Control of treatment therapy during start-up and during operation of a medical device system

• US 20040138711A1
• Filed: 10/15/2003
• Published: 07/15/2004
• 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, Carlson, David L.
• Granted Patent: US 7,715,919 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A method and medical device system for controlling treatment therapy delivered to treat a nervous system disorder. During start-up, the medical device system prevents the therapy device from delivering therapy to the patient for a predetermined time period after the therapy device has been activated. During operation, before the therapy device is programmed, the system performs a check on the programming information to ensure that the programming information will result in treatment therapy being within of an acceptable range of one or more therapy parameters.

Claims

1. A method for providing treatment therapy by a medical device to treat a nervous system disorder comprising the steps of:

(a) implanting at least one therapy delivery element within a body of a patient;

(b) implanting at least one monitoring element for sensing a neurological condition and generating a neurological signal;

(c) coupling the therapy delivery element and the monitoring element to a therapy device, wherein the therapy device is capable of delivering therapy to the therapy delivery element and receiving the neurological signal from the monitoring element;

(d) activating the therapy device to begin operation; and

(e) preventing the therapy device from delivering therapy to the patient for a predetermined time period after the therapy device has been activated.

2. The method of providing treatment therapy of claim 1, wherein the therapy device is at least a signal generator, and wherein the therapy delivery element and the monitoring element are at least one electrode.

3. The method of providing treatment therapy of claim 1, wherein the therapy device is at least a drug delivery device, the therapy delivery element is a catheter, and the monitoring element is at least one sensor.

4. The method of providing treatment therapy of claim 1, wherein the nervous system disorder is a seizure.

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

6. The method of providing treatment therapy of claim 1, wherein the step of implanting at least one monitoring element comprises the step of implanting an electrode in a brain of the patient for monitoring EEG activity.

7. The method of providing treatment therapy of claim 1, wherein the step of implanting comprises the step of implanting an electrode in a brain of the patient for monitoring a possible onset of a seizure.

8. The method of providing treatment therapy of claim 1, wherein the step of activating comprises the step of monitoring a neurological condition of the patient.

9. The method of providing treatment therapy of claim 1, wherein the step of activating comprises the step of monitoring electrical activity of the patient to determine a possible onset of a seizure.

10. The method of providing treatment therapy of claim 1, wherein the step of preventing comprises the step of preventing delivery of stimulation energy.

11. The method of providing treatment therapy of claim 1, wherein the step of preventing comprises the step of preventing delivery of stimulation energy for approximately 30 minutes.

12. The method of providing treatment therapy of claim 1, wherein the predetermined time period in the step of preventing is a predetermined quantity of block counts.

13. The method of providing treatment therapy of claim 1, wherein the predetermined time period in the step of preventing is based on a set quantity of information being obtained from the monitoring element.

14. A medical device system for treating a nervous system disorder comprising in combination:

(a) at least one therapy delivery element capable of being implanted within a body of a patient;

(b) at least one monitoring element capable of sensing a neurological condition and generating a neurological signal;

(c) a therapy device, wherein the therapy device is capable of delivering treatment therapy to the therapy delivery element and receiving a neurological signal from the monitoring element; and

(d) a processor within the therapy device configured to perform the steps of;

(i) activating the therapy device to begin operation; and

(ii) preventing the therapy device from delivering therapy to the patient for a predetermined time period after the therapy device has been activated.

15. The medical device system of claim 14, wherein the processor is within an implantable pulse generator.

16. The medical device system of claim 14, wherein the processor is within an implantable drug delivery device.

17. The medical device of claim 14, wherein the processor is within external wearable device.

18. The medical device of claim 14, wherein the processor is within an external control system.

19. The medical device of claim 14, wherein the monitoring element is capable of monitoring electrical activity of a patient.

20. The medical device of claim 14, wherein the monitoring element is capable of monitoring electrical activity of a patient to determine a possible onset of a seizure.

21. The medical device of claim 14, wherein the processor is configured to prevent delivery of stimulation energy for approximately 30 minutes.

22. The medical device of claim 14, wherein the predetermined time period in the step of preventing is a predetermined quantity of block counts.

23. The medical device of claim 14, wherein the predetermined time period in the step of preventing is based on a set quantity of information being obtained from the monitoring element.

