Blood Pressure Variability Prediction for Neuromodulation Therapy
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Solution Overview
Problem
Current methods for predicting patient responsiveness to subcutaneous neuromodulation therapy for hypertension are costly, invasive, and inconvenient, often requiring specialized measurements and expertise, which can be a barrier to effective treatment selection and research studies.
Innovation Solution
A therapy response prediction system that determines the variability of cardiovascular parameters over a predetermined time period and compares it to a reference value to classify patients as likely responsive or unresponsive to subcutaneous neuromodulation therapy, facilitating decision-making for patients and researchers, and enabling or disabling the implanted electroacupuncture device accordingly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If specialized measurements (e.g., norepinephrine spillover, sympathetic neural activity) are used to predict patient responsiveness, then prediction accuracy is improved, but cost and complexity increase
Solution Approach 1:
The patent extracts the essential predictive information from complex specialized measurements and isolates it into a single usable parameter - blood pressure variability. Instead of requiring multiple specialized measurements (norepinephrine spillover, sympathetic neural activity), the invention extracts predictive value from routine blood pressure measurements alone, separating the predictive function from the complex measurement requirements.
Solution Approach 2:
The patent creates a simplified copy or proxy of the complex prediction process. Rather than directly measuring sympathetic neural activity or norepinephrine spillover, it uses blood pressure variability as a surrogate marker that correlates with these underlying physiological processes. This copying approach maintains predictive accuracy while avoiding the need for specialized measurement equipment and expertise.
2Reliability
If specialized measurements requiring high costs and special expertise are used, then prediction reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The patent enables the prediction system to serve itself using readily available data. Blood pressure measurements are routinely collected during standard clinical visits, and the invention automatically processes this existing data to generate predictions. No additional specialized equipment, expertise, or patient burden is required - the system uses what is already available in routine practice.
Solution Approach 2:
The patent changes the parameter being measured from complex physiological markers (norepinephrine spillover, sympathetic neural activity) to a simple, routinely measured parameter (blood pressure variability). This parameter transformation maintains the ability to predict treatment responsiveness while dramatically improving ease of operation and reducing costs.
3Reliability
If invasive nerve stimulation therapies are used to treat hypertension, then treatment effectiveness is improved, but patient safety and invasiveness worsen
Solution Approach 1:
The patent performs preliminary classification of patients into responder and non-responder groups before initiating invasive treatment. By using blood pressure variability to predict treatment responsiveness in advance, the system prevents unnecessary invasive procedures in patients who would not benefit, thereby avoiding potential nerve damage and surgical risks in those patients while maintaining treatment effectiveness for predicted responders.
Data Source
AI summary
An exemplary method includes determining a variability of a plurality of measurements of a cardiovascular parameter of a patient suffering from hypertension, the plurality of measurements recorded one at a time over a predetermined time period. The method further includes comparing the determined variability with a predetermined reference value. If the comparing indicates that the determined variability is less than the predetermined reference value, the method includes designating the patient to be within a first class of patients representative of patients that are likely to be responsive to subcutaneous neuromodulation therapy as a treatment for hypertension. If the comparing indicates that the determined variability is greater than the predetermined reference value, the method includes designating the patient to be within a second class of patients representative of patients that are likely to be unresponsive to subcutaneous neuromodulation therapy as a treatment for hypertension. Corresponding systems and methods are also described.