Multi-modal operation of a medical device system

• US 8,594,798 B2
• Filed: 10/15/2003
• Issued: 11/26/2013
• 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., Rise, Mark T., Schaffner, Scott F., Graves, Nina M.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US10/687,289
• Publication Number:
  US 20040138517A1
• Time in Patent Office: 3,695 Days
• Field of Search: 600/9, 607/2, 607/45, 607/48, 607/96, 607 30- 32, 607 59- 60, 604/891.1, 604/503, 604/66
• US Class Current: 607/48
• 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 2/00 Magnetotherapy

Abstract

Apparatuses and methods support multi-modal operation of a medical device system for a nervous system disorder. The medical device system comprises an implanted component and an external component and supports a first feature and a second feature that are associated with the treatment therapy. The medical device system supports both features when the implanted component and the external component are coupled. If the external component is decoupled, the implanted component continues to support the first feature. Moreover, the embodiment may support a plurality of features during a treatment interval. Another aspect of the invention allows for modularly expanding a medical device system in order to add a feature that enhances existing functionality or that provides additional functionality. In an embodiment, a module that is associated with an external component of the medical device system supports the added feature.

Claims

1. A medical device system that provides treatment therapy for a nervous system disorder, comprising:

an implantable component configured to be implanted within a patient body and operate according to a first treatment therapy mode; and

a first external component configured to be positioned external to the patient body, generate a signal indicating the presence of the first external component to the implantable component, and provide a second treatment therapy mode;

the implantable component further configured to receive the signal from the first external component and detect that the first external component is present based on receiving the signal,

the implantable component further configured to detect that the first external component is not available based on not receiving the signal,

the implantable component further configured to begin operating in conjunction with the first external component according to the second treatment therapy mode if the implantable component detects that the first external component is present, and

stop operating according to the second treatment therapy mode if the implantable component detects that the first external component is not present.

2. The medical device system of claim 1, further comprising:

a second external component configured to communicate with the implantable component through the first external component in order to support a third treatment therapy mode.

3. The medical device system of claim 2, wherein the second external component comprises a programmer.

4. The medical device system of claim 1, wherein the first external component comprises an interface configured to couple to a triggering device and wherein an activation of the triggering device is indicative of a relevant event.

5. The medical device system of claim 1, wherein the first external component is configured to communicate with the implantable device over a first communications channel, and wherein the first external component is configured to communicate with a remote computing device over a second communications channel.

6. The medical device system of claim 1, further comprising one or more monitoring elements coupled to the implantable component, the one or more monitoring elements configured to sense neurological activity and generate a corresponding neurological signal comprising neurological data.

7. The medical device system of claim 6, wherein the first external component is configured to receive the neurological data from the implantable component and configured to store the neurological data within the first external component and/or send the neurological data to a remote site.

8. The medical device system of claim 1, wherein the implantable component is further configured to detect that the first external component is not present based on not receiving the signal from the first external component within a first period of time.

9. The medical device system of claim 1, wherein the implantable component is further configured to periodically send an outgoing signal from the implantable component to the first external component and receive the signal from the first external component in reply to the outgoing signal.

10. The medical device system of claim 1, wherein the implantable component is further configured to begin operating in the first treatment therapy mode upon stopping operating according to the second treatment therapy mode.

11. The medical device system of claim 1, wherein the first treatment therapy mode provides treatment therapy in an open-loop mode and the second treatment therapy mode provides treatment therapy in a closed-loop mode.

12. The medical device system of claim 1, wherein the first external component comprises an external wearable digital signal processing unit configured to be wearable by a patient.

13. A medical device system that provides treatment therapy for a nervous system disorder, comprising:

an implantable component configured to operate according to a first treatment therapy mode and receive a signal from a first external component the signal indicating to the implantable component the presence of the first external component, the first treatment therapy mode not requiring the presence of the first external component;

the implantable component further configured to detect that the first external component is present based on receiving the signal from the first external component,

the implantable component further configured to detect that the first external component is not available based on not receiving the signal from the external component,

the implantable component further configured to begin operating in conjunction with the first external component according to a second treatment therapy mode if the implantable component detects that the first external component is present, and

the implantable component further configured to stop operating according to the second treatment therapy mode if the implantable component detects that first external component is not present.

14. The medical device system of claim 13, wherein the implantable component is further configured to detect that the first external component is not present based on not receiving the signal from the first external component within a first period of time.

15. The medical device system of claim 13, wherein the implantable component is further configured to periodically send an outgoing signal from the implantable component to the first external component and receive the signal from the first external component in reply to the outgoing signal.

16. The medical device system of claim 13, wherein the implantable component is further configured to begin operating in the first treatment therapy mode upon stopping operating according to the second treatment therapy mode.

17. The medical device system of claim 13, wherein the first treatment therapy mode provides treatment therapy in an open-loop mode.

18. The medical device system of claim 13, further comprising one or more monitoring elements coupled to the implantable component, the one or more monitoring elements configured to sense neurological activity and generate a corresponding neurological signal comprising neurological data.

19. The medical device system of claim 18, wherein the second treatment therapy mode adjusts treatment therapy based on the neurological data.

20. The medical device system of claim 18, wherein the second treatment therapy mode supports an alarm in response to the neurological data being indicative of an impending medical condition.

21. The medical device system of claim 13, wherein the first treatment therapy mode provides a first loop recording capability, and wherein the second treatment therapy mode provides a second loop recording capability, the second loop recording capability comprising at least one of a longer period of time and a greater number of monitored signals than the first loop recording capability.

