Intravascular Speed Guidance for Accurate Catheter Pullback
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Solution Overview
Problem
Current methods for assessing the severity of stenosis in blood vessels, such as FFR and iFR, are inadequate for providing real-time guidance during intravascular procedures, leading to inefficiencies and potential need for repeated procedures due to poor data acquisition and inaccurate co-registration.
Innovation Solution
A medical processing unit tracks an intravascular instrument within radiographic images, calculates its movement speed, and provides real-time feedback to adjust the speed to achieve a target movement speed, enhancing data acquisition efficiency and co-registration accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the catheter is advanced through the aorta to reach the arch vessels, then the ability to deliver therapy to arch vessels is improved, but the risk of dislodging aortic plaque and causing stroke increases
Solution Approach 1:
The catheter system employs dynamic speed control that adjusts the advancement rate based on real-time location and patient-specific risk factors. The system transitions from static speed limits to dynamic, context-aware speed modulation, allowing faster advancement in low-risk zones and slower advancement near high-risk plaque deposits, thereby resolving the contradiction between delivery capability and stroke risk.
Solution Approach 2:
The system incorporates continuous feedback through imaging modalities (fluoroscopy, IVUS, OCT) that provide real-time information about catheter position and aortic plaque characteristics. This feedback loop enables the control system to adjust advancement speed dynamically, stopping or slowing down when approaching vulnerable plaque, thus preventing plaque dislodgement while maintaining the ability to reach target vessels.
2Productivity
If the catheter is advanced quickly to reduce procedure time, then productivity is improved, but the risk of complications such as plaque dislodgement and stroke increases
Solution Approach 1:
The system implements periodic imaging and assessment during catheter advancement, creating a rhythm of advance-assess-adjust cycles. Rather than continuous slow advancement or reckless fast advancement, the catheter moves forward in controlled intervals with periodic imaging checks, allowing the procedure to progress efficiently while maintaining safety through regular monitoring and adjustment.
Solution Approach 2:
The system dynamically changes the speed parameter based on real-time conditions. Instead of maintaining a constant slow speed throughout the procedure, the control system adjusts the advancement speed parameter continuously, increasing speed in safe zones and decreasing it in high-risk zones, thereby optimizing both procedure time and complication risk.
3Adaptability or versatility
If manual control is used by the operator, then flexibility and adaptability are improved, but operator fatigue and inconsistency increase
Solution Approach 1:
The system incorporates self-regulating features that automatically adjust advancement speed based on pre-programmed safety parameters and real-time sensor data. The catheter system serves itself by autonomously modulating speed in response to detected conditions, reducing the cognitive and physical burden on the operator while maintaining flexibility through programmable adaptability to different patient anatomies and risk profiles.
Solution Approach 2:
The control system acts as an intermediary between the operator's intent and the catheter's movement. Rather than the operator directly controlling speed with hand movements, the control system translates operator commands into appropriate speed adjustments, filtering out inconsistencies and fatigue-related variations while preserving the operator's strategic decisions about when and where to advance the catheter.
Data Source
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AI summary
In an embodiment, a medical system is disclosed. One embodiment of the medical system comprises a medical processing unit in communication with an intravascular instrument configured to be moved longitudinally within a body lumen and in further communication with a radiographic imaging source configured to obtain radiographic images of the intravascular instrument while the intravascular instrument is moved longitudinally within the body lumen. The medical processing unit is configured to receive radiographic images obtained by the radiographic imaging source, track the intravascular instrument within the radiographic images while the intravascular instrument is moved longitudinally within the body lumen, calculate a movement speed based on the tracking, compare the calculated movement speed to a predefined target movement speed, generate a speed-adjustment suggestion based on the comparison, and output the speed-adjustment suggestion to a display for review by a user.