Biological interface system

• US 8,560,041 B2
• Filed: 10/03/2005
• Issued: 10/15/2013
• Est. Priority Date: 10/04/2004
• Status: Active Grant

• Current Assignee: Braingate Incorporated
• Original Assignee: Braingate Co., LLC
• Inventors: Flaherty, J. Christopher, Van Wagenen, Richard A., Smith, Christopher, Decaria, Christine, Branner, Almut, Harvey, Nephi
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/240,652
• Publication Number:
  US 20060173259A1
• Time in Patent Office: 2,934 Days
• Field of Search: None
• US Class Current: 600/373
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance

Abstract

A system and method for an improved biological interface system that processes multicellular signals of a patient and controls one or more devices is disclosed. The system includes a sensor that detects the multicellular signals and a processing unit for producing the control signal based on the multicellular signals. The system may include improved communication, self-diagnostics, and surgical insertion tools.

Claims

1. A cellular access system comprising:

a sensor for placing multiple electrodes in close proximity to living cells below a tissue surface of a patient, the sensor comprising;

a base having a top surface and a bottom surface;

a plurality of projections extending from the bottom surface of the base, one or more of the projections including at least one electrode along its length;

a signal connector linked with the at least one electrode for providing an electrical connection to the electrode; and

a protective cap configured to protect one or more of the projections;

wherein a pattern of the projections in the base defines a periphery, and the base comprises a flange portion extending radially outward from at least a portion of the periphery, and

wherein the protective cap is configured to engage the flange portion,

further comprising

a tunneling device for passing the sensor under the skin of the patient,

a flexible sheath which is placed under the skin after which the sensor is passed therethrough, wherein the flexible sheath comprises a separator for dividing the sheath into a pair of peelable sheath portions.

2. The system of claim 1, wherein the base is constructed of a rigid material.

3. The system of claim 1, wherein the base is constructed of a flexible material.

4. The system of claim 1, wherein the base comprises flexible and rigid portions.

5. The system of claim 1, wherein the top surface of the base comprises a conductive pad for providing an electrical connection to each of the electrodes.

6. The system of claim 1, wherein at least one projection is tapered.

7. The system of claim 1, wherein at least one projection does not comprise an electrode.

8. The system of claim 7, wherein the projection that does not comprise an electrode is configured to anchor the sensor to tissue of the patient.

9. The system of claim 1, wherein at least one of the projections comprises a conductive material and an insulating material.

10. The system of claim 1, wherein one of the projections is separated from another of the projections by an insulating material.

11. The system of claim 1, wherein at least one of the projections comprises an electrode at its distal end.

12. The system of claim 1, wherein at least one of the projections comprises multiple electrodes.

13. The system of claim 12, wherein the at least one of the projections comprises a serial electrical connection with the multiple electrodes.

14. The system of claim 12, wherein each electrode comprises an independent electrical connection.

15. The system of claim 1, wherein the plurality of projections comprises a first projection and a second projection, the first projection having a geometric shape different from a geometric shape of the second projection.

16. The system of claim 1, wherein the plurality of projections comprises a first projection and a second projection, the first projection having a length different from a length of the second projection.

17. The system of claim 1, wherein the electrode is configured to receive one or more cellular signals.

18. The system of claim 1, wherein the electrode is configured to transmit signals.

19. The system of claim 18, wherein the signal transmitted is configured to stimulate one or more living cells of the patient.

20. The system of claim 1, wherein at least one of the projections comprises a conductive pathway along a majority of its length.

21. The system of claim 20, wherein the conductive pathway is surrounded by an insulating material.

22. The system of claim 1, wherein the plurality of projections comprises more than two electrodes, and the signal connector is linked with the electrodes for providing the electrical connection to each of the electrodes individually.

23. The system of claim 1, wherein the protective cap is configured to protect one or more of the projections during:

manufacturing;

shipment;

sterilization;

a surgical procedure;

a craniotomy;

a tunneling procedure of the base and projections under skin;

insertion of one or more projections, into tissue; and

any combination thereof.

24. The system of claim 1, wherein the protective cap is configured to protect one or more of the projections during a tunneling procedure from a first opening in the scalp of the patient to a second opening in the scalp of the patient.

25. The system of claim 1, wherein the protective cap is configured to protect one or more of the projections during a tunneling procedure from an opening in the scalp of the patient to an opening below the neck of the patient.

