U.S. patent application number 16/562776 was filed with the patent office on 2020-03-12 for method and system for monitoring brain function and intracranial pressure.
The applicant listed for this patent is Augusta University Research Institute, Inc.. Invention is credited to Matthew Lyon.
Application Number | 20200077906 16/562776 |
Document ID | / |
Family ID | 69718748 |
Filed Date | 2020-03-12 |
United States Patent
Application |
20200077906 |
Kind Code |
A1 |
Lyon; Matthew |
March 12, 2020 |
Method and System for Monitoring Brain Function and Intracranial
Pressure
Abstract
Embodiments of the present systems and methods may provide
improved, automated monitoring of brain function. In embodiments, a
multimodal, multi-sensor monitoring device may provide to
monitoring of the full spectrum of brain function. In an
embodiment, a system for monitoring brain function of a subject may
include an apparatus for mounting a plurality of stimulus and
response sensors on a head of the subject, including a cognizance
stimuli-sensor suite, a physiologic sensor suite, and advance
monitoring devices such as a transcranial Doppler puck, an
electroencephalograph monitor, and an optic nerve sheath parameter
sensor.
Inventors: |
Lyon; Matthew; (North
Augusta, SC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Augusta University Research Institute, Inc. |
Augusta |
GA |
US |
|
|
Family ID: |
69718748 |
Appl. No.: |
16/562776 |
Filed: |
September 6, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62728175 |
Sep 7, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/0484 20130101;
A61B 8/06 20130101; A61B 8/5223 20130101; A61B 5/6814 20130101;
A61B 8/488 20130101; A61B 5/0024 20130101; A61B 8/10 20130101; A61B
5/0476 20130101; A61B 8/483 20130101; A61B 5/743 20130101; A61B
5/031 20130101; A61B 8/00 20130101; A61B 5/0205 20130101; A61B
5/6803 20130101; A61B 7/00 20130101; A61B 8/4209 20130101; A61B
5/1075 20130101 |
International
Class: |
A61B 5/03 20060101
A61B005/03; A61B 5/00 20060101 A61B005/00; A61B 5/0476 20060101
A61B005/0476 |
Claims
1. A portable system for monitoring brain function of a subject,
comprising: an apparatus for mounting a plurality of stimulus
devices and a plurality of response sensors on a head of the
subject, the plurality of stimulus devices including at least one
cognizance stimulus device selected from a group of cognizance
stimulus devices comprising a speaker to provide auditory stimuli
to the subject and a display to provide visual stimuli to the
subject, and the plurality of response sensors including at least
one cognizance sensor selected from a group of cognizance sensors
comprising a microphone to record sounds made by the subject, a
camera to record eye position and movement of the subject, and a
touch/motion sensor to receive input from the subject; a processor
and memory for executing and storing program instructions to
provide stimuli to the subject using the plurality of stimulus
devices, to receive responses of the subject recorded by the
plurality of response sensors, and to process the received
responses to generate response information; and a display to
display the response information,
2. The system of claim I , further comprising communications
circuitry to transmit the received responses and generated response
information and to receive information relating to stimuli to he
provided to the subject.
3. The system of claim 1, wherein the plurality of sensors further
includes at least one physiological sensor selected from a group of
physiological sensors comprising a vibration sensor, a heart rate
monitor, a blood oxygen saturation sensor, a temperature sensor, a
head position sensor, and a vibration microphone.
4. The system of claim 1, wherein the vibration sensor removes
background vibration artifacts from other sensors' signals,
5. The system of claim 1, further comprising at least one of a
transcranial Doppler device, an electroencephalograph monitor
device, and an optic nerve sheath diameter measurement device.
6. The system of claim 5, wherein the optic nerve sheath diameter
measurement device comprises, a two-dimensional array of ultrasonic
transducers to scan across the optic nerve sheath; a processor in
communication with the ultrasonic transducer for receiving and
processing data obtained from the two-dimensional array of
ultrasonic transducers, wherein the processor calculates the volume
of segments of an optical nerve of a subject and optionally
produces a three dimensional image of the optical nerve on a
graphical display in communication with the processor; and a power
supply coupled to the two-dimensional array of ultrasonic
transducers.
7. The system of claim 6, wherein the processor contains an
algorithm for calculating the volume of segments of the optic
nerve.
8. The system of claim 6, wherein the two-dimensional array of
ultrasonic transducers comprises lights for aligning the transducer
with the optic nerve sheath,
9. The system of claim 1, wherein the apparatus is a pair of
goggles.
10. A portable telemedicine system for monitoring brain function of
a subject, comprising: a pair of goggles housing a plurality of
stimulus devices, a plurality of response sensors, and an external
display screen, wherein the plurality of stimulus devices comprise
a speaker to provide auditory stimuli to the subject and an
internal display to provide visual stimuli to the subject, and the
plurality of response sensors comprise a microphone to record
sounds made by the subject, a camera to record eye position and
movement of the subject, and a touch/motion sensor to receive input
from the subject, and wherein the external display screen displays
the received information; and a processor and memory for executing
and storing program instructions to provide stimuli to the subject
using the plurality of stimulus devices, to receive responses of
the subject recorded by the plurality of response sensors, and to
process the received responses to generate response
information.
11. The system of claim 10, further comprising communications
circuitry to transmit the received responses and generated response
information and to receive information relating to stimuli to be
provided to the subject.
12. The system of claim 10, wherein the plurality of sensors
further includes at least one physiological sensor selected from a
group of physiological sensors comprising a vibration sensor, a
heart rate monitor, a blood oxygen saturation sensor, a temperature
sensor, a head position sensor, and a vibration microphone.
13. The system of claim 12, wherein the vibration sensor removes
background vibration artifacts from other sensors' signals.
14. The system of claim 10, wherein the plurality of sensors are
used to monitor the subject's level of consciousness.
15. The system of claim 10, further comprising at least one of a
transcranial Doppler device, an electroencephalograph monitor
device, and an optic nerve sheath diameter measurement device,
16. The system of claim 15, wherein the transcranial Doppler
device, electroencephalograph monitor device, and optic nerve
sheath diameter measurement device are only activated after the
subject has been determined to be unconscious.
