Screening techniques for management of a nervous system disorder

• US 8,579,786 B2
• Filed: 10/15/2003
• Issued: 11/12/2013
• Est. Priority Date: 10/15/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Osorio, Ivan, Frei, Mark G., Bhavaraju, Naresh C., Peters, Thomas E., Graves, Nina M., Schaffner, Scott F., Giftakis, Jonathon E., Rise, Mark T., Werder, Jonathan C.
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US10/687,344
• Publication Number:
  US 20040158119A1
• Time in Patent Office: 3,681 Days
• Field of Search: 600300-301, 600/544, 600/545, 600/594, 128/920, 128/924, 128/925, 128/905, 128/898, 128/887, 607 45- 46, 607/27, 607/28, 607/117, 607/118
• 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 producing one or more neurological events, the method comprising:

(a) receiving a first input into at least one processor relating to a location of treatment therapy delivery;

(b) receiving a second input into the at least one processor about a set of therapy parameters that is associated with a treatment therapy;

(c) administering a treatment therapy by the at least one processor in accordance with the first and second inputs; and

(d) receiving a first indication at the at least one processor whether the treatment therapy is within a range of safety and a second indication at the at least one processor whether to utilize the first and second inputs, wherein the second indication is determined by evaluating a criterion, wherein the criterion is selected from a group consisting of a detection frequency of the one or more neurological events produced by the nervous system disorder, a duration of the one or more neurological events, an intensity of the one or more neurological events, and an electrographic spread of the one or more neurological events.

2. The method of claim 1, further comprising:

(e) if the first indication indicates that the treatment therapy is within the range of safety and if the second indication indicates that the first and second inputs are to be used, applying the treatment therapy at a future point in time.

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:

(f) if the treatment therapy applied at the future point in time is not successful, receiving into the at least one processor at least one of a third input and a fourth input, the third input relating to the location of treatment therapy delivery but different from the first input, and the fourth input relating to the set of therapy parameters but different than the second input; and

administering the treatment therapy in accordance with the at least one of the third input and the fourth input.

9. The method of claim 1, wherein the evaluating the criterion comprises:

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

(ii) obtaining comparison data during a neurological event screening, 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.

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

16. A non-transitory computer-readable medium having computer-executable instructions for performing the steps recited in claim 9.

11. 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 producing one or more neurological events, the method comprising:

(a) detecting an occurrence of a neurological event produced by the nervous system disorder by using a set of monitoring elements that obtains a set of neurological signals indicative of the neurological event;

(b) automatically identifying a neurological event focus location that is associated with the neurological event using at least one processor;

(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 using the at least one processor;

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

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

(g) receiving a second input at the at least one processor about a set of therapy parameters that is associated with a treatment therapy;

(h) administering the treatment therapy by the at least one processor in accordance with the first and second inputs;

(i) receiving a first indication at the at least one processor whether the treatment therapy is within a range of safety and a second indication at the at least one processor whether to utilize the first and second inputs, wherein the second indication is determined by evaluating a criterion characterizing the neurological event; and

(j) if the first indication indicates that the treatment therapy is within a range of safety and if the second indication indicates that the first and second inputs are to be used, administering the treatment therapy by the at least one processor at a future point in time.

12. The method of claim 11, further comprising:

(k) providing a recommendation from the at least one processor for the configuration of a treatment delivery unit and the set of therapy parameters to an output device.

13. A non-transitory computer-readable medium having computer-executable instructions for performing the steps recited in claim 11.

14. 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 producing one or more detection clusters, the method comprising the steps of:

(a) receiving a first input into at least one processor relating to a location of treatment therapy delivery;

(b) receiving a second input into at least one processor about a set of therapy parameters that is associated with a treatment therapy;

(c) administering the treatment therapy by the at least one processor in accordance with the first and second inputs, wherein the administering of the treatment comprises;

(i) applying the treatment therapy every n^th detection cluster;

(d) receiving a first indication at the at least one processor whether the treatment therapy is within a range of safety and a second indication at the at least one processor whether to utilize the first and second inputs, wherein the second indication is in accordance with an evaluation of a criterion, the evaluation comprising;

(i) obtaining treatment data by the at least one processor for a first detection cluster produced by the nervous system disorder, wherein the treatment therapy is applied;

(ii) obtaining comparison data by the at least one processor for a second detection cluster produced by the nervous system disorder, 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 by the at least one processor corresponding to a blanking interval of the treatment therapy; and

(iv) calculating a difference by the at least one processor between the treatment data and the comparison data in order to determine the efficacy of the treatment therapy; and

(e) if the first indication indicates that the treatment therapy is within the range of safety and if the second indication indicates that the first and second inputs are to be used, administering the treatment therapy at a future point in time.

15. The method of claim 14, wherein the nth cluster is at least a 2nd cluster, whereby the treatment therapy is not administered by the at least one processor to at least every other cluster.

17. A medical device system for performing neurological event screening, the medical device system providing treatment therapy to a patient with a nervous system disorder producing one or more neurological events, the medical device system comprising:

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

means for providing a first input relating to a location of treatment therapy delivery and a second input relating to a set of therapy parameters associated with the treatment therapy;

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;

(a) detect an occurrence of a neurological event produced by the nervous system disorder with a detection algorithm;

(b) identify at least one neurological event focus location that is associated with the neurological event;

(c) store the neurological event focus location as stored information; and

(d) receive a first indication whether the treatment therapy is within a range of safety and a second indication whether to utilize the first and second inputs, wherein the second indication is determined in accordance with a criterion 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, whereby if the treatment therapy is within a the range of safety and the first and second inputs are to be used, administer the treatment therapy at a future point in time in a closed loop mode or an open loop mode.

18. The medical device system of claim 17, wherein the processor is configured to use the output in (b) to:

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

19. The medical device system of claim 17, wherein the processor is further configured to:

(e) determine whether to perform algorithm adaptation; and

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

20. A medical device system for performing trial screening, the medical device system providing treatment to a patient with a nervous system disorder producing one or more neurological events, 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 indicative of a neurological event produced by the nervous system disorder, 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;

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

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

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

(d) receive a first indication whether the treatment therapy is within a range of safety and a second indication whether to utilize the first and second inputs, wherein the second indication is determined in accordance with a criterion, 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; and

(e) if the first indication indicates that the treatment therapy is within the range of safety and if the second indication indicates that the first and second inputs are to be used, administer the treatment therapy at a future point in time, wherein the treatment therapy is applied in a closed loop mode or an open loop mode.