Nested Hard Tissue Implants for Bone Conservation
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Solution Overview
Problem
Current hard tissue replacement implant procedures often result in excessive removal of healthy bone due to conservative approaches to ensure margins are free of cancerous cells, leading to time-consuming and costly iterations of resection and testing.
Innovation Solution
A nesting hard tissue replacement implant assembly is used, where an inner implant is initially secured based on pre-operative planning for a first margin likely to be cancer-free, and an outer implant is secured later if necessary, allowing the inner implant to nest within the outer, reducing the need for multiple resections and using a single implant system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conservative approach is used to ensure margins are free of cancerous cells, then reliability of cancer-free margins is improved, but excessive healthy bone is removed and time is increased
Solution Approach 1:
The implant system is segmented into multiple nested components (inner implant and outer implant) that can be selectively applied. The inner implant addresses the primary resection area, while the outer implant provides additional coverage if margins are not clear, eliminating the need for iterative resections and testing.
Solution Approach 2:
Multiple implant sizes and configurations are prepared in advance as part of the implant system. This preliminary preparation allows the surgeon to address multiple margin scenarios in a single surgical procedure without needing to perform repeated resections and wait for pathology results.
2Reliability
If a conservative approach is used to ensure margins are free of cancerous cells, then reliability of cancer-free margins is improved, but cost is increased
Solution Approach 1:
The nested implant system serves multiple functions within a single product family. The same system can be used for both single-stage and multi-stage margin management, replacing the need for multiple different implant types and iterative procedures, thereby reducing overall treatment cost.
Solution Approach 2:
The inner implant is designed to nest within the outer implant, creating a compact, space-efficient structure. This nesting design allows both implants to be part of a single integrated system that can be stored, handled, and implanted together, reducing the complexity and cost of managing multiple separate implant procedures.
3Reliability
If multiple resections are performed to ensure cancer-free margins, then reliability of cancer-free margins is improved, but healthy bone is excessively removed
Solution Approach 1:
The implant system is designed to be adaptable and dynamic in its application. The surgeon can selectively use the inner implant alone or combine it with the outer implant based on intraoperative margin assessment, allowing precise control over the extent of bone removal while ensuring cancer-free margins.
Solution Approach 2:
The nested implant structure acts as an intermediary between aggressive margin removal and conservative margin management. The inner implant provides primary coverage with minimal bone removal, while the outer implant offers additional protection if needed, mediating between the need for clear margins and preservation of healthy bone.
Data Source
AI summary
A method of replacing a portion of a cranium with a hard tissue implant can include resecting a first portion of the cranium to define a first margin region. The first portion of the cranium can be analyzed to determine if the first margin region is free of cancerous cells. A second portion of the cranium can be resected to define a second margin region that is larger than the first margin region when the first margin region is not free of cancerous cells. An outer implant can be secured to the cranium at the second margin region. An inner implant can be secured to the outer implant.