Atherectomy System With Variably Exposed Cutter

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Solution Overview

Problem

Current atherectomy devices face challenges with vessel safety, embolization, and ease of use, particularly in removing organized clots and atheromatous material, as they often produce embolic debris, are time-intensive to set up, and lack directional precision.

Innovation Solution

An atherectomy system with a variably exposed cutter and high velocity fluid jets, where a positionally fixed cutter is combined with high velocity fluid jets to remove atheromatous material, using a nitinol section with a hinge mechanism to angle the cutter and a high pressure loop emanator to evacuate debris, ensuring directional cutting and continuous evacuation of debris.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a rotational burr is used to cut through tough material, then cutting capability is improved, but embolic debris is produced and vessel safety deteriorates

Engineering Contradiction:
Improvecutting capabilityVSAvoidembolic debris
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The burr is divided into multiple cutting edges arranged in a circular pattern, allowing selective engagement with plaque while minimizing simultaneous cutting that generates embolic debris. The segmentation enables controlled material removal rather than aggressive rotational cutting.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of using a rotational burr that aggressively cuts and generates debris, the invention inverts the approach by using a stationary or minimally moving cutter head that scores and removes plaque with reduced embolization risk, transforming the harmful rotational cutting action into a safer scoring and removal mechanism.

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If a rotational cutter is used for atherectomy, then material removal is improved, but setup time increases and ease of operation deteriorates

Engineering Contradiction:
Improvematerial removalVSAvoidsetup time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The cutter head is pre-configured with multiple cutting edges and scoring mechanisms that are ready for immediate use upon delivery to the target site. The device eliminates the need for complex rotational setup procedures, allowing the operator to begin material removal directly after positioning.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention extracts the complex rotational mechanism from the distal tip, retaining only the essential cutting edges in a simplified configuration. This removal of unnecessary rotational components reduces setup time and simplifies the overall operation while maintaining effective material removal capability.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If a non-directional rotational device is used, then material removal is improved, but directional precision is lost and vessel safety deteriorates

Engineering Contradiction:
Improvematerial removalVSAvoiddirectional precision
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The cutter head features locally optimized cutting edges positioned at specific orientations to target plaque in particular directions. The scoring edges are arranged to engage with plaque from specific angles, providing directional precision while maintaining effective material removal in the local area of interest.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The cutter head design incorporates asymmetric cutting edge arrangements that provide directional precision for targeting plaque in specific locations. The non-uniform distribution of cutting edges allows the device to preferentially remove material in desired directions while minimizing impact on healthy vessel walls, resolving the contradiction between material removal and directional precision.

Inventive Principle:
Principle #4Asymmetry

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 system enhances vessel safety by controlling cutter exposure and debris evacuation, reduces embolization risk, and improves efficacy by rapidly removing atheromatous material with reduced setup complexity and increased directional precision.

Implementation Method 1

high velocity fluid jets to break up, erode and be instrumental in the removal of skived material

Methodology Applied
Scientific EffectHydraulic force: Pressure Gradient

Implementation Method 2

high velocity fluid jets to break up, erode and be instrumental in the removal of skived material

Methodology Applied
Scientific EffectCavitation: Cavitation

Implementation Method 3

a nitinol section with a hinge mechanism to angle the cutter

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 4

nitinol section with a hinge mechanism to angle the cutter

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 5

a positionally fixed cutter is combined with high velocity fluid jets to remove atheromatous material

Methodology Applied
Scientific EffectMechanical cutting: Mechanical Force

Implementation Method 6

cutter and high velocity fluid jets to remove material

Methodology Applied
Scientific EffectAbrasion: Abrasion

Data Source

PatentUS7951161B2Atherectomy system having a variably exposed cutter
Publication Date: 2011.05.31 BOSTON SCI MEDICAL DEVICE LTD
  • US7951161B2 patent drawing
  • US7951161B2 patent drawing
  • US7951161B2 patent drawing

AI summary

An atherectomy system having a variably exposed cutter wherein a distally located positionable tip closely associated with the cutter and a high pressure fluid jet emanator can be variably and angularly deployed about a hinge mechanism subsequent to entry into the vasculature. The fixed cutter slices or parts atheromatous material and/or thrombotic material from a blood vessel for interaction with high pressure jets to macerate, break up or otherwise reduce the materials for evacuation from the site.