Implantable medical device for providing chronic condition therapy and acute condition therapy using vagus nerve stimulation

• US 10,653,883 B2
• Filed: 09/29/2017
• Issued: 05/19/2020
• Est. Priority Date: 01/23/2009
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Scott, Timothy L.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/721,542
• Publication Number:
  US 20180099144A1
• Time in Patent Office: 963 Days
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Disclosed herein are methods, systems, and apparatus for treating a medical condition in a patient using an implantable medical device (IMD). The IMD is capable of generating a first electrical signal for treating a medical condition, for example epilepsy. The first electrical signal relates to a long term therapy during a first time period in which there is no indication that the patient'"'"'s brain is in an stable state, the first electrical signal being a microburst stimulation signal. The implantable device is also capable of generating a second electrical signal for treating the medical condition. The second electrical signal relates to a short term therapy during a second time period, in response to an indication that the patient'"'"'s brain is in an unstable state. The second electrical signal in one example, may be a conventional stimulation signal.

Claims

1. A method of treating a medical condition in a patient using an implantable medical device, comprising:

applying, to a cranial nerve, a first electrical signal including at least one microburst of a plurality of pulses during a first time period to treat the medical condition, the first time period being a time period during which there is no indication that an acute condition has occurred;

detecting an indication of an acute event associated with the medical condition based on at least one factor preprogrammed to the implantable medical device, the at least one preprogrammed factor comprising at least one physiological characteristic particular to the patient; and

applying, to the cranial nerve, a second electrical signal to treat the medical condition in response to the indication of the acute event and for treating the acute event, the second electrical signal including at least one burst of a second plurality of pulses during a second time period that is a non-microburst, wherein the first time period occurs prior to the second time period.

2. The method of claim 1, further comprising:

monitoring the at least one physiological characteristic during application of the second electrical signal to determine whether the at least one characteristic is active; and

in response to determining that the at least one physiological characteristic is not active, reapplying, to the cranial nerve, the first electrical signal.

3. The method of claim 1, wherein the at least one physiological characteristic particular to the patient comprises a heart rate deviancy that precedes a seizure for the patient.

4. The method of claim 1, wherein the indication is an indication that an epileptic seizure has occurred, an indication that the epileptic seizure is substantially imminent, or an indication that an imminent occurrence of the epileptic seizure is highly probable;

and

wherein applying the first electrical signal further comprises applying the first electrical signal to provide a chronic treatment for an epilepsy condition.

5. The method of claim 1, wherein detecting the indication of the acute event comprises:

sensing at least one body parameter associated with the at least one physiological characteristic; and

applying a seizure detection algorithm to the at least one sensed body parameter to detect the indication of the acute event;

wherein the at least one body parameter comprises at least one of a heart rate parameter, a temperature, an EEG signal, a breathing rate, or an eye parameter.

6. The method of claim 1, wherein applying the first electrical signal comprises at least one of applying the microburst pulses in a predetermined pattern or applying the microburst pulses substantially synchronously with a heartbeat of the patient.

7. The method of claim 1, wherein applying the second electrical signal comprises applying the second electrical signal according to a predetermined duration independent of a change in the indication of the acute event.

8. The method of claim 1, wherein the first electrical signal has a pulse range from about 2 pulses to about 10 pulses and has a microburst duration less than about 100 msec.

9. The method of claim 1, wherein the first electrical signal has a pulse range from about 2 pulses to about 6 pulses and has a microburst duration from about 20 msec to about 80 msec.

10. The method of claim 1, wherein applying the first electrical signal to the cranial nerve comprises applying the first electrical signal to at least one of a left vagus nerve or a right vagus nerve.

11. An implantable medical device comprising a memory coupled to a processor, the memory having instructions stored thereon that, when executed by the processor, cause the implantable medical device to:

apply a first electrical signal including at least one microburst of a plurality of pulses during a first time period to treat a medical condition of a patient, the first period being a time period during which there is no indication that an acute condition has occurred;

detect an indication of an acute event associated with the medical condition based on at least one factor preprogrammed to the implantable medical device, the at least one preprogrammed factor comprising at least one physiological characteristic particular to the patient; and

apply a second electrical signal to treat the medical condition in response to the indication of the acute event and for treating the acute event, the second electrical signal including at least one burst of a second plurality of pulses during a second time period that is a non-microburst, wherein the first time period occurs prior to the second time period.

12. The implantable medical device of claim 11, wherein the instructions further cause the processor to:

monitor the at least one physiological characteristic during application of the second electrical signal to determine whether the at least one characteristic is active; and

in response to determining that the at least one physiological characteristic is not active, reapply the first electrical signal.

13. The implantable medical device of claim 11, wherein the at least one physiological characteristic particular to the patient comprises a heart rate deviancy that precedes a seizure for the patient.

14. The implantable medical device of claim 11, wherein the indication is an indication that an epileptic seizure has occurred, an indication that the epileptic seizure is substantially imminent, or an indication that an imminent occurrence of the epileptic seizure is highly probable;

and

wherein the instructions cause the processor to apply the first electrical signal to provide a chronic treatment for an epilepsy condition.

15. The implantable medical device of claim 11, wherein the instructions cause the processor to detect the indication of the acute event by:

sensing at least one body parameter associated with the at least one physical characteristic; and

applying a seizure detection algorithm to the at least one sensed body parameter to detect the indication of the acute event;

wherein the at least one body parameter comprises at least one of a heart rate parameter, a temperature, an EEG signal, a breathing rate, or an eye parameter.

16. An implantable medical device for treating a medical condition in a patient, the implantable medical device comprising:

an implantable electrical signal generator configured to generate electrical signals;

at least one lead coupled to the electrical signal generator and configured to apply the electrical signals to a cranial nerve of the patient;

a processor; and

a memory coupled to the processor and having instructions stored thereon that, when executed by the processor, cause the implantable medical device to;

apply, by the at least one lead, a first electrical signal including at least one microburst of a plurality of pulses during a first time period to treat a medical condition of a patient, the first period being a time period during which there is no indication that an acute condition has occurred;

detect an indication of an acute event associated with the medical condition based on at least one factor preprogrammed to the implantable medical device, the at least one preprogrammed factor comprising at least one physiological characteristic particular to the patient;

apply, by the at least one lead, a second electrical signal to treat the medical condition in response to the indication of the acute event and for treating the acute event, the second electrical signal including at least one burst of a second plurality of pulses during a second time period that is a non-microburst, wherein the first time period occurs prior to the second time period;

monitor the at least one physiological characteristic during application of the second electrical signal to determine whether the at least one characteristic is active; and

in response to determining that the at least one physiological characteristic is not active, reapply the first electrical signal.

17. The implantable medical device of claim 16, wherein the at least one physiological characteristic particular to the patient comprises a heart rate deviancy that precedes a seizure for the patient.

18. The implantable medical device of claim 16, wherein the at least one lead is configured to apply electrical signals to at least one of a left vagus nerve or a right vagus nerve of the patient;

and

wherein the instructions cause the processor to apply the first electrical signal to at least one of the left vagus nerve or the right vagus nerve.

19. The implantable medical device of claim 16, wherein the at least one lead is configured to apply electrical signals to at least one of a left vagus nerve or a right vagus nerve of the patient;

and

wherein the instructions cause the processor to apply the second electrical signal to at least one of the left vagus nerve or the right vagus nerve.