26. The system of claim 1, wherein the flange portion comprises at least one flat electrode.

27. The system of claim 26, wherein the at least one flat electrode is located on the bottom surface of the base.

28. The system of claim 1, wherein the protective cap is configured to frictionally engage the flange portion.

29. The system of claim 1, wherein the protective cap is configured to magnetically engage the flange portion.

30. The system of claim 1, wherein the protective cap is configured to engage two opposing sides of the base.

31. The system of claim 1, further comprising a wire bundle comprising:

a proximal end and a distal end; and

at least one filamentous insulated conductor;

wherein the proximal end is attached to the base and the at least one filamentous conductor is electrically connected to the electrode.

32. The system of claim 31, wherein the wire bundle is surrounded by an outer covering.

33. The system of claim 32, wherein the outer covering comprises a flexible sheath.

34. The system of claim 32, wherein the outer covering comprises an elastomeric compound.

35. The system of claim 32, wherein the outer covering loosely surrounds the at least one filamentous conductor.

36. The system of claim 32, wherein the outer covering tightly surrounds the at least one filamentous conductor.

37. The system of claim 31, wherein the at least one filamentous insulated conductor comprises multiple filamentous conductors, and the multiple filamentous conductors are electrically connected to the electrodes.

38. The system of claim 31, wherein the protective cap is mechanically attached to a portion of the wire bundle.

39. The system of claim 31, wherein the wire bundle comprises a connector.

40. The system of claim 39, wherein the connector is configured to mate with a receptacle implanted under the skin of the patient.

41. The system of claim 31, wherein the distal end is attached to a transcutaneous pedestal connector.

42. The system of claim 41, wherein the transcutaneous pedestal connector comprises:

a first portion located above the skin of the patient;

a second portion located beneath the skin of the patient;

an attachment member for securing the second portion under the skin of the patient; and

at least one signal communication port configured to transport a signal to or from one or more electrodes.

43. The system of claim 31, wherein the distal end is attached to a second implant.

44. The system of claim 43, wherein the second implant comprises a signal processing circuitry for processing multicellular signals received from the multiple electrodes.

45. The system of claim 31, wherein at least a portion of the wire bundle is resiliently flexible.

46. The system of claim 45, wherein the wire bundle is resiliently flexible along a majority of its length.

47. The system of claim 31, wherein at least a portion of the wire bundle is plastically deformable.

48. The system of claim 47, wherein the wire bundle is plastically deformable along a majority of its length.

49. The system of claim 31, further comprising one or more templates for positioning the wire bundle.

50. The system of claim 49, wherein the one or more templates are capable of creating used to create a groove in the skull of the patient.

51. The system of claim 49, wherein the one or more templates provides instructions used by an operator to plastically deform the wire bundle into a shape.

52. The system of claim 51, wherein the wire bundle is plastically deformed by one or more of:

bending;

twisting;

winding and stretching.

53. The system of claim 49, wherein the one or more templates are adjustable.

54. The system of claim 31, further comprising a winding tool for forming the wire bundle into one or more shapes.

55. The system of claim 54, further comprising a template for indicating the number of turns to wind the wire bundle.

56. The system of claim 54, wherein the winding tool is used to create one or more bends in the wire bundle.

57. The system of claim 54, wherein the winding tool comprises at least one of the projections about which the wire bundle is wound.

58. The system of claim 54, wherein the winding tool comprises multiple cylindrical projections.

59. The system of claim 1, further comprising an insertion tool for inserting the projections into tissue of the patient.

60. The system of claim 59, wherein the tissue comprises brain tissue.

61. The system of claim 59, wherein the tissue comprises peripheral nerve tissue.

62. The system of claim 59, wherein the insertion tool is configured to mechanically connect to the protective cap during insertion.

63. The system of claim 59, wherein the insertion tool is configured to be mechanically attached to the base of the sensor.

64. The system of claim 59, wherein the insertion tool is mechanically attached to the sensor during insertion.

65. The system of claim 1, wherein the flexible sheath is wire reinforced.

66. The system of claim 1, wherein the flexible sheath is configured to be implanted in the patient.

67. The system of claim 1, wherein the tunneling device is attached to the sensor utilizing one or more of:

a magnet;

a hook;

a frictional engagement device;

a Velcro; and

any combination thereof.

68. The system of claim 1, wherein the tunneling device is attached to the sensor via one or more of:

the base;

the protective cap;

a wire bundle attached to the sensor;

or any combination thereof.

69. The system of claim 1, wherein the tunneling device has a detachable tip.

70. The system of claim 1, wherein the plurality of projections are arranged in a ten by ten array.

71. The system of claim 1, wherein the at least one electrode is configured to detect electric signals generated from neurons.

72. The system of claim 1, wherein the at least one electrode comprises at least one of a recording electrode, a stimulating electrode, and an electrode having recording and stimulating capabilities.

