Ambulatory electrocardiographic monitor for providing ease of use in women

• US 8,613,709 B2
• Filed: 07/26/2011
• Issued: 12/24/2013
• Est. Priority Date: 10/08/2010
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Bishay, Jon Mikalson, Bardy, Gust H., Felix, Jason
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/191,414
• Publication Number:
  US 20120088999A1
• Time in Patent Office: 882 Days
• Field of Search: 600/372, 600/382, 600/384, 600386-388, 600391-393, 600508-509, 607/149, 607152-153
• US Class Current: 600/508
• CPC Class Codes: A61B 2503/00 Evaluating a particular growth phase or type of persons or animals
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• 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 5/301 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

An ambulatory electrocardiographic (ECG) monitor with a jumpered sensing electrode and method of use for female and large-girthed patients is provided. Self-powered ECG sensing circuitry is fully enclosed in a housing with electrode receptacles on a bottom surface. A flexible and stretchable electrode mounting panel is provided with a layer of skin adhesive. A standoff pad is placed between the housing and the electrode mounting panel. Sensing electrodes are mounted on opposite ends of the mounting panel. Each sensing electrode includes an electrode pad facing the skin contacting surface and an oppositely-facing electrode plug. Each plug is removably and pivotably couplable into the receptacles. A jumper wire assembly includes a jumper plug electrically connected to a jumper receptacle. The jumper plug is removably and pivotably couplable into the receptacles and the jumper receptacle is removably and pivotably couplable into the plugs on the mounting panel opposite from the standoff pad.

Claims

1. An ambulatory electrocardiographic (ECG) monitor with hinged sensing electrode mounting panel, comprising:

self-powered ECG sensing circuitry;

a housing fully enclosing the sensing circuitry and providing a pair of electrode connection receptacles on a bottom surface of the housing; and

a flexible and stretchable electrode mounting panel, comprising;

an upper panel facing the bottom surface of the housing and a lower panel hingably folded under the upper panel and having an elongated shape which is proximal to standoff pads;

wherein the standoff pads are comprised of greater height affixed at opposite ends of the bottom surface of the housing than the standoff pad comprised of a lesser height;

a layer of skin adhesive on a skin contacting surface;

a standoff pad sized smaller than the electrode mounting panel and defining an opening;

a pair of sensing electrodes mounted on opposite ends of the lower panel and comprising an electrode pad facing the skin contacting surface, wherein the standoff pad is placed over one of the sensing electrodes with the electrode connection plug positioned within the opening and the upper panel and lower panel are hinged proximally to the standoff pad; and

a pair of electrode connection plugs removably and pivotably couplable into the electrode connection receptacles on the housing, each connection plug electrically connected to one of the sensing electrodes.

2. A monitor according to claim 1, further comprising one of:

a flexible circuit board integrated into the electrode mounting panel and comprising circuit traces electrically interconnecting the respective electrode connection plugs and sensing electrodes; and

a set of wires electrically connecting the respective electrode connection receptacles and the sensing electrodes.

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

a layer of electrode gel provided on the skin contacting surface of each sensing electrode, wherein the electrode pad slightly is recessed away from the skin contacting surface and is snuggly positioned between the electrode connection plug and the electrode mounting panel.

4. A monitor according to claim 1, wherein a portion of the lower panel between the sensing electrodes comprises one or more collapsible folds.

5. A monitor according to claim 1, wherein the skin adhesive comprises at least one of a single-coated silicon adhesive gel and an elastomer film.

6. A monitor according to claim 1, wherein the electrode mounting panel is further sized to fit between a patient'"'"'s suprasternal notch and manubrium.

