U.S. patent application number 11/315226 was filed with the patent office on 2007-02-08 for adaptive patient training routine for biological interface system.
Invention is credited to Abraham H. Caplan, John P. Donoghue, J. Christopher Flaherty, Daniel S. Morris, Maryam Saleh, Mijail D. Serruya.
Application Number | 20070032738 11/315226 |
Document ID | / |
Family ID | 36648013 |
Filed Date | 2007-02-08 |
United States Patent
Application |
20070032738 |
Kind Code |
A1 |
Flaherty; J. Christopher ;
et al. |
February 8, 2007 |
Adaptive patient training routine for biological interface
system
Abstract
Various embodiments of a biological interface system and related
methods are disclosed. The system may comprise a sensor comprising
a plurality of electrodes for detecting multicellular signals
emanating from one or more living cells of a patient and a
processing unit configured to receive the multicellular signals
from the sensor and process the multicellular signals to produce a
processed signal. The processing unit may be configured to transmit
the processed signal to a controlled device that is configured to
receive the processed signal. The system is configured to perform
an integrated patient training routine to generate one or more
system configuration parameters that are used by the processing
unit to produce the processed signal.
Inventors: |
Flaherty; J. Christopher;
(Topsfield, MA) ; Serruya; Mijail D.; (Providence,
RI) ; Morris; Daniel S.; (Stanford, CA) ;
Caplan; Abraham H.; (Cambridge, MA) ; Saleh;
Maryam; (Chicago, IL) ; Donoghue; John P.;
(Providence, RI) |
Correspondence
Address: |
Leslie I. Bookoff;FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, L.L.P.
901 New York Avenue, N.W.
Washington
DC
20001-4413
US
|
Family ID: |
36648013 |
Appl. No.: |
11/315226 |
Filed: |
December 23, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60642021 |
Jan 6, 2005 |
|
|
|
Current U.S.
Class: |
600/545 |
Current CPC
Class: |
A61B 5/375 20210101;
A61B 5/24 20210101; G06F 3/015 20130101 |
Class at
Publication: |
600/545 |
International
Class: |
A61B 5/04 20060101
A61B005/04 |
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; and a
processing unit configured to receive the multicellular signals
from the sensor and process the multicellular signals to produce a
processed signal, the processing unit being configured to transmit
the processed signal to a controlled device that is configured to
receive the processed signal, wherein the system is configured to
perform an integrated patient training routine to generate one or
more system configuration parameters that are used by the
processing unit to produce the processed signal, and wherein the
integrated patient training routine is configured to adapt during
its use.
2. The system of claim 1, wherein the patient training routine is
configured to adapt based on an assessment of the processed signal
produced by the processing unit during the performance of the
patient training routine.
3. The system of claim 2, wherein the assessment comprises an
assessment of control performance of the controlled device.
4. The system of claim 2, wherein a duration of the patient
training routine is decreased when the assessment is at or above a
success threshold value.
5. The system of claim 2, wherein a duration of the patient
training routine is increased when the assessment is below a
success threshold value.
6. The system of claim 2, wherein the patient training routine is
modified when the assessment is below a success threshold
value.
7. The system of claim 1, wherein the patient training routine is
configured to adapt based on a multicellular signal change.
8. The system of claim 1, wherein the patient training routine is
configured to adapt based on a change to a patient parameter.
9. The system of claim 8, wherein the patient parameter change
comprises a change in the level of patient consciousness.
10. The system of claim 9, wherein the level of patient
consciousness is determined based on the multicellular signals.
11. The system of claim 9, further comprising a second sensor,
wherein the level of patient consciousness is determined by the
second sensor.
12. The system of claim 11, wherein the second sensor comprises at
least one of an EEG sensor or an LFP sensor.
13. The system of claim 1, wherein the patient training routine is
configured to adapt automatically.
14. The system of claim 1, wherein the patient training routine is
configured to adapt based on an operator input.
15. The system of claim 1, wherein the patient training routine is
configured to adapt during a performance of a patient training
event.
16. The system of claim 1, wherein the patient training routine is
configured to adapt after a performance of a first patient training
event and prior to a performance of a second patient training
event.
17. The system of claim 1, wherein the system is configured to
allow an operator to perform the patient training routine.
18. The system of claim 17, wherein the operator comprises the
patient.
19. The system of claim 1, wherein less than full control of the
controlled device is available to the patient prior to successful
completion of the patient training routine.
20. The system of claim 19, wherein the system is configured to set
a threshold value for determining the successful completion.
21. The system of claim 20, wherein the threshold value is
adjustable.
22. The system of claim 21, wherein the system is configured to
allow a clinician to adjust the threshold value.
23. The system of claim 20, wherein the system is configured such
that an adjustment to the threshold value is made from a remote
location.
24. The system of claim 20, wherein the system is configured to
perform a permission routine prior to an adjustment to the
threshold value.
25. The system of claim 24, wherein the adjustment is controlled by
one or more of: a password; a user identification; an electronic
ID; and a mechanical key.
26. The system of claim 1, wherein the patient training routine
utilizes the controlled device.
27. The system of claim 1, further comprising a surrogate of the
controlled device for use by the patient training routine.
28. The system of claim 1, wherein the patient training routine
provides feedback to the patient.
29. The system of claim 28, wherein the feedback includes a
derivative of the multicellular signals.
30. The system of claim 29, wherein the derivative comprises neural
spike modulation rates.
31. The system of claim 28, wherein the feedback is provided by one
or more of the following forms: auditory; olfactory; gustatory;
visual; electrical stimulation; and any combination thereof.
32. The system of claim 28, wherein the feedback comprises a
representation of the processed signal produced by the processing
unit.
33. The system of claim 32, wherein the representation comprises
one or more of the following: moving an object on screen; moving a
mechanical device; moving part of patient's body; changing an
audible signal; and any combination thereof.
34. The system of claim 32, wherein the feedback further comprises
a representation of a difference between desired control conditions
and actual control conditions.
35. The system of claim 28, wherein the feedback comprises a
modified representation of the processed signal.
36. The system of claim 35, wherein the modified representation
represents an artificially improved processed signal with more
accurate control.
37. The system of claim 36, wherein the artificial improvement of
the processed signal decreases as processed signal accuracy
improves.
38. The system of claim 1, wherein the patient training routine
comprises a software program.
39. The system of claim 38, wherein the software program is
embedded in the system.
40. The system of claim 39, wherein the software program is
embedded in the processing unit.
41. The system of claim 1, further comprising a separate device in
which the patient training routine is embedded.
42. The system of claim 1, wherein the patient training routine
provides a time varying stimulus to the patient.
43. The system of claim 42, wherein the processing unit is
configured to store the multicellular signals, while the patient
training routine provides to the patient a set of states of the
time varying stimulus.
44. The system of claim 1, wherein the patient training routine
comprises a first form of feedback used to control a first form of
the controlled device and a second form of feedback used to control
a second form of the controlled device.
45. The system of claim 1, wherein the patient training routine
provides a predictory path or target.
46. The system of claim 45, wherein the predictory path or target
comprises a visual image.
47. The system of claim 1, wherein the system is configured to
perform a competitive user routine that provides a representation
of an additional control signal which is competitive with the
processed signal.
48. The system of claim 47, Wherein the additional control signal
is manipulated by an operator.
49. The system of claim 48, wherein the operator comprises a second
patient.
50. The system of claim 47, wherein the additional control signal
is manipulated by the system.
51. The system of claim 1, wherein the one or more system
configuration parameters comprise a selection of cells whose
signals are processed by the processing unit.
52. The system of claim 1, wherein the one or more system
configuration parameters comprise one or more criteria used to
select cells whose signals are to be processed by the processing
unit.
53. The system of claim 1, wherein the one or more system
configuration parameters comprise a signal processing
parameter.
54. The system of claim 53, wherein the signal processing parameter
comprises 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 any combination thereof.
55. The system of claim 1, wherein the one or more system
configuration parameters include a control signal transfer function
parameter.
56. The system of claim 55, wherein the transfer function parameter
comprises a transfer function coefficient.
57. The system of claim 55, wherein the transfer function parameter
comprises a selection of one or more of: algorithm; methodology;
mathematical equation; and any combination thereof.
58. The system of claim 1, wherein the one or more system
configuration parameters comprise a calibration parameter.
59. The system of claim 58, wherein the calibration parameter
comprises a calibration frequency.
60. The system of claim 1, wherein the one or more system
configuration parameters comprise a controlled device
parameter.
61. The system of claim 60, wherein the controlled device parameter
comprises a parameter determining a boundary limit of a controlled
device parameter.
62. The system of claim 1, wherein the one or more system
configuration parameters is selected from the group consisting of:
acceptable frequency range of cellular activity; selection of
electrodes to include; selection of cellular signals to include;
type of frequency analysis such as power spectral density;
instruction information to patient such as imagined movement type
or other imagined movement instruction; type, mode or configuration
of feedback during provision of processed signal to patient;
calibration parameter such as calibration duration and calibration
frequency; controlled device parameter such as controlled device
mode; alarm or alert threshold; success threshold; and any
combinations thereof.
63. The system of claim 1, further comprising a system electronic
memory, wherein the one or more system configuration parameters are
placed in the memory and used to produce the processed signal.
64. The system of claim 1, wherein the system comprises a neural
interface system.
65. The system of claim 1, wherein the system is configured to
provide a therapeutic benefit.
66. The system of claim 65, wherein the therapeutic benefit
comprises treatment of one or more of: obesity; an eating disorder;
a neurological disorder; a stroke; a coma; amnesia; irregular blood
flow in the brain; a psychiatric disorder; depression; a
cardiovascular disorder; an endocrine disorder; sexual dysfunction;
incontinence; a hearing disorder; a visual disorder; a sleeping
disorder; a movement disorder; impaired limb function; absence of a
limb or a limb portion; a speech disorder; a physical injury;
migraine headaches; chronic pain and other severe pain conditions;
and any combination thereof.
67. The system of claim 1, wherein the system is configured to
perform a patient diagnosis.
68. The system of claim 67, wherein the patient diagnosis comprises
one or more of: obesity; an eating disorder; a neurological
disorder; a stroke; a coma; amnesia; irregular blood flow in the
brain; a psychiatric disorder; depression; a cardiovascular
disorder; an endocrine disorder; sexual dysfunction; incontinence;
a hearing disorder; a visual disorder; a sleeping disorder; a
movement disorder; impaired limb function; absence of a limb or a
limb portion; a speech disorder; a physical injury; migraine
headaches; chronic pain and other severe pain conditions; and any
combination thereof.
69. The system of claim 1, wherein the system is configured to
restore a patient function.
70. The system of claim 69, wherein the patient function comprises
one or more of: vision; hearing; speech; communication; limb
motion; ambulation; reaching; grasping; standing; sitting; rolling
over; bowel movement; bladder evacuation; and any combination
thereof.
71. The system of claim 1, wherein the multicellular signals
comprise one or more of: neuron spikes, ECOG signals, LFP signals,
and EEG signals.
72. The system of claim 1, wherein at least one of the electrodes
detect the multicellular signals from clusters of neurons and
provide signals including a quantity of neurons between single
neuron and EEG recordings.
73. The system of claim 1, wherein the processing unit is
configured to utilize least one cellular signal generated under
voluntary control of a patient.
74. The system of claim 73, wherein the controlled device comprises
a piece of medical equipment.
75. The system of claim 73, wherein the controlled device comprises
a communication device.
76. The system of claim 1, wherein the sensor includes at least one
multi-electrode array comprising the plurality of electrodes.
77. The system of claim 76, wherein the sensor further comprises a
second multi-electrode array.
78. The system of claim 1, wherein the sensor includes electrodes
incorporated into one or more of: a subdural grid; a scalp
electrode; a wire electrode; and a cuff electrode.
79. The system of claim 1, wherein the sensor includes two or more
discrete components.
80. The system of claim 1, wherein the sensor further comprises
signal processing circuitry.
81. The system of claim 1, wherein the sensor transmits the
multicellular signals through a wireless connection.
82. The system of claim 1, wherein the sensor further comprises a
coil for power transmission to the sensor.
83. The system of claim 1, wherein one or more electrodes are
placed into tissue selected from the group consisting of: nerve
tissue; organ tissue; tumor tissue; and any combination
thereof.
84. The system of claim 1, wherein the processing unit includes one
or more of: a temperature sensor; a pressure sensor; a strain
gauge; an accelerometer; a volume sensor; an electrode; an array of
electrodes; an audio transducer; a mechanical vibrator; a drug
delivery device; a magnetic field generator; a photo detector
element; a camera or other visualization apparatus; a wireless
communication element; a light producing element; an electrical
stimulator; a physiologic sensor; a heating element; and a cooling
element.
85. The system of claim 1, wherein the processing unit is
configured to convert a monitored biological signal of the patient
to a digital signal.
86. The system of claim 1, wherein the monitored biological signal
is processed by the processing unit to produce a second processed
signal.
87. The system of claim 86, wherein the second processed signal is
used to control the controlled device.
88. The system of claim 86, wherein the second processed signal is
used to modify one or more system configuration parameters of the
system.
89. The system of claim 86, wherein the second processed signal is
used to stop control of the controlled device.
90. The system of claim 86, wherein the second processed signal is
used to reset the system.
