Guidewire with Preset Spatial Geometry for Pericardial Puncture
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Solution Overview
Problem
Current pericardium puncture devices face challenges in accurately puncturing the pericardium without damaging the underlying myocardium, especially in cases with a thickened pericardium or fat layer, and require complex setups like RF devices which are time-consuming.
Innovation Solution
An apparatus comprising an elongated introducer assembly and a guidewire assembly with a flexible preset spatial geometry, where the guidewire's distal tip forms a puncture hole and deflects away from the myocardium, minimizing the risk of damage and allowing for immediate fluid drainage during pericardiocentesis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a sharp distal tip on a guidewire is used to puncture the pericardium, then puncture effectiveness is improved, but the risk of damaging the myocardium increases
Solution Approach 1:
The guidewire is segmented into distinct functional zones: a sharp distal tip for puncture, a curved intermediate section for safety, and a straight proximal section for manipulation. This segmentation allows the sharp tip to effectively puncture the pericardium while the curved section acts as a safety buffer to prevent myocardium damage.
Solution Approach 2:
The curved section of the guidewire acts as an intermediary element between the sharp distal tip and the myocardium. This intermediate curved portion deflects the guidewire path away from the myocardium, allowing the sharp tip to puncture the pericardium without directly threatening the underlying heart muscle.
2Object-affected harmful factors
If a pre-set distal curve shape on the guidewire is used to deflect away from the myocardium, then myocardium damage is avoided, but puncture of thickened pericardium or fat layer is prevented
Solution Approach 1:
Different sections of the guidewire have different geometric properties tailored to their specific functions: the distal tip is sharp for penetrating thick tissue, the intermediate section has a curve for safety, and the proximal section is straight for control. This local differentiation of geometry allows both effective puncture and safety.
Solution Approach 2:
The guidewire's curved section is designed to be dynamic in its function - it provides deflection when needed to protect the myocardium, but can be straightened by applying force through the introducer sheath when puncture of thickened pericardium or fat layer is required. This dynamic adaptability resolves the contradiction between safety and puncture capability.
3Manufacturing precision
If RF puncture devices are used to vaporize tissue, then selective tissue vaporization is achieved, but procedural time and complexity increase
Solution Approach 1:
The invention replaces the complex RF energy system (generators, cables, electrodes) with a simple mechanical guidewire and introducer sheath system. The mechanical system achieves tissue puncture through the sharp distal tip and curved geometry, eliminating the need for time-consuming RF setup while maintaining effective tissue penetration.
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
The solution enables precise puncture of the pericardium while avoiding myocardial damage and reduces procedural complexity and time, facilitating efficient fluid drainage in emergency situations.
Implementation Method 1
The elongated guidewire assembly has a distal portion with a flexible preset spatial geometry... The pre-set spatial geometry has a distal deflective portion that begins at minimum length range of 4 mm from said distal tip and deflects a distal length away from the second biological wall
Data Source
AI summary
A method and apparatus are disclosed for an elongated introducer assembly and an elongated guidewire assembly. The elongated introducer assembly is manipulated and positioned proximate to a first biological wall. An elongated guidewire assembly is selectively maneuvered along the elongated introducer assembly and is comprised of a distal tip, distal portion, and elongated shaft section. The distal portion is further comprised of a flexible preset spatial geometry which comprises a distal length and distal deflective portion. The distal tip is used to puncture the first biological wall and the distal deflective portion directs the distal length away from a second biological wall positioned proximate to the first biological wall.