GARMENTS FOR WEARABLE MEDICAL DEVICES

• US 20170143977A1
• Filed: 11/21/2016
• Published: 05/25/2017
• Est. Priority Date: 11/23/2015
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Frank, Gregory R., Owens, Mark Jerome, Kaib, Thomas E., Volpe, Shane S., Freeman, Gary A.
• Granted Patent: US 10,729,910 B2
• Time in Patent Office: Days
• CPC Class Codes: A41D 13/1281 with incorporated means for medical monitoring
• CPC Class Codes: A41D 31/102 Waterproof and breathable
• CPC Class Codes: A41D 31/12 Hygroscopic; Water retaining
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3968 : Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock

Abstract

According to at least one aspect, a wearable cardiac device is provided. The wearable cardiac device includes a garment worn about a torso of a patient, at least one sensing electrode to monitor cardiac activity of the patient, and a controller including a plurality of separate and distinct modules distributed about and/or integrated into the garment. The plurality of separate and distinct modules includes, for example, an operations module coupled to the at least one sensing electrode and configured to detect at least one cardiac condition of the patient and/or a communications module coupled to the operations module to communicate with an external device. In some examples, the wearable cardiac device may be configured as a treatment device and include an energy storage module coupled to at least one therapy electrode and configured to store energy for at least one therapeutic shock to be applied to the patient.

Claims

1. A wearable cardiac monitoring device comprising:

a garment configured to be worn about a torso of a patient;

patient monitoring circuitry disposed in the garment and configured to monitor one or more physiological signals from the patient, the patient monitoring circuitry comprising a plurality of separate and distinct modules communicatively coupled to one another via one or more communication links, the patient monitoring circuitry being configured to monitor at least a cardiac activity of the patient, detect the presence of a cardiac arrhythmia in the patient, and provide one or more notifications regarding the cardiac arrhythmia, the plurality of the separate and distinct modules being integrated into and distributed about the garment for an ergonomic fit on the patient; and

high-voltage circuitry comprising therapy control circuitry and energy storage devices, the high-voltage circuitry being disposed within a treatment module that is configured to be separable from the wearable cardiac monitoring device.

2. The wearable cardiac monitoring device of claim 1, wherein the patient monitoring circuitry comprises ECG sensor circuitry configured to sense and process electrocardiogram (ECG) signals of the patient, acoustic sensor circuitry configured to detect and process heart and/or lung sounds of the patient, respiration sensor circuitry configured to sense and process respiration of the patient, and radio-frequency circuitry configured to detect and process fluid levels of the patient.

3. The wearable cardiac monitoring device of claim 2, wherein the ECG sensor circuitry, the acoustic sensor circuitry, the respiration sensor circuitry, and the radio-frequency circuitry are disposed within the separate and distinct modules.

4. The wearable cardiac monitoring device of claim 1, wherein the therapy control circuitry is configured to initiate a treatment to the patient based on the one or more notifications regarding the cardiac arrhythmia.

5. The wearable cardiac monitoring device of claim 1, wherein the therapy control circuitry is configured to initiate a treatment to the patient, the treatment comprising at least one of a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy.

6. The wearable cardiac monitoring device of claim 1, wherein the garment comprises at least one of a vest worn about an upper body of the patient, a wrap-around garment, and a one-shoulder garment configured to be worn about one shoulder and wrap around an upper torso of the patient.

7. The wearable cardiac monitoring device of claim 1, wherein the garment is configured to be machine washable, water resistant, permeable to transmission of moisture and water vapor from an inner layer towards an outer layer of the garment, and comprises a low-skin irritation material.

8. The wearable cardiac monitoring device of claim 7, wherein the garment is configured to have an average moisture transmission rate of between 100 g/m²/day to 250 g/m²/day.

9. The wearable cardiac monitoring device of claim 7, wherein the garment is configured to have an average moisture transmission rate of between 250 g/m²/day to 20,000 g/m²/day.

10. The wearable cardiac monitoring device of claim 7, wherein the garment is configured to have an average moisture transmission rate of between 20,000 g/m²/day to 50,000 g/m²/day.

11. The wearable cardiac monitoring device of claim 7, wherein the garment is configured to be air permeable to promote ventilation through the garment.

12. The wearable cardiac monitoring device of claim 1, wherein the plurality of separate and distinct modules are distributed by weight about the garment for an even weight distribution.

13. The wearable cardiac monitoring device of claim 1, wherein one or more of the plurality of separate and distinct modules is permanently secured into the garment.

14. The wearable cardiac monitoring device of claim 1, wherein one or more of the plurality of separate and distinct modules is configured to be removably secured into the garment.

