U.S. patent application number 12/676385 was filed with the patent office on 2011-06-30 for method, system and apparatus for using electromagnetic radiation for monitoring a tissue of a user.
Invention is credited to Benyamin Almog, Shlomi Bergida, Nadav Mizarahi, Dan Rappaport, Amir Ronen, Amir Saroka.
Application Number | 20110160549 12/676385 |
Document ID | / |
Family ID | 40429498 |
Filed Date | 2011-06-30 |
United States Patent
Application |
20110160549 |
Kind Code |
A1 |
Saroka; Amir ; et
al. |
June 30, 2011 |
METHOD, SYSTEM AND APPARATUS FOR USING ELECTROMAGNETIC RADIATION
FOR MONITORING A TISSUE OF A USER
Abstract
A wearable monitoring apparatus for monitoring at least one
biological parameter of an internal tissue of an ambulatory user.
Said wearable monitoring apparatus comprises at least one
transducer configured for delivering electromagnetic (EM) radiation
to said internal tissue and intercepting a reflection of said EM
radiation said reform in a plurality of transmission sessions
during at least 24 hours, a processing unit configured for
analyzing respective said reflection and identifying a change in
said at least one biological parameter accordingly, a reporting
unit configured for generating a report according to said change,
and a housing for containing said at least one transducer, said
reporting unit, and said processing unit, said housing being
configured for being disposed on said body of said ambulatory
user.
Inventors: |
Saroka; Amir; (Tel-Aviv,
IL) ; Bergida; Shlomi; (Tel-Aviv, IL) ;
Mizarahi; Nadav; (Tel-Aviv, IL) ; Rappaport; Dan;
(Tel-Aviv, IL) ; Ronen; Amir; (Hod-HaSharon,
IL) ; Almog; Benyamin; (Beit Arie, IL) |
Family ID: |
40429498 |
Appl. No.: |
12/676385 |
Filed: |
September 4, 2008 |
PCT Filed: |
September 4, 2008 |
PCT NO: |
PCT/IL08/01198 |
371 Date: |
July 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60969963 |
Sep 5, 2007 |
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60969965 |
Sep 5, 2007 |
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60969966 |
Sep 5, 2007 |
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Current U.S.
Class: |
600/301 ;
343/700R; 600/300; 600/309; 600/587 |
Current CPC
Class: |
A61B 5/00 20130101; A61B
5/05 20130101; A61B 5/726 20130101; A61B 5/7264 20130101; A61B
5/7275 20130101; A61B 5/7203 20130101 |
Class at
Publication: |
600/301 ;
600/300; 600/587; 600/309; 343/700.R |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/103 20060101 A61B005/103; H01Q 1/00 20060101
H01Q001/00 |
Claims
1. A wearable monitoring apparatus for monitoring at least one
biological parameter of an internal tissue of an ambulatory user,
comprising: at least one transducer having at least one antenna
configured for at least one of delivering electromagnetic (EM)
radiation to the internal tissue and intercepting said EM radiation
from said internal tissue in a plurality of transmission sessions
during a period of at least 24 hours; a processing unit configured
for analyzing said intercepted EM radiation and identifying a
change in the at least one biological parameter accordingly; and a
reporting unit configured for generating a report according to said
change; wherein said at least one antenna is configured for being
disposed on the body of the ambulatory user.
2. The wearable monitoring apparatus of claim 1, wherein said
processing unit comprises a communication module for communicating
with a remote processing unit thereby allowing performing of at
least one of said analyzing and said identifying by said remote
processing unit.
3. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for identifying said change by
detecting at least one of a trend, a biological process, and a
pattern according to said intercepted EM radiation of said
plurality of transmission sessions.
4. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for evaluating a property change in a
dielectric related property of the internal tissue in at least one
of said plurality of transmission sessions and performing said
identification according to said property change.
5. The wearable monitoring apparatus of claim 1, wherein said
plurality of transmission sessions are performed in an adaptive
rate.
6. The wearable monitoring apparatus of claim 5, wherein said
adaptive rate is determined according to a clinical state of the
user, said processing unit being configured for calculating said
clinical state according to at least one output of a non EM
radiation sensor and said intercepted EM radiation.
7. The wearable monitoring apparatus of claim 5, further comprising
a posture detection unit configured for detecting a posture of the
user, said adaptive rate being determined according to said
posture.
8. The wearable monitoring apparatus of claim 1, wherein said
reporting unit is configured for generating said report in real
time.
9. (canceled)
10. The wearable monitoring apparatus of claim 1, wherein said
change is indicative of a fluid content change in the internal
tissue during said period.
11. The wearable monitoring apparatus of claim 1, wherein said
change is indicative of a member of a group consisting of: a trauma
a degenerative process, atelectasis, a post-operative atelectasis,
an acute respiratory deficiency syndrome (ARDS), an infectious
cause, an inhaled toxins, a circulating exogenous toxins, a
vasoactive substance, a disseminated intravascular coagulopathy
(DIC), a burn, an emphysema, a immunologic processes reaction, a
uremia, a post drowning lung water level, a pulmonary venous
thrombosis, a stenosis, a veno-occlusive disease, a
hypoalbuminemia, a lymphatic insufficiency, a high altitude
pulmonary edema (HAPE), a neurogenic pulmonary edema, a drug
overdose, a pulmonary embolism, an eclampsia, a postcardioversion,
a postanesthetic, a postextubation, and a post-cardiopulmonary
bypass an inflammation progress of ARDS users, postoperative
atelectasis.
12. (canceled)
13. The wearable monitoring apparatus of claim 1, further
comprising a repository configured for storing information
pertaining to said user, said processing unit being configured for
performing said analyzing with respect to said information, wherein
said information comprises at least one of physiological,
anatomical, and clinical data related to said user.
14. The wearable monitoring apparatus of claim 1, further
comprising a non EM radiation sensor configured for evaluating an
indicator of the physical condition of said user, said processing
unit identifying said change by a combination of said indicator and
said intercepted EM radiation.
15. (canceled)
16. The wearable monitoring apparatus of claim 1, further
comprising a non EM radiation sensor configured for evaluating an
indicator to allow performing said analyzing with respect to said
evaluated indicator, said non EM radiation sensor being a member of
a group consisting of electromyogram (EMG), an ultrasound
transducer, a blood pressure sensor, an optical blood saturation
detector, a pulse oximeter, electrocardiogram (ECG), tiltmeter and
accelerometer an activity sensor, and a coagulometer.
17. The wearable monitoring apparatus of claim 1, further
comprising a non EM radiation sensor configured for detecting a
pattern of a physiological activity of the user, said processing
unit being configured for performing said analyzing with respect to
said pattern.
18. (canceled)
19. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for detecting a pattern of a
physiological activity of the user, said processing unit being
configured for performing said analyzing with respect to said
pattern.
20. (canceled)
21. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for detecting a physiological
activity of the user by analyzing said intercepted EM radiation,
said processing unit being configured for performing said
identifying with respect to said physiological activity.
22. The wearable monitoring apparatus of claim 1, further
comprising a posture detection unit configured for detecting a
posture of the user, said processing unit being configured for
analyzing said intercepted EM radiation with respect to said
posture.
23. The wearable monitoring apparatus of claim 1, wherein said
change is indicative of a change in the concentration of a solute
in the internal tissue.
24. The wearable monitoring apparatus of claim 23, wherein said
solute is a member of a group consisting of a salt, glucose, and or
inflammatory indicative fluid.
25. (canceled)
26. The wearable monitoring apparatus of claim 1, wherein said EM
radiation comprises a narrowband signal of less than 50 Mega Hertz
(MHz) bandwidth and a pulse signal of at least 0.5 gigahertz (GHz)
bandwidth.
27. The wearable monitoring apparatus of claim 1, wherein said EM
radiation is transmitted in at least one of a plurality of
frequencies and a swept frequency mode.
28. (canceled)
29. The wearable monitoring apparatus of claim 1, further
comprising a placement unit configured for providing a position of
said at least one antenna in relation to a reference internal
tissue of the user, said delivering being performed with respect to
said position.
30. (canceled)
31. The wearable monitoring apparatus of claim 1, wherein said at
least one antenna comprises a planar wide band antenna.
32. (canceled)
33. The wearable monitoring apparatus of claim 1, wherein said at
least one transducer, said reporting unit, and said processing unit
are configured to be integrated into a garment.
34. The wearable monitoring apparatus of claim 1, wherein said
reporting unit is configured for providing treatment
instructions.
35-36. (canceled)
37. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for identifying said change using a
tissue model adapted to said internal tissue.
38. The wearable monitoring apparatus of claim 1, wherein said at
least one transducer comprises a plurality of transducers
configured for delivering EM radiation to the internal tissue and
intercepting said intercepted EM radiation therefrom.
39. The wearable monitoring apparatus of claim 38, wherein said
plurality of transducers comprises at least one transmitter
configured for performing said delivering and at least one receiver
configured for performing said intercepting.
40. The wearable monitoring apparatus of claim 38, wherein said at
least one transducer being configured for intercepting said
intercepted EM radiation from a plurality of sub-areas of said
internal tissue for improving the resolution of said intercepted EM
radiation.
41. The wearable monitoring apparatus of claim 40, wherein said
processing unit is configured for reducing at least one of a noise,
a disturbance, a posture movement effect and/or an interference
intercepted by said at least one first transducer by comparing
segments of said intercepted EM radiation from said first and
second sub-areas.
42. A system for monitoring at least one biological parameter of an
internal tissue of a plurality of ambulatory users, comprising: a
plurality of wearable devices, each configured for being disposed
on the body of one of the plurality of ambulatory users and for
identifying a change in the at least one biological parameter
according to electromagnetic (EM) radiation intercepted from an
internal tissue of a respective of said ambulatory users in a
plurality of transmission sessions during a period of at least 24
hours; and a user management unit configured for receiving said
identified change from a respective said wearable device and
generating a report accordingly.
43-69. (canceled)
70. A wideband antenna, comprising: a printed metallic field
transducer for transmitting EM radiation; and an arrangement of at
least one lumped absorbing element; wherein said arrangement having
a minimal absorption area absorbing at least 75% of the energy
absorbed by said arrangement; wherein a first distance is the
smallest distance between a geometric center of said printed
metallic field transducer and a perimeter encircling a transmission
area of said printed metallic field transducer required for
transmitting 50% of the energy of said EM radiation in the lowest
end of a used frequency band with respect to infinite size
transducer; wherein the distance of each point within said minimal
absorption area from said geometric center is at least said first
distance.
71. The wearable monitoring apparatus of claim 1, wherein said
processing unit is configured for being disposed on the body of the
ambulatory user.
72. The wearable monitoring apparatus of claim 1, further
comprising an attachment unit which detachably attaches the
monitoring apparatus to said user in a specific position.
73. The wearable monitoring apparatus of claim 1, further
comprising a placement unit which computes a misplacement of said
at least one antenna in relation to an internal tissue of said
ambulatory user and outputting a notification about said
misplacement.
74. A method for monitoring at least one biological parameter of an
internal tissue of an ambulatory user, comprising: disposing a
transducer on the body of the ambulatory user; delivering
electromagnetic (EM) radiation to the internal tissue; intercepting
said EM radiation from said internal tissue in a plurality of
transmission sessions during a period of at least 24 hours;
analyzing said EM radiation and identifying a change in the at
least one biological parameter accordingly; and generating a report
according to said change.
75. The wearable monitoring apparatus of claim 1, wherein at least
one of said processing unit and said reporting unit being disposed
on the body of the ambulatory user.
76. The wearable monitoring apparatus of claim 1, wherein said
plurality of transmission sessions are intermittent.
77. The wearable monitoring apparatus of claim 1, wherein during
said period, said processing unit is configured for performing at
least one of the following: computing a reduction to at least one
movement effect, and generating guidance instructions for at least
one of repositioning the wearable monitoring apparatus and guiding
the monitored user to a posture.
78. The wearable monitoring apparatus of claim 1, wherein during
said period, said processing unit is configured for performing at
least one of the following: detecting at least one of a
misplacement and disengagement of the wearable monitoring
apparatus, identifying a period suitable for performing a data
acquisition session, and identifying said change by at least one of
calculating a baseline and identifying a normal range which are
adjusted according to the monitored user
79. The wearable monitoring apparatus of claim 1, wherein said
processing comprises reducing the effect of a movement on said
change identification, said movement comprises a member of a group
consisting of: a thoracic movement, an internal physiological
activity, and an external physiological activity irregularity.
80. The wearable monitoring apparatus of claim 1, wherein said
processing comprises reducing the effect of a movement on said
change identification, said movement comprises a member of a group
consisting of: an organ movement, an antenna movement, a change of
posture movement, a bodily movement, an activity related
movement.
81. The wearable monitoring apparatus of claim 1, said processing
unit is configured for performing said identifying according to an
analysis of differential physiological activities signals.
82. The wearable monitoring apparatus of claim 10, wherein said
processing unit is configured for detecting a pattern of at least
one physiological activity of the user, said processing unit being
configured for calculating a clinical state of said user with
respect to said fluid content change and to said pattern; wherein
said at least one intercepted EM radiation is being changed as an
outcome of at least one thoracic movement during said period.
83. The wearable monitoring apparatus of claim 29, wherein said
placement unit performs at least one of: monitoring and guiding the
positioning of said wearable monitoring apparatus, monitoring and
guiding the repositioning of said wearable monitoring apparatus,
and identifying at least one of a misplacement and a disengagement
of said wearable monitoring apparatus.
84. The wearable monitoring apparatus of claim 29, wherein said
placement unit controls a mechanical adjustment unit which changes
the positioning of said wearable monitoring apparatus.
Description
RELATED APPLICATION
[0001] This application is co filed with a patent application by
Dan RAPPAPORT, Nadav MIZRAHI, Shlomi BERGIDA, Amir SAROKA, Amir
RONEN, and Ilan KOCHBA, entitled method and system for monitoring
thoracic fluids, which the content thereof is incorporated by
reference as if fully set forth herein.
FIELD AND BACKGROUND OF THE INVENTION
[0002] The present invention, in some embodiments thereof, relates
to monitoring and, more particularly, but not exclusively, to using
EM radiation for monitoring changes of an internal biological
tissue.
[0003] Medical instruments in which an echo of a pulse of EM
radiation is used to detect and locate structures in the human body
are known, see YOUNG, J. D et. al. Examination of video pulse radar
systems as potential biological exploratory tools in LARSEN, L. E.,
and JACOBI, J. H. (Eds.): `Medical applications of microwave
imaging` (IEEE Press, New York, 1986), pp. 82-105, which is
incorporated herein by reference. Such medical instruments includes
microwave imaging devices, which may be referred to as tissue
sensing adaptive radar (TSAR) or Imaging and other medical devices
for detecting and possibly imaging internal biological tissues. The
use of electromagnetic waves eliminates the need to expose the
tissues to ionizing radiation, as performed during X-ray imaging,
and to obtain relatively large tissue contrasts according to their
water content.
[0004] One of the most common antennas which are used for such
medical instruments is the well known biconic bow-tie antenna that
maintains its port impedance and radiation pattern act in
frequencies between certain limits where the low frequency is
dictated by the size of the length of the cones and the upper limit
by the port capacitance and feeding construction, see Antenna
Theory, C. A. Balanis, 2 ed. John Willey, 1997 which is
incorporated herein by reference. Such antennas usually suffer from
a poor performance at relative low frequencies, where body
electromagnetic penetration is better, and a planar construction
that may be damaged due to electro-static discharges (ESD).
[0005] Such antennas have been used for detecting and imaging
various pathologies, such as breast cancer. For example, U.S. Pat.
No. 6,061,589 issued on May 20, 2000 describes a microwave antenna
for use in a system for detecting an incipient tumor in living
tissue such as that of a human breast in accordance with
differences in relative dielectric characteristics. In the system a
generator produces a non-ionizing electromagnetic input wave of
preselected frequency, usually exceeding three gigahertz, and that
input wave is used to irradiate a discrete volume in the living
tissue with a non-ionizing electromagnetic wave. The illumination
location is shifted in a predetermined scanning pattern. Scattered
signal returns from the living tissue are collected and processed
to segregate skin tissue scatter and to develop a segregated
backscatter or return wave signal; that segregated signal, in turn,
is employed to detect any anomaly indicative of the presence of a
tumor or other abnormality in the scanned living tissue. The
present invention is directed to a composite Maltese Cross or
bow-tie antenna construction employed to irradiate the living
tissue and to collect backscatter or other scatter returns.
