LVAD Suction Detection and Sleep Mode Control

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Solution Overview

Problem

Implantable blood pumps, such as Ventricular Assist Devices (VADs), operate at a single programmed speed, posing a difficult trade-off between congestion and suction, hypertension, hemolysis, stroke, and arrhythmias, with alerts being disruptive and challenging to manage, especially during varying patient activity levels.

Innovation Solution

A controller for an implantable blood pump with processing circuitry that adjusts the operating speed of the impeller based on suction levels, activates a sleep mode to reduce speed if suction exceeds a threshold, generates alerts, and adjusts speed according to body activity and position, allowing for clinician recommendations and silent low-urgency alerts during sleep.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If the pump operates at a single programmed speed, then the device complexity is reduced, but the reliability deteriorates due to inability to adapt to varying patient activity levels and physiological conditions

Engineering Contradiction:
Improvepump control complexityVSAvoidpump performance reliability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent implements dynamic speed adjustment by transitioning from a single fixed speed to multiple variable speeds that can be automatically modified based on real-time detection of suction events, body activity levels, and physiological parameters. The controller dynamically modifies impeller speed to optimize pump performance across different patient states.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the operating parameter (impeller speed) based on detected conditions. When suction is detected or body activity changes, the controller modifies the speed parameter to appropriate levels, thereby adapting the pump performance to current physiological requirements without requiring manual intervention.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If the pump speed is set too high to prevent congestion and heart failure, then the productivity is improved, but the harmful factors increase including suction, hypertension, hemolysis, stroke, and arrhythmias

Engineering Contradiction:
Improvepump flow rateVSAvoidadverse physiological events
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent employs feedback mechanisms where sensors continuously monitor physiological parameters and pump performance. When suction events or adverse events are detected, the feedback loop triggers automatic speed reduction to prevent worsening of harmful effects while maintaining adequate flow during normal conditions.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The pump speed is dynamically adjusted based on real-time physiological conditions rather than operating at a fixed high speed. The controller modulates impeller rotation speed to match patient needs, preventing both congestion from overly low speeds and harmful effects from excessively high speeds.

Inventive Principle:
Principle #15Dynamics

3Loss of information

If alerts are made audible and visible to notify patients of concerning situations, then the information transmission is improved, but the ease of operation deteriorates during sleep due to disruption and embarrassment

Engineering Contradiction:
Improvealert notification effectivenessVSAvoidpatient comfort during sleep
Core Design Contradiction:
Loss of informationVSEase of operation

Solution Approach 1:

The alert notification system dynamically adapts its behavior based on the patient's activity state. During sleep or low-activity periods, the system suppresses or modifies audible and visual alerts to prevent disruption. During awake or active periods, full alert notifications are delivered to ensure patient awareness of concerning conditions.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies different alert characteristics to different situations and time periods. Low-urgency alerts during sleep use minimal or no notification, while high-urgency alerts maintain full notification regardless of activity level. This localized differentiation of alert quality balances information transmission with patient comfort.

Inventive Principle:
Principle #3Local quality

4Reliability

If the pump continuously monitors and adjusts speed based on suction detection, then the reliability is improved, but the device complexity increases due to additional sensors and control logic

Engineering Contradiction:
Improvesuction detection accuracyVSAvoidcontrol system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent makes the controller multi-functional by having it perform both speed control and suction event detection and response. Rather than adding separate dedicated systems, the existing controller is enhanced to handle multiple functions including monitoring physiological parameters, detecting suction events, and automatically adjusting speed, thereby reducing overall system complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS11786721B2Sleep mode and do-not-disturb mode for a left ventricular assist device
Publication Date: 2023.10.17 BOSTON SCIENTIFIC SCIMED INC
  • US11786721B2 patent drawing
  • US11786721B2 patent drawing
  • US11786721B2 patent drawing

AI summary

A controller for an implantable blood pump, having processing circuitry configured to control an operating speed of an impeller of the implantable blood pump. The processing circuitry being further configured to control activation and deactivation of a sleep mode. During the sleep mode the processing circuitry being configured to measure a level of suction by detecting suction during a predetermined time interval, recording the time at which suction occurred during the predetermined time interval, and generating a graph demonstrating the measured level of suction. The measured level of suction being a percentage of time the implantable blood pump experienced suction during the predetermined time interval. The processing circuitry being configured to reduce the operating speed of the impeller if the measured level of suction exceeds a predetermined threshold.