Combining electronic monitoring with inhaled pharmacological therapy to manage cardiac arrhythmias including atrial fibrillation

• US 10,010,294 B2
• Filed: 02/01/2017
• Issued: 07/03/2018
• Est. Priority Date: 02/01/2016
• Status: Active Grant

• Current Assignee: Incarda Therapeutics, Inc.
• Original Assignee: Incarda Therapeutics, Inc.
• Inventors: Narasimhan, Rangachari, Belardinelli, Luiz, Schuler, Carlos A.
• Primary Examiner(s): Solola, Taofiq A
• Application Number:
  US15/422,053
• Publication Number:
  US 20170238866A1
• Time in Patent Office: 517 Days
• Field of Search: 514331
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/19 : lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61M 11/00 : Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/005 : using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/06 : of the injector type
• CPC Class Codes: A61M 15/00 : Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0085 : using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/009 : using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/06 : Antiarrhythmics
• CPC Class Codes: G16H 40/67 : for remote operation

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.

Claims

1. A method of treating cardiac arrhythmia in a subject, comprising:

(a) identifying cardiac arrhythmia in the subject with the aid of an electronic monitoring device;

(b) aerosolizing a pharmaceutical composition in less than about 9 minutes using an inhaler, wherein the pharmaceutical composition comprises a therapeutically effective amount of at least one antiarrhythmic or a pharmaceutically acceptable salt thereof; and

(c) administering the aerosolized pharmaceutical composition to the subject;

thereby treating the cardiac arrhythmia;

wherein the electronic monitoring device provides instruction for the administering the aerosolized pharmaceutical composition.

2. The method of claim 1, wherein the identifying of (a) includes an establishing of a duration of the cardiac arrhythmia.

3. The method of claim 2, wherein the duration of the cardiac arrhythmia is at least about 0.5 hours.

4. The method of claim 1, wherein the therapeutically effective amount is an amount sufficient to convert the cardiac arrhythmia to normal sinus rhythm.

5. The method of claim 4, wherein the therapeutically effective amount is at least about 30 mg of the at least one antiarrhythmic or pharmaceutically acceptable salt thereof.

6. The method of claim 4, wherein the therapeutically effective amount converts the cardiac arrhythmia to normal sinus rhythm from about 0 secs to about 2 hours after the administration.

7. The method of claim 1, wherein prior to (a), an electronic monitoring chip is inserted into the subject or is worn by the subject.

8. The method of claim 7, wherein the electronic monitoring chip is in wireless communication with the electronic monitoring device.

9. The method of claim 1, wherein prior to (a), an electronic monitoring chip is inserted into the electronic monitoring device.

10. The method of claim 1, wherein the identifying of (a) comprises a communication of a result to the subject.

11. The method of claim 1, wherein the identifying of (a) comprises a communication of a result to a healthcare professional.

12. The method of claim 1, wherein the at least one antiarrhythmic or pharmaceutically acceptable salt thereof is a class I antiarrhythmic, class II antiarrhythmic, class III antiarrhythmic, class IV antiarrhythmic, class V antiarrhythmic, or a pharmaceutically acceptable salt of any of these.

13. The method of claim 1, wherein the at least one antiarrhythmic or pharmaceutically acceptable salt thereof comprises flecainide.

14. The method of claim 1, wherein the inhaler is in communication with the electronic monitoring device, wherein the communication is a wired communication or a wireless communication.

15. A system comprising:

a. an electronic monitoring chip;

wherein the electronic monitoring chip monitors incidence of arrhythmia in a subject;

b. an electronic monitoring device;

wherein the electronic monitoring device is in wireless communication with the electronic monitoring chip; and

c. an inhaler;

wherein the electronic monitoring device is in communication with the inhaler.

16. The system of claim 15, wherein the electronic monitoring device comprises a digital display.

17. The system of claim 15, wherein the electronic monitoring device comprises auditory means capable of communicating to the subject.

18. The system of claim 15, wherein the electronic monitoring device is a smartphone.

19. The system of claim 15, wherein the electronic monitoring device comprises storage means.

20. The system of claim 19, wherein subject data is stored using the storage means, and wherein the storage means is a hard drive or a cloud based storage.