[0006] In another example, U.S. Pat. No. 6,919,838 published on
Jul. 19, 2005, describes a scanner or imager that employs a
plurality of microwave transmitters that emit a multiplicity of
pulses, which are received by a plurality of receivers. An object
or person positioned between the transmitters and receivers can be
scanned and subsequently imaged in extreme detail, due to the broad
spectral content of the pulses. The scanner can be constructed as a
stationary or portable device.
SUMMARY OF THE INVENTION
[0007] According to an aspect of some embodiments of the present
invention there is provided a wearable monitoring apparatus for
monitoring at least one biological parameter of an internal tissue
of an ambulatory user. The wearable monitoring apparatus comprises
at least one transducer configured for delivering electromagnetic
(EM) radiation to the internal tissue and intercepting at least one
reflection of the EM radiation therefrom in a plurality of
transmission sessions during a period of at least 24 hours, a
processing unit configured for analyzing the at least one
reflection and identifying a change in the at least one biological
parameter accordingly, a reporting unit configured for generating a
report according to the change, and a housing for containing the at
least one transducer, the reporting unit, and the processing unit,
the housing being configured for being disposed on the body of the
ambulatory user.
[0008] Optionally, the processing unit comprises a communication
module for communicating with a remote processing unit thereby
allowing performing of at least one of the analyzing and the
identifying by the remote processing unit.
[0009] Optionally, the processing unit is configured for
identifying the change by detecting at least one of a trend, a
biological process, and a pattern according to the at least one
reflection of the plurality of transmission sessions.
[0010] Optionally, the processing unit is configured for evaluating
a change in a dielectric related property of the internal tissue in
at least one of the plurality of transmission sessions and
performing the identification according to the dielectric related
property.
[0011] Optionally, the plurality of transmission sessions are
performed in an adaptive rate.
[0012] More optionally, the adaptive rate is determined according
to a clinical state of the user, the processing unit being
configured for calculating the clinical state according to at least
one output of a biological sensor and the at least one
reflection.
[0013] Optionally, the wearable monitoring apparatus further
comprises a posture detection unit configured detecting a posture
of the user, the adaptive rate being determined according to the
posture.
[0014] Optionally, the reporting unit configured for generating the
report in real time.
[0015] Optionally, the reporting unit is configured for presenting
the report to the ambulatory user.
[0016] Optionally, the change is indicative of a fluid content
change in the internal tissue during the period.
[0017] Optionally, the change is indicative of a member of a group
consisting of: a trauma a degenerative process, atelectasis, a
post-operative atelectasis, an acute respiratory deficiency
syndrome (ARDS), an infectious cause, an inhaled toxins, a
circulating exogenous toxins, a vasoactive substance, a
disseminated intravascular coagulopathy (DIC), a burn, an
emphysema, a immunologic processes reaction, a uremia, a post
drowning lung water level, a pulmonary venous thrombosis, a
stenosis, a veno-occlusive disease, a hypoalbuminemia, a lymphatic
insufficiency, a high altitude pulmonary edema (HAPE), a neurogenic
pulmonary edema, a drug overdose, a pulmonary embolism, an
eclampsia, a postcardioversion, a postanesthetic, a postextubation,
and a post-cardiopulmonary bypass an inflammation progress of ARDS
users, postoperative atelectasis.
[0018] Optionally, the housing is configured for being disposed on
the body of the ambulatory user during a physical exertion thereof,
the change being indicative of a fluid content change resulting
from the physical exertion.
[0019] Optionally, the wearable monitoring apparatus further
comprises a repository configured for storing information
pertaining to the user, the processing unit being configured for
performing the analyzing with respect to the information, wherein
the information comprises at least one of physiological,
anatomical, and clinical data related to the user.
[0020] Optionally, the wearable monitoring apparatus further
comprises a non EM radiation sensor configured for evaluating an
indicator of the physical condition of the user, the processing
unit being configured for performing the analyzing with respect to
the evaluated indicator.
[0021] More optionally, the processing unit is configured for
identifying the change by a combination of the indicator and the at
least one reflection of the plurality of transmission sessions.
[0022] More optionally, the non EM radiation sensor is a member of
a group consisting of electromyogram (EMG), an ultrasound
transducer, a blood pressure sensor, an optical blood saturation
detector, a pulse oximeter, electrocardiogram (ECG), tiltmeter and
accelerometer an activity sensor, and a coagulometer.
[0023] Optionally, the wearable monitoring apparatus further
comprises a biological sensor configured detecting a pattern of a
vital physiological activity of the user, the processing unit being
configured for performing the analyzing with respect to the
pattern.
[0024] More optionally, the pattern is a member of a group
consisting of: a heart beat rate, breathing cycle, systole diastole
cardiac cycle, and a blood cycle effect on the internal tissue.
[0025] Optionally, the processing unit is configured for detecting
a pattern of a vital physiological activity of the user by
analyzing the at least one reflection, the processing unit being
configured for performing the analyzing with respect to the
pattern.
[0026] More optionally, the pattern is a member of a group
consisting of: a systole diastole cardiac cycle and a breathing
cycle.
[0027] Optionally, the processing unit is configured for detecting
a vital physiological activity of the user by analyzing the at
least one reflection, the processing unit being configured for
performing the identifying with respect to the vital physiological
activity.
[0028] Optionally, the wearable monitoring apparatus further
comprises a posture detection unit configured detecting a posture
of the user, the processing unit being configured for analyzing the
at least one reflection with respect to the posture.
[0029] Optionally, the change is indicative of a change in the
concentration of a solute in the internal tissue.
[0030] More optionally, the solute is a member of a group
consisting of a salt, glucose, and or inflammatory indicative
fluid.
[0031] Optionally, the reporting unit is configured for
transmitting the report to a management center.
[0032] Optionally, the EM radiation comprises a narrowband signal
of less than 50 Mega Hertz (MHz) bandwidth and a pulse signal of at
least 0.5 gigahertz (GHz) bandwidth.
[0033] Optionally, the EM radiation is transmitted in a swept
frequency mode.
[0034] Optionally, the EM radiation is transmitted in a plurality
of frequencies.
[0035] Optionally, the wearable monitoring apparatus further
comprises a placement unit for providing a position of the at least
one transducer in relation to a reference internal tissue of the
user, the delivering being performed with respect to the
position.
[0036] Optionally, the wearable monitoring apparatus further
comprises a placement unit configured for receiving a positioning
data indicative of a historical position of at least one of a
similar wearable monitoring apparatus and the wearable monitoring
apparatus in relation to at least one reference internal tissue,
the placement unit being configured for using the historical
position as a reference for positioning the wearable monitoring
apparatus.
[0037] Optionally, the at least one transducer comprises a planar
wide band antenna.
[0038] Optionally, the at least one transducer is positioned in
proximity to the skin of the ambulatory user.
[0039] Optionally, the housing is configured to be integrated into
a garment.
[0040] Optionally, the reporting unit is configured for forwarding
the report to a dosage control unit, the dosage control unit being
configured for at least one of dispensing of a medication according
to the report and presenting a dosage recommendation according to
the report.
[0041] More optionally, the housing containing the dosage control
unit.
[0042] More optionally, the dispensing is related to an oncology
treatment.
[0043] Optionally, the processing unit is configured for
identifying the change using a tissue model adapted to the internal
tissue.
[0044] Optionally, the at least one transducer comprises a
plurality of transducers configured for delivering EM radiation to
the internal tissue and intercepting the at least one reflection
therefrom.
[0045] More optionally, the plurality of transducers comprises at
least one transmitter configured for performing the delivering and
at least one receiver configured for performing the
intercepting.
[0046] More optionally, the at least one transducer being
configured for intercepting the at least one reflection from a
plurality of sub-areas of the internal tissue for improving the
resolution of the at least one reflection.
[0047] More optionally, the processing unit is configured for
reducing at least one of a noise, a disturbance, a posture movement
effect and/or an interference intercepted by the at least one first
transducer by comparing portions of the at least one reflection
from the first and second sub-areas.
[0048] According to an aspect of some embodiments of the present
invention there is provided a system for monitoring at least one
biological parameter of an internal tissue of a plurality of
ambulatory users. The system comprises a plurality of wearable
devices, each configured for being disposed on the body of one of
the plurality of ambulatory users and for identifying a change in
the at least one biological parameter according to at least one
reflection of electromagnetic (EM) radiation from an internal
tissue of a respective of the ambulatory users and a user
management unit configured for receiving the identified change from
a respective the wearable device and generating a report
accordingly.
[0049] Optionally, the user management unit is configured for
alerting a caretaker by forwarding the report to a remote client
terminal associated with the caretaker.
[0050] Optionally, the remote client terminal is a member of a
group consisting of a cellular phone, a computer, a medical data
center, medical data system, and a medical database
[0051] Optionally, the user management unit is configured for
updating at least one of the plurality of wearable devices with
medical data related to a respective of the plurality of ambulatory
users.
[0052] Optionally, the user management unit is configured for
prioritizing a treatment to at least some of the plurality of
ambulatory users according to respective the identified change.
[0053] Optionally, the user management unit is configured for
receiving a technical status indication from each the wearable
device.
[0054] Optionally, the user management unit is configured for
forwarding at least one of the report and the identified change to
allow updating of a medical data system.
[0055] According to an aspect of some embodiments of the present
invention there is provided a wearable monitoring apparatus for
identifying a posture of a user. The wearable monitoring apparatus
comprises at least one transducer configured for delivering
electromagnetic (EM) radiation to an internal tissue and
intercepting a reflection of the EM radiation therefrom, a
processing unit configured for analyzing the reflection and
identifying a posture of the user accordingly, and an output unit
configured for generating an indication of the posture.
[0056] Optionally the apparatus further comprises a housing for
containing the at least one transducer, the processing unit and the
output unit, the housing being configured for being disposed on the
body of the user.
[0057] More optionally, the housing comprises a biological
probe.
[0058] Optionally, the output unit is configured for presenting at
least one movement instruction to execute a predefined posture
according to the posture.
[0059] Optionally, the apparatus further comprises a sensor for
detecting a biological parameter, the processing unit configured
for performing the identifying with respect to the biological
parameter.
[0060] According to an aspect of some embodiments of the present
invention there is provided a wearable monitoring apparatus for
detecting a posture of a user. The wearable monitoring apparatus
comprises at least one transducer configured for delivering
electromagnetic (EM) radiation to an internal tissue and
intercepting a reflection of the EM radiation therefrom, a
processing unit configured for analyzing the reflection and
identifying a positioning of the internal tissue in relation to the
EM radiation accordingly, and an output unit configured for
generating an indication of the positioning.
[0061] According to an aspect of some embodiments of the present
invention there is provided a method for detecting a body posture.
The method comprises delivering electromagnetic (EM) radiation to
an internal tissue of a user, intercepting a reflection of the EM
radiation therefrom, and identifying a change in the posture of the
user according to the reflection.
[0062] Optionally, the EM radiation comprises a narrowband signal
of less than 50 Mega Hertz (MHz) bandwidth and a pulse signal of at
least 0.5 gigahertz (GHz) bandwidth.
[0063] According to an aspect of some embodiments of the present
invention there is provided an apparatus for detecting a
misplacement of a biological probe in relation to an internal
tissue of a user. The apparatus comprises a repository configured
for storing at least one reference value indicative of an at least
one exemplary reflection of electromagnetic (EM) radiation
delivered to an internal tissue of the user, at least one
transducer configured for delivering, the EM radiation to the
internal tissue and intercepting at least one actual reflection of
the EM radiation therefrom, and a processing unit configured for
identifying the misplacement by comparing between the at least one
reference value and an actual value calculated according to the
intercepting at least one actual reflection.
[0064] Optionally, the EM radiation comprises a narrowband signal
of less than 50 Mega Hertz (MHz) bandwidth and a pulse signal of at
least 0.5 gigahertz (GHz) bandwidth.
[0065] Optionally, the at least one reference value is a range of
values.
[0066] Optionally, the apparatus further comprises an output unit
configured for forwarding an indication pertaining to the
misplacement to a remote system via a communication network.
[0067] Optionally, the apparatus further comprises a guiding unit
configured for presenting at least one repositioning instruction
directing at least one of the user and a caretaker to reposition
the biological probe according to the identified misplacement.
[0068] Optionally, the apparatus further comprises a mechanical
adjustment unit for automatically changing the position of the
biological probe according to the identified misplacement.
[0069] Optionally, the apparatus further comprises a communication
interface configured for notifying a management node about the
misplacement.
[0070] More optionally, the management node is configured for
changing a billing data pertaining to user according to the
indication.
[0071] Optionally, the biological probe is a wearable element.
[0072] According to an aspect of some embodiments of the present
invention there is provided a method configured for detecting a
misplacement of a biological probe in relation to an internal
tissue of a user. The method comprises providing at least one
reference value indicative of an at least one exemplary reflection
of electromagnetic (EM) radiation delivered to an internal tissue
of a user wearing the biological probe, delivering the
electromagnetic (EM) radiation to the internal tissue, intercepting
a at least one actual reflection of the EM radiation therefrom, and
identifying the misplacement by comparing between the a actual
value calculated according at least one actual reflection and the
at least one reference value.
[0073] Optionally, the method further comprises presenting a set of
instructions for instructing the placement of the biological probe
according to the misplacement.
[0074] Optionally, the EM radiation comprises a narrowband signal
of less than 50 Mega Hertz (MHz) bandwidth and a pulse signal of at
least 0.5 gigahertz (GHz) bandwidth.
[0075] Optionally, the method further comprises receiving
positioning data related to a previous positioning of the
biological probe, the misplacement identified in relation to the
positioning data.
[0076] According to an aspect of some embodiments of the present
invention there is provided a wideband antenna. The wideband
antenna comprises a printed metallic field transducer for
transmitting EM radiation and an arrangement of at least one lumped
absorbing element. The arrangement having a minimal absorption area
absorbing at least 75% of the energy absorbed by the arrangement.
The a first distance is the smallest distance between a geometric
center of the printed metallic field transducer and a perimeter
encircling a transmission area of the printed metallic field
transducer required for transmitting 50% of the energy of the EM
radiation in the lowest end of a used frequency band with respect
to infinite size transducer. The distance of each point within the
minimal absorption area from the geometric center is at least the
first distance.
[0077] Unless otherwise defined, all technical and/or scientific
terms used herein have the same meaning as commonly understood by
one of ordinary skill in the art to which the invention pertains.
Although methods and materials similar or equivalent to those
described herein can be used in the practice or testing of
embodiments of the invention, exemplary methods and/or materials
are described below. In case of conflict, the patent specification,
including definitions, will control. In addition, the materials,
methods, and examples are illustrative only and are not intended to
be necessarily limiting.
[0078] Implementation of the method and/or system of embodiments of
the invention can involve performing or completing selected tasks
manually, automatically, or a combination thereof. Moreover,
according to actual instrumentation and equipment of embodiments of
the method and/or system of the invention, several selected tasks
could be implemented by hardware, by software or by firmware or by
a combination thereof using an operating system.
[0079] For example, hardware for performing selected tasks
according to embodiments of the invention could be implemented as a
chip or a circuit. As software, selected tasks according to
embodiments of the invention could be implemented as a plurality of
software instructions being executed by a computer using any
suitable operating system. In an exemplary embodiment of the
invention, one or more tasks according to exemplary embodiments of
method and/or system as described herein are performed by a data
processor, such as a computing platform for executing a plurality
of instructions. Optionally, the data processor includes a volatile
memory for storing instructions and/or data and/or a non-volatile
storage, for example, a magnetic hard-disk and/or removable media,
for storing instructions and/or data. Optionally, a network
connection is provided as well. A display and/or a monitored user
input device such as a keyboard or mouse are optionally provided as
well.
BRIEF DESCRIPTION OF THE DRAWINGS
[0080] Some embodiments of the invention are herein described, by
way of example only, with reference to the accompanying drawings.
