Custom 3D SLA Stapes Prostheses for Anatomical Fit
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Solution Overview
Problem
Current stapes prostheses are standardized and do not match the unique shape of individual patients, leading to complications in surgeries for otosclerosis, such as stapedectomy and stapedotomy.
Innovation Solution
A custom-made stapes prosthesis is produced using 3D printing technology, specifically SLA printing, based on a patient's three-dimensional image, utilizing a non-osteogenic and non-cytotoxic polymeric material with controlled pore size and sound transmission properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standardized stapes prostheses are used, then manufacturing simplicity and cost-effectiveness are improved, but anatomical fit and surgical reliability deteriorate
Solution Approach 1:
The patent applies parameter changes by transitioning from standardized prostheses to custom-designed prostheses with patient-specific anatomical parameters. The prosthesis design incorporates patient-specific measurements including stapes size, shape, and orientation data obtained through imaging, allowing precise customization of dimensions and geometric features to match individual anatomy, thereby improving surgical reliability while maintaining manufacturing feasibility through digital design and additive manufacturing processes
2Productivity
If standardized stapes prostheses are used, then production efficiency is improved, but anatomical precision and sound conduction capability deteriorate
Solution Approach 1:
The patent applies preliminary action by performing preoperative imaging and digital modeling before prosthesis manufacturing. Patient-specific three-dimensional images are obtained and processed to create accurate digital models of the stapes and middle ear anatomy. This preliminary digital preparation enables precise customization of prosthesis dimensions and geometry before manufacturing, ensuring high anatomical precision while maintaining efficient production through digital fabrication processes
3Manufacturing precision
If custom 3D printed stapes prostheses are made, then anatomical fit and sound conduction are improved, but manufacturing complexity and material selection requirements deteriorate
Solution Approach 1:
The patent applies mechanics substitution by replacing traditional mechanical manufacturing processes with additive manufacturing technology. The custom stapes prosthesis is fabricated using selective laser melting or similar additive manufacturing processes that can precisely reproduce complex anatomical geometries from digital models. This substitution of manufacturing methodology enables high anatomical fit and customization while managing manufacturing complexity through digital fabrication capabilities
4Reliability
If custom 3D printed stapes prostheses are made, then surgical outcomes are improved, but material biocompatibility requirements and pore structure control deteriorate
Solution Approach 1:
The patent applies parameter changes in material selection by carefully controlling physical and chemical parameters of the prosthesis material to ensure biocompatibility and optimal acoustic performance. The material is selected and engineered with specific properties including appropriate density, rigidity modulus, Young's modulus, and shear modulus characteristics that match natural bone tissue. Pore size and distribution are controlled within specific ranges (5-100 micrometers average pore size) to balance mechanical integrity with bone ingrowth potential, while maintaining acoustic transparency for sound conduction. These parameter optimizations improve surgical outcomes by ensuring material compatibility and functional performance
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
The custom stapes prosthesis closely approximates the natural stapes bone, ensuring proper sound conduction and reducing surgical complications by providing a precise fit and biocompatibility.
Implementation Method 1
forming a stapes prosthesis that closely approximates a three-dimensional shape of the natural stapes bone via an additive manufacturing technique based on the three-dimensional image... the additive manufacturing technique may be 3D printing, including but not limited to 3D SLA printing
Data Source
AI summary
Methods for producing a custom-made stapes prosthesis for a patient and stapes prostheses so produced. The methods may include obtaining a three-dimensional image of a natural stapes bone of the patient; and forming a stapes prosthesis that closely approximates a three-dimensional shape of the natural stapes bone via an additive manufacturing technique based on the three-dimensional image. The stapes prosthesis comprises a suitable material that is not osteogenic and is not cytotoxic. The stapes prosthesis may include a plurality of pores having an average size of from about 5 to about 100 micrometers and may exhibit a frequency of sound transmission in a range of from about 2 to about 30 kilohertz.