Systems, Methods and Devices for a Skull/Brain Interface

• US 20090112278A1
• Filed: 10/01/2008
• Published: 04/30/2009
• Est. Priority Date: 10/30/2007
• Status: Abandoned Application

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Wingeier, Brett, Pless, Benjamin
• Application Number:
  US12/243,733
• Publication Number:
  US 20090112278A1
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body

Abstract

Disclosed are methods, devices, and systems for inducing neuromodulation by focusing a source of stimulation through a skull/brain interface in the form of an aperture formed in the skull, a naturally occurring fenestration in the skull, or a transcranial channel. Further disclosed are methods, devices, and systems for identifying where to locate skull/brain interfaces, accessories that can be used with the interfaces, and features for controlling stimulation delivered through the interfaces. Multiple indications for the skull/brain interfaces are also disclosed, including diagnosis and treatment of neurological disorders and conditions such as epilepsy, movement disorders, depression, Alzheimer'"'"'s disease, autism, coma, and pain.

Claims

1. A device for facilitating conduction from or to an aperture, naturally-occurring fenestration, or transcranial channel in the skull of a patient, comprising:

a scalp electrode formed at least in part from a material or substance that will conduct current from or to the aperture, natually-occurring fenestration, or transcranial channel.

3. The device of claim 1, further comprising:

an element for securing the scalp electrode onto the head.

2. The device of claim 1, further comprising:

an element for orienting the scalp electrode on the head with respect to at least one anatomical marker.

4. A scalp electrode pad assembly for facilitating conduction between a current source and the brain through a skull/brain interface comprising one or more of an aperture, a naturally-occurring fenestration and a transcranial channel, the scalp electrode pad assembly comprising:

a scalp electrode comprising in part a current-conducting substance;

an orienting feature for orienting the assembly on the head of a patient with respect to an anatomical landmark; and

a securing feature for temporarily securing the assembly on the head of the patient.

5. The scalp electrode pad assembly of claim 4, wherein anatomical landmark is an ear of the patient or a nasion of the patient.

6. A device for closing off a skull/brain interface comprising one or more of an aperture, a naturally-occurring fenestration and a transcranial channel, the device for closing off comprising:

a unit of material that is subtantially non-permeable to ionic current.

7. A plug for a skull/brain interface comprising one or more of an aperture, a naturally-occurring fenestration and a transcranial channel, the plug comprising:

a unit of material having dimensions that substantially correspond to the dimensions of the aperture, naturally-occurring fenestration or at least a portion of the transcranial channel wherein the material is substantially impermeable to ionic current.

8. A shield for closing off a skull/brain interface comprising one or more of an aperture, a naturally-occurring fenestration and a transcranial channel, the shield comprising:

a unit of material configured to be temporarily or permanently attached to the proximal end the skull/brain interface wherein the material is substantially resistant to the flow of ionic current.

9. The shield of claim 8, wherein the unit of material further is provided with at least one feature designed to mate with a corresponding receiving feature in the skull/brain interface to temporarily affix the shield to the skull/brain interface.

10. A valve insertable into a skull/brain interface to at least partially control conduction through the skull/brain interface, the valve comprising:

at least a first flap, the at least a first flap selectively controllable to constitute a first position that is at least partially open and a second position that is closed;

wherein the at least a first flap is at least partially formed from a substance that resists ionic current flow.

11. A valve insertable into a skull/brain interface to at least partially control conduction through the skull/brain interface, the valve comprising:

a valve control mechanism operable to selectively close and at least partially open the valve; and

a unit of material at least partially formed from a substance that resists ionic current flow disposed in the valve such that when the valve is in the closed position, the skull/brain interface will be rendered substantially nonconductive to ions.

12. A skull/brain interface comprising:

one or more of an aperture, a naturally-occurring fenestration and a transcranial channel;

at least one valve disposed in the aperture, naturally-occurring fenestration or transcranial channel, the valve having a closed position and an at least partially open position and configured so that the skull/brain interface is selectively closed or at least partially open with the at least one valve.

13. A valved transcranial channel comprising:

a conduit for conveying current consisting substantially of direct current into a patient'"'"'s brain; and

a valve for selectively controlling the conveyance of current through the conduit.

