ANI Pain Assessment Device Using Heart Rate Variability
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Solution Overview
Problem
Current pain management systems, particularly for patients under anesthesia, struggle to accurately assess pain levels in real-time and predict pain evolution, as existing methods are either subjective, unspecific, or fail to differentiate between acute and prolonged pain, and do not account for the type of pain or analgesic/hypnotic compound needs.
Innovation Solution
A device that measures cardiac variability between 0.15Hz and 4Hz to calculate an Analgesia Nociception Index (ANI), with additional processing to derive MC and ML indices representing short and long-term pain levels and their slopes, allowing for precise determination of analgesic and hypnotic compound needs, including automatic or semi-automatic injection systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If pharmacokinetic models and physiological parameters (heart rate, blood pressure) are used for pain assessment, then real-time monitoring is achieved, but measurement precision is insufficient because these parameters are not specific to pain levels and cannot sufficiently approximate the real state of a patient
Solution Approach 1:
The patent segments heart rate variability into specific frequency bands (high-frequency component beyond 0.15 Hz) that are exclusively influenced by the parasympathetic system and specifically related to pain, fear, or stress. This segmentation allows isolation of pain-specific signals from general physiological variations, thereby improving measurement precision while maintaining real-time monitoring capability.
Solution Approach 2:
The invention applies local quality by focusing on a specific frequency range (high-frequency heart rate variability beyond 0.15 Hz) within the overall heart rate signal. This localized analysis of a specific frequency band provides pain-specific information without requiring analysis of the entire physiological parameter spectrum, thus achieving both real-time monitoring and precise pain assessment.
2Measurement precision
If the ANI index based on heart rate variability is used, then pain level evaluation is achieved, but the ability to differentiate between acute and prolonged pain and predict pain evolution is lost
Solution Approach 1:
The patent adds temporal dimensionality to the pain assessment by calculating moving averages over different time windows (short-term and long-term) and computing slopes of these averages. This transforms the single-point ANI index into a multi-dimensional assessment that includes current pain level, recent trends, and predictive evolution, thereby recovering information about pain type and progression without sacrificing measurement precision.
Solution Approach 2:
The invention performs preliminary calculations of moving averages and slope trends from the ANI index data before clinical decision-making is required. By pre-processing the pain assessment data to extract temporal patterns and predictive trends, the system prepares information about pain evolution in advance, enabling faster and more informed clinical decisions about analgesic requirements.
3Ease of operation
If patient self-assessment using Visual Analogue Scale is used, then subjective pain reporting is obtained, but reliability is reduced because it assumes a conscious and lucid patient and provides only punctual assessment
Solution Approach 1:
The patent implements self-service by enabling the patient's own physiological system (autonomic nervous system controlling heart rate variability) to automatically provide pain assessment data. This eliminates the need for patient consciousness or active participation while maintaining continuous, objective monitoring, thereby simultaneously preserving ease of operation and dramatically improving reliability compared to subjective self-reporting.
Data Source
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AI summary
The present invention concerns a device and a method for assessing the medication or paramedical care requirements of a patient and an associated delivery device, the assessment device comprising: means (5) for measuring heart rate variability between 0.15Hz and 4Hz, first means (6) for processing the measured data in a sliding window allowing the calculation of an index ANI relative to the level of pain experienced by the patient, characterised in that it further comprises: second means (7) for processing from index ANI, allowing the calculation of an index MC, representative of the average of index ANI over a so-called short period, and an index ML, representative of the average value of the index ANI over a so-called long period, and the respective slopes PC and PL of said indices MC and ML, the indices and slopes corresponding to the level of pain experienced by the patient and the change in said level, means (8) for recording data relative to the patient, third means (9) for processing, for defining, on the basis of indices MC and ML, slopes PC and PL of same, and data relative to the patient, the need in terms of analgesic and/or hypnotic compounds and/or paramedical care that need to be administered to said patient.