Mapping and Ablation Catheter with Flexible Coupler and Balloon Sensing

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Solution Overview

Problem

Existing medical devices face challenges in efficiently navigating through body lumens with bends and providing precise mapping and ablation at target sites, particularly due to the limitations in securing baskets and balloons to catheter shafts, and in monitoring the expansion state of expandable balloons.

Innovation Solution

A distal coupler with projections and slots for securing a basket, a helical pattern on the shaft for enhanced stability, and sensors for monitoring balloon expansion, along with a system for detecting balloon inflation states, are integrated into the catheter design.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a catheter is advanced through a body lumen with bends, then the catheter can reach target sites, but the basket and balloon are difficult to secure to the shaft

Engineering Contradiction:

Improvesecuring of basket and balloon to shaftVSAvoidcoupler structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The coupler is divided into multiple functional segments: a first portion with slots for basket engagement, a second portion with through-holes for shaft attachment, and a third portion for balloon engagement. This segmentation allows each portion to be optimized for its specific function while maintaining overall structural integrity, resolving the contradiction between secure attachment and structural simplicity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The coupler employs a nested configuration where the basket is received within the slots of the first portion, the shaft is secured through the second portion, and the balloon is engaged at the third portion. This nested arrangement allows multiple components to be securely attached in a compact configuration, improving reliability without proportionally increasing external complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If existing coupling mechanisms are used, then the structure is simpler, but the basket and balloon cannot be securely attached during navigation through bends

Engineering Contradiction:

Improveattachment stability during navigationVSAvoidcoupler manufacturing complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The coupler is segmented into distinct functional zones (first portion for basket, second portion for shaft, third portion for balloon) that can be manufactured separately or as integrated features. This segmentation enables specialized manufacturing techniques for each portion while maintaining overall manufacturability, achieving stable attachment without excessive manufacturing complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The coupler incorporates curved leading sections with greater radius of curvature that curve out and away from the distal face, providing flexibility during navigation through bends. This curvature design allows the coupler to accommodate bending forces while maintaining secure attachments, improving reliability during navigation without requiring overly complex structural reinforcements.

Inventive Principle:

Principle #14Spheroidality (Curvature)

3Ease of operation

If a rigid coupling structure is used, then the basket and balloon are securely attached, but the catheter cannot navigate through body lumens with bends

Engineering Contradiction:

Improvenavigation capability through bendsVSAvoidsecuring of basket and balloon

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The coupler transitions from a rigid structure to a dynamic configuration with curved leading sections that can flex during navigation. The curved sections with greater radius of curvature allow the coupler to bend with the catheter while maintaining secure attachments through the slot and through-hole mechanisms. This dynamic design enables both navigation capability and secure attachment simultaneously.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

Inventive Principle:

Principle #14Spheroidality (Curvature)

4Measurement precision

If traditional monitoring methods are used, then the system is simpler, but the expansion state of the balloon cannot be accurately monitored

Engineering Contradiction:

Improveballoon expansion state detection accuracyVSAvoidsensor and detection system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The system incorporates sensors that provide real-time feedback on balloon expansion state, allowing the system to detect and respond to changes in balloon inflation. This feedback mechanism enables accurate monitoring of expansion state through electrical impedance measurements, improving measurement precision while managing system complexity through integrated sensor design.

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS20250248758A1Medical device for mapping and/or ablation

Publication Date: 2025.08.07 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A medical device includes a first shaft and an expandable end assembly configured for mapping and/or ablation. The expandable end assembly includes a basket with a plurality of splines. The basket splines are coupled to a proximal coupler and a distal coupler. The expandable end assembly may further include an expandable balloon positioned within the basket and coupled to the proximal and distal couplers. A shaft extending between the proximal and distal couplers may include a pattern cut into the wall in the section of the first shaft positioned within the expandable end assembly. The expandable end assembly may further include a sensor configured to measure a characteristic indicative of an expansion state of the expandable balloon.