Respiration-Mediated Heart Rate Pain Scoring

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Solution Overview

Problem

Current pain management systems rely heavily on subjective patient reports, which are inefficient and prone to variation, and lack the capability for immediate, automated adjustment of therapies, especially in ambulatory settings where access to medical assistance is limited.

Innovation Solution

A system that utilizes physiological sensors to measure respiration and heart rate signals, generating a pain score through respiration-mediated heart rate variation (RM-HRV) metrics, enabling objective pain assessment and closed-loop control of neuromodulation therapies such as spinal cord stimulation, brain stimulation, or peripheral nerve stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If subjective patient reports are used for pain assessment, then the system is simple to operate, but the measurement precision and reliability are poor due to cognitive constraints and intra-patient variation

Engineering Contradiction:

Improvepain assessment accuracyVSAvoidsystem complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/subjective pain assessment method (relying on patient self-reporting) with a physiological monitoring system that objectively measures pain through cardiovascular signals. The system uses ECG sensors, respiration sensors, and accelerometers to detect physiological changes associated with pain, thereby eliminating the limitations of subjective reporting while maintaining system feasibility through established sensor technologies

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces physiological parameters (heart rate variability, respiration rate, acceleration) as intermediary indicators to indirectly assess pain intensity. Instead of directly measuring pain through subjective reports, the system uses these physiological mediators that correlate with pain states, enabling objective pain quantification without requiring direct patient cognitive input

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If manual programming of pain therapy by clinician is used, then the treatment can be customized, but the productivity is low and time-consuming, especially in ambulatory settings without immediate medical assistance

Engineering Contradiction:

Improvetherapy adjustment speedVSAvoidautomated therapy control

Core Design Contradiction:

ProductivityVSExtent of automation

Solution Approach 1:

The patent implements a closed-loop feedback system where physiological pain indicators continuously monitor patient status and automatically trigger therapy adjustments. The system compares real-time physiological data against predefined thresholds and autonomously modifies neuromodulation parameters, eliminating the need for manual clinician intervention and enabling immediate therapy optimization in ambulatory settings

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system enables self-service pain management by allowing the device to autonomously assess pain levels through physiological monitoring and adjust therapy parameters without requiring external clinician programming. The implantable neuromodulator automatically responds to pain episodes based on detected physiological changes, providing autonomous pain control capability

Inventive Principle:

Principle #25Self-service

3Loss of time

If subjective pain description is relied upon, then the device complexity is low, but the loss of time increases due to inefficient pain assessment and delayed therapy initiation

Engineering Contradiction:

Improvepain therapy response timeVSAvoidmonitoring system complexity

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The system performs preliminary continuous monitoring of physiological parameters (heart rate, respiration, movement) to detect early signs of pain episodes before they fully manifest. By continuously采集 and analyzing these signals, the system can identify pain onsets and trigger therapy adjustments proactively, reducing the time delay between pain occurrence and therapy initiation

Inventive Principle:

Principle #10Preliminary action

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 provides an objective and efficient method for pain assessment and therapy adjustment, improving pain management by reducing reliance on patient reports and enabling immediate, automated adjustments to pain therapy, enhancing both the accuracy and efficiency of pain relief.

Implementation Method 1

generate one or more signal metrics indicative of respiration-mediated heart rate variation (RM-HRV) using the sensed respiration signal and the sensed heart rate signal

Methodology Applied

Scientific EffectRespiration-mediated heart rate variation:

Data Source

PatentUS10631776B2Pain management based on respiration-mediated heart rates

Publication Date: 2020.04.28 BOSTON SCI NEUROMODULATION CORP

AI summary

This document discusses, among other things, systems and methods for managing pain of a subject. A system may include a sensor circuit configured to sense a respiration signal and a heart rate signal. A pain analyzer circuit may determine respiratory cycles and respiratory phases in a respiratory cycle, and generate one or more signal metrics indicative of respiration-mediated heart rate variation. The pain analyzer may generate a pain score using the signal metrics indicative of respiration-mediated heart rate variation. The pain score may be output to a user or a process. The system may include an electrostimulator to generate and deliver closed-loop pain therapy according to the pain score.