Deflectable Mapping Sheath for Precise His Bundle Lead Placement

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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 flexible sheath and mapping electrodes is designed to navigate the vasculature, allowing precise positioning and fixation of pacing leads at the His bundle by detecting electrical signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional pacing lead placement is used, then the procedure is simpler to perform, but the implantation time is prolonged and success rate is reduced due to difficulty in locating the His bundle

Engineering Contradiction:

Improveease of locating His bundleVSAvoidimplantation time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

A delivery device with a flexible sheath acts as an intermediary tool to navigate the vasculature and position mapping electrodes at the His bundle. The sheath provides a guided pathway through the superior vena cava and right atrium, allowing precise placement of mapping electrodes without requiring complex manual manipulation of conventional pacing leads.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical trial-and-error approach of conventional lead placement with an electrically-guided system. Mapping electrodes detect electrical signals from the His bundle, allowing operators to locate the target site through electrical signal detection rather than relying solely on anatomical landmarks and mechanical positioning.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If conventional pacing methods are used, then the procedure is faster to perform, but the electrical activation sequence is abnormal resulting in ventricular dyssynchrony

Engineering Contradiction:

Improveimplantation speedVSAvoidcardiac synchronization

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The His bundle pacing system uses the heart's own electrical conduction system to achieve physiological activation. By placing the electrode at the His bundle, the pacing stimulus naturally follows the normal electrical pathway through the AV node and bundle branches, allowing the heart's intrinsic conduction system to distribute the electrical impulse to both ventricles in a physiologically appropriate sequence.

Inventive Principle:

Principle #25Self-service

3Device complexity

If the bundle of His is located using conventional pacing lead, then the procedure is simpler, but the detection precision is insufficient due to small size and weak electrical signal

Engineering Contradiction:

Improvesimplicity of detection methodVSAvoiddetection precision of His bundle

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The detection process is segmented into multiple stages using a specialized delivery device. First, mapping electrodes on the sheath detect the His bundle electrical signal during navigation. Second, once the signal is detected, the system transitions to delivering the pacing lead through the same sheath to the confirmed location. This segmentation allows precise detection without requiring the final pacing lead to perform the detection function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The delivery device with flexible sheath serves multiple functions: it navigates the vasculature, positions mapping electrodes for signal detection, and delivers the pacing lead to the target site. This multi-functional approach consolidates several steps into one device, improving both detection precision and procedural efficiency.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

Facilitates efficient and accurate placement of pacing leads at the His bundle, reducing implantation time and improving cardiac synchronization therapy outcomes.

Implementation Method 1

The bundle of His generates an electrical signal that is a small fraction of that generated by the ventricles

Methodology Applied

Scientific EffectElectrical signal detection: Conduction (electrical)

Implementation Method 2

a distal portion of the sheath having a plurality of flexible sections spaced from one another along a length of the sheath

Methodology Applied

Scientific EffectFlexibility: Elasticity

Data Source

PatentUS20260014381A1Deflectable mapping guide sheath for his bundle pacing

Publication Date: 2026.01.15 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 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.