Inflatable Compression Bra with Localized Pressure Zones

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Solution Overview

Problem

Current medical devices for postoperative compression after breast reconstruction surgery fail to provide targeted and variable orthogonal compression across the breast skin, leading to potential seroma formation and integration issues between implanted biomaterials and subcutaneous tissue, as they do not adequately address the need for homogeneous compression and varied pressure gradients.

Innovation Solution

A bra-like device with non-preformed cups containing inflatable air chambers that allow for adjustable orthogonal compression along the quadrants of the breast, minimizing pressure on the areola-nipple complex while maximizing compression on peripheral skin, using non-elastic materials and adjustable air pressure to ensure adherence of subcutaneous tissue to implanted materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If frontal compression is applied to the areola-nipple complex using traditional bras or bandage bands, then breast movement is minimized, but the risk of cutaneous necrosis increases due to perfusion problems

Engineering Contradiction:
Improvebreast stabilityVSAvoidcutaneous necrosis risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The bra is designed with differentiated compression zones: the areola-nipple complex area has reduced or zero compression to protect blood flow, while the quadrants and peripheral areas provide full compression. This local differentiation allows stable compression where needed while protecting vulnerable areas from ischemic damage.

Inventive Principle:
Principle #3Local quality

2Reliability

If homogeneous compression is applied across all breast skin to promote tissue adherence, then integration of biomaterials is improved, but the areola-nipple complex is at risk of necrosis due to its susceptibility to perfusion problems

Engineering Contradiction:
Improvetissue integrationVSAvoidcutaneous necrosis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compression garment features locally differentiated pressure distribution with excluded zones over the areola-nipple complex. This allows homogeneous compression over the quadrants and peripheral breast skin to ensure tissue-biomaterial adherence, while creating pressure-free zones to maintain perfusion and prevent necrosis in the areola-nipple region.

Inventive Principle:
Principle #3Local quality

3Volume of moving object

If submuscular expanders are gradually inflated from 200 cc to 400 cc over six months, then breast volume is increased, but the required external compression must be continuously reduced to maintain constant pressure gradient

Engineering Contradiction:
Improvebreast volumeVSAvoidcompression adjustment
Core Design Contradiction:
Volume of moving objectVSAdaptability or versatility

Solution Approach 1:

The compression bra is designed as a dynamic system with adjustable compression levels that can be modified as the expander volume increases. This allows the external compression to be reduced progressively over the six-month period to maintain a constant pressure gradient on the breast skin, adapting to the changing breast volume from 200 cc to 400 cc.

Inventive Principle:
Principle #15Dynamics

4Ease of manufacture

If empty spaces remain inside the mammary chamber after surgery, then surgical procedure is simpler, but serum build-up occurs leading to seroma formation and potential infection

Engineering Contradiction:
Improvesurgical simplicityVSAvoidseroma formation
Core Design Contradiction:
Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

The compression bra is applied immediately or shortly after surgery to begin the obliteration of dead spaces before seroma can form. The continuous compression prevents the accumulation of serum in empty spaces within the mammary chamber, proactively eliminating the condition that would lead to seroma formation and subsequent infection risk.

Inventive Principle:
Principle #10Preliminary action

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 reduces the risk of seroma formation by ensuring homogeneous compression and intimate contact between tissues, promoting better postoperative recovery and integration of implanted materials by maintaining a constant pressure gradient as the breast expands.

Implementation Method 1

internally contain, in the area that interfaces with the skin of the operated breast, several air chambers designed to be inflated with precise Pascal values in order to exert adjustable orthogonal compression on breast skin

Methodology Applied
Scientific EffectAir pressure: Pressure Increase

Implementation Method 2

compression must be exerted on the breast for at least 15 days to ensure that subcutaneous tissues adhere to the implanted biomaterials

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentEP3630020B1Medical device for postoperative compression following breast reconstruction surgery
Publication Date: 2023.11.22 DECO MED
  • EP3630020B1 patent drawingFigure 1~2
  • EP3630020B1 patent drawingFigure 3~4
  • EP3630020B1 patent drawingFigure 5~6

AI summary

Medical device for postoperative compression of breast skin following breast reconstruction surgery. The device comprises a female garment that supports the breast, and is characterised by the fact that each cup of the garment contains inflatable modules with defined pressure gradients that generate different compressive orthogonal vectors on the four quadrants of the breast, leaving the areola-nipple complex free. The inflatable tubular modules have, joined together, a shape that resembles a truncated cone with variable thickness that is minimum (equal to 0) in the area closest to the areola-nipple complex, and maximum in the area located furthest away from the areola-nipple complex. The inflatable modules can range from 2 to multiples of 2, and can be inflated separately through the valves. The medical device is made up of non-elastic tissue that prevents the cups from moving away from breast skin when air chambers are inflated, and it has two non-elastic tissue straps that cross on the spine and close like a belt on the front. In the two sub-axillary areas, the medical device presents a Velcro clasp that allows to insert the invention even when there is postoperative drainage in place.