Intra-aortic Balloon Under-inflation to Prevent Gas Leakage
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Solution Overview
Problem
Conventional intra-aortic balloon pump (IABP) systems face challenges with balloon leaks, as they often require full inflation, which can lead to stress on the balloon and potential gas leakage, and existing leak detection methods are inadequate, increasing patient risk.
Innovation Solution
A counterpulsation IABP device with an over-sized balloon that is only partially inflated to prevent gas leakage, using a drive unit with an air mover limiter to control the inflation volume based on patient blood pressure, ensuring effective cardiovascular support without full balloon inflation and minimizing the risk of gas escape.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the balloon is fully inflated to provide effective cardiovascular support, then the therapeutic effect is improved, but the stress on the balloon increases leading to potential gas leakage
Solution Approach 1:
The patent applies partial action by intentionally under-inflating the balloon to a volume less than its maximum capacity. The drive unit is configured to deliver a controlled volume of gas that achieves sufficient counterpulsation support while maintaining a safety margin that prevents balloon rupture and gas leakage into the patient's vasculature.
Solution Approach 2:
The patent implements beforehand cushioning by designing the balloon with excess capacity beyond the required therapeutic volume. This creates a safety buffer where the balloon can withstand pressure variations and minor defects without rupturing, preventing gas leakage before it becomes a clinical problem.
2Object-affected harmful factors
If the balloon is under-inflated to reduce stress and prevent gas leakage, then patient safety is improved, but the cardiovascular support effectiveness may be reduced
Solution Approach 1:
The patent employs feedback control where the drive unit monitors balloon inflation status and patient hemodynamic response, adjusting the gas delivery volume to maintain optimal counterpulsation support while preventing over-inflation. This ensures the balloon remains in the safe under-inflated range while preserving therapeutic effectiveness.
Solution Approach 2:
The patent changes the critical parameter of balloon volume from maximum capacity to a controlled sub-maximal volume. By optimizing this parameter to a specific range below full inflation, the system achieves the dual goal of maintaining adequate cardiovascular support while eliminating the risk of balloon rupture and gas leakage.
3Difficulty of detecting and measuring
If conventional leak detection methods are used, then leak detection capability is provided, but detection occurs only after gas has escaped, significantly increasing patient harm risk
Solution Approach 1:
The patent applies preliminary action by implementing preventive under-inflation strategy before any leak can occur. By maintaining the balloon at a volume below its rupture threshold, the system prevents catastrophic gas leakage into the patient's vasculature, eliminating the need for reactive leak detection and intervention.
Solution Approach 2:
The patent converts the potential harm of balloon over-inflation into a benefit by deliberately operating at under-inflation. This design choice transforms what would normally be a performance limitation into a safety feature, where the 'excess capacity' of the balloon becomes a protective buffer against rupture and gas leakage.
Data Source
AI summary
A system for limiting inflation of an expandable member (e.g., a balloon) in an intravascular circulatory support system of a patient may comprise a drive unit and an air mover limiter. The drive unit may include an air mover and a motor. The air mover may have a first end and a second end. The first end may be fixed and have a pneumatic output in fluid connection with the expandable member. The second end may be movable and pneumatically closed. The air mover limiter may be configured to restrict displacement of the second end to under-inflate the expandable member based on the blood pressure of the patient. Displacement of the second end moves a volume of air into or out of the expandable member. The volume of air corresponds to the air mover limiter configuration.