Pressure-Sensing Access Needle for Safe Pericardial Insertion
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical devices for accessing the pericardium lack pressure-sensing capabilities, leading to high complication rates and limited use to expert centers, as they are not optimized for pressure monitoring during needle insertion into the pericardial space.
Innovation Solution
A pressure-sensing access needle with a distal end and proximal end, equipped with markings for depth indication and various ports for infusion, manometry, and guidewire passage, allowing for real-time pressure monitoring during insertion to avoid internal organs and structures, and a retractable sharp edge for safe tissue access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lumbar puncture needle is used to access the pericardium, then pericardial access can be obtained, but the complication rate is high due to lack of pressure monitoring
Solution Approach 1:
The patent combines a standard lumbar puncture needle with integrated pressure sensing capabilities and depth markings into a single device. This merging allows the needle to simultaneously perform puncture access and pressure monitoring functions, reducing complications while avoiding the need for separate complex monitoring equipment.
Solution Approach 2:
The needle is designed with self-monitoring capabilities through integrated pressure sensors and depth markings that provide real-time feedback to the operator during insertion. This self-service feature allows the device to monitor its own position and the pressure environment without requiring external monitoring systems.
2Reliability
If pressure sensing capabilities are added to the needle, then complication rates are reduced through real-time monitoring, but device complexity increases
Solution Approach 1:
The patent implements pressure sensing at the specific location where it is most needed - at the needle tip and along the insertion path. Depth markings are placed at specific intervals along the needle shaft. This localized approach provides accurate monitoring where critical decisions are made without adding complex systems throughout the entire device.
Solution Approach 2:
The patent replaces complex mechanical pressure monitoring systems with simpler electronic or piezoelectric pressure sensors integrated into the needle. This substitution reduces the mechanical complexity while maintaining or improving measurement accuracy through more sensitive detection methods.
3Ease of operation
If depth markings and multiple ports are added to the needle, then ease of operation is improved for safe placement, but manufacturing complexity increases
Solution Approach 1:
The patent divides the needle into functional segments: the shaft with depth markings, the hub with multiple ports, and the tip with pressure sensing. This segmentation allows each component to be manufactured separately using standard techniques, then assembled through precision machining or bonding, reducing overall manufacturing complexity while maintaining operational ease.
Solution Approach 2:
The needle is designed with multiple ports that serve different functions - some for pressure monitoring, others for fluid injection or withdrawal, and guidewire passage. This multi-functionality is achieved through universal port designs that can accommodate various attachments and procedures, reducing the need for specialized components for each function.
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 reduces complication rates, enabling broader access to pericardial procedures beyond expert centers by providing accurate pressure readings for safe needle placement and reducing the risk of organ damage, thus improving the success rate of heart therapy procedures like ablation and pacing.
Implementation Method 1
a pressure sensor in communication with the needle for sensing pressure in the pericardium
Data Source
AI summary
A tool and method of positioning and delivering medical devices and therapeutics within the pericardial space, as well as other body part or space. A needle is inserted into the chest through a sub-xiphoid puncture, and the pressure within the needle is monitored manometrically or otherwise sensed as the needle is advanced towards the pericardial space. By reading the pressure within the needle while it is advanced, the clinician is able to know that he or she is avoiding insertion of it into organs or spaces not intended to be the target location. In addition the retractable sharp edge allows the operator to access the space and cut tissue but do so safely by retracting the sharp edge.