIRN MEDICAL DESIGN LLC
  • EP3810035B1 patent drawingFigure 1
  • EP3810035B1 patent drawingFigure 2
  • EP3810035B1 patent drawingFigure 3

AI summary

A device for removing a breast implant from a patient includes a housing defining an interior chamber for receiving the breast implant. The housing includes a distal portion, a proximal portion defining an orifice through which the breast implant passes during removal, and a suction port. The orifice is defined such that a seal is formed between the housing and the breast implant during removal of the breast implant. A related method of removing a breast implant of a patient includes the steps of exposing the breast implant, positioning the orifice of the housing in contact with the breast implant, and applying suction to the housing sufficient to draw the breast implant through the orifice.