Neural stimulation system and optical monitoring systems and methods

• US 20070100398A1
• Filed: 10/18/2006
• Published: 05/03/2007
• Est. Priority Date: 10/19/2005
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Northstar Neuroscience, Inc.
• Inventors: Sloan, Leif
• Granted Patent: US 7,729,773 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Neural stimulation and optical monitoring systems and methods are disclosed. In one embodiment, an apparatus for treating a neural condition includes a signal delivery device configured to be implanted into a patient proximate to a skull of the patient and positioned to apply electromagnetic signals to one or more target sites within the patient. The apparatus also includes an implantable optical monitoring assembly configured to monitor optical properties at one or more optical monitoring sites within the patient. The apparatus further includes a controller configured to be implanted into the patient. The controller is operatively coupled to the signal delivery device and the optical monitoring assembly and programmed to control both the signal delivery device and the optical monitoring assembly. The controller also includes a power source to power both the signal delivery device and the optical monitoring assembly.

Claims

1. An apparatus for treating a neural condition, comprising:

a signal delivery device configured to be implanted into a patient proximate to a skull of the patient and positioned to apply electromagnetic signals to one or more target sites within the patient;

an implantable optical monitoring assembly configured to monitor optical properties at one or more optical monitoring sites within the patient; and

a controller configured to be implanted into the patient, the controller being operatively coupled to the signal delivery device and the optical monitoring assembly and programmed to control both the signal delivery device and the optical monitoring assembly, and wherein the controller includes a power source to power both the signal delivery device and the optical monitoring assembly.

2. The apparatus of claim 1 wherein the signal delivery device comprises at least one electrode configured to be implanted within the skull of the patient.

3. The apparatus of claim 1 wherein the signal delivery device comprises an electrode configured to be positioned proximate to a cortical surface within the skull of the patient.

4. The apparatus of claim 1 wherein the optical monitoring assembly comprises:

an implantable support member configured to be implanted within the skull of the patient;

one or more optical emission elements carried by the support member; and

one or more optical detection elements carried by the support member, wherein the one or more optical emission elements and the one or more optical detection elements are arranged relative to each other to detect optical signals from the one or more optical monitoring sites.

5. The apparatus of claim 4 wherein the one or more optical detection elements and the one or more optical emission elements are arranged relative to each other to detect optical signals that are scattered, reflected, and/or emitted by target tissues at the one or more optical monitoring sites.

6. The apparatus of claim 4 wherein the one or more optical detection elements and the one or more optical emission elements comprise at least one of an optical fiber, a wavelength filter, and an optical signaling element.

7. The apparatus of claim 4 wherein the one or more optical detection elements and the one or more optical emission elements are separated from each other by approximately 0.5 cm to approximately 5.0 cm.

8. The apparatus of claim 4 wherein the one or more optical detection elements and the one or more optical emission elements are separated from each other by approximately 2.0 cm to approximately 3.0 cm.

9. The apparatus of claim 4 wherein a plurality of optical detection elements are arranged equidistant or approximately equidistant from an optical emission element.

10. The apparatus of claim 4 wherein a plurality of optical emission elements are arranged equidistant or approximately equidistant from an optical detection element.

11. The apparatus of claim 1 wherein the optical monitoring assembly is a first optical monitoring assembly, and wherein the apparatus further comprises one or more additional optical monitoring assemblies positioned to monitor optical properties at the one or more optical monitoring sites.

12. The apparatus of claim 1 wherein the one or more target sites are first target sites and the optical monitoring assembly is a first optical monitoring assembly, and wherein the apparatus further comprises:

a second optical monitoring assembly positioned to at least one of (a) monitor optical properties at the one or more optical monitoring sites, and (b) apply electromagnetic signals to the one or more second target sites.

13. The apparatus of claim 12 wherein the second optical monitoring assembly comprises:

an implantable second support member configured to be implanted within the skull of the patient;

one or more electrodes carried by the second support member and configured to receive and apply signals to the one or more second target sites;

one or more second optical emission elements carried by the second support member; and

one or more second optical detection elements carried by the second support member, wherein the one or more second optical emission elements and the one or more second optical detection elements are arranged relative to each other to detect optical signals from the one or more optical monitoring sites.

14. The apparatus of claim 12 wherein the first optical monitoring assembly and the second optical monitoring assembly are implanted at different brain locations of the patient.

15. The apparatus of claim 12 wherein the first optical monitoring assembly is implanted proximate to a first brain location of the patient and the second optical monitoring assembly is implanted proximate to a second brain location of the patient, and wherein the first optical monitoring assembly is positioned to detect a hemodynamic characteristic associated with neural activity in the first brain location, and the second optical monitoring assembly is positioned to detect a hemodynamic characteristic associated with neural activity in the second brain location.