91. The system of claim 1, wherein the controlled device is
selected from the group consisting of: a computer; a computer
display; a computer mouse; a computer cursor; a joystick; a
personal data assistant; a robot or robotic component; a computer
controlled device; a teleoperated device; a communication device; a
vehicle; a wheelchair; an adjustable bed; an adjustable chair; a
remote controlled device; a Functional Electrical Stimulator
device; a muscle stimulator; an exoskeletal robot brace; an
artificial or prosthetic limb; a vision enhancing device; a vision
restoring device; a hearing enhancing device; a hearing restoring
device; a movement assist device; a medical therapeutic equipment;
a drug delivery apparatus; a medical diagnostic or monitoring
equipment; a bladder control device; a bowel control device; a
human function enhancement device; a closed loop medical equipment
and other controllable devices applicable to patients with some
form of paralysis or diminished function; a device that is utilized
under direct brain or thought control in either a healthy or
unhealthy patient; and any combination thereof.
92. The system of claim 1, further comprising a second controlled
device.
93. The system of claim 1, further comprising a stimulating
device.
94. The system of claim 93, wherein the stimulating device
comprises a first discrete component, and the sensor comprises a
second discrete component.
95. The system of claim 93, wherein the stimulating device includes
multiple stimulating electrodes.
96. The system of claim 93, wherein the stimulating device includes
a stimulating power device.
97. The system of claim 96, wherein the power device comprises an
integral power supply.
98. The system of claim 96, wherein the power device comprises an
integral power receiving coil.
99. The system of claim 1, wherein the system is configured to
perform an adaptive processing routine.
100. The system of claim 99, wherein the adaptive processing
routine includes changing over time the type or combination of
types of signals processed.
101. The system of claim 100, wherein the types of signals
processed include one or more of: EEG signals, ECOG signals, LFP
signals, and neural spikes.
102. The system of claim 1, further comprising a patient feedback
module.
103. The system of claim 102, wherein the patient feedback module
includes one or more of: an audio transducer, a tactile transducer,
a visual transducer, a video display, a gustatory transducer, and
an olfactory transducer.
104. The system of claim 103, wherein the patient feedback module
includes a stimulator, and one or more neurons are stimulated to
cause movement or sensation in a part of the patient's body.
105. The system of claim 1, further comprising a drug delivery
system, wherein the processing unit sends a signal to the drug
delivery system to deliver a therapeutic agent or drug to at least
a portion of the patient's body.
106. The system of claim 1, wherein the patient training routine is
configured to adapt based on a change in the level of the patient's
consciousness.
107. The system of claim 1, wherein an assessment of controlled
device control achieved during the patient training routine
determines the duration of the patient training routine.
108. The system of claim 1, further comprising a surrogate
controlled device utilized during the patient training routine,
wherein an assessment of the surrogate controlled device control
achieved during the patient training routine determines the
duration of the patient training routine.
109. The system of claim 1, wherein the patient training routine is
configured to adapt after a performance of a first patient training
event and prior to a performance of a second patient training
event.
Description
[0001] This application claims the benefit of priority under 35
U.S.C. .sctn.119(e) of U.S. provisional application No. 60/642,021,
filed Jan. 6, 2005. This application relates to commonly assigned
U.S. application Ser. Nos. ______ and ______ of J. Christopher
Flaherty et al., all of which are entitled "PATIENT TRAINING
ROUTINE FOR BIOLOGICAL INTERFACE SYSTEM" and filed on the same date
as the present application. The complete subject matter of each of
the above-referenced applications is incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices and, more
particularly, biological interface systems that may include one or
more devices controllable by processed multicellular signals of a
patient. A processing unit produces a control signal based on
multicellular signals received from a sensor comprising multiple
electrodes. More particularly, the system includes a patient
training routine that configures the system to optimize control of
the device.
DESCRIPTION OF RELATED ART
[0003] Biological interface devices, for example neural interface
devices, are currently under development for numerous patient
applications including restoration of lost function due to
traumatic injury or neurological disease. Sensors, such as
electrode arrays, implanted in the higher brain regions that
control voluntary movement, can be activated voluntarily to
generate electrical signals that can be processed by a biological
interface device to create a thought invoked control signal. Such
control signals can be used to control numerous devices including
computers and communication devices, external prostheses, such as
an artificial arm or functional electrical stimulation of paralyzed
muscles, as well as robots and other remote control devices.
Patient's afflicted with amyotrophic lateral sclerosis (Lou
Gehrig's Disease), particularly those in advanced stages of the
disease, would also be appropriate for receiving a neural interface
device, even if just to improve communication to the external
world, including Internet access, and thus improve their quality of
life.
[0004] Early attempts to utilize signals directly from neurons to
control an external prosthesis encountered a number of technical
difficulties. The ability to identify and obtain stable electrical
signals of adequate amplitude was a major issue. Another problem
that has been encountered is caused by the changes that occur to
the neural signals that occur over time, resulting in a degradation
of system performance. Neural interface systems that utilize other
neural information, such as electrocorticogram (ECOG) signals,
local field potentials (LFPs) and electroencephalogram (EEG)
signals have similar issues to those associated with individual
neuron signals. Since all of these signals result from the
activation of large groups of neurons, the specificity and
resolution of the control signal that can be obtained is limited.
However, if these lower resolution signals could be properly
identified and the system adapt to their changes over time, simple
control signals could be generated to control rudimentary devices
or work in conjunction with the higher power control signals
processed directly from individual neurons.
[0005] Commercialization of these neural interfaces has been
extremely limited, with the majority of advances made by
universities in a preclinical research setting. As the technologies
advance and mature, the natural progression will be to more
sophisticated human applications, such as those types of devices
regulated by various governmental regulatory agencies including the
Food and Drug Administration in the United States.
[0006] As sophisticated biological interface systems are approved
by the FDA and become commercially available, these systems need to
include numerous safety features required for medical devices. It
will also be required that the systems have simplified
configuration routines, such as patient training routines, which
assure reliable functionality. Convenience and flexibility to the
patient, their caregivers and family members will also be a
requirement. There is therefore a need for an improved biological
interface system which includes a sophisticated patient training
routine. Automation, as well as convenience to health care
providers will provide numerous benefits to the patient and the
health care system.
SUMMARY OF THE INVENTION
[0007] According to one exemplary aspect of the present disclosure,
a biological interface system is disclosed. The biological
interface system collects multicellular signals emanating from one
or more living cells of a patient and transmits processed signals
to a controlled device. For example, the system may include a
sensor comprising a plurality of electrodes for detecting
multicellular signals emanating from one or more living cells of a
patient, and a processing unit configured to receive the
multicellular signals from the sensor and process the multicellular
signals to produce processed signals. The processing unit is also
configured to transmit the processed signals to a controlled device
that is configured to receive the processed signals. The processing
unit is configured to perform an integrated patient training
routine (such as an integrated software module) to generate one or
more system configuration parameters that are used by the
processing unit to produce the processed signals. The processing
unit allows an operator to perform the integrated patient training
routine at least one time during use of the system. For example,
the system has an internal function that requires that an operator
perform the integrated patient training routine at least one time
during the use of the system.
[0008] According to another exemplary aspect of the invention, a
biological interface system is disclosed. The biological interface
system collects multicellular signals emanating from one or more
living cells of a patient and transmits processed signals to a
controlled device. The system includes a sensor for detecting
multicellular signals, the sensor comprising a plurality of
electrodes. The electrodes are designed to detect the multicellular
signals. A processing unit is designed to receive the multicellular
signals from the sensor and process the multicellular signals to
produce the processed signals transmitted to the controlled device.
The system further comprises an integrated patient training routine
that provides a time varying stimulus to the patient, such as a
moving object on a display screen, a moving mechanical object such
as a moving wheelchair or moving robotic arm, and/or a device that
actually moves one or more of the patients limbs. While the patient
training routine is providing a first set of states of the time
varying stimulus, the patient imagines a movement represented by
the stimulus and the processing unit simultaneously stores a first
set of multicellular signals received by the processing unit from
the sensor.
[0009] The processing unit utilizes this first set of multicellular
data to produce one or more system configuration parameters,
including parameters that define a transfer function that can allow
the processing unit to produce processed signals or a
representation of the processed signals used in a subsequent
training event as an additional form of feedback to the patient.
The training patient training routine then provides a second set of
states of the time varying stimulus, as well as a representation of
the processed signals, utilizing similar feedback forms such as two
moving objects on a visual display, or different feedback forms
such as an audio signal for the time varying stimulus and a moving
prosthetic leg for the representation of the processed signal.
While the patient training routine provides a second set of states
of the time varying stimulus as well as the representation of the
processed signal, the patient imagines a movement represented by
the stimulus and visualizes the representation of the processed
signals based on that imagined movement, and the processing unit
simultaneously stores a second set of multicellular signals
received from the sensor.
[0010] According to still another exemplary aspect, a biological
interface system is disclosed. The biological interface system
collects multicellular signals emanating from one or more living
cells of a patient and transmits processed signals to a controlled
device. The system includes a sensor for detecting multicellular
signals, the sensor comprising a plurality of electrodes. The
electrodes are designed to detect the multicellular signals. A
processing unit is designed to receive the multicellular signals
from the sensor and process the multicellular signals to produce
the processed signals transmitted to the controlled device. The
system further comprises an integrated patient training routine
that provides a time varying stimulus to the patient, such as a
moving object on a display screen, a moving mechanical object such
as a moving wheelchair or moving robotic arm, and/or a device that
actually moves one or more of the patients limbs. While the patient
training routine is providing a set of states of the time varying
stimulus, the patient imagines a movement represented by the
stimulus and the processing unit simultaneously stores a first set
of multicellular signals received by the processing unit from the
sensor.
[0011] The processing unit utilizes this set of multicellular data
to produce one or more system configuration parameters, including
parameters that define a transfer function that can allow the
processing unit to produce processed signals or a representation of
the processed signals used in a subsequent training event as an
additional form of feedback to the patient. The set of states of
the time varying stimulus are selected from a domain of values.
Additional steps of providing a time varying stimulus and recording
multicellular signal data, such as when additional feedback is
provided in the form of a representation of the processed signal.
The data collected is used to produce a final transfer function to
produce the processed signals used to allow patient control of the
controlled device. An allowable range of values of the processed
signals exists within a subset of the time varying stimulus domain
of values. The reduction of the allowable range, such as control of
a cursor on a computer screen in which the patient training routine
uses a higher resolution screen than the controlled device
resolution, is performed to improve the performance, reliability,
and potentially safety of control of the controlled device.
[0012] According to yet still another exemplary aspect, a
biological interface system is disclosed. The biological interface
system collects multicellular signals emanating from one or more
living cells of a patient and transmits processed signals to a
controlled device. The system includes a sensor for detecting
multicellular signals, the sensor comprising a plurality of
electrodes. The electrodes are designed to detect the multicellular
signals. A processing unit is designed to receive the multicellular
signals from the sensor and process the multicellular signals to
produce the processed signals transmitted to the controlled device.
The system further comprises an integrated patient training routine
that is performed to generate one or more system configuration
parameters or values, these parameters used by the processing unit
to produce the processed signals. The patient training routine
adapts, during its use, such as within a single patient training
event, or between two patient training events. The routine adapts
due to one or more factors such as a change in controlled device
control performance, a change in multicellular signals or a change
in a patient physiologic parameter such as a level of patient
consciousness during a patient training event.
[0013] According to some exemplary aspects, a biological interface
system is disclosed. The biological interface system collects
multicellular signals emanating from one or more living cells of a
patient and transmits processed signals to a controlled device. The
system includes a sensor for detecting multicellular signals, the
sensor comprising a plurality of electrodes. The electrodes are
designed to detect the multicellular signals. A processing unit is
designed to receive the multicellular signals from the sensor and
process the multicellular signals to produce the processed signals
transmitted to the controlled device. The system further comprises
an integrated patient training routine that provides a time varying
stimulus to the patient, such as a moving object on a display
screen, a moving mechanical object such as a moving wheelchair or
moving robotic arm, and/or a device that actually moves one or more
of the patients limbs. While the patient training routine is
providing a set of states of the time varying stimulus, the patient
imagines a movement represented by the stimulus and the processing
unit simultaneously stores a first set of multicellular signals
received by the processing unit from the sensor. An operator can
adjust the time varying stimulus provided to the patient. In an
exemplary embodiment, the operator is the patient, and the patient
adjusts the time varying stimulus for one or more reasons such as
avoiding an imagined event that causes phantom pain or choosing an
icon that better fits the imagined movement.
[0014] According to another aspect, a biological interface system
is disclosed. The biological interface system collects
multicellular signals emanating from one or more living cells of a
patient and transmits processed signals to two controlled devices.
The system includes a sensor for detecting multicellular signals,
the sensor comprising a plurality of electrodes. The electrodes are
designed to detect the multicellular signals. A processing unit is
designed to receive the multicellular signals from the sensor and
process the multicellular signals to produce the processed signals
transmitted to the two controlled devices. The system further
comprises an integrated patient training routine that provides a
first time varying stimulus to the patient and a second time
varying stimulus to the patient. While the patient training routine
is providing a set of states of the first time varying stimulus,
the patient imagines a movement represented by the stimulus and the
processing unit simultaneously stores a first set of multicellular
signals received by the processing unit from the sensor. The first
set of multicellular signals is used to produce a transfer function
used by the processing unit to produce the processed signals
transmitted to the first controlled device. While the patient
training routine is providing a set of states of the second time
varying stimulus, the patient imagines a movement represented by
the stimulus and the processing unit simultaneously stores a second
set of multicellular signals received by the processing unit from
the sensor. The second set of multicellular signals is used to
produce a transfer function used by the processing unit to produce
the processed signals transmitted to the second controlled
device.
