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Publication Number
US-11529501-B2
Publication Date
2022-12-20
Expiration Date
Abstract
A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.
Core Innovation
The invention relates to an intravascular plaque perforation and serration approach in which an atherosclerotic plaque is prepared prior to balloon angioplasty by forming tiny prick points. The approach uses an intravascular balloon configured to deploy within a vessel and carry a plurality of spikes on an outer surface. During balloon expansion, the spikes form shallow microperforations and/or tiny holes at specific prick points while leaving most of the atherosclerotic plaque surface undisrupted and adhered to a wall of the vessel.
The spikes are arranged along the outer surface of the balloon at spaced intervals and are configured so that their shallow depth of penetration is not deep enough to cut through the thickness of the atherosclerotic plaque to deeper layers of the artery. The spikes are configured to change the topography of a top layer of the atherosclerotic plaque without exposing deeper layers of the artery, thereby producing more reliable serrations by leaving most of a plaque surface intact. The tiny prick points taken together as a line or pattern of perforations result in the serrations.
The document further describes preparing the atherosclerotic plaque by expanding the plurality of spikes to a lesser diameter than the original diameter of the vessel, so the spike expansion is configured to prepare the plaque and not to perform simultaneous angioplasty to enlarge the vessel. After the spikes prepare the plaque by forming microperforations, the vessel is subsequently enlarged to a size consistent with the original diameter. The approach is contrasted with routinely created crevices by cutting devices and with high-pressure angioplasty, and it is discussed in relation to integration with drug delivery concepts including DEB/DCB medication uptake and potential reduction of need for stents.
Claims Coverage
The document includes three independent claims centered on a balloon-mounted plurality of spikes that prepare an atherosclerotic plaque by forming shallow microperforations and tiny prick points while leaving most of the plaque surface intact and adhered. The inventive features are further specified by spike arrangement, stabilization and pushing behavior, penetration and height constraints, and a two-stage sizing concept before subsequent vessel enlargement.
Balloon-actuated shallow prick points leaving plaque surface adhered
An intravascular device comprising a balloon deployed within a vessel and a plurality of spikes arranged along an outer surface of the balloon, wherein the plurality of spikes are actuated by expansion of the balloon to form tiny prick points in atherosclerotic plaque with a shallow depth of penetration while leaving most of a surface of the atherosclerotic plaque undisrupted and adhered to a wall of the vessel, wherein the tiny prick points are formed in contrast with breaking down the atherosclerotic plaque by forming crevices as routinely is created with cutting devices, and wherein the plurality of spikes are located at spaced intervals.
Spike preparation with stabilized spikes and subsequent vessel enlargement
An intravascular device comprising a balloon configured to be deployed within a vessel and a plurality of spikes arranged along an outer surface of the balloon, wherein the balloon is configured to stabilize the plurality of spikes within the vessel and assist in pushing the plurality of spikes toward a wall of the vessel occluded by atherosclerotic plaque, wherein the plurality of spikes are configured to prepare the atherosclerotic plaque by forming microperforations with a shallow depth of penetration while leaving most of a surface of the atherosclerotic plaque fully adherent to the wall of the vessel, wherein the plurality of spikes are configured to have the shallow depth of penetration since the expansion of the plurality of spikes is configured not to perform simultaneous angioplasty to enlarge the vessel to a size consistent with an original diameter of the vessel prior to developing the atherosclerotic plaque and instead is configured to prepare the atherosclerotic plaque, and wherein after the plurality of spikes prepare the atherosclerotic plaque by forming microperforations, the vessel is subsequently enlarged to a size consistent with the original diameter.
Top-layer microperforations forming reliable serrations without exposing deeper layers
An intravascular device comprising a balloon configured to be deployed within a vessel and a plurality of spikes arranged along an outer surface of the balloon, wherein the plurality of spikes are configured to form tiny holes at specific prick points across an atherosclerotic plaque, wherein a height of the plurality of spikes is between 0.05 mm and 1.0 mm, wherein the height is not deep enough to cut through the thickness of the atherosclerotic plaque to deeper layers of the artery, wherein the plurality of spikes is configured to change the topography of a top layer of the atherosclerotic plaque without exposing the deeper layers of the artery, wherein the prick points taken together as a line or pattern of perforations result in more reliable serrations while leaving most of a surface of the atherosclerotic plaque intact.
Across the independent claims, the core claim coverage is directed to balloon-based spikes that create shallow plaque perforation and tiny prick points at spaced intervals or in defined patterns, while keeping most of the plaque surface intact and adhered. The claims further define spike behavior to avoid simultaneous angioplasty during spike expansion and to avoid cutting through to deeper arterial layers, and they include a subsequent enlargement step after microperforation-based plaque preparation.
Stated Advantages
More reliable serrations while leaving most of atherosclerotic plaque intact.
Shallow penetration creates tiny prick points and microperforations while leaving most of the plaque surface undisrupted and adhered to the vessel wall.
Avoids breaking down the atherosclerotic plaque by forming crevices as routinely created with cutting devices.
Spike height is not deep enough to cut through the thickness of the atherosclerotic plaque to deeper layers of the artery, changing topography of the top layer without exposing deeper layers.
Preparation is performed without simultaneous angioplasty to enlarge the vessel to the original diameter during spike expansion; the vessel is subsequently enlarged after plaque preparation.
Documented Applications
Preparing an atherosclerotic plaque prior to balloon angioplasty by forming microperforations and tiny prick points.
Integration with drug delivery concepts including DEB/DCB medication uptake and reduction of need for stents.
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