14. A method of selectively controlling the amount of direct current stimulation delivered through a skull/brain interface comprising one of an aperture, a naturally-occurring fenestration and a transcranial channel, comprising:

operating a valve disposed at least partially in the skull/brain interface to close off the interface to prevent the flow of ionic current and to at least partially open the interface to allow the flow of ionic current through the interface.

15. A transcranial interface configured to be implanted in an aperture in a skull of a patient, comprising:

a channel having a proximal surface and a device configured to selectively open and close the channel.

16. The transcranial interface of claim 15, wherein the device configured to selectively open and close the channel comprises a plurality of extensions operably connected to the proximal surface and a plurality of flaps, wherein imparting a force on the proximal surface is configured to cause an extension to open a corresponding flap.

17. The transcranial interface of claim 15, wherein the device configured to selectively open and close the channel is activated by a mechanical force.

18. The transcranial interface of claim 15, wherein the device configured to selectively open and close the channel is activated by a magnetic force.

19. The transcranial interface of claim 15, wherein the device configured to selectively open and close the channel is activated based on information received from a current detector.

20. The transcranial interface of claim 15, wherein the device configured to selectively open and close the channel is activated based on information received from a voltage detector.

21. An identification system for use with a skull/brain interface comprising one of an aperture, a fenestration and a transcranial channel, the patient identification system comprising:

at least one radio frequency identification element adapted to be disposed in or on the skull/brain interface;

a radio frequency identification antenna adapted to disposed in, on, or in the vicinity of the skull/brain interface.

22. A transcranial interface configured to be implanted in an aperture in a skull of a patient, comprising:

a channel; and

a radio frequency identification element, wherein the RFID element is configured to wirelessly transmit a patient identifier.

23. A method of providing a skull/brain interface for providing stimulation to neural tissue, comprising:

forming an aperture in a skull of a patient;

providing a transcranial channel having a radio frequency identification (RFID) elementin the aperture;

wirelessly transmitting an identifier from the RFID element.

24. The method of claim 23, further comprising:

receiving the transmitted identifier at a stimulation device; and

causing stimulation to be provided via the transcranial channel based on reception of the transmitted identifier

25. A system for providing stimulation to neural tissue, comprising:

a transcranial interface configured to be implanted in an aperture in a skull of a patient, wherein the transcranial interface comprises a channel and a radio frequency identification (RFID) element, wherein the RFID element is configured to wirelessly transmit an identifier; and

a stimulation device configured to receive wireless transmissions and to provide stimulation based upon reception of a particular identifier.

26. The system of claim 25, wherein the identifier comprises a patient identifier.

27. The system of claim 25, wherein the identifier comprises a transcranial interface identifier.

28. The system of claim 25, wherein the stimulation device is further configured to monitor an amount of stimulation provided during a time period based on a particular identifier and to prevent stimulation from being provided based on the particular identifier if a threshold is exceeded.

29. A transcranial interface configured to be implanted in an aperture in a skull of a patient, comprising:

a channel; and

a radio frequency identification (RFID) controller, wherein the RFID controller is configured to wirelessly transmit a patient identifier.

30. A transcranial channel implant kit, comprising:

at least one transcranial channel of a first size and shape and at least one transcranial channel of a second size and shape.

31. A skull/brain interface kit, comprising:

at least one skull/brain interface of a first length to correspond to a first skull thickness, and at least one skull/brain interface of a second length to correspond to a second skull thickness.

32. The skull/brain interface kit of claim 31, wherein the at least one skull/brain interface of a first length has a plurality of inner lumens.

33. The skull/brain interface kit of claim 31, further comprising:

an overlay for laying over the head of a patient to map out where to place one or more skull/brain interfaces.

34. The skull/brain interface of claim 31, further comprising:

a low-resolution stereotaxy assembly for orienting over the head of a patient to aid in determining where to locate one or more skull/brain interfaces.

36. The skull/brain interface kit of claim 31, further comprising a headpiece adapted to receive a stimulator for providing a source of stimulation to the one or more skull/brain interfaces.

37. The skull/brain interface kit of claim 36, further comprising a stimulator and wherein the headpiece is a helmet adapted to receive the stimulator.

