Pericardial Puncture System with Nested Endoscope Visualization
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Solution Overview
Problem
Current medical devices for pericardial puncture lack effective visualization and guidance, which can lead to inaccuracies and increased risk during procedures, necessitating enhanced safety measures for precise targeting and puncture execution.
Innovation Solution
A system comprising a needle, an endoscope, and an introducer, where the endoscope provides real-time visualization of the needle's position relative to the target tissue, allowing for precise pericardial puncture by guiding the needle through lumens within the introducer, with optional radiofrequency capabilities and radiopaque markers for fluoroscopic confirmation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pericardial puncture is performed without real-time visualization, then the procedure can be performed with simpler equipment, but the accuracy of needle placement and patient safety deteriorate
Solution Approach 1:
The endoscope is advanced through the introducer sheath, which itself contains the needle. This nested arrangement allows the visualization system to be integrated within the existing puncture device structure, enabling real-time visualization of needle placement accuracy without requiring a completely separate complex system.
Solution Approach 2:
The endoscope acts as an intermediary between the needle and the operator's eye. It provides real-time visual feedback about needle position relative to the pericardium, allowing precise control of needle placement while maintaining a relatively simple overall device architecture.
2Adaptability or versatility
If a single lumen is used in the introducer, then the device structure is simpler, but the ability to simultaneously guide needle and endoscope deteriorates
Solution Approach 1:
The introducer sheath is divided into multiple lumens: a first lumen for the needle and a second lumen for the endoscope. This segmentation allows both elements to be guided simultaneously through the introducer without interfering with each other, enhancing the device's versatility while maintaining manageable structural complexity.
3Measurement precision
If the camera remains inside the second lumen, then the visualization path is simpler, but the ability to assess needle position relative to pericardium deteriorates
Solution Approach 1:
The camera is extracted from the second lumen and positioned at the distal tip of the endoscope. This allows the camera to be pulled out through the side opening of the introducer sheath and positioned adjacent to the pericardium, enabling direct assessment of needle position and pericardial proximity while maintaining a relatively simple operational sequence.
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
Enhances patient safety by enabling precise pericardial puncture with real-time visualization, reducing the risk of procedural errors and improving the accuracy of needle placement, thereby facilitating safer access to the epicardial space.
Implementation Method 1
an endoscope extending between an endoscope proximal portion and an endoscope distal portion having a camera
Implementation Method 2
The needle is a radiofrequency needle and the puncturing tip includes a radiofrequency electrode
Implementation Method 3
the introducer distal portion further includes a radiopaque marker
Data Source
AI summary
A system of medical devices includes a needle, an endoscope, and an introducer. The needle extends between a needle proximal portion and a needle distal portion having a puncturing tip. The endoscope extends between an endoscope proximal portion and an endoscope distal portion having a camera. The introducer is for guiding the needle and the endoscope towards a target location. The introducer extends between an introducer proximal portion and an introducer distal portion and has a first lumen extending therethrough from the introducer proximal portion to the introducer distal portion and a second lumen extending therethrough from the introducer proximal portion to the introducer distal portion. The needle is advanceable through the first lumen to position the puncturing tip proud of the introducer distal portion and the endoscope is advanceable through the second lumen to position the camera proximate the introducer distal portion and outside of the lumen.