Patent Publication Number: US-2021186404-A1

Title: Wearable electrocardiography and physiology monitoring ensemble

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This non-provisional patent application is a continuation of U.S. patent application Ser. No. 16/378,458, filed Apr. 8, 2019, pending, which is a continuation of U.S. Pat. No. 10,251,575, issued Apr. 9, 2019, which is a continuation of U.S. Pat. No. 9,655,537, issued May 23, 2017, which is a continuation-in-part of U.S. Pat. No. 9,717,432, issued Aug. 1, 2017, which is a continuation-in-part of U.S. Pat. No. 9,545,204, issued Jan. 17, 2017, and further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent application, Ser. No. 61/882,403, filed Sep. 25, 2013, the disclosures of which are incorporated by reference. 
    
    
     FIELD 
     This application relates in general to electrocardiography and physiology monitoring and, in particular, to a wearable electrocardiography and physiology monitoring ensemble. 
     BACKGROUND 
     An electrocardiogram (ECG) measures and records electrical potential signals and visually depicts heart electrical activity over time. Conventionally, a standard 12-lead configuration is used in-clinic to record cardiac electrical signals from established chest locations. Physicians use ECGs to diagnose heart problems and other health concerns during appointments; however, spot ECG recording may not always detect sporadic conditions, including conditions affected by fluctuations in blood pressure, blood sugar, respiratory function, temperature, cardiac physiology and pathophysiology, or cardiac rhythm. 
     Physicians may provide improved diagnoses through ambulatory ECG monitoring that increases the odds of capturing sporadic conditions, during which a subject can also engage in activities of daily living. While long-term extended ambulatory monitoring in-clinic is implausible and impracticable, diagnostic efficacy can be improved through long-term extended ambulatory ECG monitoring. A 30-day observation period is considered the “gold standard,” but has heretofore proven unworkable because existing ECG monitoring systems have been arduous to employ, cumbersome to the patient, and expensive. 
     Extended ECG monitoring is further complicated by patient intolerance to long-term electrode wear and predisposition to skin irritation. Moreover, natural materials from the patient&#39;s body, such as hair, sweat, skin oils, and dead skin cells, can get between an electrode, adhesives, and the skin&#39;s surface, which can adversely affect electrode contact and cardiac signal recording quality. Patient physical movement and clothing can impart forces on the ECG electrode contact point; inflexibly fastened ECG electrodes are particularly prone to becoming dislodged. Precisely re-placing a dislodged ECG electrode may be essential to ensuring signal capture at the same fidelity. Dislodgment may occur unbeknownst to the patient, rendering the ECG recordings worthless. 
     The high cost of the patient-wearable components used to provide long-term extended ECG monitoring can also negatively influence the availability and use of monitors. Disposable components, such as adhesive electrodes, ideally should be inexpensive, while more complex components, particularly the electronic hardware that detects and records ECG and related physiological data, may be unavoidably expensive. Costs can be balanced by designing the electric hardware to be re-usable, but when the total cost of a full ECG monitoring ensemble remains high, despite the utilization of re-usable parts, the number of monitors available for use by healthcare providers can be inhibited. Cost, then, becomes a barrier to entry, which, in turn, can hinder or prevent healthcare providers from obtaining the means with which to efficaciously identify the physiology underlying sporadic cardiac arrhythmic conditions and can ultimately contribute to a failure to make proper and timely medical diagnose. 
     ECG data are crucial for diagnosing many cardiovascular conditions. For example, detecting abnormal respiratory function with ECG data showing normal respiratory variation may facilitate diagnosis, prognosis, and treatment of certain disorders. Moreover, ECG data obtained through ambulatory monitoring, when combined with additional physiological data, can be especially helpful when diagnosing athletes, who present unique concerns not generally observed in a non-physically active patient population. For example, blood sugar plays a strong role in athletic performance and recovery and correlates with cardiac function. Monitoring respiratory and ECG together can help in diagnosing cardiorespiratory conditions common to athletes, especially since such conditions not only impair performance, but when combined with overtraining, a cardiorespiratory impairment may lead to severe or even terminal conditions, including severe bronchoconstriction or sudden death. 
     Existing portable devices that monitor cardiac data and other physiological data, at best, provide suboptimal results. Such devices can be inconvenient and may restrain movement; for example, a Holter device, which is a wearable ECG monitor with leads placed in a similar position as used with a standard ECG set-up, is cumbersome, expensive, typically only available by medical prescription, and requires skilled medical staff to properly position the electrodes. 
     Wrist monitors, such as the Fitbit product line of activity trackers, manufactured by Fitbit Inc., San Francisco, Calif., and related technologies, like wristwatch smartphones (also known as smartwatches), such as the Apple Watch, manufactured by Apple Inc., Cupertino, Calif. or the Gear S smartwatch, manufactured by Samsung Electronics Co., Ltd., Suwon, South Korea, as well as clothing embedded with sensors, such as the Hexoskin product line of wearable clothing, manufactured by Cane Technologies, Inc., Montreal, Quebec, Canada, all experience fidelity problems related to variation in electrode and sensor contact. Gaps in signal quality or interruptions or distortions of the data stream can lead to false positives and false negatives critical to understanding the relationship between physiological markers and medical events or needs. 
     U.S. Pat. No. 8,668,653, to Nagata, et al., discloses an ECG-monitoring shirt with a plurality of electrodes, including four limb electrodes and sensors disposed on a beltline. To fit each of the electrodes on the body surface of the examinee, a low-irritant acrylic adhesive, for example, may be applied on each of the electrodes that fit on the body&#39;s surface. The use of adhered electrodes is incompatible in patients with a predisposition to skin irritation. 
     Therefore, a need remains for an ambulatory, extended-wear monitor that can be used by patients who are intolerant to adhesively-adhered electrodes; highly mobile individuals, such as athletes, whose movement will cause adhesively-adhered electrodes to become dislodged; and individuals of all types in whom the recording high-quality PQRSTU ECG data and related physiological data are desired. 
     SUMMARY 
     Long-term extended ECG monitoring can be provided through a form of ECG or physiological sensor embedded into clothing, rather than on the-skin electrodes. The garment is made of a material holding the sensor in place during extended wear through, for example, a compressible, breathable fabric. Electrodes are preferably placed on the garment to contact the skin along a wearer&#39;s sternal midline at specific positions to enhance P-wave detection and ECG. The electrodes are connected to an ECG monitor recorder that is either discrete from or affixed to the garment and obtains physiological telemetry through a wireless or electrical interface. Various types of physiological sensors can be provided. 
     One embodiment provides a wearable electrocardiography monitoring ensemble. At least one internal structure is formed within a garment and defined by two horizontal bands across a front surface of the garment. An electrode assembly is positioned within the internal structure and includes at least one electrode to sense cardiac electric signals. An electrical connection is connected on one end to one of the electrodes and interfaced on an other end to a monitor recorder that records the cardiac electric signals. The internal structure exerts against a top surface of the electrode assembly a compressive force that presses the electrode assembly against a wearer&#39;s skin. 
     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. 
     Still other embodiments will become readily apparent to those skilled in the art from the following detailed description, wherein are described embodiments by way of illustrating the best mode contemplated. As will be realized, other and different embodiments are possible, and the embodiments&#39; several details are capable of modifications in various obvious respects, all without departing from their spirit and the scope. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1 and 2  are diagrams showing, by way of examples, an extended wear electrocardiography monitor, including an extended wear electrode patch in accordance with one embodiment, respectively fitted to the sternal region of a female and a male. 
