Acellular Dermal Matrix Coated Breast Implant
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Solution Overview
Problem
Current implantable breast prostheses often lead to capsular contracture, a condition where the body reacts to the implant as a foreign body, resulting in excessive scarring, implant displacement, pain, and the need for frequent re-operations, as the existing solutions have been less than optimal in preventing or reducing these issues.
Innovation Solution
Incorporating a biological interface made of acellular dermal graft material, which is affixed to the implant, positioned between the implant and host tissue, to promote regenerative repair rather than scar formation, thereby reducing the immune system's reaction to the implant as a foreign body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a smooth nonreactive outer surface is used, then the implant is considered inert, but the host still reacts by forming a fibrous capsule causing capsular contracture
Solution Approach 1:
The patent introduces an acellular dermal matrix as an intermediary layer between the implant and host tissue. This biologically-derived matrix serves as a mediator that promotes tissue integration and reduces the foreign body reaction, thereby preventing capsular contracture while maintaining the inertness of the implant itself.
Solution Approach 2:
The patent creates a composite structure consisting of the implant combined with an acellular dermal matrix coating. This composite material approach allows the implant to maintain its nonreactive properties while the biologically-derived matrix provides tissue compatibility and reduces encapsulation.
2Ease of repair
If surgical corrections are performed to combat encapsulation, then capsular contracture is treated, but re-operation rates remain unacceptably high
Solution Approach 1:
The patent applies preliminary action by pre-coating the implant with acellular dermal matrix before insertion. This preventive measure is taken in advance to reduce the foreign body reaction and prevent capsular contracture from developing, thereby reducing the need for subsequent surgical corrections and re-operations.
Solution Approach 2:
The patent employs preliminary anti-action by using the acellular dermal matrix to counteract the host's immune response before the capsular contracture can fully develop. The matrix pre-empts the harmful encapsulation process by promoting tissue integration and reducing fibrous capsule formation.
3Reliability
If the fibrous capsule tightens around the implant, then the implant is walled off from host tissue, but this causes shape distortion, implant displacement, and patient discomfort
Solution Approach 1:
The acellular dermal matrix acts as an intermediary layer that prevents the direct contact between the implant and host tissue that would otherwise lead to fibrous capsule formation and tightening. This mediator allows the implant to remain isolated while preventing the harmful tightening and displacement effects.
Solution Approach 2:
The patent changes the physical and biological parameters of the implant surface by coating it with acellular dermal matrix. This modification alters the interface properties between implant and host tissue, reducing the tendency for capsule tightening and implant displacement while maintaining appropriate isolation.
Data Source
Figure 1~11
Figure 12a~12c
Figure 12d
AI summary
A medical implant assembly (10), comprising a medical implant (12) having a flexible silicone elastomeric shell and a filler of enhanced cohesive silicone gel; and a discrete and separate acellular dermal layer of material (20) which is draped to envelope the entire implant creating intimate engagement between the implant and the material; wherein the acellular dermal layer of material (20) has capsular contracture inhibiting properties.