Extended Wear Electrocardiography Monitor With Wire Electrode Assemblies

Abstract

Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch with sewn electrodes and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.

What is claimed is: 
     
         1 . An extended wear electrocardiography patch with wire electrode assemblies, comprising:
 a flexible backing;   a battery printed circuit board affixed on a proximal end of the flexible backing;   a distal electrode assembly comprising a distal wire, a portion of which is affixed to a distal end of the flexible backing and configured in a pattern and a further portion of the distal wire interlaced along the flexible backing and connected to the battery printed circuit board; and   a proximal electrode assembly comprising a proximal wire configured in a pattern on the proximal end of the flexible backing and connected to the battery printed circuit board.   
     
     
         2 . An extended wear electrocardiography patch in accordance with  claim 1 , wherein the portion of the distal wire configured in the pattern on the distal end of the flexible backing and the proximal wire configured in the pattern on the proximal end of the flexible backing are insulated or uninsulated. 
     
     
         3 . An extended wear electrocardiography patch in accordance with  claim 1 , the portion of the distal wire configured in the pattern on the distal end of the flexible backing and the proximal wire configured in the pattern on the proximal end of the flexible backing are one of stitched into the flexible backing and free riding on a surface of the flexible backing. 
     
     
         4 . An extended wear electrocardiography patch in accordance with  claim 1 , wherein the battery printed circuit board comprises a set of electrical pads configured to electrically interface with an electrocardiography monitor recorder to collect electrical potential differentials. 
     
     
         5 . An extended wear electrocardiography patch in accordance with  claim 4 , further comprising:
 a pair of battery leads configured to interface at least a portion of the electrical pads to a battery to power the electrocardiography monitor recorder.   
     
     
         6 . An extended wear electrocardiography patch in accordance with  claim 1 , wherein the further portion of the distal wire interlaced along the flexible backing is one of insulated and uninsulated. 
     
     
         7 . An extended wear electrocardiography patch in accordance with  claim 6 , further comprising:
 a layer of insulating material covering the further portion of the distal wire interlaced along the flexible backing when the further portion of the distal wire is uninsulated.   
     
     
         8 . An extended wear electrocardiography patch in accordance with  claim 7 , wherein the layer of insulating material comprises one or more of plastic, rubber-like polymers, varnish, gauze, and adhesive gel. 
     
     
         9 . An extended wear electrocardiography patch in accordance with  claim 1 , wherein the proximal and distal wires each comprise a core of one of a solid, stranded, and braided material. 
     
     
         10 . An extended wear electrocardiography patch in accordance with  claim 9 , wherein the material of the proximal and distal wires comprise one or more of metal, cooper, aluminum, silver, and a compound of materials. 
     
     
         11 . An extended wear electrocardiography monitor with wire electrode assemblies, comprising:
 an electrocardiography patch, comprising:
 a flexible backing; 
 a battery printed circuit board affixed on a proximal end of the flexible backing; 
 a distal electrode assembly comprising a distal wire, a portion of which is affixed to a distal end of the flexible backing and configured in a pattern and a further portion of the distal wire interlaced along the flexible backing and connected to the battery printed circuit board; and 
 a proximal electrode assembly comprising a proximal wire configured in a pattern on the proximal end of the flexible backing and connected to the battery printed circuit board; and 
   an electrocardiography monitor recorder, comprising:
 a sealed housing shaped to be removably attached to the electrocardiography patch; 
 an externally-powered micro-controller; and 
 an electrocardiographic front end circuit interfaced to the micro-controller and operable to sense electrocardiographic signals through the distal and proximal wires. 
   
     
     
         12 . An extended wear electrocardiography monitor in accordance with  claim 11 , wherein the portion of the distal wire configured in the pattern on the distal end of the flexible backing and the proximal wire configured in the pattern on the proximal end of the flexible backing are insulated or uninsulated. 
     
     
         13 . An extended wear electrocardiography monitor in accordance with  claim 11 , the portion of the distal wire configured in the pattern on the distal end of the flexible backing and the proximal wire configured in the pattern on the proximal end of the flexible backing are one of stitched into the flexible backing and free riding on a surface of the flexible backing. 
     
     
         14 . An extended wear electrocardiography monitor in accordance with  claim 11 , wherein the battery printed circuit board comprises a set of electrical pads configured to electrically interface with the electrocardiography monitor recorder to collect electrocardiographic signals. 
     
     
         15 . An extended wear electrocardiography monitor in accordance with  claim 14 , further comprising:
 a pair of battery leads configured to interface at least a portion of the electrical pads to a battery to power the electrocardiography monitor recorder.   
     
     
         16 . An extended wear electrocardiography monitor in accordance with  claim 11 , wherein the further portion of the distal wire interlaced along the flexible backing is one of insulated and uninsulated. 
     
     
         17 . An extended wear electrocardiography monitor in accordance with  claim 16 , further comprising:
 a layer of insulating material covering the further portion of the distal wire interlaced along the flexible backing when the further portion of the distal wire is uninsulated.   
     
     
         18 . An extended wear electrocardiography monitor in accordance with  claim 17 , wherein the layer of insulating material comprises one or more of plastic, rubber-like polymers, varnish, gauze, and adhesive gel. 
     
     
         19 . An extended wear electrocardiography monitor in accordance with  claim 11 , wherein the proximal and distal wires each comprise a core of one of a solid, stranded, and braided material. 
     
     
         20 . An extended wear electrocardiography monitor in accordance with  claim 19 , wherein the material of the proximal and distal wires comprise one or more of metal, cooper, aluminum, silver, and a compound of materials.