Occlusion Balloon Catheter Pressure Display for Safe Partial Vessel Blockage
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Solution Overview
Problem
Existing vascular occlusion catheter systems face challenges in emergency situations where imaging and monitoring capabilities are unavailable, requiring complex setups and risking catastrophic failures due to software malfunctions, especially when operated by untrained individuals.
Innovation Solution
A vascular occlusion catheter system with integrated on-board measures, including a display hub with pressure sensors and visual cues, to guide manual operation and ensure safe partial or complete occlusion without relying on closed feedback loops.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a closed feedback loop control system is used to automate balloon inflation, then the precision of occlusion control is improved, but the device complexity and risk of software malfunction increase
Solution Approach 1:
The patent extracts the feedback control system from the catheter assembly, separating the automation functionality into a standalone external device. This allows the catheter itself to remain simple while gaining automated control capabilities through a separate, dedicated unit that interfaces with the catheter's pressure sensors and inflation mechanism.
Solution Approach 2:
The patent introduces an intermediary external control device that mediates between the operator and the catheter system. This intermediary unit handles the complex feedback loop logic, pressure monitoring, and automated inflation control, shielding the operator from system complexity while providing precise occlusion control.
2Reliability
If a closed feedback loop control system is used to automate balloon inflation, then the reliability of occlusion control is improved, but the risk of catastrophic failure from software malfunction increases
Solution Approach 1:
By extracting the feedback control system into a separate external device, the patent isolates the software complexity away from the life-critical catheter components. This separation ensures that software malfunctions in the external device cannot directly cause catastrophic failures in the vascular system, as the catheter's mechanical components remain independent and fail-safe.
Solution Approach 2:
The patent incorporates fail-safe mechanical designs in the catheter that provide beforehand cushioning against software failures. The mechanical inflation system and pressure sensors are designed to default to safe states if the external control device fails, preventing catastrophic outcomes even when software malfunctions occur.
3Ease of operation
If manual operation without imaging guidance is used in emergency situations, then the ease of operation is improved, but the measurement precision of occlusion level deteriorates
Solution Approach 1:
The patent enables the catheter system to self-monitor and self-indicate its occlusion level through integrated pressure sensors and visual display components. The system automatically measures pressure differential across the balloon and provides real-time feedback to the operator, eliminating the need for external imaging guidance while maintaining precise occlusion level measurement.
Solution Approach 2:
The patent employs color-coded visual indicators on the catheter display that change based on the measured occlusion level. Different colors represent different occlusion grades, allowing the operator to immediately assess the occlusion status without complex readouts or imaging equipment, thus maintaining both ease of operation and measurement precision.
4Stability of the object's composition
If more blood flow is allowed past the occlusion balloon, then the distal perfusion is improved, but the hemorrhage increases
Solution Approach 1:
The patent enables dynamic adjustment of the balloon inflation level to optimize the balance between distal perfusion and hemorrhage control. The system allows the operator to incrementally adjust the balloon pressure and monitor the corresponding changes in distal blood pressure and hemorrhage rate, enabling real-time optimization of the trade-off between maintaining perfusion and controlling bleeding.
Solution Approach 2:
The patent incorporates feedback mechanisms that continuously monitor distal blood pressure and hemorrhage rate, providing real-time information to the operator about the effects of different occlusion levels. This feedback allows the operator to adjust the balloon inflation to achieve the optimal balance between maintaining adequate distal perfusion and minimizing hemorrhage, based on actual patient response rather than fixed protocols.
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
Provides safe and effective vascular occlusion by displaying real-time pressure readings and visual cues, reducing the risk of improper occlusion and ensuring accurate balloon inflation, suitable for both trained and untrained operators in emergency scenarios.
Implementation Method 1
A first pressure sensor may be positioned within the proximal catheter tubular member and in fluid communication with an environment external to the vascular occlusion catheter system proximal of the occlusion balloon. A second pressure sensor may be positioned within the distal catheter tubular member and in fluid communication with an environment external to the vascular occlusion catheter system distal of the occlusion balloon.
Data Source
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AI summary
A vascular occlusion catheter system for at least partial occlusion of a target vessel includes proximal and distal catheter tubular members and an intervening occlusion balloon. A display hub with a display screen is positioned upon the proximal catheter tubular member. A proximal pressure sensor is in fluid communication with an external environment proximal of the balloon. A distal pressure sensor is in fluid communication with an external environment distal of the balloon. The display hub is preset with a respective above and below balloon target blood pressure ranges each associated with safe partial occlusion of the target vessel; configured to output live proximal and distal pressure sensor readings on the display screen; configured to display visual cues on the display screen indicating whether the live proximal and/or distal pressure sensor readings are within the corresponding below and/or above balloon target blood pressure ranges.