With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of embodiments of the
invention. In this regard, the description taken with the drawings
makes apparent to those skilled in the art how embodiments of the
invention may be practiced.
[0081] In the drawings: FIG. 1 is a schematic illustration of a
wearable monitoring apparatus that is attached to the thorax of a
user 101 and optionally connected to a user management unit,
according to some embodiments of the present invention;
[0082] FIG. 2 is a schematic illustration of an exemplary system
for managing the monitoring dielectric related properties of
internal tissues of one or more users, according to some
embodiments of the present invention;
[0083] FIG. 3 is a schematic illustration of a set of components of
an exemplary wearable monitoring apparatus, according to some
embodiments of the present invention;
[0084] FIG. 4A is a schematic illustration of an exemplary EM
antenna of an exemplary EM transceiver, according to some
embodiments of the present invention;
[0085] FIG. 4B is a schematic illustration of another exemplary EM
antenna of an exemplary EM transceiver, according to some
embodiments of the present invention;
[0086] FIG. 4C is a lateral view of the exemplary EM antenna which
is depicted in FIG. 4B, according to some embodiments of the
present invention;
[0087] FIG. 5 is a schematic illustration of a right mid axillary
line in which the wearable monitoring apparatus may be positioned,
according to some embodiments of the present invention;
[0088] FIG. 6A, is a flowchart of a method for using EM radiation
for detecting a posture of a user, according to some embodiments of
the present invention;
[0089] FIG. 6B is a flowchart of a method for using EM radiation
for detecting the placement, misplacement and/or disengagement of a
biological probe, according to some embodiments of the present
invention; and
[0090] FIGS. 7 and 8 are schematic illustrations of a wearable
monitoring apparatus with a plurality of transducers designed for
beaming and/or capturing EM waves, according to some embodiments of
the present invention.
DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0091] The present invention, in some embodiments thereof, relates
to monitoring and, more particularly, but not exclusively, to using
EM radiation for monitoring changes of an internal biological
tissue.
[0092] According to some embodiments of the present invention,
there is provided a method and a wearable monitoring apparatus for
monitoring one or more biological parameters of an internal tissue
of an ambulatory user. The apparatus is based on one or more
transducers for delivering electromagnetic (EM) radiation to the
internal tissue and intercepting a reflection of the EM radiation
therefrom in a plurality of transmission sessions, which may be
continuous or intermittent. The apparatus comprises a processing
unit that is used for evaluating the change of fluid content of the
internal tissue along the monitoring period according to the
reflections captured during the sessions and identifying a change
in the biological parameters accordingly. The apparatus further
comprises a reporting unit for generating a report according to the
change. The report may be forwarded to an MMI unit on the wearable
monitoring apparatus and/or to a remote management node, such as a
medical center and/or a patient management unit.
[0093] The apparatus comprises a housing, which is optionally
designed to be attached to the body of the patient without
substantially changing her general body contour, for containing the
transducers, the reporting unit, and the processing unit. The
housing is disposed on the body of the ambulatory user that is not
confined to a certain location in which monitoring is conducted.
Optionally, in order to reduce the air-skin interface and/or
positioning change, the transducers are positioned concomitantly to
the body of the ambulatory user.
[0094] In some embodiments of the present invention, there is
provided a system for monitoring biological parameters of an
internal tissue of a plurality of ambulatory and/or hospitalized
users. The system is based on a plurality of wearable devices, each
designed for being disposed on the body of one of the plurality of
ambulatory and/or hospitalized users and for evaluating a change in
a dielectric related property of an internal tissue thereof. The
system further comprises a user management unit configured for
receiving the evaluated changes from the wearable device and
generating an alert accordingly, for example by displaying a
respective indication to a caretaker. Such a system may be used to
monitor biological parameters of a plurality of ambulatory and/or
hospitalized users, to gather statistics on these biological
parameters, to prioritize treatment to the plurality of users and
the like.
[0095] According to some embodiments of the present invention there
is provided a method and an apparatus for detecting misplacement,
placement, and or disengagement of a biological probe, such as the
wearable monitoring apparatus which is outlined above, in relation
to an internal tissue of a user. The apparatus comprises a memory
element, which may be referred to herein as a repository, for
storing reference values each indicative of an exemplary reflection
of EM radiation delivered to an internal tissue of the user from
the biological probe and one or more transducers for delivering,
from the biological probe, the EM radiation to the internal tissue
and intercepting an actual reflection of the EM radiation
therefrom. The apparatus further comprises a processing unit for
identifying the misplacement by comparing between the reference
values and the actual reflection. Such an apparatus may be used for
verifying patient compliance, alerting a user when the biological
probe is misplaced, and/or for guiding a placing and/or a replacing
of the medical biological probe.
[0096] According to some embodiments of the present invention there
is provided a wearable monitoring apparatus for detecting a posture
of a user. The wearable monitoring apparatus may be integrated with
the above mentioned apparatuses or with any medical biological
probe which is used for monitoring a biological parameter of a
patient and may be affected by the posture thereof. The apparatus
comprises one or more transducers for delivering EM radiation to an
internal tissue and intercepting a reflection of the EM radiation
therefrom and a processing unit for evaluating a dielectric related
property of the internal tissue by analyzing the reflection and
identifying a posture of the user and/or a change of the posture of
according to the intercepted reflections. The apparatus further
comprises an output unit configured for generating an indication of
the posture and the change. Such an indication may be used for
registration of related biological parameters, generating an alert
and/or a report which is related to the physical condition of the
user.
[0097] Before explaining at least one embodiment of the invention
in detail, it is to be understood that the invention is not
necessarily limited in its application to the details of
construction and the arrangement of the components and/or methods
set forth in the following description and/or illustrated in the
drawings and/or the Examples. The invention is capable of other
embodiments or of being practiced or carried out in various
ways.
[0098] Reference is now made to FIG. 1, which is a schematic
illustration of a wearable monitoring apparatus 100 that is
attached to the body of a user, optionally to the thorax, as shown
at 101. The wearable monitoring apparatus 100 is optionally
connected to a user management unit 102, optionally in a
bidirectional wireless connection, according to some embodiments of
the present invention.
[0099] It should be noted that the wearable monitoring apparatus
100 and/or the user management unit 102 may interface with and/or
integrated to different systems of various medical centers, such as
hospitals, caretaker clinics, long term care facilities, nursing
homes, and home care settings. As used herein a caretaker means a
physician, a nurse, a family member, an affiliate, a medical center
staff member, a call center any entity which is in charged and/or
should have access to the medical condition of the monitored user
and/or a team of one or more of these caretakers.
[0100] The wearable monitoring apparatus 100 is designed for
monitoring one or more clinical parameters of an internal tissue
and/or an organ by detecting changes in the fluid content and/or
composition, for example according to changes in the fluid content
thereof, for example according to dielectric related properties
that reflect changes in the amount of fluids, such as water, blood,
and/or inflammation fluids in the monitored internal tissue and/or
organ, for example in the pulmonary tissues of the user 101 and/or
in the area between the pericardium and the heart and/or in the
area between the visceral and parietal pleura. As used herein a
dielectric related property of a specific volume means the magnetic
permeability and electric permittivity of the composite material
within a specific volume. Such a dielectric related property may be
affected by a presence of fluid, a concentration of substances,
such as salts, glucose, in the fluid in the internal tissue and/or
organ, the ratio of fibrotic tissue, and a concentration of
inflammatory substance in the fluid in the internal tissue and/or
organ.
[0101] In one example of the present invention, the wearable
monitoring apparatus 100 is attached to the skull of a user and
used for monitoring a build up of intra-cranial pressure which may
be a consequence of a head injury. In another of example of the
present invention, the wearable monitoring apparatus 100 may be
attached to the abdomen for monitoring abdominal bleeding, which
may be a consequence of abdominal surgery. In another example, the
wearable monitoring apparatus 100 is positioned on the lower
abdomen for monitoring prostate related treatments, such as
irradiation and/or medication for carcinoma.
[0102] Optionally, the wearable monitoring apparatus 100 is
designed to be attached to the thorax of a user 101, optionally as
described below. The wearable monitoring apparatus 100 may
communicate, optionally wirelessly, with a user management unit
102, which may be connected to the hospital IT unit, an emergency
center and/or to a disease management center.
[0103] Optionally, the wearable monitoring apparatus 100 comprises
a thin housing, optionally curved for allowing the attaching
thereof to the body of the user 101 without substantially changing
her general body contour, for example as described below.
Optionally, the wearable monitoring apparatus 100 and/or the
housing thereof is designed to be flexible in a manner that allows
the attaching thereof to people with different contours and/or
encirclement, Optionally, the wearable monitoring apparatus 100
and/or the housing thereof is provided in various sizes.
The attaching of the wearable monitoring apparatus 100 to the
thorax of the user allows the user to wear it below a common blouse
or a shirt. Optionally, the thin housing, which is designed to
contain all the integral parts of the monitoring apparatus 400,
including a processing unit and one or more EM transducers which
are designed to implement monitoring methods, for example as
described in co filed patent application by Dan RAPPAPORT, Nadav
MIZRAHI, Shlomi BERGIDA, Amir SAROKA, Amir RONEN, and Ilan KOCHBA
titled method and system for monitoring thoracic fluids which the
content thereof is incorporated herein by reference. For brevity,
this application may be referred to herein as the co filed patent
application. Optionally, the wearable monitoring apparatus 100 is
connected to a battery, optionally rechargeable.
[0104] Optionally, the wearable monitoring apparatus 100 is
attached to the body of the user 101. Optionally, the wearable
monitoring apparatus 100 includes a replaceable body coupler that
increases the contact between the wearable monitoring apparatus 100
and the user's body and optionally reduces the skin irritation
which could have been caused by the wearable monitoring apparatus
100.
[0105] In some embodiments of the present invention, the wearable
monitoring apparatus 100 is designed to continuously track, in a
plurality of transmission sessions, the fluid content n an internal
tissue of the user 101, such as the pulmonary fluid content user.
As further described in the co filed patent application, the
wearable monitoring apparatus 100 may be used for performing such
monitoring for hospitalized and non hospitalized users during a
monitoring period which is longer than 1, 2, 4, 8, 12, 16, 20 and
24 hours, days, weeks, mouths, and/or years. Such monitoring
includes capturing reflections while the user is ambulatory. As
used herein, ambulatory means a user which is not confined to a
certain location where monitoring is conducted. For example,
ambulatory users may be monitored for periods which are longer than
one hour, without being confined to a certain area and immobilized
users may be monitored for long periods, for example for periods of
24 hours or more, without having to lay in a designated
hospitalization room that is equipped with a stationary monitoring
device.
[0106] In some embodiments of the present invention, the wearable
monitoring apparatus 100 is responsible for the continuous and/or
repetitive monitoring the fluid content, and optionally additional
clinically related parameters, in order to indicate a biological
and/or clinical condition of the user and/or to alert or notify the
user 101 and/or the user management unit 102 about a biological
process, such as a wellness indicative process, a pathological
process and/or a cause of a disease that is detected according to
the detection of an dielectric related properties As used herein,
pathological processes, pathological conditions, and causes of
diseases mean degenerative processes, trauma, atelectasis,
post-operative atelectasis, acute respiratory deficiency syndrome
(ARDS), an infectious causes, an inhaled toxins, a circulating
exogenous toxins, a vasoactive substances, a disseminated
intravascular coagulopathy (DIC), a immunologic processes
reactions, a uremia, a post drowning lung water level, a pulmonary
venous thrombosis, a stenosis, burns, a veno-occlusive disease, a
hypoalbuminemia, an emphysema, a lymphatic insufficiency, a high
altitude pulmonary edema (HAPE), a neurogenic pulmonary edema, a
drug overdose, a pulmonary embolism, an eclampsia, a
postcardioversion, a postanesthetic, a postextubation, a
post-cardiopulmonary bypass an inflammation progress of ARDS users,
postoperative atelectasis and/or any other pathological process
and/or cause of a disease with abnormal fluid content in an
internal body area as a symptom or epiphenomenon. As used herein a
biological process means a process occurring in living organism as
an outcome of a normal and/or abnormal physical action of the user,
such as an athletic activity, for example hiking. The wearable
monitoring apparatus 100 may use repetitive, continuous or
intermittent measurements for monitoring of abnormal biological
processes and/or changes in the routine of the user, for example
monitoring the effect of a certain physical exertion, a diet and/or
an altitude change on the monitored user. Such monitoring may allow
alerting the user about fat to water ratio decrease, prospective
dehydration and/or altitude sickness.
[0107] Optionally, the wearable monitoring apparatus 100 is
configured for continuously monitoring changes in the dielectric
related properties of one or more internal tissues. The reflection
of the EM radiation, which is intercepted by the EM transducers
wearable monitoring apparatus 100 are analyzed to allow tracking
and/or detecting of anatomical, physiological, and/or
pathophysiological parameters. Such an analysis, which may be
performed locally on the wearable monitoring apparatus 100 and/or
using a central server, for example as depicted at 102 of FIG. 2
facilitate generating a clinical status report and/or alert, for
example as described below.
[0108] Optionally, the analysis allows gathering data, which is
based on the intercepted reflections, which reflects a trend, a
pathological pattern, and/or one or more deductive or observational
measurements that reflect a change in the fluid content of an
internal tissue. For brevity, the outcome of such an analysis may
be referred to herein as a change. In use, as further described
below, such an analysis allows the communication interface to send
a report that is indicative of this change and the MMI 207 to
present the change and/or an alert which is based thereon. For
brevity, a communication interface and/or unit, as shown at 208,
which allows forwarding data, such as the report, to third parties,
such as the patient management unit 102 and the interrogator 152,
and a presentation unit, such as the MMI 207, may be referred to
herein as reporting unit.
[0109] The wearable monitoring apparatus 100 may function as an
independent monitoring device, as a sensing unit of a monitoring
system, and/or as a monitoring device that communicates with a
central computing unit, such as the user management unit 102,
during a period which is longer than 1, 2, 4, 8, 12, 16, 20 and 24
hours, days, weeks, mouths, and/or years, in an intermittent or
continuous measurement manner. In such an embodiment, the
monitoring device may be used for gathering, and optionally
analyzing, data, such as dielectric related properties of the
internal tissues, such as the pulmonary tissues, and transferring
the gathered and/or analyzed data to the user management unit 102
for producing a detailed report, a notification, and/or an
alert.
[0110] As used herein, an analysis may include processing any
digitized signal of any of sensors, such as the front end sensors
which are described below, for alerting, reporting, and/or allowing
any other functionality of the user management unit 102 and/or the
wearable monitoring apparatus 100, for example for determining one
or more clinical parameters, such as physiological,
pathophysiological, and anatomical parameters, determining clinical
status of the user, such as a overall health score, determining a
specific disease status, determining trends of change, determining
a probability of change, and determining one or more alert
events.
[0111] Alternatively or additionally, the wearable monitoring
apparatus 100 is designed for locally analyzing the dielectric
related properties of internal tissues, such as the pulmonary
tissues, in a manner that allows the generation of a real time
alert, for example as described in the co filed patent application.
In this context, the term "real time" means that the time the
wearable monitoring apparatus 100 and/or the user management unit
102 takes to output an alert and/or a clinical status is
sufficiently short not to introduce any significant delay in time
between the analyzing the dielectric related properties of internal
tissues and the generation of a real time alert.
[0112] In some embodiments of the present invention, the analysis
allows calculating a biological parameter, such as a clinical
state, of a user based on an integrative index. The biological
parameter may be determined based on a combination between the
dielectric related properties of an internal tissue, such as the
pulmonary tissue, and/or fluid content build up pace and vital
signs and/or detected trends of vital signs which are acquired
using one or more additional sensors.
[0113] Such additional sensors may include sensors such as
electrocardiogram (ECG), electromyogram (EMG), an ultrasound
transducer, a blood pressure sensor, for example an ultrasonic
sensor, a pulse oximeter, activity sensors, for example
accelerometers and tiltmeters, microphone, capnometer, a
coagulometer and any sensor configured for gathering data related
to the physical condition of the monitored user. As used herein, a
physical condition means data related to the physical activity,
vital signs, biological parameters, and/or any other medical and/or
biological information which indicative of the user wellness and/or
fitness of the monitored user.