73. The system of claim 1, wherein the sensor comprises a set of electrodes arranged in an array.

74. The system of claim 1, wherein the sensor comprises multiple wires or wire bundle electrodes.

75. The system of claim 1, wherein the sensor comprises electrodes incorporated into one or more of:

a subdural grid;

a scalp electrode;

a wire electrode; and

a cuff electrode.

76. The system of claim 1, wherein the sensor comprises two or more discrete components.

77. The system of claim 76, wherein each of the discrete components comprises one or more electrodes.

78. The system of claim 76, wherein each of the discrete components comprises one or more of:

a multi-electrode array;

a wire or wire bundle;

a subdural grid; and

a scalp electrode.

79. The system of claim 1, wherein the at least one electrode is configured to detect multicellular signals for less than twenty-four hours.

80. The system of claim 1, wherein the at least one electrode chronically detects multicellular signals.

81. The system of claim 1, wherein the sensor further comprises a signal processing circuitry.

82. The system of claim 1, wherein the sensor is configured to detect multicellular signals and transmit the multicellular signals through a wireless connection.

83. The system of claim 82 wherein the sensor is capable of transmitting the multicellular signals wirelessly to a receiver mounted on the skull of the patient.

84. The system of claim 1, wherein the sensor further comprises a coil for power transmission to the sensor.

85. The system of claim 1, wherein the at least one electrode is capable of recording from clusters of neurons and outputting detected signals comprising multiple neuron signals.

86. The system of claim 85, wherein detected signals are a measure of the local field potential response from neural activity.

87. The system of claim 85, wherein the multiple neuron signals comprise one or more of:

electrocorticogram signals, local field potentials, electroencephalogram signals, and peripheral nerve signals.

88. The system of claim 1, wherein the at least one electrode is capable of detecting a plurality of neuron signals.

89. The system of claim 1, wherein the system provides neural signal access.

90. The system of claim 1, wherein the patient is a human being.

91. The system of claim 1, wherein the patient is one or more of:

a quadriplegic, a paraplegic, an amputee, a spinal chord injury victim, and a physically impaired person.

92. The system of claim 1, further comprising a processing unit configured to receive multicellular signals from the sensor, process the multicellular signals to produce a processed signal, and transmit the processed signal to a controlled device.

93. The system of claim 92, wherein the controlled device comprises a piece of medical equipment.

94. The system of claim 93, wherein the medical equipment is used to perform a surgical event.

95. The system of claim 92, wherein the controlled device is a communication device.

96. The system of claim 95, wherein the communication device transmits multiple pieces of information simultaneously.

97. The system of claim 92, wherein the controlled device is a piece of equipment with controllable moving parts.

98. The system of claim 97, wherein the equipment is one or more of:

a watercraft, an aircraft;

a land vehicle, and a reconnaissance robot.

99. The system of claim 92, wherein the processing unit comprises an integrated neuron spike sorting function.

100. The system of claim 99, wherein the neuron spike sorting function is configured to classify spikes with a minimum amplitude threshold.

101. The system of claim 92, wherein the processing unit comprises an element to amplify the multicellular signals.

102. The system of claim 101, wherein the multicellular signals are amplified by a gain of at least eighty.

103. The system of claim 92, wherein the processing unit utilizes neural net software routines to map neural signals into the processed signal to control the controlled device.

104. The system of claim 92, wherein the processing unit assigns one or more cellular signals to a specific use.

105. The system of claim 104, wherein the specific use is determined by the patient attempting an imagined movement or other imagined state.

106. The system of claim 92, wherein the processing unit utilizes one or more cellular signals that is under voluntary control of the patient.

107. The system of claim 92, wherein the processing unit utilizes two or more cellular signals that are mathematically combined to create the processed signal.

108. The system of claim 92, wherein the processing unit is configured to use a cellular signal from a neuron whose signal is separated from other nearby neurons.

109. The system of claim 92, wherein the processing unit is configured to convert an analog signal that represents a cellular signal to a digital signal.

110. The system of claim 92, further comprising a patient feedback module.

111. The system of claim 110, wherein the patient feedback module comprises one or more of:

an audio transducer, a tactile transducer, a visual transducer, a video display, and an olfactory transducer.

112. The system of claim 110, wherein the patient feedback module comprises a stimulator, and a one or more neurons are stimulated to cause movement or sensation in a part of the patient'"'"'s body.

113. The system of claim 92, further comprising a drug delivery system, wherein the processing unit transmits a signal to the drug delivery system to deliver a therapeutic agent or drug to at least a portion of the patient'"'"'s body.

114. The system of claim 1, further comprising an embedded identifier.

115. The system of claim 114, wherein the embedded identifier is used to confirm compatibility of one or more discrete components of the system.