Decellularized Nipple Grafts for Projection Maintenance

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Solution Overview

Problem

Current surgical methods for nipple and areola reconstruction are unsatisfactory due to issues with maintaining nipple projection, tissue necrosis, and the need for multiple tattoo sessions, with no tissue engineering strategies successfully reconstructing the nipple and areola.

Innovation Solution

Decellularized nipple and areola grafts that retain cell adhesion molecules like laminin, fibronectin, and collagen VI, which are repopulated with keratinocytes to provide a naturally aesthetic reconstruction, using a process involving detergent-based decellularization and biocompatible occlusive coatings for grafting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical techniques are used to reconstruct nipple and areola, then reconstruction can be achieved, but nipple projection is lost over time and tissue necrosis occurs

Engineering Contradiction:
Improvenipple projection maintenanceVSAvoidtissue necrosis
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and removes damaged or necrotic tissue from the reconstruction site, then uses decellularized dermal matrix grafts to replace the compromised tissue. This extraction principle addresses tissue necrosis by eliminating dead tissue and replacing it with a biocompatible scaffold that promotes healthy tissue regeneration without the harmful effects of traditional surgical flaps.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the physical and biological parameters of the reconstruction material by using decellularized dermal matrix with specific mechanical properties and biochemical composition. This matrix provides sustained structural support that maintains nipple projection over time, unlike traditional techniques that lose projection. The controlled parameter changes in the graft material prevent tissue necrosis while ensuring long-term structural integrity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If traditional surgical techniques are used, then reconstruction is possible, but multiple tattoo sessions are required and color fades over time

Engineering Contradiction:
Improvecolor permanenceVSAvoidmultiple tattoo sessions
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent incorporates pigmentation directly into the decellularized dermal matrix graft during the manufacturing process, before implantation. This preliminary action eliminates the need for subsequent tattoo sessions, as the color is permanently integrated into the reconstructed tissue structure. The pigmentation is embedded at the cellular level within the matrix, ensuring long-term color stability without fading.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If decellularized grafts are used to maintain natural shape and projection, then cosmetic improvement is achieved, but complex decellularization processes are required

Engineering Contradiction:
Improvenatural shape retentionVSAvoiddecellularization process
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent employs controlled parameter changes during the decellularization process, including specific detergent concentrations, incubation temperatures, and processing times, to achieve consistent removal of cellular material while preserving the extracellular matrix architecture. These precisely controlled parameter changes ensure that the natural shape and projection of the nipple and areola are maintained in the decellularized graft, achieving high manufacturing precision despite process complexity.

Inventive Principle:
Principle #35Parameter changes

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 decellularized grafts maintain the natural shape and projection of the nipple and areola, providing a cosmetically improved reconstruction with keratinocytes repopulating the graft, addressing the limitations of existing surgical techniques.

Implementation Method 1

decellularized by contacting the body part with at least one detergent under conditions sufficient to decellularize the epidermis and the dermis in the body part

Methodology Applied
Scientific EffectDetergent-based decellularization:

Data Source

PatentEP3212247B1Surgical grafts for replacing the nipple and areola or damaged epidermis
Publication Date: 2021.04.07 THE ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND
  • EP3212247B1 patent drawingFigure 1
  • EP3212247B1 patent drawingFigure 2
  • EP3212247B1 patent drawingFigure 3

AI summary

The present disclosure relates to surgical grafts for replacing nipples and areolas lost to disease or trauma with surgical grafts of decellularized donor nipples and areolas and to placing and recellularizing such grafts. The disclosure further provides methods for decellularizing epidermis. The decellularized epidermis can be used as a protective cover for skin wounds.