P4HB Absorbable Implants for Breast Reconstruction Support

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Solution Overview

Problem

Current plastic surgery techniques for breast reconstruction and mastopexy often result in recurrent ptosis due to reliance on aging tissues, with existing absorbable meshes providing insufficient long-term support as they rapidly degrade, failing to allow sufficient time for regenerated host tissue to form and provide lasting support.

Innovation Solution

Development of absorbable implants made from poly-4-hydroxybutyrate (P4HB) with shape memory properties, designed to conform to the breast and chest wall without buckling, and capable of transitioning support from the implant to regenerated host tissue, featuring a prolonged strength retention profile and high suture pullout strength to resist mechanical loads.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If absorbable meshes are used to provide temporary support during tissue regeneration, then the implant can be absorbed and replaced by host tissue, but the mesh degrades too rapidly to provide sufficient long-term support

Engineering Contradiction:
Improveduration of implant supportVSAvoidstrength retention of mesh
Core Design Contradiction:
Duration of action of moving objectVSStrength

Solution Approach 1:

The patent changes the material parameter from conventional absorbable meshes (polyglactin, polyglycolide) to poly-4-hydroxybutyrate (P4HB), which has fundamentally different degradation kinetics. This parameter change extends the functional duration from weeks to months while maintaining adequate strength retention throughout the tissue regeneration period.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite construction by combining P4HB base material with reinforcing elements such as ribbing, anchoring features, and potentially multiple layers or coatings. This composite approach maintains high strength retention while the overall structure remains absorbable and biocompatible.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If permanent meshes are used to provide long-term support, then the support duration is extended, but the mesh cannot be replaced by regenerated host tissue

Engineering Contradiction:
Improveduration of support provisionVSAvoidtissue regeneration capability
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent uses an absorbable implant that serves its purpose temporarily and then degrades, being replaced by the patient's own regenerated tissue. This eliminates the need for permanent foreign materials while ensuring long-term support through biologically integrated tissue regeneration.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The implant performs preliminary support action during the critical tissue regeneration period, then transfers its load-bearing function to the regenerated host tissue. The extended duration of strength retention ensures this transition occurs smoothly without support gaps.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If traditional mastopexy techniques are used relying on pre-existing skin envelope, then the procedure uses existing tissue structures, but recurrent ptosis occurs due to aging and sagging tissues

Engineering Contradiction:
Improveuse of existing tissue structuresVSAvoidlong-term support stability
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The P4HB implant acts as an intermediary support structure between the aging skin envelope and the regenerated host tissue. It provides the additional reinforcement needed to overcome tissue aging effects, then transfers support to the newly formed tissue as it matures.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The implant performs preliminary reinforcement of the skin envelope and tissue structures before the regenerated tissue is fully mature. This preliminary support prevents recurrent ptosis during the vulnerable regeneration period when tissues are still weak.

Inventive Principle:
Principle #10Preliminary action

4Duration of action of moving object

If rapidly absorbing meshes are used to form internal support structures, then the mesh can be absorbed quickly, but insufficient time is provided for regenerated host tissue to form and provide lasting support

Engineering Contradiction:
Improvemesh absorption timeVSAvoidtissue regeneration completeness
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The patent fundamentally changes the absorption time parameter from rapid (weeks) to extended (months) by using P4HB material. This parameter adjustment ensures the mesh remains intact throughout the entire tissue regeneration process, providing continuous support until the new tissue is fully functional.

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 P4HB implants provide sustained support during the transition from implant to host tissue, minimizing recurrent ptosis and allowing for long-term tissue in-growth, maintaining breast shape and support beyond the implant's absorption timeframe, with the shape memory feature enabling minimally invasive procedures and conforming to anatomical shapes without bunching or rippling.

Implementation Method 1

The P4HB implants provide sustained support during the transition from implant to host tissue, minimizing recurrent ptosis

Methodology Applied
Scientific EffectStrength retention:

Implementation Method 2

absorbable implants made from poly-4-hydroxybutyrate (P4HB) with shape memory properties, designed to conform to the breast and chest wall without buckling

Methodology Applied
Scientific EffectShape memory: Shape Memory Polymer

Implementation Method 3

allowing for long-term tissue in-growth, maintaining breast shape and support beyond the implant's absorption timeframe

Methodology Applied
Scientific EffectTissue in-growth:

Data Source

PatentUS10722345B2Absorbable implants for plastic surgery
Publication Date: 2020.07.28 TEPHA INC
  • US10722345B2 patent drawing
  • US10722345B2 patent drawing
  • US10722345B2 patent drawing

AI summary

Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof. The implants have suture pullout strengths that can resist the mechanical loads exerted on the reconstructed breast.