LONG-TERM CUTANEOUS CARDIAC MONITORING

• US 20130116533A1
• Filed: 10/24/2012
• Published: 05/09/2013
• Est. Priority Date: 11/04/2011
• Status: Abandoned Application

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Lian, Jie, Muessig, Dirk, Lang, Volker
• Application Number:
  US13/659,177
• Publication Number:
  US 20130116533A1
• Time in Patent Office: Days
• US Class Current: 600/391
• CPC Class Codes: A61B 2560/029 adapted for auto-initiation
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence

Abstract

A system for long-term non-invasive heart monitoring includes (1) a disposable unit that has built-in electrodes, a built-in wire antenna, a watertight chamber that can be opened and closed, and an adhesive surface for cutaneous mounting; (2) an electronic controller that can acquire, process and store physiological signals, and can be fitted into the disposable unit to establish electrical contact with the built-in electrodes; and (3) a portable communication unit that can wirelessly communicate bi-directionally with the electronic controller, and further communicate bi-directionally with a remote service center.

Claims

1. A system for long-term cutaneous cardiac monitoring including:

A. a disposable unit configured to be adhered to a patient'"'"'s skin, and

B. an electronic controller detachably connected to the disposable unit,

wherein;

a. the disposable unit includes;

(1) a substantially flat skin-contacting portion having pick-up electrode poles situated to electrically contact a patient'"'"'s skin at spaced-apart locations,

(2) an antenna; and

(3) an internal chamber;

(a) attached to the skin-contacting portion,

(b) configured to accommodate the electronic controller therein in a watertight sealed manner,

(c) configured to open and close so as to allow insertion of the electronic controller therein, and removal therefrom,

(d) including electrode terminals therein that are electrically connected to the pick-up electrode poles, and

(e) including an antenna port therein that is electrically connected to the antenna; and

b. the controller;

(1) includes electrical conducting ports situated to make conductive contact with the electrode terminals and the antenna port when the controller is inserted within the chamber, thereby establishing electrical contact with the pick-up electrode poles and the antenna,

(2) is configured to acquire, process and store physiological signals acquired via the pick-up electrode poles.

2. The system of claim 1 wherein the controller further includes a battery having a capacity sufficient to allow the controller to operate for at least one year.

3. The system of claim 1 wherein the controller is configured to provide a quantitative measure of the signal quality of a signal acquired via the pick-up electrode poles.

4. The system of claim 1 wherein the controller is further configured to store a representative ECG beat template.

5. The system of claim 4 wherein the controller is further configured to construct the representative ECG beat template by averaging multiple normal beats of ECG signals:

a. acquired via the pick-up electrode poles, and

b. being aligned with a predefined fiducial point.

6. The system of claim 4 wherein the controller is further configured to:

a. start constructing the representative ECG beat template immediately upon affixing the disposable unit on a patient'"'"'s skin, and

b. continuously update the representative ECG beat template based on acquired ECG signals.

7. The system of claim 1 wherein the electrode poles are spaced apart by an inter-electrode distance of at least 3 cm.

8. The system of claim 1 wherein the controller includes:

a. an ECG sensing unit, and

b. a memory,

hermetically sealed within an outer controller case.

9. The system of claim 1 wherein the controller includes an impedance measuring unit:

a. connected to the conducting ports, and

b. configured to measure an impedance signal between the electrode poles.

10. The system of claim 1 further including a portable communication unit configured to wirelessly communicate bi-directionally with:

a. the controller via the antenna, and

b. a remote service center.

11. A system for long-term cutaneous cardiac monitoring including:

a. a disposable unit including;

(1) an openable and closable chamber, the chamber being waterproof when closed,

(2) an adhesive surface,

(3) electrodes situated to be in contact with the skin of a patient to which the adhesive surface is adhered, and

(4) an antenna,

b. an electronic controller configured to;

(1) fit into the chamber,

(2) establish electrical contact with the electrodes and antenna when fit into the chamber, and

(3) acquire, process and store signals from the electrodes, and

(4) wirelessly transmit signals from the antenna.

12. The system of claim 11 further including a battery powering the controller, wherein the battery has a battery life of at least 1 year.

13. The system of claim 11 further including a portable communication unit configured to wirelessly communicate bi-directionally with:

a. the controller via the antenna, and

b. a remote service center.

14. The system of claim 13 wherein the portable communication unit is configured to obtain from the controller information regarding:

a. the morphology, and

b. the quality,

of an ECG signal acquired from the electrodes.

15. The system of claim 13 wherein the controller is configured to:

a. wirelessly transmit a latest representative ECG beat template to the portable communication unit, and

b. thereafter compare a newly acquired representative ECG beat template to one or more old representative ECG beat templates stored in the portable communication unit.

16. The system of claim 13 wherein:

a. at least one of the portable communication unit and the controller is configured to rate the acceptability of a newly acquired representative ECG beat template, and

b. the acceptability rating is determined in accordance with the degree of correspondence between;

(1) the morphology of the newly acquired representative ECG beat template, and

(2) the morphology of at least one of the old representative ECG beat templates stored in the portable communication unit.

17. The system of claim 16 wherein at least one of the portable communication unit and the controller is configured to generate a signal indicating non-optimal placement of the disposable unit when the newly acquired representative ECG beat template is rated unacceptable.

18. The system of claim 13 wherein:

a. at least one of the portable communication unit and the controller is configured to rate the acceptability of a newly acquired representative ECG beat template, and

b. the acceptability rating is determined in accordance with a signal quality measurement determined for the newly acquired representative ECG beat template.

19. The system of claim 18 wherein the acceptability rating is also determined in accordance with the degree of correspondence between:

a. the morphology of the newly acquired representative ECG beat template, and

b. the morphology of at least one of the old representative ECG beat templates stored in the portable communication unit.

20. A system for long-term cutaneous cardiac monitoring, the system including:

a. a disposable patient-mounted electrode unit including;

(1) a skin-contacting surface bearing spaced pick-up electrode poles configured to electrically contact a patient'"'"'s skin when the skin-contacting surface is situated on the patient'"'"'s skin,

(2) an antenna; and

(3) an internal chamber including;

(a) electrode terminals therein, the electrode terminals being in conductive communication with the pick-up electrode poles, and

(b) an antenna port therein, the antenna port being in conductive communication with the antenna; and

b. a controller configured;

(1) to be removably fit into the internal chamber,

(2) to establish conductive contact with the electrode terminals, and acquire and process signals from the pick-up electrode poles, when the controller is removably fit into the internal chamber,

(3) to establish conductive contact with the antenna port, and wirelessly transmit signals from the antenna, when the controller is removably fit into the internal chamber.