Shape Memory Polymer Ear Canal Mold for Surgical Guide Fabrication
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Solution Overview
Problem
Current medical devices, particularly those involving implantable components, face challenges in accurately accessing and interacting with the unique anatomy of individual patients' ears for procedures such as cochlear implants and drug delivery, often requiring invasive methods and lacking precise, reusable guides for minimally invasive surgery.
Innovation Solution
A method and apparatus involving a material that transforms from a first state to a second state, retaining a memory of the ear's shape, allowing for the creation of a custom negative model of the ear canal and middle ear anatomy, enabling precise and reusable surgical guides for accessing the middle and inner ear, including the use of custom ear canal guides and catheters for targeted interventions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional invasive methods are used to access the ear canal and middle ear, then surgical access can be achieved, but tissue damage increases and procedural precision decreases
Solution Approach 1:
The patent applies preliminary action by creating custom-fitted ear canal guides and surgical models before the actual surgical procedure. These guides are manufactured based on pre-operative imaging data (CT or MRI scans) to match the patient's unique ear canal anatomy. By preparing these precision guides in advance, the surgery can proceed with minimal invasive actions, as the guides pre-establish the correct trajectory and positioning, thereby reducing tissue damage while improving surgical precision.
Solution Approach 2:
The patent employs copying by creating physical replicas or digital models of the patient's ear canal anatomy from medical imaging data. These copies (custom guides and surgical models) replicate the unique geometric features of the patient's ear canal, allowing surgeons to plan and execute procedures with high precision without repeatedly probing or damaging the actual tissue during surgery.
2Manufacturing precision
If custom surgical guides are created for each patient's unique ear anatomy, then procedural precision improves, but device complexity and manufacturing time increase
Solution Approach 1:
The patent applies universality by designing a modular guide system where certain components can be standardized while maintaining customization where needed. The surgical guides incorporate universal interface features and standardized manufacturing processes that can be adapted to different patients' anatomy. This allows the system to handle unique ear canal geometries while using common manufacturing techniques and tooling, thereby reducing overall device complexity and manufacturing time.
Solution Approach 2:
The patent utilizes parameter changes by varying only the necessary geometric parameters of the surgical guides based on patient-specific imaging data, while keeping other parameters standardized. The customization process adjusts specific dimensional parameters (such as curvature, diameter, and trajectory angles) to match the patient's ear canal, while maintaining standard material properties, manufacturing tolerances, and interface specifications. This selective parameter customization reduces complexity compared to complete custom design.
3Productivity
If reusable surgical guides are implemented, then procedural efficiency improves and costs decrease, but the guides must be sterilized and maintained between uses
Solution Approach 1:
The patent applies flexible shells and thin films by designing surgical guides with smooth, non-porous surfaces that are resistant to sterilization processes. The guides are constructed from biocompatible materials with surface treatments that prevent bacterial adhesion and facilitate easy cleaning. This allows the guides to withstand repeated autoclaving and chemical sterilization without degrading, making them suitable for reuse while maintaining surgical efficiency and reducing per-procedure costs.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise, minimally invasive access to the middle and inner ear, facilitating accurate placement of medical devices and drug delivery systems while allowing for repeated use of surgical guides, reducing tissue damage and improving procedural efficiency.
Implementation Method 1
transporting a material in a first state so that the material comes into contact with a wall of the outer ear, at least permitting the first material to transform to a second state, and removing the material in the second state from contact with the wall of the outer ear, wherein the material in the second state retains a memory of a shape of the wall of the outer ear
Data Source
AI summary
A method, including accessing an ear system of a live human, transporting a material in a first state so that the material comes into contact with a wall of the outer ear, at least permitting the first material to transform to a second state and removing the material in the second state from contact with the wall of the outer ear, wherein the material in the second state retains a memory of a shape of the wall of the outer ear into which the material was in contact when transforming to the second state.