7. An ambulatory electrocardiographic (ECG) monitor with extendable sensing electrode mounting panel, comprising:

self-powered ECG sensing circuitry;

a housing fully enclosing the sensing circuitry and providing a pair of electrode connection receptacles on a bottom surface of the housing;

a flexible and stretchable electrode mounting panel having an elongated shape, comprising;

an extension panel collapsibly provided on one side of the electrode mounting panel;

a layer of skin adhesive on a skin contacting surface of each of the electrode mounting panel and the extension panel, the skin adhesive layer independently suspended from the housing with a set of standoffs having non-uniform heights affixed to and defining an increasingly wide gap between the skin adhesive layer and a bottom surface of the housing, wherein the standoffs are comprised of greater height affixed at opposite ends of the bottom surface of the housing than the standoffs comprised of a lesser height; and

a portion of the extension panel further comprising at least one of;

one or more collapsible folds provided in-line with the extension panel and the electrode mounting panel;

one or more collapsible folds provided between the extension panel and the electrode mounting panel; and

an elasticized panel stretching in-line with and provided between the extension panel and the electrode mounting panel; and

a pair of sensing electrodes with one sensing electrode mounted on the extension panel and the other sensing electrode mounted on the electrode mounting panel distally from the extension panel-mounted sensing electrode, each sensing electrode comprising an electrode pad facing the skin contacting surface and an oppositely-facing electrode connection plug, the electrode connection plugs removably and pivotably couplable into the electrode connection receptacles on the housing.

8. A monitor according to claim 7, further comprising:

a standoff pad sized smaller than the electrode mounting panel and defining an opening, wherein the standoff pad is placed over one of the sensing electrodes with the electrode connection plug positioned within the opening.

9. A monitor according to claim 7, further comprising one of:

a flexible circuit board integrated into the electrode mounting panel and comprising circuit traces electrically interconnecting the respective electrode connection plugs and sensing electrodes; and

a set of wires electrically connecting the respective electrode connection receptacles and the sensing electrodes.

10. A monitor according to claim 7, further comprising:

a layer of electrode gel provided on the skin contacting surface of each sensing electrode, wherein the electrode pad slightly is recessed away from the skin contacting surface and is snuggly positioned between the electrode connection plug and the electrode mounting panel.

11. A monitor according to claim 7, wherein the skin adhesive comprises at least one of a single-coated silicon adhesive gel and an elastomer film.

12. A monitor according to claim 7, wherein the electrode mounting panel is further sized to fit between a patient'"'"'s suprasternal notch and manubrium.

13. An ambulatory electrocardiographic (ECG) monitor with an incrementally disposable sensing electrode mounting panel, comprising:

self-powered ECG sensing circuitry;

a housing fully enclosing the sensing circuitry and providing a pair of electrode connection receptacles on a bottom surface of the housing;

a flexible and stretchable electrode mounting panel having an elongated shape, comprising;

a plurality of peel-away layers, which each comprise skin adhesive and a backing on an oppositely-facing surface, the peel-away layers successively stacked with backing to skin adhesive, an outermost peel-away layer exposing the skin adhesive on a skin contacting surface of the electrode mounting panel, the peel-away layers independently suspended from the housing with a set of standoffs having non-uniform heights affixed to and defining an increasingly wide gap between the skin adhesive layer and a bottom surface of the housing;

housing, wherein the standoffs are comprised of greater height affixed at opposite ends of the bottom surface of the housing than the standoffs comprised of lesser height; and

a pair of sensing electrodes mounted on the electrode mounting panel, wherein the electrode mounting panel further comprises;

a base layer comprising a skin adhesive on a skin contacting surface and upon which an innermost peel-away layer is removable adhered, wherein the sensing electrodes are mounted on the base layer; and

a layer of electrode gel provided on the skin contacting surface of each sensing electrode, the electrode pad being slightly recessed away from the skin contacting surface and snuggly positioned between the electrode connection plug and the electrode mounting panel, a plurality of pairs of peel-away electrode pad surfaces, each comprised on one of the peel-away layers and successively stacked in electrical communication, one against the other from the outermost peel-away layer in;

each sensing electrode comprising an electrode pad facing the skin contacting surface and an oppositely-facing electrode connection plug, the electrode connection plugs removably and pivotably couplable into the electrode connection receptacles on the housing.

14. A monitor according to claim 13, wherein the electrode mounting panel is further sized to fit between a patient'"'"'s suprasternal notch and manubrium.

15. A monitor according to claim 13, wherein the skin adhesive comprises at least one of a single-coated silicon adhesive gel and an elastomer film.

16. A monitor according to claim 13, wherein the electrode mounting panel is further sized to fit between a patient'"'"'s suprasternal notch and manubrium.