Method and device for the prevention of sudden unexpected death in epilepsy (SUDEP)

• US 20100198289A1
• Filed: 02/02/2009
• Published: 08/05/2010
• Est. Priority Date: 02/02/2009
• Status: Abandoned Application

• Current Assignee: 4491343 Canada Inc.
• Original Assignee: Victhom Human Bionics Inc. (Ergoresearch Ltd.)
• Inventors: Wilson, Willard, Kameli, Nader
• Application Number:
  US12/364,363
• Publication Number:
  US 20100198289A1
• Time in Patent Office: Days
• US Class Current: 607/14
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• 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: 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 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method and system for circumventing sudden unexpected death in epilepsy (SUDEP) by monitoring a plurality of indicators related to the likelihood of SUDEP, processing and monitoring these indicators for conditions predisposing to SUDEP, selecting a preconfigured treatment to treat the existing set of high-risk conditions, and delivering or triggering apnea and/or seizure treatment of a preventive or therapeutic nature to prevent SUDEP.

Claims

1. A method to prevent SUDEP in a subject in need thereof comprising:

acquiring from the subject an electrical signal representing each of at least two SUDEP indicators;

using the electrical signals to compute a SUDEP index; and

when the SUDEP index meets a predetermined value, generating an electrical signal representing occurrence of a SUDEP-related event.

2. A method according to claim 1 wherein acquiring the electrical signals representing each of the at least two SUDEP indicators occurs continuously in real-time and the SUDEP index is computed periodically.

3. A method according to claim 1 wherein each of the at least two SUDEP indicators indicates a condition selected from the group consisting of:

sleep state, sleep position, apneic (respiratory) state, sleep state, body position, apneic state, respiratory state, blood oxygen content, seizure activity and pre-seizure activity.

4. A method according to claim 1 further comprising generating a signal instructing delivery of a SUDEP treatment to the subject.

5. A method according to claim 4 wherein the SUDEP treatment is selected from the group consisting of apnea treatment, seizure treatment, or a combination thereof.

6. A method according to claim 5 wherein apnea treatment comprises preventative treatment for apnea or therapeutic treatment for apnea.

7. A method according to claim 5 wherein seizure treatment comprises preventative treatment for seizure or therapeutic treatment for seizure.

8. A method according to claim 4 further comprising delivering the SUDEP treatment to the subject.

9. A method according to claim 5 wherein delivering a SUDEP treatment to the subject comprises generating an electrical signal representing a command for automated delivery of the SUDEP treatment to the subject.

10. A method according to claim 1 further comprising determining when one of the at least two SUDEP indicators is an apneic event indicator and generating an electrical signal representing presence or absence of apnea in the subject.

11. A method according to claim 10 wherein when presence of apnea in the subject is signaled, the SUDEP treatment includes therapeutic treatment for apnea.

12. A method according to claim 1 further comprising determining when one of the at least two SUDEP indicators is an apneic event indicator and generating an electrical signal representing presence or absence of hypopnea in the subject.

13. A method according to claim 12 wherein when presence of hypopnea in the subject is signaled, the SUDEP treatment includes preventive treatment for apnea.

14. A method according to claim 1 further comprising determining when one of the at least two indicators is a seizure indicator and generating a signal representing presence or absence of seizure in the subject.

15. A method according to claim 12 wherein when presence of seizure in the subject is signaled, the SUDEP treatment includes therapeutic treatment for seizure.

16. A method according to claim 1 further comprising conditioning the electrical signals before using the electrical signals to compute the SUDEP index.

17. A method to prevent SUDEP in a subject in need thereof, the method comprising:

acquiring from the subject an electrical signal representing each of at least two SUDEP indicators;

using the electrical signals to compute a SUDEP index;

determining when one of the at least two SUDEP indicators is an apnea indicator and generating an electrical signal representing presence or absence of apnea in the subject;

determining when one of the at least two SUDEP indicators is a seizure indicator and generating an electrical signal representing presence or absence of seizure in the subject;

when the SUDEP index meets a predetermined value, generating a signal representing occurrence of a SUDEP-related event; and

when apnea is present and seizure is absent, generating an electrical signal instructing delivery of a SUDEP treatment comprising therapeutic treatment for apnea and preventative treatment for seizure.

18. A method according to claim 17 further comprising delivering to the subject the SUDEP treatment comprising therapeutic treatment for apnea and preventative treatment for seizure.

19. A method according to claim 18 wherein at least one of the at least two SUDEP indicators is a sleep state indicator, and wherein the SUDEP treatment is selected to maintain the sleep state of the subject.