17. A method for automatic monitoring of brain function in a
subject in need thereof comprising, placing the apparatus of claim
10 onto the head of a subject in need of monitoring, providing
stimuli to the subject through one of the plurality of stimulus
devices, recording the subject's response or lack of response to
the stimuli, and displaying the subject's response on the external
screen,
18. The method of claim 17, wherein the subject is in a mass
casualty environment, is being transported, or is undergoing
surgery.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of and priority to U.S.
Provisional Patent Application No. 62/728,175 filed on Sep. 7,
2019, which is incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to techniques for improved,
automated monitoring of brain function and intracranial
pressure.
[0003] Brain function can be divided into higher levels of
consciousness (cortical brain function) such as awareness,
comprehension, and understanding of situation and environment, and
lower levels of consciousness (subcortical functions), such as
breathing and maintenance of heart rate and blood pressure.
Traditionally the assessment of brain function after head injury
(traumatic brain injury) or multisystem trauma is gauged using the
Glasgow Coma Scale (GCS). The GCS utilizes testing of a patient's
consciousness by measuring the verbal, motor and ocular responses
to stimuli. At the highest level, the patient interacts with the
environment and is oriented to their situation. As brain function
declines, the patient loses the ability to maintain awareness of
the environment and requires increased stimuli to elicit a reaction
such as responding to pain or following verbal commands. At the
lowest level (GCS 3), the patient does not respond to stimuli from
the environment. The GCS, though crude, does assess brain function
and allows a healthcare provider to measure and subsequently
monitor changes in function over time. This system also guides the
healthcare provider in the triage of multiple patients, such as in
a multi-casualty situation, and in the prioritization of diagnostic
testing or therapeutic intervention for an individual, such as
endotracheal intubation in the patient with a GCS of 8 or lower. As
such the GCS has value in gross brain measurement and
monitoring.
[0004] Intracranial pressure (ICP) has an important and critical
interaction with brain perfusion. This is an inverse relation in
that as the ICP increases the cerebral perfusion decreases. There
are brain protective reflexes (autoregulation) which can ameliorate
this association, but only up to a point. Further, the point at
which autoregulation fails and the brain perfusion drops
precipitously with any increase in ICP is different for individual
patients, being affected by factors such as genetics, prior history
of brain injury, current circumstances such as medication use or
ongoing invasive procedure, age, sex and race. Thus, being able to
monitor the ICP is useful for a wide variety of reasons during
medical practice, such as during surgical operations, post injury
brain function assessment, critical care transport of an injured
patient, procedural sedation for medical procedures, etc.
[0005] Currently, ICP monitoring where small changes in ICP can be
accurately measured can only be performed invasively by placing an
intracranial monitoring device into the brain parenchyma or using a
needle or catheter placed in the intraspinal space. Typically the
best monitoring of the ICP in a continuous fashion is done with the
intracranial monitoring device. Other methods of estimating the ICP
can be done non-invasively, however, the ICP measurements by these
methods are not sensitive to small and moderate changes in the ICP.
For example, traditional ultrasound can be used to measure the
optic nerve sheath (ONS) diameter which is directly proportional to
the ICP. However, this can only detect dramatic changes in the
intracranial pressure. This would not be useful in measuring the
ICP in normal (brain) patients, and further can only be done
intermittently and requires a clinician interpretation.
[0006] Accordingly, a need arises for techniques that may provide
improved, automated monitoring of brain function and intracranial
pressure.
SUMMARY OF THE INVENTION
[0007] Embodiments of the present systems and methods may provide
improved, automated monitoring of brain function. In embodiments, a
multimodal, multi-sensor monitoring device may provide monitoring
of the full spectrum of brain function. In embodiments, the device
may be a light-weight, portable, telemedicine device that provides
automatic monitoring during situations where a healthcare provider
cannot maintain constant or interval monitoring of patient brain
function, such as in critical care transport, mass casualty
situations, or during therapeutic procedures. In embodiments, the
device may utilize different testing modalities to determine a
level of brain function and then monitor for changes. Sensory data
may be automatically analyzed and synthesized, calculating a Brain
Function Score (similar to GCS) and giving a rapid reference as to
the overall brain function. This data may be both graphically
displayed, providing easy visualization and interpretation by a
health care provider, and transmitted to a receiving station where
multiple patients can be monitored simultaneously. As changes in
mental status occur, such as a deterioration in the level of
patient consciousness, the healthcare provider is notified and
analyzes the patient for conditions that may be modified in order
to optimize brain perfusion and oxygenation, thereby lessening
secondary injury from brain trauma. As the device is performing the
measurement and deriving the data (ICP or brain function score) in
a uniform manner for all patients in a cohort, the measurements may
provide for generalizability across the cohort of patients. This
may improve triage and patient selection for therapy based on
individual need and available resources.
[0008] Embodiments of the present systems and methods may utilize a
novel set of sensors and patient-interactive stimuli to render a
Global Brain Function Score (GBS.) The GBS may be considered a
corollary to the GCS, utilizing a composite score equivalent to the
GCS (15-3), allowing for easier adoption and interpretation by
healthcare providers. The composite GBS score may be displayed on
the device as well as transmitted wirelessly to a remote monitoring
station. To calculate the GBS, embodiments may utilize a variety of
sensors and patient stimuli to assess the interactivity of the
patient with their environment. The type of stimuli and the sensors
used may vary based on the consciousness level of the patient,
utilizing "Cognizance Stimuli-Sensors" with higher levels of brain
function and "Physiologic Sensors" and "Advanced Monitoring"
sensors as brain function declines. For example, once the patient
becomes unconscious, or at any time as determined by the healthcare
provider, Advanced Monitoring sensors, such as Transcranial Doppler
(TCD), Electroencephalograph (EEG), and Intracranial Pressure (ICP)
monitoring may be performed.
[0009] In embodiments, parameters such as the optic nerve sheath
diameter (ONSd), volume, surface structure, radial variation,
circumference, etc., may be measured and serially monitored as a
non-invasive measure of intracranial pressure (ICP). The optic
nerve sheath parameters may be monitored both as an indication of
ICP, but also to measure the impact or effects of interventions on
the ICP. Embodiments may provide real-time, non-invasive
intracranial pressure monitoring, continuously and in an automated
fashion. In embodiments, a 3D image of the optic nerve sheath (ONS)
may be obtained and utilized as a non-invasive measure of small
changes in the ICP. Embodiments may utilize a matrix type
transducer with steerable acoustic elements. This allows for the
ultrasound beam to be steered across the optic nerve sheath.