[0015] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0016] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate various
embodiments of the present invention, and, together with the
description, serve to explain the principles of the invention. In
the drawings:
[0018] FIG. 1 illustrates a patient training routine flow chart of
an exemplary embodiment of a biological interface system consistent
with the present invention;
[0019] FIG. 2 illustrates an exemplary embodiment of a portion of
the biological interface system consistent with the present
invention wherein sensor electrodes are implanted in the brain of a
patient and a portion of a processing unit is implanted on the
skull of the patient;
[0020] FIG. 3 illustrates another exemplary embodiment of a
biological interface system consistent with the present invention
wherein an operator configures the system at the patient site;
[0021] FIG. 4a illustrates a patient training display with a time
varying stimulus and a predictory path consistent with the present
invention;
[0022] FIG. 4b illustrates the patient training display of FIG. 4a
further depicting a patient controlled object and a modified
patient controlled object; and
[0023] FIG. 5 illustrates a patient training display as well as
feedback speakers and feedback tactile transducer, all consistent
with the present invention.
DESCRIPTION OF THE EMBODIMENTS
[0024] To facilitate an understanding of the invention, a number of
terms are defined immediately herebelow.
Definitions
[0025] As used herein, the term "biological interface system"
refers to a neural interface system or any system that interfaces
with living cells that produce electrical activity or cells that
produce other types of detectable signals.
[0026] The term "cellular signals," as used herein, refers to
signals or combination of signals that may emanate from any living
cell, such as, for example, subcellular signals, intracellular
signals, and extracellular signals. For example, "cellular signals"
may include, but not be limited to: neural signals (e.g., neuron
action potentials or spikes, local field potential (LFP) signals,
electroencephalogram (EEG) signals, electrocorticogram signals
(ECoG), and signals whose frequency range falls between single
neuron spikes and EEG signals); cardiac signals (e.g., cardiac
action potentials); electromyogram (EMG) signals; glial cell
signals; stomach cell signals; kidney cell signals; liver cell
signals; pancreas cell signals; osteocyte cell signals; sensory
organ cell signals (e.g., signals emanating from the eye or inner
ear); tumor cell signals; and tooth cell signals.
[0027] The term "multicellular signals," as used herein, refers to
signals emanating from two or more cells, or multiple signals
emanating from a single cell. The term "subcellular signals," as
used herein, refers to, for example, a signal derived from a part
of a cell, a signal derived from one particular physical location
along or within a cell, a signal from a cell extension (e.g.,
dendrite, dendrite branch, dendrite tree, axon, axon tree, axon
branch, pseudopod, or growth cone), and signals from organelles
(e.g., golgi apparatus or endoplasmic reticulum). The term
"intracellular signals," as used herein, refers to a signal that is
generated within a cell or by the entire cell that is confined to
the inside of the cell up to and including the membrane. The term
"extracellular signals," as used herein, refers to signals
generated by one or more cells that occur outside of the
cell(s).
[0028] As used herein, the term "patient" refers to any animal,
such as a mammal and preferably a human. Specific examples of a
"patient" include, but are not limited to: individuals requiring
medical assistance; healthy individuals; individuals with limited
function; and individuals with lost motor or other function due to
traumatic injury or neurological disease.
[0029] As used herein, the term "configuration" refers to any
alteration, improvement, repair, calibration, or other system
modifying event whether manual in nature or partially or fully
automated. The term "configuration parameter," as used herein,
refers to a variable, or a value of the variable, of a component,
device, apparatus, and/or system. A configuration parameter has a
value that can be: set or modified; used to perform a function;
used in a mathematical or other algorithm; used as a threshold to
perform a comparison; and any combinations thereof. A configuration
parameter's value determines the characteristics or behavior of
something. System configuration parameters are variables of the
system of the present invention, such as those used to by the
processing unit to produce processed signals. Other, numerous
subsets of configuration parameters are applicable, these subsets
including but not limited to: calibration parameters such as a
calibration frequency parameter; controlled device parameters such
as a time constant parameter; processing unit parameters such as a
cell selection criteria parameter; patient parameters such as a
patient physiologic parameter such as heart rate; multicellular
signal sensor parameters; other sensor parameters; system
environment parameters; mathematical algorithm parameters; a safety
parameter; and other parameters. Certain parameters may be
controlled by the patient's clinician, such as a
password-controlled parameter securely controlled by an integral
permission routine of the system. Certain parameters may represent
a "threshold" such as a success threshold used in a comparison to
determine if the outcome of an event was successful. In numerous
steps of a system configuration or other function, a minimum
performance or other measure may be maintained by comparing a
detected signal, or the output of an analysis of one or more
signals, to a success threshold.
[0030] As used herein, the term "discrete component" refers to a
component of a system such as those defined by a housing or other
enclosed or partially enclosed structure, or those defined as being
detached or detachable from another discrete component. Each
discrete component can transmit information to a separate component
through the use of a physical cable, including one or more of
electrically conductive wires or optical fibers, or transmission of
information can be accomplished wirelessly. Wireless communication
can be accomplished with a transceiver that may transmit and
receive data such as through the use of "Bluetooth" technology or
according to any other type of wireless communication means,
method, protocol or standard, including, for example, code division
multiple access (CDMA), wireless application protocol (WAP),
Infrared or other optical telemetry, radio frequency or other
electromagnetic telemetry, ultrasonic telemetry or other telemetric
technologies.
[0031] As used herein, the term "routine" refers to an established
function, operation, or procedure of a system, such as an embedded
software module that is performed or is available to be performed
by the system. Routines may be activated manually such as by an
operator of a system, or occur automatically such as a routine
whose initiation is triggered by another function, an elapsed time
or time of day, or other trigger. The devices, apparatus, systems
and methods of the present invention may include or otherwise have
integrated into one or their components, numerous types and forms
of routines. An "adaptive processing routine" is activated to
determine and/or cause a routine or other function to be modified
or otherwise adapt to maintain or improve performance. A
competitive routine is activated to provide a competitive function
for the patient of the present invention to compete with, such as a
function which allows an operator of the system to compete with the
patient in a patient training task; or an automated system function
which controls a visual object which competes with a patient
controlled object. A "configuration routine" is activated to
configure one or more system configuration parameters of the
system, such as a parameter that needs an initial value assigned or
a parameter that needs an existing parameter modified. A "language
selection routine" is activated to change a language displayed in
text form on a display and/or in audible form from a speaker. A
"patient training routine" is activated to train the patient in the
use of the system and/or train the system in the specifics of the
patient, such as the specifics of the patient's multicellular
signals that can be generated by the patient and detected by the
sensor. A "permission routine" is activated when a system
configuration or other parameter is to be initially set or modified
in a secured manner. The permission routine may use one or more of:
a password; a restricted user logon function; a user ID; an
electronic key; a electromechanical key; a mechanical key; a
specific Internet IP address; and other means of confirming the
identify of one or more operators prior to allowing a secure
operation to occur. A "remote technician routine" is activated to
allow an operator to access the system of the present invention, or
an associated device, from a location remote from the patient, or a
system component to be modified. A "system configuration routine"
is activated to configure the system, or one or more components or
associated devices of the system. In a system configuration
routine, one or more system configuration parameters may be
modified or initially set to a value. A "system reset routine" is
activated to reset the entire system or a system function.
Resetting the system is sometimes required with computers and
computer based devices such as during a power failure or a system
malfunction.
General Description of the Embodiments
[0032] Systems, methods, and devices consistent with the invention
detect cellular signals generated within a patient's body and
implement various signal processing techniques to generate
processed signals for transmission to one or more devices to be
controlled. The system includes a sensor comprising a plurality of
electrodes that detect multicellular signals from one or more
living cells, such as from the central or peripheral nervous system
of a patient. The system further includes a processing unit that
receives and processes the multicellular signals and transmits a
processed signal to a controlled device. The processing unit
utilizes various electronic, mathematic, neural net, and other
signal processing techniques in producing the processed signal.
[0033] An integrated patient training routine is embedded in one or
more components of the system. The patient training routine may be
a requirement of the system prior to allowing full control of the
controlled device to the patient. The patient training routine can
be utilized to develop a transfer function to apply to the
multicellular signals to produce the processed signal. The patient
training routine may involve a controlled device surrogate, such as
a surrogate which has more complex functionality or control
required than the intended control device. The patient training
routine may adapt over time, such as to improve system performance
and/or reduce the patient requirements of the routine. The patient
training routine includes one or more time varying stimulus and, in
some exemplary embodiments, the form, configuration, or type of the
time varying stimulus is adjustable such as by the patient. In an
alternative configuration, multiple controlled devices are included
in the system and multiple training routines correspond to the
multiple controlled devices.
Detailed Description of the Embodiments
[0034] Reference will now be made in detail to the present
embodiments of the invention, examples of which are illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0035] Referring now to FIG. 1, a flow chart of the patient
training routine of the present invention is illustrated. The flow
chart shows multiple steps and conditional statements that
determine the progression from step to step. The patient training
routine is preferably a software program, embedded in one or more
components of the system such as the processing unit.
Alternatively, an additional component is included in the system,
such as a computer system to configure the system, and the patient
training routine is embedded in whole or in part in the additional
component. The patient training routine may be activated
automatically by the system, or an operator of the system, such as
the patient's clinician or the patient themselves, may initiate
and/or conduct the patient training routine.
[0036] Referring back to FIG. 1, Step 20 includes the patient
training routine providing to the patient a set of states of a time
varying stimulus. The time varying stimulus can provide a target
for a patient's imagined movement and/or simply be a trigger to
initiate the imagined movement. The time varying stimulus can be
provided in multiple forms such as: visual; tactile; auditory;
olfactory; gustatory; electrical stimulation such as cortical
stimulation; and any combinations thereof. The time varying
stimulus may be provided in many different types such as: computer
icon; visual display object; moveable mechanical assembly such as a
robotic arm; vehicle such as a wheelchair; single or
multi-frequency sound; stimulation electrode such as cortical
stimulation electrode; robot or robotic component; tactile
transducer such as vibrating skin patch; and any combinations
thereof. The time varying stimulus can include continuous or
semi-continuous motion such as an icon moving on a computer screen.
The time varying stimulus can include a mechanical object moving in
space, such as a robotic arm or a prosthetic limb. The time varying
stimulus can be provided via one or more controlled devices of the
system, such as an exoskeleton device or FES device moving one of
the patient's own limbs. The time varying stimulus may be provided
as a short duration stimulus, such as an object that appears on a
visual display for less than one second, or a brief flash of
light.
[0037] In a preferred embodiment, the time varying stimulus has an
adjustable parameter, such as a parameter adjustable in a secured
manner such as via the permission routine described hereabove. One
or more parameters of the time varying stimulus may have a range of
applicable values, such as a range of position of a cursor or icon
on a computer screen, and these types of ranges may be an
adjustable parameter. Other adjustable parameters include but are
not limited to: display brightness or contrast; display size;
display resolution; electrical current parameter such as current or
voltage; object velocity, acceleration and position; object size
and color; sound volume; sound frequency; tactile sensor force,
frequency and pulse width; and any combinations thereof. The
adjustment to a time varying stimulus parameter may be accomplished
by one or more components of the system, such as the processing
unit. The adjustment may be accomplished by one or more users of
the system, such as the patient utilizing an input device selected
from the group consisting of: chin joystick; eyebrow EMG switch;
EEG activated switch such as the switched manufactured by
BrainFingers of Yellow Springs, Ohio, USA; eye tracker such as the
device manufactured by LC Technologies of Fairfax, Va., USA; a head
tracker such as the device manufactured by Synapse Adaptive of San
Rafael, Calif., USA; neck movement switch; shoulder movement
switch; sip-n-puff joystick controller such as the controller
manufactured by QuadJoy of Sheboygan, Wis., USA; speech recognition
switch; tongue switch such as a tongue palate switch; and any
combinations thereof.
[0038] Referring back to FIG. 1, Step 20 further includes the step
of recording and storing, such as in electronic memory of a system
component such as the processing unit, a first set of multicellular
signals simultaneous with the patient imagining a movement
associated with the provided set of states of the time varying
stimulus. In a preferred embodiment, in a previous step, not shown,
the patient has viewed the set of states of the time varying
stimulus at least one time prior to the recording of the first set
of multicellular signals. The first set of cellular signals are
correlated, or mapped, to the set of states of the time varying
stimulus. The correlation can be synchronized in time, called
temporal mapping, or correlated to another parameter including but
not limited to: a patient physiologic parameter such as heart rate;
a controlled device parameter; a system environment parameter; a
password controlled parameter; a clinician controlled parameter; a
patient training routine parameter; and any combinations
thereof.
[0039] Step 21 includes the building of a transfer function that is
used to build a representation of the processed signals. The
representation of the processed signal is a precursor to the
processed signals used to control the controlled device. The
representation of the processed signals may temporarily control the
controlled device, a surrogate of the controlled device, or another
device. In order to produce the processed signals, the processing
unit includes a transfer function that is applied to the
multicellular signals. The transfer function includes and/or is
based upon one or more system configuration parameters that are
generated and/or modified by the patient training routine. The
representation of the processed signal is also produced with a
transfer function that is applied to the multicellular signals,
such as a transfer function that has parameters determined based on
the temporal correlation of the first set of multicellular signals
and the first set of states of the time varying stimulus. In an
alternative, preferred embodiment, the representation of processed
signals is modified with a bias toward a time varying stimulus that
acts as a target for the patient's imagined movement. This improved
control signal can be used as a motivator to the patient, and
preferably has its improvement bias decrease as patient control
performance increases.
