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Publication Number
US-11504153-B1
Publication Date
2022-11-22
Expiration Date
Abstract
An improved plaque extractor for shaving, scooping, cutting, and emulsifying accumulated plaque from blood vessels into fine particles, and removing the particles from blood vessel walls without cutting or permanently stretching the walls, and without substantially blocking the blood flow through the vessel during plaque removal operation. The plaque extractor includes an extractor guide and an internal auger, in which both are rotating and moving axially inside the vessel to engage the occlusive material. The operation of the device does not substantially disrupt blood pressure within the blood vessel.
Core Innovation
A catheter-based device removes occlusive material from a vessel using a plaque extractor guide and a cutting auger. The device includes a catheter with a hollow elongated lumen, a proximal opening, and a distal opening, and a plaque extractor guide on the distal opening with a substantially cylindrical shape. The plaque extractor guide comprises a first channel traversing substantially one half of the cylindrical shape, the first channel being substantially crescent shaped, and a second channel traversing substantially the other half, the second channel being substantially circular.
The distal end of the second channel includes a slot and a scoop, where the scoop comprises a smooth, curved surface extending outward and a distal blunt edge, and the slot comprises a smooth, curved surface extending inward. A substantially cylindrical cutting auger having helical shaped edges is contained within the second channel, with at least two occlusive material cutting edges on the distal end extending outwardly from the distal opening of the second channel. During plaque extraction, the plaque extractor guide and the cutting auger are configured to independently rotate in opposite directions and move axially inside the vessel to engage the occlusive material.
The plaque extractor guide and the cutting auger rotate such that the plaque extractor guide rotates around its center axis while the cutting auger and catheter rotate in an eccentric rotation and move axially in an eccentric path. The slot and scoop shave and scoop occlusive material located outside the eccentric path into the occlusive material cutting edges for emulsification, such that the movement of the slot and scoop does not pierce or cut the vessel wall.
Occlusive material within the eccentric path is emulsified into reduced particles by the occlusive material cutting edges, and the mixture of emulsified occlusive material and blood flows proximally into the catheter lumen while remainder blood continues to flow distally through the crescent shaped first channel.
Claims Coverage
The document provides one independent claim (clm-00001). The inventive features focus on the catheter and plaque extractor guide geometry, a contained helical cutting auger with outward cutting edges, and coordinated independent opposite-direction rotation with eccentric axial motion to emulsify occlusive material without piercing or cutting vessel walls, while maintaining distal blood flow through the crescent first channel.
Catheter with hollow lumen and distal plaque extractor guide
A catheter with a hollow elongated lumen, a proximal opening, and a distal opening, and a plaque extractor guide on the distal opening having a substantially cylindrical exterior surface.
Crescent first channel and circular second channel in the plaque extractor guide
The plaque extractor guide comprises a first channel traversing substantially one half of the cylindrical shape with a proximal opening and a distal opening, the first channel being substantially crescent shaped, and a second channel traversing substantially the other half with proximal and distal openings, the second channel being substantially circular and aligned such that the proximal end of the second channel is substantially aligned with the distal opening of the catheter.
Slot and scoop at the distal end of the second channel
The distal end of the second channel comprises a slot and a scoop, where the scoop has a smooth curved surface extending outward and a distal blunt edge, and the slot has a smooth curved surface extending inward.
Contained helical cutting auger with outward cutting edges
A substantially cylindrical cutting auger comprising helical shaped edges is contained within the second channel, with a proximal end aligned with the distal opening of the catheter, where the helical shaped edges are sharp and there are at least two occlusive material cutting edges on the distal end extending outwardly from the distal opening of the second channel of the plaque extractor guide.
Independent opposite-direction rotation and eccentric axial path
The plaque extractor guide and the cutting auger are configured to each independently rotate in opposite directions during plaque extraction and move axially inside the vessel to engage the occlusive material; additionally, the plaque extractor guide rotates around its center axis while the cutting auger and catheter rotate in an eccentric rotation and move axially in an eccentric path within the vessel.
Shaving and scooping outside the eccentric path for emulsification
The slot and the scoop shave and scoop occlusive material located outside the eccentric path into the occlusive material cutting edges of the cutting auger for emulsification into reduced particles such that movement of the slot and the scoop does not pierce or cut the vessel wall.
Emulsification within the eccentric path and distal blood flow through the crescent channel
Occlusive material located within the eccentric path is emulsified into reduced particles by the occlusive material cutting edges; the mixture of emulsified occlusive material and blood flows proximally into the catheter lumen through the cutting auger while the remainder of blood flowing distally through the substantially crescent shaped first channel continues to flow downstream.
No contact between cutting auger and vessel wall
The cutting auger is configured to not contact the vessel wall.
Across the independent claim, the core inventive combination is a catheter-mounted plaque extractor guide with a crescent first channel and a circular second channel that includes a slot and scoop, together with a contained helical cutting auger that performs emulsification using eccentric rotation and independent opposite-direction rotation. The design specifies that shaving and scooping outside the eccentric path does not pierce or cut the vessel wall, that the cutting auger does not contact the vessel wall, and that distal blood continues to flow through the crescent shaped first channel while emulsified material enters the catheter lumen proximally.
Stated Advantages
Does not pierce or cut the vessel wall during plaque extraction, and the cutting auger is configured to not contact the vessel wall.
Removes occlusive material by emulsifying it into reduced particles while maintaining blood flow through the substantially crescent shaped first channel.
Minimizes friction against the sheath, catheter and vessel walls by rotating the plaque extractor guide and cutting auger in the same direction during navigation while being delivered to the occlusive material site.
Reduces increases in internal blood pressure during insertion and operation by enabling distal remaining blood flow through the first channel.
Documented Applications
Removal of occlusive material from a vessel for plaque extraction/emulsification, including insertion, operation, and navigation to an occlusive material site.
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