Utilizing the method described in U.S. Patent Application
Publication No. 2016/0000367, the volume, variation in radius,
variation in diameter, variation in the circumference, or variation
in the 3D surface geometry may be utilized to calculate the ICP.
This may be done serially, up to several times a second, to provide
a second to second calculation of the ICP.
[0010] In an embodiment, a system for monitoring brain function of
a subject includes an apparatus for mounting a plurality of
stimulus devices and a plurality of response sensors on a head of
the subject, the plurality of stimulus devices including at least
one cognizance stimulus device selected from a group of cognizance
stimulus devices consisting of a speaker to provide auditory
stimuli to the subject and a display to provide visual stimuli to
the subject, and the plurality of response sensors including at
least one cognizance sensor selected from a group of cognizance
sensors consisting of a microphone to record sounds made by the
subject, a camera to record eye position and movement of the
subject, and a touch/motion sensor to receive input from the
subject, a processor and memory for executing and storing program
instructions to provide stimuli to the subject using the plurality
of stimulus devices, to receive responses of the subject recorded
by the plurality of response sensors, and to process the received
responses to generate response information, and a display to
display the response information.
[0011] In embodiments, the system may further include
communications circuitry to transmit the received responses and
generated response information and to receive information relating
to stimuli to be provided to the subject. The plurality of sensors
may further include at least one physiological sensor selected from
a group of physiological sensors comprising a vibration sensor, a
heart rate monitor, a blood oxygen saturation sensor, a temperature
sensor, a head position sensor, and a vibration microphone. The
system may further include at least one of a transcranial Doppler
device, an electroencephalograph monitor device, and an optic nerve
sheath diameter measurement device.
[0012] In an embodiment, a system for measuring optic sheath
diameter includes a two-dimensional array of ultrasonic transducers
to scan across the optic nerve sheath, a processor in communication
with the ultrasonic transducer for receiving and processing data
obtained from the two-dimensional array of ultrasonic transducers,
wherein the processor calculates the volume of segments of an
optical nerve of a subject and optionally produces a three
dimensional image of the optical nerve on a graphical display in
communication with the processor. The processer may contain an
algorithm calculating the volume of segments of the optic nerve.
The two-dimensional array of ultrasonic transducers may comprise
lights for aligning the transducer with the optic nerve sheath.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The details of the present invention, both as to its
structure and operation, can best be understood by referring to the
accompanying drawings, in which like reference numbers and
designations refer to like elements.
[0014] FIG. 1 illustrates an exemplary embodiment of a brain
monitoring device, according to the present systems and
methods.
[0015] FIG. 2 shows exemplary block diagram of embodiments of a
brain monitoring device, according to the present systems and
methods.
[0016] FIG. 3 is an exemplary block diagram of an embodiment of a
system incorporating a brain monitoring device, according to the
present systems and methods.
[0017] FIG. 4 is an exemplary diagram of function conditions and
sensors that may be used to monitor brain function at each
condition, according to the present systems and methods.
[0018] FIG. 5 is an exemplary illustration of an embodiment of a
brain monitoring device, according to the present systems and
methods.
[0019] FIG. 6 is an exemplary block diagram of an embodiment of an
intracranial pressure (ICP) monitor, according to the present
systems and methods.
[0020] FIG. 7 is an exemplary flow diagram of a process of ICP
measurement, according to the present systems and methods.
[0021] FIG. 8 is an exemplary diagram illustrating the operation of
an ICP measurement system, according to the present systems and
methods.
[0022] FIG. 9 is exemplary block diagram of a computer system, in
which processes involved in the embodiments described herein may be
implemented
DETAILED DESCRIPTION OF THE INVENTION
[0023] Embodiments of the present systems and methods may provide
improved, automated monitoring of brain function. In embodiments, a
multimodal, multi-sensor monitoring device may provide monitoring
of the full spectrum of brain function. In embodiments, the device
may be a light-weight, portable, telemedicine device that provides
automatic monitoring during situations where a healthcare provider
cannot maintain constant or interval monitoring of patient brain
function, such as in critical care transport, mass casualty
situations, or during therapeutic procedures. In embodiments, the
device may utilize different testing modalities to determine a
level of brain function and then monitor for changes. Sensory data
may be automatically analyzed and synthesized, calculating a Global
Brain Function Score (GBS) (similar to GCS) and giving a rapid
reference as to the overall brain function. This data may be both
graphically displayed, providing easy visualization by a health
care provider, and transmitted to a receiving station where
multiple patients can be monitored simultaneously. As changes in
mental status occur, such as a deterioration in the level of
patient consciousness, the healthcare provider is notified and
analyzes the patient for conditions that may be modified in order
to optimize brain perfusion and oxygenation, thereby lessening
secondary injury from brain trauma. As the device is performing the
measurement and deriving the data (ICP or brain function score) in
a uniform manner for all patients in a cohort, the measurements may
provide for generalizability across the cohort of patients. This
may improve triage and patient selection for therapy based on
individual need and available resources.
[0024] Embodiments of the present systems and methods may utilize a
novel set of sensors and patient-interactive stimuli to render a
Global Brain Function Score (GBS.) The GBS may be considered a
corollary to the GCS, utilizing a composite score equivalent to the
GCS (15-3), allowing for easier adoption and interpretation by
healthcare providers. The composite GBS score may be displayed on
the device and transmitted wirelessly to a remote monitoring
station. To calculate the GBS, embodiments may utilize a variety of
sensors and patient stimuli to assess the interactivity of the
patient with their environment. The type of stimuli and the sensors
used may vary based on the consciousness level of the patient,
utilizing "Cognizance Stimuli-Sensors" with higher levels of brain
function and "Physiologic Sensors" and "Advanced Monitoring"
sensors as brain function declines. For example, once the patient
becomes unconscious, or at any time as determined by the healthcare
provider, Advanced Monitoring sensors, such as Transcranial Doppler
ultrasound (TCD), Electroencephalograph (EEG), and Intracranial
Pressure (ICP) monitoring may be performed.
