Multi-Catheter Balloon System for Heart Failure Hemodynamic Modulation

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Solution Overview

Problem

Current treatments for heart failure lack effective systems, devices, and methods to manage acute decompensated heart failure (ADHF) and the associated fluid volume overload.

Innovation Solution

A balloon catheter system is introduced, comprising multiple catheters with balloons positioned at specific venous locations (renal vein, subclavian vein, and pulmonary artery) to create low-pressure areas, thereby modulating hemodynamic parameters and stimulating vagus nerves to improve heart function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple catheters with balloons are positioned at specific venous locations to create low-pressure areas, then hemodynamic parameters are modulated and heart function is improved, but device complexity increases

Engineering Contradiction:
Improveheart function improvementVSAvoidmulti-catheter system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs nested doll principle by allowing the second catheter to be advanced through the first catheter and the third catheter to be advanced through the first catheter via its third lumen. This nesting approach enables multiple catheters to occupy the same access route (femoral vein) simultaneously, reducing the number of separate puncture sites and simplifying the overall procedural complexity despite the increased functional complexity of the system.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The system is divided into multiple independent catheter modules, each with specific functions: first catheter for renal vein occlusion, second catheter for subclavian vein occlusion, and third catheter for pulmonary artery monitoring. This segmentation allows each component to be optimized independently while working together as an integrated system to modulate hemodynamic parameters through targeted venous occlusion.

Inventive Principle:
Principle #1Segmentation

2Productivity

If balloons are inflated at renal vein and subclavian vein to create low-pressure areas, then venous blood backflow is reduced and lymphatic reflow is enhanced, but the procedure becomes more complex

Engineering Contradiction:
Improvefluid management efficiencyVSAvoidcatheter system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent uses balloons as intermediary devices that can be inflated at specific venous locations (renal vein, subclavian vein) to create controlled low-pressure areas. These balloons act as mediators between the catheter system and the venous system, enabling precise control over blood flow dynamics and lymphatic reflow without requiring direct manipulation of the veins themselves.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system employs pneumatic principles by using inflatable balloons within the catheters to occlude veins. The balloons are inflated with fluid or gas to create occlusion at specific locations, leveraging pressure differentials to redirect blood flow and enhance lymphatic reflow. This pneumatic approach provides reversible and adjustable control over venous flow dynamics.

Inventive Principle:
Principle #29Pneumatics and hydraulics

3Measurement precision

If the system monitors multiple hemodynamic parameters including heart rate, blood pressure, and cardiac output, then treatment precision is improved, but measurement and control complexity increases

Engineering Contradiction:
Improvehemodynamic parameter monitoringVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The third catheter is designed with multi-functionality, serving both as a monitoring device for hemodynamic parameters and as a delivery catheter for the third balloon. The catheter system integrates multiple functions including venous occlusion, hemodynamic monitoring, and therapeutic intervention, reducing the need for separate dedicated devices for each function.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Ease of operation

If the first catheter accepts both the second and third catheters through different lumens, then access route is simplified, but catheter design complexity increases

Engineering Contradiction:
Improveaccess route simplicityVSAvoidcatheter structural complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The first catheter is designed with multiple lumens that accommodate the second and third catheters, creating a nested configuration where smaller catheters pass through the larger first catheter. This nesting structure allows all three catheters to access the venous system through a single femoral vein puncture site, simplifying the access procedure while the internal lumen structure of the first catheter becomes more complex to accommodate multiple passages.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 system reduces venous blood backflow, decreases heart preload, and enhances lymphatic reflow, leading to improved cardiac remodeling, reduced fluid retention, and alleviated symptoms of heart failure.

Implementation Method 1

Inflation of the first balloon creates a low-pressure area at or near a renal vein of the subject

Methodology Applied
Scientific EffectVenous occlusion:

Implementation Method 2

Inflation of the second balloon creates a low-pressure area at or near the left internal jugular vein and/or thoracic duct

Methodology Applied
Scientific EffectVenous occlusion:

Implementation Method 3

Inflation of the second balloon stimulates a vagus nerve of the subject. Inflation of the first balloon stimulates a vagus nerve of the subject

Methodology Applied
Scientific EffectVagus nerve stimulation:

Data Source

PatentUS20250169822A1Multi-catheter systems for treating heart failure
Publication Date: 2025.05.29 PULNOVO MEDICAL INC
  • US20250169822A1 patent drawing
  • US20250169822A1 patent drawing
  • US20250169822A1 patent drawing

AI summary

The present disclosure provides a balloon catheter system for treating heart failure in a subject. The balloon catheter systems of the present disclosure form low pressure areas below the subclavian vein and above the renal vein which promotes the return of blood and lymph back to the heart. Additionally, the balloon catheter systems stimulate the vagus nerve, thereby reducing activation of the sympathetic nervous system and improving cardiac remodeling.