Single Pulse Generator for Coordinated Vagus Nerve and Baroreceptor Stimulation
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Solution Overview
Problem
Current treatment methods for chronic heart failure and hypertension, such as vagus nerve stimulation and carotid baroreceptor stimulation, require multiple sessions and prolonged recovery times due to the need for gradual titration of stimulation intensity, which can delay full therapeutic benefits and increase patient discomfort.
Innovation Solution
An implantable neurostimulation system that combines vagus nerve stimulation and carotid baroreceptor stimulation using a single pulse generator, allowing for coordinated delivery of therapies and adjustment of stimulation parameters based on patient state changes, reducing the need for frequent physician visits and accelerating the titration process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vagus nerve stimulation and carotid baroreceptor stimulation are delivered using separate implantable systems, then each therapy can be independently optimized, but the overall device complexity increases and multiple surgical procedures are required
Solution Approach 1:
The patent combines vagus nerve stimulation and carotid baroreceptor stimulation into a single implantable pulse generator system. The pulse generator contains control circuitry that can independently control both VNS and CBS therapies, allowing them to be delivered simultaneously or separately through integrated electrode assemblies. This merging approach maintains independent therapy optimization while reducing device complexity and eliminating the need for separate surgical implantations.
Solution Approach 2:
The pulse generator is designed as a universal device capable of delivering multiple therapeutic functions. It includes programmable control systems that can adjust stimulation parameters for both VNS and CBS therapies independently, allowing the single device to perform multiple functions that previously required separate specialized devices. The system can adapt its operation based on which therapy is needed and at what intensity level.
2Object-affected harmful factors
If stimulation intensity is gradually increased through multiple titration sessions, then patient discomfort and side effects are reduced, but the time to deliver full therapeutic benefit is significantly extended
Solution Approach 1:
The patent implements dynamic titration where stimulation intensity is automatically adjusted based on real-time physiological feedback. Sensors monitor patient response parameters such as heart rate, blood pressure, and neural activity, and the control system dynamically modifies stimulation intensity within safe thresholds. This allows the system to progress through titration faster than manual methods while maintaining patient comfort, as adjustments are made continuously rather than in discrete monthly sessions.
Solution Approach 2:
The system incorporates feedback mechanisms where physiological signals from the patient are continuously monitored and used to adjust stimulation parameters. The control circuitry receives feedback from sensors detecting patient state changes and automatically modulates the intensity of VNS and CBS therapies accordingly. This closed-loop feedback enables safer and faster titration by objectively determining when the patient can tolerate increased intensity, eliminating the need for conservative fixed-schedule titration.
3Adaptability or versatility
If stimulation parameters are adjusted manually by a physician during office visits, then treatment can be personalized to patient response, but scheduling conflicts and office availability extend the titration process
Solution Approach 1:
The patent implements self-service capabilities where the implantable system autonomously performs titration and parameter optimization without requiring continuous physician intervention. The control system automatically adjusts stimulation parameters based on pre-programmed protocols and real-time physiological feedback, enabling the device to personalize treatment and optimize parameters independently. Physicians can review and approve adjustments remotely or during periodic check-ups, but the actual titration process occurs automatically between visits, dramatically increasing productivity while maintaining personalization.
Solution Approach 2:
The system performs preliminary actions by pre-programming titration protocols and safety thresholds before therapy begins. The control circuitry is pre-configured with algorithms that automatically guide the titration process, allowing the system to adapt to patient response without requiring real-time physician decisions. This preliminary setup enables the device to autonomously personalize treatment parameters based on individual patient characteristics while maintaining safety, freeing physicians from frequent office visits for routine adjustments.
4Ease of manufacture
If a single integrated pulse generator is used to deliver both VNS and CBS therapies, then the number of surgical procedures is reduced and device complexity is managed, but coordination of multiple stimulation parameters requires advanced control systems
Solution Approach 1:
The patent applies segmentation by dividing the control system into distinct modules, each responsible for specific functions. The pulse generator contains separate control circuits for VNS and CBS therapies, with dedicated parameter storage and adjustment mechanisms for each modality. This modular segmentation allows the advanced control system to manage multiple stimulation parameters systematically, making the complexity manageable while maintaining the benefits of a single integrated device for surgical implantation.
Data Source
AI summary
Systems and methods are provided for delivering vagus nerve stimulation and carotid baroreceptor stimulation to patients for treating chronic heart failure and hypertension. The vagus nerve stimulation and carotid baroreceptor stimulation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies.