Force-Distributing Neonatal Cranial Support Device

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Solution Overview

Problem

The incidence of cranial molding, particularly deformational plagiocephaly, has increased in neonates due to the 'Back to Sleep' campaign, leading to potential developmental impairments, and existing solutions have not adequately addressed this issue, with ongoing challenges in reducing pressure-related deformities and skin breakdowns.

Innovation Solution

A force-distributing cranial support device that disperses external forces over a larger area, reducing pressure on the occipital region and cranium, designed to be affixed to a neonate's head to prevent and treat cranial molding, while also addressing skin interface pressures to prevent pressure ulcers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If neonates are placed in supine position for SIDS prevention, then sudden infant death syndrome risk decreases, but cranial molding incidence increases

Engineering Contradiction:
ImproveSIDS preventionVSAvoidcranial molding
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A force-distributing cranial support device is introduced as an intermediary between the neonate's occipital region and the supporting surface. This device mediates the harmful effect of supine positioning by distributing contact forces, thereby preventing cranial molding while maintaining the beneficial supine sleep position for SIDS prevention.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention changes the pressure distribution parameters at the cranial interface by using a specially designed support device with force-distributing characteristics. This modifies the contact pressure from concentrated to distributed, preventing the harmful effects of cranial molding while maintaining supine positioning.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If force-distributing cranial support device is used, then cranial molding is prevented, but device complexity increases

Engineering Contradiction:
Improvecranial molding preventionVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The force-distributing cranial support device utilizes flexible shell structures and thin film materials to achieve force distribution across the occipital region. This approach provides effective cranial molding prevention while maintaining relatively simple device construction, avoiding the need for complex rigid structures or multiple components.

Inventive Principle:
Principle #30Flexible shells and thin films

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 device effectively reduces peak pressures and increases contact areas, promoting normal head growth, preventing cranial molding, and aiding in the healing of pressure-related tissue damage, thus potentially improving cognitive development and overall health outcomes.

Implementation Method 1

the gel layer 144 dimensioned between about 5 mm and about 10 mm in thickness was dramatically effective at distributing force in a simulated use both by decreasing peak pressure and by increasing the contact area

Methodology Applied
Scientific EffectForce distribution:

Implementation Method 2

The inner pad layer 140 and the outer pad layer 142 may each comprise a polyethylene foam or a polyurethane foam

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentUS10966859B2Force distribution method and apparatus for neonates at risk of cranial molding
Publication Date: 2021.04.06 INVICTUS MEDICAL
  • US10966859B2 patent drawing
  • US10966859B2 patent drawing
  • US10966859B2 patent drawing

AI summary

A force distribution apparatus and method are presented. Various embodiments of the disclosed apparatus include a plurality of layers configured and oriented to be deployed on a subject in a manner that disperses forces and lowers peak pressures experienced by the subject when resting on a surface, which tends to minimize risks of deformation and local ischemia. An innovative combination of novel construction methods and material selections produce an apparatus that possesses an inherent three-dimensional shape despite being built from essentially flat components, while also retaining an ability to effectively distribute forces and reduce pressures.