Segmented Balloon Catheter for Bladder Wall Conformability

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Solution Overview

Problem

Current bladder mapping and ablation devices fail to conform to the asymmetric shape of the bladder and cannot reliably maintain contact with the bladder wall, leading to ineffective treatment of local anatomical abnormalities causing overactive bladder, which often requires repeated treatments and can result in urinary retention.

Innovation Solution

A catheter system with multiple inflatable balloons of varying volumes and electrode configurations that expand to conform to the bladder shape, allowing for precise mapping and ablation of abnormal tissue regions, reducing artifactual electrical measurements and minimizing damage to healthy tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a single balloon is used to map the bladder wall, then the device structure is simple, but it cannot conform to the asymmetric shape of the bladder and cannot reliably maintain contact with the bladder wall

Engineering Contradiction:
Improveconformability to bladder shapeVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The single balloon is divided into multiple segmented balloons (typically 3-5 balloons) arranged in series along the catheter. Each balloon can be independently inflated to adapt to different portions of the asymmetric bladder wall, allowing the device to conform to varying bladder shapes while maintaining reliable electrode contact throughout the mapping process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloons are designed to be dynamically adjustable through independent inflation and deflation control. This allows the operator to adjust the configuration of each balloon segment to match the specific asymmetric geometry of the patient's bladder, transforming a static single-balloon design into a dynamic multi-segment system that adapts to anatomical variations.

Inventive Principle:
Principle #15Dynamics

2Reliability

If electrodes are attached to a balloon surface, then electrode positioning is improved, but contact reliability with the asymmetric bladder wall cannot be maintained

Engineering Contradiction:
Improvecontact reliabilityVSAvoidadaptability to bladder variations
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

Electrodes are distributed across multiple balloon segments rather than concentrated on a single balloon. This segmentation allows each balloon to independently conform to local bladder wall variations, ensuring that at least some electrodes maintain reliable contact even when bladder geometry changes, thereby improving overall contact reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system allows dynamic adjustment of balloon inflation parameters (volume, pressure) for each segment to optimize electrode-bladder wall contact. By changing these parameters in response to detected contact quality or anatomical variations, the system maintains reliable electrical contact across different patient-specific bladder geometries.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If systemic treatments are applied to the entire bladder, then treatment coverage is complete, but the therapeutic effect wears off requiring repeated treatments

Engineering Contradiction:
Improveduration of therapeutic effectVSAvoidnumber of procedures required
Core Design Contradiction:
Duration of action of stationary objectVSProductivity

Solution Approach 1:

The treatment is extracted from a systemic approach affecting the entire bladder to a focal approach targeting only the specific abnormal tissue regions identified through mapping. By isolating and treating only the problematic areas (such as overactive detrusor muscle zones), the therapeutic effect is concentrated where needed, providing longer-lasting results and reducing the frequency of repeat procedures.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The mapping function identifies the precise locations of abnormal electrical activity, and the same device delivers targeted ablation treatment to those specific locations. This self-targeting capability ensures that each treatment procedure addresses the actual source of symptoms, maximizing therapeutic durability and minimizing the need for repeated interventions.

Inventive Principle:
Principle #25Self-service

4Object-affected harmful factors

If focal ablation is performed on identified tissue regions, then healthy tissue is protected, but precise mapping and contact maintenance are challenging

Engineering Contradiction:
Improvedamage to healthy tissueVSAvoidmapping precision
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The bladder wall is segmented into multiple zones corresponding to different balloon segments, each with its own set of electrodes. This segmentation allows precise identification of abnormal tissue regions through systematic electrical mapping while clearly defining treatment boundaries, thereby protecting healthy tissue between segments from inadvertent damage during focal ablation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mapping electrodes provide real-time feedback on electrical activity patterns across different bladder wall regions. This feedback guides the operator in identifying precise targets for ablation while monitoring surrounding areas to ensure healthy tissue remains outside the treatment zone, thereby enhancing both mapping precision and tissue protection.

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

The system provides enhanced electrical connection with the bladder wall, allowing for targeted treatment of overactive bladder symptoms with a permanent therapeutic effect while reducing the need for repeated procedures and minimizing urinary retention risks.

Implementation Method 1

Each of the plurality of balloons is expandable by introducing a fluid into a lumen of the balloon

Methodology Applied
Scientific EffectFluid pressure expansion: Pressure Increase

Implementation Method 2

measuring intrinsic electrical activity using the electrodes; identifying each electrode that detected an elevated electrical activity within the tissue region

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 3

delivering radiofrequency energy to the identified tissue region with the ablation device; reducing the elevated electrical activity within the tissue region

Methodology Applied
Scientific EffectRadiofrequency heating: Dielectric Heating

Data Source

PatentEP3331465B1Systems and methods for mapping and ablation in the bladder
Publication Date: 2022.11.30 BOSTON SCIENTIFIC SCIMED INC
  • EP3331465B1 patent drawingFigure 1~2
  • EP3331465B1 patent drawingFigure 3~4B
  • EP3331465B1 patent drawingFigure 5A~6

AI summary

The present disclosure relates to the field of tissue mapping and ablation. Specifically, the present disclosure relates to expandable medical devices for identifying and treating local anatomical abnormalities within a body lumen. More specifically, the present disclosure relates to systems and methods of focal treatment for overactive bladders.