[0114] The biological parameter, which may be referred to any one
or more values of biological indicators which reflect a status of a
human and/or an organ and/or a tissue thereof, may be determined
based on a combination between the dielectric related properties of
the monitored internal tissue and and/or organ, which optionally
are indicative of a fluid content and/or a fluid content build up
pace and user related medical data, such as medical history, a
diagnosis of the treating physicians, pathology information and
thresholds.
[0115] Optionally, biological parameter may be determined based on
a combination between the dielectric related properties and
additional data that is acquired using the EM transducers, such as
breathing rate and/or depth and heart rate. Optionally, biological
parameter may be determined based on a combination between the
dielectric related properties user related data from external
sources and/or sensors. Such data may include real time clock
reading, medical and/or physiological data which is updated and/or
entered by a caretaker, statistical data provided by the user
management unit 102, and/or manually inputted parameters.
[0116] The data which is acquired from the EM transducers and/or
from the additional sensors allows improving the accuracy of the
acquired biological, optionally clinical, parameters by detecting
and deducing the effect of internal and/or external physiological
activities of the monitored user. For clarity, effects of internal
physiological activities may include heart beat rate, breathing
cycle, and/or blood cycle and effects of external physiological
activities may include effects of posture change, sweating, and/or
external body heat. For brevity, different positioning of an
internal organ and/or tissue in relation to the EM transducers may
also be referred to herein as different postures.
[0117] The integrative index is optionally scaled and/or color
coded to provide intuitive follow-up of the clinical status of the
user. The medical sensors may be embedded into the wearable
monitoring apparatus 100 and/or communicate therewith via a
communication interface. In such an embodiment, the wearable
monitoring apparatus 100 may determine a current clinical state of
the user according to various vital signs, for example according to
known multi-parameters pattern classification algorithms, such as
Bayesian based algorithms and neural networks based algorithms.
[0118] Optionally, dielectric related properties and/dielectric
related propertiesdielectric related propertiesnd/or the vital
signs trends are calculated from recorded and/or logged dielectric
related properties of the user. In such an embodiment, the
dielectric related properties of the monitored tissue may be
collected during a period which is longer than 1, 2, 4, 8, 12, 16,
20 and 24 hours, days, weeks, mouths, and/or years. In such a
manner patterns and/or pace of the accumulation and/or change in
one or more dielectric related properties may be detected. For
example, as described in the co filed patent application, the
pathological pulmonary fluid content, which are calculated by the
wearable monitoring apparatus, are recorded and used for detecting
dielectric related properties, such as an accumulation and/or a
presence pace.
[0119] As the wearable monitoring apparatus 100 allows monitoring
and/or detecting dielectric related properties and/or a change,
such as a fluid content change, a pattern of an accumulation and/or
a dispersal of fluid, within a specific area of interest, a
process, such as parenchyma in the micro level and/ora change of
composition in the macro level of a tissue, such as the monitored
tissue. Optionally, the monitoring and/or detection is based on
gathered data during one or more transmission sessions, from one or
more front end sensors, and on the analysis thereof for detecting a
change caused by a trend, a pathological pattern, and/or a gradual
process. Such an analysis may be based on combination of outputs
from a plurality of sensors. In some embodiments of the present
application, the gathered data is used for detecting such a change
by arranging data in single and/or multiple dimensional model and
optionally comparing the model to a reference model and/or baseline
that reflect a trend, a pathological pattern, and/or a gradual
process. An example for such a model may be a model, such as a 4D
model, which reflects changes in a multi dimensional model, such as
a 3D model, during a period. The multi dimensional model may
reflect dielectric related properties from one or more areas in the
monitored tissue, a blood pressure, an activity level, a glucose
level, body temperature, body mass, and/or the composition of the
fluid content in the one or more areas of the monitored tissue.
[0120] Additionally or alternatively, the wearable monitoring
apparatus 100 may be used for an early detection of pathological
exacerbation, tailored titration of medical treatments and/or
monitoring of the user's clinical status. Optionally, the wearable
monitoring apparatus 100 may be used for monitoring CHF users for
the purpose of detecting the early stages of decompensation states
and/or processes and reduced heart functionalities. Such an early
detection allows a timely treatment that alleviates the symptoms
and may prevent or shorten the hospitalization period of the user
and/or reduce morbidity and/or mortality.
[0121] Optionally, the wearable monitoring apparatus 100 is used
for improving a titration and/or a prognosis process. For example,
angio-genesis medication, chemotherapy and/or irradiation
treatments may be titrated optimized according to readings of the
wearable monitoring apparatus 100. The optimization may be
performed by adjusting the type, intensity and repeatability of
these treatments. Such monitoring allows reducing the exposure of
the user to chemical agents and ionizing radiation by adjusting
their amount according to dielectric related properties of the
monitored tissue, for example by checking the actual concentration
of fluids and/or accumulation patterns. Optionally, the monitoring
allows monitoring the concentration of inflammatory fluids in
and/or between internal tissues. Optionally, the monitoring allows
evaluating the composition of fluids which are accumulated in
and/or between internal tissues, for example the concentration of a
salt, glucose, an anti inflammatory agent and/or a combination
thereof in a certain internal tissue. Such monitoring allows
estimating the wellness of the tissues and/or the pathological
condition thereof.
[0122] Optionally, the wearable monitoring apparatus 100 is used
for alerting the user and/or a medical center about one or more
predefined and/or known biological patterns. such as pathological
patterns of one or more of the following: a degenerative process,
acute respiratory distress syndrome (ARDS), congestive heart
failure (CHF), an atelectasis, a post-operative atelectasis, a
postoperative process, an osculated bronchus, a pulmonary
inflammation progress, a pulmonary blood accumulation, acute
respiratory deficiency syndrome (ARDS), an infectious causes, an
inhaled toxins, a circulating exogenous toxins, a vasoactive
substances, a disseminated intravascular coagulopathy (DIC), a
immunologic processes reactions, a uremia, a post drowning lung
water level, a pulmonary venous thrombosis, a stenosis, a
veno-occlusive disease, a hypoalbuminemia, a lymphatic
insufficiency, a high altitude pulmonary edema (HAPE), a neurogenic
pulmonary edema, a drug overdose, a pulmonary embolism, an
eclampsia, a postcardioversion, a postanesthetic, a postextubation,
and post-cardiopulmonary bypass. The predefined and/or known
biological patterns may include a pattern of a monitored
physiological activity, such as a physical exertion and/or a
predefined and/or known change that correspond with such a
physiological activity. The ability to alert the user and/or a
medical center about one or more predefined and/or known biological
patterns may be performed by an alerting mechanism which is either
implemented on the wearable monitoring apparatus 100, on a remote
medical data center and/or on a combination thereof, for example as
described below.
[0123] Optionally, the wearable monitoring apparatus 100 is used
for monitoring ARDS users. In such an embodiment, the wearable
monitoring apparatus 100 is used for monitoring inflammation
progress along the treatment. Optionally, the wearable monitoring
apparatus 100 comprises multiple front end sensors which are used
for monitoring, optionally dynamically, the spreading of the
inflammation in one or more areas, optionally in response to an
antibiotic medication treatment.
[0124] Optionally, the wearable monitoring apparatus 100 is used
for detecting a progression of post operative atelectasis. Such an
early detection may allow the user to prevent exacerbation of the
user's condition.
[0125] Reference is now made to FIG. 2, which is a schematic
illustration of an exemplary system 150 for managing the monitoring
of dielectric related properties of internal tissues of one or more
users, according to some embodiments of the present invention. The
exemplary system 150 comprises one or more wearable monitoring
device 100, optionally as outlined above and described below and a
user management unit 102, optionally as outlined above and
described below. In some embodiments of the present invention, the
user management unit 102, which may be referred to herein as a
central server, communicates with the one or more wearable
monitoring devices 100 via a computer network 154. As further
described below, each one of the one or more wearable monitoring
devices 100 may be used for analyzing inputs which are received
from their front end sensors and to produce one or more alerts
and/or reports accordingly. Optionally, the user management unit
102 is designed to receive the inputs which are received from their
front end sensors and to analyze and/or generate reports and/or
alerts in a similar manner.
[0126] As further described below, the wearable monitoring
apparatus 100 may be used for gathering data from one or more
sensors, such as EM transducers. The gathered data is either
analyzed for detecting dielectric related properties and/or
dielectric related properties changes in an internal tissue of the
user and/or forwarded for analysis by the user management unit
102.
[0127] Optionally, the wearable monitoring apparatus 100 forwards,
optionally periodically, the gathering data, analyzed or not, to an
interrogator device 152. The interrogator device 152 may be used
for forwarding the data to the user management unit 102.
Optionally, the interrogator device 152 forwards, optionally
periodically, instructions, updates, and/or reconfigurations from
the user management unit 102 to the wearable monitoring apparatus
100.
[0128] Optionally, the user management unit 102 controls and
manages, optionally technically, the one or more interrogator
devices 152, the one or more wearable monitoring apparatuses 100,
and one or more user management unit 102. Optionally, the user
management unit 102 monitors the robustness of the system 150 its
operations, allows remote configuration via the network 154, to
activate and/or deactivate any of the system components.
Optionally, the user management unit 102 may collect clinical data
from the wearable monitoring apparatuses 100 or other of the
components of the system, analyze collected data, manage alerts,
maintain and manage a central database containing user clinical
data, such as current measurements, historical measurements,
alerts, analysis outputs, treatment information, user entered
information, component statuses, component performances, component
version history data, and system management information.
Optionally, the user management unit 102 may facilitate and control
access to the information in the database for authorized system
operators, users, and/or caretakers, for example via remote client
terminals 156 which are connected to the network 154. For example,
a user may access records which are related to the outputs of her
wearable monitoring apparatus 100 for purposes of getting feedback
related to medical condition and/or user compliance. In another
example, the user's caretaker and/or an authorized family member
may access the respective data for doing the same. Optionally, the
user management unit 102 may monitor the technical status and/or
operation of the wearable monitoring apparatuses 100. In such
manner, the user management unit 102 may alert the user and/or the
caretaker about previous, concurrent, and/or prospective
malfunctions of the wearable monitoring apparatuses 100 Optionally,
the wearable monitoring apparatuses 100 are designed to sent,
periodically, continuously, randomly and/or upon the occurrence of
one or more predefined events, data, such as technical status
report, to the user management unit 102.
[0129] Optionally, the user management unit 102 may facilitate
prioritization of a medical treatment and/or procedure to users
which are managed by the system 150. The user management unit 102
may allow a priority driven management of the users according to
the inputs which are received from the wearable monitoring
apparatus 100 and/or the analysis that is performed by them, for
example according to the fluid content in the pulmonary tissue of
the monitored users. In use, the user management unit 102 may
display a GUI that includes a list of all users which are monitored
by the system 150. The list may be ordered according to current
medical risk values which are given to the users. Optionally, the
user management unit 102 may be designed to send an email, an
instant message, an MMS, an SMS, and/or any other digital content
message that includes identifiers of users with a medical risk
above a predefined threshold to a designated address.
[0130] Optionally, the user management unit 102 monitors the
functionality of components of the system 150 and/or the
communication among components of the system 150. Optionally, if a
failure is detected, a technical alert event is initiated any
transmitted to any of the components of the system 150 via
technical communication channels, as further described below. For
example, one of the wearable monitoring devices 100 may be polled
via the aforementioned technical communication channels to ensure
its proper previous, current, and/or prospective functionality
and/or positioning, for example by querying the placement unit,
which is described below. Similarly, other components of the system
could be checked for proper functionality. Optionally, each one of
the component may implement a local technical monitoring
functionality. If a local problem is detected it may relay it to
any other component of the system through the aforementioned
communication channels. The local technical monitoring
functionality may manage the replacement of the wearable monitoring
devices 100 and/or the battery thereof.
[0131] Optionally, the technical communication channels may allow
updating the wearable monitoring devices 100 with new operation
modes, software and/or firmware versions, and/or parameters of
monitoring algorithms and/or any other functional algorithms,
initiating measurements. Optionally, the technical communication
channels may allow initiating a transfer of data, deactivate the
wearable monitoring devices 100, activate the wearable monitoring
devices 100, allowing a remote access to low level memory content,
initiating self tests, resetting and the like.
[0132] Optionally, the system 150 is connected to central medical
units and/or medical data centers 155 which are designed to manage
medical data that is related to the monitored users. In such an
embodiment, the data that is gathered by the wearable monitoring
apparatus 100 and/or the analysis, reports, and/or alerts which are
based thereon are collected and/or managed by the central medical
units and/or data centers 155, which may be referred to herein as
medical data centers 155.
[0133] It should be noted that the system's functionality may be
implemented using some or all of the above mentioned components and
multiple partitioning configurations of the functionalities across
the components are possible, for example as described below. Any of
these components may be implemented as a separate device with
hardware and software; it may also be integrated into existing
third party devices and software application. For example, the user
interrogator device 152 may be integrated into a standard hospital
monitor, a third party tele-health gateway in the user's home, or a
smartphone or a PDA. In another example, the patient management
unit 102 may be integrated into the IT central station application
used in the hospital.
[0134] Optionally, the communication between the components of the
system may be via computer networks, such as 154. Such a
communication may be wired communication and/or wireless
communication, local, such as between components which are located
in the same room and/or remote, such as the communicating of
geographically distributed components over the computer network
154. This communication may be access controlled and/or secured to
protect the privacy of the user's data and the proper technical
and/or clinical operation of the system. Control will be exercised
on who can access which device and which function in the system.
And control will be exercised on which device can communicate with
which device.
[0135] Optionally, as shown at 160, a number of wearable monitoring
apparatuses 100 are connected to a certain user. Optionally, one of
the wearable monitoring apparatuses 100 of the same user may
function as a master device that communicates with the components
of the system as described above and concentrate data which is
received from the other wearable monitoring apparatuses 100 of the
same user. Optionally, the data which is acquired from wearable
monitoring apparatuses 100 of the same user is managed and
concentrated in by the user management unit 102.
[0136] Reference is now also made to FIG. 3, which is a schematic
illustration of a set of components 200 of an exemplary wearable
monitoring apparatus 100, according to some embodiments of the
present invention.
[0137] The exemplary wearable monitoring apparatus 100 which is
depicted in FIG. 3 comprises a central processing unit (CPU) and/or
a digital signal processing (DSP) which may be referred to herein
as a processing unit 201. Optionally, the processing unit 201 runs
a real-time operating system (RTOS) that is responsible for
coordinating all functions of the monitoring device 100. The
processing unit 201 is optionally used for analyzing the outputs of
the one or more front-end sensors 204 which are described below.
Optionally, the one or more front-end sensors 204 capture signals
which are forwarded to the processing unit 201 that calculates
medical indices of interest, which is optionally based on
physiological, anatomical and/or clinical parameters. For example,
the processing unit 201 may compare between the calculated
parameters and a set of one or more predefined values and sets
flags accordingly, for example as described below. The data which
is calculated by the processing unit 201 is optionally used for
generating one or more alerts and/or notifications, as further
described below and in the co filed patent application. It should
be noted, that the term processing unit means a local processing
unit, a distributed processing unit, and/or a remote processing
unit which is used for performing the functioning of the processing
unit which is described herein. In an embodiment in which the
processing unit is remote, the data which is forwarded to the
processing unit is transmitted for remote processing by the remote
processing unit.
[0138] The wearable monitoring apparatus 100 further comprises a
memory unit 202, such as a non volatile memory, that is designed
for storing the operating system and parameters which are needed
for the functioning of the wearable monitoring apparatus 100.
Optionally, the memory unit 202 is used for recording readings of
reflections from the thorax and/or calculations which are based
thereupon, for example as further described below. Optionally, as
outlined above, the dielectric related properties of the monitored
tissue, such as the fluid contents, for example pulmonary fluid
contents which are calculated according to reflections of EM waves
from the thorax, are recorded in the memory unit 202. Such a
recording allows examining changes in the predefined and/or known
biological patterns, such as in the pathological pulmonary fluid
content, along a period that lasts between few hours and days, for
example as outlined above. The recording allows calculating one or
more baselines and/or the identification of a normal range which
are adjusted according to the specific user. Optionally, the memory
unit 202 is used for recording readings of medical sensors which
are connected to the wearable monitoring apparatus 100 and/or
embedded therein. Optionally, the memory unit 202 is used for
storing additional information, such as application executables
codes, configuration files for the processing unit 201, preset
parameters, long term state parameters and tables. The memory unit
202 may be used for storing additional user related data, such as
the user identification information, version information, user
specific thresholds, authentication and/or security keys.
