Extended wear electrocardiography patch

• US 9,433,380 B1
• Filed: 06/10/2015
• Issued: 09/06/2016
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bishay, Jon Mikalson, Bardy, Gust H., Felix, Jason
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Antiskay, Brian M
• Application Number:
  US14/736,257
• Publication Number:
  US 20160278701A1
• Time in Patent Office: 454 Days
• Field of Search: 600/372, 600/382, 600/384, 600/386, 600/388, 600390-393, 600508-509
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• 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 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

Physiological monitoring can be provided through a wearable monitor that includes a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum, which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. The electrode patch is shaped to fit comfortably and conformal to the contours of the chest approximately centered on the sternal midline. The electrode patch is made from a type of stretchable spunlace fabric. To counter patient bending motions and prevent disadhesion of the electrode patch, the outward-facing aspect of the backing, to which a (non-stretchable) flexible circuit is fixedly attached, stretches at a different rate than the backing'"'"'s skin-facing aspect, where a skin adhesive removably affixes the electrode patch to the skin.

Claims

1. An extended wear electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable spunlace material with a narrow longitudinal midsection tapering evenly inward from both ends of the elongated strip;

a layer of adhesive applied on a contact surface of the flexible backing, the flexible backing defining a pair of openings on both ends;

a flexible circuit axially affixed to an outward-facing the flexible backing and comprising a pair of circuit traces both originating within one of the ends of the elongated strip;

a pair of electrocardiographic electrodes electrically coupled to each of the circuit traces and respectively affixed to and conductively exposed on the contact surface of each end of the elongated strip through each of the openings, wherein the flexible circuit forms an unstretchable structure such that upon movement of the flexible backing, the electrodes shift away from the openings in the flexible backing and the outward-facing surface of the flexible backing stretches at a different rate than the contact surface of the flexible backing;

conductive gel provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes; and

a non-conductive receptacle securely adhered on one of the ends of the elongated strip opposite the contact surface and formed to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of circuit traces to the electrocardiography monitor.

2. An electrode patch according to claim 1, further comprising:

one of the electrocardiographic electrodes being disposed for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest; and

an other of the electrocardiographic electrodes being disposed for being adhered to the region near the manubrium upwards on the patient'"'"'s chest oriented centrally (in the midline) along the sternum from the one electrocardiographic electrode.

3. An electrode patch according to claim 1, further comprising:

an upper part of the elongated strip defined on one end of the flexible backing and sized to be affixed to the bottom surface of the non-conductive receptacle, one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part of the elongated strip defined on another end of the flexible backing, an other of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the elongated strip is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part of the elongated strip oriented upwards towards the manubrium.

4. An electrode patch according to claim 1, wherein the narrow longitudinal midsection defines an hourglass-shaped pattern in the flexible backing when viewed from above conformal to fit comfortably within the intermammary cleft of a patient'"'"'s pair of breasts.

5. An electrode patch according to claim 1, further comprising:

a battery compartment provided in the non-conductive receptacle and comprising a pair of battery leads electrically coupleable to a battery; and

the non-conductive receptacle further comprising power terminals aligned to electrically interface the pair of battery leads to the electrocardiography monitor.

6. An electrode patch according to claim 1, further comprising:

a moisture-resistant seal formed on the non-conductive receptacle circumferentially about the electrode terminals and adapted to substantially protect the electrocardiography monitor against moisture intrusion.

7. An electrode patch according to claim 1, further comprising:

a contoured surface comprised on the adhesive layer on at least one end of the elongated strip.

8. An electrode patch according to claim 1, further comprising:

a plurality of fasteners comprised on the non-conductive receptacle and oriented to securely receive and to hold captive the electrocardiography monitor into the non-conductive receptacle.

9. An electrode patch according to claim 1, further comprising at least one of:

rounded edges defined about a bottom surface of the non-conductive receptacle;

a gel well circumferentially defined as one of the openings about at least one of the electrocardiographic electrodes on the contact surface of the end of the flexible backing on which the at least one electrocardiographic electrode is affixed; and

placement and removal tabs comprised as part of the flexible backing and extending longitudinally beyond at least one end of the flexible backing.