Flexible Distal Tip Tissue-Removing Catheter

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Solution Overview

Problem

Existing tissue-removing catheters face challenges in effectively navigating and removing tissue from body lumens without causing damage, particularly due to rigidity and risk of lesion hang-ups and guidewire damage during procedures like percutaneous coronary angioplasty.

Innovation Solution

A tissue-removing catheter design featuring a flexible distal tip with a coil or polymeric material that is more flexible than the tissue-removing element, providing a tapered transition and abrasive surfaces to aid in centering and loosening lesions, while being atraumatic to prevent damage to the body lumen, and an inner liner for reduced friction during guidewire passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a rigid tissue-removing element is used to effectively remove tissue, then tissue removal effectiveness is improved, but the risk of lesion hang-ups and guidewire damage increases

Engineering Contradiction:

Improvetissue removal effectivenessVSAvoidrisk of lesion hang-ups and guidewire damage

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The catheter is divided into distinct segments with different flexibility characteristics: a rigid tissue-removing element for effective tissue removal and a flexible distal tip for safe navigation. This segmentation allows each part to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter are assigned different mechanical properties: the tissue-removing element has high rigidity for effective tissue engagement, while the distal tip has high flexibility for safe navigation through body lumens. This local differentiation of material properties resolves the contradiction between effectiveness and safety.

Inventive Principle:

Principle #3Local quality

2Reliability

If a flexible distal tip is added to reduce lesion hang-ups and guidewire damage, then safety is improved, but device complexity increases

Engineering Contradiction:

Improvesafety against lesion hang-ups and guidewire damageVSAvoidcatheter structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The flexible distal tip is merged with the tissue-removing element through direct coupling, creating a unified catheter structure. This merging approach integrates the safety function into the existing device without adding separate complex subsystems, thereby minimizing the increase in device complexity.

Inventive Principle:

Principle #5Merging (Combining)

3Ease of operation

If the distal tip is made more flexible than the tissue-removing element, then navigation capability is improved, but the structural integrity for tissue removal may be compromised

Engineering Contradiction:

Improvenavigation capabilityVSAvoidstructural integrity for tissue removal

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The catheter is segmented into a rigid tissue-removing element that maintains structural integrity for effective tissue removal and a flexible distal tip that provides navigation capability. Each segment maintains its appropriate mechanical properties without being compromised by the other segment's requirements.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The catheter exhibits local quality differentiation where the tissue-removing element has high structural integrity for effective tissue engagement, while the distal tip has high flexibility for safe navigation. This spatial differentiation of mechanical properties allows both navigation capability and structural integrity to coexist.

Inventive Principle:

Principle #3Local quality

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 flexible distal tip enhances navigation and tissue removal by reducing the risk of lesion hang-ups and guidewire damage, maintaining patency of body lumens and facilitating procedures like PTCA and stent delivery with improved safety and effectiveness.

Implementation Method 1

an inner liner for reduced friction during guidewire passage

Methodology Applied

Scientific EffectFriction: Friction

Implementation Method 2

abrasive surfaces to aid in centering and loosening lesions

Methodology Applied

Scientific EffectAbrasion: Abrasion

Data Source

PatentUS20250009380A1Tissue-removing cathether with flexible distal tip

Publication Date: 2025.01.09 MEDTRONIC VASCULAR INC

AI summary

The present disclosure provides a tissue-removing catheter for removing tissue in a body lumen including an elongate drive member, tissue-removing element, and a distal tip. The elongate drive member is sized and shaped to be received in the body lumen. The elongate drive member rotates about an axis. The tissue-removing element is operatively coupled to a distal end portion of the elongate drive member and rotates by the elongate drive member to remove tissue in the body lumen. The distal tip extends distally outward from the tissue-removing element and is more flexible than tissue-removing element. The distal tip has a proximal end portion coupled to the tissue-removing element and a distal end portion spaced distally from the tissue-removing element. The distal tip defines a tip in communication with a liner passage that is configured to receive a guidewire therein.