         FIG. 3  is a perspective view showing an extended wear electrode patch in accordance with one embodiment with a monitor recorder inserted. 
         FIG. 4  is a perspective view showing the extended wear electrode patch of  FIG. 3  without a monitor recorder inserted. 
         FIG. 5  is a top view showing the flexible circuit of the extended wear electrode patch of  FIG. 3 . 
         FIG. 6  is a perspective view showing the extended wear electrode patch in accordance with a further embodiment. 
         FIG. 7  is an exploded view showing the component layers of the electrode patch of  FIG. 3 . 
         FIG. 8  is a bottom plan view of the extended wear electrode patch of  FIG. 3  with liner partially peeled back. 
         FIG. 9  is a perspective view of an extended wear electrode patch with a flexile wire electrode assembly in accordance with a still further embodiment. 
         FIG. 10  is perspective view of the flexile wire electrode assembly from  FIG. 9 , with a layer of insulating material shielding a bare distal wire around the midsection of the flexible backing. 
         FIG. 11  is a bottom view of the flexile wire electrode assembly as shown in  FIG. 9 . 
         FIG. 12  is a bottom view of a flexile wire electrode assembly in accordance with a still yet further embodiment. 
         FIG. 13  is a perspective view showing the longitudinal midsection of the flexible backing of the electrode assembly from  FIG. 9 . 
         FIG. 14  is a longitudinal cross-sectional view of the midsection of the flexible backing of the electrode assembly of  FIG. 11 . 
         FIGS. 15A-C  are the electrode assembly from  FIG. 14  under compressional, tensile, and bending force, respectively. 
         FIG. 16  is a flow diagram showing a method for constructing a stress-pliant physiological electrode assembly in accordance with a further embodiment. 
         FIG. 17  is a front view of a wearable electrocardiography and physiology monitoring ensemble in accordance with a further embodiment. 
         FIG. 18  is a contact-surface view of a flexible circuit electrode assembly of the wearable monitoring ensemble of  FIG. 17 . 
         FIG. 19  is a contact-surface view of a flexile wire interconnect of the wearable monitoring ensemble of  FIG. 17 . 
         FIG. 20  is a contact-surface view of a flexile wire electrode and interconnect of the wearable monitoring ensemble of  FIG. 17 . 
     
    
    
     DETAILED DESCRIPTION 
     Physiology monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder.  FIGS. 1 and 2  are diagrams showing, by way of examples, an extended wear electrocardiography monitor  12 , including an extended wear electrode patch  15  in accordance with one embodiment, respectively fitted to the sternal region of a female  10  and a male  11 . In a further embodiment, extended wear monitoring can be provided in the form of a wearable garment, as further described below beginning with reference to  FIG. 17  et seq. The wearable monitor  12  sits centrally (in the midline) on a human chest along the sternum  13  oriented top-to-bottom with the monitor recorder  14  preferably situated towards a human head. The electrode patch  15  is shaped to fit comfortably and conform to the contours of a human chest approximately centered on the sternal midline  16  (or immediately to either side of the sternum  13 ). The distal end of the electrode patch  15  extends towards the Xiphoid process and lower sternum and, depending upon a human build, may straddle the region over the Xiphoid process and lower sternum. The proximal end of the electrode patch  15 , located under the monitor recorder  14 , is below the manubrium and, depending upon a person&#39;s build, may straddle the region over the manubrium. 
     The placement of the wearable monitor  12  in a location at the sternal midline  16  (or immediately to either side of the sternum  13 ) significantly improves the ability of the wearable monitor  12  to cutaneously sense cardiac electric signals, particularly the P-wave (or atrial activity) and, to a lesser extent, the QRS interval signals in the ECG waveforms that indicate ventricular activity. The sternum  13  overlies the right atrium of the heart and the placement of the wearable monitor  12  in the region of the sternal midline  13  puts the ECG electrodes of the electrode patch  15  in a location better adapted to sensing and recording P-wave signals than other placement locations, say, the upper left pectoral region. In addition, placing the lower or inferior pole (ECG electrode) of the electrode patch  15  over (or near) the Xiphoid process and lower sternum facilitates sensing of right ventricular activity and provides superior recordation of the QRS interval. 
     During use, the electrode patch  15  is first adhered to the skin along the sternal midline  16  (or immediately to either side of the sternum  13 ). A monitor recorder  14  is then snapped into place on the electrode patch  15  to initiate ECG monitoring.  FIG. 3  is a perspective view showing an extended wear electrode patch  15  in accordance with one embodiment with a monitor recorder  14  inserted. The body of the electrode patch  15  is preferably constructed using a flexible backing  20  formed as an elongated strip  21  of wrap knit or similar stretchable material about 145 mm long and 32 mm at the widest point with a narrow longitudinal mid-section  23  evenly tapering inward from both sides. A pair of cut-outs  22  between the distal and proximal ends of the electrode patch  15  create a narrow longitudinal midsection  23  or “isthmus” and defines an elongated “hourglass”-like shape, when viewed from above, such as described in commonly-assigned U.S. Pat. No. D744,659, issued Dec. 1, 2015, the disclosure of which is incorporated by reference. The upper part of the “hourglass” is sized to allow an electrically non-conductive receptacle  25 , sits on top of the outward-facing surface of the electrode patch  15 , to be affixed to the electrode patch  15  with an ECG electrode placed underneath on the wearer-facing underside, or contact, surface of the electrode patch  15 ; the upper part of the “hourglass” has a longer and wider profile than the lower part of the “hourglass,” which is sized primarily to allow just the placement of an ECG electrode. 
     The electrode patch  15  incorporates features that significantly improve wearability, performance, and comfort throughout an extended monitoring period. The entire electrode patch  15  is lightweight in construction, which reduces shear forces and allows the patch to be resilient to disadhesing, displacement, or falling off and, critically, to avoid creating distracting discomfort, even when a person is asleep. In contrast, the weight of a heavy ECG monitor impedes wearer mobility and will cause the monitor to constantly tug downwards and press on the wearer&#39;s body; frequent adjustments by the wearer are needed to maintain comfort. 
     During every day wear, the electrode patch  15  is subjected to pushing, pulling, and torsional movements, including compressional and torsional forces when the wearer bends forward, and tensile and torsional forces when the wearer leans backwards. To counter these stress forces, the electrode patch  15  incorporates crimp and strain reliefs, as further described infra respectively with reference to  FIGS. 4 and 5 . In addition, the cut-outs  22  and longitudinal midsection  23  help minimize interference with and discomfort to breast tissue, particularly in women (and gynecomastic men). The cut-outs  22  and longitudinal midsection  23  allow better conformity of the electrode patch  15  to sternal bowing and to the narrow isthmus of flat skin that can occur along the bottom of the intermammary cleft between the breasts, especially in buxom women. The cut-outs  22  and longitudinal midsection  23  help the electrode patch  15  fit nicely between a pair of female breasts in the intermammary cleft. In one embodiment, the cut-outs  22  can be graduated to form the longitudinal midsection  23  as a narrow in-between stem or isthmus portion about 7 mm wide. In a still further embodiment, tabs  24  can respectively extend an additional 8 mm to 12 mm beyond the distal and proximal ends of the flexible backing  20  to facilitate purchase when adhering the electrode patch  15  to or removing the electrode patch  15  from the sternum  13 . These tabs preferably lack adhesive on the underside, or contact, surface of the electrode patch  15 . Still other shapes, cut-outs and conformities to the electrode patch  15  are possible. 
