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Publication Number
US-12232760-B2
Publication Date
2025-02-25
Expiration Date
Abstract
An intravascular device can comprise a carrier and an expansion apparatus. The device can be used for intravascular treatment of atherosclerotic plaque. The carrier can be reversibly expandable and collapsible within a vessel and can have ribbon strips extending between opposite ends in a longitudinal direction of the carrier. The ribbon strips can each be formed with a plurality of elongated protrusions thereon. The expansion apparatus can be used to actuate the ribbon strips each with the plurality elongated protrusions to pierce a luminal surface of the plaque with lines or patterns of microperforations which act as serrations for forming cleavage lines or planes in the plaque.
Core Innovation
The invention relates to an intravascular device for preparing an atherosclerotic plaque in a vessel wall. The device includes an inner balloon configured to expand to create a plurality of microperforations in the vessel wall of a vessel, where the inner balloon comprises a plurality of strips extending along an outer surface of the inner balloon. Each strip includes a plurality of microperforators spaced apart along a surface of each strip, and expanding the inner balloon forms cleavage lines or planes in an atherosclerotic plaque while leaving most of the surface of the atherosclerotic plaque intact.
An outer balloon is disposed circumferentially around the inner balloon or disposed over the plurality of strips in the spaces between microperforators, with the inner balloon extending for a length beyond the outer balloon. In these configurations, the microperforators extend through the outer balloon to form cleavage lines or planes, while the microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel. The outer balloon stabilizes and supports the plurality of microperforators as the plurality of microperforators enter the plaque to cause microperforations.
The microperforations leave most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall. The microperforations act as nucleation sites for void formation, and stress energy for compressing the atherosclerotic plaque is released along the microperforations formed in the atherosclerotic plaque to control crack propagation. The invention is directed to forming predictable cleavage lines or planes and managing crack propagation during subsequent balloon angioplasty, emphasizing low-pressure angioplasty to reduce dissection, arterial injury, and the need for stents.
Claims Coverage
The document includes three independent claims, each directed to an intravascular balloon device using an inner balloon with strips of microperforators that form microperforations in an atherosclerotic plaque while leaving most of the plaque surface intact and with microperforators not configured to deliver fluid out of the device. Across the independent claims, the inventive features focus on creating cleavage lines or planes, supporting or stabilizing microperforators with an outer balloon, and using microperforations to control plaque separation, crack propagation, and void formation.
Inner balloon strip microperforations forming cleavage lines or planes while leaving most plaque intact
An inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip including a plurality of microperforators spaced apart along a surface of each strip, each strip extending along an outer surface of the inner balloon, wherein expanding the inner balloon forms cleavage lines or planes in an atherosclerotic plaque of the vessel wall, while leaving most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall.
Outer balloon supporting microperforators with inner length beyond outer and non-fluid microperforators
An outer balloon disposed circumferentially around the inner balloon, wherein the inner balloon extends for a length beyond the outer balloon, wherein the plurality of microperforators extend through the outer balloon to form cleavage lines or planes in an atherosclerotic plaque of the vessel wall, and wherein the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.
Microperforations as nucleation sites for void formation with outer balloon stabilization and non-fluid microperforators
An inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip including a plurality of microperforators spaced apart along a surface of each strip, each strip extending along an outer surface of the inner balloon, wherein the microperforations leave most of the surface of the atherosclerotic plaque intact, leading to less separation of the atherosclerotic plaque from the vessel wall, and wherein the microperforations act as nucleation sites for void formation in an atherosclerotic plaque of the vessel wall, with an outer balloon disposed over the plurality of strips in the spaces between microperforators and configured to stabilize and support the plurality of microperforators as they enter the plaque to cause microperforations, and wherein the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.
Sleeved inner balloon with outer balloon holes aligned to microperforators and released stress energy to control crack propagation
An inner balloon configured to expand to create a plurality of microperforations in a vessel wall of a vessel, the inner balloon comprising a plurality of strips, each strip including a plurality of microperforators spaced apart along a surface of each strip, an outer balloon, wherein the inner balloon is sleeved inside the outer balloon, wherein the inner balloon extends for a length beyond the outer balloon, wherein the outer balloon comprises a plurality of holes aligned with the plurality of microperforators, wherein the plurality of microperforators extend through the plurality of holes to engage atherosclerotic plaque, wherein the plurality of microperforators of the inner balloon form microperforations while leaving most of the surface of the atherosclerotic plaque intact, and wherein stress energy for compressing the atherosclerotic plaque is released along the microperforations formed in the atherosclerotic plaque to control crack propagation, and the plurality of microperforators are not configured to deliver a fluid from within the intravascular device out to the vessel.
Across the independent claims, the inventive subject matter centers on an intravascular inner balloon carrying strips with spaced microperforators that create microperforations forming cleavage lines or planes in an atherosclerotic plaque while leaving most of the plaque surface intact to reduce separation. The claims further require an outer balloon arrangement that stabilizes or guides the microperforators as they enter the plaque, including an outer balloon with aligned holes for a sleeved configuration, and they specify that the microperforators are not configured to deliver fluid out of the device. The independent claims also include functional plaque-fracture outcomes, including nucleation sites for void formation and release of stress energy along microperforations to control crack propagation.
Stated Advantages
Less separation of the atherosclerotic plaque from the vessel wall.
Reduced dissection.
Less arterial injury.
Reduced need for stents.
Documented Applications
Preparing an atherosclerotic plaque in a vessel wall using an intravascular plaque-preparation balloon device to control crack propagation during subsequent balloon angioplasty.
Low-pressure angioplasty after pre-treatment to reduce dissection, arterial injury, and need for stents.
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