Cardiac Pacing Control Using Core Temperature Sleep Detection

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Solution Overview

Problem

Existing implantable medical devices (IMDs) struggle to accurately detect sleep and wake states in patients, leading to inappropriate diurnal and nocturnal pacing rates due to reliance on time-of-day algorithms that fail to adapt to changes in circadian rhythm and patient activity levels.

Innovation Solution

The IMD utilizes a temperature sensor to generate moving composite temperature (MCT) signals over varying periods, comparing them to control pacing rates, allowing for automatic adjustment between diurnal and nocturnal pacing based on core body temperature changes, independent of time-of-day.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If time-of-day algorithms are used to control pacing rates, then the device can provide programmable diurnal and nocturnal pacing rates, but the algorithm fails to adapt to changes in circadian rhythm and patient activity levels

Engineering Contradiction:
Improveadaptability to circadian rhythm changesVSAvoidaccuracy of sleep state detection
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent replaces the mechanical/time-based algorithm (time-of-day dependent pacing) with a physiological sensor-based system (core body temperature sensing). The temperature sensor continuously monitors core body temperature, and the control circuit uses this physiological data to detect sleep and wake states, thereby adapting pacing rates to the patient's actual circadian rhythm rather than relying on fixed time schedules.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If accelerometer sensors are used to detect patient motion, then the device can identify sleep periods, but it cannot distinguish between being asleep and being inactive while awake

Engineering Contradiction:
Improveaccuracy of sleep state detectionVSAvoidcomplexity of sleep detection algorithm
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces core body temperature as an intermediary physiological parameter to detect sleep states. Instead of directly interpreting accelerometer data (which is ambiguous), the system uses temperature changes as a more reliable mediator - core body temperature naturally decreases during sleep and increases during wakefulness, providing a clear physiological marker that resolves the ambiguity of motion-based detection.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If the pacing rate is lowered based on lack of motion detection, then nocturnal pacing can be provided, but the pacing rate may be inappropriately lowered when the patient is awake and inactive

Engineering Contradiction:
Improveautomatic pacing rate adjustmentVSAvoidappropriateness of pacing rate selection
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements a feedback mechanism where the control circuit continuously monitors core body temperature and uses this information to feedback-adjust the pacing rate. When temperature decreases indicating sleep onset, the system feedbacks by lowering the pacing rate to nocturnal levels. When temperature increases indicating wakefulness, the system feedbacks by raising the pacing rate to diurnal levels, ensuring appropriate pacing rate selection based on actual physiological state rather than just motion absence.

Inventive Principle:
Principle #23Feedback

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 accurately determines sleep and wake states by measuring core body temperature, ensuring appropriate pacing rates without relying on patient movement or time-of-day information, thereby improving patient outcomes.

Implementation Method 1

a temperature sensor configured to sense a temperature signal indicative of a core body temperature of a patient

Methodology Applied
Scientific EffectThermal sensing:

Data Source

PatentEP4470602B1System for cardiac therapy to switch between diurnal and nocturnal pacing rates using core body temperature
Publication Date: 2026.03.25 PACESETTER INC
  • EP4470602B1 patent drawingFigure 1A
  • EP4470602B1 patent drawingFigure 1B
  • EP4470602B1 patent drawingFigure 2

AI summary

Diurnal and nocturnal pacing for an implantable medical device (IMD) (100) that includes a temperature sensor (154), one or more electrodes (104, 106), one or more pulse generators (116) a control circuit (156) is managed. A temperature signal indicative of a core body temperature is sensed at the temperature sensor (154). The control circuit (156) produces first and second moving composite temperature (MCT) signals based on the temperature signal sensed over first and second periods of time, respectively, wherein the second period of time is longer than the first period of time. A current temperature signal is compared to the first and second MCT signals, and a pacing rate for pacing pulses, generated by the one or more pulse generators (116) and delivered to the one or more electrodes (104, 106), is controlled based on one or more relations between the current temperature signal, the first MCT signal and the second MCT signal.