     The monitor recorder  14  removably and reusably snaps into an electrically non-conductive receptacle  25  during use. The monitor recorder  14  contains electronic circuitry for recording and storing the wearer&#39;s electrocardiography as sensed via a pair of ECG electrodes provided on the electrode patch  15 , such as described in commonly-assigned U.S. Pat. No. 9,730,593, the disclosure of which is incorporated by reference. The circuitry includes a microcontroller, flash storage, ECG signal processing, analog-to-digital conversion (where applicable), and an external interface for coupling to the electrode patch  15  and to a download station for stored data download and device programming. The monitor recorder  14  also includes external wearer-interfaceable controls, such as a push button to facilitate event marking and provide feedback. In a further embodiment, the circuitry, with the assistance of the appropriate types of deployed electrodes or sensors, is capable of monitoring other types of physiology, in addition to ECGs. Still other types of monitor recorder components and functionality are possible. 
     The non-conductive receptacle  25  is provided on the top surface of the flexible backing  20  with a retention catch  26  and tension clip  27  molded into the non-conductive receptacle  25  to conformably receive and securely hold the monitor recorder  14  in place. The edges of the bottom surface of the non-conductive receptacle  25  are preferably rounded, and the monitor recorder  14  is nestled inside the interior of the non-conductive receptacle  25  to present a rounded (gentle) surface, rather than a sharp edge at the skin-to-device interface. 
     The electrode patch  15  is intended to be disposable. The monitor recorder  14 , however, is reusable and can be transferred to successive electrode patches  15  to ensure continuity of monitoring. The placement of the wearable monitor  12  in a location at the sternal midline  16  (or immediately to either side of the sternum  13 ) benefits long-term extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. Instead, the wearer is free to place an electrode patch  15  anywhere within the general region of the sternum  13 . 
     As a result, at any point during ECG monitoring, the wearer&#39;s skin is able to recover from the wearing of an electrode patch  15 , which increases wearer comfort and satisfaction, while the monitor recorder  14  ensures ECG monitoring continuity with minimal effort. A monitor recorder  14  is merely unsnapped from a worn out electrode patch  15 , the worn out electrode patch  15  is removed from the skin, a new electrode patch  15  is adhered to the skin, possibly in a new spot immediately adjacent to the earlier location, and the same monitor recorder  14  is snapped into the new electrode patch  15  to reinitiate and continue the ECG monitoring. 
     During use, the electrode patch  15  is first adhered to the skin in the sternal region.  FIG. 4  is a perspective view showing the extended wear electrode patch  15  of  FIG. 3  without a monitor recorder  14  inserted. A flexible circuit  32  is adhered to each end of the flexible backing  20 . A distal circuit trace  33  from the distal end  30  of the flexible backing  20  and a proximal circuit trace (not shown) from the proximal end  31  of the flexible backing  20  electrically couple ECG electrodes (not shown) with a pair of electrical pads  34 . In a further embodiment, the distal and proximal circuit traces are replaced with interlaced or sewn-in flexible wires, as further described infra beginning with reference to  FIG. 9 . The electrical pads  34  are provided within a moisture-resistant seal  35  formed on the bottom surface of the non-conductive receptacle  25 . When the monitor recorder  14  is securely received into the non-conductive receptacle  25 , that is, snapped into place, the electrical pads  34  interface to electrical contacts (not shown) protruding from the bottom surface of the monitor recorder  14 . The moisture-resistant seal  35  enables the monitor recorder  14  to be worn at all times, even during bathing or other activities that could expose the monitor recorder  14  to moisture or adverse conditions. 
     In addition, a battery compartment  36  is formed on the bottom surface of the non-conductive receptacle  25 . A pair of battery leads (not shown) from the battery compartment  36  to another pair of the electrical pads  34  electrically interface the battery to the monitor recorder  14 . The battery contained within the battery compartment  35  can be replaceable, rechargeable or disposable. 
     The monitor recorder  14  draws power externally from the battery provided in the non-conductive receptacle  25 , thereby uniquely obviating the need for the monitor recorder  14  to carry a dedicated power source. The battery contained within the battery compartment  36  can be replaceable, rechargeable or disposable. In a further embodiment, the ECG sensing circuitry of the monitor recorder  14  can be supplemented with additional sensors, including an SpO2 sensor, a blood pressure sensor, a temperature sensor, respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor, which can be incorporated directly into the monitor recorder  14  or onto the non-conductive receptacle  25 . 
     The placement of the flexible backing  20  on the sternal midline  16  (or immediately to either side of the sternum  13 ) also helps to minimize the side-to-side movement of the wearable monitor  12  in the left- and right-handed directions during wear. However, the wearable monitor  12  is still susceptible to pushing, pulling, and torqueing movements, including compressional and torsional forces when the wearer bends forward, and tensile and torsional forces when the wearer leans backwards. To counter the dislodgment of the flexible backing  20  due to compressional and torsional forces, a layer of non-irritating adhesive, such as hydrocolloid, is provided at least partially on the underside, or contact, surface of the flexible backing  20 , but only on the distal end  30  and the proximal end  31 . As a result, the underside, or contact surface of the longitudinal midsection  23  does not have an adhesive layer and remains free to move relative to the skin. Thus, the longitudinal midsection  23  forms a crimp relief that respectively facilitates compression and twisting of the flexible backing  20  in response to compressional and torsional forces. Other forms of flexible backing crimp reliefs are possible. 
     Unlike the flexible backing  20 , the flexible circuit  32  is only able to bend and cannot stretch in a planar direction.  FIG. 5  is a top view showing the flexible circuit  32  of the extended wear electrode patch  15  of  FIG. 3 . A distal ECG electrode  38  and proximal ECG electrode  39  are respectively coupled to the distal and proximal ends of the flexible circuit  32  to serve as electrode signal pickups. The flexible circuit  32  preferably does not extend to the outside edges of the flexible backing  20 , thereby avoiding gouging or discomforting the wearer&#39;s skin during extended wear, such as when sleeping on the side. During wear, the ECG electrodes  38 ,  39  must remain in continual contact with the skin. A strain relief  40  is defined in the flexible circuit  32  at a location that is partially underneath the battery compartment  36  when the flexible circuit  32  is affixed to the flexible backing  20 . The strain relief  40  is laterally extendable to counter dislodgment of the ECG electrodes  38 ,  39  due to tensile and torsional forces. A pair of strain relief cutouts  41  partially extend transversely from each opposite side of the flexible circuit  32  and continue longitudinally towards each other to define in ‘S’-shaped pattern, when viewed from above. The strain relief respectively facilitates longitudinal extension and twisting of the flexible circuit  32  in response to tensile and torsional forces. Other forms of circuit board strain relief are possible. 
     The flexible circuit  32  can be provided either above or below the flexible backing  20 .  FIG. 6  is a perspective view showing the extended wear electrode patch  15  in accordance with a further embodiment. The flexible circuit (not shown) is provided on the underside, or contact, surface of the flexible backing  20  and is electrically interfaced to the set of electrical pads  34  on the bottom surface of the non-conductive receptacle  25  through electrical contacts (not shown) pierced through the flexible backing  20 . 
