Stents having protruding drug-delivery features and associated systems and methods
Inventors
Fulkerson, John • Rizk, Isa • Mustapha, Jihad Ali • Jimenez, Jr., Teodoro S.
Assignees
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Publication Number
US-11253379-B2
Publication Date
2022-02-22
Expiration Date
Abstract
Expandable elements having drug-delivery features and associated systems and methods are disclosed herein. In one embodiment, a drug-eluting stent includes a radially expandable cylindrical frame having a plurality of struts. The frame is transformable between a low-profile delivery state and an expanded deployed state. A plurality of drug-delivery features are carried by one of the struts and configured to deliver a drug to a treatment site within the patient or piercing through the tissue wall to break the constricting of the vessel wall inwardly. When the frame is in the expanded state within a body lumen of the patient, the drug-delivery features extend radially outwardly away from the strut and are configured to engage and, in some arrangements, pass through a wall of the body lumen.
Core Innovation
The invention is a drug-eluting intravascular expandable stent or scaffold for treating a patient, including an attachment member and a frame formed by struts. The frame is radially expandable from a low-profile delivery state to an expanded deployed state within a body lumen, and in the expanded state the frame forms an inner lumen that provides a fluid pathway along a longitudinal axis. The stent diameter decreases along a length such that the frame is collapsible from the deployed state to the delivery state for retraction within a catheter and withdrawal from the body lumen.
The stent includes multiple protruding features extending from the frame, where each protruding feature has a proximal portion extending from corresponding intersections in a direction longitudinally away from the attachment member and parallel to the longitudinal axis, and a terminal end portion extending radially away from the frame to engage tissue of the body lumen while the frame is in the expanded deployed state. The terminal end portion is entirely distal to the proximal portion, and each protruding feature forms a curved shape between the proximal portion and the terminal end portion.
The protruding features are integrally formed drug-delivery features that extend radially outward in the expanded state to engage the vessel wall, including embodiments that penetrate vessel wall layers such as neointima, internal elastic lamina, media, and external elastic lamina. Drug-eluting compositions are described as being coated on the drug-delivery features or the features themselves being drug-eluting, with optional embodiments including multiple drugs and optional drug-releasing reservoirs.
Claims Coverage
The independent claim coverage centers on 2 inventive features: a radially expandable strut frame that forms an inner lumen and fluid pathway and is collapsible for catheter withdrawal, and multiple curved protruding features extending from strut intersections with a defined longitudinally oriented proximal portion and radially oriented terminal end portion that is entirely distal to the proximal portion to engage body-lumen tissue in the expanded deployed state.
Radially expandable strut frame with inner lumen fluid pathway and collapsible delivery/retraction geometry
A frame formed by struts and being radially expandable from a low-profile delivery state to an expanded deployed state at a treatment site within a body lumen, wherein pairs of the struts are joined together to form intersections, wherein the frame in the expanded deployed state forms an inner lumen extending between a proximal end and a distal end of the frame and providing a fluid pathway along a longitudinal axis of the frame, and wherein the frame is collapsible from the deployed state to the delivery state to be retracted within a catheter and withdrawn from the body lumen of the patient.
Multiple curved protruding features with proximal and terminal tissue-engagement portions
Multiple protruding features extending from the frame, wherein each protruding feature includes a proximal portion that extends from a corresponding intersection in a direction longitudinally away from the attachment member and parallel to the longitudinal axis of the frame and a terminal end portion extending radially away from the frame to engage tissue of the body lumen while the frame is in the expanded deployed state, the terminal end portion being entirely distal to the proximal portion, each protruding feature forming a curved shape between the proximal portion and the terminal end portion.
Overall, the independent claim coverage combines a collapsible radially expandable strut frame that forms an inner lumen and fluid pathway with multiple curved protruding features having defined longitudinal and radial portions for tissue engagement in the expanded deployed state.
Stated Advantages
Enables deeper or more uniform drug delivery by extending radially outward features to engage the vessel wall, including embodiments penetrating vessel wall layers.
Reduces ineffective wall contact seen with conventional drug-eluting stents or drug-eluting balloons.
Preserves blood flow and increases lumen-wall contact area.
Documented Applications
Treating a patient with an intravascular expandable stent deployed within a body lumen, including embodiments directed to drug delivery to tissue of the body lumen.
Drug delivery to vessel wall tissue, including neointima, internal elastic lamina, media, and external elastic lamina, using radially outward protruding drug-delivery features.
Histology evaluation in human cadaver vessels demonstrating feature-to-tissue engagement without perforation.
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