Integrated Dilation Catheter with Onboard Illumination and Inflation Control

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Solution Overview

Problem

Current dilation procedures for anatomical passageways, such as paranasal sinuses, lack efficient and controlled inflation/deflation mechanisms, particularly for single-operator use, and require improved visualization techniques for accurate balloon placement.

Innovation Solution

A dilation catheter system comprising a guide catheter, dilation catheter, and guidewire with an integrated inflation mechanism and illumination feature, allowing for precise balloon placement and inflation/deflation control, facilitated by a portable battery handle and onboard light source for transcutaneous illumination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If a variable direction view endoscope is used to provide visualization within the anatomical passageway, then viewing angles are improved, but the complexity of the system increases and requires additional equipment

Engineering Contradiction:
Improvevisualization capabilityVSAvoidsystem complexity
Core Design Contradiction:
Illumination intensityVSDevice complexity

Solution Approach 1:

The patent combines the endoscope, illumination source, and balloon dilation system into a single integrated catheter assembly. The variable direction view endoscope is incorporated within the catheter, and the illumination source is integrated into the handle, eliminating the need for separate external equipment and reducing overall system complexity while maintaining enhanced visualization capabilities

Inventive Principle:
Principle #5Merging (Combining)

2Illumination intensity

If an illuminating guidewire is used to provide transcutaneous illumination for position confirmation, then visualization of guidewire position is improved, but the device complexity increases

Engineering Contradiction:
Improveguidewire position visualizationVSAvoiddevice complexity
Core Design Contradiction:
Illumination intensityVSDevice complexity

Solution Approach 1:

The illumination source is integrated into the handle of the dilation catheter system, combining multiple functions (illumination, inflation control) into a single device. This eliminates the need for a separate illuminating guidewire while providing the same transcutaneous illumination capability for confirming anatomical position

Inventive Principle:
Principle #5Merging (Combining)

3Power

If traditional balloon inflation systems are used, then inflation capability is provided, but ease of operation for single operator use is reduced

Engineering Contradiction:
Improveballoon inflation capabilityVSAvoidsingle operator control
Core Design Contradiction:
PowerVSEase of operation

Solution Approach 1:

The handle incorporates an integrated inflation mechanism with a reservoir and dispensing system that allows the balloon to be inflated and deflated by simple manual operation of a single operator. The system is self-contained with all necessary components (reservoir, pump mechanism, control valve) integrated into the handle, eliminating the need for additional operators or complex external inflation equipment

Inventive Principle:
Principle #25Self-service

4Reliability

If multiple separate devices are used for visualization, illumination, and dilation, then each function can be optimized, but procedural time and complexity increase

Engineering Contradiction:
Improvefunctional performanceVSAvoidprocedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent integrates the endoscope, illumination source, balloon catheter, and inflation mechanism into a single unified device. This allows all functions to be performed sequentially without removing or changing equipment, significantly reducing procedural time while maintaining the reliability and optimization of each individual function through careful design of the integrated system

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

Enables safe, efficient, and controlled dilation of anatomical passageways with improved visualization, reducing procedural complexity and time for single operators while ensuring accurate balloon placement and effective ostium dilation.

Implementation Method 1

A variable direction view endoscope may be used with such a system to provide visualization within the anatomical passageway... Such an endoscope that may be provided in accordance with the teachings of U.S. Pub. No. 2010/0030031, entitled 'Swing Prism Endoscope,' published Feb. 4, 2010... An example of such an endoscope is the Acclarent CyclopsTM Multi-Angle Endoscope by Acclarent, Inc. of Irvine, Calif.

Methodology Applied
Scientific EffectLight: Light

Implementation Method 2

Such a guidewire may be positioned within the target area and then illuminated, with light projecting from the distal end of the guidewire. This light may illuminate the adjacent tissue (e.g., hypodermis, subdermis, etc.) and thus be visible to the naked eye from outside the patient through transcutaneous illumination.

Methodology Applied
Scientific EffectTranscutaneous illumination:

Implementation Method 3

One method of dilating anatomical passageways includes using a guidewire and catheter to position an inflatable balloon within the anatomical passageway, then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway... The expandable balloon may be positioned within an ostium at a paranasal sinus and then be inflated, to thereby dilate the ostium by remodeling the bone adjacent to the ostium

Methodology Applied
Scientific EffectPressure Increase: Pressure Increase

Implementation Method 4

One method of dilating anatomical passageways includes using a guidewire and catheter to position an inflatable balloon within the anatomical passageway... An illuminating guidewire may be provided in accordance with the teachings of U.S. Pub. No. 2012/0078118, entitled 'Sinus Illumination Lightwire Device,' published Mar. 29, 2012, issued as U.S. Pat. No. 9,155,492 on Oct. 13, 2015

Methodology Applied
Scientific EffectMechanical guidance:

Data Source

PatentUS10512764B2Actuation features for dilation system
Publication Date: 2019.12.24 ACCLARENT INC
  • US10512764B2 patent drawing
  • US10512764B2 patent drawing
  • US10512764B2 patent drawing

AI summary

An apparatus includes a handle, a guide member, a dilation catheter, a guidewire, and first and second movement assemblies. The dilation catheter is slidably housed within the handle and is slidable relative to the guide member. The guidewire is translatable relative to the dilation catheter. The first movement assembly is configured to actuate relative to the handle and includes a first body fixed with the dilation catheter and a first coupling member. The second movement assembly is proximal in relation to the first movement assembly and includes a second body and a second coupling member. The second body is configured to selectively fix to the guidewire and actuate relative to the handle. The first coupling member and the second coupling member are configured to connect the first movement assembly and the second movement assembly to translate together relative to handle in response to distal translation of the first movement assembly.