Screening techniques for management of a nervous system disorder

• US 20040158119A1
• Filed: 10/15/2003
• Published: 08/12/2004
• Est. Priority Date: 10/15/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Werder, Jonathan C., Frei, Mark G., Osorio, Ivan, Giftakis, Jonathon E., Graves, Nina M., Bhavaraju, Naresh C., Rise, Mark T., Schaffner, Scott F., Peters, Thomas E.
• Granted Patent: US 8,579,786 B2
• Time in Patent Office: Days
• US Class Current: 600/9
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• 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: 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: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 2/00 Magnetotherapy

Abstract

Apparatus and method support a neurological event screening for a medical device. The medical device assists a user in determining a configuration of the medical device for delivering an effective treatment for a nervous system disorder. The medical device detects a neurological event, such as a seizure, and reports a neurological event focus location and a neurological event spread to the user. The user may use the information to provide a configuration of a therapeutic delivery unit and associated therapy parameters. Therapeutic treatment is delivered to the patient, and the medical device is provided an indication of the patient'"'"'s acceptance to the treatment. The user may modify the configuration and therapy parameters in order to achieve efficacy and acceptance. Depending upon the patient'"'"'s acceptance, therapy is applied in either an open loop mode or a closed loop mode. The medical device determines whether the treatment is successful in accordance with a criterion.

Claims

1. A method for performing trial screening with a medical device system, the medical device system providing treatment to a patient with a nervous system disorder, the method comprising the steps of:

(a) receiving a first input relating to a location of treatment therapy delivery

(b) receiving a second input about a set of therapy parameters that is associated with a treatment therapy;

(c) administering the treatment therapy in accordance with the first and second inputs;

(d) receiving a first indication whether the treatment therapy is acceptable to the patient and second indication whether to utilize the first and second inputs; and

(e) if the first indication indicates that the treatment therapy is acceptable and if the second indication indicates that the first and second inputs are to be used, applying the treatment therapy, wherein the treatment therapy is applied in a closed loop mode or an open loop mode.

2. The method of claim 1, further comprising the steps of:

(f) in response to step (e), determining if the treatment therapy is successful in accordance with a criterion; and

(g) in response to step (f), reporting results of the treatment therapy.

3. 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.

4. The method of claim 3, 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.

5. 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.

6. 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 vagal nerve, a spinal cord, and a peripheral nerve.

7. The method of claim 1, wherein the medical device system is selected from the group consisting of an external system, a hybrid system, and an implanted system.

8. The method of claim 2, further comprising the steps of:

(h) in response to step (f), if the treatment therapy is not successful, repeating steps (a)-(g).

9. The method of claim 1, wherein the criterion is selected from a group consisting of a detection frequency of the neurological event, a duration of the neurological event, an intensity of the neurological event, and an electrographic spread of the neurological event.

10. The method of claim 2, wherein step (c) comprises the step of applying the treatment therapy every n^th detection cluster, and wherein step (f) comprises the steps of:

(i) obtaining treatment data for a first detection cluster, wherein the treatment therapy is applied;

(ii) obtaining comparison data for a second detection cluster, wherein the treatment therapy is not applied, and wherein the comparison data correspond to the treatment data;

(iii) deleting a portion of the comparison data corresponding to a blanking interval of the treatment therapy; and

(iv) calculating a difference between the treatment data and the comparison data in order to determine the efficacy of the treatment therapy.

11. The method of claim 2, wherein step (f) comprises the steps of:

(i) obtaining treatment data during the trail screening session, wherein the treatment therapy is applied;

(ii) obtaining comparison data during a neurological event screening session, wherein the treatment therapy is not applied, and wherein the comparison data correspond to the treatment data;

(iii) deleting a portion of the comparison data corresponding to a blanking interval of the treatment therapy; and

(iv) calculating a difference between the treatment data and the comparison data in order to determine the efficacy of the treatment therapy.

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

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

14. A computer-readable medium having computer-executable instructions for performing the steps recited in claim 10.

15. A method for performing neurological event screening with a medical device system, the medical device system providing treatment to a patient with a nervous system disorder, the method comprising the steps of:

(a) detecting an occurrence of a neurological event;

(b) identifying a neurological event focus location that is associated with the neurological event;

(c) reporting information about the neurological event focus location to an output device;

(d) identifying a neurological event spread that is associated with the neurological event;

(e) reporting the neurological event spread to the output device.

(f) receiving a first input about a configuration of a treatment delivery unit that is associated with the neurological event screening;

(g) receiving a second input about a set of therapy parameters that is associated with a treatment therapy;

(h) administering the treatment therapy in accordance with the first and second inputs;

(i) receiving a first indication whether the treatment therapy is acceptable to the patient and second indication whether to utilize the first and second inputs;

(j) if the first indication indicates that the treatment therapy is acceptable and if the second indication indicates that the first and second inputs are to be used, applying the treatment therapy, wherein the treatment therapy is applied in closed loop mode or an open loop mode;

(k) in response to step (j), determining if the treatment therapy is successful in accordance with a criterion; and

(l) in response to step (k), reporting results of the treatment therapy.

16. The method of claim 15, further comprising the step of:

(m) providing a recommendation for the configuration of a treatment delivery unit and the set of therapy parameters to an output device.

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

18. A medical device system for performing neurological event screening, the medical device system providing treatment therapy to a patient with a nervous system disorder, the medical device system comprising:

a set of monitoring elements that obtains a set of neurological signals, wherein each monitoring element receives a neurological signal;

an output device; and

a processor that is coupled to the at least one monitoring element and to the output device, the processor configured to perform the steps of;

(a) detecting an occurrence of a neurological event with a detection algorithm;

(b) using an output from the detection algorithm to identify at least one neurological event focus location that is associated with the neurological event; and

(c) storing the neurological event focus location as stored information.

19. The medical device system of claim 18, wherein step (b) comprises:

(i) determining a first channel that is associated with an earliest onset of the neurological event, the first channel corresponding to a first neurological signal.

20. The medical device system of claim 18, wherein the processor is configured to perform the further steps of:

(d) determining whether to perform algorithm adaptation; and

(e) computing threshold and time duration constraint settings that are associated with the detection algorithm, in response to step (d).

21. A medical device system for performing trial screening, the medical device system providing treatment to a patient with a nervous system disorder, the medical device system comprising:

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

a set of monitoring elements that obtains a set of neurological signals, wherein each monitoring element receives a neurological signal;

an input device that obtains input information from a user;

an output device that presents output information to the user; and

a processor that is coupled to the treatment therapy unit, the set of monitoring elements, the input device, and the output device, the processor configured to perform the steps of;

(a) receiving a first input relating to a location of treatment therapy delivery;

(b) receiving a second input about a set of therapy parameters that is associated with a treatment therapy;

(c) administering the treatment therapy in accordance with the first and second inputs;

(d) receiving a first indication whether the treatment therapy is acceptable to the patient and second indication whether to utilize the first and second inputs; and

(e) if the first indication indicates that the treatment therapy is acceptable and if the second indication indicates that the first and second inputs are to be used, applying the treatment therapy, wherein the treatment therapy is applied in a closed loop mode or an open loop mode.