Bladder Trigone Dissection via Catheter-Guided Balloon Dilation

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Solution Overview

Problem

The modified Inglemann-Sundberg procedure for treating overactive bladder (OAB) is limited by its invasiveness, use of rudimentary surgical tools, and the challenge of creating a dissection plane blindly without clear visual bladder landmarks from the vaginal approach, leading to its underadoption by physicians.

Innovation Solution

The development of devices and methods for creating dissection planes within the bladder trigone using balloon catheters and cutting devices, aided by visualization scopes and guide wires, to disrupt afferent nerves responsible for OAB, allowing for more precise and minimally invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the modified Inglemann-Sundberg procedure is performed via vaginal approach with basic surgical technique, then the procedure can be performed with simpler tools and less invasiveness, but the dissection plane cannot be created with precision due to lack of visual bladder landmarks

Engineering Contradiction:
Improvesimplicity of surgical tools and approachVSAvoidprecision of dissection plane creation
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

A catheter is introduced as an intermediary device through the urethra to provide visual landmarks and guide the creation of the dissection plane in the bladder trigone region. The catheter enables precise localization and guidance of the dissection process while maintaining the minimally invasive vaginal approach, thus mediating between the simplicity of the approach and the precision required for effective nerve disruption.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If basic surgical technique is used to create dissection plane blindly, then the procedure is less invasive and uses simpler tools, but the effectiveness of nerve disruption is reduced due to inability to visualize bladder landmarks

Engineering Contradiction:
Improveinvasiveness of procedureVSAvoideffectiveness of afferent nerve disruption
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The catheter serves as a mediator that enables reliable nerve disruption by providing visual landmarks and guiding the dissection plane creation, while the procedure remains minimally invasive through the vaginal approach. This intermediary device resolves the contradiction between maintaining low invasiveness and ensuring reliable treatment effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The procedure replaces blind mechanical dissection with visual guidance through the catheter, substituting the mechanical 'blind' approach with an optically-guided approach. This allows the surgeon to see bladder landmarks and create the dissection plane with precision while maintaining the minimally invasive nature of the procedure.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Device complexity

If the dissection plane is created without clear visual landmarks, then the procedure remains minimally invasive, but the precision and control of the dissection plane location is compromised

Engineering Contradiction:
Improvecomplexity of surgical instrumentationVSAvoidprecision of dissection plane location
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The catheter acts as an intermediary that provides visual landmarks without significantly increasing the complexity of the surgical instrumentation. It enables precise localization of the dissection plane in the bladder trigone region while maintaining the overall simplicity and minimally invasive nature of the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS11471180B2Devices and methods for treating conditions caused by afferent nerve signals
Publication Date: 2022.10.18 HOLOGIC INC
  • US11471180B2 patent drawing
  • US11471180B2 patent drawing
  • US11471180B2 patent drawing

AI summary

A method for treating OAB in a female patient includes positioning a visualization scope in the patent's vagina; advancing a guide wire through a working channel of a visualization scope, until a tissue penetrating distal tip of the guide wire advances out of the working channel and penetrates a wall of the superior portion of the vagina; continuing to advance the guidewire tip submucosally through the wall of the vagina, until it is positioned within tissue of the bladder trigone; advancing a balloon dilation catheter over the guidewire until a balloon carried on a distal end portion of the balloon dilation catheter is positioned proximate the distal tip of the guidewire within the bladder trigone tissue; and inflating said balloon to form a first dissection plane between separated layers of tissue within the bladder trigone.