Reverse Truncated Cone Balloon for Percutaneous Tracheostomy

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Solution Overview

Problem

Current tracheostomy techniques are invasive, traumatic, and not suitable for emergency situations due to the need for surgical intervention, high manual effort, and potential damage to tracheal tissues, with existing dilator balloons not effectively reducing friction and maintaining proper positioning during inflation.

Innovation Solution

A tracheostomy device featuring a dilating balloon with a reverse truncated cone shape, where the minor diameter is adjacent to the tracheal tube and the major diameter is distal, allowing for less resistance and precise control during dilation, and a handle connected to the tracheal tube for thrust, facilitating non-traumatic tracheal tube insertion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a conventional dilator balloon is used for tracheal dilation, then the dilation function is provided, but the friction resistance remains high and positioning control is insufficient

Engineering Contradiction:
Improvefriction reduction during advancementVSAvoidpositioning control during inflation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The balloon is designed with an asymmetric reverse truncated cone shape where the distal diameter is larger than the proximal diameter. This asymmetric geometry creates a progressive friction reduction effect during advancement, with the larger distal end entering first to dilate the tracheal wall while the smaller proximal end follows, thereby reducing overall friction resistance and improving positioning control during the inflation process.

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

Instead of using a conventional cone shape with larger diameter at the proximal end and smaller at the distal end, this invention inverts the geometry to a reverse truncated cone with larger diameter at the distal end. This inversion allows the balloon to be inserted through a small tracheal aperture with minimal friction, as the larger distal end breaks through the tissue while the smaller proximal end follows smoothly, solving the positioning control issue.

Inventive Principle:
Principle #13The other way round (Inversion)

2Reliability

If surgical tracheostomy with scalpel and dilator pincer is performed, then complete tracheal opening is achieved, but the procedure becomes complex and traumatic

Engineering Contradiction:
Improvecomplete tracheal openingVSAvoidsurgical team and sterilized environment requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts and integrates multiple surgical functions into a single self-contained device. The handle assembly combines the dilator, balloon, wire guide, and tracheal tube into one unified instrument that can be inserted through a small aperture, eliminating the need for separate surgical tools, scalpel, and complex sterile field setup, thereby reducing procedure complexity while maintaining reliable tracheal opening.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The handle assembly serves multiple functions simultaneously: it acts as a dilator to enlarge the tracheal aperture, provides a balloon for controlled tissue separation, includes a wire guide for tube placement, and houses the tracheal tube itself. This multi-functionality replaces the need for multiple separate surgical instruments and a complex surgical team, simplifying the overall procedure while ensuring complete tracheal opening.

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

3Area of stationary object

If dilators of increasing dimensions are introduced through small aperture, then the breach is enlarged, but significant manual force is required and tissue damage occurs

Engineering Contradiction:
Improvebreach size for tube placementVSAvoidmanual force on longitudinal axis
Core Design Contradiction:
Area of stationary objectVSForce

Solution Approach 1:

The invention replaces manual mechanical force with pneumatic pressure by using an inflatable balloon. The balloon is inflated through the handle assembly, generating controlled radial expansion force that enlarges the tracheal breach without requiring significant manual force on the longitudinal axis. This pneumatic mechanism reduces the effort required while minimizing tissue damage through controlled, gradual dilation.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The invention changes the physical state and geometric parameters of the dilation mechanism. Instead of using rigid dilators of increasing dimensions that require manual force, the system uses an inflatable balloon that changes its volume and shape through gas inflation. The reverse truncated cone geometry of the balloon allows it to expand progressively, changing its parameters dynamically to enlarge the breach while reducing the force required and minimizing tissue trauma.

Inventive Principle:
Principle #35Parameter changes

4Strength

If curved cone shape dilator with increasing diameter is used, then tissue dilation is achieved, but additional device is required to maintain dilation and overcome obstacles

Engineering Contradiction:
Improvetissue dilation capabilityVSAvoidadditional device for maintaining dilation
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The invention merges the dilation function and the maintenance function into a single integrated handle assembly. The reverse truncated cone balloon, when inflated, maintains its shape and size to sustain tissue dilation, while the handle assembly itself provides the structural support needed to overcome obstacles. This integration eliminates the need for separate devices to maintain dilation, reducing overall device complexity while preserving strong tissue dilation 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 effectively dilates the trachea with reduced trauma to tissues, minimizing manual effort and ensuring precise placement of the tracheal tube, suitable for both emergency and non-emergency situations, with the balloon shape optimizing the insertion process by providing a thrust for the tracheal tube.

Implementation Method 1

a dilating and introducer balloon, tracheal tube and handle assembly for use in the percutaneus insertion of a tracheostomy tube in the trachea of a patient

Methodology Applied
Scientific EffectGas pressure: Pressure Increase

Implementation Method 2

a wire guide is inserted to provide guidance for the insertion of the tubes or the dilator

Methodology Applied
Scientific EffectMechanical guidance: Mechanical Force

Implementation Method 3

forming a surgical opening between the tracheal rings using surgical and traumatic tools like a scalpel and a dilator pincer

Methodology Applied
Scientific EffectMechanical cutting: Fracture Mechanics

Data Source

PatentUS8757161B2Tracheostomy apparatus and device
Publication Date: 2014.06.24 G TRACH2 SRL
  • US8757161B2 patent drawing
  • US8757161B2 patent drawing
  • US8757161B2 patent drawing

AI summary

A device and a method for the percutaneous placement of a tracheostomy tube composed of a handle, an inflatable balloon having a reversed truncated cone shape, a tube to inflate the balloon and another to contain a wire guide, a plastic structure in the middle between the balloon and the handle made of laminar elements to strengthen the apparatus movements of the handle transmitted to the tube and the balloon. Following placement of the tracheal tube, the balloon is deflated and the apparatus or device withdrawn.