Programmable Enclosure for Implantable Pulse Generator Current Control
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Solution Overview
Problem
Conventional neurostimulator devices lack programmability and flexibility, particularly in their enclosure, which limits their effectiveness in both monopolar and bipolar modes of operation, leading to suboptimal pain relief and potential patient discomfort due to uncontrolled current distribution.
Innovation Solution
A neurostimulator system with a programmable enclosure that can function as a controlled source of current, allowing for simultaneous activation of distal electrodes and the enclosure with adjustable polarities, enabling a mixed mode of operation that combines monopolar and bipolar stimulation paths for enhanced flexibility and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the enclosure is used as a passive current sink or source in monopolar mode, then the device structure is simple, but the device lacks programmability and flexibility
Solution Approach 1:
The enclosure is designed to serve multiple functions: it acts as a current sink in monopolar mode, a current source in bipolar mode, and a programmable electrode in mixed mode. The stimulation circuit can selectively configure the enclosure's function through programming, allowing the same hardware structure to adapt to different operational requirements without adding separate dedicated components for each mode.
Solution Approach 2:
The enclosure's electrical function is made dynamic and reconfigurable through programmable control. The stimulation circuit can dynamically switch the enclosure between different operational states (current sink, current source, or active electrode) based on the selected stimulation mode, enabling the device to adapt its behavior in real-time without physical reconfiguration.
2Adaptability or versatility
If the enclosure is not used in bipolar mode, then current control at distal electrodes is simplified, but the device loses flexibility in current distribution
Solution Approach 1:
In bipolar mode, the system can selectively activate only the necessary distal electrodes while keeping the enclosure inactive, or partially activate the enclosure as an additional electrode. This partial action approach allows the system to maintain operational simplicity when full enclosure activation is not needed, while retaining the option to engage the enclosure for enhanced flexibility when required.
3Reliability
If conventional neurostimulator devices use a non-programmable enclosure, then manufacturing is simpler, but the effectiveness and flexibility of the device is diminished
Solution Approach 1:
The system achieves enhanced effectiveness through programmable parameter control of the enclosure's electrical characteristics. By allowing software-based configuration of the enclosure's current sourcing/sinking behavior and polarity, the system can optimize stimulation parameters for different patient needs and clinical scenarios without requiring different hardware designs, thus improving reliability while avoiding complex manufacturing variations.
Data Source
AI summary
An electrical stimulation apparatus including a medical device. The medical device includes: a housing component having at least one electrically conductive area. The medical device includes a plurality of conductors configured to be electrically coupled to a distal electrode array. The electrode array are implantable in a human body. The medical device includes a stimulation circuit positioned inside the housing component. The stimulation circuit includes a plurality of controllable stimulation channels. A first subset of the stimulation channels is electrically coupled to the conductors. A second subset of the stimulation channels is electrically coupled to the electrically conductive area of the housing component. The stimulation circuit is operable to simultaneously create a first stimulation path in the electrode array and a second stimulation path that extends from the electrode array to the housing component.