3D-Modeled Trimming Guide for Guided Bone Regeneration Membranes
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Solution Overview
Problem
Current methods for guided bone and tissue regeneration, such as GTR and GBR, face challenges with material limitations and procedural inefficiencies, particularly in achieving optimal bone reconstruction and minimizing complications like soft tissue dehiscence and wound healing issues.
Innovation Solution
A membrane configured for bone and tissue regeneration, featuring a reinforced polytetrafluoroethylene (PTFE) mesh with a first layer for bone contact and a second layer to prevent fibrous connective tissue growth, designed using three-dimensional modeling and simulation tools for customized manufacturing and placement, including perforations for enhanced bone ingrowth and mechanical compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional barrier membranes are used for guided bone regeneration, then bone regeneration can be guided, but fibrous connective tissue may grow into the bone defect causing complications
Solution Approach 1:
The membrane incorporates a dense PTFE layer specifically positioned to prevent fibrous connective tissue growth while allowing bone contact on the opposite side. This local differentiation of material properties (dense vs. porous) addresses different functional requirements at different locations of the same device, resolving the contradiction between guiding bone regeneration and preventing harmful tissue growth.
Solution Approach 2:
The membrane is constructed as a composite structure combining ePTFE (expanded PTFE) with dense PTFE and collagen layers. Each material contributes specific properties: ePTFE for bone contact and integration, dense PTFE for barrier function against fibrous tissue, and collagen for structural support. This composite approach enables simultaneous achievement of bone regeneration guidance and harmful tissue prevention.
2Ease of operation
If customized membranes are manufactured using 3D modeling and simulation, then handling and placement efficiency improve, but manufacturing complexity increases
Solution Approach 1:
The membrane design process utilizes 3D modeling and simulation to pre-plan the optimal membrane configuration, perforation patterns, and reinforcement binder placement before manufacturing. This preliminary digital prototyping allows for optimization of handling characteristics and placement accuracy without requiring complex manual adjustments during surgery, resolving the contradiction between ease of operation and manufacturing complexity.
Solution Approach 2:
The invention replaces manual customization processes with automated 3D modeling and simulation systems. Instead of physically trial-fitting membranes during surgery, the digital models predict optimal designs that can be manufactured with precision, reducing the need for complex intraoperative adjustments and improving overall ease of operation despite increased upfront manufacturing complexity.
3Reliability
If perforations are added to the membrane for bone ingrowth, then bone regeneration efficacy improves, but structural integrity may be compromised
Solution Approach 1:
The membrane incorporates controlled porosity through strategically placed perforations in the dense PTFE layer, allowing bone ingrowth while maintaining sufficient structural integrity. The porous structure is optimized to provide just enough openness for bone cell migration and vascularization while the surrounding dense PTFE matrix maintains mechanical strength, resolving the contradiction between bone regeneration efficacy and structural integrity.
Solution Approach 2:
The membrane is segmented into multiple functional layers (ePTFE layer, dense PTFE layer with perforations, collagen layer) with reinforcement binders providing additional structural support. This segmentation allows the perforated dense PTFE layer to focus on bone ingrowth facilitation while other layers and reinforcement elements compensate for any structural weakness, maintaining overall membrane integrity.
Data Source
AI summary
This disclosure describes manufacturing of a device configured to guide bone and tissue regeneration for a bone defect. A method may include receiving a three-dimensional digital model or scan representing an anatomical feature to be repaired, generating a simulated membrane using the three-dimensional model, the simulated membrane being configured to cover the anatomical feature to be repaired, generating a digital two-dimensional flattened version of the simulated membrane, and generating code or instructions configured to cause a three-dimensional printer or milling device to produce a trimming guide that includes an opening corresponding to the flattened version of the simulated membrane and that further includes a cut-out configured to hold a premanufactured membrane. The trimming guide may be operative as a guide for marking or cutting the premanufactured membrane through the opening while the premanufactured membrane is held in the cut-out.


