Subintimal Atherectomy Device Circumferential Dissection

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Solution Overview

Problem

Current methods for treating chronic total occlusion and highly narrowing blood vessel regions are invasive, risky, and time-consuming, with challenges in passing wires through the true lumen and risks of perforation during subintimal procedures.

Innovation Solution

A dissecting device is inserted into the subintimal space of a blood vessel, featuring a directional guide member and a cutting member that rotates around the vessel's circumference to separate the inner and outer sides, allowing for the removal of stenotic regions without passing through the true lumen, thereby reducing the risk of perforation and improving efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a guide wire is passed through the true lumen to treat chronic total occlusion, then the treatment can be performed, but it is time consuming and difficult to pass the wire through the occluded vessel

Engineering Contradiction:

Improvetreatment feasibilityVSAvoidprocedure time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

Instead of passing the guide wire through the true lumen from proximal to distal (conventional approach), the invention inverts the approach by accessing the subintimal space laterally and directing the atherectomy device back toward the true lumen. This alternative pathway avoids the difficulty of penetrating the occluded true lumen directly.

Inventive Principle:

Principle #13The other way round (Inversion)

2Productivity

If atherectomy is performed to debulk the stenotic region, then the vessel can be treated, but there is a risk of perforation during the procedure

Engineering Contradiction:

Improvedebulking efficiencyVSAvoidperforation risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The subintimal space serves as an intermediary pathway that allows the atherectomy device to approach the stenotic region from a safer angle. By accessing the subintimal space first and then directing the cutting member toward the true lumen, the device can debulk the stenosis with reduced risk of uncontrolled perforation compared to direct true lumen access.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The cutting member is designed to engage the stenotic region locally from the subintimal side, allowing controlled debulking of the plaque burden while maintaining a safety margin from the vessel wall. This localized approach enables aggressive plaque removal without proportionally increasing perforation risk.

Inventive Principle:

Principle #3Local quality

3Reliability

If endarterectomy is performed to treat stenosis, then the intimal layer can be removed, but it requires large incisions and is highly invasive

Engineering Contradiction:

Improvestenosis treatment effectivenessVSAvoidsurgical invasiveness

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The invention replaces the mechanical surgical approach of endarterectomy (which requires large incisions and manual peeling of the intimal layer) with a percutaneous atherectomy system. The cutting member mechanically debulks the stenotic region through the catheter without requiring surgical exposure, thus achieving similar therapeutic效果 with minimal invasiveness.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Loss of time

If subintimal wiring approach is used to avoid true lumen passage, then time is saved, but debulking by atherectomy cannot be performed

Engineering Contradiction:

Improvewire passage timeVSAvoiddebulking capability

Core Design Contradiction:

Loss of timeVSProductivity

Solution Approach 1:

The invention combines the advantages of both true lumen access and subintimal access by using a multi-functional atherectomy device that can perform both wiring and debulking functions. The device allows the guide wire to be passed through the subintimal space (saving time) while simultaneously enabling the cutting member to debulk the stenotic region from the subintimal side, thus achieving both speed and therapeutic effectiveness.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 enables less invasive, safer, and more efficient treatment of stenotic vessels by allowing for the removal of stenotic regions from the subintimal space, reducing the risk of complications and improving blood flow by enlarging the vessel lumen.

Implementation Method 1

a first dissecting member having a cutting member on a distal end of the first dissecting member, which is configured to be rotated around the entire circumference of the blood vessel to separate the inner side of the subintimal space and the stenotic region from the outer side of the subintimal space

Methodology Applied

Scientific EffectRotational motion:

Data Source

PatentUS10772657B2Atherectomy with subintimal space

Publication Date: 2020.09.15 TERUMO KK

AI summary

A method and dissecting device are disclosed for treating a stenotic vessel. The method including inserting a dissecting device into a subintimal space of a blood vessel; dissecting an inner side of the subintimal space from an outer side of the subintimal space over an entire circumference of the blood vessel with the dissecting device, the dissecting device including a first dissecting member having a first cutting member; and removing the dissected inner side of the subintimal space and a stenotic region attached to the inner side of the subintimal space from the blood vessel.