Impedance-Guided Cardiac Puncture Device
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Solution Overview
Problem
Current methods for accessing the pericardial cavity of the heart are invasive and carry risks of myocardial laceration due to the use of rigid piercing members, particularly when the pericardial cavity and fluid volume are small.
Innovation Solution
A method involving an energy delivery device that monitors electrical impedance to safely access the pericardial cavity by delivering energy to puncture the pericardium while minimizing risk to the myocardium, using techniques such as impedance measurement, energy delivery, and sensory feedback to guide the puncture device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a standard epidural 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 piercing action of a standard epidural needle with an energy-based puncture system. The energy delivery device delivers energy to the pericardium to create a controlled channel, eliminating the need for a rigid mechanical needle that risks lacerating the myocardium. This substitution of mechanical force with energy delivery resolves the contradiction by maintaining access capability while eliminating the harmful mechanical piercing action.
Solution Approach 2:
The patent incorporates impedance monitoring that provides real-time feedback during the puncture process. The impedance sensor detects changes in electrical impedance that indicate when the energy delivery device has penetrated the pericardium and entered the pericardial cavity. This feedback mechanism allows the operator to stop energy delivery and advance the device at the appropriate moment, preventing myocardial laceration while ensuring successful access.
2Quantity of substance
If the pericardial cavity and fluid volume are small, then the procedure is more challenging, but the risk of myocardial laceration is heightened
Solution Approach 1:
The impedance monitoring system provides critical feedback that is especially important when the pericardial cavity is small. The sensor detects impedance changes that indicate proximity to the myocardium, allowing the operator to precisely control the puncture depth and stop before penetrating the myocardium. This feedback mechanism is particularly valuable in cases with small fluid volumes where the margin for error is reduced.
Solution Approach 2:
The patent performs preliminary energy delivery to create a channel through the pericardium before advancing the device into the pericardial cavity. This preliminary action establishes a controlled pathway that reduces the risk of unintended myocardial penetration, especially important when the cavity is small and the device must be advanced precisely.
3Reliability
If impedance monitoring is used to guide the puncture device, then safety is improved, but the device complexity increases
Solution Approach 1:
The patent makes the energy delivery device multi-functional by integrating an impedance sensor into it. The same device that delivers energy to puncture the pericardium also contains the impedance sensing capability to monitor penetration depth. This multi-functionality reduces the need for separate monitoring devices, thereby limiting the increase in overall system complexity while maintaining improved safety.
Solution Approach 2:
The patent combines the energy delivery function and impedance sensing function into a single integrated device. The impedance sensor is incorporated within the energy delivery device structure, allowing both functions to operate simultaneously. This merging of functions reduces the number of separate components needed and limits the increase in device complexity while achieving improved puncture safety.
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 method reduces the risk of myocardial damage by allowing precise control of the puncture process, ensuring the energy delivery device is positioned within the pericardial cavity without penetrating the myocardium, thus enhancing safety during cardiac procedures.
Implementation Method 1
delivering energy from an energy delivery device of a puncture device... delivering energy from the energy delivery device to at least partially puncture a pericardium
Implementation Method 2
monitoring an electrical impedance at the energy delivery device... measuring an electrical impedance at the energy delivery device... impedance is measured using the energy delivery device
Data Source
AI summary
Devices and methods are disclosed for providing access to the pericardial cavity while reducing risk of myocardial damage. One method includes advancing a puncture device towards a heart, the puncture device including an energy delivery device; measuring an electrical impedance at the energy delivery device; delivering energy from the energy delivery device to at least partially puncture a pericardium; and repeating one or more of the above steps, if necessary, until the energy delivery device is located at least partially within the pericardial cavity. Some embodiments of the method include using supplemental means of monitoring, including measuring voltage to plot an ECG, medical imaging and using contrast fluid, using tactile feedback, and aspirating fluid.