Combining electronic monitoring with inhaled pharmacological therapy to manage cardiac arrhythmias including atrial fibrillation
Inventors
Narasimhan, Rangachari • Belardinelli, Luiz • Schuler, Carlos A.
Assignees
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Publication Number
US-10660578-B2
Publication Date
2020-05-26
Expiration Date
Abstract
Disclosed herein are methods of treating cardiac arrhythmia with electronic monitoring in a timely manner. Also disclosed herein are systems for electronic monitoring of cardiac arrhythmia.
Core Innovation
The disclosed invention provides a method of treating a subject suffering from cardiac arrhythmia by combining electronic monitoring with aerosolized antiarrhythmic therapy. The method includes monitoring an incidence of the cardiac arrhythmia with an electronic monitoring device and administering an aerosolized pharmaceutical composition to the subject using an aerosolization device. The aerosolized pharmaceutical composition comprises a therapeutically effective amount of at least one antiarrhythmic or a pharmaceutically acceptable salt thereof.
After administering the aerosolized pharmaceutical composition, the electronic monitoring device verifies that the aerosolized pharmaceutical composition has been administered and then provides a treatment recommendation. The monitoring-device-driven recommendation is based on the verified administration and the monitoring of the arrhythmia incidence. The described treatment workflow supports rapid, self-administered inhalation of the antiarrhythmic therapy guided by the monitoring device.
The disclosed concept further focuses on atrial fibrillation, including paroxysmal atrial fibrillation, where a monitoring chip and a monitoring device are used in communication with an aerosolization device such as an inhaler. The treatment recommendation is generated and may be tailored based on whether conversion of the arrhythmia occurs, including conversion to normal sinus rhythm within a defined period after administration. The disclosed examples emphasize use with flecainide delivered by inhaler devices and evaluation of aerosolization and monitoring correspondence.
The problem being addressed is the need to treat cardiac arrhythmia by enabling early detection and rapid response using an electronic monitoring device and an aerosolized antiarrhythmic therapy. The approach aims to coordinate monitoring, verified administration, and a treatment recommendation so that the subject receives an antiarrhythmic intervention appropriate to the observed cardiac arrhythmia incidence.
Claims Coverage
The document includes one independent claim covering a treatment method that integrates electronic monitoring, verified aerosol administration, and a monitoring-device treatment recommendation. The dependent claims in the provided material refine the independent claim by specifying antiarrhythmic selection, dosing constraints, conversion timing to normal sinus rhythm, monitoring architecture details, and recommendation content stopping criteria.
Monitoring arrhythmia incidence with an electronic monitoring device
Monitoring an incidence of said cardiac arrhythmia in said subject with aid of an electronic monitoring device.
Administering an aerosolized antiarrhythmic therapeutically effective amount
Administering an aerosolized pharmaceutical composition from an aerosolization device to said subject, wherein said aerosolized pharmaceutical composition comprises a therapeutically effective amount of at least one antiarrhythmic or a pharmaceutically acceptable salt thereof.
Receiving a treatment recommendation after verified administering
Receiving a treatment recommendation from said electronic monitoring device after said electronic monitoring device verifies said administering of said aerosolized pharmaceutical composition.
Therapeutically effective amount including at least about 30 mg
The method is carried out using a therapeutically effective dose of at least about 30 mg of at least one antiarrhythmic or a pharmaceutically acceptable salt thereof.
Converting arrhythmia to normal sinus rhythm within a time window
A therapeutically effective amount converts an arrhythmia to normal sinus rhythm from about 0 seconds to about 2 hours after administration.
Using an electronic monitoring chip inserted into or worn by the subject
The method further specifies that the electronic monitoring device communicates with an electronic monitoring chip inserted into or worn by the subject.
Selecting antiarrhythmics by Vaughan-Williams class categories
The method is carried out using at least one antiarrhythmic or a pharmaceutically acceptable salt thereof selected from class I, class II, class III, class IV, class V antiarrhythmics, or salts of any of these.
Stopping administration upon conversion to normal sinus rhythm
The treatment recommendation includes stopping the administration once the cardiac arrhythmia is converted to a normal sinus rhythm.
Across the independent claim and the shown dependent refinements, the core coverage combines electronic monitoring of a subject’s cardiac arrhythmia incidence, aerosolized administration of an antiarrhythmic in a therapeutically effective amount, and a treatment recommendation received after the monitoring device verifies administration. Additional claim refinements specify minimum dosing, a conversion-to-normal-sinus-rhythm timing window, antiarrhythmic class selection, monitoring-chip architecture, and a recommendation to stop administration once conversion occurs.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a subject suffering from cardiac arrhythmia, including atrial fibrillation (including paroxysmal atrial fibrillation), using monitoring with an electronic monitoring device followed by aerosolized self-administered antiarrhythmic therapy.
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