Variable Flow Restrictor for Patient-Specific Vascular Pressure Mapping
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Solution Overview
Problem
Current vascular restrictor devices for managing refractory angina lack the ability to personalize the diameter restriction based on individual patient responses, making it difficult to determine the optimal size for effective hemodynamic modification and therapeutic benefit.
Innovation Solution
A vascular pressure differential diagnostic system and method that uses a catheter with variable flow restrictors and pressure sensors to measure and map pressure differentials across varying flow restrictions, allowing for personalized selection of the optimal restrictor size based on patient-specific hemodynamic responses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size vascular restrictor is used, then the device structure is simple, but the ability to personalize the diameter restriction based on individual patient responses is lost
Solution Approach 1:
The patent employs a dynamic adjustability mechanism that allows the restrictor diameter to be modified during the procedure. The device includes a adjustable component that can be repositioned or reconfigured to change the orifice size, enabling real-time adaptation to different patient hemodynamic responses while maintaining a relatively simple base structure.
Solution Approach 2:
The restrictor device is divided into separable components including an adjustable element that can be independently positioned. This segmentation allows the diameter restriction to be customized by adjusting the position or configuration of specific segments of the device, achieving personalization without requiring an entirely complex monolithic structure.
2Reliability
If a temporary vascular restrictor is used to assess patient response, then the therapeutic effect can be evaluated before permanent implantation, but the duration of the diagnostic procedure is extended
Solution Approach 1:
The patent implements a temporary restrictor that can be deployed before permanent implantation to pre-assess patient response. This preliminary action allows the clinician to evaluate hemodynamic effects and determine suitability for permanent treatment in advance, reducing the need for extended trial periods or multiple procedures.
Solution Approach 2:
The device incorporates pressure sensors that provide real-time feedback on the pressure differential across the restrictor and patient physiological response. This feedback mechanism enables rapid assessment of therapeutic effect during the temporary deployment, allowing quick determination of patient response and reducing the time needed for evaluation before permanent implantation.
3Measurement precision
If pressure sensors are added to measure pressure differential, then the ability to determine optimal restrictor size is improved, but the device complexity increases
Solution Approach 1:
The pressure sensors are integrated directly into the restrictor device structure, allowing the device to self-measure and self-report pressure differential data. This self-service approach eliminates the need for separate external monitoring equipment, providing precise measurement capability while minimizing additional complexity by using the device's own components for measurement.
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
Enables precise determination of the appropriate vascular restrictor size for each patient, improving therapeutic outcomes by mimicking the hemodynamic modifications of a permanent implant during a temporary procedure, thereby identifying suitable candidates for implantation and optimizing treatment efficacy.
Implementation Method 1
a pressure differential between the first pressure sensor and second pressure sensor is measurable and mappable to varying flow restrictions
Data Source
AI summary
Systems and methods for pressure differential measurement and hemodynamic response assessment in vascular lumens are disclosed. Systems include catheter-based devices with variable flow restriction to create a controlled variable pressure differential (ΔP) within the coronary sinus. Methods are disclosed that allow a range of pressure changes to be mapped to a range of flow restriction diameters on a patient-specific basis as well as mapped to clinically measurable indicators of restriction/pressure change effect on hemodynamic and cardiac response.