[0040] Step 22 includes the patient training routine providing a
set of states of a time varying stimulus and the representation of
the processed signal whose transfer function is created in Step 21.
While the patient receives, such as through viewing a visual
display, listening to an audio signal, and/or feeling a tactile
transducer, both the set of states of the time varying stimulus as
well as the patient controlled feedback produced by the
representation of processed signals, a next set of multicellular
signals are recorded and stored. This next set is also correlated
to the set of states of the time varying stimulus, such as a
temporal correlation and/or other correlation described hereabove.
The representation of the processed signal and/or the time varying
stimulus can be presented via the controlled device, a controlled
device surrogate, or another device. The controlled device
surrogate can be configured to be more complex than the intended
controlled device, such that the patient is training with a more
complicated device to improve eventual controlled device control.
The surrogate device may have one or more differences, such as a
larger value of one or more of: degrees of freedom; resolution;
modes; discrete states; functions; boundary conditions; and any
combinations thereof. The boundary conditions of the surrogate can
differ in one or more of: maximum distance; maximum velocity;
maximum acceleration; maximum force; maximum torque; rotation;
position; and any combinations thereof.
[0041] The representation of the processed signals may be provided
in a form similar to the time varying stimulus, or in a different
form. In a preferred embodiment, the time varying stimulus is
provided as an object on a visual display, and the representation
of processed signals is the motion of a mechanical object such as a
prosthetic limb. Both the time varying stimulus and the
representation of processed signals can be provided in multiple
forms selected from at least one of: visual; tactile; auditory;
olfactory; gustatory; and electrical stimulation such as cortical
stimulation. Both the time varying stimulus and/or the
representation of processed signals can be provided as one or more
of: moving object on screen; moving mechanical device such as a
mechanical limb or wheelchair; moving part of patient's body such
as via an exoskeleton device or FES device; changing audible signal
such as a multi-frequency signal; and any combinations thereof.
[0042] As shown in FIG. 1, step 22 also includes the measuring of
the performance of the representation of the processed signal as
compared to the time varying stimulus. In a preferred embodiment,
both the time varying stimulus and the representation of processed
signals are presented as an object on a computer screen, and the
performance is based on the ability of the patient to track the
time varying stimulus object with the patient controlled object
controlled by the representation of the processed signals. A
performance measure value is determined and this value is compared
to a predetermined success threshold value. If the performance
measure value is at or above the success threshold value, the next
step to be followed is Step 23 in which the patient training
routine is completed and the current transfer function is
subsequently used produce the processed signals to control the
controlled device. If the performance measure value is below the
success threshold value, the next step to be followed is a repeat
of step 21 and its subsequent steps. In a preferred embodiment, the
success threshold value is a system configuration parameter that is
adjustable such as via a remote operator in which the permission
routine is invoked to complete the change.
[0043] As stated above, if the performance meets or exceeds the
threshold, the patient training routine proceeds to Step 23 wherein
the processing unit utilizes the transfer function determined in
the patient training routine to convert the multicellular signals
received from the sensor of the present invention, and produces the
processed signals to be transmitted to the controlled devices. In a
preferred embodiment, a third set of states of time varying
stimulus and a second representation of processed signals are used
to create the transfer function. The second representation of
processed signals is based on a second set of multicellular signals
previously recorded, or a combination of the first and second sets
of multicellular signal data. In another preferred embodiment, the
patient training routine must be performed at least one time in the
use of the system, such as prior to the patient receiving full
control of the controlled device. In an alternative embodiment, the
patient training routine must be performed at least two times in
the use of the system. In another preferred embodiment, the patient
training routine must be successfully completed, such as when a
performance parameter meets or exceeds a success threshold value,
prior to the patient receiving full control of the controlled
device. Full control of a controlled device is described in greater
detail in reference to FIG. 3 herebelow.
[0044] In another preferred embodiment, the system of the present
invention includes two controlled devices, and the patient training
routine provides different feedback to the patient during the
routine, such as different time varying stimulus or other feedback.
Alternatively or additionally, the system may include a separate
patient training routine for each controlled device. For the
multiple controlled devices, a first set of states for a time
varying stimulus will be provided to develop a transfer function
for the first controlled device, and a second set of states for a
time varying stimulus will be provided to develop a transfer
function for the second controlled device. In a preferred
embodiment, the first controlled device is a prosthetic or
exoskeleton driven arm, and the second controlled device is a
prosthetic or exoskeleton driven leg. In another preferred
embodiment, the first controlled device is a prosthetic or
exoskeleton driven arm, and the second controlled device is a
vehicle such as a wheelchair.
[0045] As stated above, the patient training routine can be used to
generate one or more system configuration parameters used by the
processing unit to develop a transfer function to produce processed
signals. The selection of cells for processing as well as criteria
for selecting cells may be generated. A signal processing parameter
can be generated such as a coefficient modifying one or more of the
following: amplification, filtering, sorting, conditioning,
translating, interpreting, encoding, decoding, combining,
extracting, sampling, multiplexing, analog to digital converting,
digital to analog converting, mathematically transforming; and any
combinations thereof. A control signal transfer function parameter,
such as a coefficient value; algorithm; methodology; mathematical
equation; and any combinations of those may be generation. A
calibration parameter such as calibration frequency and/or a
controlled device parameter such as a controlled device parameter
boundary limit may be generated. Other system configuration
parameters that can be generated by the patient training routine
include but are not limited to: acceptable frequency range of
cellular activity; selection of electrodes to include; selection of
cellular signals to include; type of frequency analysis such as
power spectral density; instruction information to patient such as
imagined movement type or other imagined movement instruction;
type, mode or configuration of feedback during provision of
processed signal to patient; calibration parameter such as
calibration duration and calibration frequency; controlled device
parameter such as controlled device mode; alarm or alert threshold;
success threshold; and any combinations thereof.
[0046] In another preferred embodiment, the patient training
routine of the present invention adapts over time. Each time the
patient training routine is invoked, a patient training event, one
or more changes may be made for the next patient training event. A
change may be caused by a measurement of performance, such as
controlled device control performance. A control at or above a
threshold, measured as has been described in detail hereabove, may
result in a subsequent patient training routine of a shorter
duration. Alternatively, performance below a similar threshold may
result in a longer patient training routine, and/or a modified
patient training routine. The patient training routine may adapt
based on a multicellular signal change, such as the death of one or
more cells previously providing cellular signals. The patient
training routine may adapt due to a change in a patient parameter,
such as a change due to a change in patience consciousness level.
In the circumstance wherein patience consciousness falls below a
threshold, a patient training routine may adapt within the routine
itself--such as to repeat a step, or delay a step until
consciousness is at a higher level. Patient consciousness may be
measured using the multicellular signals of the sensor of the
present invention, or another sensor of the system such as an EEG
or LFP sensor.
[0047] In another preferred embodiment, the patient training
routine automatically adapts, such as by being triggered by a
system-monitored parameter crossing a threshold. Alternatively, the
routine may adapt based on an operator input. Routines may adapt
within a single patient training event, or between patient training
events. Routines may adapt based on a measure of performance in a
previous patient training routine event, or based on a comparative
difference between two patient training events.
[0048] Referring now to FIG. 2, a brain implant apparatus
consistent with an embodiment of the present invention is
illustrated. As shown in FIG. 2, the system includes an array of
electrodes assembly (e.g., sensor 200), which has been inserted
into a brain 250 of patient 500, through a previously created
opening in scalp 270 and skull 260 in a surgical procedure known as
a craniotomy. Sensor 200 includes a plurality of longitudinal
projections 211 extending from a base (e.g., array substrate 210).
Projections 211 may be rigid, semi-flexible or flexible, the
flexibility such that each projection 211 can still penetrate into
neural tissue, potentially with an assisting device or with
projections that only temporarily exist in a rigid condition.
Sensor 200 has been inserted into brain 250, preferably using a
rapid insertion tool, such that the projections 211 pierce into
brain 250 and sensor substrate 210 remains in close proximity to or
in light contact with the surface of brain 250. At the end of each
projection 211 is an electrode 212. In alternative embodiments,
electrodes can be located at a location other than the tip of
projections 211 or multiple electrodes may be included along the
length of one or more of the projections 211. One or more
projections 211 may be void of any electrode, such projections
potentially including anchoring means such as bulbous tips or
barbs.
[0049] Electrodes 212 are configured to detect electrical brain
signals or impulses, such as individual neuron spikes or signals
that represent clusters of neurons such as local field potential
(LFP) and electroencephalogram (EEG) signals. Each electrode 212
may be used to individually detect the firing of multiple neurons,
separated by neuron spike discrimination techniques. Other
applicable signals include electrocorticogram (ECOG) signals and
other signals, such as signals between single neuron spikes and EEG
signals. Sensor 200 may be placed in any location of a patient's
brain allowing for electrodes 212 to detect these brain signals or
impulses. In a preferred embodiment, electrodes 212 can be inserted
into a part of brain 250 such as the cerebral cortex. Alternative
forms of penetrating electrodes, such as wire or wire bundle
electrodes, can make up or be a component of the sensor of the
present invention. In addition to or alternative from neural
signals, the system of the present invention may utilize other
types of cellular signals to produce a processed signal to control
a device. The various forms of penetrating electrodes described
above can be placed into tissue within or outside of the patient's
cranium, such tissue including but not limited to: nerve tissue
such as peripheral nerve tissue or nerves of the spine; organ
tissue such as heart, pancreas, liver or kidney tissue; tumor
tissue such as brain tumor or breast tumor tissue; other tissue and
combinations thereof.
[0050] Alternatively or additionally, the sensor of the present
invention may employ non-penetrating electrode configurations, not
shown, such as subdural grids placed inside the cranium such as to
record LFP signals. In addition to subdural grids, the sensor may
comprise other forms of non-penetrating electrodes such as flat
electrodes, coil electrodes, cuff electrodes and skin electrodes
such as scalp electrodes. These non-penetrating electrode
configurations are placed in, on, near or otherwise in proximity to
the cells whose signals are to be detected, such as neural or other
cellular signals. In another alternative embodiment, the sensor of
the present invention includes detectors other than electrodes,
such as photodetectors that detect cellular signals represented by
a light emission. The light emission can be caused by a photodiode,
integrated into the sensor or other implanted or non-implanted
system component, shining one or more wavelengths of light on the
appropriate cells. In addition to the numerous types of cells
described above, one or more of the various configurations of the
sensor of the present invention may utilize any living cell of the
body that emanates cellular signals. In a preferred embodiment, the
cellular signals are under voluntary control of the patient.
[0051] Although FIG. 2 depicts sensor 200 as a single discrete
component, in alternative embodiments the sensor may comprise
multiple discrete components, including one or more types of
electrodes or other cellular signal detecting elements, each
configured and placed to detect similar or dissimilar types of
cellular signals. Multiple sensor discrete components can be
implanted entirely within: the skull, an extracranial location such
as a peripheral nerve, or external to the body; or the components
can be placed in any combination of these locations.
[0052] Sensor 200 serves as the multicellular signal sensor of the
biological interface system of the present invention. While FIG. 2
shows sensor 200 as eight projections 211 with eight electrodes
212, sensor 200 may include one or more projections with and
without electrodes, both the projections and electrodes having a
variety of sizes, lengths, shapes, surface areas, forms, and
arrangements. Moreover, sensor 200 may be a linear array (e.g., a
row of electrodes) or a two-dimensional array (e.g., a matrix of
rows and columns of electrodes such as a ten by ten array), or wire
or wire bundle electrodes. An individual wire lead may include a
plurality of electrodes along its length. Projections and
electrodes may have the same materials of construction and
geometry, or there may be varied materials and/or geometries used
in one or more electrodes. Each projection 211 and electrode 212 of
FIG. 2 extends into brain 250 to detect one or more cellular
signals such as those generated from the neurons located in
proximity to each electrode 212's placement within the brain.
Neurons may generate such signals when, for example, the brain
instructs a particular limb to move in a particular way and/or the
brain is planning that movement. In a preferred embodiment, the
electrodes reside within the arm, hand, leg or foot portion of the
motor cortex of the brain. The processing unit of the present
invention may assign one or more specific cellular signals to a
specific use, such as a specific use correlated to a patient
imagined event. In a preferred embodiment, the one or more cellular
signals assigned to a specific use are under voluntary control of
the patient.
[0053] Referring back to FIG. 2, the processing unit of the present
invention includes processing unit first portion 130a, placed under
scalp 270 at a location near patient 500's ear 280. Processing unit
first portion 130a receives cellular signals from sensor 200 via
wire bundle 220 (e.g., a multi-conductor cable). In a preferred
embodiment, wire bundle 220 includes a conductor for each electrode
212. Processed signals are produced by processing unit first
portion 130a and other processing unit discrete components, such as
processing unit second portion 130b removably placed on the
external skin surface of patient 500 near ear 280. Processing unit
second portion 130b remains in relative close proximity to
implanted component processing unit first portion 130a through one
or more fixation means such as cooperative magnetic means in both
components, or body attachment means such that the processing unit
second portion 130b is attached to eye glasses, an ear wrapping
arm, a hat, mechanical straps, or an adhesive pad. Processing unit
first portion 130a and processing unit second portion 130b work in
combination to receive multicellular signal data and create a time
code of brain activity.
