Endoscopically guided ablation catheters with thermally resistant balloons

Inventors

Melsky, GeraldBaxter, LincolnColon, Omar

Assignees

Cardiofocus Inc

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Publication Number

US-12336757-B2

Patent

Publication Date

2025-06-24

Expiration Date


Abstract

An ablation catheter that includes a shaft having a distal end and a balloon coupled to the shaft. The balloon has an inner surface and an opposite outer surface. The inner surface has a proximal region including a proximal balloon end, a main center region, and a distal region including a distal balloon end. The ablation catheter also includes an energy emitter disposed inside the balloon and being configured to move both axially and rotationally within the inside of the balloon. The ablation catheter includes a thermally resistant coating disposed along the inner surface of the balloon within at least the main center region of the inner surface of the balloon. The thermally resistant coating is formed of a material selected from a group consisting of: silicone rubber, polyisoprene, polyurethane.

Core Innovation

The disclosed invention relates to an endoscopically guided laser ablation catheter for treating atrial fibrillation, including pulmonary vein isolation. The catheter includes a balloon having an inner surface that includes a proximal balloon end, a main center region, and a distal balloon end, and an energy emitter inside the balloon that moves axially and rotationally to emit energy through an area of the balloon.

To increase thermal resistivity of the balloon, a thermally resistant coating is provided on the inner surface within at least the main center region. The coating is made from silicone rubber, polyisoprene, or polyurethane, including thermally resistant solid polymer coating configurations, and is positioned to protect the thermoplastic polyurethane balloon from high-temperature heating, including localized high temperatures near the laser energy.

A method is also described for forming the thermally resistant solid polymer coating by positioning the balloon such that the balloon itself acts as a mold. A mixture of prepolymer, crosslinking catalyst, and optionally a volatile solvent for viscosity adjustment is introduced into the inside of the balloon, the balloon is rotated or oscillated about two or more axes simultaneously to distribute the mixture, and the mixture is cured into a solid polymer coating that covers at least one section of the inner surface and is more resistant to higher temperatures compared to a material that forms the balloon.

Claims Coverage

The partial content provides one independent claim, with dependent claims adding refinements. The independent claim covers one inventive approach for increasing thermal resistivity of a balloon inner surface by using the balloon as a mold, distributing a prepolymer/crosslinker mixture via multi-axis rotation or oscillation, and curing it into a thermally resistant solid polymer coating.

Balloon as a mold for inner-surface coating

Positioning the balloon such that the balloon itself acts as a mold, and introducing a mixture into the inside of the balloon to form a coating on the inner surface.

Multi-axis rotating or oscillating distribution of the mixture

Rotating or oscillating the balloon about two or more axes simultaneously to distribute the mixture within the inside of the balloon.

Curing a prepolymer/crosslinker mixture into a thermally resistant solid polymer coating

Preparing a mixture of prepolymer and crosslinking catalyst, optionally with a volatile solvent used to adjust viscosity, and curing the mixture into a solid polymer coating that covers at least one section of the inner surface and is more resistant to higher temperatures compared to the material forming the balloon.

Across the independent claim, the inventive approach centers on forming a thermally resistant solid polymer coating on the balloon inner surface by using the balloon as its own mold, distributing a prepolymer/crosslinker mixture via simultaneous rotation or oscillation about two or more axes, and curing the mixture into a higher-thermal-resistivity coating.

Stated Advantages

Protects the thermoplastic polyurethane balloon from high-temperature heating, including localized high temperatures near the laser energy.

Reduces risk of balloon material pinholes and leaks.

Reduces potential need for catheter replacement during repositioning.

Provides a thermally resistant solid polymer coating that is more resistant to higher temperatures compared to the material forming the balloon.

Documented Applications

Endoscopically guided laser ablation catheter use for atrial fibrillation, including pulmonary vein isolation.

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