24. A method for controlling treatment therapy provided by a medical device comprising the steps of:

(a) implanting at least one therapy delivery element within a body of a patient;

(b) coupling the therapy delivery element to a therapy device,

(c) providing programming information for configuring the therapy device to deliver therapeutic treatment to the body via the therapy delivery element;

(d) determining whether the programming information will result in treatment therapy being outside of an acceptable range for at least one therapy parameter; and

(e) preventing the therapy device from being configured according to the programming information if it would result in treatment therapy being outside of the acceptable range for at least one therapy parameter.

25. The method for controlling treatment therapy of claim 24, wherein the step of providing programming information is performed using a programmer such as a physician programmer or a patient programmer.

26. The method for controlling treatment therapy of claim 24, wherein the step of providing programming information is performed using a programmer such as a computing device.

27. The method for controlling treatment therapy of claim 24, wherein at least one of the therapy parameters is charge density and the step of determining comprises the step of determining whether the programming information will result in the therapy delivering a charge density above a predetermined charge density limit.

28. The method for controlling treatment therapy of claim 24, wherein at least one of the therapy parameters is number of stimulations per detection and the step of determining comprises the step of determining whether the programming information will result in delivery of a number of stimulations per detection above a predetermined stimulations per detection limit.

29. The method for controlling treatment therapy of claim 24, wherein at least one of the therapy parameters is number of stimulations per cluster and the step of determining comprises the step of determining whether the programming information will result in the stimulation delivering a number of stimulations per cluster above a predetermined stimulations per cluster limit.

30. The method for controlling treatment therapy of claim 24, wherein at least one of the therapy parameters is stimulation ON time and the step of determining comprises the step of determining whether the programming information will result in the stimulation delivering stimulation for a duration above a predetermined stimulation ON time limit.

31. The method for controlling treatment therapy of claim 30, wherein predetermined stimulation ON time limit is for a given time period.

32. The method for controlling treatment therapy of claim 30, wherein predetermined stimulation ON time limit is for a given time period ranging between one second and 24 hours.

33. The method for controlling treatment therapy of claim 24, wherein the step of implanting comprises the step of implanting an electrode in a brain of a patient.

34. A medical device system comprising in combination:

(a) at least one therapy delivery element capable of being implanted within a body of a patient;

(b) a therapy device, wherein the therapy device is capable of delivering treatment therapy to the therapy delivery element; and

(c) a programming device in communication with the therapy device configured to perform the steps of;

(i) receiving programming information for configuring the therapy device to deliver therapeutic treatment to the body via the therapy delivery element;

(ii) determining whether the programming information will result in treatment therapy being outside of an acceptable range for at least one therapy parameter; and

(iii) preventing the therapy device from being configured according to the programming information if it would result in treatment therapy being outside of the acceptable range for at least one therapy parameter.

35. The medical device system of claim 34, wherein the programming device is a physician programmer or a patient programmer.

36. The medical device system of claim 34, wherein at least one of the therapy parameters is charge density and the step of determining comprises the step of determining whether the programming information will result in the therapy delivering a charge density above a predetermined charge density limit.

37. The medical device system of claim 34, wherein at least one of the therapy parameters is number of stimulations per detection and the step of determining comprises the step of determining whether the programming information will result in the stimulation delivering a number of stimulations per detection above a predetermined stimulations per detection limit.

38. The medical device system of claim 34, wherein at least one of the therapy parameters is number of stimulations per cluster and the step of determining comprises the step of determining whether the programming information will result in the stimulation delivering a number of stimulations per cluster above a predetermined stimulations per cluster limit.

39. The medical device system of claim 34, wherein at least one of the therapy parameters is stimulation ON time and the step of determining comprises the step of determining whether the programming information will result in the stimulation delivering stimulation for a duration above a predetermined stimulation ON time limit.

40. The medical device system of claim 39, wherein predetermined stimulation ON time limit is for a given time period.

41. The medical device system of claim 39, wherein predetermined stimulation ON time limit is for a given time period ranging between one second and 24 hours.

42. The medical device system of claim 34, wherein the therapy delivery element is an electrode capable of being implanted in a brain of a patient.