     The electrode patch  15  is intended to be a disposable component, which enables a wearer to replace the electrode patch  15  as needed throughout the monitoring period, while maintaining continuity of physiological sensing through reuse of the same monitor recorder  14 .  FIG. 7  is an exploded view showing the component layers of the electrode patch  15  of  FIG. 3 . The flexible backing  20  is constructed of a wearable gauze, latex, woven textile, or similar wrap knit or stretchable and wear-safe material  44 , such as a Tricot-type linen with a pressure sensitive adhesive (PSA) on the underside, or contact, surface. The ends of the wearable material  44  are coated with a layer  43  of non-irritating adhesive, such as hydrocolloid, to facilitate long-term wear, while the unadhesed narrowed midsection rides freely over the skin. The hydrocolloid, for instance, is typically made of mineral oil, cellulose and water and lacks any chemical solvents, so should cause little itching or irritation. Moreover, hydrocolloid can be manufactured into an appropriate thickness and plasticity and provides cushioning between the relatively rigid and unyielding non-conductive receptacle  25  and the wearer&#39;s skin. In a further embodiment, the layer of non-irritating adhesive can be contoured, such as by forming the adhesive with a concave or convex cross-section; surfaced, such as through stripes or crosshatches of adhesive, or by forming dimples in the adhesive&#39;s surface; or applied discontinuously, such as with a formation of discrete dots of adhesive. 
     As described supra with reference to  FIG. 5 , a flexible circuit can be adhered to either the outward facing surface or the underside, or contact, surface of the flexible backing  20 . For convenience, a flexible circuit  47  is shown relative to the outward facing surface of the wearable material  44  and is adhered respectively on a distal end by a distal electrode seal  45  and on a proximal end by a proximal electrode seal  45 . In a further embodiment, the flexible circuit  47  can be provided on the underside, or contact, surface of the wearable material  44 . Through the electrode seals, only the distal and proximal ends of the flexible circuit  47  are attached to the wearable material  44 , which enables the strain relief  40  (shown in  FIG. 5 ) to respectively longitudinally extend and twist in response to tensile and torsional forces during wear. Similarly, the layer  43  of non-irritating adhesive is provided on the underside, or contact, surface of the wearable material  44  only on the proximal and distal ends, which enables the longitudinal midsection  23  (shown in  FIG. 3 ) to respectively bow outward and away from the sternum  13  or twist in response to compressional and torsional forces during wear. 
     A pair of openings  46  is defined on the distal and proximal ends of the wearable material  44  and layer  43  of non-irritating adhesive for ECG electrodes  38 ,  39  (shown in  FIG. 5 ). The openings  46  serve as “gel” wells with a layer of hydrogel  41  being used to fill the bottom of each opening  46  as a conductive material that aids electrode signal capture. The entire underside, or contact, surface of the flexible backing  20  is protected prior to use by a liner layer  40  that is peeled away, as shown in  FIG. 8 . 
     The non-conductive receptacle  25  includes a main body  54  that is molded out of polycarbonate, ABS, or an alloy of those two materials to provide a high surface energy to facilitate adhesion of an adhesive seal  53 . The main body  54  is attached to a battery printed circuit board  52  by the adhesive seal  53  and, in turn, the battery printed circuit board  52  is adhered to the flexible circuit  47  with an upper flexible circuit seal  50 . A pair of conductive transfer adhesive points  51  or, alternatively, soldered connections, or electromechanical connections, including metallic rivets or similar conductive and structurally unifying components, connect the circuit traces  33 ,  37  (shown in  FIG. 5 ) of the flexible circuit  47  to the battery printed circuit board  52 . The main body  54  has a retention catch  26  and tension clip  27  (shown in  FIG. 3 ) that fixably and securely receive a monitor recorder  14  (not shown), and includes a recess within which to circumferentially receive a die cut gasket  55 , either rubber, urethane foam, or similar suitable material, to provide a moisture resistant seal to the set of pads  34 . Other types of design, arrangement, and permutation are possible. 
     In a still further embodiment, the flexible circuit  32  (shown in  FIG. 4 ) and distal ECG electrode  38  and proximal ECG electrode  39  (shown in  FIG. 5 ) are replaced with a pair of interlaced flexile wires. The interlacing of flexile wires through the flexible backing  20  reduces both manufacturing costs and environmental impact, as further described infra. The flexible circuit and ECG electrodes are replaced with a pair of flexile wires that serve as both electrode circuit traces and electrode signal pickups.  FIG. 9  is a perspective view of an extended wear electrode patch  15  with a flexile wire electrode assembly in accordance with a still further embodiment. The flexible backing  20  maintains the unique narrow “hourglass”-like shape that aids long term extended wear, particularly in women, as described supra with reference to  FIG. 3 . For clarity, the non-conductive receptacle  25  is omitted to show the exposed battery printed circuit board  62  that is adhered underneath the non-conductive receptacle  25  to the proximal end  31  of the flexible backing  20 . Instead of employing flexible circuits, a pair of flexile wires are separately interlaced or sewn into the flexible backing  20  to serve as circuit connections for an anode electrode lead and for a cathode electrode lead. 
     To form a distal electrode assembly, a distal wire  61  is interlaced into the distal end  30  of the flexible backing  20 , continues along an axial path through the narrow longitudinal midsection of the elongated strip, and electrically connects to the battery printed circuit board  62  on the proximal end  31  of the flexible backing  20 . The distal wire  61  is connected to the battery printed circuit board  62  by stripping the distal wire  61  of insulation, if applicable, and interlacing or sewing the uninsulated end of the distal wire  61  directly into an exposed circuit trace  63 . The distal wire-to-battery printed circuit board connection can be made, for instance, by back stitching the distal wire  61  back and forth across the edge of the battery printed circuit board  62 . Similarly, to form a proximal electrode assembly, a proximal wire (not shown) is interlaced into the proximal end  31  of the flexible backing  20 . The proximal wire is connected to the battery printed circuit board  62  by stripping the proximal wire of insulation, if applicable, and interlacing or sewing the uninsulated end of the proximal wire directly into an exposed circuit trace  64 . The resulting flexile wire connections both establish electrical connections and help to affix the battery printed circuit board  62  to the flexible backing  20 . 
     The battery printed circuit board  62  is provided with a battery compartment  36 . A set of electrical pads  34  are formed on the battery printed circuit board  62 . The electrical pads  34  electrically interface the battery printed circuit board  62  with a monitor recorder  14  when fitted into the non-conductive receptacle  25 . The battery compartment  36  contains a spring  65  and a clasp  66 , or similar assembly, to hold a battery (not shown) in place and electrically interfaces the battery to the electrical pads  34  through a pair battery leads  67  for powering the electrocardiography monitor  14 . Other types of battery compartment are possible. The battery contained within the battery compartment  36  can be replaceable, rechargeable, or disposable. 
     In a yet further embodiment, the circuit board and non-conductive receptacle  25  are replaced by a combined housing that includes a battery compartment and a plurality of electrical pads. The housing can be affixed to the proximal end of the elongated strip through the interlacing or sewing of the flexile wires or other wires or threads. 
     The core of the flexile wires may be made from a solid, stranded, or braided conductive metal or metal compounds. In general, a solid wire will be less flexible than a stranded wire with the same total cross-sectional area, but will provide more mechanical rigidity than the stranded wire. The conductive core may be copper, aluminum, silver, or other material. The pair of the flexile wires may be provided as insulated wire. In one embodiment, the flexile wires are made from a magnet wire from Belden Cable, catalogue number  8051 , with a solid core of AWG  22  with bare copper as conductor material and insulated by polyurethane or nylon. Still other types of flexile wires are possible. In a further embodiment, conductive ink or graphene can be used to print electrical connections, either in combination with or in place of the flexile wires. 
