Catheter System for Dynamic Tissue Perfusion
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Solution Overview
Problem
Current methods for assessing tissue condition after vascular occlusions are limited by their reliance on static measurements that do not account for viscosity, oxygen levels, tissue volume, or auto-regulation, making them ineffective for tissues like the brain, kidneys, and heart, and fail to provide real-time actionable information for safe and effective perfusion.
Innovation Solution
A catheter-based system with sensors, a controller, and a pump that adjusts perfusion parameters such as viscosity, oxygen levels, and auto-regulation curves to ensure safe and effective perfusion of tissue distal to occlusions, providing real-time clinical actionable information and therapeutic manipulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If static measurement methods (angiography, stump pressure, FFR) are used to assess tissue condition, then the assessment can be performed with simple equipment, but the measurement precision and reliability are insufficient for tissues with auto-regulation
Solution Approach 1:
The system continuously monitors tissue perfusion parameters (pressure, flow, temperature, oxygen saturation) and uses this feedback to dynamically adjust perfusion pump settings, creating a closed-loop control system that adapts to real-time tissue conditions and resolves the contradiction between measurement precision and device complexity
Solution Approach 2:
The catheter system integrates multiple measurement capabilities (pressure sensors, flow sensors, temperature sensors, oxygen saturation sensors) into a single multi-functional device, enabling comprehensive tissue assessment without requiring multiple separate complex systems
2Reliability
If pharmacologic manipulations (adenosine, dihydropyridine) are used to obtain measurements, then the assessment can be performed, but the measurements fall outside the range of physiological responses and may cause harmful effects
Solution Approach 1:
The system converts the potential harm of aggressive pharmacologic testing into benefit by using gentle, titratable mechanical perfusion that can be precisely controlled to remain within physiological ranges, while still obtaining reliable auto-regulation curve data through incremental pressure changes
Solution Approach 2:
Instead of using pharmacologic agents, the system changes physical parameters (perfusion pressure, flow rate, temperature) in a controlled manner to elicit physiological responses, avoiding the harmful effects of drugs while maintaining measurement reliability
3Temperature
If perfusion pressure and flow are increased to improve tissue oxygenation, then oxygen delivery improves, but the risk of baro-trauma and vessel rupture increases
Solution Approach 1:
The system dynamically adjusts perfusion pressure and flow rate based on real-time feedback from pressure and flow sensors, automatically adapting to tissue response and preventing excessive pressures that could cause baro-trauma while maintaining adequate oxygenation
Solution Approach 2:
Continuous monitoring of distal pressure and flow provides feedback that prevents excessive perfusion parameters, allowing the system to maintain optimal oxygenation levels while automatically avoiding the harmful threshold of baro-trauma
4Reliability
If real-time perfusion monitoring is implemented to obtain actionable physiological information, then tissue rescue effectiveness improves, but the device complexity and cost increase
Solution Approach 1:
The catheter integrates multiple sensors (pressure, flow, temperature, oxygen saturation) and control functions into a single multi-functional device, providing comprehensive real-time monitoring and automated control without requiring multiple separate complex systems
Solution Approach 2:
The system includes automated algorithms that independently analyze sensor data, determine tissue auto-regulation status, and adjust perfusion parameters without requiring constant operator intervention, reducing the effective complexity burden on the user
Data Source
AI summary
This application describes a method and device for safely, effectively, perfusing distal to occluded arteries, based on diagnostic information from the catheter-perfusion-system based on sensors, effectors, controllers and algorithms included, with particular attention to the specific characteristics of the tissue and the fluid. Key actionable physiological values for the tissue can be calculated and derived. They include the auto-regulatory curve, with Upper and Lower limits of Auto regulation, vascular reserve, and collateral flow reserve and as auto-regulation exhaustion.