15. The wearable cardiac monitoring device of claim 1, wherein one or more of the plurality of separate and distinct modules is configured to be movably secured to the garment.

16. The wearable cardiac monitoring device of claim 1, wherein one or more of the plurality of separate and distinct modules is configured to be slidably secured to the garment.

17. The wearable cardiac monitoring device of claim 1, further comprising one or more sensors configured to monitor one or more of patient activity, patient motion, heart sounds, lung sounds, tissue fluids, lung fluid, blood oxygen levels, and blood pressure.

18. The wearable cardiac monitoring device of claim 1, further comprising one or more components for delivering a drug therapy to the patient.

19. The wearable cardiac monitoring device of claim 1, wherein at least two of the plurality of modules are electrically coupled by conductive thread integrated into the garment.

20. A wearable cardiac monitoring device comprising:

a garment configured to be worn about a torso of a patient;

a plurality of cardiac sensing electrodes supported by the garment and configured to monitor a cardiac activity of the patient;

at least one therapy electrode supported by the garment and configured to provide treatment to the patient;

cardiac monitoring circuitry disposed in the garment and configured to monitor a cardiac activity of the patient, the cardiac monitoring circuitry comprising a plurality of separate and distinct modules that are integrated into and supported by the garment; and

a controller configured to detect a cardiac condition of the patient based on the monitored cardiac activity of the patient;

wherein the plurality of separate and distinct modules comprises at least therapy control circuitry and energy storage devices disposed within at least one treatment module, the at least one treatment module configured to be removably secured to the garment and to provide treatment to the patient based on the detected cardiac condition.

21. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises low-voltage circuitry disposed within at least one low-voltage module and high-voltage circuitry disposed within at least one high-voltage module that is separate and distinct from the at least one low-voltage module.

22. The wearable cardiac monitoring device of claim 21, wherein the low-voltage circuitry is configured to control at least one of:

user interactions, cardiac signal acquisition and monitoring, cardiac arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequence, patient alerts, data communications, and data storage.

23. The wearable cardiac monitoring device of claim 20, wherein the low-voltage circuitry operates at a voltage of below about 100 volts.

24. The wearable cardiac monitoring device of claim 20, wherein the high-voltage circuitry includes at least one component that operates at a voltage above about 100 volts.

25. The wearable cardiac monitoring device of claim 20, wherein the high-voltage circuitry comprises at least one of the therapy control circuitry and the energy storage devices.

26. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises at least one processor disposed in an operations module separate from other modules to monitor the cardiac data received from the at least one electrode and communicate with the therapy control circuitry to direct administration of treatment to the patient.

27. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises communications circuitry disposed in a communications module separate from other modules and configured to communicate with at least one external system.

28. The wearable cardiac monitoring device of claim 20, wherein the energy storage devices are configured to store energy for at least one therapeutic pulse.

29. The wearable cardiac monitoring device of claim 28, wherein the energy storage devices comprise a plurality of capacitors and at least one non-rechargeable battery to provide power to the plurality of capacitors.

30. The wearable cardiac monitoring device of claim 28, wherein the energy storage devices are coupled to the therapy control circuitry and the therapy control circuitry is configured to control at least a discharge of energy from the energy storage module.

31. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises a first energy storage device to store energy for a first portion of a therapeutic pulse and a second energy storage device, distinct from the first energy storage device, to store energy for a second portion of the therapeutic pulse.

32. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises a first energy storage device integrated into a front portion of the garment and a second energy storage device integrated into a rear portion of the garment.

33. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises a plurality of capacitors distributed about and integrated into the garment.

34. The wearable cardiac monitoring device of claim 20, wherein at least one of the plurality of modules removably couples to a rechargeable battery.

35. The wearable cardiac monitoring device of claim 20, wherein the garment removably couples to a rechargeable battery for powering one or more of the plurality of modules.

36. The wearable cardiac monitoring device of claim 20, wherein the at least one therapy electrode is permanently integrated into the garment.

37. The wearable cardiac monitoring device of claim 20, further comprising at least one user interface integrated into the garment.

38. The wearable cardiac monitoring device of claim 20, further comprising at least one user interface communicatively coupled to at least one of the plurality of modules.

39. The wearable cardiac monitoring device of claim 20, wherein the plurality of modules comprises ECG sensor circuitry configured to sense and process electrocardiogram (ECG) signals of the patient, acoustic sensor circuitry configured to detect and process heart and/or lung sounds of the patient, respiration sensor circuitry configured to sense and process respiration of the patient, and radio-frequency circuitry configured to detect and process fluid levels of the patient.

