Minimally Invasive System for Selecting Patient-Specific Therapy Parameters

• US 20080033502A1
• Filed: 06/21/2007
• Published: 02/07/2008
• Est. Priority Date: 06/23/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: NeuroVista Corporation
• Inventors: Leyde, Kent, Mavoori, Jaideep, Harris, John
• Granted Patent: US 7,676,263 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/386 Accessories or supplementary instruments therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

The present invention provides systems and methods for ambulatory, long term monitoring of a physiological signal from a patient. At least a portion of the systems of the present invention may be implanted within the patient in a minimally invasive manner. In preferred embodiments, brain activity signals are sampled from the patient and are transmitted to a handheld patient communication device for further processing.

Claims

1. A method for selecting a therapy for a patient suffering from a neurological or psychiatric condition, the method comprising:

implanting a monitoring device between at least one layer of the scalp and the skull;

commencing a first therapy;

monitoring a physiological signal from the patient with the implanted device for a first time period after commencement of the first therapy;

commencing a second therapy;

monitoring a physiological signal from the patient with the implanted device for a second time period after commencement of the second therapy;

processing the physiological signals from the first time period and second time period; and

analyzing the processed physiological signals to select an appropriate therapy for the patient.

2. The method of claim 1 wherein the neurological condition comprises epilepsy and the first and second therapy comprise different pharmacological agents.

wherein processing comprises measuring seizure activity data from the first and second time periods wherein seizure activity data comprises at least one of a number a clinical seizures during the first time period, a number of sub-clinical seizures during the first time period, seizure duration, seizure patterns, seizure frequency, and time of day of seizure occurrence.

4. The method of claim 1 wherein monitoring the physiological signal comprises:

sampling the physiological signal with the implanted device;

wirelessly transmitting a signal encoded with data indicative of the sampled physiological signal from the implanted device to a device that is external to the patient'"'"'s body; and

storing the sampled physiological signal signals in a memory that is external to the patient'"'"'s body.

5. The method of claim 4 wherein monitoring during the first time period and second time period is performed substantially continuously.

6. The method of claim 4 wherein the implanted device is leadless.

7. The method of claim 4 wherein the implanted device is powered by an externally generated radiofrequency signal.

8. The method of claim 1 further comprising sampling a physiological signal from the patient with the implanted device prior to commencement of the first and second therapy to establish a patient baseline, wherein analyzing comprises comparing the patient baseline and processed physiological signals from the first and second time period.

9. The method of claim 1 further comprising stopping the first therapy prior to commencing the second therapy.

25. The method of claim 4 wherein the implanted device is powered by an assembly that derives and stores power from patient-based energy sources.

3. (canceled)

10. A method for optimizing parameters of a selected therapy for patient having a neurological or psychiatric condition, the method comprising:

implanting a device in between a patient'"'"'s skull and at least one layer of the scalp;

commencing a therapy;

sampling a physiological signal from the patient with the implanted device after commencement of the therapy for a first time period;

changing at least one parameter of the therapy;

sampling the physiological signal from the patient with the implanted device for a second time period after the at least one parameter of the therapy is changed;

processing the physiological signal from the first time period and second time period; and

analyzing the processed physiological signals from the first and second time periods to determine desirable parameters for the patient'"'"'s therapy.

11. The method of claim 10 wherein the device is leadless and is in wireless communication with a device external to the patient, the method further comprising wirelessly transmitting a data signal encoded with data that is indicative of the sampled physiological signal from the leadless implanted device and storing the data signal in a memory of the external device.

12. The method of claim 11 wherein the leadless device is powered by an externally generated radiofrequency signal.

13. The method of claim 10 wherein processing comprises measuring seizure activity data from the first and second time periods, wherein seizure activity data comprises at least one of a number a clinical seizures during the first and second time period, a number of sub-clinical seizures during the first and second time period, seizure duration during the first and second time period, seizure patterns during the first and second time period, seizure frequency during the first and second time period, and time of seizure occurrence during the first and second time period.

14. The method of claim 13 further comprising generating a report that indicates the seizure activity data for the first and second time periods.

15. The method of claim 10 wherein the therapy is a pharmacological therapy.

16. The method of claim 15 wherein the neurological condition comprises epilepsy and the pharmacological therapy comprises an anti-epileptic drug (AED).

17. The method of claim 15 wherein changing at least one parameter of the therapy comprises changing at least one of a dosage, dosage frequency, form of the AED, and formulation of the AED.

18. The method of claim 10 wherein the therapy is electrical stimulation.

19. The method of claim 18 wherein the electrical stimulation is peripheral nerve stimulation or brain stimulation.

21. The method of claim 18 wherein changing at least one parameter of the therapy comprises changing at least one of frequency, pulse amplitude, pulse width, pulses per burst, burst frequency, burst/no-burst, and duty cycle.

26. The method of claim 11 wherein the leadless device is powered by an implanted assembly that derives and stores power from patient-based energy sources.

20. (canceled)

22. A method for titrating parameters of a pharmacological agent for treating a patient having epilepsy, the method comprising:

implanting a leadless device in between a patient'"'"'s skull and at least one layer of the scalp;

commencing an anti-epileptic drug therapy;

sampling an EEG signal from the patient with the implanted device after commencement of the anti-epileptic drug therapy;

wirelessly transmitting a data signal that is encoded with the sampled EEG signal from the implanted device to a portable external device for a first time period;

adjusting at least one parameter of the anti-epileptic drug therapy;

sampling an EEG signal from the patient with the implanted device after commencement of the anti-epileptic drug therapy with the at least one adjusted parameter;

wirelessly transmitting the data signal that is encoded with the sampled EEG signal from the implanted device to a portable external device for a second time period;

processing the sampled EEG signals from the first time period and second time period to generate seizure activity data; and

analyzing the seizure activity data from the first and second time periods to determine desirable parameters for the patient'"'"'s therapy.

23. The method of claim 22 wherein facilitating comprises generating a radiofrequency signal from the portable external device to power and interrogate the leadless device.

24. The method of claim 22 wherein seizure activity data comprises at least one of a number a clinical seizures during the first time period, a number of sub-clinical seizures during the first time period, seizure duration, seizure patterns, seizure frequency, and time of seizure occurrence.

27. The method of claim 22 wherein the implanted device is powered by an assembly that derives and stores power from patient-based energy sources.