Puncture Device for Pericardial Access
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Solution Overview
Problem
Existing methods for accessing the pericardial cavity of the heart, such as using needles, pose a risk of lacerating the myocardium due to their invasive nature and potential for accidental puncture, especially when the pericardial cavity volume is small.
Innovation Solution
A method involving a puncture device that manipulates the parietal pericardium to create tension and delivers energy in a controlled, pulsed manner to puncture the parietal pericardium while maintaining the device stationary relative to the tissue, reducing the risk of myocardial damage by avoiding direct mechanical trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle is inserted to access the pericardial cavity, then access to the pericardial cavity is achieved, but the risk of myocardial laceration increases
Solution Approach 1:
The patent replaces the mechanical needle puncture system with an electrosurgical system that uses controlled electrical energy delivery. The electrosurgical generator delivers energy through a needle electrode to create a controlled channel through the pericardium, substituting uncontrolled mechanical trauma with controlled thermal/electrical energy that can be precisely regulated to avoid myocardial damage.
Solution Approach 2:
The patent employs parameter changes by controlling the electrical energy delivery parameters (voltage, pulse duration, frequency) to achieve precise puncture of the pericardium without damaging the underlying myocardium. The electrosurgical system adjusts energy parameters in real-time based on tissue characteristics and penetration depth to maintain safety margins.
2Productivity
If the pericardial cavity volume is small, then the procedure is more challenging, but the risk of accidental puncture increases
Solution Approach 1:
The patent incorporates feedback mechanisms where the electrosurgical system monitors impedance changes, temperature, and energy delivery parameters during puncture. This real-time feedback allows the system to detect when the needle approaches the myocardium and automatically adjust energy delivery or halt puncture to prevent accidental myocardial damage, thereby improving reliability in small cavity volumes.
Solution Approach 2:
The patent uses periodic pulsed energy delivery rather than continuous energy application. The electrosurgical generator delivers energy in controlled pulses, allowing the tissue to recover between pulses and enabling precise control over the puncture process. This periodic action reduces the risk of overheating and accidental damage while maintaining puncture effectiveness.
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 approach minimizes the risk of myocardial laceration and allows safe access to the pericardial cavity by creating a channel through the parietal pericardium without significantly affecting the myocardium, enhancing procedural safety and reducing the risk of complications.
Implementation Method 1
delivering energy via the puncture device to puncture the parietal pericardium
Data Source
AI summary
Devices and methods are disclosed for providing access to the pericardial cavity while reducing risk of myocardial damage. The methods include maintaining the positions of a puncture device and of a portion of a parietal pericardium relative to one other while delivering energy from the puncture device to create a channel through the pericardium. Additional embodiments disclosed include delivering a pulse or pulses of energy to the parietal pericardium and attempting to advance the puncture device through the parietal pericardium between deliveries of energy pulses.