Extended wear electrocardiography patch

• US 9,545,204 B2
• Filed: 11/14/2013
• Issued: 01/17/2017
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bishay, Jon Mikalson, Bardy, Gust H., Felix, Jason
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US14/080,717
• Publication Number:
  US 20150087948A1
• Time in Patent Office: 1,160 Days
• Field of Search: 600/372, 600/382, 600/384, 600/386, 600/388, 600390-393, 600508-509
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/259 : using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 : Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 : Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/335 : using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 : by template matching
• CPC Class Codes: A61B 5/4809 : Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G01N 27/307 : Disposable laminated or multilayered electrodes G01N27/3272 takes precedence

Abstract

Physiological monitoring can be provided through a wearable monitor that includes a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum, which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. The electrode patch is shaped to fit comfortably and conformal to the contours of the chest approximately centered on the sternal midline. To counter the dislodgment due to compressional and torsional forces, non-irritating adhesive is provided on the underside, or contact, surface of the electrode patch, but only on the distal and proximal ends. To counter dislodgment due to tensile and torsional forces, a strain relief is defined in the electrode patch'"'"'s flexible circuit using cutouts partially extending transversely from each opposite side of the flexible circuit and continuing longitudinally towards each other to define in ‘S’-shaped pattern.

Claims

1. An extended wear electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection evenly tapering inward from both ends, the elongated strip adherable only on a contact surface defined on each of the ends, and operable to serve as a crimp relief to facilitate compression of the narrow longitudinal midsection in response to compressional and torsional forces;

a pair of electrocardiographic electrodes respectively affixed to and conductively exposed on the contact surface of each end of the elongated strip;

a flexible circuit affixed on each end to the elongated strip and comprising a pair of circuit traces each originating within one of the ends of the elongated strip, respectively; and

electrically coupled to one of the electrocardiographic electrodes, respectively;

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

a laterally-extendable strain relief defined in the flexible circuit underneath such that the non-conductive receptacle on the flexible backing covers the strain relief, wherein the strain relief is operable to facilitate extension and rotation of the flexible circuit in response to tensile and torsional forces; and

a pair of strain relief cutouts comprised in the strain relief that each face towards the other strain relief cutout and is positioned transverse to a length of the flexible backing, each strain relief cutout partially extending transversely from and continuing longitudinally to a side of the flexible circuit different than the other strain relief cutout, one of the pair of the circuit traces following a path formed on the flexible circuit between the pair of the strain relief cutout.

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

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

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

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

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

a lower part of the elongated strip defined on another end of the flexible backing;

the one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

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

4. An electrocardiography patch according to claim 1, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

5. An electrocardiography patch according to claim 1, wherein the pair of the strain relief cutouts define an ‘

S’

-shaped pattern in the flexible circuit when viewed from above.

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

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

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

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

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

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

9. An electrocardiography patch according to claim 1, further comprising:

a contoured surface comprised on the non-irritating adhesive dressing on at least one end of the elongated strip.

10. An electrocardiography patch according to claim 1, further comprising:

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

11. An electrocardiography patch according to claim 1, further comprising at least one of:

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

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

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

12. An extended wear hourglass-shaped electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection evenly tapering inward from both ends into an hourglass-shaped pattern when viewed from above;

a contact surface of the flexible backing comprising a non-irritating adhesive dressing at least partially coated on each end and lacking the non-irritating adhesive dressing on the narrow longitudinal midsection;

a pair of electrocardiographic electrodes respectively affixed to and conductively exposed on the contact surface of each end of the flexible backing;

a non-conductive receptacle securely adhered on the one end of the flexible backing opposite the contact surface and operable to removably receive an electrocardiography monitor; and

a flexible circuit affixed to each end of the flexible backing, comprising;

a pair of circuit traces each originating within one of the ends of the flexible backing, respectively;

each circuit trace electrically coupled to one of the electrocardiographic electrodes, respectively; and

a pair of strain relief cutouts positioned underneath the non-conductive receptacle, transverse to a length of the flexible backing and that such that the non-conductive receptacle covers the strain relief cutouts, each of which face towards the other strain relief cutout, each strain relief cutout and partially extend transversely from and continue longitudinally to a side of the flexible circuit different than the other strain relief cutout, one of the pair of the circuit traces following a path formed on the flexible circuit between the pair of the strain relief cutouts.

13. An electrocardiography patch according to claim 12, wherein one of the electrocardiographic electrodes is disposed for being adhered to a region overlying the Xiphoid process on a patient'"'"'s chest and the other of the electrocardiographic electrodes is disposed for being adhered to the region in near the manubrium and oriented centrally (in the midline) along the sternum upwards from the one electrocardiographic electrode.

14. An electrode patch according to claim 12, further comprising:

an upper part of the hourglass-shaped pattern sized to seat the non-conductive receptacle on the outward-facing surface of the flexible backing; and

a lower part of the hourglass-shaped pattern comprising a size smaller than the upper part of the hourglass-shaped pattern.

15. An electrocardiography patch according to claim 14, wherein the lower part is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part oriented upwards towards the manubrium.

16. An electrocardiography patch according to claim 12, further comprising:

the non-conductive receptacle comprising electrode terminals aligned to electrically interface the electrocardiographic electrodes via the pair of the circuit traces to the electrocardiography monitor.

17. An electrocardiography patch according to claim 12, further comprising:

a pair of concave cut-outs defined along the longitudinal edges of the elongated strip, each concave cut-out contoured conformal to substantially clear an intermammary cleft.

18. An electrocardiography patch according to claim 12, further comprising:

a battery comprised in the non-conductive receptacle and disposed to provide power to the electrocardiography monitor.

19. An electrocardiography patch according to claim 12, wherein the stretchable material comprises at least one of wearable gauze, wearable latex, wrap knit fabric, and Tricot linen.