     In a still further embodiment, the flexile wires are uninsulated.  FIG. 10  is perspective view of the flexile wire electrode assembly from  FIG. 9 , with a layer of insulating material  69  shielding a bare uninsulated distal wire  61  around the midsection on the contact side of the flexible backing. On the contact side of the proximal and distal ends of the flexible backing, only the portions of the flexile wires serving as electrode signal pickups are electrically exposed and the rest of the flexile wire on the contact side outside of the proximal and distal ends are shielded from electrical contact. The bare uninsulated distal wire  61  may be insulated using a layer of plastic, rubber-like polymers, or varnish, or by an additional layer of gauze or adhesive (or non-adhesive) gel. The bare uninsulated wire  61  on the non-contact side of the flexible backing may be insulated or can simply be left uninsulated. 
     Both end portions of the pair of flexile wires are typically placed uninsulated on the contact surface of the flexible backing  20  to form a pair of electrode signal pickups.  FIG. 11  is a bottom view of the flexile wire electrode assembly as shown in  FIG. 9 . When adhered to the skin during use, the uninsulated end portions of the distal wire  61  and the proximal wire  71  enable the monitor recorder  14  to measure dermal electrical potential differentials. At the proximal and distal ends of the flexible backing  20 , the uninsulated end portions of the flexile wires may be configured into an appropriate pattern to provide an electrode signal pickup, which would typically be a spiral shape formed by guiding the flexile wire along an inwardly spiraling pattern. The surface area of the electrode pickups can also be variable, such as by selectively removing some or all of the insulation on the contact surface. For example, an electrode signal pickup arranged by sewing insulated flexile wire in a spiral pattern could have a crescent-shaped cutout of uninsulated flexile wire facing towards the signal source. 
     In a still yet further embodiment, the flexile wires are left freely riding on the contact surfaces on the distal and proximal ends of the flexible backing, rather than being interlaced into the ends of the flexible backing  20 .  FIG. 12  is a bottom view of a flexile wire electrode assembly in accordance with a still yet further embodiment. The distal wire  61  is interlaced onto the midsection and extends an exposed end portion  72  onto the distal end  30 . The proximal wire  71  extends an exposed end portion  73  onto the proximal end  31 . The exposed end portions  72  and  73 , not shielded with insulation, are further embedded within an electrically conductive adhesive  81 . The adhesive  81  makes contact to skin during use and conducts skin electrical potentials to the monitor recorder  14  (not shown) via the flexile wires. The adhesive  81  can be formed from electrically conductive, non-irritating adhesive, such as hydrocolloid. 
     The distal wire  61  is interlaced or sewn through the longitudinal midsection of the flexible backing  20  and takes the place of the flexible circuit  32 .  FIG. 13  is a perspective view showing the longitudinal midsection of the flexible backing of the electrode assembly from  FIG. 9 . Various stitching patterns may be adopted to provide a proper combination of rigidity and flexibility. In simplest form, the distal wire  61  can be manually threaded through a plurality of holes provided at regularly-spaced intervals along an axial path defined between the battery printed circuit board  62  (not shown) and the distal end  30  of the flexible backing  20 . The distal wire  61  can be threaded through the plurality of holes by stitching the flexile wire as a single “thread.” Other types of stitching patterns or stitching of multiple “threads” could also be used, as well as using a sewing machine or similar device to machine-stitch the distal wire  61  into place, as further described infra. Further, the path of the distal wire  61  need not be limited to a straight line from the distal to the proximal end of the flexible backing  20 . 
     The distal wire  61  is flexile yet still retains a degree of rigidity that is influenced by wire gauge, composition, stranding, insulation, and stitching pattern. For example, rigidity decreases with wire gauge; and a solid core wire tends to be more rigid than a stranded core of the same gauge. The combination of the flexibility and the rigidity of the portion of the distal wire  61  located on or close to the midsection contributes to the overall strength and wearability of the patch.  FIG. 14  is a longitudinal cross-sectional view of the midsection of the flexible backing  20  of the electrode assembly of  FIG. 11 .  FIGS. 15A-C  are the electrode assembly from  FIG. 14  under compressional, tensile, and bending force, respectively. The relative sizes of the distal wire  61  and flexible backing  20  are not to scale and are exaggerated for purposes of illustration. 
     The interlacing of the distal wire  61  through the narrow longitudinal midsection  22  of the flexible backing  20  bends the distal wire  61  into a line of rounded stitches that alternate top and bottom, which can be advantageous to long term wearability. First, the tension of the rounded stitches reinforces the planar structure of the narrow longitudinal midsection  22  and spreads a dislodging force impacting on one end of the flexible backing  20  to the other end of the flexible backing  20 . Second, the rounded stitches leave room for stretching, compressing, bending, and twisting, thus increasing the wearability of the patch extended wear electrode patch  15  by facilitating extension, compression, bending, and twisting of the narrow longitudinal midsection  22  in response to tensile, compressional, bending, and torsional forces. 
     In a further embodiment, the distal wire and the proximal wire may be stitched or sewn into the flexible backing  20 . Depending upon the type of stitching used, the distal or proximal wire may use more than one individual wire. For instance, a conventional sewing machine used to stitch fabrics uses a spool of thread and a bobbin, which are both wound with thread that together allow the creation of various stitching patterns, such as the lockstitch. Other type of stitching patterns are possible. Additionally, where more than one “threads” are used for stitching, the flexile wire may constitute all of the “threads,” thereby increasing redundancy of the circuit trace thus formed. Alternatively, just one (or fewer than all) of the threads may be conductive, with the non-conductive threads serving to reinforce the strength of the flexile wire connections and flexible backing  20 . The additional threads can be made from line, threads, or fabrics of sufficient mechanical strength and do not need to be conductive; alternatively, the same flexile wires can be employed to serve as the additional threads. 
     Conventionally, flexible circuits, such as the flexible circuit  32  (shown in  FIG. 4 ) that connects the distal ECG electrode  38  and proximal ECG electrode  39  (shown in  FIG. 5 ) to the battery printed circuit board  62  (shown in  FIG. 9 ), are constructed using subtractive processes. In general, a flexible circuit interconnects electronic components with custom point-to-point circuit traces and is typically constructed by forming the conductive circuit traces on a thin film of insulating polymer. A flexible circuit is not an off-the-shelf component; rather, each flexible circuit is designed with a specific purpose in mind. Changes to a flexible circuit&#39;s design will generally require fabricating entirely new flexible circuits, as the physical circuit traces on the polymer film cannot be changed. 
     Manufacturing a flexible circuit typically requires the use of sophisticated and specialized tools, coupled with environmentally unfriendly processes, including depositing copper on a polyamide core, etching away unwanted copper with inline etching or an acid bath to retain only the desired conductive circuit traces, and applying a coverlay to the resulting flexible circuit. Significant amounts of hazardous waste are generated by these subtractive processes during the fabrication of each flexible circuit. Properly disposing of such hazardous waste is expensive and adds to the costs of the flexible circuit. 
     In the still further embodiment described supra beginning with reference to  FIG. 9 , the distal and proximal flexile wires replace the flexible circuit  32  and enables the electrode assembly to be constructed using additive processes with off-the-shelf, low cost components. The flexile wires serve the triple functions of an electrode signal pickup, electrical circuit trace, and support for structural integrity and malleability of the electrode assembly. 
