Blood Pump Balloon Support Structure Prevents Rolling

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Solution Overview

Problem

Current intra-aortic balloon pumps (IABPs) face issues with durability and mobility due to kinking and cyclic fatigue, leading to reduced effectiveness and increased risk of vascular complications, especially when implanted using the femoral technique, which limits their use to short durations and restricts patient ambulation.

Innovation Solution

A percutaneously-delivered intravascular ventricular assist system (PiVAS) with a pneumatically driven expandable member implanted in the descending aorta via an improved axillary technique, using a support structure made of elastic or superelastic material to prevent rolling or folding of the balloon, ensuring long-term biocompatibility and safety, and allowing for partial circulatory support without cardiopulmonary bypass or blood products.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If IABP is implanted via femoral technique, then implantation is simple, but patient mobility is restricted and durability is reduced due to kinking and cyclic fatigue

Engineering Contradiction:
ImproveEase of implantationVSAvoidDurability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

A support structure acts as an intermediary element between the balloon and the driveline, providing mechanical reinforcement to prevent kinking and cyclic fatigue. This mediator structure enables the balloon to maintain its position and shape without being directly subjected to the mechanical stresses that would cause failure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support structure is made from shape memory alloy or elastic material that combines flexibility with structural integrity. This composite approach allows the support structure to accommodate physiological movements while preventing the balloon from kinking or folding, thereby improving durability without restricting patient mobility.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If IABP is implanted via femoral technique, then implantation is simple, but patient ambulation is prevented leading to poorer outcomes

Engineering Contradiction:
ImproveEase of implantationVSAvoidPatient mobility
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The support structure serves as a mediator that decouples the mechanical constraints of the driveline from the balloon, allowing the balloon to remain stable while the patient moves freely. This intermediary structure eliminates the need to restrict patient ambulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Volume of moving object

If balloon wall thickness is decreased, then device profile is reduced for easier delivery, but structural integrity is compromised causing rolling or folding

Engineering Contradiction:
ImproveDevice profileVSAvoidStructural integrity
Core Design Contradiction:
Volume of moving objectVSStrength

Solution Approach 1:

The support structure acts as a mediator that provides the necessary structural integrity to prevent rolling or folding, allowing the balloon wall thickness to be reduced for easier delivery. The support structure compensates for the reduced structural strength of the thinner balloon wall.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The balloon is designed as a thin-walled flexible structure that can be easily delivered through catheters. The support structure, made from shape memory alloy or elastic material, provides the necessary mechanical strength to prevent the thin-walled balloon from rolling or folding during operation.

Inventive Principle:
Principle #30Flexible shells and thin films

4Duration of action of moving object

If IABP is used for prolonged periods, then extended therapy is provided, but vascular complications and infections increase

Engineering Contradiction:
ImproveTherapy durationVSAvoidVascular complications
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The support structure is designed as a disposable component that is implanted with the balloon and removed after a specific therapy duration. This disposable approach prevents long-term presence of foreign material in the vasculature, reducing the risk of infections and vascular complications while still providing extended therapy coverage.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 PiVAS provides enhanced durability, reduced thrombogenic risk, and allows for non-obligatory support to a less-sick heart failure population, enabling longer-term use with reduced vascular complications and improved patient mobility, while maintaining effective counterpulsation therapy.

Implementation Method 1

the support structure is made of elastic or superelastic material to prevent rolling or folding of the balloon

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the support structure is made of elastic or superelastic material to prevent rolling or folding of the balloon

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentEP4338787A1A blood pump support apparatus and method for a blood pump assembly
Publication Date: 2024.03.20 NUPULSECV INC
  • EP4338787A1 patent drawingFigure 1A~1B
  • EP4338787A1 patent drawingFigure 2~2B
  • EP4338787A1 patent drawingFigure 3~4D

AI summary

A blood pump assembly has a balloon disposed at a distal region and a driveline disposed at a proximal region and is capable of being employed to provide mechanical circulatory support (e.g., counterpulsation). A blood pump support apparatus has a support structure with a head region and a tail region that is removably disposable in the blood pump assembly. When the support structure is disposed in the blood pump assembly, the head region is disposed within the balloon. When the blood pump assembly is implanted in the descending aorta and the support structure is disposed in the blood pump assembly, forces act on the balloon that would cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis. The head region of support structure opposes these forces.