Ambulatory Electrocardiographic Monitor For Providing Ease Of Use In Women And Method Of Use

Abstract

A method for performing ambulatory electrocardiographic monitoring on an adult female 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 between the breasts in the upper portion of the intermammary cleft. The electrodes are aligned and placed along the midline. Interference from breast tissue with placement of the ambulatory monitor at the monitoring site is evaluated. The ambulatory ECG monitor is removably adhered to the monitoring site clear of any breast tissue interference 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.

1 . A method for performing ambulatory electrocardiographic (ECG) monitoring on an adult female, 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 between the breasts in the upper portion of the intermammary cleft;   aligning and placing the electrodes along the midline;   evaluating interference from breast tissue with placement of the ambulatory monitor at the monitoring site;   removably adhering the ambulatory ECG monitor to the monitoring site clear of any breast tissue interference 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 comprised of non-uniform heights with the standoffs comprised of greater height located closer to the xiphoid process of the patient than the standoffs comprised of lesser height;   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 of an adult female, 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 between the breasts in the upper portion of the intermammary cleft;   evaluating interference from breast tissue with placement of the ambulatory monitor at the monitoring site;   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; 
 positioning the housing to avoid the breast tissue interference; 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:
 identifying the breast tissue interference by evaluating each of width, length, depth, and relative location of the adult female patient's intermammary cleft based on one or more of breast size, shape, position, symmetry, overall body physique, posture, type and fit of brassiere worn, and presence of artificial breast implants relative to the size of the flexible housing.   
     
     
         8 . 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, the standoffs comprised of non-uniform heights with the standoffs comprised of greater height affixed at opposite ends of the bottom surface of the housing than the standoffs comprised of lesser height; and   permitting the skin adhesive layer to flex and stretch in conformity with the patient's skin at the monitoring site.   
     
     
         9 . 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.   
     
     
         10 . An ambulatory electrocardiographic (ECG) monitor for an adult woman, 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 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.   
     
     
         11 . A monitor according to  claim 10 , further comprising:
 a circuit board exhibiting axial and lateral flexibility and upon which the sensing circuitry is comprised.   
     
     
         12 . A monitor according to  claim 10 , wherein one or more cutouts are defined around the periphery of the skin adhesive. 
     
     
         13 . A monitor according to  claim 10 , wherein the skin adhesive layer comprises adhesive fabric, cloth, foam, and latex. 
     
     
         14 . A monitor according to  claim 10 , 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 10 , 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 10 , wherein the housing is unshielded. 
     
     
         17 . An ambulatory electrocardiographic (ECG) monitor with conformal shape and independent suspension for an adult woman, 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 having non-uniform heights affixed to and defining an increasingly wide 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).