[0139] The wearable monitoring apparatus 100 further comprises a
rapid access volatile memory unit 206, such as a dynamic random
access memory (DRAM), a synchronous DRAM (SDRAM), and/or any other
volatile memory for storing data that is needed to be accessed in a
limited time for short terms. It may be interfaced by the
processing unit 201, the below mentioned designated IC and/or any
other component of the wearable monitoring apparatus 100.
[0140] Optionally, the wearable monitoring apparatus 100 comprises
a designated processing unit 203, such as a designated integrated
circuit (IC), for example an application-specific integrated
circuit (ASIC) or a field-programmable gate array (FPGA) that
contains logic blocks and programmable interconnects which are
programmed to implement some of the functions required to process
the data from the sensors front-ends. The designated processing
unit 203 communicates with the processing unit 201, the memory unit
202, and/or with other components of the device for various tasks.
Additionally or alternatively, the designated processing unit 203
may also implement any of the other blocks as an integrative
solution. For example, the FPGA or ASIC may incorporate the
processing unit 101 and/or another processing unit. Optionally, the
logic blocks are programmed to implement monitoring methods as
described in the co filed patent application.
[0141] As described above and depicted in FIG. 3, the wearable
monitoring apparatus 100 further comprises one or more front-end
sensors 204, such as EM transceivers, for transmitting a plurality
of electromagnetic (EM) waves toward the thorax of the user and for
capturing reflections thereof from an area of interest, such as the
pulmonary tissues of the user 101. In some embodiment, the beam is
transmitted in a desired pulse and allows the capturing of a
reflection thereof from various areas on the surface of the user's
body. Optionally, the capturing of a reflection is adjusted
according a selected operational mode, for example according to a
selected swept frequency, a selected frequency hopping chirp, and
the like. Other modes and/or gating patterns according to which the
beam is transmitted and allows the capturing thereof are described
in the co filed application.
[0142] In such a mode, time gating may be used for focusing on a
specific reflection, for example as described in the co filed
patent application. The shape of the pulse may be generated using
different shaping techniques.
[0143] In some embodiments of the present invention, the front-end
sensors 204 include EM transducers which are designed for
transmitting one or more pulses of EM radiation and intercepting
the reflections of the EM radiation from monitored tissues and/or
organs of the monitored user. Optionally, the monitored tissues are
internal tissues, such as the pulmonary tissue. The intercepted
reflection is converted to a signal having different features that
allows evaluating dielectric related properties of the monitored
tissues and/or organs, for example as described below. The EM
transducers are optionally designed to continuously transmitting
and analyzing the reflection for monitoring dielectric related
properties of the monitored tissues and/or organs, which may be
referred to herein, for brevity, as the monitored tissues.
[0144] Optionally, in order to achieve high range resolution while
keeping the implementation relatively simple close range detection
pulses are used,. The shorter the pulse the higher is the space
resolution. Such pulses are known in the art and therefore not
discussed in great detail.
[0145] Optionally, the EM transducer is designed to transmit one or
more stable frequency continuous wave (CW) radio signals and then
to receive the reflection thereof from internal tissues and/or
objects. The one or more CW radio signals may be transmitted,
simultaneously or sequentially. For example, the CW radio signals
may be transmitted in frequencies such as 900 MHz and 2.5 GHz. The
CW radio signals may sweep one or more frequency ranges allowing
measuring reflections in wide range of frequencies. CW signals
reflections as well as any narrow band signal reflection may
achieve high dynamic range by using narrow filtering around the
used frequencies. The narrow filter may track the signal over time,
for example, it may sweep together with the signal.
[0146] Optionally, the spatial and/or timing information is
extracted by using multiple frequencies. Such information is mainly
conveyed in the received phase of the signal. Optionally where a
low number of frequencies which are not well spread over a large
bandwidth results in a relatively poor or void time resolution. A
single frequency allows generating differential measurements for
measuring a movement and/or a displacement of a tissue and/or an
organ by sensing a change over time of mainly the phase but also
the amplitude of the received reflection. When a dielectric
coefficient of a tissue and/or an organ changes, mainly the
amplitude but also the phase of the reflection may respectively
change. Multiple CW signals with spatial resolution thereof are
indicative to a localized movement and/or displacement and/or
dielectric changes.
[0147] As described above, the CW radio signals may be transmitted
in one or more continuous or intermittent transmission sessions. In
such an embodiment, known changes in internal organs may be used
for performing differential measurements that may be indicative of
dielectric coefficients of a monitored tissue and/or organ.
Examples for physiological processes during which the changes in
the internal organs are known may be heart beat cycle and/or a
breathing cycle.
[0148] For example, the breathing cycle changes the dielectric
coefficient of the pulmonary tissue. Such a change affects mainly
the amplitude but also the phase of a CW signal which is reflected
from the pulmonary tissue. A record that documents changes in the
dielectric coefficient of the pulmonary tissue during at least one
breathing cycle may be used as a reference for monitored tissues
and/or organs, for example monitoring the fluid content in a
monitored pulmonary tissue, for example as described in the co
filed application.
[0149] In another exemplary embodiment, the dielectric coefficient
of a pulmonary tissue may be monitored by tracking a differential
measurement calculated based on the reflection from the interface
between the lung and the heart during the systolic and diastolic
phases of the cardiac cycle. As the movements of the heart are
relatively rapid .about.1 hertz (Hz) with respect to posture
changes and movement, such a calculation reduce the effects of
posture change and movement.
[0150] Reflections from the heart through the lung are changed, in
phase and/or amplitude, during a systole diastole cardiac cycle. In
some embodiments of the present invention, these reflections are
used to evaluate a fluid content in a monitored pulmonary tissue.
Thus, in order to improve the accuracy of this evaluation, the
effect of the systole diastole cardiac cycle on the reflection has
to be taken into account.
[0151] Changes in the phase and amplitude of reflections from the
heart through the lung are indicative of dielectric related
properties changes where the measurement itself is posture
resilient. In particular, the phase of the systole-diastole
differential measurement is indicative of a dielectric change in
the lung. Changes in the concentration of fluids in the lung affect
the phase velocity (EM radiation propagation speed) and therefore
may be used for evaluating the fluid content in the lung. The
amplitude of the differential signal is also indicative to
dielectric change in the lung, as a pulmonary tissue with a certain
concentration of fluids absorbs more of EM radiation that
propagates therethrough than a pulmonary tissue with a lower
concentration. The higher is the absorptions of reflections the
lower are the reflections from the heart. Optionally, the reduced
effect of the posture on the reflections is identified and further
reduced using the posture detection methods which are described
below.
[0152] In some embodiments of the present invention, the one or
more EM transducers use a simplified narrow band and/or a
multiple-band antenna, with one continuous band or several bands,
which are matched to the monitored tissue and/or organ. Optionally,
a placement mechanism or unit, such as the placement unit which is
described below, is used for shifting the matching bands of the
antenna according to the positioning thereof Optionally, the CW
signals are shifted each separately or jointly, so as to achieve
optimal sensitivity to one or more parameter, such as shifts in
respiration and heart rates.
[0153] Optionally, the CW signals referred to in this patent are
equivalent to narrow-band signals, and all descriptions referred to
such CW signals may be equivalently referred to the narrow-band
signals. As used herein a narrow-band signal means a signal
spreading over a small frequency band, for example up to 50 MHz,
optionally modulated and used to expand the band of the transmitted
energy. Such modulation may be frequency hopping, chirp,
frequency-shift keying (FSK), phase-shift keying (PSK), amplitude
Shift Keying (ASK) and the like. In such an embodiment, the EM
transducers may de-modulate the reflections to compress the band
back before further filtering and detection for improved
sensitivity and dynamic range.
[0154] Optionally, the frequencies of the narrow band signals are
900 Mega Hertz (MHz) and/or 2.4 gigahertz (GHz) industrial,
scientific, and medical (ISM) bands. Optionally, two frequencies,
such as the aforementioned two frequencies, may be combined to
improve time resolution and/or to separate reflections from
neighboring interfaces, or may be used for improved sensitivity. In
such an embodiment, the lower frequency penetrates deeper and less
sensitive to small displacements. In such an embodiment, radiation
in different frequency may be produced sequentially or
simultaneously.
[0155] Optionally, narrow-band signals may be used jointly with
pulsed wideband signals so as improve the overall sensitivity and
robustness of the transmission session. As commonly known, a narrow
band antenna is more directive and allow more power to be used for
the narrow band signals. Optionally, the pulse wideband
transmission may achieve improved spatial resolution while the
narrow band signals may improve the penetration depth and extract
information from deeper layers.
Optionally, the one or more front-end sensors 204 includes
additional medical sensors, such as an electrocardiogram (ECG), an
electromyogram (EMG), ultrasound transducers, pulse oximeters,
blood pressure sensors, accelerometers, tilt-meters, coagulometers,
and optical blood saturation detectors.
[0156] In one example of the present invention, the wearable
monitoring apparatus is attached to the skull of a user and used
for monitoring a build up of intra-cranial pressure which may be a
consequence of a head injury. The device may be focused on a
specific location according to inputs from an imaging modality such
as an MRI and/or a CT modality, either automatically and/or through
a manual user interface. Alternatively, a broad region should be
monitored either by a wide range of irradiated region from a single
device or by a multiple transducers in a configuration as described
below. The monitoring period is relatively short of few days, and
the measurements frequency is relatively high specifically right
after initial placement of every few minutes.
[0157] Optionally, the one or more front-end sensors 204 include
one or more EM transceivers which are designed for generating sharp
pulses. Optionally, the EM transceivers are connected to and/or
include one or more amplifiers, such as a low noise amplifier
(LNA). Optionally, the EM transceiver having a slim profile that
allows the manufacturing of a slim wearable monitoring apparatus
100, for example as depicted in FIGS. 4A and 4B.
[0158] Optionally, the EM transceiver is designed for sampling
pulse signals which are echoed from an internal area in the body of
the user, such as the pulmonary tissues, and indicative of the
dielectric related properties of fluids, such as water, blood,
and/or inflammation fluids therein.
[0159] Optionally, each EM transceiver utilizes one or more
antennas for transmitting and/or intercepting EM signals. Each
antenna may be configurable by setting antenna controls.
[0160] In some embodiments of the present invention, the antenna is
a low reverberation antenna, such as a planar wide band antenna
adapted for reducing the effect of reverberations upon the quality
of signal transmission. Such an antenna produces a short duration
fast-decaying pulses for improved time and range resolution.
Optionally, the antenna terminates the radiation using lumped
resistors to reduce reverberations, which may be referred to as
re-ringing of currents, from the far end of the antenna and emulate
an infinite antenna, without a need for printing tapered resistive
layers.
[0161] Reference is now also made to FIG. 4A, which is a schematic
illustration of an exemplary EM antenna 350 of an EM transducer,
such as a transceiver, according to some embodiments of the present
invention. In some embodiments of the present invention, the EM
antenna 350 comprises resistors 351, which are optionally discrete
resistors, a field transducer 352, a matching construction 353 and
a dielectric substrate 354, which is optionally made of a flexible
material and supports the construction of these components. The
dielectric substrate 354 contains any flexible or non-flexible
composite material, such as a polymeric film, paper, a fabric band,
a rubber band, and a leather band.
[0162] The field transducer 352, which is optionally metallic, is
circular plate having a rounded biconic slot, which etched or
engraved onto its surface. Optionally, the field transducer 352 is
made of an electrically conductive material, such as metal and
electrically conductive polymeric resins. Optionally, the rounded
biconic slot 355 forms two round cones which are connected with two
strips, such as extended strips, which may be supported by the
dielectric substrate. In another embodiment, shown at FIGS. 4B and
4C, a connector, as shown at 355, such as a subminiature version A
(SMA) connector, is used to connect the antenna and a transition
line that leads the current to the center of the antenna. The
circular plate is farther etched or engraved with two opposing gaps
that allow the assembling of the resistors, such as lumped
resistors, lumped coils, and/or lumped capacitors thereon.
Optionally, the resistors are assembled between the two round cones
at the opposing strips ends, for example as shown at 351.
[0163] As the EM antenna 350 comprises discrete resistors, printing
of resistive layers may be avoided and the manufacturing cost of
the EM antenna 350 may remain relatively low.
[0164] The structure of the exemplary EM antennas, which are
depicted in FIGS. 4A and 4B, allows the transmitted electromagnetic
energy to spread along the field transducer 352 with minimal or no
disturbance. The electromagnetic energy that is not emitted from
the EM antenna 350 is absorbed by the dielectric substrate 354 and
optionally converted to heat.
[0165] In the antenna which is depicted in FIG. 4A, the matching
construction 353 is optionally an unbalanced transmission line
having an ungrounded conductor that carries electrical current from
the power source connected at one apex of one of the round cones
that comprise the biconic slot while a shield is continuously
connected between the other apex of the other round cone and the
rounded side thereof. The unbalanced transmission line is either
pulled perpendicularly to the surface of the field transducer 352
or ended at the point in which the pulse transmitting and
intercepting circuitry is assembled. Optionally, the unbalanced
transmission line is embedded into a dielectric surface.
[0166] The arrangement that is depicted in FIGS. 4A and 4B reduce
the ringing effect in low frequency band. As used herein the
ringing effect means a distortion in the form of a damped
oscillatory waveform superimposed on the main waveform of the EM
wave that is captured by a respective transducer. For example, the
EM antenna 350 which is depicted in FIGS. 4A and 4B have a reduced
ringing effect and decays its pulse by additional -15 decibel (dB)
after 1 nano second (ns) compared with bow-tie antenna.
[0167] It should be noted that such an arrangement allows the
positioning of the EM field transducer 352 concomitantly to the
body of the user. Such a positioning may soften the high
back-scatter of energy that is caused by the antenna-skin interface
that limits the dynamic range of the EM antenna 350.
[0168] Optionally, the antenna can be embedded within dielectric
material to further decrease its dimensions or to expand its band
to lower frequencies. As commonly known, a dielectric material
improves the antenna performance by scaling of its dimensions.
Optionally, the used dielectric material is a high dielectric
material that slows the speed of light in an affective manner and
allows a reduced size antenna. Such a reduced size antenna allows
reducing the size of the wearable monitoring apparatus 100.
[0169] Optionally, the dielectric material is designed for
separating the antenna from the skin and used to improve
antenna-body EM wave penetration as well as reduce strong coupling
between the antenna and the conductive skin. Optionally, the
dielectric material is selected according to the thickness of the
skin and fat layers of the user in a manner that reduces
reverberations in these layers. In such an embodiment, the
returning reflected pulse propagating to the antenna experiences a
minimal impedance mismatch of the skin and minimal reflected power
returns into the body for a sequential rounds.
[0170] Optionally, the antenna may be adjusted to the body
impedance of a selected user by selecting matching resistors.
[0171] Optionally, the thickness of the EM antenna 350 is below 15
mm. Such a slim construction of the EM antenna 350 allows the
generation of a slim wearable monitoring apparatus 100 that may be
positioned on the surface of the user's thorax 101 relatively
without affecting on the ability of the user to perform daily
tasks, such as dressing, eating, and preparing meals. Optionally,
the antenna can be curved to match the body part. The curving may
be used to fix the antenna at a certain point on the body and
reduce or eliminate its movements while the user moves.
[0172] Optionally, the EM transducers are adjusted for transmitting
and intercepting EM radiation in intermittent data acquisition
sessions, which may be referred to herein as transmission sessions.
Optionally, the pace of the data acquisition sessions is constant.
Optionally, the pace of the data acquisition sessions is random.
