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Publication Number
US-10779971-B2
Publication Date
2020-09-22
Expiration Date
Abstract
A plaque tack can be used for holding plaque against blood vessel walls such as in treating atherosclerotic occlusive disease. The plaque tack can be formed as a thin, annular band for holding loose plaque under a spring or other expansion force against a blood vessel wall. Focal elevating elements and/or other features, such as anchors, can be used to exert a holding force on a plaque position while minimizing the amount of material surface area in contact with the plaque or blood vessel wall and reducing the potential of friction with the endoluminal surface. This approach offers clinicians the ability to perform a minimally invasive post-angioplasty treatment and produce a stent-like result without using a stent.
Core Innovation
An endovascular plaque tack is used for post-balloon-angioplasty treatment of atherosclerotic plaque dissection in a vessel lumen. The plaque tack is a thin annular band or ring, optionally in a mesh construction, that holds loose plaque against vessel walls by radially outward expansion force. The tack is configured to reduce metal and footprint coverage so it avoids stent-like scaffolding drawbacks while still providing tack retention.
The plaque tack includes plaque anchors and optionally focal elevating elements, including anchors and elevating projections that support and elevate portions of the tack relative to the vessel wall. The focal elevating elements lift portions off the vessel wall to minimize friction or micro-rubbing and reduce inflammation and restenosis risk. Anchor features can be disposed centrally or tangentially and can include structures that act as plaque anchors and elevating projections.
The tack geometry is defined by circumferential members, proximal and distal rings, and bridge members, with struts having controlled strut angles and configurations. The design includes open-cell versus closed-cell constructions, and multiple strut features such as variable and tapered struts and dual-amplitude struts for compressibility. Radiopaque markers can be provided as flat midline markers, and the device can be delivered with a catheter having an outer sheath and an actuator, where sheath retraction uncovers the tack(s).
Multiple tacks can be positioned spaced apart along a lesion with regions free of metal support so the treated vessel can bend more naturally. The patent characterizes expansion-force performance with low-slope force curves and low expansion-force, including an expansion force configured to change less than 1 N over a specified outer diameter expansion range. Additional sizing constraints include an axial length L and expanded diameter, using axial length to expanded diameter ratio constraints, axial length no more than 15 mm, and expanded diameter between 1 mm and 10 mm.
Claims Coverage
The independent claims cover three related aspects: a catheter delivery system carrying multiple independent self-expanding tubular bodies with actuator-driven sheath retraction, a catheter delivery system with defined structural and performance constraints for the self-expanding tubular bodies, and a method of treating a superficial or popliteal artery by deploying the independent self-expanding tubular bodies with regions free of metallic support. Across the independent claims, at least five spaced tubular bodies are used, and multiple inventive features are specified for geometry, radiopaque marker placement, and low expansion-force behavior.
Spaced independent self-expanding tubular bodies on a retractable-sheath catheter
A catheter shaft and a catheter sheath carry a plurality of independent self-expanding tubular bodies located on the catheter shaft and spaced apart by fixed catheter shaft protrusions, where movement of a proximal handle actuator retracts the catheter sheath and uncovers the plurality of independent self-expanding tubular bodies, and adjacent self-expanding tubular bodies are spaced apart on the catheter shaft by at least about 4 mm, the plurality comprises at least five self-expanding tubular bodies.
Low-slope expansion-force curve with radiopaque marker in an eyelet
Each independent self-expanding tubular body comprises a plurality of struts, a radiopaque marker in an eyelet, and an expansion force curve that changes less than 1 N over a 2.5 mm outer diameter expansion range.
Expansion force less than 1 N at about 5.0 mm bore with axial-length-to-expanded-diameter ratio no more than about 2
Each independent self-expanding tubular body comprises a plurality of struts, a radiopaque marker, and an expansion force configured to be less than 1 N if deployed in a lumen having a bore of about 5.0 mm, and each independent self-expanding tubular body has a ratio of an axial length to an expanded diameter that is no more than about 2.
Sloped orientation and dimensional limits for each independent self-expanding tubular body
At least a portion of each independent self-expanding tubular body has a sloped orientation relative to a longitudinal axis of the tubular body, where the axial length of each independent self-expanding tubular body is no more than 15 mm and the expanded diameter of each independent self-expanding tubular body is between 1 mm and 10 mm.
Device deployment at separated locations with regions free of metallic support to enable natural bending
A method of treating a superficial or popliteal artery comprises inserting a catheter system into at least one of a superficial artery or a popliteal artery, where the catheter system comprises a plurality of independent self-expanding tubular bodies with a radiopaque marker and a ratio of axial length to expanded diameter no more than about 2, and deploying multiple independent self-expanding tubular bodies from the catheter at locations separated by regions free of metallic support such that the artery able to bend more naturally, wherein the locations separated by regions free of metallic support are separated by a minimum spacing distance along the artery.
Overall, the independent claims emphasize a catheter delivery system that supports multiple independent self-expanding tubular bodies spaced apart on a catheter shaft and uncovered by actuator-driven sheath retraction, combined with tubular body constraints including radiopaque marker placement, low expansion-force behavior, an axial-length-to-expanded-diameter ratio no more than about 2, and at least portions with a sloped orientation. The method claim further requires deployment of the tubular bodies at separated locations with regions free of metallic support to allow more natural bending of a superficial or popliteal artery.
Stated Advantages
Holds loose plaque against vessel walls using radially outward expansion force with reduced metal and footprint coverage.
Minimizes friction or micro-rubbing and reduces inflammation and restenosis risk by lifting portions off the vessel wall.
Avoids stent-like scaffolding drawbacks by reducing metal coverage.
Allows the treated superficial or popliteal artery to bend more naturally by deploying multiple independent self-expanding tubular bodies at locations separated by regions free of metallic support.
Documented Applications
Post-balloon-angioplasty treatment of atherosclerotic plaque dissection in a vessel lumen using an endovascular plaque tack.
Treating a patient’s superficial artery or popliteal artery by inserting a catheter system and deploying multiple independent self-expanding tubular bodies at locations separated by regions free of metallic support.
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