Bolus Simulator Oral Device for Dysphagia Swallowing Stimulation

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Solution Overview

Problem

Individuals with dysphagia face challenges in swallowing due to impaired triggering of the pharyngeal stage, often associated with dry mouth and perception of dryness, leading to reduced nutritional intake and risk of foreign material entering the respiratory tract, for which existing devices have not provided effective solutions.

Innovation Solution

A swallowing exercise device featuring a bolus simulator and sensory stimulus applicator, designed to stimulate the oral cavity and oropharynx, incorporating a contoured handle, shield, and tether with a bolus simulator that can be flavored or scented, and a mechanism to deliver gas or liquid pulses to facilitate pharyngeal swallowing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If air-pulse trains are delivered through an oral device to stimulate swallowing, then the pharyngeal swallow may be facilitated, but the device complexity increases due to positioning and securing mechanisms

Engineering Contradiction:
Improveswallowing facilitationVSAvoidpositioning and securing mechanisms
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The oral device is divided into distinct functional components: a positioning member (shield) that secures the device in the oral cavity, a bolus simulator component that delivers tactile stimulation, and an air-pulse delivery system. This segmentation allows each component to be optimized independently while reducing overall positioning complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The oral device integrates multiple functions into a single apparatus: it positions itself in the oral cavity, delivers air-pulse trains for pharyngeal stimulation, provides tactile bolus simulation, and can be secured without complex external mechanisms. This multi-functionality reduces the need for separate positioning and securing devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If a bolus simulator is incorporated into the oral device to simulate food texture, then sensory stimulation is enhanced, but the device complexity increases

Engineering Contradiction:
Improvesensory stimulation effectivenessVSAvoidbolus simulator mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The bolus simulator creates a simplified tactile copy of food texture and bolus sensation without replicating the full complexity of actual food. It uses a controlled deformable element that mimics the pressure and texture sensations of a food bolus, providing adequate sensory stimulation with reduced mechanical complexity.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The bolus simulator utilizes pneumatic or hydraulic principles where air or fluid pressure is applied to a deformable element to create the sensation of a food bolus. This approach replaces complex mechanical food replication systems with simpler fluid-pressure-based deformation mechanisms.

Inventive Principle:
Principle #29Pneumatics and hydraulics

3Reliability

If the oral device is designed to deliver both air pulses and bolus simulation, then swallowing stimulation is improved, but the ease of operation decreases

Engineering Contradiction:
Improveswallowing stimulationVSAvoiddevice control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The air-pulse delivery system and bolus simulator are merged into a single integrated oral device that is positioned together in the oral cavity. This combination allows both stimulation modalities to be delivered simultaneously or sequentially without requiring separate devices, reducing operational complexity despite the enhanced stimulation capability.

Inventive Principle:
Principle #5Merging (Combining)

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 helps improve swallowing frequency and efficiency by stimulating sensory receptors, reducing the perception of dryness and enhancing the triggering of the pharyngeal stage, thereby reducing the risk of nutritional deficiencies and respiratory complications.

Implementation Method 1

A swallowing exercise device featuring a bolus simulator and sensory stimulus applicator, designed to stimulate the oral cavity and oropharynx

Methodology Applied
Scientific EffectTactile stimulation:

Implementation Method 2

a mechanism to deliver gas or liquid pulses to facilitate pharyngeal swallowing

Methodology Applied
Scientific EffectGas pulse delivery:

Data Source

PatentEP2830548B1Oral device with bolus simulator and method of use thereof
Publication Date: 2019.09.18 TRUDELL MEDICAL INT INC
  • EP2830548B1 patent drawingFigure 1A~6
  • EP2830548B1 patent drawingFigure 7A~10B
  • EP2830548B1 patent drawingFigure 11~16

AI summary

An oral device includes an intraoral bolus simulator comprising an exterior surface and having an interior volume fillable with a fluid. An extraoral user interface extends from the bolus simulator, and can be used to locate or position the intraoral bolus simulator. In various embodiments, the fluid may be a gas or a liquid, or combinations thereof. In other embodiments, an oral device includes an extraoral handle, a shield connected to the handle, a tether extending from the shield, and a bolus simulator connected to the tether.