Optionally, the pace of the data acquisition sessions, which may be
referred to herein as a sampling rate, is adaptive. In such an
embodiment, the data acquisition session rate, which may be
referred to herein as a sampling rate, may be reduced when
biological indications, which are monitored by the wearable
monitoring apparatus 100, indicate that the risks for the monitored
user decrease, for example when the monitored tissue is pulmonary
tissue and it is less likely that the user develops
cardiorespiratory decompensation. Similarly, the sampling rate may
be increased when biological indications which are monitored by the
wearable monitoring apparatus 100 indicate that the risks for the
monitored user increase. Optionally, the sampling rate is
determined according to the latest trend measurements. For example,
if the case of slow rate of change of a monitored parameter in a
given past period of time, the sampling rate me be reduced and vice
versa. Optionally, the sampling rate is manually adjusted by the
caretaker, optionally according to characteristics which are
specific to the user. Optionally, the sampling rate is
automatically adjusted, optionally according to one or more
monitored biological indications, for example according to a ratio
between the user's monitored biological indications and statistical
data which has been gathered from monitoring other users,
optionally with similar physiological characteristics and/or
medical condition. For example, if the medical condition of the
monitored user matches to a New York heart association functional
(NYHA) class-3 user without pleural effusion, an electrical
implantable device, such as CRT, ICD, and/or a pacemaker, and a
renal deficiency, the sampling rate is set to a data acquisition
session of 3 minutes every 6 hours. Optionally, the sampling rate
is updated automatically, according to changes in the medical
condition of the user.
[0173] In some embodiments of the present invention, the wearable
monitoring apparatus 100 is designed for hosting and/or accessing a
tissue model, such as the chest model, which is described in the co
filed application, or other body part model. The tissue model may
define the range of normal as well as abnormal dielectric related
properties in different tissues, their dimensions and/or respective
spatial configurations, and used in the analysis of the EM
reflected signals as described above and below and in the co filed
patent application, for example for detecting symptoms, predefined
biological patterns and/or pathological patterns and/or changes,
for example as described in the co filed patent application.
[0174] Optionally, the wearable monitoring apparatus 100 is
designed for eliminating the effects of the movements and/or
changes of postures on the analysis of the measured EM reflected
signals and determination of the biological parameter of the user.
In some embodiments of the present invention, the wearable
monitoring apparatus 100 is designed for gating the inputs of the
one or more front-end sensors 204 for example as described in the
co filed patent application. For example, the wearable monitoring
apparatus 100 may be used for allowing the selection of reflection
segments which are received from areas of interest having a static
or dynamic location in relation to the wearable monitoring
apparatus 100, for example as an outcome of physiological processes
such periodical breathing cycle and/or heart beat pace, for example
as described in the co filed patent application.
[0175] In some embodiments of the present invention the wearable
monitoring apparatus 100 is designed for eliminating the effects of
the movements and/or changes of postures on the analysis of the
measured EM reflected signals and determination of a biological
parameter of a user, for example as described in the co filed
patent application. In such an embodiment, the wearable monitoring
apparatus 100 comprises one or more posture detection sensors (not
shown), such as accelerometers and tiltmeters, which provide data
for classifying the current posture and/or activity level of the
monitored user and/or for detecting a change on the posture of the
user. In such an embodiment, the posture detection sensors may be
connected to the processing unit 102 and utilize it for calculating
the current posture and/or a change in the posture.
[0176] Optionally, the wearable monitoring apparatus 100 detects
the posture of the monitored user and movements by analyzing the EM
reflected signals as described below. In such an embodiment, data
related to posture, movement, and/or activity of the monitored user
may be used for identifying a period for performing a data
acquisition session, such as the data acquisition sessions which
are described below. In such a manner, biological indications, such
as dielectric related properties, which are related to the
monitored tissue of the monitored user may be acquired while the
user performs an activity during which she is in high risk and/or
while the data may be acquired in the most accurate and/or
productive manner. For example, performing a data acquisition
session may be triggered by the wearable monitoring apparatus 100
when the monitored user is undergoing high physical exertion and/or
while the monitored user is at rest.
[0177] In some embodiments of the present invention the wearable
monitoring apparatus 100 is designed for analyzing the EM waves
which are received from the front end sensors 204 according to the
frequency thereof For example, high frequencies may experience
changes resulting from a monitored physiological phenomenon, for
example due to frequency dependent dielectric change. For example,
fluid accumulation in the lung results in a stronger absorption of
the higher frequencies. The frequencies may be analyzed according
to wavelet transforms that provides frequency ranges and/or
locality in time.
[0178] Optionally, the wearable monitoring apparatus 100 is
connected to a power supply element circuitry 205 that is designed
for generating and distributing the power supply that is required
for the components of the wearable monitoring apparatus 100.
[0179] The power supply element circuitry 205 comprises one or more
batteries, optionally rechargeable.
[0180] Optionally, the wearable monitoring apparatus 100 comprises
a man-machine interface (MMI) 207 for presenting data, such as an
alert, a notification, statistical data, a current reading of the
one or more front-end sensors 204 or external modality to the user,
the user's caretaker, and/or others as desired. The MMI 207 may
comprise a liquid crystal display (LCD), a touch screen, a speaker,
a tactile generator, a set of light emitting diodes (LEDs), and/or
any other indicator that may be used for presenting alerts and/or
notifications which are based on a combination of the analysis of
reflections of EM waves from an internal area in the body of the
user, such as the pulmonary tissues, and indicative of the
dielectric related properties of fluids, such as water, blood,
and/or inflammation fluids therein and other parameters calculated
based on the EM reflections and\or the integrated or external
sensors. Optionally, the configuration of the wearable monitoring
apparatus 100 may allows the user and/or a caretaker to define
which alarm to present, for example whether the alarm is visual,
audible, and/or tactile.
[0181] For example, when an alert is initiated as an outcome of the
implementing of the aforementioned logic blocks the MMI 207 sounds
an alert using one or more speakers and displays an appropriate
message on an LCD display thereof.
[0182] Alternatively or additionally, an MMI 207 which is
configured to perform the aforementioned functionalities is
connected to a remote unit that communicates with the wearable
monitoring apparatus 100, such as the aforementioned interrogator
device 152 and/or any component of the user management unit
102.
[0183] Optionally, the MMI 207 and/or the MMI of the remote unit is
connected to an input unit, such as a keyboard, a keypad, a touch
screen and/or any other unit that allows the user, the user's
caretaker, and/or others as desired to configure the wearable
monitoring apparatus 100, adjust the MMI 207, make selections,
and/or change modes of the MMI 207. Optionally, the MMI 207 and/or
the MMI of the remote unit allows the monitored user to activate
and/or deactivate the wearable monitoring apparatus 100, snoozing
an alert, presenting the gathered data on which the alert is based,
changing operational mode and the like.
[0184] Alternatively or additionally, the MMI 207 is configured for
notifying the user when a battery replacement is necessary.
Optionally, the MMI 207 uses the outputs of a placement unit 210,
for example as described below, for guiding the user during the
process of repositioning the wearable monitoring apparatus 100
after the battery replacement, for example by providing voice
commands.
[0185] In some embodiments of the present invention, the wearable
monitoring apparatus 100 is disposable. In such an embodiment, the
MMI 207 may indicate to the monitored user when and optionally how
to replace the wearable monitoring apparatus 100. Optionally, the
placement unit is used for instructing the monitored user during
the positioning of the wearable monitoring apparatus 100, for
example but indicating to the monitored user when it is accurately
positioned.
[0186] Optionally, the wearable monitoring apparatus 100 is
integrated and/or designed to be integrated into a garment, such as
a chest strap, a shirt, a vest, a hat, a sticker, pants, underwear
and the like. Optionally, the wearable monitoring apparatus 100 is
divided to disposable and reusable parts. The disposable part may
include the battery, an attachment unit for attaching the wearable
monitoring apparatus 100 to the body of the user, and/or any other
electronic component that may be worn out by the use of the
wearable monitoring apparatus 100.
[0187] Optionally, the wearable monitoring apparatus 100 is
designed to perform, either automatically and/or according to a
request from the user management unit 102, a maintenance
activity.
[0188] Optionally, the wearable monitoring apparatus 100 comprises
a communication module 208 that allows a user, a caretaker, and/or
any other authorized monitored user to configure and/or update
thresholds, user related data, and/or any other data which is
related to the functionality of the wearable monitoring apparatus
100 from a remote client terminal or a communicating computing
unit, for example via the user management unit 102, an interrogator
device 152, and/or client terminal which is connected thereto. As
used herein a client terminal is a personal computer, a cellular
phone, a laptop, a personal digital assistant (PDA), and/or a
Smartphone.
[0189] Optionally, the configuration comprises a set of initial
parameters, such as the medical condition of the user, medical
history related to the user, the age of the user, the severity of
the user's condition, the weight of the user, the height of the
user, an approximation of the user's chest diameter, and an
indicator for one of the area selected for the apparatus. This
configuration allows the adjusting one or more dynamic alert
thresholds and/or any other characteristics of the alerting
mechanism. Such an alert threshold may define the conditions for
the activation of an alert for the user, the dosage control unit,
and/or notifying a medical center about the data that has been
gathered using the one or more front-end sensors 204. Several
alerts threshold may be defined in a manner that allows a graded
alerting, controlling a dose amount in a graduate manner, and/or
notifying a severity of diagnosis, for example as described in the
co filed application.
[0190] Reference is now made, once again, to FIG. 2. In some
embodiments of the present invention, the remote client terminals
156, the medical data center 155, and/or the MMI 207 of the
wearable monitoring apparatus 100 may be used for configuring the
thresholds. Optionally, a technical communication channel is
established between the remote client terminals 156, the
aforementioned interrogator device, the aforementioned patient
management unit, and/or the medical data center 155 and each one of
the wearable monitoring apparatuses 100 and allows transference,
optionally bidirectional, of data and/or instructions. In such an
embodiment, the technical communication channel may utilize a
caretaker to adjust the alerting thresholds. For example, a
caretaker may be able to use a client terminal for adjusting a
threshold for a user for whom false alerts are activated. In
another example, the caretaker selects and/or changes an
operational mode in a manner that may adjust the thresholds to the
requirements of different routines, such as hospitalized mode,
ambulatory mode, sleeping mode, and/or sport mode, unstable mode,
and/or aggressive treatment mode. The term ambulatory may be used
for describing different levels of motorial abilities, such as a
partly ambulatory users which have the ability to walk freely in a
limited pace and/or with a support, semi ambulatory users which
have the ability to walk freely in a limited pace, and fully
ambulatory which have the ability to walk, run, and/or jump freely,
in various paces.
[0191] In some embodiments of the present invention, the remote
client terminals 156, the medical data center 155, and/or the MMI
207 of the wearable monitoring apparatus 100 may be used for
adjusting and/or defining the alerting mechanism. Optionally, the
alerting mechanism is part is of the analysis of the outputs of the
aforementioned front end sensors and/or biological information that
is related to the monitored user, such as physiological,
anatomical, and clinical data related to said user. Optionally, the
multiple alerts are defined based on part and/or all of the data
that is received from the front end sensors and/or medical
databases and sources which are related to the user.
[0192] Optionally, the alerting mechanism is configured to trigger
the presentation of an alert on the wearable monitoring device and
in a set of plurality of different client terminals, medical
centers and stations, such as the remote client terminals 156, the
medical data center 155, the patient management units, the
interrogator devices, and/or the MMI 207. The set of plurality of
different devices and stations may be reconfigured by authorized
members. New members, such as any client terminal of the user, a
remote caretaker, a local caretaker, a selected family member, an
affiliated person, a staff member of call center, a nurse, a and
the like may be added.
[0193] Optionally, the alerting mechanism is designed for sending
an email, an instant message, an MMS, an SMS, and/or any other
digital content message for alerting the user and/or a caretaker.
In such an embodiment, the user, the caretaker, and/or a system
operator may enter an address identifier, such as a phone number,
an email address, and/or an IM monitored user name to which the
alerting messages will be sent. Optionally, the alerting mechanism
is designed for triggering the alarm which may be put in a snooze
mode by the user and/or the caretaker. For example, the user may
snooze an alert indicated to him by an audible signal for duration
of an hour. Once she has contacted her medical caretaker the
caretaker may direct the user to increase his medication and
snoozes the alert to different optionally longer durations.
[0194] Optionally, the wearable monitoring apparatus 100 comprises
a communication interface 208 for establishing a connection,
optionally bidirectional, with the user management unit 102, and/or
with the interrogator unit. The connection allows the wearable
monitoring apparatus 100 to transfer that data that is stored in
the memory unit 206. Optionally, the communication interface 208 is
based on wired connection, for example a universal serial bus (USB)
interface. Alternatively or additionally, the communication
interface 208 is connected to a wireless data interface, such as an
example an infrared (IR) interface, a wireless fidelity (Wi-Fi)
interface, a Bluetooth.TM. module, a electromagnetic transducer
module, a universal asynchronous receiver transmitter (UART) and
the like. Optionally, the connection allows the wearable monitoring
apparatus 100 to report on a malfunction in one of one or more
front-end sensors 204 and on any other malfunction in the
monitoring of the dielectric related properties of fluids in an
internal area of the user's body's, for example in the pulmonary
tissues of the user 101. Optionally, the communication interface
208 is used for supporting the configuration of the device, for
example by allowing the uploading of state parameters, version
control software elements for updating firmware and software
components, and for reporting current and recorded information such
as clinical parameters such as heart rate, breathing frequency,
edema condition, and/or any parameter measured by one of the
aforementioned sensors, and any parameter or data calculated based
thereupon.
[0195] Optionally, the wearable monitoring apparatus 100 is
designed to communicate with the user management unit 102 and/or an
interrogator device 152, as outlined above and described in the co
filed patent application.
[0196] Optionally, the wearable monitoring apparatus 100 is
connected to a dosage control unit (not shown). The dosage control
unit may be integrated, in a detachable or fixed manner, into the
wearable monitoring apparatus 100. Optionally, the dosage control
unit is designed to control the dispensing of a medication.
Optionally, the wearable monitoring apparatus 100 is designed to
generate a treating dosage recommendation according to the measured
dielectric related properties, vital signs, and/or any other data
which has been captured by the front end sensors or available
otherwise. The treating dosage may define a change in the quantity
and/or frequency of a certain treatment. Optionally, the wearable
monitoring apparatus 100 changes the manner the dosage control unit
controls the dispensing of a medication according to the defined
change and/frequency.
[0197] Optionally, the wearable monitoring apparatus 100 is
connected, optionally wirelessly to a control unit (not shown),
such as a valve in a system for assisted ventilation of patients
and for administration of anesthetic gas, based on the estimations
of the breathing depth and the degree of the independent
respiration muscle operation. Examples of ventilation techniques
include positive airway pressure (CPAP), assisted or controlled
ventilation and intermittent mandatory ventilation, among others.
In use, the patient's lungs are ventilated by cycling airway
pressure between ambient atmospheric pressure and some higher
ventilation pressure. During the high pressure phase of the cycle,
the lungs are inflated with the breathing gas mixture supplied by
the system. During the ambient pressure phase, the lungs deflate as
the patient spontaneously exhales the gas into the atmosphere or
other suitable exhaust facility. Optionally, the valve control unit
is designed to control the opening and/or closing of the valve
and/or the size of its orifice. Optionally, the wearable monitoring
apparatus 100 is connected, optionally wirelessly to an implanted
medical device. In such an embodiment, the communication interface
208 may be used for transmitting and/or forwarding instructions to
the implanted medical device according to the detected change, for
example according to a detected change in dielectric related
property.
Optionally, the dosage control unit is designed to control or
provide a feedback to treatments in oncology, such as irradiation
therapy, chemotherapy, anti angio-genesis therapy, and the like. In
such an embodiment, the communication interface 208 may be used for
transmitting and/or forwarding instructions to the dosage control
unit and/or to a presentation unit that present a recommended
dosage and/or medicament to the user and/or to a treating medical
personnel. Optionally, the dosage control unit is designed to
provide data regarding the effectiveness of the treatment in the
current posture of the patient and/or placement of the wearable
device, and providing a feedback regarding the frequency of the
treatment and the dosage in use. Moreover, it may be used to
provide a feedback regarding the peripheral damage to a normal
tissue as a consequence of the treatment. This feedback may be used
for directing instructions and may be based on the dielectric
related properties, changes and/or patterns which are calculated by
the designated processing unit 203, according to intercepted
reflections and integrated and external sensors.
