ADHERENT DEVICE WITH MULTIPLE PHYSIOLOGICAL SENSORS

• US 20130253285A1
• Filed: 10/08/2012
• Published: 09/26/2013
• 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 8,818,481 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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

1-27. -27. (canceled)

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

a first adherent patch comprising a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient, the adherent patch also comprising a plurality of electrodes affixed to the breathable tape and capable of electrically coupling to a skin of the patient; and

an electronics module comprising electrocardiogram circuitry coupled to at least two of the plurality of electrodes, the electronics module also comprising wireless communications circuitry coupled to the electrocardiogram circuitry to transmit to a remote server an electrocardiogram signal derived from an output of the electrocardiogram circuitry;

wherein the electronics module is coupled to the breathable tape to support the electronics module when the tape is adhered to the patient;

and wherein the electronics module is separable from the adherent patch such that the electronics module can be reused with a second adherent patch to provide monitoring for an extended period.

29. The adherent device of claim 28, wherein the electronics module further comprises impedance circuitry coupled to at least two of the plurality of electrodes, 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.

30. The adherent device of claim 29, wherein the electronics module further comprises 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.

31. The adherent device of claim 28, wherein the adherent patch is disposable.

32. The adherent device of claim 28, wherein the adherent patch further comprises a respective gel disposed over a contact surface of each of the plurality of electrodes to electrically connect the respective electrode to the skin of the patient.

33. The adherent device of claim 32, wherein the adherent patch further comprises a gel cover positioned over the breathable tape to inhibit a flow of the gel through the breathable tape and wherein the electronics module is located over the gel cover such that the gel cover is disposed between the breathable tape and the electronics module.

34. The adherent device of claim 28, further comprising a breathable cover disposed over the electronics module.

35. The adherent device of claim 28, wherein the adherent device comprises four electrodes arranged linearly, the four electrodes comprising two end electrodes and two inner electrodes, and wherein the distance between the inner electrodes is larger than the distance between either end electrode and its adjacent inner electrode.

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

a first adherent patch comprising a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient, the adherent patch also comprising a plurality of electrodes affixed to the breathable tape and capable of electrically coupling to a skin of the patient; and

an electronics module comprising impedance circuitry coupled to at least two of the plurality of electrodes, the electronics module also comprising wireless communications circuitry coupled to the electrocardiogram circuitry to transmit to a remote server one or both of an impedance signal derived from an output of the impedance circuitry and a hydration signal derived from an output of the impedance circuitry;

wherein the electronics module is coupled to the breathable tape to support the electronics module when the tape is adhered to the patient;

and wherein the electronics module is separable from the adherent patch such that the electronics module can be reused with a second adherent patch to provide monitoring for an extended period.

37. The adherent device of claim 36, wherein the electronics module further comprises 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.

38. The adherent device of claim 36, wherein the adherent patch is disposable.

39. The adherent device of claim 36, wherein the adherent device comprises four electrodes arranged linearly, the four electrodes comprising two end electrodes and two inner electrodes, and wherein the distance between the inner electrodes is larger than the distance between either end electrode and its adjacent inner electrode.

40. A system for monitoring a patient, the system comprising:

an adherent device comprising an adherent patch and an electronics module; and

an intermediate device;

wherein the adherent patch comprises a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient, and a plurality of electrodes affixed to the breathable tape and capable of electrically coupling to a skin of the patient;

wherein the electronics module is coupled to the breathable tape to support the electronics module when the tape is adhered to the patient;

wherein the electronics module is separable from the adherent patch such that the electronics module can be reused with a second adherent patch to provide monitoring for an extended period;

wherein the electronics module comprises circuitry coupled to at least two of the plurality of electrodes to measure a physiologic signal of the patient, and also comprises wireless communications circuitry coupled to the circuitry to transmit the physiologic signal to the intermediate device;

and wherein the intermediate device transmits the physiologic signal to a remote server.

41. The system of claim 40, wherein the circuitry comprises electrocardiogram circuitry and the physiologic signal is an electrocardiogram signal derived from an output of the electrocardiogram circuitry.

42. The system of claim 40, wherein the circuitry comprises impedance circuitry and the physiologic signal is an impedance signal derived from an output of the impedance circuitry or a hydration signal derived from an output of the impedance circuitry.

43. A method of monitoring a patient, the method comprising:

providing an adherent device comprising a first adherent patch and an electronics module, wherein the first adherent patch comprises a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient and the first adherent patch comprises a plurality of electrodes affixed to the breathable tape and capable of electrically coupling to a skin of the patient, wherein the electronics module is coupled to the breathable tape to support the electronics module when the tape is adhered to the patient, and wherein the electronics module comprises electrocardiogram circuitry coupled to at least two of the plurality of electrodes to measure an electrocardiogram signal of the patient, and also comprises wireless communications circuitry coupled to the circuitry to transmit the electrocardiogram signal to a remote server;

adhering the adherent device to the patient;

monitoring the patient for a first period of time, including transmitting the electrocardiogram signal to the remote server;

separating the first adherent patch from the electronics module;

providing a second adherent patch like the first;

coupling the electronics module to the second adherent patch and adhering the second adherent patch to the skin of the patient; and

monitoring the patient for a second period of time, including transmitting the electrocardiogram signal to the remote server.

44. The method of claim 43, wherein the electronics module further comprises impedance circuitry coupled to at least two of the plurality of electrodes to measure an impedance of the patient, and wherein monitoring the patient further comprises transmitting to the remote server an impedance signal derived from an output of the impedance circuitry or a hydration signal derived from an output of the impedance circuitry.

45. The method of claim 43, further comprising disposing of the first adherent patch.