Porous Breast Implant Wrap Anchoring to Limit Rotation and Migration

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Solution Overview

Problem

Existing breast implants suffer from rotation, migration, and capsular contraction issues, leading to undesirable aesthetic outcomes and potential health risks, particularly with macro-textured implants, which also increase the risk of breast implant-associated anaplastic large cell lymphoma.

Innovation Solution

A breast implant fixation device comprising a porous polymeric wrap with tabs and anchors that anchor to the pectoralis major muscle and chest wall, allowing tissue in-growth to secure the implant in place, reducing palpability and preventing indentations, while limiting rotation and migration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If macro-textured breast implants are used to limit rotation and movement, then implant stability is improved, but the risk of anaplastic large cell lymphoma and capsular contraction increases

Engineering Contradiction:
Improveimplant stabilityVSAvoidlymphoma risk and capsular contraction
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

A porous polymeric wrap is introduced as an intermediary layer between the breast implant and the body's tissue response. The wrap acts as a mediator that prevents direct interaction between the implant surface and the capsule-forming tissue, thereby reducing capsular contraction and lymphoma risk while still providing rotational control through its anchoring mechanism to the pectoralis major muscle

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The fixation device utilizes a porous polymeric wrap that allows tissue in-growth through its porous structure. This porosity enables biological integration and secure anchoring to the pectoralis major muscle while maintaining a barrier function that reduces harmful capsular responses. The porous material provides both mechanical fixation and biological compatibility

Inventive Principle:
Principle #31Porous materials

2Shape

If breast implants are placed in a pocket under the chest muscle, then implant coverage is improved, but postoperative pain and surgical complexity increase

Engineering Contradiction:
Improveimplant coverageVSAvoidsurgical complexity and postoperative pain
Core Design Contradiction:
ShapeVSEase of operation

Solution Approach 1:

The porous polymeric wrap is pre-formed and prepared before implantation, with attachment features already integrated into its structure. This preliminary preparation allows the wrap to be positioned and anchored to the pectoralis major muscle before the implant is fully seated, simplifying the surgical procedure and reducing the need for extensive muscle dissection and repositioning

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The fixation device is segmented into distinct functional components: a porous polymeric wrap for coverage, integrated anchors for securing to muscle tissue, and attachment features for surgical fixation. This segmentation allows each component to perform its specific function independently, simplifying the overall implantation process while ensuring both coverage and stability

Inventive Principle:
Principle #1Segmentation

3Shape

If anatomical breast implants are used to achieve natural appearance, then aesthetic outcome is improved, but rotation and migration occur leading to suboptimal appearance

Engineering Contradiction:
Improveaesthetic appearanceVSAvoidimplant position and orientation
Core Design Contradiction:
ShapeVSStability of the object's composition

Solution Approach 1:

The porous polymeric wrap incorporates asymmetric attachment features and anchoring points that are specifically designed to match the asymmetric geometry of anatomical breast implants. The wrap's attachment features are positioned and shaped to engage with specific regions of the implant, providing directional control that prevents rotation while maintaining the natural asymmetric appearance of the implant

Inventive Principle:
Principle #4Asymmetry

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 effectively limits breast implant movement by more than 30 degrees, reduces palpability, and decreases capsular contraction, enhancing aesthetic outcomes and minimizing health risks associated with implant migration.

Implementation Method 1

The wrap or tabs may be fixated to the pectoralis major muscle and or the patient's chest wall. The wrap or tabs may be sutured or stapled to fixate and anchor the wrap in the breast of the patient. The wraps limit movement of the breast implants by allowing tissue in-growth into the wraps

Methodology Applied
Scientific EffectTissue in-growth: Absorption (physical)

Data Source

PatentEP4065043B1Breast implant wraps to limit movement of breast implants
Publication Date: 2025.12.24 TEPHA INC
  • EP4065043B1 patent drawingFigure 1A~1D
  • EP4065043B1 patent drawingFigure 2
  • EP4065043B1 patent drawingFigure 3

AI summary

Described herein are breast implant fixation devices for use in breast reconstruction and breast augmentation. Novel wraps are designed to avert lateral displacement and bottoming out of breast implants, reduce capsular contraction and implant extrusion, eliminate skin indentations and ripples caused by breast implants, and reduce or eliminate palpability. The wraps are adapted to securely fold around the breast implants, limiting relative movement between the wrap and breast implant and reducing wrinkles. Tissue in-growth into the wraps limits movement of the wrap-breast implant assembly and thereby limits movement of the breast implant.