Temporary Pacemaker Guidance via Electromagnetic Positioning

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Solution Overview

Problem

Current methods for temporary cardiac pacing, such as transcutaneous and transvenous pacing, are often uncomfortable and painful for patients, and require conventional imaging procedures like fluoroscopy, which limits accessibility and expertise for placement and increases exposure to x-rays.

Innovation Solution

A temporary transvenous pacemaker system with a patient drape device featuring indicator lights and electromagnets or RF antennas to guide the positioning of a bipolar electrode pair without the need for fluoroscopy, allowing for percutaneous navigation and anchoring of the electrode wire within the vasculature, enabling pacing without x-ray exposure and broadening the range of clinicians who can perform the procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transcutaneous pacing is used, then pacing can be delivered without invasive procedures, but patient comfort deteriorates due to skeletal muscle contractions and pain

Engineering Contradiction:
Improvepacing delivery accessibilityVSAvoidpatient discomfort and pain
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical transcutaneous pacing approach with a transvenous pacing system that uses a catheter inserted through a vein to deliver pacing leads directly to the heart. This substitution eliminates the need for high-energy transcutaneous pacing, thereby reducing patient discomfort and pain while maintaining pacing functionality.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If transvenous pacing is performed using conventional methods, then pacing effectiveness is improved, but procedure complexity and resource requirements increase due to fluoroscopy and specialized expertise

Engineering Contradiction:
Improvepacing effectivenessVSAvoidprocedure complexity and resource requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts and removes the fluoroscopy imaging system from the pacing procedure. By using alternative guidance methods such as echocardiography or anatomical landmarks, the system achieves effective transvenous pacing without requiring fluoroscopy, thereby reducing procedure complexity and resource requirements while maintaining pacing effectiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a universal pacing system that can be performed by clinicians with general cardiac knowledge rather than requiring specialized radiology expertise. The system incorporates multi-functional guidance capabilities that work across different clinical settings, making the procedure accessible to a broader range of healthcare providers without sacrificing pacing effectiveness.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If fluoroscopy is used for transvenous pacing placement, then positioning accuracy is improved, but patient radiation exposure increases

Engineering Contradiction:
Improvepositioning accuracyVSAvoidpatient radiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent converts the harmful radiation exposure associated with fluoroscopy into a beneficial alternative by using non-radiation-based guidance methods. Techniques such as echocardiographic imaging, anatomical landmarks, and real-time anatomical visualization provide sufficient positioning accuracy without exposing patients to ionizing radiation, thereby eliminating the harmful effect while maintaining the beneficial positioning capability.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

4Reliability

If conventional transvenous pacing is performed, then pacing capability is achieved, but accessibility and clinician involvement are limited by technical expertise requirements

Engineering Contradiction:
Improvepacing capabilityVSAvoidclinician accessibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the skill parameter requirements by simplifying the procedural steps and removing the need for fluoroscopy expertise. The system incorporates intuitive guidance methods and real-time feedback mechanisms that enable clinicians with general cardiac training to perform transvenous pacing successfully, thereby expanding clinician accessibility while maintaining pacing capability through standardized, learnable procedures.

Inventive Principle:
Principle #35Parameter changes

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

This solution reduces patient discomfort, recovery times, and treatment costs by allowing for central access pacing without fluoroscopy, making it possible to perform temporary pacing in various settings and by a broader range of clinicians, while reducing x-ray exposure.

Implementation Method 1

Each of the indicator lights actuates to a lit condition in response to a magnetic field or radiofrequency (RF) emanating from within the patient

Methodology Applied
Scientific EffectMagnetic field detection: Magnetic Field

Implementation Method 2

Each of the indicator lights actuates to a lit condition in response to a magnetic field or radiofrequency (RF) emanating from within the patient

Methodology Applied
Scientific EffectRadiofrequency detection:

Implementation Method 3

The patient drape may also include one or more electromagnets attached to the flexible substrate

Methodology Applied
Scientific EffectElectromagnetism: Electromagnet

Data Source

PatentUS12178542B2Temporary pacemaker systems and deployment systems
Publication Date: 2024.12.31 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • US12178542B2 patent drawing
  • US12178542B2 patent drawing

AI summary

Devices and methods for the treatment of heart conditions, and other medical purposes, include cardiac pacing systems. For example, this document describes temporary transvenous endocardial pacemaker systems and devices for deploying such systems without the need for conventional imaging procedures.