Digital Angioplasty Balloon Inflation for Precise Pressure Control
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Solution Overview
Problem
Conventional balloon angioplasty devices lack precise control over pressure and expansion rate, leading to risks of vascular damage, restenosis, and dissection due to excessively high pressures and rapid expansion rates, with limited intra-procedural feedback and data capture.
Innovation Solution
A digital inflation device with a motor, pressure sensor, and processor that controls angioplasty balloon pressure, providing precise control over pressurization rate and magnitude, data recording, and one-handed operation, compatible with various balloon types.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional analog step devices are used for balloon angioplasty, then the device complexity is low and ease of operation is maintained, but pressure control precision is insufficient leading to excessively high pressures and rapid expansion rates
Solution Approach 1:
The patent implements a feedback control system where a pressure sensor continuously monitors balloon pressure and feeds this information to a processor, which then adjusts motor actuation to maintain precise pressure control. This closed-loop feedback mechanism enables precise pressure and expansion rate control while avoiding excessively high pressures that cause vascular damage.
Solution Approach 2:
The patent replaces conventional mechanical analog step devices with an electronically controlled system featuring a motor-driven plunger, pressure sensor, and processor. This substitution of mechanical systems with electronic control enables continuous, precise adjustment of pressurization rate and magnitude, resolving the contradiction between precision and complexity.
2Productivity
If high pressures are applied to reopen vessels with stiff plaque, then the stenosis is successfully treated, but vascular cell damage and wall injury increase leading to dissection and restenosis
Solution Approach 1:
The patent implements dynamic pressure control that adapts to the three distinct phases of balloon pressurization: rapid unfolding and expansion, engagement and radial extension of the vessel wall, and rapid expansion as stenotic plaques yield. The system continuously adjusts pressure based on real-time sensor feedback, maintaining optimal pressure throughout each phase to treat stenosis effectively while minimizing vascular damage.
Solution Approach 2:
The patent changes the parameter of pressure from fixed analog steps to continuously adjustable digital values, enabling precise control of both pressure magnitude and pressurization rate. This allows the system to apply exactly the right pressure needed to reopen vessels (average 4.4±2.3 atm) without exceeding safe limits, thereby treating stenosis effectively while preventing vascular cell damage and wall injury.
3Manufacturing precision
If coarse pressure adjustments are made by direct plunger translation, then the device structure is simple, but fine-tuning capability is insufficient
Solution Approach 1:
The patent introduces a motor as an intermediary between the user's command and the plunger actuation. The motor converts electrical signals into precise mechanical motion, enabling fine-tuning of pressure adjustments that would be difficult to achieve with direct manual plunger translation. This intermediary mechanism maintains ease of operation through simple interface while achieving high precision control.
4Manufacturing precision
If user's two-handed dexterity and reaction time are relied upon for pressure control, then no additional control mechanisms are needed, but control over the rate of pressurization is limited
Solution Approach 1:
The patent implements automated feedback control where the pressure sensor continuously monitors balloon pressure and the processor automatically adjusts motor actuation to maintain the desired pressurization rate. This eliminates reliance on user reaction time and dexterity, providing precise control over pressurization rate through automated regulation based on real-time pressure feedback.
Solution Approach 2:
The system performs self-regulation of pressurization rate by automatically responding to pressure sensor feedback without requiring continuous user intervention. The processor monitors pressure and autonomously adjusts motor speed and direction to maintain optimal pressurization rate, enabling the system to service itself and achieve precise rate control without depending on user reaction time.
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
Reduces vascular damage, enhances drug transfer, minimizes reintervention rates, and standardizes procedures by offering precise pressure control, real-time data recording, and compatibility with diverse balloon-catheter systems.
Implementation Method 1
a pressure sensor coupled to the processor
Implementation Method 2
a motor coupled to the processor... the motor is configured to adjust the pressure in the angioplasty balloon
Data Source
AI summary
Provided herein is an angioplasty balloon inflation device. The angioplasty balloon inflation device includes a processor; a pressure sensor coupled to the processor; a motor coupled to the processor; and an inflation element including a first end coupled to the motor and a second end configured for coupling to an angioplasty balloon. The motor is configured to adjust the pressure in the angioplasty balloon through the inflation element, the pressure sensor is configured to monitor pressure in the angioplasty balloon, and the processor is configured to control the motor based upon the pressure monitored by the pressure sensor. Also provided herein is a method of performing percutaneous transluminal balloon angioplasty (PTA) using the device.