Minimally invasive system for selecting patient-specific therapy parameters

• US 7,676,263 B2
• Filed: 06/21/2007
• Issued: 03/09/2010
• Est. Priority Date: 06/23/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: NeuroVista Corporation
• Inventors: Leyde, Kent W., Harris, John F., Mavoori, Jaideep
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US11/766,760
• Publication Number:
  US 20080033502A1
• Time in Patent Office: 992 Days
• Field of Search: 600/544, 600/378, 607/2, 607/45
• US Class Current: 600/544
• 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, wherein said implanting comprises injecting the monitoring device between at least one layer of the scalp and the skull or delivering the monitoring device through a cannula to a target area;

commencing a first therapy;

monitoring a physiological signal from the patient with the implanted device on an ambulatory basis for a first time period after commencement of the first therapy, wherein said monitoring for the first time period comprises sampling the physiological signal with the implanted device;

commencing a second therapy;

monitoring a physiological signal from the patient with the implanted device on an ambulatory basis for a second time period after commencement of the second therapy, wherein said monitoring for the second time period comprises sampling the physiological signal with the implanted device;

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 said analyzing comprises measuring seizure activity data from the first and second time periods, wherein seizure activity data comprises at least one of a number of 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.

3. The method of claim 1 wherein monitoring the physiological signal for each of the first time period and the second time period comprises:

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 in a memory that is external to the patient'"'"'s body.

4. The method of claim 3 wherein said monitoring during the first time period is performed substantially continuously and said monitoring during the second time period is performed substantially continuously.

5. The method of claim 3 wherein the implanted device is leadless.

6. The method of claim 3 wherein the implanted device is powered by an externally generated radiofrequency signal.

7. The method of claim 3 wherein the implanted device is powered by an assembly that derives and stores power from patient-based energy sources.

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.

10. The method of claim 1, wherein the step of commencing a first therapy comprises providing a first pharmacological agent for treating epilepsy, and further wherein the step of commencing a second therapy comprises providing a second pharmacological agent for treating epilepsy different from the first pharmacological agent.

11. The method of claim 1, wherein said implanting the monitoring device comprises injecting the monitoring device between at least one layer of the scalp and the skull.

12. The method of claim 1, wherein said implanting the monitoring device comprises delivering the monitoring device through the cannula to the target area.

13. 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, wherein said implanting comprises injecting the device between the skull and at least one layer of the scalp or delivering the device through a cannula to a target area;

commencing a therapy;

sampling a physiological signal from the patient on an ambulatory basis 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 on an ambulatory basis 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.

14. The method of claim 13 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.

15. The method of claim 14 wherein the leadless device is powered by an externally generated radiofrequency signal.

16. The method of claim 14 wherein the leadless device is powered by an implanted assembly that derives and stores power from patient-based energy sources.

17. The method of claim 13 wherein said analyzing 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.

18. The method of claim 17 further comprising generating a report that indicates the seizure activity data for the first and second time periods.

19. The method of claim 13 wherein the therapy is a pharmacological therapy.

20. The method of claim 19 wherein the neurological condition comprises epilepsy and the pharmacological therapy comprises an anti-epileptic drug (AED).

21. The method of claim 19 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.

22. The method of claim 13 wherein the therapy is electrical stimulation.

23. The method of claim 22 wherein the electrical stimulation is peripheral nerve stimulation or brain stimulation.

24. The method of claim 22 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.

25. The method of claim 13, wherein the step of commencing the therapy comprises providing a first pharmacological agent for treating epilepsy, and further wherein the step of changing at least one parameter of the therapy comprises providing a second pharmacological agent for treating epilepsy different from the first pharmacological agent.

26. The method of claim 13, wherein said implanting the device comprises injecting the device between at least one layer of the scalp and the skull.

27. The method of claim 13, wherein said implanting the device comprises delivering the device through a cannula to a target area.

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

injecting a monitoring device beneath at least one layer of the patient'"'"'s scalp;

monitoring a physiological signal from the patient with the implanted device on an ambulatory basis for a first time period after commencement of the first therapy, wherein said monitoring for the first time period comprises sampling the physiological signal with the monitoring device;

commencing a therapy;

monitoring a physiological signal from the patient with the implanted device on an ambulatory basis for a second time period after commencement of the therapy, wherein said monitoring for the second time period comprises sampling the physiological signal with the monitoring device;

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

analyzing the processed physiological signals to evaluate efficacy of the therapy.

29. The method of claim 28, wherein:

the neurological condition comprises epilepsy; and

said analyzing comprises measuring seizure activity data from the first and second time periods, wherein seizure activity data comprises at least one of a number of 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.

30. The method of claim 28 wherein monitoring the physiological signal comprises:

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 in a memory that is external to the patient'"'"'s body.

31. The method of claim 28 wherein said monitoring during the first time period is performed substantially continuously and said monitoring during the second time period is performed substantially continuously.

32. The method of claim 28 wherein the implanted device is leadless.

33. The method of claim 32 wherein the implanted device is powered by an externally generated radiofrequency signal.