35. A skull/brain interface kit, comprising:

an overlay for laying over the head of a patient to locate where to place one or more skull/brain interfaces.

38. The skull/brain interface kit of claim 35, further comprising a drill to assist in forming the one or more skull/brain interfaces.

39. A transcranial channel implant kit, comprising:

at least one transcranial channel of a first size and shape and length and an ultrasound tool for gauging the thickness of a patient'"'"'s skull.

40. The transcranial channel implant kit of claim 39, wherein the ultrasound tool is an ultrasonic transducer adapted to be fitted on a drill to monitor the thickness of the skull while an aperture is being formed in the skull.

41. The method of claim 40, wherein the form of neuromodulation is transcranial magnetic stimulation.

40-1. A method for identifying where to locate a skull/brain interface in a skull of a patient, comprising:

directing a form of neuromodulation to a target area of the brain;

determining whether a response is produced by the neuromodulation;

if a response is produced, determining whether the produced response correlates to a predicted response in a set of predicted responses, wherein the set of predicted responses includes at least one predicted response; and

if the produced response correlates to the predicted response, identifying an area of the skull in the vicinity of the target area of the brain as a location for a skull/brain interface.

42. A stimulator to introduce a form of stimulation through a skull/brain interface comprising one of an aperture, a naturally-occurring fenestration, and a transcranial channel, the stimulator comprising:

at least one element for positioning the stimulator in the vicinity of the skull/brain interface;

a remote control device for remotely controlling at least one operating parameter of the stimulator.

43. A stimulator for introducing direct current stimulation through a skull/brain interface comprising one of an aperture, a naturally-occurring fenestration and a transcranial channel, the stimulator comprising:

at least one element for positioning the source of direct current so that the direct current will be focused at a proximal end of the skull/brain interface; and

at least one element for adjusting the current of the stimulator to keep at least one parameter within a predetermined range when stimulation is being delivered.

44. The stimulator of claim 43, wherein the element for adjusting the current of the stimulator includes at least one circuit for monitoring a voltage, and adjusting the current to maintain the voltage within a predetermined range when stimulation is being delivered.

45. A method for diagnosing or treating a neurological disorder or dysfunction using a skull/brain interface in a patient, comprising:

installing a skull/brain interface comprising one of an aperture in the skull of a patient and a channel in the skull of a patient over a target area of the patient'"'"'s brain;

focusing a form of neuromodulation through the skull/brain interface towards the target area.

46. The method of claim 45, wherein the form of neuromodulation is direct current stimulation.

47. The method of claim 45, wherein the neurological disorder or dysfunction is one or more of the following:

epilepsy, a movement disorder, a psychiatric disorder, the result of a stroke, Alzheimer'"'"'s disease, a cognitive disorder, an anxiety disorder, an eating disorder, an addition or craving, restless leg syndrome, a sleep disorder, Tourette'"'"'s syndrome, a stress disorder, coma, autism, a hearing disorder, a speech disorder, amblyopia, headaches, and pain.

48. A method for providing neuromodulation to the brain of a patient responsive to a neurological state, comprising:

sensing at least a first neurological state through a skull/brain interface comprising one of an aperture in the skull of a patient and a channel in the skull of a patient over a target area of a patient'"'"'s brain;

focusing a form of neuromodulation through the skull/brain interface towards the target area when the first neurological state is sensed.

49. The method of claim 48, wherein the first neurological state corresponds to a sleep stage.

50. The method of claim 49, wherein the form of neuromodulation is direct current stimulation.

51. A system for providing neuromodulation to the brain of a patient responsive to an event detected in a sensed signal, comprising:

at least one module for sensing signals through a skull/brain interface comprising one of an aperture in the skull of a patient and a channel in the skull of a patient located in the vicinity of a target area of neural tissue;

at least one module for identifying at least one parameter of the sensed signals;

at least one module for generating a form of neuromodulation based upon a set of neuromodulation parameters;

at least one module for varying at least one of the neuromodulation parameters in response to changes in the at least one sensed parameter; and

at least one module for focusing the form of neuromodulation generated by the generating subsystem through the skull/brain interface to the target area of neural tissue.