[0054] In the preferred embodiment depicted in FIG. 2, bone flap
261 (e.g., the original bone portion removed in the craniotomy) may
be used to close the hole made in the skull 260 during the
craniotomy, obviating the need for a prosthetic closure implant.
Bone flap 261 is attached to skull 260 with one or more straps
(e.g., bands 263), which preferably comprises titanium or stainless
steel. Band 263 is secured to bone flap 261 and skull 260 with bone
screws 262. Wire bundle 220 passes between bone flap 261 and the
hole cut into skull 260. During the surgical procedure, bone recess
265 was made in skull 260 such that processing unit first portion
130a could be placed in the indentation, allowing scalp 270 to lie
relatively flat and free of tension in the area proximal to
processing unit first portion 130a. A long incision in scalp 270
between the craniotomy site and the recess 265 can be made to place
processing unit first portion 130a in recess 265. Alternatively, an
incision can be made to perform the craniotomy, and a separate
incision made to form recess 265, after which the processing unit
first portion 130a and wire bundle 220 can be tunneled under scalp
270 to the desired location. Processing unit first portion 130a is
attached to skull 260 with one or more bone screws or a
biocompatible adhesive.
[0055] In an alternative embodiment, processing unit first portion
130a may be placed entirely within skull 260 or be geometrically
configured and surgically placed to fill the craniotomy hole
instead of bone flap 261. Processing unit first portion 130a can be
placed in close proximity to sensor 200, or a distance of 5-20 cm
can separate the two components. Processing unit first portion 130a
includes a biocompatible housing which creates a fluid seal around
wire bundle 220 and numerous internal components of processing unit
first portion 130a, internal components not shown. Internal
components of Processing unit first portion 130a may provide one or
more of the following functions: signal processing of the cellular
signals received from sensor 200 such as buffering, amplification,
digital conversion and multiplexing, wireless transmission of
cellular signals, a partially processed, or derivative form of the
cellular signals, or other data; inductive power receiving and
conversion; and other functions well known to implanted electronic
assemblies such as implanted pacemakers, defibrillators, and
pumps.
[0056] Processing unit second portion 130b, removably placed at a
location proximate to implanted processing unit first portion 130a,
but external to patient 500, receives data from processing unit
first portion 130a via wireless communication through the skin,
such as infrared or radiofrequency wireless data transfer means.
Processing unit second portion 130b includes, in addition to
wireless data receiving means, wireless power transfer means such
as an RF coil which inductively couples to an implanted coil,
signal processing circuitry, an embedded power supply such as a
battery, and data transfer means. The data transfer means of
processing unit second portion 130b may be wired or wireless, and
transfer data to one or more of: implanted processing unit first
portion 130a; a different implanted device; and an external device
such as an additional component of the processing unit of the
present invention, a controlled device of the present invention or
a computer device such as a configuration computer with Internet
access.
[0057] Referring back to FIG. 2, electrodes 212 transfer the
detected cellular signals to processing unit first portion 130a via
array wires 221 and wire bundle 220. Wire bundle 220 includes
multiple conductive elements and array wires 221, which preferably
include a conductor for each electrode 212 of sensor 200. Also
included in wire bundle 220 are two conductors: first reference
wire 222 and second reference wire 223, each of which is placed in
an area in relative proximity to sensor 200 such as on the surface
of brain 250 near the insertion location. First reference wire 222
and second reference wire 223 may be redundant and provide
reference signals used by one or more signal processing elements of
the processing unit of the present invention to process the
cellular signal data detected by one or more electrodes. In an
alternative embodiment, not shown, sensor 200 may comprise multiple
discrete components and multiple bundles of wires connect to one or
more discrete components of the processing unit, such as processing
unit first portion 130a. In another alternative embodiment,
cellular signals detected by sensor 200 are transmitted to
processing unit first portion 130a via wireless technologies, such
as infrared communication incorporated into an electronic module of
sensor 200. Such transmissions penetrate the skull of the patient,
obviating the need for wire bundle 220, array wires 221, and any
physical conduit passing through skull 260 after the surgical
implantation procedure is completed.
[0058] Processing unit first portion 130a and processing unit
second portion 130b independently or in combination preprocess the
received cellular signals (e.g., impedance matching, noise
filtering, or amplifying), digitize them, and further process the
cellular signals to extract neural data that processing unit second
portion 130b may then transmit to an external device, such as an
additional processing unit component and/or any device to be
controlled by the processed multicellular signals. For example, the
external device may decode the received neural data into control
signals for controlling a prosthetic limb or limb assist device or
for controlling a computer cursor. In an alternative embodiment,
the external device may analyze the neural data for a variety of
other purposes. In another alternative embodiment, the device
receiving transmissions from processing unit second portion 130b is
an implanted device. Processing unit first portion 130a and
processing unit second portion 130b independently or in combination
include signal processing circuitry to perform multiple signal
processing functions including but not limited to: amplification,
filtering, sorting, conditioning, translating, interpreting,
encoding, decoding, combining, extracting, sampling, multiplexing,
analog to digital converting, digital to analog converting,
mathematically transforming and/or otherwise processing cellular
signals to generate a control signal for transmission to a
controlled device. Processing unit first portion 130a and
processing unit second portion 130b may include one or more
components to assist in processing the multicellular signals or to
perform additional functions. These components include but are not
limited to: a temperature sensor; a pressure sensor; a strain
gauge; an accelerometer; a volume sensor; an electrode; an array of
electrodes; an audio transducer; a mechanical vibrator; a drug
delivery device; a magnetic field generator; a photo detector
element; a camera or other visualization apparatus; a wireless
communication element; a light producing element; an electrical
stimulator; a physiologic sensor; a heating element; and a cooling
element.
[0059] Processing unit first portion 130a transmits raw or
processed cellular signal data to processing unit second portion
130b through integrated wireless communication means, such as the
infrared communication means of FIG. 2, or alternative means
including but not limited to radiofrequency communications, other
optical communications, inductive communications, ultrasound
communications and microwave communications. In a preferred,
alternate embodiment, processing unit first portion 130a includes
both infrared communication means for short-range high baud rate
communication, and radiofrequency communication means for longer
range, lower baud rate communication. This wireless transfer allows
sensor 200 and processing unit first portion 130a to be completely
implanted under the skin of the patient, avoiding the need for
implanted devices that require protrusion of a portion of the
device or wired connections through the skin surface. In an
alternative embodiment, a through the skin pedestal connector is
utilized between either the implanted sensor 200 or processing unit
first portion 130a and an external component. Processing unit first
portion 130a includes a coil, not shown, which receives power
through inductive coupling, on a continual or intermittent basis
from an external power transmitting device such as processing unit
second portion 130b. The inductive coupling power transfer
configuration obviates the need for any permanent power supply,
such as a battery, integral to processing unit first portion
130a.
[0060] In addition to or in place of power transmission, the
integrated coil of processing unit first portion 130a and its
associated circuitry may receive data from an external coil whose
signal is modulated in correlation to a specific data signal. The
power and data can be delivered to processing unit first portion
130a simultaneously such as through simple modulation schemes in
the power transfer that are decoded into data for processing unit
first portion 130a to use, store or facilitate another function. A
second data transfer means, in addition to a wireless means such as
an infrared LED, can be accomplished by modulating a signal in the
coil of processing unit first portion 130a that data is transmitted
from the implant to an external device including a coil and
decoding elements. In a preferred embodiment, the processing unit
first portion 130a includes an embedded ID, which can be wirelessly
transmitted to the processing unit second portion 130b or a
separate discrete component via the various wireless transmission
means described above. In another preferred embodiment, processing
unit second portion 130b includes means of confirming proper ID
from processing unit first portion 130a, and processing unit second
portion 130b also includes an embedded ID.
[0061] Processing unit first portion 130a and processing unit
second portion 130b may independently or in combination conduct
adaptive processing of the received cellular signals by changing
one or more parameters of the system to achieve acceptable or
improved performance. Examples of adaptive processing include, but
are not limited to: changing a system configuration parameter
during a system configuration; changing a method of encoding neural
or other cellular signal data; changing the type, subset, or amount
of cellular signal data that is processed; or changing a method of
decoding neural or other cellular signal data. Changing an encoding
method may include changing neuron spike sorting methodology,
calculations, thresholds, or pattern recognition methodologies.
Changing a decoding methodology may include changing variables,
coefficients, algorithms, and/or filter selections. Other examples
of adaptive processing may include changing over time the type or
combination of types of signals processed, such as EEG, ECoG, LFP,
neural spikes, or other cellular signal types.
[0062] Processing unit first portion 130a and processing unit
second portion 130b may independently or in combination also
transmit electrical signals to one or more electrodes 212 such as
to stimulate, polarize, hyperpolarize or otherwise cause an effect
on one or more cells of neighboring tissue. Specific electrodes may
record cellular signals only, or deliver energy only, and specific
electrodes may provide both functions. In an alternative
embodiment, a separate device, not shown but preferably an
implanted device with the ability to independently or in
combination provide an electrical signal to multiple electrodes,
delivers stimulating energy to one or more electrodes 212 or
different electrodes. Stimulating electrodes in various locations
can transmit signals to the central nervous system, peripheral
nervous system, other body systems, body organs, muscles and other
tissue or cells. The transmission of these signals is used to
perform one or more functions including but not limited to: pain
therapy; muscle stimulation; seizure disruption; stroke
rehabilitation; coma recovery; and patient feedback.
[0063] In an alternative embodiment, processing unit first portion
130a and potentially additional signal processing functions are
integrated into sensor 200, such as, for example, through the use
of a bonded electronic microchip. In another alternative
embodiment, processing unit first portion 130a may also receive
non-neural cellular signals and/or other biologic signals, such as
from an implanted sensor. These signals may be in addition to
received neural multicellular signals, and they may include but are
not limited to: EKG signals, respiration signals, blood pressure
signals, electromyographic activity signals and glucose level
signals. Such biological signals may be used to change the state of
the biological interface system of the present invention or one of
its discrete components. Such state changes include but are not
limited to: turn system or component on or off; to begin a
configuration routine; to initiate or conclude a step of a
configuration or other routine; and to start or stop another system
function. In another alternative embodiment, processing unit first
portion 130a and processing unit second portion 130b independently
or in combination produce one or more additional processed signals,
to additionally control the controlled device of the present
invention or to control one or more additional controlled
devices.
[0064] In an alternative, preferred configuration of implanted
components, a discrete component such as a sensor of the present
invention is implanted within the cranium of the patient, such as
sensor 200 of FIG. 2, a processing unit or a portion of the
processing unit is implanted in the torso of the patient, and one
or more discrete components are external to the body of the
patient. The processing unit may receive multicellular signals from
the sensor via wired (e.g., conductive wires and optic fibers) or
wireless communication. The sensor 200 preferably includes signal
processing means including signal processing up to and including
digitizing the multicellular signals. In another alternative
embodiment, for an acute (less than 24 hours) or sub-chronic (less
than 30 days) application, for example, a through the skin, or
transcutaneous device is used to transmit or enable the
transmission of the multicellular signals and/or a derivative or
pre-processed form of the multicellular signals.
[0065] As shown in FIG. 3, a biological interface system 100 may
comprise implanted components (not shown) and components external
to the body of a patient 500. A sensor for detecting multicellular
signals, preferably a two dimensional array of multiple protruding
electrodes, has been implanted in the brain of patient 500, in an
area such as the motor cortex. In a preferred embodiment, the
sensor is placed in an area to record multicellular signals that
are under voluntary control of the patient. Alternatively or
additionally to the two dimensional array, the sensor may include
one or more wires or wire bundles which include a plurality of
electrodes. Patient 500 of FIG. 3 is shown as a human being, but
other mammals and life forms that produce recordable multicellular
signals would also be applicable. Patient 500 may be a patient with
a spinal cord injury or afflicted with a neurological disease that
has resulted in a loss of voluntary control of various muscles
within the patient's body. Alternatively or additionally, patient
500 may have lost a limb, and system 100 will include a prosthetic
limb as its controlled device. Numerous types of patients,
including healthy individuals, are applicable to the system of the
present invention. The patient of the present invention may be a
quadriplegic, a paraplegic, an amputee, a spinal cord injury
victim, or an otherwise physically impaired person. Alternatively
or in addition, patient 500 may have been diagnosed with one or
more of: obesity, an eating disorder, a neurological disorder, a
psychiatric disorder, a cardiovascular disorder, an endocrine
disorder, sexual dysfunction, incontinence, a hearing disorder, a
visual disorder, sleeping disorder, a movement disorder, a speech
disorder, physical injury, migraine headaches, or chronic pain.
System 100 can be used to treat one or more medical conditions of
patient 500, or to restore, partially restore, replace or partially
replace a lost function of patient 500.
[0066] Alternatively, system 100 can be utilized by patient 500 to
enhance performance, such as, for example, if patient 500 did not
have a disease or condition from which a therapy or restorative
device could provide benefit, but did have an occupation wherein
thought control of a device provided an otherwise unachieved
advancement in healthcare, crisis management and national defense.
Thought control of a device can be advantageous in numerous healthy
individuals including but not limited to: a surgeon, such as an
individual surgeon using thought control to maneuver three or more
robotic arms in a complex laparoscopic procedure or a surgeon
controlling various instruments at a location remote from the
instruments and the surgical procedure; a crisis control expert,
such as a person who in attempting to minimize death and injury
uses thought control to communicate different pieces of information
and/or control multiple pieces of equipment, such as urban search
and rescue equipment, simultaneously during an event such as an
earthquake or other disaster, both natural disasters and those
caused by man; a member of a bomb squad, such as an expert who uses
thoughts to control multiple robots and/or robotic arms to remotely
diffuse a bomb; and military personnel who uses thought control to
communicate with other personnel and control multiple pieces of
defense equipment, such as artillery, aircraft, watercraft, land
vehicles, and reconnaissance robots. It should be noted that the
above advantages of system 100 to a healthy individual are also
advantages achieved in a patient such as a quadriplegic or
paraplegic. In other words, a quadriplegic could provide
significant benefit to society, such as in controlling multiple
bomb diffusing robots, in addition to his or her own ambulation and
other quality of life devices. Patients undergoing implantation and
use of the system 100 of the present invention may provide numerous
occupational and other functions not available to individuals that
do not have the biological interface system of the present
invention.
[0067] The sensor electrodes of system 100 can be used to detect
various multicellular signals as has been described in detail in
reference to FIG. 2 hereabove. The sensor is connected via a
multi-conductor cable, implanted in patient 500, to an implanted
portion of the processing unit (e.g., processing unit first portion
130a) which includes some signal processing elements as well as
wireless communication means as has been described in detail in
reference to FIG. 2. The implanted multi-conductor cable preferably
includes a separate conductor for each electrode, as well as
additional conductors to serve other purposes, such as providing
reference signals and ground. A processing unit second portion 130b
receives the wireless communications from the implanted portion.
Processing unit second portion 130b is removably located just above
ear 280 of patient 500, such as to be aligned with an infrared data
transmission element of the implanted device. Multicellular signals
or derivatives of the multicellular signals are transmitted from
the implanted processing unit to processing unit second portion
130b for further processing. The processing unit components of
system 100 perform various signal processing functions as have been
described in detail in reference to FIG. 2. The processing unit may
process signals that are mathematically combined, such as combining
neuron spikes that are first separated using spike discrimination
methods. In alternative embodiments, the processing unit may
comprise multiple components or a single component. Each of the
processing unit components can be fully implanted in patient 500,
be external to the body, or be implanted with a portion of the
component exiting through the skin.
[0068] In FIG. 3, a first controlled device is a computer including
CPU 305 that may be attached to monitor 302 and integrated into
configuration cart 121. Through the use of system 100, patient 500
can control one or more computer functions including but not
limited to: an on/off function, a reset function, a language
function, a modem function, a printer function, an Internet
function, a cursor, a keyboard, a joystick, a trackball or other
input device. Each function may be controlled individually or in
combination. System 100 includes a second controlled device (e.g.,
wheelchair 310). Numerous other controlled devices can be included
in the systems of this application, individually or in combination,
including but not limited to: a computer; a computer display; a
mouse; a cursor; a joystick; a personal data assistant; a robot or
robotic component; a computer controlled device; a teleoperated
device; a communication device or system; a vehicle such as a
wheelchair; an adjustable bed; an adjustable chair; a remote
controlled device; a Functional Electrical Stimulator device or
system; a muscle stimulator; an exoskeletal robot brace; an
artificial or prosthetic limb; a vision enhancing device; a vision
restoring device; a hearing enhancing device; a hearing restoring
device; a movement assist device; medical therapeutic equipment
such as a drug delivery apparatus; medical diagnostic equipment
such as epilepsy monitoring apparatus; other medical equipment such
as a bladder control device, a bowel control device and a human
enhancement device; closed loop medical equipment and other
controllable devices applicable to patients with some form of
paralysis or diminished function as well as any device that may be
utilized under direct brain or thought control in either a healthy
or unhealthy patient.
[0069] Processing unit second portion 130b includes a unique
electronic ID, such as a unique serial number or any alphanumeric
or other retrievable, identifiable code associated uniquely with
the system 100 of patient 500. The unique electronic identifier may
take many different forms in processing unit second portion 130b,
such as, for example, a piece of electronic data stored in a memory
module; a semiconductor element or chip that can be read
electronically via serial, parallel or telemetric communication;
pins or other conductive parts that can be shorted or otherwise
connected to each other or to a controlled impedance, voltage or
ground, to create a unique code; pins or other parts that can be
masked to create a binary or serial code; combinations of different
impedances used to create a serial code that can be read or
measured from contacts, features that can be optically scanned and
read by patterns and/or colors; mechanical patterns that can be
read by mechanical or electrical detection means or by mechanical
fit, a radio frequency ID or other frequency spectral codes sensed
by radiofrequency or electromagnetic fields, pads and/or other
marking features that may be masked to be included or excluded to
represent a serial code, or any other digital or analog code that
can be retrieved from the discrete component.
[0070] Alternatively or in addition to embedding the unique
electronic ID in processing unit second portion 130b, the unique
electronic ID can be embedded in one or more implanted discrete
components. Under certain circumstances, processing unit second
portion 130b or another external or implanted component may need to
be replaced, temporarily or permanently. Under these circumstances,
a system compatibility check between the new component and the
remaining system components can be confirmed at the time of the
repair or replacement surgery through the use of the embedded
unique electronic ID. The unique electronic ID can be embedded in
one or more of the discrete components at the time of manufacture,
or at a later date such as at the time of any clinical procedure
involving the system, such as a surgery to implant the sensor
electrodes into the brain of patient 500. Alternatively, the unique
electronic ID may be embedded in one or more of the discrete
components at an even later date such as during a system
configuration routine (e.g., a calibration routine).
[0071] Processing unit second portion 130b communicates with one or
more discrete components of system 100 via wireless communication
means. Processing unit second portion 130b communicates with
selector module 400, a component utilized to select the specific
device or devices to be controlled by the processed signals of
system 100. Selector module 400 includes a touch screen set of
buttons, input element 402, used to perform the selection process.
Processing unit second portion 130b also communicates with
controlled device CPU 305, such as to control a cursor, joystick,
keyboard or other function of CPU 305. Processing unit second
portion 130b further communicates with processing unit third
portion 130c. Processing unit third portion 130c provides
additional signal processing functions, as have been described
above, to control wheelchair 310. An additional processing unit
discrete component (e.g., processing unit fourth portion 130d) may
be included to perform additional processing of the multicellular
signals and/or derivatives of these processed signals and/or
processing of additional information, such as collective processing
used to control one or more additional controlled devices of the
present invention. System 100 may utilize selector module 400 to
select one or more of CPU 305, wheelchair 310, or another
controlled device to be controlled by the processed signals
produced by the processing unit of the present invention. In system
100 of FIG. 3, one set of processed signals emanate from one
portion of the processing unit (e.g., processing unit second
portion 130b) and a different set of processed signals emanate from
a different portion of the processing unit (e.g., processing unit
third portion 130c).
[0072] The various components of system 100 communicate with
wireless transmission means. However, it should be appreciated that
physical cables can be used to transfer data alternatively or in
addition to wireless means. These physical cables may include
electrical wires, optical fibers, sound wave guide conduits, other
physical means of transmitting data, and/or power, and any
combination of those means.
[0073] A qualified individual, such as an operator 110 in
cooperation with patient 500, is performing a patient training
routine, one of numerous configuration programs or routines of the
system. In an alternative embodiment, patient 500 is the operator
of the patient training routine or other configuration routine. The
patient training routine may be performed with controlled device
305. Displayed on monitor 302 is planned trajectory 711, system
controlled target 712 and patient controlled object 713. In the
performance of the patient training routine, multiple time varying
stimulus, such as a moving system controlled target 712 are
provided to the patient such that the patient can imagine moving
that target, and a set of multicellular signals can be collected by
the processing unit to produce one or more algorithms to produce
the processed signals. In a preferred embodiment, after a first set
of multicellular signals is collected, and a first transfer
function for producing processed signals is developed, a second set
of time varying stimulus is provided in combination with a patient
controlled object, such as patient controlled object 713. During
the time that the patient tries to mimic the motion of the system
controlled target 712 with the visual feedback of the patient
controlled target 713, and a second set of multicellular signals is
collected and a second, improved transfer function is produced by
the system. Additional forms of feedback can be provided to the
patient, such as tactile transducer 701 shown attached to patient
500's neck, and speaker 702 shown attached (e.g., fixedly mounted
to the back of controlled wheelchair 310) to processing unit third
portion 130c. Speaker 702 and tactile transducer 701 can provide
feedback in the form of a time varying stimulus, a derivative of
the multicellular signals, and/or a representation of the processed
signals as controlled by patient 500.
[0074] In an embodiment, one or more system configuration routines
can be performed without an operator, with the patient as the
operator, or with an operator at a remote location such as when the
system of the present invention is electronically connected with a
computer or computer network such as the Internet. In another
embodiment, the patient training routine is performed at least one
time during the use of the system, preferably before patient 500 is
given, by the system, full control of one or more controlled
devices. For example, limited control of CPU 305 may include the
ability to send and receive email but not the ability to adjust a
computer-controlled thermostat. Limited control of wheelchair 310
may be to turn left or right, but not move forward or back, or to
only allow travel at a limited velocity. Limited control may also
include no control of one or more controlled devices. Each
controlled device will have different parameters limited by system
100 when patient 500 has not been given full control. In an
embodiment, the selection of these parameters, the values to be
limited, the criteria for achieving full control such as the value
of a success threshold achieved during a system configuration
routine such as a patient training routine, and any combinations of
these may be modified only in a secured way such as only by a
clinician utilizing electronic or mechanical keys or passwords.
[0075] In addition to successful completion of the patient training
routine, completion of one or more other configuration routines may
be required for patient 500 to have full control of one or more
controlled devices, or multiple successful completions of a single
routine. Success is preferably measured through the measurement of
one or more performance parameters during or after the
configuration routine. Success will be achieved by a performance
parameter being above a threshold, such as a threshold adjustable
only by a clinician, such as a clinician at a remote site utilizing
a password, user identification, an electronic ID and/or a
mechanical key. These configuration routines are utilized by the
system to not only determine the applicability of full control to
the patient, but to set or reset one or more system configuration
parameters. System configuration parameters include but are not
limited to: selection of cellular signals for processing by the
processing unit; criteria for the selection of cells for
processing; a coefficient of a signal processing function such as
amplification, filtering, sorting, conditioning, translating,
interpreting, encoding, decoding, combining, extracting, sampling,
multiplexing, analog to digital converting, digital to analog
converting, mathematically transforming; a control signal transfer
function parameter such as a transfer function coefficient,
algorithm, methodology, mathematical equation, a calibration
parameter such as calibration frequency; a controlled device
parameter such as a controlled device boundary limit; acceptable
frequency range of cellular activity; selection of electrodes to
include; selection of cellular signals to include; type of
frequency analysis such as power spectral density; instruction
information to patient such as imagined movement type or other
imagined movement instruction; type, mode or configuration of
feedback during provision of processed signal to patient;
calibration parameter such as calibration duration and calibration
frequency; controlled device parameter such as controlled device
mode; alarm or alert threshold; and a success threshold.
[0076] As depicted in FIG. 3, operator 110 utilizes configuration
apparatus 120 which includes two monitors (first configuration
monitor 122a and second configuration monitor 122b), configuration
keyboard 123, and configuration CPU 125, to perform a calibration
routine or other system configuration process such as a patient
training routine, algorithm and algorithm parameter selection and
output device setup. The configuration routines, such as the
patient training routine, include software programs and hardware
required to perform the configuration. The embedded software and/or
hardware may be included in the processing unit, such as processing
unit second portion 130b, be included in selector module 400, be
incorporated into configuration apparatus 120, a controlled device,
or combinations of these. Configuration apparatus 120 may include
additional input devices, such as a mouse or joystick, or an input
device for a patient with limited motion, such as a tongue switch;
a tongue palate switch; a chin joystick; a Sip-n-puff joystick
controller; an eye tracker device; a head tracker device; an EMG
switch such as an eyebrow EMG switch; an EEG activated switch; and
a speech recognition device.
[0077] Configuration apparatus 120 may include various elements,
functions, and data including but not limited to: memory storage
for future recall of configuration activities, operator
qualification routines, standard human data, standard synthesized
or artificial data, neuron spike discrimination software, operator
security and access control, controlled device data, wireless
communication means, remote (such as via the Internet)
configuration communication means and other elements, functions and
data used to provide an effective and efficient configuration on a
broad base of applicable patients and a broad base of applicable
controlled devices. A system electronic ID can be embedded in one
or more of the discrete components at the time, including an ID
embedded at the time of system configuration. In an alternative
embodiment, all or part of the functionality of configuration
apparatus 120 is integrated into selector module 400 such that
system 100 can perform one or more configuration processes such as
a calibration procedure or patient training routine, utilizing
selector module 400 without the availability of configuration
apparatus 120.
[0078] In order to change a system configuration parameter, system
100 includes a permission routine, such as an embedded software
routine or software driven interface that allows the operator to
view information and enter data into one or more components of
system 100. The data entered must signify an approval of the
parameter modification in order for the modification to take place.
