Tracheostoma Spacer with Expandable Framework

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Solution Overview

Problem

Percutaneous tracheotomy methods face challenges where the tracheostoma closes quickly after removal of the cannula or tube, making repeated insertion difficult or impossible due to the large and bulky nature of existing cannulae or tubes, which do not conform to patient anatomy and fail to assist in dilatation.

Innovation Solution

A tracheostoma spacer with a tubular support framework that can be expanded from an initial compressed state to a larger diameter, featuring a fixing element to prevent displacement and adjustable length, allowing for individual adaptation to anatomical needs, and incorporating features like shape memory elements and atraumatic edges for secure placement and easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If large and bulky cannulae or tubes are used to keep the tracheostoma open, then the tracheostoma remains patent, but the device protrudes from the patient's neck, extends deep into the tracheal lumen, and requires a relatively large tracheostoma to be made

Engineering Contradiction:

Improvetracheostoma patencyVSAvoidcannula length

Core Design Contradiction:

ReliabilityVSLength of moving object

Solution Approach 1:

The support framework transitions from a compressed delivery state to an expanded functional state. The framework is delivered in a collapsed configuration through a small incision, then expanded radially to provide tracheostoma patency, allowing the device to adapt its dimensions dynamically rather than requiring a large fixed-size cannula

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The support framework is nested within a delivery device during insertion. The framework collapses around a central axis or within a sheath, allowing it to pass through a small tracheostoma opening, then expands outward to provide structural support, effectively placing a large device through a small opening

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If thick-walled cannulae or tubes with large fixed diameters are used, then the tracheostoma remains open, but they are obtrusive to the patient and do not conform to patient anatomy

Engineering Contradiction:

Improvetracheostoma patencyVSAvoidanatomical conformance

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The support framework provides adaptability through its expandable structure that can be customized to different anatomical configurations. The framework's diameter and length can be adjusted during deployment to match the patient's specific tracheal anatomy, whereas fixed-diameter cannulae cannot adapt

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The support framework consists of multiple struts or radial elements that can be independently positioned or adjusted. This segmented structure allows the device to conform to the irregular geometry of the tracheal lumen and surrounding anatomy, providing both patency and anatomical compatibility

Inventive Principle:

Principle #1Segmentation

3Area of stationary object

If percutaneous dilation tracheotomy is performed with inflatable balloon, then the opening is widened, but bleeding at the wound site requires extreme firm pressure to be applied

Engineering Contradiction:

Improvetracheostoma diameterVSAvoidwound site bleeding

Core Design Contradiction:

Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The support framework is deployed in a controlled expansion sequence that gradually widens the tracheostoma opening while providing immediate structural support to the tracheal walls. This preliminary scaffolding effect prevents uncontrolled tissue tearing and minimizes bleeding during the dilation process

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The support framework acts as an intermediary structure between the dilation process and the tracheal tissue. As the framework expands, it provides a scaffold that guides tissue separation and reduces direct trauma to the vascular structures, thereby minimizing bleeding compared to direct balloon dilation

Inventive Principle:

Principle #24Intermediary (Mediator)

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 tracheostoma spacer maintains the opening with minimal tissue disruption, allowing for easy insertion and removal, and is designed to conform to the patient's anatomy, reducing the need for large tracheostoma expansion and promoting quicker healing.

Implementation Method 1

The support framework can be expanded from an initial state to a supporting state of increased diameter

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS8985099B2Tracheostoma spacer, tracheotomy method, and device for inserting a tracheostoma spacer

Publication Date: 2015.03.24 BREATHE TECHNOLOGIES INC

AI summary

The invention relates to a tracheostoma spacer with a tubular support framework. The support framework can be expand from an initial state to a supporting state of increased diameter and has a fixing element at the ends. The tracheostoma spacer is intended for use as a spacer in a tracheostoma (an opening in the trachea). The invention further relates to a device for inserting a tracheostoma spacer into a tracheostoma with a cutting instrument in the form of a trocar, the tracheostoma spacer being able to be positioned on the shaft of said trocar. A cover sleeve is also provided which can be moved on the shaft over a tracheostoma spacer positioned there.