EXTERNAL PACING DEVICE WITH DISCOMFORT MANAGEMENT

• US 20160303371A1
• Filed: 06/29/2016
• Published: 10/20/2016
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Whiting, Jason T., Kaib, Thomas E., Carlson, Rachel H., Frank, Gregory R., Freeman, Gary A.
• Granted Patent: US 10,328,266 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• 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 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

An external medical device includes at least one therapy electrode configured to be disposed on a patient; and a treatment manager configured to execute a baseline process to determine at least one of a range of values for a discomfort parameter and a patient discomfort threshold value corresponding to the at least one pacing routine, detect a cardiac condition of the patient, execute the at least one pacing routine, the at least one pacing routine being associated with the cardiac condition, monitor the discomfort parameter during execution of the at least one pacing routine, determine whether the discomfort parameter transgresses the at least one of the range of values and the patient discomfort threshold value, and adjust at least one characteristic of the at least one pacing routine upon the discomfort parameter transgressing the at least one of the range of values and the patient discomfort threshold value.

Claims

1. An external medical device comprising:

at least one therapy electrode configured to be disposed on a patient; and

a treatment manager, coupled to the at least one therapy electrode, configured to

execute a baseline process to determine at least one of a range of values for a discomfort parameter corresponding to at least one pacing routine and a patient discomfort threshold value corresponding to the at least one pacing routine,

detect a cardiac condition of the patient,

execute the at least one pacing routine, the at least one pacing routine being associated with the cardiac condition,

monitor the discomfort parameter associated with the patient during execution of the at least one pacing routine,

determine whether the discomfort parameter transgresses the at least one of the range of values and the patient discomfort threshold value, and

adjust at least one characteristic of the at least one pacing routine in response to determining that the discomfort parameter transgresses the at least one of the range of values and the patient discomfort threshold value.

2. The device of claim 1, further comprising a user interface for receiving discomfort information regarding the patient in connection with the at least one pacing routine.

3. The device of claim 2, wherein the discomfort parameter is based on at least one of the discomfort information received from a user via the user interface and information automatically detected by at least one sensor distinct from the user interface.

4. The device of claim 3, wherein the user interface comprises at least one of a touch screen, a button, a microphone for receiving audible commands, a strain gauge, a force sensor, a piezoelectric transducer, and a rotating spring-loaded dial.

5. The device of claim 3, wherein the treatment manager is configured to receive the discomfort information descriptive of the discomfort parameter with reference to an amount of pressure exerted by the user on an element of the user interface.

6. The device of claim 5, wherein the treatment manager is configured to determine a present value of the discomfort parameter during execution of the at least one pacing routine based on at least one of an amount of pressure detected by the user interface and a duration of time the element of the user interface remains actuated.

7. The device of claim 5, wherein the element of the user interface is at least one of a quartz sensor, a ceramic force sensor, and a piezoelectric transducer.

8. The device of claim 3, wherein the user interface comprises a force sensor configured to detect a force applied by the user squeezing at least one surface of the force sensor.

9. The device of claim 3, wherein the at least one sensor includes at least one of a motion sensor, an audio sensor, a physiological sensor, an electrode, an accelerometer, and a blood pressure sensor.

10. The device of claim 2, wherein the treatment manager is configured to receive the discomfort information regarding the patient responsive to selection of an element of the user interface.

11. The device of claim 10, wherein the user interface displays a discomfort scale and the element includes a selectable point on the discomfort scale.

12. The device of claim 11, wherein the discomfort scale is at least one of numeric and image-based.

13. The device of claim 11, wherein the user interface includes a touch screen configured to display a plurality of selectable points on the discomfort scale.

14. The device of claim 10, wherein the selection includes at least one of a touch and an utterance.

15. The device of claim 14, wherein the utterance includes at least one predefined word.

16. The device of claim 10, wherein the treatment manager is further configured to:

detect, via a touch detector, a touch having a duration; and

determine whether the discomfort parameter transgresses the patient discomfort threshold value based on the duration.

17. The device of claim 1, wherein the treatment manager is further configured to adjust at least one characteristic of the at least one pacing routine in response to determining that a value of the discomfort parameter is equal to or transgresses the patient discomfort threshold value.

