Tissue Viability Testing via Perfusion Pressure Measurement
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Solution Overview
Problem
Current methods for testing tissue viability during anastomosis are subjective and unreliable, leading to a high incidence of anastomotic leakage, which can result in life-threatening complications and significant medical expenses.
Innovation Solution
A system and method using a perfusion measuring device controlled by a computer to rapidly apply and then slowly release pressure on a tissue test area, measuring local perfusion pressure and comparing it to systemic blood pressure to determine tissue viability through a bowel-brachial index, providing a reliable and accurate prediction of anastomosis viability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If visual estimation by surgeon experience is used to assess tissue viability, then the assessment process is simple and quick, but the reliability and accuracy of the assessment is low leading to high anastomotic leakage rates
Solution Approach 1:
The patent replaces the subjective visual assessment method with an objective automated optical system that uses image processing and analysis algorithms to evaluate tissue perfusion and viability, thereby improving reliability while managing complexity through computerized automation
Solution Approach 2:
The patent introduces an intermediary optical imaging system and image processing software that acts as a mediator between the surgeon and the tissue, providing quantifiable objective data about tissue viability rather than relying directly on subjective visual judgment
2Measurement precision
If jaw members are used to apply pressure to tissue for perfusion measurement, then the measurement process can be performed, but the non-uniform pressure distribution makes reliable and reproducible measurements difficult
Solution Approach 1:
The patent employs multiple independently controllable pressure application points or zones that can apply different pressure levels to different local areas of the tissue, ensuring uniform pressure distribution across the measurement area while maintaining ease of operation through automated control
Solution Approach 2:
The patent dynamically adjusts pressure parameters (magnitude, distribution, duration) based on real-time feedback from the tissue response, optimizing the pressure application profile to achieve both measurement precision and operational simplicity
3Productivity
If rapid pressure ramp up is used to measure local perfusion pressure, then the measurement speed is improved, but the force applied to tissue increases which may cause tissue damage
Solution Approach 1:
The patent uses periodic or cyclic pressure application with controlled ramp-up and ramp-down phases, allowing the tissue to respond and recover between cycles, thereby maintaining measurement speed while reducing the risk of permanent tissue damage through repeated high-force exposure
Solution Approach 2:
The patent incorporates real-time feedback monitoring of tissue response during pressure application, automatically adjusting the pressure profile to stop or reduce force when signs of tissue stress or damage are detected, thus maintaining productivity while preventing harmful effects
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 system significantly reduces the risk of anastomotic leakage by offering a highly reliable and accurate prediction of tissue viability, with a positive predictive value of 86% to 89% for anastomotic leakage, allowing surgeons to make informed decisions during surgery.
Implementation Method 1
The system includes a system for measuring a local perfusion pressure and a systemic perfusion pressure and determining an index on the basis of the measured pressures
Data Source
AI summary
A method is described for testing the viability of a tissue of a patient for an anastomosis using a perfusion measuring device wherein the method may comprise: controlling at least one actuating structure of the perfusion measuring device to rapidly ramp up a force exerted on at least one test area of the tissue selected for an anastomosis, the force exerted on the at least one test area defining a local (systolic) perfusion pressure; and, during the ramp up of the force, the computer receiving a sensor signal from at least one sensor of the perfusion measuring device and a signal from a blood pressure device, the sensor signal being indicative of perfusion of blood through the micro vascularization in the first test area and the blood pressure signal being indicative of a general (systolic) blood pressure of the patient; controlling the first actuating structure to slowly ramp down the force exerted on the first test area, when the sensor signal signals the computer that the perfusion of the blood in the tissue of the first test area has stopped; and, during the ramp down of the force, the computer determining the local perfusion pressure at which the sensor signal indicates a start of perfusion of blood through the micro vascularization, the determined local perfusion pressure defining a reperfusion pressure value of the first test area; and, determining a prediction whether or not the tissue of the at least one test area is viable for an anastomosis on the basis of the local reperfusion pressure value of the at least one test area and the general systolic blood pressure value.