Helical Tip Catheter for Emboli Removal
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Solution Overview
Problem
Current medical procedures for removing occlusions from blood vessels are limited by the risk of embolism, inefficient removal of occlusions, and the challenge of accessing small and varying-sized vessels, with a need for a system that can effectively contain and remove emboli without excessive removal of native blood and tissue.
Innovation Solution
A laser cutting and aspiration atherectomy system comprising a catheter with a ring of cutting fibers and an inner lumen for material removal, which uses pulsed aspiration and an in-line filter for efficient emboli removal, along with mechanical cutting features and deflection components to create pilot channels and larger lumens, allowing for precise extraction of occlusive material.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If constant flow suction or vacuum pressure is used to remove occlusions, then occlusion removal is effective, but excessive amounts of native blood and tissue are removed
Solution Approach 1:
The catheter tip is segmented into distinct functional zones: a cutting element array for precise occlusion fragmentation, an aspiration lumen for debris removal, and an outer surface for selective engagement. This segmentation allows the cutting elements to fragment occlusions into small particles that can be efficiently aspirated without requiring high vacuum pressure that would remove excessive blood and tissue.
Solution Approach 2:
The cutting elements are positioned only at the distal tip of the catheter, creating a localized cutting zone. This local concentration of cutting function allows precise engagement with occlusions while leaving the proximal portions of the vessel untouched, enabling effective occlusion removal with minimal impact on native blood and tissue elsewhere in the vessel.
2Reliability
If surgical procedures like carotid endarterectomy are performed to remove blockages, then embolism risk is reduced, but substantial surgical risks and complexity are introduced
Solution Approach 1:
The catheter extracts occlusive material from the vessel lumen through aspiration after mechanical cutting. By removing the occlusion in situ through the catheter, the procedure avoids the need for surgical extraction methods like carotid endarterectomy, thereby reducing embolism risk while maintaining procedural simplicity.
Solution Approach 2:
The mechanical cutting elements at the catheter tip replace the need for surgical mechanical intervention. The cutting elements mechanically fragment occlusions, and the aspiration system removes debris, substituting a minimally invasive mechanical system for complex surgical procedures.
3Productivity
If atherectomy and stent deployment are performed to treat blocked vessels, then blood flow is restored, but embolism risk from dislodged blocking material increases
Solution Approach 1:
The cutting elements convert the harmful occlusive material into small fragmented particles through mechanical cutting. These fragmented particles are then beneficially aspirated through the catheter, converting the potential harm of dislodged material into a controlled removal process that prevents embolism while restoring blood flow.
Solution Approach 2:
The aspiration lumen acts as an intermediary between the cutting elements and the vessel lumen. It captures and removes cut occlusive particles before they can dislodge and cause embolism, serving as a mediator that prevents harmful material from entering the circulation while allowing blood flow restoration.
4Reliability
If complete vessel occlusion is maintained during emboli removal procedure, then emboli containment is effective, but procedure time increases and blood perfusion to end organs is stopped
Solution Approach 1:
The catheter enables periodic aspiration of emboli during the procedure. By periodically removing emboli as they are generated, the system maintains effective containment without requiring continuous complete occlusion, thereby reducing procedure time and minimizing interruption of blood perfusion to end organs.
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 enables faster creation of smoother lumens with minimal native tissue ablation, effective removal of emboli, and improved access to small vessels, reducing the risk of embolism and excess blood/tissue removal, while accommodating varying emboli sizes and hard materials like calcium.
Implementation Method 1
A rotating helical tip cuts and fragments the occlusion
Implementation Method 2
A vacuum for suctioning debris generated during the cutting process is provided
Data Source
AI summary
Catheter devices for ablation and removal of occlusions from blood vessels and methods of using the same are provided. Catheter devices are useful to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. Distal features of the catheter devices comprise arrangements of laser ablative or mechanical cutting features that generally provide enhanced surface areas and cutting functions. Spiral or helical arrangements are provided to aid in cutting operations.