Baroreflex Stimulator with Circadian Rhythm Modulation

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Solution Overview

Problem

Current medical technologies fail to effectively synchronize baroreflex stimulation with the natural circadian rhythm, which is essential for mimicking the body's natural fluctuations in blood pressure, leading to inadequate hypertension management in patients.

Innovation Solution

A baroreflex stimulator system that includes a pulse generator and a modulator to provide stimulation levels that rise and fall throughout the day, mimicking the natural circadian rhythm by accessing a circadian rhythm template to set and apply baroreflex stimulation levels to baroreceptor sites in the pulmonary artery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If baroreflex stimulation is provided continuously at a constant level, then hypertension management is simplified, but the natural circadian rhythm of blood pressure fluctuations is not mimicked, leading to inadequate treatment effectiveness

Engineering Contradiction:

Improvesimplicity of stimulation deliveryVSAvoideffectiveness of hypertension management

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The baroreflex stimulation level is made dynamic rather than static. The stimulation intensity varies over time to match the circadian rhythm pattern, with higher stimulation during daytime hours and reduced stimulation during nighttime sleep hours. This dynamic adjustment allows the system to effectively manage hypertension while respecting the body's natural circadian variations in blood pressure regulation.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The stimulation parameters (intensity, duration, frequency) are changed according to the time of day and circadian rhythm patterns. The system transitions between different stimulation regimes based on predefined circadian templates, adjusting the baroreflex stimulation level to rise and fall throughout the day, thereby mimicking natural blood pressure fluctuations and improving treatment effectiveness.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If baroreflex stimulation levels are increased to effectively manage hypertension, then blood pressure control improves, but the stimulation may interfere with the body's natural circadian rhythm and sleep patterns

Engineering Contradiction:

Improveblood pressure control effectivenessVSAvoidinterference with circadian rhythm and sleep

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The baroreflex stimulation is delivered in a periodic manner that synchronizes with circadian rhythm. The stimulation intensity is modulated to peak during daytime hours when blood pressure control is most needed and is reduced or suppressed during nighttime sleep hours. This periodic variation in stimulation intensity allows effective hypertension management while preserving natural circadian rhythms and sleep patterns.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The system uses pre-programmed circadian rhythm templates that define the expected stimulation pattern in advance. These templates are configured to provide higher stimulation during daytime and reduced stimulation during nighttime, allowing the system to proactively adjust stimulation levels to match natural circadian variations rather than reacting to blood pressure changes after they occur.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If the baroreflex stimulator uses complex circadian rhythm templates to synchronize with natural rhythms, then treatment effectiveness improves, but the device complexity increases

Engineering Contradiction:

Improvesynchronization with circadian rhythmVSAvoidcomplexity of rhythm modulation system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system uses pre-programmed circadian rhythm templates that copy or replicate the natural circadian pattern of blood pressure fluctuations. Instead of requiring complex real-time analysis and adaptation algorithms, the device uses stored templates that define the expected stimulation pattern, simplifying the control system while maintaining effective synchronization with circadian rhythms.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The control system dynamically switches between different circadian rhythm templates based on the time of day and patient-specific parameters. This dynamic template switching allows the system to adapt to different circadian patterns without requiring a completely complex redesign of the modulation architecture, as the same basic framework can handle multiple templates through parameter adjustment.

Inventive Principle:

Principle #15Dynamics

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

This approach effectively reduces blood pressure during sleep and promotes activity, improving quality of life for patients by reflexively inhibiting sympathetic nerve activity and reducing systemic arterial pressure, thus addressing the limitations of existing hypertension treatments.

Implementation Method 1

baroreflex stimulation therapy... providing baroreflex stimulation to a baroreceptor site... reflexively inhibiting sympathetic nerve activity and reducing systemic arterial pressure

Methodology Applied

Scientific EffectBaroreflex:

Data Source

PatentUS9020595B2Baroreflex activation therapy with conditional shut off

Publication Date: 2015.04.28 CARDIAC PACEMAKERS INC

AI summary

An embodiment of a baroreflex stimulator comprises a pulse generator to provide a baroreflex stimulation signal through an electrode, and a modulator to modulate the baroreflex stimulation signal based on a circadian rhythm template.