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Publication Number
US-11738181-B2
Publication Date
2023-08-29
Expiration Date
Abstract
A cage can be positioned around a medical balloon, such as an angioplasty balloon, to assist in a medical procedure. The cage can include a plurality of strips, each extending between a set of rings including first and second rings. As the balloon expands, the first and second rings move closer together and allow the strips to expand outward. The cage may have wedge dissectors on the strips.
Core Innovation
The invention relates to a balloon catheter with a cage for medical balloon, in which an angioplasty balloon includes an elongate member with an inner lumen defining a longitudinal axis and a balloon connected to the elongate member at a distal end. The medical balloon carries at least one strip, the strip including a plurality of wedge dissectors spaced apart along a surface by open spaces between adjacent wedge dissectors such that a height of adjacent wedge dissectors is greater than the height of the open spaces.
The balloon, the at least one strip, and at least one ring are configured to have an initial state and an expanded state. The cage structure includes first and second rings and multiple longitudinal strips that expand outward as the balloon inflates by moving the rings closer together, and the rings secure the strips at ends and/or intermediate points while allowing a pre-expansion and expanded state.
The rings include a central aperture receiving the balloon and holes extending through the ring that are linearly arranged, where each hole accommodates a corresponding tip of a wedge dissector, and circumferential ring portions overlie corresponding open spaces to permit wedge dissector features to protrude through ring material. The disclosure further describes strip layout and deliverability options, including segmented, helical, and row configurations, and an optional spring zone on the strips to improve flexibility, orientation, and refolding assistance.
Claims Coverage
The independent claim coverage is based on a single independent claim that defines a balloon catheter having an elongate member, a distal balloon, at least one strip carrying spaced wedge dissectors with open spaces, and at least one ring that secures the strip while enabling an initial and expanded state, with ring apertures and hole arrangements configured to accommodate wedge dissector tips and overlie open spaces. Dependent claims further refine the ring material, strip and wedge geometry constraints, and interaction with plaque/perforation, plus specific strip layout configurations and quantitative limitations.
Balloon catheter with initial and expanded states
The balloon, the at least one strip, and the at least one ring are configured to have an initial state and an expanded state.
Spaced wedge dissectors defined by open spaces height relationship
At least one strip comprising a plurality of wedge dissectors spaced apart along a surface by open spaces between adjacent wedge dissectors such that a height of adjacent wedge dissectors is greater than a height of the open spaces in between adjacent wedge dissectors.
Ring with central aperture and linearly arranged holes for wedge tips
When assembled, the at least one ring comprises a central aperture that receives the balloon, and the at least one ring comprises a plurality of holes extending through the at least one ring that are linearly arranged and separated by a circumferential portion, where each hole accommodates a corresponding tip of a wedge dissector therethrough and the circumferential portion overlies a corresponding open space between adjacent wedge dissectors.
Ring material using heat-shrink material
The at least one ring is made from a heat-shrink material.
Open-space to adjacent wedge dissector length ratio constraint
An open-space length ratio between adjacent wedge dissectors is from 4:1 to 3:1.
Ring pierced wedge dissectors for perforating plaque
The wedge dissectors are configured to protrude through at least one ring to perforate plaque.
Helical longitudinal strip layout
At least one strip runs longitudinally across the balloon in a helical pattern.
Serial rows with multiple strips per row around balloon
At least one strip includes a plurality of serial rows around the balloon, with 2 to 6 strips per row.
Across the claim coverage, the core structure is a balloon/strip/ring assembly that provides an initial and expanded state, where spaced wedge dissectors are defined relative to open spaces and are structurally supported by a ring having a central aperture and linearly arranged holes that accommodate wedge tips while circumferential ring portions overlie open spaces. Dependent claims further specify heat-shrink ring material, an open-space length ratio constraint, wedge dissector protrusion through the ring to perforate plaque, and defined strip layout configurations including helical patterns and serial rows with specified strip counts.
Stated Advantages
Provides radial protection of a drug-coated surface during pre-expansion by radially covering the drug-coated surface.
Reduces “dog boning” by varying expansion resistance with least resistance at the cage center.
Enables improved controlled expansion/deflation profile.
Improves strip flatness and/or orientation during operation.
Enables wedge dissector and/or spike features to protrude through ring material to cut and/or perforate plaque.
Provides options for manufacturing and assembly of the cage, including described extruded tube and strip/ring assembly approaches.
Documented Applications
Angioplasty balloon use as part of a balloon catheter in which wedge dissectors and/or spikes cut and/or perforate plaque.
Drug-coated balloon delivery where the cage provides protection of drug coatings during delivery in a pre-expansion state.
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