Medical balloon catheters with enhanced pushability
Inventors
Giasolli, Robert M. • Schneider, Peter • Johansson, Peter • Burns, Carol
Assignees
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Publication Number
US-11369779-B2
Publication Date
2022-06-28
Expiration Date
Abstract
Systems and methods can involve wedge dissectors attached to strips in turn attached to medical balloons, for forming serrations within vascular wall tissue for angioplasty as well as drug delivery.
Core Innovation
The invention provides a medical balloon catheter for angioplasty and drug delivery that includes an elongate member defining a longitudinal axis and a first expandable balloon connected to the elongate member proximate a distal end. The balloon is supported by a plurality of strips extending longitudinally along an outer surface of the first expandable balloon, where each strip includes a plurality of wedge dissectors spaced apart along a surface of each strip. Each wedge dissector forms a radially outward facing surface and rises above a pre-fabricated cover comprising a polymer walled structure.
To enable effective penetration while limiting tearing, the catheter includes a pre-fabricated cover positioned over the plurality of strips including the plurality of wedge dissectors. The first expandable balloon is bonded to the pre-fabricated cover with a UV curable adhesive directly in contact with the first expandable balloon and the pre-fabricated cover, and the cover is configured to allow the wedge dissectors to penetrate plaque effectively but not tear along the spaces between the wedge dissectors during expansion of the first expandable balloon.
The disclosure further refines the wedge dissector surface characteristics and orientation for the radially outward facing surface, including configurations in which a surface width profile is wider at lateral edges and narrower toward a center. It also includes configurations where the orientation of a narrowest portion of the radially-facing surface aligns with the longitudinal axis of the strip, together with relationships in which the cover is more stretchable or pliable and has length and diameter greater than the length and diameter of the first expandable balloon.
Claims Coverage
The consolidated claim coverage includes four independent inventive features. The claims center on a medical balloon catheter architecture combining a first expandable balloon carrying strips of spaced wedge dissectors with a polymer walled, pre-fabricated cover bonded via UV curable adhesive, where the cover permits plaque penetration by wedge dissectors while preventing tearing in spaces between wedge dissectors during expansion.
Wedge dissector strips on an expandable balloon
A plurality of strips extending longitudinally along an outer surface of the first expandable balloon, each strip including a plurality of wedge dissectors spaced apart along a surface of each strip, wherein each wedge dissector forms a radially outward facing surface and rises above the polymer walled structure.
Polymer walled pre-fabricated cover bonded by UV curable adhesive
A pre-fabricated cover comprising a polymer walled structure, positioned over the plurality of strips including the plurality of wedge dissectors, where the first expandable balloon is bonded to the pre-fabricated cover with a UV curable adhesive directly in contact with the first expandable balloon and the pre-fabricated cover.
Penetration without tearing along spaces between wedge dissectors
The pre-fabricated cover is configured to allow the plurality of wedge dissectors to penetrate plaque effectively but not tear along the spaces between the wedge dissectors during expansion of the first expandable balloon.
Wedge dissector radially outward facing width profile and orientation
Configurations of the radially outward facing surface including a surface that is wider at lateral edges and narrower toward a center, and configurations in which the orientation of a narrowest portion of the radially-facing surface aligns with the longitudinal axis of the strip.
Relative stretchability and size relationship between cover and balloon
Configurations in which the pre-fabricated cover is more stretchable or pliable than the first expandable balloon, and configurations where the cover’s length and diameter are greater than the length and diameter of the first expandable balloon.
Inflation relationship between balloon strips and pre-fabricated cover
Configurations where the first expandable balloon is made of a plurality of strips and is configured to be inflated inside a pre-fabricated cover.
Overall, the claims center on enabling plaque penetration by radially outward facing wedge dissectors carried on balloon strips while preventing tearing between wedge dissectors during balloon expansion, achieved through a UV-curable adhesive-bonded polymer walled pre-fabricated cover, with additional constraints on wedge dissector surface width and orientation and on relative cover and balloon pliability and dimensions.
Stated Advantages
Allows the plurality of wedge dissectors to penetrate plaque effectively.
Prevents tearing along the spaces between the wedge dissectors during expansion of the first expandable balloon.
Reduces trauma from large-bore sheath expansion.
Documented Applications
Angioplasty and drug delivery using a medical balloon catheter with a first expandable balloon and wedge dissector-based plaque penetration.
TAVR access vessel preparation using serratoplasty.
EVAR access vessel preparation using serratoplasty.
FEVAR access vessel preparation using serratoplasty.
TEVAR access vessel preparation using serratoplasty.
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