18. The device of claim 17, wherein the at least one characteristic of the at least one pacing routine includes at least one of an amplitude of pacing pulses, a width of the pacing pulses, a rate of the pacing pulses, a waveform of the pacing pulses, a period of the pacing pulses, a duty cycle of the pacing pulses, and a ramp time constant of the pacing pulses.

19. The device of claim 1, wherein the cardiac condition comprises at least one of bradycardia, tachycardia, asystole, pulseless electrical activity, and erratic heart rate.

20. The device of claim 1, wherein the at least one pacing routine comprises at least one of fixed rate pacing, fixed energy pacing, adjustable rate pacing, and capture management pacing.

21. The device of claim 1, wherein the discomfort parameter is indicative of a level of discomfort experienced by the patient during the at least one pacing routine.

22. The device of claim 1, wherein the treatment manager is configured to execute the baseline process during an initial fitting of the external medical device to the patient.

23. The device of claim 1, wherein the treatment manager is further configured to optimize at least one characteristic of the at least one pacing routine in response to the determination that the discomfort parameter transgresses the at least one of the range of values and the patient discomfort value.

24. The device of claim 23, wherein the treatment manager is configured to optimize the at least one characteristic along a scale selected from at least one of a linear scale, a logarithmic scale, and an exponential scale.

25. The device of claim 23, wherein the treatment manager is configured to optimize the at least one characteristic at least in part by executing a regression analysis using historical values of the at least one characteristic.

26. The device of claim 1, wherein the treatment manager is further configured to adjust the patient discomfort threshold value based on the patient'"'"'s state of consciousness.

27. The device of claim 1, further comprising a transcutaneous electrical nerve stimulation unit configured to provide background stimulation to the patient during execution of the at least one pacing routine.

28. The device of claim 1, wherein executing the baseline process further comprises setting at least one characteristic of the at least one pacing routine to an appropriate level based on a physiological condition of the patient.

29. The device of claim 28, wherein the appropriate level is determined based on typical impedance values for an adult or child.

30. The device of claim 1, wherein executing the baseline process further comprises setting at least one characteristic of the at least one pacing routine with reference to pacing parameter baselines associated with multiple patients.

31. A method of controlling patient discomfort during pacing by an external medical device, the method comprising:

determining, during a baseline process, at least one of a range of values for a discomfort parameter corresponding to at least one pacing routine of the external medical device and a patient discomfort threshold value corresponding to the at least one pacing routine;

detecting a cardiac condition of the patient, the cardiac condition being associated with the at least one pacing routine;

executing the at least one pacing routine;

monitoring the discomfort parameter of the patient during execution of the at least one pacing routine; and

adjusting, responsive to the discomfort parameter transgressing at least one of the range of values and the patient discomfort threshold value, at least one characteristic of the at least one pacing routine.

32. The method of claim 31, further comprising receiving, via a user interface, discomfort information regarding the patient in connection with the at least one pacing routine.

33. The method of claim 32, wherein the discomfort parameter is based on at least one of the discomfort information received from a user via the user interface and information automatically detected by at least one sensor distinct from the user interface.

34. The method of claim 33, further comprising receiving the discomfort information from a user selection of an element of the user interface.

35. The method of claim 33, wherein the user interface comprises a touch sensor, the method further comprising:

detecting, via the touch sensor, a touch having a duration; and

determining whether the discomfort parameter is equal to or transgresses the patient discomfort threshold value with reference to the duration.

36. The method of claim 31, wherein executing the baseline process further comprises setting at least one characteristic of the at least one pacing routine to an appropriate level based on at least one of a physiological condition of the patient, typical impedance values for an adult or child, and pacing parameter baselines associated with multiple patients.

37. A bodily-attached ambulatory medical device comprising:

at least one therapy electrode configured to be disposed on a patient; and

a treatment manager, coupled to the at least one therapy electrode, configured to

execute a baseline process to determine at least one of a range of values for a discomfort parameter corresponding to at least one pacing routine and a patient discomfort threshold value corresponding to the at least one pacing routine,

detect a cardiac condition of the patient, and

execute the at least one pacing routine, the at least one pacing routine being associated with the cardiac condition and having at least one characteristic configured for the patient'"'"'s tolerance for discomfort based on the at least one of the range of values for the discomfort parameter and the patient discomfort threshold value.