Alternatively, the permission routine may be partially or fully
located in a separate device such as configuration apparatus 120 of
FIG. 3, or a remote computer such as a computer that accesses
system 100 via the Internet or utilizing wireless technologies. In
order to access the permission routine, and/or approve the
modification of the system configuration parameters, a password or
security key, mechanical, electrical, electromechanical or software
based, may be required of the operator. Multiple operators may be
needed or required to approve a parameter modification. Each
specific operator or operator type may be limited by system 100,
via passwords and other control configurations, to approve the
modification of only a portion of the total set of modifiable
parameters of the system. Additionally or alternatively, a specific
operator or operator type may be limited to only approve a
modification to a parameter within a specific range of values, such
as a range of values set by a clinician when the operator is a
family member. Operator or operator types, hereinafter operator,
include but are not limited to: a clinician, primary care
clinician, surgeon, hospital technician, system 100 supplier or
manufacturer technician, computer technician, family member,
immediate family member, caregiver, and patient.
[0079] In a preferred embodiment, the system 100 of FIG. 3 includes
an interrogation function, which interrogates the system to
retrieve certain information such as on the demand of an operator.
Based on the analysis of the information, a recommendation for a
parameter value change can be made available to the operator, such
as by automatic configuration or calibration routines that are
initiated by the operator initiated interrogation function. After
viewing the modification, the appropriate operator would approve
the change via the permission routine, such as using a computer
mouse to click "OK" on a confirmation box displayed on a display
monitor, or a more sophisticated, password controlled
methodology.
[0080] In a preferred embodiment, an automatic or semi-automatic
configuration function or routine is embedded in system 100. This
embedded configuration routine can be used in place of a
configuration routine performed manually by operator 110 as is
described hereabove, or can be used in conjunction with one or more
manual configurations. Automatic and/or semi-automatic
configuration triggering event or causes can take many forms
including but not limited to: monitoring of cellular activity,
wherein the system automatically changes which particular signals
are chosen to produce the processed signals; running parallel
algorithms in the background of the one or more algorithms
currently used to create the processed signals, and changing one or
more algorithms when improved performance is identified in the
background event; monitoring of one or more system functions, such
as alarm or warning condition events or frequency of events,
wherein the automated system shuts down one or more functions
and/or improves performance by changing a relevant variable; and
other methods that monitor one or more pieces of system data,
identify an issue or potential improvement, and determine new
parameters that would reduce the issue or achieve an
improvement.
[0081] In an exemplary emdobiment, when specific system
configuration parameters are identified, by an automated or
semi-automated calibration or other configuration routine, to be
modified for the reasons described above, an integral permission
routine of the system requires approval of a specific operator when
one or more of the system configuration parameters are
modified.
[0082] Operator 110 may be a clinician, technician, caregiver,
patient family member or even the patient themselves in some
circumstances. Multiple operators may be needed or required to
perform a configuration routine or approve a modification of a
system configuration parameter, and each operator may be limited by
system 100, via passwords and other control configurations, to only
perform or access specific functions. For example, only the
clinician may be able to change specific critical parameters, or
set upper and lower limits on other parameters, while a caregiver,
or the patient, may not be able to access those portions of the
configuration procedure or the permission procedure. The
configuration routine includes the setting of numerous parameters
needed by system 100 to properly control one or more controlled
devices. The parameters include but are not limited to various
signal conditioning parameters as well as selection and
de-selection of specific multicellular signals for processing to
generate the device control creating a subset of signals received
from the sensor to be processed. The various signal conditioning
parameters include, but are not limited to: threshold levels for
amplitude sorting, other sorting and pattern recognition
parameters, amplification parameters, filter parameters, signal
conditioning parameters, signal translating parameters, signal
interpreting parameters, signal encoding and decoding parameters,
signal combining parameters, signal extracting parameters,
mathematical parameters including transformation coefficients and
other signal processing parameters used to generate a control
signal for transmission to a controlled device.
[0083] The configuration routine will result in the setting of
various system configuration output parameters, all such parameters
to be considered system configuration parameters. Configuration
output parameters may include but be not limited to: 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 and
filter parameters by group of signals. In a preferred embodiment,
the configuration output parameters are stored in memory in one or
more discrete components, and the parameters are linked to the
system's unique electronic ID.
[0084] Calibration, patient training, and other configuration
routines, including manual, automatic and semi-automatic routines,
may be performed on a periodic basis, and may include the selection
and deselection of specific cellular signals over time. The initial
configuration routine may include initial values, or starting
points, for one or more of the configuration output parameters.
Setting initial values of specific parameters, may invoke a
permission routine. Subsequent configuration routines may involve
utilizing previous configuration output parameters that have been
stored in a memory storage element of system 100. Subsequent
configuration routines may be shorter in duration than an initial
configuration and may require less patient involvement. Subsequent
configuration routine results may be compared to previous
configuration results, and system 100 may require a repeat of
configuration if certain comparative performance is not
achieved.
[0085] The configuration routine may include: (a) setting a
preliminary set of configuration output parameters; (b) generating
processed signals to control the controlled device; (c) measuring
the performance of the controlled device control; and (d) modifying
the configuration output parameters. The configuration routine may
further include the steps of repeating steps (b) through (d). The
configuration routine may also require invoking a permission
routine.
[0086] In the performance of a configuration routine, the operator
110 may involve patient 500 or perform steps that do not involve
the patient. In the patient training routine and other routines,
the operator 110 may have patient 500 imagine one or more
particular movements, imagined states, or other imagined events,
such as a memory, an emotion, the thought of being hot or cold, or
other imagined event not necessarily associated with movement. The
patient participation may include: the patient training routine
providing one or more time varying stimulus, such as audio cues,
visual cues, olfactory cues, tactile cues, moving objects on a
display such as a computer screen, moving mechanical devices such
as a robotic arm or a prosthetic limb, moving a part of the
patient's body such as with an exoskeleton or FES implant, changing
audio signals, changing electrical stimulation such as cortical
stimulation, moving a vehicle such as a wheelchair or car; moving a
model of a vehicle; moving a transportation device; and other
sensory stimulus. The imagined movements may include the imagined
movement of a part of the body, such as a limb, arm, wrist, finger,
shoulder, neck, leg, angle, and toe, as well as imagining moving to
a location, moving in a direction, moving at a velocity or moving
at an acceleration.
[0087] The patient imagines moving system controlled target 712
along planned trajectory 711, as target 712 is moving as controlled
by the system or manually by operator 110. The current processed
signal, hereinafter a representation of the processed signal,
available by applying a transfer function to the multicellular
signals detected during the imagined movement or other step of the
patient training routine, is displayed in the form of control of
patient controlled target 713. The transfer function is preferably
based on multicellular signals stored during a previous imagined
movement, or multiple previous imagined movements, preferably two
or more sets of states of time varying stimulus. The representation
of the processed signal may mimic the time varying stimulus,
similar to patient controlled object 713 being a similar form to
system controlled object 712.
[0088] Alternatively, the time varying stimulus and representation
of the processed signals may take different forms, such as a time
varying stimulus including an object on a visual display, wherein
the representation is a moving mechanical structure, or the
stimulus being a moving mechanical structure and the representation
comprising an object on a visual display. The representation of the
processed signals can be provided to the patient in visual form
such as a visual representation of limb motion displayed on a
computer monitor, or in one or more sensory forms such as auditory,
olfactory, gustatory, and electrical stimulation such as cortical
stimulation. The representation of the processed signals can be
provided in combinations of these and other forms.
[0089] In some exemplary embodiments, the first patient training
step may not include patient controlled object 713, or it may
include a patient controlled target whose processed signal is not
based on a set of multicellular signals collected during a previous
imagined movement. Multiple steps of providing a set of states of
the time varying stimulus and recording the multicellular signal
data may involve different subsets of cells from which the
multicellular signals are detected. Also, different sets of states
of time varying stimulus may have different numbers of cells in
each. Alternative to the system controlled target 712 along planned
trajectory 711, the patient may imagine movements while viewing a
time varying stimulus comprising a video or animation of a person
performing the specific movement pattern. In a preferred
embodiment, this visual feedback is shown from the patient's
perspective, such as a video taken from the person performing the
motion's own eye level and directional view. Multiple motion
patterns and multiple corresponding videos may be available to
improve or otherwise enhance the patient training process. The
patient training routine temporally correlates a set of states of
the time varying stimulus with the set of multicellular signal
signals captured and stored during that time period, such that a
transfer function can be developed for future training or
controlled device control. Correlations can be based on numerous
variables of the motion including but not limited to: position,
velocity and acceleration of the time varying stimulus; a patient
physiologic parameter such as heart rate; a controlled device
parameter; a system environment parameter; a password controlled
parameter; a clinician controlled parameter; and a patient training
routine parameter. In the patient training routine of FIG. 3, the
controlled device, CPU 305 and controlled monitor 302 are used in
the patient training routine to display the time varying stimulus
as well as the representation of the processed signal. In a
subsequent step, wheelchair 310 can also be employed, such as by a
system controlling the wheelchair while the patient imagines the
control, the wheelchair movement being the time varying
stimulus.
[0090] During the time period that a set of states of the time
varying stimulus is applied, multicellular signal data detected by
the implanted sensor is stored and temporally correlated to that
set of states of the time varying stimulus provided to the patient.
In a preferred embodiment, the system of the present invention
includes a second patient training routine and a second controlled
device, wherein the first patient training routine is used to
configure the first controlled device and the second patient
training routine is used to configure the second controlled device.
The two patient training routines may include different time
varying stimulus, chosen to optimize the routine for the specific
controlled device, such as a moving cursor for a computer mouse
control system, and a computer simulated prosthetic limb for a
prosthetic limb control system. In a preferred system, the first
controlled device is a prosthetic arm and the second controlled
device is a prosthetic leg, this system having two different time
varying stimulus in the two corresponding patient training
routines.
[0091] In one embodiment, the first controlled device is a
prosthetic arm and the second controlled device is a wheelchair.
This system may also have two different time varying stimulus in
the two corresponding patient training routines. In an alternative,
preferred embodiment, a controlled device surrogate is utilized in
the patient training routine. The controlled device surrogate
preferably has a larger value of one or more of: degrees of
freedom; resolution; modes; discrete states; functions; and
boundary conditions. Numerous boundary conditions with greater
values for the surrogate device can be employed. Such boundary
conditions may include: maximum distance; maximum velocity; maximum
acceleration; maximum force; maximum torque; rotation; and
position. The surrogate device employing larger values of these
parameters creates the scenario wherein the patient is trained
and/or tested with a device of more complexity than the eventual
controlled device to be used.
[0092] The time varying stimulus may be supplied to the patient in
numerous forms such as visual, tactile, olfactory, gustatory, and
electrical stimulation such as cortical stimulation. The time
varying stimulus may be moved around manually, automatically
produced and controlled by a component of the system such as the
processing unit, or produced by a separate device. The time varying
stimulus may include continuous or semi-continuous motion of an
object, such as an object moving on a visual display, a mechanical
object moving in space, or a part of the patient's body moving in
space. The time varying stimulus may be of a short duration, such
as an object appearing and disappearing quickly on a display, or a
flash of light.
[0093] In an embodiment, the patient training routine includes
multiple forms of feedback, in addition to the time varying
stimulus, such feedback provided to the patient in one or more
forms including but not limited to: visual; tactile; auditory;
olfactory; gustatory; and electrical stimulation. The additional
feedback may be a derivative of the multicellular signals, such as
visual or audio feedback of one or more neuron spike modulation
rates. Different forms of feedback may be provided as based on a
particular device to be controlled by the processed signals.
Numerous parameters for the time varying stimulus and other
feedback may be adjustable, such as by an operator such as the
patient. These parameters including but not limited to: sound
volume and frequency; display brightness, contrast, size and
resolution; display object size; electrical current parameter such
as current or voltage; mechanical or visual object size, color,
configuration, velocity or acceleration; and any combinations of
these.
[0094] A configuration routine such as a calibration or patient
training routine may utilize one or more configuration input
parameters to determine one or more system output parameters used
to develop a processed signal transfer function. In addition to the
multicellular signals themselves, system or controlled device
performance criteria can be utilized. Other configuration input
parameters include various properties associated with the
multicellular signals including one or more of: signal to noise
ratio, frequency of signal, amplitude of signal, neuron firing
rate, average neuron firing rate, standard deviation in neuron
firing rate, modulation of neuron firing rate as well as a
mathematical analysis of any signal property including but not
limited to modulation of any signal property. Additional
configuration input parameters include but are not limited to:
system performance criteria, controlled device electrical time
constants, controlled device mechanical time constants, other
controlled device criteria, types of electrodes, number of
electrodes, patient activity during configuration, target number of
signals required, patient disease state, patient condition, patient
age and other patient parameters and event based (such as a patient
imagined movement event) variations in signal properties including
neuron firing rate activity. In a preferred embodiment, one or more
configuration input parameters are stored in memory and linked to
the embedded, specific, unique electronic identifier. All
configuration input parameters shall be considered a system
configuration parameter of the system.
[0095] In some exemplary embodiments, it may be desirous for the
configuration routine to exclude one or more multicellular signals
based on a desire to avoid signals that respond to certain patient
active functions, such as non-paralyzed functions, or even certain
imagined states. The configuration routine may include having the
patient imagine a particular movement or state, and based on
sufficient signal activity such as firing rate or modulation of
firing rate, exclude that signal from the signal processing based
on that particular undesired imagined movement or imagined state.
Alternatively real movement accomplished by the patient may also be
utilized to exclude certain multicellular signals emanating from
specific electrodes of the sensor. In a preferred embodiment, an
automated or semi-automated calibration or other configuration
routine may include through addition, or exclude through deletion,
a signal based on insufficient activity during known patient
movements.