20. A method to prevent SUDEP in a subject in need thereof, the method comprising:

acquiring from the subject an electrical signal representing each of at least two SUDEP indicators;

using the electrical signals to compute a SUDEP index;

determining when one of the at least two SUDEP indicators is a seizure indicator and generating an electrical signal representing presence or absence of seizure in the subject;

determining when one of the at least two SUDEP indicators is an apnea indicator and generating an electrical signal representing presence or absence of apnea in the subject;

when the SUDEP index meets a predetermined value, generating a signal representing occurrence of a SUDEP-related event;

when apnea is absent and seizure is present, generating an electrical signal instructing delivery of a SUDEP treatment comprising preventative treatment for apnea and therapeutic treatment for seizure.

21. A method according to claim 20 further comprising delivering to the subject the SUDEP treatment comprising preventative treatment for apnea and therapeutic treatment for seizure.

22. A method according to claim 21 wherein at least one of the at least two SUDEP indicators is a sleep state indicator, and wherein the SUDEP treatment is selected to maintain the sleep state of the subject.

23. A method to prevent SUDEP in a subject in need thereof, the method comprising:

acquiring from the subject an electrical signal representing each of at least two SUDEP indicators;

using the electrical signals to compute a SUDEP index;

determining when one of the at least two SUDEP indicators is a seizure indicator and generating an electrical signal representing presence or absence of seizure in the subject;

determining that one of the at least two SUDEP indicators is an apnea indicator and generating an electrical signal representing presence or absence of apnea in the subject;

when the SUDEP index meets a predetermined value, generating a signal representing occurrence of a SUDEP-related event;

when apnea is present and seizure is present, generating an electrical signal instructing delivery of a SUDEP treatment comprising therapeutic treatment for apnea and therapeutic treatment for seizure.

24. A method according to claim 23 further comprising delivering to the subject the SUDEP treatment comprising therapeutic treatment for apnea and therapeutic treatment for seizure.

25. A method according to claim 24 wherein at least one of the at least two SUDEP indicators is a sleep state indicator, and wherein the SUDEP treatment is selected to maintain the sleep state of the subject.

26. A method to prevent respiratory failure in a subject suffering from a seizure, the method comprising:

acquiring from the subject an electrical signal representing each of at least two SUDEP indicators wherein at least one SUDEP indicator is a seizure indicator;

using the electrical signals to compute a SUDEP index; and

when the SUDEP index meets a predetermined value, generating an electrical signal representing occurrence of a SUDEP-related event.

27. A method according to claim 26 wherein at least one of the at least two SUDEP indicators indicate a condition selected from the group consisting of:

sleep state, sleep position, apneic state, and blood oxygen content.

28. A method according to claim 26 further comprising generating a signal instructing delivery of a SUDEP treatment to the subject.

29. A method according to claim 28 further comprising delivering a SUDEP treatment to the subject.

30. A method according to claim 29 wherein delivering a SUDEP treatment to the subject comprises generating an electrical signal representing a command for automated delivery of the SUDEP treatment to the subject.

31. A method according to claim 29wherein the SUDEP treatment is selected from the group consisting of:

waking the patient, apnea treatment, seizure treatment, and a combination thereof.

32. A method according to claim 31 wherein when apnea is present the SUDEP treatment includes therapeutic treatment for apnea, and when seizure is absent, the SUDEP treatment includes preventive treatment for apnea.

33. A method according to claim 31 wherein when seizure is present the SUDEP treatment includes therapeutic treatment for seizure, and when seizure is absent, the SUDEP treatment includes preventive treatment for seizure.

45. A system according to claim 30 wherein at least one of the plurality of sensors is an apnea sensor and the system is further configured to generate an electrical signal representing presence or absence of apnea in the subject.

34. A method to prevent SUDEP in a subject in need thereof, the method comprising:

wherein the subject is treated with vagal nerve stimulation (VNS), preventing obstructive apnea in the subject by acquiring from the subject an electrical signal representing each of at least two SUDEP indicators wherein at least one of the SUDEP indicators indicates respiratory state;

using the electrical signals to compute a SUDEP index;

when the SUDEP index meets a predetermined value, generating an electrical signal representing a command to periodically deliver the VNS to the subject in synchrony with the expiration of the subject.

