Inflatable Sleeve Catheter for Cardiac Ablation

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Solution Overview

Problem

Conventional cardiac catheters with rigid distal sections struggle to accommodate variable anatomical shapes, leading to incomplete electrode-tissue contact, interference from blood-borne electrophysiological signals, and side effects during ablation procedures due to electrical power injection into the blood.

Innovation Solution

An inflatable sleeve catheter with a resilient inner end section that assumes a predefined shape, enveloped by an inflatable sleeve, allows for full contact of large-area electrodes with tissue while minimizing exposure to blood, using a flexible PCB sheet with electrodes and adjustable inflation to achieve structural stiffness and anatomical accommodation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If rigid distal sections are used in conventional cardiac catheters, then structural stability is maintained, but the ability to accommodate variable anatomical shapes deteriorates

Engineering Contradiction:
Improvestructural stabilityVSAvoidability to accommodate variable anatomical shapes
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The catheter transitions from a rigid structure to a dynamically adjustable structure through inflation. The inflatable sleeve can be inflated to assume different shapes (arcuate, planar, or three-dimensional configurations) to match various anatomical geometries, while maintaining structural stability when inflated. This dynamic adaptability resolves the contradiction between rigidity and shape accommodation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical state of the catheter is changed by varying the inflation pressure and volume of the sleeve. By adjusting these parameters, the catheter can transition between different shapes and stiffness levels, enabling it to accommodate variable anatomical shapes while maintaining sufficient structural stability for electrode-tissue contact.

Inventive Principle:
Principle #35Parameter changes

2Strength

If rigid distal sections are used in conventional cardiac catheters, then structural support is provided, but electrode-tissue contact completeness deteriorates

Engineering Contradiction:
Improvestructural supportVSAvoidelectrode-tissue contact completeness
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The inflatable sleeve acts as a flexible shell that can conform to the target tissue surface. When inflated, it provides sufficient structural support to press the electrodes against the tissue, ensuring complete contact. The flexibility of the thin film allows adaptation to irregular tissue geometries, resolving the contradiction between structural support and contact completeness.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If large-area electrodes are used to ensure comprehensive tissue contact, then diagnostic and therapeutic effectiveness is improved, but exposure to blood-borne electrophysiological signals increases

Engineering Contradiction:
Improvediagnostic and therapeutic effectivenessVSAvoidexposure to blood-borne electrophysiological signals
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The inflatable sleeve serves as an intermediary between the electrodes and the blood environment. It allows large-area electrodes to contact tissue comprehensively while the sleeve itself acts as a barrier that minimizes direct exposure to blood-borne signals. The sleeve mediates the interaction, enabling effective tissue contact while reducing harmful signal interference.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If electrical power is injected during ablation procedures, then therapeutic effectiveness is improved, but side effects from electrical power injection into blood increase

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidside effects during ablation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The inflatable sleeve acts as a mediator that directs electrical power injection primarily to the tissue through firm electrode-tissue contact, while minimizing current dispersion into the blood. This reduces side effects such as thrombus formation while maintaining therapeutic effectiveness for arrhythmia treatment.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 inflatable sleeve catheter ensures comprehensive tissue contact, reduces unwanted electrophysiological signal interference, and enhances the effectiveness and safety of cardiac ablation treatments by maintaining electrodes in firm contact with tissue, thereby improving diagnostic and therapeutic outcomes.

Implementation Method 1

the inner end section is made at least partially of a shape memory alloy having a self-configurable pre-formed shape including a straight base segment and an arcuated segment parts

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentUS20250017649A1Inflatable sleeve multi-electrode catheter
Publication Date: 2025.01.16 BIOSENSE WEBSTER (ISRAEL) LTD
  • US20250017649A1 patent drawing
  • US20250017649A1 patent drawing
  • US20250017649A1 patent drawing

AI summary

An apparatus includes a shaft and an inflatable sleeve catheter. The shaft is configured for insertion through a sheath into a cavity of an organ of a patient. The inflatable sleeve catheter is fixed to a distal end of the shaft, with the inflatable sleeve catheter including (i) a resilient inner end section, which is fixed to the distal end of the shaft and is formed so as to assume a predefined shape when unconstrained, (ii) an inflatable sleeve that envelopes the inner end section, and a plurality of electrodes that are disposed over the inflatable sleeve and are configured to contact tissue.