40. The wearable cardiac monitoring device of claim 39, wherein the ECG sensor circuitry, the acoustic sensor circuitry, the respiration sensor circuitry, and the radio-frequency circuitry are disposed within the plurality of modules.

41. The wearable cardiac monitoring device of claim 20, wherein the therapy control circuitry is configured to initiate a treatment to the patient based on one or more notifications regarding a cardiac arrhythmia.

42. The wearable cardiac monitoring device of claim 20, wherein the treatment comprises at least one of a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy.

43. The wearable cardiac monitoring device of claim 20, wherein the garment comprises at least one of a vest worn about an upper boldy of the patient, a wrap-around garment, and a one-shoulder garment configured to be worn about one shoulder and wrap around an upper torso of the patient.

44. The wearable cardiac monitoring device of claim 20, wherein the garment is configured to be machine washable, water resistant, permeable to transmission of moisture and water vapor from an inner layer towards an outer layer of the garment, and comprises a low-skin irritation material.

45. The wearable cardiac monitoring device of claim 44, wherein the garment is configured to have an average moisture transmission rate of between 100 g/m²/day to 250 g/m²/day.

46. The wearable cardiac monitoring device of claim 44, wherein the garment is configured to have an average moisture transmission rate of between 250 g/m²/day to 20,000 g/m²/day.

47. The wearable cardiac monitoring device of claim 44, wherein the garment is configured to have an average moisture transmission rate of between 20,000 g/m²/day to 50,000 g/m²/day.

48. The wearable cardiac monitoring device of claim 44, wherein the garment is configured to be air permeable to promote ventilation through the garment.

49. A wearable cardiac device, comprising:

a garment configured to be worn about a torso of a patient;

at least one sensing electrode disposed in the garment and configured to monitor cardiac activity of the patient;

at least one therapy electrode disposed in the garment and configured to provide an electrical therapy to the patient based on the monitored cardiac activity;

cardiac monitoring circuitry disposed in the garment and configured to monitor a cardiac activity of the patient and detect a cardiac condition of the patient based on the monitored cardiac activity of the patient and provide at least one therapeutic pulse to the patient based on the detected cardiac condition, the cardiac monitoring circuitry comprising a plurality of separate and distinct modules distributed about the garment, the plurality of separate and distinct modules comprising at least one high-voltage module and at least one low-voltage module, the high-voltage module comprises high-voltage circuitry operating at one or more high-voltage levels and the low-voltage module comprises low-voltage circuitry operating at below the one or more high-voltage levels; and

conductive wire integrated into the garment to electrically couple at least two of the plurality of modules.

50. The wearable cardiac device of claim 49, wherein the high-voltage module comprises one or more components that operate at voltage levels of between about 100 V and about 2000 V.

51. The wearable cardiac device of claim 49, wherein the high-voltage module comprises one or more components that operate at voltage levels of between about 400 V and about 2000 V.

52. The wearable cardiac device of claim 49, wherein the high-voltage module comprises one or more components that operate at voltage levels of between about 500 V and about 2000 V.

53. The wearable cardiac device of claim 49, wherein the high-voltage module comprises one or more components that operate at voltage levels of about 1600 V.

54. The wearable cardiac device of claim 49, wherein the high-voltage module comprises one or more components that operate at voltage levels of between 25% to 100% of a peak voltage value of the at least one therapeutic pulse.

55. The wearable cardiac device of claim 49, wherein the low-voltage module comprises one or more components that operate at voltage levels of between about 5 V and 100 V.

56. The wearable cardiac device of claim 49, wherein the low-voltage module comprises one or more components that operate at voltage levels of between about 1 mV and 5 V.

57. The wearable cardiac device of claim 49, wherein the conductive wire comprises a link gauge of between 5-gauge and 40-gauge wire.

58. The wearable cardiac device of claim 49, wherein the conductive wire comprises a link gauge of between 10-gauge and 35-gauge wire.

59. A wearable cardiac device comprising:

a garment configured to be worn about a torso of a patient;

at least one sensing electrode configured to monitor cardiac activity of the patient;

at least one therapy electrode configured to provide treatment to the patient;

cardiac monitoring circuitry comprising a plurality of separate and distinct modules distributed about the garment, the plurality of modules including;

an operations module coupled to the at least one sensing electrode and configured to detect at least one cardiac condition of the patient;

an energy storage module coupled to the at least one therapy electrode and configured to store energy for at least one therapeutic shock to be applied to the patient; and

a communications circuitry disposed within a communications module that is separate and independent from the operations module and the energy storage module and coupled to at least one of the operations module and the energy storage module, the communications circuitry configured to communicate with at least one external device.

