Ambulatory Electrocardiographic Monitor And Method Of Use

• US 20120089001A1
• Filed: 10/08/2010
• Published: 04/12/2012
• Est. Priority Date: 10/08/2010
• Status: Abandoned Application

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Bishay, Jon Mikalson, Bardy, Gust H., Felix, Jason
• Application Number:
  US12/901,444
• Publication Number:
  US 20120089001A1
• Time in Patent Office: Days
• US Class Current: 600/391
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/301 providing electrical separation, e.g. by using isolating transformers or optocouplers
• CPC Class Codes: A61B 5/308 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts

Abstract

A method for performing ambulatory electrocardiographic monitoring is provided. An ambulatory ECG monitor, that includes a plurality of sensing electrodes coupled to self-powered sensing circuitry, is provisioned. A monitoring site is located on the surface of a patient'"'"'s chest at midline and above the body of the sternum adjacent to the fourth and fifth intercostal spaces. The electrodes are aligned and placed along the midline. The ambulatory ECG monitor is removably adhered to the monitoring site for the duration of monitoring. ECG data is sensed through the sensing electrodes at the monitoring site and the sensed ECG data is recorded into the sensing circuitry.

Claims

1. A method for performing ambulatory electrocardiographic (ECG) monitoring, comprising:

provisioning an ambulatory ECG monitor comprising a plurality of sensing electrodes coupled to self-powered sensing circuitry;

locating a monitoring site on the surface of a patient'"'"'s chest at midline and above the body of the sternum adjacent to the fourth and fifth intercostal spaces;

aligning and placing the electrodes along the midline and removably adhering the ambulatory ECG monitor to the monitoring site for the duration of monitoring; and

sensing ECG data through the sensing electrodes at the monitoring site and recording the sensed ECG data into the sensing circuitry.

2. A method according to claim 1, further comprising:

selecting a circuit board exhibiting axial and lateral flexibility;

provisioning the sensing circuitry on the selected circuit board and enclosing the sensing circuitry within a housing; and

conformably flexing the circuit board within the housing along the contours of the chest'"'"'s surface.

3. A method according to claim 1, further comprising:

enclosing the sensing circuitry within a housing;

selecting a layer of skin adhesive and a set of standoffs;

attaching the skin adhesive layer to a bottom surface of the housing separated by the set of standoffs; and

conformably adhering the skin adhesive layer to the chest'"'"'s surface with the housing separated from the chest'"'"'s surface by a gap formed by the heights of the set of standoffs.

4. A method according to claim 3, further comprising one of:

defining the skin adhesive layer in a shape comparable to the shape of the bottom of the housing; and

defining the skin adhesive layer in a shape differing from the shape of the bottom of the housing.

5. A method according to claim 1, further comprising:

fashioning a housing comprised of an elongated triangular shape with rounded vertices; and

enclosing the sensing circuitry within a housing, wherein the housing is removably adhered to the monitoring site with the narrowest part of the triangular shape facing towards the patient'"'"'s feet.

6. A method for performing ambulatory electrocardiographic (ECG) monitoring at a midline sternum-centered location, comprising:

provisioning an ambulatory ECG monitor comprising a plurality of sensing electrodes coupled to self-powered sensing circuitry and enclosed in a flexible housing;

independently suspending a layer of skin adhesive from a bottom of the flexible housing;

locating a monitoring site on the surface of a patient'"'"'s chest at midline and above the body of the sternum adjacent to the fourth and fifth intercostal spaces;

conformably placing the ambulatory ECG monitor, comprising;

aligning and placing the electrodes along the midline;

removably adhering the skin adhesive to the monitoring site for the duration of monitoring; and

bending the housing axially and laterally along the contours of the monitoring site; and

sensing ECG data through the sensing electrodes at the monitoring site and recording the sensed ECG data into the sensing circuitry.

7. A method according to claim 6, further comprising:

providing a set of standoffs between the skin adhesive layer and the bottom surface of the housing; and

permitting the skin adhesive layer to flex and stretch in conformity with the patient'"'"'s skin at the monitoring site.

8. A method according to claim 6, further comprising one of:

defining the skin adhesive layer in a shape comparable to the shape of the bottom of the housing; and

defining the skin adhesive layer in a shape differing from the shape of the bottom of the housing.

9. An ambulatory electrocardiographic (ECG) monitor, comprising:

self-powered ECG sensing circuitry;

a plurality of sensing electrodes coupled to the sensing circuitry;

a housing enclosing the sensing circuitry; and

a skin adhesive layer facing a contact surface and independently suspended from the housing.

10. A monitor according to claim 9, further comprising:

a circuit board exhibiting axial and lateral flexibility and upon which the sensing circuitry is comprised.

11. A monitor according to claim 9, further comprising:

a set of standoffs affixed to and defining a gap between the skin adhesive layer and a bottom surface of the housing.

12. A monitor according to claim 9, wherein one or more cutouts are defined around the periphery of the skin adhesive.

13. A monitor according to claim 9, wherein the skin adhesive layer comprises adhesive fabric, cloth, foam, and latex.

14. A monitor according to claim 9, wherein the skin adhesive layer is defined in a shape comparable to one of the shape of the bottom of the housing and a shape differing from the shape of the bottom of the housing.

15. A monitor according to claim 9, wherein the sensing circuitry compensates for gaps in recording of ECG data resulting from disconnection and reconnection of the sensing electrodes.

16. A monitor according to claim 9, wherein the housing is unshielded.

17. An ambulatory electrocardiographic (ECG) monitor with conformal shape and independent suspension, comprising:

a flexible ECG circuitry body, comprising;

self-powered ECG sensing circuitry comprising a processor, memory, and finite power supply;

a circuit board exhibiting axial and lateral flexibility and upon which the sensing circuitry is comprised; and

a housing enclosing the circuit board;

a plurality of sensing electrodes coupled to the processor, which processes and stores sensed ECG data into the memory; and

a skin adhesion assembly, comprising;

a layer of skin adhesive facing a contact surface; and

a set of standoffs affixed to and defining a gap between the skin adhesive layer and a bottom surface of the housing of the circuitry body.

18. A monitor according to claim 17, further comprising:

a hole defined through a center of each of the standoffs, wherein the sensing electrodes are positioned in each of the holes facing the contact surface.

19. A monitor according to claim 17, wherein one or more cutouts are defined around the periphery of the skin adhesive.

20. A monitor according to claim 17, further comprising:

a radio frequency identification tag comprised with the flexible ECG circuitry body and providing a unique identifier.

21. A monitor according to claim 17, further comprising:

an actimetry sensor coupled with the sensing circuitry and storing gross motor activity data into the memory.

22. A monitor according to claim 17, wherein at least one of the memory and the finite power supply are comprised on the skin adhesive layer instead of the circuitry body.

23. A monitor according to claim 17, the skin adhesive layer comprises adhesive fabric, cloth, foam, and latex.

24. A monitor according to claim 17, wherein the skin adhesive layer is defined in a shape comparable to one of the shape of the bottom of the housing and a shape differing from the shape of the bottom of the housing.

25. A monitor according to claim 17, wherein the plurality of electrodes are spaced less than 6 cm apart.

26. A monitor according to claim 17, wherein the monitor weighs not more than 28 g (1.0 oz).