[0025] Embodiments of the present systems and method may provide
the capability for cognitive monitoring during transport, and may
function in austere environments with loud ambient noise and in
darkness. Embodiments may provide broad monitoring functions of
brain function corresponding to GCS 15 to 3 and may provide
multi-modal sensors with telemedicine transmission of data. In
embodiments, components may include monitoring of higher cognitive
functions using one or more of a digital video screen to display
visual stimuli to a patient, a noise canceling microphone to
monitor for patient sounds and ambient sounds, an In-ear speaker to
provide auditory commands and stimuli to the patient, a camera for
eye tracking, adjunct sensors, such as one or more of a vibration
sensor to accept tactile input from the patient and to cancel out
environmental vibrations to other sensors, an intra-auricular
temperature monitor, a heart rate sensor, an oxygen saturation
sensor, a position sensor/gyroscope to monitor head elevation and
rotation of the patient, and automatic lower cognitive function
monitoring using one or more of a TCD Ultrasound to auto-locate and
auto-Doppler the Middle Cerebral Artery for brain blood flow, an
EEG Monitor to monitor EEG signals for brain function/seizures, and
ICP measurements, such as those obtained from measurement of Optic
Nerve Sheath parameters. In embodiments, brain function may be
monitored on a spectrum from higher brain function to lower brain
function, such as reflexes. Higher brain functions may be monitored
by patient cognition, such as the ability to follow commands.
Higher cognitive function monitoring may include visual stimulus,
such as words to read and instructions, displayed on a screen, such
as "read this sentence." A microphone may pick up the speech for
analysis. If the patient is able to read as instructed, then the
brain function may be determined to be in the normal range.
Embodiments may monitor for speech and cadence so changes may be
monitored over time. If a patient is unable to speak, a camera may
monitor pupil location and movement. Visual stimuli may be
displayed in various locations on the screen to evaluate for
interaction with the stimulus. Audio may provide a method for
stimulating the patient as mental status declines.
[0026] In embodiments, adjunct sensors may be used to optimize the
patient environment to protect from brain injury. For example, a
position sensor/gyroscope may sense that the head is not elevated
and head elevation may be recommended. A temperature monitor may
sense hypothermia and warming may be recommended. A blood
oxygenation sensor may sense hypoxia and oxygenation/intubation may
be recommended. In embodiments, some sensors may be used as both
main sensors and as adjunct sensors. For example, a microphone may
also be used to monitor for airway obstruction, a camera may also
be used to monitor for eye deviation and seizure, and a vibration
sensor may also be used to monitor to remove background vibration
artifacts from other sensors' signals.
[0027] Embodiments of the present systems and methods may be used,
for example for military transport, multi-casualty events,
intraoperative monitoring and patient comfort, and procedural
sedation monitoring.
[0028] As brain function decreases, lower brain functions may be
evaluated to determine the amount of change in brain function and
rapidity of change. As all higher brain functions decrease or
cease, advanced monitoring may begin, such as TCD and EEG
monitoring. Once unconscious, direct, noninvasive measurement may
begin, such as ICP measurement
[0029] In embodiments, parameters such as the optic nerve sheath
diameter (ONSd), volume, surface structure, radial variation,
circumference, etc., may be measured and serially monitored as a
non-invasive measure of intracranial pressure (ICP). The optic
nerve sheath parameters may be monitored both as an indication of
ICP, but also to measure the impact or effects of interventions on
the ICP. Embodiments may provide real-time, non-invasive
intracranial pressure monitoring, continuously and in an automated
fashion. In embodiments, a 3D image of the optic nerve sheath (ONS)
may be obtained and utilized as a non-invasive measure of small
changes in the ICP. Embodiments may utilize a matrix type
transducer with steerable acoustic elements. This allows for the
ultrasound beam to be steered across the optic nerve sheath.
Utilizing the method described in U.S. Patent Application
Publication No. 2016/0000367, the volume, variation in radius,
variation in diameter, variation in the circumference, or variation
in the 3D surface geometry may be utilized to calculate the ICP.
This may be done serially, up to several times a second, to provide
a second to second calculation of the ICP.
[0030] An exemplary embodiment of a brain monitoring device 100,
according to the present systems and methods, is shown in FIG. 1.
Brain monitoring device 100 may include a wearable platform--the
goggles--including, for example, observer display screen 102,
patient microphone 104, in-ear speaker 106, "eye camera" 108
capable of tracking eye movements, patient video screen 110 and
touch/motion sensor 112. These components are part of the
"Cognizance Stimuli-Sensor" suite, as shown in FIG. 2, which may be
included in embodiments of the present systems and methods. This
suite may be used to stimulate, monitor, and gauge the patient's
level of consciousness. At the highest levels of consciousness,
patients are able to interact with the stimuli provided visually by
patient screen 110 or auditorily by speaker 106. The stimuli can be
simple (look at the right side of the screen) or complex (look at
the left side of the screen after looking to the right or blink
twice and look up) to evaluate the level of cognizance.
[0031] Responses may be measured by tracking eye movements with
patient camera 108 or by the patient responding verbally to
provocative stimuli (read the sentence on the screen aloud) as
picked up by microphone 104. Patient camera 108 can detect
pupillary constriction and dilation, helping to determine if the
patient is able to focus on a displayed image on screen 110. There
are advantages for using multiple patient senses for the detecting
interaction with the stimulus environment. Patients may have
multiple injuries, affecting one or more of their senses. For
example, the patient may have an eye injury but still be able to
talk or the patient may have ruptured ear drums after a blast
injury. Embodiments primarily use visual and auditory stimuli, but
if these modalities are not possible, touch/motion sensor 112 may
be utilized to have the patient interact by touch with the goggles.
The results of such interaction with the stimulus environment may
be displayed on observer display screen 102 and/or transmitted to
external processing and display equipment.
