Ablation system with automated sweeping ablation energy element

Inventors

Melsky, GeraldEstabrook, Brian

Assignees

Cardiofocus Inc

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Publication Number

US-11344365-B2

Patent

Publication Date

2022-05-31

Expiration Date


Abstract

The present disclosure relates to ablation instruments and methods of use thereof, in particular to ablation catheters and methods for an automated sweeping ablation element. The automated sweeping ablation element is configured to provide ablative energy to an initial ablation site and move a predetermined number of degrees to one or both sides of the site in an arcuate path using a sweeping motion while still providing the ablative energy. The sweeping movement of the ablation element can be automated via input parameters entered by a user via a graphical user interface or other device (controller).

Core Innovation

The invention provides an endoscope-guided cardiac tissue ablation system in which an elongate catheter made of a material substantially transparent to radiant energy delivers a distal end to a patient's heart. An expandable member attached to the catheter includes an elastic portion configured to conform to a shape of a target tissue region upon expansion, while remaining substantially transparent to radiant energy.

An energy emitter assembly is movably disposed within a lumen of the catheter, with an energy emitter configured to deliver a series of discrete segments of radiant ablative energy through the expandable member to the target tissue region, thereby forming a lesion segment upon impingement. A first motor operatively coupled to the energy emitter provides controlled continuous sweeping motion, and a controller with a user interface receives a first end point and a second end point, defines an ablation path extending from the first end point to the second end point, and directs fully automated motion along the ablation path.

A manual override device allows the user to manually control both rotation and axial movement of the energy emitter assembly and to override the fully automated motion. Real-time lesion quality and continuity assessment is performed using imaging of distal blood pool perturbation before, during, and/or after ablation, with software modules that generate a composite image, compare to a baseline image, and provide visual warning signals related to lesion continuity or gaps or breaks.

Claims Coverage

The provided material includes one independent claim. The claim coverage is centered on an automated continuous sweeping ablation path with endpoint alignment, using a radiant-energy transparent catheter and a substantially transparent, conforming expandable member, together with user-controlled manual override of rotation and axial movement.

Radiant-energy transparent cardiac ablation with conforming expandable member

An elongate catheter formed of a material substantially transparent to radiant energy configured to deliver a distal end to a patient's heart; an expandable member attached to a distal portion and a proximal portion of the catheter, the expandable member substantially transparent to radiant energy and having an elastic portion configured to conform to the shape of a target tissue region upon expansion.

Movable energy emitter forming lesion segments through expandable member

An energy emitter assembly movably disposed within a lumen of the catheter, including an energy emitter configured to deliver a series of discrete segments of radiant ablative energy through the expandable member to the target tissue region, wherein a distal end of the energy emitter provides an exposure pattern upon impingement with the target tissue region resulting in formation of a lesion segment in the target tissue.

Continuous fully automated sweeping motion along an ablation path defined by endpoints

A first motor operatively coupled to the energy emitter for controlled movement of the energy emitter in a continuous sweeping manner; and a controller operatively coupled to the first motor with a user interface allowing a user to input a first end point and a second end point for aligning the energy emitter, wherein the controller defines an ablation path extending from the first end point to the second end point based on a current position of the energy emitter and directs the motor to execute a continuous, fully automated motion positioning the energy emitter assembly to deliver radiant ablative energy along the ablation path, thereby forming the lesion segment in a fully automated manner.

Manual override for rotation and axial movement of the energy emitter

A manual override device configured to allow the user to manually control both rotation and axial movement of the energy emitter assembly and to override the fully automated motion of the energy emitter assembly under operation of the motor.

Across the independent claim, the core inventive coverage is an automated continuous sweeping radiant-energy ablation system that defines an ablation path from user-input endpoints while using a radiant-energy transparent catheter and a conforming, substantially radiant-energy transparent expandable member to form lesion segments, with manual override controlling rotation and axial movement.

Stated Advantages

Enables continuous, fully automated motion that positions the energy emitter assembly to deliver radiant ablative energy along the ablation path in a fully automated manner, thereby forming the lesion segment.

Allows a user to manually control both rotation and axial movement of the energy emitter assembly and override fully automated motion.

Provides real-time lesion quality and continuity assessment using imaging of distal blood pool perturbation, with software modules and visual warning signals.

Documented Applications

Cardiac tissue ablation in a patient's heart, including formation of lesion segments along a user-defined ablation path.

Lesion quality and continuity assessment in connection with ablation using imaging of distal blood pool perturbation before, during, and/or after ablation.

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