3D-Printed Immobilization Element for Fast Custom Fit
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Solution Overview
Problem
Current methods for manufacturing individualized immobilization elements, such as splints and masks, are inefficient and uncomfortable for patients due to the need for direct shaping of thermoplastic materials, which can take a long time and require significant patient restraint, and often result in suboptimal fit and increased risk of contamination.
Innovation Solution
A method utilizing additive manufacturing with a thermoplastic polymer having a melting point less than or equal to 100°C, combined with a nucleating agent, to create immobilization elements based on three-dimensional images of the body part, allowing for precise shaping and reduced material waste, and enabling re-shaping post-manufacture for optimal fit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If thermoplastic material is heated and shaped directly on the body part, then the fit of the immobilization element is improved, but the production time increases and patient comfort deteriorates
Solution Approach 1:
The patent applies preliminary action by creating a negative mold of the body part before the actual immobilization element production. This mold captures the exact contours and dimensions, allowing subsequent additive manufacturing to proceed without time-consuming direct shaping on the patient's body, thus reducing production time while maintaining precise fit.
Solution Approach 2:
The patent uses copying by creating a negative mold that replicates the body part's surface geometry. This mold serves as a template for additive manufacturing, enabling the immobilization element to be produced with accurate dimensional correspondence to the body part without requiring direct contact and shaping during the manufacturing process.
2Manufacturing precision
If thermoplastic material is heated and shaped directly on the body part, then the fit of the immobilization element is improved, but patient comfort and restraint requirements worsen
Solution Approach 1:
The negative mold is created in advance during a brief scanning process, capturing all necessary geometric information. This preliminary action eliminates the need for prolonged heating and shaping procedures on the patient's body, significantly improving comfort while maintaining manufacturing precision through the mold-based replication process.
Solution Approach 2:
By copying the body part's geometry into a negative mold, the patent separates the measurement phase from the manufacturing phase. The actual immobilization element is then produced through additive manufacturing based on this copy, eliminating the need for continuous patient restraint and direct body contact during production, thereby improving ease of operation.
3Reliability
If connecting means are added to the immobilization element, then the stability of fixation is improved, but the risk of contamination increases
Solution Approach 1:
The patent merges the connecting means with the immobilization element by integrating them into a single monolithic structure produced through additive manufacturing. This eliminates separate components and assembly steps, reducing contamination risk from multiple material interfaces and assembly operations while maintaining fixation stability through the integrated design.
Solution Approach 2:
The patent employs composite materials by incorporating multiple functional features (immobilization surface, connecting profiles, reinforcement structures) into a single multi-material or multi-functional polymer structure. This integrated composite approach reduces the number of separate components that could introduce contamination while maintaining or enhancing fixation reliability.
4Productivity
If additive manufacturing is used to produce immobilization elements, then production time and material waste are reduced, but the need for post-manufacturing shaping increases
Solution Approach 1:
The patent applies parameter changes by utilizing the programmable nature of additive manufacturing to directly control the geometric parameters of the immobilization element. The negative mold data provides precise dimensional constraints that guide the additive manufacturing process, enabling production of near-net-shape components that require minimal post-manufacturing adjustment while maintaining high productivity.
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
This approach enables immediate production of immobilization elements in the desired shape and dimensions, improving patient comfort, reducing production time, and enhancing immobilization stability with minimal risk of contamination and pressure points, while allowing for adjustments to fit changing body shapes.
Implementation Method 1
a thermoplastic polymer having a melting point less than or equal to 100°C
Implementation Method 2
The polymer material is deposited in the molten or softened state, or is at least partially cross-linked after having been deposited, after which the polymer material is cooled
Implementation Method 3
the polymer material contains a nucleating agent capable of enhancing crystallization of the thermoplastic polymer
Implementation Method 4
the polymer material contains a cross-linking agent capable of cross-linking the thermoplastic polymer
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
This invention relates to a method for manufacturing an individualized immobilization element for the non-invasive immobilization and/or mobilization of at least a segment of a body part of a patient in a predetermined position relative to a reference and/or in a pre- certain configuration. The method comprises the steps of (i) providing a data set that comprises a three-dimensional image of an outer contour of at least a part of the segment of the body part to be immobilized and/or mobilized and (ii) the manufacture of at least a part of the immobilization element by rapid manufacturing of a shape on the basis of said data set using a polymeric material containing a thermoplastic polymer having a melting point less than or equal to 100°C, wherein the polymer material contains a nucleating agent for enhancing the of the crystallization of the thermoplastic polymer.