IP Library › Granted Patent US 12,226,645
Granted Patent B2
US 12,226,645 · App. 18/053,613 · Granted Feb 18, 2025

Medical device operational modes

Inventors: Gary A. Freeman (Waltham, MA); Thomas E. Kaib (Irwin, PA); Shane S. Volpe (Saltsburg, PA)
Assignee: ZOLL Medical Corporation
A61N1/3987A61B5/02438A61B5/361A61B5/4809A61B5/746A61N1/046A61N1/0484A61N1/3625A61N1/3925A61B5/0205A61B5/02055A61B5/1112A61B5/1118A61B5/4836A61B5/6805A61B5/6831A61B2560/0242
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Quick Facts
Patent No.
US 12,226,645
App. No.
18/053,613
Granted
Feb 18, 2025
Kind
B2
Abstract

An ambulatory medical device comprising: a monitoring component comprising at least one sensing electrode for detecting a cardiac condition of a patient; at least one processor configured for: adjusting one or more detection parameters for detecting the cardiac condition of the patient based at least in part on at least one of 1) one or more environmental conditions and 2) input received from the monitoring component; and providing at least one of an alarm and a treatment in response to detecting the cardiac condition of the patient based on the adjusted one or more detection parameters.

Claims (58)

1. An ambulatory medical device configured for multiple operating modes, comprising:

a plurality of ECG sensing electrodes for sensing ECG signals of a patient;

a data storage having stored therein one or more arrhythmia detection parameters;

at least one processor that is coupled with the plurality of ECG sensing electrodes and that is configured to detect a cardiac arrhythmia condition indicated by the ECG signals based on the one or more arrhythmia detection parameters;

a plurality of therapy electrodes configured to deliver a treatment to the patient in response to detection of the cardiac arrhythmia condition indicated by the ECG signals; and

a moisture sensor configured to detect moisture content in an environment of the patient,

wherein the at least one processor is also coupled with the moisture sensor and the plurality of therapy electrodes, and

wherein the at least one processor is also configured to

in a default operating mode, deliver the treatment to the patient based on the one or more arrhythmia detection parameters in response to detection of the cardiac arrhythmia condition,

change from operating in the default operating mode to operating in a water operating mode based on the detected moisture content transgressing a predetermined threshold value, and

in the water operating mode, change the one or more arrhythmia detection parameters relative to the default operating mode.

2. The ambulatory medical device of claim 1 , wherein the treatment comprises one or both of defibrillation current and a pacing pulse.

3. The ambulatory medical device of claim 1 ,

wherein the ambulatory medical device further comprises a wearable medical device, and

wherein the plurality of therapy electrodes are coupled to the wearable medical device.

4. The ambulatory medical device of claim 1 ,

wherein the ambulatory medical device comprises a garment configured to be worn about a torso of the patient, and

wherein the plurality of ECG sensing electrodes are coupled to the garment.

5. The ambulatory medical device of claim 1 , wherein the at least one processor is further configured to:

in response to detecting the cardiac arrhythmia condition in the default operating mode or in the water operating mode, provide an indication to the patient, via a user interface, that the treatment will be delivered, wherein the indication prompts the patient to provide a response via the user interface;

in the default operating mode, in response to receiving the response from the patient within a first time period, refrain from delivering the treatment to the patient; and

in the water operating mode, in response to receiving the response from the patient within a second time period, refrain from delivering the treatment to the patient, the second time period being greater than the first time period.

6. The ambulatory medical device of claim 5 ,

wherein the indication is an audible indication,

wherein, in the default operating mode, the at least one processor is configured to provide the indication at a first volume level, and

wherein, in the water operating mode, the at least one processor is configured to provide the indication at a second volume level greater than the first volume level.

7. The ambulatory medical device of claim 1 ,

wherein the one or more arrhythmia detection parameters includes a sensitivity level used to detect the cardiac arrhythmia condition, and

wherein to change the one or more arrhythmia detection parameters in the water operating mode, the at least one processor is configured to decrease the sensitivity level.

8. The ambulatory medical device of claim 7 , wherein, to decrease the sensitivity level, the at least one processor is configured to increase an amount of time to detect the cardiac arrhythmia condition in the water operating mode relative to a default amount of time to detect the cardiac arrhythmia condition in the default operating mode.

