Rotatable Tip Atherectomy Device for Plaque 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 and improving blood flow due to limitations in device design and material properties, leading to incomplete removal of deposits and potential complications like restenosis and balloon rupture.

Innovation Solution

An atherectomy device with a rotatable tip and shaft designed for high-speed rotation, featuring a unique geometry and material composition to enhance plaque removal, including a scalloped region and differential density materials, which allows for increased plaque removal area and efficient aspiration of debris through a guidewire lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If balloon angioplasty is used to treat vessel occlusion, then the procedure is minimally invasive, but the plaque is only stretched or cracked and not removed from the vessel wall leading to restenosis

Engineering Contradiction:
Improveminimally invasive procedureVSAvoidrestenosis prevention
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The atherectomy device extracts and removes plaque from the vessel wall through rotational cutting action. The burr contacts the plaque and cuts it away from the vessel wall, with debris being suctioned through the catheter, thereby completely removing rather than just stretching the plaque to prevent restenosis

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical stretching action of balloon angioplasty with a rotational cutting mechanism. A motor drives a burr to rotate at high speed, mechanically cutting and removing plaque through abrasion and suction, substituting the ineffective stretching mechanism with an active removal system

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If a larger rotating tip is used to remove more plaque, then plaque removal effectiveness improves, but the device requires a larger introducer sheath increasing patient trauma

Engineering Contradiction:
Improveplaque removal effectivenessVSAvoidpatient trauma
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The rotating burr is nested within the catheter structure, with the burr having a diameter smaller than the catheter's internal lumen. This allows the burr to rotate freely inside the catheter while the catheter itself passes through a relatively small introducer sheath, enabling effective plaque removal without requiring a large access site

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent creates a gap between the rotating burr and the catheter wall, utilizing the radial dimension for plaque removal while maintaining a compact axial profile. This dimensional arrangement allows the burr to contact plaque effectively while the overall device maintains a small external diameter for minimal invasive access

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Productivity

If high-speed rotation is used to improve plaque removal, then productivity increases, but the risk of balloon rupture and complications increases

Engineering Contradiction:
Improveplaque removal speedVSAvoidcomplication risk
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The device extracts plaque through rotational cutting with a burr that rotates at high speed. The motor-driven burr cuts and removes plaque efficiently, and the suction system simultaneously extracts debris, preventing buildup and reducing complications associated with high-speed rotation

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a suction system as an intermediary mechanism that works in conjunction with the high-speed rotating burr. The suction lumen removes debris and coolant, mediating the high-speed rotation process to prevent overheating, balloon rupture, and other complications while maintaining high productivity

Inventive Principle:
Principle #24Intermediary (Mediator)

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 and debris, widening the blood passageway and reducing the risk of complications like restenosis, while allowing for smaller introducer sheath sizes to minimize trauma and improve access to occluded vessels.

Implementation Method 1

rotating the device at high speed to cut through or ablate the plaque

Methodology Applied
Scientific EffectMechanical abrasion: Abrasion

Implementation Method 2

an auger positioned on the rotatable shaft, the auger positioned proximally of the rotatable tip and distally of a distalmost edge of the outer member, wherein rotation of the shaft rotates the auger to move particles abraded by the tip proximally into the outer member

Methodology Applied
Scientific EffectScrew conveyance: Screw

Implementation Method 3

particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member

Methodology Applied
Scientific EffectSuction: Suction

Data Source

PatentUS20230270463A1Atherectomy device
Publication Date: 2023.08.31 REX MEDICAL LP
  • US20230270463A1 patent drawing
  • US20230270463A1 patent drawing
  • US20230270463A1 patent drawing

AI summary

An atherectomy device for removing deposits such as plaque from an interior of a vessel including an outer member and a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member. A tip is mounted to the distal region of the rotatable shaft and is positioned distally of the distal end of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member. The rotatable tip has a longitudinal axis mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the shaft, the shaft including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the device.