Bi-stable Balloon Dilator for Rapid Aperture Expansion

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Solution Overview

Problem

Existing dilator sets for surgical incisions require significant time for sequential insertion of dilator tubes, causing tissue trauma and are mechanically complex, necessitating a more efficient and minimally invasive method for expanding access apertures.

Innovation Solution

Automatic balloon dilator devices using pneumatic inflation with annular shaped structures and bi-stable mechanical designs to expand tissues radially, allowing for quicker and less traumatic access aperture creation, which can be robotically controlled and maintain expanded form without continuous inflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If sequential insertion of multiple dilator tubes is used, then the incision aperture can be enlarged to the desired size, but the procedure time increases significantly and tissue trauma is exacerbated

Engineering Contradiction:
Improveaperture expansion speedVSAvoidprocedure time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent merges multiple sequential dilation steps into a single balloon expansion action. Instead of inserting multiple dilator tubes one after another, the invention uses a single dilator with an expandable balloon that performs the work of multiple dilators simultaneously, thereby reducing procedure time and tissue trauma while achieving the same aperture enlargement.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent employs a dynamic structure where the dilator transitions from a collapsed low-profile state during insertion to an expanded high-diameter state during dilation. The balloon expandable structure allows the device to dynamically change its dimensions, enabling rapid aperture expansion without the need for multiple static dilator tubes of increasing sizes.

Inventive Principle:
Principle #15Dynamics

2Productivity

If multiple dilator tubes are inserted sequentially, then the aperture can be enlarged, but the device complexity increases due to requiring multiple tubes and coordination mechanisms

Engineering Contradiction:
Improveaperture expansion capabilityVSAvoiddilator set complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention combines the functions of multiple dilator tubes into a single integrated device. The balloon expandable dilator performs the aperture enlargement function that previously required a set of multiple tubes, thereby reducing device complexity while maintaining or improving aperture expansion capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single balloon expandable dilator serves multiple functions: it acts as the insertion device, the expansion device, and the final aperture holder. This multi-functional design eliminates the need for multiple specialized tubes and their coordination mechanisms, simplifying the overall device system.

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

3Productivity

If mechanical spreader tubes are used for dilation, then the incision can be enlarged, but tissue trauma increases due to mechanical spreading forces

Engineering Contradiction:
Improveaperture expansion efficiencyVSAvoidtissue trauma
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical spreading forces with pneumatic expansion forces. Instead of using mechanical spreader tubes that physically push tissues apart, the invention uses a balloon inflated with fluid or gas to expand the aperture. This pneumatic approach distributes the expansion force more evenly and reduces focal points of tissue trauma while maintaining aperture expansion efficiency.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The balloon expandable structure uses a flexible membrane that conforms to the surrounding tissues during expansion. This flexible shell distributes the expansion forces uniformly across the tissue interface, reducing stress concentrations and minimizing tissue trauma compared to rigid mechanical spreader tubes.

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 solution enables rapid and minimally invasive expansion of surgical access apertures with reduced tissue trauma, maintaining stability in the expanded state without continuous balloon inflation, thus improving efficiency and safety over traditional mechanical dilator sets.

Implementation Method 1

The devices use pneumatic inflation to enlarge the incision aperture, rather than the mechanical insertion of spreader tubes as in the systems of prior art dilator sets.

Methodology Applied
Scientific EffectPneumatic inflation: Pressure Increase

Implementation Method 2

the axial balloon can be inflated, thereby causing the thin expandable or deployable walls of the structure to move radially outwards, and to radially distract the soft tissues surrounding the structure

Methodology Applied
Scientific EffectRadial distraction: Mechanical Force

Implementation Method 3

Once the unexpanded structure has been inserted in place through the soft tissue, the axial balloon can be inflated, thereby causing the thin expandable or deployable walls of the structure to move radially outwards... the radially expanded state is a state of minimum mechanical potential energy, such that the structure maintains its expanded state when the balloon is deflated

Methodology Applied
Scientific EffectBi-stable mechanical equilibrium: Metastability

Data Source

PatentUS11701099B2Balloon dilator
Publication Date: 2023.07.18 MAZOR ROBOTICS
  • US11701099B2 patent drawing
  • US11701099B2 patent drawing
  • US11701099B2 patent drawing

AI summary

A balloon dilator device, comprising an annularly shaped, cylindrical type structure having walls that are expandable from a radially collapsed state to a radially expanded state by inflation of a balloon inserted within the annular structure. Once the walls have been expanded, they remain in the expanded state even if the balloon is deflated, because the radially expanded state is a state of minimum mechanical potential energy, and in order to return to the collapsed state, the structure would have to pass a state of higher potential energy. The device walls require sufficient stiffness in their longitudinal direction to enable the device to be pushed into a minimally invasive incision made in the subject. This device stiffness can be achieved either by its mechanical material properties, or by its substantially closed wall structure, or by use of a stiff protector sheath used to protect the walls during insertion.