52. The system of claim 51, wherein the at least one module for varying at least one of the neuromodulation parameters in response to changes in the at least one sensed parameters is configured to apply at least one feedback control law to determine how to vary the at least one neuromodulation parameter.

53. The system of claim 52, wherein the form of neuromodulation is direct current stimulation.

54. The system of claim 52, wherein the form of neuromodulation is one of direct current stimulation, near direct current stimulation, pulsatile current stimulation, and alternating current stimulation.

55. A system for providing neuromodulation to the brain of a patient responsive to an event detected in a neurological state, comprising:

a subsystem for sensing at least a first neurological state through a skull/brain interface comprising one of an aperture in the skull of a patient and a channel in the skull of a patient located in the vicinity of a target area of neural tissue;

a subsystem for registering at least one condition of the at least one first neurological state as a detected event;

a subsystem for generating a form of neuromodulation in response to the detected event; and

at least one element for focusing the stimulation generated by the generating subsystem through the skull/brain interface to the target area of neural tissue.

56. The system of claim 55, wherein the form of neuromodulation is direct current stimulation.

57. The system of claim 55, wherein the neurological state is a sleep stage.

58. A method of enhancing a patient'"'"'s performance through a skull/brain interface, comprising:

providing an aperture between a skull and a brain of a patient in the vicinity of a target area of neural tissue; and

introducing a source of modulation through the aperture to improve one or more facilities of the patient.

59. The method of claim 58, wherein the one or more facilities comprise one or more of the following:

memory retention, visual acuity, verbal fluency, and creativity.

60. The method of claim 58, wherein the source of modulation is a source of direct current, and further comprising providing a transcranial channel in the aperture.

61. The method of claim 58, wherein the target area of neural tissue is the occipital cortex, and the source of modulation is a source of anodal direct current stimulation.

62. The method of claim 58, wherein the target area is selected such that when a source of modulation is introduced through the skull/brain interface the dorsolateral prefrontal cortex will be modulated.

63. The method of claim 62, wherein the source of modulation is a source of direct current.

64. The method of claim 58, wherein the target area is selected such that when a source of modulation is introduced through the skull/brain interface the left prefrontal cortex will be modulated.

65. The method of claim 58, wherein the target area is selected such that when a source of modulation is introduced through the skull/brain interface an area of the brain corresponding to executive function will be modulated.

66. The method of claim 65, wherein the area of the brain corresponding to executive function is the prefrontal cortex.

67. A method of promoting axonal regrowth in an area of neural tissue, comprising:

providing a skull/brain interface in a patient in the vicinity of a target area of neural tissue using an aperture; and

introducing a direct current electrical field through the aperture.

68. A method of guiding stem cell migration in an intracranial volume of a patient, comprising:

providing a skull/brain interface in a patient in the vicinity of a target area of neural tissue with a transcranial channel; and

introducing a direct current electrical field through the channel.

69. A method of improving memory or cognitive function in a human patient, comprising:

providing a skull/brain interface in a patient in the vicinity of a target area of neural tissue, the interface comprising one of an aperture and a transcranial channel;

and focusing stimulation substantially comprising direct current stimulation through the interface.

70. The method of claim 69, wherein the direct current stimulation is anodal direct current stimulation and the target area of neural tissue is a temporopareital area.

71. A method for treating Alzheimer'"'"'s disease, comprising:

focusing stimulation comprising substantially direct current stimulation on a target area of neural tissue through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient.

72. The method of claim 71, wherein focusing the stimulation includes focusing the stimulation on a temporoparietal area of the brain.

73. A method for treating a psychiatric disorder, comprising:

focusing stimulation comprising substantially direct current stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

74. The method of claim 73, further comprising focusing stimulation comprising substantially direct current stimulation on a first area of neural tissue and focusing stimulation comprising substantially direct current stimulation on a second area of neural tissue comprising at least one deep brain structure through at least one transparenchymal channel in communication with the skull/brain interface.

75. A method for treating a patient in a coma or a minimally-conscious state, comprising:

focusing stimulation comprising substantially direct current stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

76. The method of claim 75, further comprising focusing stimulation comprising substantially direct current stimulation on a first area of neural tissue and focusing stimulation comprising substantially direct current stimulation on a second area of neural tissue comprising at least one deep brain structure through at least one transparenchymal channel in communication with the skull/brain interface.

