Methods for the detection and/or diagnosis of biological rhythm disorders
Inventors
Narayan, Sanjiv • Rappel, Wouter-Jan
Assignees
Office of General Counsel of VA • University of California San Diego UCSD
Publication Number
US-8521266-B2
Publication Date
2013-08-27
Expiration Date
2029-10-09
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Abstract
Method, system and apparatus to detect, diagnose and treat biological rhythm disorders. In preferred particularly desirable embodiment relating to the real-time detection of heart rhythm disorders, this invention identifies localized sources for complex rhythms including atrial fibrillation to guide the localized application of energy to modify the source and treat the rhythm disorder.
Core Innovation
The invention provides a method, system, and apparatus to detect, diagnose, and treat biological rhythm disorders, with a particular embodiment focusing on real-time detection of heart rhythm disorders. It identifies localized sources such as electrical rotors and focal beats causing complex rhythms including atrial fibrillation, guiding the localized application of energy to modify or eliminate these sources for therapy.
Heart rhythm disorders, especially complex forms like atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF), present significant clinical challenges due to difficulties in identifying and localizing their causes for effective treatment. Current therapeutic approaches like pharmacologic therapy or ablation suffer from suboptimal success rates and complications largely because existing tools fail to pinpoint the precise origin of these disorders.
The problem addressed by the invention is the lack of methods and tools capable of accurately identifying and locating the causes of complex heart rhythm disorders in human patients. Prior art methods either rely on indirect surrogates or fail to detect the localized sources of complex arrhythmias like AF and VF, limiting the effectiveness of ablation and other therapies. The invention overcomes these limitations by collecting activation signals from multiple sensor locations, ordering them into activation trails, and analyzing them to find distinct patterns indicative of the rhythm disorder's cause.
Claims Coverage
The claims introduce a comprehensive method and system for detecting and diagnosing causes of heart and biological rhythm disorders, focusing on activation signal collection, sequencing, analysis, and core region identification that signifies the source of the disorder.
Activation trail creation and core region identification
The method includes sensing activation signals at multiple locations, collecting data with sensor locations and activation onset times, arranging these onset times in sequence to create an activation trail, and determining at least one approximate core region indicative of the cause of a rhythm disorder.
Selection of primary cause from multiple causes
Selecting one or more causes as indicative of a primary cause based on various criteria including number and rate of activation trail repetitions, number of localized causes, tissue volume associated, localization degree, and anatomical location.
Recognition of distinct activation patterns
Identification of activation trails comprising rotational patterns (rotors) or radially emanating patterns (focal activations) revolving about or emanating from the core region, which are visualized and repeatable.
Use of multiple sensor configurations and spatial coverage
Utilization of multiple sensors—at least 15 per cardiac chamber—covering approximately 25% of the heart chamber surface area, with sensing performed concurrently or stepwise.
Construction and utilization of electrographs with physiological pattern insertion
Constructing voltage-time tracings (electrographs) at sensor locations by inserting physiological patterns derived from prior recordings or simulated data, which may represent unipolar/bipolar electrograms or action potential representations, adjusted for rate and modeling cellular ion function or pharmacologic ligand behavior.
Application to both heart and other biological rhythm disorders
The method is applicable not only to heart rhythm disorders but also biological rhythm disorders generally, involving sensing, collecting, arranging, and analyzing activation signals to identify causes.
The claims cover innovative methods and systems that collect and analyze activation signals from multiple locations to create activation trails identifying and localizing core regions as causes of rhythm disorders, with visual display, selection of primary causes, and application to various biological rhythms, incorporating sophisticated signal processing and spatial sensing techniques.
Stated Advantages
Identification and localization of causes for complex heart rhythm disorders such as AF and VF that were previously not identifiable.
Improved ability to guide, select, and apply targeted curative therapies, including minimally invasive ablation.
Ability to use minimal activation events for detection, enhancing efficiency and accuracy.
Adaptive spatial resolution in sensing to survey large areas and then focus on high-resolution sensing for precise localization.
Use of stored databases to assist diagnosis, classification, and improve clarity of activation trail interpretation.
Visual and auditory display methods that provide clear guidance to practitioners for locating and treating disorder sources.
Capability for both real-time and non-real-time data analysis, including offline review and planning.
Potential to treat complex disorders by targeting sources for modulation, isolation, or elimination using various treatment modalities including ablation, pacing, pharmaceutical or gene therapy.
Documented Applications
Detection, diagnosis, and treatment of heart rhythm disorders including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, atrial flutter, supraventricular tachycardia, and other complex or simple cardiac arrhythmias.
Minimally invasive or surgical therapeutic procedures guided by identification and localization of rhythm disorder causes.
Use in other biological rhythm disorders such as electrical impulse disorders in the brain (e.g., epilepsy, seizure foci), peripheral nervous system tumors, skeletal muscle disorders, and smooth muscle disorders in the gastrointestinal, genitourinary, and respiratory systems.
Development and use of sensor devices capable of adjusting spatial resolution and contacting heart chamber surfaces for signal sensing and treatment delivery.
Creation and use of databases for storing and comparing rhythm disorder source data to aid in diagnosis and treatment planning.
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