Vibrating Drug-Coated Balloon for Restenosis Prevention

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Solution Overview

Problem

Existing treatments for vascular and venous occlusions often result in elastic recoil and restenosis, as traditional balloon angioplasty may not effectively deliver therapeutic agents to the deeper layers of the vessel wall.

Innovation Solution

A drug-coated balloon catheter system that incorporates mechanical vibration, using an ultrasound transmission member to vibrate the drug-coated balloon at ultrasonic frequencies, thereby enhancing drug delivery to the vessel wall and preventing restenosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional balloon angioplasty is used to treat vascular occlusions, then the procedure is simple and widely applicable, but elastic recoil and restenosis occur due to ineffective drug delivery to deeper vessel wall layers

Engineering Contradiction:
Improveprevention of restenosisVSAvoidcomplexity of drug delivery mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies mechanical vibration at ultrasonic frequencies to the drug-coated balloon through an ultrasound transmission member. This vibration enhances drug penetration into the deeper layers of the vessel wall, improving therapeutic efficacy and preventing restenosis without requiring complex multi-component delivery systems

Inventive Principle:
Principle #18Mechanical vibration

Solution Approach 2:

The patent replaces conventional mechanical drug delivery mechanisms with ultrasonic vibration technology. The ultrasound transmission member converts electrical energy to mechanical vibrations that facilitate drug penetration, offering a more effective and less invasive approach compared to traditional mechanical pressure-based delivery

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

2Manufacturing precision

If drug-coated balloons are used to deliver therapeutic agents, then drug delivery to vessel wall is improved, but the drugs fail to reach deeper layers of the vessel wall effectively

Engineering Contradiction:
Improvedrug delivery precisionVSAvoiddrug penetration depth
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

Ultrasonic vibration of the drug-coated balloon at high frequencies enhances the penetration depth of therapeutic agents into the vessel wall. The mechanical oscillation creates micro-movements that facilitate drug transport across the vessel wall barrier, achieving reliable delivery to deeper layers

Inventive Principle:
Principle #18Mechanical vibration

Solution Approach 2:

The patent changes the physical state and delivery parameters of the drug by applying ultrasonic vibration. This alters the interaction between the drug coating and vessel wall, enabling deeper penetration through enhanced molecular movement and increased contact efficiency

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If ultrasound catheters with small diameter transmission members are used, then access through tortuous vasculature is improved, but the structural integrity and vibration transmission efficiency are reduced

Engineering Contradiction:
Improvecatheter navigabilityVSAvoidvibration transmission capability
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent uses a flexible drug-coated balloon as the transmission medium that can navigate tortuous vasculature. The balloon material is designed to be sufficiently flexible for navigation while maintaining the ability to transmit ultrasonic vibrations effectively to the vessel wall

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The ultrasound transmission member is constructed from composite materials that provide both flexibility for navigation through tortuous vessels and sufficient structural integrity for effective vibration transmission. The composite structure combines materials with complementary properties to resolve the contradiction between flexibility and strength

Inventive Principle:
Principle #40Composite materials

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 mechanical vibration of the drug-coated balloon increases the effectiveness of drug delivery to the sub-layers of the vessel wall, reducing the likelihood of restenosis and improving treatment outcomes for vascular and venous occlusions.

Implementation Method 1

incorporates mechanical vibration, using an ultrasound transmission member to vibrate the drug-coated balloon at ultrasonic frequencies

Methodology Applied
Scientific EffectUltrasonic vibration: Ultrasonic Vibration

Data Source

PatentUS12201314B2Drug delivery via mechanical vibration balloon
Publication Date: 2025.01.21 FLOWCARDIA INC
  • US12201314B2 patent drawing
  • US12201314B2 patent drawing
  • US12201314B2 patent drawing

AI summary

A drug-delivery device for vessels comprising a catheter body, an elongate ultrasound transmission member, an inflatable balloon, and a plurality of support wires. The catheter body has at least one lumen extending longitudinally therethrough. The elongate ultrasound transmission member extends longitudinally through the lumen. The elongate ultrasound transmission member has a distal portion and a proximal end configured to be coupled to an ultrasound transducer. The inflatable balloon, having an exterior surface, is coupled to the distal portion. The plurality of support wires are connected to the elongate ultrasound transmission member at two locations. A coating of at least one drug is on the exterior surface of the inflatable balloon. The elongate ultrasound transmission member is configured to transmit longitudinal vibrations to the inflatable balloon such that the inflatable balloon is longitudinally vibrated. The coating is removed by mechanical vibration of the inflatable balloon.