60. The wearable cardiac monitoring device of claim 59, wherein the plurality of separate and distinct modules comprises low-voltage circuitry disposed within at least one low-voltage module and high-voltage circuitry disposed within at least one high-voltage module that is separate and distinct from the at least one low-voltage module.

61. The wearable cardiac monitoring device of claim 60, wherein the low-voltage circuitry operates at a voltage of below about 100 volts.

62. The wearable cardiac monitoring device of claim 60, wherein the high-voltage circuitry includes at least one component that operates at a voltage above about 100 volts.

63. The wearable cardiac monitoring device of claim 60, wherein the low-voltage circuitry is configured to control at least one of:

user interactions, cardiac signal acquisition and monitoring, cardiac arrhythmia detection, synchronization of defibrillation pulses with cardiac signals, treatment sequence, patient alerts, data communications, and data storage.

64. The wearable cardiac monitoring device of claim 60, wherein the high-voltage circuitry comprises at least one of the therapy control circuitry and the energy storage devices.

65. The wearable cardiac monitoring device of claim 59, wherein the plurality of modules comprises a first energy storage device integrated into a front portion of the garment and a second energy storage device integrated into a rear portion of the garment.

66. The wearable cardiac monitoring device of claim 59, wherein the plurality of modules comprises a plurality of capacitors distributed about and integrated into the garment.

67. The wearable cardiac monitoring device of claim 59, wherein the plurality of modules comprises ECG sensor circuitry configured to sense and process electrocardiogram (ECG) signals of the patient, acoustic sensor circuitry configured to detect and process heart and/or lung sounds of the patient, respiration sensor circuitry configured to sense and process respiration of the patient, and radio-frequency circuitry configured to detect and process fluid levels of the patient.

68. The wearable cardiac monitoring device of claim 67, wherein the ECG sensor circuitry, the acoustic sensor circuitry, the respiration sensor circuitry, and the radio-frequency circuitry are disposed within the plurality of modules.

69. The wearable cardiac monitoring device of claim 59, wherein the therapy control circuitry is configured to initiate a treatment to the patient based on one or more notifications regarding a cardiac arrhythmia.

70. The wearable cardiac monitoring device of claim 59, wherein the treatment comprises at least one of a pacing therapy, a defibrillation therapy, and a transcutaneous electrical nerve stimulation (TENS) therapy.

71. A wearable cardiac device comprising:

a garment configured to be worn about a torso of a patient;

at least one sensing electrode configured to monitor cardiac activity of the patient;

at least one therapy electrode configured to provide treatment to the patient; and

cardiac monitoring circuitry configured to detect a cardiac condition of the patient based on the monitored cardiac activity of the patient and provide at least one therapeutic pulse to the patient based on the detected cardiac condition, the cardiac monitoring circuitry comprising a plurality of separate and distinct capacitor modules, each capacitor module comprising a capacitor having a form factor adapted to be housed within a corresponding enclosure, the enclosure adapted to conform to a predetermined portion of a patient'"'"'s body, each capacitor module being coupled to the at least one therapy electrode and at least one charger circuit to charge the plurality of capacitors.

72. The wearable cardiac monitoring device of claim 71, wherein the garment comprises at least one of a vest worn about an upper body of the patient, a wrap-around garment, and a one-shoulder garment configured to be worn about one shoulder and wrap around an upper torso of the patient.

73. The wearable cardiac monitoring device of claim 71, wherein the garment is configured to be machine washable, water resistant, permeable to transmission of moisture and water vapor from an inner layer towards an outer layer of the garment, and comprises a low-skin irritation material.

74. The wearable cardiac monitoring device of claim 71, wherein the garment is configured to have an average moisture transmission rate of between 100 g/m²/day to 250 g/m²/day.

75. The wearable cardiac monitoring device of claim 71, wherein the garment is configured to have an average moisture transmission rate of between 250 g/m²/day to 20,000 g/m²/day.

76. The wearable cardiac monitoring device of claim 71, wherein the garment is configured to have an average moisture transmission rate of between 20,000 g/m²/day to 50,000 g/m²/day.

77. The wearable cardiac monitoring device of claim 71, wherein the garment is configured to be air permeable to promote ventilation through the garment.

78. The wearable cardiac monitoring device of claim 71, wherein the cardiac monitoring circuitry further comprises a plurality of modules comprises ECG sensor circuitry configured to sense and process electrocardiogram (ECG) signals of the patient, acoustic sensor circuitry configured to detect and process heart and/or lung sounds of the patient, respiration sensor circuitry configured to sense and process respiration of the patient, and radio-frequency circuitry configured to detect and process fluid levels of the patient.