22. The medical device system of claim 13, wherein the implantable component is further configured to simultaneously operate according to the first treatment therapy mode and according to the second treatment therapy mode if the implantable component detects that the first external component is present.

23. The medical device system of claim 13, wherein the implantable component is further configured to detect the presence of a second external component and begin operating in conjunction with the second external component according to a third treatment therapy mode if the implantable component detects that the second external component is present.

24. The medical device system of claim 13, 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.

25. The medical device system of claim 13, 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.

26. The medical device system of claim 13, wherein at least one of the first and the second treatment therapy modes provide a treatment therapy selected from the group consisting of electrical stimulation, magnetic stimulation, drug infusion, brain temperature control, and a sensory warning.

27. The medical device system of claim 26, 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.

28. A method for a treatment of a nervous system disorder with a medical device system, comprising:

operating an implantable component of the medical device system in a first treatment therapy mode;

receiving a signal from a first external component of the medical device system, the signal indicating the presence of the first external component;

detecting that the first external component is present based on receiving the signal;

detecting that the first external component is not available based on not receiving the signal;

operating the implantable component in conjunction with the first external component according to a second treatment therapy mode if the first external component is detected as present; and

not operating according to the second treatment therapy mode if the first external component is detected as not present.

29. The method of claim 28, wherein the first treatment therapy mode includes a first loop recording capability, and wherein the second treatment therapy mode includes a second loop recording capability, the second loop recording capability comprising at least one of a longer period of time and a greater number of monitored signals than the first loop recording capability.

30. The method of claim 28, further comprising sensing neurological data using one or more monitoring elements coupled to the implantable component and generating a corresponding neurological signal comprising neurological data corresponding to a patient.

31. The method of claim 30, further comprising receiving the neurological data from the implantable component and storing the neurological data within the external component.

32. The method of claim 30, further comprising receiving the neurological data from the implantable component with the first external component, and sending the neurological data to a remote site via the external component.

33. The method of claim 32, comprising communicating with a health care professional about the neurological data.

34. The method of claim 33, wherein the neurological data further comprises location information, the location information being indicative of a location of the patient.

35. The method of claim 28, further comprising detecting that the external component is not available based on not receiving the signal within a predetermined time interval.

36. The method of claim 28, further comprising, detecting the presence of a second external component and operating the implantable component in conjunction with the second external component according to a third treatment therapy mode if the implantable component detects that the second external component is present.

37. The method of claim 28, 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.

38. The method of claim 28, 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.

39. The method of claim 30, wherein the first treatment therapy mode corresponds to an open-loop treatment therapy and wherein the second treatment therapy mode corresponds to an incremental treatment therapy.

40. The method of claim 39, further comprising:

monitoring the neurological data; and

triggering a delivery of the incremental treatment therapy in response to the monitored neurological data.

41. The method of claim 39, wherein the incremental treatment therapy comprises an application of at least one of a pharmaceutical agent and electrical stimulation.

42. The method of claim 30, wherein the second treatment therapy mode supports an alarm in response to the neurological data, the neurological data being indicative of an impending medical condition.

43. The method of claim 28, wherein the first treatment therapy mode corresponds to an open-loop treatment therapy mode and the second treatment therapy mode corresponds to a closed-loop treatment therapy mode.

44. The method of claim 28, wherein at least one of the first treatment therapy mode and the second treatment therapy mode provides a treatment therapy selected from the group consisting of electrical stimulation, magnetic stimulation, drug infusion, brain temperature control, and a sensory warning.

45. The method of claim 28, further comprising:

operating the implantable component of the medical device system in the first treatment therapy mode without the use of the first external component; and

operating the implantable component of the medical device system in a third treatment therapy mode without the use of the first external component,

wherein the first treatment therapy mode is an open-loop mode and the third treatment therapy mode is a closed-loop mode.

46. A method for treatment of a nervous system disorder with a medical device system, comprising:

operating an implantable component of the medical device system in an open-loop treatment therapy mode;

receiving a signal from a first external component of the medical device system, the signal indicating the presences of the first external component;

detecting that the first external component is present based on receiving the signal;

operating the implantable component in conjunction with the first external component according to a closed-loop treatment therapy mode if the first external component is detected as present; and

detecting that the first external component is not available based on not receiving the signal; and

not operating according to the closed-loop treatment therapy mode if the first external component is detected as not present.

47. A medical device system that provides treatment therapy for a nervous system disorder, comprising:

an implantable component configured to receive a signal from an external component, the signal indicating the presence of the external component,

the implantable component further configured to operate according to an open-loop treatment therapy mode that does not require the presence of the external component and operate according to a closed-loop treatment therapy mode that does not require the presence of the external component;

the implantable component further configured to detect that the external component is present based on receiving the signal from the external component and begin operating in conjunction with the external component according to a third treatment therapy mode if the implantable component detects that the external component is present; and

the implantable component further configured to detect that the external component is not available based on not receiving the signal, and to stop operating according to the third treatment therapy mode if the implantable component detects that the external component is not present, and to operate according to either one of the open-loop treatment therapy mode and the closed-loop treatment therapy mode upon stopping operating according to the third treatment therapy mode.

48. A medical device system for treating a nervous system disorder, the medical device system comprising an implantable component configured to

operate according to an open-loop treatment therapy mode,

receive a signal from a first external component, the signal indicating the presence of the first external component,

detect that the first external component is present based on receiving the signal,

begin operating in conjunction with the first external component according to a closed-loop treatment therapy mode if the implantable component detects that the first external component is present,

detect that the first external component is not present based on not receiving the signal, and

stop operating according to the closed-loop treatment therapy mode if the implantable component detects that the first external component is not present.