研究目的
To develop an optimized configuration of an optically sensorized epidural catheter for improved epidural space identification and catheter monitoring, addressing biocompatibility issues and enhancing the effectiveness of epidural procedures.
研究成果
The proposed sensorized epidural catheter effectively identifies the epidural space through force drop detection and prevents catheter kinking via intensity monitoring. It addresses biocompatibility issues and enhances patient safety compared to previous configurations. The device shows potential as a complete guidance system for epidural procedures, but more extensive testing is required for clinical application.
研究不足
The study is preliminary with a small sample size (three punctures in one animal), limiting statistical significance. Further tests are needed to improve reliability and generalize findings. The device may require optimization for human use and integration into catheter walls for drug administration without fiber removal.
1:Experimental Design and Method Selection:
The study involved designing a sensorized epidural catheter with an integrated fiber Bragg grating (FBG) for strain sensing. The FBG measures force variations during tissue penetration, and a discrimination algorithm was developed to identify true epidural space entry. In vivo tests on a porcine model were conducted to validate the device.
2:Sample Selection and Data Sources:
A female porcine model of 7 months age and 70 kg weight was used for in vivo testing. Punctures were performed in L5/L6, L6/L7, and L7/S1 spaces by a skilled clinician.
3:List of Experimental Equipment and Materials:
Equipment includes a standard 20 G nylon epidural catheter, an 18 G Tuohy needle, a customized blocking/sliding system (BSS), a single-ended FBG inscribed in smf28e optical fiber with polyimide coating, a Micron Optics sm130 interrogator, a PC with Labview software, and X-ray fluoroscopy equipment.
4:Experimental Procedures and Operational Workflow:
The sensorized catheter was integrated into the needle using the BSS. Calibration tests correlated force with Bragg wavelength shifts. In vivo procedures involved inserting the needle, setting a baseline, advancing the needle while monitoring FBG signals, and advancing the catheter to detect kinking via intensity drops. X-ray scans confirmed positions.
5:Data Analysis Methods:
Data from the interrogator (Bragg wavelength and intensity) were analyzed using a customized Labview plug-in. A discrimination algorithm processed force variations and derivatives to distinguish true epidural space entry. Statistical analysis included mean and standard deviation calculations.
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