[0032] As brain function declines and the patient loses the ability
to follow commands, first complex commands and then simple, the
"Physiologic Sensor" suite 204 may engage. Physiologic Sensor Suite
204 may monitor both the patient and the environment to evaluate
lower levels of brain function--lower GBS--and to aid the
healthcare provider in optimizing the patient environment for brain
protection. The Physiologic Sensor helps the healthcare provider
optimize brain protection strategies to prevent secondary brain
injury. Physiologic Sensor Suite 204 may include sensors such
as:
[0033] One or more vibration sensors 206 may detect both background
vibration (which will be encountered during transport), as well as
monitoring for seizures or tonic movements (decorticate and
decerebrate posturing).
[0034] One or more heart rate monitors 208 may be used to measure
autonomic function (beat to beat variability--lost as autonomic
function declines), onset of a Cushing response to elevations in
intracranial pressure, and tachycardia which may indicate
hemodynamic compromise which may affect brain function (hemorrhagic
shock).
[0035] One or more oxygen saturation sensors 210 may help to
optimize blood oxygenation (critical in brain protection
strategies), while also providing an adjunct method of monitoring
for cerebral events such as seizure.
[0036] One or more in-ear temperature monitors 212 may aid in
helping monitor for the optimal brain-protection environmental
modifications.
[0037] One or more head position and gyroscope monitors may aid in
maintaining head neutral position (brain protection strategy) as
well as assisting in detection of seizures and posturing.
[0038] One or more vibration microphones 216 may aid in monitoring
verbal responses to commands in a noisy environment as well as
monitoring for airway obstruction--which is a sign of decreasing
mental status and a factor which must be corrected in a brain
protection strategy.
[0039] Embodiments may include "Advance Monitoring" suite 218,
which may include auto-optimizing transcranial Doppler (TCD) puck
220, electroencephalograph monitor (EEG) 222 and intracranial
pressure monitor (ICP) monitor 224. Advanced Monitoring suite 218
may be utilized once brain function has started to decline. The
included sensors may operate in an "operator-less" fashion,
requiring no assistance from the health care provider. These
sensors are most critical once the patient develops a decreased
level of consciousness (unconscious), and stops interacting with
the other sensors. EEG and ultrasound are non-invasive monitors
which give a better idea of brain function that may not be possible
in any other way.
[0040] TCD Puck 220 may include a non-imaging ultrasound-based
device that may automatically identify the middle cerebral artery
(MCA) and may determine the MCA blood flow velocity and other brain
arterial hemodynamics. TCD monitoring of the MCA has been shown to
be a measure of brain function and injury (TBI). TCD Puck 220 may
intermittently interrogate the MCA flow, giving a time-based
measurement of brain function. The data collected by TCD Puck 220
is not comprehensive, but is focused on measures which relate to
changes in intracranial pressure (ICP). These measures may include
MCA hemodynamic measures such as but not limited to Peak Velocity,
Resistive Index, and Mean Velocity.
[0041] EEG monitor 222 measures brain waves. While traditional EEG
utilizes many electrodes for precisely evaluating brain waves for
diagnosis of multiple conditions, the EEG monitor utilized in
embodiments of the present systems and methods may be simplified,
using fewer electrodes, to achieve the goal of detecting
subclinical seizure activity. Subclinical seizures present as
seizures without obvious muscle shaking) and may occur after a head
injury. If not treated in a timely fashion, they can lead to
secondary brain injury.
[0042] Ultrasound (US) (ICP) monitor 224 may be used to
noninvasively measure the optic nerve sheath parameters in multiple
planes. For example, the optical nerve sheath diameter (ONSd)
increases with increasing intracranial pressure and is an
outstanding noninvasive measure in the unconscious patient who has
suffered a brain injury. In the conscious patient, the ONSd and
other optic nerve sheath parameters, such as volume, surface
structure, radial variation, circumference, etc., may be useful for
determining normal versus elevated ICP and the measurement may be
done at any time by placing US ICP monitor 224 on the patient's
closed eye to obtain a reading. Once the patient is unconscious, US
ICP monitor 224 may be attached to the device frame and placed on
the eye in continuous contact. Once attached in the device, optic
nerve sheath parameter measurements may be done routinely for
frequent or constant monitoring of optic nerve sheath parameter
changes. US ICP monitor 224 may be a non-imaging ultrasound based
monitor, capable of taking frequent measurements and averaging the
measurements to account for errors in measurement and vibration. As
the ICP and the optic nerve sheath parameters change, the
healthcare provider may be notified of the change in this
measurement advising them what parameters (such as head position)
can be modified to decrease the ICP. Using US ICP monitor 224, the
healthcare provider can monitor the effect of their interventions
on the patient's ICP. US ICP monitor 224 is described further
below.
[0043] An exemplary block diagram of a system 300 incorporating
device 100 is shown in FIG. 3. In this example, system 300 may
include brain monitoring device 100 and remote station 310. Brain
monitoring device 100 may include processor 302, memory 304,
communications circuitry 306, sensors 308, and operator interface
310. Processor 302 and memory 304 may implement a computing device,
such as a microprocessor, embedded processor, system on a chip,
etc. Communications circuitry may provide communications
functionality using any wired or wireless, standard or proprietary
communications system or protocol. Such communications may be
directly with remote station 310, or may be via one or more
intermediate networks, such as a local area network, a wide area
network, the Internet, etc. Sensors 308 may include cognizance
stimuli-sensor suite 202, physiologic sensor suite 204, and
advanced monitoring suite 218, as described above. Operator
interface 310 may include operator display 102, described above, as
well as other input and/or output components that may provide the
capability for operator control of brain monitoring device 100.
[0044] Remote station 310 may include processor 312, memory 314,
communications circuitry 316, analysis software 318, and user
interface 320. Processor 302 and memory 304 may implement a
computer system, such as a programmed general-purpose computer
system, such as a microprocessor, embedded processor, system on a
chip, personal computer, workstation, server system, and
minicomputer or mainframe computer, or distributed, networked
computing environments, etc. Communications circuitry may provide
communications functionality using any wired or wireless, standard
or proprietary communications system or protocol. Such
communications may be directly with brain monitoring device 100, or
may be via one or more intermediate networks, such as a local area
network a wide area network, the Internet, etc. Remote station 310
may further communicate with other systems as well. Analysis
software 318 may receive data from brain monitoring device 100,
process and analyze the data so as to be useful to a health care
provider or other user or operator, and may display the resulting
analysis, using for example display capabilities in user interface
320. Remote station 310 may further communicate analysis results
with other systems. Operator interface 310 may include a display as
well as other input and/or output components that may provide the
capability for operator control of brain monitoring device 100 and
remote station 310.
[0045] In embodiments, the sensors may work in a coordinated
fashion--each providing a unique piece of information to calculate
the GBS. The sensor suites may be utilized only when needed. This
saves energy as well as complexity in design. All of the sensors
may be built into the device 100 platform. This allows the
healthcare provider to place device 100 onto the patient and not be
concerned with exact placement of multiple sensors. This allows for
standardization of the sensors, as precise distance between the
monitors can allow for a more reliable interpretation of the sensor
data. Vibration sensors may be incorporated into brain monitoring
device 100 to help with removing noise from the data signals. The
vibration signals may be removed from the various sensor data
streams. Calculations may be done by processor 302 incorporated
into brain monitoring device 100. Processor 302, as well as other
circuitry, may be housed behind observer display 102, which may be
used to display the GBS, a color-coded patient condition status
(Green, Yellow, Red), and other important physiologic data which
the healthcare provider can utilize as they treat the patient
bedside. An integrated telemetry module, such as communications
circuitry 306, may wirelessly stream the data to any platform, such
as remote station 310, allowing for remote monitoring of a single
or multiple patients simultaneously.
[0046] An example of brain function conditions and sensors that may
be used to monitor brain function at each condition is shown in
FIG. 4.
[0047] An example of an embodiment of a brain monitoring device 100
is shown in FIG. 5. In this example, EEG lead location 502 and TCD
puck location 504 are shown. Also shown are patient video screens
506.
[0048] Embodiments of the present systems and method may be used to
provide critical care monitoring of brain function in a hostile
environment. The sensors may be tuned to remove or exclude
environmental noise in the data signal. This allows for embodiments
to function during patient transport such as helicopter evacuation
and mass casualty events. Embodiments may be used in other
healthcare situations such as during procedures such as surgery
(intraoperative monitoring) and procedural sedation.
[0049] An exemplary embodiment of an intracranial pressure (ICP)
monitor 224 is shown in FIG. 6. In embodiments, monitor 224 may be
incorporated in or attached to brain monitoring device 100. In
embodiments, monitor 224 may be a standalone device, or may be
incorporated in other devices or systems.
[0050] As shown in this example, monitor 224 may include a patient
unit 602 and a base unit 604. Patient unit 602 may include a
two-dimensional matrix array of ultrasound transducers 606 that are
placed in contact with an eye 608 of a patient. Ultrasound array
606 may be any standard or proprietary two-dimensional array of
ultrasound transducers. Each transducer in array 606 may be
connected to interface circuitry 610, which may provide electrical
signals to cause each transducer to emit an ultrasonic signal into
eye 608, and may receive electrical signals from each transducer
corresponding to the return or echo ultrasonic signal from eye 608.
Interface circuitry 610 may include analog circuitry to transmit
electrical signals to array 606 and to receive electrical signals
from array 606. Interface circuitry 610 may include
analog-to-digital converter circuitry (ADC) to convert received
analog signals to digital signals and may include digital-to-analog
converter circuitry to convert digital signals to transmitted
analog signals. Interface circuitry 610 may further include digital
circuitry to generate the signals to be transmitted and digital
circuitry to process the digital signals converted from the
received analog signals.
[0051] Interface circuitry 610 may be connected to communication
circuitry 612, which may transmit and receive signals between
patient unit 602 and base unit 604. Both interface circuitry 610
and communication circuitry 612 may be connected to control
circuitry 614, which may control the operation of interface
circuitry 610 and communication circuitry 612. Power supply 615,
which may be a battery, mains power converter, inductively-coupled
supply, etc., may supply power to the components of patient unit
602. Patient
[0052] Ultrasound array 606 may be placed in contact with patient
eye 608 and held in place using any means of attachment. Ultrasound
array 606 may perform its functions with the eyelid of eye 608
closed. Accordingly, array 606 may, for example, be affixed to the
eyelid of eye 608 using a mild adhesive, mechanical means, such as
an elastic or inelastic strap or band, etc. In embodiments, array
606 may be attached in place and may connect using wired or
wireless connections to the remainder of patient unit 602. In
embodiments, patient unit 602 may be small enough that the entire
patient unit 602 may be attached in place. Such embodiments are a
matter of engineering design.
[0053] Base unit 604 may include communication circuitry 616, which
may communicate with communication circuitry 612 in patient unit
602, and processing circuitry 618, which may process the signals
from patient unit 602 to compute an ICP result and other associated
data. Processing circuitry 618 may include one or more computing
systems, such as personal computers, work stations, smartphones,
etc., which may include or be connected to one or more display
devices, such as a monitor, display screen, etc. The communication
techniques used may be proprietary communications techniques, as
well as standard communications techniques, such as WiFi,
BLUETOOTH.RTM., cellular carrier networks such 3G, 9G, LTE, etc. In
such embodiments, base unit 604 may comprise the computing system,
such as a personal computer, work station, smartphone, etc.
[0054] An exemplary flow diagram of a process 700 of ICP
measurement is shown in FIG. 7. It is best viewed in conjunction
with FIG. 8, which is an exemplary diagram illustrating the
operation of an ICP measurement system. Process 700 begins with
702, in which a patient unit 802 may be brought into contact with
an eye 804 of a patient. As described above, patient unit 802 may
be attached or affixed to a patient using an adhesive, strap, etc.,
with ultra-sound matrix array 806 in contact with a closed eyelid
of the patient. Patient unit 802 may include array 806 and
communication and control circuitry 808. In FIG. 8, each row 810 of
ultrasound transducers in array 806 is shown in an end view. Each
box, such as 810, represents a row of transducers, not just a
single transducer.
