Non-steerable EP Catheter with Flexible Tip for Steerable Sheath

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Steerable electrophysiology catheters face challenges in precision and stability due to the need for directional control and material hardness, while non-steerable catheters lack the ability to navigate complex vasculature effectively.

Innovation Solution

A non-steerable electrophysiology catheter with a flexible hollow elongate tip electrode and a helical coil structure, designed for use with a steerable introducer sheath, providing enhanced flexibility and precision for tissue ablation and mapping without independent directional control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If steerable electrophysiology catheters are used to provide directional control, then navigation capability is improved, but precision and stability deteriorate due to material hardness requirements

Engineering Contradiction:

Improvenavigation capabilityVSAvoidprecision and stability

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The catheter system is divided into two separate components: a steerable introducer sheath for navigation and a non-steerable electrophysiology catheter for precise procedures. The introducer sheath handles directional control while the EP catheter focuses on procedural precision, eliminating the compromise between steering capability and stability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The steerable introducer sheath acts as an intermediary device that provides directional control and steering capability to the non-steerable EP catheter. The introducer sheath with its pull-wire mechanism enables navigation through vasculature while the EP catheter itself remains simple and stable for precise ablation and mapping procedures.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If non-steerable catheters are used to simplify structure, then manufacturing ease is improved, but ability to navigate complex vasculature deteriorates

Engineering Contradiction:

Improvestructural simplicityVSAvoidnavigation capability

Core Design Contradiction:

Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The navigation function is separated from the EP catheter and assigned to the introducer sheath. This allows the EP catheter to be manufactured with simple, non-steerable construction while the introducer sheath incorporates the complex steering mechanisms needed for navigating tortuous vasculature.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The steerable introducer sheath serves as a mediator that enables the simple non-steerable EP catheter to reach distant and difficult-to-access sites within the heart and vasculature. The introducer's pull-wire steering system navigates the catheter through complex anatomical pathways without requiring the EP catheter itself to be steerable.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If steerable catheters are used to achieve directional control, then navigation is improved, but patient safety deteriorates due to harder materials required

Engineering Contradiction:

Improvedirectional controlVSAvoidpatient safety

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The system separates the steering function (in introducer sheath) from the patient-contacting EP catheter. This allows the EP catheter to be made of softer, more compliant materials that are safer for patient tissue, while the introducer sheath made of harder materials provides the necessary steering rigidity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The introducer sheath acts as a protective intermediary that provides structural strength and steering capability, allowing the EP catheter to be constructed from softer, more biocompatible materials that reduce risk of tissue damage during the actual procedure.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If non-steerable catheters are used with softer polymers to enhance safety, then patient safety is improved, but ability to withstand compressive forces deteriorates

Engineering Contradiction:

Improvepatient safetyVSAvoidcompressive force resistance

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The mechanical strength requirements are assigned to the introducer sheath while the EP catheter uses softer materials for patient safety. The introducer sheath's structural integrity protects the softer EP catheter from compressive forces during navigation and delivery.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The introducer sheath serves as a protective intermediary that absorbs and withstands compressive forces and mechanical stresses, allowing the EP catheter to be made of softer polymers that enhance patient safety without compromising overall system strength.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS8974454B2Kit for non-invasive electrophysiology procedures and method of its use

Publication Date: 2015.03.10 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC

AI summary

An electrophysiology catheter for use with a steerable introducer sheath includes a flexible catheter body having a proximal end and a distal end and at least one hollow elongate tip electrode disposed at the distal end of the catheter body. The hollow elongate tip electrode includes a sidewall having at least one elongate gap that provides flexibility allowing the tip electrode to bend relative to a longitudinal axis of the catheter body. The catheter body is an independent, non-steerable structure, and can be moved via movement of the steerable introducer through which it is introduced into a patient.