77. The method of claim 76, wherein the at least one deep brain structure includes tissue comprising at least a portion of the reticular activating network.

78. A method for treating a patient in a coma or a minimally-conscious state, comprising:

providing a skull/brain interface in the form of an aperture or a channel in a patient; and

focusing stimulation substantially comprising direct current stimulation on an area of neural tissue comprising at least one deep brain structure through at least one transparenchymal channel in communication with the skull/brain interface.

79. A method for treating tinnitus, comprising:

focusing stimulation comprising substantially direct current stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

80. The method of claim 79, wherein the area of neural tissue is the left temporoparietal area.

81. A method for improving language performance in a human patient, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

82. The method of claim 81, wherein the form of stimulation is stimulation substantially comprising direct current, and the area of neural tissue is one or both of the left perisylvian area and the left frontotemporal area.

83. A method for stroke rehabilitation, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

84. The method of claim 83, wherein the form of stimulation is stimulation substantially comprising direct current.

85. The method of claim 83, wherein the area of neural tissue is the left frontotemporal area.

86. A method for treating headaches, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

87. The method of claim 86, wherein the form of stimulation is stimulation substantially comprising direct current.

88. The method of claim 86, wherein the form of stimulation is repetitive electrical stimulation.

90. The method of claim 88, wherein delivering a form of stimulation further comprises delivering a form of stimulation characterized by a plurality of stimulation parameters, and further comprising varying at least one of the stimulation parameters in response to variations in the at least one sensed parameter.

91. The method of claim 90, wherein varying at least one of the stimulation parameters in response to variations in the at least one sensed parameter includes applying a control law to determine how to vary the at least one of the stimulation parameters in response to variations in the at least one sensed parameter.

89. A method of counteracting abnormal cortical activity, comprising:

sensing signals corresponding to cortical activity;

identifying at least one sensed parameter of the signals correlatable to an abnormal cortical activity;

delivering a form of stimulation through a skull/brain interface comprising one of an aperture, a naturally-occuring fenestration, and a channel when an abnormal cortical activity is identified.

92. A method for treating pain, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

93. The method of claim 92, wherein the form of stimulation is stimulation substantially comprising direct current.

94. The method of claim 92, wherein the area of neural tissue is one or more of the primary motor cortex, the somatosensory cortex, and the dorsolateral prefrontal cortex.

95. The method of claim 92, wherein the pain is one or more of post-herpetic pain, phantom limb pain, failed back surgery syndrome, complex regional pain syndrome, fibromyalgia, and traumatic spinal cord injury.

96. A method for improving a patient'"'"'s response to pain, comprising:

focusing a form of stimulation through a transcranial channel in a patient on the dorsolateral prefrontal cortex.

97. A method for treating autism, comprising:

focusing stimulation substantially comprising direct current stimulation through a transcranial channel in a patient on the left frontotemporal cortex.

98. A method for providing neuroprotection for stroke, comprising:

focusing stimulation comprising substantially direct current stimulation through a transcranial channel in a patient on a first area of neural tissue.

99. A method providing neuroprotection for stroke, comprising:

providing a skull/brain interface in the form of an aperture or a channel in a patient; and

focusing stimulation substantially comprising direct current stimulation on an area of neural tissue comprising at least one deep brain structure through at least one transparenchymal channel in communication with the skull/brain interface.

100. A method for counteracting an addition or craving in a human patient, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

101. The method of claim 100, wherein the area of neural tissue is one or both of the left dorsolateral prefrontal cortex and the right dorsolateral prefrontal cortex.

102. A method for managing a semi-voluntary or involuntary behavior in a human patient, comprising:

focusing a form of stimulation through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient on an area of neural tissue.

103. The method of claim 102, wherein the semi-voluntary or involuntary behavior is one of obsessive-compulsive disorder and Tourette'"'"'s syndrome.

103-2. A method for improving visual function in amblyopia, comprising:

focusing a form of stimulation substantially comprising direct current stimulation on the visual cortex through a skull/brain interface comprising one of an aperture and a transcranial channel in a patient.