Wearable monitoring and treatment device

• US 8,644,925 B2
• Filed: 08/29/2012
• Issued: 02/04/2014
• Est. Priority Date: 09/01/2011
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Volpe, Shane S., Kaib, Thomas E.
• Primary Examiner(s): Kahelin, Michael
• Application Number:
  US13/598,380
• Publication Number:
  US 20130085538A1
• Time in Patent Office: 524 Days
• Field of Search: 607/6, 607/8
• US Class Current: 607/6
• CPC Class Codes: A41D 13/1281 with incorporated means for medical monitoring
• 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 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A wearable therapeutic device to facilitate care of a subject is provided. The wearable therapeutic device can include a garment having a sensing electrode. The garment includes at least one of an inductive element and a capacitive element, and a controller identifies an inductance of the inductive element or a capacitance of the capacitive element, and determines a confidence level of information received from the sensing electrode based on the inductance or the capacitance. The wearable therapeutic device also includes an alarm module coupled with the controller and configured to provide a notification to a subject based on the confidence level.

Claims

1. A wearable therapeutic device, comprising:

a garment that includes a sensing electrode;

at least one of an inductive element having an inductance and a capacitive element having a capacitance included in at least part of the garment; and

a controller configured to

determine an amount of garment expansion based on at least one of the inductance of the inductive element and the capacitance of the capacitive element,

verify positioning of the sensing electrode on the subject at least in part by determining that the amount of garment expansion is above a minimum threshold, and

determine a confidence level of information received from the sensing electrode based on the determined amount of garment expansion.

2. The device of claim 1, further comprising:

an alarm module coupled to the controller and configured to provide a notification to a subject based on the determined amount of garment expansion.

3. The device of claim 2, wherein the notification indicates that the garment is one of:

properly positioned about a subject, too loose about the subject, and too tight about the subject.

4. The device of claim 1, further comprising:

a therapy electrode included in the garment;

wherein the controller is further configured to determine, based on the expansion, that positioning of at least one of the sensing electrode and the therapy electrode is outside a tolerance range, and to withhold treatment of the subject by the therapy electrode based on the positioning of the at least one of the sensing electrode and the therapy electrode.

5. The device of claim 1, further comprising:

a therapy electrode included in the garment;

wherein the controller is further configured to determine respiratory function of the subject based on the expansion of the garment.

6. The device of claim 1, further comprising:

a therapy electrode included in the garment; and

an alarm module configured to provide instructions to the subject regarding positioning of at least one of the sensing electrode and the therapy electrode based on the expansion of the garment.

7. The device of claim 1, wherein the inductive element is included in at least part of the garment, the inductance of the inductive element is a first inductance value, and wherein the controller is further configured to:

determine a second inductance value of the inductive element; and

determine the confidence level based on a difference between the first inductance value and the second inductance value.

8. The device of claim 1, wherein the information received from the sensing electrode includes electrocardiograph information of a subject, and wherein the controller is further configured to:

determine the confidence level based on the expansion of the garment and the electrocardiograph information of the subject;

identify an arrhythmic cardiac event based on the confidence level;

verify positioning of a therapy electrode included in the garment based on the confidence level; and

instruct the therapy electrode to apply treatment to the subject.

9. The device of claim 1, wherein the sensing electrode is further configured to sense electrocardiograph information of a subject, and wherein the controller is further configured to determine the confidence level based on the electrocardiograph information of the subject.

10. The device of claim 1, wherein the sensing electrode is further configured to sense electrocardiograph information of a subject, and wherein the controller is further configured to determine an absence of an arrhythmic cardiac event based on the at least one of the inductance of the inductive element and the capacitance of the capacitive element, and the electrocardiograph information of the subject.

11. The device of claim 1, wherein the garment includes:

at least one of a belt and a strap configured to include the at least one of the capacitive element and the inductive element, and to include at least one of the sensing electrode, the controller, an alarm module, a therapy electrode, and a defibrillator.

12. The device of claim 11, wherein the belt includes the inductive element and a core, and wherein the inductive element is coiled around the core.

13. The device of claim 1, wherein the wearable therapeutic device includes both the inductive element and the capacitive element, and wherein the controller is configured to determine the confidence level of information received from the sensing electrode based on both the inductance of the inductive element and the capacitance of the capacitive element.

14. The device of claim 1, wherein the at least one of an inductive element and a capacitive element included in at least part of the garment includes only the inductive element, and wherein the controller is configured to determine the confidence level of information received from the sensing electrode based on the inductance of the inductive element.

15. The device of claim 1, wherein the at least one of an inductive element and a capacitive element included in at least part of the garment includes only the capacitive element, and wherein the controller is configured to determine the confidence level of information received from the sensing electrode based on the capacitance of the capacitive element.

16. The wearable therapeutic device of claim 1, wherein the controller is further configured to increase the minimum threshold responsive to received noise from the sensing electrode.

17. A method of facilitating care of a subject, comprising:

providing a wearable therapeutic device that includes a sensing electrode and a garment;

receiving, from the sensing electrode, information about the subject;

determining an amount of garment expansion based on at least one of an inductance of an inductive element and a capacitance of a capacitive element included in the wearable therapeutic device;

verifying positioning of the sensing electrode on the subject at least in part by determining that the amount of garment expansion is above a minimum threshold; and

determining a confidence level of the information about the subject based on the determined amount of garment expansion.

