Pericardial Drain Sheath Access Using a Needle-in-Needle Technique
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Solution Overview
Problem
Traditional pericardiocentesis methods using large-bore needles pose significant risks, including trauma to the myocardium, difficulty in visualization, and poor drainage efficiency, particularly in patients with dry pericardium, pectus deformities, or crowded ribs.
Innovation Solution
A dual needle-in-needle technique using a smaller inner microneedle and a large outer needle, combined with a microwire, guide sheath, stiffer guide wire, drain sheath, stay fix device, and drainage bulb, all featuring radiopaque markers and hydrophilic coatings for enhanced visualization and localized medication delivery, to minimize trauma and enhance procedural safety and efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If large-bore needles are used for pericardiocentesis, then drainage efficiency is improved, but trauma to the myocardium increases
Solution Approach 1:
The patent employs a needle-in-needle configuration where a smaller inner microneedle is nested within a larger outer needle. The outer needle provides structural support and enables successful skin and tissue penetration, while the inner microneedle performs the actual pericardial puncture with minimal trauma. This nested structure resolves the contradiction by separating the functions of penetration support and tissue interaction.
Solution Approach 2:
The drainage system is segmented into multiple functional components: outer needle for initial access, inner microneedle for precise pericardial penetration, guide sheath for stabilization, and drainage catheter for fluid removal. This segmentation allows each component to be optimized for its specific function, with the microneedle being sufficiently small to minimize myocardial trauma while the larger outer needle and sheath provide necessary structural support for effective drainage.
2Object-affected harmful factors
If smaller needles are used for pericardiocentesis, then myocardial trauma is reduced, but drainage efficiency deteriorates
Solution Approach 1:
The smaller inner microneedle is nested within the larger outer needle, allowing the microneedle to minimize myocardial trauma during pericardial penetration while the outer needle and subsequent guide sheath provide the structural framework necessary for effective drainage. The drainage catheter is then introduced through this nested structure to achieve efficient fluid removal.
Solution Approach 2:
The guide sheath acts as an intermediary component that is introduced after the microneedle creates the initial access. The guide sheath provides structural support and stabilization, enabling effective drainage through the small puncture created by the microneedle. This intermediary structure allows small-needle access to be combined with large-bore drainage capability.
3Device complexity
If traditional needle techniques are used, then procedural simplicity is maintained, but visualization of needle tip deteriorates
Solution Approach 1:
The patent incorporates radiopaque markers and coatings on the needles, guide sheath, and drainage catheter that enable visualization under fluoroscopic imaging. These radiopaque elements appear as distinct contrast against surrounding tissues, allowing real-time visualization of needle tip position and device placement while maintaining a relatively simple procedural approach.
4Device complexity
If traditional needle techniques are used, then procedural simplicity is maintained, but drainage efficiency deteriorates
Solution Approach 1:
The nested needle-in-needle configuration combined with guide sheath and drainage catheter creates a systematic approach that, while involving multiple components, provides a logical step-by-step procedure. The structured nesting allows each component to be introduced in sequence, maintaining procedural clarity while achieving superior drainage efficiency through the combination of precise microneedle access and adequate drainage lumen.
Data Source
AI summary
Embodiments include methods for draining fluids from a body organ, such as pericardiocentesis. Embodiments include inserting a large diameter outer needle through the chest wall towards an organ, inserting a smaller diameter microneedle through the outer needle and into the organ, threading a microwire through the lumen of the inner microneedle into the organ, removing the outer needle and inner microneedle, threading a guide sheath over the microwire into the organ, removing the inner dilator and microwire from the guide sheath, inserting a stiffer guide wire through the guide sheath into the organ, removing the guide sheath, threading a drain sheath over the stiffer guide wire into the organ, removing the stiffer guide wire, securing the drain sheath to the patient using a stay fix device, and connecting a suction device to the proximal end of the drain sheath and creating negative pressure to facilitate fluid drainage.