Implantable Cardiac Stimulation Device for Long-Term Preload Reduction

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Solution Overview

Problem

Current cardiac resynchronization therapy (CRT) pacing interventions in heart failure patients do not provide clear, long-term improvements in hemodynamic outcomes due to unclear relationships between acute changes in cardiac output and long-term effects, as the body's compensatory mechanisms often mask sub-optimal pacing configurations, leading to unclear changes in left ventricular diastolic pressure and afterload.

Innovation Solution

Implantable cardiac stimulation devices automatically adjust pacing parameters to achieve a long-term reduction in left ventricular diastolic pressure by cycling through sets of parameters over extended periods, allowing compensatory mechanisms to reach a steady state, thereby optimizing preload and cardiac output.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Power

If acute hemodynamic optimization of paced pulse timing is performed, then cardiac output may show temporary improvement, but long-term clinical outcomes show little tangible improvement due to body's compensatory mechanisms

Engineering Contradiction:
Improvecardiac outputVSAvoidlong-term clinical outcomes
Core Design Contradiction:
PowerVSReliability

Solution Approach 1:

The patent implements dynamic adjustment of pacing parameters over time, transitioning from static acute optimization to continuous long-term adaptation. The system automatically modifies pulse timing parameters based on ongoing hemodynamic feedback, allowing the therapy to evolve with the patient's changing physiological state rather than remaining fixed.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent employs self-adjusting algorithms that automatically optimize pacing parameters without requiring repeated manual interventions. The system monitors hemodynamic responses and autonomously modifies pulse timing to maintain optimal cardiac output, reducing the need for external clinician adjustments and ensuring continuous adaptation to the patient's needs.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If hemodynamic sensors are used to guide pacing intervention, then acute hemodynamic changes can be detected, but it cannot determine if improvements come at the expense of greater energy expenditure or maladaptive neurohormonal mechanisms

Engineering Contradiction:
Improvehemodynamic measurementVSAvoidenergy expenditure and neurohormonal mechanism information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent uses left ventricular diastolic pressure as an intermediary marker that indirectly reflects the effectiveness of unloading the left ventricle without requiring direct measurement of energy expenditure or neurohormonal mechanisms. This surrogate measurement provides practical guidance for optimizing pacing therapy while avoiding the complexity of direct metabolic and hormonal assessments.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces direct measurement of complex physiological parameters (energy expenditure, neurohormonal activity) with mechanical pressure measurements. By substituting cumbersome direct measurements with more practical pressure-based indicators, the system achieves effective therapy optimization through accessible hemodynamic proxies.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Device complexity

If pacing parameters are fixed, then device complexity is reduced, but the ability to adapt to changing patient conditions and optimize long-term outcomes is limited

Engineering Contradiction:
Improvepacing parameter managementVSAvoidresponse to changing patient conditions
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The patent implements feedback loops that continuously monitor hemodynamic responses to pacing therapy and automatically adjust parameters accordingly. The system measures outcomes such as left ventricular diastolic pressure and uses this information to refine pulse timing, ensuring ongoing optimization as patient conditions evolve without requiring manual reprogramming.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent automatically modifies pacing parameters including pulse timing, amplitude, and duration based on detected hemodynamic responses. The system dynamically alters these parameters to optimize cardiac output and unload the left ventricle, adapting to changing patient needs through programmed parameter adjustments rather than fixed settings.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS9265964B2Implantable stimulation devices, and methods and systems for use therewith, that automatically adjust stimulation parameters to improve preload in an HF patient
Publication Date: 2016.02.23 PACESETTER INC
  • US9265964B2 patent drawing
  • US9265964B2 patent drawing
  • US9265964B2 patent drawing

AI summary

Methods, systems and devices described herein can be used for automatically adjusting one or more cardiac resynchronization therapy (CRT) pacing parameters (and more generally stimulation parameters), to achieve a long term reduction in left ventricular (LV) diastolic pressure (and more generally, preload) of a heart failure (HF) patient. A reduction in LV diastolic pressure is indicative of a reduction in preload (the force of blood the fills the left ventricle), which is typically indicative of an improvement in a patient's HF condition. In accordance with certain embodiments, when a set of stimulation parameters is tested, the set is tested for a period that is sufficiently long enough to allow the patient's compensatory mechanisms to react to the set of stimulation parameters and achieve a substantially steady-state LV diastolic pressure corresponding to the using the set of stimulation parameters. Such techniques are believed to provide better results than achieved using acute hemodynamic optimization techniques.