Conformal Bioelectronic Catheter for His Bundle Mapping

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Solution Overview

Problem

Current cardiac resynchronization therapy (CRT) and His bundle pacing (HBP) techniques are limited by suboptimal lead positioning, scar burden, and difficulty in accurately sensing and selectively pacing the His bundle, leading to ineffective treatment for a significant portion of patients with heart failure.

Innovation Solution

A novel conformal bioelectronic catheter with multimodal, multilayered soft electronics is developed for precise mapping and selective pacing of the His bundle, incorporating pressure, temperature, and electrical sensing capabilities to guide optimal lead placement and minimize invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional CRT pacing is used to treat heart failure, then biventricular pacing can be achieved, but lead positioning is suboptimal and 30-40% of patients do not respond favorably

Engineering Contradiction:

Improvetreatment efficacyVSAvoidlead positioning accuracy

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces conventional mechanical lead positioning with magnetic navigation technology. The pacing lead incorporates magnetic particles that respond to externally applied magnetic fields, enabling precise positioning at the His bundle site without relying on operator skill or anatomical landmarks. This magnetic guidance system substitutes the mechanical trial-and-error positioning approach with a controllable magnetic field-based navigation system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces magnetic particles as an intermediary between the external magnetic navigation system and the pacing lead. These magnetic particles embedded in the lead tip act as a mediator that translates external magnetic field commands into precise positional control at the target site, enabling accurate His bundle positioning without direct mechanical manipulation.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If His bundle pacing is implemented, then more physiological activation can be achieved, but accurate sensing and selective pacing of the His bundle is difficult

Engineering Contradiction:

Improvephysiological activationVSAvoidHis bundle sensing accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary magnetic navigation to position the pacing lead tip at the optimal His bundle site before attempting pacing. The magnetic navigation system pre-positions the lead based on anatomical mapping and electrogram analysis, ensuring that when pacing is initiated, the electrode is already at the correct location. This preliminary positioning action eliminates the need for trial-and-error pacing attempts.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent employs real-time feedback through electrogram analysis and magnetic field monitoring to confirm proper His bundle positioning. The system continuously monitors local electrograms at the lead tip and adjusts magnetic field application to maintain optimal positioning. This closed-loop feedback ensures accurate sensing of His bundle activity and confirms selective pacing before permanent implantation.

Inventive Principle:

Principle #23Feedback

3Reliability

If invasive procedures are performed for lead placement, then pacing can be achieved, but patient trauma and procedure complexity increase

Engineering Contradiction:

Improvepacing capabilityVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces invasive mechanical lead insertion with magnetic navigation through blood vessels. Instead of requiring surgical exposure or complex catheter manipulation, the pacing lead is guided magnetically through the venous system to the His bundle site. This magnetic navigation approach minimizes vascular trauma and eliminates the need for surgical incisions or complex catheter delivery systems.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12290689B2Systems and methods for selective his bundle mapping and pacing

Publication Date: 2025.05.06 GEORGE WASHINGTON UNIVERSITY

AI summary

Systems and methods are disclosed for an electrical sensing, pacing, and ablation device comprising a bendable and stretchable balloon catheter and a bendable and stretchable first layer connected to or embedded in said balloon catheter, where the first layer has an electrode array with a plurality of electrodes. The is also a bendable and stretchable second layer connected to or embedded in the balloon catheter, and the second layer has a pressure sensor array with a plurality of pressure sensors.