Biological interface system with thresholded configuration

• US 7,881,780 B2
• Filed: 12/30/2005
• Issued: 02/01/2011
• Est. Priority Date: 01/18/2005
• Status: Active Grant

• Current Assignee: Braingate Incorporated
• Original Assignee: Braingate Co., LLC
• Inventors: Flaherty, J. Christopher
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US11/321,860
• Publication Number:
  US 20060195042A1
• Time in Patent Office: 1,859 Days
• Field of Search: 600/301, 600/306, 600/345, 600/347, 600/365, 600/485, 600/486, 600/529, 600544-547, 600/549, 600/587
• US Class Current: 600/544
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61F 2/50 Prostheses not implantable in the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/72 Bioelectric control, e.g. myoelectric
• CPC Class Codes: A61F 2/741 using powered actuators, e.g. stepper motors or solenoids
• CPC Class Codes: A61F 2002/701 operated by electrically controlled means, e.g. solenoids or torque motors
• CPC Class Codes: A61F 2002/704 computer-controlled, e.g. robotic control
• CPC Class Codes: A61F 2002/7615 Measuring means for implanting artificial joints A61F2/4657
• CPC Class Codes: G06F 3/015 Input arrangements based on nervous system activity detection, e.g. brain waves [EEG] detection, electromyograms [EMG] detection, electrodermal response detection
• CPC Class Codes: G06N 3/061 using biological neurons, e.g. biological neurons connected to an integrated circuit

Abstract

A system and method for a 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 further includes an automated configuration routine that is used to set or modify the value of one or more system configuration parameters.

Claims

1. A biological interface system comprising:

a sensor comprising a plurality of electrodes for detecting multicellular signals emanating from one or more living cells of a patient;

a processing unit configured to receive the multicellular signals from the sensor, process the multicellular signals to produce a processed signal, and transmit the processed signal to a controlled device;

the controlled device for receiving the processed signal; and

an integrated patient training routine performed to generate one or more system configuration parameters used by the processing unit to produce the processed signal, the patient training routine comprising;

a system configuration plan comprising a first configuration of steps to be performed;

means for collecting a first set of patient data, the first set of patient data collected prior to patient control of the controlled device;

means for analyzing the first set of patient data and providing an output of the analysis; and

means for modifying the system configuration plan;

wherein the system configuration plan is modified when the output of the analysis of the first set of patient data falls below a success threshold value, and

wherein the success threshold value is set to require at least one modification of the configuration plan prior to the patient controlling the controlled device.

2. The system of claim 1, wherein the first set of patient data does not include data regarding control of the controlled device.

3. The system of claim 1, wherein the first configuration of steps includes a cell sorting algorithm to select a set of cells for processing.

4. The system of claim 3, wherein the cell sorting algorithm is a neuron spike sorting algorithm.

5. The system of claim 3, wherein the success threshold value is a minimum number of cells selected for processing.

6. The system of claim 1, wherein the first configuration of steps includes a measurement and analysis of one or more cellular signal modulation rates.

7. The system of claim 1, wherein the first configuration of steps includes a measurement and analysis of neural signals.

8. The system of claim 7, wherein the output of the analysis includes a quantification of neural spikes and the threshold value is a minimum number of spikes.

9. The system of claim 7, wherein the output of the analysis includes a cellular signal modulation rate quantification and the threshold value is a minimum level for the quantification.

10. The system of claim 7, wherein the output of the analysis includes a multicellular signal modulation rate quantification and the threshold value is a minimum level for the quantification.

11. The system of claim 1, wherein the first configuration of steps includes a measurement and analysis of one or more patient physiologic parameters.

12. The system of claim 11, wherein the patient physiologic parameter is selected from the group consisting of:

EKG;

respiration;

blood glucose;

temperature;

blood pressure;

EEG;

perspiration; and

combinations thereof.

