Deep brain stimulation for sleep disorders

• US 9,821,162 B2
• Filed: 04/14/2015
• Issued: 11/21/2017
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wu, Jianping, Gupta, Rahul, Nelson, Dwight E.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/685,690
• Publication Number:
  US 20150306391A1
• Time in Patent Office: 952 Days
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

In some examples, a medical device delivers electrical stimulation to the external portion of the globus pallidus of a brain of a patient in order to treat a sleep impairment of the patient. In some examples, the electrical stimulation may be delivered via one or more electrodes implanted in the GPe of the brain. In some examples, an electrical stimulation device is configured to deliver electrical stimulation therapy to the GPe based on detection of a sleep state of a patient. The sleep state may include, for example, a state in which the patient is awake and intending on sleeping, is awake and attempting to sleep or has initiated sleep. In addition, in some examples, an electrical stimulation device is configured to deliver electrical stimulation therapy to the GPe based on detection of an awake state of a patient.

Claims

1. A method comprising:

determining, by a processor, a patient is in a sleep state; and

controlling, by the processor, an electrical stimulation generator to deliver deep brain electrical stimulation to a globus pallidus externus of a brain of the patient according to a therapy program defining electrical stimulation configured to induce sleep of the patient, based on the determination that the patient is in the sleep state.

2. The method of claim 1, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus comprises controlling the electrical stimulation generator to initiate delivery of electrical stimulation to the globus pallidus externus according to the therapy program in response to detecting the sleep state.

3. The method of claim 1, wherein determining the patient is in the sleep state comprises receiving user input indicating the sleep state.

4. The method of claim 1, wherein determining the patient is in the sleep state comprises:

receiving, by the processor, a signal indicative of a patient parameter of the patient; and

determining whether the patient is in the sleep state based on the signal indicative of the patient parameter.

5. The method of claim 4, wherein the patient parameter comprises at least one of an activity level, a patient posture, a heart rate, a respiration rate, a respiratory volume, a blood pressure, a blood oxygen saturation, a partial pressure of oxygen within blood, a partial pressure of oxygen within cerebrospinal fluid, muscular activity, a core temperature, an arterial blood flow or a galvanic skin response of the patient.

6. The method of claim 1, wherein determining the patient is in the sleep state comprises:

determining an activity level of the patient; and

determining whether the patient is in the sleep state based on the activity level of the patient.

7. The method of claim 1, further comprising:

determining, by the processor, the patient is in an awake state; and

controlling the electrical stimulation generator to deactivate delivery of electrical stimulation to the globus pallidus externus according to the therapy program in response to determining the patient is in the awake state.

8. The method of claim 7, wherein determining the patient is in the awake state comprises receiving user input indicating the awake state.

9. The method of claim 7, wherein determining the patient is in the awake state comprises:

receiving, by the processor, a signal indicative of a physiological parameter of the patient; and

determining whether the patient is in the awake state based on the signal indicative of the physiological parameter.

10. The method of claim 7, wherein determining the patient is in the awake state comprises:

determining an activity level of the patient; and

determining whether the patient is in the awake state based on the activity level of the patient.

11. The method of claim 1, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus comprises controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the therapy program substantially continuously during the sleep state.

12. The method of claim 1, further comprising determining a sleep stage of the patient, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus comprises controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the therapy program based on the determined sleep stage of the patient.

13. The method of claim 12, wherein determining the sleep stage of a patient comprises:

receiving, from a sensing module, a biosignal that is indicative of activity within the brain of the patient; and

determining the sleep stage based on the biosignal.

14. The method of claim 12, wherein determining the sleep stage of a patient comprises determining whether the patient is in at least one of:

a Stage 1 sleep stage, a rapid eye movement sleep stage, a Deep Sleep sleep stage, or a Stage 2 sleep stage.

15. The method of claim 1, wherein the therapy program comprises a first therapy program, the method further comprising controlling, by the processor, the electrical stimulation generator to deliver electrical stimulation to at least one of a subthalamic nucleus or a globus pallidus internus of the brain of the patient according to a second therapy program based on the determination that the patient is in the sleep state, wherein delivery of electrical stimulation to the globus pallidus externus according to the first therapy program and delivery of the electrical stimulation to the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program are independently controlled.

16. The method of claim 15, further comprising determining a sleep stage of the patient, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the at least one of the subthalamic nucleus or the globus pallidus internus of the brain of the patient according to the second therapy program comprises controlling the electrical stimulation generator to deliver electrical stimulation to the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program based on the determined sleep stage of the patient.

17. The method of claim 16, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the first therapy program and the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program comprises controlling the electrical stimulation generator to deliver electrical stimulation according to the first and second therapy programs substantially simultaneously.

18. The method of claim 16, wherein controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the first therapy program and the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program comprises controlling the electrical stimulation generator to deliver electrical stimulation according to the first and second therapy programs at different times.

19. The method of claim 16, wherein controlling the electrical stimulation generator to deliver electrical stimulation according to at least one of the first or second therapy programs comprises modifying at least one therapy parameter value of at least one of the first or second therapy programs based on the determined sleep stage.

20. The method of claim 15, wherein the second therapy program is different than the first therapy program, the second therapy program defining electrical stimulation configured to manage a symptom of a movement disorder of the patient.

21. The method of claim 1, wherein the sleep state is at least one of:

a first state in which the patient is awake and intending on sleeping, a second state in which the patient is awake and is attempting to sleep, or a third state in which the patient is asleep.

22. A system comprising:

an electrical stimulation generator; and

a processor configured to determine a patient is in a sleep state and control the electrical stimulation generator to deliver deep brain electrical stimulation to a globus pallidus externus of a brain of the patient according to a therapy program defining electrical stimulation configured to induce sleep of the patient, based on the determination that the patient is in the sleep state.