16. The apparatus of claim 1, further comprising an implantable support member, and wherein at least a portion of both the signal delivery device and the optical monitoring assembly are carried by the support member.

17. The apparatus of claim 1, further comprising a chemical delivery device positioned to release or apply one or more chemical substances to one or more chemical delivery sites in the patient.

18. The apparatus of claim 17 wherein the chemical delivery device includes an implantable chemical delivery device

19. The apparatus of claim 1, further comprising:

a communication device; and

a programming device external to the patient and coupled to the controller via the communication device, the programming device having instructions to perform at least one of (a) directing the stimulation signals and optical monitoring instructions and their issuance to the controller, (b) receiving, processing, and analyzing information received from the controller, (c) visually indicating signal delivery and stimulation information, and (d) visually indicating detected, estimated, or measured optical properties and physiologic or physiologic correlate properties.

20. A neural stimulation and optical monitoring system, the system comprising:

an implantable electrode positioned to transmit signals to a target neural population of a patient;

an optical monitoring assembly positioned to apply optical signals to and detect optical signals scattered within or reflected by tissue of the patient at one or more optical monitoring sites proximate to a skull of the patient; and

an implantable controller operatively coupled to the electrode and the optical monitoring assembly, the controller being programmed with instructions to manage (a) the application of signals to the target neural population, and (b) the detection and processing of optical signals at the one or more optical monitoring sites.

21. The system of claim 20, further comprising an implantable chemical delivery device positioned to release or apply one or more chemical substances to one or more chemical delivery sites on or in the patient'"'"'s body.

22. The system of claim 20 wherein:

the electrode is configured to be implanted epidurally or subdurally; and

the optical monitoring assembly is configured to be implanted subcutaneously, epidurally, or subdurally.

23. The system of claim 20 wherein the optical monitoring assembly is positioned to selectively measure changes in one or more hemodynamic properties.

24. The system of claim 20 wherein the optical monitoring assembly comprises an implantable, generally planar support member configured to be implanted into the skull of the patient, and wherein the optical monitoring assembly includes one or more optical emission elements carried by the support member and one or more optical detection elements carried by the support member, the one or more optical emission elements and the one or more optical detection elements being arranged relative to each other in a predetermined pattern to detect optical signals from the one or more optical monitoring sites.

25. The system of claim 20 wherein the optical monitoring assembly is a first optical monitoring assembly positioned to detect hemodynamic characteristics associated with neural activity at a healthy brain location of the patient, and wherein the system further comprises a second optical monitoring assembly positioned to apply optical signals to and detect optical signals scattered within or reflected by tissue of the patient at a homologous brain location of the patient that exhibits a neurologic dysfunction.

26. The system of claim 20 wherein the controller is configured to analyze the optical signals and, based at least in part on the analyzed optical signals, determine whether to apply, modify, or discontinue transmitting signals to the target neural population.

27. The system of claim 20 wherein the signals transmitted by the electrode include at least one of electromagnetic signals, thermal signals, and mechanical forces capable of affecting neural function in the patient.

28. The system of claim 20 wherein the electrode is a first electrode and the optical monitoring assembly is a first optical monitoring assembly, and wherein the system further comprises (a) at least one additional electrode positioned at one or more target neural populations of the patient, and (b) at least one additional optical monitoring assembly positioned to apply optical signals to and detect optical signals scattered within or reflected by tissue of the patient at the one or more optical monitoring sites.

29. An apparatus for treating a neural condition, comprising:

one or more implantable signal delivery devices positioned to apply electromagnetic signals to one or more corresponding target neural populations of a patient;

one or more optical monitoring devices positioned to monitor optical properties at one or more optical monitoring sites within or proximate to the skull of the patient; and

an implantable controller operatively coupled to the one or more signal delivery devices, the controller including a computer-readable medium having instructions for;

affecting the one or more target neural populations of the patient by directing the delivery of one or more electromagnetic signals to the corresponding target neural populations;

receiving information from the one or more optical monitoring devices corresponding to at least one characteristic of the patient that is correlated at least in part with the delivery of the electromagnetic signals; and

based at least in part on the characteristic, controlling at least one parameter in accordance with which the electromagnetic signals are applied to the patient.

30. The apparatus of claim 29 wherein controlling at least one parameter in accordance with which the electromagnetic signals are applied to the patient comprises changing the at least one parameter.

31. The apparatus of claim 29 wherein controlling at least one stimulation parameter in accordance with which the electromagnetic signals are applied to the patient comprises at least one of initiating, continuing, varying, interrupting, resuming, and discontinuing the delivery of the electromagnetic signals to the corresponding target neural populations.

