ADHERENT DEVICE WITH MULTIPLE PHYSIOLOGICAL SENSORS

• US 20120108920A1
• Filed: 01/10/2012
• Published: 05/03/2012
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Bly, Mark J., Amurthur, Badri, James, Kristofer J., Libbus, Imad, Manicka, Yatheendhar D., Mazar, Scott T., Wang, Jerry S.
• Granted Patent: US 8,285,356 B2
• Time in Patent Office: Days
• US Class Current: 600/306
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• 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 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/30 : Input circuits therefor
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 : Detecting fibrillation
• CPC Class Codes: A61B 5/363 : Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/443 : Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/4869 : Determining body composition
• CPC Class Codes: A61B 5/4875 : Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/00 : Instruments for auscultation
• CPC Class Codes: A61B 7/003 : Detecting lung or respiration noise
• CPC Class Codes: A61N 1/046 : Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0476 : Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 : Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36521 : the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36535 : controlled by body position or posture
• CPC Class Codes: A61N 1/36542 : controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36592 : controlled by the heart rate variability
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

An adherent device to monitor a patient for an extended period comprises a breathable tape. The breathable tape comprises a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient. At least one electrode is affixed to the breathable tape and capable of electrically coupling to a skin of the patient. A printed circuit board is connected to the breathable tape to support the printed circuit board with the breathable tape when the tape is adhered to the patient. Electronic components electrically are connected to the printed circuit board and coupled to the at least one electrode to measure physiologic signals of the patient. A breathable cover and/or an electronics housing is disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape.

Claims

1. An adherent device to monitor a patient for an extended period, the device comprising:

a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient;

at least one electrode affixed to the breathable tape and capable of electrically coupling to a skin of the patient;

electronic components electrically coupled to the at least one electrode to measure physiologic signals of the patient, the electronic components coupled to the breathable tape to support the electronic components when the tape is adhered to the patient;

an electronics housing covering the electronic components; and

a breathable cover disposed over the electronic components such that the electronics housing is disposed between the cover and the electronic components.

2. The adherent device of claim 1, further comprising a printed circuit board to which the electronic components are electrically connected.

3. The adherent device of claim 2, further comprising a flexible connection structure to couple the electrodes to the printed circuit board so as to relieve strain between the electrodes and the printed circuit board.

4. The adherent device of claim 1, wherein the electronics housing is adhered to at least one of the electronic components.

5. The adherent device of claim 1, wherein the breathable cover is connected to the breathable tape.

6. The adherent device of claim 1, wherein the breathable cover comprises a stretchable material.

7. The adherent device of claim 1, wherein the breathable cover fits loosely over the electronics housing, such that a portion of the breathable cover can move with respect to the electronics housing.

8. The adherent device of claim 7, wherein the electronics housing is smooth, such that the breathable cover is slidably coupled with the electronics housing.

9. The adherent device of claim 1, wherein the electronic components comprise wireless communications circuitry that transmits at least one physiologic signal to a remote server.

10. The adherent device of claim 9, wherein the electronic components comprise impedance circuitry, and wherein the wireless communications circuitry is coupled to the impedance circuitry to transmit to the remote server a hydration signal derived from an output of the impedance circuitry.

11. The adherent device of claim 9, wherein the electronic components comprise electrocardiogram circuitry, and wherein the wireless communications circuitry is coupled to the electrocardiogram circuitry to transmit to the remote server an electrocardiogram signal derived from an output of the electrocardiogram circuitry.

12. The adherent device of claim 9, wherein the electronic components comprise an accelerometer, and wherein the wireless communications circuitry is coupled to the accelerometer to transmit to the remote server an inclination signal derived from an output of the accelerometer.

13. The adherent device of claim 1, wherein the breathable tape comprises an acrylate pressure sensitive adhesive on an underside of the tape, the adhesive having a thickness less than about 0.004″

to allow the tape to breath when the adhesive is applied to the patient.

14. The adherent device of claim 1, wherein the electronics housing comprises a waterproof encapsulant to protect the electronic components from moisture and/or mechanical forces.

15. The adherent device of claim 1, further comprising a gel cover positioned over the breathable tape to inhibit a flow of the gel through the breathable tape and wherein the electronic components are located over the gel cover such that the gel cover is disposed between the breathable tape and the electronic components.

16. The adherent device of claim 15, wherein the gel cover comprises at least one of a polyurethane film or polyurethane non-woven backing and an acrylate pressure sensitive adhesive.

17. The adherent device of claim 15, wherein the gel cover comprises a porosity of at least about 200 sec./100 cc/in̂

2 to protect the hydrogel from external moisture.

18. The adherent device of claim 15, wherein the breathable tape comprises a knit polyester fabric backing and the gel cover comprises a polyurethane film backing.

19. The adherent device of claim 15, wherein the breathable tape comprises a first porosity and wherein the gel cover comprises a breathable tape with a second porosity, the second porosity less than the first porosity to inhibit flow of the gel through the breathable tape having the first porosity.

20. The adherent device of claim 1, wherein the electronic components are comprised in an electronics module that is separable from the breathable tape, the adhesive coating, and the at least one electrode.

21. The adherent device of claim 20, wherein the electronics module is reusable.

22. The adherent device of claim 21, wherein the breathable tape, the adhesive coating, and the at least one electrode are not reusable.

23. The adherent device of claim 20, wherein the electronics module includes the breathable cover.

24. The adherent device of claim 20, wherein the electronics module includes the electronics housing.

25. The adherent device of claim 1, further comprising at least one gel disposed over a contact surface of the at least one electrode to electrically connect the electrode to the skin.

26. The adherent device of claim 1, further comprising an adhesive disposed around the breathable tape to connect the cover to the breathable tape.

27. The adherent device of claim 1, further comprising a gel cover positioned over the breathable tape and wherein a moisture vapor transmission rate (MVTR) through the breathable tape, the gel cover, and the breathable cover is at least about 400 g/m²/24 hrs.