35. A system for preventing SUDEP in a subject, comprising:

an apneic event detection module configured to detect presence of an apneic event from an electroneurogram signal from a nerve of the subject by computing an index of respiratory activity, and to generate an electronic signal representing presence of an apneic event when the index of respiratory activity meets a predetermined value;

a seizure event detection module operatively coupled to the apneic event detection module, the seizure event detection module configured to detect presence of seizure activity from an EEG signal from the subject, and to generate an electronic signal representing presence of seizure activity in the subject;

a control module operatively coupled to the apneic event detection module and the seizure event detection module, the control module configured to generate a first stimulation signal and a second stimulation signal when an apneic event and a seizure event are detected, the first stimulation signal having a first amplitude and a first frequency for stimulating the nerve of the subject, the second stimulation signal having a second amplitude and a second frequency for stimulating the central nervous system of the subject, wherein the second amplitude is different than the first amplitude and the second frequency is different than the first frequency.

36. A system for preventing SUDEP in a subject, comprising:

a plurality of sensors, each sensor configured to obtain a physical signal from the subject, wherein the physical signal from each sensor generates an electrical signal representative of a SUDEP indicator; and

a control unit operatively coupled to the plurality of sensors, the control unit configured to acquire the electrical signals from the sensors and use the electrical signals from the sensors to compute a SUDEP index, and to generate an electrical signal representing occurrence of a SUDEP-related event when the SUDEP index meets a predetermined value.

37. A system according to claim 36 wherein the SUDEP index is computed by assigning one of a plurality of predetermined values to each SUDEP indicator wherein the assigned value indicates presence or absence of a condition corresponding to the SUDEP indicator;

and performing a logical AND operation on the values assigned to the plurality of SUDEP indicators to obtain the SUDEP index.

38. A system according to claim 36 wherein the control unit is further configured to reiteratively acquire the electrical signals representing each of the at least two SUDEP indicators in real-time and to periodically compute the SUDEP index.

39. A system according to claim 36 wherein each of the plurality of sensors is configured to obtain a physical signal from the subject that indicates a condition selected from the group consisting of:

sleep state, sleep position, apneic event, respiratory state, blood oxygen content, seizure activity and pre-seizure activity.

40. A system according to claim 36 wherein the control unit is further configured to generate a signal instructing delivery of a SUDEP treatment to the subject.

41. A system according to claim 40 further comprising a SUDEP treatment device operatively coupled to the control unit.

42. A system according to claim 41 wherein the SUDEP treatment device comprises an apnea treatment component and a seizure treatment component.

43. A system according to claim 42 wherein the apnea treatment component comprises at least one of a nerve stimulation device, a muscle stimulation device, an apnea drug delivery device, an atrial overdrive pacing device and a waking alarm.

46. A system according to claim 43 wherein when presence of apnea in the subject is signaled, the SUDEP treatment includes therapeutic treatment for apnea.

47. A system according to claim 36 wherein at least one of the plurality of sensors is a seizure sensor and the system is further configured to generate an electrical signal representing presence or absence of seizure in the subject.

48. A system according to claim 47 wherein when presence of seizure in the subject is signaled, the SUDEP treatment includes therapeutic treatment for seizure.

44. A system according to claim 44 wherein the seizure treatment device comprises at least one of a seizure drug delivery device, a nerve stimulation device and a brain stimulation device.

49. A system for preventing respiratory failure during seizure in a subject at risk of seizure, the system comprising:

a plurality of sensors, each sensor configured to obtain a physical signal from the subject, wherein the physical signal from each sensor generates an electrical signal representative of a SUDEP indicator, wherein at least one sensor is a seizure sensor configured to generate an electrical signal indicating presence or absence of a seizure in the subject; and

a control unit operatively coupled to the plurality of sensors, the control unit configured to acquire the electrical signals from the sensors and use the electrical signals from the sensors to compute a SUDEP index, and further configured to generate an electrical signal representing occurrence of a SUDEP-related event when the SUDEP index meets a predetermined value and the seizure sensor indicates presence of a seizure.

50. A system for preventing SUDEP in a subject being treated with Vagal Nerve Stimulation (VNS), the system comprising:

a plurality of sensors, each sensor configured to obtain a physical signal from the subject, wherein the physical signal from each sensor generates an electrical signal representative of a SUDEP indicator, wherein at least one sensor is a sensor configured to indicate respiratory state of the subject; and

a control unit operatively coupled to the plurality of sensors, the control unit configured to acquire the electrical signals from the sensors and use the electrical signals from the sensors to compute a SUDEP index, and further configured to generate an electrical signal representing a command to periodically deliver the VNS to the subject in synchrony with an expiratory phase of the subject'"'"'s respiratory state.

51. A system according to claim 50 further comprising a VNS device operatively coupled to the control unit.