Wearable electrocardiography and physiology monitoring ensemble

• US 9,655,537 B2
• Filed: 06/09/2015
• Issued: 05/23/2017
• 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, Felix, Jason, Bardy, Gust H., Handfelt, Mark
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/734,853
• Publication Number:
  US 20160278658A1
• Time in Patent Office: 714 Days
• Field of Search: 600382, 600393, 600509
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

A wearable electrocardiography monitoring ensemble is provided, which includes a garment made of a compressible and elastomeric material. The garment is wearable about an upper region of the torso and further includes an internal structure forming a compressive bias circumferential to the torso. The ensemble also includes an electrode assembly provided on an inside surface of the garment on an underside of the internal structure. The electrode assembly has a pair of electrocardiography electrodes, a pair of terminated electrical connections that are each coupled to one of the electrocardiography electrodes, and a backing to which the electrocardiography electrodes are affixed. The wearable monitoring ensemble creates a more natural experience for wearers and can be used to produce an expanded dataset for diagnosis because the ensemble can collect data during activities of daily living and can capture cardiovascular events outside of clinical observation, which is otherwise not practicable, especially for athletes.

Claims

1. A wearable electrocardiography monitoring ensemble, comprising:

a garment comprised of a compressible and elastomeric material and wearable about an upper region of a torso, the garment further comprising an internal structure forming a compressive bias circumferential to the torso;

an electrode assembly provided on an inside surface of the garment on an underside of the internal structure, comprising;

a pair of electrocardiography electrodes;

a pair of terminated electrical connections that are each coupled to one of the electrocardiography electrodes; and

a backing to which the electrocardiography electrodes are affixed; and

a receptacle adapted to removably receive a monitor recorder and comprising a set of electrical pads formed on a bottom surface, a pair of the electrical pads into which each of the terminated electrical connections are coupled and further comprising a battery compartment formed on the bottom surface from which a pair of battery leads extend to another pair of the electrical pads electrically interfacing a battery to the monitor recorder,

wherein the monitor recorder comprises electrical contacts that protrude from a bottom surface and is configured to establish electrical connections to the pair of electrocardiography electrodes in the garment by interfacing to at least a portion of the remaining electrical pads in the set on the receptacle via the electrical contacts upon receipt into the receptacle.

2. A wearable electrocardiography monitoring ensemble according to claim 1, the electrode assembly further comprising:

a pair of flexible circuits each comprising one of the pair of terminated electrical connections, each flexible circuit further comprising an electrical pad that terminates the respective terminated electrical connection.

3. A wearable electrocardiography monitoring ensemble according to claim 2,

wherein the electrical pads of the flexible circuits mate with the pair of electrical pads on the receptacle.

4. A wearable electrocardiography monitoring ensemble according to claim 1, the electrode assembly further comprising:

a pair of flexile wires each comprising one of the pair of terminated electrical connections interlaced into the backing, each flexile wire further comprising an electrical pad that terminates the respective terminated electrical connection.

5. A wearable electrocardiography monitoring ensemble according to claim 1, the electrode assembly further comprising:

pair of flexile wires each comprising one of the pair of terminated electrical connections interlaced into the backing, each flexile wire further comprising an electrical pad that terminates the respective terminated electrical connection,

wherein each of the electrocardiography electrodes is comprised of one of the flexile wires interlaced into a distal end of the backing and comprises an electrically conductive area only exposed on a contact surface.

6. A wearable electrocardiography monitoring ensemble according to claim 1, wherein the pair of electrocardiography electrodes are adapted to be positioned axially along the midline of a sternum with one of the electrocardiography electrodes adapted to be positioned at a region overlying a xiphoid process on a human chest and the other electrocardiography electrode adapted to be positioned at a region near the manubrium upwards on the human chest oriented centrally (in the midline) along the sternum from the one electrode.