In Vivo Physiological Sensor for Early Anastomotic Leak Detection
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Solution Overview
Problem
Current methods for detecting leaks after gastrointestinal surgery, such as monitoring clinical signs or using imaging modalities, are inadequate as they result in delayed detection, leading to escalated severity of complications and increased morbidity and mortality rates.
Innovation Solution
A real-time monitoring system that includes a sensor and transmitter to measure preselected physiological parameters, such as analytes indicative of anastomatic leakage, which can be positioned adjacent to tissue sections during surgery and transmit data to an extracorporeal receiving unit, allowing for early detection and intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If clinical signs are monitored for leak detection, then the monitoring method is simple and non-invasive, but there is a lag between leak occurrence and symptom onset resulting in delayed detection
Solution Approach 1:
The monitoring device is positioned adjacent to the tissue sections during surgery before the leak can occur, establishing real-time monitoring capability in advance. This preliminary placement allows immediate detection of physiological parameter changes as soon as a leak begins, eliminating the time lag inherent in monitoring clinical signs that only appear after symptoms develop.
2Measurement precision
If imaging modalities such as fluoroscopy are used for leak detection, then visual confirmation of leakage is achieved, but significant resources and cost are required and sensitivity and specificity are limited
Solution Approach 1:
The patent replaces complex imaging modalities like fluoroscopy with a simpler sensor-based monitoring device that measures physiological parameters directly. This substitution maintains or improves detection sensitivity by continuously monitoring analyte levels or other physiological indicators adjacent to the tissue, while dramatically reducing device complexity, resource requirements, and cost compared to imaging systems.
3Reliability
If drain effluent measurement is used for leak detection, then some leak detection success is achieved, but drain use is inconsistent due to complications and marker identification is significantly delayed
Solution Approach 1:
The monitoring device acts as an intermediary positioned directly adjacent to the tissue sections, providing a reliable and immediate detection mechanism that eliminates the inconsistencies of drain placement and use. By measuring physiological parameters in real-time at the source, the device provides consistent and timely leak detection without the complications associated with drain management or delayed marker identification.
Data Source
AI summary
A monitoring system is disclosed for in vivo monitoring of preselected physiological parameters associated with acute and/or chronic tissue compromise or failure in one or multiple tissue/organ sites in real time. In one method, a body portion of a surgical stapling device is positioned adjacent a first tissue section, an anvil assembly adapted to engage the body portion is positioned adjacent a second tissue section, and a monitoring device is positioned adjacent the first and/or second tissue sections. The monitoring device includes a sensor adapted to measure a preselected physiological parameter and a transmitter for transmitting signal to an extracorporeal receiving unit. The surgical stapling device is fired to mechanically secure the first and second tissue sections with at least one staple and the preselected physiological parameter is monitored via the information transmitted from the monitoring device to the receiving unit.