Autonomic Modulation Therapy Dosing via Cardiac-Synchronized Pulses
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Solution Overview
Problem
Current neural stimulation therapies for autonomic modulation lack an intuitive method for dosing, making it challenging to effectively deliver treatments for conditions like hypertension, heart failure, and other cardiovascular diseases.
Innovation Solution
A system that delivers neural stimulation as a dose per cardiac cycle, allowing for user-programmable neural stimulation bursts synchronized with cardiac events, reducing the complexity of programming by determining the number of pulses per cardiac cycle based on sensed cardiac events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If neural stimulation is delivered using intermittently delivered bursts with multiple stimulation parameters (pulse width, pulse frequency, ON/OFF timing, amplitude), then the therapy can be delivered to modulate the autonomic system, but the dosing method becomes complex and non-intuitive
Solution Approach 1:
The patent segments the neural stimulation therapy into discrete pulses delivered per cardiac cycle rather than using continuous or complex intermittent bursts. By counting pulses per cardiac cycle as the dosing unit, the system breaks down the complex parameters (pulse width, frequency, ON/OFF timing, amplitude) into a simpler, more intuitive metric that is easier to program and adjust.
Solution Approach 2:
The patent changes the fundamental dosing parameter from complex multi-parameter burst configurations to a simple pulse count per cardiac cycle. This parameter transformation makes the dosing method more intuitive and easier to operate, directly addressing the contradiction between ease of operation and programming complexity.
2Reliability
If the number of NS pulses per cardiac cycle is increased to improve treatment efficacy, then better treatment outcomes are achieved, but energy consumption increases reducing battery lifespan
Solution Approach 1:
The patent implements dynamic adjustment of pulse delivery based on sensed cardiac events and patient response. The system can adapt the number of pulses per cardiac cycle in real-time, allowing optimization of treatment efficacy while managing energy consumption. This dynamic approach enables the device to deliver higher pulse counts when clinically beneficial while conserving battery life when lower doses are sufficient.
Solution Approach 2:
The system incorporates feedback mechanisms to monitor treatment response and adjust pulse delivery accordingly. By sensing cardiac events and patient response, the system can optimize the balance between treatment efficacy and energy consumption, delivering appropriate doses without unnecessarily depleting battery life.
Data Source
AI summary
An example of a method embodiment may include receiving a user programmable neural stimulation (NS) dose for an intermittent neural stimulation (INS) therapy, and delivering the INS therapy with the user programmable NS dose to an autonomic neural target of a patient. Delivering the INS therapy may include delivering NS bursts, and delivering the NS bursts may include delivering a number of NS pulses per cardiac cycle during a portion of the cardiac cycles and not delivering NS pulses during a remaining portion of the cardiac cycles. The method may further include sensing cardiac events within the cardiac cycles, and controlling delivery of the user programmable NS dose of INS therapy using the sensed cardiac events to time delivery of the number of NS pulses per cardiac cycle to provide the user programmable NS dose. The user programmable NS dose may determine the number of NS pulses per cardiac cycle.