13. The system of claim 1, wherein the means for collecting patient data includes the sensor.

14. The system of claim 1, further comprising a second sensor and wherein the means for collecting patient data includes the second sensor.

15. The system of claim 14, wherein the second sensor is selected from the group consisting of:

EKG sensor;

respiration sensor;

blood glucose sensor;

temperature sensor;

blood pressure and other pressure sensors;

EEG sensor;

perspiration sensor;

cellular signal activity including neural activity sensor;

skin conductance and other impedance sensor;

strain gauge;

light sensor; and

combinations thereof.

16. The system of claim 1, wherein the patient training routine includes providing the patient with a time varying stimulus, and the first set of patient data is collected while the time varying stimulus is provided.

17. The system of claim 16, wherein the time varying stimulus is manipulated manually by an operator.

18. The system of claim 16, wherein the time varying stimulus is produced by the processing unit.

19. The system of claim 16, wherein the time varying stimulus is produced by a separate device.

20. The system of claim 16, wherein the threshold value is a measure of a patient response to the time varying stimulus.

21. The system of claim 1, further comprising a time varying stimulus producing element.

22. The system of claim 21, wherein the time varying stimulus producing element is selected from the group consisting of:

a display;

a touch screen display;

an audio transducer;

a speaker;

a tactile transducer;

an electrical stimulator;

an electrode array;

an olfactory transducer;

a gustatory transducer; and

combinations thereof.

23. The system of claim 21, wherein the time varying stimulus provided to the patient is a continuous or semi-continuous motion of an object.

24. The system of claim 23, wherein the object moves on a visual display.

25. The system of claim 23, wherein the object is a mechanical object moving in physical space.

26. The system of claim 23, wherein the object is a part of the patient'"'"'s body moving in space.

27. The system of claim 21, wherein the time varying stimulus provides a fixed position of an object for a limited time.

28. The system of claim 27, wherein the object is on a visual display.

29. The system of claim 27, wherein the limited time is less than one second.

30. The system of claim 21, wherein the time varying stimulus provides one or more flashes of light.

31. The system of claim 1, further comprising an internal memory storage element, wherein the first set of patient data is stored in the memory storage element.

32. The system of claim 31, wherein the storage element is integral to a component of the system.

33. The system of claim 32, wherein the component of the system is configured to be located proximate the patient.

34. The system of claim 32, wherein the component of the system is configured to be located at a site remote from the patient.

35. The system of claim 1, wherein the first set of patient data includes neural data of the patient.

36. The system of claim 35, wherein the neural data includes data from neurons of the patient'"'"'s brain.

37. The system of claim 36, wherein the neural data includes data from neurons of the motor cortex of the patient'"'"'s brain.

38. The system of claim 35, wherein the neural data includes EEG or LFP data.

39. The system of claim 1, wherein the first set of data includes patient physiologic data.

40. The system of claim 39, wherein the physiologic data is selected from the group consisting of:

EKG;

respiration;

blood glucose;

temperature;

blood pressure;

EEG;

perspiration;

cellular signal activity including neural activity;

skin conductance; and

combinations thereof.

41. The system of claim 1, wherein the system configuration plan is modified automatically.

42. The system of claim 1, wherein the system configuration plan is modified manually by an operator of the system.

43. The system of claim 1, wherein the system configuration plan modification includes a change to an order of the first configuration of steps.

44. The system of claim 1, wherein the system configuration plan modification includes an additional step added to the first configuration of steps.

45. The system of claim 1, wherein the system configuration plan modification includes the elimination of a step from the first configuration of steps.

46. The system of claim 1, wherein the system configuration plan modification increases a time required to complete the system configuration plan.

47. The system of claim 1, wherein the system configuration plan modification decreases a time required to complete the system configuration plan.

48. The system of claim 1, wherein the system configuration plan modification requires input from an operator of the system.

49. The system of claim 48, wherein the system configuration plan modification further requires input from a second operator of the system.

50. The system of claim 1, wherein the system configuration plan modification requires analysis of controlled device data that does not include data of the patient controlling the controlled device.

51. The system of claim 50, wherein the controlled device data is selected from the group consisting of:

time constant data;

input level data;

range of value data;

output level data;

boundary condition data;

alarm condition data; and

combinations thereof.

52. The system of claim 1, further comprising an integral permission routine, and wherein the system configuration plan modification invokes the permission routine.

53. The system of claim 1, wherein the output of the analysis includes multiple values.

54. The system of claim 53, wherein at least two multiple values are compared to the threshold value.

55. The system of claim 54, wherein the at least two multiple values are compared to different threshold values.

56. The system of claim 1, wherein the first set of patient data is a set of the multicellular signals received by the processing unit from the sensor.

57. The system of claim 56, wherein the success threshold value is a minimum modulation rate level.

58. The system of claim 57, wherein the minimum modulation rate level is a minimum modulation rate of one or more cells.

59. The system of claim 57, wherein the minimum modulation rate level is a minimum modulation rate of a number of cells used for producing the processed signal.

60. The system of claim 56, wherein the threshold value is a minimum number of cells applicable to a transfer function to produce the processed signal.

61. The system of claim 1, wherein the success threshold value is a level of patient consciousness.

62. The system of claim 1, further comprising means for analyzing controlled device performance.

63. The system of claim 62, wherein the means for analyzing controlled device performance includes one or more sensors in proximity to the controlled device.

64. The system of claim 62, wherein the analysis of controlled device performance includes an error measurement of controlled device actual control versus controlled device intended control.

65. The system of claim 64, wherein the controlled device actual control is compared to the controlled device intended control.

66. The system of claim 1, wherein the patient training routine provides a visual representation of a human figure to the patient, the representation including multiple human body movements provided for the patient to imagine the movement.

67. The system of claim 66, wherein the first set of patient data includes multicellular signals generated while the patient imagines the movement.

68. The system of claim 66, further comprising audible information provided coincident with the visual representation.

69. The system of claim 68, wherein the audible information includes spoken words.

70. The system of claim 1, wherein the patient training routine comprises an integrated software module embedded in the system.

71. The system of claim 1, wherein the patient training routine comprises a set of steps.

72. The system of claim 71, wherein at least one step is advanced to the subsequent step based on the completion of one or more patient involved events.

73. The system of claim 72, wherein the patient involved event is an activation of an input device by the patient.

74. The system of claim 73, wherein the input device is selected from the group consisting of:

chin joystick;

eyebrow EMG switch;

EEG activated switch;

eye tracker head tracker;

neck movement switch;

shoulder movement switch;

sip-and-puff joystick controller;

speech recognition switch;

tongue switch; and

combinations thereof.

75. The system of claim 1, wherein at least one system configuration parameter is confirmed for modification by an operator utilizing a permission routine of the system.

76. The system of claim 75, wherein the permission routine requires an operator to utilize one or more of:

a password;

a user ID;

a specific Internet IP address;

a mechanical key;

an electronic key; and

an electromechanical key.

77. The system of claim 1, further comprising a patient input device for performing a function selected from the group consisting of:

performing a selection;

confirming a command;

confirming a modification of a system parameter;

modifying the state of the system;

performing a system reset; and

combinations thereof.

78. The system of claim 77, wherein the parameter is modified utilizing a device selected from the group consisting of:

chin joystick;

eyebrow EMG switch;

EEG activated switch;

eye tracker;

head tracker;

neck movement switch;

shoulder movement switch;

sip-and-puff joystick controller;

speech recognition switch;

tongue switch; and

combinations thereof.

79. The system of claim 1, wherein the system configuration parameters include the selection of cells whose signals are processed by the processing unit.

80. The system of claim 1, wherein the system configuration parameters include one or more criteria used to select cells whose signals are to be processed by the processing unit.

81. The system of claim 1, wherein the system configuration parameters include a signal processing parameter.

82. The system of claim 81, wherein the signal processing parameter is a coefficient of a signal processing function selected from the group consisting of:

amplification;

filtering;

sorting;

conditioning;

translating;

interpreting;

encoding;

decoding;

combining;

extracting;

sampling;

multiplexing;

analog to digital converting;

digital to analog converting;

mathematically transforming; and

combinations thereof.

83. The system of claim 1, wherein the system configuration parameters include a control signal transfer function parameter.

84. The system of claim 83, wherein the transfer function parameter is a transfer function coefficient.

85. The system of claim 83, wherein the transfer function parameter is the selection of one or more of:

algorithm;

methodology;

mathematical equation; and

combinations thereof.

86. The system of claim 1, wherein the system configuration parameters include a calibration parameter.

87. The system of claim 86, wherein the calibration parameter is a calibration frequency.

88. The system of claim 1, wherein the system configuration parameters include a controlled device parameter.

89. The system of claim 88, wherein the controlled device parameter is a parameter determining a boundary limit of a controlled device parameter.

90. The system of claim 1, wherein a system configuration parameter is selected from the group consisting of:

acceptable frequency range of cellular activity;

cellular signal amplitude threshold value;

selection of electrodes to include;

selection of cellular signals to include;

type of frequency analysis;

power spectral density;

instruction information to patient;

imagined movement type;

imagined movement instruction;

type, mode or configuration of feedback during provision of processed signal to patient;

calibration parameter;

calibration duration;

calibration frequency;

controlled device parameter;

controlled device mode;

alarm or alert threshold value;

success threshold value; and

combinations thereof.

91. The system of claim 1, wherein a system configuration parameter is stored within at least one discrete component of the system.

92. The system of claim 1, wherein a system configuration parameter is a spike sorting parameter.

93. The system of claim 92, wherein the spike sorting parameter is an amplitude threshold parameter.

94. The system of claim 1, wherein a system configuration parameter is a signal processing parameter.

95. The system of claim 94, wherein the signal processing parameter is selected from the group consisting of:

sampling rate by signal;

sampling rate by group of signals;

amplification by signal;

amplification by group of signals;

filter parameter by signal;

filter parameter by group of signals;

sorting variable;

conditioning variable;

translating variable;

interpreting variable;

encoding variable;

decoding variable;

extracting variable;

mathematical transformation variable;

signal to noise ratio variable;

frequency of signal variable;

amplitude of signal variable;

neuron firing rate variable;

standard deviation in neuron firing rate variable;

modulation of neuron firing rate variable; and

combinations thereof.

96. The system of claim 1, wherein a system configuration parameter is a signal selection parameter.

97. The system of claim 96, wherein the signal selection parameter is selected from the group consisting of:

electrode selection variable;

cellular signal selection variable;

neuron spike selection variable;

electrocorticogram signal selection variable;

local field potential selection variable;

electroencephalogram signal selection variable; and

combinations thereof.

98. The system of claim 1, wherein a system configuration parameter is a controlled device parameter.

99. The system of claim 98, wherein the controlled device parameter is selected from the group consisting of:

allowed devices that the patient can control;

unique ID for device;

a handshaking protocol;

parameter indicating partial control of a multi-function device;

movement parameter of device;

a position, velocity, acceleration, torque, direction and/or momentum variable of a device;

a maximum velocity parameter;

a power parameter;

a therapeutic device parameter;

dose amount;

time for start of dose;

rate of dose;

duty cycle of dose;

amount of energy;

stimulation energy;

mechanical time constant variable;

electrical time constant variable; and

combinations thereof.

100. The system of claim 1, wherein one or more system configuration parameters are selected from the group consisting of:

a list of permissions for specific operator or operator types;

operator usemames;

operator passwords;

on or off variables;

system reset parameters;

maximum on time of system parameters; and

allowable times of day for system use by the patient.

