Water resistant wearable medical device

• US 9,827,434 B2
• Filed: 10/17/2016
• Issued: 11/28/2017
• Est. Priority Date: 12/16/2010
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Volpe, Shane S., Clark, John G.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/295,726
• Publication Number:
  US 20170043175A1
• Time in Patent Office: 407 Days
• Field of Search: 607149, 607 36, 607 7
• 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 1/3925 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
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A wearable medical device includes a water-resistant/waterproof housing configured to be continuously or nearly continuously worn by a patient and formed from a water-resistant/waterproof material, and configured to prevent ingress of water in a wet environment; a plurality of ECG sensing electrodes configured to be removably coupled to the patient and to monitor an ECG of the patient; a plurality of therapy electrodes configured to be removably coupled to the patient and to deliver at least one therapeutic pulse to the patient; and a control unit disposed within the water-resistant/waterproof housing and configured to be electrically coupled to the plurality of ECG sensing electrodes and the plurality of therapy electrodes, the control unit configured to receive the monitored ECG of the patient, and responsive to detection of a cardiac arrhythmia, provide the at least one therapeutic pulse to the patient via the at least one therapy electrode.

Claims

1. A wearable medical device, comprising:

a water-resistant or waterproof housing configured to be continuously or nearly continuously worn by a patient, the water-resistant or waterproof housing formed from a water-resistant or waterproof material and configured to prevent ingress of water during operation of the wearable medical device in a wet environment;

a plurality of ECG sensing electrodes configured to be removably coupled to the patient and configured to monitor an ECG of the patient during operation of the wearable medical device;

a plurality of therapy electrodes configured to be removably coupled to the patient and configured to deliver at least one therapeutic pulse to the patient;

a control unit disposed within the water-resistant or waterproof housing and configured to be electrically coupled to the plurality of ECG sensing electrodes and the plurality of therapy electrodes; and

at least one patient responsiveness button configured to allow the patient to indicate to the control unit that the patient is conscious in response to detection of a cardiac arrhythmia;

wherein the control unit is configured to receive the monitored ECG of the patient, and responsive to the detection of the cardiac arrhythmia based on the monitored ECG of the patient, provide the at least one therapeutic pulse to the patient via at least one therapy electrode of the plurality of therapy electrodes while the patient is in the wet environment if the patient does not indicate via the at least one patient responsiveness button that the patient is conscious; and

wherein the plurality of ECG sensing electrodes and the plurality of therapy electrodes comprises a pair of combined ECG/therapy electrodes, each combined ECG/therapy electrode of the pair of combined ECG/therapy electrodes including at least one of the plurality of ECG sensing electrodes and at least one of the plurality of the therapy electrodes that are disposed on a common adhesive backing.

2. The wearable medical device of claim 1, wherein each of the plurality of therapy electrodes is of a sufficient dimension so as to be capable of delivering the at least one therapeutic pulse to a body of the patient.

3. The wearable medical device of claim 1, wherein the plurality of therapy electrodes comprises a first therapy electrode configured to be adhesively attached to a front of a torso of the patient and a second therapy electrode configured to be adhesively attached to a back of the torso of the patient.

4. The wearable medical device of claim 1, wherein the plurality of therapy electrodes is configured to be applied to at least one of spaced-apart positions and opposing lateral sides of a torso of the patient.

5. The wearable medical device of claim 4, wherein the plurality of therapy electrodes comprises a first therapy electrode configured to be positioned substantially below a left breast of the patient and a second therapy electrode configured to be positioned substantially above a right breast of the patient.

6. The wearable medical device of claim 1, wherein the plurality of ECG sensing electrodes comprises two ECG sensing electrodes that are placed on either side of the at least one of the plurality of therapy electrodes.

7. The wearable medical device of claim 1, wherein the plurality of ECG sensing electrodes comprises at least three ECG sensing electrodes and the plurality of therapy electrodes comprises two therapy electrodes, and wherein each of the ECG sensing electrodes is disposed substantially adjacent a therapy electrode.

8. The wearable medical device of claim 7, wherein the at least three ECG sensing electrodes and the plurality of therapy electrodes are configured to be positioned on a front of a torso of the patient.

9. The wearable medical device of claim 1, wherein the patient responsiveness button is provided on a wireless user interface pod.

