Automated Biodegradable Nerve Guide Fabrication System
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Solution Overview
Problem
Current treatments for long gap peripheral nerve injuries, such as autografting, are limited by longer operating times and suboptimal repair due to lack of cellular cues for nerve regrowth, and commercially available allografts fail to provide the necessary Schwann cell secretome for optimal repair.
Innovation Solution
A system and method for producing biodegradable constructs with a reservoir, mandrel, and mechanisms to create a tube with embedded particles and polymers, allowing for controlled delivery of active agents like GDNF to promote nerve regeneration, using a microcontroller to automate the process and ensure precise orientation and coating of the mandrel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If autografting is used to repair long gap peripheral nerve injuries, then nerve repair can be achieved, but operating time increases and permanent numbness may occur
Solution Approach 1:
The patent employs a biodegradable nerve guide construct that is disposed of after serving its temporary function of guiding nerve regeneration. The construct degrades over time as the nerve regenerates, eliminating the need for long-term implants or complex retrieval procedures, thus reducing overall surgical time and resource investment.
Solution Approach 2:
The biodegradable nerve guide acts as an intermediary structure that temporarily bridges the nerve gap and facilitates regeneration. It provides mechanical support and guides nerve growth without requiring the patient's own nerve tissue, thereby avoiding the time-consuming autograft harvesting process while still achieving effective nerve repair.
2Reliability
If autografting is used to repair peripheral nerve injuries, then nerve repair can be achieved, but a second surgical site is required causing longer operating times
Solution Approach 1:
The biodegradable nerve guide is a single-use, disposable construct that eliminates the need for complex autograft harvesting and transplantation procedures. By using a pre-fabricated biodegradable scaffold, the surgery becomes simpler and does not require a second surgical site, reducing overall procedural complexity.
Solution Approach 2:
The nerve guide construct is segmented into multiple functional components including different polymer layers, embedded particles, and growth factor reservoirs. This segmentation allows each component to perform its specific function independently, simplifying the overall surgical implantation process while maintaining repair effectiveness.
3Ease of manufacture
If commercially available allografts are used for nerve repair, then nerve guide function is provided, but cellular cues for nerve regrowth are insufficient
Solution Approach 1:
The nerve guide construct uses composite materials including biodegradable polymers (PLLA, PCL), embedded particles (hydroxyapatite, bioactive glass), and growth factors (GDNF). This composite structure provides both the mechanical framework and the biological cues necessary for effective nerve regeneration, overcoming the limitations of commercial allografts.
Solution Approach 2:
The construct incorporates different materials and growth factors at specific locations within the nerve guide. For example, GDNF is embedded in specific layers or zones where it can locally stimulate nerve regeneration, while other regions provide structural support. This localized functional differentiation enhances nerve regrowth support compared to uniform commercial allografts.
4Duration of action of moving object
If biodegradable constructs with embedded particles are produced, then controlled delivery of active agents is achieved, but manufacturing complexity increases
Solution Approach 1:
The construct employs a nested structure where particles are embedded within polymer layers, which themselves are contained within the overall nerve guide structure. This nesting allows multiple functional components to be integrated in a compact manner, extending active agent delivery duration without proportionally increasing external complexity.
Solution Approach 2:
The active agents and particles are pre-loaded into the nerve guide construct during manufacturing, before implantation. This preliminary action allows the complex multi-component structure to be prepared in advance with controlled release characteristics, simplifying the implantation process while maintaining extended duration of action.
Data Source
AI summary
The presently disclosed subject matter relates to systems for making an implantable construct comprising a reservoir coupled to the at least one frame; a mandrel base coupled to the at least one frame; a mandrel coupled to the mandrel base; a first mechanism configured to be coupled to the at least one frame and configured to move the at least one frame along a first axis; a second mechanism configured to be coupled to the at least one frame and configured to rotate the least one mandrel base along a second axis between a first orientation and a second orientation; and a container configured to be coupled to the at least one frame and configured to receive the mandrel in the second orientation. The disclosed mechanisms can manually, semi-automatically, or automatically control the movements of the at least one frame, reservoir, mandrel, mandrel base, and container to produce the construct with a lumen. The presently disclosed subject matter also relates to methods for making the construct.