Balloon Catheter Drug Crystal Nesting

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Solution Overview

Problem

Existing balloon catheters face challenges in effectively delivering drugs to lesion affected areas due to drug coating morphology, which affects drug release and transferability, leading to potential restenosis issues.

Innovation Solution

A balloon catheter with a coating layer comprising elongate crystals of water-insoluble drugs extending into the balloon's interior, ensuring enhanced drug delivery and reduced risk of coating detachment during treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If drug crystals are formed on the balloon surface, then drug release property is improved, but the crystals may fall off during delivery to the affected area

Engineering Contradiction:
Improvedrug release propertyVSAvoidcrystal retention on balloon surface
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The crystal structure is designed with a nested configuration where the crystal body extends from the outer surface into the interior of the balloon, with the proximal portion embedded in the balloon material and the distal portion protruding outward. This nesting approach ensures the crystal remains retained on the balloon surface during delivery while maintaining drug release capability.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The crystal is designed with a three-dimensional extended structure rather than a two-dimensional surface coating. The crystal extends from the outer surface into the balloon interior, creating a dimensional transition that provides both retention (through embedding in the proximal portion) and release capability (through the distal portion protruding toward the affected area).

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If the balloon is inflated to deliver drug to the lesion affected area, then therapeutic effect is improved, but excessive proliferation of smooth muscle cells may occur causing new stenosis

Engineering Contradiction:
Improvetherapeutic effectVSAvoidrestenosis
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The crystal structure acts as an intermediary carrier that releases drug to the living body tissue through controlled mechanisms. The crystal's extended structure with proximal and distal portions facilitates controlled drug release to the lesion affected area, preventing excessive smooth muscle cell proliferation and restenosis while maintaining therapeutic effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If the elongate body proximal portions extend into the interior of the balloon, then crystal retention is improved, but the coating structure becomes more complex

Engineering Contradiction:
Improvecrystal retention on balloon surfaceVSAvoidcoating structure
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The crystal is segmented into distinct functional portions: a proximal portion that extends into the balloon interior for retention and an distal portion that protrudes from the outer surface for drug release. This segmentation allows each portion to perform its specific function while maintaining an integrated crystal structure that does not significantly increase coating complexity.

Inventive Principle:
Principle #1Segmentation

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 configuration enhances drug release and transferability to living body tissue, effectively inhibiting restenosis by maintaining drug crystals on the balloon surface and within the tissue, improving therapeutic outcomes.

Implementation Method 1

The elongate body proximal portions (which are the crystals continuing from the elongate body) extend into the interior of the balloon. Therefore, the elongate bodies are less liable to fall off (i.e., be removed from) the outer surface of the balloon during delivery to an affected area

Methodology Applied
Scientific EffectPhysical anchoring:

Implementation Method 2

The elongate bodies may be hollow at least on a distal side of each of the elongate bodies. The surface areas of the crystals making contact with the living body tissue are thus enlarged. Therefore, the releasing property of the drug from the outer surface of the balloon (i.e., the ability of the drug to be released from the outer surface) and the tissue transferability of the drug can be enhanced

Methodology Applied
Scientific EffectSurface area expansion:

Implementation Method 3

The surface areas of the crystals making contact with the living body tissue are thus enlarged. Therefore, the releasing property of the drug from the outer surface of the balloon and the tissue transferability of the drug can be enhanced, and the drug can be effectively delivered to the living body tissue

Methodology Applied
Scientific EffectDrug transfer:

Data Source

PatentUS11369776B2Balloon catheter and manufacturing method thereof, and treatment method
Publication Date: 2022.06.28 TERUMO KK
  • US11369776B2 patent drawing
  • US11369776B2 patent drawing
  • US11369776B2 patent drawing

AI summary

A balloon catheter that includes an elongated main body extending in an axial direction and a balloon connected to the distal portion of the elongated main body. The balloon includes an interior and is inflatable and deflatable. The balloon catheter also includes a plurality of elongate bodies extending radially away from the outer surface of the balloon. The elongate bodies are crystals of a water-insoluble drug. The elongate bodies each possess an independent longitudinal axis. Each of the elongate bodies includes a base portion at the proximal end of the elongate body. A plurality of elongate body proximal portions extend radially inwardly from the base portion of each of the elongate bodies toward the interior of the balloon. The elongate body proximal portions are continuous extensions of the crystal of the water-insoluble drug.