Custom Cranial Remodeling Device via Point-of-Service Additive Manufacturing

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Solution Overview

Problem

Current methods for manufacturing custom cranial remodeling devices are prone to errors and require multiple steps, leading to inaccuracies and time delays due to physical separation between data capture and manufacturing locations, and they often rely on foam liners that can compress unevenly and lose conformance, necessitating frequent device changes and adjustments for patient growth.

Innovation Solution

Implementing point-of-service additive manufacturing at the clinic using a processor to generate a device file for a custom cranial remodeling device, which includes removable manufacturing supports and electronic sensors, allowing for on-site production with layers of varying strength and material properties, eliminating the need for foam layers and enabling real-time adjustments for patient growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional multi-step manufacturing process is used, then device can be manufactured with foam liner, but manufacturing precision deteriorates due to multiple steps and errors

Engineering Contradiction:

Improvemanufacturing process simplicityVSAvoiddevice shape accuracy

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent combines multiple manufacturing steps into a single additive manufacturing process. Instead of separately creating the shell and foam liner, both are manufactured together in one continuous process, eliminating the need for assembly and reducing cumulative errors from multiple steps.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent uses composite materials by manufacturing the shell and foam liner as integrated components. The foam liner is grown directly within the shell structure through selective deposition, creating a unified composite device that maintains both structural integrity and conformability.

Inventive Principle:

Principle #40Composite materials

2Adaptability or versatility

If foam liner is used to accommodate patient growth, then device adaptability improves, but reliability deteriorates due to uneven compression and spring back

Engineering Contradiction:

Improvedevice adjustability for growthVSAvoidfoam liner conformance retention

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent creates a dynamic foam liner structure with varying densities and stiffness properties in different regions. The foam is manufactured with gradient properties that allow it to deform and adapt to patient growth while maintaining overall structural support and preventing uneven compression.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The foam liner is manufactured with non-uniform properties - different regions have different cell densities and material characteristics. Areas requiring more compliance have softer foam, while areas needing structural support have denser foam, allowing localized adaptation without compromising overall reliability.

Inventive Principle:

Principle #3Local quality

3Ease of manufacture

If physical separation between clinic and manufacturing facility exists, then manufacturing can be specialized, but loss of time increases due to shipping delays

Engineering Contradiction:

Improvespecialized manufacturing capabilityVSAvoiddevice delivery time

Core Design Contradiction:

Ease of manufactureVSLoss of time

Solution Approach 1:

The patent enables the clinic to perform manufacturing itself using an additive manufacturing device on-site. The clinic captures the patient's head geometry and immediately manufactures the custom device in the same location, eliminating the need for external manufacturing facilities and shipping logistics.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the mechanical shipping and transportation system with digital data transmission. Instead of physically transporting device components between facilities, the head geometry data is transmitted electronically and used for immediate local manufacturing, dramatically reducing delivery time.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Adaptability or versatility

If frequent device changes are implemented to accommodate growth, then adaptability improves, but loss of time increases due to manufacturing and shipping cycles

Engineering Contradiction:

Improvedevice lifespan extensionVSAvoiddevice replacement frequency

Core Design Contradiction:

Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent manufactures the device with built-in growth accommodation features from the beginning. The foam liner is pre-configured with expansion capacity and adjustable elements that allow the device to grow with the patient, eliminating the need for frequent replacements and extending device lifespan.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS10603203B2Custom cranial remodeling devices manufactured by additive manufacture

Publication Date: 2020.03.31 CRANIAL TECHNOLOGIES INC

AI summary

A custom cranial remodeling device to correct a deformed head of a subject comprises an inner layer shaped to contact the head of the subject at predetermined areas, the inner layer is deposited by an additive manufacturing device and an outer layer deposited by the additive manufacturing device. The inner layer and the outer layer are each formed by the additive manufacture device utilizing a device data file derived from a subject data file, the subject data file representative of the shape of the deformed head, the device data file determining the shape of the cranial remodeling device to correct the shape of the deformed head.