Pre-Shaped ADM Graft Pockets for Time-Efficient Breast Reconstruction

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Solution Overview

Problem

Existing acellular dermal matrix (ADM) grafts face challenges in efficiency, efficacy, and repeatability during reconstructive surgeries due to the need for shaping and cutting during surgical procedures, which can be time-consuming and resource-intensive.

Innovation Solution

The development of pre-shaped, meshed ADM grafts derived from full-thickness skin, which are manufactured into specific shapes and patterns, verified for thickness, packaged, and irradiated to ensure sterility, allowing for off-the-shelf use in surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If ADM grafts are provided as solid or perforated material requiring shaping and cutting during surgery, then the grafts can be customized to patient-specific needs, but the surgical procedure becomes time-consuming and resource-intensive

Engineering Contradiction:

Improvecustomization to patient needsVSAvoidsurgical procedure time

Core Design Contradiction:

Adaptability or versatilityVSLoss of time

Solution Approach 1:

The ADM grafts are pre-shaped and pre-cut into specific configurations (such as rectangular, circular, or anatomically-specific shapes) during the manufacturing process before sterilization and packaging. This preliminary action eliminates the need for surgeons to perform time-consuming shaping and cutting operations during the surgical procedure, directly resolving the contradiction between customization adaptability and surgical time consumption.

Inventive Principle:

Principle #10Preliminary action

2Productivity

If ADM grafts are pre-shaped and manufactured into specific configurations, then surgical efficiency and repeatability improve, but the manufacturing process complexity increases

Engineering Contradiction:

Improvesurgical efficiencyVSAvoidmanufacturing process complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The manufacturing process utilizes controlled parameter changes including temperature-controlled forming, precision cutting parameters, and standardized dimension specifications to create pre-shaped grafts. These parameter-controlled processes, while adding manufacturing steps, ensure consistent quality and repeatability that ultimately improve surgical efficiency and productivity.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The manufacturing process is segmented into distinct standardized steps (decellularization, shaping, cutting, sterilization, packaging) that can be independently optimized and quality-controlled. This segmentation of the manufacturing process manages complexity by creating modular, repeatable operations rather than a single complex continuous process.

Inventive Principle:

Principle #1Segmentation

3Stability of the object's composition

If ADM grafts are decellularized using ionic and nonionic detergent methods, then the extracellular matrix structure is preserved, but the manufacturing process requires multiple chemical treatment steps

Engineering Contradiction:

Improveextracellular matrix integrityVSAvoidmanufacturing process steps

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The decellularization process merges multiple chemical treatment steps (ionic detergent treatment, nonionic detergent treatment, and enzymatic digestion) into a coordinated sequential process that works synergistically to remove cells while preserving the extracellular matrix. This combined approach achieves better matrix preservation than single-method approaches, justifying the multiple steps through their cumulative beneficial effect.

Inventive Principle:

Principle #5Merging (Combining)

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 pre-shaped, meshed ADM grafts provide efficient fluid drainage, reduce seroma formation, and enhance integration into the body, offering a repeatable and time-efficient solution for surgeons by eliminating the need for on-site shaping and cutting.

Implementation Method 1

irradiating the packaged, pre-shaped, and meshed ADM graft to a sterility assurance level of 10−6 to form the ADM graft product

Methodology Applied

Scientific EffectIrradiation: Radiation

Data Source

PatentUS12458730B2Pre-shaped allograft implant for reconstructive surgical use and methods of manufacture and use, and tools for forming a pre-shaped allograft implant for reconstructive surgical use

Publication Date: 2025.11.04 ALLOSOURCE

AI summary

There is disclosed an acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket product prepared by a process that includes providing a portion of ADM tissue having a thickness between 1 mm and 2 mm. The process includes scoring the portion of the ADM tissue into a pre-defined shape to form the domed shape ADM graft. The process includes verifying the thickness of the domed shape ADM graft; shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. The process includes packaging the ADM graft pocket to form a packaged ADM graft pocket. The process includes irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product. Other embodiments are also disclosed.