Methods and apparatus for plaque disruption
Inventors
Sirhan, Motasim • Serna, Benjamyn • Treadwell, Bozena • Yan, John
Assignees
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Publication Number
US-12678180-B2
Publication Date
2026-07-14
Expiration Date
Abstract
Balloon catheters, sleeves, cages, and endoluminal prostheses are provided with stress-applying and spacing features coupled to expandable surfaces thereof. The stress-applying features may have blunt and/or rounded contact regions which contact tissue or calcified regions in the vasculature. The contact regions dent or fracture occlusive material on the wall of a vascular lumen and/or patient valve leaflets when expanded. The spacing features permit blood, drug, and contrast perfusion past structures expanded in the vasculature, particularly balloon catheters.
Core Innovation
The apparatus treats calcification on a wall in a patient's body lumen using a catheter with an expandable polymeric balloon disposed at its distal segment. A plurality of plaque-disrupting features is distributed over the balloon's outer surface, which is configured to displace radially outward toward the lumen wall. At least some features are discrete bodies directly bonded to the balloon's outer surface, with upper surfaces configured to fracture calcification while reducing damage to the body lumen upon balloon expansion.
At least some discrete bodies comprise shapes including a ball, sphere, partial sphere, hemisphere, ellipsoidal solid, or dome, with each body having a bottom-most surface directly bonded to the balloon's outer surface. Additional configurations depict alternative feature geometries, distributions, cross-sectional arrangements, attachment and encapsulation-layer coverage, and paired balloons with features concentrated between them. The background section is not included, so a separate background problem statement is not explicitly described in patent.
Claims Coverage
The claims identify one independent claim comprising three inventive features covering a catheter apparatus with an expandable polymeric balloon and directly bonded, discrete plaque-disrupting bodies.
Catheter with an expandable polymeric balloon
A catheter body has a proximal end and a distal segment, with an expandable polymeric balloon disposed at the distal segment, wherein the balloon's outer surface is configured to be displaced radially outward toward the inner surface of the wall in a patient's body lumen.
Plaque-disrupting features distributed over the balloon
A plurality of plaque-disrupting features is distributed over the balloon's outer surface, wherein at least some features have an upper surface configured to fracture calcification while reducing damage to the patient's body lumen when the balloon is expanded within the lumen.
Directly bonded discrete rounded bodies
At least some plaque-disrupting features comprise discrete bodies in the form of any one or any combination of a ball, sphere, partial sphere, hemisphere, ellipsoidal solid, or dome, where the bottom-most surface of each body is directly bonded to the balloon's outer surface.
The independent claim covers all elements of the claim relating to the catheter and expandable polymeric balloon bearing directly bonded, discrete plaque-disrupting bodies configured to fracture calcification while reducing damage to the patient's body lumen.
Stated Advantages
The plaque-disrupting features are configured to fracture calcification while reducing damage to the patient's body lumen when the balloon is expanded.
Feature spacing and through-holes can preserve fluid or contrast flow during balloon expansion.
Documented Applications
Treatment of calcification on a wall in a patient's body lumen using a catheter with an expandable polymeric balloon bearing plaque-disrupting features.
Drug-delivery balloons.
Valvuloplasty using opposed or segmented balloons that capture calcified valve leaflets.
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