Deflectable Guide Sheath for Weak-Signal His Bundle Mapping

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Solution Overview

Problem

Current cardiac rhythm management systems face challenges in accurately locating and implanting electrode leads to the His bundle due to its small size and weak electrical signal, leading to prolonged implantation times and a reliance on conventional pacing methods.

Innovation Solution

A delivery device with a deflectable sheath and mapping electrodes is designed to facilitate the precise positioning of pacing leads at the His bundle, featuring a multi-layer construction for maneuverability and deflection, along with split ring electrodes for enhanced signal detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional pacing leads are used to locate the His bundle, then the small size and weak electrical signal of the bundle make it extremely difficult to find, but using larger or more sensitive leads is not feasible due to anatomical constraints

Engineering Contradiction:

Improvedetection sensitivityVSAvoidlocating difficulty

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The delivery device is divided into distinct functional segments: a delivery sheath for navigation, mapping electrodes for signal detection, and a pacing lead for therapy delivery. This segmentation allows each component to be optimized for its specific function while working together as an integrated system

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Mapping electrodes are positioned on the delivery device to serve as intermediaries between the operator and the His bundle. These electrodes detect electrical signals and provide feedback about the device's proximity to the bundle, enabling precise localization without requiring direct contact with the small bundle structure

Inventive Principle:

Principle #24Intermediary (Mediator)

2Manufacturing precision

If the bundle of His is successfully located, then accurate pacing can be achieved, but it is difficult to maintain the position of the lead while affixing it to the cardiac tissue

Engineering Contradiction:

Improveimplantation accuracyVSAvoidposition stability

Core Design Contradiction:

Manufacturing precisionVSStability of the object's composition

Solution Approach 1:

The delivery device is pre-configured with the pacing lead positioned within the sheath and the lead's fixation mechanism (such as a helix or anchor) prepared in advance. Once the mapping electrodes confirm proper positioning near the His bundle, the lead can be deployed and fixed in a single controlled motion, eliminating the need for repeated positioning adjustments

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The pacing lead incorporates self-fixating features such as expandable anchors or helical tips that automatically secure the lead to the cardiac tissue upon deployment. This self-service mechanism maintains lead position stability without requiring additional manual intervention or complex fixation procedures

Inventive Principle:

Principle #25Self-service

3Measurement precision

If a delivery device with deflection capability is used to navigate to the His bundle, then positioning accuracy is improved, but the device complexity increases

Engineering Contradiction:

Improvepositioning accuracyVSAvoiddevice structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The delivery sheath incorporates a pull wire mechanism that allows dynamic adjustment of the sheath's curvature. By pulling on the wire from the proximal end, the operator can deflect the distal end of the sheath to navigate around anatomical obstacles and position the mapping electrodes and pacing lead accurately at the His bundle location

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The delivery sheath is constructed with flexible materials that allow it to bend and conform to the cardiac anatomy while maintaining structural integrity. This flexibility enables the sheath to navigate the complex geometry of the heart chambers and reach the His bundle without requiring rigid, complex mechanical structures

Inventive Principle:

Principle #30Flexible shells and thin films

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 device enables efficient and accurate placement of pacing leads at the His bundle, reducing implantation time and improving the physiological pacing of the heart, thereby minimizing risks associated with traditional CRT pacing.

Implementation Method 1

a plurality of mapping electrodes positioned on the distal end of the sheath

Methodology Applied

Scientific EffectElectrical signal detection: Conduction (electrical)

Data Source

PatentUS12440684B2Deflectable mapping guide sheath for his bundle pacing

Publication Date: 2025.10.14 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.