Atherectomy Device Proximal Debris Removal

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Solution Overview

Problem

Current minimally invasive vascular surgical methods, such as balloon angioplasty and atherectomy, face challenges in effectively removing plaque from vessel walls while minimizing trauma and recovery time, as they require larger introducer sheaths for effective plaque removal, which increases procedural risks and complications.

Innovation Solution

An atherectomy device with a rotatable tip and shaft designed for high-speed rotation, featuring a series of outer threads and fluid injection to direct dislodged plaque proximally, and a suction mechanism to aspirate debris through the tip and between the shaft and introducer sheath, allowing for plaque removal through a smaller introducer sheath size without compromising effectiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a larger introducer sheath is used to remove plaque effectively, then plaque removal effectiveness is improved, but patient trauma and recovery time increase

Engineering Contradiction:

Improveplaque removal effectivenessVSAvoidpatient trauma

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The atherectomy device is segmented into multiple functional components: a rotatable cutting tip for plaque removal, a threaded shaft for debris engagement, and a suction mechanism for debris extraction. This segmentation allows each component to be optimized for its specific function while fitting through a smaller introducer sheath, resolving the contradiction between effective plaque removal and reduced patient trauma.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device employs a nested structure where the rotatable cutting tip is positioned at the distal end of the shaft, the suction mechanism is integrated within the device structure, and the entire atherectomy device fits within the introducer sheath. This nesting allows maximum functionality within minimal space constraints, enabling effective plaque removal through a smaller sheath size.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Productivity

If a larger introducer sheath is used for effective plaque removal, then plaque removal effectiveness is improved, but bleeding and infection risks increase

Engineering Contradiction:

Improveplaque removal effectivenessVSAvoidprocedural safety

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The device utilizes hydraulic principles through the suction mechanism that creates negative pressure to draw debris through the device and into collection. This pneumatic/hydraulic action enables effective debris removal without requiring a large sheath, thereby maintaining procedural safety by minimizing access site trauma, bleeding, and infection risks while preserving plaque removal effectiveness.

Inventive Principle:

Principle #29Pneumatics and hydraulics

3Productivity

If high-speed rotation is used to remove plaque, then plaque removal speed is improved, but device complexity increases

Engineering Contradiction:

Improveplaque removal speedVSAvoiddevice structure

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The device merges multiple functions into a single integrated structure: the rotatable cutting tip combines plaque cutting with debris engagement, the threaded shaft integrates debris propulsion, and the suction mechanism consolidates debris extraction. This merging achieves high-speed plaque removal while minimizing device complexity by eliminating the need for separate components for each function.

Inventive Principle:

Principle #5Merging (Combining)

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 device effectively removes plaque from vessel walls with reduced trauma and recovery time by using a smaller introducer sheath, minimizing bleeding and infection risks, while maintaining the ability to clear a sufficient area of obstructive deposits, thus improving patient outcomes.

Implementation Method 1

a rotatable tip...rotatable about its longitudinal axis upon rotation of the shaft about its longitudinal axis to remove deposits from the interior of the vessel

Methodology Applied

Scientific EffectAbrasion: Abrasion

Implementation Method 2

the rotatable shaft including a series of outer threads dimensioned to direct deposits (particles) proximally

Methodology Applied

Scientific EffectArchimedes Screw: Archimedes Screw

Implementation Method 3

a suction mechanism to aspirate debris through the tip and between the shaft and introducer sheath

Methodology Applied

Scientific EffectSuction: Suction

Implementation Method 4

fluid injection to direct dislodged plaque proximally

Methodology Applied

Scientific EffectPressure Gradient: Pressure Gradient

Data Source

PatentUS10751083B2Atherectomy device

Publication Date: 2020.08.25 REX MEDICAL LP

AI summary

A surgical apparatus for removing deposits from an interior of a vessel including an outer member and a rotatable shaft having a lumen to receive a guidewire. The lumen has a cross-sectional dimension to enable fluid injection between an inner diameter of the shaft and an outer diameter of the guidewire. A tip is mounted to the shaft for rotation about its longitudinal axis and mounted such that the distal opening of the shaft is axially spaced from a distal internal surface of the tip such that fluid injected through the lumen of the shaft contacts the distal internal surface of the tip and is redirected proximally to direct in a proximal direction deposits removed by the rotational movement of the shaft. The tip includes including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the apparatus.