9. The ambulatory medical device of claim 7 ,

wherein the one or more arrhythmia detection parameters includes one or more baseline ECG signals and one or more comparison parameters used to determine a match between the ECG signals sensed by the ECG sensing electrodes and the one or more baseline ECG signals,

wherein to detect the cardiac arrythmia condition the at least one processor is configured to compare the ECG signals sensed by the ECG sensing electrodes with the one or more baseline ECG signals, and

wherein to decrease the sensitivity level, the at least one processor is configured to adjust the one or more comparison parameters.

10. The ambulatory medical device of claim 9 ,

wherein the one or more comparison parameters include a zero crossing range, and

wherein adjusting the one or more comparison parameters to decrease the sensitivity level includes increasing the zero crossing range relative to a zero crossing range used in the default operating mode.

11. The ambulatory medical device of claim 9 ,

wherein the one or more comparison parameters include a magnitude threshold, and

wherein adjusting the one or more comparison parameters to decrease the sensitivity level includes increasing a variation range for the magnitude threshold relative to a variation range used in the default operating mode.

12. The ambulatory medical device of claim 7 ,

wherein the one or more arrhythmia detection parameters includes a threshold ECG score indicative of the cardiac arrhythmia condition, and

wherein to decrease the sensitivity level, the at least one processor is configured to automatically increase the threshold ECG score in the water operating mode.

13. The ambulatory medical device of claim 7 , wherein, after the cardiac arrythmia condition has been detected, the at least one processor is configured to apply a noise detector to the ECG signals to confirm detection of the cardiac arrythmia condition.

14. The ambulatory medical device of claim 13 ,

wherein the at least one processor is configured to perform an analysis of the ECG signals and determine an ECG score based on the analysis of the ECG signals,

wherein, in the default operating mode, the noise detector is configured to confirm the detection of the cardiac arrythmia condition based on the ECG score exceeding a first threshold value, and

wherein, in the water operating mode, the noise detector is configured to confirm the detection of the cardiac arrythmia condition based on the ECG score exceeding a second threshold value greater than the first threshold value.

15. The ambulatory medical device of claim 1 , wherein the at least one processor is further configured to automatically change from operating in the water operating mode to operating in the default operating mode based on the detected moisture content falling below the predetermined threshold value.

16. The ambulatory medical device of claim 1 , wherein the at least one processor is further configured to automatically change from operating in the water operating mode to operating in the default operating mode after a predetermined amount of time has elapsed.

17. The ambulatory medical device of claim 1 , further comprising a user interface configured to receive a manual selection of the default operating mode,

wherein the at least one processor is further configured to change from operating in the water operating mode to operating in the default operating mode based on the manual selection of the default operating mode, and

wherein the manual selection is received via the user interface of the ambulatory medical device.

18. The ambulatory medical device of claim 1 , wherein the at least one processor is further configured to:

in response to detecting the cardiac arrhythmia condition in the default operating mode or in the water operating mode, provide an indication to the patient, via a user interface, that the treatment will be delivered, wherein the indication prompts the patient to provide a response via the user interface; and

in response to receiving the response from the patient within a predetermined time period, refrain from delivering the treatment to the patient, wherein the predetermined time period is longer in the water operating mode than in the default operating mode.

19. The ambulatory medical device of claim 1 , wherein, in the water operating mode, the at least one processor is further configured to change one or more treatment parameters of the treatment to be delivered by the plurality of therapy electrodes.

20. The ambulatory medical device of claim 19 , wherein the one or more treatment parameters include one or more of a number of defibrillation shocks and an energy intensity of the defibrillation shocks.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 10, 2022
From: FREEMAN, GARY A; KAIB, THOMAS E; VOLPE, SHANE S
To: ZOLL MEDICAL CORPORATION
Reel/Frame 061715/0053 →
Continuity (4)
Continuation 16693769 · Nov 25, 2019
Continuation 15265973 · Sep 15, 2016
Provisional Application 62235165 · Sep 30, 2015
Related Publication 20230066047A1 · Mar 2, 2023
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