Occlusion Bypassing Apparatus With Stabilization Tube

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Solution Overview

Problem

Current medical catheters face challenges in consistently and reliably redirecting subintimally advanced guidewires back into the true lumen of arteries for treating chronic total occlusions, particularly due to the difficulty in penetrating hard, calcified plaque and maintaining stability during the re-entry process.

Innovation Solution

An occlusion bypassing apparatus comprising a handle, an outer shaft component with a side port and a needle lumen, a stabilization tube, and a needle component that minimizes resistive forces, allowing the needle to be slidably disposed within the stabilization tube and removable, which helps in stabilizing the apparatus and reducing friction during deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional guidewire is used to penetrate hard, calcified plaque, then the guidewire may deviate and create a subintimal tract, but the guidewire becomes trapped and cannot reliably re-enter the true lumen

Engineering Contradiction:

Improvereliability of re-entry into true lumenVSAvoiddifficulty of manipulating guidewire

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The catheter is divided into distinct functional segments: a stabilization tube for anchoring, a needle component for puncture, and a guidewire for navigation. This segmentation allows each component to perform its specific function optimally, with the needle providing controlled penetration and the stabilization tube ensuring proper positioning for reliable re-entry.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The needle component acts as an intermediary tool between the stabilization tube and the vessel wall. It provides a controlled mechanism for penetrating the intima and creating a precise re-entry point into the true lumen, mediating the transition from subintimal to intraluminal position.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If the needle component is made stiffer to penetrate calcified plaque, then penetration capability improves, but resistive forces from the outer shaft increase

Engineering Contradiction:

Improvepenetration capabilityVSAvoidresistive forces

Core Design Contradiction:

StrengthVSForce

Solution Approach 1:

The catheter system separates the penetration function (needle component) from the support structure (outer shaft and stabilization tube). The needle can be optimized for penetration strength independently, while the outer shaft maintains flexibility. The stabilization tube minimizes resistive forces by providing a low-friction interface.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stabilization tube serves as an intermediary that reduces the interaction forces between the needle component and the outer shaft. By minimizing friction and resistive forces, it allows the needle to penetrate calcified plaque more effectively without being hindered by the shaft's structural resistance.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If the catheter structure is made more complex to improve re-entry reliability, then recanalization success improves, but device complexity increases

Engineering Contradiction:

Improverecanalization successVSAvoidcatheter structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The catheter is segmented into specialized components (stabilization tube, needle component, outer shaft) where each segment performs a specific function. This modular approach achieves reliable recanalization through functional specialization rather than overall structural complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The needle component is nested within the stabilization tube, which itself is positioned within the outer shaft. This nested configuration allows multiple functional elements to be integrated in a compact manner, achieving complex functionality with a space-efficient structure.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentEP3352833B1Occlusion bypassing apparatus with a re-entry needle and a stabilization tube

Publication Date: 2022.11.09 MEDTRONIC VASCULAR INC

Figure 1~1A
Figure 1B~1C
Figure 2~3

AI summary

An occlusion bypassing apparatus (100) for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component (102, 602) having a needle lumen (109) there-through. A proximal end (104) of the outer shaft component is fixed within a handle (151) of the apparatus at a first attachment point (124). A stabilization tube (110) of the apparatus is disposed within the needle lumen. A proximal end (111) of the stabilization tube is fixed within the handle at a second attachment point (128) that is spaced apart from the first attachment point and an elongated body (114) and a distal end (115) of the stabilization tube are not attached to the outer shaft component. A needle component (134) of the apparatus is configured to be slidably disposed within the stabilization tube and removable therefrom, and the stabilization tube minimizes resistive forces exerted onto the needle component by the outer shaft component.