18. The method of claim 17, further comprising:

providing, based on the confidence level, a notification to the subject regarding at least one of a diagnosis and information about the wearable therapeutic device.

19. The method of claim 17, wherein receiving the information about the subject includes receiving electrocardiograph information of the subject, the method further comprising:

identifying an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductive element and the capacitive element;

determining the confidence level based on the expansion of the portion of the wearable therapeutic device and the electrocardiograph information of the subject;

identifying an arrhythmic cardiac event based on the confidence level; and

applying treatment to the subject.

20. The method of claim 17, wherein the wearable therapeutic device includes a therapy electrode, the method further comprising:

verifying positioning of the therapy electrode based on the at least one of the inductance of the inductive element and the capacitance of the capacitive element; and

applying treatment to the subject using the therapy electrode.

21. The method of claim 17, wherein the wearable therapeutic device includes a belt, the method further comprising:

identifying an expansion of a circumference of the belt based on the at least one of the inductance of the inductive element and the capacitance of the capacitive element; and

determining the confidence level based on the expansion of the circumference of the belt.

22. The method of claim 17, wherein the wearable therapeutic device includes a therapy electrode, the method further comprising:

identifying an expansion of the garment based on the at least one of the inductance of the inductive element and the capacitance of the capacitive element; and

providing instructions to the subject regarding positioning of at least one of the sensing electrode and the therapy electrode based on the expansion of the garment.

23. The method of claim 17, wherein receiving the information about the subject includes receiving electrocardiograph information of the subject, the method further comprising:

identifying an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductance of the inductive element and the capacitance of the capacitive element;

determining the confidence level based on the expansion of the portion of the wearable therapeutic device and the electrocardiograph information of the subject; and

identifying an absence of an arrhythmic cardiac event based on the confidence level.

24. The method of claim 17, wherein receiving the information about the subject includes receiving electrocardiograph information of the subject, the method further comprising:

identifying an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductance of the inductive element and the capacitance of the capacitive element;

identifying improper positioning of the sensing electrode based on the expansion; and

identifying an absence of an arrhythmic cardiac event based on the improper positioning of the sensing electrode.

25. The method of claim 17, wherein the wearable therapeutic device includes a therapy electrode, and wherein receiving the information about the subject includes receiving electrocardiograph information of the subject, the method further comprising:

identifying an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductance of the inductive element and the capacitance of the capacitive element;

identifying improper positioning of at least one of the sensing electrode and the therapy electrode based on the expansion; and

withholding treatment of the subject by the therapy electrode based on the improper positioning of the at least one of the sensing electrode and the therapy electrode.

26. The method of claim 17, further comprising:

providing instructions to operate the wearable therapeutic device.

27. A non-transitory computer readable medium having stored thereon sequences of instructions including instructions that cause a processor to:

receive, from a sensing electrode of a wearable therapeutic device, information about a subject;

determine an amount of garment expansion based on at least one of an inductance of an inductive element and a capacitance of a capacitive element included in the wearable therapeutic device;

verify positioning of the sensing electrode on the subject at least in part by determining that the amount of garment expansion is above a minimum threshold; and

determine a confidence level of the information about the subject based on the determined amount of garment expansion.

28. The computer readable medium of claim 27, further comprising instructions that cause the processor to:

provide, based on the confidence level, a notification to the subject regarding at least one of a diagnosis and information about the wearable therapeutic device.

29. The computer readable medium of claim 27, wherein the information about the subject is electrocardiograph information of the subject, the computer readable medium further comprising instructions that cause the processor to:

identify an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductive element and the capacitive element;

determine the confidence level based on the expansion of the portion of the wearable therapeutic device and the electrocardiograph information of the subject;

identify an arrhythmic cardiac event based on the confidence level; and

control a therapy electrode of the wearable therapeutic device to apply treatment to the subject.

30. The computer readable medium of claim 27, wherein the information about the subject is electrocardiograph information of the subject, the computer readable medium further comprising instructions that cause the processor to:

identify an expansion of a portion of the wearable therapeutic device that includes the at least one of the inductive element and the capacitive element;

determine the confidence level based on the expansion of the portion of the wearable therapeutic device and the electrocardiograph information of the subject; and

determine an absence of an arrhythmic cardiac event based on the confidence level.

31. A wearable therapeutic device to be worn by a subject, comprising:

a garment that includes an electrode;

at least one of an inductive element having an inductance and a capacitive element having a capacitance included in the garment; and

a controller configured to

measure at least one of the inductance of the inductive element and the capacitance of the capacitive element,

determine an amount of garment expansion based on the at least one of the measured inductance and the measured capacitance, and

determine that the electrode is properly positioned on the subject at least in part by determining that the determined amount of garment expansion is above a minimum threshold.

32. The wearable therapeutic device of claim 31, wherein the controller is further configured to receive information from the electrode, and to determine a confidence level of the received information based on the at least one of the measured inductance and the measured capacitance.