Bladder Thermal Energy Delivery for Nerve Denervation

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Solution Overview

Problem

Current treatments for overactive bladder and urinary incontinence, such as anticholinergic drugs, sacral nerve stimulation, and botulinum toxin injections, are either ineffective, invasive, or have significant side effects, failing to provide durable relief for many patients.

Innovation Solution

A minimally invasive method involving the delivery of thermal energy to denervate selected portions of the bladder, specifically the afferent nerves within or proximate to the trigone region, to modulate bladder function and reduce symptoms like urge, incontinence, frequency, and nocturia, using RF energy, microwaves, or high-intensity focused ultrasound.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If thermal energy is delivered to denervate selected portions of the bladder, then durable relief from overactive bladder symptoms is achieved, but risk of damaging the mucosal layer increases

Engineering Contradiction:

Improvedurable relief from symptomsVSAvoiddamage to mucosal layer

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies different treatment approaches to different regions of the bladder. The mucosal layer is preserved with cooling applied specifically to this layer, while the underlying detrusor muscle and nerve tissue are heated to denervation temperatures. This spatial differentiation of thermal treatment achieves durable symptom relief while protecting the mucosal integrity.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

A cooling medium is introduced as an intermediary between the thermal energy source and the mucosal layer. This cooling medium acts as a thermal barrier that protects the mucosa from direct thermal damage while allowing the underlying tissue to be heated to the required denervation temperature.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If existing treatments like anticholinergic drugs and botulinum toxin injections are used, then overactive bladder symptoms are treated, but side effects and ineffectiveness increase

Engineering Contradiction:

Improvesymptom treatment effectivenessVSAvoidside effects

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces pharmacological interventions (anticholinergic drugs, botulinum toxin injections) with a physical therapy approach using controlled thermal energy delivery. This substitution eliminates drug-related side effects while providing durable symptom relief through denervation of the detrusor muscle.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If invasive procedures are used to treat urinary incontinence, then treatment effectiveness may improve, but patient safety and comfort deteriorate

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidinvasiveness and patient discomfort

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The treatment procedure is segmented into distinct phases: positioning of the catheter with its multiple sensors and energy delivery elements, verification of correct placement using pressure sensors, application of cooling to the mucosal layer, and controlled heating of the underlying tissue. This segmentation allows for precise control and verification at each step, reducing invasiveness while maintaining effectiveness.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The catheter incorporates pressure sensors that provide real-time feedback on the position and depth of the energy delivery elements. This feedback mechanism ensures correct positioning before thermal energy is applied, preventing inadvertent damage to the mucosa or other structures, thereby reducing patient discomfort and safety risks.

Inventive Principle:

Principle #23Feedback

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

This approach provides durable relief from overactive bladder symptoms by precisely targeting non-superficial tissue without damaging the mucosal layer, offering a more effective and safer alternative to existing treatments with reduced side effects.

Implementation Method 1

delivery of thermal energy to denervate selected portions of the bladder

Methodology Applied

Scientific EffectThermal energy delivery: Heating

Implementation Method 2

using RF energy, microwaves, or high-intensity focused ultrasound

Methodology Applied

Scientific EffectRadio frequency energy: Electromagnetic Induction

Implementation Method 3

using RF energy, microwaves, or high-intensity focused ultrasound

Methodology Applied

Scientific EffectMicrowave radiation: Microwave Radiation

Implementation Method 4

using RF energy, microwaves, or high-intensity focused ultrasound

Methodology Applied

Scientific EffectHigh-intensity focused ultrasound: Ultrasound

Implementation Method 5

A cooling medium can be introduced between the energy delivery element and the mucosa to prevent inadvertent damage to the mucosa

Methodology Applied

Scientific EffectCooling: Cooling

Data Source

PatentUS12133678B2Apparatus and methods to modulate bladder function

Publication Date: 2024.11.05 HOLOGIC INC

AI summary

Apparatus and methods are provided to concentrate energy delivery in non-superficial target tissue within a trigone region of a human bladder wall to modulate bladder function.