Wireless Pressure Sensor for Central Venous Catheter Placement Verification
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Solution Overview
Problem
Current methods for verifying needle or catheter placement during central venous catheter (CVC) insertion, such as manometry and ultrasound, are inadequate as they can lead to accidental arterial cannulation, are not routinely used, or are costly and labor-intensive, and do not provide reliable real-time feedback.
Innovation Solution
A medical device with a housing that includes a pressure sensor, processing unit, and output unit, configured to wirelessly monitor and display mean pressure values, providing real-time visual and auditory feedback on whether a needle or catheter is correctly placed in a venous or arterial site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manometry is used to verify needle or catheter placement, then the ability to assess blood column height is improved, but the reliability of placement verification deteriorates due to false conclusions from needle occlusion or patient condition
Solution Approach 1:
The patent replaces the manual visual assessment mechanism with an automated electronic pressure sensing system. The sensor automatically detects and measures pressure changes in real-time, eliminating the need for manual blood column height assessment and reducing human error in interpretation.
Solution Approach 2:
The patent implements real-time feedback through continuous pressure monitoring and immediate visual/audio alerts. The system provides continuous feedback during the procedure, allowing immediate detection of arterial versus venous placement, rather than delayed manual assessment after the procedure.
2Difficulty of detecting and measuring
If ultrasound is used for determining needle position, then the ability to visualize anatomical structures is improved, but the productivity deteriorates due to time consumption and labor intensity
Solution Approach 1:
The patent enables the system to perform verification automatically without requiring external ultrasound equipment or operator intervention. The pressure sensor system self-monitors placement continuously, eliminating the need for separate ultrasound imaging steps and reducing procedural time.
Solution Approach 2:
The patent substitutes the complex ultrasound imaging system with a simple electronic pressure sensor. This replacement maintains adequate verification capability while dramatically simplifying the system and reducing time requirements.
3Measurement precision
If conventional manometry with extension sets is used, then the ability to form blood column is improved, but the device complexity increases due to additional components and setup requirements
Solution Approach 1:
The patent extracts the essential function of pressure measurement from the complex manometry system. By removing the extension sets, elevation mechanisms, and manual assessment requirements, only the critical pressure sensing function remains, integrated directly into the needle hub.
Solution Approach 2:
The patent merges the pressure sensing function directly into the needle hub assembly, eliminating separate extension sets and external monitoring equipment. This integration reduces the number of components and simplifies the overall system while maintaining measurement capability.
4Reliability
If real-time pressure monitoring is implemented, then the reliability of placement verification is improved, but the use of energy increases due to electronic sensing and wireless transmission
Solution Approach 1:
The patent optimizes the sampling rate and transmission frequency of the pressure data to balance reliability with energy consumption. By adjusting these parameters, the system maintains accurate real-time monitoring while minimizing power usage during the procedure.
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 device enables accurate and efficient verification of needle placement, reducing the risk of arterial cannulation and providing immediate, reliable feedback to medical professionals, thus improving the safety and efficiency of CVC insertion procedures.
Implementation Method 1
a pressure sensor carried by the housing, the sensor configured to generate a pressure signal in response to a pressure of a tissue environment in which a distal portion of the probe is positioned
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
Methods and structures for detecting a physiologic parameter of a target anatomical environment. The device including a housing with a distal portion first port couplable to a probe and a proximal portion; and a sensing unit, a processing unit, and an output unit carried by the housing, the output unit configured to output a reporting signal based on the determined physiologic parameter value such as pressure; the sensing unit, processing unit, and output unit being disposed substantially between the first port and the proximal portion of the housing.