[0055] At 704, communication and control circuitry 808 may control
each row 810 of ultrasound transducers in array 806 to perform an
ultrasound scan 812A-E of a slice of eye 804 and optic nerve sheath
814. For example, scan 812A may generate an image 816A of a slice
of eye 804 and optic nerve sheath 814. Likewise, scans 812B, 812C,
812D, and 812E may generate images 816B, 816C, 816D, and 816E,
respectively. The slices may be scanned sequentially or in any
other suitable order. As shown in FIG. 8, a number of parameters
818 of the optic nerve sheath 814 may be determined. For example,
the diameter of the optic nerve sheath may be determined from one
or more of the slice images 816A-E. For example, image 820 may be
used to determine the diameter of optic nerve sheath 814. In the
example shown in FIG. 8, the diameter of optic nerve sheath 814 at
a distance of 3 mm behind the retina of eye 804 is 3 mm. Likewise,
image 820 and image 822 may be used together to determine the
volume of optic nerve sheath 814. In the example shown in FIG. 8,
the volume of optic nerve sheath 814 at a distance of 3 mm behind
the retina of eye 804 is 4 ml. Another example of a parameter that
may be determined is the variability of the radius of optic nerve
sheath 814 at a distance of 3 mm behind the retina of eye 804 is
0.2 mm. The process of determination of these parameters is
described in more detail in U.S. Patent Application Publication No.
2016/0000367.
[0056] At 706, the images 816A-E of the slices may be combined to
form a three-dimensional (3D) image of optic nerve sheath 814, as
described in U.S. Patent Application Publication No. 2016/0000367.
At 708, the 3D image of optic nerve sheath 814 may be used to
generate an ICP value, as described in U.S. Patent Application
Publication No. 2016/0000367.
[0057] At 710, a change in the ICP value may be determined. The
above-described technique may be most advantageous when determining
a change in ICP, rather than an absolute value of ICP. Relatively
small changes in ICP may be detected, as described in U.S. Patent
Application Publication No. 2016/0000367. Further, the 3D image of
optic nerve sheath 814 may be used to determine the presence or
absence of traumatic brain injury (TBI), and to characterize the
TBI of the patient, as described in U.S. Patent Application
Publication No. 2016/0000367.
[0058] An exemplary block diagram of a computer system 902, in
which processes involved in the embodiments described herein may be
implemented, is shown in FIG. 9. Computer system 902 may be
implemented using one or more programmed general-purpose computer
systems, such as embedded processors, systems on a chip, personal
computers, workstations, server systems, and minicomputers or
mainframe computers, or in distributed, networked computing
environments. Computer system 902 may include one or more
processors (CPUs) 902A-902N, input/output circuitry 904, network
adapter 906, and memory 908. CPUs 902A-902N execute program
instructions in order to carry out the functions of the present
communications systems and methods. Typically, CPUs 902A-902N are
one or more microprocessors, such as an INTEL CORE.RTM. processor.
FIG. 9 illustrates an embodiment in which computer system 902 is
implemented as a single multi-processor computer system, in which
multiple processors 902A-902N share system resources, such as
memory 908, input/output circuitry 904, and network adapter 906.
However, the present communications systems and methods also
include embodiments in which computer system 902 is implemented as
a plurality of networked computer systems, which may be
single-processor computer systems, multi-processor computer
systems, or a mix thereof
[0059] Input/output circuitry 904 provides the capability to input
data to, or output data from, computer system 902. For example,
input/output circuitry may include input devices, such as
keyboards, mice, touchpads, trackballs, scanners, analog to digital
converters, etc., output devices, such as video adapters, monitors,
printers, etc., and input/output devices, such as, modems, etc.
Network adapter 906 interfaces device 900 with a network 910.
Network 910 may be any public or proprietary LAN or WAN, including,
but not limited to the Internet.
[0060] Memory 908 stores program instructions that are executed by,
and data that are used and processed by, CPU 902 to perform the
functions of computer system 902. Memory 908 may include, for
example, electronic memory devices, such as random-access memory
(RAM), read-only memory (ROM), programmable read-only memory
(PROM), electrically erasable programmable read-only memory
(EEPROM), flash memory, etc., and electro-mechanical memory, such
as magnetic disk drives, tape drives, optical disk drives, etc.,
which may use an integrated drive electronics (IDE) interface, or a
variation or enhancement thereof, such as enhanced IDE (EIDE) or
ultra-direct memory access (UDMA), or a small computer system
interface (SCSI) based interface, or a variation or enhancement
thereof, such as fast-SCSI, wide-SCSI, fast and wide-SCSI, etc., or
Serial Advanced Technology Attachment (SATA), or a variation or
enhancement thereof, or a fiber channel-arbitrated loop (FC-AL)
interface.
[0061] The contents of memory 908 may vary depending upon the
function that computer system 902 is programmed to perform. In the
example shown in FIG. 9, exemplary memory contents are shown
representing routines and data for embodiments of the processes
described above. However, one of skill in the art would recognize
that these routines, along with the memory contents related to
those routines, may not be included on one system or device, but
rather may be distributed among a plurality of systems or devices,
based on well-known engineering considerations. The present
communications systems and methods may include any and all such
arrangements.
[0062] In the example shown in FIG. 9, memory 908 may include
sensor data capture and control routines 912, image processing
routines 914, ICP determination routines 916, and operating system
920. Sensor data capture and control routines 912 may include
software routines to control ultrasound scanning performed by an
ultrasound transducer array and to receive data produced by
scanning with such an array. Image processing routines 914 may
include software routines to process receive data produced by
scanning to generate 3D images of an eye and optic nerve/optic
nerve sheath. ICP determination routines 916 may include software
routines to generate an ICP value based on the generated 3D images
of an eye and optic nerve/optic nerve sheath. Operating system 920
may provide overall system functionality.
[0063] As shown in FIG. 9, the present communications systems and
methods may include implementation on a system or systems that
provide multi-processor, multi-tasking, multi-process, and/or
multi-thread computing, as well as implementation on systems that
provide only single processor, single thread computing.