10. The wearable medical device of claim 9, wherein the wireless user interface pod is constructed from a water-resistant or waterproof material and configured to prevent ingress of water during operation of the wearable medical device in the wet environment.

11. The wearable medical device of claim 1, wherein each combined ECG/therapy electrode of the pair of combined ECG/therapy electrodes includes a pair of the ECG sensing electrodes and a single therapy electrode that are disposed on the common adhesive backing.

12. The wearable medical device of claim 1, wherein the at least one patient responsiveness button is included on a combined ECG/therapy electrode of the at least one pair of combined ECG/therapy electrodes.

13. A wearable medical device, comprising:

a water-resistant or waterproof housing configured to be continuously or nearly continuously worn by a patient, the water-resistant or waterproof housing formed from a water-resistant or waterproof material and configured to prevent ingress of water during operation of the wearable medical device in a wet environment;

a plurality of ECG sensing electrodes configured to be removably coupled to the patient and configured to monitor an ECG of the patient during operation of the wearable medical device;

a plurality of therapy electrodes configured to be removably coupled to the patient and configured to deliver at least one therapeutic pulse to the patient;

a control unit disposed within the water-resistant or waterproof housing and configured to be electrically coupled to the plurality of ECG sensing electrodes and the plurality of therapy electrodes; and

at least one patient responsiveness button configured to allow the patient to indicate to the control unit that the patient is conscious in response to the detection of a cardiac arrhythmia; and

wherein one or more of the plurality of ECG sensing electrodes and the plurality of therapy electrodes comprises an adhesive for adhesively attaching the one or more of the plurality of ECG sensing electrodes and the plurality of therapy electrodes to the patient;

wherein the plurality of ECG sensing electrodes is configured to monitor the ECG of the patient during operation of the wearable medical device in the wet environment and the plurality of therapy electrodes is configured to deliver the at least one therapeutic pulse to the patient during the operation of the wearable medical device in the wet environment; and

wherein the control unit is configured to receive the monitored ECG of the patient, and responsive to the detection of the cardiac arrhythmia based on the monitored ECG of the patient, provide the at least one therapeutic pulse of energy to the patient via the at least one therapy electrode while the patient is in the wet environment if the patient does not indicate via the at least one patient responsiveness button that the patient is conscious.

14. The wearable medical device of claim 13, wherein each of the plurality of therapy electrodes is of a sufficient dimension so as to be capable of delivering the at least one therapeutic pulse to a body of the patient.

15. The wearable medical device of claim 13, wherein the plurality of therapy electrodes comprises a first therapy electrode configured to be adhesively attached to a front of a torso of the patient and a second therapy electrode configured to be adhesively attached to a back of the torso of the patient.

16. The wearable medical device of claim 13, wherein the plurality of therapy electrodes is configured to be applied to at least one of spaced-apart positions and opposing lateral sides of a torso of the patient.

17. The wearable medical device of claim 16, wherein the plurality of therapy electrodes comprises a first therapy electrode configured to be positioned substantially below a left breast of the patient and a second therapy electrode configured to be positioned substantially above a right breast of the patient.

18. The wearable medical device of claim 13, wherein the plurality of ECG sensing electrodes comprises two ECG sensing electrodes that are placed on either side of at least one of the plurality of therapy electrodes.

19. The wearable medical device of claim 13, wherein the plurality of ECG sensing electrodes comprises at least three ECG sensing electrodes and the plurality of therapy electrodes comprises two therapy electrodes, and wherein each of the ECG sensing electrodes is disposed substantially adjacent a therapy electrode.

20. The wearable medical device of claim 19, wherein the at least three ECG sensing electrodes and the plurality of therapy electrodes are configured to be positioned on a front of a torso of the patient.

21. The wearable medical device of claim 13, wherein the plurality of ECG sensing electrodes and the plurality of therapy electrodes comprises at least one pair of combined ECG/therapy electrodes.

22. The wearable medical device of claim 21, wherein each of the at least one pair of combined ECG/therapy electrodes includes a pair of the ECG sensing electrodes and a single therapy electrode that are disposed on a common adhesive backing.

23. The wearable medical device of claim 21, wherein the at least one patient responsiveness button is disposed along with a combined ECG/therapy electrode of the at least one pair of combined ECG/therapy electrodes on a common adhesive backing.