Lubricious Insertion Tool for Balloon Catheter Drug Coating Protection

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Solution Overview

Problem

Current medical devices lack effective tools for safely inserting balloon catheters into the vasculature while protecting the device and preventing contamination or loss of drug coatings, especially in procedures involving atherosclerotic plaques.

Innovation Solution

The development of insertion tools with a tubular portion and separation margins that accommodate balloon catheters, allowing for safe passage through hemostatic valves and minimizing contact with drug coatings, along with a method for using these tools to facilitate the insertion of balloon catheters while protecting the device from contamination and coating loss.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If balloon catheter is inserted directly into vasculature, then insertion speed is improved, but device protection and contamination prevention deteriorate

Engineering Contradiction:

Improveinsertion speedVSAvoiddevice protection

Core Design Contradiction:

SpeedVSReliability

Solution Approach 1:

The insertion tool is divided into distinct functional segments: a tubular portion for initial insertion and protection, and a release mechanism for device deployment. This segmentation allows the catheter to be protected during insertion while enabling rapid deployment when needed.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insertion tool acts as an intermediary device between the operator and the balloon catheter. It provides a protective interface that shields the catheter from contamination during insertion while allowing controlled release into the vasculature, thus maintaining both speed and reliability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Device complexity

If balloon catheter contacts hemostatic valve during insertion, then insertion path is simplified, but drug coating loss increases

Engineering Contradiction:

Improveinsertion path complexityVSAvoiddrug coating loss

Core Design Contradiction:

Device complexityVSLoss of substance

Solution Approach 1:

The insertion tool serves as a mediator that allows the balloon catheter to pass through the hemostatic valve without direct contact. The tool's tubular portion guides the catheter through the valve while the release mechanism ensures the catheter is only deployed after successful passage, minimizing drug coating loss while maintaining a straightforward insertion path.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The insertion tool is prepared in advance with the balloon catheter loaded and protected within its tubular portion. This preliminary configuration allows the catheter to be inserted through the hemostatic valve in a protected state, preventing drug coating loss before the catheter is released into the vasculature.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If insertion tool protects balloon catheter, then device integrity is improved, but insertion tool complexity increases

Engineering Contradiction:

Improvedevice integrityVSAvoidinsertion tool complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The insertion tool is segmented into a tubular protective portion and a release mechanism with separation margins. This segmentation provides protection for the balloon catheter while keeping each component relatively simple in design, avoiding excessive overall complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The protective features are localized to specific areas of the insertion tool where they are most needed, such as the tubular portion that直接接触 the catheter and the separation margins at the release point. This localized approach maintains device integrity without requiring complex protection mechanisms throughout the entire tool.

Inventive Principle:

Principle #3Local quality

4Ease of operation

If separation margin is introduced in tubular portion, then device release is improved, but structural strength deteriorates

Engineering Contradiction:

Improvedevice release easeVSAvoidtubular portion strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The separation margin is pre-formed in the tubular portion during manufacturing, creating a predetermined weak point that will fracture under controlled conditions. This preliminary preparation allows for easy device release during insertion while maintaining sufficient structural strength during the insertion phase, as the margin is designed to fail only when the release force is applied.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS11712545B2Lubricious insertion tools for medical devices and methods for using

Publication Date: 2023.08.01 SURMODICS MD LLC

AI summary

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body, and that can provide advantages in terms of balloon insertion, safety, and drug delivery. The insertion tool includes a tubular portion that accommodates a balloon portion of a balloon catheter, and one or more separation margin(s) in the wall of the tubular portion or one or more split(s) in the tubular wall. The insertion tool also includes a proximal tab that extends from a second lengthwise half having a portion at an angle skew to the lengthwise axis, or that is in the form of a solid article comprising a concave surface that is fastened to an outer surface of the second lengthwise half of the tubular portion; or first and second tabs that extend from first and second lengthwise halves of the tubular portion, respectively.