     The general manner of constructing the electrode assembly can be applied to other forms of electronic components in which custom point-to-point circuit traces need to be affixed to a gauze or textile backing, as well as backings made from other materials. The circuit traces are replaced by the interlaced or sewn flexile wires, and the ends of each flexile wire are terminated, as appropriate to the application. The flexile wires may, by example, connect two circuit boards, or connect to an electrical terminal, power source, or electrical component. In addition, flexile wires may be used to replace a printed circuit board entirely, with each flexile wire serving as a form of sewn interconnect between two or more discrete components, including resistors, capacitors, transistors, diodes, operational amplifiers (op amps) and other integrated circuits, and other electronic or electromechanical components. 
     By way of illustration, the flexile wires will be described as terminated for use in an electrode assembly, specifically, as terminated on one end to form an electrode signal pickup and on the other end to connect into a circuit board. Constructing the electrode assembly entails interlacing, including manually threading, or machine sewing the flexile, conductive wire through the flexible backing  20 .  FIG. 16  is a flow diagram showing a method  90  for constructing a stress-pliant physiological electrode assembly in accordance with a further embodiment. The method can be performed by a set of industrial machines, including a gauze cutting machine to cut the flexible backing  20  to form; a hole punch to cut a plurality of holes provided at regularly-spaced intervals; a stitching or sewing machine to interleave or sew the flexile wire through the flexible backing  20 ; a wire stripper or plasma jet to remove insulation from the flexile wire, when applicable; and a glue or adhesive dispenser to embed or coat electrode signal pickup in hydrocolloid gel or equivalent non-irritating adhesive. Other forms or combinations of industrial machines, including a single purpose-built industrial machine, could be used. 
     As an initial step, a backing is cut to shape and, if required, holes are cut at regularly-spaced intervals along an axial path (step  91 ) through which the flexile wire will be interlaced. Holes will need to be cut, for instance, if the flexile wire is to be hand-guided through the backing, or where the backing is cut from a material that is difficult to puncture with a threaded needle, such as used by a sewing machine. In one embodiment, the backing is cut from wearable gauze, latex, woven textile, or similar wrap knit or stretchable and wear-safe material, such as a Tricot-type linen; the resulting backing is flexible and yielding. The backing is also cut into an elongated “hourglass”-like shape, when viewed from above, with a pair of cut-outs and a longitudinal midsection that together help minimize interference with and discomfort to breast tissue, particularly in women (and gynecomastic men), such as described supra with reference to  FIG. 3 . The backing can be cut into other shapes as appropriate to need. In addition, depending upon the application, other materials could be substituted for the backing. For example, neoprene, such as used in wetsuits, could be used where a high degree of elasticity and ruggedness is desired. 
     The flexile wire is then interlaced or sewn into the backing (step  92 ). Interlacing can be performed by a machine that guides the flexile wire through the holes previously cut in the material in a crisscrossed, interwoven, or knitted fashion, as well as by hand. The flexile wire can also be guided through the backing without first cutting holes, provided that the weave of the material is sufficiently loose to allow passage of the flexile wire if the flexile wire is otherwise incapable of passing through the backing without the assistance of a needle or other piercing instrument. 
     Alternatively, the flexile wire could be sewn into the backing by using the flexile wire as “thread” that is stitched into place using a needle or similar implement. If a single flexile wire is employed, the stitching will be a line of rounded stitches that alternate top and bottom, as described supra; however, if more than one flexile wire is used, or the stitching pattern requires the use of more than one thread, other forms of conventional machine-stitching patterns could be employed, such as a lockstitch. 
     Once completed, the interlacing or sewing of the flexile wire into the backing creates an integrated point-to-point electrical path that takes the place of a custom circuit trace using an additive, rather than subtractive, manufacturing process. The flexile wire can be interlaced or sewn along a straight, curved, or arbitrary path. One flexile wire is required per point-to-point circuit trace. The strength and pliability of the flexile wire reinforces the backing and, in the still further embodiment described supra beginning with reference to  FIG. 9 , facilitates extension, compression, bending, and twisting of the narrow longitudinal midsection  22  in response to tensile, compressional, bending, and torsional forces. Thus, the path of the flexile wire along the backing can be mapped to take advantage of the strength and reinforcing properties of the flexile wire, which, when interlaced or sewn into the backing, help the backing counter the stresses to which the backing will be subjected when deployed. 
     The flexile wire itself may be insulated or bare (step  93 ). When one end of the flexile wire is connected to (or forms) an electrode, particularly a dermal physiology electrode that senses electrical potentials on the skin&#39;s surface, insulated flexile wire will ordinarily be used, with only a portion of the flexile wire incident to the electrode stripped of insulation. However, bare uninsulated flexile wire could alternatively be used throughout, so long as those portions of the uninsulated flexile wire that are exposed on the contact-facing surface of the backing are insulated and shielded from electrical contact (step  94 ), such as by applying a layer of plastic, rubber-like polymers, or varnish, or by an additional layer of gauze or adhesive (or non-adhesive) gel over the exposed wire. The uninsulated flexile wire exposed on other surfaces of the backing could also be insulated or simply be left bare. 
     One end of the flexile wire may be terminated as an electrode signal pickup (step  95 ). If insulated flexile wire is used, a portion of the end of the flexile wire is stripped of insulation (step  96 ) using, for instance, a wire stripper or plasma jet. The electrode signal pickup could either be formed by interlacing (or sewing) the flexile wire (step  97 ) into the backing in the shape of the desired electrode (step  98 ) or positioned over the contact-facing area of the backing designated to serve as an electrode signal pickup and embedded within an electrically conductive adhesive (step  99 ). In a yet further embodiment, the flexile wire could be terminated as a connection to a discrete electrode, such as by sewing an uninsulated portion of the end of the electrode wire into the discrete electrode to thereby establish an electrical contact and affix the discrete electrode to the backing. The Universal ECG EKG electrode, manufactured by Bio Protech Inc., Tustin, Calif., is one example of a discrete electrode. 
     Finally, the other end of the flexile wire may be terminated as a connection to a circuit board (step  100 ). The flexile wire can be interlaced or sewn onto the circuit board, for instance, by back stitching the flexile wire back and forth across the edge of the circuit board to thereby establish an electrical contact and affix the discrete electrode to the backing. 
     In a further embodiment, flexile wire can be used to replace all or part of a printed circuit board, such as battery printed circuit board  62  used in constructing a stress-pliant physiological electrode assembly, as described supra, or for any other application that requires interconnection of electrical or electro mechanical components on a physical substrate or backing. Flexile wire in place of conductive circuit traces can work especially well with simple circuit board layouts, where ample space between components and relatively uncomplicated layouts are amenable to stitched-in interconnections. In addition, the use of flexile wire can simplify circuit layout design in multilayer circuits, as insulated flexile wires can be run across each other in situations that would otherwise require the use of a multilayer printed circuit board or similar solution. 
     Through such use of flexile wire, a printed circuit board can be omitted in whole or in part. Interconnects between and connections to the electronic and electro mechanical components formerly placed on the printed circuit board can instead be sewn from flexile wire. For instance, the battery printed circuit board  62  can be replaced by flexile wire interconnects that connect the electrodes to a sewn set of electrical pads formed by over-stitching the flexile wire into electrical contact surfaces of sufficient size to interface with a monitor recorder  14  when fitted into the non-conductive receptacle  25 . Likewise, the spring  65  and clasp  66  can be sewn in place using flexile wire to hold a battery in place with flexile wire interconnects connecting the battery to a sewn set of electrical pads formed by over-stitching the flexile wire into electrical contact surfaces of sufficient size to interface with a monitor recorder  14  when fitted into the non-conductive receptacle  25 . Still other approaches to replacing printed circuit boards with flexile wire interconnects are possible. 
