Click event identification in delivery devices
Inventors
Steck, Jürg • Schneider, Andreas • DÄHLER, Simon • Hirschel, Jürg • Kappeler, Krista • Kühni, Florian • SCHÜPBACH, Simon • Feriani, Amir • ZULLIGER, Ludovic
Assignees
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Publication Number
US-12337152-B2
Publication Date
2025-06-24
Expiration Date
Abstract
Monitoring an injection process executed by a variable dose injection device with feedback means for generating a number of feedback events proportionate to the dose to be determined is disclosed. A dialed or injected dose is determined by measuring a first signal of the process comprising a first signal peak related to a feedback event; detecting the first signal peak in the first signal; selecting an evaluation interval comprising the detected peak and adapted to an expected peak duration; deriving, from the first signal limited to the evaluation interval, a feature or characterizing parameter of the feedback event; identifying, from the derived feature, the feedback event as one of a dial up, dial down, or expel feedback event, and counting identified feedback events to determine the dialed or the ejected dose. The two-stage approach with serially executed peak detection and peak identification allows to optimize data storage and processing power.
Core Innovation
The invention provides a method of determining a dose of a variable-dose injection device with feedback means generating a number of feedback events proportionate to the dose. A first feedback sensor configured as a multi-axis gyroscope measures a first signal comprising a first signal peak related to a feedback event, and the method detects the first signal peak in the first signal. The method then selects an evaluation interval comprising the detected first signal peak and limits the first signal to the evaluation interval for subsequent processing.
From the first signal limited to the evaluation interval, the invention derives a feature of the feedback event using data from the multi-axis gyroscope. Deriving the feature includes calculating, for each axis of the gyroscope, a correlation value of a test signal with a single-axis gyroscope signal and adding the correlation values; or calculating, for each axis of the gyroscope, a sum of absolute derivatives of a single-axis gyroscope signal and adding the sums. Using the derived feature, the method identifies the feedback event as an expel feedback event and counts the number of identified expel feedback events to determine an expelled dose.
The invention also supports classifying feedback events as a dial up, dial down, or expel feedback event. In addition, the invention includes electronic module embodiments that perform peak detection and evaluation-interval feature derivation in association with the detected peak, together with refinements such as deriving a non-event feature to identify false positives, handling evaluation intervals across successive fixed-length data frames, and classifying an expel process as an injection process based on a position plausibility check within concentric spherical surfaces within a penetration depth.
Claims Coverage
The partial content includes three independent claims. Across these independent claims, the inventive features cover peak detection with a multi-axis gyroscope signal, evaluation-interval feature derivation using axis-wise correlation or summed absolute derivatives, and classification of feedback events as expel for dose counting or as dial up, dial down, or expel, with additional module-level refinements addressing data framing, false-positive discrimination, and position plausibility during an expel process.
Gyroscope peak detection with evaluation-interval feature derivation for expel-dose determination
Measuring a first signal comprising a first signal peak related to a feedback event using a first feedback sensor configured as a multi-axis gyroscope; detecting the first signal peak; selecting an evaluation interval comprising the detected first signal peak; deriving a feature of the feedback event from the first signal limited to the evaluation interval by calculating per-axis correlation values of a test signal with a single-axis gyroscope signal and adding them, or calculating per-axis sums of absolute derivatives of single-axis gyroscope signals and adding the sums; identifying the feedback event as an expel feedback event; and counting the number of identified expel feedback events to determine an expelled dose.
Multi-axis gyroscope electronic module classifying dial up, dial down, or expel feedback events
An electronic module comprising a first feedback sensor configured as a multi-axis gyroscope and adapted to measure a first signal comprising a first signal peak related to a feedback event; and a signal processing unit configured to detect the first signal peak, select an evaluation interval comprising the detected peak, derive a feature using per-axis correlation values added together or per-axis sums of absolute derivatives added together, and identify the feedback event as one of a dial up, dial down, or expel feedback event.
Electronic module with multiple data frames and gyroscope-based feature derivation for dose dial up, dial down, or dose expel classification
An electronic module comprising a first feedback sensor configured as a multi-axis gyroscope adapted to measure a first signal comprising a first signal peak related to a feedback event generated with the variable dose delivery device; and a signal processing unit configured to receive a plurality of data frames sampled from the first signal; detect the first signal peak in a data frame sampled from the first signal; select an evaluation interval from a portion of the first signal comprising the detected peak; derive, from the evaluation interval, a feature of the feedback event using data from the first feedback sensor and a second feedback sensor, where deriving the feature includes calculating per-axis correlation values and adding them, or calculating per-axis sums of absolute derivatives and adding the sums; and identify the feedback event as one of a dose dial up, dose dial down, or dose expel feedback event.
The independent claims share a core signal-processing approach: detect a gyroscope-related peak, select an evaluation interval around the peak, derive a feature from per-axis correlation or summed absolute derivatives within that interval, and classify the feedback event as expel or as dial up, dial down, or expel. Additional module-level aspects described include multi-frame sampling, evaluation-interval selection within data framing, and further discrimination and plausibility checks.
Stated Advantages
Provides an expelled dose by counting identified expel feedback events proportionate to the dose.
Identifies feedback events as an expel feedback event and enables dose determination for variable-dose injection.
Classifies feedback events as dial up, dial down, or expel feedback events.
Includes false-positive discrimination by deriving a non-event feature and identifying false positives.
Handles evaluation intervals across fixed-length data frames by selecting and processing evaluation-interval signal data across frame boundaries.
Improves injection process determination during an expel process using position plausibility constrained between concentric spherical surfaces within a penetration depth.
Documented Applications
Determining an expelled dose of a variable-dose injection device based on feedback events proportionate to the dose.
Determining dialed dose by identifying dial up feedback events and dial down feedback events and counting them.
Providing electronic module functionality for variable dose delivery devices including classification of feedback events (dial up, dial down, expel) from gyroscope-based signal peaks.
Detecting device handling activity using signals measured independently of a dose setting or dose expel process.
A position plausibility check during an expel process to acknowledge the expel as an injection process when tracked position lies between two concentric spherical surfaces within a distance less than the penetration depth.
User-visible indication of a dialed dose via an illuminated module housing opening/window so a user can view a dialed dose.
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