23. The system of claim 22, wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus by at least controlling, in response to detecting the sleep state, the electrical stimulation generator to initiate delivery of electrical stimulation to the globus pallidus externus according to the therapy program.

24. The system of claim 22, further comprising a user interface, wherein the processor is configured to determine the patient is in the sleep state by at least receiving user input indicating the sleep state via the user interface.

25. The system of claim 22, further comprising a sensor configured to generate a signal indicative of a patient parameter of the patient, wherein the processor is configured to determine the patient is in the sleep state by at least determining whether the patient is in the sleep state based on the signal indicative of the patient parameter.

26. The system of claim 25, wherein the patient parameter comprises at least one of an activity level, a patient posture, a heart rate, a respiration rate, a respiratory volume, a blood pressure, a blood oxygen saturation, a partial pressure of oxygen within blood, a partial pressure of oxygen within cerebrospinal fluid, muscular activity, a core temperature, an arterial blood flow or a galvanic skin response of the patient.

27. The system of claim 22, wherein the processor is configured to determine the patient is in the sleep state by at least:

determining an activity level of the patient; and

determining whether the patient is in the sleep state based on the activity level of the patient.

28. The system of claim 22, wherein the processor is further configured to determine the patient is in an awake state, and control the electrical stimulation generator to deactivate delivery of electrical stimulation to the globus pallidus externus according to the therapy program in response to determining the patient is in the awake state.

29. The system of claim 28, further comprising a user interface, wherein the processor is configured to determine the patient is in the awake state by at least receiving user input indicating the awake state.

30. The system of claim 28, further comprising a sensor configured to generate a signal indicative of a patient parameter of the patient, wherein the processor is configured to determine the patient is in the awake state by at least determining whether the patient is in the awake state based on the signal indicative of the patient parameter.

31. The system of claim 28, wherein the processor is configured to determine the patient is in the awake state by at least:

determining an activity level of the patient; and

determining whether the patient is in the awake state based on the activity level of the patient.

32. The system of claim 22, wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus by at least controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the therapy program substantially continuously during the sleep state.

33. The system of claim 22, wherein the processor is further configured to determine a sleep stage of the patient, and wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus by at least controlling the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the therapy program based on the determined sleep stage of the patient.

34. The system of claim 33, further comprising a sensing module configured to sense a biosignal that is indicative of activity within the brain of the patient, wherein the processor is configured to determine the sleep stage of a patient based on the biosignal.

35. The system of claim 33, wherein the processor is configured determine the sleep stage of the patient by at least determining whether the patient is in at least one of Stage 1, rapid eye movement, Deep Sleep, or Stage 2 sleep stages.

36. The system of claim 22, wherein the therapy program comprises a first therapy program, and wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to at least one of a subthalamic nucleus or a globus pallidus internus of the brain of the patient according to a second therapy program based on the determination that the patient is in the sleep state, wherein the processor is configured to independently control the delivery of electrical stimulation to the globus pallidus externus according to the first therapy program and the delivery of the electrical stimulation to the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program.

37. The system of claim 36, wherein the processor is further configured determine a sleep stage of the patient, and control the electrical stimulation generator to deliver electrical stimulation to the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program of the brain of the patient based on the determined sleep stage of the patient.

38. The system of claim 36, wherein the second therapy program is different than the first therapy program, the second therapy program defining electrical stimulation configured to manage a symptom of a movement disorder of the patient.

39. The system of claim 36, wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the first therapy program and the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program substantially simultaneously.

40. The system of claim 36, wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation to the globus pallidus externus according to the first therapy program and the at least one of the subthalamic nucleus or the globus pallidus internus according to the second therapy program at different times.

41. The system of claim 36, wherein the processor is configured to control the electrical stimulation generator to deliver electrical stimulation according to at least one of the first or second therapy programs by at least modifying at least one therapy parameter value of at least one of the first or second therapy programs based on the determined sleep stage.

42. The system of claim 22, wherein the sleep state is at least one of:

a first state in which the patient is awake and intending on sleeping, a second state in which the patient is awake and is attempting to sleep, or a third state in which the patient is asleep.

43. A system comprising:

means for generating electrical stimulation;

means for determining a patient is in a sleep state; and

means for controlling the means for generating electrical stimulation to deliver deep brain electrical stimulation to a globus pallidus externus of a brain of the patient according to a therapy program defining electrical stimulation configured to induce sleep of the patient, based on a determination, by the means for determining, that the patient is in the sleep state.

44. The system of claim 43, wherein the means for controlling controls the means for generating electrical stimulation to initiate delivery of electrical stimulation to the globus pallidus externus according to the therapy program in response to detecting the sleep state.

45. The system of claim 43, wherein the sleep state is at least one of a first state in which the patient is awake and intending on sleeping, a second state in which the patient is awake and is attempting to sleep, or a third state in which the patient is asleep.

46. A non-transitory computer-readable medium comprising instructions that, when executed by a processor, cause the processor to:

determine a patient is in a sleep state; and

in response to determining the patient is in the sleep state, control an electrical stimulation generator to deliver deep brain electrical stimulation to a globus pallidus externus of a brain of the patient according to a therapy program defining electrical stimulation configured to induce sleep of the patient, based on the determination that the patient is in the sleep state.

47. The non-transitory computer-readable medium of claim 46, wherein the instructions cause the processor to control the electrical stimulation generator to initiate delivery of electrical stimulation to the globus pallidus externus according to the therapy program in response to detecting the sleep state.

48. The non-transitory computer-readable medium of claim 46, wherein the sleep state is at least one of:

a first state in which the patient is awake and intending on sleeping, a second state in which the patient is awake and is attempting to sleep, or a third state in which the patient is asleep.