Multi-processor computing involves performing computing using more
than one processor. Multi-tasking computing involves performing
computing using more than one operating system task. A task is an
operating system concept that refers to the combination of a
program being executed and bookkeeping information used by the
operating system. Whenever a program is executed, the operating
system creates a new task for it. The task is like an envelope for
the program in that it identifies the program with a task number
and attaches other bookkeeping information to it. Many operating
systems, including Linux, UNIX.RTM., OS/2.RTM., and Windows.RTM.,
are capable of running many tasks at the same time and are called
multitasking operating systems. Multi-tasking is the ability of an
operating system to execute more than one executable at the same
time. Each executable is running in its own address space, meaning
that the executables have no way to share any of their memory. This
has advantages, because it is impossible for any program to damage
the execution of any of the other programs running on the system.
However, the programs have no way to exchange any information
except through the operating system (or by reading files stored on
the file system). Multi-process computing is similar to
multi-tasking computing, as the terms task and process are often
used interchangeably, although some operating systems make a
distinction between the two.
[0064] The present invention may be a system, a method, and/or a
computer program product at any possible technical detail level of
integration. The computer program product may include a computer
readable storage medium (or media) having computer readable program
instructions thereon for causing a processor to carry out aspects
of the present invention. The computer readable storage medium can
be a tangible device that can retain and store instructions for use
by an instruction execution device.
[0065] The computer readable storage medium may be, for example,
but is not limited to, an electronic storage device, a magnetic
storage device, an optical storage device, an electromagnetic
storage device, a semiconductor storage device, or any suitable
combination of the foregoing. A non-exhaustive list of more
specific examples of the computer readable storage medium includes
the following: a portable computer diskette, a hard disk, a random
access memory (RAM), a read-only memory (ROM), an erasable
programmable read-only memory (EPROM or Flash memory), a static
random access memory (SRAM), a portable compact disc read-only
memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a
floppy disk, a mechanically encoded device such as punch-cards or
raised structures in a groove having instructions recorded thereon,
and any suitable combination of the foregoing. A computer readable
storage medium, as used herein, is not to be construed as being
transitory signals per se, such as radio waves or other freely
propagating electromagnetic waves, electromagnetic waves
propagating through a waveguide or other transmission media (e.g.,
light pulses passing through a fiber-optic cable), or electrical
signals transmitted through a wire.
[0066] Computer readable program instructions described herein can
be downloaded to respective computing/processing devices from a
computer readable storage medium or to an external computer or
external storage device via a network, for example, the Internet, a
local area network, a wide area network and/or a wireless network.
The network may comprise copper transmission cables, optical
transmission fibers, wireless transmission, routers, firewalls,
switches, gateway computers, and/or edge servers. A network adapter
card or network interface in each computing/processing device
receives computer readable program instructions from the network
and forwards the computer readable program instructions for storage
in a computer readable storage medium within the respective
computing/processing device.
[0067] Computer readable program instructions for carrying out
operations of the present invention may be assembler instructions,
instruction-set-architecture (ISA) instructions, machine
instructions, machine dependent instructions, microcode, firmware
instructions, state-setting data, configuration data for integrated
circuitry, or either source code or object code written in any
combination of one or more programming languages, including an
object oriented programming language such as Smalltalk, C++, or the
like, and procedural programming languages, such as the "C"
programming language or similar programming languages. The computer
readable program instructions may execute entirely on the user's
computer, partly on the user's computer, as a stand-alone software
package, partly on the user's computer and partly on a remote
computer or entirely on the remote computer or server. In the
latter scenario, the remote computer may be connected to the user's
computer through any type of network, including a local area
network (LAN) or a wide area network (WAN), or the connection may
be made to an external computer (for example, through the Internet
using an Internet Service Provider). In some embodiments,
electronic circuitry including, for example, programmable logic
circuitry, field-programmable gate arrays (FPGA), or programmable
logic arrays (PLA) may execute the computer readable program
instructions by utilizing state information of the computer
readable program instructions to personalize the electronic
circuitry, in order to perform aspects of the present
invention.
[0068] Aspects of the present invention are described herein with
reference to flowchart illustrations and/or block diagrams of
methods, apparatus (systems), and computer program products
according to embodiments of the invention. It will be understood
that each block of the flowchart illustrations and/or block
diagrams, and combinations of blocks in the flowchart illustrations
and/or block diagrams, can be implemented by computer readable
program instructions.
[0069] These computer readable program instructions may be provided
to a processor of a general-purpose computer, special purpose
computer, or other programmable data processing apparatus to
produce a machine, such that the instructions, which execute via
the processor of the computer or other programmable data processing
apparatus, create means for implementing the functions/acts
specified in the flowchart and/or block diagram block or blocks.
These computer readable program instructions may also be stored in
a computer readable storage medium that can direct a computer, a
programmable data processing apparatus, and/or other devices to
function in a particular manner, such that the computer readable
storage medium having instructions stored therein comprises an
article of manufacture including instructions which implement
aspects of the function/act specified in the flowchart and/or block
diagram block or blocks.
[0070] The computer readable program instructions may also be
loaded onto a computer, other programmable data processing
apparatus, or other device to cause a series of operational steps
to be performed on the computer, other programmable apparatus or
other device to produce a computer implemented process, such that
the instructions which execute on the computer, other programmable
apparatus, or other device implement the functions/acts specified
in the flowchart and/or block diagram block or blocks.
[0071] The flowchart and block diagrams in the Figures illustrate
the architecture, functionality, and operation of possible
implementations of systems, methods, and computer program products
according to various embodiments of the present invention. In this
regard, each block in the flowchart or block diagrams may represent
a module, segment, or portion of instructions, which comprises one
or more executable instructions for implementing the specified
logical function(s). In some alternative implementations, the
functions noted in the blocks may occur out of the order noted in
the Figures. For example, two blocks shown in succession may, in
fact, be executed substantially concurrently, or the blocks may
sometimes be executed in the reverse order, depending upon the
functionality involved. It will also be noted that each block of
the block diagrams and/or flowchart illustration, and combinations
of blocks in the block diagrams and/or flowchart illustration, can
be implemented by special purpose hardware-based systems that
perform the specified functions or acts or carry out combinations
of special purpose hardware and computer instructions.
[0072] Although specific embodiments of the present invention have
been described, it will be understood by those of skill in the art
that there are other embodiments that are equivalent to the
described embodiments. Accordingly, it is to be understood that the
invention is not to be limited by the specific illustrated
embodiments, but only by the scope of the appended claims.
* * * * *