Carotid Reverse-Flow Catheter for Embolic Debris Capture

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Solution Overview

Problem

Existing medical devices for carotid artery procedures face challenges in effectively preventing embolic events by ensuring full retrograde flow to capture debris dislodged from lesions without advancing protection devices across the lesion, which can dislodge further particles.

Innovation Solution

A catheter system with an occlusion balloon and flow control device to establish and confirm full retrograde flow in the carotid arteries using pressure differentials and active aspiration, ensuring debris is captured in the venous system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If protection devices are advanced across the lesion to capture debris, then embolic protection is improved, but the risk of dislodging additional particles increases

Engineering Contradiction:

Improveembolic protection effectivenessVSAvoidparticle dislodgement

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The catheter system reverses the conventional approach by establishing retrograde flow from distal to proximal direction, capturing debris at its source near the lesion rather than advancing protection devices across the lesion. The occlusion balloon blocks antegrade flow and the pump system creates negative pressure to draw blood and debris backward into the catheter, preventing emboli from reaching the brain while avoiding additional particle dislodgement.

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The system performs preliminary occlusion of the carotid artery with the balloon before performing the lesion procedure. This preemptive measure establishes the retrograde flow pathway in advance, ensuring that any debris generated during the procedure is immediately captured and redirected away from the brain, rather than attempting to capture debris after it has been dislodged.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If occlusion balloon is inflated to block antegrade flow, then retrograde flow establishment is improved, but arterial pressure and flow disruption increase

Engineering Contradiction:

Improveretrograde flow establishmentVSAvoidarterial pressure

Core Design Contradiction:

ReliabilityVSStress or pressure

Solution Approach 1:

The pump system continuously monitors flow conditions and adjusts its operation to maintain optimal retrograde flow. Sensors detect the establishment of retrograde flow and provide feedback to the control system, which modulates the pump rate and occlusion balloon pressure accordingly, preventing excessive pressure buildup while ensuring complete flow reversal for effective embolic protection.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system dynamically adjusts the occlusion balloon inflation pressure and pump flow rate based on real-time hemodynamic conditions. Rather than maintaining constant high pressure, the system adapts its parameters to achieve the minimum necessary occlusion pressure while establishing adequate retrograde flow, thereby reducing arterial wall stress and potential complications.

Inventive Principle:

Principle #15Dynamics

3Reliability

If pump system operates at high flow rate to ensure complete reverse flow, then embolic protection is improved, but energy consumption and system complexity increase

Engineering Contradiction:

Improvecomplete reverse flow assuranceVSAvoidpump energy consumption

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The pump system is designed to operate at the minimum necessary flow rate to establish complete retrograde flow, utilizing the natural pressure gradient created by occluding the artery. Rather than continuously operating at high power, the system self-regulates to match the actual flow requirements, reducing energy consumption while ensuring adequate embolic protection through intelligent pump control algorithms.

Inventive Principle:

Principle #25Self-service

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

Ensures effective embolic protection by maintaining full retrograde flow during procedures, capturing debris and reducing the risk of embolism by directing it away from the brain.

Implementation Method 1

establish and confirm full retrograde flow in the carotid arteries using pressure differentials

Methodology Applied

Scientific EffectPressure differential: Pressure Gradient

Implementation Method 2

active aspiration, ensuring debris is captured in the venous system

Methodology Applied

Scientific EffectActive aspiration: Suction

Data Source

PatentUS20250339150A1Embolic protection devices, systems, and methods for carotid procedures

Publication Date: 2025.11.06 BOSTON SCIENTIFIC SCIMED INC

AI summary

A reverse flow system for performing vasculature procedures may include a catheter and a flow control system. The catheter may extend from a proximal end to a distal end that is adapted to terminate within a common carotid artery (CCA) and include an occlusion balloon, an inflation lumen in communication with the occlusion balloon, and a working lumen terminating at the distal end of the catheter. The flow control device may be in communication with the working lumen and configured to control a flow rate of fluid through the working lumen and to confirm a full reverse flow of fluid in an internal carotid artery in communication with the CCA and an external carotid artery in communication with the CCA based on a measure related to an amount of force required for the flow control device to achieve the flow rate of fluid through the working lumen.