[0198] Optionally, the wearable monitoring apparatus 100
communicates, optionally wirelessly, with one or more other
wearable monitoring apparatuses which are used for monitoring
dielectric related properties of fluids in other internal tissues
of the body of the monitored user.
[0199] Optionally, the wearable monitoring apparatus 100 may be
placed in several positions in relation to the user's thorax 101. A
location for positioning the apparatus may be selected such that
the pulmonary tissues are monitored during a full breathing cycle
of the user 101. For example, the position may be in front of the
fifth and sixth ribs, at the right mid axillary line, for example
as shown at FIG. 5. It should be noted that positions in which the
lungs wall is monitored in portions of the breathing cycle may also
be selected.
[0200] In some embodiments of the present invention, the wearable
monitoring apparatus is designed to beam different areas of
interest of the thorax from different angles. Optionally, the
wearable monitoring apparatus includes a number of different
antenna elements which are spaced from one another. Such a spatial
diversity allows separately focusing on one or more of the areas of
interest and improves spatial and time separation in transmission
and/or reception. Optionally, the ROI may change according to one
or more physiological activities such as breathing. Optionally, a
tracking mechanism is used to adaptively change the phase and
amplitude of one or more of the antenna elements. Measurements of
two or more areas may improve relative measurements which are used
as an informative feature for posture cancelation and/or
physiological parameter extraction, as explained below.
[0201] Optionally, a number of transducers are directed to capture
reflections from a common tissue. In such an embodiment, the
captured reflections may be combined for improving the lungs
dielectric coefficient sensitivity.
[0202] Separating the angle of transmission from the angle of
reception reduces effects of undesired near antenna changes, such
as movements and posture changes. The reception from a transmission
path results in a relatively strong reflection from the near
antenna layers. A change in such a layer may override important
information from an internal tissue in the body. Two or more
transmitting and receiving elements may reduce the strength of the
reflection received from layers which are close to the antenna
while giving more weight to reflection from the internal
tissues.
[0203] The positioning of the number of different antenna elements
may be adjusted for specific suspected pathologies. For example,
for monitoring co-morbidities of heart failure and chronic
obstructive pulmonary disease (COPD), designated antenna may be
located in front of the right upper pulmonary segment and the lower
left pulmonary segment. Such antenna elements allow the detection
of differences of congestion levels between different segments, for
instance by a function of posture and/or activity which may assist
in the diagnosis of the current etiology of the fluid
congestion.
[0204] Reference is now made, once again, to FIGS. 1 and 2. In some
embodiments of the present invention, the wearable monitoring
apparatus 100 is designed for detecting the posture and/or the
activity of the user, thereby to generate clinical parameters that
take into account the posture of the monitored user.
[0205] Reference is also made to FIG. 6A, which is a flowchart 450
of a method for using EM radiation for alerting a user, and the
posture detection block 450 detecting a posture of a user,
according to some embodiments of the present invention. FIG. 6A
depicts, inter alia, exemplary modus operandi of the posture
detection unit 211, which is depicted in FIG. 3.
[0206] Optionally, the wearable monitoring apparatus 100 is
designed for identifying postures based on dielectric related
properties of internal organs and/or tissues as extracted from the
analysis of the EM reflected signals and/or other outputs of other
sensors. In the EM-based posture detector case, posture may be
defined as the relative position of the radiating element and
monitored internal or external organ. As shown at 452, data from
the one or more EM transducers is received at the wearable
monitoring apparatus 100. Optionally, additional data 441 from the
front end sensors 204 and/or from external data sources 443, such
medical data about the user from medical databases is gathered. As
shown at 454 the medical data may be stored and/or received from
the memory of the wearable monitoring apparatus 100. The data
441-443 may be received simultaneously, sequentially and/or
interpedently.
[0207] Optionally, the EM radiation 442, such as the aforementioned
reflected signals, and the additional data 441, 443 is processed,
as shown at 455 to allow the extraction of features therefrom, for
example as shown at 456. A feature may be based on the morphology
and/or timing of the received EM signals. For the posture detection
functionality features indicative to the posture are extracted,
such features may include for example the reflected signal gated to
the near-antenna layers reflections, assumed to have strong posture
indication. Other features are extracted for the purpose of
measuring the dielectric related properties of the desired organ
and used in 459. These features are indicative to the measured
tissue and/or organ dielectric related properties. Some of them are
sensitive to posture changes and some are more resilient. Examples
of features that may be used for posture classification and
acquired by analyzing reflections of EM radiations are morphologies
reflections, amplitudes, positions of peak of signals from
reflections of selected tissue boundaries, such as fat-muscle,
lung-heart, and muscle-lung, differences of amplitudes in signals
which are based on reflections and/or peak positions, either among
different segments of the signal or between signals measured at
different time instances, for example amplitude difference of the
reflection received from lung-heart boundary in a signal measured
in the time instance of contraction, compared to a signal measured
in the following relaxation; or similarly for the muscle-lung
boundary during end-expiratory and end-inspiratory time instances.
Optionally, frequency domain features may be extracted from the EM
reflection, like amplitude and phase response of a gated signal,
where the gating may localize a reflection from a specific
interface between tissues. In some embodiments one or more features
may represent EM reflections of narrow band signals, described
earlier, like phase and amplitude. Optionally, one or more features
may represent information extracted from the external sensors.
[0208] As shown at 457, the extracted features may be used for
classifying the posture of the monitored user. In use, the current
posture of the monitored user may be found by a match between
signals received from the one or more EM transducers and/or an
analysis thereof and a value, a feature, a pattern, and/or a range
from a posture bank 458.
[0209] Optionally, the posture bank 458 includes a scale of values,
or a range of values, of exemplary features, and/or a combination
of features. Optionally, the each value or range in the scale is
associated with a tag of a selected posture. Optionally, during the
classification the identified features are matched with the class
values in the scale. The matching may be performed using known
matching methods. Optionally, each class value is generated using
known supervised and unsupervised learning algorithms. These
matching, clustering and/or classification algorithms are known in
the art and therefore not elaborated herein in greater detail.
[0210] Optionally, the posture classifier and grouping, 457, may
output soft decisions like the probability of each known posture to
be the current posture. Its output may be regarded as a feature for
any following classifier or estimator, such as the measuring
dielectric related properties block 459.
Features which are posture resilient can be used to relax the
demands from the posture detector and achieve improved dielectric
related properties and measurement sensitivity.
[0211] Such features are required to be highly sensitive to
measured tissue and/or organ dielectric related property, while
being less affected by other changes like posture changes. For
example, features extracted from differential signals, where
differential signals are referred to as the differences between two
or more signals measured during a short period of time as
elaborated above.
[0212] Different postures may be identified according to their
effect on the pattern of signals which are reflected from different
areas in the body. In one exemplary embodiment the wearable
monitoring apparatus 100 is used for measuring dielectric related
properties of the pulmonary tissues, for example as described in
the co filed application, and the extracted feature is the position
of the highest peak in a differential signal based on EM radiation
reflected from the thorax. In this exemplary embodiment, the
position of the peak is indicative of a relative position of the
muscle-lung boundary and therefore may be used for classifying the
posture of the user. Optionally, the amplitude of the same peak may
be used as a feature for measuring the dielectric related
properties of the lung, due to its sensitivity to the dielectric
coefficient of the lung.
[0213] Optionally, the posture detection based on the EM reflection
from an exit boundary between tissues. This may promote the
sensitivity and robustness for the measurement of the dielectric
coefficient of the measured tissue due to the propagation of the EM
radiation in and out the measured organ as well being reflected
from a reference tissue and/or organ. For example, measuring a
differential signal between the systolic and diastolic phases, and
analyzing the reflection from the lung-heart interface.
[0214] The posture detector is used for reducing changes to the EM
reflections due to dielectric related properties changes as a
consequence of postures changes. In some aspect of the invention
this functionality of the posture detection may be referred to as
posture compensation. In some embodiments of the present invention
the posture detection is based on a tissue model which has been
adapted according to the reflection signals. Optionally, the
expected reflection signal is used as a baseline and a difference
between the baseline and a signal which is based on the actual
measured reflections is analyzed to extract changes and/or values
which are related to the dielectric related properties of the
monitored tissue and/or organ dielectric related properties.
Optionally, the estimated model is calculated according to data
acquired by EM sensor a non EM sensor, such as an ultrasound
imager, computerized tomography (CT) and/or magnetic resonance
imager (MRI). The model is a simplified one-dimensional, a two
dimensional (2D), three dimensional (3D) model and/or four
dimensional model and so on and so forth. The estimated model may
be used for compensating for the posture effect prior to the
processing of the signals 455, and/or prior to the feature
extraction 456, and/or prior to the posture classification and
clustering block 457 and/or the measuring of dielectric related
properties 459. The model based posture compensation can reduce
posture effect on some or whole of the measured reflection signals,
therefore, improving posture detection statistics and reduces
posture variance.
[0215] In some embodiments of the present invention, as shown at
459 and described above, the wearable monitoring apparatus 100
measures and/or monitor dielectric related properties of internal
tissues and/or organs according to segments of a signal that is
based on reflections from tissue boundaries of the monitored tissue
and/or organ and/or other reference internal tissues and/or organs.
These signals may be monitored over a period and/or in multiple
discrete instances or in a single instance. As described above, the
posture classification 457 may be used for reducing and/or removing
the effect of the posture on the calculations which are based on
the dielectric related properties of internal tissues and/or
organs. In such a manner, alerts and/or the reports which are based
on the dielectric related properties, for example as shown at 460,
may take into account the effect of the posture of the user. In
such a manner, the number of false alerts may be reduced and the
reports may provide a more accurate and complete presentation of
the medical condition of the user. Optionally, user specific alert
are also generated according to the posture detection, for example
with respect to a treatment which is adjusted for the user. In such
an embodiment, the device may be used for monitoring the movement
of the user and to reduce harm that the user may cause to her, to
the progress of a given treatment, and/or for a monitoring process
by the biological probe.
[0216] The detection of the posture of the monitored user allows
taking into account the effect of the posture on the dielectric
related properties of the monitored pulmonary tissue, for example
by normalizing the values. In such an embodiment, the
aforementioned biological parameters reports and/or alerts do not
ignore the effect of the posture of the user on the measured
clinical parameters.
[0217] In some embodiments of the present invention, the posture
detection is used for guiding the monitored user to get into at an
optimal, or substantially optimal, posture before and/or during a
monitoring session. Optionally, the guiding may be used for
instructing the user to change posture in an automatic diagnosis
and/or treatment that is performed by the wearable monitoring
apparatus 100 and/or another monitoring apparatus. Optionally, the
MMI 207 implements an interactive process during which the user
tunes her posture until reaching the optimal, or substantially
optimal, posture and/or moves through several postures.
[0218] Optionally, the MMI 207 includes a minimal monitored user
interface, such as a single push button and/or minimal number of
audible and/or visual signals.
[0219] For brevity, all the features and embodiments which are
described herein with regard to the wearable monitoring apparatus
100 may be used by the posture detection unit when used for
detecting postures of users that wear other wearable elements
and/or probed by various biological probes.
[0220] Reference is now made to FIG. 6B, which is a flowchart 470
of a method for using EM radiation for detecting the placement,
misplacement and/or disengagement of a biological probe, such as
the wearable monitoring apparatus, according to some embodiments of
the present invention. FIG. 6B depicts, inter alia, exemplary modus
operandi of the placement unit 210, which is depicted in FIG. 3.
Blocks 450-461 are as described in FIG. 6A, with respective changes
for placement, misplacement, and/or disengagement monitoring and/or
detection. However FIG. 6B depicts few functions and/or processes
which are related to misplacement and/or disengagement of a
biological probe.
[0221] Optionally, the wearable monitoring apparatus 100 comprises
a placement unit 210 for monitoring the positioning of the wearable
monitoring apparatus 100 on the body of the user. Such a monitoring
allows detecting a displacement of the wearable monitoring
apparatus 100 and/or alerting the user and/or a remote caretaker
when the wearable monitoring apparatus 100 is displaced and/or
intentionally and/or unintentionally changes a position.
[0222] It should be noted that such a placement unit 210 may be
used for monitoring placement and/or displacement of various
monitoring and therapeutic devices, such as imaging modalities, for
example ultrasound imaging modalities, stationary and/or mobile
biological probes, and/or any other monitoring device which the
positioning thereof on the body of the patient has an effect on the
receptions and/or outputs thereof. In such an embodiment, the
placement unit 210 comprises a memory element, such as the memory
element which is depicted in FIG. 3 and described above, for
storing one or more reference values each indicative of exemplary
reflection of EM radiations delivered to the monitored internal
tissue of the user and/or one or more exemplary dielectric related
properties. Optionally, the reference values are stored in a
positioning bank, for example as shown at 472. Such reference
values, which are optionally ranges of values, represent the values
which are supposed to be reflected from the monitored tissue. The
placement unit 210 comprises and/or connected to one or more EM
which deliver, from the monitored wearable element, EM radiation
and intercept the actual reflection thereof. The placement unit 210
comprises processing unit and/or configured to use the processing
unit of the monitored wearable device. The processing unit is used
for identifying and/or classifying the misplacement, placement,
and/or disengagement, as shown at 471, optionally by comparing
between the reference value and the actual reflection. For brevity,
all the features and embodiments which are described herein with
regard to the wearable monitoring apparatus 100 may be used by the
placement unit 210 when used for monitoring the placement and/or
displacement of other wearable elements and/or biological
probes.
[0223] Optionally, the placement unit 210 is used for monitoring
the initial placement of the wearable monitoring apparatus 100.
Optionally, the placement unit 210 is used for monitoring the
positioning in a periodic or continuous manner. Optionally, as
depicted in 460 the placement unit 210 is designed for alerting the
user and/or a medical center when disengagement and/or an improper
functioning of the wearable monitoring apparatus 100 are detected.
Such an improper functioning may be an outcome of a low power, a
system failure, and/or corrupted and/or unintelligible readings of
the one or more front end sensors. For example, if disengagement is
detected, the MMI 207 is instructed, optionally automatically, to
alert to the user and/or a medical center. Optionally terminate
other functionalities of the device, such as transmission and/or
reception shut down. This functionality enables avoiding undesired
EM emissions to air and a situation in which the device is not
properly coupled to the body. If the placer identifies a suspicious
change in reflection it may terminate transmission sessions or
reduce power to the minimum required for detecting reflections from
layers which are positioned in proximity to the antenna. When the
reflection from these layers matches to an expected reflection, the
transmission power may be raised gradually.
[0224] The placement, misplacement and/or disengagement detection,
which may be referred to herein, for brevity, as placement
detection, is based on the detection of an unexpected change and/or
an irregular pattern. Optionally, one or more control patterns
and/or values are defined as features in 456, in order to allow the
monitoring of the disengagement detection.
[0225] Optionally, the disengagement is detected when the pattern
of features extracted from the received reflections from the front
end sensors 204 substantially differ from the pattern of features
which is expected to be received at the position of the wearable
monitoring apparatus 100. As described above, the wearable
monitoring apparatus 100 is designed to be positioned in one or
more areas. The configuration of the wearable monitoring apparatus
100 allows the user and/or a caretaker to enter the position of the
wearable monitoring apparatus 100. This position may be used for
selecting a model, such as the wall chest model that is depicted
and described in the co filed patent application that is adapted
thereto.
[0226] In such an embodiment, the disengagement is detected if the
data which is received from the front end sensors 204 does not
match the adjusted model.
[0227] Optionally, the disengagement and/or misplacement is
detected when the data which is received from the front end sensors
204 does not express an expected physiological process, such as a
breathing cycle, the pace of the heart beats, and/or any other
process that have detectable effect on the backscatter of EM waves
which are emitted toward the front end sensors 204. For example,
when the front end sensors 204 are attached to the chest, it is
expected that the acquired signal is modulated by the breathing
cycle which affects the dielectric coefficients of the lung.