     The resultant stress-pliant physiological electrode assembly may be electrically coupled to a broad range of physiological monitors not limited to electrocardiographic measurement. The foregoing method of constructing a stress-pliant electrode assembly is adaptable to manufacturing other forms of dermal electrodes, including electrodes for electrocardiography, electroencephalography, and skin conductance measurements. Further, by adjusting the number of electrodes, the distances among the electrode signal pickups, and the thickness of the flexile wire, the method can be adapted to manufacturing at low cost an electrode assembly that is lightweight and resistant to tensile, compressional and torsional forces, thus contributing to long-term wear and versatility. 
     The extended wear electrocardiography monitor, described supra with reference to  FIGS. 1-16 , is generally worn as a patch adhered to the skin during use. Some patients, however, may not be able to wear an adhesive patch due to allergic reaction, skin condition, or other factors that make the wearing of an adhesive patch, even for a short duration, either undesirable or impracticable. Moreover, athletes, particularly when interested in monitoring performance during training and sports activities, may find the wearing of an adhesive patch a hindrance to movement and at odds with performance monitoring. 
     As an alternative to an adhesively-attached electrode patch, the electrodes of the extended wear electrocardiography monitor can be integrated into a wearable garment that can be coupled with a monitor recorder  14  (shown in  FIG. 1 ) or similar recordation device.  FIG. 17  is a front view of a wearable electrocardiography and physiology monitoring ensemble  300  in accordance with a further embodiment. The wearable monitoring ensemble  300  is provided through a wearable garment  301 , such as a shirt, blouse, or tunic, that is worn about the upper region of the torso that is equipped with an electrode assembly  313 . The wearable garment  301  is constructed, at least in part, using a compressible and elastomeric material, such as Spandex, formerly manufactured by E.I. du Pont de Nemours and Company (“DuPont”), Wilmington, Del.; Lycra, manufactured by Koch Industries, Inc., Wichita, Kans.; or elastane. Other types or combinations of compressible and elastomeric materials are possible. 
     An electrode patch achieves fully continuous electrode contact through an adhesive or a fixing agent that adheres a gauze or similarly-woven or flexible material against the skin; the gauze serves as a backing to each electrode, which is held captive and firmly in place between the skin and the gauze. In addition, the electrodes themselves could be coated with an adhesive to self-adhere the electrodes directly to the skin. In both forms, the presence of adhesive on the skin&#39;s surface can be at variance with extended long-term wear, especially on patients with sensitive or fragile skin or who have allergies or sensitivities to the chemicals or materials used in adhesive patches. 
     The construction of the wearable garment  301  employs an internal structure  302  that obviates the need to use adhesives or other fixing agents to hold electrophysiology and physiology sensing electrodes into place. The internal structure  302  allows the wearable garment  301  to exert a compressive force against an electrode assembly  313  that is sufficient to keep the electrodes  309  and  310  in usably-continuous contact with the wearer&#39;s skin throughout the monitoring period. The electrode assembly  313  contains at least two electrodes  309  and  310  that are both affixed to a backing, either individually or combined. The electrode assembly  313  is provided on an inside-facing surface of the wearable garment  301  on an underside of the internal structure  302  to keep the electrode assembly  313  firmly against the wearer&#39;s skin. In contrast to an electrode-equipped adhesive patch, the wearable garment  301  permits unconstrained free movement during monitoring and the wearer is typically unaware of the presence of the electrode assembly  313 . However, to effectively measure electrophysiology, the electrodes  309  and  310  need to be kept in fairly continuous, albeit not absolutely constant, physical contact with the skin. 
     The wearable monitoring ensemble  300  obviates the necessity of adhesives or other fixing agents that adhere directly to the skin by utilizing the internal structure  302  of the wearable garment  301  to place and retain the electrode assembly  313  securely against the skin. To some degree, internal structure  302  inherent in the overall design of the wearable garment  301 , when in the form of clothing worn about the torso, specifically, a shirt, blouse, or tunic, will retain the relative positions of the various panels that make up the wearable garment  301  in place during wear. Elements of the inherent garment design include, for instance, the openings for the arms  303   a  and  303   b , the neck  304 , and torso  305  proper. Other elements of inherent garment design are possible. 
     To facilitate monitoring purposes, though, the relative position of the panel upon which the sensory assembly  313  is affixed to the internal structure  302  on the inside surface of the wearable garment  301  must be kept from dramatically shifting about; the location of the electrode assembly  313  ought to be sufficiently stable, so as to avoid displacing the underlying electrodes  309  and  310  to the degree that cardiac electric potential signals are degraded or change character. 
     The inherent design of the wearable garment  301  only provides a partial solution and these structures alone will not suffice to maintain the electrode assembly  313  in fairly continuous physical contact with the skin. The internal structure  302  of the wearable garment  301  is biased to press snuggly against the skin in at least those portions of the wearable garment  301  where the electrode assembly  313  need be held in a relatively stable orientation. The compressive bias is provided by the compressible and elastomeric material and the internal structure  302 , which can include elastic bands  306   a ,  306   b ,  306   c , and  306   d , embedded longitudinally across the chest, or by a combination of fabric components with varying characteristics of elasticity. 
     The compressive force imparted by the wearable garment  301  on the electrode assembly  313  is provided by placing the electrode assembly  313  on an inside surface of the wearable garment  301  on an underside of the internal structure  302 , such that the electrode assembly  313  is firmly “pinned” in place against the skin, yet not adhered. The amount of side-to-side shift or momentary loss of contact that can be tolerated without signal degradation or compromise depends upon the monitoring location. For instance, to optimize capture of P-wave signals, the electrode assembly  313  can advantageously be positioned axially along the midline of a wearer&#39;s sternum, such as described in commonly-assigned U.S. Pat. No. 9,700,227, the disclosure of which is incorporated by reference. To secure the electrode assembly  313  in the desired orientation axially along the sternal midline, the wearable garment  301  integrates a bias that imparts compressive force circumferentially about the wearer&#39;s torso; the compressive force is sufficient to keep the two electrodes  309  and  310  against the skin for the majority of the time during wear and monitoring. However, whereas an electrode patch seeks to keep the electrodes in continuous and stationary contact with the skin at all times, the electrodes here are permitted to actively “float” over the skin&#39;s surface, so long at least a part of an electrode&#39;s surface contacts the skin. Thus, to a limited extent, the electrodes  309  and  310  can slide around the general region on the skin where a cardiac electric potential signal sensing is desired. In addition, the occasional loss of signal pick up that can occur if the electrode assembly  313  briefly loses contact with the skin, such as happens if the wearer makes a sudden movement, can be weathered; cardiac electric potential signals lost through a momentary loss of skin contact are not likely to adversely degrade overall signal fidelity, so long as the loss of contact is sufficiently brief and spans say, no more than a few heartbeats. As a result, the wearable garment  301  needs to keep the electrode assembly  313  oriented on the skin in the same overall spot, but the electrode assembly  313  need not be fixed as an absolutely stationary location and some degree of sliding movement or “float” along the skin&#39;s surface is permissible. 
     The electrode assembly  313  is also provided with two electrical connections  311  and  312  through which a monitor recorder can receive and record electrical potential signals. One end of each of the electrical connections  311  and  312  is connected to one of the electrodes  309  and  310 , while the other end of each of the electrical connections  311  and  312  is terminated to suit interfacing with a compatible form of monitor recorder. In one embodiment, the electrical connections  311  and  312  can be connected to the pair of electrical pads  34  provided on the non-conductive receptacle  25  (shown in  FIG. 4 ) to electrically couple the electrodes  309  and  310  to a reusable monitor recorder  14 . In a further embodiment, the electrical connections can be adapted to wirelessly interface to a wireless-capable monitor recorder. Each of the electrical connections  311  and  312  are interfaced to a wireless transceiver over which the cardiac electric potential signals sensed by the electrodes  309  and  310  are transmitted. Other forms of terminating the electrical connections  311  and  312  to interface to a monitor recorder are possible. 