[0096] The configuration routines of the system of the present
invention, such as a patient training routine in which a time
varying stimulus is provided to the patient, may conduct adaptive
processing, such as adapting between uses or within a single
patient training routine. The adaptation may be caused by a
superior or inadequate level of performance, as compared to a
threshold, such as an adjustable threshold. In a preferred
embodiment, performance during a patient training routine above a
threshold causes the duration of the routine to decrease, and
performance below a threshold causes the duration of the routine to
increase. Control of the controlled device or surrogate controlled
device is a preferred way of measuring performance. Alternatively,
a change in multicellular signals, such as a change in modulation
rate may cause an adaptation to occur. A monitored difference is a
first patient training event and a second patient training event,
such as a difference in signal modulation, may cause an adaptation
in the patient training routine, such as to preferentially choose
one time varying stimulus over another time varying stimulus. Other
causes include a change to a patient parameter, such as the level
of patience consciousness. In a preferred embodiment, at a low
level of consciousness, the patient training routine changes or
discontinues. The level of consciousness may be determined by the
multicellular signals detected by the sensor. Alternatively, the
level of consciousness can be detected utilizing a separate sensor,
such as a sensor to detect EEG or LFP signals. The patient training
routine may automatically adapt, such as due to a calculation
performed by the processing unit, or may adapt due to operator
input.
[0097] In an exemplary embodiment, the system may include a
processing unit that processes multicellular signals received from
patient 500. Processing unit second portion 130b and other
processing unit components, singly or in combination, perform one
or more functions. The functions performed by the processing unit
include but are not limited to: producing the processed signals;
transferring data to a separate device; receiving data from a
separate device; producing processed signals for a second
controlled device; activating an alarm, alert or warning; shutting
down a part of or the entire system; ceasing control of a
controlled device; storing data; and performing a
configuration.
[0098] In order for the processing unit of system 100 to perform
one or more functions, one or more system configuration parameters
are utilized. These parameters include pieces of data stored in,
sent to, or received from, any component of system 100, including
but not limited to: the sensor; a processing unit component;
processing unit second portion 130b; or a controlled device.
Parameters can be received from devices outside of system 100 as
well, such as configuration apparatus 120, a separate medical
therapeutic or diagnostic device, a separate Internet based device,
or a separate wireless device. These parameters can be numeric or
alphanumeric data, and can change over time, either automatically
or through an operator involved configuration or other
procedure.
[0099] The processing unit, or other component of system 100 may
produce multiple processed signals for controlling one or more
controlled device. This second processed signal may be based on
multicellular signals of the sensor, such as the same set of cells
as the first processed signal is based on, or a different set of
cells emanating signals. The signal processing used to produce the
additional processed signals can be the same as the first, or
utilize different processing, such as different transfer functions.
Transfer functions may include different algorithms, coefficients
such as scaling factors, different types of feedback, and other
transfer function variations. Alternatively, the additional
processed signals may be based on signals not received from the
sensor in which the first processed signal is derived. An
additional sensor, such as a similar or dissimilar sensor, may
provide the signals to produce the additional processed signals, or
the system may receive a signal from an included input device such
as a tongue switch; tongue palate switch; chin joystick; Sip-n-puff
joystick controller; eye gaze tracker; head tracker; EMG switch
such as eyebrow EMG switch; EEG activated switch; speech
recognition device; and any combinations thereof. The additional
processed signal may be derived from a monitored biological signal
such as a signal based on eye motion; eyelid motion; facial muscle
activation or other electromyographic activity; heart rate; EEG;
LFP; respiration; and any combinations thereof. In creating the
additional processed signal or signals, the processing unit may
convert these alternative input signals into a digital signal, such
as a digital signal used to change the state of the system, such as
a change in state of an integrated configuration routine.
[0100] Referring now to FIGS. 4a and 4b, a patient training display
depicting a time varying stimulus and predictory path is
illustrated. FIG. 4a shows a time varying stimulus comprising
target 712 within a display area 126 on configuration monitor 122.
In the patient training routine of the present invention, target
712 will move, at a constant or non-constant rate, along predictory
path 711. Target 712 may be moved around manually, such as by an
operator of the system, preferably not the patient. The target may
be controlled without operator input, such as by the processing
unit of the system. Alternatively, a separate device, such as a
configuration system, can be used during the patient training
routine and control target 712. The target will assume a set of
states that result in continuous or semi-continuous motion of
target 712.
[0101] Referring specifically to FIG. 4b, target 712 has moved
along trajectory path 711 such as in the middle of a patient
training routine step. Also depicted are two more forms of feedback
to the patient, patient controlled object 713, and modified patient
controlled object 714. Patient controlled object 713 is an icon or
other screen object that is moved within display area 126 by the
representation of processed signals as described in detail in
reference to FIG. 1. Modified patient controlled object 714 is
moved within display area 126 by a modified representation of
processed signals, such as a modification with a bias toward target
712, such as shown by object 714 being closer to target 712 than
object 713. In a preferred embodiment, the amount of bias
improvement used decreases as the patient's actual performance
increases. In addition to, or alternative to object 713 and object
714, the patient may receive feedback in the form of: moving
mechanical device such as a mechanical limb or wheelchair; moving
part of patient's body such as via an exoskeleton device or FES
device; changing audible signal such as a multi-frequency signal;
and any combinations thereof. The patient may also receive a
feedback that represents the difference between a desired level of
control, and an actual or achieved level of control.
[0102] In an alternative embodiment, a competitive user routine is
included in the system of the present invention. A competitive
routine is activated to provide a competitive function for the
patient during the patient training task. The function may allow an
operator to also attempt to track target 712. Alternatively, the
system itself may provide a competitive function, such as a
competitive software algorithm which uses random values for
parameters to create a competitive environment. In another
preferred embodiment, a separate patient, such as a patient at a
remote location in communication with the system of the present
invention such as via a computer network such as the Internet,
attempts to track target 712 with that patient's system including
that patient's multicellular signals. For certain patients, such as
patients who have competed in competitive sports prior to an
accident causing their injury, a competitive function may help to
improve the outcomes of one or more configuration routines of the
system such as patient training routines.
[0103] Referring now to FIG. 5, a patient training display of the
present invention is illustrated with additional feedback in the
form of audio and tactile feedback. Configuration monitor 122,
which is preferably the monitor of a computer that is also a
controlled device of the system, includes a time varying stimulus
comprising multiple targets 712 that are displayed as existing
within a domain of values defined by first display area 126a. First
display area 126a includes a set of values corresponding to a set
of two-dimensional positions within first display area 126a. In an
alternative embodiment, the set of values may correspond to
three-dimensional positions wherein the third dimension is
represented by varying one or more parameters of the object, such
as color or size, or by adding additional feedback such as a sound
that corresponds to the third dimensional coordinate. Targets 712
may appear sequentially, such as to have the patient imagine moving
from one to the other. The targets may be sequentially numbered,
sequentially change color, or include other sequence defining
means.
[0104] After a first set of multicellular signals is collected
simultaneous to the patient imagining movement from target to
target, a representation of processed signals can be created, such
as via the temporal correlation of the multicellular signals to set
of states of the time varying stimulus. In a subsequent step, both
the time varying stimulus and the patient controlled, via the
representation of processed signals control of patient controlled
object 713 while a second set of multicellular signals is collected
and correlated. When the patient training routine is successfully
completed, as has been described in detail hereabove in reference
to FIG. 1, the patient may control an icon or cursor on the
computer screen within an allowable range of values (e.g., second
display area 126b). This allowable range of values with the set of
positions defined by second display area 126b, is a subset of the
domain of values defined by first display area 126a. In a preferred
embodiment, the number of positions defined by the allowable range
of values is at least ninety percent of the number of positions
defined by the domain of values. After the patient training routine
is completed, the computer screen can be adjusted, such as via a
monitor configuration, such that the second display area 126b fills
the entire screen. In an alternative embodiment, the patient
training routine is performed at a higher screen resolution than
the subsequent control of the computer.
[0105] The components of the system of FIG. 5 providing the patient
training routine further include speaker 702, such as to provide
audio feedback to the patient, and tactile transducer 701, such as
to provide tactile feedback to the patient, such as to the
patient's neck or other body portion that has functional sensory
feedback to the patient's brain. Speaker 702 and tactile transducer
701 can additionally or alternatively provide feedback in the form
of the time varying stimulus of the patient training routine, or
the representation of the processed signals also of the patient
training routine. Numerous forms of feedback can be used for either
or both of these purposes, such feedback forms including but not
limited to: auditory; olfactory; gustatory; visual; electrical
stimulation such as cortical stimulation; and any combinations
thereof. Neural signal display 703, which may be an additional
patient feedback, includes multiple bar graph meters which display
derivatives of the multicellular signals, such as a level of
modulation of one or more neurons of the patient's motor cortex, or
other cellular signal parameter that can be quantified, or
processed and quantified. The multiple forms of feedback can be
used to help the patient prior to, during, or after an imagined
movement or other imagined event, improve the quantity and or
quality of the multicellular signals received from the sensor or
sensors of the present invention.
[0106] While the components of FIG. 5 include a domain of values
for the time varying stimulus and an allowable range of values for
processed signal controlled objects that are represented by
moveable objects on a visual display, other forms of time varying
stimulus ranges can be utilized by the system of the present
invention. In an alternative embodiment, a movable mechanical
device can be moved through a set of positions in space.
Alternatively, the system may incorporate for the time varying
stimulus and/or the representation of processed signals one or more
of the following: a set of sounds within a frequency range; a set
of tactile forces or force patterns; a set of stimulation energies;
or other varying feedback form that can exist within a domain of
values wherein the allowable range of the controlled device
processed signals is a subset of the domain of values. Devices used
to represent either or both the time varying stimulus and the
object controlled by the representation of processed signals
preferably include: a human body part such as an FES driven limb; a
prosthetic limb; a robotic mechanism such as a robotic arm; a
vehicle such as a wheelchair, car or tank; moving or changing
objects on a visual display; and any combinations thereof.
[0107] Numerous methods are provided in the multiple embodiments of
the disclosed invention. An exemplary embodiment provides a patient
training routine for a biological interface apparatus that must be
performed by an operator. The biological interface system is for
collecting multicellular signals emanating from one or more living
cells of a patient and for transmitting processed signals to
control a device. The biological interface system comprises: a
sensor for detecting the multicellular signals, the sensor
comprising a plurality of electrodes to allow for detection of the
multicellular signals; a processing unit for receiving the
multicellular signals from the sensor, for processing the
multicellular signals to produce processed signals, and for
transmitting the processed signals; a controlled device for
receiving the processed signals; and a patient training routine for
generating one or more system configuration parameters.
[0108] It should be understood that numerous other configurations
of the systems, devices, and methods described herein could be
employed without departing from the spirit or scope of this
application. It should be understood that the system includes
multiple functional components, such as a sensor for detecting
multicellular signals, a processing unit for processing the
multicellular signals to produce processed signals, and the
controlled device that is controlled by the processed signals.
Different from the logical components are physical or discrete
components, which may include a portion of a logical component, an
entire logical component and any combinations of portions of
logical components and entire logical components. These discrete
components may communicate or transfer information to or from each
other, or communicate with devices outside the system. In each
system, physical wires, such as electrical wires or optical fibers,
can be used to transfer information between discrete components, or
wireless communication means can be utilized. Each physical cable
can be permanently attached to a discrete component, or can include
attachment means to allow attachment and potentially allow, but not
necessarily permit, detachment. Physical cables can be permanently
attached at one end, and include attachment means at the other.
[0109] The sensors of the systems of this application can take
various forms, including multiple discrete component forms, such as
multiple penetrating arrays that can be placed at different
locations within the body of a patient. The processing unit of the
systems of this application can also be contained in a single
discrete component or multiple discrete components, such as a
system with one portion of the processing unit implanted in the
patient, and a separate portion of the processing unit positioned
external to the body of the patient. The sensors and other system
components may be utilized for short term applications, such as
applications less than twenty four hours, sub-chronic applications
such as applications less than thirty days, and chronic
applications. Processing units may include various signal
conditioning elements such as amplifiers, filters, signal
multiplexing circuitry, signal transformation circuitry and
numerous other signal processing elements. In a preferred
embodiment, an integrated spike sorting function is included. The
processing units performs various signal processing functions
including but not limited to: amplification, filtering, sorting,
conditioning, translating, interpreting, encoding, decoding,
combining, extracting, sampling, multiplexing, analog to digital
converting, digital to analog converting, mathematically
transforming and/or otherwise processing cellular signals to
generate a control signal for transmission to a controllable
device. The processing unit utilizes numerous algorithms,
mathematical methods and software techniques to create the desired
control signal. The processing unit may utilize neural net software
routines to map cellular signals into desired device control
signals. Individual cellular signals may be assigned to a specific
use in the system. The specific use may be determined by having the
patient attempt an imagined movement or other imagined state. For
most applications, it is preferred that that the cellular signals
be under the voluntary control of the patient. The processing unit
may mathematically combine various cellular signals to create a
processed signal for device control.
[0110] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims. In addition, where this application has listed
the steps of a method or procedure in a specific order, it may be
possible, or even expedient in certain circumstances, to change the
order in which some steps are performed, and it is intended that
the particular steps of the method or procedure claim set forth
herebelow not be construed as being order-specific unless such
order specificity is expressly stated in the claim.
* * * * *