Timed delay for redelivery of treatment therapy for a medical device system

• US 7,282,030 B2
• Filed: 10/15/2003
• Issued: 10/16/2007
• Est. Priority Date: 10/15/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Frei, Mark G., Osorio, Ivan, Giftakis, Jonathon E., Graves, Nina M., Bhavaraju, Naresh C., Carlson, David L.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Rajan; Kai
• Application Number:
  US10/687,567
• Publication Number:
  US 20040152958A1
• Time in Patent Office: 1,462 Days
• Field of Search: 600300-301, 607/45
• US Class Current: 600/300
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• 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: Y10S 128/92 Computer assisted medical diagnostics

Abstract

Apparatus and method support a repetitive administration of a therapeutic treatment through a delivery unit during a neurological event, such as a seizure, of a nervous system disorder. The medical device system monitors signal data from a sensor and through an amplifier. A neurological event is detected by a medical device system using a detection algorithm. Consequently, a electrical stimulation pulse is applied to an electrode. During the delivery of the electrical stimulation pulse, the medical device system blanks signal data that is associated with the electrode. Subsequently, additional blanking is providing during a time interval in which signal artifacts may occur and the amplifier is stabilizing. The medical device system then collects signal data for the detection algorithm to stabilize. Subsequently, the medical device system collects additional signal data in order to obtain statistically meaningful data. If the medical device system detects a continuation of the seizure, therapeutic treatment continues.

Claims

1. A method for treating a patient for a nervous system disorder, the method comprising:

(a) receiving a neurological signal through a monitoring element and an amplifier, wherein the neurological signal is a member of a set of neurological signals;

(b) detecting, by a detection algorithm, a first detection cluster based upon the neurological signal;

(c) in response to (b), delivering a treatment therapy through a delivery unit during a first time interval;

(d) blanking the neurological signal during the first time interval of time;

(e) blanking the neurological signal during a second time interval that extends beyond the first time interval, wherein the neurological signal is adversely affected by the delivering of treatment therapy in (c) the first time interval during the second time interval;

(f) processing the neurological signal during a third time interval corresponding to a detection window; and

(g) after the third interval, determining whether to redeliver the treatment therapy using an algorithm output based on the processing in (f).

2. The method of claim 1, wherein the determining in (g) comprises:

(i) processing the neurological signal for sufficient time to provide statistical analysis regarding efficacy of the treatment therapy.

3. The method of claim 2, wherein the determining in (g) further comprises:

(ii) determining whether a maximum ratio is above a predetermined threshold.

4. The method of claim 1, wherein the first time interval is associated with blanking hardware and the second time interval is associated with blanking software.

5. The method of claim 1, wherein the first time interval is associated with blanking software and the second time interval is associated with blanking hardware.

6. The method of claim 1, wherein at least one of the first, second and third time intervals is predetermined.

7. The method of claim 6, wherein the predetermined time interval is based on at least one factor selected from the group consisting of the treatment therapy, a noise level, and a duration of amplifier saturation.

8. The method of claim 1, wherein the nervous system disorder is selected from the group consisting of a disorder of a central nervous system, a disorder of a peripheral nervous system, a mental health disorder, and a psychiatric disorder.

9. The method of claim 8, wherein the nervous system disorder is selected from the group consisting of epilepsy, Parkinson'"'"'s disease, essential tremor, dystonia, multiple sclerosis (MS), anxiety, a mood disorder, a sleep disorder, obesity, and anorexia.

10. The method of claim 1, wherein the treatment therapy is selected from the group consisting of electrical stimulation, magnetic stimulation, drug infusion, and brain temperature control.

11. The method of claim 1, wherein the neurological signal is selected from the group consisting of an electrical signal, a chemical signal, a biological signal, a temperature signal, a pressure signal, a respiration signal, a heart rate signal, a pH-level signal, and a peripheral nerve signal.

12. The method of claim 1, wherein the monitoring element is selected from the group consisting of an electrode and a sensor.

13. The method of claim 1, wherein the treatment therapy is provided to a location of a body selected from the group consisting of a brain, a cranial nerve, a spinal cord, and a peripheral nerve.

14. The method of claim 1, further comprising:

(h) detecting a subsequent detection cluster through the amplifier and the monitoring element; and

(i) repeating (c)(g).

15. The method of claim 1, further comprising:

(h) processing the neurological signal for a fifth time interval, wherein a subsequent detection cluster is not detected;

(i) at a subsequent time after the fifth time interval, detecting the subsequent detection cluster; and

(j) repeating (c)(g).