[0228] Optionally, the disengagement and/or misplacement are
detected when the data which is received does not match a set of
reference records. In such an embodiment a set of reference records
is recorded, automatically and/or manually, after a proper
positioning of the wearable monitoring apparatus 100. The recorded
set of reference records is used for generating a reference pattern
that a deviation therefrom may be used for detecting
disengagement.
[0229] Optionally, the disengagement and/or misplacement are
detected when the data which is received does not match a
predefined range of values defined for each feature.
[0230] Optionally, the placement unit 210 is designed to report the
positioning of the wearable monitoring apparatus 100 and/or the
accuracy of the positioning of the wearable monitoring apparatus
100 to a remote client and/or server, for example using the
aforementioned technical communication channels, which are
described in relation to FIG. 2.
[0231] Optionally, the placement unit 210 estimates the quality of
the positioning in reference to prior measurements recorded in
memory or expected reflections. It may measure specific features
and compare them to the references or the actual measurement. It
then notifies the user and the algorithm of its findings.
[0232] A manual search for the correct position may include sliding
the device in different directions on the body until a fixed visual
and/or audible is heard.
Optionally, the placement unit 210 is connected to a mechanical
adjustment unit for automatically changing the position of the
wearable monitoring apparatus 100, the one or more transducers
thereof and/or any other biological probe, in relation to the body
of the user. The mechanical adjustment unit may include an
actuation unit that comprises one or more motors, gearwheels, and
ratchets for automatically adjusting the extended strips, and/or
any other attachment elements which are connected to the wearable
monitoring apparatus 100.
[0233] In some embodiments of the present invention, the monitoring
is performed by placing the apparatus for short period repetitive
monitoring sessions, for example a monitoring session of 5 minute
measurement a once, twice, and or three times a day.
[0234] It should be noted that the posture and/or the engagement,
placement, and/or misplacement processes may be used during the
calculation of values which are related to intervening tissues, for
example for normalizing their values.
[0235] In some embodiments of the present invention, the monitoring
apparatus is designed as disposable device which is designed to
replace and/or being replaced by a similar monitoring apparatus
and/or with a placement unit that allows repositioning it after
performing a maintenance activity, such as replacing a battery
and/or cleansing. In such embodiments, the monitoring apparatus is
designed to be placed and/or replaced, optionally a number of
times, in a predefined position in relation to a reference internal
tissue of the body of the user. In some embodiments, the monitoring
apparatus may be wearable, as shown at 100, and/or designed to be
taken off intermittently, for example, for convenience reasons
and/or for allowing the replacement and/or fixing of a component
due to wearing-off of the package, an adhering material used for
attaching the monitoring apparatus or a portion thereof to the
body, and/or a battery. As described above, the functionality,
configuration, and/or use case of the monitoring device may depend
also on user posture and/or internal tissue position. For example,
a biological sensor such as the EM pulmonary content fluid sensor
described in herein and in the co-filed patent application.
[0236] During a placement processing, the posture detection unit
may use prior posture positioning data, optionally stored as
records of the aforementioned posture bank 458, as reference data
indicative of the position to which the posture detection unit
should be replaced.
[0237] Optionally, the placement unit may detect a misplacement of
the device after being worn, for example, due to movements of the
user and/or wearing off of the glue. Where the placement unit may
alert the device or the user upon misplacement and/or eliminate or
reduce radiating EM power so as to avoid interferences.
[0238] Optionally, the placement unit may be designed to receive
historical positioning data that is used as a reference point
during the placement and/or replacement process. The historical
positioning data may be received via a wireless and/or a wired
connection with a similar monitoring apparatus which is replaced by
the monitoring apparatus housing the placement unit and/or from a
information originating from the replaced monitoring apparatus
which has been saved in the patient management unit or elsewhere
and/or from the position bank 472 which is depicted in FIG. 6B. In
such a manner, historical positioning data may be generated by the
similar and/or housing monitoring apparatus before the replacement
and forwarded to the placement unit to allow the placing and/or the
replacing of the monitoring apparatus as described above.
[0239] Reference is now made to FIGS. 7 and 8, which are schematic
illustrations of a wearable monitoring apparatus 100 with a
plurality of transducers for beaming and/or capturing EM waves,
according to some embodiments of the present invention. FIG. 7
depicts a wearable monitoring apparatus 100 with an array of
transducers 401 that is designed for transmitting EM signals
capturing its reflections from a plurality of different directions.
FIG. 8 depicts a wearable monitoring apparatus 100 with an array of
transducers 401 that includes separate transducers for capturing
reflections from the tissues 405 and separate transducers for
transmitting EM waves toward the tissues 406. The different
elements may be located in proximity to one another or spread over
different locations, in a similar manner the elements can have the
same pointing direction or can have different pointing directions.
For example, one antenna element may be placed on the back of the
user, another on the side and third on the front of the user
thorax. In the group of antenna elements which are depicted in
FIGS. 7 and 8 the relative phases of the respective signals feeding
the antenna elements are varied in such a manner that the effective
radiation power of the phased-array is reinforced in a specific
internal area of the user's body, for example in the pulmonary
tissues of the user 101, and optionally suppressed in other
directions. In an equivalent manner, the phases of the received
signals from the different antenna elements may be combined to
focus the elements on a specific internal location. As described
above, reflections from the pulmonary tissue may be calibrated
according to the reflections from reference tissues, for example
increasing the received reflected power from the muscle-to-lung
interface, by increasing the inflate-deflate differential signal on
the lung gating. Any or all of the transmission and/or reception of
the EM signals can be adjusted jointly or separately to maximize
the described lung reflection.
[0240] By using multiple transducers the time/space separation may
be improved. For example, different antenna elements are designed
to be focused on reception and/or transmission in different
directions, where the interception of the transmission and
reception areas of focus are strongly emphasized respective to
other areas, so as to improve isolation from internal weaker
signals from strong reflection which may or may not overlap in
time.
[0241] Optionally, the array of transducers 401 comprises
transmitting and intercepting antenna elements. By separating
between transmitting and intercepting antenna elements,
transmission and reception isolation is increased. The improved
isolation increases sensitivity to weaker reflections from inner
tissues and/or organs, by reducing the reflections received from
layers which are in proximity to the transmitting antenna elements.
Reception of strong reflections from the first layers in proximity
to the transmitting antenna elements, such as skin and fat, are
reduced or eliminated in separated receiving antenna elements,
therefore achieving improved sensitivity to weaker signals from
deeper layers.
[0242] The separation of different reflection according to
reflected areas allows overcoming microwave monitoring
difficulties. For example, when two or more reflections from
different areas are simultaneously, or substantially
simultaneously, but overlap in time of reception, physiological
phenomenon may be masked for example due to mutual cancellation.
Focusing the reception and/or transmission to different areas may
isolate the two or more reflections from each other and enable
efficient extraction of the physiological phenomenon. Optionally,
multiple antenna elements and/or multiple transducers are used to
reduce irregularities, such as noises, disturbances and/or
interferences, which are intercepted in part of the antenna element
and/or transducers. Such irregularities may be an outcome of power
source instability, noise-figure changes, and changes in the
attenuation of the electromagnetic waves which are caused by
fluctuations in the gap between the antenna and the skin. Using
multi antenna elements and/or multi transducers allows identifying
and/or reducing and/or factoring out noises and disturbances. By
separately tracking reflections from different sub areas of the
monitored tissue and/or organ, noises and disturbances may be
separated, for example by detecting similar irregularities in
reflections from different tissues.
[0243] In such cases array of transducers 401 may separate the
reflection.
[0244] The wearable monitoring apparatus 100 may direct some or all
of the transducers to capture reflection from a certain tissue or
split it over separate tissues or connective tissues.
[0245] In some embodiments of the present invention, the wearable
monitoring apparatus 100 implements one or more gating techniques
for gating the reflected EM waves, for example as described in the
co filed patent application. Such gating techniques allow
synchronizing the monitoring with cyclic physiological processes,
such as the breathing cycle and the pace of the heart beats. As
described in the co filed patent application, the time gating
techniques may be used for focusing on reflections from the
pulmonary tissue. However, time gating may not separate reflections
if the reflections are adjacent to one another on the time axis.
Optionally, the spatial separation is improved by beaming the
microwave from one transducer and capturing the reflections from
another transducer. Optionally, the wearable monitoring apparatus,
for example as described in FIGS. 7 and 8, beams EM waves from one
of the antenna elements 401 and captures the reflections thereof
from one or more other antenna elements. Optionally, the beamed EM
waves are directed to form a phased-array antenna with directivity
pointing with some angle to the desired reflection 405. In such a
manner, the backscattering radiation is scattered in an angle which
is relatively wide, for example in relation to the backscattering
radiation that is beamed and captured by the same transducer.
Optionally, where beams of the transmitting and intercepting
transducers do not overlap, reflections resulting from tissue
transitions are received off-beam and attenuated. In such a manner,
the reflections from the borders of the tissue are not attenuated
and the desired reflections are kept in there original
intensity.
[0246] Optionally, one or more intercepting transducers are focused
on the reference tissue while other intercepting transducers are
focused on the desired pulmonary tissue. Optionally, two or more
different intercepting transducers are focused on one or more
reflection points.
[0247] As described above, the reflected EM waves may be gated
during and/or before the analysis process. Using multiple
transmitters, as depicted in FIGS. 7 and 8, may be used for
increasing the separation between different reflections which are
intercepted by the wearable monitoring apparatus. Optionally, the
beams a microwave is a CW, as described above. Optionally, the CW
is a chirp in which the frequency increases or decreases with time.
In such an embodiment, multiple-antenna-elements may be used to
transmit and receive the CWs and still have focusing capabilities.
For example, one radiating transducer may distribute its radiation
across a wide area while the reception is phased by several
transducers. In another example, a phased-array forms several beams
which are directed to different locations. Optionally, some or more
of the transducers includes phase shifters which are designed to
point to the desired location. The positioning of a phase-shifter
may be adjusted according to the requirements of the reference
chest model. Optionally, the phase-shifter is dynamically adjusted
according to the analysis of the received reflections. For example,
the phase-shifter may be directed to intercept a fat-to-muscle
reflection by identifying a strong pass and an opposite-signed
reflection from muscle-to-lung.
[0248] Optionally, phase-shifters are used for maximizing the
amplitude of the waveform of the received reflections. The waveform
variance may be affected by the breathing cycle and/or by the
dielectric changes of the pulmonary tissue. For example, the
phase-shifters are used for maximizing the amplitude of periodic
signals such as the signal that reflects the breathing process or
the heart beating process.
The intensification of the waveform variance may be used for
emphasizing in the small changes in the dielectric coefficients of
the pulmonary tissue and for focusing the beam on the pulmonary
tissue and/or on lungs transitions. Maximizing the waveform
variance resulting from breathing cycles may be measured by
correlating between the received reflections and separate
measurements of the monitored user breathing.
[0249] In some embodiments of the present invention, the wearable
monitoring apparatus 100 is adjusted according to the physical and
anatomical condition and/or medical history of the monitored user.
Optionally, the configuration is performed, either automatically
and/or manually, after the wearable monitoring apparatus 100 is
attached to user's body. Optionally, a configuration process is
associated with the initial placement of the wearable monitoring
apparatus 100. The automatic configuration may be based on
measurements which are preformed in real time. Optionally a
semi-manual configuration process is used where the user and/or the
treating caretaker are required to enter medical data and/or to
select a monitoring pattern and\or define various thresholds for
notifications of either the medical treating team and/or the user.
Optionally, the area of the receiving and/or transmitting element
may be adapted to the physiology of the user. If the user has
relatively thick layers of fat, larger antenna element or elements
may be used in order to increase the sensitivity and the effective
monitoring range. Optionally, the transducer may be defined to
transmit more energy in order to improve the sensitivity of the
wearable monitoring apparatus.
[0250] Reference is now made, once again, to FIG. 2. In some
embodiments of the present invention, a management node, such as
the medical data center 155 and/or the patient management unit
allows the production of statistical reports, such as financial
and/or usage related reports. In such an embodiment the data about
the risks and/or the medical condition of the users may be combined
with billing and/or accounting data which is related to the user.
The medical data center 155 may contain usage and/or statistics
data that may be accessed by administrative system users for
billing, auditing and the like. For example, a medical insurance
company may use usage statistics to ensure that user comply with
medical treatment instructions they receive and/or with a
requirement to wear the wearable monitoring apparatus 100.
[0251] Optionally, the system 150 may be integrated with a medical
data system, such as a radiology information system (RIS), an
electronic medical record (EMR), and/or a personal health record
(PHR). In such an embodiment, the system 150 may streaming the
aforementioned data about the monitored users to the medical data
system. Optionally, the integration may support records, in
standards such as health level 7 (HL7), general electric (GE) EMR
format, EPIC EMR format, and Google.TM. health format. In such an
embodiment, data which is related to the placement of the wearable
monitoring apparatus and/or any other wearable biological probe may
be used for updating insurance rate and/or in a manner that
improves patient compliance rates.
[0252] Optionally, the system 150 may include a device
identification module which is configured for Identifying a match
between the outputs of a certain wearable monitoring apparatus 100
and the monitored user that wears it. Such identification may be
used for preventing from outputs of a device that is worn by a
first user to be associated with records which related to a second
user. For example, the wearable monitoring apparatus 100 may
identify the user using characteristics of the measured signal
unique to him. In the case of a mismatch the system will alert.
[0253] Optionally, the system 150 may include a device
authorization and activation module which is configured for
identifying and authenticating a device before it is allowed to be
connected to the system and/or activated and/or enabled for
activation. Authentication can be based on unique information
stored in the wearable monitoring apparatus 100, Authentication
information may be valid for a limited duration and/or number of
activations. Such a module reduces fraud where a non-original
wearable monitoring apparatus is used within the system.
It is expected that during the life of a patent maturing from this
application many relevant methods and systems will be developed and
the scope of the term a microwave, a transmitter, a receiver,
and/or a device are intended to include all such new technologies a
priori.
[0254] As used herein the term "about" refers to .+-.10%.
[0255] The terms "comprises", "comprising", "includes",
"including", "having" and their conjugates mean "including but not
limited to".
[0256] The term "consisting of means "including and limited
to".
[0257] The term "consisting essentially of" means that the
composition, method or structure may include additional
ingredients, steps and/or parts, but only if the additional
ingredients, steps and/or parts do not materially alter the basic
and novel characteristics of the claimed composition, method or
structure.
[0258] As used herein, the singular form "a", "an" and "the"
include plural references unless the context clearly dictates
otherwise. For example, the term "a compound" or "at least one
compound" may include a plurality of compounds, including mixtures
thereof.
[0259] Throughout this application, various embodiments of this
invention may be presented in a range format. It should be
understood that the description in range format is merely for
convenience and brevity and should not be construed as an
inflexible limitation on the scope of the invention. Accordingly,
the description of a range should be considered to have
specifically disclosed all the possible subranges as well as
individual numerical values within that range. For example,
description of a range such as from 1 to 6 should be considered to
have specifically disclosed subranges such as from 1 to 3, from 1
to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as
well as individual numbers within that range, for example, 1, 2, 3,
4, 5, and 6. This applies regardless of the breadth of the
range.
[0260] Whenever a numerical range is indicated herein, it is meant
to include any cited numeral (fractional or integral) within the
indicated range. The phrases "ranging/ranges between" a first
indicate number and a second indicate number and "ranging/ranges
from" a first indicate number "to" a second indicate number are
used herein interchangeably and are meant to include the first and
second indicated numbers and all the fractional and integral
numerals therebetween.
[0261] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention, which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable subcombination
or as suitable in any other described embodiment of the invention.
Certain features described in the context of various embodiments
are not to be considered essential features of those embodiments,
unless the embodiment is inoperative without those elements.
[0262] Although the invention has been described in conjunction
with specific embodiments thereof, it is evident that many
alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the spirit and broad scope of the appended claims.
[0263] All publications, patents and patent applications mentioned
in this specification are herein incorporated in their entirety by
reference into the specification, to the same extent as if each
individual publication, patent or patent application was
specifically and individually indicated to be incorporated herein
by reference. In addition, citation or identification of any
reference in this application shall not be construed as an
admission that such reference is available as prior art to the
present invention. To the extent that section headings are used,
they should not be construed as necessarily limiting.
* * * * *