101. The system of claim 1, wherein a system configuration parameter is a calibration parameter.

102. The system of claim 101, wherein the calibration parameter is selected from the group consisting of:

electrode selection;

cellular signal selection;

neuron spike selection;

electrocorticogram signal selection;

local field potential signal selection;

electroencephalogram signal selection;

sampling rate by signal;

sampling rate by group of signals;

amplification by signal;

amplification by group of signals;

filter parameters by signal;

filter parameters by group of signals;

patient activity during calibration;

target number of signals required;

patient disease state;

patient condition;

patient age and other patient parameters; and

combinations thereof.

103. The system of claim 1, wherein a system configuration parameter is a system performance criteria.

104. The system of claim 103, wherein the system performance criteria is selected from the group consisting of:

target number of signals required;

patient disease state;

patient condition;

patient age and other patient parameters.

105. The system of claim 1, wherein one or more system configuration parameters is selected from the group consisting of:

algorithm selection parameter;

group of mathematical algorithms parameter;

information upload command;

information download command;

alarm, warning or alert parameter;

criteria to determine adequate performance of system;

failure threshold parameter; and

combinations thereof.

106. A method comprising:

detecting multicellular signals emanating from one or more living cells of a patient using a sensor comprising a plurality of electrodes

processing unit receiving the multicellular signals from the sensor

processing the multicellular signals to produce a processed signal

transmitting the processed signal to a controlled device

the controlled device receiving the processed signal, and

performing an integrated patient training routine to generate one or more system configuration parameters used by the processed unit to produce the processed signal, wherein the integrated patient training routine comprises;

performing a first configuration of steps defined by a system configuration plan

the processing unit collecting a first set of patient data, the first set of patient data collected prior to patient control of the controlled device

the processing unit analyzing the first set of patient data and providing an output of the analysis and

modifying the system configuration plan when the output of the analysis of the first set of patient data falls below a success threshold value,

wherein the success threshold value is set to require at least one modification of the configuration plan prior to the patient controlling the controlled device.

107. The method of claim 106 wherein the first set of patient data does not include data regarding control of the controlled device.

108. The method of claim 106 wherein the first configuration of steps includes a cell sorting algorithm to select a set of cells for processing.

109. The method of claim 108 wherein the cell sorting algorithm is a neuron spike sorting algorithm.

110. The method of claim 106 further comprising

providing the patient with a time varying stimulus, wherein the first set of patient data is collected while the time varying stimulus is provided.

111. The method of claim 110 wherein the time varying stimulus is manipulated manually by an operator.

112. The method of claim 110 wherein the threshold value is a measure of a patient response to the time varying stimulus.

113. The method of claim 110 wherein the time varying stimulus is provided to the patient by a time varying stimulus producing element.

114. The method of claim 113 wherein the time varying stimulus producing element is selected from the group consisting of:

a display;

a touch screen display;

an audio transducer;

a speaker;

a tactile transducer;

an electrical stimulator;

an electrode array;

an olfactory transducer;

a gustatory transducer; and

combinations thereof.

115. The method of claim 113 wherein the time varying stimulus provided to the patient is a continuous or semi-continuous motion of an object.

116. The method of claim 115 wherein the object moves on a visual display.

117. The method of claim 115 wherein the object is a mechanical object moving in physical space.

118. The method of claim 106 wherein the first set of patient data includes neural data of the patient.

119. The method of claim 118 wherein the neural data includes data from neurons of the patient'"'"'s brain.

120. The method of claim 119 wherein the neural data includes data from neurons of the motor cortex of the patient'"'"'s brain.

121. The method of claim 118 wherein the neural data includes EEG or LFP data.

122. The method of claim 106 wherein modifying the system configuration plan is done automatically.

123. The method of claim 106 wherein modifying the system configuration plan includes a change to an order of the first configuration of steps.

124. The method of claim 106 wherein modifying the system configuration plan requires analysis of controlled device data that does not include data of the patient controlling the controlled device.