Stimulation Probe Epicardial Access Feedback

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Solution Overview

Problem

Accessing the epicardial space for cardiac procedures is challenging due to the need for intimate knowledge of cardiac anatomy and expertise to avoid complications like inadvertent right ventricular perforation, despite advancements in technology such as carbon dioxide insufflation and electroanatomic mapping.

Innovation Solution

A system comprising a stimulation probe and controller that provides adjustable electrical stimulation signals to detect heart activity, allowing for precise determination of the pericardium contact and adjustment of stimulation amplitude and frequency to safely pierce the pericardium, utilizing a needle configured for epicardial access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional methods are used to access the epicardial space, then procedural expertise and anatomical knowledge are required, but the risk of complications such as inadvertent right ventricular perforation increases

Engineering Contradiction:

Improvesafety of epicardial accessVSAvoidrisk of right ventricular perforation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors electrical signals from the heart during the puncture procedure and provides real-time feedback to the operator. When the probe approaches the pericardium, the system detects changes in electrical signal characteristics (such as QRS complex morphology) and alerts the operator, enabling safe identification of the pericardial plane without penetrating the right ventricle

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system replaces purely mechanical reliance on anatomical knowledge with an electrical sensing mechanism. Instead of depending solely on the operator's anatomical expertise to identify the pericardium, the system uses electrical stimulation and signal detection to precisely locate the pericardial plane, reducing the risk of perforation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If electrical stimulation signals are used to detect heart activity, then precise determination of pericardium contact is achieved, but the complexity of the device increases

Engineering Contradiction:

Improveprecision of pericardium contact detectionVSAvoidcomplexity of stimulation probe system

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The stimulation probe serves multiple functions: it delivers electrical stimulation signals to the heart, detects electrical responses from the heart, and provides mechanical puncture capability. By combining these functions into a single device, the system achieves precise pericardium contact detection without requiring separate complex systems for each function

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The probe uses the heart's own electrical activity as the sensing mechanism. The heart's natural electrical signals (QRS complexes) are detected and processed to determine probe position and pericardium contact, eliminating the need for external sensors or complex imaging systems

Inventive Principle:

Principle #25Self-service

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

Enables safer and more precise access to the epicardial space by detecting heart activity and adjusting stimulation parameters, reducing the risk of complications and improving procedural success.

Implementation Method 1

a stimulation probe configured to advance toward a pericardium and configured to provide an electrical stimulation signal of a selected amplitude and frequency

Methodology Applied

Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

the controller configured to detect the stimulation of the heart in response to the electrical stimulation signal

Methodology Applied

Scientific EffectElectrical response detection: Electric Field

Data Source

PatentUS20250009415A1Surgical system with location detection

Publication Date: 2025.01.09 BOSTON SCI MEDICAL DEVICE LTD

AI summary

A system to access an epicardium of a heart is disclosed. The system includes a stimulation probe and a controller. The stimulation probe is advanced toward a pericardium and provides an electrical stimulation signal of a selected amplitude and frequency. The controller is coupled to the to the stimulation probe. The controller provides the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjusts the selected amplitude, frequency, or both of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.