System and method for targeting heart rhythm disorders using shaped ablation

Inventors

Narayan, SanjivBriggs, Carey Robert

Assignees

US Department of Veterans AffairsTopera IncOffice of General Counsel of VAUniversity of California San Diego UCSD

Publication Number

US-9282910-B2

Publication Date

2016-03-15

Expiration Date

2032-05-02

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Abstract

A system and method to target a biological rhythm disorder, such as a heart rhythm disorder, include processing cardiac signals via a computing device to determine a shape in a region of tissue defined by a source associated with the biological rhythm disorder that migrates spatially on or within the shape, and identifying at least one portion of the tissue proximate to the shape to enable selective modification of the at least one portion of tissue in order to terminate or alter the heart rhythm disorder.

Core Innovation

The invention provides systems, methods, and devices for diagnosing, identifying, locating, and treating biological rhythm disorders, particularly heart rhythm disorders, through the use of shaped ablation. It processes cardiac signals via a computing device to determine a spatial shape in a region of tissue defined by a migrating source associated with the heart rhythm disorder. The source migrates spatially on or within this shape. The method identifies at least one portion of the tissue proximate to the shape to enable selective modification of the tissue, such as by ablation, to terminate or alter the heart rhythm disorder.

The problem addressed is the difficulty in treating complex heart rhythm disorders such as atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF), due to poor tools for identifying the precise sources of these disorders. Existing ablation techniques deliver lesions at single points or empirically shaped lines without conforming to the actual spatial shapes of the sources, leading to extensive tissue damage and suboptimal success rates. Since sources migrate within spatially constrained regions and vary beat by beat, prior methods fail to identify and localize these sources accurately, resulting in inefficient and potentially harmful treatments.

Claims Coverage

The claims present eleven main inventive features covering methods and systems for detecting migrating sources of cardiac rhythm disorders, defining spatial shapes of migration, identifying proximate tissue regions for intervention, and selectively modifying these regions to terminate or alter the disorder.

Processing cardiac signals to track migrating sources and determine shapes

A method and system to process cardiac signals to track the path of migration of a source causing the cardiac rhythm disorder over multiple time periods, determining a shape in a region of tissue defined by that migrating source.

Identifying tissue portions proximate to the shape for targeted modification

Identification of at least one portion of tissue proximate to the spatial shape associated with the migrating source, enabling selective modification to terminate or alter the cardiac rhythm disorder.

Selective modification of tissue including ablation and therapeutic interventions

Delivering targeted modification to the identified tissue portions, which can include destruction (ablation) or other therapies like electrical, mechanical, drug, gene, or stem cell therapy to treat the disorder.

Defining the shape by tracking spatial points and paths of migration

Determining the spatial shape by identifying spatial points associated with the source at specific times, tracking their migration over multiple cardiac activations to define paths, and forming a perimeter or shape around these paths.

Refining the shape based on tissue dimensions and type

Adjusting the determined shape based on characteristics such as width, height, depth, and tissue type related to the migration of the source.

Applicability to various heart rhythm disorders and tissue regions

Suitability for one or more cardiac rhythm disorders including AF, VF, atrial flutter, ventricular flutter, and other electrical disturbances, and for regions including heart tissue, nerves supplying the heart, brain regions controlling nerves, and adjacent tissues.

System and computing device configured to perform the method

Systems including at least one processing device configured to perform the signal processing, shape determination, identification of tissue portions, and a device configured to selectively modify the tissue to treat the disorder.

Catheter devices with adaptable sensor configurations

Catheters comprising multiple sensors whose spatial relationship can be adjusted based on data indicating the shape and tissue portions, allowing targeted delivery of therapy conforming to the shape.

Data transmission over networks for remote analysis and treatment planning

Methods and systems involving receiving cardiac signals over networks, processing to determine migrating source shapes, identifying tissue for modification, and transmitting data to enable selective treatment remotely.

Coverage of both migrating and fixed impulse generators and reentrant sources

Inclusion of impulse generators that migrate within or on the shape, fixed impulse generators generating multiple excitation waves within or on the shape, and reentrant generators producing multiple waves within or on the shape.

Selective modification of multiple tissue portions including within and outside the shape

Capability to identify and selectively modify one or more portions within, on, or outside the spatial shape to effectively treat the cardiac rhythm disorder, including cases where modification of the shape itself is not fully feasible.

The claims comprehensively cover novel methods and systems for accurately identifying and locating spatially migrating sources of cardiac rhythm disorders, defining their spatial shapes, and enabling targeted, shaped modification of tissue proximate to these shapes to effectively treat and terminate the disorders with minimal collateral damage.

Stated Advantages

Allows precise identification and localization of cause(s) of complex heart rhythm disorders, including spatially migrating sources which were not previously identifiable.

Enables tailored ablation therapy conforming to the actual spatial shape and migration area of the arrhythmia source to minimize damage to healthy tissue.

Facilitates faster and more effective treatment, such as acute termination of atrial fibrillation with significantly less ablated tissue compared to traditional empiric methods.

Supports both real-time and offline analysis modes, improving procedural planning and outcome assessment.

Provides flexibility in ablation and treatment targeting, including modification inside, on, or proximate to the source migration shape, as well as alternative therapies such as electrical, drug, gene, or stem cell therapies.

Documented Applications

Minimally invasive catheter-based diagnosis and treatment of heart rhythm disorders such as atrial fibrillation, ventricular fibrillation, atrial flutter, ventricular tachycardia, and focal tachycardias.

Surgical therapies for heart rhythm disorders with direct exposure of the heart, using shaped ablation guided by computed spatial shapes of sources.

Processing and analyzing cardiac signals from implanted devices, electrocardiograms, intracardiac electrodes, and external sensors for accurate mapping of rhythm disorder sources.

Remote processing systems that receive cardiac or biological signals over a network, process to identify source shapes, and transmit data for treatment guidance.

Extending the detection and treatment methods to other biological rhythm disorders in organs such as brain (for epilepsy), gastrointestinal tract, urogenital and respiratory systems, skeletal muscle, and nervous system disorders.

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