Adaptive Therapy Program Modification for Implantable Medical Devices
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Solution Overview
Problem
Implantable medical devices face challenges in maintaining efficacious therapy delivery due to changes in the therapy field, such as impedance changes or electrode misplacement, which can lead to reduced therapeutic efficacy and increased side effects.
Innovation Solution
A system that modifies therapy programs based on information indicative of changes in the therapy field by comparing an algorithmic model of the current therapy field to a baseline model, adjusting parameters such as current or voltage amplitude to maintain optimal field characteristics, using a processor and memory to generate and compare therapy field models.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a medical device delivers therapy using fixed therapy programs, then the device structure is simple and easy to operate, but the therapeutic efficacy decreases when therapy field changes occur (such as impedance changes or electrode misplacement)
Solution Approach 1:
The system continuously monitors therapy field characteristics (such as impedance, electrode position, and field distribution) and uses this feedback information to automatically adjust therapy program parameters. The processor compares current field characteristics with baseline values and modifies stimulation parameters in real-time to maintain optimal therapeutic effect, resolving the contradiction between maintaining high reliability and avoiding complex device structure.
Solution Approach 2:
The patent transforms fixed, static therapy programs into dynamic, adaptive therapy delivery. The system automatically adjusts therapy parameters based on real-time detection of therapy field changes, enabling the device to adapt to varying physiological conditions and maintain therapeutic efficacy without requiring complex manual reprogramming or intervention.
2Reliability
If therapy program parameters are adjusted manually in response to therapy field changes, then therapeutic efficacy can be maintained, but the ease of operation decreases and requires clinician intervention
Solution Approach 1:
The medical device performs self-adjustment of therapy program parameters by automatically detecting changes in therapy field characteristics and modifying stimulation parameters accordingly. The processor executes algorithms that compare current field measurements with baseline values and autonomously select optimal therapy programs, eliminating the need for manual clinician intervention and maintaining ease of operation while ensuring therapeutic efficacy.
3Reliability
If the system continuously monitors and adjusts therapy programs based on real-time field changes, then therapeutic efficacy is maintained, but energy consumption increases
Solution Approach 1:
The system performs periodic monitoring and adjustment of therapy programs rather than continuous real-time adjustment. The processor monitors therapy field characteristics at predetermined intervals or based on detected threshold changes, allowing the device to maintain therapeutic efficacy while reducing energy consumption by entering low-power states between monitoring cycles.
Data Source
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AI summary
A therapy program may be modified based on information indicative of a change in a therapy field, which may represent a region of a patient's tissue to which therapy is delivered. Upon receiving information indicative of a therapy field change, an algorithmic model of a present therapy field may be generated and compared to an algorithmic model of a baseline therapy field, which indicates a therapy field that provides efficacious therapy to the patient. If a characteristic of the present therapy field differs from the baseline therapy field model, the current therapy program may be modified. In another example, upon receiving information indicative of a therapy field change, the current therapy program may be modified, and an algorithmic model of a therapy field based on the modified therapy program may be compared to a baseline therapy field model to determine whether the modified therapy program is a suitable alternative.