     The electrode assembly  313  can be packaged in at least three different forms, including a flexible circuit electrode assembly and flexile wire electrode assemblies with discrete or sewn-in electrodes. These forms of sensor assemblies will now be discussed. First,  FIG. 18  is a contact-surface view of a flexible circuit electrode assembly  313  of the wearable monitoring ensemble  300  of  FIG. 17 . The electrode assembly  313  contains two electrodes  309  and  310 , which are formed on two flexible circuits  314  and  315 , respectively. In a further embodiment, the two electrodes  309  and  310  can be formed on a single flexible circuit. The flexile circuits include circuit traces  311  and  312  that terminate respectively with electrical pads  316  and  317  for mating with, for instance, the pair of electrical pads  34  provided on the non-conductive receptacle  25 . 
     Second, the two flexible circuits  314  and  315  can be replaced with a pair of flexile wires that are sewn or stitched into a pair of discrete electrodes, such as described supra with reference to  FIGS. 9 through 15A -C.  FIG. 19  is a contact-surface view of a flexile wire interconnect  320  of the wearable monitoring ensemble  300  of  FIG. 17 . The two electrodes  309  and  310  are stitched or sewn  323  and  324  into the compressible and elastomeric material (not shown) using a pair of flexile wires  321  and  322 . The insulation is first stripped from the ends of the pair of flexile wires  321  and  322  and an electrical connection is established between the two electrodes  309  and  310  and the pair of flexile wires  321  and  322 . In similar fashion, the pair of flexile wires  321  and  322  can be electrically connected on their opposite ends to additional components  325  and  326 , such as the non-conductive receptacle  25 , electrical terminals, or a wireless transceiver, by stripping insulation from and sewing or stitching  327  and  328  the other ends of the flexile wires  321  and  322  into the additional components  325  and  326 . Other ways of interconnecting electrodes and additional components using flexile wire, including soldering and crimping, are possible. 
     Finally, both the two flexible circuits  314  and  315  and the two electrodes  309  and  310  can be respectively replaced with a pair of flexile wires and a pair of sewn-in electrodes.  FIG. 20  is a contact-surface view of a flexile wire electrode and interconnect  330  of the wearable monitoring ensemble  300  of  FIG. 17 . A pair of electrodes  323  and  324  are stitched or sewn into the compressible and elastomeric material (not shown) using a pair of flexile wires  321  and  322 . The pair of flexile wires  321  and  322  can be electrically connected on their opposite ends to additional components  325  and  326 , such as the non-conductive receptacle  25 , electrical terminals or a wireless transceiver, by stripping insulation from and sewing or stitching  327  and  328  the other ends of the flexile wires  321  and  322  into the additional components  325  and  326 . Other ways of interconnecting electrodes and additional components using flexile wire, including soldering and crimping, are possible. 
     The wearable monitoring ensemble  300  is advantageous for both patients and athletes because the ambulatory apparatus can collect high-quality ECG and physiological data while the wearer engages in activities of daily living. ECG data are crucial for diagnosing many cardiovascular conditions, but additional data are often necessary for differential diagnoses, such as in diabetic and hypertensive patients. Cardiovascular patients must take particular care in monitoring their status to avoid related adverse events; for example, monitoring temperature can be helpful in cardiovascular patients because cardiovascular system compromises patients&#39; capacity for maintaining a normal body temperature, and cardiovascular patients may be more susceptible to hypothermia in cool environments. 
     Athletes also benefit from ECG data combined with additional physiological data to prevent adverse cardiac events, including power sports athletes, aged athletes, and young athletes with congenital heart conditions. Moreover, ECG data combined with other physiological data may aid athletes in optimizing performance. In many instances, blood sugar measurements may aid in generating a diagnosis, prognosis, and treatment plan as well as predicting athletic performance. For example, patients with diabetes or blood sugar levels that are greater than normal are also more likely to develop certain heart diseases, such as ischemic heart disease and myocardial infarction. Moreover, multiple types of physiological data may be combined to predict additional disease conditions, such as the combination of high blood pressure, coronary heart disease, and diabetes, which can severely damage cardiac muscle and lead to heart failure. In addition, blood sugar plays a strong role in athletic performance and recovery; thus, athletes benefit from both monitoring their blood sugar before, during, and after exercise as well as using the monitoring data to elucidate undiagnosed blood sugar conditions. For example, exercise-induced hypoglycemia can severely hamper performance and may indicate a more serious condition that can lead to sudden death. 
     Monitoring blood pressure may also be key to elucidating a patient&#39;s or athlete&#39;s underlying physical condition. Hypertension is the greatest risk factor for cardiovascular disease in both normal and athlete populations. Dubbed the “silent killer,” hypertension is both common as well as under-diagnosed and can damage various organs, leading to a higher risk of left ventricular hypertrophy and sudden death, among other conditions. Further, combined with ECG data, it may provide critical data for determining a patient&#39;s cardiovascular condition. For example, as noted above, heart failure is more likely in patients with high blood pressure combined with heart disease and blood sugar dysregulation. Further, silent ischemia is often diagnosed through detecting hypertension and ST depression, which is best observed using an ambulatory ECG device; a combined prolonged QT interval and hypertension are associated with increased risk of pathological cardiovascular conditions, including the risk of sudden death; and hypertensive patients with abnormal T wave patterns exhibit increased left ventricular mass, which enhances the risk of adverse cardiac events, including sudden death. Moreover, while the athletic population maintains a lower blood pressure generally, hypertension remains the greatest cardiac risk factor for athletes. Further, athletes benefit from blood pressure monitoring, particularly during exercise, because untreated hypertension can significantly impair athletic performance; moreover, older athletes are at particular risk for undiagnosed hypertension. 
     Further, detecting abnormal respiratory function may facilitate diagnosis, prognosis, and treatment of certain disorders in both patients and athletes. For example, Cheyne-Stokes breathing associated with chronic heart failure is a predictor of poor prognoses associated with cardiac death. In addition, cardiorespiratory conditions are common in athletes but are often undiagnosed. Such conditions not only impair performance, but overtraining with a cardiorespiratory may lead to severe consequences, such as sudden death due to severe bronchoconstriction. Further, sleep decreases the diagnostic efficacy of ECG monitoring alone due to natural heart rate decrease during sleep. As a patient enters non-rapid eye movement (NREM) sleep, the patient undergoes physiological changes due to less sympathetic nervous system activity. Thus, even healthy people may experience sinus bradyarrhythmia during sleep, and ECG monitoring alone may reveal whether the bradyarrhythmia is natural or due to a pathological condition, such as an apnea. Further, if a patient experiences other types of arrhythmias during sleep, a physician may not be able to determine whether an arrhythmia is due to sleep apnea or other morbidity without measuring the patient&#39;s air flow, which is the flow of air in and out of the patient&#39;s lungs during breathing, or other respiration indicator. However, considering that cardiac manifestations of sleep apnea are most apparent at night, short-term ECG monitoring during business hours may not reveal cardiac arrhythmia. 
     While the invention has been particularly shown and described as referenced to the embodiments thereof, those skilled in the art will understand that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope.