Electrosurgical Puncture Shut-Off Using Marker-Sensor Feedback
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Solution Overview
Problem
Current medical devices lack the ability to automatically deactivate radiofrequency energy delivery after a puncture is completed, leading to potential inadvertent damage to surrounding tissues during transseptal procedures, such as cardiac tamponade or aortic perforation.
Innovation Solution
An electrosurgical puncturing device with a marker and sensor system that aligns to enable and disable energy delivery automatically, using a puncturing device with a marker and a dilator with a detector to ensure energy delivery only occurs when the puncture is complete.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the user manually controls the duration of energy delivery, then the energy delivery can be stopped before completion, but there is no way to confirm during delivery if the puncture was successful, leading to inadvertent damage to surrounding tissues
Solution Approach 1:
The patent implements a feedback mechanism where a sensor detects when the puncturing device has successfully created a puncture and provides real-time feedback to automatically terminate energy delivery. This resolves the contradiction by providing puncture success confirmation during energy delivery, preventing inadvertent damage to surrounding tissues while maintaining reliable energy delivery control.
2Reliability
If the energy delivery duration is extended to ensure complete puncture, then the puncture is more likely to be successful, but the risk of damaging surrounding tissues increases
Solution Approach 1:
The sensor-based feedback system detects puncture completion in real-time and automatically stops energy delivery at the precise moment the puncture is achieved. This resolves the contradiction by ensuring puncture completion while preventing over-delivery that would damage surrounding tissues, eliminating the need to extend energy delivery duration beyond what is actually required.
3Loss of information
If the user manually monitors puncture success using fluoroscopy or pressure readings, then some information about puncture status can be obtained, but the monitoring is not continuous and real-time confirmation during energy delivery is not available
Solution Approach 1:
The patent integrates a sensor that provides continuous, real-time feedback about puncture status directly during energy delivery. This resolves the contradiction by providing complete puncture status information continuously without requiring separate monitoring procedures, making real-time confirmation available exactly when needed during energy delivery.
Solution Approach 2:
The patent replaces manual monitoring methods (fluoroscopy, pressure readings) with an automated sensor-based detection system. This substitution provides continuous monitoring capability without the complexity and limitations of manual methods, resolving the contradiction between information availability and ease of operation.
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
Prevents inadvertent tissue damage by automatically shutting off energy delivery once the puncture is completed, reducing risks of complications like cardiac tamponade and aortic perforation.
Implementation Method 1
A sensor positioned along a length of the dilator detects when the marker is no longer aligned with the sensor, indicating the puncture is complete
Implementation Method 2
The delivery of radiofrequency energy to a tissue results in vaporization of the intracellular fluid of the cells which are in contact with the energy delivery device
Implementation Method 3
The delivery of radiofrequency energy to a tissue results in vaporization of the intracellular fluid of the cells
Data Source
AI summary
A method and apparatus are disclosed for creating a puncture in a tissue. The assembly includes a puncturing device having a distal tip configured to deliver energy to the tissue, creating the puncture. The puncturing device further includes a marker positioned along the puncturing device. The assembly further includes a dilator which has a lumen extending from a proximal portion to a distal portion and configured to receive the puncturing device. The dilator further comprises a sensor positioned along a length of the dilator. When the marker and the sensor are aligned, energy is delivered to the distal tip of the puncturing device.