Needleless Catheter Guidewire Re-entry Into True Lumen

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Solution Overview

Problem

Current catheter devices face challenges in effectively bypassing chronic total occlusions in arteries, particularly in navigating guidewires from a subintimal space back into the true lumen, especially when occlusions are caused by hard, calcified plaque, leading to deviations and entrapment in the subintimal space.

Innovation Solution

A catheter system with a flexible elongate catheter and a side outlet opening, equipped with a penetrating guidewire and an optional orientation element, allows for the advancement of the guidewire from the subintimal space into the true lumen, facilitating the re-entry and enabling the delivery of devices to target locations within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a guidewire is advanced through hard, calcified atherosclerotic plaque, then the guidewire may penetrate through the intima and create a subintimal space, but the guidewire becomes entrapped within the subintimal space and cannot remain within the artery lumen

Engineering Contradiction:

Improveguidewire penetration capabilityVSAvoidguidewire re-entry difficulty

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

A catheter device is introduced as an intermediary tool between the guidewire and the subintimal space. The catheter has a distal end that can be positioned within the subintimal space and a lateral opening that directs the guidewire back into the true lumen. This intermediary device facilitates the re-entry process without requiring complex manual manipulation of the guidewire itself.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The catheter device is designed with nested components where the guidewire can be advanced through the catheter's lumen and directed through the lateral opening. The catheter itself can be advanced over a tracking guidewire, creating a nested configuration that enables sequential deployment of tools through the occlusion site.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Adaptability or versatility

If a catheter device is designed to redirect guidewires from subintimal space to true lumen, then re-entry capability is improved, but device complexity increases

Engineering Contradiction:

Improveguidewire redirection capabilityVSAvoidcatheter structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The catheter device is segmented into distinct functional zones: a tracking guidewire lumen for initial navigation, a main body for structural support, a lateral opening for guidewire redirection, and a distal end for positioning within the subintimal space. This segmentation allows each component to perform its specific function while keeping the overall design relatively simple.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The catheter device serves multiple functions: it acts as a delivery system for the penetrating guidewire, provides a tracking lumen for initial wire navigation, offers a lateral opening for redirection, and can be positioned within the subintimal space. This multi-functionality reduces the need for multiple separate devices, thereby managing complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Length of moving object

If the catheter is made of small diameter to treat coronary CTOs, then applicability to coronary arteries is improved, but device strength and penetration capability may be reduced

Engineering Contradiction:

Improvecatheter diameterVSAvoidcatheter structural strength

Core Design Contradiction:

Length of moving objectVSStrength

Solution Approach 1:

The catheter is constructed using composite materials that combine polymers with high tensile strength and potentially reinforcement elements. This allows the catheter to maintain a small diameter suitable for coronary arteries while achieving the necessary structural strength to navigate through calcified plaque and maintain its shape during the procedure.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS8374680B2Needleless catheters and methods for true lumen re-entry in treatment of chronic total occlusions and other disorders

Publication Date: 2013.02.12 MEDTRONIC VASCULAR INC

AI summary

A catheter system comprising a) an elongate flexible catheter; b) a lumen that extends from a proximal insertion port to a side outlet opening; c) a penetrating guidewire insertable into the proximal insertion port and thereafter advanceable through the lumen and out of the side outlet opening; and d) an orientation element useable to provide an indication of the trajectory on which the penetrating guidewire will advance from the catheter body. Also disclosed are methods for using such catheter to direct the penetrating guidewire out of the side opening and into the true lumen of a blood vessel when bypassing an obstruction in the blood vessel such as a chronic total occlusion (CTO) of an artery.