Implantable Device Guiding Heart Failure Therapy via Fluid Status Monitoring

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Solution Overview

Problem

Current therapies for acute decompensated heart failure (ADHF) face challenges in determining optimal fluid volume status and dosage of intravenous diuretics or vasodilators, leading to risks of overdiuresis and inadequate fluid removal, which can burden compromised kidneys and fail to achieve desired symptom relief.

Innovation Solution

An implantable medical device (IMD) capable of monitoring physiological signals such as transthoracic impedance and intracardiac pressure to derive fluid status measurements, guiding the delivery of ADHF therapy by setting and adjusting dosages to maintain a targeted optivolemic level, thereby preventing overdiuresis and ensuring effective symptom management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If intravenous infusion of diuretics or vasodilators is delivered at high dosage or for long duration, then fluid removal effectiveness is improved, but overdiuresis occurs causing harmful effects

Engineering Contradiction:
Improvefluid removal effectivenessVSAvoidoverdiuresis
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors fluid status measurements (such as intrathoracic impedance, intracardiac pressure, or renal function markers) and uses this feedback to dynamically adjust the dosage and duration of intravenous diuretic or vasodilator infusion. This closed-loop control enables precise titration of fluid removal therapy, maximizing effectiveness while preventing overdiuresis by automatically reducing or stopping infusion when target fluid status is achieved or exceeded.

Inventive Principle:
Principle #23Feedback

2Productivity

If fluid is removed too rapidly or in excessive amounts, then symptom relief is improved, but kidney burden increases due to renal insufficiency

Engineering Contradiction:
Improvesymptom relief speedVSAvoidkidney burden
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system dynamically adjusts the fluid removal rate based on real-time monitoring of fluid status measurements and patient response. Rather than using fixed high-rate diuresis protocols, the infusion rate is continuously modified to match the patient's actual fluid accumulation rate and renal handling capacity, enabling rapid symptom relief when needed while automatically slowing down when renal function suggests reduced tolerance, thereby minimizing kidney burden.

Inventive Principle:
Principle #15Dynamics

3Object-affected harmful factors

If fluid removal is insufficient, then kidney burden is reduced, but desired symptom relief is not achieved

Engineering Contradiction:
Improvekidney burdenVSAvoidsymptom relief adequacy
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The system uses continuous monitoring of fluid status measurements to determine when adequate fluid removal has been achieved. When measurements indicate that target fluid status is reached or exceeded, the system automatically reduces or stops diuretic/vasodilator infusion, preventing both overdiuresis and excessive kidney burden. This feedback-driven approach ensures symptom relief adequacy by maintaining infusion until therapeutic goals are met.

Inventive Principle:
Principle #23Feedback

4Reliability

If there is lag time between optimal fluid volume status and symptom alleviation, then therapy safety is improved, but therapy control precision deteriorates

Engineering Contradiction:
Improvetherapy safetyVSAvoidtherapy control precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The system monitors fluid status measurements continuously and identifies trends indicating approaching optimal fluid volume status before overt symptoms manifest. By detecting early changes in fluid status (such as gradual impedance changes or pressure trends), the system can anticipate the need to adjust therapy parameters in advance, maintaining precise control throughout the therapy course and avoiding both under- and over-treatment during the lag period between volume correction and symptom resolution.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The IMD enables precise control of ADHF therapy, reducing the risk of overdiuresis and ensuring stable fluid status, thereby improving patient outcomes by maintaining optimal fluid volume and reducing hospitalization burdens.

Implementation Method 1

An implantable medical device (IMD) capable of monitoring physiological signals such as transthoracic impedance and intracardiac pressure to derive fluid status measurements

Methodology Applied
Scientific EffectTransthoracic impedance: Electrical Impedance Tomography

Implementation Method 2

An implantable medical device (IMD) capable of monitoring physiological signals such as transthoracic impedance and intracardiac pressure to derive fluid status measurements

Methodology Applied
Scientific EffectIntracardiac pressure: Pressure Gradient

Data Source

PatentUS9943236B2Methods for guiding heart failure decompensation therapy
Publication Date: 2018.04.17 MEDTRONIC INC
  • US9943236B2 patent drawing
  • US9943236B2 patent drawing
  • US9943236B2 patent drawing

AI summary

An implantable medical device system and associated method for use in guiding an acute decompensated heart failure therapy set an optimal fluid status measurement level. A physiological sensor signal sensed by an implantable medical device is used to compute the fluid status measurement. A target rate of change of the fluid status measurement is computed for guiding the therapy.