Blood Pressure-Guided Atherectomy Cutter for Stenosis Control
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Solution Overview
Problem
Existing medical devices struggle to effectively treat stenosed sites in blood vessels due to calcification or bifurcations, and require complex imaging procedures to assess lesion areas, increasing patient radiation exposure.
Innovation Solution
A medical device with a rotatable drive shaft, cutting unit, and blood pressure sensors that calculate fractional flow reserve to control the cutting operation based on pressure measurements, allowing for non-imaging assessment of lesion areas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If X-ray imaging is used to check the lesion area state, then the target size can be confirmed, but radiation exposure to the patient increases and the technique becomes complicated
Solution Approach 1:
The patent replaces the X-ray imaging system with a blood pressure measurement system. Instead of using electromagnetic radiation (X-rays) to visualize the lesion area, the system uses mechanical pressure sensors to measure blood pressure changes, which indirectly reflects the lesion state and guides the cutting operation.
Solution Approach 2:
The patent introduces blood pressure as an intermediary parameter to assess the lesion area. Rather than directly imaging the lesion, the system uses blood pressure measurements (both proximal and distal to the lesion) as a mediator to infer the lesion's impact on blood flow and guide the cutting procedure.
2Measurement precision
If multiple X-ray imaging procedures are repeated to check the lesion area, then the target size can be confirmed, but the technique becomes complicated and radiation exposure increases
Solution Approach 1:
The patent replaces the complex X-ray imaging procedure with a simpler blood pressure measurement system. Instead of requiring multiple imaging sequences and complex image analysis, the system uses straightforward blood pressure measurements at two points to calculate fractional flow reserve, significantly simplifying the procedure.
Solution Approach 2:
The patent extracts the essential information needed for lesion assessment from the complex X-ray imaging process and concentrates it into a single, simple blood pressure measurement-based calculation. This extracts the critical decision-making parameter (fractional flow reserve) from the complex imaging workflow.
3Productivity
If the cutter operates without precise control, then the cutting procedure can be performed, but overcutting or insufficient cutting may occur
Solution Approach 1:
The patent implements a feedback control system where blood pressure measurements are continuously monitored during the cutting procedure. The fractional flow reserve calculation provides real-time feedback on the cutting progress, allowing the operator to adjust the cutting operation to achieve the precise target without overcutting or insufficient cutting.
Solution Approach 2:
The patent makes the cutting operation dynamic and adaptive rather than static. The cutting parameters can be adjusted in real-time based on the changing blood pressure measurements and fractional flow reserve calculations, allowing the procedure to adapt to the actual tissue conditions and achieve precise cutting.
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 and controlled cutting of stenosed sites without radiation exposure, ensuring effective removal of thrombi and plaque while preventing overcutting.
Implementation Method 1
a distal-side blood pressure sensor at a distal portion of the second device and a proximal-side blood pressure sensor on a proximal side of the distal-side blood pressure sensor
Data Source
AI summary
A medical device for removing an object in a body cavity, includes a first device including a rotatable drive shaft and a cutter attached to a distal end of the drive shaft and by which the object is cut, a second device movable with respect to the drive shaft along a longitudinal direction of the drive shaft and including a distal-side blood pressure sensor at a distal portion of the second device and a proximal-side blood pressure sensor on a proximal side of the distal-side blood pressure sensor, and a controller configured to acquire a first measurement value from the distal-side blood pressure sensor and a second measurement value from the proximal-side blood pressure sensor, calculate a fractional flow reserve using the first and second measurement values, and control the cutter to cut the object in accordance with the calculated fractional flow reserve.