16. The method of claim 1, wherein the second time interval is approximately three seconds.

17. The method of claim 1, wherein the third time interval is approximately two seconds.

18. The method of claim 1, wherein the fourth time interval is approximately one half of a second.

19. The method of claim 1, wherein the monitoring element comprises an electrode array, and wherein (b) comprises:

(i) determining a ratio that is associated with each electrode of the electrode array, wherein the ratio approximately equal to a short-term value of an associated neurological signal divided by a long-term value of the associated neurological signal; and

(ii) determining one of the ratios that is larger than the other ratios.

20. The method of claim 19, wherein the short-term value is selected from the group consisting of a short-term average and a short-term median data point.

21. The method of claim 19, wherein the long-term value is selected from the group consisting of a long-term average and a long-term median data point.

22. The method of claim 1, wherein the blanking in (d) is hardware blanking.

23. The method of claim 1, wherein the blanking in (e) is software blanking.

24. The method of claim 1, further comprising:

(h) blanking a second neurological signal during the second time interval, wherein the second neurological signal is affected by the signal artifact.

25. The method of claim 1, farther comprising:

(h) if a maximum ratio of the set of neurological signals is always as great as a predetermined threshold during the third interval and the fourth interval, stimulating the patient subsequent to the fourth interval.

26. The method of claim 1, farther comprising:

(h) if a maximum ratio of the set of neurological signals is less than a predetermined threshold during the third interval and the fourth interval, preventing a stimulation of the patent until an occurrence of a subsequent seizure detection.

27. The method of claim 26, wherein the subsequent seizure detection occurs when the maximum ratio is always as great as a predetermined threshold during a duration constraint.

28. The method of claim 25, wherein a number of allowable stimulations per detection cluster is limited to a predetermined number.

29. The method of claim 25, wherein a number of allowable stimulations per seizure detection is limited to a predetermined number.

30. The method of claim 25, wherein a number of allowable stimulations per hour is limited to a predetermined number.

31. The method of claim 25, wherein a number of allowable stimulations per day is limited to a predetermined number.

32. A computer-readable medium having computer-executable instructions for performing the method recited in claim 1.

33. A computer-readable medium having computer-executable instructions for performing the method recited in claim 2.

34. A computer-readable medium having computer-executable instructions for performing the method recited in claim 14.

35. A computer-readable medium having computer-executable instructions for performing the method recited in claim 15.

36. A computer-readable medium having computer-executable instructions for performing the method recited in claim 24.

37. A computer-readable medium having computer-executable instructions for performing the method recited in claim 25.

38. A computer-readable medium having computer-executable instructions for performing the method recited in claim 26.

39. An apparatus for treating a patient for a nervous system disorder, the apparatus comprising:

a treatment therapy unit that delivers treatment therapy to the patient;

a set of monitoring elements that obtains a set of neurological signals; and

a processor that is coupled to the treatment therapy unit and the set of monitoring elements, wherein the processor is configured to perform;

(a) receiving a neurological signal through a monitoring element and an amplifier, wherein the neurological signal is a member of a set of neurological signals;

(b) detecting, by a detection algorithm, a first detection cluster based upon the neurological signal;

(c) delivering a treatment therapy through a treatment therapy unit during a first time interval;

(d) blanking the neurological signal during the first time interval of time;

(e) blanking the neurological signal during a second time interval that ends after the first time interval ends, wherein the neurological signal is affected by a signal artifact and wherein the amplifier is stabilizing during the second time interval;

(f) processing the neurological signal during a third time interval in order to stabilize the detection algorithm; and

(g) in response to (e), processing the neurological signal for a fourth time interval that is sufficient to provide statistical analysis regarding efficacy of the treatment therapy.

40. The apparatus of claim 39, wherein the processor is configured to perform:

(h) if a maximum ratio of the set of neurological signals is always as great as a predetermined threshold during the third interval and the fourth interval, stimulating the patient subsequent to the fourth interval.

41. The apparatus of claim 39, wherein the processor is configured to perform:

(h) if a maximum ratio of the set of neurological signals is less than a predetermined threshold during the third interval and the fourth interval, preventing stimulating the patent until an occurrence of a subsequent seizure detection.

42. A method for treating a nervous system disorder, the method comprising:

(a) receiving a neurological signal through a recording or sensing element;

(b) detecting;

changes in the neurological signal through a detection algorithm;

(c) in response to (b) delivering a therapy through a delivery unit for a pre-specified duration;

(d) blanking the neurological signal during the delivery of the therapy;

(e) blanking the neurological signal for an additional time interval after a termination of the delivery of therapy to allow for amplifier recovery; and

(f) resuming processing of the neurological signal immediately after completion of (d) and (e) for a further interval of time sufficient to stabilize the detection algorithm.