32. The apparatus of claim 29 wherein the computer-readable medium further includes instructions for directing delivery of a chemical substance to the patient at one or more chemical delivery sites in the patient.

33. The apparatus of claim 29 wherein the at least one characteristic of the patient comprises optical signals scattered within or reflected by living tissue of the patient at the one or more optical monitoring sites.

34. An apparatus for treating a neural condition, comprising:

a substance delivery device configured to release or apply one or more chemical substances to one or more corresponding target sites upon or within a patient;

an implantable optical monitoring assembly configured to monitor optical properties at one or more optical monitoring sites within or proximate to the skull of the patient; and

a controller configured to be implanted into the patient, the controller being operatively coupled to the substance delivery device and the optical monitoring assembly and programmed to control both the substance delivery device and the optical monitoring assembly.

35. A method for treating a patient, comprising:

affecting a target neural population of a patient by providing electromagnetic signals to the target neural population;

detecting at least one optical signal in tissue of the patient at one or more optical monitoring sites after providing the electromagnetic signals at the target neural population; and

based on the detected optical signal, controlling at least one signal delivery parameter in accordance with which the electromagnetic signals are applied to the target neural population.

36. The method of claim 35 wherein controlling at least one signal delivery parameter comprises controlling at least one signal delivery parameter on an at least approximately real time basis with respect to the detected optical signal.

37. The method of claim 35 wherein controlling at least one signal delivery parameter comprises changing at least one signal delivery parameter.

38. The method of claim 35 wherein detecting at least one optical signal in tissue of the patient comprises detecting the at least one optical signal in tissue at or proximate to the target neural population.

39. The method of claim 35 wherein detecting at least one optical signal in tissue of the patient comprises detecting the at least one optical signal in tissue spaced apart from the target neural population.

40. The method of claim 35, further comprising providing to the patient a chemical substance before, during, or after providing the electromagnetic signals to the patient.

41. The method of claim 35 wherein providing electromagnetic signals to the patient at the target neural population comprises applying electrical signals from one or more electrodes implanted within the patient'"'"'s skull.

42. The method of claim 35, further comprising selecting the target neural population to which the electromagnetic signals are provided.

43. The method of claim 35, further comprising implanting a signal delivery device within the patient'"'"'s skull.

44. The method of claim 35 wherein providing electromagnetic signals to the patient at the target neural population comprises providing electromagnetic signals via one or more electrodes implanted at least proximate to the patient'"'"'s cortex.

45. The method of claim 35, further comprising identifying the one or more optical monitoring sites and implanting at least one optical monitoring device before affecting the target neural population of the patient.

46. The method of claim 35 wherein providing electromagnetic signals to the patient, detecting the at least one optical signal, and controlling the at least one signal delivery parameter are performed at least in part by a practitioner.

47. The method of claim 35 wherein providing electromagnetic signals to the patient, detecting the at least one optical signal, and controlling the at least one signal delivery parameter are performed at least in part by a computer-readable medium.

48. A method for treating a patient, comprising:

applying electromagnetic signals having a first set of signal delivery parameters to a target neural population of a patient via an electrode;

detecting optical signals in tissue at or proximate to one or more brain regions of the patient at least one of before, during, and after applying the electromagnetic signals;

selecting a second set of signal delivery parameters based, at least in part, on the detected optical signals; and

applying additional electromagnetic signals to the patient in accordance with the second set of signal delivery parameters.

49. The method of claim 48 wherein the target neural population is a first target neural population, and wherein applying additional electromagnetic signals to the patient comprises applying additional electromagnetic signals to a second target neural population different than the first target neural population.

50. The method of claim 48 wherein applying electromagnetic signals having a first set of signal delivery parameters comprises applying electrical signals having a first waveform to the target neural population, and wherein applying additional electromagnetic signals in accordance with the second set of signal delivery parameters comprises applying additional electromagnetic signals having a second waveform different than the first waveform.

51. The method of claim 48 wherein applying electromagnetic signals having a first set of signal delivery parameters, detecting optical signals, selecting a second set of signal delivery parameters, and applying additional electromagnetic signals occurs approximately in real-time.

52. The method of claim 48 wherein detecting optical signals in tissue at or proximate to one or more brain regions comprises detecting one or more hemodynamic characteristics associated, at least in part, with the electromagnetic signals applied to the target neural population.

53. The method of claim 48 wherein applying electromagnetic signals to a target neural population of a patient via an electrode comprises applying electromagnetic signals via a surface electrode.

54. A method for treating a patient, comprising:

affecting a target neural population of a patient by providing to the patient one or more chemical substances;

detecting at least one optical signal in tissue at or proximate to one or more brain regions of the patient after providing the one or more chemical substances; and

based on the detected optical signal, controlling at least one substance delivery parameter in accordance with which the one or more chemical substances are provided.