Biomaterial Mesh for Muscle-Sparing Breast Reconstruction
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Solution Overview
Problem
Current breast reconstruction techniques after mastectomy often result in muscle damage and loss of movement, particularly affecting the pectoralis major muscle, leading to deficiencies in arm flexion, internal rotation, and adduction, which impact daily activities and require costly rehabilitation therapies.
Innovation Solution
A medical device comprising a biomaterial box element with multiple partitions, designed to enclose a breast implant and be sutured to the pectoralis major muscle, allowing for muscle-sparing reconstruction without compromising muscle functionality, reducing postoperative pain, and minimizing surgical complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional submuscular pocket creation is used for breast reconstruction, then the breast implant can be placed and secured, but the pectoralis major muscle is dissected and resected causing loss of movement and muscle functionality
Solution Approach 1:
A mesh device acts as an intermediary structure between the breast implant and the pectoralis major muscle. The mesh is secured to the muscle fascia and provides attachment points for the implant, eliminating the need for direct muscle dissection and resection while maintaining reconstruction stability.
Solution Approach 2:
The reconstruction approach is segmented into distinct functional layers: the mesh device attached to the muscle fascia provides structural support, while the breast implant provides the cosmetic result. This segmentation allows the muscle to remain intact and functional while still achieving secure implant placement.
2Reliability
If muscle dissection and resection is performed to create submuscular pocket, then the implant can be covered and positioned, but postoperative pain and rehabilitation requirements increase
Solution Approach 1:
The mesh device serves as a mediator that provides implant coverage and positioning without requiring extensive muscle dissection. By anchoring to the muscle fascia rather than dissecting through the muscle, postoperative pain is reduced and rehabilitation requirements are minimized.
3Reliability
If pectoralis major muscle is disconnected for implant placement, then the implant can be secured in submuscular position, but arm flexion, internal rotation, and adduction are compromised
Solution Approach 1:
The mesh device acts as an intermediary anchoring system that secures the implant without disconnecting the pectoralis major muscle. The mesh attaches to the muscle fascia and provides secure implant positioning while preserving the muscle's integrity and full range of motion for arm flexion, internal rotation, and adduction.
4Volume of moving object
If traditional two-stage reconstruction with tissue expander is used, then large breasts can be reconstructed, but the process requires multiple operations and extended time
Solution Approach 1:
The mesh device is pre-positioned and secured to the muscle fascia before implant placement, creating a prepared framework that allows for single-stage reconstruction. This preliminary action eliminates the need for separate tissue expander stages, reducing the number of operations and total reconstruction time while still achieving appropriate breast volume.
Data Source
AI summary
Medical device made of biomaterial, for implant-based breast reconstruction, having a flat original shape of plane geometry, with sections, which sutured together define the front part, lateral, upper and lower of a box element, at least one of the aforesaid sections having at least one appendix adapted to define the rear part of the box element, said box element being adapted to wrap and contain integrally a breast prosthesis, said box element being configured to be interposed between the subcutaneous layer and the pectoralis major muscle and being suturable to the latter.